,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #ecjd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #d1 #bjai,mr4 ,s*rad] 7= himself & ,mr4 ,gian=te7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d title ,,xxvii ( ! ,public ,heal? ,s]vice ,act to require heal? plan ov]sight ( ph>macy b5efit manag] s]vices1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,pbm ,transp>5cy 9 ,prescription ,drug ,co/s ,act4 #b4 ,heal? plan ov]sight ( ph>macy b5efit manag] s]vices ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgbi;,a4 ,heal? plan ov]sight ( ph>macy b5efit manag] s]vices 7a7 ,9 g5]al ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age or an entity or subsidi>y provid+ ph>macy b5efits managem5t s]vices %all n ent] into a contract ) a drug manufactur]1 di/ributor1 :olesal]1 subcontractor1 rebate aggregator1 or any associat$ ?ird p>ty t limits ! disclosure ( in=mation to plan sponsors 9 su* a mann] t prev5ts ! plan or cov]age1 or an entity or subsidi>y provid+ ph>macy b5efits managem5t s]vices on behalf ( a plan or cov]age f mak+ ! reports describ$ 9 subsection 7b74 7b7 ,reports to gr\p plan sponsors 7#a7 ,9 g5]al ,beg9n+ ) ! fir/ plan ye> t beg9s aft] ! date ( enactm5t ( ?is section1 n less frequ5tly ?an once e six mon?s1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan %all submit to ! self-fund$ gr\p heal? plan & at ! reque/ ( any o!r gr\p heal? plan a report 9 accordance ) ?is subsection & make su* report available to ! plan sponsor 9 a ma*9e-readable =mat4 ,ea* su* report %all include1 ) respect to ! applicable gr\p heal? plan or heal? insurance cov]age-- 7,a7 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 ! enrollees 9 su* plan or cov]age2 7,b7 a li/ ( ea* cov]$ drug disp5s$ dur+ ! report+ p]iod1 includ+1 ) respect to ea* su* drug dur+ ! report+ p]iod-- 7i7 ! br& "n1 *emical entity1 & ,national ,drug ,code2 7ii7 ! numb] ( enrollees = :om ! drug 0 fill$ dur+ ! plan ye>1 ! total numb] ( prescription fills = ! drug 7includ+ orig9al prescriptions & refills71 & ! total numb] ( dosage units ( ! drug disp5s$ across ! plan ye>1 includ+ :e!r ! disp5s+ *annel 0 by retail1 mail ord]1 or specialty ph>macy2 7iii7 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] pill1 or 9 ! case ( a drug 9 ano!r =m1 p] dose2 7iv7 ! total out-(-pocket sp5d+ by enrollees on su* drug1 includ+ enrollee sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 & 7v7 = any drug = :i* gross sp5d+ ( ! gr\p heal? plan or heal? insurance cov]age exce$$ #aj1jjj dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r available drugs 9 ! same !rapeutic category or class1 includ+ br& "n drugs & biological products & g5]ic drugs or biosimil> biological products t are 9 ! same !rapeutic category or class2 & 7,,ii7 ! rationale = pref]r$ =mul>y placem5t ( a p>ticul> drug or drugs 9 t !rapeutic category or class2 7,c7 a li/ ( ea* !rapeutic category or class ( drugs t 7 disp5s$ "u ! heal? plan or heal? insurance cov]age dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic category or class ( drugs1 dur+ ! report+ p]iod-- 7i7 total gross sp5d+ by ! plan1 be=e manufactur] rebates1 fees1 or o!r manufactur] remun]ation2 7ii7 ! numb] ( enrollees :o fill$ a prescription = a drug 9 t category or class2 7iii7 if applicable to t category or class1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t category or class2 7iv7 ! total out-(-pocket sp5d+ by enrollees1 includ+ enrollee sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 & 7v7 = ea* !rapeutic category or class "u :i* ?ree or m drugs are m>ket$ & available-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 f drug manufactur]s 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation-- 7aa7 to be paid by drug manufactur]s = claims incurr$ dur+ ! report+ p]iod2 or 7bb7 t is relat$ to utilization ( drugs1 9 su* !rapeutic category or class2 7,,ii7 ! total net sp5d+ by ! heal? plan or heal? insurance cov]age on t category or class ( drugs2 & 7,,iii7 ! net price p] dosage unit or c\rse ( treatm5t incurr$ by ! heal? plan or heal? insurance cov]age & its enrollees1 aft] manufactur] rebates1 fees1 & o!r remun]ation = drugs disp5s$ )9 su* !rapeutic category or class dur+ ! report+ p]iod2 7,d7 total gross sp5d+ on prescription drugs by ! plan or cov]age dur+ ! report+ p]iod1 be=e rebates & o!r manufactur] fees or remun]ation2 7,e7 total am\nt receiv$1 or expect$ to be receiv$1 by ! heal? plan or heal? insurance cov]age 9 drug manufactur] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f ! manufactur] or any ?ird p>ty relat$ to utilization ( drug or drug sp5d+ "u t heal? plan or heal? insurance cov]age dur+ ! report+ p]iod2 7,f7 ! total net sp5d+ on prescription drugs by ! heal? plan or heal? insurance cov]age dur+ ! report+ p]iod2 & 7,g7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( remun]ation to brok]s1 consultants1 advisors1 or any o!r individual or firm :o ref]r$ ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to ! ph>macy b5efit manag]4 7#b7 ,privacy requirem5ts ,heal? insurance issu]s (f]+ gr\p heal? insurance cov]age & entities provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan %all provide in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy1 security1 & brea* notification regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7or successor regulations71 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations4 7#c7 ,disclosure & r$isclosure 7,a7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to bus9ess associates ( su* plan z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7,b7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section prev5ts a heal? insurance issu] (f]+ gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efits managem5t s]vices on behalf ( a gr\p heal? plan f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a74 7c7 ,limitations on spread pric+ 7#a7 ,pass-?r\gh (f]+ to plan ,a designat$ plan adm9i/rator ( an applicable self-insur$ heal? plan1 or an entity provid+ ph>macy b5efit managem5t s]vices to su* heal? plan %all (f] at lea/ "o contractual arrangem5t t does n *>ge ! plan or enrollee1 a price = a prescription drug t exce$s ! price paid to ! ph>macy1 exclud+ p5alties or fees paid by ph>macies to su* plan1 issu]1 or entity4 7#b7 ,default to pass-?r\gh pric+ ,= purposes ( p>agraph 7#a71 a designat$ plan adm9i/rator ( an applicable self-insur$ heal? plan1 or an entity provid+ ph>macy b5efit managem5t s]vices to su* heal? plan %all n *>ge ! plan or enrollee an am\nt = a presciption drug t exce$s ! price paid to ! ph>macy1 exclud+ p5alties paid by ph>macies to su* plan or entity1 )\t ! express p]mission ( ! heal? plan sponsor4 7#c7 ,supplem5t>y report+ = intra-company prescription drug transactions ,a heal? insurance issu] ( gr\p heal? insurance cov]age or an entity provid+ ph>macy b5efits managem5t s]vices "u a gr\p heal? plan or gr\p heal? insurance cov]age t conducts transactions ) a :olly or p>tially own$ ph>macy1 z describ$ 9 p>agraph 7#b71 %all submit1 toge!r ) ! report "u subsection 7b71 a supplem5t>y qu>t]ly report to ! plan sponsor t includes-- 7,a7 an explanation ( any b5efit design p>amet]s t enc\rage enrollees 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,b7 ! p]c5tage ( total prescriptions *>g$ to ! plan1 cov]age1 or enrollees 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 b5efits managem5t s]vices2 & 7,c7 a li/ ( all drugs disp5s$ by su* :olly or p>tially own$ ph>macy & *>g$ to ! plan or cov]age1 or enrollees ( ! plan or cov]age1 dur+ ! applicable qu>t]1 &1 ) respect to ea* drug-- 7i7 ! am\nt *>g$ p] dosage unit or c\rse ( treatm5t ) respect to enrollees 9 ! plan or cov]age1 includ+ am\nts *>g$ to ! plan or cov]age & am\nts *>g$ to ! enrollee2 7ii7 ! m$ian am\nt *>g$ to ! plan or cov]age1 p] dosage unit or c\rse ( treatm5t1 & includ+ am\nts paid by ! enrollee1 :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 7iii7 ! int]qu>tile range ( ! co/s1 p] dosage unit or c\rse ( treatm5t1 & includ+ am\nts paid by ! enrollee1 :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 & 7iv7 ! l[e/ co/ p] dosage unit or c\rse ( treatm5t1 = su* drug1 includ+ am\nts *>g$ to ! plan or issu] & enrollee1 t is available f any ph>macy includ$ 9 ! network ( ! plan or cov]age4 7d7 ,full rebate pass-,?r\gh to plan 7#a7 ,9 g5]al ,a ph>macy b5efits manag]1 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 b5efits managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all remit #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation receiv$ f a ph>maceutical manufactur]1 di/ributor or any o!r ?ird p>ty1 t are relat$ to utilization ( drugs "u su* heal? plan or heal? insurance cov]age1 to ! heal? plan issu]4 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 or o!r remun]ation is calculat$1 & 9 no case lat] ?an #abj days aft] ! end ( su* p]iod2 7,b7 fully disclos$ & enum]at$ to ! gr\p heal? plan sponsor1 z describ$ 9 7b77#a72 7,c7 available = audit by ! plan sponsor1 or a ?ird p>ty designat$ by a plan sponsor no 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 ph>macy b5efits manag]1 a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ a gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efits managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all make rebate contracts ) drug manufactur]s available = audit by su* plan sponsor or designat$ ?ird p>ty1 subject to confid5tiality agreem5ts to prev5t re-disclosure ( su* contracts4 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 7a71 fails to provide in=mation requir$ "u subsection 7b71 engages 9 spread pric+ z def9$ 9 subsection 7c71 or fails to comply ) ! requirem5ts ( subsection 7d71 or a drug manufactur] t fails to provide in=mation "u subsection 7b77#a77;,a71 9 a timely mann] %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 ,safe h>bor ,! ,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 prohibit entities provid+ ph>macy b5efits managem5t s]vices f reta9+ bona fide s]vice fees1 provid$ t su* fees are transp>5t to gr\p heal? plans & heal? insurance issu]s & are n l9k$ directly to ! price or =mul>y placem5t or position ( a drug4 7g7 ,def9itions ,9 ?is section-- 7#a7 ! t]m simil>ly situat$ ph>macy means1 ) respect to a p>ticul> ph>macy1 ano!r ph>macy t is approximately ! same size 7z measur$ by ! numb] ( prescription drugs disp5s$71 & t s]ves pati5ts 9 ! same geographical area1 :e!r ?r\gh physical locations or mail ord]2 7#b7 ! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act2 & 7#c7 ! t]m bona fide s]vice fees means fees paid by a manufactur]1 cu/om]1 or cli5t 7o!r ?an a gr\p heal? plan or heal? insurance issu]7 ( an entity provid+ ph>macy b5efit managem5t s]vices1 to an entity provid+ ph>macy b5efit managem5t s]vices1 t repres5t fair m>ket value = bona fide1 itemiz$ s]vices actually p]=m$ on behalf ( ! manufactur]1 cu/om]1 or cli5t w\ld o!rwise p]=m or contract = 9 ! abs5ce ( ! s]vice arrangem5t1 )\t prior cons5t = any specific arrangem5ts4 4 #c4 ,?ird-p>ty adm9i/rators ,any obligation on a ?ird-p>ty adm9i/rator "u ?is ,act 7includ+ ! am5dm5t made by ?is ,act7 %all n affect any o!r direct or indirect requirem5t "u any o!r provision ( ,f$]al law t applies to ?ird-p>ty adm9i/rators (f]+ s]vices to gr\p heal? plans4