,i #aai? ,,congress #a/ ,session ,h4 ,r4 #bdej ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #bg1 #bjbe,ms4 ,mc,donald ,rivet 7= h]self1 ,mr4 ,c>t] ( ,georgia1 ,mr4 ,m55dez1 & ,mr4 ,james7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,education & ,work=ce1 & ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act1 ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 & ! ,int]nal ,rev5ue ,code ( #aihd to increase ov]sight ( ph>macy b5efit managem5t s]vices1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prescription ,drug ,transp>5cy & ,af=dability ,act4 #b4 ,ov]sight ( 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$-- 7#a7 9 "p ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section 7ref]r$ to 9 ?is subsection & subsection 7b7 z ! effective date71 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 %all n ent] into a contract1 includ+ an ext5sion or r5ewal ( a contract1 ent]$ into on or aft] ! effective date1 ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit or delay ! disclosure ( in=mation to ! gr\p heal? plan 7includ+ su* a plan (f]$ ?r\gh a heal? insurance issu]7 9 su* a mann] t prev5ts 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 mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] 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] ! effective date1 9 ! case ( any contract betwe5 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan & an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]1 includ+ an ext5sion or r5ewal ( su* a contract1 ent]$ into on or aft] ! effective date1 ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a gr\p heal? plan or heal? insurance issu]1 n less frequ5tly ?an e #f mon?s 7or1 at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 & "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 pla9 language1 9 a ma*9e-readable =mat1 & z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan or gr\p heal? insurance cov]age (f]$ by a heal? insurance issu] 9 connection ) a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan1 & is n (f]$ z heal? insurance cov]age1 or 9 ! case ( heal? insurance cov]age = :i* ! election "u p>agraph 7#c7 is made = ! applicable report+ p]iod-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! contract$ comp5sation paid by ! gr\p heal? plan or heal? insurance issu] = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code7 to ! entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]2 7,,ii7 ! contract$ comp5sation paid to ! ph>macy1 by any entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]1 = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code72 7,,iii7 = ea* su* claim1 ! diff]5ce betwe5 ! am\nt paid "u subclause 7,i7 & ! am\nt paid "u subclause 7,,ii72 7,,iv7 ! propriet>y "n1 e/abli%$ "n or prop] "n1 & ,national ,drug ,code2 7,v7 = ea* claim = ! drug 7includ+ orig9al prescriptions & refills7 & = ea* dosage unit ( ! drug = :i* a claim 0 fil$1 ! type ( disp5s+ *annel us$ to furni% ! drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,vi7 ) respect to ea* drug disp5s$1 = ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$ ?r\gh ! applicable disp5s+ *annel2 7,,cc7 dosage units & dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,vii7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan or cov]age aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation receiv$ f applicable entities2 7,,viii7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug1 includ+ 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]age1 or = :i* no claim is submitt$ "u ! plan or cov]age2 7,,ix7 ! total net sp5d+ on ! drug2 7,x7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7,,xi7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( su* drug or sp5d+ on su* drug2 & 7,,xii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drug1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]71 to ! p>ticipants & b5efici>ies enroll$ 9 su* plan or cov]age2 7ii7 a li/ ( ea* !rapeutic class 7z def9$ by ! ,secret>y7 = :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-- 7,i7 ! total gross sp5d+ on drugs 9 su* class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,ii7 ! net sp5d+ 9 su* class aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,iii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,iv7 ! 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,v7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 su* class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,vi7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 & 7,,vii7 ! total out-(-pocket sp5d+ "u ! plan or cov]age by p>ticipants & b5efici>ies1 includ+ 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$ "u ! plan or cov]age2 7iii7 ) respect to any drug = :i* gross sp5d+ "u ! gr\p heal? plan or heal? insurance cov]age exce$$ #aj1jjj dur+ ! report+ p]iod or1 9 ! case t gross sp5d+ "u ! gr\p heal? plan or cov]age exce$$ #aj1jjj dur+ ! report+ p]iod ) respect to few] ?an #ej drugs1 ) respect to ! #ej prescription drugs ) ! highe/ sp5d+ dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class z su* drug2 7,,ii7 if applicable1 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 & 7iv7 9 ! case t su* plan or issu] 7or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]7 has an affiliat$ ph>macy or ph>macy "u common own]%ip1 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 s]vices-- 7,i7 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>macies2 7,,ii7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to p>ticipants or b5efici>ies 9 su* plan or cov]age2 & 7,,iii7 a li/ ( all drugs disp5s$ by su* ph>macies to p>ticipants or b5efici>ies enroll$ 9 su* plan or cov]age1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan or issu]1 & to p>ticipants & b5efici>ies2 7bb7 ! m$ian am\nt *>g$ to su* plan or issu]1 & ! 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 ( su* plan or cov]age2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan or cov]age & to p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( su* plan or cov]age2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 & 7,b7 ) respect to any gr\p heal? plan1 includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan1 reg>dless ( :e!r ! plan or cov]age is (f]$ by a specifi$ l>ge employ] or :e!r x is a specifi$ l>ge plan-- 7i7 a summ>y docum5t = ! gr\p heal? plan t includes su* in=mation describ$ 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,a71 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+71 t ! ,secret>y det]m9es useful to gr\p heal? plans = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to gr\p heal? plan & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y2 7ii7 a summ>y docum5t = plans & issu]s to provide to p>ticipants & b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to _! gr\p heal? plan 7includ+ 9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan71 t-- 7,i7 conta9s su* in=mation describ$ 9 clauses 7iii71 7iv71 7v71 & 7vi71 z applicable1 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+7 t ! ,secret>y det]m9es useful to p>ticipants or b5efici>ies 9 bett] und]/&+ ! plan or cov]age or b5efits "u su* plan or cov]age2 7,,ii7 conta9s only aggregate in=mation2 & 7,,iii7 /ates t p>ticipants & b5efici>ies may reque/ specific1 claims-level in=mation requir$ to be furni%$ "u subsection 7c7 f ! gr\p heal? plan or heal? insurance issu]2 & 7iii7 ) respect to drugs cov]$ by su* plan or cov]age dur+ su* report+ p]iod-- 7,i7 ! total net sp5d+ by ! plan or cov]age = all su* drugs2 7,,ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 & 7,,iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drugs1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]7 to p>ticipants & b5efici>ies2 7iv7 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 ,act7 to brok]age firms1 brok]s1 consultants1 advisors1 or any o!r individual or firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to an entity provid+ ph>macy b5efit managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,,ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan or heal? insurance issu]2 or 7,,iii7 ! ret5tion ( ! entity by ! gr\p heal? plan or heal? insurance issu]2 7v7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 su* 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 "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7vi7 total gross sp5d+ on all drugs "u ! plan or cov]age dur+ ! report+ p]iod4 7#c7 ,opt-9 = gr\p heal? insurance cov]age (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan ,9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or is a specifi$ l>ge plan1 su* 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 ( ?is section1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! heal? insurance issu] to submit to su* gr\p heal? plan a report t includes all ( ! in=mation describ$ 9 p>agraph 7#b77;,a71 9 addition to ! in=mation describ$ 9 p>agraph 7#b77;,b74 7#d7 ,privacy requirem5ts 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all report in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,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 t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,9 c>ry+ out ?is subsection1 a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation71 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction 7i7 ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,no?+ 9 ?is section %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et sec71 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 gr\p heal? plans1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age to submit reports to gr\p heal? plans "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa privacy regulations4 7,f7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t 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]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n-- 7i7 re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury2 or 7ii7 prev5t disclosure = ! purposes ( subsection 7c71 or any o!r public disclosure requirem5t "u ?is section4 7,g7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to any gr\p heal? plan e/abli%$ by a plan sponsor t is1 or is affiliat$ )1 a drug manufactur]1 drug :olesal]1 or o!r direct p>ticipant 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,/&>d =mat & regulations 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ a /&>d =mat = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans & heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 to submit reports requir$ "u p>agraph 7#a74 7,b7 ,additional regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all1 ?r\gh rulemak+1 promulgate any o!r f9al regulations necess>y to implem5t ! requirem5ts ( ?is section4 ,9 promulgat+ su* regulations1 ! ,secret>y %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is section ) ! report+ requirem5ts "u section #bgii;,a-#aj4 7c7 ,requirem5t ,to provide in=mation to p>ticipants or b5efici>ies ,a gr\p heal? plan1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 ^u reque/ ( a p>ticipant or b5efici>y1 %all provide to su* p>ticipant or b5efici>y-- 7#a7 ! summ>y docum5t describ$ 9 subsection 7b77#b77;,b77ii72 & 7#b7 ! in=mation describ$ 9 subsection 7b77#b77;,a77i77,,iii7 ) respect to a claim made by or on behalf ( su* p>ticipant or b5efici>y4 7d7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y %all en=ce ?is section4 ,! en=cem5t au?ority "u ?is subsection %all apply only ) respect to gr\p heal? plans 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 to :i* ! requirem5ts ( subp>ts ,i & ,,ii ( "p ,a & "p ,d apply 9 accordance ) section #bgbb1 & ) respect to entities provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plans & applicable entities provid+ s]vices on behalf ( su* plans4 7#b7 ,failure to provide in=mation ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or an applicable entity provid+ s]vices on behalf ( su* a plan or issu] t violates subsection 7a72 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] t fails to provide ! in=mation requir$ "u subsection 7b72 or a gr\p heal? plan t fails to provide ! in=mation requir$ "u subsection 7c71 %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$4 7#c7 ,false in=mation ,a heal? insurance issu]1 an entity provid+ ph>macy b5efit managem5t s]vices1 or a ?ird p>ty adm9i/rator provid+ s]vices on behalf ( su* issu] (f]$ by a heal? insurance issu] t kn[+ly provides false in=mation "u ?is section %all be subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil monet>y 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 su* section4 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 ) ! requirem5ts 9 ?is section4 7e7 ,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 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 7f7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! 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>y may specify ?r\gh rulemak+4 7#b7 ,applicable gr\p pur*as+ organization ,! 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]vices4 7#c7 ,contract$ comp5sation ,! t]m contract$ comp5sation means ! sum ( any +r$i5t co/ & disp5s+ fee = a drug 7inclusive ( ! out-(-pocket co/s to ! p>ticipant or b5efici>y71 or ano!r analog\s comp5sation /ructure t ! ,secret>y may specify ?r\gh regulations4 7#d7 ,gross sp5d+ ,! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#e7 ,net sp5d+ ,! 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]ation4 7#f7 ,plan sponsor ,! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd4 7#g7 ,remun]ation ,! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y ?r\gh rulemak+1 :i* %all be reevaluat$ by ! ,secret>y e #e ye>s4 7#h7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ajj employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7#i7 ,specifi$ l>ge plan ,! t]m specifi$ l>ge plan means a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd t _h an av]age ( at lea/ #ajj p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 7#aj7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 2 & 7#b7 9 section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7ii7 9 p>agraph 7#b71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 7ii7 9 p>agraph 7#b77;,a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7iii7 9 p>agraph 7#b77;,c77ii71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d4 7b7 ,employee ,retirem5t ,income ,security ,act ( #aigd 7#a7 ,9 g5]al ,subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is am5d$-- 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 ( ?is section 7ref]r$ to 9 ?is subsection & subsection 7b7 z ! effective date71 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 %all n ent] into a contract1 includ+ an ext5sion or r5ewal ( a contract1 ent]$ into on or aft] ! effective date1 ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit or delay ! disclosure ( in=mation to ! gr\p heal? plan 7includ+ su* a plan (f]$ ?r\gh a heal? insurance issu]7 9 su* a mann] t prev5ts 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 mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] 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] ! effective date1 9 ! case ( any contract betwe5 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan & an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]1 includ+ an ext5sion or r5ewal ( su* a contract1 ent]$ into on or aft] ! effective date1 ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a gr\p heal? plan or heal? insurance issu]1 n less frequ5tly ?an e #f mon?s 7or1 at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 & "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 pla9 language1 9 a ma*9e-readable =mat1 & z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan or gr\p heal? insurance cov]age (f]$ by a heal? insurance issu] 9 connection ) a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan1 & is n (f]$ z heal? insurance cov]age1 or 9 ! case ( heal? insurance cov]age = :i* ! election "u p>agraph 7#c7 is made = ! applicable report+ p]iod-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! contract$ comp5sation paid by ! gr\p heal? plan or heal? insurance issu] = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code7 to ! entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]2 7,,ii7 ! contract$ comp5sation paid to ! ph>macy1 by any entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]1 = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code72 7,,iii7 = ea* su* claim1 ! diff]5ce betwe5 ! am\nt paid "u subclause 7,i7 & ! am\nt paid "u subclause 7,,ii72 7,,iv7 ! propriet>y "n1 e/abli%$ "n or prop] "n1 & ,national ,drug ,code2 7,v7 = ea* claim = ! drug 7includ+ orig9al prescriptions & refills7 & = ea* dosage unit ( ! drug = :i* a claim 0 fil$1 ! type ( disp5s+ *annel us$ to furni% ! drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,vi7 ) respect to ea* drug disp5s$1 = ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$ ?r\gh ! applicable disp5s+ *annel2 7,,cc7 dosage units & dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,vii7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan or cov]age aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation receiv$ f applicable entities2 7,,viii7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug1 includ+ 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]age1 or = :i* no claim is submitt$ "u ! plan or cov]age2 7,,ix7 ! total net sp5d+ on ! drug2 7,x7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7,,xi7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( su* drug or sp5d+ on su* drug2 & 7,,xii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drug1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]71 to ! p>ticipants & b5efici>ies enroll$ 9 su* plan or cov]age2 7ii7 a li/ ( ea* !rapeutic class 7z def9$ by ! ,secret>y7 = :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-- 7,i7 ! total gross sp5d+ on drugs 9 su* class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,ii7 ! net sp5d+ 9 su* class aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,iii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,iv7 ! 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,v7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 su* class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,vi7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 & 7,,vii7 ! total out-(-pocket sp5d+ "u ! plan or cov]age by p>ticipants & b5efici>ies1 includ+ 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$ "u ! plan or cov]age2 7iii7 ) respect to any drug = :i* gross sp5d+ "u ! gr\p heal? plan or heal? insurance cov]age exce$$ #aj1jjj dur+ ! report+ p]iod or1 9 ! case t gross sp5d+ "u ! gr\p heal? plan or cov]age exce$$ #aj1jjj dur+ ! report+ p]iod ) respect to few] ?an #ej drugs1 ) respect to ! #ej prescription drugs ) ! highe/ sp5d+ dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class z su* drug2 7,,ii7 if applicable1 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 & 7iv7 9 ! case t su* plan or issu] 7or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]7 has an affiliat$ ph>macy or ph>macy "u common own]%ip1 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 s]vices-- 7,i7 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>macies2 7,,ii7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to p>ticipants or b5efici>ies 9 su* plan or cov]age2 & 7,,iii7 a li/ ( all drugs disp5s$ by su* ph>macies to p>ticipants or b5efici>ies enroll$ 9 su* plan or cov]age1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan or issu]1 & to p>ticipants & b5efici>ies2 7bb7 ! m$ian am\nt *>g$ to su* plan or issu]1 & ! 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 ( su* plan or cov]age2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan or cov]age & to p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( su* plan or cov]age2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 & 7,b7 ) respect to any gr\p heal? plan1 includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan1 reg>dless ( :e!r ! plan or cov]age is (f]$ by a specifi$ l>ge employ] or :e!r x is a specifi$ l>ge plan-- 7i7 a summ>y docum5t = ! gr\p heal? plan t includes su* in=mation describ$ 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,a71 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+71 t ! ,secret>y det]m9es useful to gr\p heal? plans = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to gr\p heal? plan & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y2 7ii7 a summ>y docum5t = plans & issu]s to provide to p>ticipants & b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to _! gr\p heal? plan 7includ+ 9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan71 t-- 7,i7 conta9s su* in=mation describ$ 9 clauses 7iii71 7iv71 7v71 & 7vi71 z applicable1 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+7 t ! ,secret>y det]m9es useful to p>ticipants or b5efici>ies 9 bett] und]/&+ ! plan or cov]age or b5efits "u su* plan or cov]age2 7,,ii7 conta9s only aggregate in=mation2 & 7,,iii7 /ates t p>ticipants & b5efici>ies may reque/ specific1 claims-level in=mation requir$ to be furni%$ "u subsection 7c7 f ! gr\p heal? plan or heal? insurance issu]2 7iii7 ) respect to drugs cov]$ by su* plan or cov]age dur+ su* report+ p]iod-- 7,i7 ! total net sp5d+ by ! plan or cov]age = all su* drugs2 7,,ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 & 7,,iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drugs1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]7 to p>ticipants & b5efici>ies2 7iv7 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]age firms1 brok]s1 consultants1 advisors1 or any o!r individual or firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to an entity provid+ ph>macy b5efit managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,,ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan or heal? insurance issu]2 or 7,,iii7 ! ret5tion ( ! entity by ! gr\p heal? plan or heal? insurance issu]2 7v7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 su* 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 "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7vi7 total gross sp5d+ on all drugs "u ! plan or cov]age dur+ ! report+ p]iod4 7#c7 ,opt-9 = gr\p heal? insurance cov]age (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan ,9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or is a specifi$ l>ge plan1 su* 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 ( ?is section1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! heal? insurance issu] to submit to su* gr\p heal? plan a report t includes all ( ! in=mation describ$ 9 p>agraph 7#b77;,a71 9 addition to ! in=mation describ$ 9 p>agraph 7#b77;,b74 7#d7 ,privacy requirem5ts 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all report in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a77 & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,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 t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,9 c>ry+ out ?is subsection1 a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation71 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction 7i7 ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,no?+ 9 ?is section %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et sec71 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 gr\p heal? plans1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age to submit reports to gr\p heal? plans "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa privacy regulations4 7,f7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t 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]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n-- 7i7 re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury2 or 7ii7 prev5t disclosure = ! purposes ( subsection 7c71 or any o!r public disclosure requirem5t "u ?is section4 7,g7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to any gr\p heal? plan e/abli%$ by a plan sponsor t is1 or is affiliat$ )1 a drug manufactur]1 drug :olesal]1 or o!r direct p>ticipant 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,/&>d =mat & regulations 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ a /&>d =mat = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans & heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 to submit reports requir$ "u p>agraph 7#a74 7,b7 ,additional regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all1 ?r\gh rulemak+1 promulgate any o!r f9al regulations necess>y to implem5t ! requirem5ts ( ?is section4 ,9 promulgat+ su* regulations1 ! ,secret>y %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is section ) ! report+ requirem5ts "u section #gbe4 7c7 ,requirem5t ,to provide in=mation to p>ticipants or b5efici>ies ,a gr\p heal? plan1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 ^u reque/ ( a p>ticipant or b5efici>y1 %all provide to su* p>ticipant or b5efici>y-- 7#a7 ! summ>y docum5t describ$ 9 subsection 7b77#b77;,b77ii72 & 7#b7 ! in=mation describ$ 9 subsection 7b77#b77;,a77i77,,iii7 ) respect to a claim made by or on behalf ( su* p>ticipant or b5efici>y4 7d7 ,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 to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 or 7c7 ( ?is section or section #ejb7;c77#ac7 by su* issu]1 plan1 or entity4 7e7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! 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>y may specify ?r\gh rulemak+4 7#b7 ,applicable gr\p pur*as+ organization ,! 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]vices4 7#c7 ,contract$ comp5sation ,! t]m contract$ comp5sation means ! sum ( any +r$i5t co/ & disp5s+ fee = a drug 7inclusive ( ! out-(-pocket co/s to ! p>ticipant or b5efici>y71 or ano!r analog\s comp5sation /ructure t ! ,secret>y may specify ?r\gh regulations4 7#d7 ,gross sp5d+ ,! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#e7 ,net sp5d+ ,! 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]ation4 7#f7 ,plan sponsor ,! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b74 7#g7 ,remun]ation ,! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y ?r\gh rulemak+1 :i* %all be reevaluat$ by ! ,secret>y e #e ye>s4 7#h7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ajj employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7#i7 ,specifi$ l>ge plan ,! t]m specifi$ l>ge plan means a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 t _h an av]age ( at lea/ #ajj p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 7#aj7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 7,b7 9 section #ejb 7#bi ,u4,s4,c4 #aacb7-- 7i7 9 subsection 7a77#f71 by /rik+ or 7#i7 & ins]t+ 7#i71 or 7#ac72 7ii7 9 subsection 7b77#c71 by /rik+ "u subsection 7c77#i7 & ins]t+ "u p>agraphs 7#i7 & 7#ac7 ( subsection 7c72 & 7iii7 9 subsection 7c71 by add+ at ! end ! foll[+3 7#ac7 ,secret>ial en=cem5t au?ority relat+ to ov]sight ( ph>macy b5efit managem5t s]vices 7,a7 ,failure to provide in=mation ,! ,secret>y may impose a p5alty aga9/ a plan adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or an applicable entity 7z def9$ 9 section #gbf7;f77 t violates section #gbf7;a72 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] t fails to provide ! in=mation requir$ "u section #gbf7;b72 or any p]son :o causes a gr\p heal? plan to fail to provide ! in=mation requir$ "u section #gbf7;c71 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7,b7 ,false in=mation ,! ,secret>y may impose a p5alty aga9/ a plan adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 an entity provid+ ph>macy b5efit managem5t s]vices1 or an applicable entity 7z def9$ 9 section #gbf7;f77 t kn[+ly provides false in=mation "u section #gbf1 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7,c7 ,waiv]s ,! ,secret>y may waive p5alties "u subp>agraph 7,a71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( section #gbf t has made a good-fai? ef=t to comply ) ! requirem5ts ( section #gbf4 2 & 7,c7 9 section #gcb7;a7 7#bi ,u4,s4,c4 #aaia;a7a771 by /rik+ section #gaa & ins]t+ sections #gaa & #gbf4 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 ( #aihf 7#a7 ,9 g5]al ,*apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7,a7 by add+ at ! end ( sub*apt] ,b ! foll[+3 #ihbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section 7ref]r$ to 9 ?is subsection & subsection 7b7 z ! effective date71 a gr\p heal? plan1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan1 %all n ent] into a contract1 includ+ an ext5sion or r5ewal ( a contract1 ent]$ into on or aft] ! effective date1 ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit or delay ! disclosure ( in=mation to ! gr\p heal? plan 9 su* a mann] t prev5ts an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan f mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan 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] ! effective date1 9 ! case ( any contract betwe5 a gr\p heal? plan & an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan1 includ+ an ext5sion or r5ewal ( su* a contract1 ent]$ into on or aft] ! effective date1 ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a gr\p heal? plan1 n less frequ5tly ?an e #f mon?s 7or1 at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 & "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 pla9 language1 9 a ma*9e-readable =mat1 & z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan1 & is n (f]$ z heal? insurance cov]age1 or 9 ! case ( heal? insurance cov]age = :i* ! election "u p>agraph 7#c7 is made = ! applicable report+ p]iod-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! contract$ comp5sation paid by ! gr\p heal? plan = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code7 to ! entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan2 7,,ii7 ! contract$ comp5sation paid to ! ph>macy1 by any entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan1 = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code72 7,,iii7 = ea* su* claim1 ! diff]5ce betwe5 ! am\nt paid "u subclause 7,i7 & ! am\nt paid "u subclause 7,,ii72 7,,iv7 ! propriet>y "n1 e/abli%$ "n or prop] "n1 & ,national ,drug ,code2 7,v7 = ea* claim = ! drug 7includ+ orig9al prescriptions & refills7 & = ea* dosage unit ( ! drug = :i* a claim 0 fil$1 ! type ( disp5s+ *annel us$ to furni% ! drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,vi7 ) respect to ea* drug disp5s$1 = ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$ ?r\gh ! applicable disp5s+ *annel2 7,,cc7 dosage units & dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,vii7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation receiv$ f applicable entities2 7,,viii7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan1 or = :i* no claim is submitt$ "u ! plan2 7,,ix7 ! total net sp5d+ on ! drug2 7,x7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7,,xi7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( su* drug or sp5d+ on su* drug2 & 7,,xii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drug1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]71 to ! p>ticipants & b5efici>ies enroll$ 9 su* plan2 7ii7 a li/ ( ea* !rapeutic class 7z def9$ by ! ,secret>y7 = :i* a claim 0 fil$ "u ! gr\p heal? plan dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class-- 7,i7 ! total gross sp5d+ on drugs 9 su* class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,ii7 ! net sp5d+ 9 su* class aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,iii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,iv7 ! 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,v7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 su* class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,vi7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 & 7,,vii7 ! total out-(-pocket sp5d+ "u ! plan by p>ticipants & b5efici>ies1 includ+ 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$ "u ! plan2 7iii7 ) respect to any drug = :i* gross sp5d+ "u ! gr\p heal? plan exce$$ #aj1jjj dur+ ! report+ p]iod or1 9 ! case t gross sp5d+ "u ! gr\p heal? plan exce$$ #aj1jjj dur+ ! report+ p]iod ) respect to few] ?an #ej drugs1 ) respect to ! #ej prescription drugs ) ! highe/ sp5d+ dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class z su* drug2 7,,ii7 if applicable1 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 & 7iv7 9 ! case t su* plan 7or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan7 has an affiliat$ ph>macy or ph>macy "u common own]%ip1 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 s]vices-- 7,i7 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>macies2 7,,ii7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to p>ticipants or b5efici>ies 9 su* plan2 & 7,,iii7 a li/ ( all drugs disp5s$ by su* ph>macies to p>ticipants or b5efici>ies enroll$ 9 su* plan1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan1 & to p>ticipants & b5efici>ies2 7bb7 ! m$ian am\nt *>g$ to su* plan1 & ! 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 ( su* plan2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan & to p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( su* plan2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 & 7,b7 ) respect to any gr\p heal? plan1 reg>dless ( :e!r ! plan is (f]$ by a specifi$ l>ge employ] or :e!r x is a specifi$ l>ge plan-- 7i7 a summ>y docum5t = ! gr\p heal? plan t includes su* in=mation describ$ 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,a71 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+71 t ! ,secret>y det]m9es useful to gr\p heal? plans = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to gr\p heal? plan & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y2 7ii7 a summ>y docum5t = plans to provide to p>ticipants & b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to _! gr\p heal? plan1 t-- 7,i7 conta9s su* in=mation describ$ 9 clauses 7iii71 7iv71 7v71 & 7vi71 z applicable1 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+7 t ! ,secret>y det]m9es useful to p>ticipants or b5efici>ies 9 bett] und]/&+ ! plan or b5efits "u su* plan2 7,,ii7 conta9s only aggregate in=mation2 & 7,,iii7 /ates t p>ticipants & b5efici>ies may reque/ specific1 claims-level in=mation requir$ to be furni%$ "u subsection 7c7 f ! gr\p heal? plan2 & 7iii7 ) respect to drugs cov]$ by su* plan dur+ su* report+ p]iod-- 7,i7 ! total net sp5d+ by ! plan = all su* drugs2 7,,ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 & 7,,iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drugs1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]7 to p>ticipants & b5efici>ies2 7iv7 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 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77dd77,,aa777 to brok]age firms1 brok]s1 consultants1 advisors1 or any o!r individual or firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? plan's bus9ess to an entity provid+ ph>macy b5efit managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,,ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan2 or 7,,iii7 ! ret5tion ( ! entity by ! gr\p heal? plan2 7v7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 su* 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 "u su* plan1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7vi7 total gross sp5d+ on all drugs "u ! plan dur+ ! report+ p]iod4 7#c7 ,opt-9 = gr\p heal? insurance cov]age (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan ,9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or is a specifi$ l>ge plan1 su* 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 ( ?is section1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! heal? insurance issu] to submit to su* gr\p heal? plan a report t includes all ( ! in=mation describ$ 9 p>agraph 7#b77;,a71 9 addition to ! in=mation describ$ 9 p>agraph 7#b77;,b74 7#d7 ,privacy requirem5ts 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan %all report in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a77 & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,9 c>ry+ out ?is subsection1 a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation71 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction 7i7 ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,no?+ 9 ?is section %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et sec71 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 gr\p heal? plans %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan to submit reports to gr\p heal? plans "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa privacy regulations4 7,f7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan or entity may n-- 7i7 re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury2 or 7ii7 prev5t disclosure = ! purposes ( subsection 7c71 or any o!r public disclosure requirem5t "u ?is section4 7,g7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to any gr\p heal? plan e/abli%$ by a plan sponsor t is1 or is affiliat$ )1 a drug manufactur]1 drug :olesal]1 or o!r direct p>ticipant 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,/&>d =mat & regulations 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ a /&>d =mat = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans1 to submit reports requir$ "u p>agraph 7#a74 7,b7 ,additional regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all1 ?r\gh rulemak+1 promulgate any o!r f9al regulations necess>y to implem5t ! requirem5ts ( ?is section4 ,9 promulgat+ su* regulations1 ! ,secret>y %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is section ) ! report+ requirem5ts "u section #ihbe4 7c7 ,requirem5t ,to provide in=mation to p>ticipants or b5efici>ies ,a gr\p heal? plan1 ^u reque/ ( a p>ticipant or b5efici>y1 %all provide to su* p>ticipant or b5efici>y-- 7#a7 ! summ>y docum5t describ$ 9 subsection 7b77#b77;,b77ii72 & 7#b7 ! in=mation describ$ 9 subsection 7b77#b77;,a77i77,,iii7 ) respect to a claim made by or on behalf ( su* p>ticipant or b5efici>y4 7d7 ,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 to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 or 7c7 ( ?is section or section #dihj;,d7g7 by su* issu]1 plan1 or entity4 7e7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! 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>y may specify ?r\gh rulemak+4 7#b7 ,applicable gr\p pur*as+ organization ,! 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]vices4 7#c7 ,contract$ comp5sation ,! t]m contract$ comp5sation means ! sum ( any +r$i5t co/ & disp5s+ fee = a drug 7inclusive ( ! out-(-pocket co/s to ! p>ticipant or b5efici>y71 or ano!r analog\s comp5sation /ructure t ! ,secret>y may specify ?r\gh regulations4 7#d7 ,gross sp5d+ ,! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan1 means ! am\nt sp5t by a gr\p heal? plan on prescription drug b5efits1 calculat$ be=e ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#e7 ,net sp5d+ ,! 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]ation4 7#f7 ,plan sponsor ,! 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;,b774 7#g7 ,remun]ation ,! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ?r\gh rulemak+1 :i* %all be reevaluat$ by ! ,secret>y e #e ye>s4 7#h7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ajj employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7#i7 ,specifi$ l>ge plan ,! t]m specifi$ l>ge plan means a gr\p heal? plan e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b77 t _h an av]age ( at lea/ #ajj p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 7#aj7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 7#b7 ,exception = c]ta9 gr\p heal? plans ,section #ihca7;a77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ o!r ?an ) respect to section #ihbf1 be=e any gr\p heal? plan4 7#c7 ,en=cem5t ,section #dihj;,d ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subsection3 7g7 ,application to requirem5ts impos$ on c]ta9 entities provid+ ph>macy b5efit managem5t s]vices ,9 ! case ( any requirem5t "u section #ihbf t applies ) respect to an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan1 any ref]5ce 9 ?is section to su* gr\p heal? plan 7& ! ref]5ce 9 subsection 7e77#a7 to ! employ]7 %all be treat$ z includ+ a ref]5ce to su* entity4 4 7#d7 ,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]vices44