,,ii #aaf? ,,congress #a/ ,session ,s4 #cabi ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #ai1 #bjai,mr4 ,crapo 7= himself1 ,mr4 ,enzi1 ,mr4 ,burr1 ,mr4 ,b>rasso1 ,mr4 ,tillis1 & ,mr4 ,ris*7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to provide = c]ta9 re=ms ) respect to ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai4 #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,sec4 #ajf4 ,paym5t = biosimil> biological products dur+ initial p]iod4,sec4 #ajg4 ,education on biological & biosimil> products4,sec4 #ajh4 ,,gao /udy & report on av]age sales price4,subtitle ,b--,m$ic>e ,"p ,d ,provisions,sec4 #aaa4 ,m$ic>e "p ,d b5efit r$esign4,sec4 #aab4 ,transitional cov]age & retroactive ,m$ic>e "p ,d cov]age = c]ta9 l[-income b5efici>ies4,sec4 #aac4 ,all[+ ! (f]+ ( additional prescription drug plans "u ,m$ic>e "p ,d4,sec4 #aad4 ,all[+ c]ta9 enrollees ( prescription drug plans & ,,ma-,,pd plans "u ! ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4,sec4 #aae4 ,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 #aaf4 ,gr[? rate ( ,m$ic>e "p ,d out-(-pocket co/ ?re%old4,sec4 #aag4 ,requir+ prescription drug plan sponsors to include real-"t b5efit in=mation z "p ( su* sponsor's electronic prescription program "u ! ,m$ic>e program4,sec4 #aah4 ,requir+ prescription drug plans & ,,ma-,,pd plans to report pot5tial fraud1 wa/e1 & abuse to ! ,secret>y ( ,,hhs4,sec4 #aai4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4,,title ,,ii--,drug ,price ,transparency,sec4 #bja4 ,report+ on explanation = drug price increases4,sec4 #bjb4 ,public disclosure ( drug disc\nts4,sec4 #bjc4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program4,sec4 #bjd4 ,mak+ prescription drug m>ket+ sample in=mation report$ by manufactur]s available to c]ta9 individuals & entities4,sec4 #bje4 ,provid+ ! ,m$ic>e ,paym5t ,advisory ,commission & ,m$icaid & ,,*ip ,paym5t & ,access ,commission ) access to c]ta9 drug paym5t in=mation1 includ+ c]ta9 rebate in=mation4,sec4 #bjf4 ,s5se ( ! ,s5ate reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms4,,title ,,iii--,rev5ue ,provisions,sec4 #cja4 ,p]man5t ext5sion ( r$uction 9 m$ical exp5se d$uction floor4,sec4 #cjb4 ,safe h>bor = high d$uctible heal? plans )\t d$uctible = insul94,sec4 #cjc4 ,inclusion ( c]ta9 ov]-!-c\nt] m$ical products z qualifi$ m$ical exp5ses4,,title ,,iv--,miscellaneous,sec4 #dja4 ,improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4,sec4 #djb4 ,pati5t consultation 9 ,m$ic>e national & local cov]age det]m9ations 9 ord] to mitigate b>ri]s to inclusion ( su* p]spectives4,sec4 #djc4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d4,sec4 #djd4 ,requirem5t t direct-to-consum] adv]tisem5ts = prescription drugs & biological products include tru?ful & non-mislead+ pric+ in=mation4,sec4 #dje4 ,*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] "u ?is title2 & 7iii7 by ins]t+ 7or #bjba ) 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 #bjba1 ! ,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 #acie-c;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,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] ,july #a1 #bjba1 ! ,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] ,july #a1 #bjba1 ! 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] ,july #a1 #bjba1 an am\nt equal to ! e/imat$ am\nt 7if any7 by :i*-- 7i7 ! product (-- 7,i7 ! total numb] ( units ( ! bill+ & paym5t code = su* drug t 7 disc>d$ dur+ su* qu>t] 7z det]m9$ "u p>agraph 7#a772 & 7,,ii7 7aa7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a s+le s\rce drug or biological1 ! am\nt det]m9$ = su* drug "u subsection 7b77#d72 or 7bb7 9 ! case ( a refundable s+le-dose conta9] or s+le-use package drug t is a biosimil> biological product1 ! av]age sales price det]m9$ "u subsection 7b77#h77;,a72 exce$s 7ii7 an am\nt equal to ! applicable p]c5tage 7z def9$ 9 subp>agraph 7,b77 ( ! e/imat$ total all[$ *>ges = su* drug dur+ ! qu>t]4 7,b7 ,applicable p]c5tage def9$ 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a77ii71 ! t]m applicable p]c5tage means-- 7,i7 subject to subclause 7,,ii71 #aj p]c5t2 & 7,,ii7 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;,b71 ! ,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 e/abli%$ "u ?is "p & t is furni%$ f a s+le-dose conta9] or s+le-use package4 7,b7 ,exclusions ,! t]m refundable s+le-dose conta9] or s+le-use package drug does n include-- 7i7 a drug or biological t is ei!r a radioph>maceutical or an imag+ ag5t2 7ii7 a drug or biological = :i* dosage & adm9i/ration in/ructions approv$ by ! ,commission] ( ,food & ,drugs 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 = less ?an #ah mon?s4 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 #bjba1 ! 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 #bjba1 ! 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 clause 7ii71 ) respect to a drug or biological furni%$ 9 a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjba1 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 #bjba1 = 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 arrange 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* 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 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 #bjba1 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 or allog5]ic cellul> immuno!rapy7-- 7,i7 = ea* ( #bjba ?r\gh #bjbh1 #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 or allog5]ic cellul> immuno!rapy-- 7,i7 = ea* ( #bjba ?r\gh #bjbh1 #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 #bjba1 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 #bjba1 ! 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 #bjba1 %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 #ajf4 ,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 #bjbj1 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 #ajg4 ,education on biological & biosimil> products 7a7 ,9 ,g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %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 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 #ajg7;a7 ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai 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 #ajh4 ,,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 ,b ,m$ic>e ,"p ,d ,provisions #aaa4 ,m$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 #bjba1 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 #bjbb4 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 ) "o 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 #bjbb1 &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 #bjbb1 ) 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$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "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 = #bjbb & 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 ( #bjai4 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 #bjbb1 & p>agraphs 7#d7 ?r\gh 7#f7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ on or aft] ,janu>y #a1 #bjbb4 2 & 7#c7 9 subsection 7c71 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ! ,secret>y det]m9es t 9 ! p]iod beg9n+ on ,janu>y #a1 #bjaa1 & end+ on ,decemb] #ca1 #bjaa 7) respect to p>agraphs 7#a7 ?r\gh 7#c7 ( subsection 7a771 or ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ ,decemb] #ca1 #bjbb 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$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or = a ye> prec$+ #bjbb 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$+ #bjbb or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbb & 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$+ #bjbb1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbb1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbb1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e7-- 7,i7 by ins]t+ = a ye> prec$+ #bjbb1 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$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbb1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ 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 = #bjbb & 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$-- 7,a7 by ins]t+ = a ye> be=e #bjbb aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7h7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye> #bjbb & subsequ5t plan ye>s4 #aab4 ,transitional cov]age & retroactive ,m$ic>e "p ,d cov]age = c]ta9 l[-income b5efici>ies ,section #ahfj;,d-#ad ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7 is am5d$-- 7#a7 by r$esignat+ subsection 7e7 z subsection 7f72 & 7#b7 by add+ aft] subsection 7d7 ! foll[+ new subsection3 7e7 ,limit$ income newly eligible transition program 7#a7 ,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all c>ry out a program to provide transitional cov]age = cov]$ "p ,d drugs = ,,li ,,net eligible individuals 9 accordance ) ?is subsection4 7#b7 ,,li net eligible individual def9$ ,= purposes ( ?is subsection1 ! t]m ,,li ,,net eligible individual means a "p ,d eligible individual :o-- 7,a7 meets ! requirem5ts ( clauses 7ii7 & 7iii7 ( subsection 7a77#c77;,a72 & 7,b7 has n yet enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan1 or1 :o has s enroll$1 b ) respect to :om cov]age "u su* plan has n yet tak5 effect4 7#c7 ,transitional cov]age ,= purposes ( ?is subsection1 ! t]m transitional cov]age means1 ) respect to an ,,li ,,net eligible individual-- 7,a7 imm$iate access to cov]$ "p ,d drugs at ! po9t-(-sale dur+ ! p]iod t beg9s on ! fir/ day ( ! mon? su* individual is det]m9$ to meet ! requirem5ts ( clauses 7ii7 & 7iii7 ( subsection 7a77#c77;,a7 & ends on ! date t cov]age "u a prescription drug plan or ,,ma-,,pd plan takes effect ) respect to su* individual2 & 7,b7 9 ! case ( an ,,li ,,net eligible individual :o is a full-b5efit dual eligible individual 7z def9$ 9 section #aice7;c77#f77 or a recipi5t ( supplem5tal security income b5efits "u title ,,xvi1 retroactive cov]age 79 ! =m ( reimbursem5t ( ! am\nts t w\ld h be5 paid "u ?is "p _h su* individual be5 enroll$ 9 a prescription drug plan or ,,ma-,,pd plan7 ( cov]$ "p ,d drugs pur*as$ by su* individual dur+ ! p]iod t-- 7i7 beg9s on ! date t is ! lat] (-- 7,i7 ! date t su* individual 0 fir/ eligible = a l[-income subsidy "u ?is "p2 or 7,,ii7 ! date t is #cf mon?s prior to ! date su* individual enrolls 9 a prescription drug plan or ,,ma-,,pd plan2 & 7ii7 ends on ! date t cov]age "u su* plan takes effect4 7#d7 ,program adm9i/ration 7,a7 ,s+le po9t ( contact ,! ,secret>y %all1 to ! ext5t feasible1 adm9i/] ! program "u ?is subsection ?r\gh a contract ) a s+le program adm9i/rator4 7,b7 ,b5efit design ,! ,secret>y %all ensure t ! transitional cov]age provid$ to ,,li ,,net eligible individuals "u ?is subsection-- 7i7 provides access to all cov]$ "p ,d drugs "u an op5 =mul>y2 7ii7 p]mits all ph>macies det]m9$ by ! ,secret>y to be 9 good /&+ to process claims "u ! program2 7iii7 is consi/5t ) su* requirem5ts z ! ,secret>y consid]s necess>y to improve pati5t safety & ensure appropriate disp5s+ ( m$ication2 & 7iv7 meets su* o!r requirem5ts z ! ,secret>y may e/abli%4 7#e7 ,relation%ip to o!r provisions ( ?is title2 waiv] au?ority 7,a7 ,9 g5]al ,! foll[+ provisions %all n apply ) respect to ! program "u ?is subsection3 7i7 ,p>agraphs 7#a7 & 7#c77;,b7 ( section #ahfj;,d-#d7;a7 7dissem9ation ( g5]al in=mation2 availability ( in=mation on *anges 9 =mul>y ?r\gh ! int]net74 7ii7 ,subp>agraphs 7,a7 & 7,b7 ( section #ahfj;,d-#d7;b77#c7 7developm5t & revision by a ph>macy & !rapeutic committee2 =mul>y developm5t74 7iii7 ,p>agraphs 7#a77;,c7 & 7#b7 ( section #ahfj;,d-#d7;c7 7m$ication !rapy managem5t program74 7,b7 ,waiv] au?ority ,! ,secret>y may waive su* o!r requirem5ts ( title ,,xi & ?is title z may be necess>y to c>ry out ! purposes ( ! program e/abli%$ "u ?is subsection4 4 #aac4 ,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 #aad4 ,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 #aaa1 is 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 %all 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 #aae4 ,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 #aaa & #aad1 is 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 #aaa1 is am5d$-- 7,a7 9 clause 7ii71 by /rik+ section #ahfj;,d-#b7;b77#b7 & ins]t+ section #ahfj;,d-#b7;b77#b77;,a72 & 7,b7 9 clause 7iii71 by /rik+ section #ahfj;,d-#b7;b77#b7 & ins]t+ section #ahfj;,d-#b7;b77#b77;,a74 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all apply ) respect to plan ye> #bjbb & ea* subsequ5t plan ye>4 #aaf4 ,gr[? rate ( ,m$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 #ace ( ! ,l[] ,co/s1 ,m ,cures ,act ( #bjai _h n be5 enact$2 or 4 #aag4 ,requir+ prescription drug plan sponsors to include real-"t b5efit in=mation z "p ( su* sponsor's electronic prescription program "u ! ,m$ic>e program ,section #ahfj;,d-#d7;e77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ ,to ! ext5t & ins]t+ ,except z provid$ 9 subp>agraph 7,f71 to ! ext5t2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,real-"t b5efit in=mation 7i7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! program %all implem5t real-"t b5efit tools t are capable ( integrat+ ) a prescrib+ heal? c>e pr(essional's electronic prescrib+ or electronic heal? record sy/em = ! transmission ( =mul>y & b5efit in=mation 9 real "t to prescrib+ heal? c>e pr(essionals4 ,) respect to a cov]$ "p ,d drug1 su* tools %all be capable ( transmitt+ su* in=mation specific to an individual enroll$ 9 a prescription drug plan4 ,su* in=mation %all include ! foll[+3 7,i7 ,a li/ ( any cl9ically appropriate alt]natives to su* drug includ$ 9 ! =mul>y ( su* plan4 7,,ii7 ,co/-%>+ in=mation = su* drug & su* alt]natives1 includ+ a description ( any v>iance 9 co/-%>+ bas$ on ! ph>macy disp5s+ ( su* drug or su* alt]natives4 7,,iii7 ,in=mation relat+ to :e!r su* drug is includ$ 9 ! =mul>y ( su* plan & any prior au?orization or o!r utilization managem5t requirem5ts applicable to su* drug & su* alt]natives s includ$4 7ii7 ,electronic transmission ,! provisions ( subclauses 7,i7 & 7,,ii7 ( clause 7ii7 ( subp>agraph 7,e7 %all apply to an electronic transmission describ$ 9 clause 7i7 9 ! same mann] z su* provisions apply ) respect to an electronic transmission describ$ 9 clause 7i7 ( su* subp>agraph4 7iii7 ,special rule = #bjba ,! program %all be deem$ to be 9 compliance ) clause 7i7 = #bjba if ! program complies ) ! provisions ( section #dbc4afj7;b77#g7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 = su* ye>4 7iv7 ,rule ( con/ruction ,no?+ 9 ?is subp>agraph %all be con/ru$ z to all[ a real-"t b5efits tool to /e] an individual1 )\t ! cons5t ( ! individual1 to a p>ticul> ph>macy or ph>macy sett+ ov] _! pref]r$ ph>macy sett+ nor prohibit ! designation ( a pref]r$ ph>macy "u su* tool4 4 #aah4 ,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 #bjba1 ! ,,pdp sponsor ( a prescription drug plan %all report to ! ,secret>y1 z specifi$ by ! ,secret>y-- 7#a7 any sub/antiat$ or suspici\s activities 7z def9$ by ! ,secret>y7 ) respect to ! program "u ?is "p z x relates to fraud1 wa/e1 & abuse2 & 7#b7 any /eps made by ! ,,pdp sponsor aft] id5tify+ su* activities to take corrective actions4 4 #aai4 ,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 ,,ii ,drug ,price ,transp>5cy #bja4 ,report+ on explanation = drug price increases 7a7 ,9 g5]al ,title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by ins]t+ aft] section #aabh,k ! foll[+ new section3 #aabh,l4 ,drug price report+ 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 ( ! ,public ,heal? ,s]vice ,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$ic>e program "u title ,,xviii or "u a ,/ate ,m$icaid plan "u title ,,xix 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;,b74 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y-- 7,a7 = ea* increase 9 ! price ( a qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a s+le cal5d> ye> beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7ii7 #be p]c5t or m )9 ?ree consecutive cal5d> ye>s = :i* ! fir/ su* cal5d> ye> beg9s on or aft] ,janu>y #a1 #bjai2 & 7,b7 9 ! case t ! qualify+ drug is fir/ cov]$ "u title ,,xviii ) respect to an applicable ye>1 if ! e/imat$ co/ or sp5d+ "u su* title p] individual or p] us] ( su* drug 7z e/imat$ by ! ,secret>y7 = su* applicable ye> 7or p] c\rse ( treatm5t 9 su* applicable ye>1 z def9$ by ! ,secret>y7 is at lea/ #bf1jjj4 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 #bjai1 & 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+ drug2 & 7,c7 9 ! case ( a report ) respect to a qualify+ drug t meets ! crit]ia describ$ 9 p>agraph 7#a77;,b71 n lat] ?an #cj days aft] su* drug meets su* crit]ia4 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 ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ 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 ( ! ,public ,heal? ,s]vice ,act1 z applicable2 7,i7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7,j7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ 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$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ 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 7h7 ,annual report to ,congress 7#a7 ,9 ,g5]al ,subject to p>agraph 7#b71 ! ,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 ?is section2 7,b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to ?is section2 7,c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out ?is section2 & 7,d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7#b7 ,protect$ in=mation ,no?+ 9 ?is subsection %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 %all take effect on ! date ( enactm5t ( ?is ,act4 #bjb4 ,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 #bjbj1 ! ,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 #bjc4 ,requir+ c]ta9 manufactur]s to report drug pric+ in=mation ) respect to drugs "u ! ,m$ic>e program 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b77;,a71 by ins]t+ or subsection 7f77#b71 z applicable be=e ! p]iod at ! end2 7,b7 9 p>agraph 7#c71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or subsection 7f77#b71 z applicable1 be=e det]m9$ by2 & 7,c7 9 p>agraph 7#f77;,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ or subsection 7f77#b71 z applicable1 be=e det]m9$ by2 & 7#b7 9 subsection 7f7-- 7,a7 by /rik+ ,= requirem5ts & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,= requirem5ts 2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,manufactur]s )\t a rebate agreem5t "u title ,,xix 7,a7 ,9 g5]al ,if ! manufactur] ( a drug or biological describ$ 9 subp>agraph 7,c71 7,e71 or 7,g7 ( section #ahdb7o77#a7 or 9 section #ahha7;b77#ad77;,b7 t is payable "u ?is "p has n ent]$ into & does n h 9 effect a rebate agreem5t describ$ 9 subsection 7b7 ( section #aibg1 = cal5d> qu>t]s beg9n+ on or aft] ,janu>y #a1 #bjbj1 su* manufactur] %all report to ! ,secret>y ! in=mation describ$ 9 subsection 7b77#c77;,a77iii7 ( su* section #aibg ) respect to su* drug or biological 9 a "t & mann] specifi$ by ! ,secret>y4 ,= purposes ( apply+ ?is p>agraph1 a drug or biological describ$ 9 ! previ\s s5t5ce includes items1 s]vices1 supplies1 & products t are payable "u ?is "p z a drug or biological4 7,b7 ,audit ,in=mation report$ "u subp>agraph 7,a7 is subject to audit by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7,c7 ,v]ification ,! ,secret>y may survey :olesal]s & manufactur]s t directly di/ribute drugs describ$ 9 subp>agraph 7,a71 :5 necess>y1 to v]ify manufactur] prices & manufactur]'s av]age sales prices 7includ+ :olesale acquisition co/7 if requir$ to make paym5t report$ "u subp>agraph 7,a74 ,! ,secret>y may impose a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj on a :olesal]1 manufactur]1 or direct sell]1 if ! :olesal]1 manufactur]1 or direct sell] ( su* a drug refuses a reque/ = in=mation ab\t *>ges or prices by ! ,secret>y 9 connection ) a 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 subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7,d7 ,confid5tiality ,not)/&+ any o!r provision ( law1 in=mation disclos$ by manufactur]s or :olesal]s "u ?is p>agraph 7o!r ?an ! :olesale acquisition co/ = purposes ( c>ry+ out ?is section7 is confid5tial & %all n be disclos$ by ! ,secret>y 9 a =m :i* discloses ! id5tity ( a specific manufactur] or :olesal] or prices *>g$ = drugs by su* manufactur] or :olesal]1 except-- 7i7 z ! ,secret>y det]m9es to be necess>y to c>ry out ?is section 7includ+ ! det]m9ation & implem5tation ( ! paym5t am\nt71 or to c>ry out section #ahdg;,b2 7ii7 to p]mit ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates to review ! in=mation provid$2 & 7iii7 to p]mit ! ,director ( ! ,congressional ,budget ,(fice to review ! in=mation provid$4 4 7b7 ,en=cem5t ,section #ahdg;,a ( su* ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is fur!r am5d$-- 7#a7 9 subsection 7d77#d7-- 7,a7 9 subp>agraph 7,a71 by /rik+ ,9 g5]al & ins]t+ ,misrepres5tation2 7,b7 9 subp>agraph 7,b71 by /rik+ subp>agraph 7,b7 & ins]t+ subp>agraph 7,a71 7,b71 or 7,c72 7,c7 by r$esignat+ subp>agraph 7,b7 z subp>agraph 7,d72 & 7,d7 by ins]t+ aft] subp>agraph 7,a7 ! foll[+ new subp>agraphs3 7,b7 ,failure to provide timely in=mation ,if ! ,secret>y det]m9es t a manufactur] describ$ 9 subsection 7f77#b7 has fail$ to report on in=mation describ$ 9 section #aibg7;b77#c77;,a77iii7 ) respect to a drug or biological 9 accordance ) su* subsection1 ! ,secret>y %all apply a civil money p5alty 9 an am\nt ( #aj1jjj = ea* day ! manufactur] has fail$ to report su* in=mation & su* am\nt %all be paid to ! ,treasury4 7,c7 ,false in=mation ,any manufactur] requir$ to submit in=mation "u subsection 7f77#b7 t kn[+ly provides false in=mation is subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alties are 9 addition to o!r p5alties z may be prescrib$ by law4 2 & 7#b7 9 subsection 7c77#f77;,a71 by /rik+ ! p]iod at ! end & ins]t+ 1 except t1 = purposes ( subsection 7f77#b71 ! ,secret>y may1 if ! ,secret>y det]m9es appropriate1 exclude repackag]s ( a drug or biological f su* t]m44 7c7 ,manufactur]s ) a rebate agreem5t 7#a7 ,9 g5]al ,section #aibg7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,= purposes ( apply+ clause 7iii71 a drug or biological describ$ 9 ! flu% matt] foll[+ su* clause includes items1 s]vices1 supplies1 & products t are payable "u ?is "p z a drug or biological44 7#b7 ,te*nical am5dm5t ,section #aibg7;b77#c77;,a77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is am5d$ by /rik+ section #ahha7;b77#ac77;,a77ii7 & ins]t+ section #ahha7;b77#ad77;,b74 7d7 ,report ,n lat] ?an ,janu>y #a1 #bjba1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all assess & submit to ,congress a report on ! accuracy ( av]age sales price in=mation submitt$ by manufactur]s "u section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,su* report %all include any recomm5dations on h[ to improve ! accuracy ( su* in=mation4 #bjd4 ,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+ ) #bjba71 ! ,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$ic>e ,paym5t ,advisory ,commission %all conduct a /udy on ! impact ( drug samples on provid] prescrib+ practices & heal? c>e co/s & may1 z ! ,commission deems appropriate1 make recomm5dations on su* /udy4 #bje4 ,provid+ ! ,m$ic>e ,paym5t ,advisory ,commission & ,m$icaid & ,,*ip ,paym5t & ,access ,commission ) access to c]ta9 drug paym5t in=mation1 includ+ c]ta9 rebate in=mation 7a7 ,access to c]ta9 "p ,d paym5t data ,section #ahfj;,d-#ae7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;f77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a77ii71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ at ! end ! foll[+ new subp>agraph3 7,c7 by ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( monitor+1 mak+ recomm5dations1 & analysis ( ! program "u ?is title & by ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission = purposes ( monitor+1 mak+ recomm5dations1 & analysis ( ! ,m$icaid program e/abli%$ "u title ,,xix & ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi4 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,additional re/rictions on disclosure ( in=mation ,! ,executive ,directors describ$ 9 p>agraph 7#b77;,c7 %all n disclose any ( ! foll[+ in=mation disclos$ to su* ,executive ,directors or obta9$ by su* ,executive ,directors pursuant to su* p>agraph1 ) respect to a prescription drug plan (f]$ by a ,,pdp sponsor or an ,,ma-,,pd plan (f]$ by an ,,ma organization3 7,a7 ,! specific am\nts or ! id5tity ( ! s\rce ( any rebates1 price concessions1 or o!r =ms ( direct or indirect remun]ation "u su* prescription drug plan or su* ,,ma-,,pd plan4 7,b7 ,in=mation submitt$ ) ! bid submitt$ "u section #ahfj;,d-#aa by su* ,,pdp sponsor or section #ahed by su* ,,ma organization4 7,c7 ,9 ! case ( su* in=mation f prescription drug ev5t records1 9 a =m t w\ld n be p]mitt$ "u section #dbc4eje7m7 ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation1 if made by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 4 7b7 ,access to c]ta9 rebate & paym5t data "u ,m$ic>e & ,m$icaid ,section #aibg7;b77#c77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77 is am5d$-- 7#a7 9 ! matt] be=e clause 7i71 by /rik+ subsection 7a77#f77;,a77ii7 & ins]t+ subsection 7a77#f77;,a72 7#b7 9 clause 7v71 by /rik+ & at ! end2 7#c7 9 clause 7vi71 by /rik+ ! p]iod at ! end & ins]t+ 1 &2 7#d7 by ins]t+ aft] clause 7vi7 ! foll[+ new clause3 7vii7 to p]mit ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission & ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission to review ! in=mation provid$4 2 7#e7 9 ! matt] at ! end1 by /rik+ #ahfj;,d-#d7;c77#b77;,e7 & ins]t+ #ahfj;,d-#d7;c77#b77;,g72 & 7#f7 by add+ at ! end ! foll[+ new s5t5ce3 ,any in=mation disclos$ to ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission or ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission pursuant to ?is subp>agraph %all n be disclos$ by ei!r su* ,executive ,director 9 a =m :i* discloses ! id5tity ( a specific manufactur] or :olesal] or prices *>g$ = drugs by su* manufactur] or :olesal]44 #bjf4 ,s5se ( ! ,s5ate reg>d+ ! ne$ to exp& comm]cially available drug pric+ comp>ison plat=ms ,x is ! s5se ( ! ,s5ate 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 ,,iii ,rev5ue ,provisions #cja4 ,p]man5t ext5sion ( r$uction 9 m$ical exp5se d$uction floor 7a7 ,9 g5]al ,section #bac7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #aj p]c5t & ins]t+ #g4e p]c5t4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #bac ( su* ,code is am5d$ by /rik+ subsection 7f74 7#b7 ,section #ef7;b77#a7 ( su* ,code is am5d$ by /rik+ subp>agraph 7,b7 & by r$esignat+ subp>agraphs 7,c71 7,d71 7,e71 & 7,f71 z subp>agraphs 7,b71 7,c71 7,d71 & 7,e71 respectively4 7c7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s end+ aft] ,decemb] #ca1 #bjah4 #cjb4 ,safe h>bor = high d$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 #cjc4 ,inclusion ( c]ta9 ov]-!-c\nt] m$ical products z qualifi$ m$ical exp5ses 7a7 ,h,s,as ,section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 by /rik+ ! la/ s5t5ce ( subp>agraph 7,a7 & ins]t+ ! foll[+3 ,= purposes ( ?is subp>agraph1 am\nts paid = m5/rual c>e products %all be treat$ z paid = m$ical c>e42 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,m5/rual c>e product ,= purposes ( ?is p>agraph1 ! t]m m5/rual c>e product means a tampon1 pad1 l9]1 cup1 sponge1 or simil> product us$ by individuals ) respect to m5/ruation or o!r g5ital-tract secretions4 4 7b7 ,ar*] ,m,s,as ,section #bbj7;d77#b77;,a7 ( su* ,code is am5d$ by /rik+ ! la/ s5t5ce & ins]t+ ! foll[+3 ,= purposes ( ?is subp>agraph1 am\nts paid = m5/rual c>e products 7z def9$ 9 section #bbc7;d77#b77;,d77 %all be treat$ z paid = m$ical c>e44 7c7 ,heal? flexible sp5d+ arrangem5ts & heal? reimbursem5t arrangem5ts ,section #ajf ( su* ,code is am5d$ by /rik+ subsection 7f7 & ins]t+ ! foll[+ new subsection3 7f7 ,reimbursem5ts = m5/rual c>e products ,= purposes ( ?is section & section #aje1 exp5ses incurr$ = m5/rual c>e products 7z def9$ 9 section #bbc7;d77#b77;,d77 %all be treat$ z incurr$ = m$ical c>e4 4 7d7 ,effective dates 7#a7 ,di/ributions f sav+s acc\nts ,! am5dm5t made by subsections 7a7 & 7b7 %all apply to am\nts paid aft] ,decemb] #ca1 #bjai4 7#b7 ,reimbursem5ts ,! am5dm5t made by subsection 7c7 %all apply to exp5ses incurr$ aft] ,decemb] #ca1 #bjai4 ,,iv ,miscellane\s #dja4 ,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 #djb4 ,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 #djc4 ,med,p,a,c report on %ift+ cov]age ( c]ta9 ,m$ic>e "p ,b drugs to ,m$ic>e "p ,d 7a7 ,/udy ,! ,m$ic>e ,paym5t ,advisory ,commission 79 ?is section ref]r$ to z ! ,commission7 %all conduct a /udy on %ift+ cov]age ( c]ta9 drugs & biologicals = :i* paym5t is curr5tly made "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 to "p ,d ( su* title 7#db ,u4,s4,c4 #aciew-#ba et seq474 ,su* /udy %all include an analysis (-- 7#a7 diff]5ces 9 program /ructures & paym5t me?ods = drugs & biologicals cov]$ "u su* p>ts ,b & ,d1 includ+ effects ( su* a %ift on program sp5d+1 b5efici>y co/-%>+ liability1 & utilization managem5t te*niques = su* drugs & biologicals2 & 7#b7 ! feasibility & policy implications ( %ift+ cov]age ( drugs & biologicals = :i* paym5t is curr5tly made "u su* "p ,b to su* "p ,d4 7b7 ,report 7#a7 ,9 g5]al ,n lat] ?an ,june #cj1 #bjba1 ! ,commission %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a74 7#b7 ,cont5ts ,! report "u p>agraph 7#a7 %all include in=mation1 & recomm5dations z ! ,commission deems appropriate1 reg>d+-- 7,a7 =mul>y design "u su* "p ,d2 7,b7 ! ability ( ! b5efit /ructure "u su* "p ,d to control total sp5d+ on drugs & biologicals = :i* paym5t is curr5tly made "u su* "p ,b2 7,c7 *anges to ! bid process "u su* "p ,d1 if any1 t may be necess>y to integrate cov]age ( su* drugs & biologicals into su* "p ,d2 7,d7 any o!r *anges to ! program t ,congress %\ld consid] 9 det]m9+ :e!r to %ift cov]age ( su* drugs & biologicals f su* "p ,b to su* "p ,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 #djd4 ,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 #dje4 ,*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+ ! #a-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