,,ii ,cal5d> ,no4 #fdg #aag? ,,congress #b;d ,session ,s4 #dbic ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bd1 #bjbb,ms4 ,cantwell 7= h]self1 ,mr4 ,grassley1 ,mr4 ,boozman1 ,mr4 ,braun1 ,mr4 ,moran1 ,mr4 ,tillis1 ,mr4 ,te/]1 ,mrs4 ,hyde-,smi?1 & ,mrs4 ,capito7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ,decemb] #ad1 #bjbb,report$ by ,ms4 ,cantwell1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to prev5t unfair & deceptive acts or practices & ! dissem9ation ( false in=mation relat$ to ph>macy b5efit managem5t s]vices = prescription drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,ph>macy ,b5efit ,manag] ,transp>5cy ,act ( #bjbb4 #b4 ,prohibition on unfair or deceptive prescription drug pric+ practices 7a7 ,conduct prohibit$ ,except z provid$ 9 subsection 7b71 x %all be unlawful = any ph>macy b5efit manag] 7or affiliate1 subsidi>y1 or ag5t ( a ph>macy b5efit manag]71 directly or indirectly1 to engage 9 any ( ! foll[+ activities relat$ to ph>macy b5efit managem5t s]vices3 7#a7 ,*>ge a heal? plan or pay] a diff]5t am\nt = a prescription drug's +r$i5t co/ or disp5s+ fee ?an ! am\nt ! ph>macy b5efit manag] reimburses a ph>macy = ! prescription drug's +r$i5t co/ or disp5s+ fee :]e ! ph>macy b5efit manag] reta9s ! am\nt ( any su* diff]5ce4 7#b7 ,arbitr>ily1 unfairly1 or deceptively1 by contract or any o!r means1 r$uce1 resc9d1 or o!rwise claw back any reimbursem5t paym5t1 9 :ole or 9 "p1 to a ph>maci/ or ph>macy = a prescription drug's +r$i5t co/ or disp5s+ fee4 7#c7 ,arbitr>ily1 unfairly1 or deceptively1 by contract or any o!r means1 increase fees or l[] reimbursem5t to a ph>macy 9 ord] to (fset reimbursem5t *anges in/ruct$ by ! ,f$]al ,gov]nm5t "u any heal? plan fund$ by ! ,f$]al ,gov]nm5t4 7b7 ,exceptions ,a ph>macy b5efit manag] %all n be 9 violation ( subsection 7a7 if ! ph>macy b5efit manag] meets ! foll[+ conditions3 7#a7 ,! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t passes along or returns #ajj p]c5t ( any price concession to a heal? plan or pay]1 includ+ any rebate1 disc\nt1 or o!r price concession4 7#b7 ,! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t provides full & complete disclosure (-- 7,a7 ! co/1 price1 & reimbursem5t ( ! prescription drug to ea* heal? plan1 pay]1 & ph>macy ) :i* ! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t has a contract or agreem5t to provide ph>macy b5efit managem5t s]vices2 7,b7 ea* fee1 m>kup1 & disc\nt *>g$ or impos$ by ! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t to ea* heal? plan1 pay]1 & ph>macy ) :i* ! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t has a contract or agreem5t = ph>macy b5efit managem5t s]vices2 or 7,c7 ! aggregate am\nt ( all remun]ation ! ph>macy b5efit manag] receives f a prescription drug manufactur] = a prescription drug1 includ+ any rebate1 disc\nt1 adm9i/ration fee1 & any o!r paym5t or cr$it obta9$ or reta9$ by ! ph>macy b5efit manag]1 or affiliate1 subsidi>y1 or ag5t ( ! ph>macy b5efit manag]1 pursuant to a contract or agreem5t = ph>macy b5efit managem5t s]vices to a heal? plan1 pay]1 or any ,f$]al ag5cy 7^u ! reque/ ( ! ag5cy74 #c4 ,prohibition on false in=mation ,x %all be unlawful = any p]son to report in=mation relat$ to ph>macy b5efit managem5t s]vices to a ,f$]al dep>tm5t or ag5cy if-- 7#a7 ! p]son knew1 or reasonably %\ld h kn[n1 ! in=mation to be false or mislead+2 7#b7 ! in=mation 0 requir$ by law to be report$2 & 7#c7 ! false or mislead+ in=mation report$ by ! p]son w\ld affect analysis or in=mation compil$ by ! ,f$]al dep>tm5t or ag5cy = /ati/ical or analytical purposes ) respect to ! m>ket = ph>macy b5efit managem5t s]vices4 #d4 ,transp>5cy 7a7 ,report+ by ph>macy b5efit manag]s ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ea* ph>macy b5efit manag] 7or affiliate1 subsidi>y1 or ag5t ( a ph>macy b5efit manag]7 %all report to ! ,commission ! foll[+ in=mation3 7#a7 ,! aggregate am\nt ( ! diff]5ce betwe5 ! am\nt ! ph>macy b5efit manag] 0 paid by ea* heal? plan & ! am\nt t ! ph>macy b5efit manag] paid ea* ph>macy on behalf ( ! heal? plan = prescription drugs4 7#b7 ,! aggregate am\nt ( any-- 7,a7 g5]ic effective rate fee *>g$ to ea* ph>macy2 7,b7 direct & indirect remun]ation fee *>g$ or o!r price concession to ea* ph>macy2 & 7,c7 paym5t resc9d$ or o!rwise claw$ back f a reimbursem5t made to ea* ph>macy4 7#c7 ,if1 dur+ ! report+ ye>1 ! ph>macy b5efit manag] mov$ or reassign$ a prescription drug to a =mul>y ti] t has a high] co/1 high] copaym5t1 high] co9surance1 or high] d$uctible to a consum]1 or a l[] reimbursem5t to a ph>macy1 an explanation ( ! reason :y ! drug 0 mov$ or reassign$ f #a ti] to ano!r1 includ+ :e!r ! move or reassignm5t 0 det]m9$ or reque/$ by a prescription drug manufactur] or o!r entity4 7#d7 ,) respect to any ph>macy b5efit manag] t owns1 controls1 or is affiliat$ ) a ph>macy1 a report reg>d+ any diff]5ce 9 reimbursem5t rates or practices1 direct & indirect remun]ation fees or o!r price concessions1 & clawbacks betwe5 a ph>macy t is own$1 controll$1 or affiliat$ ) ! ph>macy b5efit manag] & any o!r ph>macy4 7b7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,commission %all submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t addresses1 at a m9imum-- 7,a7 ! numb] actions br\ght by ! ,commission dur+ ! report+ ye> to en=ce ?is ,act & ! outcome ( ea* su* en=cem5t action2 7,b7 ! numb] ( op5 inve/igations or inquiries into pot5tial violations ( ?is ,act z ( ! "t ! report is submitt$2 7,c7 ! numb] & nature ( compla9ts receiv$ by ! ,commission relat+ to an allegation ( a violation ( ?is ,act dur+ ! report+ ye>2 7,d7 an anonymiz$ summ>y ( ! reports fil$ ) ! ,commission pursuant to subsection 7a7 = ! report+ ye>2 & 7,e7 policy or legislative recomm5dations to /r5g!n any en=cem5t action relat+ to a violation ( ?is ,act1 includ+ recomm5dations to include additional prohibit$ conduct$ 9 section #b7;a74 7#b7 ,=mul>y design or placem5t practices ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t addresses ! policies1 practices1 & role ( ph>macy b5efit manag]s 7includ+ _! affiliates1 subsidi>ies1 & ag5ts7 reg>d+ =mul>y design or placem5t1 includ+ :e!r-- 7,a7 ph>macy b5efit manag]s 7includ+ _! affiliates1 subsidi>ies1 & ag5ts7 use =mul>y design or placem5t to increase _! gross rev5ue )\t an accompany+ increase 9 pati5t access or decrease 9 pati5t co/2 or 7,b7 su* policies or practices ( ph>macy b5efit manag]s reg>d+ =mul>y design or placem5t violate section #e7;a7 ( ! ,f$]al ,trade ,commission ,act 7#de ,u4,s4,c4 #de7;a774 7#c7 ,con/ruction ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,commission to disclose any in=mation t is a trade secret or confid5tial in=mation describ$ 9 section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 #e4 ,:i/lebl[] protections 7a7 ,9 g5]al ,a ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re( %all n1 directly or indirectly1 dis*>ge1 demote1 susp5d1 dim9i%1 or )draw b5efits f1 ?reat51 h>ass1 or 9 any o!r mann] discrim9ate aga9/ or adv]sely impact a cov]$ individual because-- 7#a7 ! cov]$ individual1 or anyone p]ceiv$ z assi/+ ! cov]$ individual1 takes 7or is suspect$ to h tak5 or w take7 a lawful action 9 provid+ to ,congress1 an ag5cy ( ! ,f$]al ,gov]nm5t1 ! attorney g5]al ( a ,/ate1 a ,/ate regulator ) au?ority ov] ! di/ribution or insurance cov]age ( prescription drugs1 or a law en=cem5t ag5cy relat+ to any act or omission t ! cov]$ individual reasonably believes to be a violation ( ?is ,act2 7#b7 ! cov]$ individual provides in=mation t ! cov]$ individual reasonably believes evid5ces su* a violation to-- 7,a7 a p]son ) sup]visory au?ority ov] ! cov]$ individual at ! ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re(2 or 7,b7 ano!r individual work+ = ! ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re( :o ! cov]$ individual reasonably believes has ! au?ority to inve/igate1 discov]1 or t]m9ate ! violation or to take any o!r action to address ! violation2 7#c7 ! cov]$ individual te/ifies 7or x is suspect$ t ! cov]$ individual w te/ify7 9 an inve/igation or judicial or adm9i/rative proce$+ conc]n+ su* a violation2 7#d7 ! cov]$ individual assi/s or p>ticipates 7or x is expect$ t ! cov]$ individual w assi/ or p>ticipate7 9 su* an inve/igation or judicial or adm9i/rative proce$+2 or 7#e7 ! cov]$ individual takes any o!r action to assi/ 9 c>ry+ out ! purposes ( ?is ,act4 7b7 ,en=cem5t ,an individual :o alleges any adv]se action 9 violation ( subsection 7a7 may br+ an action = a jury trial 9 ! appropriate di/rict c\rt ( ! ,unit$ ,/ates = ! foll[+ relief3 7#a7 ,tempor>y relief :ile ! case is p5d+4 7#b7 ,re9/atem5t ) ! same s5iority /atus t ! individual w\ld h _h1 b = ! dis*>ge or discrim9ation4 7#c7 ,twice ! am\nt ( back pay o!rwise ow$ to ! individual1 ) int]e/4 7#d7 ,consequ5tial & comp5satory damages1 & comp5sation = litigation co/s1 exp]t witness fees1 & reasonable attorneys' fees4 7c7 ,waiv] ( rights & rem$ies ,! rights & rem$ies provid$ = 9 ?is section %all n be waiv$ by any policy =m or condition ( employm5t1 includ+ by a pr$ispute arbitration agreem5t4 7d7 ,pr$ispute arbitration agreem5ts ,no pr$ispute arbitration agreem5t %all be valid or en=ceable if ! agreem5t requires arbitration ( a dispute aris+ "u ?is section4 #f4 ,en=cem5t 7a7 ,en=cem5t by ! ,commission 7#a7 ,unfair & deceptive acts or practices ,a violation ( ?is ,act %all be treat$ z a violation ( a rule def9+ an unfair or deceptive act or practice "u section #ah7;a77#a77;,b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b774 7#b7 ,p[]s ( ! ,commission 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,c71 ! ,commission %all en=ce ?is ,act 9 ! same mann]1 by ! same means1 & ) ! same jurisdiction1 p[]s1 & duties z ?\gh all applicable t]ms & provisions ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 7 incorporat$ into & made a "p ( ?is ,act4 7,b7 ,privileges & immunities ,subject to p>agraph 7#c71 any p]son :o violates ?is ,act %all be subject to ! p5alties & entitl$ to ! privileges & immunities provid$ 9 ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et4 seq474 7,c7 ,nonpr(it organizations & insurance ,not)/&+ section #d or #f ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd1 #df71 section #b ( ,mc,carran-,f]guson ,act 7#ae ,u4,s4,c4 #ajab71 or any o!r jurisdictional limitation ( ! ,commission1 ! ,commission %all also en=ce ?is ,act1 9 ! same mann] provid$ 9 subp>agraphs 7,a7 & 7,b7 ( ?is p>agraph1 ) respect to-- 7i7 organizations n organiz$ to c>ry on bus9ess = _! own pr(it or t ( _! memb]s2 & 7ii7 ! bus9ess ( insurance1 & p]sons engag$ 9 su* bus9ess4 7,d7 ,au?ority pres]v$ ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,commission "u any o!r provision ( law4 7#c7 ,p5alties 7,a7 ,additional civil p5alty ,9 addition to any p5alty applicable "u ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq471 any p]son t violates ?is ,act %all be liable = a civil p5alty ( n m ?an #a1jjj1jjj4 7,b7 ,me?od ,! p5alties provid$ by subp>agraph 7,a7 %all be obta9$ 9 ! same mann] z civil p5alties impos$ "u section #ah7;a77#a77;,b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b774 7,c7 ,multiple (f5ses2 mitigat+ factors ,9 assess+ a p5alty "u subp>agraph 7,a7-- 7i7 ea* day ( a cont9u+ violation %all be consid]$ a sep>ate violation2 & 7ii7 ! c\rt %all take into consid]ation1 among o!r factors-- 7,i7 ! s]i\sness ( ! violation2 7,,ii7 ! ef=ts ( ! p]son committ+ ! violation to rem$y ! h>m caus$ by ! violation 9 a timely mann]2 & 7,,iii7 :e!r ! violation 0 int5tional4 7b7 ,en=cem5t by ,/ates 7#a7 ,9 g5]al ,if ! attorney g5]al ( a ,/ate has reason to believe t an int]e/ ( ! resid5ts ( ! ,/ate has be5 or is be+ ?reat5$ or adv]sely affect$ by a practice t violates ?is ,act1 ! attorney g5]al ( ! ,/ate may br+ a civil action on behalf ( ! resid5ts ( ! ,/ate 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates to obta9 appropriate relief4 7#b7 ,rights ( ! ,commission 7,a7 ,notice to ! ,commission 7i7 ,9 g5]al ,except z provid$ 9 clause 7iii71 ! attorney g5]al ( a ,/ate1 be=e initiat+ a civil action "u p>agraph 7#a71 %all provide writt5 notification to ! ,commission t ! attorney g5]al int5ds to br+ su* civil action4 7ii7 ,cont5ts ,! notification requir$ "u clause 7i7 %all include a copy ( ! compla9t to be fil$ to initiate ! civil action4 7iii7 ,exception ,if x is n feasible = ! attorney g5]al ( a ,/ate to provide ! notification requir$ "u clause 7i7 be=e initiat+ a civil action "u p>agraph 7#a71 ! attorney g5]al %all notify ! ,commission imm$iately ^u in/itut+ ! civil action4 7,b7 ,int]v5tion by ! ,commission ,! ,commission may-- 7i7 int]v5e 9 any civil action br\ght by ! attorney g5]al ( a ,/ate "u p>agraph 7#a72 & 7ii7 ^u int]v5+-- 7,i7 be he>d on all matt]s aris+ 9 ! civil action2 & 7,,ii7 file petitions = appeal ( a decision 9 ! civil action4 7#c7 ,con/ruction ,no?+ 9 ?is subsection may be con/ru$ to prev5t ! attorney g5]al ( a ,/ate f ex]cis+ ! p[]s conf]r$ on ! attorney g5]al by ! laws ( ! ,/ate to conduct inve/igations1 to adm9i/] oa?s or affirmations1 or to compel ! att5dance ( witnesses or ! production ( docum5t>y or o!r evid5ce4 7#d7 ,v5ue2 s]vice ( process 7,a7 ,v5ue ,any action br\ght "u p>agraph 7#a7 may be br\ght 9-- 7i7 ! di/rict c\rt ( ! ,unit$ ,/ates t meets applicable requirem5ts relat+ to v5ue "u section #acia ( title #bh1 ,unit$ ,/ates ,code2 or 7ii7 ano!r c\rt ( compet5t jurisdiction4 7,b7 ,s]vice ( process ,9 an action br\ght "u p>agraph 7#a71 process may be s]v$ 9 any di/rict 9 :i*-- 7i7 ! def5dant is an inhabitant1 may be f\nd1 or transacts bus9ess2 or 7ii7 v5ue is prop] "u section #acia ( title #bh1 ,unit$ ,/ates ,code4 7#e7 ,actions by o!r ,/ate (ficials 7,a7 ,9 g5]al ,9 addition to a civil action br\ght by an attorney g5]al "u p>agraph 7#a71 any o!r (fic] ( a ,/ate :o is au?oriz$ by ! ,/ate to d s may br+ a civil action "u p>agraph 7#a71 subject to ! same requirem5ts & limitations t apply "u ?is subsection to civil actions br\ght by attorneys g5]al4 7,b7 ,sav+s provision ,no?+ 9 ?is subsection may be con/ru$ to prohibit an au?oriz$ (ficial ( a ,/ate f initiat+ or cont9u+ any proce$+ 9 a c\rt ( ! ,/ate = a violation ( any civil or crim9al law ( ! ,/ate4 7c7 ,affirmative def5se ,9 an action br\ght "u ?is section to en=ce section #b1 x %all be an affirmative def5se1 on :i* ! def5dant has ! burd5 ( p]suasion by a prepond]ance ( ! evid5ce1 t ! conduct alleg$ to be a violation ( section #b 0 nonpretextual & reasonably necess>y to-- 7#a7 prev5t a violation (1 or comply )1 ,f$]al or ,/ate law2 7#b7 protect pati5t safety2 or 7#c7 protect pati5t access4 #g4 ,effect on ,/ate laws ,no?+ 9 ?is ,act %all be con/ru$ to preempt1 displace1 or supplant any ,/ate laws1 rules1 regulations1 or requirem5ts1 or ! en=cem5t !re(4 #h4 ,def9itions ,9 ?is ,act3 7#a7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 7#b7 ,cov]$ individual ,! t]m cov]$ individual means a curr5t or =m] employee1 contractor1 subcontractor1 s]vice provid]1 or ag5t ( a ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re(4 7#c7 ,heal? plan ,! t]m heal? plan means any gr\p or individual heal? insurance plan or cov]age1 includ+ any heal? insurance plan or cov]age sponsor$ or fund$ by ! ,f$]al ,gov]nm5t or ! gov]nm5t ( any ,/ate1 ,t]ritory1 or subdivision !re(4 7#d7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any entity t provides ph>macy b5efit managem5t s]vices on behalf ( a heal? plan1 a pay]1 or heal? insurance issu]4 7#e7 ,ph>macy b5efit managem5t s]vices ,! t]m ph>macy b5efit managem5t s]vices means1 pursuant to a writt5 agreem5t ) a pay] or heal? plan (f]+ gr\p or individual heal? insurance cov]age1 directly or ?r\gh an int]m$i>y1 ! s]vice (-- 7,a7 negotiat+ t]ms & conditions1 includ+ rebates & price concessions1 ) respect to a prescription drug on behalf ( ! heal? plan1 cov]age1 or pay]2 or 7,b7 manag+ ! prescription drug b5efits provid$ by ! heal? plan1 cov]age1 or pay]1 :i* may include =mul>y managem5t ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! adjudication ( appeals or grievances relat$ to ! prescription drug b5efit1 contract+ ) network ph>macies1 or ! provision ( relat$ s]vices4 7#f7 ,prescription drug ,! t]m prescription drug means-- 7,a7 a drug1 z t t]m is def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g771 t is-- 7i7 approv$ by ! ,food & ,drug ,adm9i/ration "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee72 & 7ii7 subject to ! requirem5ts ( section #ejc7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 7,b7 a biological product z t t]m is def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a772 or 7,c7 a product t is biosimil> to1 or int]*angeable )1 a biologic product "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i774 #a4 ,%ort title ,?is ,act may be cit$ z ! ,ph>macy ,b5efit ,manag] ,transp>5cy ,act ( #bjbb4 #b4 ,prohibition on unfair or deceptive prescription drug pric+ practices 7a7 ,conduct prohibit$ ,except z provid$ 9 subsection 7b71 x %all be unlawful = any ph>macy b5efit manag] 7or affiliate1 subsidi>y1 or ag5t ( a ph>macy b5efit manag]71 directly or indirectly1 to engage 9 any ( ! foll[+ activities relat$ to ph>macy b5efit managem5t s]vices3 7#a7 ,*>ge a heal? plan or pay] a diff]5t am\nt = a prescription drug's +r$i5t co/ or disp5s+ fee ?an ! am\nt ! ph>macy b5efit manag] reimburses a ph>macy = ! prescription drug's +r$i5t co/ or disp5s+ fee :]e ! ph>macy b5efit manag] reta9s ! am\nt ( any su* diff]5ce4 7#b7 ,arbitr>ily1 unfairly1 or deceptively1 by contract or any o!r means1 r$uce1 resc9d1 or o!rwise claw back any reimbursem5t paym5t1 9 :ole or 9 "p1 to a ph>maci/ or ph>macy = a prescription drug's +r$i5t co/ or disp5s+ fee4 7#c7 ,arbitr>ily1 unfairly1 or deceptively1 by contract or any o!r means1 increase fees or l[] reimbursem5t to a ph>macy 9 ord] to (fset reimbursem5t *anges in/ruct$ by ! ,f$]al ,gov]nm5t "u any heal? plan fund$ by ! ,f$]al ,gov]nm5t4 7b7 ,exceptions ,a ph>macy b5efit manag] %all n be 9 violation ( subsection 7a7 if ! ph>macy b5efit manag] meets ! foll[+ conditions3 7#a7 ,! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t passes along or returns #ajj p]c5t ( any price concession to a heal? plan or pay]1 includ+ any rebate1 disc\nt1 or o!r price concession4 7#b7 ,! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t provides full & complete disclosure (-- 7,a7 ! co/1 price1 & reimbursem5t ( ! prescription drug to ea* heal? plan1 pay]1 & ph>macy ) :i* ! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t has a contract or agreem5t to provide ph>macy b5efit managem5t s]vices2 7,b7 ea* fee1 m>kup1 & disc\nt *>g$ or impos$ by ! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t to ea* heal? plan1 pay]1 & ph>macy ) :i* ! ph>macy b5efit manag]1 affiliate1 subsidi>y1 or ag5t has a contract or agreem5t = ph>macy b5efit managem5t s]vices2 or 7,c7 ! aggregate am\nt ( all remun]ation ! ph>macy b5efit manag] receives f a prescription drug manufactur] = a prescription drug1 includ+ any rebate1 disc\nt1 adm9i/ration fee1 & any o!r paym5t or cr$it obta9$ or reta9$ by ! ph>macy b5efit manag]1 or affiliate1 subsidi>y1 or ag5t ( ! ph>macy b5efit manag]1 pursuant to a contract or agreem5t = ph>macy b5efit managem5t s]vices to a heal? plan1 pay]1 or any ,f$]al ag5cy 7^u ! reque/ ( ! ag5cy74 #c4 ,prohibition on false in=mation ,x %all be unlawful = any p]son to report in=mation relat$ to ph>macy b5efit managem5t s]vices to a ,f$]al dep>tm5t or ag5cy if-- 7#a7 ! p]son knew1 or reasonably %\ld h kn[n1 ! in=mation to be false or mislead+2 7#b7 ! in=mation 0 requir$ by law to be report$2 & 7#c7 ! false or mislead+ in=mation report$ by ! p]son w\ld affect analysis or in=mation compil$ by ! ,f$]al dep>tm5t or ag5cy = /ati/ical or analytical purposes ) respect to ! m>ket = ph>macy b5efit managem5t s]vices4 #d4 ,transp>5cy 7a7 ,report+ by ph>macy b5efit manag]s ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ea* ph>macy b5efit manag] 7or affiliate1 subsidi>y1 or ag5t ( a ph>macy b5efit manag]7 %all report to ! ,commission ! foll[+ in=mation3 7#a7 ,! aggregate am\nt ( ! diff]5ce betwe5 ! am\nt ! ph>macy b5efit manag] 0 paid by ea* heal? plan & ! am\nt t ! ph>macy b5efit manag] paid ea* ph>macy on behalf ( ! heal? plan = prescription drugs4 7#b7 ,! aggregate am\nt ( any-- 7,a7 g5]ic effective rate fee *>g$ to ea* ph>macy2 7,b7 direct & indirect remun]ation fee *>g$ or o!r price concession to ea* ph>macy2 & 7,c7 paym5t resc9d$ or o!rwise claw$ back f a reimbursem5t made to ea* ph>macy4 7#c7 ,if1 dur+ ! report+ ye>1 ! ph>macy b5efit manag] mov$ or reassign$ a prescription drug to a =mul>y ti] t has a high] co/1 high] copaym5t1 high] co9surance1 or high] d$uctible to a consum]1 or a l[] reimbursem5t to a ph>macy1 an explanation ( ! reason :y ! drug 0 mov$ or reassign$ f #a ti] to ano!r1 includ+ :e!r ! move or reassignm5t 0 det]m9$ or reque/$ by a prescription drug manufactur] or o!r entity4 7#d7 ,) respect to any ph>macy b5efit manag] t owns1 controls1 or is affiliat$ ) a ph>macy1 a report reg>d+ any diff]5ce 9 reimbursem5t rates or practices1 direct & indirect remun]ation fees or o!r price concessions1 & clawbacks betwe5 a ph>macy t is own$1 controll$1 or affiliat$ ) ! ph>macy b5efit manag] & any o!r ph>macy4 7b7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 & annually !reaft]1 ! ,commission %all submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t addresses1 at a m9imum-- 7,a7 ! numb] actions br\ght by ! ,commission dur+ ! report+ ye> to en=ce ?is ,act & ! outcome ( ea* su* en=cem5t action2 7,b7 ! numb] ( op5 inve/igations or inquiries into pot5tial violations ( ?is ,act z ( ! "t ! report is submitt$2 7,c7 ! numb] & nature ( compla9ts receiv$ by ! ,commission relat+ to an allegation ( a violation ( ?is ,act dur+ ! report+ ye>2 7,d7 an anonymiz$ summ>y ( ! reports fil$ ) ! ,commission pursuant to subsection 7a7 = ! report+ ye>2 & 7,e7 policy or legislative recomm5dations to /r5g!n any en=cem5t action relat+ to a violation ( ?is ,act1 includ+ recomm5dations to include additional prohibit$ conduct$ 9 section #b7;a74 7#b7 ,=mul>y design or placem5t practices ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,commission %all submit to ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t addresses ! policies1 practices1 & role ( ph>macy b5efit manag]s 7includ+ _! affiliates1 subsidi>ies1 & ag5ts7 reg>d+ =mul>y design or placem5t1 includ+ :e!r-- 7,a7 ph>macy b5efit manag]s 7includ+ _! affiliates1 subsidi>ies1 & ag5ts7 use =mul>y design or placem5t to increase _! gross rev5ue )\t an accompany+ increase 9 pati5t access or decrease 9 pati5t co/2 or 7,b7 su* policies or practices ( ph>macy b5efit manag]s reg>d+ =mul>y design or placem5t violate section #e7;a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a774 7#c7 ,con/ruction ,no?+ 9 ?is section %all be con/ru$ z au?oriz+ ! ,commission to disclose any in=mation t is a trade secret or confid5tial in=mation describ$ 9 section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 7c7 ,,gao /udy ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,f9ance & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & to ! ,committee on ,ways & ,means & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t-- 7#a7 addresses1 at m9imum-- 7,a7 ! role t ph>macy b5efit manag]s play 9 ! ph>maceutical supply *a92 7,b7 ! /ate ( competition among ph>macy b5efit manag]s1 includ+ ! m>ket %>e = ! ,nation's #aj l>ge/ ph>macy b5efit manag]s2 7,c7 ! use ( rebates & fees by ph>macy b5efit manag]s1 includ+ data = ea* ( ! #aj l>ge/ ph>macy b5efit manag]s t reflects1 = ea* drug 9 ! =mul>y ( ea* su* ph>macy b5efit manag]-- 7i7 ! am\nt ( ! rebate pass$ on to pati5ts2 7ii7 ! am\nt ( ! rebate pass$ on to payors2 7iii7 ! am\nt ( ! rebate kept by ! ph>macy b5efit manag]2 & 7iv7 ! role ( fees *>g$ by ! ph>macy b5efit manag]2 7,d7 :e!r ph>macy b5efit manag]s /ructure _! =mul>ies 9 favor ( high-rebate prescription drugs ov] l[]-co/1 l[]-rebate alt]natives2 7,e7 ! av]age prior au?orization approval "t = ea* ( ! #aj l>ge/ ph>macy b5efit manag]s2 7,f7 factors affect+ ! use ( /ep !rapy 9 ea* ( ! #aj l>ge/ ph>macy b5efit manag]s2 & 7,g7 ! ext5t to :i* ! price t ph>macy b5efit manag]s *>ge payors1 su* z ! ,m$ic>e program "u title ,,xxviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 ,/ate ,m$icaid programs "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 ! ,f$]al ,employees ,heal? ,b5efits ,program "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code1 or private payors1 = a drug is m ?an su* ph>macy b5efit manag]s pay ! ph>macy = ! drug2 & 7#b7 provides recomm5dations = legislative action to l[] ! co/ ( prescription drugs = consum]s & payors1 improve ! effici5cy ( ! ph>maceutical supply *a9 by l[]+ int]m$i>y co/s1 improve competition 9 ph>macy b5efit managem5t1 & provide transp>5cy 9 ph>macy b5efit managem5t4 #e4 ,:i/lebl[] protections 7a7 ,9 g5]al ,a ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re( %all n1 directly or indirectly1 dis*>ge1 demote1 susp5d1 dim9i%1 or )draw b5efits f1 ?reat51 h>ass1 or 9 any o!r mann] discrim9ate aga9/ or adv]sely impact a cov]$ individual because-- 7#a7 ! cov]$ individual1 or anyone p]ceiv$ z assi/+ ! cov]$ individual1 takes 7or is suspect$ to h tak5 or w take7 a lawful action 9 provid+ to ,congress1 an ag5cy ( ! ,f$]al ,gov]nm5t1 ! attorney g5]al ( a ,/ate1 a ,/ate regulator ) au?ority ov] ! di/ribution or insurance cov]age ( prescription drugs1 or a law en=cem5t ag5cy relat+ to any act or omission t ! cov]$ individual reasonably believes to be a violation ( ?is ,act2 7#b7 ! cov]$ individual provides in=mation t ! cov]$ individual reasonably believes evid5ces su* a violation to-- 7,a7 a p]son ) sup]visory au?ority ov] ! cov]$ individual at ! ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re(2 or 7,b7 ano!r individual work+ = ! ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re( :o ! cov]$ individual reasonably believes has ! au?ority to inve/igate1 discov]1 or t]m9ate ! violation or to take any o!r action to address ! violation2 7#c7 ! cov]$ individual te/ifies 7or x is suspect$ t ! cov]$ individual w te/ify7 9 an inve/igation or judicial or adm9i/rative proce$+ conc]n+ su* a violation2 7#d7 ! cov]$ individual assi/s or p>ticipates 7or x is expect$ t ! cov]$ individual w assi/ or p>ticipate7 9 su* an inve/igation or judicial or adm9i/rative proce$+2 or 7#e7 ! cov]$ individual takes any o!r action to assi/ 9 c>ry+ out ! purposes ( ?is ,act4 7b7 ,en=cem5t ,an individual :o alleges any adv]se action 9 violation ( subsection 7a7 may br+ an action = a jury trial 9 ! appropriate di/rict c\rt ( ! ,unit$ ,/ates = ! foll[+ relief3 7#a7 ,tempor>y relief :ile ! case is p5d+4 7#b7 ,re9/atem5t ) ! same s5iority /atus t ! individual w\ld h _h1 b = ! dis*>ge or discrim9ation4 7#c7 ,twice ! am\nt ( back pay o!rwise ow$ to ! individual1 ) int]e/4 7#d7 ,consequ5tial & comp5satory damages1 & comp5sation = litigation co/s1 exp]t witness fees1 & reasonable attorneys' fees4 7c7 ,waiv] ( rights & rem$ies ,! rights & rem$ies provid$ = 9 ?is section %all n be waiv$ by any policy =m or condition ( employm5t1 includ+ by a pr$ispute arbitration agreem5t4 7d7 ,pr$ispute arbitration agreem5ts ,no pr$ispute arbitration agreem5t %all be valid or en=ceable if ! agreem5t requires arbitration ( a dispute aris+ "u ?is section4 #f4 ,en=cem5t 7a7 ,en=cem5t by ! ,commission 7#a7 ,unfair & deceptive acts or practices ,a violation ( ?is ,act %all be treat$ z a violation ( a rule def9+ an unfair or deceptive act or practice "u section #ah7;a77#a77;,b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b774 7#b7 ,p[]s ( ! ,commission 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraph 7,c71 ! ,commission %all en=ce ?is ,act 9 ! same mann]1 by ! same means1 & ) ! same jurisdiction1 p[]s1 & duties z ?\gh all applicable t]ms & provisions ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 7 incorporat$ into & made a "p ( ?is ,act4 7,b7 ,privileges & immunities ,subject to p>agraph 7#c71 any p]son :o violates ?is ,act %all be subject to ! p5alties & entitl$ to ! privileges & immunities provid$ 9 ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et4 seq474 7,c7 ,nonpr(it organizations & insurance ,not)/&+ section #d or #f ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd1 #df71 section #b ( ,mc,carran-,f]guson ,act 7#ae ,u4,s4,c4 #ajab71 or any o!r jurisdictional limitation ( ! ,commission1 ! ,commission %all also en=ce ?is ,act1 9 ! same mann] provid$ 9 subp>agraphs 7,a7 & 7,b7 ( ?is p>agraph1 ) respect to-- 7i7 organizations n organiz$ to c>ry on bus9ess = _! own pr(it or t ( _! memb]s2 & 7ii7 ! bus9ess ( insurance1 & p]sons engag$ 9 su* bus9ess4 7,d7 ,au?ority pres]v$ ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,commission "u any o!r provision ( law4 7#c7 ,p5alties 7,a7 ,additional civil p5alty ,9 addition to any p5alty applicable "u ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq471 any p]son t violates ?is ,act %all be liable = a civil p5alty ( n m ?an #a1jjj1jjj4 7,b7 ,me?od ,! p5alties provid$ by subp>agraph 7,a7 %all be obta9$ 9 ! same mann] z civil p5alties impos$ "u section #ah7;a77#a77;,b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a7#a77;,b74 7,c7 ,multiple (f5ses2 mitigat+ factors ,9 assess+ a p5alty "u subp>agraph 7,a7-- 7i7 ea* day ( a cont9u+ violation %all be consid]$ a sep>ate violation2 & 7ii7 ! c\rt %all take into consid]ation1 among o!r factors-- 7,i7 ! s]i\sness ( ! violation2 7,,ii7 ! ef=ts ( ! p]son committ+ ! violation to rem$y ! h>m caus$ by ! violation 9 a timely mann]2 & 7,,iii7 :e!r ! violation 0 int5tional4 7b7 ,en=cem5t by ,/ates 7#a7 ,9 g5]al ,if ! attorney g5]al ( a ,/ate has reason to believe t an int]e/ ( ! resid5ts ( ! ,/ate has be5 or is be+ ?reat5$ or adv]sely affect$ by a practice t violates ?is ,act1 ! attorney g5]al ( ! ,/ate may br+ a civil action on behalf ( ! resid5ts ( ! ,/ate 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates to obta9 appropriate relief4 7#b7 ,rights ( ! ,commission 7,a7 ,notice to ! ,commission 7i7 ,9 g5]al ,except z provid$ 9 clause 7iii71 ! attorney g5]al ( a ,/ate1 be=e initiat+ a civil action "u p>agraph 7#a71 %all provide writt5 notification to ! ,commission t ! attorney g5]al int5ds to br+ su* civil action4 7ii7 ,cont5ts ,! notification requir$ "u clause 7i7 %all include a copy ( ! compla9t to be fil$ to initiate ! civil action4 7iii7 ,exception ,if x is n feasible = ! attorney g5]al ( a ,/ate to provide ! notification requir$ "u clause 7i7 be=e initiat+ a civil action "u p>agraph 7#a71 ! attorney g5]al %all notify ! ,commission imm$iately ^u in/itut+ ! civil action4 7,b7 ,int]v5tion by ! ,commission ,! ,commission may-- 7i7 int]v5e 9 any civil action br\ght by ! attorney g5]al ( a ,/ate "u p>agraph 7#a72 & 7ii7 ^u int]v5+-- 7,i7 be he>d on all matt]s aris+ 9 ! civil action2 & 7,,ii7 file petitions = appeal ( a decision 9 ! civil action4 7#c7 ,con/ruction ,no?+ 9 ?is subsection may be con/ru$ to prev5t ! attorney g5]al ( a ,/ate f ex]cis+ ! p[]s conf]r$ on ! attorney g5]al by ! laws ( ! ,/ate to conduct inve/igations1 to adm9i/] oa?s or affirmations1 or to compel ! att5dance ( witnesses or ! production ( docum5t>y or o!r evid5ce4 7#d7 ,v5ue2 s]vice ( process 7,a7 ,v5ue ,any action br\ght "u p>agraph 7#a7 may be br\ght 9-- 7i7 ! di/rict c\rt ( ! ,unit$ ,/ates t meets applicable requirem5ts relat+ to v5ue "u section #acia ( title #bh1 ,unit$ ,/ates ,code2 or 7ii7 ano!r c\rt ( compet5t jurisdiction4 7,b7 ,s]vice ( process ,9 an action br\ght "u p>agraph 7#a71 process may be s]v$ 9 any di/rict 9 :i*-- 7i7 ! def5dant is an inhabitant1 may be f\nd1 or transacts bus9ess2 or 7ii7 v5ue is prop] "u section #acia ( title #bh1 ,unit$ ,/ates ,code4 7#e7 ,actions by o!r ,/ate (ficials 7,a7 ,9 g5]al ,if an attorney g5]al lacks appropriate jurisdiction to br+ a civil action "u p>agraph 7#a71 any o!r (fic] ( a ,/ate :o is au?oriz$ by ! ,/ate to d s may br+ a civil action "u p>agraph 7#a71 subject to ! same requirem5ts & limitations t apply "u ?is subsection to civil actions br\ght by attorneys g5]al4 7,b7 ,cl>ification ( au?ority ,! au?ority provid$ by subp>agraph 7,a7 %all supplant1 & n supplem5t1 ! au?orities ( ,/ate attorneys g5]al "u p>agraph 7#a74 7,c7 ,sav+s provision ,no?+ 9 ?is subsection may be con/ru$ to prohibit an au?oriz$ (ficial ( a ,/ate f initiat+ or cont9u+ any proce$+ 9 a c\rt ( ! ,/ate = a violation ( any civil or crim9al law ( ! ,/ate4 7c7 ,affirmative def5se ,9 an action br\ght "u ?is section to en=ce section #b1 x %all be an affirmative def5se1 on :i* ! def5dant has ! burd5 ( p]suasion by a prepond]ance ( ! evid5ce1 t ! conduct alleg$ to be a violation ( section #b 0 nonpretextual & reasonably necess>y to-- 7#a7 prev5t a violation (1 or comply )1 ,f$]al or ,/ate law2 7#b7 protect pati5t safety2 or 7#c7 protect pati5t access4 #g4 ,effect on ,/ate laws ,no?+ 9 ?is ,act %all be con/ru$ to preempt1 displace1 or supplant any ,/ate laws1 rules1 regulations1 or requirem5ts1 or ! en=cem5t !re(4 #h4 ,def9itions ,9 ?is ,act3 7#a7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 7#b7 ,cov]$ individual ,! t]m cov]$ individual means a curr5t or =m] employee1 contractor1 subcontractor1 s]vice provid]1 or ag5t ( a ph>macy b5efit manag]1 heal? plan1 ph>maceutical manufactur]1 ph>macy1 or any affiliate1 subsidi>y1 or ag5t !re(4 7#c7 ,heal? plan ,! t]m heal? plan means any gr\p or individual heal? insurance plan or cov]age1 includ+ any heal? insurance plan or cov]age sponsor$ or fund$ by ! ,f$]al ,gov]nm5t or ! gov]nm5t ( any ,/ate1 ,t]ritory1 or subdivision !re(4 7#d7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any entity t provides ph>macy b5efit managem5t s]vices on behalf ( a heal? plan1 a pay]1 or heal? insurance issu]4 7#e7 ,ph>macy b5efit managem5t s]vices ,! t]m ph>macy b5efit managem5t s]vices means1 pursuant to a writt5 agreem5t ) a pay] or heal? plan (f]+ gr\p or individual heal? insurance cov]age1 directly or ?r\gh an int]m$i>y1 ! s]vice (-- 7,a7 negotiat+ t]ms & conditions1 includ+ rebates & price concessions1 ) respect to a prescription drug on behalf ( ! heal? plan1 cov]age1 or pay]2 or 7,b7 manag+ ! prescription drug b5efits provid$ by ! heal? plan1 cov]age1 or pay]1 :i* may include =mul>y managem5t ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! adjudication ( appeals or grievances relat$ to ! prescription drug b5efit1 contract+ ) network ph>macies1 or ! provision ( relat$ s]vices4 7#f7 ,prescription drug ,! t]m prescription drug means-- 7,a7 a drug1 z t t]m is def9$ 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g771 t is-- 7i7 approv$ by ! ,food & ,drug ,adm9i/ration "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee72 & 7ii7 subject to ! requirem5ts ( section #ejc7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 7,b7 a biological product z t t]m is def9$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a772 or 7,c7 a product t is biosimil> to1 or int]*angeable )1 a biologic product "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i774 ,decemb] #ad1 #bjbb,report$ ) an am5dm5t