,i #aag? ,,congress #a/ ,session ,h4 ,r4 #ai ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #ba1 #bjba,mrs4 ,rodg]s ( ,wa%+ton 7= h]self1 ,mr4 ,brady1 ,ms4 ,foxx1 ,mr4 ,gu?rie1 ,mr4 ,nunes1 & ,mr4 ,all57 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to provide = c]ta9 re=ms ) respect to ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! ,m$icaid program "u title ,,xix ( su* ,act1 ! ,food & ,drug ,adm9i/ration1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,co/s1 ,m ,cures ,act ( #bjba4 #b4 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title4,sec4 #b4 ,table ( cont5ts4,title ,i--,m$ic>e ,p>ts ,b & ,d,subtitle ,a--,m$ic>e ,"p ,b ,provisions ,sec4 #aja4 ,improvem5ts to ,m$ic>e site-(-s]vice transp>5cy4,sec4 #ajb4 ,requir+ manufactur]s ( c]ta9 s+le-dose conta9] or s+le-use package drugs payable "u "p ,b ( ! ,m$ic>e program to provide refunds ) respect to disc>d$ am\nts ( su* drugs4,sec4 #ajc4 ,provid+ = v>iation 9 paym5t = c]ta9 drugs cov]$ "u "p ,b ( ! ,m$ic>e program4,sec4 #ajd4 ,e/abli%m5t ( maximum add-on paym5t = drugs & biologicals4,sec4 #aje4 ,treatm5t ( drug adm9i/ration s]vices furni%$ by c]ta9 except$ (f-campus outpati5t dep>tm5ts ( a provid]4,subtitle ,b--,drug ,price ,transparency,sec4 #aaa4 ,report+ on explanation = drug price increases4,sec4 #aab4 ,public disclosure ( drug disc\nts4,sec4 #aac4 ,/udy ( ph>maceutical supply *a9 int]m$i>ies & m]g] activity4,sec4 #aad4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities4,sec4 #aae4 ,s5se ( ,congress reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms4,subtitle ,c--,m$ic>e ,"p ,d ,b5efit ,redesign,sec4 #aba4 ,m$ic>e "p ,d b5efit r$esign4,subtitle ,d--,o!r ,m$ic>e ,"p ,d ,provisions,sec4 #aca4 ,all[+ ! (f]+ ( additional prescription drug plans "u ,m$ic>e "p ,d4,sec4 #acb4 ,all[+ c]ta9 enrollees ( prescription drug plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4,sec4 #acc4 ,e/abli%+ a mon?ly cap on b5efici>y incurr$ co/s = insul9 products & supplies "u a prescription drug plan or ,,ma-,,pd plan4,sec4 #acd4 ,gr[? rate ( ,m$ic>e "p ,d out-(-pocket co/ ?re%old4,title ,,ii--,medicaid,sec4 #bja4 ,m$icaid ph>macy & !rapeutics committee improvem5ts4,sec4 #bjb4 ,,gao report on conflicts ( int]e/ 9 ,/ate ,m$icaid program drug use review bo>ds & ph>macy & !rapeutics 7,p,t7 committees4,sec4 #bjc4 ,ensur+ ! accuracy ( manufactur] price & drug product in=mation "u ! ,m$icaid drug rebate program4,sec4 #bjd4 ,improv+ transp>5cy & prev5t+ ! use ( abusive spread pric+ & relat$ practices 9 ,m$icaid4,sec4 #bje4 ,t-,,msis drug data analytics reports4,sec4 #bjf4 ,risk-%>+ value-bas$ paym5t agreem5ts = cov]$ outpati5t drugs "u ,m$icaid4,sec4 #bjg4 ,apply+ ,m$icaid drug rebate requirem5t to drugs provid$ z "p ( outpati5t hospital s]vices4,title ,,iii--,food & ,drug ,administration,subtitle ,a--,pay-=-,delay,sec4 #cja4 ,unlawful agreem5ts4,sec4 #cjb4 ,notice & c]tification ( agreem5ts4,sec4 #cjc4 ,=feiture ( #ahj-;day exclusivity p]iod4,sec4 #cjd4 ,commission litigation au?ority4,sec4 #cje4 ,/atute ( limitations4,subtitle ,b--,advanc+ ,education on ,biosimilars,sec4 #cba4 ,education on biological products4,subtitle ,c--,o!r ,provisions,sec4 #cca4 ,cl>ify+ ! mean+ ( new *emical entity4,title ,,iv--,rev5ue ,provision,sec4 #dja4 ,safe h>bor = high d$uctible heal? plans )\t d$uctible = insul94,title ,v--,miscellaneous,sec4 #eja4 ,paym5t = biosimil> biological products dur+ initial p]iod4,sec4 #ejb4 ,,gao /udy & report on av]age sales price4,sec4 #ejc4 ,requir+ prescription drug plans & ,,ma-,,pd plans to report pot5tial fraud1 wa/e1 & abuse to ! ,secret>y ( ,,hhs4,sec4 #ejd4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4,sec4 #eje4 ,improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4,sec4 #ejf4 ,pati5t consultation 9 ,m$ic>e national & local cov]age det]m9ations 9 ord] to mitigate b>ri]s to inclusion ( su* p]spectives4,sec4 #ejg4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d4,sec4 #ejh4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation4,sec4 #eji4 ,*ief ,ph>maceutical ,negotiator at ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 ,i ,m$ic>e ,p>ts ,b & ,d ,a ,m$ic>e ,"p ,b ,provisions #aja4 ,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 z 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 %all 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 #ajb4 ,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 #aciew-#c;a7 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 ( paym5t det]m9$ = su* drug or biological "u subsection 7b77#a77;,b7 = su* qu>t]2 or 7bb7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a biosimil> biological product1 ! am\nt ( paym5t det]m9$ = su* product "u subsection 7b77#a77;,c7 = su* qu>t]2 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 "u ?is "p 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 if applicable1 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug describ$ 9 clause 7ii71 a p]c5tage specifi$ by ! ,secret>y pursuant to su* clause4 7ii7 ,treatm5t ( drugs t h unique circum/ances ,9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t has unique circum/ances involv+ simil> loss ( product z t describ$ 9 p>agraph 7#h77;,b77ii71 ! ,secret>y1 ?r\gh notice & comm5t rulemak+1 may increase ! applicable p]c5tage o!rwise applicable "u clause 7i77,i7 z det]m9$ appropriate by ! ,secret>y4 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 made "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-- 7i7 a drug or biological t is ei!r a radioph>maceutical or an imag+ ag5t2 7ii7 a drug or biological approv$ by ! ,food & ,drug ,adm9i/ration = :i* dosage & adm9i/ration in/ructions includ$ 9 ! label+ require 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 process2 or 7iii7 a drug or biological approv$ by ! ,food & ,drug ,adm9i/ration on or aft] ! date ( enactm5t ( ?is subsection & ) respect to :i* paym5t has be5 made "u ?is "p = few] ?an #ah mon?s4 7#i7 ,report to ,congress ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,(fice ( ! ,inspector ,g5]al1 aft] consultation ) ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,food & ,drug ,adm9i/ration1 %all submit to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance 9 ! ,s5ate1 a report on any impact ?is section is report$ to h on ! lic5sure1 m>ket entry1 m>ket ret5tion1 or m>ket+ ( biosimil> biological products4 ,su* report %all be updat$ p]iodically at ! direction ( ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance 9 ! ,s5ate4 4 #ajc4 ,provid+ = v>iation 9 paym5t = c]ta9 drugs cov]$ "u "p ,b ( ! ,m$ic>e program 7a7 ,9 g5]al ,section #ahdg;,a7b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ aft] or #ajf p]c5t ! foll[+3 7or1 = a multiple s\rce drug 7o!r ?an autolog\s cellul> immuno!rapy7 furni%$ on or aft] ,janu>y #a1 #bjbb1 ! applicable p]c5t specifi$ 9 p>agraph 7#i77;,a7 = ! drug & qu>t] involv$72 & 7,b7 9 subp>agraph 7,b7 ( p>agraph 7#a71 by ins]t+ aft] #ajf p]c5t ! foll[+3 7or1 = a s+le s\rce drug or biological 7o!r ?an autolog\s cellul> immuno!rapy7 furni%$ on or aft] ,janu>y #a1 #bjbb1 ! applicable p]c5t specifi$ 9 p>agraph 7#i77;,a7 = ! drug or biological & qu>t] involv$72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,application ( v>iable p]c5tages bas$ on p]c5tile rank+ ( p] b5efici>y all[$ *>ges 7,a7 ,applicable p]c5t to be appli$ 7i7 ,9 g5]al ,subject to clauses 7ii71 ) respect to a drug or biological furni%$ 9 a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 if ! ,secret>y det]m9es t ! p]c5tile rank ( a drug or biological "u subp>agraph 7,b77i77,,iii71 ) respect to p] b5efici>y all[$ *>ges = all su* drugs or biologicals1 is-- 7,i7 at lea/ equal to ! #he? p]c5tile1 ! applicable p]c5t = ! drug = su* qu>t] "u ?is subp>agraph is #ajd p]c5t2 7,,ii7 at lea/ equal to ! #gj? p]c5tile1 b less ?an ! #he? p]c5tile1 su* applicable p]c5t is #ajf p]c5t2 7,,iii7 at lea/ equal to ! #ej? p]c5tile1 b less ?an ! #gj? p]c5tile1 su* applicable p]c5t is #ajh p]c5t2 or 7,,iv7 less ?an ! #ej? p]c5tile1 su* applicable p]c5t is #aaj p]c5t4 7ii7 ,cases :]e data n suffici5tly available to compute p] b5efici>y all[$ *>ges ,subject to clause 7iii71 9 ! case ( a drug or biological furni%$ = :i* ! am\nt ( paym5t is det]m9$ "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 & n "u subsection 7c77#d71 = cal5d> qu>t]s dur+ a p]iod 9 :i* data are n suffici5tly available to compute a p] b5efici>y all[$ *>ges = ! drug or biological1 ! applicable p]c5t is #ajf p]c5t4 7,b7 ,det]m9ation ( p]c5tile rank ( p] b5efici>y all[$ *>ges ( drugs 7i7 ,9 g5]al ,) respect to a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjbb1 = drugs & biologicals = :i* ! am\nt ( paym5t is det]m9$ "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a71 except = drugs or biologicals = :i* data are n suffici5tly available1 ! ,secret>y %all-- 7,i7 compute ! p] b5efici>y all[$ *>ges 7z def9$ 9 subp>agraph 7,c77 = ea* su* drug or biological2 7,,ii7 adju/ su* p] b5efici>y all[$ *>ges = ! qu>t]1 to ! ext5t provid$ "u subp>agraph 7,d72 & 7,,iii7 array su* adju/$ p] b5efici>y all[$ *>ges = all su* drugs or biologicals f high to l[ & rank su* drugs or biologicals by p]c5tile ( su* array$ p] b5efici>y all[$ *>ges4 7ii7 ,frequ5cy ,! ,secret>y %all make ! computations "u clause 7i77,i7 e #f mon?s 7or1 if necess>y1 z det]m9$ by ! ,secret>y1 e #i or #ab mon?s7 & su* computations %all apply to succe$+ cal5d> qu>t]s until a new computation has be5 made4 7iii7 ,applicable data p]iod ,= purposes ( ?is p>agraph1 ! t]m applicable data p]iod means ! mo/ rec5t p]iod = :i* ! data necess>y = mak+ ! computations "u clause 7i7 are available1 z det]m9$ by ! ,secret>y4 7,c7 ,p] b5efici>y all[$ *>ges def9$ ,9 ?is p>agraph1 ! t]m p] b5efici>y all[$ *>ges means1 ) respect to a drug or biological = :i* ! am\nt ( paym5t is det]m9$ "u subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7-- 7i7 ! all[$ *>ges = ! drug or biological = :i* paym5t is s made = ! applicable data p]iod1 z e/imat$ by ! ,secret>y2 divid$ by 7ii7 ! numb] ( individuals = :om any paym5t = ! drug or biological 0 made "u p>agraph 7#a7 = ! applicable data p]iod1 z e/imat$ by ! ,secret>y4 7,d7 ,adju/m5t to reflect *anges 9 av]age sales price ,9 apply+ ?is p>agraph = a p>ticul> cal5d> qu>t]1 ! ,secret>y %all adju/ ! p] b5efici>y all[$ *>ges = a drug or biological by multiply+ su* p] b5efici>y all[$ *>ges "u subp>agraph 7,c7 = ! applicable data p]iod by ! ratio (-- 7i7 ! av]age sales price = ! drug or biological = ! mo/ rec5t cal5d> qu>t] us$ "u subsection 7c77#e77;,b72 to 7ii7 ! av]age sales price = ! drug or biological = ! cal5d> qu>t] 7or ! weight$ av]age = ! qu>t]s involv$7 includ$ 9 ! applicable data p]iod4 4 7b7 ,application ( judicial review provisions ,section #ahdg;,a7g7 ( ! ,social ,security ,act is am5d$-- 7#a7 by /rik+ & at ! end ( p>agraph 7#d72 7#b7 by /rik+ ! p]iod at ! end ( p>agraph 7#e7 & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ! det]m9ation ( p] b5efici>y all[$ *>ges ( drugs or biologicals & rank+ ( su* *>ges "u subsection 7b77#i74 4 #ajd4 ,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;a71 z am5d$ by section #ajc1 is fur!r 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#aj72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,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$ = ! applicable p]c5t 7z def9$ 9 p>agraph 7#i77 = su* drug4 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$ = ! applicable p]c5t 7z def9$ 9 p>agraph 7#i77 = su* drug or biological4 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 ) respect to a drug or biological 7o!r ?an autolog\s cellul> immuno!rapy7-- 7,i7 = ea* ( #bjbb ?r\gh #bjbi1 #a1jjj2 & 7,,ii7 = 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>2 or 7ii7 ) respect to a drug or biological consi/+ ( autolog\s cellul> immuno!rapy-- 7,i7 = ea* ( #bjbb ?r\gh #bjbi1 #b1jjj2 & 7,,ii7 = 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#aj71 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#aj7 ( 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 #aje4 ,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 ,b ,drug ,price ,transp>5cy #aaa4 ,report+ on explanation = drug price increases 7a7 ,9 g5]al ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,drug ,price ,report+2 ,drug ,value ,fund #cii,,oo4 ,report+ on explanation = drug price increases 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ?is ,act2 or 7,b7 :o is responsible = sett+ ! :olesale acquisition co/ = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m1 adju/$ = inflation occurr+ aft] ! date ( enactm5t ( ?is section1 = a mon?'s supply or a typical c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 adm9i/]$ or o!rwise disp5s$ to treat a disease or condition affect+ m ?an #bjj1jjj p]sons 9 ! ,unit$ ,/ates2 & 7iii7 n a vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or "u a ,/ate ,m$icaid plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y = ea* increase 9 ! price ( a qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7,a7 #aj p]c5t or m )9 a s+le cal5d> ye> beg9n+ on or aft] ,janu>y #a1 #bjba2 or 7,b7 #be p]c5t or m )9 ?ree consecutive cal5d> ye>s = :i* ! fir/ su* cal5d> ye> beg9s on or aft] ,janu>y #a1 #bjba4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y-- 7,a7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjba1 & end+ on ! day t is #fj days aft] ! date ( enactm5t ( ?is section1 n lat] ?an #ij days aft] su* date ( enactm5t2 & 7,b7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs aft] ! p]iod describ$ 9 subp>agraph 7,a71 n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase = su* qualify+ drug4 7c7 ,cont5ts ,a report "u subsection 7b71 consi/5t ) ! /&>d = disclosures describ$ 9 section #bac4c7;d7 ( title #ab1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is section71 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug )9 ! cal5d> ye> or ?ree consecutive cal5d> ye>s z describ$ 9 subsection 7b77#a77;,a7 or 7b77#a77;,b71 if applicable1 & ! effective date ( su* price increase2 7,b7 an explanation =1 & description (1 ea* price increase = su* drug t w occur dur+ ! cal5d> ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! ?ree consecutive cal5d> ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,c7 if kn[n & diff]5t f ! manufactur] ( ! qualify+ drug1 ! id5tity (-- 7i7 ! sponsor or sponsors ( any inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = cl9ical inve/igations ) respect to su* drug1 = :i* ! full reports are submitt$ z "p ( ! application-- 7,i7 = approval ( ! drug "u section #eje ( su* ,act2 or 7,,ii7 = lic5sure ( ! drug "u section #cea ( ?is ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ?is ,act2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ?is ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 if applicable2 7,e7 ! curr5t :olesale acquisition co/ ( ! drug2 7,f7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 & 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 7,g7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,h7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is necess>y to demon/rate t x meets applicable /atutory /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea ( ?is ,act1 z applicable2 7,i7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act2 7,j7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,k7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,l7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #a-ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #c-ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #a-ye> p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #c-ye> p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials1 includ+ on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate & z specifi$ by ! ,secret>y ?r\gh notice-&-comm5t rulemak+4 7d7 ,in=mation provid$ ,! manufactur] ( a qualify+ drug t is requir$ to submit a report "u subsection 7b71 %all ensure t su* report & any explanation =1 & description (1 ea* price increase describ$ 9 subsection 7c77#a77;,b7 %all be tru?ful1 n mislead+1 & accurate4 7e7 ,civil monet>y p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 foll[+ notification by ! ,secret>y to ! manufactur] t ! manufactur] is n 9 compliance ) ?is section1 %all be subject to a civil monet>y p5alty ( #ge1jjj = ea* day on :i* ! violation cont9ues4 7f7 ,false in=mation ,any manufactur] t submits a report = a drug z requir$ by ?is section t kn[+ly provides false in=mation 9 su* report is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ge1jjj = ea* item ( false in=mation4 7g7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 ! ,secret>y %all po/ ea* report submitt$ "u subsection 7b7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! day ! price increase ( a qualify+ drug is s*$ul$ to g into effect4 7#b7 ,=mat ,9 develop+ ! =mat 9 :i* reports w be publicly po/$ "u p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back f consum] advocates & readability exp]ts on ! =mat & pres5tation ( ! cont5t ( su* reports to ensure t su* reports are-- 7,a7 us]-fri5dly to ! public2 & 7,b7 writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,protect$ in=mation ,no?+ 9 ?is section %all be con/ru$ to au?orize ! public disclosure ( in=mation submitt$ by a manufactur] t is prohibit$ f disclosure by applicable laws conc]n+ ! protection ( trade secrets1 comm]cial in=mation1 & o!r in=mation cov]$ "u su* laws4 #cii,,oo-#a4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ,congress1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is us]-fri5dly to ! public & writt5 9 pla9 language t consum]s c readily und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #cii,,oo2 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section2 7#c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out section #cii,,oo2 & 7#d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7b7 ,protect$ in=mation ,no?+ 9 ?is section %all be con/ru$ to au?orize ! public disclosure ( in=mation submitt$ by a manufactur] t is prohibit$ f disclosure by applicable laws conc]n+ ! protection ( trade secrets1 comm]cial in=mation1 & o!r in=mation cov]$ "u su* laws4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 takes effect on ! date ( enactm5t ( ?is ,act4 #aab4 ,public disclosure ( drug disc\nts ,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 ins]t+ 7o!r ?an z p]mitt$ "u subsection 7e77 aft] disclos$ by ! ,secret>y2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7e7 ,public availability ( c]ta9 in=mation 7#a7 ,9 g5]al ,9 ord] to all[ ! comp>ison ( ,p,b,ms' ability to negotiate rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions & ! am\nt ( su* rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions t are pass$ ?r\gh to plan sponsors1 beg9n+ ,janu>y #a1 #bjbb1 ! ,secret>y %all make available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! in=mation ) respect to ! second prec$+ cal5d> ye> provid$ to ! ,secret>y on g5]ic disp5s+ rates 7z describ$ 9 p>agraph 7#a7 ( subsection 7b77 & in=mation provid$ to ! ,secret>y "u p>agraphs 7#b7 & 7#c7 ( su* subsection t1 z det]m9$ by ! ,secret>y1 is ) respect to ea* ,,pbm4 7#b7 ,availability ( data ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all ensure ! foll[+3 7,a7 ,confid5tiality ,! in=mation describ$ 9 su* p>agraph is display$ 9 a mann] t prev5ts ! disclosure ( in=mation1 ) respect to an individual drug or an individual plan1 on rebates1 disc\nts1 direct & indirect remun]ation fees1 adm9i/rative fees1 & price concessions4 7,b7 ,class ( drug ,! in=mation describ$ 9 su* p>agraph is made available by class ( drug1 us+ an exi/+ classification sy/em1 b only if ! class conta9s su* numb] ( drugs1 z specifi$ by ! ,secret>y 7b n few] ?an ?ree drugs71 to ensure confid5tiality ( propriet>y in=mation or o!r in=mation t is prev5t$ to be disclos$ "u subp>agraph 7,a74 4 #aac4 ,/udy ( ph>maceutical supply *a9 int]m$i>ies & m]g] activity 7a7 ,initial report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! appropriate committees ( ,congress a report t-- 7#a7 addresses at m9imum-- 7,a7 :e!r ph>macy b5efit manag]s-- 7i7 *>ge pay]s a high] price ?an ! reimbursem5t rate at :i* ! ph>macy b5efit manag]s reimburse compet+ ph>macies2 7ii7 /e] pati5ts = anticompetitive purposes to any ph>macies1 includ+ retail1 mail-ord]1 or any o!r type ( ph>macy1 9 :i* ! ph>macy b5efit manag] has an own]%ip int]e/2 7iii7 audit or review propriet>y data1 includ+ acquisition co/s1 pati5t in=mation1 or disp5s+ in=mation1 ( compet+ ph>macies t c be us$ = anticompetitive purposes2 or 7iv7 use =mul>y designs to increase ! m>ket %>e ( high] co/ prescription drugs & depress ! m>ket %>e ( l[] co/ prescription drugs 7ea* net ( rebates & disc\nts72 7,b7 h[ companies & pay]s assess ! b5efits1 co/s1 & risks ( contract+ ) int]m$i>ies1 includ+ ph>macy s]vices adm9i/rative organizations1 & :e!r m in=mation ab\t ! roles ( int]m$i>ies %\ld be available to consum]s & pay]s2 & 7,c7 :e!r !re are any specific legal or regulatory ob/acles ! ,commission curr5tly faces 9 ensur+ a competitive & transp>5t m>ketplace 9 ! ph>maceutical supply *a91 includ+ ! ph>macy b5efit manag] m>ketplace & ph>macy s]vices adm9i/rative organizations2 & 7#b7 provides-- 7,a7 obs]vations or conclusions drawn f ! ,novemb] #bjag r\ndtable entitl$ ,und]/&+ ,competition 9 ,prescription ,drug ,m>kets3 ,entry & ,supply ,*a9 ,dynamics1 & any simil> ef=ts2 7,b7 specific actions ! ,commission int5ds to take z a result ( ! ,novemb] #bjag r\ndtable1 & any simil> ef=ts1 includ+ a detail$ description ( relevant =?com+ actions1 additional rese>* or r\ndtable discussions1 consum] education ef=ts1 or en=cem5t actions2 & 7,c7 policy or legislative recomm5dations to-- 7i7 improve transp>5cy & competition 9 ! ph>maceutical supply *a92 7ii7 prev5t & det] anticompetitive behavior 9 ! ph>maceutical supply *a92 & 7iii7 be/ ensure t consum]s b5efit f any co/ sav+s or effici5cies t may result f m]g]s & consolidations4 7b7 ,int]im report ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! appropriate committees ( ,congress an int]im report on ! progress ( ! report requir$ by subsection 7a71 along ) prelim9>y f9d+s & conclusions bas$ on in=mation collect$ to t date4 7c7 ,def9itions ,9 ?is section3 7#a7 ,appropriate committees ( ,congress ,! t]m appropriate committees ( ,congress means-- 7,a7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 7,b7 ! ,committee on ! ,judici>y ( ! ,s5ate2 & 7,c7 ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives4 7#b7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 #aad4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities 7a7 ,9 g5]al ,section #aabh;,h ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;i7 is am5d$-- 7#a7 by r$esignat+ subsection 7b7 z subsection 7e72 & 7#b7 by ins]t+ aft] subsection 7a7 ! foll[+ new subsections3 7b7 ,data %>+ agreem5ts 7#a7 ,9 g5]al ,! ,secret>y %all ent] into agreem5ts ) ! specifi$ data %>+ individuals & entities describ$ 9 p>agraph 7#b7 "u :i*-- 7,a7 ^u reque/ ( su* an individual or entity1 z applicable1 ! ,secret>y makes available to su* individual or entity ! in=mation submitt$ "u subsection 7a7 by manufactur]s & au?oriz$ di/ributors ( record2 & 7,b7 su* individual or entity agrees to n disclose publicly or to ano!r individual or entity any in=mation t id5tifies a p>ticul> practition] or heal? c>e facility4 7#b7 ,specifi$ data %>+ individuals & entities ,= purposes ( p>agraph 7#a71 ! specifi$ data %>+ individuals & entities describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,ov]sight ag5cies ,heal? ov]sight ag5cies 7z def9$ 9 section #afd4eja ( title #de1 ,code ( ,f$]al ,regulations71 includ+ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,gov]nm5t ,acc\ntability ,(fice1 ! ,congressional ,budget ,(fice1 ! ,m$ic>e ,paym5t ,advisory ,commission1 & ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission4 7,b7 ,rese>*]s ,individuals :o conduct sci5tific rese>* 7z def9$ 9 section #afd4eja ( title #de1 ,code ( ,f$]al ,regulations7 9 relevant areas z det]m9$ by ! ,secret>y4 7,c7 ,pay]s ,private & public heal? c>e pay]s1 includ+ gr\p heal? plans1 heal? insurance cov]age (f]$ by heal? insurance issu]s1 ,f$]al heal? programs1 & ,/ate heal? programs4 7#c7 ,exemption f ,fre$om ( ,in=mation ,act ,except z describ$ 9 p>agraph 7#a71 ! ,secret>y may n be compell$ to disclose ! in=mation submitt$ "u subsection 7a7 to any individual or entity4 ,= purposes ( section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,fre$om ( ,in=mation ,act71 ?is p>agraph %all be consid]$ a /atute describ$ 9 subsection 7b77#c77;,b7 ( su* section4 7c7 ,p5alties 7#a7 ,data %>+ agreem5ts ,subject to p>agraph 7#c71 any specifi$ data %>+ individual or entity describ$ 9 subsection 7b77#b7 t violates ! t]ms ( a data %>+ agreem5t ! individual or entity has ) ! ,secret>y "u subsection 7b77#a7 %all be subject to a civil money p5alty ( n less ?an #a1jjj1 b n m ?an #aj1jjj1 = ea* su* violation4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a are impos$ & collect$ "u t section4 7#b7 ,failure to report ,subject to p>agraph 7#c71 any manufactur] or au?oriz$ di/ributor ( record ( an applicable drug "u subsection 7a7 t fails to submit in=mation requir$ "u su* subsection 9 a timely mann] 9 accordance ) rules or regulations promulgat$ to c>ry out su* subsection %all be subject to a civil money p5alty ( n less ?an #a1jjj1 b n m ?an #aj1jjj1 = ea* su* failure4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a are impos$ & collect$ "u t section4 7#c7 ,limitation ,! total am\nt ( civil money p5alties impos$ "u p>agraph 7#a7 or 7#b7 ) respect to a ye> & an individual or entity describ$ 9 p>agraph 7#a7 or a manufactur] or di/ributor describ$ 9 p>agraph 7#b71 respectively1 %all n exce$ #aej1jjj4 7d7 ,drug sample di/ribution in=mation 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a ( ea* ye> 7beg9n+ ) #bjbb71 ! ,secret>y %all ma9ta9 a li/ conta9+ in=mation relat$ to ! di/ribution ( samples ( applicable drugs4 ,su* li/ %all provide ! foll[+ in=mation ) respect to ! prec$+ ye>3 7,a7 ,! "n ( ! manufactur] or au?oriz$ di/ributor ( record ( an applicable drug = :i* samples 7 reque/$ or di/ribut$ "u ?is section4 7,b7 ,! quantity & class ( drug samples reque/$4 7,c7 ,! quantity & class ( drug samples di/ribut$4 7#b7 ,public availability ,! ,secret>y %all make ! in=mation 9 su* li/ available to ! public on ! ,int]net website ( ! ,food & ,drug ,adm9i/ration4 4 7b7 ,,fda ma9t5ance ( in=mation ,! ,food & ,drug ,adm9i/ration %all ma9ta9 in=mation available to affect$ report+ companies to ensure _! ability to fully comply ) ! requirem5ts ( section #aabh;,h ( ! ,social ,security ,act4 7c7 ,prohibition on di/ribution ( samples ( opioids ,section #ejc7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;d77 is am5d$-- 7#a7 by mov+ ! m>g9 ( p>agraph 7#d7 #b ems to ! left2 & 7#b7 by add+ at ! end ! foll[+3 7#e7 ,no p]son may di/ribute a drug sample ( a drug t is-- 7,a7 an applicable drug 7z def9$ 9 section #aabh;,h7e7 ( ! ,social ,security ,act72 7,b7 a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act7 = :i* ! f9d+s requir$ "u section #bjb7;b77#b7 ( su* ,act h be5 made2 & 7,c7 approv$ "u section #eje = use 9 ! managem5t or treatm5t ( pa9 7o!r ?an = ! managem5t or treatm5t ( a sub/ance use disord]74 4 7d7 ,med,p,a,c report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy on ! impact ( drug samples on provid] prescrib+ practices & heal? c>e co/s & may1 z ! ,commission deems appropriate1 make recomm5dations on su* /udy4 #aae4 ,s5se ( ,congress reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms ,x is ! s5se ( ,congress t-- 7#a7 comm]cially available drug pric+ comp>ison plat=ms c1 at no co/1 help pati5ts f9d ! l[e/ price = _! m$ications at _! local ph>macy2 7#b7 su* plat=ms %\ld be integrat$1 to ! maximum ext5t possible1 9 ! heal? c>e deliv]y ecosy/em2 & 7#c7 ph>macy b5efit manag]s %\ld "w to disclose g5]ic & br& "n drug prices to su* plat=ms to ensure t-- 7,a7 pati5ts c b5efit f ! l[e/ possible price available to !m2 & 7,b7 ov]all drug prices c be r$uc$ z m educat$ pur*as+ decisions are made bas$ on price transp>5cy4 ,c ,m$ic>e ,"p ,d ,b5efit ,r$esign #aba4 ,m$ic>e "p ,d b5efit r$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,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb & = 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 = #bjbb & ea* subsequ5t ye> aft] p>agraph 7#c72 7ii7 9 clause 7i71 by ins]t+ aft] #be p]c5t ! foll[+3 7or1 = #bjbb & ea* subsequ5t ye>1 #ae p]c5t72 & 7iii7 9 clause 7ii71 by ins]t+ 7or1 = #bjbb & ea* subsequ5t ye>1 #ae p]c5t7 aft] #be p]c5t2 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ & #bjba2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 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 #bjba2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjba2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjba2 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+ is equal to-- 7,i7 = a ye> prec$+ #bjbb1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & 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] #bjba = 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+ = #bjba2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbb1 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$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ & = a ye> prec$+ #bjbb = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( #bjaa ?r\gh #bjba1 9 apply+4 7b7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is am5d$-- 7#a7 by /rik+ equal to #hj p]c5t & ins]t+ equal to- 7,a7 = a ye> prec$+ #bjbb1 #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 = #bjbb & ea* subsequ5t ye>1 ! sum (-- 7i7 an am\nt equal to #bj p]c5t ( ! all[able re9surance co/s 7z specifi$ 9 p>agraph 7#b77 attributable to t portion ( gross cov]$ 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 #cj p]c5t ( ! all[able re9surance co/s 7z specifi$ 9 p>agraph 7#b77 attributable to t portion ( gross cov]$ 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$74 4 7c7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ 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 #bjbc1 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 #bjbd4 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 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 on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 94 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 equal to or exce$ ! 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* section72 & 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 means1 ) respect to an applicable drug ( a manufactur] furni%$ dur+ a ye> to an applicable b5efici>y1 #ij p]c5t ( ! negotiat$ price ( su* drug4 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 ,special case = claims spann+ d$uctible ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall at or above ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price "u ?is section on only ! portion ( ! negotiat$ price ( ! applicable drug t falls at or above su* annual d$uctible4 7#e7 ,manufactur] ,! t]m manufactur] means any entity :i* is engag$ 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 = an applicable drug4 7#g7 ,qualifi$ retiree prescription drug plan ,! t]m qualifi$ retiree prescription drug plan has ! mean+ giv5 su* t]m 9 section #aahfj;,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 #bjbd1 &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 #bjbd1 ) 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$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "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+ an 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 = #bjbd & 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 7d7 ,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$-- 7#a7 9 p>agraph 7#b7-- 7,a7 by /rik+ ,co/s4--,= purposes & ins]t+ ,co/s4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 = purposes 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,inclusion ( manufactur] disc\nts on applicable drugs ,= purposes ( apply+ subp>agraph 7,a71 ! t]m all[able re9surance co/s %all include ! portion ( ! negotiat$ price 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#f77 ( an applicable drug 7z def9$ 9 section #ahfj;,d-#ad7;g77#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 7e7 ,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$esign ,! ,secret>y %all update ! risk adju/m5t model us$ 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 ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjba4 4 7f7 ,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 #bjbd1 & p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ on or aft] ,janu>y #a1 #bjbd4 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 7a77 or ! p]iod beg9n+ on ,janu>y #a1 #bjbd1 & end+ ,decemb] #ca1 #bjbd 7) respect to p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection71 !re 7 ext5uat+ circum/ances4 4 7g7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or = a ye> prec$+ #bjbd 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$+ #bjbd or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbd & 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$+ #bjbd1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbd1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbd1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbd1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbd1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e7-- 7,i7 by ins]t+ = a ye> prec$+ #bjbd1 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#d77;,b77i7 & ins]t+ section #ahfj;,d-#b7;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$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbd1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ 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 = #bjbd & 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$-- 7,a7 by ins]t+ = a ye> be=e #bjbd aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7h7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye> #bjbd & subsequ5t plan ye>s4 ,d ,o!r ,m$ic>e ,"p ,d ,provisions #aca4 ,all[+ ! (f]+ ( additional prescription drug plans "u ,m$ic>e "p ,d 7a7 ,resc9d+ & issuance ( new guidance ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all-- 7#a7 resc9d sections ( any sub-regulatory guidance t limit ! numb] ( prescription drug plans 9 ea* ,,pdp region t may be (f]$ by a ,,pdp sponsor "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq472 & 7#b7 issue new guidance specify+ t a ,,pdp sponsor may (f] up to #d 7or a great] numb] if det]m9$ appropriate by ! ,secret>y7 prescription drug plans 9 ea* ,,pdp region1 except 9 cases :]e ! ,,pdp sponsor may (f] up to #b additional plans 9 a ,,pdp region pursuant to section #ahfj;,d-#aa7;d77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;d77#d771 z add$ by subsection 7b74 7b7 ,(f]+ ( additional plans ,section #ahfj;,d-#aa7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;d77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,(f]+ ( additional plans 7,a7 ,9 g5]al ,= plan ye> #bjbb & ea* subsequ5t plan ye>1 a ,,pdp sponsor may (f] up to #b additional prescription drug plans 9 a ,,pdp region 79 addition to any limit e/abli%$ by ! ,secret>y "u ?is "p7 provid$ t ! ,,pdp sponsor complies ) subp>agraph 7,b7 ) respect to at lea/ "o su* prescription drug plan4 7,b7 ,requirem5ts ,9 ord] to be eligible to (f] up to #b additional plans 9 a ,,pdp region pursuant to subp>agraph 7,a71 a ,,pdp sponsor mu/ ensure t1 ) respect to at lea/ "o su* prescription drug plan1 ! sponsor or any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) any su* sponsor or plan does n receive direct or indirect remun]ation1 z def9$ 9 section #dbc4cjh ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 unless at lea/ #be p]c5t ( ! aggregate r$uctions 9 price or o!r remun]ation receiv$ by ! ,,pdp sponsor or entity f drug manufactur]s ) respect to ! plan & plan ye>-- 7i7 are reflect$ at ! po9t-(-sale to ! enrollee2 or 7ii7 are us$ to r$uce total b5efici>y co/-%>+ e/imat$ by ! ,,pdp sponsor = prescription drug cov]age "u ! plan 9 ! annual bid submitt$ by ! ,,pdp sponsor "u section #ahfj;,d-#aa7;b74 7,c7 ,def9ition ( r$uctions 9 price ,= purposes ( subp>agraph 7,b71 ! t]m r$uctions 9 price ref]s only to collectible am\nts1 z det]m9$ by ! ,secret>y1 :i* excludes am\nts :i* aft] adjudication & reconciliation ) ph>macies & manufactur]s are duplicate 9 nature1 contr>y to o!r contractual clauses1 or o!rwise ineligible 7su* z due to b5efici>y dis5rollm5t or coord9ation ( b5efits74 4 7c7 ,rule ( con/ruction ,no?+ 9 ! provisions (1 or am5dm5ts made by1 ?is section %all be con/ru$ z limit+ ! ability ( ! ,secret>y to increase any limit o!rwise applicable on ! numb] ( prescription drug plans t a ,,pdp sponsor may (f]1 at ! discretion ( ! ,,pdp sponsor1 9 a ,,pdp region "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 #acb4 ,all[+ c]ta9 enrollees ( prescription drug plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances 7a7 ,/&>d prescription drug cov]age ,section #ahfj;,d-#b7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 z am5d$ by section #aba1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,subject to subp>agraphs 7,c7 & 7,d7 & ins]t+ ,subject to subp>agraphs 7,c71 7,d71 & 7,e72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,enrollee option reg>d+ spread+ co/-%>+ 7i7 ,9 g5]al ,! ,secret>y %all e/abli% by regulation a process "u :i*1 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 a prescription drug plan or an ,,ma-,,pd plan %all1 9 ! case ( a "p ,d eligible individual enroll$ ) su* plan = su* plan ye> ) respect to :om ! plan projects t ! disp5s+ ( a cov]$ "p ,d drug to su* individual w result 9 ! individual incurr+ co/s )9 a #cj-;day p]iod t are equal to a significant p]c5tage 7z specifi$ by ! ,secret>y pursuant to su* regulation7 ( ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = su* plan ye>1 provide su* individual ) ! option to make ! co9surance paym5t requir$ "u subp>agraph 7,a7 = su* co/s 9 ! =m ( equal mon?ly in/allm5ts ov] ! rema9d] ( su* plan ye>4 7ii7 ,significant p]c5tage limitations ,9 specify+ a significant p]c5tage pursuant to ! regulation e/abli%$ by ! ,secret>y "u clause 7i71 ! ,secret>y may n specify a p]c5tage t is less ?an #cj p]c5t or great] ?an #ajj p]c5t4 4 7b7 ,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 enrollee option reg>d+ spread+ co/-%>+ ,= plan ye> #bjbb & subsequ5t plan ye>s1 ! cov]age provides ! enrollee option reg>d+ spread+ co/-%>+ describ$ 9 & requir$ "u subsection 7b77#b77;,e74 4 #acc4 ,e/abli%+ a mon?ly cap on b5efici>y incurr$ co/s = insul9 products & supplies "u a prescription drug plan or ,,ma-,,pd plan 7a7 ,9 g5]al ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb71 z am5d$ by sections #aba & #acc1 is fur!r am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & 7,e7 & ins]t+ 7,e71 & 7,f72 7,b7 9 subp>agraph 7,b71 by /rik+ & 7,d7 & ins]t+ 7,d71 & 7,f72 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,cap on incurr$ co/s = insul9 products & supplies 7i7 ,9 g5]al ,! cov]age provides b5efits1 = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old describ$ 9 p>agraph 7#d77;,b7 & ) respect to a mon? 7beg9n+ ) ,janu>y ( #bjbb71 ) co/ %>+ t is equal to #j = a specifi$ cov]$ "p ,d drug 7z def9$ 9 clause 7iii77 furni%$ to an individual :o has incurr$ co/s dur+ su* mon? ) respect to specifi$ cov]$ "p ,d drugs equal to-- 7,i7 = mon?s occurr+ 9 #bjbb1 #ej2 or 7,,ii7 = mon?s occurr+ 9 a subsequ5t ye>1 ! am\nt applicable "u ?is clause = mon?s occurr+ 9 ! ye> prec$+ su* subsequ5t ye>1 increas$ by ! annual p]c5tage increase specifi$ 9 p>agraph 7#f7 = su* subsequ5t ye> & r\nd$ to ! ne>e/ doll>4 7ii7 ,application ,! provisions ( clauses 7i7 ?r\gh 7iii7 ( p>agraph 7#d77;,c7 %all apply ) respect to ! det]m9ation ( ! incurr$ co/s = specifi$ cov]$ "p ,d drugs = purposes ( clause 7i7 9 ! same mann] z su* provisions apply ) respect to ! det]m9ation ( incurr$ co/s = cov]$ "p ,d drugs = purposes ( p>agraph 7#d77;,a74 7iii7 ,specifi$ cov]$ "p ,d drug ,= purposes ( ?is subp>agraph1 ! t]m specifi$ cov]$ "p ,d drug means a cov]$ "p ,d drug t is-- 7,i7 insul92 or 7,,ii7 a m$ical supply associat$ ) ! injection ( insul9 7z def9$ 9 regulations ( ! ,secret>y promulgat$ pursuant to subsection 7e77#a77;,b774 2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,same protection ) respect to exp5ditures = insul9 & c]ta9 m$ical supplies ,! cov]age provides ! cov]age requir$ "u subsection 7b77#b77;,f74 4 7b7 ,con=m+ am5dm5ts 7#a7 ,9 g5]al ,section #ahfj;,d-#ad7;a77#a77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#a77;,d771 z am5d$ by section #aba1 is fur!r am5d$-- 7,a7 9 clause 7ii71 by /rik+ section #ahfj;,d-#b7;b77#b7 & ins]t+ section #ahfj;,d-#b7;b77#b77;,a72 & 7,b7 9 clause 7iii71 by /rik+ section #ahfj;,d-#b7;b77#b7 & ins]t+ section #ahfj;,d-#b7;b77#b77;,a74 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply ) respect to plan ye> #bjbb & ea* subsequ5t plan ye>4 #acd4 ,gr[? rate ( ,m$ic>e "p ,d out-(-pocket co/ ?re%old 7a7 ,provid+ ,m$ic>e "p ,d b5efici>ies ) c]ta9 #bjbj (fset paym5ts ,section #ahfj;,d-#b7;b77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 #bjbj (fset paym5ts 7i7 ,9 g5]al ,subject to clause 7iv71 ! ,secret>y %all provide = paym5t f ! ,m$ic>e ,prescription ,drug ,acc\nt z foll[s3 7,i7 ,9 ! case ( a specifi$ individual 7z def9$ 9 clause 7ii77,i77 :o z ( ! la/ day ( a cal5d> qu>t] 9 #bjbj has incurr$ co/s = cov]$ "p ,d drugs s t ! individual has exce$$ ! annual out-(-pocket ?re%old appli$ "u subp>agraph 7,b77i77,v7 = #bjbj1 paym5t to ! individual by n lat] ?an #ae? day ( ! ?ird mon? foll[+ ! end ( su* qu>t] ( ! am\nt by :i* su* ?re%old s appli$ exce$$ ! t>get ?re%old = #bjbj4 7,,ii7 ,9 ! case ( a specifi$ individual :o is n describ$ 9 subclause 7,i7 & :o z ( ! la/ day ( #bjbj has incurr$ co/s = cov]$ "p ,d drugs s t ! individual has exce$$ ! t>get ?re%old = #bjbj1 paym5t to ! individual by n lat] ?an ,decemb] #ca1 #bjba1 ( ! am\nt by :i* su* incurr$ co/s exce$$ ! t>get ?re%old = #bjbj4 7ii7 ,def9itions ,= purposes ( ?is subp>agraph3 7,i7 ,specifi$ individual ,! t]m specifi$ individual means an individual :o-- 7aa7 is enroll$ 9 a prescription drug plan or an ,,ma- ,,pd plan2 7bb7 is n enroll$ 9 a qualifi$ retiree prescription drug plan2 & 7cc7 is n entitl$ to an income-relat$ subsidy "u section #ahfj;,d-#ad7;a74 7,,ii7 ,t>get ?re%old = #bjbj ,! t]m t>get ?re%old = #bjbj means ! annual out-(-pocket ?re%old t w\ld h be5 appli$ "u subp>agraph 7,b77i7 = #bjbj if su* ?re%old _h be5 det]m9$ 9 accordance ) subclause 7,,iv7 ( su* subp>agraph in/ead ( subclause 7,v7 ( su* subp>agraph4 7iii7 ,notification ,9 ! case ( any specifi$ individual :o dur+ #bjbj has incurr$ co/s = cov]$ "p ,d drugs s t ! individual has exce$$ ! t>get ?re%old = #bjbj1 ! ,secret>y %all1 n lat] ?an ,septemb] #cj1 #bjba1 provide to su* individual a notification in=m+ su* individual ( su* individual's "r to a paym5t describ$ 9 clause 7i7 & ! e/imat$ tim+ ( su* paym5t4 7iv7 ,cl>ification ,! ,secret>y %all provide only #a paym5t "u ?is subp>agraph ) respect to any individual4 7v7 ,implem5tation ,! ,secret>y may implem5t ?is subp>agraph by program in/ruction or o!rwise4 4 7b7 ,r$uc$ gr[? rate = #bjba ( ,m$ic>e "p ,d out-(-,pocket co/ ?re%old ,section #ahfj;,d-#b7;b77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77;,b77i77 is am5d$-- 7#a7 9 subclause 7,v71 by /rik+ at ! end or2 7#b7 by r$esignat+ subclause 7,,vi7 z subclause 7,,viii72 & 7#c7 by ins]t+ aft] subclause 7,v7 ! foll[+ new subclauses3 7,,vi7 = #bjba1 is equal to ! am\nt t w\ld h be5 appli$ "u ?is subp>agraph = #bjbj if su* am\nt _h be5 det]m9$ 9 accordance ) subclause 7,,iv7 in/ead ( subclause 7,v71 increas$ by ! less] (-- 7aa7 ! annual p]c5tage increase describ$ 9 p>agraph 7#g7 = #bjba1 plus #b p]c5tage po9ts2 or 7bb7 ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = #bjba2 7,,vii7 = #bjbb1 is equal to ! am\nt t w\ld h be5 appli$ "u ?is subp>agraph = #bjbb if ! am5dm5ts made by section #aaja7;d77#a7 ( ! ,heal? ,c>e & ,education ,reconciliation ,act ( #bjaj & by section #acd ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjba _h n be5 enact$2 or 4 ,,ii ,m$icaid #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 includes at lea/ #a actively practic+ physician & at lea/ #a actively practic+ ph>maci/1 ea* ( :om-- 7aa7 is indep5d5t & free ( conflict ) respect to manufactur]s & ,m$icaid p>ticipat+ plans or subcontractors1 includ+ ph>macy b5efit manag]s2 & 7bb7 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 illnesses2 & 7,,ii7 is made publicly available4 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 ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjba1 ! ,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 ,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 7c7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #bjb4 ,,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 7collectively 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 #bjc4 ,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 ongo+ 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> #bjbb & 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 = late report+ ( 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 #bjd4 ,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 & 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 ( ! ,,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 regulation71 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/-9-voice fees4 ,disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all 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 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 ,clause 7xiii7 ( section #aijc7m77#b77;,a7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a771 z am5d$ by section #bjb1 is fur!r 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 entity1 %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 fails to respond to a survey conduct$ "u ?is subsection on a timely basis may be subject to a civil monet>y p5alty 9 ! am\nt ( #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$+s "u section #aabh;,a7a74 7,i7 ,report on specialty ph>macies 7i7 ,9 g5]al ,n lat] ?an #a ye> 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> #bjbb & 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#c771 z am5d$ by section #ada1 is fur!r 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 ( subclauses 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 7vi71 by /rik+ & aft] ! comma2 7,c7 9 clause 7vii71 by /rik+ ! p]iod & ins]t+ 1 &2 & 7,d7 by ins]t+ aft] clause 7vii7 ! foll[+3 7viii7 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 #bje4 ,t-,,msis drug data analytics reports 7a7 ,9 g5]al ,n lat] ?an ,may #a ( ea* cal5d> ye> beg9n+ ) cal5d> ye> #bjbc1 ! ,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 provid] prescrib+ patt]ns "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 =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 codes2 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 ( ,/ates71 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 ,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+ behaviors2 & 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 %all-- 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> #bjbb & ea* fiscal ye> !reaft]1 !re is appropriat$ to ! ,secret>y #b1jjj1jjj to c>ry out ?is section4 #bjf4 ,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] is p>ty to rebate agreem5t & 9 compliance ) 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 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 su* propos$ agreem5t w\ld n result 9 great] e/imat$ ,f$]al sp5d+ "u ?is title ?an ! net ,f$]al sp5d+ t w\ld result 9 ! abs5ce ( ! 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 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u 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 = 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 pur*as$ "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$ 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$]al ,regulations 7or any successor regulations71 = purposes ( det]m9+ av]age manufactur] price & be/ price "u ?is section ) respect to ! cov]$ 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 ) 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> #bjbb & 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$-- 7,a7 9 p>agraph 7#a77;,a71 by ins]t+ 7except = drugs = :i* paym5t is made by a ,/ate "u a risk-%>+ value-bas$ paym5t agreem5t "u subsection 7l77 aft] "u ! ,/ate plan = su* p]iod2 & 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$+ clause 7i71 by ins]t+ 1 "u subsection 7l77#b77;,a71 aft] "u ?is p>agraph4 #bjg4 ,apply+ ,m$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 = :i* ! ,/ate is ! prim>y pay] "u ?is title or a demon/ration project conc]n+ ?is title1 & t is 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 & = :i* paym5t is made z "p ( paym5t = su* s]vices4 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#e7771 & o!r relevant /akehold]s1 includ+ heal? c>e provid]s1 reg>d+ implem5tation ( ! am5dm5t made by subsection 7a74 ,,iii ,food & ,drug ,adm9i/ration ,a ,pay-=-,delay #cja4 ,unlawful agreem5ts 7a7 ,agreem5ts prohibit$ ,subject to subsections 7b7 & 7c71 x %all be unlawful = an ,,nda or ,,bla hold] & a subsequ5t fil] 7or = two subsequ5t fil]s7 to ent] into1 or c>ry out1 an agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim on a f9al or int]im basis if "u su* agreem5t-- 7#a7 a subsequ5t fil] directly or indirectly receives f su* hold] 7or 9 ! case ( su* an agreem5t betwe5 two subsequ5t fil]s1 ! o!r subsequ5t fil]7 any?+ ( value1 includ+ a lic5se2 & 7#b7 ! subsequ5t fil] agrees to limit or =ego rese>* on1 or developm5t1 manufactur+1 m>ket+1 or sales1 = any p]iod ( "t1 ( ! cov]$ product t is ! subject ( ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h74 7b7 ,exclusion ,x %all n be unlawful "u subsection 7a7 if a p>ty to an agreem5t describ$ 9 su* subsection demon/rates by cle> & conv9c+ evid5ce t ! value describ$ 9 subsection 7a77#a7 is comp5sation solely = o!r goods or s]vices t ! subsequ5t fil] has promis$ to provide4 7c7 ,limitation ,no?+ 9 ?is section %all prohibit an agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim 9 :i* ! consid]ation grant$ by ! ,,nda or ,,bla hold] to ! subsequ5t fil] 7or f "o subsequ5t fil] to ano!r7 z "p ( ! resolution or settlem5t includes only "o or m ( ! foll[+3 7#a7 ,! "r to m>ket ! cov]$ product t is ! subject ( ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h7 9 ! ,unit$ ,/ates be=e ! expiration (-- 7,a7 any pat5t t is ! basis ( ! cov]$ pat5t infr+em5t claim2 or 7,b7 any pat5t "r or o!r /atutory exclusivity t w\ld prev5t ! m>ket+ ( su* cov]$ product4 7#b7 ,a paym5t = reasonable litigation exp5ses n to exce$ #g1ejj1jjj 9 ! aggregate4 7#c7 ,a cov5ant n to sue on any claim t su* cov]$ product infr+es a pat5t4 7d7 ,en=cem5t by ,f$]al ,trade ,commission 7#a7 ,g5]al application ,! requirem5ts ( ?is section apply1 accord+ to _! t]ms1 to an ,,nda or ,,bla hold] or subsequ5t fil] t is-- 7,a7 a p]son1 p>tn]%ip1 or corporation ov] :i* ! ,commission has au?ority pursuant to section #e7;a77#b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b772 or 7,b7 a p]son1 p>tn]%ip1 or corporation ov] :i* ! ,commission w\ld h au?ority pursuant to su* section b = ! fact t su* p]son1 p>tn]%ip1 or corporation is n organiz$ to c>ry on bus9ess = its own pr(it or t ( its memb]s4 7#b7 ,unfair or deceptive acts or practices en=cem5t au?ority 7,a7 ,9 g5]al ,a violation ( ?is section %all be treat$ z an unfair or deceptive act or practice 9 violation ( section #e7;a77#a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7,b7 ,p[]s ( ,commission ,except z provid$ 9 subp>agraph 7,c7 & p>agraphs 7#a77;,b7 & 7#c7-- 7i7 ! ,commission %all en=ce ?is section 9 ! same mann]1 by ! same means1 & ) ! same jurisdiction1 p[]s1 & duties z ?\gh all applicable t]ms & provisions ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 7 incorporat$ into & made a "p ( ?is section2 & 7ii7 any ,,nda or ,,bla hold] or subsequ5t fil] t violates ?is section %all be subject to ! p5alties & entitl$ to ! privileges & immunities provid$ 9 ! ,f$]al ,trade ,commission ,act4 7,c7 ,judicial review ,9 ! case ( a cease & desi/ ord] issu$ by ! ,commission "u section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 = violation ( ?is section1 a p>ty to su* ord] may obta9 judicial review ( su* ord] z provid$ 9 su* section #e1 except t-- 7i7 su* review may only be obta9$ 9-- 7,i7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit2 7,,ii7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity1 z def9$ 9 section #hja4a7;a77#c7 ( title #af1 ,code ( ,f$]al ,regulations1 or any successor !reto1 ( ! ,,nda or ,,bla hold] 7if any su* hold] is a p>ty to su* ord]7 is incorporat$ z ( ! date t ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h7 or an approv$ application t is deem$ to be a lic5se = a biological product "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh2 #abd ,/at4 #hag7 is submitt$ to ! ,commission] ( ,food & ,drugs2 or 7,,iii7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity1 z s def9$1 ( any subsequ5t fil] t is a p>ty to su* ord] is incorporat$ z ( ! date t ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7g77#h7 is submitt$ to ! ,commission] ( ,food & ,drugs2 & 7ii7 ! petition = review %all be fil$ 9 ! c\rt n lat] ?an #cj days aft] su* ord] is s]v$ on ! p>ty seek+ review4 7#c7 ,additional en=cem5t au?ority 7,a7 ,civil p5alty ,! ,commission may comm5ce a civil action to recov] a civil p5alty 9 a di/rict c\rt ( ! ,unit$ ,/ates aga9/ any ,,nda or ,,bla hold] or subsequ5t fil] t violates ?is section4 7,b7 ,special rule = recov]y ( p5alty if cease & desi/ ord] issu$ 7i7 ,9 g5]al ,if ! ,commission has issu$ a cease & desi/ ord] 9 a proce$+ "u section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 = violation ( ?is section-- 7,i7 ! ,commission may comm5ce a civil action "u subp>agraph 7,a7 to recov] a civil p5alty aga9/ any p>ty to su* ord] at any "t be=e ! expiration ( ! #a-ye> p]iod beg9n+ on ! date on :i* su* ord] becomes f9al "u section #e7;g7 ( su* ,act 7#ae ,u4,s4,c4 #de7;g772 & 7,,ii7 9 su* civil action1 ! f9d+s ( ! ,commission z to ! mat]ial facts 9 su* proce$+ %all be conclusive1 unless-- 7aa7 ! t]ms ( su* ord] expressly provide t ! ,commission's f9d+s %all n be conclusive2 or 7bb7 su* ord] became f9al by reason ( section #e7;g77#a7 ( su* ,act 7#ae ,u4,s4,c4 #de7;g77#a771 9 :i* case su* f9d+s %all be conclusive if support$ by evid5ce4 7ii7 ,relation%ip to p5alty = violation ( an ord] ,! p5alty provid$ 9 clause 7i7 = violation ( ?is section is sep>ate f & 9 addition to any p5alty t may be incurr$ = violation ( an ord] ( ! ,commission "u section #e7l7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7l774 7,c7 ,am\nt ( p5alty 7i7 ,9 g5]al ,! am\nt ( a civil p5alty impos$ 9 a civil action "u subp>agraph 7,a7 on a p>ty to an agreem5t describ$ 9 subsection 7a7 %all be suffici5t to det] violations ( ?is section1 b 9 no ev5t great] ?an-- 7,i7 if su* p>ty is ! ,,nda or ,,bla hold] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o gave ! value describ$ 9 subsection 7a77#a771 ! great] (-- 7aa7 #c times ! value receiv$ by su* ,,nda or ,,bla hold] 7or by su* subsequ5t fil]7 t is reasonably attributable to ! violation ( ?is section2 or 7bb7 #c times ! value giv5 to ! subsequ5t fil] 7or to ! o!r subsequ5t fil]7 reasonably attributable to ! violation ( ?is section2 & 7,,ii7 if su* p>ty is ! subsequ5t fil] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o receiv$ ! value describ$ 9 subsection 7a77#a771 #c times ! value receiv$ by su* subsequ5t fil] t is reasonably attributable to ! violation ( ?is section4 7ii7 ,factors = consid]ation ,9 det]m9+ su* am\nt1 ! c\rt %all take into acc\nt-- 7,i7 ! nature1 circum/ances1 ext5t1 & gravity ( ! violation2 7,,ii7 ) respect to ! violator1 ! degree ( culpability1 any hi/ory ( violations1 ! ability to pay1 any effect on ! ability to cont9ue do+ bus9ess1 pr(its e>n$ by ! ,,nda or ,,bla hold] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o gave ! value describ$ 9 subsection 7a77#a771 comp5sation receiv$ by ! subsequ5t fil] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 ! subsequ5t fil] :o receiv$ ! value describ$ 9 subsection 7a77#a771 & ! am\nt ( comm]ce affect$2 & 7,,iii7 o!r matt]s t ju/ice requires4 7,d7 ,injunctions & o!r equitable relief ,9 a civil action "u subp>agraph 7,a71 ! ,unit$ ,/ates di/rict c\rts are emp[]$ to grant m&atory injunctions & su* o!r & fur!r equitable relief z !y deem appropriate4 7#d7 ,rem$ies 9 addition ,rem$ies provid$ 9 ?is subsection are 9 addition to1 & n 9 lieu (1 any o!r rem$y provid$ by ,f$]al law4 7#e7 ,pres]vation ( au?ority ( ,commission ,no?+ 9 ?is section %all be con/ru$ to affect any au?ority ( ! ,commission "u any o!r provision ( law4 7e7 ,f$]al ,trade ,commission rulemak+ ,! ,commission may1 9 its discretion1 by rule promulgat$ "u section #eec ( title #e1 ,unit$ ,/ates ,code1 exempt f ?is section c]ta9 agreem5ts describ$ 9 subsection 7a7 if ! ,commission f9ds su* agreem5ts to be 9 fur!rance ( m>ket competition & = ! b5efit ( consum]s4 7f7 ,antitru/ laws ,no?+ 9 ?is section %all modify1 impair1 limit1 or sup]s$e ! applicability ( ! antitru/ laws z def9$ 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 & ( section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section #e applies to unfair me?ods ( competition4 ,no?+ 9 ?is section %all modify1 impair1 limit1 or sup]s$e ! "r ( a subsequ5t fil] to ass]t claims or c\nt]claims aga9/ any p]son1 "u ! antitru/ laws or o!r laws relat+ to unfair competition4 7g7 ,def9itions ,9 ?is section3 7#a7 ,agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim ,! t]m agreem5t resolv+ or settl+ a cov]$ pat5t infr+em5t claim means any agreem5t t-- 7,a7 resolves or settles a cov]$ pat5t infr+em5t claim2 or 7,b7 is cont+5t ^u1 provides = a cont+5t condition =1 or is o!rwise relat$ to ! resolution or settlem5t ( a cov]$ pat5t infr+em5t claim4 7#b7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 7#c7 ,cov]$ pat5t infr+em5t claim ,! t]m cov]$ pat5t infr+em5t claim means an allegation made by ! ,,nda or ,,bla hold] to a subsequ5t fil] 7or1 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 by "o subsequ5t fil] to ano!r71 :e!r or n includ$ 9 a compla9t fil$ ) a c\rt ( law1 t-- 7,a7 ! submission ( ! application describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#i71 or ! manufacture1 use1 (f]+ = sale1 sale1 or importation into ! ,unit$ ,/ates ( a cov]$ product t is ! subject ( su* an application-- 7i7 9 ! case ( an agreem5t betwe5 an ,,nda or ,,bla hold] & a subsequ5t fil]1 infr+es any pat5t own$ by1 or exclusively lic5s$ to1 ! ,,nda or ,,bla hold] ( ! cov]$ product2 or 7ii7 9 ! case ( an agreem5t betwe5 two subsequ5t fil]s1 infr+es any pat5t own$ by ! subsequ5t fil]2 or 7,b7 9 ! case ( an agreem5t betwe5 an ,,nda or ,,bla hold] & a subsequ5t fil]1 ! cov]$ product to be manufactur$ "u su* application uses a cov]$ product z claim$ 9 a publi%$ pat5t application4 7#d7 ,cov]$ product ,! t]m cov]$ product means a drug 7z def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 includ+ a biological product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i7774 7#e7 ,,nda or ,,bla hold] ,! t]m ,,nda or ,,bla hold] means-- 7,a7 ! hold] (-- 7i7 an approv$ new drug application fil$ "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 = a cov]$ product2 or 7ii7 a biologics lic5se application fil$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 ) respect to a biological product2 7,b7 a p]son own+ or controll+ en=cem5t ( ! pat5t on-- 7i7 ! li/ publi%$ "u section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 9 connection ) ! application describ$ 9 subp>agraph 7,a77i72 or 7ii7 any li/ publi%$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 compris$ ( pat5ts associat$ ) biologics lic5se applications fil$ "u section #cea7;a7 ( su* ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,c7 ! pr$ecessors1 subsidi>ies1 divisions1 gr\ps1 & affiliates controll$ by1 controll+1 or "u common control ) any entity describ$ 9 subp>agraph 7,a7 or 7,b7 7su* control to be presum$ by direct or indirect %>e own]%ip ( #ej p]c5t or great]71 z well z ! lic5sees1 lic5sors1 successors1 & assigns ( ea* ( ! entities4 7#f7 ,pat5t ,! t]m pat5t means a pat5t issu$ by ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice4 7#g7 ,/atutory exclusivity ,! t]m /atutory exclusivity means ^? prohibitions on ! submission or approval ( drug applications "u clauses 7ii7 ?r\gh 7iv7 ( section #eje7;c77#c77;,e7 7#e- & #c-ye> exclusivity71 clauses 7ii7 ?r\gh 7iv7 ( section #eje7;j77#e77;,f7 7#e-ye> & #c-ye> exclusivity71 section #eje7;j77#e77;,b77iv7 7#ahj-;day exclusivity71 section #ebg 7orphan drug exclusivity71 section #eje;,a 7p$iatric exclusivity71 or section #eje;,e 7qualifi$ infecti\s disease product exclusivity7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cee7;j77#e77;,b77iv71 #cee7;j77#e77;,f71 #cfj;cc1 #cee;a1 #cee;f71 or prohibitions on ! submission or lic5s+ ( biologics lic5se applications "u section #cea7k77#f7 7int]*angeable biological product exclusivity7 or section #cea7k77#g7 7biological product ref]5ce product exclusivity7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 7#h7 ,subsequ5t fil] ,! t]m subsequ5t fil] means-- 7,a7 9 ! case ( a drug1 a p>ty t owns or controls an abbreviat$ new drug application submitt$ pursuant to section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application submitt$ pursuant to section #eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b77 & fil$ "u section #eje7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or has ! exclusive rights to di/ribute ! cov]$ product t is ! subject ( su* application2 or 7,b7 9 ! case ( a biological product1 a p>ty t owns or controls an application fil$ ) ! ,food & ,drug ,adm9i/ration "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 or has ! exclusive rights to di/ribute ! biological product t is ! subject ( su* application4 7h7 ,effective date ,?is section applies ) respect to agreem5ts describ$ 9 subsection 7a7 ent]$ into on or aft] ! date ( ! enactm5t ( ?is ,act4 #cjb4 ,notice & c]tification ( agreem5ts 7a7 ,notice ( all agreem5ts ,section #aaaa7g7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note7 is am5d$ by ins]t+ or ! own] ( a pat5t = :i* a claim ( infr+em5t c\ld reasonably be ass]t$ aga9/ any p]son = mak+1 us+1 (f]+ to sell1 sell+1 or import+ into ! ,unit$ ,/ates a biological product t is ! subject ( a biosimil> biological product application be=e ! p]iod at ! end4 7b7 ,c]tification ( agreem5ts ,section #aaab ( su* ,act 7#ba ,u4,s4,c4 #cee note7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,c]tification ,! ,*ief ,executive ,(fic] or ! company (ficial responsible = negotiat+ any agreem5t "u subsection 7a7 or 7b7 t is requir$ to be fil$ "u subsection 7c7 %all1 )9 #cj days ( su* fil+1 execute & file ) ! ,assi/ant ,attorney ,g5]al & ! ,commission a c]tification z foll[s3,i decl>e t ! foll[+ is true1 correct1 & complete to ! be/ ( my k3 ,! mat]ials fil$ ) ! ,f$]al ,trade ,commission & ! ,dep>tm5t ( ,ju/ice "u section #aaab ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc1 ) respect to ! agreem5t ref]5c$ 9 ?is c]tification-- 7#a7 repres5t ! complete1 f9al1 & exclusive agreem5t betwe5 ! p>ties2 7#b7 include any ancill>y agreem5ts t are cont+5t ^u1 provide a cont+5t condition =1 7 ent]$ into )9 #cj days (1 or are o!rwise relat$ to1 ! ref]5c$ agreem5t2 & 7#c7 include writt5 descriptions ( any oral agreem5ts1 repres5tations1 commitm5ts1 or promises betwe5 ! p>ties t are responsive to subsection 7a7 or 7b7 ( su* section #aaab & h n be5 r$uc$ to writ+4 4 #cjc4 ,=feiture ( #ahj-;day exclusivity p]iod ,section #eje7;j77#e77;,d77i77,v7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is am5d$ by ins]t+ section #cja ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjba or aft] t ! agreem5t has violat$4 #cjd4 ,commission litigation au?ority ,section #af7;a77#b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ or aft] ! semicolon2 7#b7 9 subp>agraph 7,e71 by mov+ ! m>g9 #b ems to ! left & ins]t+ or aft] ! semicolon2 & 7#c7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+3 7,f7 "u section #cja7;d77#c77;,a7 ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjba2 4 #cje4 ,/atute ( limitations 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 ! ,commission %all comm5ce any adm9i/rative proce$+ or civil action to en=ce section #cja ( ?is ,act n lat] ?an #f ye>s aft] ! date on :i* ! p>ties to ! agreem5t file ! ,notice ( ,agreem5t z provid$ by section #aaab7;c77#b7 & 7d7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note74 7b7 ,civil action aft] issuance ( cease & desi/ ord] ,if ! ,commission has issu$ a cease & desi/ ord] "u section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 = violation ( section #cja ( ?is ,act & ! proce$+ = ! issuance ( su* ord] 0 comm5c$ )9 ! p]iod requir$ by subsection 7a7 ( ?is section1 su* subsection does n prohibit ! comm5cem5t1 aft] su* p]iod1 ( a civil action "u section #cja7;d77#c77;,a7 aga9/ a p>ty to su* ord] or a civil action "u subsection 7l7 ( su* section #e = violation ( su* ord]4 ,b ,advanc+ ,education on ,biosimil>s #cba4 ,education on biological products 7a7 ,website2 cont9u+ education ,subp>t #a ( "p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$ by add+ at ! end ! foll[+3 #ceb;,a4 ,education on biological products 7a7 ,int]net website 7#a7 ,9 g5]al ,! ,secret>y %all ma9ta9 & op]ate an int]net website to provide educational mat]ials = heal? c>e provid]s1 pati5ts1 & c>egiv]s1 reg>d+ ! mean+ ( ! t]ms1 & ! /&>ds = review & lic5s+ (1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 7#b7 ,cont5t ,educational mat]ials provid$ "u p>agraph 7#a7 may include-- 7,a7 explanations ( key /atutory & regulatory t]ms1 includ+ biosimil> & int]*angeable1 & cl>ification reg>d+ ! use ( int]*angeable biosimil> biological products2 7,b7 in=mation relat$ to developm5t programs = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products & relevant cl9ical consid]ations = prescrib]s1 :i* may include1 z appropriate & applicable1 in=mation relat$ to ! comp>ability ( su* biological products2 7,c7 an explanation ( ! process = report+ adv]se ev5ts = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products2 & 7,d7 an explanation ( ! relation%ip betwe5 biosimil> biological products & int]*angeable biosimil> biological products lic5s$ "u section #cea7k7 & ref]5ce products 7z def9$ 9 section #cea7;i771 includ+ ! /&>ds = review & lic5s+ ( ea* su* type ( biological product4 7#c7 ,=mat ,! educational mat]ials provid$ "u p>agraph 7#a7 may be-- 7,a7 9 =mats su* z web9>s1 cont9u+ m$ical education modules1 videos1 fact %eets1 infographics1 /akehold] toolkits1 or o!r =mats z appropriate & applicable2 & 7,b7 tailor$ = ! unique ne$s ( heal? c>e provid]s1 pati5ts1 c>egiv]s1 & o!r audi5ces1 z ! ,secret>y det]m9es appropriate4 7#d7 ,o!r in=mation ,9 addition to ! in=mation describ$ 9 p>agraph 7#b71 ! ,secret>y %all cont9ue to publi% ! foll[+ in=mation3 7,a7 ,! action package ( ea* biological product lic5s$ "u subsection 7a7 or 7k74 7,b7 ,! summ>y review ( ea* biological product lic5s$ "u subsection 7a7 or 7k74 7#e7 ,confid5tial & trade secret in=mation ,?is subsection does n au?orize ! disclosure ( any trade secret1 confid5tial comm]cial or f9ancial in=mation1 or o!r matt] describ$ 9 section #eeb7;b7 ( title #e4 7b7 ,cont9u+ education ,! ,secret>y %all advance education & aw>5ess among heal? c>e provid]s reg>d+ biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products1 z appropriate1 includ+ by develop+ or improv+ cont9u+ education programs t advance ! education ( su* provid]s on ! prescrib+ (1 & relevant cl9ical consid]ations ) respect to1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 4 7b7 ,application "u ! ,m$ic>e ,m]it-,bas$ ,inc5tive ,paym5t ,sy/em ,section #ahdh7q77#e77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#e77;,c77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iv7 ,cl9ical m$ical education program on biosimil> biological products ,completion ( a cl9ical m$ical education program develop$ or improv$ "u section #ceb;,a7b7 ( ! ,public ,heal? ,s]vice ,act by a ,,mips eligible pr(essional dur+ a p]=mance p]iod %all e>n su* eligible pr(essional "o-half ( ! highe/ pot5tial score = ! p]=mance category describ$ 9 p>agraph 7#b77;,a77iii7 = su* p]=mance p]iod4 ,a ,,mips eligible pr(essional may only c\nt ! completion ( su* a program = purposes ( su* category "o "t dur+ ! eligible pr(essional's lifetime4 4 ,c ,o!r ,provisions #cca4 ,cl>ify+ ! mean+ ( new *emical entity ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 9 subsection 7c77#c77;,e7-- 7i7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 9 clause 7iii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 subsection 7j77#e77;,f7-- 7i7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 9 clause 7iii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,c7 9 subsection 7l77#b77;,a77i71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,d7 9 subsection 7s71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7,e7 9 subsection 7u77#a71 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 by /rik+ same active +r$i5t & ins]t+ same active moiety2 7#b7 9 section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f77-- 7,a7 9 clause 7i71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7,c7 9 clause 7v71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#c7 9 section #ebd7;a77#d77;,c7 7#ba ,u4,s4,c4 #cfjn7a77#d77;,c771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#d7 9 section #ebi7;a77#d77;,a77ii7 7#ba ,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7#e7 9 section #efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d77;,d771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations774 ,,iv ,rev5ue ,provision #dja4 ,safe h>bor = high d$uctible heal? plans )\t d$uctible = insul9 7a7 ,9 g5]al ,section #bbc7;c77#b77;,c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or = insul9 or any device = ! deliv]y ( insul9 be=e ! p]iod at ! end4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to mon?s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 ,v ,miscellane\s #eja4 ,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] ,july #a1 #bjbc1 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 #ejb4 ,,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 ?an #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 #ejc4 ,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-#ajd7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7p7 ,report+ pot5tial fraud1 wa/e1 & abuse ,beg9n+ ,janu>y #a1 #bjbb1 ! ,,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 #ejd4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ( ph>macy quality measures 7,a7 ,9 g5]al ,a ,,pdp sponsor t implem5ts inc5tive paym5ts to a ph>macy or price concessions paid by a ph>macy bas$ on quality measures %all use measures e/abli%$ or approv$ by ! ,secret>y "u subp>agraph 7,b7 ) respect to paym5t = cov]$ "p ,d drugs disp5s$ by su* ph>macy4 7,b7 ,/&>d ph>macy quality measures ,! ,secret>y %all e/abli% or approve /&>d quality measures f a cons5sus & evid5ce-bas$ organization = paym5ts describ$ 9 subp>agraph 7,a74 ,su* measures %all focus on pati5t heal? outcomes & be bas$ on prov5 crit]ia measur+ ph>macy p]=mance4 7,c7 ,effective date ,! requirem5t "u subp>agraph 7,a7 %all take effect = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 or su* e>li] date specifi$ by ! ,secret>y if ! ,secret>y det]m9es !re are suffici5t measures e/abli%$ or approv$ "u subp>agraph 7,b7 to meet ! requirem5t "u subp>agraph 7,a74 4 #eje4 ,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 ,! public meet+ %all include-- 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]vices2 7ii7 /akehold]s ) exp]tise 9 ! rese>* & developm5t ( novel m$ical products1 includ+ manufactur]s ( su* products2 7iii7 repres5tatives ( comm]cial heal? insurance pay]s2 7iv7 /akehold]s ) exp]tise 9 ! adm9i/ration & use ( novel m$ical products1 includ+ physicians2 & 7v7 /akehold]s repres5t+ pati5ts & ) exp]tise 9 ! utilization ( pati5t exp]i5ce data 9 m$ical product developm5t4 7,c7 ,topics ,! public meet+ %all include a discussion (-- 7i7 ! /atus ( ! drug & m$ical device developm5t pipel9e relat$ to ! availability ( novel m$ical products2 7ii7 ! anticipat$ 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$ical products4 7,d7 ,trade secrets & confid5tial in=mation ,no in=mation discuss$ z a "p ( ! public meet+ "u ?is p>agraph %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>agraph 7,a7 & 7,b71 respectively1 ( section #ahfb7l77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#f7772 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 m$ical product1 includ+ a drug1 biological 7includ+ g5e & cell !rapy71 or m$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 #ejf4 ,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 ,! ,secret>y may consult ) pati5ts & organizations repres5t+ pati5ts 9 mak+ national & local cov]age det]m9ations4 4 #ejg4 ,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 #bjbc1 ! ,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 ,d2 & 7,e7 ! feasibility & policy implications ( creat+ a me?odology to pres]ve ! heal?c>e provid]'s ability to take title ( ! drug1 includ+ a me?odology "u :i*-- 7i7 prescription drug plans negotiate reimbursem5t rates & o!r arrangem5ts ) drug manufactur]s on behalf ( a :olesal]2 7ii7 :olesal]s pur*ase ! drugs f ! manufactur]s at ! negotiat$ rate & %ip !m ?r\gh di/ributors to physicians to adm9i/] to pati5ts2 7iii7 physicians & hospitals pur*ase ! drug f ! :olesal] via ! di/ributor2 7iv7 aft] adm9i/]+ ! drug1 ! physician submits a claim to ! ,,mac = _! drug adm9i/ration fee2 7v7 to be reimburs$ = ! pur*ase ( ! drug f ! di/ributor1 ! physician furni%es ! claim = ! drug itself to ! :olesal] & ! :olesal] w\ld refund ! co/ ( ! drug to ! physician2 & 7vi7 ! :olesal] passes ?is claim to ! ,,pdp to receive reimbursem5t4 #ejh4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new section3 #aaej;,c4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation 7a7 ,9 g5]al ,! ,secret>y %all require t ea* direct-to-consum] adv]tisem5t = a prescription drug or biological product = :i* paym5t is available "u title ,,xviii or ,,xix includes an appropriate disclosure ( tru?ful & non-mislead+ pric+ in=mation ) respect to ! drug or product4 7b7 ,det]m9ation by ,,cms ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all det]m9e ! compon5ts ( ! requirem5t "u subsection 7a71 su* z ! =ms ( adv]tis+1 ! mann] ( disclosure1 ! price po9t li/+1 & ! price in=mation = disclosure4 4 #eji4 ,*ief ,ph>maceutical ,negotiator at ! ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative 7a7 ,9 g5]al ,section #ada ( ! ,trade ,act ( #aigd 7#ai ,u4,s4,c4 #baga7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 by /rik+ & "o ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ "o ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 & "o ,*ief ,ph>maceutical ,negotiator2 7,b7 by /rik+ or ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 or ! ,*ief ,ph>maceutical ,negotiator2 & 7,c7 by /rik+ & ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator & ins]t+ ! ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 & ! ,*ief ,ph>maceutical ,negotiator2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,! pr9cipal function ( ! ,*ief ,ph>maceutical ,negotiator %all be to conduct trade negotiations & to en=ce trade agreem5ts relat+ to ,unit$ ,/ates ph>maceutical products & s]vices4 ,! ,*ief ,ph>maceutical ,negotiator %all be a vigor\s advocate on behalf ( ,unit$ ,/ates ph>maceutical int]e/s4 ,! ,*ief ,ph>maceutical ,negotiator %all p]=m su* o!r functions z ! ,unit$ ,/ates ,trade ,repres5tative may direct4 4 7b7 ,comp5sation ,section #ecad ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 & ins]t+ ! foll[+3 ,*ief ,innovation & ,intellectual ,prop]ty ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4,*ief ,ph>maceutical ,negotiator1 ,(fice ( ! ,unit$ ,/ates ,trade ,repres5tative4 4 7c7 ,report requir$ ,n lat] ?an ! date t is "o ye> aft] ! appo9tm5t ( ! fir/ ,*ief ,ph>maceutical ,negotiator pursuant to p>agraph 7#b7 ( section #ada7;b7 ( ! ,trade ,act ( #aigd1 z am5d$ by subsection 7a71 & annually !reaft]1 ! ,unit$ ,/ates ,trade ,repres5tative %all submit to ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives a report describ+ 9 detail-- 7#a7 en=cem5t actions tak5 by ! ,unit$ ,/ates ,trade ,repres5tative dur+ ! "o-ye> p]iod prec$+ ! submission ( ! report to ensure ! protection ( ,unit$ ,/ates ph>maceutical products & s]vices2 & 7#b7 o!r actions tak5 by ! ,unit$ ,/ates ,trade ,repres5tative to advance ,unit$ ,/ates ph>maceutical products & s]vices4