,,ii #aaf? ,,congress #b;d ,session ,s4 #daii ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #b1 #bjbj,mr4 ,grassley 7= himself1 ,mr4 ,portman1 ,mr4 ,cassidy1 ,mr4 ,da9es1 ,ms4 ,coll9s1 ,ms4 ,ern/1 ,ms4 ,mc,sally1 ,mr4 ,braun1 ,mrs4 ,hyde-,smi?1 & ,ms4 ,murk[ski7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d titles ,,xi1 ,,xviii1 & ,,xix ( ! ,social ,security ,act to l[] prescription drug prices 9 ! ,m$ic>e & ,m$icaid programs1 to improve transp>5cy relat$ to ph>maceutical prices & transactions1 to l[] pati5ts' out-(-pocket co/s1 & to ensure acc\ntability to taxpay]s1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,prescription ,drug ,pric+ ,r$uction ,act ( #bjbj4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,medicare,subtitle ,a--,"p ,b,sec4 #aja4 ,improv+ manufactur]s' report+ ( av]age sales prices to set accurate paym5t rates4,sec4 #ajb4 ,inclusion ( value ( c\pons 9 det]m9ation ( av]age sales price = drugs & biologicals "u ,m$ic>e "p ,b4,sec4 #ajc4 ,paym5t = biosimil> biological products dur+ initial p]iod4,sec4 #ajd4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = biosimil> biological products4,sec4 #aje4 ,improvem5ts to ,m$ic>e site-(-s]vice transp>5cy4,sec4 #ajf4 ,m$ic>e "p ,b rebate by manufactur]s = drugs or biologicals ) prices increas+ fa/] ?an inflation4,sec4 #ajg4 ,requir+ manufactur]s ( c]ta9 s+le-dose conta9] or s+le-use package drugs payable "u "p ,b ( ! ,m$ic>e program to provide refunds ) respect to disc>d$ am\nts ( su* drugs4,sec4 #ajh4 ,,hhs ,inspector ,g5]al /udy & report on bona fide s]vice fees4,sec4 #aji4 ,e/abli%m5t ( maximum add-on paym5t = drugs & biologicals4,sec4 #aaj4 ,treatm5t ( drug adm9i/ration s]vices furni%$ by c]ta9 except$ (f-campus outpati5t dep>tm5ts ( a provid]4,sec4 #aaa4 ,,gao /udy & report on av]age sales price4,sec4 #aab4 ,au?ority to use alt]native paym5t = drugs & biologicals to prev5t pot5tial drug %ortages4,subtitle ,b--,"p ,d,sec4 #aba4 ,m$ic>e "p ,d mod]nization r$esign4,sec4 #aba;,a4 ,maximum mon?ly cap on co/-%>+ paym5ts "u prescription drug plans & ,,ma-,,pd plans4,sec4 #aba;,b4 ,requir+ ph>macy-negotiat$ price concessions1 paym5t1 & fees to be includ$ 9 negotiat$ prices at ! po9t-(-sale "u "p ,d ( ! m$ic>e program4,sec4 #abb4 ,provid+ ! ,m$ic>e ,paym5t ,advisory ,commission & ,m$icaid & ,,*ip ,paym5t & ,access ,commission ) access to c]ta9 drug paym5t in=mation1 includ+ c]ta9 rebate in=mation4,sec4 #abc4 ,public disclosure ( drug disc\nts & o!r ph>macy b5efit manag] 7,,pbm7 provisions4,sec4 #abd4 ,public disclosure ( direct & indirect remun]ation review & audit results4,sec4 #abe4 ,increas+ ! use ( real-"t b5efit tools to l[] b5efici>y co/s4,sec4 #abf4 ,improvem5ts to provision ( p>ts ,a & ,b claims data to prescription drug plans4,sec4 #abg4 ,p]man5tly au?orize a successful pilot on retroactive ,m$ic>e "p ,d cov]age = l[-income b5efici>ies4,sec4 #abh4 ,m$ic>e "p ,d rebate by manufactur]s = c]ta9 drugs ) prices increas+ fa/] ?an inflation4,sec4 #abi4 ,prohibit+ br&+ on "p ,d b5efit c>ds4,sec4 #acj4 ,requir+ prescription drug plans & ,,ma-,,pd plans to report pot5tial fraud1 wa/e1 & abuse to ! ,secret>y ( ,,hhs4,sec4 #aca4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4,sec4 #acb4 ,addition ( new measures bas$ on access to biosimil> biological products to ! #e-/> rat+ sy/em "u ,m$ic>e ,advantage4,sec4 #acc4 ,fairness 9 ! calculation ( ! "p ,d premium4,sec4 #acd4 ,,hhs /udy & report on ! influ5ce ( ph>maceutical manufactur] ?ird-p>ty reimbursem5t hubs on heal? c>e provid]s :o prescribe _! drugs & biologicals4,subtitle ,c--,miscellaneous,sec4 #ada4 ,drug manufactur] price transp>5cy4,sec4 #adb4 ,/r5g!n+ & exp&+ ph>macy b5efit manag]s transp>5cy requirem5ts4,sec4 #adc4 ,prescription drug pric+ da%bo>ds4,sec4 #add4 ,improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4,sec4 #ade4 ,pati5t consultation 9 ,m$ic>e national & local cov]age det]m9ations 9 ord] to mitigate b>ri]s to inclusion ( su* p]spectives4,sec4 #adf4 ,,gao /udy on increases to ,m$ic>e & ,m$icaid sp5d+ due to copaym5t c\pons & o!r pati5t assi/ance programs4,sec4 #adg4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d4,sec4 #adh4 ,tak+ /eps to fulfill treaty obligations to tribal communities4,,title ,,ii--,m$icaid drug pric+ reforms,sec4 #bja4 ,m$icaid ph>macy & !rapeutics committee improvem5ts4,sec4 #bjb4 ,improv+ report+ requirem5ts & develop+ /&>ds = ! use ( drug use review bo>ds 9 ,/ate ,m$icaid programs4,sec4 #bjc4 ,,gao report on conflicts ( int]e/ 9 ,/ate ,m$icaid program drug use review bo>ds & ph>macy & !rapeutics 7,p,t7 committees4,sec4 #bjd4 ,ensur+ ! accuracy ( manufactur] price & drug product in=mation "u ! ,m$icaid drug rebate program4,sec4 #bje4 ,apply+ ,m$icaid drug rebate requirem5t to drugs provid$ z "p ( outpati5t hospital s]vices4,sec4 #bjf4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid4,sec4 #bjg4 ,t-,,msis drug data analytics reports4,sec4 #bjh4 ,risk-%>+ value-bas$ paym5t agreem5ts = cov]$ outpati5t drugs "u ,m$icaid4,sec4 #bji4 ,modification ( maximum rebate am\nt "u ,m$icaid drug rebate program4 ,i ,m$ic>e ,a ,"p ,b #aja4 ,improv+ manufactur]s' report+ ( av]age sales prices to set accurate paym5t rates 7a7 ,9 g5]al ,section #ahdg;,a7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7f77 is am5d$-- 7#a7 by /rik+ price4--,= requirem5ts & ins]t+ 8price4-- 7#a7 ,9 g5]al ,= requirem5ts 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,manufactur]s t d n h a rebate agreem5t 7,a7 ,9 g5]al ,= cal5d> qu>t]s beg9n+ ) ! second cal5d> qu>t] aft] ! date ( ! enactm5t ( ?is p>agraph1 ! foll[+ provisions %all apply ) respect to a manufactur] ( an applicable drug or biological 7z def9$ 9 subp>agraph 7,b77 t has n ent]$ into & does n h 9 effect a rebate agreem5t describ$ 9 subsection 7b7 ( section #aibg 9 ! same mann] & to ! same ext5t z su* provisions apply ) respect to a manufactur] t has ent]$ into & has 9 effect su* a rebate agreem5t3 7i7 ,section #aibg7;b77#c77;,a77iii74 7ii7 ,subp>agraphs 7,b7 & 7,c7 7o!r ?an ! rebate agreem5t susp5sion describ$ 9 su* subp>agraph 7,c77 ( section #aibg7;b77#c74 7,b7 ,applicable drug or biological def9$ ,= purposes ( subp>agraph 7,a71 ! t]m applicable drug or biological means a drug or biological describ$ 9 subp>agraph 7,c71 7,e71 or 7,g7 ( section #ahdb7o77#a7 or 9 section #ahha7;b77#ad77;,b7 t is payable "u ?is "p4 ,= purposes ( apply+ ?is p>agraph1 a drug or biological describ$ 9 ! previ\s s5t5ce includes an item1 s]vice1 supply1 or product t is payable "u ?is "p z a drug or biological4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,title ,,xviii ,section #ahdg;,a7b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77 is am5d$-- 7,a7 9 p>agraph 7#b77;,a71 by ins]t+ or subsection 7f77#b71 z applicable aft] "u section #aibg7;b77#c77;,a77iii72 & 7,b7 9 ea* ( p>agraphs 7#c7 & 7#f77;,a71 9 ! matt] prec$+ subp>agraph 7,a7 & clause 7i71 respectively1 by ins]t+ or subsection 7f77#b71 z applicable1 aft] "u section #aibg7;b77#c77;,a77iii74 7#b7 ,title ,,xix ,section #aibg7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$-- 7,a7 9 subp>agraph 7,a71 9 ! flu% matt] foll[+ clause 7iv71 by ins]t+ or section #ahdg;,a7f77#b7 aft] ,in=mation report$ "u ?is subp>agraph2 & 7,b7 9 subp>agraph 7,d71 9 ! matt] prec$+ clause 7i71 by /rik+ or :olesal]s "u ?is p>agraph or "u & ins]t+ or :olesal]s "u ?is p>agraph1 "u section #ahdg;,a7f77#b71 or "u4 7#c7 ,te*nical correction ,section #aibg7;b77#c77;,a77iii7 ( su* ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is am5d$ by /rik+ section #ahha7;b77#ac77;,a77ii7 & ins]t+ section #ahha7;b77#ad77;,b74 #ajb4 ,inclusion ( value ( c\pons 9 det]m9ation ( av]age sales price = drugs & biologicals "u ,m$ic>e "p ,b ,section #ahdg;,a7c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77 is am5d$-- 7#a7 9 p>agraph 7#c7-- 7,a7 by /rik+ disc\nts4--,9 calculat+ & ins]t+ 8disc\nts to pur*as]s & c\pons provid$ to privately insur$ individuals4-- 7,a7 ,disc\nts to pur*as]s ,9 calculat+ 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,c\pons provid$ to r$uce co/-,%>+ ,= cal5d> qu>t]s beg9n+ on or aft] ,july #a1 #bjbb1 9 calculat+ ! manufactur]'s av]age sales price "u ?is subsection1 su* price %all include ! value 7z def9$ 9 p>agraph 7#f77;,j77 ( any c\pons provid$ "u a drug c\pon program ( a manufactur] 7z ^? t]ms are def9$ 9 subp>agraphs 7,k7 & 7,l71 respectively1 ( p>agraph 7#f774 2 & 7#b7 9 p>agraph 7#f71 by add+ at ! end ! foll[+ new subp>agraphs3 7,j7 ,value ,! t]m value means1 ) respect to a c\pon 7z def9$ 9 subp>agraph 7,k771 ! diff]5ce1 if any1 betwe5-- 7i7 ! am\nt ( any r$uction or elim9ation ( co/-%>+ or o!r out-(-pocket co/s describ$ 9 su* subp>agraph to a pati5t z a result ( ! use ( su* c\pon2 & 7ii7 any *>ge to ! pati5t = ! use ( su* c\pon4 7,k7 ,c\pon ,! t]m c\pon means any f9ancial support t is provid$ to a pati5t1 ei!r directly to ! pati5t or indirectly to ! pati5t ?r\gh a physician1 prescrib]1 ph>macy1 or o!r provid]1 "u a drug c\pon program ( a manufactur] 7z def9$ 9 subp>agraph 7,l77 t is us$ to r$uce or elim9ate co/-%>+ or o!r out-(-pocket co/s ( ! pati5t1 includ+ co/s relat$ to a d$uctible1 co9surance1 or copaym5t1 ) respect to a drug or biological1 includ+ a biosimil> biological product1 ( ! manufactur]4 7,l7 ,drug c\pon program 7i7 ,9 g5]al ,subject to clause 7ii71 ! t]m drug c\pon program means1 ) respect to a manufactur]1 a program ?r\gh :i* ! manufactur] provides c\pons to pati5ts z describ$ 9 subp>agraph 7,k74 7ii7 ,exclusions ,su* t]m does n include-- 7,i7 a pati5t assi/ance program op]at$ by a manufactur] t provides free or disc\nt$ drugs or biologicals1 includ+ biosimil> biological products1 7?r\gh 9-k9d donations7 to pati5ts ( l[ income2 or 7,,ii7 a contribution by a manufactur] to a nonpr(it or ,f\ndation t provides free or disc\nt$ drugs or biologicals1 includ+ biosimil> biological products1 7?r\gh 9-k9d donations7 to pati5ts ( l[ income4 4 #ajc4 ,paym5t = biosimil> biological products dur+ initial p]iod ,section #ahdg;,a7c77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#d77 is am5d$-- 7#a7 9 ea* ( subp>agraphs 7,a7 & 7,b71 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii71 respectively1 & mov+ su* subclauses #b ems to ! "r2 7#b7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii7 & mov+ su* clauses #b ems to ! "r2 7#c7 by /rik+ unavailable4--,9 ! case & ins]t+ 8unavailable4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 ! case 2 & 7#d7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,limitation on paym5t am\nt = biosimil> biological products dur+ initial p]iod ,9 ! case ( a biosimil> biological product furni%$ on or aft] ,janu>y #a1 #bjba1 9 lieu ( apply+ subp>agraph 7,a7 dur+ ! initial p]iod describ$ 9 su* subp>agraph ) respect to ! biosimil> biological product1 ! am\nt payable "u ?is section = ! biosimil> biological product is ! less] ( ! foll[+3 7i7 ,! am\nt det]m9$ "u clause 7ii7 ( su* subp>agraph = ! biosimil> biological product4 7ii7 ,! am\nt det]m9$ "u subsection 7b77#a77;,b7 = ! ref]5ce biological product4 4 #ajd4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = biosimil> biological products ,section #ahdg;,a7b77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#h77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & ind5t+ appropriately2 7#b7 by /rik+ product4--,! am\nt & ins]t+ ! foll[+3 8product4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! am\nt 2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,tempor>y paym5t increase = biosimil> biological products 7i7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjba1 9 ! case ( a biosimil> biological product describ$ 9 p>agraph 7#a77;,c7 t is furni%$ dur+ ! applicable #e-ye> p]iod = su* product1 ! am\nt specifi$ 9 ?is p>agraph = su* product is an am\nt equal to ! less] ( ! foll[+3 7,i7 ,! am\nt specifi$ 9 subp>agraph 7,a7 = su* product if clause 7ii7 ( su* subp>agraph 0 appli$ by sub/itut+ #h p]c5t = #f p]c5t4 7,,ii7 ,! am\nt det]m9$ "u subsection 7b77#a77;,b7 = ! ref]5ce biological product4 7ii7 ,applicable #e-ye> p]iod ,= purposes ( clause 7i71 ! applicable #e-ye> p]iod = a biosimil> biological product is-- 7,i7 9 ! case ( su* a product = :i* paym5t 0 made "u ?is p>agraph z ( ,decemb] #ca1 #bjbj1 ! #e-ye> p]iod beg9n+ on ,janu>y #a1 #bjba2 & 7,,ii7 9 ! case ( su* a product t is n describ$ 9 subclause 7,i71 ! #e-ye> p]iod beg9n+ on ! fir/ day ( ! fir/ cal5d> qu>t] 9 :i* paym5t 0 made = su* product "u ?is p>agraph4 4 #aje4 ,improvem5ts to ,m$ic>e site-(-s]vice transp>5cy ,section #ahcd7t7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7t77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! head+1 by /rik+ ,9 g5]al & ins]t+ ,site paym5t2 7,b7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ or to & ins]t+ 1 to2 7ii7 by ins]t+ 1 or to a physician = s]vices furni%$ 9 a physician's (fice aft] surgical c5t]2 & 7iii7 by ins]t+ 7or #bjbb ) respect to a physician = s]vices furni%$ 9 a physician's (fice7 aft] #bjah2 & 7,c7 9 subp>agraph 7,a7-- 7i7 by /rik+ & ! & ins]t+ 1 !2 & 7ii7 by ins]t+ 1 & ! physician fee s*$ule "u section #ahdh 7) respect to ! practice exp5se compon5t ( su* paym5t am\nt7 aft] su* section2 7#b7 by r$esignat+ p>agraphs 7#b7 ?r\gh 7#d7 & p>agraphs 7#c7 ?r\gh 7#e71 respectively2 & 7#c7 by ins]t+ aft] p>agraph 7#a7 ! foll[+ new p>agraph3 7#b7 ,physician paym5t ,beg9n+ 9 #bjbb1 ! ,secret>y may exp& ! in=mation includ$ on ! ,int]net website describ$ 9 p>agraph 7#a7 to include-- 7,a7 ! am\nt paid to a physician "u section #ahdh = an item or s]vice = ! sett+s describ$ 9 p>agraph 7#a72 & 7,b7 ! e/imat$ am\nt ( b5efici>y liability applicable to ! item or s]vice4 4 #ajf4 ,m$ic>e "p ,b rebate by manufactur]s = drugs or biologicals ) prices increas+ fa/] ?an inflation 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,rebate by manufactur]s = drugs or biologicals ) prices increas+ fa/] ?an inflation 7#a7 ,requirem5ts 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #f mon?s aft] ! end ( ea* rebate p]iod 7z def9$ 9 p>agraph 7#b77;,a77 beg9n+ on or aft] ,janu>y #a1 #bjbb1 ! ,secret>y %all1 = ea* rebatable drug 7z def9$ 9 p>agraph 7#b77;,b771 report to ea* manufactur] ( su* rebatable drug ! foll[+ = su* rebate p]iod3 7i7 ,in=mation on ! total numb] ( units ( ! bill+ & paym5t code describ$ 9 subp>agraph 7,a77i7 ( p>agraph 7#c7 ) respect to su* rebatable drug & rebate p]iod4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age sales price increase describ$ 9 subp>agraph 7,a77ii7 ( su* p>agraph = su* rebatable drug & rebate p]iod4 7iii7 ,! rebate am\nt specifi$ "u su* p>agraph = su* rebatable drug & rebate p]iod4 7,b7 ,manufactur] rebate 7i7 ,9 g5]al ,subject to clause 7ii71 = ea* rebate p]iod beg9n+ on or aft] ,janu>y #a1 #bjbb1 ! manufactur] ( a rebatable drug %all1 = su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation & rebate am\nt pursuant to subp>agraph 7,a7 = su* rebate p]iod1 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* rebate p]iod4 7ii7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u ?is subp>agraph ) respect to a rebatable drug t is li/$ on ! drug %ortage li/ ma9ta9$ by ! ,food & ,drug ,adm9i/ration pursuant to section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,c7 ,reque/ = reconsid]ation ,! ,secret>y %all e/abli% proc$ures "u :i* a manufactur] ( a rebatable drug may reque/ a reconsid]ation by ! ,secret>y ( ! rebate am\nt specifi$ "u p>agraph 7#c7 = su* rebatable drug & rebate p]iod1 z report$ to ! manufactur] pursuant to subp>agraph 7,a77iii74 7#b7 ,rebate p]iod & ,rebatable drug def9$ ,9 ?is subsection3 7,a7 ,rebate p]iod ,! t]m rebate p]iod means a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb4 7,b7 ,rebatable drug ,! t]m rebatable drug means a s+le s\rce drug or biological 7o!r ?an a biosimil> biological product7-- 7i7 describ$ 9 section #ahdb7o77#a77;,c7 = :i* ! paym5t am\nt is provid$ "u ?is section2 or 7ii7 = :i* paym5t is made sep>ately "u section #ahcc7;i7 or section #ahcc7t7 & = :i* ! paym5t am\nt is calculat$ bas$ on ! paym5t am\nt "u ?is section4 7#c7 ,rebate am\nt 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! am\nt specifi$ 9 ?is p>agraph = a rebatable drug assign$ to a bill+ & paym5t code = a rebate p]iod is1 subject to p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraph 7,b71 ! total numb] ( units ( ! bill+ & paym5t code = su* rebatable drug furni%$ dur+ ! rebate p]iod2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! am\nt det]m9$ "u subsection 7b77#d7 = su* rebatable drug dur+ ! rebate p]iod2 exce$s 7,,ii7 ! inflation-adju/$ base paym5t am\nt det]m9$ "u subp>agraph 7,c7 ( ?is p>agraph = su* rebatable drug dur+ ! rebate p]iod4 7,b7 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( units ( ! bill+ & paym5t code = rebatable drugs furni%$ dur+ a rebate p]iod %all n include units ) respect to :i* ! manufactur] provides a disc\nt "u ! program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or a rebate "u section #aibg4 7,c7 ,det]m9ation ( inflation-adju/$ paym5t am\nt ,! inflation-adju/$ paym5t am\nt det]m9$ "u ?is subp>agraph = a rebatable drug = a rebate p]iod is-- 7i7 ! am\nt det]m9$ "u subsection 7b77#d7 = su* rebatable drug 9 ! paym5t am\nt b5*m>k qu>t] 7z def9$ 9 subp>agraph 7,d772 increas$ by 7ii7 ! p]c5tage by :i* ! rebate p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,f77 = ! rebate p]iod exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,e774 7,d7 ,paym5t am\nt b5*m>k qu>t] ,! t]m paym5t am\nt b5*m>k qu>t] means ! cal5d> qu>t] beg9n+ ,july #a1 #bjai4 7,e7 ,b5*m>k p]iod ,,cpi-,u ,! t]m b5*m>k p]iod ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,july #bjai4 7,f7 ,rebate p]iod ,,cpi-,u ,! t]m rebate p]iod ,,cpi-,u means1 ) respect to a rebate p]iod1 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! la/ mon? ( ! cal5d> qu>t] t is two cal5d> qu>t]s prior to ! rebate p]iod4 7#d7 ,application to new drugs ,9 ! case ( a rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjai1 ! foll[+ %all apply3 7,a7 ,dur+ initial p]iod ,= qu>t]s dur+ ! initial p]iod 9 :i* ! paym5t am\nt = su* drug is det]m9$ us+ ! me?odology describ$ 9 subsection 7c77#d7-- 7i7 clause 7ii77,i7 ( p>agraph 7#c77;,a7 %all be appli$ z if ! ref]5ce to ! am\nt det]m9$ "u subsection 7b77#d71 7 a ref]5ce to ! :olesale acquisition co/ applicable "u subsection 7c77#d72 7ii7 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$-- 7,i7 z if ! ref]5ce to ! am\nt det]m9$ "u subsection 7b77#d71 7 a ref]5ce to ! :olesale acquisition co/ applicable "u subsection 7c77#d72 & 7,,ii7 z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! fir/ full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$2 & 7iii7 clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#d77;,e7 z if ! ref]5ce to ,july #bjai "u su* p>agraph 7 a ref]5ce to ! fir/ mon? ( ! fir/ full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$4 7,b7 ,aft] initial p]iod ,= qu>t]s beg9n+ aft] su* initial p]iod-- 7i7 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! fir/ full cal5d> qu>t] = :i* ! ,secret>y is able to compute an av]age sales price = ! rebatable drug2 & 7ii7 clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#d77;,e7 z if ! ref]5ce to ,july #bjai "u su* p>agraph 7 a ref]5ce to ! fir/ mon? ( ! fir/ full cal5d> qu>t] = :i* ! ,secret>y is able to compute an av]age sales price = ! rebatable drug4 7#e7 ,rebate deposits ,am\nts paid z rebates "u p>agraph 7#a77;,b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#f7 ,en=cem5t 7,a7 ,civil money p5alty 7i7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] t fails to comply ) ! requirem5ts "u p>agraph 7#a77;,b7 ) respect to provid+ a rebate = a rebatable drug = a rebate p]iod = ea* su* failure 9 an am\nt equal to ! sum (-- 7,i7 ! rebate am\nt specifi$ pursuant to p>agraph 7#c7 = su* drug = su* rebate p]iod2 & 7,,ii7 #be p]c5t ( su* am\nt4 7ii7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7,b7 ,no paym5t = manufactur]s :o fail to pay p5alty ,if ! manufactur] ( a rebatable drug fails to pay a civil money p5alty "u subp>agraph 7,a7 ) respect to ! failure to provide a rebate = a rebatable drug = a rebate p]iod by a date specifi$ by ! ,secret>y aft] ! imposition ( su* p5alty1 no paym5t %all be available "u ?is "p = su* rebatable drug = cal5d> qu>t]s beg9n+ on or aft] su* date until ! ,secret>y det]m9es ! manufactur] has paid ! p5alty due "u su* subp>agraph4 4 7b7 ,implem5tation ,section #ahdg;,a7g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;g77 is am5d$-- 7#a7 9 p>agraph 7#d71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 det]m9ation ( ! rebate am\nt = a rebatable drug "u p>agraph 7#c7 ( subsection 7h71 includ+ ) respect to a new drug pursuant to p>agraph 7#d7 ( su* subsection1 includ+-- 7,a7 a decision by ! ,secret>y ) respect to a reque/ = reconsid]ation "u p>agraph 7#a77;,c72 & 7,b7 ! det]m9ation (-- 7i7 ! total numb] ( units ( ! bill+ & paym5t code "u p>agraph 7#c77;,a77i72 & 7ii7 ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,c74 4 7c7 ,con=m+ am5dm5t to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is am5d$ by ins]t+ or subsection 7h7 aft] section #aibg4 #ajg4 ,requir+ manufactur]s ( c]ta9 s+le-dose conta9] or s+le-use package drugs payable "u "p ,b ( ! ,m$ic>e program to provide refunds ) respect to disc>d$ am\nts ( su* drugs ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-c;a71 z am5d$ by section #ajf1 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,refund = c]ta9 disc>d$ s+le-,dose conta9] or s+le-,use package drugs 7#a7 ,secret>ial provision ( in=mation 7,a7 ,9 g5]al ,= ea* cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 ! ,secret>y %all1 ) respect to a refundable s+le-dose conta9] or s+le-use package drug 7z def9$ 9 p>agraph 7#h771 report to ea* manufactur] 7z def9$ 9 subsection 7c77#f77;,a77 ( su* refundable s+le-dose conta9] or s+le-use package drug ! foll[+ = ! cal5d> qu>t]3 7i7 ,subject to subp>agraph 7,c71 in=mation on ! total numb] ( units ( ! bill+ & paym5t code ( su* drug1 if any1 t 7 disc>d$ dur+ su* qu>t]1 z det]m9$ us+ a me*anism su* z ! ,,jw modifi] us$ z ( ! date ( enactm5t ( ?is subsection 7or any su* successor modifi] t includes su* data z det]m9$ appropriate by ! ,secret>y74 7ii7 ,! refund am\nt t ! manufactur] is liable = pursuant to p>agraph 7#c74 7,b7 ,det]m9ation ( disc>d$ am\nts ,= purposes ( subp>agraph 7,a77i71 ) respect to a refundable s+le-dose conta9] or s+le-use package drug furni%$ dur+ a qu>t]1 ! am\nt ( su* drug t 0 disc>d$ %all be det]m9$ bas$ on ! am\nt ( su* drug t 0 unus$ & disc>d$ = ea* drug on ! date ( s]vice4 7,c7 ,exclusion ( units ( packag$ drugs ,! total numb] ( units ( ! bill+ & paym5t code ( a refundable s+le-dose conta9] or s+le-use package drug ( a manufactur] furni%$ dur+ a cal5d> qu>t] = purposes ( subp>agraph 7,a77i71 & ! det]m9ation ( ! e/imat$ total all[$ *>ges = ! drug 9 ! qu>t] = purposes ( p>agraph 7#c77;,a77ii71 %all n include su* units t are packag$ into ! paym5t am\nt = an item or s]vice & are n sep>ately payable4 7#b7 ,manufactur] requirem5t ,= ea* cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 ! manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug %all1 = su* drug1 provide to ! ,secret>y a refund t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* qu>t]4 7#c7 ,refund am\nt 7,a7 ,9 g5]al ,! am\nt ( ! refund specifi$ 9 ?is p>agraph is1 ) respect to a refundable s+le-dose conta9] or s+le-use package drug ( a manufactur] assign$ to a bill+ & paym5t code = a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 an am\nt equal to ! e/imat$ am\nt 7if any7 by :i*-- 7i7 ! product (-- 7,i7 ! total numb] ( units ( ! bill+ & paym5t code = su* drug t 7 disc>d$ dur+ su* qu>t] 7z det]m9$ "u p>agraph 7#a772 & 7,,ii7 7aa7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a s+le s\rce drug or biological1 ! am\nt det]m9$ = su* drug "u subsection 7b77#d72 or 7bb7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a biosimil> biological product1 ! av]age sales price det]m9$ "u subsection 7b77#h77;,a72 exce$s 7ii7 an am\nt equal to ! applicable p]c5tage 7z def9$ 9 subp>agraph 7,b77 ( ! e/imat$ total all[$ *>ges = su* drug dur+ ! qu>t]4 7,b7 ,applicable p]c5tage def9$ 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a77ii71 ! t]m applicable p]c5tage means-- 7,i7 subject to subclause 7,,ii71 #aj p]c5t2 & 7,,ii7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,i7 ( clause 7iii7 &1 if applicable1 a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,,ii7 ( su* clause1 a p]c5tage specifi$ by ! ,secret>y pursuant to clause 7ii74 7ii7 ,treatm5t ( drugs t require filtration or o!r unique circum/ances ,! ,secret>y1 ?r\gh notice & comm5t rulemak+-- 7,i7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,i7 ( clause 7iii71 %all increase ! applicable p]c5tage o!rwise applicable "u clause 7i77,i7 z det]m9$ appropriate by ! ,secret>y2 & 7,,ii7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 subclause 7,,ii7 ( clause 7iii71 may increase ! applicable p]c5tage o!rwise applicable "u clause 7i77,i7 z det]m9$ appropriate by ! ,secret>y4 7iii7 ,drug describ$ ,= purposes ( clause 7ii71 a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 ?is clause is ei!r ( ! foll[+3 7,i7 ,a refundable s+le-dose conta9] or s+le-use package drug = :i* prep>ation in/ructions requir$ & approv$ by ! ,commission] ( ! ,food & ,drug ,adm9i/ration include filtration dur+ ! drug prep>ation process1 prior to dilution & adm9i/ration1 & require t any unus$ portion ( su* drug aft] ! filtration process be disc>d$ aft] ! completion ( su* filtration process4 7,,ii7 ,any o!r refundable s+le-dose conta9] or s+le-use package drug t has unique circum/ances involv+ simil> loss ( product4 7#d7 ,frequ5cy ,am\nts requir$ to be refund$ pursuant to p>agraph 7#b7 %all be paid 9 regul> int]vals 7z det]m9$ appropriate by ! ,secret>y74 7#e7 ,refund deposits ,am\nts paid z refunds pursuant to p>agraph 7#b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#f7 ,en=cem5t 7,a7 ,audits 7i7 ,manufactur] audits ,ea* manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug t is requir$ to provide a refund "u ?is subsection %all be subject to p]iodic audit ) respect to su* drug & su* refunds by ! ,secret>y4 7ii7 ,provid] audits ,! ,secret>y %all conduct p]iodic audits ( claims submitt$ "u ?is "p ) respect to refundable s+le-dose conta9] or s+le-use package drugs 9 accordance ) ! au?ority "u section #ahcc7;e7 to ensure compliance ) ! requirem5ts applicable "u ?is subsection4 7,b7 ,civil money p5alty 7i7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] ( a refundable s+le-dose conta9] or s+le-use package drug :o has fail$ to comply ) ! requirem5t "u p>agraph 7#b7 = su* drug = a cal5d> qu>t] 9 an am\nt equal to ! sum (-- 7,i7 ! am\nt t ! manufactur] w\ld h paid "u su* p>agraph ) respect to su* drug = su* qu>t]2 & 7,,ii7 #be p]c5t ( su* am\nt4 7ii7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7#g7 ,implem5tation ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+4 7#h7 ,def9ition ( refundable s+le-dose conta9] or s+le-use package drug 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 9 ?is subsection1 ! t]m refundable s+le-dose conta9] or s+le-use package drug means a s+le s\rce drug or biological 7z def9$ 9 section #ahdg;,a7c77#f77;,d77 or a biosimil> biological product 7z def9$ 9 section #ahdg;,a7c77#f77;,h77 = :i* paym5t is e/abli%$ "u ?is "p & t is furni%$ f a s+le-dose conta9] or s+le-use package4 7,b7 ,exclusions ,! t]m refundable s+le-dose conta9] or s+le-use package drug does n include a drug or biological t is ei!r a radioph>maceutical or an imag+ ag5t4 4 #ajh4 ,,hhs ,inspector ,g5]al /udy & report on bona fide s]vice fees 7a7 ,/udy ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,inspector ,g5]al7 %all conduct a /udy on ! effect ( ! use ( bona fide s]vice fee contract+ arrangem5ts by drug manufactur]s & o!r entities on ,m$ic>e paym5ts = drugs & biologicals furni%$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq474 ,su* /udy %all include an analysis (-- 7#a7 ! v>i\s types ( entities t ent] into contract+ arrangem5ts t use bona fide s]vice fees1 su* z gr\p pur*as+ organizations1 :olesal]s1 provid]s1 & ph>macies2 7#b7 ! v>i\s types ( bona fide s]vice fee contract+ arrangem5ts us$ by su* entities2 7#c7 ! types ( s]vices t are paid = ?r\gh su* arrangem5ts2 7#d7 :e!r manufactur]s def9e bona fide s]vice fees diff]5tly across diff]5t entities2 7#e7 h[ su* arrangem5ts are /ructur$2 7#f7 :e!r ! /ructure or use ( su* arrangem5ts has *ang$ ov] "t2 7#g7 ! ext5t1 if any1 to :i* !re is consi/5cy across manufactur]s 9 :at !y consid] to be a bona fide s]vice fee z oppos$ to a disc\nt or rebate t %\ld be exclud$ f ! det]m9ation ( av]age sales price pursuant to ! me?odology "u section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a72 7#h7 ! ov]all magnitude ( bona fide s]vice fees2 7#i7 :at %>e ( bona fide s]vice fees are paid to v>i\s entities2 7#aj7 h[ ! magnitude ( bona fide s]vice fees comp>es to o!r fees & rebates t are includ$ 9 ! det]m9ation ( av]age sales price2 7#aa7 :e!r &1 if s1 h[ mu*1 ! magnitude ( bona fide s]vice fees has gr[n ov] "t & h[ su* gr[? comp>es to gr[? 9 ! magnitude ( o!r fees & rebates2 & 7#ab7 :at %>e ( bona fide s]vice fees are bas$ on a p]c5tage ( sales4 7b7 ,report ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,inspector ,g5]al %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,inspector ,g5]al det]m9es appropriate4 #aji4 ,e/abli%m5t ( maximum add-on paym5t = drugs & biologicals 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraph 7#g7 & ins]t+ p>agraphs 7#g7 & 7#i72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,maximum add-on paym5t am\nt 7,a7 ,9 g5]al ,9 det]m9+ ! paym5t am\nt "u ! provisions ( subp>agraph 7,a71 7,b71 or 7,c7 ( p>agraph 7#a7 ( ?is subsection1 subsection 7c77#d77;,a77ii71 or subsection 7d77#c77;,c7 = a drug or biological furni%$ on or aft] ,janu>y #a1 #bjbb1 if ! applicable add-on paym5t 7z def9$ 9 subp>agraph 7,b77 = ea* drug or biological on a claim = a date ( s]vice exce$s ! maximum add-on paym5t am\nt specifi$ "u subp>agraph 7,c7 = ! drug or biological1 !n ! paym5t am\nt o!rwise det]m9$ = ! drug or biological "u ^? provisions1 z applicable1 %all be r$uc$ by ! am\nt ( su* excess4 7,b7 ,applicable add-on paym5t def9$ ,9 ?is p>agraph1 ! t]m applicable add-on paym5t means ! foll[+ am\nts1 det]m9$ )\t reg>d to ! application ( subp>agraph 7,a73 7i7 ,9 ! case ( a multiple s\rce drug1 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u p>agraph 7#a77;,a72 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* p>agraph if #ajj p]c5t 7 sub/itut$ = #ajf p]c5t4 7ii7 ,9 ! case ( a s+le s\rce drug or biological1 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u p>agraph 7#a77;,b72 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* p>agraph if #ajj p]c5t 7 sub/itut$ = #ajf p]c5t4 7iii7 ,9 ! case ( a biosimil> biological product1 ! am\nt o!rwise det]m9$ "u p>agraph 7#h77;,b74 7iv7 ,9 ! case ( a drug or biological dur+ ! initial p]iod describ$ 9 subsection 7c77#d77;,a71 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u subsection 7c77#d77;,a77ii72 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* subsection if #ajj p]c5t 7 sub/itut$1 z applicable1 =-- 7aa7 #ajc p]c5t 9 subclause 7,i7 ( su* subsection2 or 7bb7 any p]c5t 9 excess ( #ajj p]c5t appli$ "u subclause 7,,ii7 ( su* subsection4 7v7 ,9 ! case ( a drug or biological to :i* subsection 7d77#c77;,c7 applies1 an am\nt equal to ! diff]5ce betwe5-- 7,i7 ! am\nt t w\ld o!rwise be appli$ "u su* subsection2 & 7,,ii7 ! am\nt t w\ld be appli$ "u su* subsection if #ajj p]c5t 7 sub/itut$1 z applicable1 =-- 7aa7 any p]c5t 9 excess ( #ajj p]c5t appli$ "u clause 7i7 ( su* subsection2 or 7bb7 #ajc p]c5t 9 clause 7ii7 ( su* subsection4 7,c7 ,maximum add-on paym5t am\nt specifi$ ,= purposes ( subp>agraph 7,a71 ! maximum add-on paym5t am\nt specifi$ 9 ?is subp>agraph is-- 7i7 = ea* ( #bjbb ?r\gh #bjbi1 #a1jjj2 & 7ii7 = a subsequ5t ye>1 ! am\nt specifi$ 9 ?is subp>agraph = ! prec$+ ye> increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>4 ,any am\nt det]m9$ "u ?is subp>agraph t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 2 & 7#b7 9 subsection 7c77#d77;,a77ii71 by /rik+ 9 ! case & ins]t+ subject to subsection 7b77#i71 9 ! case4 7b7 ,con=m+ am5dm5ts relat+ to sep>ately payable drugs 7#a7 ,,opps ,section #ahcc7t77#ad7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ad77 is am5d$-- 7,a7 9 subp>agraph 7,a77iii77,,ii71 by ins]t+ 1 subject to subp>agraph 7,i7 aft] are n available2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,i7 ,application ( maximum add-on paym5t = sep>ately payable drugs & biologicals ,9 e/abli%+ ! am\nt ( paym5t "u subp>agraph 7,a7 = a specifi$ cov]$ outpati5t drug t is furni%$ z "p ( a cov]$ ,,opd s]vice 7or gr\p ( s]vices7 on or aft] ,janu>y #a1 #bjbb1 if su* paym5t is det]m9$ bas$ on ! av]age price = ! ye> e/abli%$ "u section #ahdg;,a pursuant to clause 7iii77,,ii7 ( su* subp>agraph1 ! provisions ( subsection 7b77#i7 ( section #ahdg;,a %all apply to ! am\nt ( paym5t s e/abli%$ 9 ! same mann] z su* provisions apply to ! am\nt ( paym5t "u section #ahdg;,a4 4 7#b7 ,,asc ,section #ahcc7;i77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d77 is am5d$-- 7,a7 by mov+ clause 7v7 #f ems to ! left2 7,b7 by r$esignat+ clause 7vi7 z clause 7vii72 & 7,c7 by ins]t+ aft] clause 7v7 ! foll[+ new clause3 7vi7 ,if !re is a sep>ate paym5t "u ! sy/em describ$ 9 clause 7i7 = a drug or biological furni%$ on or aft] ,janu>y #a1 #bjbb1 ! provisions ( subsection 7t77#ad77;,i7 %all apply to ! e/abli%m5t ( ! am\nt ( paym5t = ! drug or biological "u su* sy/em 9 ! same mann] 9 :i* su* provisions apply to ! e/abli%m5t ( ! am\nt ( paym5t "u subsection 7t77#ad77;,a74 4 #aaj4 ,treatm5t ( drug adm9i/ration s]vices furni%$ by c]ta9 except$ (f-campus outpati5t dep>tm5ts ( a provid] ,section #ahcc7t77#af7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#af77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,special paym5t rule = drug adm9i/ration s]vices furni%$ by an except$ dep>tm5t ( a provid] 7i7 ,9 g5]al ,9 ! case ( a cov]$ ,,opd s]vice t is a drug adm9i/ration s]vice 7z def9$ by ! ,secret>y7 furni%$ by a dep>tm5t ( a provid] describ$ 9 clause 7ii7 or 7iv7 ( p>agraph 7#ba77;,b71 ! paym5t am\nt = su* s]vice furni%$ on or aft] ,janu>y #a1 #bjbb1 %all be ! same paym5t am\nt 7z det]m9$ 9 p>agraph 7#ba77;,c77 t w\ld apply if ! drug adm9i/ration s]vice 0 furni%$ by an (f-campus outpati5t dep>tm5t ( a provid] 7z def9$ 9 p>agraph 7#ba77;,b774 7ii7 ,application )\t reg>d to budget neutrality ,! r$uctions made "u ?is subp>agraph-- 7,i7 %all n be consid]$ an adju/m5t "u p>agraph 7#b77;,e72 & 7,,ii7 %all n be implem5t$ 9 a budget neutral mann]4 4 #aaa4 ,,gao /udy & report on av]age sales price 7a7 ,/udy 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is section ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy on sp5d+ = applicable drugs "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 7#b7 ,applicable drugs def9$ ,9 ?is section1 ! t]m applicable drugs means drugs & biologicals-- 7,a7 = :i* reimbursem5t "u su* "p ,b is bas$ on ! av]age sales price ( ! drug or biological2 & 7,b7 t acc\nt = ! l>ge/ p]c5tage ( total sp5d+ on drugs & biologicals "u su* "p ,b 7z det]m9$ by ! ,comptroll] ,g5]al1 b 9 no case less t #be drugs or biologicals74 7#c7 ,requirem5ts ,! /udy "u p>agraph 7#a7 %all include an analysis ( ! foll[+3 7,a7 ,! ext5t to :i* ea* applicable drug is paid =-- 7i7 "u su* "p ,b = ,m$ic>e b5efici>ies2 or 7ii7 by private pay]s 9 ! comm]cial m>ket4 7,b7 ,any *ange 9 ,m$ic>e sp5d+ or ,m$ic>e b5efici>y co/-%>+ t w\ld occur if ! av]age sales price ( an applicable drug 0 bas$ solely on paym5ts by private pay]s 9 ! comm]cial m>ket4 7,c7 ,! ext5t to :i* drug manufactur]s provide rebates1 disc\nts1 or o!r price concessions to private pay]s 9 ! comm]cial m>ket = applicable drugs1 :i* ! manufactur] includes 9 its av]age sales price calculation1 =-- 7i7 =mul>y placem5t2 7ii7 utilization managem5t consid]ations2 or 7iii7 o!r purposes4 7,d7 ,b>ri]s to drug manufactur]s provid+ su* price concessions = applicable drugs4 7,e7 ,o!r areas det]m9$ appropriate by ! ,comptroll] ,g5]al4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! /udy conduct$ "u subsection 7a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,secret>y det]m9es appropriate4 #aab4 ,au?ority to use alt]native paym5t = drugs & biologicals to prev5t pot5tial drug %ortages 7a7 ,9 g5]al ,section #ahdg;,a7e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7e77 is am5d$-- 7#a7 by /rik+ ,paym5t 9 ,response to ,public ,heal? ,em]g5cy4--,9 ! case & ins]t+ 8,paym5ts4-- 7#a7 ,9 response to public heal? em]g5cy ,9 ! case 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,prev5t+ pot5tial drug %ortages 7,a7 ,9 g5]al ,9 ! case ( a drug or biological t ! ,secret>y det]m9es is describ$ 9 subp>agraph 7,b7 = "o or m qu>t]s beg9n+ on or aft] ,janu>y #a1 #bjba1 ! ,secret>y may use :olesale acquisition co/ 7or o!r reasonable measure ( a drug or biological price7 in/ead ( ! manufactur]'s av]age sales price = su* qu>t]s & = subsequ5t qu>t]s until ! end ( ! qu>t] 9 :i* su* drug or biological is remov$ f ! drug %ortage li/ "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 or 9 ! case ( a drug or biological describ$ 9 subp>agraph 7,b77ii71 ! date on :i* ! ,secret>y det]m9es t ! total manufactur+ capacity or ! total numb] ( manufactur]s ( su* drug or biological is suffici5t to mitigate a pot5tial %ortage ( ! drug or biological4 7,b7 ,drug or biological describ$ ,= purposes ( subp>agraph 7,a71 a drug or biological describ$ 9 ?is subp>agraph is a drug or biological-- 7i7 t is li/$ on ! drug %ortage li/ ma9ta9$ by ! ,food & ,drug ,adm9i/ration pursuant to section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & ) respect to :i* any manufactur] ( su* drug or biological notifies ! ,secret>y ( a p]man5t discont9uance or an int]ruption t is likely to lead to a mean+ful disruption 9 ! manufactur]'s supply ( t drug pursuant to section #ejf;,c7a7 ( su* ,act2 or 7ii7 t-- 7,i7 is describ$ 9 section #ejf;,c7a7 ( su* ,act2 7,,ii7 0 li/$ on ! drug %ortage li/ ma9ta9$ by ! ,food & ,drug ,adm9i/ration pursuant to section #ejf;,e ( su* ,act )9 ! prec$+ #e ye>s2 & 7,,iii7 = :i* ! total manufactur+ capacity ( all manufactur]s ) an approv$ application = su* drug or biological t is curr5tly m>ket$ or total numb] ( manufactur]s ) an approv$ application = su* drug or biological t is curr5tly m>ket$ decl9es dur+ a #f-mon? p]iod1 z det]m9$ by ! ,secret>y4 7,c7 ,provision ( additional in=mation ,= ea* qu>t] 9 :i* ! am\nt ( paym5t = a drug or biological describ$ 9 subp>agraph 7,b7 pursuant to subp>agraph 7,a7 exce$s ! am\nt ( paym5t = ! drug or biological o!rwise applicable "u ?is section1 ea* manufactur] ( su* drug or biological %all provide to ! ,secret>y in=mation relat$ to ! pot5tial cause or causes ( ! %ortage & ! expect$ duration ( ! %ortage ) respect to su* drug4 4 7b7 ,track+ %ortage drugs ?r\gh claims ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all e/abli% a me*anism 7su* z a modifi]7 = purposes ( track+ utilization "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 ( drugs & biologicals li/$ on ! drug %ortage li/ ma9ta9$ by ! ,food & ,drug ,adm9i/ration pursuant to section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e74 7c7 ,,hhs report & recomm5dations 7#a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress a report on %ortages ( drugs )9 ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq474 ,! report %all include-- 7,a7 an analysis (-- 7i7 ! effect ( drug %ortages on ,m$ic>e b5efici>y access1 quality1 safety1 & out-(-pocket co/s2 7ii7 ! effect ( drug %ortages on heal? provid]s1 includ+ hospitals & physicians1 across ! ,m$ic>e program2 7iii7 ! curr5t role ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7,,cms7 9 address+ drug %ortages1 includ+ ,,cms's work+ relation%ip & communication ) o!r ,f$]al ag5cies & /akehold]s2 7iv7 ! role ( all actors 9 ! drug supply *a9 7includ+ drug manufactur]s1 di/ributors1 :olesal]s1 second>y :olesal]s1 gr\p pur*as+ organizations1 hospitals1 & physicians7 on drug %ortages )9 ! ,m$ic>e program2 & 7v7 paym5t /ructures & inc5tives "u p>ts ,a1 ,b1 ,c1 & ,d ( ! ,m$ic>e program & _! effect1 if any1 on drug %ortages2 & 7,b7 relevant f9d+s & recomm5dations to ,congress4 7#b7 ,public availability ,! report "u ?is subsection %all be made available to ! public4 7#c7 ,consultation ,! ,secret>y %all consult ) ! drug %ortage task =ce au?oriz$ "u section #ejf;,d7a77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;d7a77#a77;,a77 9 prep>+ ! report "u ?is subsection1 z appropriate4 ,b ,"p ,d #aba4 ,m$ic>e "p ,d mod]nization r$esign 7a7 ,b5efit /ructure r$esign ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbc & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbc & ea* subsequ5t ye> aft] p>agraph 7#c72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbc1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ 1 #bjba1 & #bjbb2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbc1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjbb2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjbb2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbc1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjbb2 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i7-- 7,i7 by r$esignat+ subclauses 7,i7 & 7,,ii7 z items 7aa7 & 7bb71 respectively1 & ind5t+ appropriately2 7,,ii7 9 ! matt] prec$+ item 7aa71 z r$esignat$ by subclause 7,i71 by /rik+ is equal to ! great] (-- & ins]t+ 8is equal to-- 7,i7 = a ye> prec$+ #bjbc1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbc & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii7-- 7,i7 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 & 7,,ii7 by add+ at ! end ! foll[+ new s5t5ce3 ,! ,secret>y %all cont9ue to calculate ! doll> am\nts specifi$ 9 clause 7i77,i77aa71 includ+ ) ! adju/m5t "u ?is clause1 aft] #bjbb = purposes ( section #ahfj;,d-#ad7;a77#a77;,d77iii742 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 9 subclause 7,v71 by /rik+ or at ! end2 7,,ii7 9 subclause 7,,vi7-- 7aa7 by /rik+ = a subsequ5t ye> & ins]t+ = #bjba & #bjbb2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbc1 is equal to #c1ajj2 or 7,,viii7 = a subsequ5t ye>1 is equal to ! am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = ! ye> involv$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ & = a ye> prec$+ #bjbc = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( #bjaa ?r\gh #bjbb1 9 apply+4 7b7 ,r$uction 9 b5efici>y co9surance 7#a7 ,9 g5]al ,section #ahfj;,d-#b7;b77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b77;,a771 z am5d$ by subsection 7a71 is am5d$-- 7,a7 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii7 & mov+ su* subclauses #b ems to ! "r2 7,b7 by /rik+ #be p]c5t co9surance4--,subject to & ins]t+ 8,co9surance4-- 7i7 ,9 g5]al ,subject to 2 7,c7 9 ea* ( subclauses 7,i7 & 7,,ii71 z r$esignat$ by subp>agraph 7,a71 by /rik+ #be p]c5t & ins]t+ ! applicable p]c5tage 7z def9$ 9 clause 7ii772 & 7,d7 by add+ at ! end ! foll[+ new clause3 7ii7 ,applicable p]c5tage def9$ ,= purposes ( clause 7i71 ! t]m applicable p]c5tage means-- 7,i7 = a ye> prec$+ #bjbc1 #be p]c5t2 & 7,,ii7 = #bjbc & ea* subsequ5t ye>1 #bj p]c5t4 4 7#b7 ,con=m+ am5dm5t ,section #ahfj;,d-#ad7;a77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#b77;,d77 is am5d$ by /rik+ #be p]c5t & ins]t+ ! applicable p]c5tage4 7c7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ equal to #hj p]c5t & ins]t+ 8equal to-- 7,a7 = a ye> prec$+ #bjbc1 #hj p]c5t 2 7,b7 9 subp>agraph 7,a71 z add$ by p>agraph 7#a71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 = #bjbc & ea* subsequ5t ye>1 ! sum (-- 7i7 an am\nt equal to ! applicable p]c5tage specifi$ 9 p>agraph 7#e77;,a7 ( su* all[able re9surance co/s attributable to t portion ( gross prescription drug co/s z specifi$ 9 p>agraph 7#c7 incurr$ 9 ! cov]age ye> aft] su* individual has incurr$ co/s t exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 ) respect to applicable drugs 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#b772 & 7ii7 an am\nt equal to ! applicable p]c5tage specifi$ 9 p>agraph 7#e77;,b7 ( all[able re9surance co/s attributable to t portion ( gross prescription drug co/s z specifi$ 9 p>agraph 7#c7 incurr$ 9 ! cov]age ye> aft] su* individual has incurr$ co/s t exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 ) respect to cov]$ "p ,d drugs t are n applicable drugs 7z s def9$74 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,applicable p]c5tage specifi$ ,= purposes ( p>agraph 7#a77;,b71 ! applicable p]c5tage specifi$ 9 ?is p>agraph is-- 7,a7 ) respect to applicable drugs 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#b77-- 7i7 = #bjbc1 #fj p]c5t2 7ii7 = #bjbd1 #dj p]c5t2 & 7iii7 = #bjbe & ea* subsequ5t ye>1 #bj p]c5t2 & 7,b7 ) respect to cov]$ "p ,d drugs t are n applicable drugs 7z s def9$7-- 7i7 = #bjbc1 #hj p]c5t2 7ii7 = #bjbd1 #fj p]c5t2 & 7iii7 = #bjbe & ea* subsequ5t ye>1 #dj p]c5t4 4 7d7 ,manufactur] disc\nt program dur+ initial & cata/rophic phases ( cov]age 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,a 7#db ,u4,s4,c4 #adiew-#aad7 ! foll[+ new section3 #ahfj;,d-#ad;,b4 ,manufactur] disc\nt program 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a manufactur] disc\nt program 79 ?is section ref]r$ to z ! program74 ,"u ! program1 ! ,secret>y %all ent] into agreem5ts describ$ 9 subsection 7b7 ) manufactur]s & provide = ! p]=mance ( ! duties describ$ 9 subsection 7c74 ,! ,secret>y %all e/abli% a model agreem5t = use "u ! program by n lat] ?an ,janu>y #a1 #bjbb1 9 consultation ) manufactur]s1 & all[ = comm5t on su* model agreem5t4 7b7 ,t]ms ( agreem5t 7#a7 ,9 g5]al 7,a7 ,agreem5t ,an agreem5t "u ?is section %all require ! manufactur] to provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbc4 7,b7 ,provision ( disc\nt$ prices at ! po9t-(-sale ,! disc\nt$ prices describ$ 9 subp>agraph 7,a7 %all be provid$ to ! applicable b5efici>y at ! ph>macy or by ! mail ord] s]vice at ! po9t-(-sale ( an applicable drug4 7#b7 ,provision ( appropriate data ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all collect & h available appropriate data1 z det]m9$ by ! ,secret>y1 to ensure t x c demon/rate to ! ,secret>y compliance ) ! requirem5ts "u ! program4 7#c7 ,compliance ) requirem5ts = adm9i/ration ( program ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all comply ) requirem5ts impos$ by ! ,secret>y or a ?ird p>ty ) a contract "u subsection 7d77#c71 z applicable1 = purposes ( adm9i/]+ ! program1 includ+ any det]m9ation "u subp>agraph 7,a7 ( subsection 7c77#a7 or proc$ures e/abli%$ "u su* subsection 7c77#a74 7#d7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section %all be effective = an initial p]iod ( n less ?an #ab mon?s & %all be automatically r5ew$ = a p]iod ( n less ?an #a ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ! ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = a kn[+ & willful violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice to ! manufactur] ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 & su* he>+ %all take place prior to ! effective date ( ! t]m9ation ) suffici5t "t = su* effective date to be repeal$ if ! ,secret>y det]m9es appropriate4 7ii7 ,by a manufactur] ,a manufactur] may t]m9ate an agreem5t "u ?is section = any reason4 ,any su* t]m9ation %all be effective1 ) respect to a plan ye>-- 7,i7 if ! t]m9ation occurs be=e ,janu>y #cj ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( a plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7iii7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is subp>agraph %all n affect disc\nts = applicable drugs ( ! manufactur] t are due "u ! agreem5t be=e ! effective date ( its t]m9ation4 7iv7 ,notice to ?ird p>ty ,! ,secret>y %all provide notice ( su* t]m9ation to a ?ird p>ty ) a contract "u subsection 7d77#c7 )9 n less ?an #cj days be=e ! effective date ( su* t]m9ation4 7#e7 ,effective date ( agreem5t ,an agreem5t "u ?is section %all take effect on a date det]m9$ appropriate by ! ,secret>y1 :i* may be at ! />t ( a cal5d> qu>t]4 7c7 ,duties describ$ ,! duties describ$ 9 ?is subsection are ! foll[+3 7#a7 ,adm9i/ration ( program ,adm9i/]+ ! program1 includ+-- 7,a7 ! det]m9ation ( ! am\nt ( ! disc\nt$ price ( an applicable drug ( a manufactur]2 7,b7 ! e/abli%m5t ( proc$ures "u :i* disc\nt$ prices are provid$ to applicable b5efici>ies at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( an applicable drug2 7,c7 ! e/abli%m5t ( proc$ures to ensure t1 n lat] ?an ! applicable numb] ( cal5d> days aft] ! disp5s+ ( an applicable drug by a ph>macy or mail ord] s]vice1 ! ph>macy or mail ord] s]vice is reimburs$ = an am\nt equal to ! diff]5ce betwe5-- 7i7 ! negotiat$ price ( ! applicable drug2 & 7ii7 ! disc\nt$ price ( ! applicable drug2 7,d7 ! e/abli%m5t ( proc$ures to ensure t ! disc\nt$ price = an applicable drug "u ?is section is appli$ be=e any cov]age or f9ancial assi/ance "u o!r heal? b5efit plans or programs t provide cov]age or f9ancial assi/ance = ! pur*ase or provision ( prescription drug cov]age on behalf ( applicable b5efici>ies z ! ,secret>y may specify2 & 7,e7 provid+ a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 applicable b5efici>ies1 & ! ?ird p>ty ) a contract "u subsection 7d77#c74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,secret>y %all monitor compliance by a manufactur] ) ! t]ms ( an agreem5t "u ?is section4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7d77#c7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u subsection 7e74 7#c7 ,collection ( data f prescription drug plans & ma-pd plans ,! ,secret>y may collect appropriate data f prescription drug plans & ,,ma-,,pd plans 9 a timeframe t all[s = disc\nt$ prices to be provid$ = applicable drugs "u ?is section4 7d7 ,adm9i/ration 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y %all provide = ! implem5tation ( ?is section1 includ+ ! p]=mance ( ! duties describ$ 9 subsection 7c74 7#b7 ,limitation ,9 provid+ = ! implem5tation ( ?is section1 ! ,secret>y %all n receive or di/ribute any funds ( a manufactur] "u ! program4 7#c7 ,contract ) ?ird p>ties ,! ,secret>y %all ent] into a contract ) #a or m ?ird p>ties to adm9i/] ! requirem5ts e/abli%$ by ! ,secret>y 9 ord] to c>ry out ?is section4 ,at a m9imum1 ! contract ) a ?ird p>ty "u ! prec$+ s5t5ce %all require t ! ?ird p>ty-- 7,a7 receive & transmit in=mation betwe5 ! ,secret>y1 manufactur]s1 & o!r individuals or entities ! ,secret>y det]m9es appropriate2 7,b7 receive1 di/ribute1 or facilitate ! di/ribution ( funds ( manufactur]s to appropriate individuals or entities 9 ord] to meet ! obligations ( manufactur]s "u agreem5ts "u ?is section2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is section1 z necess>y = ! manufactur] to fulfill its obligations "u ?is section2 & 7,d7 p]mit manufactur]s to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ by ! ?ird p>ty to det]m9e disc\nts = applicable drugs ( ! manufactur] "u ! program4 7#d7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#c7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is section4 7#e7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 7#f7 ,fund+ ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all provide = ! transf]1 f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 ( #d1jjj1jjj = ea* ( fiscal ye>s #bjbj ?r\gh #bjbc1 to rema9 available until exp5d$404 7e7 ,en=cem5t 7#a7 ,audits ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all be subject to p]iodic audit by ! ,secret>y4 7#b7 ,civil money p5alty 7,a7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] t fails to provide applicable b5efici>ies disc\nts = applicable drugs ( ! manufactur] 9 accordance ) su* agreem5t = ea* su* failure 9 an am\nt ! ,secret>y det]m9es is comm5surate ) ! sum (-- 7i7 ! am\nt t ! manufactur] w\ld h paid ) respect to su* disc\nts "u ! agreem5t1 :i* w !n be us$ to pay ! disc\nts :i* ! manufactur] _h fail$ to provide2 & 7ii7 #be p]c5t ( su* am\nt4 7,b7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7f7 ,cl>ification reg>d+ availability ( o!r cov]$ "p d drugs ,no?+ 9 ?is section %all prev5t an applicable b5efici>y f pur*as+ a cov]$ "p ,d drug t is n an applicable drug 7includ+ a g5]ic drug or a drug t is n on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 974 7g7 ,def9itions ,9 ?is section3 7#a7 ,applicable b5efici>y ,! t]m applicable b5efici>y means an individual :o1 on ! date ( disp5s+ a cov]$ "p ,d drug-- 7,a7 is enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is n enroll$ 9 a qualifi$ retiree prescription drug plan2 & 7,c7 has incurr$ co/s = cov]$ "p ,d drugs 9 ! ye> t are above ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = su* ye>4 7#b7 ,applicable drug ,! t]m applicable drug means1 ) respect to an applicable b5efici>y1 a cov]$ "p ,d drug-- 7,a7 approv$ "u a new drug application "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or1 9 ! case ( a biologic product1 lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7includ+ a product lic5s$ "u subsection 7k7 ( su* section #cea72 & 7,b7 7i7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan uses a =mul>y1 :i* is on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 7ii7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan does n use a =mul>y1 = :i* b5efits are available "u ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 or 7iii7 is provid$ ?r\gh an exception or appeal4 7#c7 ,applicable numb] ( cal5d> days ,! t]m applicable numb] ( cal5d> days means-- 7,a7 ) respect to claims = reimbursem5t submitt$ electronically1 #ad days2 & 7,b7 ) respect to claims = reimbursem5t submitt$ o!rwise1 #cj days4 7#d7 ,disc\nt$ price 7,a7 ,9 g5]al ,! t]m disc\nt$ price means-- 7i7 ) respect to an applicable drug disp5s$ = an applicable b5efici>y :o has incurr$ co/s t are bel[ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 = ! ye>1 #ic p]c5t ( ! negotiat$ price ( ! applicable drug ( a manufactur]2 & 7ii7 ) respect to an applicable drug disp5s$ = an applicable b5efici>y :o has incurr$ co/s = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 = ! ye>1 #hf p]c5t ( ! negotiat$ price ( ! applicable drug ( a manufactur]4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+ ! responsibility ( an applicable b5efici>y = paym5t ( a disp5s+ fee = an applicable drug4 7,c7 ,cl>ification = c]ta9 claims ,) respect to ! am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y1 ! manufactur] ( ! applicable drug %all provide-- 7i7 ! disc\nt$ price "u clause 7i7 ( subp>agraph 7,a7 only on ! portion ( ! negotiat$ price ( ! applicable drug t falls above ! d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = ! ye> & bel[ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 = ! ye>2 & 7ii7 ! disc\nt$ price "u clause 7ii7 ( subp>agraph 7,a7 only on ! portion ( ! negotiat$ price ( ! applicable drug t falls at or above su* annual out-(-pocket ?re%old4 7#e7 ,manufactur] ,! t]m manufactur] means any entity :i* is engag$ 9 ! production1 prep>ation1 propagation1 comp\nd+1 conv]sion1 or process+ ( prescription drug products1 ei!r directly or indirectly by extraction f sub/ances ( natural orig91 or indep5d5tly by means ( *emical syn!sis1 or by a comb9ation ( extraction & *emical syn!sis4 ,su* t]m does n include a :olesale di/ributor ( drugs or a retail ph>macy lic5s$ "u ,/ate law4 7#f7 ,negotiat$ price ,! t]m negotiat$ price has ! mean+ giv5 su* t]m 9 section #ahfj;,d-#b7;d77#a77;,b71 except t su* negotiat$ price %all n include any disp5s+ fee = ! applicable drug4 7#g7 ,qualifi$ retiree prescription drug plan ,! t]m qualifi$ retiree prescription drug plan has ! mean+ giv5 su* t]m 9 section #ahfj;,d-#bb7;a77#b74 4 7#b7 ,sunset ( ,m$ic>e cov]age gap disc\nt program ,section #ahfj;,d-#ad;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is am5d$-- 7,a7 9 subsection 7a71 9 ! fir/ s5t5ce1 by /rik+ ,! ,secret>y & ins]t+ ,subject to subsection 7h71 ! ,secret>y2 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7h7 ,sunset ( program 7#a7 ,9 g5]al ,! program %all n apply to applicable drugs disp5s$ on or aft] ,janu>y #a1 #bjbc1 &1 subject to p>agraph 7#b71 agreem5ts "u ?is section %all be t]m9at$ z ( su* date4 7#b7 ,cont9u$ application = applicable drugs disp5s$ prior to sunset ,! provisions ( ?is section 7includ+ all responsibilities & duties7 %all cont9ue to apply aft] ,janu>y #a1 #bjbc1 ) respect to applicable drugs disp5s$ prior to su* date4 4 7#c7 ,inclusion ( actu>ial value ( manufactur] disc\nts 9 bids ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ 8assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbc & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,b subtract$ f ! actu>ial value to produce su* bid2 & 2 & 7,b7 9 subsection 7c77#a77;,c7-- 7i7 by /rik+ an actu>ial valuation ( ! re9surance & ins]t+ 8an actu>ial valuation (-- 7i7 ! re9surance 2 7ii7 9 clause 7i71 z add$ by clause 7i7 ( ?is subp>agraph1 by add+ & at ! end2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 = #bjbc & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,b2 4 7#d7 ,cl>ification reg>d+ exclusion ( manufactur] disc\nts f ,tr,o,o,p ,section #ahfj;,d-#b7;b77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77 is am5d$-- 7,a7 9 subp>agraph 7,c71 by ins]t+ & subject to subp>agraph 7,f7 aft] subp>agraph 7,e72 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,cl>ification reg>d+ exclusion ( manufactur] disc\nts ,9 apply+ subp>agraph 7,a71 incurr$ co/s %all n include any manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,b4 4 7e7 ,det]m9ation ( all[able re9surance co/s ,section #ahfj;,d-#ae7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 by /rik+ co/s4--,= purposes & ins]t+ 8co/s4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 = purposes 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,inclusion ( manufactur] disc\nts on applicable drugs ,= purposes ( apply+ subp>agraph 7,a71 ! t]m all[able re9surance co/s %all include ! portion ( ! negotiat$ price 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#f77 ( an applicable drug 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#b77 t 0 paid by a manufactur] "u ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,b4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 ! fir/ s5t5ce1 by /rik+ ,= purposes & ins]t+ ,subject to p>agraph 7#b77;,b71 = purposes2 & 7,b7 9 ! second s5t5ce1 by ins]t+ or1 9 ! case ( an applicable drug1 by a manufactur] aft] by ! individual or "u ! plan4 7f7 ,updat+ risk adju/m5t me?odologies ,to acc\nt = "p ,d mod]nization r$esign ,section #ahfj;,d-#ae7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,updat+ risk adju/m5t me?odologies to acc\nt = "p ,d mod]nization r$esign ,! ,secret>y %all update ! risk adju/m5t me?odologies us$ to adju/ bid am\nts pursuant to ?is subsection z appropriate to take into acc\nt *anges 9 b5efits "u ?is "p pursuant to ! am5dm5ts made by section #aba ( ! ,prescription ,drug ,pric+ ,r$uction ,act ( #bjbj4 4 7g7 ,conditions = cov]age ( drugs "u ?is "p ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#c71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+ new p>agraphs3 7#d7 p>ticipate 9 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,b2 7#e7 h ent]$ into & h 9 effect an agreem5t describ$ 9 subsection 7b7 ( su* section #ahfj;,d-#ad;,b ) ! ,secret>y2 & 7#f7 h ent]$ into & h 9 effect1 "u t]ms & conditions specifi$ by ! ,secret>y1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( su* section #ahfj;,d-#ad;,b4 2 7#b7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,effective date ,p>agraphs 7#a7 ?r\gh 7#c7 ( subsection 7a7 %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjaa1 & be=e ,janu>y #a1 #bjbc1 & p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ on or aft] ,janu>y #a1 #bjbc4 2 & 7#c7 9 subsection 7c71 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ! ,secret>y det]m9es t 9 ! p]iod beg9n+ on ,janu>y #a1 #bjaa1 & end+ on ,decemb] #ca1 #bjaa 7) respect to p>agraphs 7#a7 ?r\gh 7#c7 ( subsection 7a771 or ! p]iod beg9n+ on ,janu>y #a1 #bjbc1 & end+ ,decemb] #ca1 #bjbc 7) respect to p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection71 !re 7 ext5uat+ circum/ances4 4 7h7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or = a ye> prec$+ #bjbc an increase 9 ! initial2 7,b7 9 subsection 7c77#a77;,c7-- 7i7 9 ! subp>agraph head+1 by /rik+ at initial cov]age limit2 & 7ii7 by ins]t+ = a ye> prec$+ #bjbc or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbc & ea* subsequ5t ye> aft] subsection 7b77#c7 = ! ye> ea* place x appe>s2 & 7,c7 9 subsection 7d77#a77;,a71 by /rik+ or an initial & ins]t+ or = a ye> prec$+ #bjbc an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbc1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbc1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbc1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbc1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e7-- 7,i7 by ins]t+ = a ye> prec$+ #bjbc1 aft] subsection 7c72 & 7,,ii7 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is am5d$ by /rik+ section #ahfj;,d-#b7;b77,b77#d77;,b77i7 & ins]t+ section #ahfj;,d-#b7;b77,b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is am5d$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 8! value (-- 7i7 = ye>s prior to #bjbc1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ by subp>agraph 7,a7 ( ?is p>agraph1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7ii7 = #bjbc & ea* subsequ5t ye>1 any disc\nt provid$ pursuant to section #ahfj;,d-#ad;,b4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is am5d$-- 7,a7 by ins]t+ = a ye> be=e #bjbc aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7i7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye> #bjbc & subsequ5t plan ye>s4 #aba;,a4 ,maximum mon?ly cap on co/-%>+ paym5ts "u prescription drug plans & ,,ma-,,pd plans 7a7 ,9 g5]al ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b771 z am5d$ by section #aba1 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & 7,d7 & ins]t+ 1 7,d71 & 7,e72 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,maximum mon?ly cap on co/-%>+ paym5ts 7i7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 ! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 e/abli% a process "u :i* ea* ,,pdp sponsor (f]+ a prescription drug plan & ea* ,,ma organization (f]+ an ,,ma-,,pd plan %all provide to any enrollee1 includ+ an enrollee :o is a subsidy eligible individual 7z def9$ 9 p>agraph 7#c7 ( section #ahfj;,d-#ad7;a771 ! option to elect ) respect to a plan ye> to h _! mon?ly co/-%>+ paym5ts "u ! plan capp$ 9 accordance ) ?is subp>agraph4 7ii7 ,det]m9ation ( maximum mon?ly cap ,= ea* mon? 9 ! plan ye> aft] an enrollee 9 a prescription drug plan or an ,,ma-,,pd plan has made an election pursuant to clause 7i71 ! ,,pdp sponsor or ,,ma organization %all det]m9e a maximum mon?ly cap 7z def9$ 9 clause 7iv77 = su* enrollee4 7iii7 ,b5efici>y mon?ly paym5ts ,) respect to an enrollee :o has made an election pursuant to clause 7i71 = ea* mon? describ$ 9 clause 7ii71 ! ,,pdp sponsor or ,,ma organization %all bill su* enrollee an am\nt 7n to exce$ ! maximum mon?ly cap7 = ! out-(-pocket co/s ( su* enrollee 9 su* mon?4 7iv7 ,maximum mon?ly cap def9$ ,9 ?is subp>agraph1 ! t]m maximum mon?ly cap means1 ) respect to an enrollee-- 7,i7 = ! fir/ mon? 9 :i* ?is subp>agraph applies1 an am\nt det]m9$ by calculat+-- 7aa7 ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 m9us ! incurr$ co/s ( ! enrollee z describ$ 9 p>agraph 7#d77;,c72 divid$ by 7bb7 ! numb] ( mon?s rema9+ 9 ! plan ye>2 & 7,,ii7 = a subsequ5t mon?1 an am\nt det]m9$ by calculat+-- 7aa7 ! sum ( any rema9+ out-(-pocket co/s ow$ by ! enrollee f a previ\s mon? t h n yet be5 bill$ to ! enrollee & any additional co/s incurr$ by ! enrollee2 divid$ by 7bb7 ! numb] ( mon?s rema9+ 9 ! plan ye>4 7v7 ,additional requirem5ts ,! foll[+ requirem5ts %all apply ) respect to ! option to make an election pursuant to clause 7i7 "u ?is subp>agraph3 7,i7 ,secret>ial responsibilities ,! ,secret>y %all provide in=mation to "p ,d eligible individuals on ! option to make su* election ?r\gh educational mat]ials1 includ+ ?r\gh ! notices provid$ "u section #ahjd7;a74 7,,ii7 ,tim+ ( election ,an enrollee 9 a prescription drug plan or an ,,ma-,,pd plan may make su* an election-- 7aa7 prior to ! beg9n+ ( ! plan ye>2 or 7bb7 9 any mon? dur+ ! plan ye>4 7,,iii7 ,,pdp sponsor & ,,ma organization responsibilities ,ea* ,,pdp sponsor (f]+ a prescription drug plan or ,,ma organization (f]+ an ,,ma-,,pd plan-- 7aa7 may n limit ! option = an enrollee to make su* an election to c]ta9 cov]$ "p ,d drugs2 7bb7 %all1 prior to ! plan ye>1 notify prospective enrollees ( ! option to make su* an election 9 promotional mat]ials2 7cc7 %all include in=mation on su* option 9 enrollee educational mat]ials2 7dd7 %all h 9 place a me*anism to notify a ph>macy dur+ ! plan ye> :5 an enrollee incurs out-(-pocket co/s ) respect to cov]$ "p ,d drugs t make x likely ! enrollee may b5efit f mak+ su* an election2 7ee7 %all provide t a ph>macy1 aft] receiv+ a notification describ$ 9 item 7dd7 ) respect to an enrollee1 in=ms ! enrollee ( su* notification2 7ff7 %all ensure t su* an election by an enrollee has no effect on ! am\nt paid to ph>macies 7or ! tim+ ( su* paym5ts7 ) respect to cov]$ "p ,d drugs disp5s$ to ! enrollee2 & 7gg7 %all h 9 place a f9ancial reconciliation process to correct inaccuracies 9 paym5ts made by an enrollee "u ?is subp>agraph ) respect to cov]$ "p ,d drugs dur+ ! plan ye>4 7,,iv7 ,failure to pay am\nt bill$ ,if an enrollee fails to pay ! am\nt bill$ = a mon? z requir$ "u ?is subp>agraph1 ! election ( ! enrollee pursuant to clause 7i7 %all be t]m9at$ & enrollee %all pay ! co/-%>+ o!rwise applicable = any cov]$ "p ,d drugs subsequ5tly disp5s$ to ! enrollee up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b74 7,v7 ,cl>ification reg>d+ pa/ due am\nts ,no?+ 9 ?is subp>agraph %all be con/ru$ z prohibit+ a ,,pdp sponsor or an ,,ma organization f bill+ an enrollee = an am\nt ow$ "u ?is subp>agraph4 7,,vi7 ,treatm5t ( unsettl$ balances ,any unsettl$ balances ) respect to am\nts ow$ "u ?is subp>agraph %all be treat$ z plan losses & ! ,secret>y %all n be liable = any su* balances outside ( ^? assum$ z losses e/imat$ 9 plan bids4 2 & 7#b7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,c71 by /rik+ & subject to subp>agraph 7,f7 & ins]t+ & subject to subp>agraphs 7,f7 & 7,g72 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,inclusion ( co/s paid "u maximum mon?ly cap option ,9 apply+ subp>agraph 7,a71 ) respect to an enrollee :o has made an election pursuant to clause 7i7 ( p>agraph 7#b77;,e71 co/s %all be treat$ z incurr$ if su* co/s are paid by a ,,pdp sponsor or an ,,ma organization "u ! process provid$ "u su* p>agraph4 4 7b7 ,application to alt]native prescription drug cov]age ,section #ahfj;,d-#b7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,same maximum mon?ly cap on co/-%>+ ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 ! maximum mon?ly cap on co/-%>+ paym5ts "u ! process provid$ "u subsection 7b77#b77;,e7 %all apply to su* cov]age4 4 #aba;,b4 ,requir+ ph>macy-negotiat$ price concessions1 paym5t1 & fees to be includ$ 9 negotiat$ prices at ! po9t-(-sale "u "p ,d ( ! m$ic>e program ,section #ahfj;,d-#b7;d77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;d77#a77;,b77 is am5d$-- 7#a7 by /rik+ prices4--,= purposes & ins]t+ 8prices4-- 7i7 ,9 g5]al ,= purposes 2 & 7#b7 by add+ at ! end ! foll[+ new clause3 7ii7 ,prices negotiat$ ) ph>macy at po9t-(-sale ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb1 a negotiat$ price = a cov]$ "p ,d drug describ$ 9 clause 7i7 %all be ! approximate l[e/ possible reimbursem5t = su* drug negotiat$ ) ! ph>macy disp5s+ su* drug1 & %all include all cont+5t & noncont+5t price concessions1 paym5ts1 & fees negotiat$ ) su* ph>macy1 b %all n include positive inc5tive paym5ts paid or to be paid to su* ph>macy4 ,su* negotiat$ price %all be provid$ at ! po9t-(-sale ( su* drug4 4 #abb4 ,provid+ ! ,m$ic>e ,paym5t ,advisory ,commission & ,m$icaid & ,,*ip ,paym5t & ,access ,commission ) access to c]ta9 drug paym5t in=mation1 includ+ c]ta9 rebate in=mation 7a7 ,access to c]ta9 "p ,d paym5t data ,section #ahfj;,d-#ae7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;f77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a77ii71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ at ! end ! foll[+ new subp>agraph3 7,c7 by ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( monitor+1 mak+ recomm5dations1 & analysis ( ! program "u ?is title & by ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission = purposes ( monitor+1 mak+ recomm5dations1 & analysis ( ! ,m$icaid program e/abli%$ "u title ,,xix & ! ,*ildr5's ,heal? ,insurance ,program e/abli%$ "u title ,,xxi4 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,additional re/rictions on disclosure ( in=mation ,! ,executive ,directors describ$ 9 p>agraph 7#b77;,c7 %all n disclose any ( ! foll[+ in=mation disclos$ to su* ,executive ,directors or obta9$ by su* ,executive ,directors pursuant to su* p>agraph1 ) respect to a prescription drug plan (f]$ by a ,,pdp sponsor or an ,,ma-,,pd plan (f]$ by an ,,ma organization3 7,a7 ,! specific am\nts or ! id5tity ( ! s\rce ( any rebates1 price concessions1 or o!r =ms ( direct or indirect remun]ation "u su* prescription drug plan or su* ,,ma-,,pd plan4 7,b7 ,in=mation submitt$ ) ! bid submitt$ "u section #ahfj;,d-#aa by su* ,,pdp sponsor or section #ahed by su* ,,ma organization4 7,c7 ,9 ! case ( su* in=mation f prescription drug ev5t records1 9 a =m t w\ld n be p]mitt$ "u section #dbc4eje7m7 ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation1 if made by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 4 7b7 ,access to c]ta9 rebate & paym5t data "u ,m$ic>e & ,m$icaid ,section #aibg7;b77#c77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77 is am5d$-- 7#a7 9 ! matt] be=e clause 7i71 by /rik+ subsection 7a77#f77;,a77ii7 & ins]t+ subsection 7a77#f77;,a72 7#b7 9 clause 7v71 by /rik+ & at ! end2 7#c7 9 clause 7vi71 by /rik+ ! p]iod at ! end & ins]t+ 1 &2 7#d7 by ins]t+ aft] clause 7vi7 ! foll[+ new clause3 7vii7 to p]mit ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission & ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission to review ! in=mation provid$4 2 7#e7 9 ! matt] at ! end1 by /rik+ #ahfj;,d-#d7;c77#b77;,e7 & ins]t+ #ahfj;,d-#d7;c77#b77;,g72 & 7#f7 by add+ at ! end ! foll[+ new s5t5ce3 ,any in=mation disclos$ to ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission or ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission pursuant to ?is subp>agraph %all n be disclos$ by ei!r su* ,executive ,director 9 a =m :i* discloses ! id5tity ( a specific manufactur] or :olesal] or prices *>g$ = drugs by su* manufactur] or :olesal]44 #abc4 ,public disclosure ( drug disc\nts & o!r ph>macy b5efit manag] 7,,pbm7 provisions 7a7 ,public disclosure ( drug disc\nts 7#a7 ,9 g5]al ,section #aaej;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc7 is am5d$-- 7,a7 9 subsection 7c71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ?is section & ins]t+ subsection 7b77#a72 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7e7 ,public availability ( c]ta9 in=mation 7#a7 ,9 g5]al ,subject to p>agraphs 7#b7 & 7#c71 9 ord] to all[ pati5ts & employ]s to comp>e ,p,b,ms' ability to negotiate rebates1 disc\nts1 & price concessions & ! am\nt ( su* rebates1 disc\nts1 & price concessions t are pass$ ?r\gh to plan sponsors1 n lat] ?an ,july #a1 #bjbb1 ! ,secret>y %all make available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! in=mation provid$ to ! ,secret>y & describ$ 9 p>agraphs 7#b7 & 7#c7 ( subsection 7b7 ) respect to ea* ,,pbm4 7#b7 ,lag 9 data ,! in=mation made available 9 a plan ye> "u p>agraph 7#a7 %all n include in=mation ) respect to su* plan ye> or ! two prec$+ plan ye>s4 7#c7 ,confid5tiality ,! ,secret>y %all ensure t su* in=mation is display$ 9 a mann] t prev5ts ! disclosure ( in=mation on rebates1 disc\nts1 & price concessions ) respect to an individual drug or an individual ,,pdp sponsor1 ,,ma organization1 or qualifi$ heal? b5efits plan4 4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a77;,a7 %all take effect on ,janu>y #a1 #bjbb4 7b7 ,plan audit ( ph>macy b5efit manag] data ,section #ahfj;,d-#b7;d77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;d77#c77 is am5d$-- 7#a7 by /rik+ ,audits4--,to protect & ins]t+ ! foll[+3 8,audits4-- 7,a7 ,audits ( plans by ! ,secret>y ,to protect 2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,audits ( ph>macy b5efit manag]s by ,,pdp sponsors & ,,ma organizations 7i7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbb1 9 ord] to ensure t-- 7,i7 contract+ t]ms betwe5 a ,,pdp sponsor (f]+ a prescription drug plan or an ,,ma organization (f]+ an ,,ma-,,pd plan & its contract$ or own$ ph>macy b5efit manag] are met2 & 7,,ii7 ! ,,pdp sponsor & ,,ma organization c acc\nt = ! co/ ( ea* cov]$ "p ,d drug net ( all direct & indirect remun]ation2 ! ,,pdp sponsor or ,,ma organization %all conduct f9ancial audits4 7ii7 ,indep5d5t ?ird p>ty ,an audit describ$ 9 clause 7i7 %all-- 7,i7 be conduct$ by an indep5d5t ?ird p>ty2 & 7,,ii7 acc\nt & reconcile fl[s ( funds t det]m9e ! net co/ ( cov]$ "p ,d drugs1 includ+ direct & indirect remun]ation f drug manufactur]s & ph>macies or provid$ to ph>macies4 7iii7 ,rebate agreem5ts ,a ,,pdp sponsor & an ,,ma organization %all require ph>macy b5efit manag]s to make rebate contracts ) drug manufactur]s made on _! behalf available "u audits describ$ 9 clause 7i74 7iv7 ,confid5tiality agreem5ts ,audits describ$ 9 clause 7i7 %all be subject to confid5tiality agreem5ts to prev5t1 except z requir$ "u clause 7vii71 ! r$isclosure ( data transmitt$ "u ! audit4 7v7 ,frequ5cy ,a f9ancial audit "u clause 7i7 %all be conduct$ p]iodically 7b 9 no case less frequ5tly ?an once e #b ye>s74 7vi7 ,timeframe = ,,pbm to provide in=mation ,a ,,pdp sponsor & an ,,ma organization %all require t a ph>macy b5efit manag] t is be+ audit$ "u clause 7i7 provide 7z "p ( _! contract+ agreem5t7 ! reque/$ in=mation to ! indep5d5t ?ird p>ty conduct+ ! audit )9 #de days ( ! date ( ! reque/4 7vii7 ,submission ( audit reports to ! ,secret>y 7,i7 ,9 g5]al ,a ,,pdp sponsor & an ,,ma organization %all submit to ! ,secret>y ! f9al report on any audit conduct$ "u clause 7i7 )9 #cj days ( ! ,,pdp sponsor or ,,ma organization receiv+ ! report f ! indep5d5t ?ird p>ty conduct+ ! audit4 7,,ii7 ,review ,! ,secret>y %all review f9al reports submitt$ "u clause 7i7 to det]m9e ! ext5t to :i* ! goals specifi$ 9 subclauses 7,i7 & 7,,ii7 ( subp>agraph 7,b77i7 are met4 7,,iii7 ,confid5tiality ,not)/&+ any o!r provision ( law1 in=mation disclos$ 9 a report submitt$ "u clause 7i7 relat$ to ! net co/ ( a cov]$ "p ,d drug is confid5tial & %all n be disclos$ by ! ,secret>y or a ,m$ic>e contractor4 7viii7 ,notice ( noncompliance ,a ,,pdp sponsor & an ,,ma organization %all notify ! ,secret>y if any ph>macy b5efit manag] is n comply+ ) reque/s = access to in=mation requir$ "u an audit "u clause 7i74 7ix7 ,civil monet>y p5alties 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 if ! ,secret>y det]m9es t a ,,pdp sponsor or an ,,ma organization has fail$ to conduct an audit "u clause 7i71 ! ,secret>y may impose a civil monet>y p5alty ( n m ?an #aj1jjj = ea* day ( su* noncompliance4 7,,ii7 ,proc$ure ,! provisions ( section #aabh;,a1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil monet>y p5alties "u ?is clause 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a4 4 7c7 ,disclosure to ph>macy ( po/-,po9t-(-,sale ph>macy price concessions & inc5tive paym5ts ,section #ahfj;,d-#b7;d77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;d77#b77 is am5d$-- 7#a7 by /rik+ ,disclosure4--,a ,,pdp sponsor & ins]t+ ! foll[+3 8,disclosure4-- 7,a7 ,to ! ,secret>y ,a ,,pdp sponsor 2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,to ph>macies 7i7 ,9 g5]al ,= plan ye> #bjbb & subsequ5t plan ye>s1 a ,,pdp sponsor (f]+ a prescription drug plan & an ,,ma organization (f]+ an ,,ma-,,pd plan %all report any ph>macy price concession or inc5tive paym5t t occurs ) respect to a ph>macy aft] paym5t = cov]$ "p ,d drugs at ! po9t-(-sale1 includ+ by an int]m$i>y organization ) :i* a ,,pdp sponsor or ,,ma organization has contract$1 to ! ph>macy4 7ii7 ,tim+ ,! report+ ( price concessions & inc5tive paym5ts to a ph>macy "u clause 7i7 %all be made on a p]iodic basis 7b 9 no case less frequ5tly ?an annually74 7iii7 ,claim level ,! report+ ( price concessions & inc5tive paym5ts to a ph>macy "u clause 7i7 %all be at ! claim level or approximat$ at ! claim level if ! price concession or inc5tive paym5t 0 appli$ at a level o!r ?an at ! claim level4 4 7d7 ,disclosure ( ,p,t ,committee conflicts ( int]e/ 7#a7 ,9 g5]al ,section #ahfj;,d-#d7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#c77;,a77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,disclosure ( conflicts ( int]e/ ,) respect to plan ye> #bjbb & subsequ5t plan ye>s1 a ,,pdp sponsor ( a prescription drug plan & an ,,ma organization (f]+ an ,,ma-,,pd plan %all1 z "p ( its bid submission "u section #ahfj;,d-#aa7;b71 provide ! ,secret>y ) a complet$ /atem5t ( f9ancial conflicts ( int]e/1 includ+ ) manufactur]s1 f ea* memb] ( any ph>macy & !rapeutic committee us$ by ! sponsor or organization pursuant to ?is p>agraph4 4 7#b7 ,inclusion 9 bid ,section #ahfj;,d-#aa7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;b77#b77 is am5d$-- 7,a7 by r$esignat+ subp>agraph 7,f7 z subp>agraph 7,g72 & 7,b7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 ,p,t ,committee conflicts ( int]e/ ,! in=mation requir$ to be disclos$ "u section #ahfj;,d-#d7;b77#c77;,a77iii74 4 7e7 ,in=mation on direct & indirect remun]ation requir$ ,to be includ$ 9 bid ,section #ahfj;,d-#aa7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by add+ at ! end ! foll[+ new s5t5ce3 ,) respect to actual am\nts ( direct & indirect remun]ation submitt$ pursuant to clause 7v7 ( p>agraph 7#b71 su* am\nts %all be consi/5t ) data report$ to ! ,secret>y 9 a prior ye>42 & 7#b7 9 p>agraph 7#b77;,c7-- 7,a7 9 clause 7iii71 by /rik+ & at ! end2 7,b7 9 clause 7iv71 by /rik+ ! p]iod at ! end & ins]t+ ! foll[+3 1 &1 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 actual & project$ adm9i/rative exp5ses assum$ 9 ! bid1 categoriz$ by ! type ( su* exp5se1 includ+ actual & project$ price concessions reta9$ by a ph>macy b5efit manag]2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7v7 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 actual & project$ direct & indirect remun]ation1 categoriz$ z receiv$ f ea* ( ! foll[+3 7,i7 ,a ph>macy4 7,,ii7 ,a manufactur]4 7,,iii7 ,a ph>macy b5efit manag]4 7,,iv7 ,o!r entities1 z det]m9$ by ! ,secret>y4 4 #abd4 ,public disclosure ( direct & indirect remun]ation review & audit results ,section #ahfj;,d-#db ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7e7 ,public disclosure ( direct & indirect remun]ation review & f9ancial audit results 7#a7 ,direct & indirect remun]ation review results 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,b71 9 #bjba & ea* subsequ5t ye>1 ! ,secret>y %all make available to ! public on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices in=mation on discrepancies relat$ to summ>y & detail$ direct & indirect remun]ation reports submitt$ by ,,pdp sponsors pursuant to section #ahfj;,d-#ae across all prescription drug plans bas$ on ! mo/ rec5t data available4 ,in=mation made available "u ?is subp>agraph %all include ! foll[+3 7i7 ,! numb] ( pot5tial discrepancies 9 summ>y & detail$ direct & indirect remun]ation id5tifi$ by ! ,secret>y = ,,pdp sponsors to review4 7ii7 ,! ext5t to :i* ,,pdp sponsors resubmitt$ summ>y direct & indirect remun]ation reports to make *anges = previ\s contract ye>s4 7iii7 ,! ext5t to :i* resubmitt$ summ>y direct & indirect remun]ation reports result$ 9 an increase or decrease 9 direct & indirect remun]ation 9 a previ\s contract ye>4 7,b7 ,exclusion ( c]ta9 submissions 9 calculation ,! ,secret>y %all exclude any in=mation 9 direct & indirect remun]ation reports submitt$ ) respect to ,,pace programs "u section #ahid 7pursuant to section #ahfj;,d-#ba7;f77 & qualifi$ retiree prescription drug plans 7z def9$ 9 section #ahfj;,d-#bb7;a77#b77 f ! in=mation t is made available to ! public "u subp>agraph 7,a74 7#b7 ,f9ancial audit results ,9 #bjba & ea* subsequ5t ye>1 ! ,secret>y %all make available to ! public on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices data on ! results ( f9ancial audits requir$ "u section #ahfj;,d-#ab7;b77#c77;,c74 ,in=mation made available "u ?is p>agraph %all include ! foll[+3 7,a7 ,) respect to a ye>1 ! numb] ( ,,pdp sponsors t receiv$ ea* ( ! foll[+ 7or successor categories71 ) an indication ( ! numb] t p]ta9 to direct & indirect remun]ation3 7i7 ,a notice ( obs]vations or f9d+s4 7ii7 ,an unqualifi$ audit op9ion t r5d]s ! audit clos$4 7iii7 ,a qualifi$ audit op9ion t requires ! sponsor to submit a corrective action plan to ! ,secret>y4 7iv7 ,an adv]se op9ion1 ) a description ( ! types ( actions t ! ,secret>y takes :5 issu+ an adv]se op9ion4 7v7 ,a disclaim$ op9ion4 7,b7 ,) respect to a ye>1 ! numb] ( ,,pdp sponsors-- 7i7 t reop5$ a previ\sly clos$ reconciliation z a result ( an audit1 indicat+ ^? t p]ta9 to direct & indirect remun]ation *anges2 & 7ii7 = :i* ! ,secret>y rec\p$ a paym5t or made a paym5t z a result ( a reop5+ ( a previ\sly clos$ reconciliation1 indicat+ :5 su* rec\pm5t or paym5t p]ta9s to direct & indirect remun]ation4 7#c7 ,no id5tification ( specific ,,pdp sponsors ,! in=mation to be made available on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices describ$ 9 p>agraph 7#a7 & p>agraph 7#b7 %all n id5tity ! specific ,,pdp sponsor to :i* any det]m9ation or action p]ta9s4 7#d7 ,def9ition ( direct & indirect remun]ation ,= purposes ( ?is subsection1 ! t]m direct & indirect remun]ation means direct & indirect remun]ation z describ$ 9 section #dbc4cjh ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation4 4 #abe4 ,increas+ ! use ( real-"t b5efit tools to l[] b5efici>y co/s 7a7 ,requir+ prescription drug plan sponsors & ,m$ic>e ,advantage organizations ,to include real-,"t b5efit in=mation "u ,m$ic>e "p ,d ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is am5d$-- 7#a7 by r$esignat+ subsection 7m7 7relat+ to program integrity transp>5cy measures71 z add$ by section #fjfc7;c7 ( ! ,sub/ance ,use-,disord] ,prev5tion t ,promotes ,opioid ,recov]y & ,treatm5t = ,pati5ts & ,communities ,act 7,public ,law #aae-bga71 z subsection 7n72 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7o7 ,real-,"t b5efit in=mation 7#a7 ,9 g5]al ,aft] ! ,secret>y has adopt$ a /&>d "u p>agraph 7#c7 = electronic real-"t b5efit tools1 & at a "t det]m9$ appropriate by ! ,secret>y1 a ,,pdp sponsor ( a prescription drug plan %all implem5t "o or m ( su* tools t meet ! requirem5ts describ$ 9 p>agraph 7#b74 7#b7 ,requirem5ts ,= purposes ( p>agraph 7#a71 ! requirem5ts describ$ 9 ?is p>agraph1 ) respect to an electronic real-"t b5efit tool1 are t ! tool is capable (-- 7,a7 integrat+ ) electronic prescrib+ & electronic heal? record sy/ems ( prescrib+ heal? c>e pr(essionals = ! transmission ( eligibility & =mul>y & b5efit in=mation 9 real "t to su* pr(essionals2 & 7,b7 ) respect to a cov]$ "p ,d drug1 transmitt+ su* in=mation specific to an individual enroll$ 9 a prescription drug plan1 includ+ ! foll[+3 7i7 ,a li/ ( any cl9ically-appropriate alt]natives to su* drug includ$ 9 ! =mul>y ( su* plan4 7ii7 ,co/-%>+ in=mation & ! negotiat$ price = su* drug & su* alt]natives at-- 7,i7 multiple ph>macy options1 includ+ ! individual's pref]r$ ph>macy &1 z applicable1 o!r retail ph>macies & a mail ord] ph>macy2 & 7,,ii7 ! =mul>y /atus ( su* drug & su* alt]natives & any prior au?orization or o!r utilization managem5t requirem5ts applicable to su* drug & su* alt]natives includ$ 9 ! =mul>y ( su* plan4 7#c7 ,/&>ds ,9 ord] to be treat$ 7= purposes ( ?is subsection7 z an electronic real-"t b5efit tool describ$ 9 p>agraph 7#a71 su* tool %all comply ) te*nical /&>ds adopt$ by ! ,secret>y 9 consultation ) ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 ! ,national ,c\ncil = ,prescription ,drug ,programs1 o!r /&>d sett+ organizations det]m9$ appropriate by ! ,secret>y1 & /akehold]s includ+ ,,pdp sponsors1 ,m$ic>e ,advantage organizations1 heal? c>e pr(essionals1 & heal? in=mation te*nology s(tw>e v5dors4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to prohibit ! application ( p>agraph 7b77#g7 ( section #dbc4afj ( title #db1 ,code ( ,f$]al ,regulations1 z is to be add$ to su* section pursuant to ! f9al rule publi%$ 9 ! ,f$]al ,regi/] on ,may #bc1 #bjai1 & titl$ ,mod]niz+ ,"p ,d & ,m$ic>e ,advantage ,to ,l[] ,drug ,prices & ,r$uce ,out-(-,pocket ,exp5ses 7#hd ,f$4 ,reg4 #bchcb ?r\gh #bchhd74 4 7b7 ,requir+ qualifi$ electronic heal? records ,to include real-,"t b5efit tools ,section #cjjj7ac7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj7#ac77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,c7 includes1 or is capable ( includ+1 a real-"t b5efit tool t conveys pati5t-specific real-"t co/ & cov]age in=mation ) respect to prescription drugs t1 ) respect to any heal? in=mation te*nology c]tifi$ = electronic prescrib+1 ! te*nology %all be capable ( incorporat+ ! in=mation describ$ 9 clauses 7i7 & 7ii7 ( p>agraph 7#b77;,b7 ( section #ahfj;,d-#d7o7 ( ! ,social ,security ,act at a "t specifi$ by ! ,secret>y b n be=e ! ,secret>y adopts a /&>d = su* tools z describ$ 9 p>agraph 7#a7 ( su* section4 4 7c7 ,inclusion ( use ( real-,"t electronic in=mation 9 %>$ decision-,mak+ "u ,,mips ,section #ahdh7q77#b77;,b77iii77,,iv7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#b77;,b77iii77,,iv77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,?is subcategory %all include z an activity option1 beg9n+ ) ! p]=mance p]iod />t+ on ,janu>y #a1 #bjba1 use ( a real-"t b5efit tool z describ$ 9 #ahfj;,d-#d7o744 #abf4 ,improvem5ts to provision ( p>ts ,a & ,b claims data to prescription drug plans 7a7 ,data use 7#a7 ,9 g5]al ,p>agraph 7#f7 ( section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 z add$ by section #ejced ( division ,e ( ! ,bip>tisan ,budget ,act ( #bjah 7,public ,law #aae-abc71 relat+ to provid+ prescription drug plans ) p>ts ,a & ,b claims data to promote ! appropriate use ( m$ications & improve heal? outcomes1 is am5d$-- 7,a7 9 subp>agraph 7,b7-- 7i7 by r$esignat+ clauses 7i71 7ii71 & 7iii7 z subclauses 7,i71 7,,ii71 & 7,,iii71 respectively1 & mov+ su* subclauses #b ems to ! "r2 7ii7 by /rik+ ,purposes4--,a ,,pdp sponsor & ins]t+ ,purposes-- 7i7 ,9 g5]al ,a ,,pdp sponsor4 2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7ii7 ,cl>ification ,! limitation on data use "u subp>agraph 7,c77i7 %all n apply to ! ext5t t ! ,,pdp sponsor is us+ ! data provid$ to c>ry out any ( ! purposes describ$ 9 clause 7i74 2 & 7,b7 9 subp>agraph 7,c77i71 by /rik+ ,to in=m & ins]t+ ,subject to subp>agraph 7,b77ii71 to in=m4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb4 7b7 ,mann] ( provision ,subp>agraph 7,d7 ( su* p>agraph 7#f7 is am5d$-- 7#a7 by /rik+ describ$4--,! data describ$ 9 ?is clause & ins]t+ 8describ$4-- 7i7 ,9 g5]al ,! data describ$ 9 ?is subp>agraph 2 & 7#b7 by add+ at ! end ! foll[+ new clause3 7ii7 ,mann] ( provision 7,i7 ,9 g5]al ,su* data may be provid$ pursuant to ?is p>agraph 9 ! same mann] z data "u ! ,"p ,d ,enhanc$ ,m$ication ,!rapy ,managem5t model te/$ "u section #aaae;,a1 ?r\gh ,application ,programm+ ,int]face1 or 9 ano!r mann] z det]m9$ by ! ,secret>y4 7,,ii7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is clause by program in/ruction or o!rwise4 4 7c7 ,te*nical correction ,su* p>agraph 7#f7 is r$esignat$ z p>agraph 7#g74 #abg4 ,p]man5tly au?orize a successful pilot on retroactive ,m$ic>e "p ,d cov]age = l[-income b5efici>ies ,section #ahfj;,d-#ad ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7 is am5d$-- 7#a7 by r$esignat+ subsection 7e7 z subsection 7f72 & 7#b7 by ins]t+ aft] subsection 7d7 ! foll[+ new subsection3 7e7 ,limit$ income newly eligible transition 7,,li ,,net7 program 7#a7 ,9 g5]al ,by n lat] ?an #bjbb1 ! ,secret>y %all e/abli% a program to provide transitional cov]age = cov]$ "p ,d drugs = ,,li ,,net eligible individuals 9 accordance ) ?is subsection4 7#b7 ,,li ,,net eligible individual def9$ ,= purposes ( ?is subsection1 ! t]m ,,li ,,net eligible individual means a "p ,d eligible individual :o-- 7,a7 meets ! requirem5ts ( clauses 7ii7 & 7iii7 ( subsection 7a77#c77;,a72 & 7,b7 has n yet enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan1 or1 :o has s enroll$1 b ) respect to :om cov]age "u su* plan has n yet tak5 effect4 7#c7 ,transitional cov]age def9$ ,= purposes ( ?is subsection1 ! t]m transitional cov]age means ! foll[+ ) respect to a ,,li ,,net eligible individual3 7,a7 ,all ,,li ,,net eligible individuals ,imm$iate access to cov]$ "p ,d drugs at ! po9t ( sale dur+ ! p]iod t beg9s on ! fir/ day ( ! mon? su* individual is det]m9$ to meet ! requirem5ts ( clauses 7ii7 & 7iii7 ( subsection 7a77#c77;,a7 & ends on ! date t cov]age "u a prescription drug plan or an ,,ma-,,pd plan takes effect ) respect to su* individual4 7,b7 ,full-b5efit dual eligibles & ,,ssi recipi5ts ,9 ! case ( a ,,li ,,net eligible individual :o is a full-b5efit dual eligible individual 7z def9$ 9 section #aice7;c77#f77 or recipi5t ( supplem5tal security income b5efits "u title ,,xvi1 retroactive cov]age 79 ! =m ( reimbursem5t ( ! am\nts t w\ld h be5 paid "u ?is "p _h su* individual be5 enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan7 ( cov]$ "p ,d drugs pur*as$ by su* individual dur+ ! p]iod t-- 7i7 beg9s on ! date t is ! lat] ( ! date t-- 7,i7 su* individual 0 fir/ eligible = a l[ income subsidy "u ?is "p2 or 7,,ii7 is #cf mon?s prior to ! date su* individual enrolls 9 a prescription drug plan or an ,,ma-,,pd plan2 & 7ii7 ends on ! date t cov]age "u su* plan takes effect4 7#d7 ,program adm9i/ration 7,a7 ,s+le po9t ( contact ,! ,secret>y %all1 to ! ext5t feasible1 adm9i/] ! program "u ?is subsection ?r\gh a contract ) a s+le program adm9i/rator :o w provide = a s+le po9t ( contact = ,,li ,,net eligible individuals4 7,b7 ,b5efit design ,! ,secret>y %all ensure t ! transitional cov]age provid$ to ,,li ,,net eligible individuals "u ?is subsection-- 7i7 provides access to all cov]$ "p ,d drugs "u an op5 =mul>y2 7ii7 p]mits all ph>macies det]m9$ by ! ,secret>y to be 9 good /&+ to process claims "u ! program2 7iii7 is consi/5t ) su* requirem5ts z ! ,secret>y consid]s necess>y to improve pati5t safety & ensure appropriate disp5s+ ( m$ication2 & 7iv7 meets su* o!r requirem5ts z ! ,secret>y may e/abli%4 7#e7 ,relation%ip to o!r provisions ( ?is title2 waiv] au?ority 7,a7 ,9 g5]al ,! foll[+ provisions %all n apply to ! program "u ?is subsection3 7i7 ,p>agraphs 7#a7 & 7#c77;,b7 ( section #ahfj;,d-#d7;a7 7dissem9ation ( g5]al in=mation2 availability ( in=mation on *anges 9 =mul>y ?r\gh ! int]net74 7ii7 ,subp>agraphs 7,a7 & 7,b7 ( section #ahfj;,d-#d7;b77#c7 7developm5t & revision by a ph>macy & !rapeutic committee2 =mul>y developm5t74 7iii7 ,p>agraphs 7#a77;,c7 & 7#b7 ( section #ahfj;,d-#d7;c7 7m$ication !rapy managem5t program74 7,b7 ,waiv] au?ority ,! ,secret>y may waive su* o!r requirem5ts ( title ,,xi & ?is title z may be necess>y to c>ry out ! purposes ( ! program e/abli%$ "u ?is subsection4 4 #abh4 ,m$ic>e "p ,d rebate by manufactur]s = c]ta9 drugs ) prices increas+ fa/] ?an inflation 7a7 ,9 g5]al ,subp>t #b ( "p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,b1 z add$ by section #aba1 ! foll[+ new section3 #ahfj;,d-#ad;,c4 ,manufactur] rebate = c]ta9 drugs ) prices increas+ fa/] ?an inflation 7a7 ,requirem5ts 7#a7 ,secret>ial provision ( in=mation 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 n lat] ?an #f mon?s aft] ! end ( ea* rebate p]iod 7z def9$ 9 p>agraph 7#d77;,a77 beg9n+ on or aft] ,janu>y #a1 #bjbc1 ! ,secret>y %all1 = ea* rebatable cov]$ "p ,d drug 7z def9$ 9 p>agraph 7#d77;,b771 report to ea* manufactur] 7z def9$ 9 p>agraph 7#d77;,c77 ( su* rebatable cov]$ "p ,d drug ! foll[+ = ! rebate p]iod3 7i7 ,in=mation on ! total numb] ( units 7z def9$ 9 p>agraph 7#d77;,d77 ( ea* dosage =m & /r5g? describ$ 9 p>agraph 7#a77;,a7 ( subsection 7b7 = su* rebatable cov]$ "p ,d drug & rebate p]iod4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess price describ$ 9 p>agraph 7#a77;,b7 ( su* subsection = su* rebatable cov]$ "p ,d drug & rebate p]iod4 7iii7 ,! rebate am\nt specifi$ "u su* subsection = su* rebatable cov]$ "p ,d drug & rebate p]iod4 7iv7 ,o!r in=mation det]m9$ appropriate by ! ,secret>y4 7,b7 ,transition rule = in=mation 9 #bjbc ,not)/&+ subp>agraph 7,a71 ! ,secret>y may1 = ea* rebatable cov]$ "p ,d drug1 delay ! timeframe = report+ ! in=mation & rebate am\nt describ$ 9 clauses 7i71 7ii71 7iii71 & 7iv7 ( su* subp>agraph = rebate p]iods 9 #bjbc until n lat] ?an ,decemb] #ca1 #bjbd4 7#b7 ,manufactur] rebate 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 = ea* rebate p]iod beg9n+ on or aft] ,janu>y #a1 #bjbc1 ea* manufactur] ( a rebatable cov]$ "p ,d drug %all1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation & rebate am\nt pursuant to p>agraph 7#a71 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 subsection 7b7 = su* drug = su* rebate p]iod4 7,b7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u ?is p>agraph ) respect to a rebatable cov]$ "p ,d drug t is li/$ on ! drug %ortage li/ ma9ta9$ by ! ,food & ,drug ,adm9i/ration pursuant to section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7#c7 ,reque/ = reconsid]ation ,! ,secret>y %all e/abli% proc$ures "u :i* a manufactur] ( a rebatable cov]$ "p ,d drug may reque/ a reconsid]ation by ! ,secret>y ( ! rebate am\nt specifi$ "u subsection 7b7 = su* drug & rebate p]iod1 z report$ to ! manufactur] pursuant to p>agraph 7#a74 ,tim+ = a reconsid]ation %all be coord9at$ ) ! tim+ ( reconciliation1 z describ$ 9 subsection 7b77#f7 & z det]m9$ appropriate by ! ,secret>y4 7#d7 ,def9itions ,9 ?is section3 7,a7 ,rebate p]iod 7i7 ,9 g5]al ,subject to clause 7ii71 ! t]m rebate p]iod means1 ) respect to a ye>1 ea* ( ! six mon? p]iods t beg9 on ,janu>y #a & ,july #a ( ! ye>4 7ii7 ,initial rebate p]iod = subsequ5tly approv$ drugs ,9 ! case ( a rebatable cov]$ "p ,d drug describ$ 9 subsection 7c71 ! initial rebate p]iod = :i* a rebate am\nt is det]m9$ = su* rebatable cov]$ "p ,d drug pursuant to su* subsection %all be ! p]iod beg9n+ ) ! fir/ mon? aft] ! la/ day ( ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$ & end+ on ! la/ day ( ! fir/ full rebate p]iod "u clause 7i7 t foll[s ! la/ day ( su* six mon? p]iod4 7,b7 ,rebatable cov]$ "p ,d drug ,! t]m rebatable cov]$ "p ,d drug means a cov]$ "p ,d drug approv$ "u a new drug application "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or1 9 ! case ( a biologic product1 lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 7,c7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 su* t]m 9 section #ahfj;,d--#ad;,a7g74 7,d7 ,units ,! t]m units means1 ) respect to a rebatable cov]$ "p ,d drug1 ! l[e/ common quantity 7su* z ! numb] ( capsules or tablets1 milligrams ( molecules1 or grams7 ( su* drug disp5s$ to individuals "u ?is "p4 7,e7 ,price ,! t]m price means1 ) respect to a rebatable cov]$ "p ,d drug1 ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = su* drug4 7b7 ,rebate am\nt 7#a7 ,9 g5]al ,subject to subsection 7e77#b71 ! am\nt ( ! rebate specifi$ 9 ?is subsection = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug1 is ! am\nt equal to ! product (-- 7,a7 ! total numb] ( units ( su* dosage =m & /r5g? = ea* rebatable cov]$ "p ,d drug dur+ ! rebate p]iod2 & 7,b7 ! am\nt 7if any7 by :i*-- 7i7 ! unit-weight$ av]age price = su* dosage =m & /r5g? ( ! drug det]m9$ "u p>agraph 7#b7 = ! rebate p]iod2 exce$s 7ii7 ! inflation-adju/$ price = su* dosage =m & /r5g? det]m9$ "u p>agraph 7#c7 = ! rebate p]iod4 7#b7 ,det]m9ation ( unit-weight$ av]age price 7,a7 ,9 g5]al ,! unit-weight$ av]age price det]m9$ "u ?is p>agraph = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( a rebatable cov]$ ,"p ,d drug1 is ! sum ( ! products (-- 7i7 ! weight$ av]age price det]m9$ "u subp>agraph 7,b7 ) respect to ea* package size ( su* dosage =m & /r5g? disp5s$ dur+ ! rebate p]iod2 & 7ii7 ! ratio (-- 7,i7 ! total numb] ( units ( su* package size disp5s$ dur+ ! rebate p]iod2 to 7,,ii7 ! total numb] ( units ( su* dosage =m & /r5g? ( su* drug disp5s$ dur+ su* rebate p]iod4 7,b7 ,computation ( weight$ av]age price ,! weight$ av]age price1 ) respect to ea* package size ( su* dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug disp5s$ dur+ a rebate p]iod1 is ! sum ( ! products (-- 7i7 ea* price1 z calculat$ = a unit ( su* drug1 applicable to ea* package size ( su* dosage =m & /r5g? ( su* drug dur+ ! rebate p]iod2 & 7ii7 ! ratio (-- 7,i7 ! numb] ( days = :i* ea* su* price is applicable dur+ ! rebate p]iod2 to 7,,ii7 ! total numb] ( days 9 su* rebate p]iod4 7#c7 ,det]m9ation ( inflation-adju/$ price 7,a7 ,9 g5]al ,! inflation-adju/$ price det]m9$ "u ?is p>agraph = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug1 is-- 7i7 ! b5*m>k unit-weight$ price det]m9$ "u subp>agraph 7,b7 = ! rebate p]iod2 increas$ by 7ii7 ! p]c5tage by :i* ! rebate p]iod ,,cpi-,u 7z def9$ 9 p>agraph 7#d77 = ! rebate p]iod exce$s ! b5*m>k ,,cpi-,u 7z def9$ 9 p>agraph 7#e774 7,b7 ,det]m9ation ( b5*m>k unit-weight$ price ,! b5*m>k unit-weight$ price det]m9$ "u ?is subp>agraph = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug1 is ! sum ( ! products (-- 7i7 ea* price1 z calculat$ = a unit ( su* drug1 applicable to ea* package size ( su* dosage =m & /r5g? ( su* drug on ,july #a1 #bjai2 & 7ii7 ! ratio (-- 7,i7 ! total numb] ( units ( su* package size disp5s$ on ,july #a1 #bjai2 to 7,,ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ on ,july #a1 #bjai4 7#d7 ,b5*m>k ,,cpi-,u ,! t]m b5*m>k ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,july #bjai4 7#e7 ,rebate p]iod ,,cpi-,u ,! t]m rebate p]iod ,,cpi-,u means1 ) respect to a rebate p]iod1 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! la/ mon? ( ! rebate p]iod4 7#f7 ,annual reconciliation ( rebate am\nt ,! ,secret>y %all1 on an annual basis1 conduct a "o-"t reconciliation ( ! rebate am\nts ow$ by a manufactur] "u ?is section bas$ on any *anges submitt$ by a ,,pdp sponsor ( a prescription drug plan or an ,,ma organization (f]+ an ,,ma-,,pd plan to ! numb] ( units ( a rebatable cov]$ "p ,d drug disp5s$ dur+ ! prec$+ ye>4 ,su* reconciliation %all be complet$ n lat] ?an #f mon?s aft] ! date by :i* ! ,secret>y reconciles paym5t = cov]$ "p ,d drugs ) ,,pdp sponsors ( prescription drug plans or ,,ma organizations (f]+ ,,ma-,,pd plans4 7c7 ,treatm5t ( subsequ5tly approv$ drugs ,subject to subsection 7e77#b71 9 ! case ( a rebatable cov]$ "p ,d drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjai-- 7#a7 subp>agraph 7,a77ii7 ( subsection 7b77#c7 %all be appli$ z if ! t]m b5*m>k ,,cpi-,u 7 def9$ "u subsection 7b77#d7 z if ! ref]5ce to ,july #bjai "u su* subsection 7 a ref]5ce to ! fir/ mon? aft] ! la/ day ( ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$2 & 7#b7 subsection 7b77#c7 %all be appli$ by sub/itut+1 = ! b5*m>k unit-weight$ price o!rwise det]m9$ "u subp>agraph 7,b7 ( su* subsection1 ! b5*m>k unit-weight$ av]age price det]m9$ "u p>agraph 7#c7 = ! rebate p]iod2 7#c7 ! b5*m>k unit-weight$ av]age price det]m9$ "u ?is p>agraph = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug1 is ! sum ( ! products (-- 7,a7 ! subsequ5tly rebatable drug weight$ av]age price det]m9$ "u p>agraph 7#d7 ) respect to ea* package size ( su* dosage =m & /r5g? ( su* drug disp5s$ dur+ ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$2 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units ( su* package size disp5s$ dur+ ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? ( su* drug disp5s$ dur+ su* six mon? p]iod2 & 7#d7 ! subsequ5tly rebatable drug weight$ av]age price1 ) respect to ea* package size ( su* dosage =m & /r5g? ( su* rebatable cov]$ "p ,d drug disp5s$ dur+ ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$1 is ! sum ( ! products (-- 7,a7 ea* price1 z calculat$ = a unit ( su* drug1 applicable to ea* package size ( su* dosage =m & /r5g? ( su* drug dur+ ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$2 & 7,b7 ! ratio (-- 7i7 ! numb] ( days = :i* ea* su* price is applicable dur+ su* six mon? p]iod2 to 7ii7 ! total numb] ( days 9 su* six mon? p]iod4 7d7 ,rebate deposits ,am\nts paid z rebates "u subsection 7b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7e7 ,adm9i/ration 7#a7 ,p]iodic audits ,! ,secret>y %all p]mit a manufactur] ( a rebatable cov]$ "p ,d drug to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ to det]m9e ! rebate am\nt = su* drug "u ?is section4 7#b7 ,special rules = calculation ( b5*m>k unit-weight$ price & b5*m>k-unit-weight$ av]age price 7,a7 ,b5*m>k unit-weight$ price ,9 ! case t ! b5*m>k unit-weight$ price ( a dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug is det]m9$ "u subsection 7b77#c77;,b7 to be #j due to no units ( su* dosage =m & /r5g? ( su* drug be+ disp5s$ on ,july #a1 #bjai1 ! ,secret>y may use a calculation1 z det]m9$ appropriate by ! ,secret>y1 to det]m9e ! b5*m>k-unit weight$ price = su* dosage =m & /r5g? ( su* drug t is diff]5t ?an ! calculation describ$ 9 su* subsection4 7,b7 ,b5*m>k unit-weight$ av]age price ,9 ! case t ! b5*m>k unit-weight$ av]age price ( a dosage =m & /r5g? ( a rebatable cov]$ "p ,d drug describ$ "u subsection 7c7 is det]m9$ "u p>agraph 7#c7 ( su* subsection to be #j due to no units ( su* dosage =m & /r5g? ( su* drug be+ disp5s$ dur+ ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$1 ! ,secret>y may use a calculation1 z det]m9$ appropriate by ! ,secret>y1 to det]m9e ! b5*m>k-unit weight$ av]age price = su* dosage =m & /r5g? ( su* drug t is diff]5t ?an ! calculation describ$ 9 su* p>agraph4 7#c7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 7#d7 ,judicial review ,!re %all be no adm9i/rative or judicial review "u section #ahfi1 section #ahgh1 or o!rwise ( ! det]m9ation ( ! rebate am\nt "u subsection 7b71 includ+ ) respect to a subsequ5tly approv$ drug pursuant to subsection 7c71 includ+-- 7,a7 ! det]m9ation (-- 7i7 ! total numb] ( units ( ea* rebatable cov]$ "p ,d drug "u subsection 7b77#a77;,a72 7ii7 ! unit-weight$ av]age price "u subsection 7b77#b72 7iii7 ! inflation-adju/$ price "u subsection 7b77#c72 7iv7 ! b5*m>k unit-weight$ av]age price "u subsection 7c77#c72 & 7v7 ! subsequ5tly rebatable drug weight$ av]age price "u subsection 7c77#d72 & 7,b7 ! application ( special rules = calculation ( b5*m>k unit-weight$ price & b5*m>k unit-weight$ av]age price "u p>agraph 7#b7 ( ?is subsection4 7f7 ,civil money p5alty 7#a7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] t fails to comply ) ! requirem5ts "u subsection 7a77#b7 ) respect to provid+ a rebate = a rebatable cov]$ "p ,d drug = a rebate p]iod = ea* su* failure 9 an am\nt equal to ! sum (-- 7,a7 ! rebate am\nt det]m9$ pursuant to subsection 7b7 = su* drug = su* rebate p]iod2 & 7,b7 #be p]c5t ( su* am\nt4 7#b7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z hav+ any effect on-- 7#a7 any =mul>y design "u section #ahfj;,d-#d7;b77#c72 or 7#b7 any disc\nts provid$ "u ! cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a or ! manufactur] cata/rophic disc\nt program "u section #ahfj;,d-#ad;,b4 7h7 ,rebate agreem5t 7#a7 ,9 g5]al ,! ,secret>y %all ent] into agreem5ts describ$ 9 p>agraph 7#b7 ) manufactur]s4 7#b7 ,t]ms ( agreem5t 7,a7 ,9 g5]al ,a rebate agreem5t "u ?is p>agraph %all require ! manufactur] to provide to ! ,secret>y rebates requir$ "u subsection 7a77#b77;,a7 ) respect to a rebate p]iod4 7,b7 ,manufactur] provision ( price & drug product in=mation ,ea* manufactur] ) an agreem5t 9 effect "u ?is subsection %all report to ! ,secret>y1 ) respect to ea* rebatable cov]$ "p ,d drug ( ! manufactur]1 at a "t specifi$ by ! ,secret>y-- 7i7 = ea* cal5d> mon? "u ! rebate agreem5t-- 7,i7 ea* :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77 applicable dur+ ! mon?1 applicable to ea* ,national ,drug ,code = ! dosage =m & /r5g? ( su* rebatable cov]$ "p ,d drug2 & 7,,ii7 ! numb] ( days ) respect to :i* ea* :olesale acquisition co/ report$ 0 applicable2 7ii7 ! :olesale acquisition co/ 7z s def9$7 applicable on ,july #a1 #bjai1 applicable to ea* ,national ,drug ,code = ! dosage =m & /r5g? ( su* rebatable cov]$ "p ,d drug 7or1 9 ! case ( a rebatable cov]$ "p ,d drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjai1 ea* :olesale acquisition co/ applicable to ea* ,national ,drug ,code ( ea* dosage =m & /r5g? ( ! rebatable cov]$ "p ,d drug ( ! manufactur] dur+ ! six mon? p]iod t beg9s on ! day on :i* ! drug 0 fir/ m>ket$72 & 7iii7 su* o!r in=mation z ! ,secret>y %all require4 ,in=mation report$ "u ?is subp>agraph is subject to audit by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#c7 ,civil money p5alties ,! provisions ( subp>agraph 7,c7 ( section #aibg7;b77#c7 %all apply ) respect to in=mation requir$ pursuant to p>agraph 7#b77;,b7 ( ?is subsection & ! failure to provide su* in=mation 9 ! same mann] & to ! same ext5t z su* provisions apply ) respect to in=mation requir$ "u subp>agraph 7,a7 ( su* section #aibg7;b77#c7 & ! failure to provide su* in=mation4 7#d7 ,coord9ation ,! ,secret>y may coord9ate rebate agreem5ts requir$ "u ?is subsection ) agreem5ts requir$ "u section #ahfj;,d-#ad;,b4 7i7 ,fund+ 7#a7 ,9 g5]al ,!re are appropriat$ to ! ,secret>y1 f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda-- 7,a7 = ea* ( cal5d> ye>s #bjbj ?r\gh #bjbe1 #d1jjj1jjj2 & 7,b7 = ea* subsequ5t cal5d> ye>1 su* sums z are necess>y to c>ry out ?is section4 7#b7 ,availability ,am\nts appropriat$ "u p>agraph 7#a7 %all rema9 available until exp5d$4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec71 z am5d$ by section #aba7;g71 is am5d$-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#e71 by /rik+ & at ! end2 7ii7 9 p>agraph 7#f71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new p>agraph3 7#g7 h ent]$ into & h 9 effect an agreem5t describ$ 9 section #ahfj;,d-#ad;,c7h77#b7 ) ! ,secret>y4 2 7,b7 9 subsection 7b71 by /rik+ 7#f7 & ins]t+ 7#g72 & 7,c7 9 subsection 7c71 by /rik+ 7#f7 & ins]t+ 7#g74 7#b7 ,section #aibg7;c77#a77;,c77,,vi7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77,,vi77 is am5d$-- 7,a7 by /rik+ or any disc\nts & ins]t+ any disc\nts2 & 7,b7 by ins]t+ 1 or any rebates "u section #ahfj;,d-#ad;,c be=e ! p]iod4 #abi4 ,prohibit+ br&+ on "p ,d b5efit c>ds 7a7 ,9 g5]al ,section #ahea7;j77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;j77#b77;,b77 is am5d$ by /rik+ co-br&$ network provid] & ins]t+ co-br&$1 co-own$1 or affiliat$ network provid]1 ph>macy1 or ph>macy b5efit manag]4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb4 #acj4 ,requir+ prescription drug plans & ,,ma-,,pd plans to report pot5tial fraud1 wa/e1 & abuse to ! ,secret>y ( ,,hhs ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd71 z am5d$ by section #abe1 is am5d$ by add+ at ! end ! foll[+ new subsection3 7p7 ,report+ pot5tial fraud1 wa/e1 & abuse ,beg9n+ ,janu>y #a1 #bjba1 ! ,,pdp sponsor ( a prescription drug plan %all report to ! ,secret>y1 z specifi$ by ! ,secret>y-- 7#a7 any sub/antiat$ or suspici\s activities 7z def9$ by ! ,secret>y7 ) respect to ! program "u ?is "p z x relates to fraud1 wa/e1 & abuse2 & 7#b7 any /eps made by ! ,,pdp sponsor aft] id5tify+ su* activities to take corrective actions4 4 #aca4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c771 z am5d$ by section #abf1 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ( ph>macy quality measures 7,a7 ,9 g5]al ,a ,,pdp sponsor t makes inc5tive paym5ts to a ph>macy or receives price concessions paid by a ph>macy bas$ on quality measures %all1 = ! purposes ( su* inc5tive paym5ts or price concessions ) respect to cov]$ "p ,d drugs disp5s$ by su* ph>macy1 only use measures-- 7i7 e/abli%$ or adopt$ by ! ,secret>y "u subp>agraph 7,b71 z li/$ "u clause 7ii7 ( su* subp>agraph2 & 7ii7 t are relevant to ! p]=mance ( su* ph>macy ) respect to areas t ! ph>macy c impact4 7,b7 ,/&>d ph>macy quality measures 7i7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y %all e/abli% or adopt quality measures f "o or m multi-/akehold]1 cons5sus organizations to be us$ by a ,,pdp sponsor = ! purposes ( det]m9+ inc5tive paym5ts & price concessions describ$ 9 subp>agraph 7,a74 ,su* measures %all be evid5ce-bas$ & focus on ph>macy p]=mance on pati5t heal? outcomes & o!r areas1 z det]m9$ by ! ,secret>y1 t ! ph>macy c impact4 7ii7 ,ma9t5ance ( li/ ,! ,secret>y %all ma9ta9 a s+le li/ ( measures e/abli%$ or adopt$ "u ?is subp>agraph4 7,c7 ,effective date ,! requirem5t "u subp>agraph 7,a7 %all take effect = plan ye>s beg9n+ on ,janu>y #a1 #bjbb1 or su* e>li] date specifi$ by ! ,secret>y if ! ,secret>y det]m9es !re are suffici5t measures e/abli%$ or adopt$ "u subp>agraph 7,b7 = ! purposes ( ! requirem5t "u subp>agraph 7,a74 4 #acb4 ,addition ( new measures bas$ on access to biosimil> biological products to ! #e-/> rat+ sy/em "u ,m$ic>e ,advantage 7a7 ,9 g5]al ,section #ahec7o77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,addition ( new measures bas$ on access to biosimil> biological products 7i7 ,9 g5]al ,= #bjbf & subsequ5t ye>s1 ! ,secret>y %all add a new set ( measures to ! #e-/> rat+ sy/em bas$ on access to biosimil> biological products cov]$ "u "p ,b &1 9 ! case ( ,,ma-,,pd plans1 su* products t are cov]$ "p ,d drugs4 ,su* measures %all assess ! impact a plan's b5efit /ructure may h on enrollees' utilization ( or ability to access biosimil> biological products1 includ+ 9 comp>ison to ! ref]5ce biological product1 & %all include measures1 z applicable1 ) respect to ! foll[+3 7,i7 ,cov]age ,assess+ :e!r a biosimil> biological product is on ! plan =mul>y 9 lieu ( or 9 addition to ! ref]5ce biological product4 7,,ii7 ,pref]5c+ ,assess+ ti] placem5t or co/-%>+ = a biosimil> biological product relative to ! ref]5ce biological product4 7,,iii7 ,utilization managem5t tools ,assess+ :e!r & h[ utilization managem5t tools are us$ ) respect to a biosimil> biological product relative to ! ref]5ce biological product4 7,,iv7 ,utilization ,assess+ ! p]c5tage ( enrollees prescrib$ ! biosimil> biological product & ! p]c5tage ( enrollees prescrib$ ! ref]5ce biological product :5 ! ref]5ce biological product is also on ! plan =mul>y4 7ii7 ,def9itions ,9 ?is subp>agraph1 ! t]ms biosimil> biological product & ref]5ce biological product h ! mean+ giv5 ^? t]ms 9 section #ahdg;,a7c77#f74 7iii7 ,protect+ ,pati5t ,int]e/s ,9 develop+ su* measures1 ! ,secret>y %all ensure t ea* measure develop$ to address cov]age1 pref]5c+1 or utilization managem5t is con/ruct$ su* t pati5ts reta9 access to appropriate !rapeutic options )\t undue adm9i/rative burd54 4 7b7 ,cl>ification reg>d+ application to prescription drug plans ,to ! ext5t ! ,secret>y ( ,heal? & ,human ,s]vices applies ! #e-/> rat+ sy/em "u section #ahec7o77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77#d771 or a simil> sy/em1 to prescription drug plans "u "p ,d ( title ,,xviii ( su* ,act1 ! provisions ( subp>agraph 7,e7 ( su* section1 z add$ by subsection 7a7 ( ?is section1 %all apply "u ! sy/em ) respect to su* plans 9 ! same mann] z su* provisions apply to ! #e-/> rat+ sy/em "u su* section #ahec7o77#d74 #acc4 ,fairness 9 ! calculation ( ! "p ,d premium 7a7 ,9 g5]al ,section #ahfj;,d-#ac7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aac7;a77 is am5d$-- 7#a7 9 p>agraph 7#c77;,a71 by /rik+ #be4e p]c5t & ins]t+ ! applicable p]c5t 7z specifi$ 9 p>agraph 7#h772 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,applicable p]c5t ,= purposes ( p>agraph 7#c77;,a71 ! applicable p]c5t specifi$ 9 ?is p>agraph is-- 7,a7 = ye>s prior to #bjbb1 #be4e p]c5t2 & 7,b7 = #bjbb & subsequ5t ye>s1 #bd4e p]c5t4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,subsidy ,section #ahfj;,d-#ae7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;a77 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 7or1 = #bjbj & subsequ5t ye>s1 #ge4e p]c5t7 aft] #gd4e p]c5t4 7#b7 ,fallback area mon?ly b5efici>y premium ,section #ahfj;,d-#aa7;g77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;g77#f77 is am5d$ by /rik+ #be4e p]c5t & ins]t+ ! applicable p]c5t 7z specifi$ 9 section #ahfj;,d-#ac7;a77#h774 7#c7 ,income-relat$ mon?ly adju/m5t am\nt 7,,irmaa7 ,section #ahfj;,d-#ac7;a77#g77;,b77i77,,ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aac7;a77#g77;,b77i77,,ii77 is am5d$ by /rik+ #be4e p]c5t & ins]t+ ! applicable p]c5t 7z specifi$ 9 p>agraph 7#h774 #acd4 ,,hhs /udy & report on ! influ5ce ( ph>maceutical manufactur] ?ird-p>ty reimbursem5t hubs on heal? c>e provid]s :o prescribe _! drugs & biologicals 7a7 ,/udy 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all conduct a /udy on ! influ5ce ( ph>maceutical manufactur] di/ribution models t provide ?ird-p>ty reimbursem5t hub s]vices on heal? c>e provid]s :o prescribe ! manufactur]'s drugs & biologicals1 includ+ = ,m$ic>e "p ,d b5efici>ies4 7#b7 ,requirem5ts ,! /udy "u p>agraph 7#a7 %all include an analysis ( ! foll[+3 7,a7 ,! influ5ce ( ph>maceutical manufactur] di/ribution models t provide ?ird-p>ty reimbursem5t hub s]vices to heal? c>e provid]s :o prescribe ! manufactur]'s drugs & biologicals1 includ+-- 7i7 ! op]ations ( ph>maceutical manufactur] di/ribution models t provide reimbursem5t hub s]vices = heal? c>e provid]s :o prescribe ! manufactur]'s products2 7ii7 ,f$]al laws affect+ ^! ph>maceutical manufactur] di/ribution models2 & 7iii7 :e!r hub s]vices c\ld improp]ly inc5tivize heal? c>e provid]s to deem a drug or biological z m$ically necess>y "u section #dbc4egh ( title #db1 ,code ( ,f$]al ,regulations4 7,b7 ,o!r areas det]m9$ appropriate by ! ,secret>y4 7b7 ,report ,n lat] ?an ,july #a1 #bjbb1 ! ,secret>y %all submit to ,congress a report on ! /udy conduct$ "u subsection 7a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,secret>y det]m9es appropriate4 7c7 ,consultation ,9 conduct+ ! /udy "u subsection 7a7 & prep>+ ! report "u subsection 7b71 ! ,secret>y %all consult ) ! ,attorney ,g5]al4 ,c ,miscellane\s #ada4 ,drug manufactur] price transp>5cy ,title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by ins]t+ aft] section #aabh,k ! foll[+ new section3 #aabh,l4 ,drug manufactur] price transp>5cy 7a7 ,9 g5]al 7#a7 ,det]m9ations ,beg9n+ ,july #a1 #bjbb1 ! ,secret>y %all make det]m9ations z to :e!r a drug is an applicable drug z describ$ 9 subsection 7b74 7#b7 ,requir$ ju/ification ,if ! ,secret>y det]m9es "u p>agraph 7#a7 t an applicable drug is describ$ 9 subsection 7b71 ! manufactur] ( ! applicable drug %all submit to ! ,secret>y ! ju/ification describ$ 9 subsection 7c7 9 accordance ) ! tim+ describ$ 9 subsection 7d74 7b7 ,applicable drug describ$ 7#a7 ,9 g5]al ,an applicable drug is describ$ 9 ?is subsection if x meets any ( ! foll[+ at ! "t ( ! det]m9ation3 7,a7 ,l>ge increase ,! drug 7p] dose7-- 7i7 has a :olesale acquisition co/ ( at lea/ #aj2 & 7ii7 _h an increase 9 ! :olesale acquisition co/1 ) respect to det]m9ations made-- 7,i7 dur+ #bjbj1 ( at lea/ #ajj p]c5t s9ce ! date ( ! enactm5t ( ?is section2 7,,ii7 dur+ #bjba1 ( at lea/ #ajj p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #aej p]c5t 9 ! prec$+ #bd mon?s2 7,,iii7 dur+ #bjbb1 ( at lea/ #ajj p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #bjj p]c5t 9 ! prec$+ #cf mon?s2 7,,iv7 dur+ #bjbc1 ( at lea/ #ajj p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #bej p]c5t 9 ! prec$+ #dh mon?s2 or 7,v7 on or aft] ,janu>y #a1 #bjbd1 ( at lea/ #ajj p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #cjj p]c5t 9 ! prec$+ #fj mon?s4 7,b7 ,high sp5d+ ) increase ,! drug-- 7i7 0 9 ! top #ej? p]c5tile ( net sp5d+ "u title ,,xviii or ,,xix 7to ! ext5t data is available7 dur+ any #ab-mon? p]iod 9 ! prec$+ #fj mon?s2 & 7ii7 p] dose1 _h an increase 9 ! :olesale acquisition co/1 ) respect to det]m9ations made-- 7,i7 dur+ #bjbj1 ( at lea/ #ae p]c5t s9ce ! date ( ! enactm5t ( ?is section2 7,,ii7 dur+ #bjba1 ( at lea/ #ae p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #bj p]c5t 9 ! prec$+ #bd mon?s2 7,,iii7 dur+ #bjbb1 ( at lea/ #ae p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #cj p]c5t 9 ! prec$+ #cf mon?s2 7,,iv7 dur+ #bjbc1 ( at lea/ #ae p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #dj p]c5t 9 ! prec$+ #dh mon?s2 or 7,v7 on or aft] ,janu>y #a1 #bjbd1 ( at lea/ #ae p]c5t 9 ! prec$+ #ab mon?s or ( at lea/ #ej p]c5t 9 ! prec$+ #fj mon?s4 7,c7 ,high laun* price = new drugs ,9 ! case ( a drug t is m>ket$ = ! fir/ "t on or aft] ,janu>y #a1 #bjbj1 & = :i* ! manufactur] has e/abli%$ ! fir/ :olesale acquisition co/ on or aft] su* date1 su* :olesale acquisition co/ = a ye>'s supply or a c\rse ( treatm5t = su* drug exce$s ! gross sp5d+ = cov]$ "p ,d drugs at :i* ! annual out-(-pocket ?re%old "u section #ahfj;,d-#b7;b77#d77;,b7 w\ld be met = ! ye>4 7#b7 ,special ,rules 7,a7 ,au?ority ( ,secret>y to sub/itute p]c5tages )9 a de m9imis range ,= purposes ( apply+ p>agraph 7#a71 ! ,secret>y may sub/itute = ea* p]c5tage describ$ 9 subp>agraph 7,a7 or 7,b7 ( su* p>agraph 7o!r ?an ! p]c5tile describ$ subp>agraph 7,b77i7 ( su* p>agraph7 a p]c5tage )9 a de m9imis range specifi$ by ! ,secret>y bel[ ! p]c5tage s describ$4 7,b7 ,drugs ) high laun* prices annually report until a !rapeutic equival5t is available ,9 ! case ( a drug t ! ,secret>y det]m9es is an applicable drug describ$ 9 subp>agraph 7,c7 ( p>agraph 7#a71 su* drug %all rema9 describ$ 9 su* subp>agraph 7,c7 7& ! manufactur] ( su* drug %all annually report ! ju/ification "u subsection 7c77#b77 until ! ,secret>y det]m9es t !re is a !rapeutic equival5t 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations1 or any successor regulation7 = su* drug4 7#c7 ,dose ,= purposes ( apply+ p>agraph 7#a71 ! ,secret>y %all e/abli% a def9ition ( ! t]m dose4 7c7 ,ju/ification describ$ 7#a7 ,increase 9 ,,wac ,9 ! case ( a drug t ! ,secret>y det]m9es is an applicable drug describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7b77#a71 ! ju/ification describ$ 9 ?is subsection is all relevant1 tru?ful1 & nonmislead+ in=mation & support+ docum5tation necess>y to ju/ify ! increase 9 ! :olesale acquisition co/ ( ! applicable drug ( ! manufactur]1 z det]m9$ appropriate by ! ,secret>y & :i* may include ! foll[+3 7,a7 ,! individual factors t h contribut$ to ! increase 9 ! :olesale acquisition co/4 7,b7 ,an explanation ( ! role ( ea* factor 9 contribut+ to su* increase4 7,c7 ,total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 7ii7 acquir+ pat5ts & lic5s+ = ea* drug ( ! manufactur]2 & 7iii7 co/s to pur*ase or acquire ! drug f ano!r company1 if applicable4 7,d7 ,! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds4 7,e7 ,! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug4 7,f7 ,! total rev5ue & net pr(it g5]at$ f ! applicable drug = ea* cal5d> ye> s9ce drug approval4 7,g7 ,! total exp5ditures ( ! manufactur] t are associat$ ) m>ket+ & adv]tis+ = ! applicable drug4 7,h7 ,additional in=mation specific to ! manufactur] ( ! applicable drug1 su* z-- 7i7 ! total rev5ue & net pr(it ( ! manufactur] = ! p]iod ( su* increase1 z det]m9$ by ! ,secret>y2 7ii7 metrics us$ to det]m9e executive comp5sation2 7iii7 any additional in=mation relat$ to drug pric+ decisions ( ! manufactur]1 su* z total exp5ditures on-- 7,i7 drug rese>* & developm5t2 or 7,,ii7 cl9ical trials on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration4 7#b7 ,high laun* price ,9 ! case ( a drug t ! ,secret>y det]m9es is an applicable drug describ$ 9 subp>agraph 7,c7 ( subsection 7b77#a71 ! ju/ification describ$ 9 ?is subsection is all relevant1 tru?ful1 & nonmislead+ in=mation & support+ docum5tation necess>y to ju/ify ! :olesale acquisition co/ ( ! applicable drug ( ! manufactur]1 z det]m9$ by ! ,secret>y & :i* may include ! items describ$ 9 subp>agraph 7,c7 ?r\gh 7,h7 ( p>agraph 7#a74 7d7 ,tim+ 7#a7 ,notification ,n lat] ?an #fj days aft] ! date on :i* ! ,secret>y makes ! det]m9ation t a drug is an applicable drug "u subsection 7b71 ! ,secret>y %all notify ! manufactur] ( ! applicable drug ( su* det]m9ation4 7#b7 ,submission ( ju/ification ,n lat] ?an #ahj days aft] ! date on :i* a manufactur] receives a notification "u p>agraph 7#a71 ! manufactur] %all submit to ! ,secret>y ! ju/ification requir$ "u subsection 7a74 7#c7 ,po/+ on ,int]net website 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 n lat] ?an #cj days aft] receiv+ ! ju/ification "u p>agraph 7#b71 ! ,secret>y %all po/ on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ! ju/ification1 toge!r ) a summ>y ( su* ju/ification t is writt5 & =matt$ us+ language t is easily und]/&able by b5efici>ies "u titles ,,xviii & ,,xix4 7,b7 ,exclusion ( propriet>y in=mation ,! ,secret>y %all exclude propriet>y in=mation1 su* z trade secrets & intellectual prop]ty1 submitt$ by ! manufactur] 9 ! ju/ification "u p>agraph 7#b7 f ! po/+ describ$ 9 subp>agraph 7,a74 7e7 ,exception to requirem5t = submission ,9 ! case ( a drug t ! ,secret>y det]m9es is an applicable drug describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7b77#a71 ! requirem5t to submit a ju/ification "u subsection 7a7 %all n apply :]e ! manufactur]1 aft] receiv+ ! notification "u subsection 7d77#a7 ) respect to ! applicable drug ( ! manufactur]1 r$uces ! :olesale acquisition co/ ( a drug s t x no long] is describ$ 9 su* subp>agraph 7,a7 or 7,b7 = at lea/ a #d-mon? p]iod1 z det]m9$ by ! ,secret>y4 7f7 ,p5alties 7#a7 ,failure to submit timely ju/ification ,if ! ,secret>y det]m9es t a manufactur] has fail$ to submit a ju/ification z requir$ "u ?is section1 includ+ 9 accordance ) ! tim+ & =m requir$1 ) respect to an applicable drug1 ! ,secret>y %all apply a civil monet>y p5alty 9 an am\nt ( #aj1jjj = ea* day ! manufactur] has fail$ to submit su* ju/ification z s requir$4 7#b7 ,false in=mation ,any manufactur] t submits a ju/ification "u ?is section & kn[+ly provides false in=mation 9 su* ju/ification is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7#c7 ,application ( proc$ures ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,civil monet>y p5alties impos$ "u ?is subsection are 9 addition to o!r p5alties z may be prescrib$ by law4 7g7 ,def9itions ,9 ?is section3 7#a7 ,drug ,! t]m drug means a drug1 z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 t is int5d$ = human use & subject to section #ejc7;b77#a7 ( su* ,act1 includ+ a product lic5s$ "u section #cea ( ! ,public heal? ,s]vice ,act4 7#b7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,a74 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b74 4 #adb4 ,/r5g!n+ & exp&+ ph>macy b5efit manag]s transp>5cy requirem5ts ,section #aaej;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc71 z am5d$ by section #abc1 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by /rik+ or at ! end2 7,b7 9 p>agraph 7#b71 by /rik+ ! comma at ! end & ins]t+ 2 or2 & 7,c7 by ins]t+ aft] p>agraph 7#b7 ! foll[+ new p>agraph3 7#c7 a ,/ate plan "u title ,,xix1 includ+ a manag$ c>e entity 7z def9$ 9 section #aicb7;a77#a77;,b771 2 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 by /rik+ 7exclud+ bona fide & all t foll[s ?r\gh pati5t education programs772 & 7ii7 by /rik+ aggregate am\nt ( & ins]t+ aggregate am\nt & p]c5tage (2 7,b7 9 p>agraph 7#c71 by /rik+ aggregate am\nt ( & ins]t+ aggregate am\nt & p]c5tage 7def9$ z a %>e ( gross drug co/s7 (2 & 7,c7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,! aggregate am\nt ( bona fide s]vice fees 7:i* include di/ribution s]vice fees1 inv5tory managem5t fees1 product /ock+ all[ances1 & fees associat$ ) adm9i/rative s]vices agreem5ts & pati5t c>e programs 7su* z m$ication compliance programs & pati5t education programs77 ! ,,pbm receiv$ f-- 7,a7 ,,pdp sponsors2 7,b7 qualifi$ heal? b5efit plans2 7,c7 manag$ c>e entities 7z def9$ 9 section #aicb7;a77#a77;b772 & 7,d7 drug manufactur]s4 2 7#c7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraphs3 7#e7 ,to ,/ates to c>ry out _! adm9i/ration & ov]sight ( ! ,/ate plan "u title ,,xix4 7#f7 ,to ! ,f$]al ,trade ,commission to c>ry out section #e7;a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de;a7 & any o!r relevant consum] protection or antitru/ au?orities en=c$ by su* ,commission1 includ+ review+ propos$ m]g]s 9 ! prescription drug sector4 7#g7 ,to assi/ ! ,dep>tm5t ( ,ju/ice to c>ry out its antitru/ au?orities1 includ+ review+ propos$ m]g]s 9 ! prescription drug sector4 2 & 7#d7 by add+ at ! end ! foll[+ new subsection3 7f7 ,annual ,,oig evaluation & report 7#a7 ,analysis ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct an annual evaluation ( ! in=mation provid$ to ! ,secret>y "u ?is section4 ,su* evaluation %all include an analysis (-- 7,a7 ,,pbm rebates2 7,b7 adm9i/rative fees2 7,c7 ! diff]5ce betwe5 :at plans pay ,p,b,ms & :at ,p,b,ms pay ph>macies2 7,d7 g5]ic disp5s+ rates2 & 7,e7 o!r areas det]m9$ appropriate by ! ,inspector ,g5]al4 7#b7 ,report ,n lat] ?an ,july #a1 #bjba1 & annually !reaft]1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all submit to ,congress a report conta9+ ! results ( ! evaluation conduct$ "u p>agraph 7#a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,inspector ,g5]al det]m9es appropriate4 ,su* report %all n disclose ! id5tity ( a specific ,,pbm1 plan1 or price *>g$ = a drug4 4 #adc4 ,prescription drug pric+ da%bo>ds ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new section3 #aaej;,c4 ,prescription drug pric+ da%bo>ds 7a7 ,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all e/abli%1 & annually update1 int]net website-bas$ da%bo>ds1 ?r\gh :i* b5efici>ies1 cl9icians1 rese>*]s1 & ! public c review in=mation on sp5d+ =1 & utilization (1 prescription drugs & biologicals 7& relat$ supplies & me*anisms ( deliv]y7 cov]$ "u ea* ( p>ts ,b & ,d ( title ,,xviii & "u a ,/ate program "u title ,,xix1 includ+ in=mation on tr5ds ( su* sp5d+ & utilization ov] "t4 7b7 ,m$ic>e "p ,b drug & biological da%bo>d 7#a7 ,9 g5]al ,! da%bo>d e/abli%$ "u subsection 7a7 = "p ,b ( title ,,xviii %all provide ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,! in=mation describ$ 9 ?is p>agraph is ! foll[+ in=mation ) respect to drug or biologicals cov]$ "u su* "p ,b3 7,a7 ,! br& "n &1 if applicable1 ! g5]ic names ( ! drug or biological4 7,b7 ,consum]-fri5dly in=mation on ! uses & cl9ical indications ( ! drug or biological4 7,c7 ,! manufactur] or label] ( ! drug or biological4 7,d7 ,to ! ext5t feasible1 ! foll[+ in=mation3 7i7 ,av]age total sp5d+ p] dosage unit ( ! drug or biological 9 ! mo/ rec5t #b cal5d> ye>s = :i* data is available4 7ii7 ,! p]c5tage *ange 9 av]age sp5d+ on ! drug or biological p] dosage unit betwe5 ! mo/ rec5t cal5d> ye> = :i* data is available &-- 7,i7 ! prec$+ cal5d> ye>2 & 7,,ii7 ! prec$+ #e & #aj cal5d> ye>s4 7iii7 ,! annual gr[? rate 9 av]age sp5d+ p] dosage unit ( ! drug or biological 9 ! mo/ rec5t #e or #aj cal5d> ye>s = :i* data is available4 7iv7 ,total sp5d+ = ! drug or biological = ! mo/ rec5t cal5d> ye> = :i* data is available4 7v7 ,! numb] ( b5efici>ies receiv+ ! drug or biological 9 ! mo/ rec5t cal5d> ye> = :i* data is available4 7vi7 ,av]age sp5d+ on ! drug p] b5efici>y = ! mo/ rec5t cal5d> ye> = :i* data is available4 7,e7 ,! av]age sales price ( ! drug or biological 7z det]m9$ "u section #ahdg;,a7 = ! mo/ rec5t qu>t]4 7,f7 ,consum]-fri5dly in=mation ab\t ! co9surance am\nt = ! drug or biological = b5efici>ies = ! mo/ rec5t qu>t]4 ,su* in=mation %all n include co9surance am\nts = qualifi$ m$ic>e b5efici>ies 7z def9$ 9 section #aije7p77#a774 7,g7 ,= ! mo/ rec5t cal5d> ye> = :i* data is available-- 7i7 ! #ae drugs & biologicals ) ! highe/ total sp5d+ "u su* "p2 & 7ii7 any drug or biological = :i* ! av]age annual p] b5efici>y sp5d+ exce$s ! gross sp5d+ = cov]$ "p ,d drugs at :i* ! annual out-(-pocket ?re%old "u section #ahfj;,d-#b7;b77#d77;,b7 w\ld be met = ! ye>4 7,h7 ,o!r in=mation 7n o!rwise prohibit$ 9 law f be+ disclos$7 t ! ,secret>y det]m9es w\ld provide b5efici>ies1 cl9icians1 rese>*]s1 & ! public ) helpful in=mation ab\t drug & biological sp5d+ & utilization 7includ+ tr5ds ( su* sp5d+ & utilization74 7c7 ,m$ic>e cov]$ "p ,d drug da%bo>d 7#a7 ,9 g5]al ,! da%bo>d e/abli%$ "u subsection 7a7 = "p ,d ( title ,,xviii %all provide ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,! in=mation describ$ 9 ?is p>agraph is ! foll[+ in=mation ) respect to cov]$ "p ,d drugs "u su* "p ,d3 7,a7 ,! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,d7 ( subsection 7b77#b74 7,b7 ,in=mation on av]age annual b5efici>y out-(-pocket co/s bel[ & above ! annual out-(-pocket ?re%old "u section #ahfj;,d-#b7;b77#d77;,b7 = ! curr5t plan ye>4 ,su* in=mation %all n include out-(-pocket co/s = subsidy eligible individuals "u section #ahfj;,d-#ad4 7,c7 ,in=mation on h[ to access res\rces z describ$ 9 sections #ahfj;,d-#a7;c7 & #ahea7;d74 7,d7 ,= ! mo/ rec5t cal5d> ye> = :i* data is available-- 7i7 ! #ae cov]$ "p ,d drugs ) ! highe/ total sp5d+ "u su* "p2 & 7ii7 any cov]$ "p ,d drug = :i* ! av]age annual p] b5efici>y sp5d+ exce$s ! gross sp5d+ = cov]$ "p ,d drugs at :i* ! annual out-(-pocket ?re%old "u section #ahfj;,d-#b7;b77#d77;,b7 w\ld be met = ! ye>4 7,e7 ,o!r in=mation 7n o!rwise prohibit$ 9 law f be+ disclos$7 t ! ,secret>y det]m9es w\ld provide b5efici>ies1 cl9icians1 rese>*]s1 & ! public ) helpful in=mation ab\t cov]$ "p ,d drug sp5d+ & utilization 7includ+ tr5ds ( su* sp5d+ & utilization74 7d7 ,m$icaid cov]$ outpati5t drug da%bo>d 7#a7 ,9 g5]al ,! da%bo>d e/abli%$ "u subsection 7a7 = title ,,xix %all provide ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,! in=mation describ$ 9 ?is p>agraph is ! foll[+ in=mation ) respect to cov]$ outpati5t drugs "u su* title3 7,a7 ,! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,d7 ( subsection 7b77#b74 7,b7 ,= ! mo/ rec5t cal5d> ye> = :i* data is available1 ! #ae cov]$ outpati5t drugs ) ! highe/ total sp5d+ "u su* title4 7,c7 ,o!r in=mation 7n o!rwise prohibit$ 9 law f be+ disclos$7 t ! ,secret>y det]m9es w\ld provide b5efici>ies1 cl9icians1 rese>*]s1 & ! public ) helpful in=mation ab\t cov]$ outpati5t drug sp5d+ & utilization 7includ+ tr5ds ( su* sp5d+ & utilization74 7e7 ,data files ,! ,secret>y %all make available ! und]ly+ data = ea* da%bo>d e/abli%$ "u subsection 7a7 9 a ma*9e-readable =mat4 4 #add4 ,improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 7a7 ,9 g5]al 7#a7 ,public meet+ 7,a7 ,9 g5]al ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conv5e a public meet+ = ! purposes ( discuss+ & provid+ input on improvem5ts to coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 9 prep>+ = ! availability ( novel m$ical products describ$ 9 subsection 7c7 on ! m>ket 9 ! ,unit$ ,/ates4 7,b7 ,att5dees ,! ,secret>y %all invite ! foll[+ to ! public meet+3 7i7 ,repres5tatives ( relevant ,f$]al ag5cies1 includ+ repres5tatives f ea* ( ! m$ical product c5t]s )9 ! ,food & ,drug ,adm9i/ration & repres5tatives f ! cod+1 cov]age1 & paym5t (fices )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7ii7 ,/akehold]s ) exp]tise 9 ! rese>* & developm5t ( novel m$ical products1 includ+ manufactur]s ( su* products4 7iii7 ,repres5tatives ( comm]cial heal? insurance pay]s4 7iv7 ,/akehold]s ) exp]tise 9 ! adm9i/ration & use ( novel m$ical products1 includ+ physicians4 7v7 ,/akehold]s repres5t+ pati5ts & ) exp]tise 9 ! utilization ( pati5t exp]i5ce data 9 m$ical product developm5t4 7,c7 ,topics ,! public meet+ ag5da %all include-- 7i7 an ov]view ( ! types ( products & product categories 9 ! drug & m$ical device developm5t pipel9e & ! volume ( products :i* may meet ! description ( a novel m$ical product "u subsection 7c72 7ii7 ! anticipat$ exp]tise necess>y to review ! safety & effectiv5ess ( su* products at ! ,food & ,drug ,adm9i/ration & curr5t gaps 9 su* exp]tise1 if any2 7iii7 ! exp]tise necess>y to make cod+1 cov]age1 & paym5t decisions ) respect to su* products )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 & curr5t gaps 9 su* exp]tise1 if any2 7iv7 tr5ds 9 ! diff]5ces 9 ! data necess>y to det]m9e ! safety & effectiv5ess ( a novel m$ical product & ! data necess>y to det]m9e :e!r a novel m$ical product meets ! reasonable & necess>y requirem5ts = cov]age & paym5t "u title ,,xviii ( ! ,social ,security ,act pursuant to section #ahfb7;a77#a77;,a7 ( su* ,act 7#db ,u4,s4,c4 #aciey7a77#a77;,a772 7v7 ! availability ( in=mation = sponsors ( su* novel m$ical products to meet ea* ( ^? requirem5ts2 & 7vi7 ! coord9ation ( in=mation relat$ to significant cl9ical improvem5t ov] exi/+ !rapies = pati5ts betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ) respect to novel m$ical products4 7,d7 ,trade secrets & confid5tial in=mation ,no?+ "u ?is section %all be con/ru$ z au?oriz+ ! ,secret>y to disclose any in=mation t is a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,improv+ transp>5cy ( crit]ia = ,m$ic>e cov]age 7,a7 ,draft guidance ,n lat] ?an #ah mon?s aft] ! public meet+ "u p>agraph 7#a71 ! ,secret>y %all update ! f9al guidance titl$ ,national ,cov]age ,det]m9ations ) ,data ,collection z a ,condition ( ,cov]age3 ,cov]age ) ,evid5ce ,developm5t to address any opportunities to improve ! availability & coord9ation ( in=mation z describ$ 9 clauses 7iv7 ?r\gh 7vi7 ( p>agraph 7#a77;,c74 7,b7 ,f9al guidance ,n lat] ?an #ab mon?s aft] issu+ draft guidance "u subp>agraph 7,a71 ! ,secret>y %all f9alize ! updat$ guidance to address any su* opportunities4 7b7 ,report on cod+1 cov]age1 & paym5t processes "u m$ic>e = novel m$ical products ,n lat] ?an #ab mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all publi% a report on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices reg>d+ processes "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 ) respect to ! cod+1 cov]age1 & paym5t ( novel m$ical products describ$ 9 subsection 7c74 ,su* report %all include ! foll[+3 7#a7 ,a description ( *all5ges 9 ! cod+1 cov]age1 & paym5t processes "u ! ,m$ic>e program = novel m$ical products4 7#b7 ,recomm5dations to-- 7,a7 incorporate pati5t exp]i5ce data 7su* z ! impact ( a disease or condition on ! lives ( pati5ts & pati5t treatm5t pref]5ces7 into ! cov]age & paym5t processes )9 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7,b7 decrease ! l5g? ( "t to make national & local cov]age det]m9ations "u ! ,m$ic>e program 7z ^? t]ms are def9$ 9 subp>agraphs 7,a7 & 7,b71 respectively1 ( section #ahfb7l77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#f772 7,c7 /reaml9e ! cov]age process "u ! ,m$ic>e program & incorporate input f relevant /akehold]s into su* cov]age det]m9ations2 & 7,d7 id5tify pot5tial me*anisms to incorporate novel paym5t designs simil> to ^? 9 developm5t 9 comm]cial insurance plans & ,/ate plans "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 into ! ,m$ic>e program4 7c7 ,novel m$ical products describ$ ,= purposes ( ?is section1 a novel m$ical product describ$ 9 ?is subsection is a drug1 includ+ a biological product 7includ+ g5e & cell !rapy71 or m$ical device1 t has be5 designat$ z a break?r\gh !rapy "u section #ejf7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771 a break?r\gh device "u section #eae;,b ( su* ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 or a reg5]ative advanc$ !rapy "u section #ejf7;g7 ( su* ,act 7#ba ,u4,s4,c4 #cef7;g774 #ade4 ,pati5t consultation 9 ,m$ic>e national & local cov]age det]m9ations 9 ord] to mitigate b>ri]s to inclusion ( su* p]spectives ,section #ahfb7l7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,pati5t consultation 9 national & local cov]age det]m9ations ,) respect to national cov]age det]m9ations1 ! ,secret>y1 & ) respect to local cov]age det]m9ations1 ! ,m$ic>e adm9i/rative contractor1 may consult ) pati5ts & organizations repres5t+ pati5ts1 includ+ pati5ts ) disabilities1 9 mak+ national & local cov]age det]m9ations4 4 #adf4 ,,gao /udy on increases to ,m$ic>e & ,m$icaid sp5d+ due to copaym5t c\pons & o!r pati5t assi/ance programs 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! impact ( copaym5t c\pons & o!r pati5t assi/ance programs on prescription drug pric+ & exp5ditures )9 ! ,m$ic>e & ,m$icaid programs4 ,! /udy %all assess ! foll[+3 7#a7 ,! ext5t to :i* copaym5t c\pons & o!r pati5t assi/ance programs contribute to inflat$ prescription drug prices "u su* programs4 7#b7 ,! impact copaym5t c\pons & o!r pati5t assi/ance programs h 9 ! ,m$ic>e ,"p ,d program e/abli%$ "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 on utilization ( high]-co/ br& drugs & l[] utilization ( g5]ic drugs 9 t program4 7#c7 ,! ext5t to :i* manufactur]s report or obta9 tax b5efits1 includ+ d$uctions ( bus9ess exp5ses & *>itable contributions1 = any ( ! foll[+3 7,a7 ,(f]+ copaym5t c\pons or o!r pati5t assi/ance programs4 7,b7 ,sponsor+ manufactur] pati5t assi/ance programs4 7,c7 ,pay+ = sponsor%ips at outrea* & advocacy ev5ts organiz$ by pati5t assi/ance programs4 7#d7 ,! efficacy ( ov]sight conduct$ to ensure t indep5d5t *>ity pati5t assi/ance programs adh]e to guidance f ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices on avoid+ wa/e1 fraud1 & abuse4 7b7 ,def9itions ,9 ?is section3 7#a7 ,indep5d5t *>ity pati5t assi/ance program ,! t]m indep5d5t *>ity pati5t assi/ance program means any organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f taxation "u section #eja7;a7 ( su* ,code & :i* is n a private f\ndation 7z def9$ 9 section #eji7;a7 ( su* ,code7 t (f]s pati5t assi/ance4 7#b7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 t t]m 9 section #aibg7k77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#e774 7#c7 ,manufactur] pati5t assi/ance program ,! t]m manufactur] pati5t assi/ance program means an organization1 includ+ a private f\ndation 7z s def9$71 t is sponsor$ by1 or receives fund+ f1 a manufactur] & t (f]s pati5t assi/ance4 ,su* t]m does n include an indep5d5t *>ity pati5t assi/ance program4 7#d7 ,pati5t assi/ance ,! t]m pati5t assi/ance means assi/ance provid$ to (fset ! co/ ( drugs = individuals4 ,su* t]m includes free products1 c\pons1 rebates1 copay or disc\nt c>ds1 & o!r means ( provid+ assi/ance to individuals relat$ to drug co/s1 z det]m9$ by ! ,secret>y ( ,heal? & ,human ,s]vices4 7c7 ,report ,n lat] ?an #bd mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report describ+ ! f9d+s ( ! /udy requir$ "u subsection 7a74 #adg4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d 7a7 ,/udy ,! ,m$ic>e ,paym5t ,advisory ,commission 79 ?is section ref]r$ to z ! ,commission7 %all conduct a /udy on %ift+ cov]age ( c]ta9 drugs & biologicals = :i* paym5t is curr5tly made "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 to "p ,d ( su* title 7#db ,u4,s4,c4 #aciew-#ba et seq474 ,su* /udy %all include an analysis (-- 7#a7 diff]5ces 9 program /ructures & paym5t me?ods = drugs & biologicals cov]$ "u su* p>ts ,b & ,d1 includ+ effects ( su* a %ift on program sp5d+1 b5efici>y co/-%>+ liability1 & utilization managem5t te*niques = su* drugs & biologicals2 & 7#b7 ! feasibility & policy implications ( %ift+ cov]age ( drugs & biologicals = :i* paym5t is curr5tly made "u su* "p ,b to su* "p ,d4 7b7 ,report 7#a7 ,9 g5]al ,n lat] ?an ,june #cj1 #bjba1 ! ,commission %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a74 7#b7 ,cont5ts ,! report "u p>agraph 7#a7 %all include in=mation1 & recomm5dations z ! ,commission deems appropriate1 reg>d+-- 7,a7 =mul>y design "u su* "p ,d2 7,b7 ! ability ( ! b5efit /ructure "u su* "p ,d to control total sp5d+ on drugs & biologicals = :i* paym5t is curr5tly made "u su* "p ,b2 7,c7 *anges to ! bid process "u su* "p ,d1 if any1 t may be necess>y to integrate cov]age ( su* drugs & biologicals into su* "p ,d2 & 7,d7 any o!r *anges to ! program t ,congress %\ld consid] 9 det]m9+ :e!r to %ift cov]age ( su* drugs & biologicals f su* "p ,b to su* "p ,d4 #adh4 ,tak+ /eps to fulfill treaty obligations to tribal communities 7a7 ,,gao /udy ,! ,comptroll] ,g5]al %all conduct a /udy reg>d+ access to1 & ! co/ (1 prescription drugs among ,indians4 ,! /udy %all include-- 7#a7 a review ( :at ,indian heal? programs pay = prescription drugs on res]vations1 9 urban c5t]s1 & 9 ,tribal communities relative to o!r consum]s2 7#b7 recomm5dations to align ! value ( prescription drug disc\nts available "u ! ,m$icaid drug rebate program e/abli%$ "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 ) prescription drug disc\nts available to ,tribal communities ?r\gh ! pur*as$_/ref]r$ c>e program ( ! ,indian ,heal? ,s]vice = physician adm9i/]$ drugs2 & 7#c7 an exam9ation ( h[ ,tribal communities & urban ,indian organizations utilize ! ,m$ic>e "p ,d program e/abli%$ "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 & recomm5dations to improve enrollm5t among ,indians 9 t program4 7b7 ,report ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 7c7 ,def9itions ,9 ?is section3 7#a7 ,comptroll] ,g5]al ,! t]m ,comptroll] ,g5]al means ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates4 7#b7 ,indian2 ,indian heal? program2 ,indian tribe ,! t]ms ,indian1 ,indian heal? program1 & ,indian tribe h ! mean+s giv5 ^? t]ms 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act 7#be ,u4,s4,c4 #afjc74 ,,ii ,m$icaid drug pric+ re=ms #bja4 ,m$icaid ph>macy & !rapeutics committee improvem5ts 7a7 ,9 g5]al ,subp>agraph 7,a7 ( section #aibg7;d77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;d77#d77 is am5d$ to read z foll[s3 7,a7 7i7 ,! =mul>y is develop$ & review$ by a ph>macy & !rapeutics committee consi/+ ( physicians1 ph>maci/s1 & o!r appropriate individuals appo9t$ by ! ,gov]nor ( ! ,/ate4 7ii7 ,subject to clause 7vi71 ! ,/ate e/abli%es & implem5ts a conflict ( int]e/ policy = ! ph>macy & !rapeutics committee t-- 7,i7 is publicly accessible2 7,,ii7 requires all committee memb]s to complete1 on at lea/ an annual basis1 a disclosure ( relation%ips1 associations1 & f9ancial deal+s t may affect _! indep5d5ce ( judgem5t 9 committee matt]s2 & 7,,iii7 conta9s cle> processes1 su* z recusal f vot+ or discussion1 = ^? memb]s :o report a conflict ( int]e/1 along ) appropriate processes to address any in/ance :]e a memb] fails to report a conflict ( int]e/4 7iii7 ,! memb]%ip ( ! ph>macy & !rapeutics committee-- 7,i7 is made publicly available2 7,,ii7 is compos$ ( memb]s :o are indep5d5t & free ( any conflict1 includ+ ) respect to manufactur]s1 m$icaid manag$ c>e entities1 & ph>macy b5efit manag]s2 & 7,,iii7 includes at lea/ #a actively practic+ physician & at lea/ #a actively practic+ ph>maci/1 ea* ( :om has exp]tise 9 ! c>e ( #a or m ,m$icaid-specific populations su* z eld]ly or disabl$ individuals1 *ildr5 ) complex m$ical ne$s1 or l[-income individuals ) *ronic illnesses4 7iv7 ,at ! option ( ! ,/ate1 ! ,/ate's drug use review bo>d e/abli%$ "u subsection 7g77#c7 may s]ve z ! ph>macy & !rapeutics committee provid$ ! ,/ate ensures t su* bo>d meets ! requirem5ts ( clauses 7ii7 & 7iii74 7v7 ,! ,/ate reviews & has f9al approval ( ! =mul>y e/abli%$ by ! ph>macy & !rapeutics committee4 7vi7 ,if ! ,secret>y det]m9es x appropriate or necess>y bas$ on ! f9d+s & recomm5dations ( ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 9 ! report submitt$ to ,congress "u section #bjc ( ! ,prescription ,drug ,pric+ ,r$uction ,act ( #bjbj1 ! ,secret>y %all issue guidance t ,/ates mu/ foll[ = e/abli%+ conflict ( int]e/ policies = ! ph>macy & !rapeutics committee 9 accordance ) ! requirem5ts ( clause 7ii71 includ+ appropriate /&>ds & requirem5ts = id5tify+1 address+1 & report+ on conflicts ( int]e/4 4 7b7 ,application to ,m$icaid manag$ c>e organizations 7#a7 ,9 g5]al ,clause 7xiii7 ( section #aijc7m77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is am5d$-- 7,a7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 7,b7 by /rik+ ! p]iod at ! end & ins]t+ 1 & 7,,iv7 any =mul>y us$ by ! entity = cov]$ outpati5t drugs disp5s$ to individuals eligible = m$ical assi/ance :o are enroll$ ) ! entity is develop$ & review$ by a ph>macy & !rapeutics committee t meets ! requirem5ts ( clauses 7ii7 & 7iii7 ( section #aibg7;d77#d77;,a742 & 7,c7 by mov+ ! left m>g9 #b ems to ! left4 7#b7 ,application to ,p,i,h,ps & ,p,a,h,ps ,section #aijc7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,no paym5t %all be made "u ?is title to a ,/ate ) respect to exp5ditures incurr$ by ! ,/ate = paym5t = s]vices provid$ by an o!r specifi$ entity 7z def9$ 9 p>agraph 7#i77;,d77iii77 unless su* s]vices are provid$ 9 accordance ) a contract betwe5 ! ,/ate & ! entity :i* satisfies ! requirem5ts ( p>agraph 7#b77;,a77xiii74 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #bjb4 ,improv+ report+ requirem5ts & develop+ /&>ds = ! use ( drug use review bo>ds 9 ,/ate ,m$icaid programs 7a7 ,9 g5]al ,section #aibg7;g77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;g77#c77 is am5d$-- 7#a7 by am5d+ subp>agraph 7,b7 to read z foll[s3 7,b7 ,memb]%ip 7i7 ,9 g5]al ,! memb]%ip ( ! ,,dur ,bo>d %all include heal? c>e pr(essionals :o h recogniz$ k & exp]tise 9 "o or m ( ! foll[+3 7,i7 ,! cl9ically appropriate prescrib+ ( cov]$ outpati5t drugs4 7,,ii7 ,! cl9ically appropriate disp5s+ & monitor+ ( cov]$ outpati5t drugs4 7,,iii7 ,drug use review1 evaluation1 & int]v5tion4 7,,iv7 ,m$ical quality assurance4 7ii7 ,memb]%ip requirem5ts ,! memb]%ip ( ! ,,dur ,bo>d %all-- 7,i7 be made publicly available2 7,,ii7 be compos$ ( memb]s :o are indep5d5t & free ( any conflict1 includ+ ) respect to manufactur]s1 m$icaid manag$ c>e entities1 & ph>macy b5efit manag]s2 7,,iii7 be made up ( at lea/ #a_/c b no m ?an #ea p]c5t memb]s :o are lic5s$ & actively practic+ physicians & at lea/ #a_/c memb]s :o are lic5s$ & actively practic+ ph>maci/s2 & 7,,iv7 include at lea/ #a actively practic+ physician & at lea/ #a actively practic+ ph>maci/1 ea* ( :om has exp]tise 9 ! c>e ( #a or m ,m$icaid-specific populations su* z eld]ly or disabl$ individuals1 *ildr5 ) complex m$ical ne$s1 or l[-income individuals ) *ronic illnesses4 7iii7 ,conflict ( int]e/ policy ,! ,/ate %all e/abli% & implem5t a conflict ( int]e/ policy = ! ,,dur ,bo>d t-- 7,i7 is publicly accessible2 7,,ii7 requires all bo>d memb]s to complete1 on at lea/ an annual basis1 a disclosure ( relation%ips1 associations1 & f9ancial deal+s t may affect _! indep5d5ce ( judgem5t 9 bo>d matt]s2 & 7,,iii7 conta9s cle> processes1 su* z recusal f vot+ or discussion1 = ^? memb]s :o report a conflict ( int]e/1 along ) appropriate processes to address any in/ance :]e a memb] fails to report a conflict ( int]e/4 2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,,dur ,bo>d memb]%ip reports 7i7 ,,dur ,bo>d reports ,ea* ,/ate %all require ! ,,dur ,bo>d to prep>e & submit to ! ,/ate an annual report on ! ,,dur ,bo>d memb]%ip4 ,ea* su* report %all include any conflicts ( int]e/ ) respect to memb]s ( ! ,,dur ,bo>d t ! ,,dur ,bo>d record$ or 0 aw>e ( dur+ ! p]iod t is ! subject ( ! report1 & ! process appli$ to address su* conflicts ( int]e/1 9 addition to any o!r in=mation requir$ by ! ,/ate4 7ii7 ,inclusion ( ,,dur ,bo>d memb]%ip in=mation 9 ,/ate reports ,ea* annual ,/ate report to ! ,secret>y requir$ "u subp>agraph 7,d7 %all include-- 7,i7 ! numb] ( individuals s]v+ on ! ,/ate's ,,dur ,bo>d2 7,,ii7 ! names & pr(essions ( ! individuals s]v+ on su* ,,dur ,bo>d2 7,,iii7 any conflicts ( int]e/ or recusals ) respect to memb]s ( su* ,,dur ,bo>d report$ by ! ,,dur ,bo>d or t ! ,/ate 0 aw>e ( dur+ ! p]iod t is ! subject ( ! report2 & 7,,iv7 :e!r ! ,/ate has elect$ = su* ,,dur ,bo>d to s]ve z ! committee responsible = develop+ a ,/ate =mul>y "u subsection 7d77#d77;,a74 4 7b7 ,manag$ c>e requirem5ts ,section #aicb7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;i77 is am5d$-- 7#a7 by ins]t+ & ea* contract "u a ,/ate plan ) an o!r specifi$ entity 7z def9$ 9 section #aijc7m77#i77;,d77iii77 aft] "u section #aijc7m72 7#b7 by /rik+ section #dhc4c7s77#d7 & ins]t+ section #dch4c7s77#d72 7#c7 by /rik+ #dhc4c7s77#e7 & ins]t+ #dch4c7s77#e72 & 7#d7 by add+ at ! end ! foll[+3 ,su* a manag$ c>e entity or o!r specifi$ entity %all n be consid]$ to be 9 compliance ) ! requirem5t ( su* section #dch4c7s77#e7 t ! entity provide a detail$ description ( its drug utilization review activities unless ! entity includes a description ( ! prospective drug review activities describ$ 9 p>agraph 7#b77;,a7 ( section #aibg7;g7 & ! activities li/$ 9 p>agraph 7#c77;,c7 ( section #aibg7;g71 makes ! und]ly+ drug utilization review data available to ! ,/ate & ! ,secret>y1 & provides su* o!r in=mation z deem$ appropriate by ! ,secret>y44 7c7 ,developm5t ( national /&>ds = ,m$icaid drug use review ,! ,secret>y ( ,heal? & ,human ,s]vices may promulgate regulations or guidance e/abli%+ national /&>ds = ,m$icaid drug use review programs "u section #aibg7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 & drug utilization review activities & requirem5ts "u section #aicb7;i7 ( su* ,act 7#db ,u4,s4,c4 #acifu-#b7;i771 = ! purpose ( align+ review crit]ia = prospective & retrospective drug use review across all ,/ate ,m$icaid programs4 7d7 ,,cms guidance ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance-- 7#a7 outl9+ /eps t ,/ates mu/ take to come into compliance ) /atutory & regulatory requirem5ts = prospective & retrospective drug use review "u section #aibg7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;g77 & drug utilization review activities & requirem5ts "u section #aicb7;i7 ( su* ,act 7#db ,u4,s4,c4 #acifu-#b7;i77 7includ+ ) respect to requirem5ts t 7 9 effect be=e ! date ( enactm5t ( ?is ,act72 & 7#b7 describ+ ! actions t ! ,secret>y w take to en=ce su* requirem5ts4 7e7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 #bjc4 ,,gao report on conflicts ( int]e/ 9 ,/ate ,m$icaid program drug use review bo>ds & ph>macy & !rapeutics 7,p,t7 committees 7a7 ,inve/igation ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct an inve/igation ( pot5tial or exi/+ conflicts ( int]e/ among memb]s ( ,/ate ,m$icaid program ,/ate drug use review bo>ds 79 ?is section ref]r$ to z ,,dur ,bo>ds7 & ph>macy & !rapeutics committees 79 ?is section ref]r$ to z ,p,t ,committees74 7b7 ,report ,n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ,congress a report on ! inve/igation conduct$ "u subsection 7a7 t includes ! foll[+3 7#a7 ,a description outl9+ h[ ,,dur ,bo>ds & ,p,t ,committees op]ate 9 ,/ates1 includ+ details ) respect to-- 7,a7 ! /ructure & op]ation ( ,,dur ,bo>ds & /atewide ,p,t ,committees2 7,b7 ,/ates t op]ate sep>ate ,p,t ,committees = _! fee-=-s]vice ,m$icaid program & _! ,m$icaid manag$ c>e organizations or o!r ,m$icaid manag$ c>e arrangem5ts 7includ+ o!r specifi$ entities 7z def9$ 9 section #aijc7m77#i77;,d77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#i77;,d77iii77 & collectively ref]r$ to 9 ?is section z ,m$icaid ,m,c,os72 & 7,c7 ,/ates t all[ ,m$icaid ,m,c,os to h _! own ,p,t ,committees & ! ext5t to :i* ph>macy b5efit manag]s adm9i/] or p>ticipate 9 su* ,p,t ,committees4 7#b7 ,a description outl9+ ! diff]5ces betwe5 ,,dur ,bo>ds e/abli%$ 9 accordance ) section #aibg7;g77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr7g77#c77 & ,p,t ,committees4 7#c7 ,a description outl9+ ! tools ,p,t ,committees may use to det]m9e ,m$icaid drug cov]age & utilization managem5t policies4 7#d7 ,an analysis ( :e!r & h[ ,/ates or ,p,t ,committees e/abli% p>ticipation & indep5d5ce requirem5ts = ,,dur ,bo>ds & ,p,t ,committees1 includ+ ) respect to entities ) connections ) drug manufactur]s1 ,/ate ,m$icaid programs1 manag$ c>e organizations1 & o!r entities or individuals 9 ! ph>maceutical indu/ry4 7#e7 ,a description outl9+ h[ ,/ates1 ,,dur ,bo>ds1 or ,p,t ,committees def9e conflicts ( int]e/4 7#f7 ,a description ( h[ ,,dur ,bo>ds & ,p,t ,committees address conflicts ( int]e/1 includ+ :o is responsible = implem5t+ su* policies4 7#g7 ,a description ( ! tools1 if any1 ,/ates use to ensure t !re are no conflicts ( int]e/ on ,,dur ,bo>ds & ,p,t ,committees4 7#h7 ,an analysis ( ! effectiv5ess ( tools ,/ates use to ensure t !re are no conflicts ( int]e/ on ,,dur ,bo>ds & ,p,t ,committees &1 if applicable1 recomm5dations z to h[ su* tools c\ld be improv$4 7#i7 ,a review ( /rategies ,/ates may use to gu>d aga9/ conflicts ( int]e/ on ,,dur ,bo>ds & ,p,t ,committees & to ensure compliance ) ! requirem5ts ( titles ,,xi & ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq41 #acif et seq47 & access to effective1 cl9ically appropriate1 & m$ically necess>y drug treatm5ts = ,m$icaid b5efici>ies1 includ+ recomm5dations = su* legislative & adm9i/rative actions z ! ,comptroll] ,g5]al det]m9es appropriate4 #bjd4 ,ensur+ ! accuracy ( manufactur] price & drug product in=mation "u ! ,m$icaid drug rebate program 7a7 ,audit ( manufactur] price & drug product in=mation 7#a7 ,9 g5]al ,subp>agraph 7,b7 ( section #aibg7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$ to read z foll[s3 7,b7 ,audits & surveys ( manufactur] price & drug product in=mation 7i7 ,audits ,! ,secret>y %all conduct regul> audits ( ! price & drug product in=mation report$ by manufactur]s "u subp>agraph 7,a7 = ! mo/ rec5tly end$ rebate p]iod to ensure ! accuracy & timel9ess ( su* in=mation4 ,9 conduct+ su* audits1 ! ,secret>y may employ evaluations1 surveys1 /ati/ical sampl+1 pr$ictive analytics & o!r relevant tools & me?ods4 7ii7 ,v]ifications surveys ( av]age manufactur] price & manufactur]'s av]age sales price ,9 addition to ! audits requir$ "u clause 7i71 ! ,secret>y may survey :olesal]s & manufactur]s 7includ+ manufactur]s t directly di/ribute _! cov]$ outpati5t drugs 79 ?is subp>agraph ref]r$ to z direct sell]s771 :5 necess>y1 to v]ify manufactur] prices & manufactur]'s av]age sales prices 7includ+ :olesale acquisition co/7 to make paym5t report$ "u subp>agraph 7,a74 7iii7 ,p5alties ,9 addition to o!r p5alties z may be prescrib$ by law1 includ+ "u subp>agraph 7,c7 ( ?is p>agraph1 ! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #ahe1jjj on an annual basis on a :olesal]1 manufactur]1 or direct sell]1 if ! :olesal]1 manufactur]1 or direct sell] ( a cov]$ outpati5t drug refuses a reque/ = in=mation ab\t *>ges or prices by ! ,secret>y 9 connection ) an audit or survey "u ?is subp>agraph or kn[+ly provides false in=mation4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is clause 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7iv7 ,reports 7,i7 ,report to ,congress ,! ,secret>y %all1 n lat] ?an #ah mon?s aft] date ( enactm5t ( ?is subp>agraph1 submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate reg>d+ additional regulatory or /atutory *anges t may be requir$ 9 ord] to ensure accurate & timely report+ & ov]sight ( manufactur] price & drug product in=mation1 includ+ :e!r *anges %\ld be made to reasonable assumption requirem5ts to ensure su* assumptions are reasonable & accurate or :e!r ano!r me?odology = ensur+ accurate & timely report+ ( price & drug product in=mation %\ld be consid]$ to ensure ! integrity ( ! drug rebate program "u ?is section4 7,,ii7 ,annual reports ,! ,secret>y %all1 on at lea/ an annual basis1 submit a report to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate summ>iz+ ! results ( ! audits & surveys conduct$ "u ?is subp>agraph dur+ ! p]iod t is ! subject ( ! report4 7,,iii7 ,cont5t ,ea* report submitt$ "u subclause 7,,ii7 %all1 ) respect to ! p]iod t is ! subject ( ! report1 include summ>ies (-- 7aa7 error rates 9 ! price1 drug product1 & o!r relevant in=mation suppli$ by manufactur]s "u subp>agraph 7,a72 7bb7 ! timel9ess ) :i* manufactur]s1 :olesal]s1 & direct sell]s provide in=mation requir$ "u subp>agraph 7,a7 or "u clause 7i7 or 7ii7 ( ?is subp>agraph2 7cc7 ! numb] ( manufactur]s1 :olesal]s1 & direct sell]s & drug products audit$ "u ?is subp>agraph2 7dd7 ! types ( price & drug product in=mation review$ "u ! audits conduct$ "u ?is subp>agraph2 7ee7 ! tools & me?odologies employ$ 9 su* audits2 7ff7 ! f9d+s ( su* audits1 includ+ :i* manufactur]s1 if any1 7 p5aliz$ "u ?is subp>agraph2 & 7gg7 su* o!r relevant in=mation z ! ,secret>y %all deem appropriate4 7,,iv7 ,protection ( in=mation ,9 prep>+ a report requir$ "u subclause 7,,ii71 ! ,secret>y %all r$act su* propriet>y in=mation z ! ,secret>y det]m9es appropriate to prev5t disclosure (1 & to safegu>d1 su* in=mation4 7v7 ,appropriations ,out ( any funds 9 ! ,treasury n o!rwise appropriat$1 !re is appropriat$ to ! ,secret>y #b1jjj1jjj = fiscal ye> #bjbj & ea* fiscal ye> !reaft] to c>ry out ?is subp>agraph4 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! fir/ day ( ! fir/ fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is ,act4 7b7 ,increas$ p5alties = noncompliance ) report+ requirem5ts 7#a7 ,increas$ p5alty = failure to provide timely in=mation ,section #aibg7;b77#c77;,c77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77i77 is am5d$ by /rik+ increas$ by #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$ & su* am\nt %all be paid to ! ,treasury & ins]t+ 1 = ea* cov]$ outpati5t drug ) respect to :i* su* in=mation is n provid$1 #ej1jjj = ! fir/ day t su* in=mation is n provid$ on a timely basis & #ai1jjj = ea* subsequ5t day t su* in=mation is n provid$4 7#b7 ,increas$ p5alty = kn[+ly report+ false in=mation ,section #aibg7;b77#c77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77ii77 is am5d$ by /rik+ #ajj1jjj & ins]t+ #ejj1jjj4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect on ! fir/ day ( ! fir/ fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is ,act4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section or ! am5dm5ts made by ?is section %all be con/ru$ to affect ! application ( ! ,f$]al ,civil ,p5alties ,inflation ,adju/m5t ,act ( #aiij 7#bh ,u4,s4,c4 #bdfa note7 to any civil p5alty am\nt "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h74 #bje4 ,apply+ ,m$icaid drug rebate requirem5t to drugs provid$ z "p ( outpati5t hospital s]vices 7a7 ,9 g5]al ,section #aibg7k77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#c77 is am5d$ to read z foll[s3 7#c7 ,limit+ def9ition 7,a7 ,9 g5]al ,! t]m cov]$ outpati5t drug does n include any drug1 biological product1 or insul9 provid$ z "p (1 or z incid5t to & 9 ! same sett+ z1 any ( ! foll[+ 7& = :i* paym5t may be made "u ?is title z "p ( paym5t = ! foll[+ & n z direct reimbursem5t = ! drug73 7i7 ,inpati5t hospital s]vices4 7ii7 ,hospice s]vices4 7iii7 ,d5tal s]vices1 except t drugs = :i* ! ,/ate plan au?orizes direct reimbursem5t to ! disp5s+ d5ti/ are cov]$ outpati5t drugs4 7iv7 ,physicians' s]vices4 7v7 ,outpati5t hospital s]vices4 7vi7 ,nurs+ facility s]vices & s]vices provid$ by an int]m$iate c>e facility = ! m5tally ret>d$4 7vii7 ,o!r laboratory & x-ray s]vices4 7viii7 ,r5al dialysis4 7,b7 ,o!r exclusions ,su* t]m also does n include any su* drug or product = :i* a ,national ,drug ,code numb] is n requir$ by ! ,food & ,drug ,adm9i/ration or a drug or biological us$ = a m$ical indication :i* is n a m$ically accept$ indication4 7,c7 ,/ate option ,at ! option ( a ,/ate1 su* t]m may include any drug1 biological product1 or insul9 provid$ on an outpati5t basis z "p (1 or z incid5t to & 9 ! same sett+ z1 describ$ 9 clause 7iv7 or 7v7 ( subp>agraph 7,a7 7su* z a drug1 biological product1 or insul9 be+ provid$ z "p ( a bundl$ paym5t74 7,d7 ,no effect on be/ price ,any drug1 biological product1 or insul9 exclud$ f ! def9ition ( su* t]m z a result ( ?is p>agraph %all be treat$ z a cov]$ outpati5t drug = purposes ( det]m9+ ! be/ price 7z def9$ 9 subsection 7c77#a77;,c77 = su* drug1 biological product1 or insul94 4 7b7 ,effective date2 implem5tation guidance 7#a7 ,9 g5]al ,! am5dm5t made by subsection 7a7 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,implem5tation & guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance & relevant in=mational bullet9s = ,/ates1 manufactur]s 7z def9$ 9 section #aibg7k77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#e771 & o!r relevant /akehold]s1 includ+ heal? c>e provid]s1 reg>d+ implem5tation ( ! am5dm5t made by subsection 7a74 #bjf4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid 7a7 ,pass-,?r\gh pric+ requir$ 7#a7 ,9 g5]al ,section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,pass-?r\gh pric+ requir$ ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm71 or a contract betwe5 ! ,/ate & a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d77 t includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs disp5s$ to individuals enroll$ ) ! entity1 %all require t paym5t = su* drugs 7exclud+1 at ! option ( ! ,/ate1 any drug t is subject to an agreem5t "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act7 & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or entity1 is bas$ on a pass-?r\gh pric+ model "u :i*-- 7,a7 any paym5t made by ! entity or ! ,,pbm 7z applicable7 = su* a drug-- 7i7 is limit$ to-- 7,i7 +r$i5t co/2 & 7,,ii7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate plan or waiv] w\ld pay if ! plan or waiv] 0 mak+ ! paym5t directly2 7ii7 is pass$ ?r\gh 9 its entirety by ! entity or ,,pbm to ! ph>macy t disp5ses ! drug2 & 7iii7 is made 9 a mann] t is consi/5t ) section #aijb7;a77#cj77;,a7 & sections #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 z if su* requirem5ts appli$ directly to ! entity or ! ,,pbm2 7,b7 paym5t to ! entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! entity or ,,pbm is limit$ to a reasonable adm9i/rative fee t cov]s ! reasonable co/ ( provid+ su* s]vices2 7,c7 ! entity or ! ,,pbm 7z applicable7 %all make available to ! ,/ate1 & ! ,secret>y ^u reque/1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices incurr$1 receiv$1 or made by ! entity or ! ,,pbm1 includ+ +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees1 po/-sale & po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all o!r remun]ation2 & 7,d7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! entity or ! ,,pbm 7z applicable7 is 9 excess ( ! am\nt paid to ! ph>macies on behalf ( ! entity1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 effective rate contract adju/m5ts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts 7aft] all[+ = a reasonable adm9i/rative fee z describ$ 9 subp>agraph 7,b77 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 4 7#b7 ,con=m+ am5dm5t ,section #aijc7m77#b77;,a77xiii7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77xiii771 z am5d$ by section #bja7;b77#a71 is am5d$-- 7,a7 by /rik+ & 7,,iv7 & ins]t+ 7,,iv72 & 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,v7 ph>macy b5efit managem5t s]vices provid$ by ! entity1 or provid$ by a ph>macy b5efit manag] on behalf ( ! entity "u a contract or o!r arrangem5t betwe5 ! entity & ! ph>macy b5efit manag]1 %all comply ) ! requirem5ts ( section #aibg7;e77#f74 7#c7 ,effective date ,! am5dm5ts made by ?is subsection apply to contracts betwe5 ,/ates & manag$ c>e entities1 o!r specifi$ entities1 or ph>macy b5efits manag]s t are ent]$ into or r5ew$ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7b7 ,survey ( retail prices 7#a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7,a7 by /rik+ & aft] ! semicolon at ! end ( p>agraph 7#a77;,a77i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,survey ( retail prices ,! ,secret>y %all conduct a survey ( retail community drug prices1 to include at lea/ ! national av]age drug acquisition co/1 z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation on a mon?ly basis ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs = su* ph>macies1 net ( all disc\nts & rebates 7to ! ext5t any in=mation ) respect to su* disc\nts & rebates is available71 ! av]age reimbursem5t receiv$ = su* drugs by su* ph>macies f all s\rces ( paym5t1 includ+ ?ird p>ties1 &1 to ! ext5t available1 ! usual & cu/om>y *>ges to consum]s = su* drugs2 & 2 7,b7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,9 ord] to meet ! requirem5t ( section #aijb7;a77#ed71 a ,/ate %all require t any retail community ph>macy 9 ! ,/ate t receives any paym5t1 adm9i/rative fee1 disc\nt1 or rebate relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 fee1 disc\nt1 or rebate is receiv$ f ! ,/ate or a manag$ c>e entity directly or f a ph>macy b5efit manag] or ano!r entity t has a contract ) ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d771 %all respond to surveys ( retail prices conduct$ "u ?is subsection4 7,g7 ,survey in=mation ,in=mation on retail community prices obta9$ "u ?is p>agraph %all be made publicly available & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate ( ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ frame & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,*>act]i/ics ( report+ ph>macies1 includ+ type 7su* z indep5d5t or *a971 geographic or regional location1 & disp5s+ volume4 7iv7 ,report+ ( a sep>ate national av]age drug acquisition co/ = ea* drug = indep5d5t retail ph>macies & *a9 op]at$ ph>macies4 7v7 ,in=mation on price concessions includ+ on & (f invoice disc\nts1 rebates1 & o!r price concessions4 7vi7 ,in=mation on av]age pr(essional disp5s+ fees paid4 7,h7 ,p5alties 7i7 ,failure to provide timely in=mation ,a retail community ph>macy t kn[+ly fails to respond to a survey conduct$ "u ?is subsection on a timely basis may be subject to a civil monet>y p5alty 9 an am\nt n to exce$ #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$4 7ii7 ,false in=mation ,a retail community ph>macy t kn[+ly provides false in=mation 9 response to a survey conduct$ "u ?is subsection may be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7iii7 ,o!r p5alties ,any civil money p5alties impos$ "u ?is subp>agraph %all be 9 addition to o!r p5alties z may be prescrib$ by law4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7,i7 ,report on specialty drugs & ph>macies 7i7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! effective date ( ?is subp>agraph1 ! ,secret>y %all submit a report to ,congress exam9+ specialty drug cov]age & reimbursem5t "u ?is title4 7ii7 ,cont5t ( report ,su* report %all include a description ( h[ ,/ate ,m$icaid programs def9e specialty drugs1 h[ mu* ,/ate ,m$icaid programs pay = specialty drugs1 h[ ,/ates & manag$ c>e plans det]m9e paym5t = specialty drugs1 ! sett+s 9 :i* specialty drugs are disp5s$ 7su* z retail community ph>macies or specialty ph>macies71 :e!r acquisition co/s = specialty drugs are captur$ 9 ! national av]age drug acquisition co/ survey1 & recomm5dations z to :e!r specialty ph>macies %\ld be includ$ 9 ! survey ( retail prices to ensure national av]age drug acquisition co/s capture drugs sold at specialty ph>macies & h[ su* specialty ph>macies %\ld be def9$4 2 7,c7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ paym5ts rates "u ,m$icaid manag$ c>e plans1 aft] "u ?is title2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ & ! basis = su* disp5s+ fees be=e ! semicolon2 & 7,d7 9 p>agraph 7#d71 by ins]t+ 1 & #e1jjj1jjj = fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 aft] #bjaj4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection take effect on ! #a/ day ( ! #a/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7c7 ,manufactur] report+ ( :olesale acquisition co/ ,section #aibg7;b77#c7 ( su* ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a77i7-- 7,a7 9 subclause 7,i71 by /rik+ & aft] ! semicolon2 7,b7 9 subclause 7,,ii71 by add+ & aft] ! semicolon2 7,c7 by mov+ ! left m>g9s ( subclause 7,i7 & 7,,ii7 #b ems to ! "r2 & 7,d7 by add+ at ! end ! foll[+3 7,,iii7 9 ! case ( rebate p]iods t beg9 on or aft] ! date ( enactm5t ( ?is subclause1 on ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = cov]$ outpati5t drugs = ! rebate p]iod "u ! agreem5t 7includ+ = all su* drugs t are sold "u a new drug application approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act72 2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ & clause 7vii7 ( ?is subp>agraph aft] #ahdg;,a2 7,b7 9 clause 7v71 by /rik+ & aft] ! comma2 7,c7 9 clause 7vi71 by /rik+ ! p]iod & ins]t+ 1 &2 & 7,d7 by ins]t+ aft] clause 7vi7 ! foll[+3 7vii7 to ! ,secret>y to disclose 7?r\gh a website accessible to ! public7 ! mo/ rec5tly report$ :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 = ea* cov]$ outpati5t drug 7includ+ = all su* drugs t are sold "u a new drug application approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 z report$ "u subp>agraph 7,a77i77,,iii74 4 #bjg4 ,t-,,msis drug data analytics reports 7a7 ,9 g5]al ,n lat] ?an ,may #a ( ea* cal5d> ye> beg9n+ ) cal5d> ye> #bjba1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all publi% on a website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices t is accessible to ! public a report ( ! mo/ rec5tly available data on patt]ns relat$ to prescriptions fill$ by provid]s & reimburs$ "u ! ,m$icaid program4 7b7 ,cont5t ( report 7#a7 ,requir$ cont5t ,ea* report requir$ "u subsection 7a7 = a cal5d> ye> %all include ! foll[+ in=mation ) respect to ea* ,/ate 7&1 to ! ext5t available1 ) respect to ,pu]to ,rico1 ! ,unit$ ,/ates ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa73 7,a7 ,a comp>ison ( cov]$ outpati5t drug 7z def9$ 9 section #aibg7k77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b777 prescrib+ patt]ns "u ! ,/ate ,m$icaid plan or waiv] ( su* plan 7includ+ drugs prescrib$ on a fee-=-s]vice basis & drugs prescrib$ "u manag$ c>e arrangem5ts "u su* plan or waiv]7-- 7i7 across all available =ms or models ( reimbursem5t us$ "u ! plan or waiv]2 7ii7 )9 specialties & subspecialties1 z def9$ by ! ,secret>y2 7iii7 by episodes ( c>e =-- 7,i7 ea* *ronic disease category1 z def9$ by ! ,secret>y1 t is repres5t$ 9 ! #aj conditions t acc\nt$ = ! greate/ %>e ( total sp5d+ "u ! plan or waiv] dur+ ! ye> t is ! subject ( ! report2 7,,ii7 proc$ural gr\p+s2 & 7,,iii7 r>e disease diagnosis codes 7except :]e ! inclusion ( su* in=mation w\ld jeop>dize ! privacy ( an individual1 z det]m9$ by ! ,secret>y72 7iv7 by pati5t demographic *>act]i/ics1 includ+ race 7to ! ext5t t ! ,secret>y det]m9es t !re is suffici5t data available ) respect to su* *>act]i/ic 9 a majority ( ,/ates & t inclusion ( su* *>act]i/ic w\ld n jeop>dize ! privacy ( ! individual71 g5d]1 & age2 7v7 by pati5t high-utiliz] or risk /atus2 & 7vi7 by high & l[ res\rce sett+s by facility & place ( s]vice categories1 z det]m9$ by ! ,secret>y4 7,b7 ,9 ! case ( m$ical assi/ance = cov]$ outpati5t drugs 7z s def9$7 provid$ "u a ,/ate ,m$icaid plan or waiv] ( su* plan 9 a manag$ c>e sett+1 an analysis ( ! diff]5ces 9 manag$ c>e prescrib+ patt]ns :5 a cov]$ outpati5t drug is prescrib$ 9 a manag$ c>e sett+ z comp>$ to :5 ! drug is prescrib$ 9 a fee-=-s]vice sett+4 7#b7 ,additional cont5t ,to ! ext5t available1 a report requir$ "u subsection 7a7 = a cal5d> ye> may include ,/ate-specific in=mation ab\t prescription utilization managem5t tools "u ,/ate ,m$icaid plans or waiv]s ( su* plans1 includ+-- 7,a7 a description ( prescription utilization managem5t tools "u ,/ate programs to provide long-t]m s]vices & supports "u a ,/ate ,m$icaid plan or a waiv] ( su* plan2 7,b7 a comp>ison ( prescription utilization managem5t tools applicable to populations cov]$ "u a ,/ate ,m$icaid plan waiv] "u section #aaae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae7 & ! models applicable to populations t are n cov]$ "u ! waiv]2 7,c7 a comp>ison ( ! prescription utilization managem5t tools employ$ by diff]5t ,m$icaid manag$ c>e organizations1 ph>macy b5efit manag]s1 & relat$ entities )9 ! ,/ate2 7,d7 a comp>ison ( ! prescription utilization managem5t tools applicable to ea* enrollm5t category "u a ,/ate ,m$icaid plan or waiv]2 & 7,e7 a comp>ison ( ! prescription utilization managem5t tools applicable "u ! ,/ate ,m$icaid plan or waiv] by pati5t high-utiliz] or risk /atus4 7#c7 ,additional analysis ,to ! ext5t practicable1 ! ,secret>y %all include 9 ea* report publi%$ "u subsection 7a7-- 7,a7 analyses ( national1 ,/ate1 & local patt]ns ( ,m$icaid population-bas$ prescrib+ behaviors 7includ+ an analysis ( ! impact ( non-fill$ prescriptions on id5tify+ su* patt]ns72 & 7,b7 recomm5dations = adm9i/rative or legislative action to improve ! effectiv5ess (1 & r$uce co/s =1 cov]$ outpati5t drugs "u ,m$icaid :ile ensur+ timely b5efici>y access to m$ically necess>y cov]$ outpati5t drugs4 7c7 ,use ( ,t-,,msis data ,ea* report requir$ "u subsection 7a7 %all1 to ! ext5t practicable-- 7#a7 be prep>$ us+ data & def9itions f ! ,trans=m$ ,m$icaid ,/ati/ical ,in=mation ,sy/em 7,t-,,msis7 data set 7or a successor data set7 t is n m ?an #bd mon?s old on ! date t ! report is publi%$2 & 7#b7 z appropriate1 include a description ) respect to ea* ,/ate ( ! quality & complet5ess ( ! data1 z well z any necess>y caveats describ+ ! limitations ( ! data report$ to ! ,secret>y by ! ,/ate t are suffici5t to communicate ! appropriate uses = ! in=mation4 7d7 ,prep>ation ( report ,ea* report requir$ "u subsection 7a7 %all be prep>$ by ! ,adm9i/rator = ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7e7 ,appropriation ,= fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 !re is appropriat$ to ! ,secret>y #b1jjj1jjj to c>ry out ?is section4 #bjh4 ,risk-%>+ value-bas$ paym5t agreem5ts = cov]$ outpati5t drugs "u ,m$icaid 7a7 ,9 g5]al ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7l7 ,/ate option ,to pay = cov]$ outpati5t drugs ?r\gh risk-,%>+ value-,bas$ agreem5ts 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbb1 a ,/ate %all h ! option to pay 7:e!r on a fee-=-s]vice or manag$ c>e basis7 = cov]$ outpati5t drugs t are pot5tially curative treatm5ts int5d$ = "o-"t use t are adm9i/]$ to individuals "u ?is title by ent]+ into a risk-%>+ value-bas$ paym5t agreem5t ) ! manufactur] ( ! drug 9 accordance ) ! requirem5ts ( ?is subsection4 7#b7 ,secret>ial approval 7,a7 ,9 g5]al ,a ,/ate %all submit a reque/ to ! ,secret>y to ent] into a risk-%>+ value-bas$ paym5t agreem5t1 & ! ,secret>y %all n approve a propos$ risk-%>+ value-bas$ paym5t agreem5t betwe5 a ,/ate & a manufactur] = paym5t = a cov]$ outpati5t drug ( ! manufactur] unless ! foll[+ requirem5ts are met3 7i7 ,manufactur] has 9 effect a rebate agreem5t & is 9 compliance ) all applicable requirem5ts ,! manufactur] has a rebate agreem5t 9 effect z requir$ "u subsections 7a7 & 7b7 ( ?is section & is 9 compliance ) all applicable requirem5ts "u ?is title4 7ii7 ,no expect$ increase to project$ net ,f$]al sp5d+ 7,i7 ,9 g5]al ,! ,*ief ,actu>y c]tifies t ! project$ paym5ts = ea* cov]$ outpati5t drug "u a propos$ risk-%>+ value-bas$ paym5t agreem5t is n expect$ to result 9 great] e/imat$ ,f$]al sp5d+ "u ?is title ?an ! net ,f$]al sp5d+ t w\ld result 9 ! abs5ce ( su* agreem5t4 7,,ii7 ,net f$]al sp5d+ def9$ ,= purposes ( ?is subsection1 ! t]m net ,f$]al sp5d+ means ! am\nt ( ,f$]al paym5ts ! ,*ief ,actu>y e/imates w\ld be made "u ?is title = adm9i/]+ a cov]$ outpati5t drug to an individual eligible = m$ical assi/ance "u a ,/ate plan or a waiv] ( su* plan1 r$uc$ by ! am\nt ( all rebates ! ,*ief ,actu>y e/imates w\ld be paid ) respect to ! adm9i/]+ ( su* drug1 includ+ all rebates "u ?is title & any supplem5tal or o!r additional rebates1 9 ! abs5ce ( su* an agreem5t4 7,,iii7 ,in=mation ,! ,*ief ,actu>y %all make ! c]tifications requir$ "u ?is clause bas$ on ! mo/ rec5tly available & reliable drug pric+ & product in=mation4 ,! ,/ate & manufactur] %all provide ! ,secret>y & ! ,*ief ,actu>y ) all necess>y in=mation requir$ to make ! e/imates ne$$ = su* c]tifications4 7iii7 ,laun* & li/ price ju/ifications ,! manufactur] submits all relevant in=mation & support+ docum5tation necess>y = pric+ decisions z deem$ appropriate by ! ,secret>y1 :i* %all be tru?ful & non-mislead+1 includ+ manufactur] in=mation & support+ docum5tation = laun* price or li/ price increases1 & any applicable ju/ification requir$ "u section #aabh,l4 7iv7 ,confid5tiality ( in=mation2 p5alties ,! provisions ( subp>agraphs 7,c7 & 7,d7 ( subsection 7b77#c7 %all apply to a manufactur] t fails to submit ! in=mation & docum5tation requir$ "u clauses 7ii7 & 7iii7 on a timely basis1 or t kn[+ly provides false or mislead+ in=mation1 9 ! same mann] z su* provisions apply to a manufactur] ) a rebate agreem5t "u ?is section4 7,b7 ,consid]ation ( ,/ate reque/ = approval 7i7 ,9 g5]al ,! ,secret>y %all treat a ,/ate reque/ = approval ( a risk-%>+ value-bas$ paym5t agreem5t 9 ! same mann] t ! ,secret>y treats a ,/ate plan am5dm5t1 & subp>t ,b ( "p #dcj ( title #db1 ,code ( ,f$]al ,regulations1 includ+1 subject to clause 7ii71 ! tim+ requirem5ts ( section #dcj4af ( su* title 7z 9 effect on ! date ( enactm5t ( ?is subsection71 %all apply to a reque/ = approval ( a risk-%>+ value-bas$ paym5t agreem5t 9 ! same mann] z su* subp>t applies to a ,/ate plan am5dm5t4 7ii7 ,tim+ ,! ,secret>y %all consult ) ! ,commission] ( ,food & ,drugs z requir$ "u subp>agraph 7,c7 & make a det]m9ation on :e!r to approve a reque/ f a ,/ate = approval ( a propos$ risk-%>+ value-bas$ paym5t agreem5t 7or reque/ additional in=mation necess>y to all[ ! ,secret>y to make a det]m9ation ) respect to su* reque/ = approval7 )9 ! "t p]iod1 to ! ext5t practicable1 specifi$ 9 section #dcj4af ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is subsection71 b 9 no case %all ! ,secret>y take m ?an #ahj days aft] ! receipt ( su* reque/ = approval or response to su* reque/ = additional in=mation to make su* a det]m9ation 7or reque/ additional in=mation74 7,c7 ,consultation ) ! ,commission] ( ,food & ,drugs ,9 consid]+ :e!r to approve a risk-%>+ value-bas$ paym5t agreem5t1 ! ,secret>y1 to ! ext5t necess>y1 %all consult ) ! ,commission] ( ,food & ,drugs to det]m9e :e!r ! relevant cl9ical p>amet]s specifi$ 9 su* agreem5t are appropriate4 7#c7 ,in/allm5t-bas$ paym5t /ructure 7,a7 ,9 g5]al ,a risk-%>+ value-bas$ paym5t agreem5t %all provide = a paym5t /ructure "u :i*1 = e in/allm5t ye> ( ! agreem5t 7subject to subp>agraph 7,b771 ! ,/ate %all pay ! total in/allm5t ye> am\nt 9 equal in/allm5ts to be paid at regul> int]vals ov] a p]iod ( "t t %all be specifi$ 9 ! agreem5t4 7,b7 ,requirem5ts = in/allm5t paym5ts 7i7 ,tim+ ( fir/ paym5t ,! ,/ate %all make ! fir/ ( ! in/allm5t paym5ts describ$ 9 subp>agraph 7,a7 = an in/allm5t ye> n lat] ?an #cj days aft] ! end ( su* ye>4 7ii7 ,l5g? ( in/allm5t p]iod ,! p]iod ( "t ov] :i* ! ,/ate %all make ! in/allm5t paym5ts describ$ 9 subp>agraph 7,a7 = an in/allm5t ye> %all n be long] ?an #e ye>s4 7iii7 ,nonpaym5t or r$uc$ paym5t ( in/allm5ts foll[+ a failure to meet cl9ical p>amet] ,if1 prior to ! paym5t date 7z specifi$ 9 ! agreem5t7 ( any in/allm5t paym5t describ$ 9 subp>agraph 7,a7 or any o!r alt]native date or "t frame 7z o!rwise specifi$ 9 ! agreem5t71 ! cov]$ outpati5t drug :i* is subject to ! agreem5t fails to meet a relevant cl9ical p>amet] ( ! agreem5t1 ! agreem5t %all provide t-- 7,i7 ! in/allm5t paym5t %all n be made2 or 7,,ii7 ! in/allm5t paym5t %all be r$uc$ by a p]c5tage specifi$ 9 ! agreem5t t is bas$ on ! outcome a*iev$ by ! drug relative to ! relevant cl9ical p>amet]4 7#d7 ,notice ( int5t 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 a manufactur] ( a cov]$ outpati5t drug %all n be eligible to ent] into a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection ) respect to su* drug unless ! manufactur] notifies ! ,secret>y t ! manufactur] is int]e/$ 9 ent]+ into su* an agreem5t ) respect to su* drug4 ,! decision to submit & tim+ ( a reque/ to ent] into a propos$ risk-%>+ value-bas$ paym5t agreem5t %all rema9 solely )9 ! discretion ( ! ,/ate & %all only be effective ^u ,secret>ial approval z requir$ "u ?is subsection4 7,b7 ,treatm5t ( subsequ5tly approv$ drugs 7i7 ,9 g5]al ,9 ! case ( a manufactur] ( a cov]$ outpati5t drug designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetics ,act1 & approv$ "u section #eje ( su* ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ?is subsection1 n m ?an #ij days aft] meet+ ) ! ,food & ,drug ,adm9i/ration foll[+ phase ,,ii cl9ical trials = su* drug 7or1 9 ! case ( a drug describ$ 9 clause 7ii71 n lat] ?an ,m>* #ca1 #bjbb71 ! manufactur] mu/ notify ! ,secret>y ( ! manufactur]'s int5t to ent] into a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection ) respect to su* drug4 ,if no su* meet+ has occurr$1 ! ,secret>y may use discretion z to :e!r a pot5tially curative treatm5t int5d$ = "o-"t use may qualify = a risk-%>+ value-bas$ paym5t agreem5t "u ?is section4 ,a manufactur] notification ( int]e/ %all n h any influ5ce on a decision = drug approval by ! ,food & ,drug ,adm9i/ration4 7ii7 ,application to c]ta9 subsequ5tly approv$ drugs ,a drug describ$ 9 ?is clause is a cov]$ outpati5t drug ( a manufactur]-- 7,i7 t is approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ?is subsection2 & 7,,ii7 ) respect to :i*1 z ( ,janu>y #a1 #bjbb1 m ?an #ij days h pass$ aft] ! manufactur]'s meet+ ) ! ,food & ,drug ,adm9i/ration foll[+ phase ,,ii cl9ical trials = su* drug4 7iii7 ,p>allel approval ,! ,secret>y1 9 coord9ation ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,commission] ( ,food & ,drugs1 %all1 to ! ext5t practicable1 approve a ,/ate's reque/ to ent] into a propos$ risk-%>+ value-bas$ paym5t agreem5t t o!rwise meets ! requirem5ts ( ?is subsection at ! "t t su* a drug is approv$ by ! ,food & ,drug ,adm9i/ration to help provide t no ,/ate t wi%es to ent] into su* an agreem5t is requir$ to pay = ! drug 9 full at "o "t if ! ,/ate is seek+ to pay ov] a p]iod ( "t z outl9$ 9 ! propos$ agreem5t4 7iv7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be appli$ or con/ru$ to modify or affect ! timeframes or factors involv$ 9 ! ,secret>y's det]m9ation ( :e!r to approve or lic5se a drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7#e7 ,special paym5t rules 7,a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is p>agraph1 ) respect to an individual :o is adm9i/]$ a unit ( a cov]$ outpati5t drug t is reimburs$ "u a ,/ate plan by a ,/ate ,m$icaid ag5cy "u a risk-%>+ value-bas$ paym5t agreem5t 9 an in/allm5t ye>1 ! ,/ate %all rema9 liable to ! manufactur] ( su* drug = paym5t = su* unit )\t reg>d to :e!r ! individual rema9s enroll$ 9 ! ,/ate plan "u ?is title 7or a waiv] ( su* plan7 = ea* in/allm5t ye> = :i* ! ,/ate is to make in/allm5t paym5ts = cov]$ outpati5t drugs pur*as$ "u ! agreem5t 9 su* ye>4 7,b7 ,dea? ,9 ! case ( an individual describ$ 9 subp>agraph 7,a7 :o dies dur+ ! p]iod describ$ 9 su* subp>agraph1 ! ,/ate plan %all n be liable = any rema9+ paym5t = ! unit ( ! cov]$ outpati5t drug adm9i/]$ to ! individual :i* is ow$ "u ! agreem5t describ$ 9 su* subp>agraph4 7,c7 ,)drawal ( approval ,9 ! case ( a cov]$ outpati5t drug t is ! subject ( a risk-%>+ value-bas$ paym5t agreem5t betwe5 a ,/ate & a manufactur] "u ?is subsection1 includ+ a drug approv$ 9 accordance ) section #ejf7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & su* drug is ! subject ( an application t has be5 )drawn by ! ,secret>y1 ! ,/ate plan %all n be liable = any rema9+ paym5t t is ow$ "u ! agreem5t4 7,d7 ,alt]native arrangem5t "u agreem5t ,subject to approval by ! ,secret>y1 ! t]ms ( a propos$ risk-%>+ value-bas$ paym5t agreem5t submitt$ = approval by a ,/ate may provide t subp>agraph 7,a7 %all n apply4 7,e7 ,guidance ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,secret>y %all issue guidance to ,/ates e/abli%+ a process = ,/ates to notify ! ,secret>y :5 an individual :o is adm9i/]$ a unit ( a cov]$ outpati5t drug t is pur*as$ by a ,/ate plan "u a risk-%>+ value-bas$ paym5t agreem5t ceases to be enroll$ "u ! ,/ate plan "u ?is title 7or a waiv] ( su* plan7 or dies be=e ! end ( ! in/allm5t p]iod applicable to su* unit "u ! agreem5t4 7#f7 ,treatm5t ( paym5ts "u risk-%>+ value-bas$ agreem5ts = purposes ( av]age manufactur] price2 be/ price ,! ,secret>y %all treat any paym5ts made to ! manufactur] ( a cov]$ outpati5t drug "u a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection dur+ a rebate p]iod 9 ! same mann] t ! ,secret>y treats paym5ts made "u a ,/ate supplem5tal rebate agreem5t "u sections #ddg4ejd7;c77#ai7 & #ddg4eje7;c77#g7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations7 = purposes ( det]m9+ av]age manufactur] price & be/ price "u ?is section ) respect to ! cov]$ outpati5t drug & a rebate p]iod & = purposes ( (fsets requir$ "u subsection 7b77#a77;,b74 7#g7 ,assessm5ts & report to ,congress 7,a7 ,assessm5ts 7i7 ,9 g5]al ,n lat] ?an #ahj days aft] ! end ( ea* assessm5t p]iod ( any risk-%>+ value-bas$ paym5t agreem5t = a ,/ate approv$ "u ?is subsection1 ! ,secret>y %all conduct an evaluation ( su* agreem5t :i* %all include an evaluation by ! ,*ief ,actu>y to det]m9e :e!r program sp5d+ "u ! risk-%>+ value-bas$ paym5t agreem5t align$ ) ! projections = ! agreem5t made "u p>agraph 7#b77;,a77ii71 includ+ an assessm5t ( :e!r actual ,f$]al sp5d+ "u ?is title "u ! agreem5t 0 less or m ?an net ,f$]al sp5d+ w\ld h be5 9 ! abs5ce ( ! agreem5t4 7ii7 ,assessm5t p]iod ,= purposes ( clause 7i7-- 7,i7 ! fir/ assessm5t p]iod = a risk-%>+ value-bas$ paym5t agreem5t %all be ! p]iod ( "t ov] :i* paym5ts are s*$ul$ to be made "u ! agreem5t = ! fir/ #aj individuals :o are adm9i/]$ cov]$ outpati5t drugs "u ! agreem5t except t su* p]iod %all n exce$ ! #e-ye> p]iod aft] ! date on :i* ! ,secret>y approves ! agreem5t2 & 7,,ii7 ea* subsequ5t assessm5t p]iod = a risk-%>+ value-bas$ paym5t agreem5t %all be ! #e-ye> p]iod foll[+ ! end ( ! previ\s assessm5t p]iod4 7,b7 ,results ( assessm5ts 7i7 ,t]m9ation option ,if ! ,secret>y det]m9es z a result ( ! assessm5t by ! ,*ief ,actu>y "u subp>agraph 7,a7 t ! actual ,f$]al sp5d+ "u ?is title = any cov]$ outpati5t drug t 0 ! subject ( ! ,/ate's risk-%>+ value-bas$ paym5t agreem5t 0 great] ?an ! net ,f$]al sp5d+ t w\ld h result$ 9 ! abs5ce ( ! agreem5t1 ! ,secret>y may t]m9ate approval ( su* agreem5t & %all imm$iately conduct an assessm5t "u ?is p>agraph ( any o!r ongo+ risk-%>+ value-bas$ paym5t agreem5t to :i* ! same manufactur] is a p>ty4 7ii7 ,repaym5t requir$ 7,i7 ,9 g5]al ,if ! ,secret>y det]m9es z a result ( ! assessm5t by ! ,*ief ,actu>y "u subp>agraph 7,a7 t ! ,f$]al sp5d+ "u ! risk-%>+ value-bas$ agreem5t = a cov]$ outpati5t drug t 0 subject to su* agreem5t 0 great] ?an ! net ,f$]al sp5d+ t w\ld h result$ 9 ! abs5ce ( ! agreem5t1 ! manufactur] %all repay ! diff]5ce to ! ,/ate & ,f$]al gov]nm5ts 9 a timely mann] z det]m9$ by ! ,secret>y4 7,,ii7 ,t]m9ation = failure to pay ,! failure ( a manufactur] to make repaym5ts requir$ "u subclause 7,i7 9 a timely mann] %all result 9 imm$iate t]m9ation ( all risk-%>+ value-bas$ agreem5ts to :i* ! manufactur] is a p>ty4 7,,iii7 ,additional p5alties ,9 ! case ( a manufactur] t fails to make repaym5ts requir$ "u subclause 7,i71 ! ,secret>y may treat su* manufactur] 9 ! same mann] z a manufactur] t fails to pay requir$ rebates "u ?is section1 & ! ,secret>y may-- 7aa7 susp5d or t]m9ate ! manufactur]'s rebate agreem5t "u ?is section2 & 7bb7 pursue any o!r rem$y t w\ld be available if ! manufactur] _h fail$ to pay requir$ rebates "u ?is section4 7,c7 ,report to congress ,n lat] ?an #e ye>s aft] ! fir/ risk-%>+ value-bas$ paym5t agreem5t is approv$ "u ?is subsection1 ! ,secret>y %all submit to ,congress & make available to ! public a report t includes-- 7i7 an assessm5t ( ! impact ( risk-%>+ value-bas$ paym5t agreem5ts on access = individuals :o are eligible = b5efits "u a ,/ate plan or waiv] "u ?is title to m$ically necess>y cov]$ outpati5t drugs & relat$ treatm5ts2 7ii7 an analysis ( ! impact ( su* agreem5ts on ov]all ,/ate & ,f$]al sp5d+ "u ?is title2 7iii7 an assessm5t ( ! impact ( su* agreem5ts on drug prices1 includ+ laun* price & price increases2 & 7iv7 su* recomm5dations to ,congress z ! ,secret>y deems appropriate4 7#h7 ,guidance & regulations 7,a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,secret>y %all issue guidance to ,/ates seek+ to ent] into risk-%>+ value-bas$ paym5t agreem5ts "u ?is subsection t includes a model template = su* agreem5ts4 ,! ,secret>y may issue any additional guidance or promulgate regulations z necess>y to implem5t & en=ce ! provisions ( ?is subsection4 7,b7 ,model agreem5ts 7i7 ,9 g5]al ,if a ,/ate expresses an int]e/ 9 pursu+ a risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection ) a manufactur] = ! pur*ase ( a cov]$ outpati5t drug1 ! ,secret>y may %>e ) su* ,/ate any risk-%>+ value-bas$ agreem5t betwe5 a ,/ate & ! manufactur] = ! pur*ase ( su* drug t has be5 approv$ "u ?is subsection4 ,:ile su* %>$ agreem5t may s]ve z a template = a ,/ate t wi%es to propose1 ! use ( a previ\sly approv$ agreem5t %all n affect ! submission & approval process = approval ( a propos$ risk-%>+ value-bas$ paym5t agreem5t "u ?is subsection1 includ+ ! requirem5ts "u p>agraph 7#b77;,a74 7ii7 ,confid5tiality ,9 ! case ( a risk-%>+ value-bas$ paym5t agreem5t t is disclos$ to a ,/ate by ! ,secret>y "u ?is subp>agraph & t is only 9 effect ) respect to a s+le ,/ate1 ! confid5tiality ( in=mation provisions describ$ 9 subsection 7b77#c77;,d7 %all apply to su* in=mation4 7,c7 ,,oig consultation 7i7 ,9 g5]al ,! ,secret>y %all consult ) ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices to det]m9e :e!r !re are pot5tial program integrity conc]ns 7includ+ issues relat$ to compliance ) sections #aabh;,b & #ahgg7 ) agreem5t approvals or templates & address accord+ly4 7ii7 ,,oig policy updates z necess>y ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all review & update1 z necess>y1 any policies or guidel9es ( ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,human ,s]vices 7includ+ policies relat$ to ! en=cem5t ( section #aabh;,b7 to accommodate ! use ( risk-%>+ value-bas$ paym5t agreem5ts 9 accordance ) ?is section4 7#i7 ,rules ( con/ruction 7,a7 ,modifications ,no?+ 9 ?is subsection or any regulations promulgat$ "u ?is subsection %all prohibit a ,/ate f reque/+ a modification f ! ,secret>y to ! t]ms ( a risk-%>+ value-bas$ paym5t agreem5t4 ,a modification t is expect$ to result 9 any increase to project$ net ,/ate or ,f$]al sp5d+ "u ! agreem5t %all be subject to rec]tification by ! ,*ief ,actu>y z describ$ 9 p>agraph 7#b77;,a77ii7 be=e ! modification may be approv$4 7,b7 ,rebate agreem5ts ,no?+ 9 ?is subsection %all be con/ru$ z requir+ a ,/ate to ent] into a risk-%>+ value-bas$ paym5t agreem5t or z limit+ or sup]s$+ ! ability ( a ,/ate to ent] into a supplem5tal rebate agreem5t = a cov]$ outpati5t drug4 7,c7 ,,ffp = paym5ts "u risk-%>+ value-bas$ paym5t agreem5ts ,f$]al f9ancial p>ticipation %all be available "u ?is title = any paym5t made by a ,/ate to a manufactur] = a cov]$ outpati5t drug "u a risk-%>+ value-bas$ paym5t agreem5t 9 accordance ) ?is subsection1 except t no ,f$]al f9ancial p>ticipation %all be available = any paym5t made by a ,/ate to a manufactur] "u su* an agreem5t on & aft] ! effective date ( a disapproval ( su* agreem5t by ! ,secret>y4 7,d7 ,cont9u$ application ( o!r provisions ,except z expressly provid$ 9 ?is subsection1 no?+ 9 ?is subsection or 9 any regulations promulgat$ "u ?is subsection %all affect ! application ( any o!r provision ( ?is ,act4 7#aj7 ,appropriations ,= fiscal ye> #bjbj & ea* fiscal ye> !reaft]1 !re are appropriat$ to ! ,secret>y #e1jjj1jjj = ! purpose ( c>ry+ out ?is subsection4 7#aa7 ,def9itions ,9 ?is subsection3 7,a7 ,*ief ,actu>y ,! t]m ,*ief ,actu>y means ! ,*ief ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,b7 ,in/allm5t ye> ,! t]m in/allm5t ye> means1 ) respect to a risk-%>+ value-bas$ paym5t agreem5t1 a #ab-mon? p]iod dur+ :i* a cov]$ outpati5t drug is adm9i/]$ "u ! agreem5t4 7,c7 ,pot5tially curative treatm5t int5d$ = "o-"t use ,! t]m pot5tially curative treatm5t int5d$ = "o-"t use means a treatm5t t consi/s ( ! adm9i/ration ( a cov]$ outpati5t drug t-- 7i7 is a =m ( g5e !rapy = a r>e disease1 z def9$ by ! ,commission] ( ,food & ,drugs1 designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetics ,act1 & approv$ "u section #eje ( su* ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act to treat a s]i\s or life-?reat5+ disease or condition2 7ii7 if adm9i/]$ 9 accordance ) ! label+ ( su* drug1 is expect$ to result 9 ei!r-- 7,i7 ! cure ( su* disease or condition2 or 7,,ii7 a r$uction 9 ! symptoms ( su* disease or condition to ! ext5t t su* disease or condition is n expect$ to lead to e>ly mortality2 & 7iii7 is expect$ to a*ieve a result describ$ 9 clause 7ii71 :i* may be a*iev$ ov] an ext5d$ p]iod ( "t1 aft] n m ?an #c adm9i/rations4 7,d7 ,relevant cl9ical p>amet] ,! t]m relevant cl9ical p>amet] means1 ) respect to a cov]$ outpati5t drug t is ! subject ( a risk-%>+ value-bas$ paym5t agreem5t-- 7i7 a cl9ical endpo9t specifi$ 9 ! drug's label+ or support$ by "o or m ( ! comp5dia describ$ 9 section #ahfa7t77#b77;,b77ii77,i7 t-- 7,i7 is able to be measur$ or evaluat$ on an annual basis = ea* ye> ( ! agreem5t on an indep5d5t basis by a provid] or o!r entity2 & 7,,ii7 is requir$ to be a*iev$ 7bas$ on obs]v$ metrics 9 pati5t populations7 "u ! t]ms ( ! agreem5t2 or 7ii7 a surrogate endpo9t 7z def9$ 9 section #ejg7;e77#i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 includ+ ^? develop$ by pati5t-focus$ drug developm5t tools1 t-- 7,i7 is able to be measur$ or evaluat$ on an annual basis = ea* ye> ( ! agreem5t on an indep5d5t basis by a provid] or o!r entity2 & 7,,ii7 has be5 qualifi$ by ! ,food & ,drug ,adm9i/ration4 7,e7 ,risk-%>+ value-bas$ paym5t agreem5t ,! t]m risk-%>+ value-bas$ paym5t agreem5t means an agreem5t betwe5 a ,/ate plan & a manufactur]-- 7i7 = ! pur*ase ( a cov]$ outpati5t drug ( ! manufactur] t is a pot5tially curative treatm5t int5d$ = "o-"t use2 7ii7 "u :i* paym5t = su* drug %all be made pursuant to an in/allm5t-bas$ paym5t /ructure t meets ! requirem5ts ( p>agraph 7#c72 7iii7 :i* conditions paym5t on ! a*ievem5t ( at lea/ #b relevant cl9ical p>amet]s 7z def9$ 9 subp>agraph 7,c772 7iv7 :i* provides t-- 7,i7 ! ,/ate plan w directly reimburse ! manufactur] = ! drug2 or 7,,ii7 a ?ird p>ty w reimburse ! manufacture 9 a mann] approv$ by ! ,secret>y2 7v7 is approv$ by ! ,secret>y 9 accordance ) p>agraph 7#b74 7,f7 ,total in/allm5t ye> am\nt ,! t]m total in/allm5t ye> am\nt means1 ) respect to a risk-%>+ value-bas$ paym5t agreem5t = ! pur*ase ( a cov]$ outpati5t drug & an in/allm5t ye>1 an am\nt equal to ! product (-- 7i7 ! unit price ( ! drug *>g$ "u ! agreem5t2 & 7ii7 ! numb] ( units ( su* drug adm9i/]$ "u ! agreem5t dur+ su* in/allm5t ye>4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #aijc7;i77#aj77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#aj77;,a77 is am5d$ by /rik+ or unless section #aibg7;a77#c7 applies & ins]t+ 1 section #aibg7;a77#c7 applies ) respect to su* drugs1 or su* drugs are ! subject ( a risk-%>+ value-bas$ paym5t agreem5t "u section #aibg7l74 7#b7 ,section #aibg7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a71 by ins]t+ b exclud+ any drugs = :i* paym5t is made by a ,/ate "u a risk-%>+ value-bas$ paym5t agreem5t "u subsection 7l77 aft] = cov]age ( su* drugs2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,c77i71 by ins]t+ or subsection 7l77#b77;,a7 aft] subp>agraph 7,a72 & 7ii7 9 subp>agraph 7,d71 9 ! matt] prec$+ clause 7i71 by ins]t+ 1 "u subsection 7l77#b77;,a71 aft] "u ?is p>agraph4 #bji4 ,modification ( maximum rebate am\nt "u ,m$icaid drug rebate program 7a7 ,9 g5]al ,subp>agraph 7,d7 ( section #aibg7;c77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77 is am5d$ to read z foll[s3 7,d7 ,maximum rebate am\nt 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 9 no case %all ! sum ( ! am\nts appli$ "u p>agraph 7#a77;,a77ii7 & ?is p>agraph ) respect to ea* dosage =m & /r5g? ( a s+le s\rce drug or an innovator multiple s\rce drug = a rebate p]iod exce$-- 7,i7 = rebate p]iods beg9n+ aft] ,decemb] #ca1 #bjji1 & be=e ,septemb] #cj1 #bjbb1 #ajj p]c5t ( ! av]age manufactur] price ( ! drug2 & 7,,ii7 = rebate p]iods beg9n+ on or aft] ,octob] #a1 #bjbb1 #abe p]c5t ( ! av]age manufactur] price ( ! drug4 7ii7 ,no maximum am\nt = drugs if ,,amp increases outpace inflation 7,i7 ,9 g5]al ,if ! av]age manufactur] price ) respect to ea* dosage =m & /r5g? ( a s+le s\rce drug or an innovator multiple s\rce drug increases on or aft] ,octob] #a1 #bjba1 & su* increas$ av]age manufactur] price exce$s ! inflation-adju/$ av]age manufactur] price det]m9$ ) respect to su* drug "u subclause 7,,ii7 = ! rebate p]iod1 clause 7i7 %all n apply & !re %all be no limitation on ! sum ( ! am\nts appli$ "u p>agraph 7#a77;,a77ii7 & ?is p>agraph = ! rebate p]iod1 & any subsequ5t rebate p]iod until ! av]age manufactur] price ( ! drug is ! same or less ?an ! inflation-adju/$ av]age manufactur] price det]m9$ ) respect to su* drug "u subclause 7,,ii7 = ! rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( ! s+le s\rce drug or innovator multiple s\rce drug4 7,,ii7 ,inflation-adju/$ av]age manufactur] price def9$ ,9 ?is clause1 ! t]m inflation-adju/$ av]age manufactur] price means1 ) respect to a s+le s\rce drug or an innovator multiple s\rce drug & a rebate p]iod1 ! av]age manufactur] price = ea* dosage =m & /r5g? ( ! drug = ! cal5d> qu>t] beg9n+ ,july #a1 #aiij 7)\t reg>d to :e!r or n ! drug has be5 sold or transf]r$ to an entity1 includ+ a division or subsidi>y ( ! manufactur]1 aft] ! #a/ day ( su* qu>t]71 increas$ by ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! mon? be=e ! mon? 9 :i* ! rebate p]iod beg9s exce$s su* index = ,septemb] #aiij4 4 7b7 ,treatm5t ( subsequ5tly approv$ drugs ,section #aibg7;c77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,b77 is am5d$ by ins]t+ & clause 7ii77,,ii7 ( subp>agraph 7,d7 aft] clause 7ii77,,ii7 ( subp>agraph 7,a74 7c7 ,te*nical am5dm5ts ,section #aibg7;c77#c77;,c77ii77,,iv7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#i7;c77#c77;,c77ii77,,iv77 is am5d$-- 7#a7 by /rik+ subp>agraph 7,a7 & ins]t+ p>agraph 7#c77;,a72 & 7#b7 by /rik+ ?is subp>agraph & ins]t+ p>agraph 7#c77;,c74