,,ii #aai? ,,congress #b;d ,session ,s4 #chbb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #aj1 #bjbf,ms4 ,w>r5 7= h]self & ,mr4 ,hawley7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to prohibit ph>macy b5efit manag]s1 insur]s1 & prescription drug or m$ical device :olesal]s f be+ "u common own]%ip ) c]ta9 m$ical s]vice provid]s1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,break ,up ,big ,m$ic9e ,act4 #b4 ,f9d+s ,! ,congress f9ds ! foll[+3 7#a7 ,l>ge1 v]tically integrat$ heal? c>e plat=ms dom9ate ! ,am]ican heal? c>e sy/em4 ,^! corporate entities own or control e "p ( ! heal? c>e supply *a91 includ+ up/ream bus9ess l9es1 l heal? insurance plans1 & d[n/ream suppli]s1 l ph>macies & physicians4 ,?is is ! end result ( an unprec$5t$ wave ( consolidation4 7#b7 ,l>ge1 publicly trad$ insurance conglom]ates h increas+ly engag$ 9 aggressive acquisition /rategies1 becom+ "s ( ! l>ge/ employ]s ( physicians 9 ! c\ntry4 ,z ( #bjbc1 "o conglom]ate controls approximately #aj p]c5t ( all ,am]ican physicians1 mak+ x ! s+le l>ge/ employ] ( physicians 9 ! nation4 7#c7 ,m ?an ?ree-qu>t]s ( all ,am]ican doctors are employ$ by corporate entities1 ) indep5d5t physicians compris+ a small & %r9k+ %>e ( ,am]ica's doctors4 7#d7 ,l>ge :olesal]s ( drugs & m$ical devices h simil>ly engag$ 9 a wave ( consolidation4 ,! #c l>ge/ drug :olesal]s control #ih p]c5t ( ! ,unit$ ,/ates drug di/ribution m>ket4 ,^! conglom]ates h also engag$ 9 sub/antial v]tical integration1 acquir+ d[n/ream suppli]s includ+ specialty m$ical practices & m$ical supply di/ributors4 ,s9ce ,janu>y #bjbd1 ! #c l>ge/ drug :olesal]s h propos$ or complet$ acquisitions ( d[n/ream suppli]s wor? approximately #af1jjj1jjj1jjj & spann+ m ?an #a1jjj locations across #ce ,/ates4 7#e7 ,ph>macy b5efit manag]s are corporate entities t det]m9e :at drugs w be cov]$ by heal? plans1 :at prices pati5ts w pay1 & h[ mu* ph>macies w be reimburs$4 ,! #c l>ge/ ph>macy b5efit manag]s are ea* integrat$ into l>ge1 corporate heal? c>e plat=ms4 ,^! #c ph>macy b5efit manag]s alone process ne>ly #hj p]c5t ( prescription drug claims4 7#f7 ,own]%ip ( bo? up/ream & d[n/ream bus9esses creates inh]5t conflicts ( int]e/ = corporate heal? c>e plat=ms4 7,a7 ,! ,f$]al ,trade ,commission has f\nd t v]tically integrat$ ph>macy b5efit manag]s h bo? ! ability & inc5tive to /e] bus9ess to _! own affiliat$ ph>macies1 :i* r$uces competition & increases prescription drug co/s = pati5ts4 7,b7 ,9 ! physician m>ket1 l>ge insur]s h ! ability & inc5tive to /e] enrollees to provid]s own$ by ! same p>5t company4 7,c7 ,self-pref]5c+ ( affiliat$ ph>macies or physicians may all[ l>ge1 v]tically integrat$ heal? conglom]ates to evade /atutory limits on pr(its kn[n z ! ,m$ical ,loss ,ratio4 ,gam+ ( ! pr(it con/ra9t us+ transf] pric+ te*niques may all[ affiliat$ heal? insurance bus9esses to hide pr(its 9 ! unregulat$ ph>macy or physician bus9ess segm5ts1 co/+ enrollees & taxpay]s money4 7,d7 ,ext5sive evid5ce supports claims t private insur]s issu+ ,m$ic>e ,advantage plans use employ$ physicians to int5sively docum5t ! m$ical conditions ( _! enrollees1 g5]at+ inflat$ paym5ts f ! ,f$]al ,gov]nm5t )\t improv+ c>e quality4 7,e7 ,9 ! :olesale drug di/ribution m>ket1 acquisitions ( specialty c>e provid]s by l>ge :olesal]s c create ! inc5tive & ability = ! new1 v]tically integrat$ company to /e] speciali/s t[>d prescrib+ ! mo/ lucrative drugs & devices r ?an ! be/ treatm5t = ! pati5t4 7#g7 ,pursuant to its p[]s "u article ,i1 section #h1 ( ! ,unit$ ,/ates ,con/itution1 ,congress has ! ability to create any law necess>y & appropriate to regulate int]/ate comm]ce4 ,l>ge1 national heal? conglom]ates op]ate across /ate l9es & engage 9 intra/ate activities t sub/antially relate to int]/ate comm]ce4 ,congress int5ds to regulate ^! corporate heal? c>e plat=ms 9 ! public int]e/4 7#h7 ,9 ord] to elim9ate ! conflicts ( int]e/ describ$ 9 p>agraphs 7#a7 ?r\gh 7#g7 & re/ore competition to ! m>ketplace1 ! ,f$]al ,gov]nm5t %\ld-- 7,a7 protect pati5ts1 physicians1 ph>macies1 & taxpay]s by /ructurally sep>at+ v]tically integrat$ heal? conglom]ates2 7,b7 require p>5t companies t own an insur] or ph>macy b5efit manag] to dive/ any m$ical provid]s !y ei!r directly own or control ?r\gh managem5t s]vice organizations2 7,c7 require p>5t companies t own a prescription drug or m$ical device :olesal] to dive/ any m$ical provid] or managem5t s]vice organizations !y own2 7,d7 enable ,f$]al ag5cies1 ,/ate attorneys g5]al1 & private citiz5s to br+ civil actions to en=ce ! /ructural sep>ation ( ^! companies2 & 7,e7 grant ! ,f$]al ,trade ,commission & ,dep>tm5t ( ,ju/ice additional au?ority to review & block future actions t w\ld h>m ! public int]e/ by re-creat+ ! conflicts ( int]e/ describ$ above4 #c4 ,prohibitions relat+ to anticompetitive own]%ip & contracts 7a7 ,prohibition on c]ta9 common own]%ip 7#a7 ,involv+ an insurance company or ph>macy b5efit manag] 7,a7 ,9 g5]al ,x %all be unlawful = any p]son to bo?-- 7i7 directly or indirectly own1 op]ate1 control1 or direct ! op]ation ( ! :ole or any "p (-- 7,i7 a provid]2 or 7,,ii7 a managem5t s]vices organization2 & 7ii7 directly or indirectly own1 op]ate1 or control ! :ole or any "p (-- 7,i7 an insurance company2 & 7,,ii7 a ph>macy b5efit manag]4 7,b7 ,dive/m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 any p]son 9 violation ( subp>agraph 7,a7 %all dive/ "o ( ! foll[+3 7i7 ,all entities describ$ 9 subp>agraph 7,a77i74 7ii7 ,all entities describ$ 9 subp>agraph 7,a77ii74 7#b7 ,involv+ a :olesal] 7,a7 ,9 g5]al ,x %all be unlawful = any p]son to bo?-- 7i7 directly or indirectly own1 op]ate1 control1 or direct ! op]ation ( ! :ole or any "p ( a provid] or managem5t s]vices organization2 & 7ii7 directly or indirectly own1 op]ate1 or control ! :ole or any "p ( a prescription drug or m$ical device :olesal]4 7,b7 ,dive/m5t ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 any p]son 9 violation ( subp>agraph 7,a7 %all dive/ "o ( ! foll[+3 7i7 ,all entities describ$ 9 subp>agraph 7,a77i74 7ii7 ,all entities describ$ 9 subp>agraph 7,a77ii74 7b7 ,antitru/ en=cem5t 7#a7 ,9 g5]al ,bo? ! ,f$]al ,trade ,commission & ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division %all h jurisdiction1 jo9tly or sep>ately1 to en=ce ?is section4 7#b7 ,p5alties = failure to dive/ 7,a7 ,guidance ,n lat] ?an #cj days aft] ! date ( enactm5t ( ?is ,act1 ! ,*air ( ! ,f$]al ,trade ,commission & ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division %all issue guidance specify+ mile/ones = dive/m5t )9 ! deadl9e "u subsection 7a74 7,b7 ,p5alties 7i7 ,9 g5]al ,= any p]son t does n comply ) ! mile/ones specifi$ "u subp>agraph 7,a71 ! ,*air ( ! ,f$]al ,trade ,commission or ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division %all cause #aj p]c5t ( ! pr(its ( ! p]son to be transf]r$ into escr[ on a mon?ly basis1 to be-- 7,i7 return$ to ! p]son if dive/m5t occurs by ! deadl9e "u subsection 7a72 or 7,,ii7 deposit$ into ! fund describ$ 9 subsection 7c77#g7 if dive/m5t does n occur by ! deadl9e "u subsection 7a74 7,c7 ,tru/ee ,if dive/iture does n occur by ! deadl9e "u subsection 7a71 a dive/iture tru/ee %all ov]see ! dive/iture requir$ "u t p>agraph4 ,! dive/iture tru/ee %all h ! au?ority to sell ! entity to :i* ! dive/iture requirem5t applies4 7c7 ,civil actions 7#a7 ,9 g5]al ,:5 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division ( ! ,dep>tm5t ( ,ju/ice1 ! ,f$]al ,trade ,commission1 or an attorney g5]al ( a ,/ate has reason to believe t a p]son is 9 violation ( subsection 7a71 su* ,inspector ,g5]al1 ,assi/ant ,attorney ,g5]al1 ,f$]al ,trade ,commission or attorney g5]al ( a ,/ate may br+ a civil action 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates4 7#b7 ,private "r ( action 7,a7 ,9 g5]al ,an individual alleg+ damages z a result ( a violation ( ?is ,act may br+ a civil action 9 any c\rt ( compet5t jurisdiction1 ,/ate or ,f$]al4 7,b7 ,relief ,9 a civil action br\ght "u subp>agraph 7,a7 9 :i* ! pla9tiff prevails1 ! c\rt may aw>d-- 7i7 treble damages2 7ii7 reasonable attorney's fees & litigation co/s2 & 7iii7 any o!r relief1 includ+ equitable or decl>atory relief1 t ! c\rt det]m9es appropriate4 7#c7 ,actions by /ate attorneys g5]al ,if ! attorney g5]al ( a ,/ate has reason to believe t an int]e/ ( ! resid5ts ( ! ,/ate has be5 or is be+ ?reat5$ or adv]sely affect$ by a practice t violates subsection 7a71 ! attorney g5]al ( ! ,/ate may1 z p>5s patriae1 br+ a civil action on behalf ( ! resid5ts ( ! ,/ate 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates to obta9 appropriate relief1 includ+ monet>y damages4 7#d7 ,injunctive & equitable relief ,9 any action describ$ 9 p>agraph 7#a71 7#b71 or 7#c71 ! applicable c\rt1 on a f9d+ t a p]son is 9 violation ( subsection 7a71 %all issue an ord] requir+ su* p]son-- 7,a7 to cease & desi/ f su* violation1 &1 if applicable1 dive/ an entity ( su* p]son 9 accordance ) p>agraph 7#a77;,b7 or p>agraph 7#b77;,b7 ( su* subsection 7a71 z applicable2 & 7,b7 to disgorge any rev5ue receiv$ f an entity subject to dive/m5t 9 accordance ) su* subsection 7a7 = ! p]iod ( su* violation4 7#e7 ,o!r relief ,9 addition to any relief obta9$ "u p>agraph 7#a71 7#b71 7#c71 or 7#d71 ! c\rt may grant any o!r equitable relief necess>y to r$ress & prev5t recurr5ce ( ! violation4 7#f7 ,"r to jury trial ,ei!r p>ty1 ^u reque/1 %all h ! "r to a jury trial4 7#g7 ,deposit ,any rev5ue disgorg$ pursuant to an action "u p>agraph 7#a7 %all be deposit$ 9 a fund creat$ by ! ,f$]al ,trade ,commission & di/ribut$ by ! ,f$]al ,trade ,commission to be put to use 9 ! int]e/ ( s]v+ ! heal? c>e ne$s ( ! h>m$ community1 includ+ consum]s ov]*>g$ = m$ical s]vices at v]tically integrat$ heal? c>e conglom]ates4 7d7 ,,ftc & ,,doj review 7#a7 ,report+ requir$ ,any dive/m5t ( an entity requir$ "u subsection 7a7 %all be report$ to ! ,f$]al ,trade ,commission & ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division ( ! ,dep>tm5t ( ,ju/ice "u section #g;,a ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ah;a7 )\t respect to ! ?re%olds "u subsection 7a77#b7 ( t section4 7#b7 ,toll+ ( dive/m5t p]iod dur+ review ,! dive/m5t p]iod "u subsection 7a7 %all be toll$ dur+ ! p5d5cy ( any wait+ p]iod requir$ "u section #g;,a ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ah;a74 7#c7 ,review ( effect ( dive/iture ,) respect to ea* dive/iture und]tak5 pursuant to subsection 7a71 9 addition to any applicable review "u section #g;,a ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ah;a71 ! ,f$]al ,trade ,commission & ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division ( ! ,dep>tm5t ( ,ju/ice %all review ! effect on competition1 f9ancial viability1 & ! public int]e/-- 7,a7 ( ! dive/iture2 & 7,b7 ( ! subsequ5t acquisition ( ! dive/$ entity by ! acquir+ p]son4 7#d7 ,block+ ( actions ,! ,f$]al ,trade ,commission & ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division ( ! ,dep>tm5t ( ,ju/ice1 jo9tly or sep>ately1 may br+ a civil action 9 any c\rt ( compet5t jurisdiction to block any action t w\ld h>m competition to ! detrim5t ( ! public int]e/ ) respect to ! conflicts ( int]e/ describ$ 9 subsection 7a74 7e7 ,rulemak+ au?ority ,! ,f$]al ,trade ,commission %all promulgate rules to c>ry out ?is section4 ,su* rules %all n dim9i% any obligation "u ?is section4 7f7 ,reports requir$ ,! ,*air ( ! ,f$]al ,trade ,commission & ! ,assi/ant ,attorney ,g5]al 9 *>ge ( ! ,antitru/ ,division ( ! ,dep>tm5t ( ,ju/ice %all submit to ! appropriate congressional committees qu>t]ly reports on compliance ) ?is ,act1 includ+ ! /atus ( any dive/itures requir$ "u ?is ,act4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! au?ority ( ! ,f$]al ,trade ,commission1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,ju/ice1 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 or ! attorney g5]al ( a ,/ate "u any o!r provision ( law4 7h7 ,sev]ability ,if any provision ( ?is ,act or ! application !re( to any p]son or circum/ance is held invalid1 ! rema9d] ( ?is ,act1 or ! application ( t provision to p]sons or circum/ances o!r ?an ^? z to :i* x is held invalid1 %all n be affect$ !reby4 7i7 ,def9itions ,9 ?is section3 7#a7 ,drug2 device ,! t]ms drug & device h ! mean+s giv5 ^? t]ms1 respectively1 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#b7 ,heal? plan ,! t]m heal? plan means any public or private heal? insurance plan4 7#c7 ,managem5t s]vices organization ,! t]m managem5t s]vices organization means an entity t has ent]$ into an agreem5t ) a provid] to furni% s]vices to su* provid]1 includ+ s]vices relat+ to payroll1 human res\rces1 employm5t scre5+1 pay] contract+1 bill+ & collection1 cod+1 in=mation te*nology s]vices1 pati5t s*$ul+1 prop]ty or equipm5t leas+1 & adm9i/rative or bus9ess s]vices t d n con/itute ! practice ( m$ic9e4 7#d7 ,p]son ,! t]m p]son has ! mean+ giv5 ! t]m 9 section #h ( ! ,%]man ,act 7#ae ,u4,s4,c4 #g74 7#e7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any p]son1 bus9ess1 or o!r entity1 su* z a ?ird-p>ty adm9i/rator1 reg>dless ( :e!r su* p]son1 bus9ess1 or entity id5tifies itself z a ph>macy b5efit manag]1 t1 ei!r directly or indirectly ?r\gh an int]m$i>y 7includ+ an affiliate1 subsidi>y1 or ag5t7 or an arrangem5t ) a ?ird p>ty-- 7,a7 acts z a negotiator ( prices1 rebates1 fees1 or disc\nts = prescription drugs on behalf ( a heal? plan or heal? plan sponsor2 7,b7 contracts ) ph>macies to create ph>macy networks & designs & manages su* networks2 or 7,c7 manages or adm9i/]s ! prescription drug b5efits provid$ by a heal? plan1 includ+ ! process+ & paym5t ( claims = prescription drugs1 arrang+ alt]native access to or fund+ = prescription drugs1 ! p]=mance ( utilization managem5t s]vices1 includ+ drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! adjudication ( appeals or grievances relat$ to ! prescription drug b5efit1 contract+ ) network ph>macies1 controll+ ! co/ ( cov]$ prescription drugs1 or ! provision ( relat$ s]vices4 7#f7 ,prescription drug ,! t]m prescription drug means a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 t is subject to section #ejc7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cec7;b77#a774 7#g7 ,prescription drug or m$ical device :olesal] ,! t]m prescription drug or m$ical device :olesal]-- 7,a7 means a p]son engag$ 9 :olesale di/ribution ( a prescription drug or a device2 & 7,b7 includes a p>5t 7direct or indirect7 (1 a subsidi>y 7direct or indirect1 & p>tial or complete7 (1 & any entity "u ! common control or own]%ip ( a p]son describ$ 9 subp>agraph 7,a74 7#h7 ,provid] ,! t]m provid] means a practition] or entity ! ,national ,provid] ,in/itute regi/ration ( :i* has #a or m taxonomy codes "u ! ,national ,uni=m ,claim ,committee 7or subsequ5t organization71 includ+ any 9-pati5t or outpati5t ph>macy1 physician practice1 ambulatory surg]y c5t]1 urg5t c>e c5t]1 po/-acute c>e facility1 home-heal? provid]1 or hospital4 7#i7 ,:olesale di/ribution ,! t]m :olesale di/ribution-- 7,a7 means a p]son engag$ 9 ! sale1 pur*ase1 trade1 deliv]y1 h&l+1 /orage or receipt ( a drug or device by a p]son o!r ?an ! consum] or pati5t2 & 7,b7 does n include-- 7i7 disp5s+ ( a drug or device to a consum] or pati5t by a p]son hav+ a valid lic5se "u ,/ate law to d s2 7ii7 pur*ase1 h&l+1 /orage1 receipt1 or o!r acquisition ( a drug or device by a p]son hav+ a valid lic5se "u ,/ate law to disp5se or adm9i/] drugs or devices or1 a hospital1 ph>macy1 or o!r heal? c>e entity1 = use by su* p]son1 hospital1 ph>macy1 or o!r heal? c>e entity2 7iii7 sale1 pur*ase1 trade1 deliv]y1 h&l+1 /orage1 or receipt ( a drug or device by a p]son hold+ an application approv$ "u section #eje or #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj;e7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = su* drug or device1 a co-lic5s$ p>tn] ( any p]son describ$ 9 ?is clause1 or an affiliate ( any p]son describ$ 9 ?is clause2 7iv7 possession by1 receipt by1 or transf] to a-- 7,i7 ?ird-p>ty logi/ics provid] t provides or coord9ates w>eh\s+ or o!r logi/ics s]vices 9 int]/ate comm]ce2 or 7,,ii7 repackag] :o owns or op]ates an e/abli%m5t t repacks & relabels drugs or devices = fur!r sale or di/ribution1 provid$ t su* ?ird-p>ty logi/ics provid] or repackag] does n take own]%ip ( ! drug or device2 7v7 possession by1 receipt by1 or transf] to a common c>ri] t transports a drug or device1 provid$ t ! common c>ri] does n take own]%ip ( ! drug2 7vi7 intracompany transf] ( any drug or device by an entity describ$ 9 clause 7i71 7ii71 or 7iii71 includ+ transf]s betwe5 affiliates !re(1 or w>eh\s+ by su* p]son incid5tal to su* intracompany transf]2 or 7vii7 returns or rev]se di/ribution by any p]son describ$ 9 clause 7i71 7ii71 7iii71 7iv71 or 7v74