,,ii #aah? ,,congress #a/ ,session ,s4 #acci ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #bg1 #bjbc,mr4 ,s&]s 7= himself1 ,mr4 ,cassidy1 ,mrs4 ,murray1 & ,mr4 ,m>%all7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide = increas$ ov]sight ( entities t provide ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans & heal? insurance cov]age4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 #b4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,,phsa ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$-- 7#a7 9 "p ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] %all n ent] into a contract ) an applicable entity t limits ! disclosure ( in=mation to plan sponsors 9 su* a mann] t prev5ts ! plan or issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan or issu]1 f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a cov]$ gr\p heal? plan %all submit to ! plan sponsor ( su* cov]$ gr\p heal? plan a report 9 accordance ) ?is subsection & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat &1 z ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury may det]m9e1 o!r =mats4 ,ea* su* report %all include1 ) respect to ! cov]$ gr\p heal? plan-- 7,a7 z applicable1 in=mation collect$ f drug manufactur]s by su* issu] or entity on ! total am\nt ( copaym5t assi/ance doll>s paid1 or copaym5t c>ds appli$1 t 7 fund$ by ! drug manufactur] ) respect to ! p>ticipants & b5efici>ies 9 su* plan2 7,b7 a li/ ( ea* drug cov]$ by su* plan or entity provid+ ph>macy b5efit managem5t s]vices t 0 bill$ dur+ ! report+ p]iod1 includ+1 ) respect to ea* su* drug dur+ ! report+ p]iod-- 7i7 ! br& "n1 g5]ic or nonpropriet>y "n1 & ,national ,drug ,code2 7ii7 ! numb] ( p>ticipants & b5efici>ies = :om ! drug 0 bill$ dur+ ! report+ p]iod1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug disp5s$ across ! report+ p]iod2 7iii7 = ea* claim or dosage unit describ$ 9 clause 7ii71 ! type ( disp5s+ *annel us$1 su* z retail1 mail ord]1 or specialty ph>macy2 7iv7 ! :olesale acquisition co/1 li/$ z co/ p] days supply1 co/ p] dosage unit1 & co/ p] typical c\rse ( treatm5t 7z applicable72 7v7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug aft] application ( any b5efits "u ! plan or cov]age1 includ+ p>ticipant & b5efici>y sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ to ! plan or cov]age2 & 7vi7 = any drug = :i* gross sp5d+ by ! plan exce$$ #aj1jjj & t is "o ( ! #ej prescription drugs = :i* ! gr\p heal? plan sp5t ! mo/ on prescription drug b5efits dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class1 includ+ br& "n drugs & biological products & g5]ic drugs or biosimil> biological products t are 9 ! same !rapeutic class z su* drug2 & 7,,ii7 if applicable1 ! rationale = pref]r$ =mul>y placem5t ( su* drug 9 t !rapeutic class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y2 7,c7 a li/ ( ea* !rapeutic class ( drugs t 7 disp5s$ "u ! heal? plan dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan1 be=e rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7ii7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 t class2 7iii7 if applicable to t class1 a description ( ! =mul>y ti]s & utilization managem5t me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 7iv7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies1 includ+ p>ticipant & b5efici>y sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 & 7v7 = ea* !rapeutic class "u :i* #c or m drugs are includ$ on ! =mul>y ( su* plan-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 by su* entity1 f an applicable entity1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation t-- 7aa7 has be5 paid1 or w be paid1 by su* an applicable entity = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 is relat$ to utilization ( drugs or drug sp5d+2 7,,ii7 ! total net sp5d+ by ! heal? plan on t class ( drugs2 & 7,,iii7 ! net price p] typical c\rse ( treatm5t or #cj-;day supply incurr$ by ! heal? plan & its p>ticipants & b5efici>ies1 aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation provid$ by an applicable entity1 = drugs disp5s$ )9 su* !rapeutic class dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan dur+ ! report+ p]iod1 be=e rebates1 fees1 alt]native disc\nts1 or o!r remun]ation provid$ by an applicable entity2 7,e7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! heal? plan1 f an applicable entity1 9 rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f any su* entities1 relat$ to utilization ( drug or drug sp5d+ "u t heal? plan dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! heal? plan dur+ ! report+ p]iod2 7,g7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd7 to brok]s1 consultants1 advisors1 or any o!r individual or firm :o ref]r$ ! gr\p heal? plan's bus9ess to ! ph>macy b5efit manag]2 & 7,h7 a summ>y docum5t t includes su* in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,g7 z ! ,secret>y det]m9es useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to plan sponsor & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y4 7#b7 ,supplem5t>y report+ = intra-company prescription drug transactions 7,a7 ,9 g5]al ,a heal? insurance issu] (f]+ cov]$ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices "u a cov]$ gr\p heal? plan or cov]$ gr\p heal? insurance cov]age %all submit1 toge!r ) ! report "u p>agraph 7#a71 a supplem5t>y report e #f mon?s to ! plan sponsor t includes-- 7i7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 ! plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by t issu] or entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & copaym5t inc5tives fund$ by an entity provid+ ph>macy b5efit managem5t s]vices2 7ii7 ! p]c5tage ( total prescriptions *>g$ to ! plan1 cov]age1 or p>ticipants & b5efici>ies 9 ! plan or cov]age1 t 7 disp5s$ by mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by ! issu] or entity provid+ ph>macy b5efit managem5t s]vices2 & 7iii7 a li/ ( all drugs disp5s$ by su* :olly or p>tially-own$ ph>macy & *>g$ to ! plan or cov]age1 or p>ticipants & b5efici>ies ( ! plan or cov]age1 dur+ ! applicable qu>t]1 &1 ) respect to ea* drug-- 7,i7 ! am\nts *>g$1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 ) respect to p>ticipants & b5efici>ies 9 ! plan or cov]age1 includ+ am\nts *>g$ to ! plan or cov]age & am\nts *>g$ to ! p>ticipants & b5efici>ies2 7,,ii7 ! m$ian am\nt *>g$ to ! plan or cov]age1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n :olly or p>tially-own$ by ! issu] or entity & t are includ$ 9 ! ph>macy network ( t plan or cov]age2 7,,iii7 ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n :olly or p>tially-own$ by ! issu] or entity & t are includ$ 9 ! ph>macy network ( t plan or cov]age2 7,,iv7 ! l[e/ co/1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan or issu] & p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( ! plan or cov]age2 7,v7 ! net acquisition co/ p] dosage unit & = a #cj day-supply1 & ! acquisition co/ p] typical c\rse ( treatm5t1 if ! drug is subject to a maximum price disc\nt2 & 7,,vi7 o!r in=mation ) respect to ! co/ ( ! drug1 z det]m9$ by ! ,secret>y1 su* z av]age sales price1 :olesale acquisition co/1 & national av]age drug acquisition co/ p] dosage unit1 p] typical c\rse ( treatm5t1 or p] #cj-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan or issu] & p>ticipants & b5efici>ies among all ph>macies includ$ 9 ! network ( ! plan or cov]age4 7,b7 ,plans & cov]age (f]$ by small employ]s ,a heal? insurance issu] (f]+ cov]$ gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices "u a gr\p heal? plan t is n a cov]$ gr\p heal? plan or "u gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance cov]age t conducts transactions ) a :olly or p>tially-own$ ph>macy %all submit1 toge!r ) ! report "u p>agraph 7#a71 a supplem5t>y report e #f mon?s to ! plan sponsor t includes ! in=mation describ$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a74 7#c7 ,privacy requirem5ts 7,a7 ,relation%ip to ,,hipaa regulations ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! privacy1 security1 brea* notification1 & en=cem5t regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,b7 ,requirem5t ,a report submitt$ "u p>agraph 7#a7 or 7#b7 %all conta9 only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,c7 ,cl>ification reg>d+ c]ta9 disclosures ( in=mation 7i7 ,reasonable re/rictions ,no?+ 9 ?is section prev5ts a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or gr\p heal? insurance cov]age f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report "u p>agraph 7#a7 or 7#b74 7ii7 ,limitations ,a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or gr\p heal? insurance cov]age may n re/rict disclosure ( su* reports to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or any o!r ,f$]al ag5cy responsible = en=cem5t activities "u ?is section = purposes ( en=cem5t "u ?is section or o!r applicable law1 or to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 9 accordance ) p>agraph 7#f74 7#d7 ,use & disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may n-- 7i7 fail or refuse to hire1 or dis*>ge1 any employee1 or o!rwise discrim9ate aga9/ any employee ) respect to ! comp5sation1 t]ms1 conditions1 or privileges ( employm5t ( ! employee1 because ( in=mation submitt$ "u p>agraph 7#a7 or 7#b7 attribut$ to ! employee or a dep5d5t ( ! employee2 or 7ii7 limit1 segregate1 or classify ! employees ( ! employ] 9 any way t w\ld deprive or t5d to deprive any employee ( employm5t opportunities or o!rwise adv]sely affect ! /atus ( ! employee z an employee1 because ( in=mation submitt$ "u p>agraph 7#a7 or 7#b7 attribut$ to ! employee or a dep5d5t ( ! employee4 7,b7 ,disclosure & r$isclosure ,a plan sponsor %all n disclose ! in=mation receiv$ "u p>agraph 7#a7 or 7#b7 except-- 7i7 to an occupational or o!r heal? rese>*] if ! rese>* is conduct$ 9 compliance ) ! regulations & protections provid$ = "u "p #df ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations72 7ii7 9 response to an ord] ( a c\rt1 except t ! plan sponsor may disclose only ! in=mation expressly au?oriz$ by su* ord]2 7iii7 to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or o!r ,f$]al ag5cy responsible = en=cem5t activities "u ?is section2 or 7iv7 to a contractor or ag5t = purposes ( heal? plan adm9i/ration1 if su* contractor or ag5t agrees1 9 writ+1 to abide by ! same use & disclosure re/rictions z ! plan sponsor4 7,c7 ,relation%ip to ,,hipaa regulations ,) respect to ! regulations promulgat$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u "p ,c ( title ,,xi ( ! ,social ,security ,act & section #bfd ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 subp>agraph 7,b7 does n prohibit a cov]$ entity 7z def9$ = purposes ( su* regulations7 f any use or disclosure ( heal? in=mation t is au?oriz$ = ! cov]$ entity "u su* regulations4 ,! previ\s s5t5ce does n affect ! au?ority ( su* ,secret>y to modify su* regulations4 7,d7 ,en=cem5t 7i7 ,9 g5]al ,! p[]s1 proc$ures1 & rem$ies provid$ 9 section #bjg ( ! ,g5etic ,in=mation ,nondiscrim9ation ,act to a p]son alleg+ a violation ( title ,,ii ( su* ,act %all be ! p[]s1 proc$ures1 & rem$ies ?is subp>agraph provides = any p]son alleg+ a violation ( ?is p>agraph4 7ii7 ,prohibition aga9/ retaliation ,no p]son %all discrim9ate aga9/ any individual because su* individual has oppos$ any act or practice made unlawful by ?is p>agraph or because su* individual made a *>ge1 te/ifi$1 assi/$1 or p>ticipat$ 9 any mann] 9 an inve/igation1 proce$+1 or he>+ "u ?is p>agraph4 ,! rem$ies & proc$ures o!rwise provid$ = "u ?is subp>agraph %all be available to aggriev$ individuals ) respect to violations ( ?is clause4 7#e7 ,additional report+ 7,a7 ,report+ ) respect to gr\p heal? plans (f]$ by small employ]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan t is n a cov]$ gr\p heal? plan %all submit to ! plan sponsor ( su* gr\p heal? plan a report 9 accordance ) ?is p>agraph1 & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat1 & su* o!r =mats z ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury may det]m9e4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan1 ! in=mation describ$ 9 subp>agraphs 7,a71 7,d71 7,e71 7,f71 7,g71 & 7,h7 ( p>agraph 7#a74 7,b7 ,opt-9 = gr\p heal? insurance cov]age 7i7 ,9 g5]al ,a plan sponsor may1 on an annual basis1 beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 elect to require a heal? insurance issu] (f]+ gr\p heal? insurance cov]age to submit to su* plan sponsor a report 9 accordance ) ?is subsection4 7ii7 ,cont5ts ( reports 7,i7 ,cov]$ gr\p heal? insurance cov]age ,9 ! case ( an issu] t (f]s cov]$ gr\p heal? insurance cov]age1 a report provid$ pursuant to clause 7i7 %all include1 ) respect to ! applicable cov]$ gr\p heal? insurance cov]age1 ! in=mation requir$ "u p>agraph 7#a7 = cov]$ gr\p heal? plans4 7,,ii7 ,o!r gr\p heal? insurance cov]age ,9 ! case ( an issu] t (f]s gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance1 a report provid$ pursuant to clause 7i7 %all include1 ) respect to ! applicable gr\p heal? insurance cov]age1 ! in=mation describ$ 9 subp>agraphs 7,a71 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a74 7iii7 ,application ,= purposes ( reports submitt$ 9 accordance ) ?is subp>agraph1 p>agraph 7#a7 %all be appli$ by sub/itut+ gr\p heal? insurance cov]age or heal? insurance issu]1 z applicable1 = gr\p heal? plan1 gr\p plan1 & plan :]e su* t]ms appe> 9 su* p>agraph4 7iv7 ,requir$ report+ = all gr\p heal? insurance cov]age ,ea* heal? insurance issu] ( heal? insurance cov]age %all annually submit ! in=mation describ$ 9 p>agraph 7#a77;,h71 reg>dless ( :e!r ! plan sponsor made ! election describ$ 9 clause 7i7 = ! applicable ye>4 7#f7 ,submissions to ,,gao ,a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan %all submit to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #b reports submitt$ to a plan sponsor "u p>agraph 7#a7 or 7#e7 ) respect to su* cov]age or plan1 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#c71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #b7;f7 ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 7#g7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbd1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all specify1 ?r\gh rulemak+1 /&>d =mats = heal? insurance issu]s & entities provid+ ph>macy b5efit managem5t s]vices to submit reports requir$ "u ?is subsection4 7,b7 ,limit$ =m ( report ,! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all def9e ?r\gh rulemak+ a limit$ =m ( ! reports "u p>agraphs 7#a7 & 7#b7 requir$ to be submitt$ to plan sponsors :o also are drug manufactur]s1 drug :olesal]s1 entities provid+ ph>macy b5efit managem5t s]vices1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n *>ge p>ticipants & b5efici>ies1 & an entity provid+ ph>macy b5efit managem5t s]vices "u su* a plan or cov]age %all n *>ge ! plan1 issu]1 or p>ticipants & b5efici>ies1 a price = a prescription drug t exce$s ! price paid to ! ph>macy = su* drug1 exclud+ p5alties paid by ! ph>macy 7z describ$ 9 p>agraph 7#b77 to su* plan1 issu]1 or entity4 7#b7 ,rule ( con/ruction ,= purposes ( p>agraph 7#a71 p5alties paid by ph>macies include only ! foll[+3 7,a7 ,a p5alty paid if an orig9al claim = a prescription drug 0 submitt$ fraudul5tly by ! ph>macy to ! plan1 issu]1 or entity4 7,b7 ,a p5alty paid if ! orig9al claim paym5t made by ! plan1 issu]1 or entity to ! ph>macy 0 inconsi/5t ) ! reimbursem5t t]ms 9 any contract betwe5 ! ph>macy & ! plan1 issu]1 or entity4 7,c7 ,a p5alty paid if ! ph>maci/ s]vices bill$ to ! plan1 issu]1 or entity 7 n r5d]$ by ! ph>macy4 7d7 ,full rebate pass-,?r\gh to plan 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all-- 7,a7 remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f any applicable entity t are relat$ to utilization ( drugs "u su* heal? plan or heal? insurance cov]age1 to ! gr\p heal? plan2 & 7,b7 ensure t any contract ent]$ into by su* ?ird-p>ty adm9i/rator1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices ) an applicable entity remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ to ! ?ird-p>ty adm9i/rator1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,=m & mann] ( remittance ,su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be-- 7,a7 remitt$ to ! gr\p heal? plan or gr\p heal? insurance cov]age 9 a timely fa%ion aft] ! p]iod = :i* su* rebates1 fees1 alt]native disc\nts1 or o!r remun]ation is calculat$1 & 9 no case lat] ?an #ij days aft] ! end ( su* p]iod2 7,b7 fully disclos$ & enum]at$ to ! gr\p heal? plan sponsor1 z describ$ 9 p>agraphs 7#a7 & 7#d7 ( subsection 7b72 7,c7 available = audit by ! plan sponsor1 or a ?ird-p>ty designat$ by a plan sponsor n less ?an once p] plan ye>2 & 7,d7 return$ to ! issu] or entity provid+ ph>maceutical b5efit managem5t s]vices by ! gr\p heal? plan if audits by su* issu] or entity indicate t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan4 7#c7 ,audit ( rebate contracts ,a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by su* plan sponsor or designat$ ?ird-p>ty1 subject to confid5tiality agreem5ts to prev5t re-disclosure ( su* contracts4 7#d7 ,auditors ,! applicable plan sponsor may select an auditor = purposes ( c>ry+ out audits "u p>agraphs 7#b77;,c7 & 7#c74 7#e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to prohibit paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n contemplat$ by ?is subsection1 provid$ t su* fees are transp>5t to gr\p heal? plans & heal? insurance issu]s4 7e7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 %all en=ce ?is section4 7#b7 ,failure to provide timely in=mation ,a heal? insurance issu] or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7a7 or fails to provide in=mation requir$ "u subsection 7b72 a gr\p heal? plan1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7c72 or a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7d7 %all be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7#c7 ,false in=mation ,a heal? insurance issu]1 entity provid+ ph>macy b5efit managem5t s]vices1 or drug manufactur] t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7#d7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#e7 ,waiv]s ,! ,secret>y may waive p5alties "u p>agraph 7#b71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( ?is section t has made a good-fai? ef=t to comply ) ?is section4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a heal? insurance issu]1 gr\p heal? plan1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,dep>tm5t ( ,heal? & ,human ,s]vices to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsection 7a7 by su* issu]1 plan1 or entity4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m applicable entity means-- 7,a7 a drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 gr\p pur*as+ organization1 or associat$ ?ird p>ty2 7,b7 any subsidi>y1 p>5t1 affiliate1 or subcontractor ( a gr\p heal? plan1 heal? insurance issu]1 entity t provides ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or any entity describ$ 9 subp>agraph 7,a72 or 7,c7 su* o!r entity z ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury may specify ?r\gh rulemak+2 7#b7 ! t]m cov]$ gr\p heal? insurance cov]age means heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#c7 ! t]m cov]$ gr\p heal? plan means a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#d7 ! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( manufactur] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#e7 ! t]m l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 7#f7 ! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( manufactur] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#g7 ! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd2 7#h7 ! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 ?r\gh notice & comm5t rulemak+2 7#i7 ! t]m small employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #a b n m ?an #di employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 & 7#aj7 ! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 2 & 7#b7 9 section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7ii7 9 p>agraph 7#b71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 7ii7 9 p>agraph 7#b77;,a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7iii7 9 p>agraph 7#b77;,c77ii71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d4 7b7 ,,erisa 7#a7 ,9 g5]al ,subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is am5d$-- 7,a7 9 subp>t ,b ( "p #g 7#bi ,u4,s4,c4 #aahe et seq471 by add+ at ! end ! foll[+3 #gbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a gr\p heal? plan 7or heal? insurance issu] (f]+ gr\p heal? insurance cov]age 9 connection ) su* a plan7 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] %all n ent] into a contract ) an applicable entity t limits ! disclosure ( in=mation to plan sponsors 9 su* a mann] t prev5ts ! plan or issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan or issu]1 f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a cov]$ gr\p heal? plan %all submit to ! plan sponsor ( su* cov]$ gr\p heal? plan a report 9 accordance ) ?is subsection & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat &1 z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include1 ) respect to ! cov]$ gr\p heal? plan-- 7,a7 z applicable1 in=mation collect$ f drug manufactur]s by su* issu] or entity on ! total am\nt ( copaym5t assi/ance doll>s paid1 or copaym5t c>ds appli$1 t 7 fund$ by ! drug manufactur] ) respect to ! p>ticipants & b5efici>ies 9 su* plan2 7,b7 a li/ ( ea* drug cov]$ by su* plan or entity provid+ ph>macy b5efit managem5t s]vices t 0 bill$ dur+ ! report+ p]iod1 includ+1 ) respect to ea* su* drug dur+ ! report+ p]iod-- 7i7 ! br& "n1 g5]ic or nonpropriet>y "n1 & ,national ,drug ,code2 7ii7 ! numb] ( p>ticipants & b5efici>ies = :om ! drug 0 bill$ dur+ ! report+ p]iod1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug disp5s$ across ! report+ p]iod2 7iii7 = ea* claim or dosage unit describ$ 9 clause 7ii71 ! type ( disp5s+ *annel us$1 su* z retail1 mail ord]1 or specialty ph>macy2 7iv7 ! :olesale acquisition co/1 li/$ z co/ p] days supply1 co/ p] dosage unit1 & co/ p] typical c\rse ( treatm5t 7z applicable72 7v7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug aft] application ( any b5efits "u ! plan or cov]age1 includ+ p>ticipant & b5efici>y sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ to ! plan or cov]age2 & 7vi7 = any drug = :i* gross sp5d+ by ! plan exce$$ #aj1jjj & t is "o ( ! #ej prescription drugs = :i* ! gr\p heal? plan sp5t ! mo/ on prescription drug b5efits dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class1 includ+ br& "n drugs & biological products & g5]ic drugs or biosimil> biological products t are 9 ! same !rapeutic class z su* drug2 & 7,,ii7 if applicable1 ! rationale = pref]r$ =mul>y placem5t ( su* drug 9 t !rapeutic class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y2 7,c7 a li/ ( ea* !rapeutic class ( drugs t 7 disp5s$ "u ! heal? plan dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan1 be=e rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7ii7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 t class2 7iii7 if applicable to t class1 a description ( ! =mul>y ti]s & utilization managem5t me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 7iv7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies1 includ+ p>ticipant & b5efici>y sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 & 7v7 = ea* !rapeutic class "u :i* #c or m drugs are includ$ on ! =mul>y ( su* plan-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 by su* entity1 f an applicable entity1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation t-- 7aa7 has be5 paid1 or w be paid1 by su* an applicable entity = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 is relat$ to utilization ( drugs or drug sp5d+2 7,,ii7 ! total net sp5d+ by ! heal? plan on t class ( drugs2 & 7,,iii7 ! net price p] typical c\rse ( treatm5t or #cj-;day supply incurr$ by ! heal? plan & its p>ticipants & b5efici>ies1 aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation provid$ by an applicable entity1 = drugs disp5s$ )9 su* !rapeutic class dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan dur+ ! report+ p]iod1 be=e rebates1 fees1 alt]native disc\nts1 or o!r remun]ation provid$ by an applicable entity2 7,e7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! heal? plan1 f an applicable entity1 9 rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f any su* entities1 relat$ to utilization ( drug or drug sp5d+ "u t heal? plan dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! heal? plan dur+ ! report+ p]iod2 7,g7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa77 to brok]s1 consultants1 advisors1 or any o!r individual or firm :o ref]r$ ! gr\p heal? plan's bus9ess to ! ph>macy b5efit manag]2 & 7,h7 a summ>y docum5t t includes su* in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,g7 z ! ,secret>y det]m9es useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to plan sponsor & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y4 7#b7 ,supplem5t>y report+ = intra-company prescription drug transactions 7,a7 ,9 g5]al ,a heal? insurance issu] (f]+ cov]$ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices "u a cov]$ gr\p heal? plan or cov]$ gr\p heal? insurance cov]age %all submit1 toge!r ) ! report "u p>agraph 7#a71 a supplem5t>y report e #f mon?s to ! plan sponsor t includes-- 7i7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 ! plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by t issu] or entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & copaym5t inc5tives fund$ by an entity provid+ ph>macy b5efit managem5t s]vices2 7ii7 ! p]c5tage ( total prescriptions *>g$ to ! plan1 cov]age1 or p>ticipants & b5efici>ies 9 ! plan or cov]age1 t 7 disp5s$ by mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by ! issu] or entity provid+ ph>macy b5efit managem5t s]vices2 & 7iii7 a li/ ( all drugs disp5s$ by su* :olly or p>tially-own$ ph>macy & *>g$ to ! plan or cov]age1 or p>ticipants & b5efici>ies ( ! plan or cov]age1 dur+ ! applicable qu>t]1 &1 ) respect to ea* drug-- 7,i7 ! am\nts *>g$1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 ) respect to p>ticipants & b5efici>ies 9 ! plan or cov]age1 includ+ am\nts *>g$ to ! plan or cov]age & am\nts *>g$ to ! p>ticipants & b5efici>ies2 7,,ii7 ! m$ian am\nt *>g$ to ! plan or cov]age1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n :olly or p>tially-own$ by ! issu] or entity & t are includ$ 9 ! ph>macy network ( t plan or cov]age2 7,,iii7 ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n :olly or p>tially-own$ by ! issu] or entity & t are includ$ 9 ! ph>macy network ( t plan or cov]age2 7,,iv7 ! l[e/ co/1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan or issu] & p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( ! plan or cov]age2 7,v7 ! net acquisition co/ p] dosage unit & = a #cj day-supply1 & ! acquisition co/ p] typical c\rse ( treatm5t1 if ! drug is subject to a maximum price disc\nt2 & 7,,vi7 o!r in=mation ) respect to ! co/ ( ! drug1 z det]m9$ by ! ,secret>y1 su* z av]age sales price1 :olesale acquisition co/1 & national av]age drug acquisition co/ p] dosage unit1 p] typical c\rse ( treatm5t1 or p] #cj-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan or issu] & p>ticipants & b5efici>ies among all ph>macies includ$ 9 ! network ( ! plan or cov]age4 7,b7 ,plans & cov]age (f]$ by small employ]s ,a heal? insurance issu] (f]+ cov]$ gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices "u a gr\p heal? plan t is n a cov]$ gr\p heal? plan or "u gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance cov]age t conducts transactions ) a :olly or p>tially-own$ ph>macy %all submit1 toge!r ) ! report "u p>agraph 7#a71 a supplem5t>y report e #f mon?s to ! plan sponsor t includes ! in=mation describ$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a74 7#c7 ,privacy requirem5ts 7,a7 ,relation%ip to ,,hipaa regulations ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! privacy1 security1 brea* notification1 & en=cem5t regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,b7 ,requirem5t ,a report submitt$ "u p>agraph 7#a7 or 7#b7 %all conta9 only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,c7 ,cl>ification reg>d+ c]ta9 disclosures ( in=mation 7i7 ,reasonable re/rictions ,no?+ 9 ?is section prev5ts a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or gr\p heal? insurance cov]age f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report "u p>agraph 7#a7 or 7#b74 7ii7 ,limitations ,a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or gr\p heal? insurance cov]age may n re/rict disclosure ( su* reports to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or any o!r ,f$]al ag5cy responsible = en=cem5t activities "u ?is section = purposes ( en=cem5t "u ?is section or o!r applicable law1 or to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 9 accordance ) p>agraph 7#f74 7#d7 ,use & disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may n-- 7i7 fail or refuse to hire1 or dis*>ge1 any employee1 or o!rwise discrim9ate aga9/ any employee ) respect to ! comp5sation1 t]ms1 conditions1 or privileges ( employm5t ( ! employee1 because ( in=mation submitt$ "u p>agraph 7#a7 or 7#b7 attribut$ to ! employee or a dep5d5t ( ! employee2 or 7ii7 limit1 segregate1 or classify ! employees ( ! employ] 9 any way t w\ld deprive or t5d to deprive any employee ( employm5t opportunities or o!rwise adv]sely affect ! /atus ( ! employee z an employee1 because ( in=mation submitt$ "u p>agraph 7#a7 or 7#b7 attribut$ to ! employee or a dep5d5t ( ! employee4 7,b7 ,disclosure & r$isclosure ,a plan sponsor %all n disclose ! in=mation receiv$ "u p>agraph 7#a7 or 7#b7 except-- 7i7 to an occupational or o!r heal? rese>*] if ! rese>* is conduct$ 9 compliance ) ! regulations & protections provid$ = "u "p #df ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations72 7ii7 9 response to an ord] ( a c\rt1 except t ! plan sponsor may disclose only ! in=mation expressly au?oriz$ by su* ord]2 7iii7 to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or o!r ,f$]al ag5cy responsible = en=cem5t activities "u ?is section2 or 7iv7 to a contractor or ag5t = purposes ( heal? plan adm9i/ration1 if su* contractor or ag5t agrees1 9 writ+1 to abide by ! same use & disclosure re/rictions z ! plan sponsor4 7,c7 ,relation%ip to ,,hipaa regulations ,) respect to ! regulations promulgat$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u "p ,c ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq47 & section #bfd ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b71 subp>agraph 7,b7 does n prohibit a cov]$ entity 7z def9$ = purposes ( su* regulations7 f any use or disclosure ( heal? in=mation t is au?oriz$ = ! cov]$ entity "u su* regulations4 ,! previ\s s5t5ce does n affect ! au?ority ( su* ,secret>y to modify su* regulations4 7,d7 ,en=cem5t 7i7 ,9 g5]al ,! p[]s1 proc$ures1 & rem$ies provid$ 9 section #bjg ( ! ,g5etic ,in=mation ,nondiscrim9ation ,act 7#db ,u4,s4,c4 #bjjj;ff-#f7 to a p]son alleg+ a violation ( title ,,ii ( su* ,act %all be ! p[]s1 proc$ures1 & rem$ies ?is subp>agraph provides = any p]son alleg+ a violation ( ?is p>agraph4 7ii7 ,prohibition aga9/ retaliation ,no p]son %all discrim9ate aga9/ any individual because su* individual has oppos$ any act or practice made unlawful by ?is p>agraph or because su* individual made a *>ge1 te/ifi$1 assi/$1 or p>ticipat$ 9 any mann] 9 an inve/igation1 proce$+1 or he>+ "u ?is p>agraph4 ,! rem$ies & proc$ures o!rwise provid$ = "u ?is subp>agraph %all be available to aggriev$ individuals ) respect to violations ( ?is clause4 7#e7 ,additional report+ 7,a7 ,report+ ) respect to gr\p heal? plans (f]$ by small employ]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan t is n a cov]$ gr\p heal? plan %all submit to ! plan sponsor ( su* gr\p heal? plan a report 9 accordance ) ?is p>agraph1 & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat1 & su* o!r =mats z ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor may det]m9e4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan1 ! in=mation describ$ 9 subp>agraphs 7,a71 7,d71 7,e71 7,f71 7,g71 & 7,h7 ( p>agraph 7#a74 7,b7 ,opt-9 = gr\p heal? insurance cov]age 7i7 ,9 g5]al ,a plan sponsor may1 on an annual basis1 beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 elect to require a heal? insurance issu] (f]+ gr\p heal? insurance cov]age to submit to su* plan sponsor a report 9 accordance ) ?is subsection4 7ii7 ,cont5ts ( reports 7,i7 ,cov]$ gr\p heal? insurance cov]age ,9 ! case ( an issu] t (f]s cov]$ gr\p heal? insurance cov]age1 a report provid$ pursuant to clause 7i7 %all include1 ) respect to ! applicable cov]$ gr\p heal? insurance cov]age1 ! in=mation requir$ "u p>agraph 7#a7 = cov]$ gr\p heal? plans4 7,,ii7 ,o!r gr\p heal? insurance cov]age ,9 ! case ( an issu] t (f]s gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance1 a report provid$ pursuant to clause 7i7 %all include1 ) respect to ! applicable gr\p heal? insurance cov]age1 ! in=mation describ$ 9 subp>agraphs 7,a71 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a74 7iii7 ,application ,= purposes ( reports submitt$ 9 accordance ) ?is subp>agraph1 p>agraph 7#a7 %all be appli$ by sub/itut+ gr\p heal? insurance cov]age or heal? insurance issu]1 z applicable1 = gr\p heal? plan1 gr\p plan1 & plan :]e su* t]ms appe> 9 su* p>agraph4 7iv7 ,requir$ report+ = all gr\p heal? insurance cov]age ,ea* heal? insurance issu] ( heal? insurance cov]age %all annually submit ! in=mation describ$ 9 p>agraph 7#a77;,h71 reg>dless ( :e!r ! plan sponsor made ! election describ$ 9 clause 7i7 = ! applicable ye>4 7#f7 ,submissions to ,,gao ,a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan %all submit to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #b reports submitt$ to a plan sponsor "u p>agraph 7#a7 or 7#e7 ) respect to su* cov]age or plan1 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#c71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #b7;f7 ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 7#g7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbd1 ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all specify1 ?r\gh rulemak+1 /&>d =mats = heal? insurance issu]s & entities provid+ ph>macy b5efit managem5t s]vices to submit reports requir$ "u ?is subsection4 7,b7 ,limit$ =m ( report ,! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all def9e ?r\gh rulemak+ a limit$ =m ( ! reports "u p>agraphs 7#a7 & 7#b7 requir$ to be submitt$ to plan sponsors :o also are drug manufactur]s1 drug :olesal]s1 entities provid+ ph>macy b5efit managem5t s]vices1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all n *>ge p>ticipants & b5efici>ies1 & an entity provid+ ph>macy b5efit managem5t s]vices "u su* a plan or cov]age %all n *>ge ! plan1 issu]1 or p>ticipants & b5efici>ies1 a price = a prescription drug t exce$s ! price paid to ! ph>macy = su* drug1 exclud+ p5alties paid by ! ph>macy 7z describ$ 9 p>agraph 7#b77 to su* plan1 issu]1 or entity4 7#b7 ,rule ( con/ruction ,= purposes ( p>agraph 7#a71 p5alties paid by ph>macies include only ! foll[+3 7,a7 ,a p5alty paid if an orig9al claim = a prescription drug 0 submitt$ fraudul5tly by ! ph>macy to ! plan1 issu]1 or entity4 7,b7 ,a p5alty paid if ! orig9al claim paym5t made by ! plan1 issu]1 or entity to ! ph>macy 0 inconsi/5t ) ! reimbursem5t t]ms 9 any contract betwe5 ! ph>macy & ! plan1 issu]1 or entity4 7,c7 ,a p5alty paid if ! ph>maci/ s]vices bill$ to ! plan1 issu]1 or entity 7 n r5d]$ by ! ph>macy4 7d7 ,full rebate pass-,?r\gh to plan 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all-- 7,a7 remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r applicable remun]ation receiv$ f any applicable entity t are relat$ to utilization ( drugs "u su* heal? plan or heal? insurance cov]age1 to ! gr\p heal? plan2 & 7,b7 ensure t any contract ent]$ into by su* ?ird-p>ty adm9i/rator1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices ) an applicable entity remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ to ! ?ird-p>ty adm9i/rator1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,=m & mann] ( remittance ,su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be-- 7,a7 remitt$ to ! gr\p heal? plan or gr\p heal? insurance cov]age 9 a timely fa%ion aft] ! p]iod = :i* su* rebates1 fees1 alt]native disc\nts1 or o!r remun]ation is calculat$1 & 9 no case lat] ?an #ij days aft] ! end ( su* p]iod2 7,b7 fully disclos$ & enum]at$ to ! gr\p heal? plan sponsor1 z describ$ 9 p>agraphs 7#a7 & 7#d7 ( subsection 7b72 7,c7 available = audit by ! plan sponsor1 or a ?ird-p>ty designat$ by a plan sponsor n less ?an once p] plan ye>2 & 7,d7 return$ to ! issu] or entity provid+ ph>maceutical b5efit managem5t s]vices by ! gr\p heal? plan if audits by su* issu] or entity indicate t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan4 7#c7 ,audit ( rebate contracts ,a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by su* plan sponsor or designat$ ?ird-p>ty1 subject to confid5tiality agreem5ts to prev5t re-disclosure ( su* contracts4 7#d7 ,auditors ,! applicable plan sponsor may select an auditor = purposes ( c>ry+ out audits "u p>agraphs 7#b77;,c7 & 7#c74 7#e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to prohibit paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n contemplat$ by ?is subsection1 provid$ t su* fees are transp>5t to gr\p heal? plans & heal? insurance issu]s4 7e7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 %all en=ce ?is section4 7#b7 ,failure to provide timely in=mation ,a heal? insurance issu] or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7a7 or fails to provide in=mation requir$ "u subsection 7b72 a gr\p heal? plan1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7c72 or a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7d7 %all be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7#c7 ,false in=mation ,a heal? insurance issu]1 entity provid+ ph>macy b5efit managem5t s]vices1 or drug manufactur] t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7#d7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#e7 ,waiv]s ,! ,secret>y may waive p5alties "u p>agraph 7#b71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( ?is section t has made a good-fai? ef=t to comply ) ?is section4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a heal? insurance issu]1 gr\p heal? plan1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,dep>tm5t ( ,labor to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsection 7a7 by su* issu]1 plan1 or entity4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m applicable entity means-- 7,a7 a drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 gr\p pur*as+ organization1 or associat$ ?ird p>ty2 7,b7 any subsidi>y1 p>5t1 affiliate1 or subcontractor ( a gr\p heal? plan1 heal? insurance issu]1 entity t provides ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or any entity describ$ 9 subp>agraph 7,a72 or 7,c7 su* o!r entity z ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury may specify ?r\gh rulemak+2 7#b7 ! t]m cov]$ gr\p heal? insurance cov]age means heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#c7 ! t]m cov]$ gr\p heal? plan means a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#d7 ! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( manufactur] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#e7 ! t]m l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 7#f7 ! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( manufactur] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#g7 ! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b72 7#h7 ! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury1 ?r\gh notice & comm5t rulemak+2 7#i7 ! t]m small employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #a b n m ?an #di employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 & 7#aj7 ! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 & 7,b7 9 section #ejb7;b77#c7 7#bi ,u4,s4,c4 #aacb7;b77#c771 by ins]t+ 7o!r ?an section #gbf7 aft] "p #g4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is am5d$ by ins]t+ aft] ! item relat+ to section #gbe ! foll[+ new item3 ,sec4 #gbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices4 4 7c7 ,int]nal ,rev5ue ,code 7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+3 #ihbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan %all n ent] into a contract ) an applicable entity t limits ! disclosure ( in=mation to plan sponsors 9 su* a mann] t prev5ts ! plan1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan1 f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a cov]$ gr\p heal? plan %all submit to ! plan sponsor ( su* cov]$ gr\p heal? plan a report 9 accordance ) ?is subsection & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat &1 z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include1 ) respect to ! cov]$ gr\p heal? plan-- 7,a7 z applicable1 in=mation collect$ f drug manufactur]s by su* entity on ! total am\nt ( copaym5t assi/ance doll>s paid1 or copaym5t c>ds appli$1 t 7 fund$ by ! drug manufactur] ) respect to ! p>ticipants & b5efici>ies 9 su* plan2 7,b7 a li/ ( ea* drug cov]$ by su* plan or entity provid+ ph>macy b5efit managem5t s]vices t 0 bill$ dur+ ! report+ p]iod1 includ+1 ) respect to ea* su* drug dur+ ! report+ p]iod-- 7i7 ! br& "n1 g5]ic or nonpropriet>y "n1 & ,national ,drug ,code2 7ii7 ! numb] ( p>ticipants & b5efici>ies = :om ! drug 0 bill$ dur+ ! report+ p]iod1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug disp5s$ across ! report+ p]iod2 7iii7 = ea* claim or dosage unit describ$ 9 clause 7ii71 ! type ( disp5s+ *annel us$1 su* z retail1 mail ord]1 or specialty ph>macy2 7iv7 ! :olesale acquisition co/1 li/$ z co/ p] days supply1 co/ p] dosage unit1 & co/ p] typical c\rse ( treatm5t 7z applicable72 7v7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug aft] application ( any b5efits "u ! plan1 includ+ p>ticipant & b5efici>y sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or = :i* no claim is submitt$ to ! plan2 & 7vi7 = any drug = :i* gross sp5d+ by ! plan exce$$ #aj1jjj & t is "o ( ! #ej prescription drugs = :i* ! gr\p heal? plan sp5t ! mo/ on prescription drug b5efits dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class1 includ+ br& "n drugs & biological products & g5]ic drugs or biosimil> biological products t are 9 ! same !rapeutic class z su* drug2 & 7,,ii7 if applicable1 ! rationale = pref]r$ =mul>y placem5t ( su* drug 9 t !rapeutic class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y2 7,c7 a li/ ( ea* !rapeutic class ( drugs t 7 disp5s$ "u ! heal? plan dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan1 be=e rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7ii7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 t class2 7iii7 if applicable to t class1 a description ( ! =mul>y ti]s & utilization managem5t me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 7iv7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies1 includ+ p>ticipant & b5efici>y sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 & 7v7 = ea* !rapeutic class "u :i* #c or m drugs are includ$ on ! =mul>y ( su* plan-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 by su* entity1 f an applicable entity1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation t-- 7aa7 has be5 paid1 or w be paid1 by su* an applicable entity = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 is relat$ to utilization ( drugs or drug sp5d+2 7,,ii7 ! total net sp5d+ by ! heal? plan on t class ( drugs2 & 7,,iii7 ! net price p] typical c\rse ( treatm5t or #cj-;day supply incurr$ by ! heal? plan & its p>ticipants & b5efici>ies1 aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation provid$ by an applicable entity1 = drugs disp5s$ )9 su* !rapeutic class dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan dur+ ! report+ p]iod1 be=e rebates1 fees1 alt]native disc\nts1 or o!r remun]ation provid$ by an applicable entity2 7,e7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! heal? plan1 f an applicable entity1 9 rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f any su* entities1 relat$ to utilization ( drug or drug sp5d+ "u t heal? plan dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! heal? plan dur+ ! report+ p]iod2 7,g7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77dd77,a777 to brok]s1 consultants1 advisors1 or any o!r individual or firm :o ref]r$ ! gr\p heal? plan's bus9ess to ! ph>macy b5efit manag]2 & 7,h7 a summ>y docum5t t includes su* in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,g7 z ! ,secret>y det]m9es useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to plan sponsor & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y4 7#b7 ,supplem5t>y report+ = intra-company prescription drug transactions 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices "u a cov]$ gr\p heal? plan %all submit1 toge!r ) ! report "u p>agraph 7#a71 a supplem5t>y report e #f mon?s to ! plan sponsor t includes-- 7i7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 ! plan to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by t entity provid+ ph>macy b5efit managem5t s]vices "u su* plan1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & copaym5t inc5tives fund$ by an entity provid+ ph>macy b5efit managem5t s]vices2 7ii7 ! p]c5tage ( total prescriptions *>g$ to ! plan or p>ticipants & b5efici>ies 9 ! plan1 t 7 disp5s$ by mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by ! entity provid+ ph>macy b5efit managem5t s]vices2 & 7iii7 a li/ ( all drugs disp5s$ by su* :olly or p>tially-own$ ph>macy & *>g$ to ! plan1 or p>ticipants & b5efici>ies ( ! plan1 dur+ ! applicable qu>t]1 &1 ) respect to ea* drug-- 7,i7 ! am\nts *>g$1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 ) respect to p>ticipants & b5efici>ies 9 ! plan1 includ+ am\nts *>g$ to ! plan & am\nts *>g$ to ! p>ticipants & b5efici>ies2 7,,ii7 ! m$ian am\nt *>g$ to ! plan1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n :olly or p>tially-own$ by ! entity & t are includ$ 9 ! ph>macy network ( t plan2 7,,iii7 ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n :olly or p>tially-own$ by ! entity & t are includ$ 9 ! ph>macy network ( t plan2 7,,iv7 ! l[e/ co/1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan & p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( ! plan2 7,v7 ! net acquisition co/ p] dosage unit & = a #cj day-supply1 & ! acquisition co/ p] typical c\rse ( treatm5t1 if ! drug is subject to a maximum price disc\nt2 & 7,,vi7 o!r in=mation ) respect to ! co/ ( ! drug1 z det]m9$ by ! ,secret>y1 su* z av]age sales price1 :olesale acquisition co/1 & national av]age drug acquisition co/ p] dosage unit1 p] typical c\rse ( treatm5t1 or p] #cj-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan & p>ticipants & b5efici>ies among all ph>macies includ$ 9 ! network ( ! plan4 7,b7 ,plans (f]$ by small employ]s ,an entity provid+ ph>macy b5efit managem5t s]vices "u a gr\p heal? plan t is n a cov]$ gr\p heal? plan t conducts transactions ) a :olly or p>tially-own$ ph>macy %all submit1 toge!r ) ! report "u p>agraph 7#a71 a supplem5t>y report e #f mon?s to ! plan sponsor t includes ! in=mation describ$ 9 clauses 7i7 & 7ii7 ( subp>agraph 7,a74 7#c7 ,privacy requirem5ts 7,a7 ,relation%ip to ,,hipaa regulations ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! privacy1 security1 brea* notification1 & en=cem5t regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,b7 ,requirem5t ,a report submitt$ "u p>agraph 7#a7 or 7#b7 %all conta9 only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,c7 ,cl>ification reg>d+ c]ta9 disclosures ( in=mation 7i7 ,reasonable re/rictions ,no?+ 9 ?is section prev5ts an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report "u p>agraph 7#a7 or 7#b74 7ii7 ,limitations ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or gr\p heal? insurance cov]age may n re/rict disclosure ( su* reports to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or any o!r ,f$]al ag5cy responsible = en=cem5t activities "u ?is section = purposes ( en=cem5t "u ?is section or o!r applicable law1 or to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 9 accordance ) p>agraph 7#f74 7#d7 ,use & disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may n-- 7i7 fail or refuse to hire1 or dis*>ge1 any employee1 or o!rwise discrim9ate aga9/ any employee ) respect to ! comp5sation1 t]ms1 conditions1 or privileges ( employm5t ( ! employee1 because ( in=mation submitt$ "u p>agraph 7#a7 or 7#b7 attribut$ to ! employee or a dep5d5t ( ! employee2 or 7ii7 limit1 segregate1 or classify ! employees ( ! employ] 9 any way t w\ld deprive or t5d to deprive any employee ( employm5t opportunities or o!rwise adv]sely affect ! /atus ( ! employee z an employee1 because ( in=mation submitt$ "u p>agraph 7#a7 or 7#b7 attribut$ to ! employee or a dep5d5t ( ! employee4 7,b7 ,disclosure & r$isclosure ,a plan sponsor %all n disclose ! in=mation receiv$ "u p>agraph 7#a7 or 7#b7 except-- 7i7 to an occupational or o!r heal? rese>*] if ! rese>* is conduct$ 9 compliance ) ! regulations & protections provid$ = "u "p #df ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations72 7ii7 9 response to an ord] ( a c\rt1 except t ! plan sponsor may disclose only ! in=mation expressly au?oriz$ by su* ord]2 7iii7 to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or o!r ,f$]al ag5cy responsible = en=cem5t activities "u ?is section2 or 7iv7 to a contractor or ag5t = purposes ( heal? plan adm9i/ration1 if su* contractor or ag5t agrees1 9 writ+1 to abide by ! same use & disclosure re/rictions z ! plan sponsor4 7,c7 ,relation%ip to ,,hipaa regulations ,) respect to ! regulations promulgat$ by ! ,secret>y ( ,heal? & ,human ,s]vices "u "p ,c ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq47 & section #bfd ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b71 subp>agraph 7,b7 does n prohibit a cov]$ entity 7z def9$ = purposes ( su* regulations7 f any use or disclosure ( heal? in=mation t is au?oriz$ = ! cov]$ entity "u su* regulations4 ,! previ\s s5t5ce does n affect ! au?ority ( su* ,secret>y to modify su* regulations4 7,d7 ,en=cem5t 7i7 ,9 g5]al ,! p[]s1 proc$ures1 & rem$ies provid$ 9 section #bjg ( ! ,g5etic ,in=mation ,nondiscrim9ation ,act 7#db ,u4,s4,c4 #bjjj;ff-#f7 to a p]son alleg+ a violation ( title ,,ii ( su* ,act %all be ! p[]s1 proc$ures1 & rem$ies ?is subp>agraph provides = any p]son alleg+ a violation ( ?is p>agraph4 7ii7 ,prohibition aga9/ retaliation ,no p]son %all discrim9ate aga9/ any individual because su* individual has oppos$ any act or practice made unlawful by ?is p>agraph or because su* individual made a *>ge1 te/ifi$1 assi/$1 or p>ticipat$ 9 any mann] 9 an inve/igation1 proce$+1 or he>+ "u ?is p>agraph4 ,! rem$ies & proc$ures o!rwise provid$ = "u ?is subp>agraph %all be available to aggriev$ individuals ) respect to violations ( ?is clause4 7#e7 ,report+ ) respect to gr\p heal? plans (f]$ by small employ]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan t is n a cov]$ gr\p heal? plan %all submit to ! plan sponsor ( su* gr\p heal? plan a report 9 accordance ) ?is p>agraph1 & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan1 ! in=mation describ$ 9 subp>agraphs 7,a71 7,d71 7,e71 7,f71 7,g71 & 7,h7 ( p>agraph 7#a74 7#f7 ,submissions to ,,gao ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan %all submit to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #b reports submitt$ to a plan sponsor "u p>agraph 7#a7 or 7#e7 ) respect to su* plan1 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#c71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #b7;f7 ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 7#g7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbd1 ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor %all specify1 ?r\gh rulemak+1 /&>d =mats = heal? insurance issu]s & entities provid+ ph>macy b5efit managem5t s]vices to submit reports requir$ "u ?is subsection4 7,b7 ,limit$ =m ( report ,! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor %all def9e ?r\gh rulemak+ a limit$ =m ( ! reports "u p>agraphs 7#a7 & 7#b7 requir$ to be submitt$ to plan sponsors :o also are drug manufactur]s1 drug :olesal]s1 entities provid+ ph>macy b5efit managem5t s]vices1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,9 g5]al ,a gr\p heal? plan %all n *>ge p>ticipants & b5efici>ies1 & an entity provid+ ph>macy b5efit managem5t s]vices "u su* a plan %all n *>ge ! plan or p>ticipants & b5efici>ies1 a price = a prescription drug t exce$s ! price paid to ! ph>macy = su* drug1 exclud+ p5alties paid by ! ph>macy 7z describ$ 9 p>agraph 7#b77 to su* plan or entity4 7#b7 ,rule ( con/ruction ,= purposes ( p>agraph 7#a71 p5alties paid by ph>macies include only ! foll[+3 7,a7 ,a p5alty paid if an orig9al claim = a prescription drug 0 submitt$ fraudul5tly by ! ph>macy to ! plan or entity4 7,b7 ,a p5alty paid if ! orig9al claim paym5t made by ! plan1 issu]1 or entity to ! ph>macy 0 inconsi/5t ) ! reimbursem5t t]ms 9 any contract betwe5 ! ph>macy & ! plan or entity4 7,c7 ,a p5alty paid if ! ph>maci/ s]vices bill$ to ! plan or entity 7 n r5d]$ by ! ph>macy4 7d7 ,full rebate pass-,?r\gh to plan 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices "u su* heal? plan %all-- 7,a7 remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f any applicable entity t are relat$ to utilization ( drugs "u su* heal? plan1 to ! gr\p heal? plan2 & 7,b7 ensure t any contract ent]$ into by su* ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices ) an applicable entity remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ to ! ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,=m & mann] ( remittance ,su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be-- 7,a7 remitt$ to ! gr\p heal? plan 9 a timely fa%ion aft] ! p]iod = :i* su* rebates1 fees1 alt]native disc\nts1 or o!r remun]ation is calculat$1 & 9 no case lat] ?an #ij days aft] ! end ( su* p]iod2 7,b7 fully disclos$ & enum]at$ to ! gr\p heal? plan sponsor1 z describ$ 9 p>agraphs 7#a7 & 7#d7 ( subsection 7b72 7,c7 available = audit by ! plan sponsor1 or a ?ird-p>ty designat$ by a plan sponsor n less ?an once p] plan ye>2 & 7,d7 return$ to ! issu] or entity provid+ ph>maceutical b5efit managem5t s]vices by ! gr\p heal? plan if audits by su* entity indicate t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan4 7#c7 ,audit ( rebate contracts ,a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices "u su* heal? plan %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by su* plan sponsor or designat$ ?ird-p>ty1 subject to confid5tiality agreem5ts to prev5t re-disclosure ( su* contracts4 7#d7 ,auditors ,! applicable plan sponsor may select an auditor = purposes ( c>ry+ out audits "u p>agraphs 7#b77;,c7 & 7#c74 7#e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to prohibit paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n contemplat$ by ?is subsection1 provid$ t su* fees are transp>5t to gr\p heal? plans4 7e7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor & ! ,secret>y ( ,heal? & ,human ,s]vices1 %all en=ce ?is section4 7#b7 ,failure to provide timely in=mation ,a heal? insurance issu] or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7a7 or fails to provide in=mation requir$ "u subsection 7b72 a gr\p heal? plan or entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7c72 or a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7d7 %all be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7#c7 ,false in=mation ,an entity provid+ ph>macy b5efit managem5t s]vices1 or drug manufactur] t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7#d7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#e7 ,waiv]s ,! ,secret>y may waive p5alties "u p>agraph 7#b71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( ?is section t has made a good-fai? ef=t to comply ) ?is section4 7f7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a gr\p heal? plan or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,dep>tm5t ( ! ,treasury to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsection 7a7 by su* plan or entity4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m applicable entity means-- 7,a7 a drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 gr\p pur*as+ organization1 or associat$ ?ird p>ty2 7,b7 any subsidi>y1 p>5t1 affiliate1 or subcontractor ( a gr\p heal? plan1 heal? insurance issu]1 entity t provides ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or any entity describ$ 9 subp>agraph 7,a72 or 7,c7 su* o!r entity z ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor may specify ?r\gh rulemak+2 7#b7 ! t]m cov]$ gr\p heal? insurance cov]age means heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#c7 ! t]m cov]$ gr\p heal? plan means a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#d7 ! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( manufactur] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#e7 ! t]m l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 7#f7 ! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( manufactur] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#g7 ! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b772 7#h7 ! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices1 ?r\gh notice & comm5t rulemak+2 7#i7 ! t]m small employ] means1 9 connection ) a gr\p heal? plan ) respect to a cal5d> ye> & a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #a b n m ?an #di employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 & 7#aj7 ! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices4 4 7d7 ,fund+ 7#a7 ,= purposes ( c>ry+ out ! am5dm5ts made by subsection 7a71 !re are appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #hj1jjj1jjj = fiscal ye> #bjbd4 7#b7 ,= purposes ( c>ry+ out ! am5dm5ts made by subsection 7b71 !re are appropriat$ to ! ,dep>tm5t ( ,labor1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #dc1gej1jjj = fiscal ye> #bjbd4 7e7 ,,aspe ,/udy ,! ,assi/ant ,secret>y = ,plann+ & ,evaluation ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct or commission a /udy on h[ ! ,unit$ ,/ates heal? c>e m>ket w\ld be impact$ by pot5tial regulatory *anges disall[+ manufactur] rebates 9 ! mann] & to ! ext5t all[$ on ! date ( enactm5t ( ?is ,act1 ) a focus on ! impact to /akehold]s 9 ! comm]cial insurance m>ket1 &1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 submit a report to ,congress on ! results ( su* /udy4 ,su* /udy & report %all consid] ! foll[+3 7#a7 ,! impact on ! impact ( mak+ no su* regulatory *anges1 z well z pot5tial behavioral *anges by plan sponsors1 memb]s1 & ph>maceutical manufactur]s1 su* z tight] =mul>ies1 *anges to price concessions1 *anges 9 utilization1 if su* regulatory *anges are made4 7#b7 ,! me*anics ne$$ 9 ! ph>maceutical supply *a9 7:e!r exi/+ or n7 to move a manufactur] rebate to ! po9t ( sale4 7#c7 ,! feasibility ( a p>tial po9t-(-sale manufactur] rebate v]sus a full po9t-(-sale manufactur] rebate4 7#d7 ,! impact on pati5t out-(-pocket co/s1 premiums1 & o!r co/-%>+4 7#e7 ,possible behavioral *anges by o!r ?ird p>ties 9 ! ph>maceutical supply *a9 includ+ drug manufactur]1 di/ributor1 :olesal]1 rebate aggregators1 ph>macy s]vices adm9i/rative organizations1 or gr\p pur*as+ organizations4 7#f7 ,behavioral *anges betwe5 entities t contract ) ph>maceutical manufactur]s & ph>maceutical supply *a94 7#g7 ,alt]native price negotiation me*anisms1 includ+ ! impact ( ! ,act ( ,june #ai1 #aicf 7commonly kn[n z ! ,rob9son-,patman ,act2 #di ,/at4 #aebf1 *apt] #eib2 #ae ,u4,s4,c4 #ac;a et seq471 & ! am5dm5ts made by t ,act1 on drug pric+ negotiations4 7#h7 ,! impact on ph>macies1 includ+ ph>macy rebates1 ph>macy fees1 & disp5s+ *annels4 7f7 ,,gao /udy 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbi1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all report to ,congress on-- 7,a7 ph>macy networks ( gr\p heal? plans1 heal? insurance issu]s1 & entities provid+ ph>macy b5efit managem5t s]vices "u su* gr\p heal? plan or gr\p or individual heal? insurance cov]age1 includ+ networks t h ph>macies t are "u common own]%ip 79 :ole or "p7 ) gr\p heal? plans1 heal? insurance issu]s1 or entities provid+ ph>macy b5efit managem5t s]vices or ph>macy b5efit adm9i/rative s]vices "u gr\p heal? plan or gr\p or individual heal? insurance cov]age2 7,b7 z x relates to ph>macy networks t include ph>macies "u common own]%ip describ$ 9 subp>agraph 7,a7-- 7i7 :e!r su* networks are design$ to enc\rage p>ticipants & b5efici>ies ( a plan or cov]age to use su* ph>macies ov] o!r network ph>macies = specific s]vices or drugs1 & if s1 ! reasons ! networks give = enc\rag+ use ( su* ph>macies2 & 7ii7 :e!r su* ph>macies are us$ by p>ticipants & b5efici>ies disproportionately m 9 ! aggregate or = specific s]vices or drugs comp>$ to o!r network ph>macies2 7,c7 :e!r gr\p heal? plans & heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age h options to elect diff]5t network pric+ arrangem5ts 9 ! m>ketplace ) entities t provide ph>macy b5efit managem5t s]vices1 ! preval5ce ( elect+ su* diff]5t network pric+ arrangem5ts2 7,d7 ph>macy network design p>amet]s t enc\rage p>ticipants & b5efici>ies 9 ! plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are :olly or p>tially-own$ by t issu] or entity2 & 7,e7 ! degree to :i* mail ord]1 specialty1 or retail ph>macies t disp5se prescription drugs to p>ticipants & b5efici>ies 9 a gr\p heal? plan or heal? insurance cov]age t are "u common own]%ip 79 :ole or "p7 ) gr\p heal? plans1 heal? insurance issu]s1 or entities provid+ ph>macy b5efit managem5t s]vices or ph>macy b5efit adm9i/rative s]vices "u gr\p heal? plan or gr\p or individual heal? insurance cov]age receive reimbursem5t t is great] ?an ! m$ian price *>g$ to ! gr\p heal? plan or heal? insurance issu] :5 ! same drug is disp5s$ to p>ticipants & b5efici>ies 9 ! plan or cov]age by o!r ph>macies includ$ 9 ! ph>macy network ( t plan1 issu]1 or entity t are n :olly or p>tially own$ by ! heal? insurance issu] or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,requirem5t ,9 c>ry+ out p>agraph 7#a71 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all n disclose-- 7,a7 in=mation t w\ld all[ = id5tification ( a specific individual1 plan sponsor1 heal? insurance issu]1 plan1 or entity provid+ ph>macy b5efit managem5t s]vices2 or 7,b7 comm]cial or f9ancial in=mation t is privileg$ or confid5tial4 7#c7 ,def9itions ,9 ?is subsection1 ! t]ms gr\p heal? plan1 heal? insurance cov]age1 & heal? insurance issu] h ! mean+s giv5 su* t]ms 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74