,,ii ,cal5d> ,no4 #aac #aah? ,,congress #a/ ,session ,s4 #acci ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #bg1 #bjbc,mr4 ,s&]s 7= himself1 ,mr4 ,cassidy1 ,mrs4 ,murray1 ,mr4 ,m>%all1 & ,mr4 ,braun7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,june #bb1 #bjbc,report$ by ,mr4 ,s&]s1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,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 #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 ,public ,heal? ,s]vice ,act ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$-- 7#a7 9 "p ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] %all n ent] into a contract ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit ! disclosure ( in=mation to plan sponsors 9 su* a mann] t prev5ts ! plan or issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan or issu]1 f mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan or issu]1 relevant in=mation necess>y to make ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a cov]$ gr\p heal? plan or gr\p heal? insurance cov]age 7reg>dless ( :e!r su* cov]age is cov]$ gr\p heal? insurance cov]age z def9$ 9 subsection 7g77#c77 %all submit to ! plan sponsor ( su* cov]$ gr\p heal? plan or issu] ( su* heal? insurance cov]age a report 9 accordance ) ?is subsection & make su* report available to ! plan sponsor or issu] 9 pla9 language1 9 a ma*9e-readable =mat1 &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 or heal? insurance cov]age-- 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 su* drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan or cov]age2 7,b7 a li/ ( ea* drug cov]$ by ! plan1 cov]age1 or entity provid+ ph>macy b5efit managem5t s]vices = :i* a claim 0 fil$ 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 a claim = ! drug 0 fil$ dur+ ! report+ p]iod1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug = :i* a claim 0 fil$ 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' supply & co/ p] dosage unit2 7v7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug aft] application ( any b5efits "u ! plan or cov]age-- 7,i7 includ+ copaym5ts1 co9surance1 & d$uctibles2 & 7,,ii7 n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ to ! plan or cov]age2 & 7vi7 = ea* ( ! #ej prescription drugs ) ! highe/ gross sp5d+ "u ! gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class 7z def9$ by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury71 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>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 7,c7 a li/ ( ea* !rapeutic class ( drugs = :i* a claim 0 fil$ "u ! gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class 7z def9$ z describ$ 9 subp>agraph 7,b77vi77,i77 ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan or by ! issu] (f]+ su* cov]age2 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>ies on drugs 9 su* !rapeutic class1 aft] application ( any b5efits "u ! plan or cov]age-- 7,i7 includ+ copaym5ts1 co9surance1 & d$uctibles2 & 7,,ii7 n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ to ! plan or issu]2 & 7v7 = ea* !rapeutic class "u :i* #c or m drugs are includ$ on ! =mul>y ( su* plan or cov]age-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 by su* entity1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,ii7 ! total net sp5d+ by ! plan or by ! issu] ) respect to su* cov]age on t class ( drugs2 & 7,,iii7 ! av]age net sp5d+ p] #cj-;day supply & p] #ij-;day supply by ! plan or by ! issu] ) respect to su* cov]age & its p>ticipants & b5efici>ies1 among all drugs )9 ! !rapeutic class = :i* a claim 0 fil$ dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan or by ! issu] ) respect to su* cov]age dur+ ! report+ p]iod2 7,e7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! gr\p heal? plan or heal? insurance issu]1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f su* entities1 relat$ to utilization ( drugs or drug sp5d+ "u t gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! gr\p heal? plan or heal? insurance issu] ) respect to ! cov]age 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 =-- 7i7 ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to ! ph>macy b5efit manag]2 7ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan or heal? insurance issu]2 or 7iii7 ! ret5tion ( ! entity by ! gr\p heal? plan or heal? insurance issu]2 7,h7 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 affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives fund$ by an entity provid+ ph>macy b5efit managem5t s]vices2 7ii7 ! p]c5tage ( total prescriptions *>g$ to ! plan1 issu]1 or p>ticipants & b5efici>ies 9 ! plan or cov]age1 t 7 disp5s$ by mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices2 & 7iii7 a li/ ( all drugs disp5s$ by su* affiliat$ ph>macy or ph>macy "u common own]%ip & *>g$ to ! plan1 issu]1 or p>ticipants & b5efici>ies ( ! plan or cov]age1 dur+ ! applicable p]iod1 &1 ) respect to ea* drug-- 7,i7 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 ) respect to p>ticipants & b5efici>ies 9 ! plan or cov]age1 to ! plan or issu]2 & 7bb7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply to p>ticipants & b5efici>ies2 7,,ii7 ! m$ian am\nt *>g$ to ! plan or issu]1 p] dosage unit1 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 affiliat$ ) or "u common own]%ip ) ! 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] #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 affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( t plan or cov]age2 7,,iv7 ! l[e/ co/1 p] dosage unit1 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 ( ! plan or cov]age2 7,v7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 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 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 su* z av]age sales price1 :olesale acquisition co/1 & national av]age drug acquisition co/ p] dosage unit 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]age2 7,i7 a summ>y docum5t = plan sponsors or issu]s t includes ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,h7 t ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury det]m9e useful to plan sponsors & heal? insurance issu]s = 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>y2 & 7,j7 a summ>y docum5t = p>ticipants or b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to ! plan sponsor1 t conta9s ! in=mation describ$ 9 subp>agraphs 7,d7 ?r\gh 7,g7 t ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury det]m9e useful to p>ticipants or b5efici>ies 9 bett] und]/&+ _! plan or b5efits1 except t su* summ>y docum5t = p>ticipants or b5efici>ies %all conta9 only aggregate in=mation4 7#b7 ,regulations ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all1 ?r\gh notice & comm5t rulemak+1 promulgate f9al regulations to implem5t ! requirem5ts ( ?is subsection4 ,9 promulgat+ su* regulations1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is subsection ) ! report+ requirem5ts "u section #bgii;,a-#aj4 7#c7 ,additional report+ 7,a7 ,report+ ) respect to gr\p heal? plans (f]$ by small employ]s ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 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 ( ,labor1 & ! ,secret>y ( ! ,treasury may specify4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan-- 7i7 ! in=mation describ$ 9 subp>agraphs 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a72 7ii7 z applicable1 in=mation collect$ f drug manufactur]s by su* plan on ! total am\nt ( copaym5t assi/ance doll>s paid1 or copaym5t c>ds appli$1 t 7 fund$ by applicable drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan1 except t su* in=mation %all n id5tify any drug manufactur]2 & 7iii7 a summ>y docum5t t includes ! in=mation describ$ 9 clauses 7i7 & 7ii7 t ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury det]m9e useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 provid$ t su* summ>y docum5ts include only aggregate in=mation4 7,b7 ,opt-9 = gr\p heal? insurance cov]age 7i7 ,9 g5]al ,a plan sponsor ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan may1 on an annual basis1 = plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( 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 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( 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 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( 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]age-- 7aa7 ! in=mation describ$ 9 subp>agraphs 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a72 & 7bb7 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 applicable drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan1 except t su* in=mation %all n id5tify any drug manufactur]4 7iii7 ,requir$ report+ = cov]$ gr\p heal? insurance cov]age ,ea* heal? insurance issu] t (f]s cov]$ gr\p heal? insurance cov]age %all annually submit to ! plan sponsor ! in=mation describ$ 9 p>agraph 7#a77;,i71 reg>dless ( :e!r ! plan sponsor made ! election describ$ 9 clause 7i7 = ! applicable ye>4 7iv7 ,requir$ report+ = o!r gr\p heal? insurance cov]age ,ea* heal? insurance issu] t (f]s gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance %all annually submit a summ>y docum5t t includes su* in=mation describ$ 9 items 7aa7 & 7bb7 ( clause 7ii77,,ii7 z ! ,secret>y & ! ,secret>y ( ,labor det]m9e useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 provid$ t su* summ>y docum5ts include only aggregate in=mation4 7#d7 ,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 ! ,,hipaa privacy regulations1 z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act4 7,b7 ,requirem5t ,a report submitt$ "u p>agraph 7#a7 or 7#c7 %all conta9 only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,c7 ,cl>ification reg>d+ c]ta9 disclosures ( in=mation 7i7 ,reasonable re/rictions ,no?+ 9 ?is section prev5ts a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age f plac+ reasonable re/rictions 7z ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury may det]m9e7 on ! public disclosure ( ! in=mation conta9$ 9 a report "u p>agraph 7#a7 or 7#c74 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 heal? insurance issu] (f]+ 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#e7 ,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#c7 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#c7 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#c7 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$]al ag5cy responsible = en=cem5t activities "u ?is section2 or 7iv7 to a contractor or ag5t = purposes ( heal? plan adm9i/ration1 if su* contractor or ag5t agrees1 9 writ+1 & z a t]m ( ! contract1 to abide by ! same use & disclosure re/rictions z ! plan sponsor4 7,c7 ,relation%ip to ,,hipaa regulations ,) respect to ! ,,hipaa privacy regulations1 z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act1 subp>agraph 7,b7 does n prohibit a cov]$ entity 7z def9$ = purposes ( su* regulations promulgat$ "u section #bfd ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif7 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 ,writt5 notice ,plan sponsors ( gr\p heal? plans & gr\p heal? insurance cov]age %all provide to ea* employee writt5 notice in=m+ ! employee ( ! requirem5t = heal? insurance issu]s or entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! plan or cov]age to submit reports to plan sponsors "u p>agraphs 7#a7 & 7#c71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! employee1 an employee h&book provid$ to ! employee1 or individual notification4 7,e7 ,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#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 submit1 ^u reque/1 to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #b reports submitt$ to a plan sponsor "u p>agraph 7#a7 or 7#c7 ) respect to su* cov]age or plan1 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#d71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #b7;f7 ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 7#g7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbd1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all specify1 ?r\gh rulemak+1 /&>d =mats = entities provid+ ph>macy b5efit managem5t s]vices to submit reports requir$ "u ?is subsection4 ,su* secret>ies may provide = sep>ate /&>d =mats = reports to plan sponsors ( gr\p heal? plans & reports to plan sponsors ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan4 7,b7 ,=m ( report ,! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all def9e ?r\gh rulemak+ a =m ( ! reports "u p>agraphs 7#a7 & 7#c7 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 ! case t su* secret>ies det]m9e t *anges to ! /&>d =mat are necess>y to prev5t anticompetitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all ensure t ! am\nt requir$ to be paid by a p>ticipant1 b5efici>y1 or enrollee = a prescription drug cov]$ "u ! plan or cov]age1 & a ?ird-p>ty adm9i/rator or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or cov]age %all ensure t ! total am\nt requir$ to be paid by ! plan or issu] & p>ticipant1 b5efici>y1 or enrollee = a prescription drug cov]$ "u ! plan or cov]age1 does n exce$ ! price paid to ! ph>macy1 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 = :i* a claim 0 fil$ ) ! plan1 issu]1 or entity 7 n r5d]$ by ! ph>macy4 7d7 ,full rebate pass-?r\gh to plan or heal? insurance issu] 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p 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* gr\p heal? plan or heal? insurance cov]age1 to ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age2 & 7,b7 ensure t any contract ent]$ into1 by su* ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or cov]age1 ) rebate aggregators 7or o!r pur*as+ entity design$ to aggregate rebates71 applicable gr\p pur*as+ organizations1 or any subsidi>y1 p>5t1 affiliate1 or subcontractor ( ! plan1 entity1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 or applicable gr\p pur*as+ organization remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ t are relat$ to utilization ( drugs "u su* gr\p heal? plan or heal? insurance cov]age1 to ! ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,=m & mann] ( remittance ,) respect to su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation-- 7,a7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u p>agraph 7#a77;,a7 %all be-- 7i7 remitt$-- 7,i7 on a qu>t]ly basis1 to ! gr\p heal? plan or ! gr\p heal? insurance issu]1 n lat] ?an #ij days aft] ! end ( ea* qu>t]2 or 7,,ii7 9 ! case ( an und]paym5t 9 a remittance = a prior qu>t]1 z soon z practicable1 b n lat] ?an #ij days aft] notice ( ! und]paym5t is fir/ giv52 7ii7 fully disclos$ & enum]at$ to ! gr\p heal? plan or heal? insurance issu]1 z describ$ 9 p>agraphs 7#a7 & 7#c7 ( subsection 7b72 & 7iii7 return$ to ! issu] or entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan if an audit by a plan sponsor1 or a ?ird p>ty designat$ by a plan sponsor1 indicates t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan or heal? insurance issu]2 7,b7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u p>agraph 7#a77;,b7 %all be remitt$ 9 accordance ) su* proc$ures z ! ,secret>y1 ,secret>y ( ,labor1 & ,secret>y ( ! ,treasury e/abli%2 & 7,c7 ! records ( su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be available = audit by ! plan sponsor1 issu]1 or a ?ird p>ty designat$ by a plan sponsor1 n less ?an once p] plan ye>4 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 on behalf ( su* gr\p heal? plan or heal? insurance cov]age %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by ! plan sponsor or designat$ ?ird p>ty1 subject to reasonable re/rictions 7z det]m9$ by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury7 on confid5tiality to prev5t re-disclosure ( su* contracts4 7#d7 ,auditors ,audits c>ri$ out "u p>agraphs 7#b77;,c7 & 7#c7 %all be p]=m$ by an auditor select$ by ! applicable plan sponsor4 7#e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to-- 7,a7 prohibit paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n describ$ 9 ?is subsection1 provid$ t su* fees are transp>5t to gr\p heal? plans & heal? insurance issu]s2 7,b7 require a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age to remit bona fide s]vice fees to gr\p heal? plans or heal? insurance issu]s2 or 7,c7 limit ! ability ( a gr\p heal? plan or heal? insurance issu] to pass ?r\gh rebates1 fees1 alt]native disc\nts1 & o!r remun]ation to ! p>ticipant or b5efici>y4 7e7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y %all en=ce ?is section4 7#b7 ,violations ,a gr\p heal? plan1 a heal? insurance issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7a72 an entity provid+ ph>macy b5efit managem5t s]vices t 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]1 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$4 7#c7 ,false in=mation ,a gr\p heal? plan1 a heal? insurance issu]1 an entity provid+ ph>macy b5efit managem5t s]vices1 or a ?ird-p>ty adm9i/rator t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #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$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsection 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "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 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu]1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 or ! ,secret>y ( ! ,treasury to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 7c71 or 7d7 by su* issu]1 plan1 or entity4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m applicable entity means-- 7,a7 an applicable gr\p pur*as+ organization1 drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 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 applicable gr\p pur*as+ organization means a gr\p pur*as+ organization t is affiliat$ ) or "u common own]%ip ) an entity provid+ ph>macy b5efit managem5t s]vices2 7#c7 ! 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#d7 ! t]m cov]$ gr\p heal? plan means a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#e7 ! 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 ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#f7 ! 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$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 7#g7 ! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#h7 ! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd2 7#i7 ! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 ?r\gh rulemak+1 :i* %all be reevaluat$ by su* secret>ies e #e ye>s2 & 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 ,d2 & 7#c7 9 section #bgii;,a-#aj 7#db ,u4,s4,c4 #cjj;gg-#abj71 by add+ at ! end ! foll[+3 7d7 ,entities provid+ ph>macy b5efit managem5t s]vices ,beg9n+ #b ye>s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 entities provid+ ph>macy b5efit managem5t s]vices %all report to plan sponsors ( gr\p heal? plans or gr\p heal? insurance cov]age in=mation requir$ "u p>agraphs 7#d71 7#e71 7#f71 7#g77;,a77iii71 & 7#g77;,b7 ( subsection 7a74 4 7b7 ,employee ,retirem5t ,income ,security ,act ( #aigd 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$-- 7,a7 9 subp>t ,b ( "p #g 7#bi ,u4,s4,c4 #aahe et seq471 by add+ at ! end ! foll[+3 #gbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a gr\p heal? plan 7or heal? insurance issu] (f]+ gr\p heal? insurance cov]age 9 connection ) su* a plan7 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] %all n ent] into a contract ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit ! disclosure ( in=mation to plan sponsors 9 su* a mann] t prev5ts ! plan or issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan or issu]1 f mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan or issu]1 relevant in=mation necess>y to make ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 n less frequ5tly ?an annually1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a cov]$ gr\p heal? plan or gr\p heal? insurance cov]age 7reg>dless ( :e!r su* cov]age is cov]$ gr\p heal? insurance cov]age z def9$ 9 subsection 7g77#c77 %all submit to ! plan sponsor ( su* cov]$ gr\p heal? plan or issu] ( su* heal? insurance cov]age a report 9 accordance ) ?is subsection & make su* report available to ! plan sponsor or issu] 9 pla9 language1 9 a ma*9e-readable =mat1 &1 z ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury may det]m9e1 o!r =mats4 ,ea* su* report %all include1 ) respect to ! cov]$ gr\p heal? plan or heal? insurance cov]age-- 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 su* drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan or cov]age2 7,b7 a li/ ( ea* drug cov]$ by ! plan1 cov]age1 or entity provid+ ph>macy b5efit managem5t s]vices = :i* a claim 0 fil$ 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 a claim = ! drug 0 fil$ dur+ ! report+ p]iod1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug = :i* a claim 0 fil$ 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' supply & co/ p] dosage unit2 7v7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug aft] application ( any b5efits "u ! plan or cov]age-- 7,i7 includ+ copaym5ts1 co9surance1 & d$uctibles2 & 7,,ii7 n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ to ! plan or cov]age2 & 7vi7 = ea* ( ! #ej prescription drugs ) ! highe/ gross sp5d+ "u ! gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class 7z def9$ by ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury71 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>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 7,c7 a li/ ( ea* !rapeutic class 7z def9$ z describ$ 9 subp>agraph 7,b77vi77,i77 ( drugs = :i* a claim 0 fil$ "u ! gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan or by ! issu] (f]+ su* cov]age2 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>ies on drugs 9 su* !rapeutic class1 aft] application ( any b5efits "u ! plan or cov]age-- 7,i7 includ+ copaym5ts1 co9surance1 & d$uctibles2 & 7,,ii7 n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ to ! plan or issu]2 & 7v7 = ea* !rapeutic class "u :i* #c or m drugs are includ$ on ! =mul>y ( su* plan or cov]age-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 by su* entity1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,ii7 ! total net sp5d+ by ! plan or by ! issu] ) respect to su* cov]age on t class ( drugs2 & 7,,iii7 ! av]age net sp5d+ p] #cj-;day supply & p] #ij-;day supply by ! plan or by ! issu] ) respect to su* cov]age & its p>ticipants & b5efici>ies1 among all drugs )9 ! !rapeutic class = :i* a claim 0 fil$ dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan or cov]age dur+ ! report+ p]iod2 7,e7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! gr\p heal? plan or heal? insurance issu]1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f su* entities1 relat$ to utilization ( drugs or drug sp5d+ "u t gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! gr\p heal? plan or heal? insurance issu] ) respect to ! cov]age 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 =-- 7i7 ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to ! ph>macy b5efit manag]2 7ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan or heal? insurance issu]2 or 7iii7 ! ret5tion ( ! entity by ! gr\p heal? plan or heal? insurance issu]2 7,h7 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 affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives fund$ by an entity provid+ ph>macy b5efit managem5t s]vices2 7ii7 ! p]c5tage ( total prescriptions *>g$ to ! plan1 issu]1 or p>ticipants & b5efici>ies 9 ! plan or cov]age1 t 7 disp5s$ by mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices2 & 7iii7 a li/ ( all drugs disp5s$ by su* affiliat$ ph>macy or ph>macy "u common own]%ip & *>g$ to ! plan1 issu]1 or p>ticipants & b5efici>ies ( ! plan or cov]age1 dur+ ! applicable p]iod1 &1 ) respect to ea* drug-- 7,i7 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 ) respect to p>ticipants & b5efici>ies 9 ! plan or cov]age1 to ! plan or issu]2 & 7bb7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply to p>ticipants & b5efici>ies2 7,,ii7 ! m$ian am\nt *>g$ to ! plan or issu]1 p] dosage unit1 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 affiliat$ ) or "u common own]%ip ) ! 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] #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 affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( t plan or cov]age2 7,,iv7 ! l[e/ co/1 p] dosage unit1 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 ( ! plan or cov]age2 7,v7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 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 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury1 su* z av]age sales price1 :olesale acquisition co/1 & national av]age drug acquisition co/ p] dosage unit 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]age2 7,i7 a summ>y docum5t = plan sponsors or issu]s t includes ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,h7 t ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury det]m9e useful to plan sponsors & heal? insurance issu]s = 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>y2 & 7,j7 a summ>y docum5t = p>ticipants or b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to ! plan sponsor1 t conta9s ! in=mation describ$ 9 subp>agraphs 7,d7 ?r\gh 7,g7 t ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury det]m9e useful to p>ticipants or b5efici>ies 9 bett] und]/&+ _! plan or b5efits1 except t su* summ>y docum5t = p>ticipants or b5efici>ies %all conta9 only aggregate in=mation4 7#b7 ,regulations ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all1 ?r\gh notice & comm5t rulemak+1 promulgate f9al regulations to implem5t ! requirem5ts ( ?is subsection4 ,9 promulgat+ su* regulations1 ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is subsection ) ! report+ requirem5ts "u section #gbe4 7#c7 ,additional report+ 7,a7 ,report+ ) respect to gr\p heal? plans (f]$ by small employ]s ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 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 specify4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan-- 7i7 ! in=mation describ$ 9 subp>agraphs 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a72 7ii7 z applicable1 in=mation collect$ f drug manufactur]s by su* plan on ! total am\nt ( copaym5t assi/ance doll>s paid1 or copaym5t c>ds appli$1 t 7 fund$ by applicable drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan1 except t su* in=mation %all n id5tify any drug manufactur]2 & 7iii7 a summ>y docum5t t includes ! in=mation describ$ 9 clauses 7i7 & 7ii7 t ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury det]m9e useful to plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 provid$ t su* summ>y docum5ts include only aggregate in=mation4 7,b7 ,opt-9 = gr\p heal? insurance cov]age 7i7 ,9 g5]al ,a plan sponsor ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan may1 on an annual basis1 = plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( 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 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( 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 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( 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]age-- 7aa7 ! in=mation describ$ 9 subp>agraphs 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a72 & 7bb7 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 applicable drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan1 except t su* in=mation %all n id5tify any drug manufactur]4 7iii7 ,requir$ report+ = cov]$ gr\p heal? insurance cov]age ,ea* heal? insurance issu] t (f]s cov]$ gr\p heal? insurance cov]age %all annually submit to ! plan sponsor ! in=mation describ$ 9 p>agraph 7#a77;,i71 reg>dless ( :e!r ! plan sponsor made ! election describ$ 9 clause 7i7 = ! applicable ye>4 7iv7 ,requir$ report+ = o!r gr\p heal? insurance cov]age ,ea* heal? insurance issu] t (f]s gr\p heal? insurance cov]age t is n cov]$ gr\p heal? insurance %all annually submit a summ>y docum5t t includes su* in=mation describ$ 9 items 7aa7 & 7bb7 ( clause 7ii77,,ii7 z ! ,secret>y & ! ,secret>y ( ,heal? & ,human ,s]vices det]m9e useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 provid$ t su* summ>y docum5ts include only aggregate in=mation4 7#d7 ,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 ! ,,hipaa privacy regulations1 z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c774 7,b7 ,requirem5t ,a report submitt$ "u p>agraph 7#a7 or 7#c7 %all conta9 only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,c7 ,cl>ification reg>d+ c]ta9 disclosures ( in=mation 7i7 ,reasonable re/rictions ,no?+ 9 ?is section prev5ts a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age f plac+ reasonable re/rictions 7z ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury may det]m9e7 on ! public disclosure ( ! in=mation conta9$ 9 a report "u p>agraph 7#a7 or 7#c74 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 heal? insurance issu] (f]+ 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#e7 ,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#c7 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#c7 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#c7 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$]al ag5cy responsible = en=cem5t activities "u ?is section2 or 7iv7 to a contractor or ag5t = purposes ( heal? plan adm9i/ration1 if su* contractor or ag5t agrees1 9 writ+1 & z a t]m ( ! contract1 to abide by ! same use & disclosure re/rictions z ! plan sponsor4 7,c7 ,relation%ip to ,,hipaa regulations ,) respect to ,,hipaa privacy regulations1 z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c771 subp>agraph 7,b7 does n prohibit a cov]$ entity 7z def9$ = purposes ( su* regulations promulgat$ "u section #bfd ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b77 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 ,writt5 notice ,plan sponsors ( gr\p heal? plans & gr\p heal? insurance cov]age %all provide to ea* employee writt5 notice in=m+ ! employee ( ! requirem5t = heal? insurance issu]s or entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! plan or cov]age to submit reports to plan sponsors "u p>agraphs 7#a7 & 7#c71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! employee1 an employee h&book provid$ to ! employee1 or individual notification4 7,e7 ,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#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 submit1 ^u reque/1 to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #b reports submitt$ to a plan sponsor "u p>agraph 7#a7 or 7#c7 ) respect to su* cov]age or plan1 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#d71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #b7;f7 ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 7#g7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbd1 ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all specify1 ?r\gh rulemak+1 /&>d =mats = entities provid+ ph>macy b5efit managem5t s]vices to submit reports requir$ "u ?is subsection4 ,su* secret>ies may provide = sep>ate /&>d =mats = reports to plan sponsors ( gr\p heal? plans & reports to plan sponsors ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan4 7,b7 ,=m ( report ,! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury %all def9e ?r\gh rulemak+ a =m ( ! reports "u p>agraphs 7#a7 & 7#c7 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 ! case t su* secret>ies det]m9e t *anges to ! /&>d =mat are necess>y to prev5t anticompetitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all ensure t ! am\nt requir$ to be paid by a p>ticipant or b5efici>y = a prescription drug cov]$ "u ! plan or cov]age1 & a ?ird-p>ty adm9i/rator or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or cov]age %all ensure t ! total am\nt requir$ to be paid by ! plan or issu] & p>ticipant or b5efici>y = a prescription drug cov]$ "u ! plan or cov]age1 does n exce$ ! price paid to ! ph>macy1 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 = :i* a claim 0 fil$ ) ! plan1 issu]1 or entity 7 n r5d]$ by ! ph>macy4 7d7 ,full rebate pass-?r\gh to plan or heal? insurance issu] 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p 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* gr\p heal? plan or heal? insurance cov]age1 to ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age2 & 7,b7 ensure t any contract ent]$ into1 by su* ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or cov]age1 ) rebate aggregators 7or o!r pur*as+ entity design$ to aggregate rebates71 applicable gr\p pur*as+ organizations1 or any subsidi>y1 p>5t1 affiliate1 or subcontractor ( ! plan1 entity1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 or applicable gr\p pur*as+ organization remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ t are relat$ to utilization ( drugs "u su* gr\p heal? plan or heal? insurance cov]age1 to ! ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,=m & mann] ( remittance ,) respect to su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation-- 7,a7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u p>agraph 7#a77;,a7 %all be-- 7i7 remitt$-- 7,i7 on a qu>t]ly basis1 to ! gr\p heal? plan or ! gr\p heal? insurance issu]1 n lat] ?an #ij days aft] ! end ( ea* qu>t]2 or 7,,ii7 9 ! case ( an und]paym5t 9 a remittance = a prior qu>t]1 z soon z practicable1 b n lat] ?an #ij days aft] notice ( ! und]paym5t is fir/ giv52 7ii7 fully disclos$ & enum]at$ to ! gr\p heal? plan or heal? insurance issu]1 z describ$ 9 p>agraphs 7#a7 & 7#c7 ( subsection 7b72 & 7iii7 return$ to ! issu] or entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan if an audit by a plan sponsor1 or a ?ird p>ty designat$ by a plan sponsor1 indicates t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan or heal? insurance issu]2 7,b7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u p>agraph 7#a77;,b7 %all be remitt$ 9 accordance ) su* proc$ures z ! ,secret>y1 ,secret>y ( ,heal? & ,human ,s]vices1 & ,secret>y ( ! ,treasury e/abli%2 & 7,c7 ! records ( su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be available = audit by ! plan sponsor1 issu]1 or a ?ird p>ty designat$ by a plan sponsor1 n less ?an once p] plan ye>4 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 on behalf ( su* gr\p heal? plan or heal? insurance cov]age %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by ! plan sponsor or designat$ ?ird p>ty1 subject to reasonable re/rictions 7z det]m9$ by ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury7 on confid5tiality to prev5t re-disclosure ( su* contracts4 7#d7 ,auditors ,audits c>ri$ out "u p>agraphs 7#b77;,c7 & 7#c7 %all be p]=m$ by an auditor select$ by ! applicable plan sponsor4 7#e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to-- 7,a7 prohibit paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n describ$ 9 ?is subsection1 provid$ t su* fees are transp>5t to gr\p heal? plans & heal? insurance issu]s2 7,b7 require a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age to remit bona fide s]vice fees to ! gr\p heal? plans or heal? insurance issu]s2 or 7,c7 limit ! ability ( a gr\p heal? plan or heal? insurance issu] to pass ?r\gh rebates1 fees1 alt]native disc\nts1 & o!r remun]ation to ! p>ticipant or b5efici>y4 7e7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y %all en=ce ?is section4 7#b7 ,violations ,a gr\p heal? plan1 a heal? insurance issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7a72 an entity provid+ ph>macy b5efit managem5t s]vices t 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]1 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$4 7#c7 ,false in=mation ,a gr\p heal? plan1 a heal? insurance issu]1 an entity provid+ ph>macy b5efit managem5t s]vices1 or a ?ird-p>ty adm9i/rator t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #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$ure ,! ,secret>y %all impose civil monet>y p5alties "u ?is subsection 9 ! same mann] & accord+ to ! same proc$ures z ! ,secret>y imposes civil monet>y p5alties z describ$ 9 section #ejb7;c77#aj74 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 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu]1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y ( ,labor1 ! ,secret>y ( ,heal? & ,human ,s]vices1 or ! ,secret>y ( ! ,treasury to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 7c71 or 7d7 by su* issu]1 plan1 or entity4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m applicable entity means-- 7,a7 an applicable gr\p pur*as+ organization1 drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 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 applicable gr\p pur*as+ organization means a gr\p pur*as+ organization t is affiliat$ ) or "u common own]%ip ) an entity provid+ ph>macy b5efit managem5t s]vices2 7#c7 ! 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#d7 ! t]m cov]$ gr\p heal? plan means a gr\p heal? plan ma9ta9$ by a l>ge employ]2 7#e7 ! 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 ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#f7 ! 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$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 7#g7 ! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7#h7 ! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b72 7#i7 ! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ! ,treasury1 ?r\gh rulemak+1 :i* %all be reevaluat$ by su* secret>ies e #e ye>s2 & 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 7#c7 ,additional report+ requirem5t ,section #gbe ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahen7 is am5d$ by add+ at ! end ! foll[+3 7d7 ,entities provid+ ph>macy b5efit managem5t s]vices ,beg9n+ #b ye>s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 entities provid+ ph>macy b5efit managem5t s]vices %all report to plan sponsors ( gr\p heal? plans in=mation requir$ "u p>agraphs 7#d71 7#e71 7#f71 7#g77;,a77iii71 & 7#g77;,b7 ( subsection 7a74 4 7c7 ,int]nal ,rev5ue ,code ( #aihf 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] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 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 unless su* applicable entity agrees to-- 7#a7 n limit ! 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 7b72 & 7#b7 provide ! gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a plan1 relevant in=mation necess>y to make ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 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 pla9 language1 9 a ma*9e-readable =mat1 &1 z ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices 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 su* drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan2 7,b7 a li/ ( ea* drug cov]$ by ! plan or entity provid+ ph>macy b5efit managem5t s]vices = :i* a claim 0 fil$ 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 a claim = ! drug 0 fil$ dur+ ! report+ p]iod1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug = :i* a claim 0 fil$ 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' supply & co/ p] dosage unit2 7v7 ! total out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug aft] application ( any b5efits "u ! plan-- 7,i7 includ+ copaym5ts1 co9surance1 & d$uctibles2 & 7,,ii7 n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or = :i* no claim is submitt$ to ! plan2 & 7vi7 = ea* ( ! #ej prescription drugs ) ! highe/ gross sp5d+ "u ! gr\p heal? plan dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class 7z def9$ by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices71 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>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 7,c7 a li/ ( ea* !rapeutic class 7z def9$ z describ$ 9 subp>agraph 7,b77vi77,i77 ( drugs = :i* a claim 0 fil$ "u ! gr\p heal? plan dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan2 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>ies on drugs 9 su* !rapeutic class1 aft] application ( any b5efits "u ! plan-- 7,i7 includ+ copaym5ts1 co9surance1 & d$uctibles2 & 7,,ii7 n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or = :i* no claim is submitt$ to ! plan2 & 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$1 by su* entity1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,ii7 ! total net sp5d+ by ! plan on t class ( drugs2 & 7,,iii7 ! av]age net sp5d+ p] #cj-;day supply & p] #ij-;day supply by ! plan & its p>ticipants & b5efici>ies1 among all drugs )9 ! !rapeutic class = :i* a claim 0 fil$ dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan dur+ ! report+ p]iod2 7,e7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! gr\p heal? plan1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f su* entities1 relat$ to utilization ( drugs or drug sp5d+ "u t gr\p heal? plan dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! gr\p 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 =-- 7i7 ref]ral ( ! gr\p heal? plan's bus9ess to ! ph>macy b5efit manag]2 7ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan2 or 7iii7 ! ret5tion ( ! entity by ! gr\p heal? plan2 7,h7 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 affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance 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 affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices2 & 7iii7 a li/ ( all drugs disp5s$ by su* affiliat$ ph>macy or ph>macy "u common own]%ip & *>g$ to ! plan1 or p>ticipants & b5efici>ies ( ! plan1 dur+ ! applicable p]iod1 &1 ) respect to ea* drug-- 7,i7 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 ) respect to p>ticipants & b5efici>ies 9 ! plan1 to ! plan2 & 7bb7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply to p>ticipants & b5efici>ies2 7,,ii7 ! m$ian am\nt *>g$ to ! plan1 p] dosage unit1 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 affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( t plan2 7,,iii7 ! int]qu>tile range ( ! co/s1 p] dosage unit1 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 affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( t plan2 7,,iv7 ! l[e/ co/1 p] dosage unit1 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 unit1 p] #cj-;day supply1 & p] #ij-;day supply1 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 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices1 su* z av]age sales price1 :olesale acquisition co/1 & national av]age drug acquisition co/ p] dosage unit or p] #cj-;day supply1 = su* drug1 includ+ am\nts *>g$ to ! plan & p>ticipants & b5efici>ies among all ph>macies includ$ 9 ! network ( ! plan2 7,i7 a summ>y docum5t = plan sponsors t includes ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,h7 t ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices det]m9e useful to 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>y2 & 7,j7 a summ>y docum5t = p>ticipants or b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to ! plan sponsor1 t conta9s ! in=mation describ$ 9 subp>agraphs 7,d7 ?r\gh 7,g7 t ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices det]m9e useful to p>ticipants or b5efici>ies 9 bett] und]/&+ _! plan or b5efits1 except t su* summ>y docum5t = p>ticipants or b5efici>ies %all conta9 only aggregate in=mation4 7#b7 ,regulations ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices %all1 ?r\gh notice & comm5t rulemak+1 promulgate f9al regulations to implem5t ! requirem5ts ( ?is subsection4 ,9 promulgat+ su* regulations1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is subsection ) ! report+ requirem5ts "u section #ihbe4 7#c7 ,additional report+ ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 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 ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices may specify4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan-- 7,a7 ! in=mation describ$ 9 subp>agraphs 7,d71 7,e71 7,f71 & 7,g7 ( p>agraph 7#a72 7,b7 z applicable1 in=mation collect$ f drug manufactur]s by su* plan on ! total am\nt ( copaym5t assi/ance doll>s paid1 or copaym5t c>ds appli$1 t 7 fund$ by applicable drug manufactur]s ) respect to ! p>ticipants & b5efici>ies 9 su* plan1 except t su* in=mation %all n id5tify any drug manufactur]2 & 7,c7 a summ>y docum5t t includes t in=mation describ$ 9 subp>agraphs 7,a7 & 7,b7 t ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices det]m9e useful = plan sponsors = purposes ( select+ ph>macy b5efit managem5t s]vices1 provid$ t su* summ>y docum5ts include only aggregate in=mation4 7#d7 ,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 ! ,,hipaa privacy regulations1 z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c774 7,b7 ,requirem5t ,a report submitt$ "u p>agraph 7#a7 or 7#c7 %all conta9 only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,c7 ,cl>ification reg>d+ c]ta9 disclosures ( in=mation 7i7 ,reasonable re/rictions ,no?+ 9 ?is section prev5ts an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan f plac+ reasonable re/rictions 7z ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices may det]m9e7 on ! public disclosure ( ! in=mation conta9$ 9 a report "u p>agraph 7#a7 or 7#c74 7ii7 ,limitations ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan 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#e7 ,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#c7 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#c7 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#c7 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$]al ag5cy responsible = en=cem5t activities "u ?is section2 or 7iv7 to a contractor or ag5t = purposes ( heal? plan adm9i/ration1 if su* contractor or ag5t agrees1 9 writ+1 & z a t]m ( ! contract1 to abide by ! same use & disclosure re/rictions z ! plan sponsor4 7,c7 ,relation%ip to ,,hipaa regulations ,) respect to ! ,,hipaa privacy regulations1 z def9$ 9 section #aahj7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c771 subp>agraph 7,b7 does n prohibit a cov]$ entity 7z def9$ = purposes ( su* regulations promulgat$ "u section #bfd ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b77 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 ,writt5 notice ,plan sponsors ( gr\p heal? plans %all provide to ea* employee writt5 notice in=m+ ! employee ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices to submit reports to plan sponsors "u p>agraphs 7#a7 & 7#c71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! employee1 an employee h&book provid$ to ! employee1 or individual notification4 7,e7 ,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#f7 ,submissions to ,,gao ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan %all submit1 ^u reque/1 to ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates ea* ( ! fir/ #b reports submitt$ to a plan sponsor "u p>agraph 7#a7 or 7#c7 ) respect to su* plan1 & o!r su* reports z reque/$1 9 accordance ) ! privacy requirem5ts "u p>agraph 7#d71 & su* o!r in=mation t ! ,comptroll] ,g5]al det]m9es necess>y to c>ry out ! /udy "u section #b7;f7 ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act4 7#g7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbd1 ! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor %all specify1 ?r\gh rulemak+1 /&>d =mats = entities provid+ ph>macy b5efit managem5t s]vices to submit reports requir$ "u ?is subsection4 ,su* secret>ies may provide = sep>ate /&>d =mats = reports to plan sponsors ( gr\p heal? plans & reports to plan sponsors ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan4 7,b7 ,=m ,! ,secret>y1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor %all def9e ?r\gh rulemak+ a =m ( ! reports "u p>agraphs 7#a7 & 7#c7 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 ! case t su* secret>ies det]m9e t *anges to ! /&>d =mat are necess>y to prev5t anticompetitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a gr\p heal? plan %all ensure t ! am\nt requir$ to be paid by a p>ticipant or b5efici>y = a prescription drug cov]$ "u ! plan1 & a ?ird-p>ty adm9i/rator or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan %all ensure t ! total am\nt requir$ to be paid by ! plan & p>ticipant or b5efici>y = a prescription drug cov]$ "u ! plan1 does n exce$ ! price paid to ! ph>macy1 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 ! plan 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 = :i* a claim 0 fil$ ) ! 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] ! date t is #cj mon?s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p 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* plan1 to ! gr\p heal? plan2 & 7,b7 ensure t any contract ent]$ into1 by su* ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan1 ) rebate aggregators 7or o!r pur*as+ entity design$ to aggregate rebates71 applicable gr\p pur*as+ organizations1 or any subsidi>y1 p>5t1 affiliate1 or subcontractor ( ! plan1 entity1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 or applicable gr\p pur*as+ organization remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ t are relat$ to utilization ( drugs "u su* plan1 to ! ?ird-p>ty adm9i/rator or entity provid+ ph>macy b5efit managem5t s]vices4 7#b7 ,=m & mann] ( remittance ,) respect to su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation-- 7,a7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u p>agraph 7#a77;,a7 %all be-- 7i7 remitt$-- 7,i7 on a qu>t]ly basis1 to ! gr\p heal? plan1 n lat] ?an #ij days aft] ! end ( ea* qu>t]2 or 7,,ii7 9 ! case ( an und]paym5t 9 a remittance = a prior qu>t]1 z soon z practicable1 b n lat] ?an #ij days aft] notice ( ! und]paym5t is fir/ giv52 7ii7 fully disclos$ & enum]at$ to ! gr\p heal? plan1 z describ$ 9 p>agraphs 7#a7 & 7#c7 ( subsection 7b72 & 7iii7 return$ to ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan if an audit by a plan sponsor1 or a ?ird p>ty designat$ by a plan sponsor1 indicates t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan2 7,b7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u p>agraph 7#a77;,b7 %all be remitt$ 9 accordance ) su* proc$ures z ! ,secret>y1 ,secret>y ( ,heal? & ,human ,s]vices1 & ,secret>y ( ,labor e/abli%2 & 7,c7 ! records ( su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be available = audit by ! plan sponsor1 or a ?ird p>ty designat$ by a plan sponsor1 n less ?an once p] plan ye>4 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 on behalf ( su* gr\p heal? plan %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by ! plan sponsor or designat$ ?ird p>ty1 subject to reasonable re/rictions 7z det]m9$ by ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices7 on confid5tiality to prev5t re-disclosure ( su* contracts4 7#d7 ,auditors ,audits c>ri$ out "u p>agraphs 7#b77;,c7 & 7#c7 %all be p]=m$ by an auditor select$ by ! applicable plan sponsor4 7#e7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to-- 7,a7 prohibit paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n describ$ 9 ?is subsection1 provid$ t su* fees are transp>5t to gr\p heal? plans2 7,b7 require a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan to remit bona fide s]vice fees to plan sponsors ( ! gr\p heal? plan2 or 7,c7 limit ! ability ( a gr\p heal? plan to pass ?r\gh rebates1 fees1 alt]native disc\nts1 & o!r remun]ation to ! p>ticipant or b5efici>y4 7e7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y %all en=ce ?is section4 7#b7 ,violations ,a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices t violates subsection 7a72 an entity provid+ ph>macy b5efit managem5t s]vices t 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$4 7#c7 ,false in=mation ,a gr\p heal? plan1 an entity provid+ ph>macy b5efit managem5t s]vices1 or a ?ird-p>ty adm9i/rator t kn[+ly provides false in=mation "u ?is section %all be subject to a civil money p5alty 9 an am\nt n to exce$ #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$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsection 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "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? plan1 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y ( ! ,treasury to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 7c71 or 7d7 by su* plan or entity4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m applicable entity means-- 7,a7 an applicable gr\p pur*as+ organization1 drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 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 applicable gr\p pur*as+ organization means a gr\p pur*as+ organization t is affiliat$ ) or "u common own]%ip ) an entity provid+ ph>macy b5efit managem5t s]vices2 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? plan1 means ! am\nt sp5t by a gr\p heal? plan on prescription drug b5efits1 calculat$ be=e ! application ( 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$+ cal5d> ye> & :o employs at lea/ #a employee on ! fir/ day ( ! plan ye>2 7#f7 ! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan1 means ! am\nt sp5t by a gr\p heal? plan on prescription drug b5efits1 calculat$ aft] ! application ( 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 rulemak+1 :i* %all be reevaluat$ by su* secret>ies e #e ye>s2 & 7#i7 ! 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 7#c7 ,additional report+ requirem5t ,section #ihbe ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+3 7d7 ,entities provid+ ph>macy b5efit managem5t s]vices ,beg9n+ #b ye>s aft] ! date ( enactm5t ( ! ,ph>macy ,b5efit ,manag] ,re=m ,act1 entities provid+ ph>macy b5efit managem5t s]vices %all report to plan sponsors ( gr\p heal? plans in=mation requir$ "u p>agraphs 7#d71 7#e71 7#f71 7#g77;,a77iii71 & 7#g77;,b7 ( subsection 7a74 4 7d7 ,fund+ 7#a7 ,= purposes ( c>ry+ out ! am5dm5ts made by subsection 7a7 !re is appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #dj1jjj1jjj = fiscal ye> #bjbc1 to rema9 available until exp5d$4 7#b7 ,= purposes ( c>ry+ out ! am5dm5ts made by subsection 7b71 !re is appropriat$ to ! ,dep>tm5t ( ,labor1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #d1ejj1jjj = fiscal ye> #bjbc1 to rema9 available until exp5d$4 7e7 ,,aspe ,/udy ,! ,assi/ant ,secret>y = ,plann+ & ,evaluation ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct or commission a /udy on h[ ! ,unit$ ,/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 ( 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 or *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]s1 di/ributors1 :olesal]s1 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 & entities t p>ticipate 9 ! 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 7#i7 ,! impact ( manufactur] rebates on gett+ insul9 products to m>ket1 & ! m>ket dynamics & ext5t to :i* biosimil> biological product developm5t & competition c\ld increase1 or is increas+1 ! numb] ( biological products approv$ & available to pati5ts1 includ+ by exam9+ b>ri]s to-- 7,a7 placem5t ( biosimil> biological products on heal? insurance =mul>ies2 7,b7 m>ket entry ( insul9 products 9 ! ,unit$ ,/ates1 z comp>$ to o!r highly develop$ nations2 & 7,c7 pati5t & provid] education ar\nd biosimil> biological products4 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 ( a selection ( gr\p heal? plans1 heal? insurance issu]s1 & entities provid+ ph>macy b5efit managem5t s]vices on behalf ( su* gr\p heal? plan or gr\p or individual heal? insurance cov]age1 includ+ networks t h ph>macies t are affiliat$ ) or 9 common own]%ip ) 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 affiliat$ ) or 9 common own]%ip ) plans1 issu]s1 or entities1 z 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 drugs comp>$ to o!r network ph>macies2 7,c7 :e!r gr\p heal? plans & heal? insurance issu]s (f]+ gr\p 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+ arrangem5ts among a selection ( su* plans & issu]s2 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 = a selection ( plans & issu]s1 ! 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 gr\p heal? insurance cov]age t are affiliat$ ) or 9 common own]%ip ) 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 a gr\p heal? plan or gr\p 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 plan or issu] t are n affiliat$ ) or 9 common own]%ip ) ! 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 gr\p heal? 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 #c4 ,report+ on ju/ification = drug price increases ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,drug ,price ,report+2 ,drug ,value ,fund #cii,,oo4 ,report+ on ju/ification = drug price increases 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! lic5se issu$ "u section #cea ( ?is ,act2 or 7,b7 :o is engag$ 9 manufactur+1 prep>+1 propagat+1 comp\nd+1 process+1 packag+1 repackag+1 or label+ ( a prescription drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m p] mon? supply1 or p] a c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7ii7 n a vacc9e2 & 7iii7 n an antibiotic2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 0 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or "u a ,/ate ,m$icaid plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y = ea* plann$ increase 9 price ( a qualify+ drug t w result 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7,a7 #aj p]c5t or m ov] a #ab-mon? p]iod2 or 7,b7 #be p]c5t or m ov] a #cf-mon? p]iod4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y n lat] ?an #cj days prior to ! effective date ( su* plann$ increase 9 price4 7c7 ,cont5ts ,a report "u subsection 7b7 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug on ! plann$ effective date ( su* plann$ increase 9 price2 7,b7 a ju/ification =1 & description (1 ea* manufactur]'s plann$ increase 9 price t w occur dur+ ! #ab-mon? p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable1 t %all be accompani$ by in=mation to sub/antiate ! basis = ! ju/ification & a c]tification t1 to ! manufactur]'s k & belief1 ! ju/ification is tru?ful & nonmislead+ & does n describe uses ( ! drug beyond ^? li/$ z an indication or use 9 its approv$ label+2 7,c7 ! id5tity ( ! initial develop] ( ! drug1 if applicable2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 z applicable2 7,e7 ! curr5t :olesale acquisition co/ ( ! drug2 7,f7 ! total exp5ditures ( ! manufactur] = ! #c ye>s prec$+ ! plann$ increase 9 price on-- 7i7 mat]ials & manufactur+ = su* drug2 & 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 7,g7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,h7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t1 = ! #c ye>s prec$+ ! plann$ increase 9 price = su* drug1 t is necess>y to demon/rate t x meets applicable /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u su* section #cea1 z applicable2 7,i7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is pursu+ new or exp&$ indications = su* drug ?r\gh supplem5tal applications "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a7 ( ?is ,act2 7,j7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ ^? "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,k7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,l7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur]-- 7i7 = ! #ab-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,a72 7ii7 = ! #cf-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,b72 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation-- 7i7 = ! #ab-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,a72 or 7ii7 = ! #cf-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,b72 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials on drugs1 conduct$ ) ! int5t ( us+ ! data to support approval ( an application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a71 b = :i* su* application 0 n submitt$ or fil$1 or fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate1 z specifi$ ?r\gh notice & comm5t rulemak+4 7d7 ,civil money p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 or kn[+ly provides false in=mation1 %all be subject to a civil money p5alty ( #ajj1jjj = ea* day on :i* ! violation cont9ues4 7e7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 n lat] ?an #cj days aft] ! submission ( a report "u subsection 7b71 ! ,secret>y %all po/ ! report on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 accompani$ by language indicat+ t su* public po/+ does n repres5t an endorsem5t or validation ( ! report's cont5t by ! ,secret>y4 7#b7 ,=mat ,9 develop+ ! =mat ( su* report = public po/+1 ! ,secret>y %all consult /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back on ! cont5t & =mat f consum] advocates & readability exp]ts to ensure su* public reports are us]-fri5dly to ! public & are writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,trade secrets & confid5tial in=mation ,?is section does n au?orize ! disclosure ( confid5tial comm]cial in=mation or trade secrets4 4 #cii,,oo-#a4 ,use ( civil p5alty am\nts ,! ,secret>y %all1 )\t fur!r appropriation1 collect civil p5alties "u section #cii,,oo & use ! funds d]iv$ f su* civil p5alties1 9 addition to any o!r am\nts available to ! ,secret>y1 to c>ry out activities describ$ 9 ?is "p & to improve consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ,congress1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is easy to f9d1 use1 & und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #cii,,oo2 & 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to section #cii,,oo4 7b7 ,trade secrets & confid5tial in=mation ,?is section does n au?orize ! disclosure ( confid5tial comm]cial in=mation or trade secrets4 4 #d4 ,/udy on fiduci>y duties ( ph>macy b5efit manag]s 7a7 ,9 g5]al ,! ,secret>y ( ,labor %all conduct1 & submit to ,congress a report describ+ ! results (1 a /udy on ! impacts ( a *ange 9 policy describ$ 9 subsection 7b74 7b7 ,policy describ$ ,"u a policy ref]r$ to 9 subsection 7a7-- 7#a7 an entity provid+ ph>macy b5efit managem5t s]vices w\ld be consid]$ a fiduci>y )9 ! mean+ ( section #c7ba7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajjb7ba77 ) respect to a gr\p heal? plan or gr\p heal? insurance cov]age2 & 7#b7 su* an entity w\ld-- 7,a7 be subject to ! responsibilities1 obligations1 & duties impos$ on fiduci>ies "u "p #d ( subtitle ,b ( title ,i ( su* ,act 7#bi ,u4,s4,c4 #aaja et seq472 & 7,b7 make ! requir$ fiduci>y disclosure "u section #djh7;b77#b77;,b77iii7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77iii77 ) respect to ! ph>macy b5efit managem5t s]vices provid$ to ! plan or cov]age4 7c7 ,def9ition ( ph>macy b5efit managem5t s]vices ,9 ?is section1 ! t]m ph>macy b5efit managem5t s]vices means s]vices relat$ to-- 7#a7 negotiat+ prices ) respect to prescription drugs on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age2 & 7#b7 manag+ ! prescription drug b5efits provid$ by su* plan or cov]age1 includ+ design+ & implem5t+ a drug =mul>y1 ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! adjudication ( appeals or grievances relat$ to ! prescription drug b5efit1 contract+ ) network ph>macies1 controll+ ! co/ ( cov]$ prescription drugs1 or ! provision ( relat$ s]vices4 #e4 ,cl>ification ( requirem5t to disclose direct & indirect comp5sation = brok]s & consultants to employ]-sponsor$ heal? plans 7a7 ,9 g5]al ,section #djh7;b77#b77;,b77ii77,i77bb7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77 is am5d$ by add+ at ! end ! foll[+3 7,,cc7 ,ph>macy b5efit managem5t s]vices provid$ by ph>macy b5efit manag]s or o!r s]vice provid]s & relat$ s]vices provid$ by ?ird-p>ty adm9i/rators 7or o!r entities provid+ su* s]vices7 = :i* ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive indirect comp5sation or direct comp5sation describ$ 9 item 7dd74 4 7b7 ,regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,labor %all promulgate regulations1 ?r\gh notice & comm5t rulemak+1 cl>ify+ ! requirem5ts ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 ) respect to cov]$ s]vice provid]s provid+ s]vices describ$ 9 subitem 7,,cc7 ( subclause 7,i77bb7 ( su* section1 z am5d$ by subsection 7a74 ,su* regulations %all apply ) respect to any plan ye> t beg9s on or aft] ! date t is #f mon?s aft] su* regulations are promulgat$4 7c7 ,s5se ( ,congress ,x is ! s5se ( ,congress t ! am5dm5t made by subsection 7a7 cl>ifies ! exi/+ requirem5t ( cov]$ s]vice provid]s ) respect to s]vices describ$ 9 section #djh7;b77#b77;,b77ii77,i77bb77,,bb7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77,,bb77 t 7 9 effect s9ce ! application date describ$ 9 section #bjb7;e7 ( ! ,no ,surprises ,act 7,public ,law #aaf-bfj2 #bi ,u4,s4,c4 #aajh note71 & does n impose any additional requirem5t "u section #djh7;b77#b77;,b7 ( su* ,act4 #f4 ,/udy on naloxone access 7a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on actions t may be tak5 to ensure appropriate access & af=dability ( naloxone = individuals seek+ to pur*ase naloxone4 ,su* /udy %all address :at is kn[n ab\t-- 7#a7 cov]age ( naloxone 79 any available =m71 includ+ :e!r naloxone c be cov]$ z an ov]-!-c\nt] drug "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia772 7#b7 ! out-(-pocket co/ to consum]s pur*as+ naloxone-- 7,a7 ) a prescription1 ) & )\t cov]age "u any su* plan or cov]age2 & 7,b7 ov] ! c\nt]1 ) & )\t cov]age "u any su* plan or cov]age2 & 7#c7 o!r factors impact+ cov]age1 includ+ b>ri]s 9 cov]+ naloxone z an ov]-!-c\nt] drug1 ! relative net co/s ( naloxone :5 pur*as$ ov] ! c\nt] )\t insurance cov]age comp>$ to :5 pur*as$ ) a prescription & cov]$ "u a gr\p heal? plan or heal? insurance cov]age1 & ! availability ( naloxone pur*as$ & di/ribut$ ?r\gh public heal? entities4 7b7 ,report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report t conta9s ! f9d+s ( ! /udy conduct$ "u subsection 7a74 #g4 ,prohibition on block+ consum] decision-support tools 7a7 ,,phsa ,"p ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 z am5d$ by section #b1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgii;,a-#ab4 ,prohibition on block+ consum] decision-support tools 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n ent] into a contract ) an entity t provides ph>macy b5efit managem5t s]vices ) respect to su* plan or cov]age if su* contract includes any t]ms1 conditions1 or co/s t w\ld prev5t or re/rict a cov]$ ?ird p>ty f access+ or us+ in=mation1 = purposes ( ! consum] decision-support tool1 relevant to ! op]ability1 implem5tation1 & utilization ( ! consum]-decision support tool reg>d+ prescription drug b5efits "u ! plan or cov]age t are adm9i/]$ by ! entity provid+ ph>macy b5efit managem5t s]vices 9 contract ) ! plan or issu]4 7b7 ,def9itions ,9 ?is section3 7#a7 ,consum] decision-support tool ,! t]m consum] decision-support tool means a tool design$ to in=m enrollees 9 a gr\p heal? plan or heal? insurance cov]age ab\t all co/s to ! enrollee = prescription drugs cov]$ by ! plan or cov]age1 includ+ out-(-pocket1 copaym5t1 & co9surance responsibility1 z well z means = r$uc+ ! co/ to ! enrollee1 su* z manufactur] copaym5t assi/ance1 pur*as+ at ! ca% price1 & pur*as+ ?r\gh mail ord] ph>macy b5efits4 7#b7 ,cov]$ ?ird p>ty ,! t]m cov]$ ?ird p>ty means a ?ird p>ty t is 9 contract1 z a bus9ess associate 7z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations771 ) a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age to provide a consum] decision-support tool4 7c7 ,rules ( con/ruction reg>d+ privacy 7#a7 ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations ( a cov]$ entity or bus9ess associate "u ! privacy1 security1 & brea* notification regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,no?+ 9 ?is section %all be con/ru$ to require a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices to %>e protect$ heal? in=mation1 z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 ) a cov]$ ?ird p>ty4 4 7b7 ,,erisa 7#a7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe et seq471 z am5d$ by section #b1 is fur!r am5d$ by add+ at ! end ! foll[+3 #gbg4 ,prohibition on block+ consum] decision-support tools 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all n ent] into a contract ) an entity t provides ph>macy b5efit managem5t s]vices ) respect to su* plan or cov]age if su* contract includes any t]ms1 conditions1 or co/s t w\ld prev5t or re/rict a cov]$ ?ird p>ty f access+ or us+ in=mation1 = purposes ( ! consum] decision-support tool1 relevant to ! op]ability1 implem5tation1 & utilization ( ! consum]-decision support tool reg>d+ prescription drug b5efits "u ! plan or cov]age t are adm9i/]$ by ! entity provid+ ph>macy b5efit managem5t s]vices 9 contract ) ! plan or issu]4 7b7 ,def9itions ,9 ?is section3 7#a7 ,consum] decision-support tool ,! t]m consum] decision-support tool means a tool design$ to in=m p>ticipants & b5efici>ies 9 a gr\p heal? plan or heal? insurance cov]age ab\t all co/s to ! p>ticipant or b5efici>y = prescription drugs cov]$ by ! plan or cov]age1 includ+ out-(-pocket1 copaym5t1 & co9surance responsibility1 z well z means = r$uc+ ! co/ to ! p>ticipant or b5efici>y1 su* z manufactur] copaym5t assi/ance1 pur*as+ at ! ca% price1 & pur*as+ ?r\gh mail ord] ph>macy b5efits4 7#b7 ,cov]$ ?ird p>ty ,! t]m cov]$ ?ird p>ty means a ?ird p>ty t is 9 contract1 z a bus9ess associate 7z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations771 ) a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age to provide a consum] decision-support tool4 7c7 ,rules ( con/ruction 7#a7 ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations ( a cov]$ entity or bus9ess associate "u ! privacy1 security1 & brea* notification regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,no?+ 9 ?is section %all be con/ru$ to require 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 to %>e protect$ heal? in=mation1 z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 ) a cov]$ ?ird p>ty4 4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq471 z am5d$ by section #b1 is fur!r am5d$ by ins]t+ aft] ! item relat+ to section #gbf ! foll[+3 ,sec4 #gbg4 ,prohibition on block+ consum] decision-support tools4 4 7c7 ,int]nal ,rev5ue ,code 7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #b1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #ihbg4 ,prohibition on block+ consum] decision-support tools 7a7 ,9 g5]al ,a gr\p heal? plan (f]+ gr\p heal? insurance cov]age %all n ent] into a contract ) an entity t provides ph>macy b5efit managem5t s]vices ) respect to su* plan if su* contract includes any t]ms1 conditions1 or co/s t w\ld prev5t or re/rict a cov]$ ?ird p>ty f access+ or us+ in=mation1 = purposes ( ! consum] decision-support tool1 relevant to ! op]ability1 implem5tation1 & utilization ( ! consum]-decision support tool reg>d+ prescription drug b5efits "u ! plan t are adm9i/]$ by ! entity provid+ ph>macy b5efit managem5t s]vices 9 contract ) ! plan4 7b7 ,def9itions ,9 ?is section3 7#a7 ,consum] decision-support tool ,! t]m consum] decision-support tool means a tool design$ to in=m p>ticipants & b5efici>ies 9 a gr\p heal? plan ab\t all co/s to ! p>ticipant or b5efici>y = prescription drugs cov]$ by ! plan1 includ+ out-(-pocket1 copaym5t1 & co9surance responsibility1 z well z means = r$uc+ ! co/ to ! p>ticipant or b5efici>y1 su* z manufactur] copaym5t assi/ance1 pur*as+ at ! ca% price1 & pur*as+ ?r\gh mail ord] ph>macy b5efits4 7#b7 ,cov]$ ?ird p>ty ,! t]m cov]$ ?ird p>ty means a ?ird p>ty t is 9 contract1 z a bus9ess associate 7z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations771 ) a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age to provide a consum] decision-support tool4 7c7 ,rules ( con/ruction 7#a7 ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations ( a cov]$ entity or bus9ess associate "u ! privacy1 security1 & brea* notification regulations 9 p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#b7 ,no?+ 9 ?is section %all be con/ru$ to require a gr\p heal? plan or an entity provid+ ph>macy b5efit managem5t s]vices to %>e protect$ heal? in=mation1 z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 ) a cov]$ ?ird p>ty4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( su* ,code1 z am5d$ by section #b1 is fur!r am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbg4 ,prohibition on block+ consum] decision-support tools4 4 7d7 ,application ,! am5dm5ts made by subsections 7a71 7b71 & 7c7 %all apply ) respect to plan ye>s beg9n+ on or aft] ! date t is #b ye>s aft] ! date ( enactm5t ( ?is ,act4 7e7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury %all jo9tly promulgate regulations to c>ry out ! am5dm5ts made by subsections 7a71 7b71 & 7c71 & %all issue draft regulations n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act4 #h4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation 7a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$ by ins]t+ aft] section #bgae;,a ! foll[+3 #bgae;,b4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all make available = access1 ex*ange1 & use )\t special ef=t1 ?r\gh application programm+ int]faces 7or successor te*nology or /&>ds71 consi/5t ) /&>ds & implem5tation specifications adopt$ "u section #cjjd1 ! in=mation describ$ 9 subsection 7b71 9 ! mann] describ$ 9 subsection 7b71 z applicable1 & o!rwise consi/5t ) ?is section4 7b7 ,electronic in=mation ,! foll[+ electronic in=mation is requir$ to be made available1 z ! ,secret>y may specify3 7#a7 ,hi/orical claims1 provid] enc\nt]1 & paym5t data = ea* enrollee1 :i*-- 7,a7 may include adjudicat$ m$ical & prescription drug claims & equival5t enc\nt]s1 includ+ all data elem5ts conta9$ 9 su* transactions-- 7i7 t 7 adjudicat$ by ! gr\p heal? plan or heal? insurance issu] dur+ ! previ\s #e ye>s or ! enrollee's entire p]iod ( enrollm5t 9 ! applicable plan or cov]age if su* p]iod is less ?an ! previ\s #e ye>s2 7ii7 t involve b5efits manag$ by any ?ird p>ty1 su* z a ph>macy b5efits manag] or radiology b5efits manag] t manages b5efits or adjudicates claims on behalf ( ! plan or cov]age2 & 7iii7 f any o!r gr\p heal? plan or heal? insurance cov]age (f]$ by ! same insurance issu]1 9 :i* ! same enrollee 0 enroll$ dur+ ! previ\s #e ye>s2 & 7,b7 %all be available to an enrollee or =m] enrollee1 ! enrollee's provid]s1 & any ?ird-p>ty applications or s]vices au?oriz$ by ! enrollee-- 7i7 ?r\gh ! application programm+ int]faces 7or successor te*nology or /&>ds7 consi/5t ) /&>ds & specifications adopt$ "u section #cjjd1 9 a s+le1 longitud9al =mat t is easy to und]/&1 secure1 & t may update automatically2 7ii7 z soon z practicable1 & 9 no case lat] ?an ! p]iod ( "t det]m9$ by ! ,secret>y1 aft] ! claim is adjudicat$ or ! data is receiv$ by ! gr\p heal? plan or heal? insurance issu]2 & 7iii7 = a p]iod ( #e ye>s aft] ! end date ( ! enrollee's enrollm5t 9 ! plan or 9 any cov]age (f]$ by ! heal? insurance issu]4 7#b7 ,id5tify+ directory in=mation = all 9-network provid]s1 includ+ facilities & practition]s1 t p>ticipate 9 ! plan or cov]age1 :i* %all-- 7,a7 include-- 7i7 ! national provid] id5tifi] = 9-network facilities & practition]s2 & 7ii7 ! "n1 address1 phone numb]1 & specialty = ea* su* facility & practition]1 )9 a timeframe det]m9$ by ! ,secret>y1 f :5 ! plan or cov]age receives provid] directory in=mation or updates f t facility or practition]2 7,b7 be capable ( return+ ! in=mation necess>y to e/abli% a li/ ( p>ticipat+ 9-network facilities & practition]s1 9 a giv5 specialty or at a p>ticul> facility type1 )9 a specifi$ geographic radius2 & 7,c7 be capable ( return+ ! network /atus1 :5 pres5t$ ) id5tifi]s = a giv5 enrollee & facility or practition]4 7#c7 ,e/imat$ enrollee out-(-pocket co/s1 includ+ co/s expect$ to be incurr$ ?r\gh a d$uctible1 co-paym5t1 co9surance1 or o!r =m ( co/-%>+1 =-- 7,a7 a designat$ set ( common s]vices or episodes ( c>e1 to be e/abli%$ by ! ,secret>y ?r\gh rulemak+1 includ+1 at a m9imum-- 7i7 9 ! case ( s]vices provid$ by a hospital1 ! #ajj mo/ common diagnosis-relat$ gr\ps1 z us$ 9 ! ,m$ic>e ,inpati5t ,prospective ,pati5t ,sy/em 7or successor episode-bas$ reimbursem5t me?odology7 at t hospital1 bas$ on claims data adjudicat$ by ! gr\p heal? plan or heal? insurance issu]2 7ii7 9 ! case ( s]vices provid$ 9 an out-pati5t sett+1 includ+ radiology1 lab te/s1 & out-pati5t surgical proc$ures1 any s]vice r5d]$ by ! facility or practition]1 & reimburs$ by ! gr\p heal? plan or heal? insurance issu]2 & 7iii7 9 ! case ( po/-acute c>e1 includ+ home heal? provid]s1 skill$ nurs+ facilities1 inpati5t rehabilitation facilities1 & long-t]m c>e hospitals1 ! pati5t out-(-pocket co/s = an episode ( c>e1 z ! ,secret>y may det]m9e1 :i* p]mits us]s to reasonably comp>e co/s across diff]5t facility & s]vice types2 & 7,b7 all prescription drugs curr5tly includ$ on any ti] ( ! =mul>y ( ! plan or cov]age4 7c7 ,availability & access ,subject to all applicable ,f$]al & ,/ate privacy1 security1 & brea* notification laws1 & )9 a timeframe det]m9$ by ! ,secret>y1 ! application programm+ int]faces 7or successor te*nology or /&>ds71 includ+ all data requir$ to be made available ?r\gh su* int]faces1 %all-- 7#a7 be made available by ! applicable gr\p heal? plan or heal? insurance issu]1 at no *>ge1 to-- 7,a7 enrollees & prospective enrollees 9 ! gr\p heal? plan or heal? insurance cov]age2 7,b7 ?ird p>ties au?oriz$ by ! enrollee2 7,c7 facilities & practition]s :o are "u contract ) ! plan or cov]age2 & 7,d7 bus9ess associates ( su* facilities & practition]s1 z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7#b7 be available to enrollees 9 ! gr\p heal? plan or heal? insurance cov]age1 & to ?ird-p>ty applications or s]vices facilitat+ su* access by enrollees1 dur+ ! enrollm5t process & = a m9imum ( #e ye>s aft] ! end date ( ! enrollee's enrollm5t 9 ! plan or 9 any cov]age (f]$ by ! heal? insurance issu]2 7#c7 p]mit p]si/5t access by ?ird-p>ty applications or s]vices au?oriz$ by ! enrollee1 = a reasonable p]iod ( "t2 7#d7 employ ! applicable cont5t1 vocabul>y1 & te*nical /&>ds1 z det]m9$ by ! ,secret>y pursuant to title ,,xxx2 & 7#e7 employ security & au!ntication /&>ds1 z ! ,secret>y det]m9es appropriate4 7d7 ,d5ial or discont9uance ( access ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age may d5y access or discont9ue access ( ! application programm+ int]faces 7or successor te*nology or /&>ds7 to ?ird-p>ty applications or s]vices on ! basis ( reasonable privacy or security conc]ns1 z det]m9$ by ! ,secret>y1 includ+ at ! reque/ ( ! enrollee4 7e7 ,notification ,:5 obta9+ enrollee au?orization to %>e in=mation ) a ?ird p>ty "u ?is section1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all include a notification = ! enrollee t in=mation %>$ ) a ?ird p>ty t is n a cov]$ entity or bus9ess associate is n subject to ! privacy1 security1 or brea* notification rules "u p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7f7 ,rule ( con/ruction reg>d+ privacy ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations ( a cov]$ entity or bus9ess associate "u ! privacy1 security1 & brea* notification rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act or section #acdjb ( ! ,,hite* ,act1 or to alt] ! ,secret>y's exi/+ au?ority to modify su* rules1 "u "p #b ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations71 "u section #ddd ( ! ,g5]al ,education ,provisions ,act 7#bj ,u4,s4,c4 #abcb;g7 7commonly ref]r$ to z ! ,family ,educational ,rights & ,privacy ,act ( #aigd71 "u ! am5dm5ts made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act1 or "u ,/ate privacy law4 4 7b7 ,effective date ,section #bgae;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 #i4 ,requir$ exceptions process = m$ication /ep !rapy protocols 7a7 ,%ort title ,?is section may be cit$ z ! ,safe ,/ep ,act4 7b7 ,requir$ exceptions process = m$ication /ep !rapy protocols ,! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by ins]t+ aft] section #gac ( su* ,act 7#bi ,u4,s4,c4 #aahe;b7 ! foll[+ new section3 #gac;,a4 ,requir$ exceptions process = m$ication /ep !rapy protocols 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ cov]age (f]$ 9 connection ) su* a plan t provides cov]age ( a prescription drug pursuant to a m$ication /ep !rapy protocol1 ! plan or issu] %all-- 7#a7 implem5t a cle>1 prompt1 & transp>5t process = a p>ticipant or b5efici>y 7or ! prescrib+ heal? c>e provid] 7ref]r$ to 9 ?is section z ! prescrib]7 on behalf ( ! p>ticipant or b5efici>y7 to reque/ an exception to su* m$ication /ep !rapy protocol1 pursuant to subsection 7b72 & 7#b7 :]e ! p>ticipant or b5efici>y or prescrib]'s reque/ = an exception to ! m$ication /ep !rapy protocols satisfies ! crit]ia & requirem5ts ( subsection 7b71 cov] ! reque/$ drug 9 accordance ) ! t]ms e/abli%$ by ! plan or cov]age = pati5t co/-%>+ rates or am\nts at ! beg9n+ ( ! plan ye>4 7b7 ,circum/ances = exception approval ,! circum/ances requir+ an exception to a m$ication /ep !rapy protocol1 pursuant to a reque/ "u subsection 7a71 are any ( ! foll[+3 7#a7 ,any treatm5ts o!rwise requir$ "u ! protocol1 or treatm5ts 9 ! same ph>macological class or hav+ ! same me*anism ( action1 includ+ treatm5ts provid$ prior to ! effective date ( ! p>ticipant's or b5efici>y's cov]age "u ! plan or cov]age1 h be5 ineffective 9 ! treatm5t ( ! disease or condition ( ! p>ticipant or b5efici>y1 :5 prescrib$ consi/5t ) cl9ical indications1 cl9ical guidel9es1 or o!r pe]-review$ evid5ce1 bas$ on ! prescrib+ heal? c>e pr(essional's judgem5t or relevant in=mation provid$ by ! p>ticipant or b5efici>y 7includ+ ! m$ical records ( ! p>ticipant or b5efici>y74 7#b7 ,delay ( effective treatm5t w\ld lead to sev]e or irrev]sible consequ5ces1 or wors5 disease progression or a comorbidity & ! treatm5t o!rwise requir$ "u ! protocol is reasonably expect$ by ! prescrib] to be ineffective bas$ ^u ! docum5t$ physical or m5tal *>act]i/ics ( ! p>ticipant or b5efici>y & ! kn[n *>act]i/ics ( su* treatm5t4 7#c7 ,any treatm5ts o!rwise requir$ "u ! protocol are contra9dicat$ = ! p>ticipant or b5efici>y or h caus$1 or are likely to cause1 bas$ on cl9ical1 pe]-review$ evid5ce1 an adv]se reaction or o!r physical or m5tal h>m to ! p>ticipant or b5efici>y4 7#d7 ,any treatm5t o!rwise requir$ "u ! protocol has prev5t$1 w prev5t1 or is likely to prev5t a p>ticipant or b5efici>y f a*iev+ or ma9ta9+ reasonable & safe functional ability 9 p]=m+ occupational responsibilities or activities ( daily liv+ 7z def9$ 9 section #dda4eje ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations774 7#e7 ,! p>ticipant or b5efici>y is /able = 8 or h] disease or condition on ! prescription drug or drugs select$ by ! prescrib] & has previ\sly receiv$ approval = cov]age ( ! relevant drug or drugs = ! disease or condition by any public or private heal? plan4 7#f7 ,o!r circum/ances1 z det]m9$ by ! ,secret>y4 7c7 ,requirem5t ( a cle> process 7#a7 ,9 g5]al ,! process requir$ by subsection 7a7 %all-- 7,a7 provide ! prescrib] or p>ticipant or b5efici>y an opportunity to pres5t su* prescrib]'s cl9ical rationale & relevant m$ical in=mation = ! gr\p heal? plan or heal? insurance issu] to evaluate su* reque/ = exception2 7,b7 develop & use a /&>d =m & in/ructions = ! reque/ ( an exception "u subsection 7b71 available 9 pap] & electronic =ms1 & all[ = submission ( su* =m by pap] & electronic means2 7,c7 provide bo? pap] & electronic means = ! submission ( reque/s = additional in=mation2 7,d7 cle>ly set =? all requir$ in=mation & ! specific crit]ia t w be us$ to det]m9e :e!r an exception is w>rant$1 :i* may require disclosure (-- 7i7 ! m$ical hi/ory or o!r heal? records ( ! p>ticipant or b5efici>y demon/rat+ t ! p>ticipant or b5efici>y seek+ an exception-- 7,i7 has tri$ o!r drugs includ$ 9 ! drug !rapy class )\t success2 or 7,,ii7 has tak5 ! reque/$ drug = a cl9ically appropriate am\nt ( "t to e/abli% /ability1 9 relation to ! condition be+ treat$ & prescription guidel9es giv5 by ! prescrib+ physician2 or 7ii7 o!r cl9ical in=mation t may be relevant to conduct+ ! exception review2 7,e7 n require ! submission ( any in=mation or support+ docum5tation beyond :at is /rictly necess>y 7z det]m9$ by ! ,secret>y7 to det]m9e :e!r a circum/ance li/$ 9 subsection 7b7 exi/s2 7,f7 cle>ly outl9e conditions "u :i* an exception reque/ w>rants exp$it$ resolution f ! gr\p heal? plan or heal? insurance issu]1 pursuant to subsection 7d77#b72 & 7,g7 all[ a repres5tative ( a p>ticipant or b5efici>y1 :i* may include a designat$ ?ird-p>ty advocate1 to act on behalf ( ! p>ticipant or b5efici>y4 7#b7 ,availability ( process in=mation ,! gr\p heal? plan or heal? insurance issu] %all make in=mation reg>d+ ! process requir$ "u subsection 7a7 readily available 9 ! relevant plan mat]ials1 includ+ ! summ>y ( b5efits &1 if available1 on ! website ( ! gr\p heal? plan or heal? insurance issu]4 ,su* in=mation %all include-- 7,a7 ! requirem5ts = reque/+ an exception to a m$ication /ep !rapy protocol pursuant to ?is section2 & 7,b7 any =ms1 support+ in=mation1 & contact in=mation1 z appropriate4 7d7 ,tim+ = det]m9ation ( exception ,! process requir$ "u subsection 7a77#a7 %all provide = ! disposition ( reque/s receiv$ "u su* p>agraph 9 accordance ) ! foll[+3 7#a7 ,subject to p>agraph 7#b71 n lat] ?an #gb h\rs aft] receiv+ an initial exception reque/1 ! plan or issu] %all respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib] ) ei!r a det]m9ation ( exception eligibility or a reque/ = additional requir$ in=mation /rictly necess>y to make a det]m9ation ( :e!r ! conditions specifi$ 9 subsection 7b7 are met4 ,! plan or issu] %all respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib]1 ) a det]m9ation ( exception eligibility no lat] ?an #gb h\rs aft] receipt ( ! additional requir$ in=mation4 7#b7 ,9 ! case ( a reque/ "u circum/ances 9 :i* ! applicable m$ication /ep !rapy protocol may s]i\sly jeop>dize ! life or heal? ( ! p>ticipant or b5efici>y1 may jeop>dize ! ability ( ! p>ticipant or b5efici>y to rega9 maximum function1 or may subject ! p>ticipant or b5efici>y to sev]e pa9 t _c be adequately manag$ )\t ! treatm5t t is ! subject ( ! reque/1 ! plan or issu] %all conduct a review ( ! reque/ & respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib]1 ) ei!r a det]m9ation ( exception eligibility or a reque/ = additional requir$ in=mation /rictly necess>y to make a det]m9ation ( :e!r ! conditions specifi$ 9 subsection 7b7 are met1 9 accordance ) ! foll[+3 7,a7 ,if ! plan or issu] c make a det]m9ation ( exception eligibility )\t additional in=mation1 su* det]m9ation %all be made on an exp$it$ basis1 & no lat] ?an #bd h\rs aft] receipt ( su* reque/4 7,b7 ,if ! plan or issu] requires additional in=mation be=e mak+ a det]m9ation ( exception eligibility1 ! plan or issu] %all respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib]1 ) a reque/ = su* in=mation )9 #bd h\rs ( ! reque/ = a det]m9ation1 & %all respond ) a det]m9ation ( exception eligibility z quickly z ! condition or disease requires1 & no lat] ?an #bd h\rs aft] receipt ( ! additional requir$ in=mation4 7e7 ,duration ( a grant ,if an exception to a m$ication /ep !rapy protocol is grant$ "u ?is section to a p>ticipant or b5efici>y1 cov]age = ! reque/$ drug %all rema9 9 effect ) respect to su* p>ticipant or b5efici>y = n less ?an "o ye>4 7f7 ,m$ication /ep !rapy protocol ,9 ?is section1 ! t]m m$ication /ep !rapy protocol means a drug !rapy utilization managem5t protocol or program "u :i* a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age ( prescription drugs requires a p>ticipant or b5efici>y to try an alt]native pref]r$ prescription drug or drugs be=e ! plan or heal? insurance issu] approves cov]age = ! non-pref]r$ drug !rapy prescrib$4 7g7 ,cl>ification ,?is section %all apply ) respect to any gr\p heal? plan or heal? insurance cov]age (f]$ 9 connection ) su* a plan t provides cov]age ( a prescription drug pursuant to a policy t meets ! def9ition ( ! t]m m$ication /ep !rapy protocol 9 subsection 7f71 reg>dless ( :e!r su* policy is describ$ by su* gr\p heal? plan or heal? insurance cov]age z a /ep !rapy protocol4 7h7 ,report+ 7#a7 ,report+ to ! ,secret>y ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,safe ,/ep ,act & n lat] ?an ,octob] #a ( ea* ye> !reaft]1 ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all report to ! ,secret>y1 9 su* mann] z ! ,secret>y %all require1 ! foll[+3 7,a7 ,! numb] ( /ep !rapy exception reque/s receiv$ = ea* exception circum/ance describ$ 9 p>agraphs 7#a7 ?r\gh 7#f7 ( subsection 7b71 & ! numb]s ( su* reque/s = ea* su* circum/ance t 7-- 7i7 approv$2 7ii7 deem$ approv$ "u subsection 7d77#c7 due to ! failure ( ! plan or issu] to timely respond2 7iii7 d5i$1 & ! reasons = ! d5ials2 7iv7 initially d5i$ & appeal$2 & 7v7 initially d5i$ & !n subsequ5tly rev]s$ by int]nal appeals or ext]nal reviews4 7,b7 ,! numb] ( times a plan or issu] reque/$ additional in=mation 9 response to a /ep !rapy exception reque/1 by exception circum/ance describ$ 9 p>agraphs 7#a7 ?r\gh 7#f7 ( subsection 7b74 7,c7 ,! numb] ( exception reque/s submitt$ by p>ticipants or b5efici>ies1 & ! numb] ( exception reque/s submitt$ by prescrib]s1 by m$ical specialty4 7,d7 ,! m$ical conditions = :i* p>ticipants & b5efici>ies 7 grant$ exceptions due to ! likelihood t swit*+ f a prescription drug w likely cause an adv]se reaction by1 or physical or m5tal h>m to1 ! p>ticipant or b5efici>y1 z describ$ 9 subsection 7b77#c74 7,e7 ,! entities responsible = provid+ ph>macy b5efit managem5t s]vices = ! gr\p heal? plan or heal? insurance cov]age4 7#b7 ,in=mation ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all n ent] into a contract ) a ?ird-p>ty adm9i/rator or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! plan or cov]age t prev5ts ! plan or issu] f obta9+ f ! ?ird-p>ty adm9i/rator or ! entity provid+ ph>macy b5efit managem5t s]vices any in=mation ne$$ = ! plan or issu] to comply ) ! report+ requirem5ts "u p>agraph 7#a74 7#c7 ,reports to ,congress ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,safe ,/ep ,act1 & n lat] ?an ,octob] #a ( ea* ye> !reaft]1 ! ,secret>y %all submit to ,congress1 & make publicly available1 a report t conta9s a summ>y & analysis ( ! in=mation report$ "u p>agraph 7#a71 includ+ an analysis (1 ) respect to reque/s = exceptions "u ?is section1 approvals1 & d5ials1 includ+ ! reasons = d5ials2 appeals & ext]nal reviews2 & tr5ds1 if any1 9 exception reque/s by m$ical specialty or m$ical condition4 4 7c7 ,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 #gac ! foll[+ new items3 ,sec4 #gac;,a4 ,requir$ exceptions process = m$ication /ep !rapy protocols4 4 7d7 ,effective date 7#a7 ,9 g5]al ,! am5dm5t made by subsection 7b7 applies ) respect to plan ye>s beg9n+ ) ! fir/ plan ye> t beg9s at lea/ #f mon?s aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,regulations ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,labor %all issue f9al regulations1 ?r\gh notice & comm5t rulemak+1 to implem5t ! provisions ( section #gac;,a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z add$ by subsection 7b74 ,june #bb1 #bjbc,report$ ) an am5dm5t