,,ii #aai? ,,congress #a/ ,session ,s4 #ibg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #aa 7legislative day1 ,m>* #aj71 #bjbe,mr4 ,wel* 7= himself1 ,mr4 ,m>%all1 ,mr4 ,w>n]1 & ,mr4 ,cassidy7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xix ( ! ,social ,security ,act to ensure accurate paym5ts to ph>macies "u ,m$icaid & to prev5t ! use ( abusive spread pric+ practices "u ,m$icaid4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,protect+ ,ph>macies 9 ,m$icaid ,act4 #b4 ,ensur+ accurate paym5ts to ph>macies "u ,m$icaid 7a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a7-- 7,a7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7,b7 by /rik+ & aft] ! semicolon at ! end ( clause 7i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,det]m9+ ph>macy actual acquisition co/s ,! ,secret>y %all conduct a survey ( retail community ph>macy drug prices & applicable non-retail ph>macy drug prices to det]m9e national av]age drug acquisition co/ b5*m>ks 7z su* t]m is def9$ by ! ,secret>y7 z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 7ii7 ) respect to applicable non-retail ph>macies-- 7,i7 ! det]m9ation ( survey prices1 sep>ate f ! survey prices describ$ 9 clause 7i71 ( ! non-retail national av]age drug acquisition co/ = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 7,,ii7 at ! discretion ( ! ,secret>y1 = ea* type ( applicable non-retail ph>macy1 ! det]m9ation ( survey prices1 sep>ate f ! survey prices describ$ 9 clause 7i7 or subclause 7,i7 ( ?is clause1 ( ! national av]age drug acquisition co/ = su* type ( ph>macy = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 2 7#b7 9 subp>agraph 7,b7 ( p>agraph 7#a71 by /rik+ subp>agraph 7,a77ii7 & ins]t+ subp>agraph 7,a77iii72 7#c7 9 subp>agraph 7,d7 ( p>agraph 7#a71 by /rik+ clauses 7ii7 & 7iii7 & ins]t+ ! foll[+3 7ii7 ,! v5dor mu/ update ! ,secret>y no less (t5 ?an mon?ly on ! survey prices = cov]$ outpati5t drugs4 7iii7 ,! v5dor mu/ diff]5tiate1 9 collect+ & report+ survey data1 = all co/ in=mation collect$1 :e!r a ph>macy is a retail community ph>macy or an applicable non-retail ph>macy1 includ+ :e!r su* ph>macy is an affiliate 7z def9$ 9 subsection 7k77#ad771 &1 9 ! case ( an applicable non-retail ph>macy1 :i* type ( applicable non-retail ph>macy x is us+ ! relevant ph>macy type indicators includ$ 9 ! guidance requir$ by subsection 7d77#b7 ( section #b ( ! ,protect+ ,ph>macies 9 ,m$icaid ,act4 2 7#d7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,9 ord] to meet ! requirem5t ( section #aijb7;a77#ed71 a ,/ate %all require t any retail community ph>macy or applicable non-retail ph>macy 9 ! ,/ate t receives any paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 rebate1 or o!r price concession relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 rebate1 or o!r price concession is receiv$ f ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d77 directly or f a ph>macy b5efit manag] or ano!r entity t has a contract ) ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z s def9$71 %all respond to surveys conduct$ "u ?is p>agraph4 7,g7 ,survey in=mation ,in=mation on national drug acquisition prices obta9$ "u ?is p>agraph %all be made publicly available 9 a =m & mann] to be det]m9$ by ! ,secret>y & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate to ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ me?odology & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,in=mation on price concessions to ph>macies1 includ+ disc\nts1 rebates1 & o!r price concessions1 to ! ext5t t su* in=mation may be publicly releas$ & has be5 collect$ by ! ,secret>y z "p ( ! survey4 7,h7 ,p5alties 7i7 ,9 g5]al ,subject to clauses 7ii71 7iii71 & 7iv71 ! ,secret>y %all en=ce ! provisions ( ?is p>agraph ) respect to a ph>macy ?r\gh ! e/abli%m5t ( civil money p5alties applicable to a retail community ph>macy or an applicable non-retail ph>macy4 7ii7 ,basis = p5alties ,! ,secret>y %all impose a civil money p5alty e/abli%$ "u ?is subp>agraph on a retail community ph>macy or applicable non-retail ph>macy if-- 7,i7 ! retail ph>macy or applicable non-retail ph>macy refuses or o!rwise fails to respond to a reque/ = in=mation ab\t prices 9 connection ) a survey "u ?is subsection2 7,,ii7 kn[+ly provides false in=mation 9 response to su* a survey2 or 7,,iii7 o!rwise fails to comply ) ! requirem5ts e/abli%$ "u ?is p>agraph4 7iii7 ,p>amet]s = p5alties 7,i7 ,9 g5]al ,a civil money p5alty e/abli%$ "u ?is subp>agraph may be assess$ ) respect to ea* violation1 & ) respect to ea* non-compliant retail community ph>macy 7includ+ a ph>macy t is "p ( a *a97 or non-compliant applicable non-retail ph>macy 7includ+ a ph>macy t is "p ( a *a971 9 an am\nt n to exce$ #ajj1jjj = ea* su* violation4 7,,ii7 ,consid]ations ,9 det]m9+ ! am\nt ( a civil money p5alty impos$ "u ?is subp>agraph1 ! ,secret>y may consid] ! size1 bus9ess /ructure1 & type ( ph>macy involv$1 z well z ! type ( violation & o!r relevant factors1 z det]m9$ appropriate by ! ,secret>y4 7iv7 ,rule ( application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil money p5alty or proce$+ "u section #aabh;,a7a74 7,i7 ,limitation on use ( applicable non-retail ph>macy pric+ in=mation ,no ,/ate %all use pric+ in=mation report$ by applicable non-retail ph>macies "u subp>agraph 7,a77ii7 to develop or in=m paym5t me?odologies = retail community ph>macies4 2 7#e7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ paym5t rates & me?odologies = det]m9+ +r$i5t co/ reimbursem5t "u manag$ c>e entities or o!r specifi$ entities 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d771 aft] "u ?is title2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ & ! basis = su* disp5s+ fees be=e ! semicolon2 7#f7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 7#g7 by ins]t+ aft] p>agraph 7#c7 ! foll[+ new p>agraph3 7#d7 ,ov]sight 7,a7 ,9 g5]al ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct p]iodic /udies ( ! survey data report$ "u ?is subsection1 z appropriate1 includ+ ) respect to sub/antial v>iations 9 acquisition co/s or o!r applicable co/s1 z well z ) respect to h[ int]nal transf] prices & relat$ p>ty transactions may influ5ce ! co/s report$ by ph>macies t are affiliates 7z def9$ 9 subsection 7k77#ad77 or are own$ by1 controll$ by1 or relat$ "u a common own]%ip /ructure ) a :olesal]1 di/ributor1 or o!r entity t acquires cov]$ outpati5t drugs relative to co/s report$ by ph>macies n affiliat$ ) su* entities4 ,! ,inspector ,g5]al %all provide p]iodic updates to ,congress on ! results ( su* /udies1 z appropriate1 9 a mann] t does n disclose trade secrets or o!r propriet>y in=mation4 7,b7 ,appropriation ,!re is appropriat$ to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #e1jjj1jjj = fiscal ye> #bjbf1 to rema9 available until exp5d$1 to c>ry out ?is p>agraph4 2 & 7#h7 9 p>agraph 7#e71 z s r$esignat$-- 7,a7 by ins]t+ 1 & #i1jjj1jjj = fiscal ye> #bjbf & ea* fiscal ye> !reaft]1 aft] #bjaj2 & 7,b7 by ins]t+ ,funds appropriat$ "u ?is p>agraph = fiscal ye> #bjbf & any subsequ5t fiscal ye> %all rema9 available until exp5d$4 aft] ! p]iod4 7b7 ,def9itions ,section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,9 ! section & ins]t+ ,9 ?is section2 & 7#b7 by add+ at ! end ! foll[+ new p>agraphs3 7#ab7 ,applicable non-retail ph>macy ,! t]m applicable non-retail ph>macy means a ph>macy t is lic5s$ z a ph>macy by ! ,/ate & t is n a retail community ph>macy1 includ+ a ph>macy t disp5ses prescription m$ications to pati5ts prim>ily ?r\gh mail & specialty ph>macies4 ,su* t]m does n include nurs+ home ph>macies1 long-t]m c>e facility ph>macies1 hospital ph>macies1 cl9ics1 *>itable or n-=-pr(it ph>macies1 gov]nm5t ph>macies1 or l[ disp5s+ ph>macies 7z def9$ by ! ,secret>y74 7#ac7 ,affiliate ,! t]m affiliate means any entity t is own$ by1 controll$ by1 or relat$ "u a common own]%ip /ructure ) a ph>macy b5efit manag] or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d774 4 7c7 ,effective date 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! am5dm5ts made by ?is section %all take effect on ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #f mon?s aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,delay$ application to applicable non-retail ph>macies ,! ph>macy survey requirem5ts e/abli%$ by ! am5dm5ts to section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 made by ?is section %all apply to retail community ph>macies beg9n+ on ! effective date describ$ 9 p>agraph 7#a71 b %all n apply to applicable non-retail ph>macies until ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,id5tification ( applicable non-,retail ph>macies 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbg1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) /akehold]s z appropriate1 publi% guidance specify+ ph>macies t meet ! def9ition ( applicable non-retail ph>macies 7z su* t]m is def9$ 9 subsection 7k77#ab7 ( section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 z add$ by subsection 7b771 & t w be subject to ! survey requirem5ts "u subsection 7f77#a7 ( su* section1 z am5d$ by subsection 7a74 7#b7 ,inclusion ( ph>macy type indicators ,! guidance publi%$ "u p>agraph 7#a7 %all include ph>macy type indicators to di/+ui% betwe5 diff]5t types ( applicable non-retail ph>macies1 su* z ph>macies t disp5se prescriptions prim>ily ?r\gh ! mail & ph>macies t disp5se prescriptions t require special h&l+ or di/ribution4 ,an applicable non-retail ph>macy may be id5tifi$ ?r\gh multiple ph>macy type indicators4 7e7 ,implem5tation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 7#b7 ,nonapplication ( ,adm9i/rative ,proc$ure ,act ,implem5tation ( ! am5dm5ts made by ?is section %all be exempt f ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code4 7f7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any data collection und]tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f771 z am5d$ by ?is section4 #c4 ,prev5t+ ! use ( abusive spread pric+ 9 ,m$icaid 7a7 ,9 g5]al ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7#a7 9 subsection 7e71 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,transp>5t prescription drug pass-?r\gh pric+ requir$ 7,a7 ,9 g5]al ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm71 or a contract betwe5 ! ,/ate & a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d7 & collectively ref]r$ to 9 ?is p>agraph z ! entity7 t includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs disp5s$ to individuals enroll$ ) ! entity1 %all require t paym5t = su* drugs & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or entity1 is bas$ on a transp>5t prescription drug pass-?r\gh pric+ model "u :i*-- 7i7 any paym5t made by ! entity or ! ,,pbm 7z applicable7 = su* a drug-- 7,i7 is limit$ to-- 7aa7 +r$i5t co/2 & 7bb7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate w\ld pay if ! ,/ate 7 mak+ ! paym5t directly 9 accordance ) ! ,/ate plan2 7,,ii7 is pass$ ?r\gh 9 its entirety 7except z r$uc$ "u ,f$]al or ,/ate laws & regulations 9 response to in/ances ( wa/e1 fraud1 or abuse7 by ! entity or ,,pbm to ! ph>macy or provid] t disp5ses ! drug2 & 7,,iii7 is made 9 a mann] t is consi/5t ) sections #ddg4ejb1 #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 z if su* requirem5ts appli$ directly to ! entity or ! ,,pbm1 except t any paym5t by ! entity or ! ,,pbm = ! +r$i5t co/ ( su* drug pur*as$ by a cov]$ entity 7z def9$ 9 subsection 7a77#e77;,b77 may exce$ ! actual acquisition co/ 7z def9$ 9 #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation7 = su* drug if-- 7aa7 su* drug 0 subject to an agreem5t "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 7bb7 su* paym5t = ! +r$i5t co/ ( su* drug does n exce$ ! maximum paym5t t w\ld h be5 made by ! entity or ! ,,pbm = ! +r$i5t co/ ( su* drug if su* drug _h n be5 pur*as$ by su* cov]$ entity2 & 7cc7 su* cov]$ entity reports to ! ,secret>y 79 a =m & mann] specifi$ by ! ,secret>y71 on an annual basis & ) respect to paym5ts = ! +r$i5t co/s ( su* drugs s pur*as$ by su* cov]$ entity t are 9 excess ( ! actual acquisition co/s = su* drugs1 ! aggregate am\nt ( su* excess2 7ii7 paym5t to ! entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! entity or ,,pbm is limit$ to an adm9i/rative fee t reflects ! fair m>ket value 7z def9$ by ! ,secret>y7 ( su* s]vices2 7iii7 ! entity or ! ,,pbm 7z applicable7 makes available to ! ,/ate1 & ! ,secret>y ^u reque/ 9 a =m & mann] specifi$ by ! ,secret>y1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices 7z describ$ 9 clause 7ii77 incurr$1 receiv$1 or made by ! entity or ! ,,pbm1 brok5 d[n 7z specifi$ by ! ,secret>y71 to ! ext5t su* co/s & paym5ts are attributable to an individual cov]$ outpati5t drug1 by ea* su* drug1 includ+ any +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees 7z describ$ 9 clause 7ii771 po/-sale & po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all o!r remun]ation1 z def9$ by ! ,secret>y2 & 7iv7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! entity or ! ,,pbm 7z applicable7 t exce$s ! am\nt paid to ! ph>macies or provid]s on behalf ( ! ,/ate or entity1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts1 z def9$ by ! ,secret>y1 7aft] all[+ = an adm9i/rative fee z describ$ 9 clause 7ii77 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 7,b7 ,publication ( in=mation ,! ,secret>y %all publi%1 n less frequ5tly ?an on an annual basis & 9 a mann] t does n disclose ! id5tity ( a p>ticul> cov]$ entity or organization1 in=mation receiv$ by ! ,secret>y pursuant to subp>agraph 7,a77iii77,,iii7 t is brok5 out by ,/ate & by ea* ( ! foll[+ categories ( cov]$ entity )9 ea* su* ,/ate3 7i7 ,cov]$ entities describ$ 9 subp>agraph 7,a7 ( section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act4 7ii7 ,cov]$ entities describ$ 9 subp>agraphs 7,b7 ?r\gh 7,k7 ( su* section4 7iii7 ,cov]$ entities describ$ 9 subp>agraph 7,l7 ( su* section4 7iv7 ,cov]$ entities describ$ 9 subp>agraph 7,m7 ( su* section4 7v7 ,cov]$ entities describ$ 9 subp>agraph 7,n7 ( su* section4 7vi7 ,cov]$ entities describ$ 9 subp>agraph 7,o7 ( su* section4 2 & 7#b7 9 subsection 7k71 z am5d$ by section #b7;b71 by add+ at ! end ! foll[+ new p>agraph3 7#ad7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any p]son or entity t1 ei!r directly or ?r\gh an int]m$i>y1 acts z a price negotiator or gr\p pur*as] on behalf ( a ,/ate1 manag$ c>e entity 7z def9$ 9 section #aijc7m77#i77;,d771 or o!r specifi$ entity 7z s def9$71 or manages ! prescription drug b5efits provid$ by a ,/ate1 manag$ c>e entity1 or o!r specifi$ entity1 includ+ ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! manag+ ( appeals or grievances relat$ to ! prescription drug b5efits1 contract+ ) ph>macies1 controll+ ! co/ ( cov]$ outpati5t drugs1 or ! provision ( s]vices relat$ !reto4 ,su* t]m includes any p]son or entity t acts z a price negotiator 7) reg>d to paym5t am\nts to ph>macies & provid]s = a cov]$ outpati5t drug or ! net co/ ( ! drug7 or gr\p pur*as] on behalf ( a ,/ate1 manag$ c>e entity1 or o!r specifi$ entity or t c>ries out #a or m ( ! o!r activities describ$ 9 ! prec$+ s5t5ce1 irrespective ( :e!r su* p]son or entity calls itself a ph>macy b5efit manag]4 4 7b7 ,con=m+ am5dm5ts ,section #aijc7m7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$-- 7#a7 9 p>agraph 7#b77;,a77xiii7-- 7,a7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,,iv7 if ! contract includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs1 ! entity %all comply ) ! requirem5ts ( section #aibg7;e77#f72 & 7,c7 by mov+ ! m>g9 #b ems to ! left2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,no paym5t %all be made "u ?is title to a ,/ate ) respect to exp5ditures incurr$ by ! ,/ate = paym5t = s]vices provid$ by an o!r specifi$ entity 7z def9$ 9 p>agraph 7#i77;,d77iii77 unless su* s]vices are provid$ 9 accordance ) a contract betwe5 ! ,/ate & su* entity :i* satisfies ! requirem5ts ( p>agraph 7#b77;,a77xiii74 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to contracts betwe5 ,/ates & manag$ c>e entities1 o!r specifi$ entities1 or ph>macy b5efit manag]s t h an effective date beg9n+ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,implem5tation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 7#b7 ,nonapplication ( adm9i/rative proc$ure act ,implem5tation ( ! am5dm5ts made by ?is section %all be exempt f ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code4 7e7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any data collection und]tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e771 z am5d$ by ?is section4