,,ii ,cal5d> ,no4 #acc #aaf? ,,congress #a/ ,session ,s4 #ahie ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #ai1 #bjai,mr4 ,alex&] 7= himself & ,mrs4 ,murray7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,july #h1 #bjai,report$ by ,mr4 ,alex&]1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to l[] heal? c>e co/s4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,heal? ,c>e ,co/s ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,title ,i--,end+ ,surprise ,m$ical ,bills,sec4 #aja4 ,protect+ pati5ts aga9/ out-(-network d$uctibles 9 em]g5cies4,sec4 #ajb4 ,protection aga9/ surprise bills4,sec4 #ajc4 ,b5*m>k = paym5t4,sec4 #ajd4 ,effective date4,sec4 #aje4 ,end+ surprise air ambulance bills4,sec4 #ajf4 ,report4,title ,,ii--,r$uc+ ! ,prices ( ,prescription ,drugs,sec4 #bja4 ,biological product pat5t transp>5cy4,sec4 #bjb4 ,orange book mod]nization4,sec4 #bjc4 ,ensur+ timely access to g5]ics4,sec4 #bjd4 ,protect+ access to biological products4,sec4 #bje4 ,prev5t+ block+ ( g5]ic drugs4,sec4 #bjf4 ,education on biological products4,sec4 #bjg4 ,biological product innovation4,sec4 #bjh4 ,cl>ify+ ! mean+ ( new *emical entity4,sec4 #bji4 ,/reaml9+ ! transition ( biological products4,sec4 #baj4 ,orphan drug cl>ification4,sec4 #baa4 ,prompt approval ( drugs relat$ to safety in=mation4,sec4 #bab4 ,conditions ( use = biosimil> biological products4,sec4 #bac4 ,mod]niz+ ! label+ ( c]ta9 g5]ic drugs4,title ,,iii--,improv+ ,transp>5cy 9 ,heal? ,care,sec4 #cja4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation4,sec4 #cjb4 ,bann+ anticompetitive t]ms 9 facility & insurance contracts t limit access to high] quality1 l[] co/ c>e4,sec4 #cjc4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s4,sec4 #cjd4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation4,sec4 #cje4 ,timely bills = pati5ts4,sec4 #cjf4 ,heal? plan ov]sight ( ph>macy b5efit manag] s]vices4,sec4 #cjg4 ,gov]nm5t ,acc\ntability ,(fice /udy on pr(it- & rev5ue-%>+ 9 heal? c>e4,sec4 #cjh4 ,disclosure ( direct & indirect comp5sation = brok]s & consultants to employ]-sponsor$ heal? plans & enrollees 9 plans on ! individual m>ket4,sec4 #cji4 ,ensur+ enrollee access to co/-%>+ in=mation4,sec4 #caj4 ,/r5g!n+ p>ity 9 m5tal heal? & sub/ance use disord] b5efits4,sec4 #caa4 ,te*nical am5dm5ts4,sec4 #cab4 ,?ird-p>ty adm9i/rators4,title ,,iv--,improv+ ,public ,health,sec4 #dja4 ,improv+ aw>5ess ( disease prev5tion4,sec4 #djb4 ,grants to address vacc9e-prev5table diseases4,sec4 #djc4 ,guide on evid5ce-bas$ /rategies = public heal? dep>tm5t obesity prev5tion programs4,sec4 #djd4 ,exp&+ capacity = heal? outcomes4,sec4 #dje4 ,public heal? data sy/em mod]nization4,sec4 #djf4 ,innovation = mat]nal heal?4,sec4 #djg4 ,tra9+ = heal? c>e provid]s4,sec4 #djh4 ,/udy on tra9+ to r$uce & prev5t discrim9ation4,sec4 #dji4 ,p]9atal quality collaboratives4,sec4 #daj4 ,integrat$ s]vices = pregnant & po/p>tum wom54,sec4 #daa4 ,ext5sion = community heal? c5t]s1 ! ,national ,heal? ,s]vice ,corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs4,sec4 #dab4 ,o!r programs4,,title ,v--,improv+ ! ,ex*ange ( ,heal? ,information,sec4 #eja4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation4,sec4 #ejb4 ,recognition ( security practices4,sec4 #ejc4 ,,gao /udy on ! privacy & security risks ( electronic transmission ( individually id5tifiable heal? in=mation to & f entities n cov]$ by ! ,heal? ,insurance ,portability & ,acc\ntability ,act4,sec4 #ejd4 ,te*nical corrections4 ,i ,end+ ,surprise ,m$ical ,bills #aja4 ,protect+ pati5ts aga9/ out-(-network d$uctibles 9 em]g5cies ,section #bgai;,a7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or a free/&+ em]g5cy room aft] hospital2 & 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7ii77,i71 by ins]t+ or em]g5cy room aft] em]g5cy dep>tm5t2 & 7ii7 9 subp>agraph 7,c77ii77,,ii71 by add+1 a d$uctible1 aft] 7express$ z2 & 7#b7 9 p>agraph 7#b77;,b7-- 7,a7 9 clause 7i7-- 7i7 by ins]t+ or free/&+ em]g5cy room aft] hospital2 & 7ii7 by ins]t+ or em]g5cy room aft] em]g5cy dep>tm5t2 & 7,b7 9 clause 7ii71 by ins]t+ or em]g5cy room aft] hospital4 #ajb4 ,protection aga9/ surprise bills 7a7 ,,phsa ,section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is am5d$ by add+ at ! end ! foll[+3 7e7 ,cov]age ( c]ta9 out-(-,network s]vices 7#a7 ,9 g5]al ,subject to subsection 7h71 9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives out-(-network1 ancill>y1 non-em]g5cy s]vices at an 9-network facility1 includ+ any ref]rals = diagno/ic s]vices-- 7,a7 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to su* s]vices %all be ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by an 9-network practition]1 & any co9surance or d$uctible %all be bas$ on 9-network rates2 & 7,b7 su* co/-%>+ am\nts %all be c\nt$ t[>ds ! 9-network d$uctible & 9-network out-(-pocket maximum am\nt "u ! plan or cov]age = ! plan ye>4 7#b7 ,def9ition ,= purposes ( ?is subsection1 ! t]m facility has ! mean+ giv5 ! t]m heal? c>e facility 9 section #bgbi;,a7c74 7f7 ,cov]age ( out-(-,network s]vices = enrollees admitt$ aft] em]g5cy s]vices 7#a7 ,notice & cons5t ,subject to subsection 7h71 9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives em]g5cy s]vices1 or mat]nal c>e = a woman 9 labor1 9 ! em]g5cy dep>tm5t ( an out-(-network facility & has be5 /abiliz$ 7)9 ! mean+ ( subsection 7b77#b77;,c771 if ! pati5t is subsequ5tly admitt$ to ! out-(-network facility = c>e1 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to any out-(-network s]vices is ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by a p>ticipat+ provid]1 unless ! enrollee1 once /able & 9 a condition to receive su* in=mation1 includ+ hav+ suffici5t m5tal capacity-- 7,a7 has be5 provid$ by ! facility1 prior to ! provision ( any po/-/abilization1 out-(-network s]vice at su* facility1 )-- 7i7 pap] & electronic notification t ! practition] or facility is an out-(-network heal? c>e provid] & ! out-(-network rate ( ! provid]1 z applicable1 & ! option to affirmatively cons5t to receiv+ s]vices f su* practition] or facility2 & 7ii7 ! e/imat$ am\nt t su* provid] may *>ge ! p>ticipant1 b5efici>y1 or enrollee = su* items & s]vices involv$2 7,b7 has be5 provid$ by ! plan or cov]age1 prior to ! provision ( any po/-/abilization1 out-(-network s]vice at su* facility1 )-- 7i7 pap] & electronic notification t ! practition] or facility is an out-(-network heal? c>e provid] & ! out-(-network rate ( ! provid]1 z applicable1 & ! option to affirmatively cons5t to receiv+ s]vices f su* practition] or facility2 7ii7 a li/ ( 9-network practition]s or facilities t c\ld provide ! same s]vices1 & an option = a ref]ral to su* provid]s2 & 7iii7 in=mation ab\t :e!r prior au?orization or o!r c>e managem5t limitations may be requir$ 9 advance ( receiv+ 9-network c>e at ! facility2 & 7,c7 has ackn[l$g$ t ! out-(-network treatm5t may n be cov]$ or may be cov]$ at an out-(-network co/-%>+ am\nt1 requir+ high] co/-%>+ obligations ( ! enrollee ?an if ! s]vice 7 provid$ at an 9-network facility1 & has assum$1 9 writ+1 full responsibility ( out-(-pocket co/s associat$ ) s]vices furni%$ aft] ! enrollee has be5 /abiliz$1 f ! out-(-network practition] or facility1 z applicable4 7#b7 ,requirem5ts ( notice ,! notice "u p>agraph 7#a7 %all be 9 a =mat det]m9$ by ! ,secret>y to give a reasonable layp]son cle> compreh5sion ( ! t]ms ( ! agreem5t1 includ+ all possible f9ancial responsibilities1 includ+ ! requirem5ts t ! notice-- 7,a7 does n exce$ "o page 9 l5g?2 7,b7 is readily id5tifiable = its purpose & z a contract ( cons5t2 7,c7 cle>ly /ates t cons5t is optional2 7,d7 includes an e/imate ( ! am\nt t su* provid] w *>ge ! p>ticipant1 b5efici>y1 or enrollee = su* items & s]vices involv$2 & 7,e7 be available 9 ! #ae mo/ common languages 9 ! facility's geographic area1 ) ! facility mak+ a good fai? ef=t to provide oral notice 9 ! enrollee's prim>y language if x is n "o ( su* #ae languages4 7g7 ,prohibition on bill+ m ?an an 9-,network rate "u c]ta9 circum/ances 7#a7 ,9 g5]al ,a facility or practition] furni%+-- 7,a7 em]g5cy s]vices1 z def9$ 9 subsection 7b77#b71 reg>dless ( ! ,/ate 9 :i* ! pati5t resides2 7,b7 s]vices at an 9-network facility describ$ 9 subsection 7e72 or 7,c7 out-(-network s]vices furni%$ aft] ! enrollee has be5 /abiliz$ 7)9 ! mean+ ( subsection 7b77#b77;,c771 :]e ! notice & option = ref]ral requir$ "u subsection 7f77#a7 h n be5 provid$ to ! enrollee & ! assumption ( responsibility = out-(-pocket co/s "u subsection 7f77#b7 has n be5 obta9$1 may n bill an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age = am\nts beyond ! co/-%>+ am\nt t w\ld apply "u subsection 7b77#a77;,c77ii77,,ii71 7e71 or 7f71 z applicable4 7#b7 ,notice ,a facility furni%+ s]vices describ$ 9 p>agraph 7#a7 %all provide enrollees 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age ) a "o-page notice1 9 #af-po9t font1 ^u intake at ! em]g5cy room or be+ admitt$ at ! facility ( ! prohibition on balance bill+ "u p>agraph 7#a7 & :o to contact = rec\rse if !y are s5t a balance bill 9 violation ( su* p>agraph4 ,! facility %all be responsible = obta9+ ! signature f ! enrollee on su* notice4 ,! ,secret>y %all issue regulations )9 #f mon?s ( ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act on ! requirem5ts = ! notice "u ?is p>agraph4 7#c7 ,en=cem5t 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 a facility or practition] t violates a requirem5t "u p>agraph 7#a7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7,b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7,c7 ,safe h>bor ,! ,secret>y %all waive ! p5alties describ$ "u subp>agraph 7,a7 ) respect to a facility or1 practition] :o unkn[+ly violates p>agraph 7#a7 ) respect to an enrollee1 if su* facility or practition]1 )9 #cj days ( ! violation1 )draws ! bill t 0 9 violation ( p>agraph 7#a71 &1 z applicable1 reimburses ! gr\p heal? plan1 heal? insurance issu]1 or enrollee1 z applicable1 9 an am\nt equal to ! am\nt bill$ 9 violation ( p>agraph 7#a71 plus int]e/1 at an int]e/ rate det]m9$ by ! ,secret>y4 7h7 ,ma9ta9+ ,/ate surprise bill+ protections 7#a7 ,9 g5]al ,not)/&+ section #ead ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 except ) respect to self-insur$ gr\p heal? plans1 no?+ 9 ?is section %all prev5t a ,/ate f e/abli%+ or cont9u+ 9 effect an alt]nate me?od "u ,/ate law = det]m9+ ! appropriate comp5sation = s]vices describ$ 9 subsection 7b71 7e71 or 7f74 7#b7 ,additional application ,9 ! case ( gr\p heal? plans or heal? insurance cov]age 9 ! individual or gr\p m>ket (f]$ 9 a ,/ate t has n enact$ an alt]nate me?od describ$ 9 p>agraph 7#a71 su* z arbitration or a b5*m>k1 or = s]vices describ$ 9 subsection 7b71 7e71 or 7f7 t are n cov]$ by su* ,/ate's alt]nate me?od describ$ 9 p>agraph 7#a71 ! provisions ( ?is section %all apply4 7#c7 ,self-insur$ plans ,subsections 7b71 7e71 & 7f7 %all apply to a self-insur$ gr\p heal? plan t is n subject to ,/ate insurance regulation4 4 7b7 ,cov]age "u ,f$]al ,employees ,heal? ,b5efits ,program ,section #hijd ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7c7 ,any heal? b5efits plan (f]$ "u ?is *apt] %all be treat$ z a gr\p heal? plan or gr\p or individual heal? insurance cov]age = purposes ( subsections 7e7 ?r\gh 7g7 ( section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 7except = p>agraph 7#c7 ( su* subsection 7g774 4 #ajc4 ,b5*m>k = paym5t 7a7 ,9 g5]al ,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 ,b5*m>k = paym5t 7a7 ,e/abli%m5t ( b5*m>k ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all pay facilities or practition]s furni%+ s]vices = :i* su* facilities & practition]s are prohibit$ f bill+ enrollees "u section #bgai;,a7g71 ! m$ian 9-network rate1 us+ a me?odology det]m9$ "u subsection 7b7 = ! same or simil> s]vices (f]$ by ! gr\p heal? plan or heal? insurance issu] 9 t geographic region4 7b7 ,m$ian 9-,network rate 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m m$ian 9-network rate means1 ) respect to heal? c>e s]vices cov]$ by a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! m$ian negotiat$ rate "u ! applicable plan or cov]age recogniz$ "u ! plan or cov]age z ! total maximum paym5t = ! s]vice m9us ! 9-network co/-%>+ = su* s]vice "u ! plan or cov]age1 = ! same or a simil> s]vice t is provid$ by a provid] 9 ! same or simil> specialty & 9 ! geographic region 9 :i* ! s]vice is furni%$4 7#b7 ,rulemak+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all1 ?r\gh rulemak+1 det]m9e ! me?odology a gr\p heal? plan or heal? insurance issu] is requir$ to use to det]m9e ! m$ian 9-network rate describ$ 9 p>agraph 7#a71 diff]5tiat+ by bus9ess l9e1 ! in=mation ! plan or issu] %all %>e ) ! nonp>ticipat+ provid] involv$ :5 mak+ su* a det]m9ation1 & ! geographic regions appli$ = purposes ( ?is subp>agraph4 ,su* rulemak+ %all take into acc\nt paym5ts t are made by heal? insurance issu]s t are n on a fee-=-s]vice basis4 7#c7 ,c]ta9 insur]s ,if a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age does n h suffici5t in=mation to calculate a m$ian 9-network rate = ?is s]vice or provid] type1 or am\nt (1 claims = s]vices 7z det]m9$ by ! applicable ,/ate au?ority1 9 ! case ( heal? insurance cov]age1 or by ! ,secret>y ( ,labor1 9 ! case ( a self-insur$ gr\p heal? plan7 cov]$ "u ! li/ ( out-(-network s]vices set by ! ,/ate au?ority or ,secret>y ( ,labor1 z applicable1 9 a p>ticul> geographic area1 su* plan or issu] %all demon/rate t x w use a database free ( conflicts ( int]e/ t has suffici5t in=mation reflect+ all[$ am\nts paid to individual heal? c>e provid]s = relevant s]vices provid$ 9 ! applicable geographic region1 & t su* plan or issu] w use t database to det]m9e a m$ian 9-network rate4 ,! gr\p heal? plan or heal? insurance issu] %all cov] ! co/ ( access+ ! database4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all prev5t a gr\p heal? plan or heal? insurance issu] f e/abli%+ sep>ate calculations ( a m$ian 9-network rate "u p>agraph 7#a7 = s]vices deliv]$ 9 nonhospital facilities1 includ+ free/&+ em]g5cy rooms4 7c7 ,facility ,= purposes ( ?is section1 ! t]m heal? c>e facility includes hospitals1 hospital outpati5t dep>tm5ts1 critical access hospitals1 ambulatory surg]y c5t]s1 laboratories1 radiology cl9ics1 & any o!r facility t provides s]vices t are cov]$ "u a gr\p heal? plan or heal? insurance cov]age1 includ+ sett+s ( c>e subject to section #bgai;,a7b74 4 7b7 ,non-,f$]al gov]nm5tal plans ,section #bgbb7;a77#b77;,e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ba7;a77#b77;,e77 is am5d$ by ins]t+ 1 except t su* election %all be available ) respect to section #bgbi;,a be=e ! p]iod4 #ajd4 ,effective date ,! am5dm5ts made by sections #aja1 #ajb1 & #ajc %all take effect beg9n+ 9 ! second plan ye> t beg9s aft] ! date ( enactm5t ( ?is ,act4 #aje4 ,end+ surprise air ambulance bills 7a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgai;,a 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 ! foll[+3 #bgai;,b4 ,end+ surprise air ambulance bills 7a7 ,9 g5]al ,9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives air ambulance s]vices f an out-(-network provid]-- 7#a7 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to su* s]vices %all be ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by an 9-network practition]1 & any co9surance or d$uctible %all be bas$ on 9-network rates2 & 7#b7 su* co/-%>+ am\nts %all be c\nt$ t[>ds ! 9-network d$uctible & 9-network out-(-pocket maximum am\nt "u ! plan or cov]age = ! plan ye>4 7b7 ,paym5t rate ,a gr\p heal? plan or heal? insurance issu] %all pay = air ambulance s]vices = purposes ( subsection 7a7 at ! m$ian 9-network z def9$ 9 subsection 7c74 7c7 ,m$ian 9-,network rate 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m m$ian 9-network rate means1 ) respect to air ambulance s]vices cov]$ by a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! m$ian negotiat$ rate "u ! applicable plan or cov]age recogniz$ "u ! plan or cov]age z ! total maximum paym5t = ! s]vice1 m9us ! 9-network co/-%>+ = su* s]vice "u ! plan or cov]age1 = ! same or a simil> s]vice t is provid$ by a provid] 9 ! same or simil> specialty1 & 9 ! geographic region 9 :i* ! s]vice is furni%$4 7#b7 ,rulemak+ ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all1 ?r\gh rulemak+1 det]m9e ! me?odology a gr\p heal? plan or heal? insurance issu] is requir$ to use to det]m9e ! m$ian 9-network rate describ$ 9 p>agraph 7#a71 ! in=mation ! plan or issu] %all %>e ) ! non-p>ticipat+ provid] involv$ :5 mak+ su* a det]m9ation1 & ! geographic regions appli$ = purposes ( ?is subsection4 ,su* rulemak+ %all take into acc\nt paym5ts t are made by issu]s t are n on a fee-=-s]vice basis4 7#c7 ,c]ta9 insur]s ,if a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age does n h suffici5t in=mation to calculate a m$ian 9-network rate = ?is s]vice or provid] type1 or am\nt (1 claims = s]vices 7z det]m9$ by ! applicable ,/ate au?ority1 9 ! case ( heal? insurance cov]age1 or by ! ,secret>y ( ,labor1 9 ! case ( a self-insur$ gr\p heal? plan7 cov]$ "u ! li/ ( out-(-network s]vices set by ! ,/ate au?ority or ,secret>y ( ,labor1 z applicable1 9 a p>ticul> geographic area1 su* plan or issu] %all demon/rate t x w use a database free ( conflicts ( int]e/ t has suffici5t in=mation reflect+ all[$ am\nts paid to individual heal? c>e provid]s = relevant s]vices provid$ 9 ! applicable geographic region1 & t su* plan or issu] w use t database to det]m9e a m$ian 9-network rate4 ,! gr\p heal? plan or heal? insurance issu] %all cov] ! co/ ( access+ ! database4 7#d7 ,cl>ification ,= purposes ( ?is subsection1 ! ,secret>y may def9e geographic regions t are diff]5t f ! geographic regions id5tifi$ = purposes ( section #bgbi;,a7b7 to ensure t an adequate numb] ( air ambulance s]vices are 9-network 9 ea* geographic region s t a m$ian 9-network rate = air ambulance s]vices may be calculat$ = ea* su* region4 7d7 ,co/-,%>+ limitation ,an air ambulance s]vice provid] may n bill an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age = am\nts beyond ! co/-%>+ am\nt t applies "u subsection 7a74 7e7 ,en=cem5t 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 an air ambulance s]vice provid] t violates subsection 7d7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7#b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#c7 ,safe h>bor ,! ,secret>y %all waive ! p5alties describ$ "u p>agraph 7#a7 ) respect to an air ambulance s]vice provid] :o unkn[+ly violates subsection 7d7 ) respect to an enrollee1 if su* air ambulance s]vice provid] )9 #cj days ( ! violation1 )draws ! bill t 0 9 violation ( subsection 7d71 &1 z applicable1 reimburses ! gr\p heal? plan1 heal? insurance issu]1 or enrollee1 z applicable1 9 an am\nt equal to ! am\nt bill$ 9 violation ( subsection 7d71 plus int]e/1 at an int]e/ rate det]m9$ by ! ,secret>y4 4 7b7 ,effective date ,section #bgai;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #ajf4 ,report ,n lat] ?an #a ye> aft] ! effective date describ$ 9 section #ajd1 & annually = ! foll[+ #d ye>s1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,f$]al ,trade ,commission & ! ,attorney ,g5]al1 %all-- 7#a7 conduct a /udy on-- 7,a7 ! effects ( ! am5dm5ts made by sections #aja1 #ajb1 & #ajc1 includ+ any patt]ns ( v]tical or horizontal integration ( heal? c>e facilities1 provid]s1 gr\p heal? plans1 or heal? insurance issu]s2 7,b7 ! effects ( ! am5dm5ts made by sections #aja1 #ajb1 & #ajc on ov]all heal? c>e co/s2 & 7,c7 recomm5dations = effective en=cem5t ( #bgbi;,a z add$ by section #ajc1 includ+ pot5tial *all5ges to address+ anti-competitive consolidation by heal? c>e facilities1 provid]s1 gr\p heal? plans1 or heal? insurance issu]s2 & 7#b7 submit a report on su* /udy to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation1 ! ,committee on ,f9ance1 & ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ,education & ,labor1 ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,ways & ,means1 & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives4 ,,ii ,r$uc+ ! ,prices ( ,prescription ,drugs #bja4 ,biological product pat5t transp>5cy 7a7 ,9 g5]al ,section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is am5d$ by add+ at ! end ! foll[+3 7o7 ,additional requirem5ts ) respect to pat5ts 7#a7 ,approv$ application hold] li/+ requirem5ts 7,a7 ,9 g5]al ,beg9n+ on ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 )9 #fj days ( approval ( an application "u subsection 7a7 or 7k71 ! hold] ( su* approv$ application %all submit to ! ,secret>y a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7,b7 ,previ\sly approv$ or lic5s$ biological products 7i7 ,products lic5s$ "u section #cea ( ! ,,phsa ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! hold] ( a biological product lic5se t 0 approv$ "u subsection 7a7 or 7k7 be=e ! date ( enactm5t ( su* ,act %all submit to ! ,secret>y a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7ii7 ,products approv$ "u section #eje ( ! ,,ffdca ,n lat] ?an #cj days aft] ,m>* #bc1 #bjbj1 ! hold] ( an approv$ application = a biological product "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act t is deem$ to be a lic5se = ! biological product "u ?is section on ,m>* #bc1 #bjbj1 %all submit to ! ,secret>y a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7,c7 ,updates ,! hold] ( a biological product lic5se t is ! subject ( an application "u subsection 7a7 or 7k7 %all submit to ! ,secret>y a li/ t includes-- 7i7 any pat5t n previ\sly requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c77 "u subp>agraph 7,a7 or 7,b71 z applicable1 )9 #cj days ( ! e>li] (-- 7,i7 ! date ( issuance ( su* pat5t by ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice2 or 7,,ii7 ! date ( approval ( a supplem5tal application = ! biological product2 & 7ii7 any pat5t1 or any claim ) respect to a pat5t1 includ$ on ! li/ pursuant to ?is p>agraph1 t ! ,pat5t ,trial & ,appeal ,bo>d ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice det]m9es 9 a decision to be invalid or un5=ceable1 )9 #cj days ( su* decision4 7#b7 ,publication ( in=mation 7,a7 ,9 g5]al ,)9 #a ye> ( ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all publi% & make available to ! public a s+le1 easily se>*able1 li/ t includes-- 7i7 ! (ficial & propriet>y "n ( ea* biological product lic5s$ "u subsection 7a7 or 7k71 & ( ea* biological product application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & deem$ to be a lic5se = ! biological product "u ?is section on ,m>* #bc1 #bjbj2 7ii7 ) respect to ea* biological product describ$ 9 clause 7i71 ea* pat5t submitt$ 9 accordance ) p>agraph 7#a72 7iii7 ! date ( approval & application numb] = ea* su* biological product2 7iv7 ! m>ket+ /atus1 dosage =m1 r\te ( adm9i/ration1 /r5g?1 &1 if applicable1 ref]5ce product1 = ea* su* biological product2 7v7 ! lic5sure /atus = ea* su* biological product1 includ+ :e!r ! lic5se at ! "t ( li/+ is approv$1 )drawn1 or revok$2 7vi7 ) respect to ea* su* biological product1 any p]iod ( any exclusivity "u p>agraph 7#f71 7#g77;,a71 or 7#g77;,b7 ( subsection 7k7 ( ?is section or section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & any ext5sion ( su* p]iod 9 accordance ) subsection 7m7 ( ?is section1 = :i* ! ,secret>y has det]m9$ su* biological product to be eligible1 & ! date on :i* su* exclusivity expires2 7vii7 in=mation reg>d+ any det]m9ation ( biosimil>ity or int]*angeability = ea* su* biological product2 & 7viii7 in=mation reg>d+ approv$ indications = ea* su* biological product1 9 su* mann] z ! ,secret>y det]m9es appropriate4 7,b7 ,updates ,e #cj days aft] ! publication ( ! fir/ li/ "u subp>agraph 7,a71 ! ,secret>y %all revise ! li/ to include-- 7i7 7,i7 ea* biological product lic5s$ "u subsection 7a7 or 7k7 dur+ ! #cj-;day p]iod2 & 7,,ii7 ) respect to ea* biological product describ$ 9 subclause 7,i71 ! in=mation describ$ 9 clauses 7i7 ?r\gh 7viii7 ( subp>agraph 7,a72 & 7ii7 any updates to in=mation previ\sly publi%$ 9 accordance ) subp>agraph 7,a74 7,c7 ,noncompliance ,beg9n+ #ah mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y1 9 consultation ) ! ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice1 %all publi% & make available to ! public a li/ ( any hold]s ( biological product lic5ses1 & ! correspond+ biological product or products1 t fail$ to submit in=mation z requir$ "u p>agraph 7#a71 includ+ any updates requir$ "u p>agraph 7#a77;,c71 9 su* mann] & =mat z ! ,secret>y det]m9es appropriate4 ,if in=mation requir$ "u p>agraph 7#a7 is submitt$ foll[+ publication ( su* li/1 ! ,secret>y %all remove su* hold]s ( su* biological product lic5ses f ! public li/ 9 a reasonable p]iod ( "t4 7#c7 ,pat5ts requir$ to be disclos$ ,9 ?is section1 a pat5t requir$ to be disclos$ is any pat5t = :i* ! hold] ( a biological product lic5se approv$ "u subsection 7a7 or 7k71 or a biological product application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & deem$ to be a lic5se = a biological product "u ?is section on ,m>* #bc1 #bjbj1 believes a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ by ! hold]1 or by a pat5t own] t has grant$ an exclusive lic5se to ! hold] ) respect to ! biological product t is ! subject ( su* lic5se1 if a p]son n lic5s$ by ! hold] engag$ 9 ! mak+1 us+1 (f]+ to sell1 sell+1 or import+ into ! ,unit$ ,/ates ( ! biological product t is ! subject ( su* lic5se4 4 7b7 ,disclosure ( pat5ts ,section #cea7l77#c77;,a77i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is am5d$ by ins]t+ includ$ 9 ! li/ provid$ by ! ref]5ce product sponsor "u subsection 7o77#a7 aft] a li/ ( pat5ts4 7c7 ,review & ,report on ,noncompliance ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all-- 7#a7 solicit public comm5ts reg>d+ appropriate rem$ies1 9 addition to ! publication ( ! li/ "u subsection 7o77#b77;,c7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z add$ by subsection 7a71 ) respect to hold]s ( biological product lic5ses :o fail to timely submit in=mation z requir$ "u subsection 7o77#a7 ( su* section #cea1 includ+ any updates requir$ "u subp>agraph 7,c7 ( su* subsection 7o77#a72 & 7#b7 submit to ,congress an evaluation ( comm5ts receiv$ "u p>agraph 7#a7 & ! recomm5dations ( ! ,secret>y conc]n+ appropriate rem$ies4 7d7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices may promulgate regulations to c>ry out subsection 7o7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z add$ by subsection 7a74 7e7 ,rule ( con/ruction ,no?+ 9 ?is ,act1 includ+ an am5dm5t made by ?is ,act1 %all be con/ru$ to require or all[ ! ,secret>y ( ,heal? & ,human ,s]vices to delay ! lic5s+ ( a biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 #bjb4 ,orange book mod]nization 7a7 ,submission ( pat5t in=mation = br& "n drugs 7#a7 ,9 g5]al ,p>agraph 7#a7 ( section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is am5d$ to read z foll[s3 7b7 7#a7 7,a7 ,any p]son may file ) ! ,secret>y an application ) respect to any drug subject to ! provisions ( subsection 7a74 ,su* p]sons %all submit to ! ,secret>y z "p ( ! application-- 7i7 full reports ( inve/igations :i* h be5 made to %[ :e!r or n su* drug is safe = use & :e!r su* drug is effective 9 use2 7ii7 a full li/ ( ! articles us$ z compon5ts ( su* drug2 7iii7 a full /atem5t ( ! composition ( su* drug2 7iv7 a full description ( ! me?ods us$ 91 & ! facilities & controls us$ =1 ! manufacture1 process+1 & pack+ ( su* drug2 7v7 su* samples ( su* drug & ( ! articles us$ z compon5ts !re( z ! ,secret>y may require2 7vi7 specim5s ( ! label+ propos$ to be us$ = su* drug2 7vii7 any assessm5ts requir$ "u section #eje;,b2 & 7viii7 ! pat5t numb] & expiration date1 ( ea* pat5t = :i* a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ if a p]son n lic5s$ by ! own] engag$ 9 ! manufacture1 use1 or sale ( ! drug1 & t-- 7,i7 claims ! drug = :i* ! applicant submitt$ ! application & is a drug sub/ance pat5t or a drug product pat5t2 or 7,,ii7 claims ! me?od ( us+ ! drug = :i* approval is s\ght or has be5 grant$ 9 ! application4 7,b7 ,if an application is fil$ "u ?is subsection = a drug1 & a pat5t ( ! type describ$ 9 subp>agraph 7,a77viii7 t claims su* drug or a me?od ( us+ su* drug is issu$ aft] ! fil+ date b be=e approval ( ! application1 ! applicant %all am5d ! application to include su* pat5t in=mation4 7,c7 ,^u approval ( ! application1 ! ,secret>y %all publi% ! in=mation submitt$ "u subp>agraph 7,a77viii74 4 7#b7 ,guidance ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal? & ) repres5tatives ( ! drug manufactur+ indu/ry1 review & develop guidance1 z appropriate1 on ! inclusion ( wom5 & m9orities 9 cl9ical trials requir$ "u subsection 7b77#a77;,a77i7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 z am5d$ by p>agraph 7#a74 7b7 ,con=m+ *anges to requirem5ts = subsequ5t submission ( pat5t in=mation ,section #eje7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$-- 7#a7 by ins]t+ be=e ! fir/ s5t5ce ! foll[+3 ,n lat] ?an #cj days aft] ! date ( approval ( an application "u subsection 7b71 ! hold] ( ! approv$ application %all file ) ! ,secret>y ! pat5t numb] & ! expiration date ( any pat5t describ$ 9 subclause 7,i7 or 7,,ii7 ( subsection 7b77#a77;,a77viii71 except t a pat5t t claims a me?od ( us+ su* drug %all be fil$ only if approval = su* use has be5 grant$ 9 ! application4 ,! hold] ( ! approv$ application %all file ) ! ,secret>y ! pat5t numb] & ! expiration date ( any pat5t describ$ 9 subclause 7,i7 or 7,,ii7 ( subsection 7b77#a77;,a77viii7 t is issu$ aft] ! date ( approval ( ! application1 n lat] ?an #cj days ( ! date ( issuance ( ! pat5t1 except t a pat5t t claims a me?od ( us+ su* drug %all be fil$ only if approval = su* use has be5 grant$ 9 ! application42 7#b7 by ins]t+ aft] ! pat5t numb] & ! expiration date ( any pat5t :i* ! foll[+3 fulfills ! crit]ia 9 subsection 7b7 &2 7#c7 by ins]t+ aft] ! ?ird s5t5ce 7z am5d$ by p>agraph 7#a77 ! foll[+3 ,pat5t in=mation t is n ! type ( pat5t in=mation requir$ by subsection 7b77#a77;,a77viii7 %all n be submitt$ "u ?is p>agraph42 & 7#d7 by ins]t+ aft] c\ld n file pat5t in=mation "u subsection 7b7 because no pat5t ! foll[+3 ( ! type requir$ to be submitt$ 9 subsection 7b74 7c7 ,li/+ ( exclusivities ,subp>agraph 7,a7 ( section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7iv7 ,= ea* drug includ$ on ! li/1 ! ,secret>y %all specify any exclusivity p]iod t is applicable1 = :i* ! ,secret>y has det]m9$ ! expiration date1 & = :i* su* p]iod has n yet expir$ "u-- 7,i7 clause 7ii71 7iii71 or 7iv7 ( subsection 7c77#c77;,e7 ( ?is section2 7,,ii7 clause 7iv7 or 7v7 ( p>agraph 7#e77;,b7 ( ?is subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 ( p>agraph 7#e77;,f7 ( ?is subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 7,,vi7 section #ebg7;a72 or 7,,vii7 section #eje7u7 4 7d7 ,orange book updates ) respect to invalidat$ pat5ts 7#a7 ,9 g5]al 7,a7 ,am5dm5ts ,section #eje7;j77#g77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a771 z am5d$ by subsection 7c71 is fur!r am5d$ by add+ at ! end ! foll[+3 7v7 ,9 ! case ( a li/$ drug = :i* ! li/ "u clause 7i7 includes a pat5t or pat5t claim = ! drug1 or a pat5t or a pat5t claim = ! use ( su* drug1 & :]e ! ,"u ,secret>y ( ,comm]ce = ,intellectual ,prop]ty & ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice has cancel$ any claim ( ! pat5t relat+ to su* drug or su* use pursuant to a decision by ! ,pat5t ,trial & ,appeal ,bo>d 9 an int] p>tes review conduct$ "u *apt] #ca ( title #ce1 ,unit$ ,/ates ,code1 or a po/-grant review conduct$ "u *apt] #cb ( t title1 & f :i* no appeal has be5 tak51 or c be tak51 ! hold] ( ! applicable approv$ application %all notify ! ,secret>y1 9 writ+1 )9 #ad days ( su* cancellation1 &1 if ! pat5t has be5 deem$ :olly inop]ative or invalid1 or if a pat5t claim has be5 cancel$1 ! revisions requir$ "u clause 7iii7 %all include /rik+ ! pat5t or in=mation reg>d+ su* pat5t claim f ! li/ ) respect to su* drug4 4 7,b7 ,application ,! am5dm5t made by subp>agraph 7,a7 %all n apply ) respect to any det]m9ation ) respect to a pat5t or pat5t claim t is made prior to ! date ( enactm5t ( ?is ,act4 7#b7 ,no effect on fir/ applicant exclusivity p]iod ,section #eje7;j77#e77;,b77iv77,i7 is am5d$ by add+ at ! end ! foll[+3 ,?is subclause %all apply ev5 if a pat5t is /rick5 f ! li/ "u p>agraph 7#g77;,a71 pursuant to p>agraph 7#g77;,a77v71 provid$ t1 at ! "t t ! fir/ applicant submitt$ an application "u ?is subsection conta9+ a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv71 ! pat5t t 0 ! subject ( su* c]tification 0 includ$ 9 su* li/ ) respect to ! li/$ drug44 #bjc4 ,ensur+ timely access to g5]ics ,section #eje7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77#a77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a77i71 by ins]t+ 1 #aj4ca1 aft] #aj4cj2 7,b7 9 subp>agraph 7,e7-- 7i7 by /rik+ application & & ins]t+ application or2 7ii7 by /rik+ ,if ! ,secret>y & ins]t+ ! foll[+3 7i7 ,9 g5]al ,if ! ,secret>y 2 & 7iii7 by /rik+ ! second s5t5ce & ins]t+ ! foll[+3 7ii7 ,prim>y purpose ( delay+ 7,i7 ,9 g5]al ,= purposes ( ?is subp>agraph1 a petition or supplem5t to a petition may be consid]$ to be submitt$ ) ! prim>y purpose ( delay+ an application "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 if ! petition] has ! purpose ( sett+ aside1 delay+1 resc9d+1 )draw+1 or prev5t+ submission1 review1 or ! approval ( su* an application4 7,,ii7 ,factors ,9 det]m9+ :e!r a petition 0 submitt$ ) ! prim>y purpose ( delay+ an application1 ! ,secret>y may consid] ! foll[+ factors3 7aa7 ,:e!r ! petition 0 submitt$ 9 accordance ) p>agraph 7#b77;,b71 bas$ on :5 ! petition] knew or reasonably %\ld h kn[n ! relevant in=mation reli$ ^u to =m ! basis ( su* petition4 7bb7 ,:e!r ! petition] has submitt$ multiple or s]ial petitions rais+ issues t reasonably c\ld h be5 kn[n to ! petition] at ! "t ( submission ( ! e>li] petition or petitions4 7cc7 ,:e!r ! petition 0 submitt$ close 9 "t to a kn[n1 fir/ date ^u :i* an application "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act c\ld be approv$4 7dd7 ,:e!r ! petition 0 submitt$ )\t any relevant data or in=mation 9 support ( ! sci5tific positions =m+ ! basis ( su* petition4 7ee7 ,:e!r ! petition raises ! same or sub/antially simil> issues z a prior petition to :i* ! ,secret>y has respond$ sub/antively already1 includ+ if ! subsequ5t submission foll[s su* response f ! ,secret>y closely 9 "t4 7ff7 ,:e!r ! petition reque/s *ang+ ! applicable /&>ds t o!r applicants are requir$ to meet1 includ+ reque/+ te/+1 data1 or label+ /&>ds t are m on]\s or rigor\s ?an ! /&>ds applicable to ! li/$ drug1 ref]5ce product1 or petition]'s v]sion ( ! same drug4 7gg7 ,! petition]'s record ( submitt+ petitions to ! ,food & ,drug ,adm9i/ration t h be5 det]m9$ by ! ,secret>y to h be5 submitt$ ) ! prim>y purpose ( delay4 7hh7 ,o!r relevant & appropriate factors1 :i* ! ,secret>y %all describe 9 guidance4 7,,iii7 ,guidance ,! ,secret>y may issue or update guidance1 z appropriate1 to describe factors ! ,secret>y consid]s 9 accordance ) subclause 7,,ii74 2 7,c7 by add+ at ! end ! foll[+3 7iii7 ,ref]ral to ! ,f$]al ,trade ,commission ,! ,secret>y %all e/abli% proc$ures = ref]r+ to ! ,f$]al ,trade ,commission any petition or supplem5t to a petition t ! ,secret>y det]m9es 0 submitt$ ) ! prim>y purpose ( delay+ approval ( an application4 ,su* proc$ures %all include notification to ! petition] & an opportunity = judicial review aft] ! issuance ( an ord] by ! ,f$]al ,trade ,commission4 2 7,d7 by /rik+ subp>agraph 7,f72 7,e7 by r$esignat+ subp>agraphs 7,g7 ?r\gh 7,i7 z subp>agraphs 7,f7 ?r\gh 7,h71 respectively2 & 7,f7 9 subp>agraph 7,h71 z s r$esignat$1 by /rik+ submission ( ?is petition & ins]t+ submission ( ?is docum5t2 7#b7 9 p>agraph 7#b7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,c7 z subp>agraphs 7,c7 ?r\gh 7,e71 respectively2 7,b7 by ins]t+ be=e subp>agraph 7,c71 z s r$esignat$1 ! foll[+3 7,a7 ,9 g5]al ,a p]son %all submit a petition to ! ,secret>y "u p>agraph 7#a7 be=e fil+ a civil action 9 :i* ! p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act4 ,su* petition & any supplem5t to su* a petition %all describe all in=mation & argum5ts t =m ! basis ( ! relief reque/$ 9 any civil action describ$ 9 ! previ\s s5t5ce4 7,b7 ,timely submission ( citiz5 petition ,a petition & any supplem5t to a petition %all be submitt$ )9 #fj days aft] ! p]son knew1 or reasonably %\ld h kn[n1 ! in=mation t =ms ! basis ( ! reque/ made 9 ! petition or supplem5t4 2 7,c7 9 subp>agraph 7,c71 z s r$esignat$1 by-- 7i7 9 ! head+1 /rik+ )9 #aej days2 7ii7 9 clause 7i71 /rik+ dur+ ! #aej-;day p]iod ref]r$ to 9 p>agraph 7#a77;,f712 & 7iii7 am5d+ clause 7ii7 to read z foll[s3 7ii7 on or aft] ! date t is #aea days aft] ! date ( submission ( ! petition1 ! ,secret>y approves or has approv$ ! application t is ! subject ( ! petition )\t hav+ made su* a f9al decision4 2 7,d7 by am5d+ subp>agraph 7,d71 z s r$esignat$1 to read z foll[s3 7,d7 ,dismissal ( c]ta9 civil actions 7i7 ,petition ,if a p]son files a civil action aga9/ ! ,secret>y 9 :i* a p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act )\t comply+ ) ! requirem5ts ( subp>agraph 7,a71 ! c\rt %all dismiss )\t prejudice ! action = failure to exhau/ adm9i/rative rem$ies4 7ii7 ,timel9ess ,if a p]son files a civil action aga9/ ! ,secret>y 9 :i* a p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act )\t comply+ ) ! requirem5ts ( subp>agraph 7,b71 ! c\rt %all dismiss ) prejudice ! action = failure to timely file a petition4 7iii7 ,f9al response ,if a civil action is fil$ aga9/ ! ,secret>y ) respect to any issue rais$ 9 a petition timely fil$ "u p>agraph 7#a7 9 :i* ! petition] reque/s t ! ,secret>y take any =m ( action t c\ld1 if tak51 set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act be=e ! ,secret>y has issu$ a f9al response to any su* petition submitt$1 ! c\rt %all dismiss )\t prejudice ! action = failure to exhau/ adm9i/rative rem$ies4 2 & 7,e7 9 subp>agraph 7,e71 z s r$esignat$-- 7i7 9 clause 7ii71 by /rik+ 1 if issu$2 & 7ii7 9 clause 7iii71 by /rik+ f9al ag5cy action z def9$ "u subp>agraph 7#b77;,a7 & ins]t+ ! f9al response to ! petition]2 & 7#c7 9 p>agraph 7#d7-- 7,a7 by /rik+ ,exceptions & all t foll[s ?r\gh ,?is subsection does & ins]t+ ,exceptions--,?is subsection does2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ clauses 7i7 & 7ii7 z subp>agraphs 7,a7 & 7,b71 respectively1 & adju/+ ! m>g9s accord+ly4 #bjd4 ,protect+ access to biological products ,section #cea7k77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is am5d$ by add+ at ! end ! foll[+3 7,d7 ,deem$ lic5ses 7i7 ,no additional exclusivity ?r\gh deem+ ,an approv$ application t is deem$ to be a lic5se = a biological product "u ?is section pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji %all n be treat$ z hav+ be5 fir/ lic5s$ "u subsection 7a7 = purposes ( subp>agraphs 7,a7 & 7,b74 7ii7 ,limitation on exclusivity ,subp>agraph 7,c7 %all apply to any ref]5ce product1 )\t reg>d to :e!r-- 7,i7 su* product 0 fir/ lic5s$ "u subsection 7a72 or 7,,ii7 ! approv$ application = su* product 0 deem$ to be a lic5se = a biological product z describ$ 9 clause 7i74 7iii7 ,applicability ,any unexpir$ p]iod ( exclusivity "u section #ebg or section #eje;,a7c77#a77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to a biological product %all cont9ue to apply to su* biological product aft] an approv$ application = ! biological product is deem$ to be a lic5se = ! biological product z describ$ 9 clause 7i74 4 #bje4 ,prev5t+ block+ ( g5]ic drugs ,section #eje7;j77#e77;,b77iv77,i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77,i77 is am5d$-- 7#a7 by /rik+ #ahj days aft] ! date & ins]t+ 8#ahj days aft] ! e>li] ( ! foll[+3 7aa7 ,! date 2 & 7#b7 by add+ at ! end ! foll[+3 7bb7 ,! date on :i* all ( ! foll[+ conditions are fir/ met3 7,,aa7 ,an application = ! drug submitt$ by an applicant o!r ?an a fir/ applicant c\ld receive approval1 if no fir/ applicant 7 eligible = #ahj-;day exclusivity "u ?is clause4 7,,bb7 ,?irty-?ree mon?s h pass$ s9ce ! date ( submission ( an application = ! drug by "o fir/ applicant1 if !re is only "o fir/ applicant1 or1 9 ! case ( m ?an "o fir/ applicant1 #cc mon?s h pass$ s9ce ! date ( submission ( all su* applications4 7,,cc7 ,approval ( an application = ! drug submitt$ by at lea/ "o fir/ applicant w\ld n be preclud$ "u clause 7iii74 7,,dd7 ,no application = ! drug submitt$ by any fir/ applicant is approv$ at ! "t ! conditions "u subitems 7,,aa71 7,,bb71 & 7,,cc7 are all met1 reg>dless ( :e!r su* an application is subsequ5tly approv$4 4 #bjf4 ,education on biological products ,subp>t #a ( "p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$ by add+ at ! end ! foll[+3 #ceb;,a4 ,education on biological products 7a7 ,int]net website 7#a7 ,9 g5]al ,! ,secret>y may e/abli%1 ma9ta91 & op]ate an int]net website to provide educational mat]ials = heal? c>e provid]s1 pati5ts1 & c>egiv]s1 reg>d+ ! mean+ ( ! t]ms1 & ! /&>ds = review & lic5s+ (1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 7#b7 ,cont5t ,educational mat]ials provid$ "u p>agraph 7#a7 may include explanations (-- 7,a7 key /atutory & regulatory t]ms1 includ+ biosimil> & int]*angeable1 & cl>ification reg>d+ ! appropriate use ( int]*angeable biosimil> biological products2 7,b7 in=mation relat$ to developm5t programs = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products & relevant cl9ical consid]ations = prescrib]s1 :i* may include1 z appropriate & applicable1 in=mation relat$ to ! comp>ability ( su* biological products2 7,c7 ! process = report+ adv]se ev5ts = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products2 & 7,d7 ! relation%ip betwe5 biosimil> biological products & int]*angeable biosimil> biological products lic5s$ "u section #cea7k7 & ref]5ce products 7z def9$ 9 section #cea7;i771 includ+ ! /&>ds = review & lic5s+ ( ea* su* type ( biological product4 7#c7 ,=mat ,! educational mat]ials provid$ "u p>agraph 7#a7 may be-- 7,a7 9 =mats su* z web9>s1 cont9u+ m$ical education modules1 videos1 fact %eets1 infographics1 /akehold] toolkits1 or o!r =mats z appropriate & applicable2 & 7,b7 tailor$ = ! unique ne$s ( heal? c>e provid]s1 pati5ts1 c>egiv]s1 & o!r audi5ces1 z ! ,secret>y det]m9es appropriate4 7#d7 ,o!r in=mation ,9 addition to ! in=mation describ$ 9 p>agraph 7#b71 ! int]net website e/abli%$ "u p>agraph 7#a7 %all include ! foll[+ in=mation1 z a s+le1 se>*able database3 7,a7 ,! action package ( ea* biological product lic5s$ "u subsection 7a7 or 7k71 )9 #cj days ( lic5sure1 or1 9 ! case ( a biological product lic5s$ be=e ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 n lat] ?an #a ye> aft] su* date ( enactm5t4 7,b7 ,! summ>y review ( ea* biological product lic5s$ "u subsection 7a7 or 7k71 )9 #g days ( lic5sure1 except :]e su* mat]ials require r$action by ! ,secret>y1 or1 9 ! case ( a biological product lic5s$ be=e ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 n lat] ?an #a ye> aft] su* date ( enactm5t4 7#e7 ,confid5tial & trade secret in=mation ,?is subsection does n au?orize ! disclosure ( any trade secret1 confid5tial comm]cial or f9ancial in=mation1 or o!r matt] describ$ 9 section #eeb7;b7 ( title #e4 7b7 ,cont9u+ m$ical education ,! ,secret>y %all advance education & aw>5ess among heal? c>e provid]s reg>d+ biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products1 z appropriate1 includ+ by develop+ or improv+ cont9u+ m$ical education programs t advance ! education ( su* provid]s on ! prescrib+ (1 & relevant cl9ical consid]ations ) respect to biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 4 #bjg4 ,biological product innovation ,section #cea7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;j77 is am5d$-- 7#a7 by /rik+ except t a product & ins]t+ 8except t-- 7#a7 a product 2 7#b7 by /rik+ ,act4 & ins]t+ ,act2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#b7 no requirem5t "u su* ,act reg>d+ an (ficial comp5dium 7z def9$ 9 section #bja7;j7 ( su* ,act71 or o!r ref]5ce 9 su* ,act to an (ficial comp5dium 7z s def9$71 %all apply ) respect to a biological product subject to regulation "u ?is section4 4 #bjh4 ,cl>ify+ ! mean+ ( new *emical entity ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 9 subsection 7c77#c77;,e7-- 7i7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 9 clause 7iii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 subsection 7j77#e77;,f7-- 7i7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 9 clause 7iii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,c7 9 subsection 7l77#b77;,a77i71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,d7 9 subsection 7s71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7,e7 9 subsection 7u77#a71 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 by /rik+ same active +r$i5t & ins]t+ same active moiety2 7#b7 9 section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f77-- 7,a7 9 clause 7i71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 clause 7ii71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7,c7 9 clause 7v71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#c7 9 section #ebd7;a77#d77;,c7 7#ba ,u4,s4,c4 #cfjn7a77#d77;,c771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#d7 9 section #ebi7;a77#d77;,a77ii7 7#ba ,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7#e7 9 section #efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d77;,d771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations774 #bji4 ,/reaml9+ ! transition ( biological products ,section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh7 is am5d$ by add+ at ! end ! foll[+3 ,) respect to an application = a biological product "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 ) a fil+ date t is n lat] ?an ,septemb] #bc1 #bjai1 ! ,secret>y %all cont9ue to review & approve su* application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 ev5 if su* review & approval process cont9ues aft] ,m>* #bc1 #bjbj4 ,effective on ! lat] ( ,m>* #bc1 #bjbj1 or ! date ( approval ( su* application "u su* section #eje1 su* approv$ application %all be deem$ to be a lic5se = ! biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act44 #baj4 ,orphan drug cl>ification ,section #ebg7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7c77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,applicability ,?is subsection applies to any drug designat$ "u section #ebf t 0 approv$ "u section #eje ( ?is ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 reg>dless ( ! date ( on :i* su* drug 0 designat$ "u section #ebf4 4 #baa4 ,prompt approval ( drugs relat$ to safety in=mation ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$ by add+ at ! end ! foll[+3 7z7 ,prompt ,approval ( ,drugs ,:5 safety in=mation ,is ,add$ to ,label+ 7#a7 ,g5]al rule ,a drug = :i* an application has be5 submitt$ or approv$ "u subsection 7b77#b7 or 7j7 %all n be consid]$ ineligible = approval "u ?is section or misbr&$ "u section #ejb on ! basis t ! label+ ( ! drug omits safety in=mation1 includ+ contra9dications1 w>n+s1 precautions1 dos+1 adm9i/ration1 or o!r in=mation p]ta9+ to safety1 :5 ! omitt$ safety in=mation is protect$ by exclusivity "u clause 7iii7 or 7iv7 ( subsection 7j77#e77;,f71 clause 7iii7 or 7iv7 ( subsection 7c77#c77;,e71 or section #ebg7;a71 or by an ext5sion ( su* exclusivity "u section #eje;,a or #eje;,e4 7#b7 ,label+ ,not)/&+ clauses 7iii7 & 7iv7 ( subsection 7j77#e77;,f71 clauses 7iii7 & 7iv7 ( subsection 7c77#c77;,e71 or section #ebg1 ! ,secret>y %all require t ! label+ ( a drug approv$ pursuant to an application submitt$ "u subsection 7b77#b7 or 7j7 t omits safety in=mation describ$ 9 p>agraph 7#a7 include a /atem5t ( any appropriate safety in=mation t ! ,secret>y consid]s necess>y to assure safe use4 7#c7 ,availability & scope ( exclusivity ,?is subsection does n affect-- 7,a7 ! availability or scope ( exclusivity or an ext5sion ( exclusivity describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #eje;,a7o77#c72 7,b7 ! "q ( ! eligibility = approval "u ?is section ( any application describ$ 9 subsection 7b77#b7 or 7j7 t omits any o!r aspect ( label+ protect$ by exclusivity "u-- 7i7 clause 7iii7 or 7iv7 ( subsection 7j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 ( subsection 7c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,c7 except z expressly provid$ 9 p>agraphs 7#a7 & 7#b71 ! op]ation ( ?is section or section #ebg4 4 #bab4 ,conditions ( use = biosimil> biological products ,section #cea7k77#b77;,a77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,,iii7 may include in=mation to %[ t ! conditions ( use prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ propos$ = ! biological product h be5 previ\sly approv$ = ! ref]5ce product4 4 #bac4 ,mod]niz+ ! label+ ( c]ta9 g5]ic drugs ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejc;,c ! foll[+3 #ejc;,d4 ,process to update label+ = c]ta9 drugs 7a7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m cov]$ drug means a drug approv$ "u section #eje7;c7-- 7,a7 = :i* !re are no unexpir$ pat5ts includ$ 9 ! li/ "u section #eje7;j77#g7 & no unexpir$ p]iod ( m>ket exclusivity2 7,b7 = :i* ! approval ( ! application has be5 )drawn = reasons o!r ?an safety or effectiv5ess2 & 7,c7 = :i*1 ) respect to ! label+-- 7i7 new sci5tific evid5ce is available reg>d+ ! conditions ( use ( ! drug2 7ii7 !re is a relevant accept$ use 9 cl9ical practice t is n reflect$ 9 ! approv$ label+2 or 7iii7 ! label+ ( su* drug does n reflect curr5t legal & regulatory requirem5ts4 7#b7 ,! t]m p]iod ( m>ket exclusivity1 ) respect to a drug approv$ "u section #eje7;c71 means any p]iod ( m>ket exclusivity "u clause 7ii71 7iii71 or 7iv7 ( section #eje7;c77#c77;,e71 clause 7ii71 7iii71 or 7iv7 ( section #eje7;j77#e77;,f71 or section #eje;,a1 #eje;,e1 or #ebg4 7#c7 ,! t]m g5]ic v]sion means a drug approv$ "u section #eje7;j7 ^: ref]5ce drug is a cov]$ drug4 7#d7 ,! t]m relevant accept$ use means a use = a drug 9 cl9ical practice t is support$ by sci5tific evid5ce t appe>s to ! ,secret>y to meet ! /&>ds = approval "u section #eje4 7#e7 ,! t]m select$ drug means a cov]$ drug = :i* ! ,secret>y has det]m9$ ?r\gh ! process "u subsection 7c7 t ! label+ %\ld be *ang$4 7b7 ,id5tification ( cov]$ drugs ,! ,secret>y may id5tify cov]$ drugs = :i* label+ updates w\ld provide a public heal? b5efit4 ,to assi/ 9 id5tify+ cov]$ drugs1 ! ,secret>y may d "o or bo? ( ! foll[+3 7#a7 ,ent] into coop]ative agreem5ts or contracts ) public or private entities to review ! available sci5tific evid5ce conc]n+ su* drugs4 7#b7 ,seek public input conc]n+ su* drugs1 includ+ input on :e!r !re is a relevant accept$ use 9 cl9ical practice t is n reflect$ 9 ! approv$ label+ ( su* drugs or :e!r new sci5tific evid5ce is available reg>d+ ! conditions ( use = su* drug1 by-- 7,a7 hold+ "o or m public meet+s2 7,b7 op5+ a public docket = ! submission ( public comm5ts2 or 7,c7 o!r means1 z ! ,secret>y det]m9es appropriate4 7c7 ,selection ( drugs = updat+ ,if ! ,secret>y det]m9es1 ) respect to a cov]$ drug1 t ! available sci5tific evid5ce meets ! /&>ds "u section #eje = add+ or modify+ in=mation to ! label+ or provid+ supplem5tal in=mation to ! label+ reg>d+ ! use ( ! cov]$ drug1 ! ,secret>y may initiate ! process "u subsection 7d74 7d7 ,initiation ( ! process ( updat+ ,if ! ,secret>y det]m9es t label+ *anges are appropriate = a select$ drug pursuant to subsection 7c71 ! ,secret>y %all provide notice to ! hold]s ( approv$ applications = a g5]ic v]sion ( su* drug t-- 7#a7 summ>izes ! f9d+s support+ ! det]m9ation ( ! ,secret>y t ! available sci5tific evid5ce meets ! /&>ds "u section #eje = add+ or modify+ in=mation or provid+ supplem5tal in=mation to ! label+ ( ! cov]$ drug pursuant to subsection 7c72 7#b7 provides a cle> /atem5t reg>d+ ! additional1 modifi$1 or supplem5tal in=mation = su* label+1 accord+ to ! det]m9ation by ! ,secret>y 7includ+1 z applicable1 modifications to add ! relevant accept$ use to ! label+ ( ! drug z an additional indication = ! drug72 & 7#c7 /ates :e!r ! /atem5t "u p>agraph 7#b7 applies to ! select$ drug z a class ( cov]$ drugs or only z to a specific drug product4 7e7 ,response to notification ,)9 #cj days ( receipt ( notification provid$ by ! ,secret>y pursuant to subsection 7d71 ! hold] ( an approv$ application = a g5]ic v]sion ( ! select$ drug %all-- 7#a7 agree to *ange ! approv$ label+ to reflect ! additional1 modifi$1 or supplem5tal in=mation ! ,secret>y has det]m9$ to be appropriate2 or 7#b7 notify ! ,secret>y t ! hold] ( ! approv$ application does n believe t ! reque/$ label+ *anges are w>rant$ & submit a /atem5t detail+ ! reasons :y su* *anges are n w>rant$4 7f7 ,review ( application hold]'s response 7#a7 ,9 g5]al ,^u receipt ( ! application hold]'s response1 ! ,secret>y %all promptly review ea* /atem5t receiv$ "u subsection 7e77#b7 & det]m9e :i* label+ *anges pursuant to ! ,secret>y's notice "u subsection 7d7 are appropriate1 if any4 ,if ! ,secret>y disagrees ) ! reasons :y su* label+ *anges are n w>rant$1 ! ,secret>y %all provide opportunity = discussions ) ! application hold]s to rea* agreem5t on :e!r ! label+ = ! cov]$ drug %\ld be updat$ to reflect curr5t sci5tific evid5ce1 & if s1 ! cont5t ( su* label+ *anges4 7#b7 ,*anges to label+ ,aft] consid]+ all responses f ! hold] ( an approv$ application "u p>agraph 7#a7 or 7#b7 ( subsection 7e71 & any discussion "u p>agraph 7#a71 ! ,secret>y may ord] su* hold] to make ! label+ *anges ! ,secret>y det]m9es are appropriate4 ,su* hold] ( an approv$ application %all-- 7,a7 update its pap] label+ = ! drug at ! next pr9t+ ( t label+2 7,b7 update any electronic label+ = ! drug )9 #cj days2 & 7,c7 submit ! revis$ label+ ?r\gh ! =m1 ,supplem5t--,*anges ,be+ ,effect$4 7g7 ,violation ,if ! hold] ( an approv$ application = ! g5]ic v]sion ( ! select$ drug does n comply ) ! requirem5ts ( subsection 7f77#b71 su* g5]ic v]sion ( ! select$ drug %all be deem$ to be misbr&$ "u section #ejb4 7h7 ,limitations2 g5]ic drugs 7#a7 ,9 g5]al ,) respect to any label+ *ange requir$ "u ?is section1 ! g5]ic v]sion %all be deem$ to h ! same conditions ( use & ! same label+ z a ref]5ce drug = purposes ( clauses 7i7 & 7v7 ( section #eje7;j77#b77;,a74 ,any label+ *ange s requir$ %all n h any legal effect = ! applicant t is diff]5t ?an ! legal effect t w\ld h result$ if a supplem5tal application _h be5 submitt$ & approv$ to con=m ! label+ ( ! g5]ic v]sion to a *ange 9 ! label+ ( ! ref]5ce drug4 7#b7 ,supplem5tal applications ,*anges to label+ made 9 accordance ) ?is p>agraph %all n be eligible = an exclusivity p]iod "u ?is ,act4 7i7 ,drug product classes ,9 ! case ( a select$ drug = :i* ! label+ *anges ord]$ by ! ,secret>y "u subsection 7d77#b7 are requir$ = a class ( cov]$ drugs1 su* label+ *anges %all be made = g5]ic v]sions ( su* drug 9 t class4 7j7 ,rules ( con/ruction 7#a7 ,approval /&>ds ,?is section %all n be con/ru$ z alt]+ ! applicability ( ! /&>ds = approval ( an application "u section #eje4 ,no ord] %all be issu$ "u ?is subsection unless ! evid5ce support+ ! *ang$ label+ meets ! /&>ds = approval applicable to any *ange to label+ "u section #eje4 7#b7 ,removal ( in=mation ,no?+ 9 ?is section %all be con/ru$ to give ! ,secret>y additional au?ority to remove approv$ indications = drugs1 o!r ?an ! au?ority to remove c]ta9 indications f ! labels ( c]ta9 cov]$ drugs1 z describ$ 9 ?is section4 7k7 ,reports ,n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act & e #d ye>s !reaft]1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report t-- 7#a7 describes ! actions ( ! ,secret>y "u ?is section1 includ+-- 7,a7 ! numb] ( cov]$ drugs & description ( ! types ( drugs ! ,secret>y has select$ = label+ *anges & ! rationale = su* recomm5d$ *anges2 & 7,b7 ! numb] ( times ! ,secret>y ent]$ into discussions conc]n+ a disagreem5t ) an application hold] or hold]s & a summ>y ( ! decision reg>d+ a label+ *ange1 if any2 & 7#b7 includes any recomm5dations ( ! ,secret>y = modify+ ! program "u ?is section4 4 ,,iii ,improv+ ,transp>5cy 9 ,heal? ,c>e #cja4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 z am5d$ by section #ajc1 is am5d$ by add+ at ! end ! foll[+3 #bgbi;,b4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation 7a7 ,increas+ price & quality transp>5cy = plan sponsors & consum]s 7#a7 ,gr\p heal? plans ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age may n ent] into an agreem5t ) a heal? c>e provid]1 network or association ( provid]s1 ?ird-p>ty adm9i/rator1 or o!r s]vice provid] (f]+ access to a network ( provid]s t w\ld directly or indirectly re/rict a gr\p heal? plan or heal? insurance issu] f-- 7,a7 provid+ provid]-specific co/ or quality ( c>e in=mation1 ?r\gh a consum] engagem5t tool or any o!r means1 to ref]r+ provid]s1 ! plan sponsor1 enrollees1 or eligible enrollees ( ! plan or cov]age2 7,b7 electronically access+ de-id5tifi$ claims & enc\nt] data = ea* enrollee 9 ! plan or cov]age1 ^u reque/ & consi/5t ) ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij1 ) respect to ! applicable heal? plan or heal? insurance cov]age1 includ+1 on a p] claim basis-- 7i7 f9ancial in=mation1 su* z ! all[$ am\nt1 or any o!r claim-relat$ f9ancial obligations includ$ 9 ! provid] contract2 7ii7 provid] in=mation1 includ+ "n & cl9ical designation2 7iii7 s]vice codes2 or 7iv7 any o!r data elem5t normally includ$ 9 claim or enc\nt] transactions :5 receiv$ by a plan or issu]2 or 7,c7 %>+ data describ$ 9 subp>agraph 7,a7 or 7,b7 ) a bus9ess associate z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 consi/5t ) ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij4 7#b7 ,individual heal? insurance cov]age ,a heal? insurance issu] (f]+ individual heal? insurance cov]age may n ent] into an agreem5t ) a heal? c>e provid]1 network or association ( provid]s1 or o!r s]vice provid] (f]+ access to a network ( provid]s t w\ld1 directly or indirectly re/rict ! heal? insurance issu] f-- 7,a7 provid+ provid]-specific price or quality ( c>e in=mation1 ?r\gh a consum] engagem5t tool or any o!r means1 to ref]r+ provid]s or ! plan sponsor1 enrollees1 or eligible enrollees ( ! plan or cov]age2 or 7,b7 %>+ data describ$ 9 subp>agraph 7,a7 ) a bus9ess associate z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 consi/5t ) ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij1 = plan design1 plan adm9i/ration1 & plan1 f9ancial1 legal1 & quality improvem5t activities4 7#c7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 p>agraph 7#a77;,a7 or 7#b77;,a7 prev5ts a heal? c>e provid]1 network or association ( provid]s1 or o!r s]vice provid] f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation describ$ 9 su* p>agraphs 7#a7 & 7#b74 7#d7 ,atte/ation ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all annually submit to1 z applicable1 ! applicable au?ority describ$ 9 section #bgbc or ! ,secret>y ( ,labor1 an atte/ation t su* plan or issu] is 9 compliance ) ! requirem5ts ( ?is subsection4 7#e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to o!rwise limit gr\p heal? plan or plan sponsor access to data curr5tly p]mitt$ "u ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij4 4 #cjb4 ,bann+ anticompetitive t]ms 9 facility & insurance contracts t limit access to high] quality1 l[] co/ c>e 7a7 ,9 g5]al ,section #bgbi;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #cja1 is am5d$ by add+ at ! end ! foll[+3 7b7 ,protect+ ,heal? ,plans ,network ,design ,flexibility 7#a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n ent] into an agreem5t ) a provid]1 network or association ( provid]s1 or o!r s]vice provid] (f]+ access to a network ( s]vice provid]s if su* agreem5t1 directly or indirectly-- 7,a7 re/ricts ! gr\p heal? plan or heal? insurance issu] f-- 7i7 direct+ or /e]+ enrollees to o!r heal? c>e provid]s2 or 7ii7 (f]+ inc5tives to enc\rage enrollees to utilize specific heal? c>e provid]s2 7,b7 requires ! gr\p heal? plan or heal? insurance issu] to ent] into any additional contract ) an affiliate ( ! provid] z a condition ( ent]+ into a contract ) su* provid]2 7,c7 requires ! gr\p heal? plan or heal? insurance issu] to agree to paym5t rates or o!r t]ms = any affiliate n p>ty to ! contract ( ! provid] involv$2 or 7,d7 re/ricts o!r gr\p heal? plans or heal? insurance issu]s n p>ty to ! contract1 f pay+ a l[] rate = items or s]vices ?an ! contract+ plan or issu] pays = su* items or s]vices4 7#b7 ,additional requirem5t = self-insur$ plans ,a self-insur$ gr\p heal? plan %all n ent] into an agreem5t ) a provid]1 network or association ( provid]s1 ?ird-p>ty adm9i/rator1 or o!r s]vice provid] (f]+ access to a network ( provid]s if su* agreem5t1 directly or indirectly requires ! gr\p heal? plan to c]tify1 atte/1 or o!rwise confirm 9 writ+ t ! gr\p heal? plan is b\nd by ! t]ms ( ! contract betwe5 ! s]vice provid] & a ?ird-p>ty adm9i/rator t ! gr\p heal? plan is n p>ty to & is n all[$ to review4 7#c7 ,exception = c]ta9 gr\p model issu]s ,p>agraph 7#a77;,a7 %all n apply to a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age ) respect to a heal? ma9t5ance organization 7z def9$ 9 section #bgia7;b77#c77 if su* heal? ma9t5ance organization op]ates prim>ily ?r\gh exclusive contracts ) multi-specialty physician gr\ps1 nor to any arrangem5t betwe5 su* a heal? ma9t5ance organization & its affiliates4 7#d7 ,atte/ation ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all annually submit to1 z applicable1 ! applicable au?ority describ$ 9 section #bgbc or ! ,secret>y ( ,labor1 an atte/ation t su* plan or issu] is 9 compliance ) ! requirem5ts ( ?is subsection4 7c7 ,ma9t5ance ( exi/+ ,,hipaa1 ,,g9a1 & ,,ada protections ,no?+ 9 ?is section %all modify1 r$uce1 or elim9ate ! exi/+ privacy protections & /&>ds provid$ by reason ( ,/ate & ,f$]al law1 includ+ ! requirem5ts ( p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7d7 ,regulations ,! ,secret>y1 9 coord9ation ) ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 %all promulgate regulations to c>ry out ?is section4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit network design or co/ or quality initiatives by a gr\p heal? plan or heal? insurance issu]1 includ+ acc\ntable c>e organizations1 exclusive provid] organizations1 networks t ti] provid]s by co/ or quality or /e] enrollees to c5t]s ( excell5ce1 or o!r pay-=-p]=mance programs4 4 7b7 ,effective date ,section #bgbi;,b ( ! ,public ,heal? ,s]vice ,act 7z add$ by section #cja & am5d$ by subsection 7a77 %all apply ) respect to any contract ent]$ into aft] ! date ( enactm5t ( ?is ,act4 ,) respect to an applicable contract t is 9 effect on ! date ( enactm5t ( ?is ,act1 su* section #bgbi;,b %all apply on ! e>li] ( ! date ( r5ewal ( su* contract or #c ye>s aft] su* date ( enactm5t4 #cjc4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s 7a7 ,9 g5]al ,subp>t ,c ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaia et seq47 is am5d$ by add+ at ! end ! foll[+3 #gce4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s 7a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 %all h 9 effect a contract ) a nonpr(it entity to support ! e/abli%m5t & ma9t5ance ( a database t receives & utilizes heal? c>e claims in=mation & relat$ in=mation & issues reports t are available to ! public & au?oriz$ us]s1 & are submitt$ to ! ,dep>tm5t ( ,labor4 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! database e/abli%$ "u subsection 7a7 %all-- 7,a7 improve transp>5cy by us+ de-id5tifi$ heal? c>e data to-- 7i7 in=m pati5ts ab\t ! co/1 quality1 & value ( _! c>e2 7ii7 assi/ provid]s & hospitals1 z !y "w ) pati5ts1 to make in=m$ *oices ab\t c>e2 7iii7 enable provid]s1 hospitals1 & communities to improve s]vices & outcomes = pati5ts by b5*m>k+ _! p]=mance aga9/ t ( o!r provid]s1 hospitals1 & communities2 7iv7 enable pur*as]s1 includ+ employ]s1 employee organizations1 & heal? plans1 to develop value-bas$ pur*as+ models1 improve quality1 & r$uce ! co/ ( heal? c>e & insurance cov]age = enrollees2 7v7 enable employ]s & employee organizations to evaluate network design & con/ruction1 & ! co/ ( c>e = enrollees2 7vi7 facilitate ,/ate-l$ initiatives to l[] heal? c>e co/s & improve quality2 & 7vii7 promote competition bas$ on quality & co/2 7,b7 collect m$ical claims1 prescription drug claims1 & remittance data consi/5t ) ! protections & requirem5ts ( subsection 7d72 7,c7 be e/abli%$ 9 su* a mann] t all[s ! data collect$ pursuant to subp>agraph 7,b7 to be %>$ ) any ,/ate all-pay] claims database or regional database op]at$ ) au?orization f ,/ates1 at co/1 us+ a /&>diz$ =mat1 if su* ,/ate or regional database also submits claims data to ! database e/abli%$ "u ?is section2 & 7,d7 be available to-- 7i7 ! ,director ( ! ,congressional ,budget ,(fice1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission1 & ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t ,advisory ,commission1 ^u reque/1 subject to ! privacy & security requirem5ts ( au?oriz$ us]s "u subsection 7e77#b72 & 7ii7 au?oriz$ us]s1 includ+ employ]s1 employee organizations1 provid]s1 rese>*]s1 & policymak]s1 subject to subsection 7e74 7#b7 ,privacy & security ,! entity receiv+ a contract "u subsection 7a7 %all-- 7,a7 be subject to ! brea* notification rule "u subp>t ,d ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ! security rule "u "p #afj & subp>ts ,a & ,c ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 & ! privacy rule "u "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7,b7 consi/5t ) ! requirem5ts & prohibitions 9 ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif-- 7i7 ensure t ! database "u subsection 7a7 is capable (-- 7,i7 receiv+ data "u subsection 7d72 7,,ii7 provid+ data access to au?oriz$ us]s2 & 7,,iii7 /or+ data on secure s]v]s 9 a mann] t is consi/5t ) ! privacy1 security1 & brea* notification requirem5ts "u section #acdjb ( ! ,,hite* ,act & "u ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif2 7ii7 n disclose to ! public any individually id5tifiable heal? in=mation or propriet>y f9ancial in=mation2 7iii7 /rictly limit /aff access to ! data to /aff ) appropriate tra9+1 cle>ance1 & backgr\nd *ecks & require regul> privacy & security tra9+2 7iv7 ma9ta9 effective security /&>ds = transf]r+ data or mak+ data available to au?oriz$ us]s2 7v7 develop a process = provid+ access to data to au?oriz$ us]s1 9 a secure mann] t ma9ta9s privacy & confid5tiality ( data2 7vi7 adh]e to curr5t be/ security practices ) respect to ! managem5t & use ( su* data = heal? s]vices rese>*1 9 accordance ) applicable ,f$]al privacy law2 & 7vii7 report on ! security me?ods ( ! entity to ! ,secret>y1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives4 7#c7 ,consultation 7,a7 ,advisory committee ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all conv5e an ,advisory ,committee 7ref]r$ to 9 ?is section z ! ,committee71 consi/+ ( #aa memb]s1 to advise ! ,secret>y1 ! contract+ entity1 & ,congress on ! e/abli%m5t1 op]ations1 & use ( ! database e/abli%$ "u ?is section4 7,b7 ,memb]%ip 7i7 ,appo9tm5t ,9 accordance ) clause 7ii71 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 appo9t memb]s to ! ,committee :o h di/+ui%$ !mselves 9 ! fields ( heal? s]vices rese>*1 heal? economics1 heal? in=matics1 or ! gov]nance ( ,/ate all-pay] claims databases1 or :o repres5t organizations likely to submit data to or use ! database1 includ+ pati5ts1 employ]s1 or employee organizations t sponsor gr\p heal? plans1 heal? c>e provid]s1 heal? insurance issu]s1 & ?ird-p>ty adm9i/rators ( gr\p heal? plans4 ,su* memb]s %all s]ve #c-ye> t]ms on a /agg]$ basis4 ,vacancies on ! ,committee %all be fill$ by appo9tm5t consi/5t ) ?is subsection n lat] ?an #c mon?s aft] ! vacancy arises4 7ii7 ,composition ,9 accordance ) clause 7i7-- 7,i7 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all appo9t to ! ,committee-- 7aa7 #a memb] select$ by ! ,secret>y1 9 coord9ation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 to s]ve z ! *air ( ! ,committee2 7bb7 ! ,assi/ant ,secret>y = ,plann+ & ,evaluation ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7cc7 #a repres5tative ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7dd7 #a repres5tative ( ! ,ag5cy = ,heal? ,rese>* & ,quality2 7ee7 #a repres5tative ( ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ) exp]tise 9 data privacy & security2 & 7ff7 #a repres5tative ( ! ,national ,c5t] = ,heal? ,/ati/ics2 & 7,,ii7 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all appo9t to ! ,committee-- 7aa7 #a repres5tative ( an employ] t sponsors a gr\p heal? plan2 7bb7 #a repres5tative ( an employee organization t sponsors a gr\p heal? plan2 7cc7 #a academic rese>*] ) exp]tise 9 heal? economics or heal? s]vices rese>*2 7dd7 #a pati5t advocate2 & 7ee7 #b additional memb]s4 7,c7 ,duties ,! ,committee %all-- 7i7 assi/ & advise ! ,secret>y on ! managem5t ( ! contract "u subsection 7a72 7ii7 assi/ & advise ! entity receiv+ ! contract "u subsection 7a7 9 e/abli%+-- 7,i7 ! scope & =mat ( ! data to be submitt$ "u subsection 7d72 7,,ii7 ! appropriate uses ( data by au?oriz$ us]s1 includ+ develop+ /&>ds = ! approval ( reque/s by organizations to access & use ! data2 & 7,,iii7 ! appropriate =mats & me?ods = mak+ reports & analyses bas$ on ! database to ! public2 7iii7 conduct an annual review ( :e!r data 0 us$ accord+ to ! appropriate uses z describ$ 9 clause 7ii77,,ii71 & advise ! designat$ entity on us+ ! data = au?oriz$ purposes2 7iv7 report1 z appropriate1 to ! ,secret>y & ,congress on ! op]ation ( ! database & opportunities to bett] a*ieve ! objectives ( ?is section2 7v7 e/abli% additional re/rictions on rese>*]s :o receive comp5sation f entities describ$ 9 subsection 7e77#b77;,b77ii71 9 ord] to protect propriet>y f9ancial in=mation2 & 7vi7 e/abli% objectives = rese>* & public report+4 7#d7 ,/ate requirem5ts ,a ,/ate may require heal? insurance issu]s & o!r pay]s to submit claims data to ! database e/abli%$ "u ?is section1 provid$ t su* data is submitt$ 9 a =m & mann] e/abli%$ by ! ,secret>y1 & pursuant to subsection 7d77#d77;,b74 7#e7 ,sanctions ,! ,secret>y %all take appropriate action to sanction us]s :o attempt to re-id5tify data access$ pursuant to p>agraph 7#a77;,d74 7c7 ,contract requirem5ts 7#a7 ,competitive proc$ures ,! ,secret>y %all ent] into ! contract "u subsection 7a7 us+ full & op5 competition proc$ures pursuant to *apt] #cc ( title #da1 ,unit$ ,/ates ,code4 7#b7 ,eligible entities ,to be eligible to ent] into a contract describ$ 9 subsection 7a71 an entity %all-- 7,a7 be a private nonpr(it entity gov]n$ by a bo>d t includes repres5tatives ( ! academic rese>* community & individuals ) exp]tise 9 employ]-sponsor$ insurance1 rese>* us+ heal? c>e claims data & actu>ial analysis2 7,b7 conduct its bus9ess 9 an op5 & transp>5t mann] t provides ! opportunity = public comm5t on its activities2 & 7,c7 agree to ma9ta9 an active c]tification z a qualifi$ entity "u section #ahgd7;e7 ( ! ,social ,security ,act 7or any successor program7 ?r\gh\t ! contract p]iod4 7#c7 ,consid]ations ,9 aw>d+ ! contract "u subsection 7a71 ! ,secret>y %all consid] an entity's exp]i5ce 9-- 7,a7 heal? c>e claims data collection1 aggregation1 quality assurance1 analysis1 & security2 7,b7 support+ academic rese>* on heal? co/s1 sp5d+1 & utilization = & by privately insur$ pati5ts2 7,c7 work+ ) l>ge heal? insurance issu]s & ?ird-p>ty adm9i/rators to assemble a national claims database2 7,d7 effectively collaborat+ ) & engag+ /akehold]s to develop reports2 7,e7 meet+ budgets & timel9es1 includ+ 9 connection ) report g5]ation2 & 7,f7 facilitat+ ! creation (1 or support+1 ,/ate all-pay] claims databases4 7#d7 ,contract t]m ,a contract aw>d$ "u ?is section %all be = a p]iod ( #e ye>s1 & may be r5ew$ aft] a subsequ5t competitive bidd+ process "u ?is section4 7#e7 ,transition ( contract ,if ! ,secret>y1 foll[+ a competitive process at ! end ( ! contract p]iod1 selects a new entity to ma9ta9 ! database1 all data %all be transf]r$ to ! new entity accord+ to a s*$ule & process to be det]m9$ by ! ,secret>y4 ,^u t]m9ation ( a contract1 no entity may keep data held by ! database or disclose su* data to any entity o!r ?an ! entity s designat$ by ! ,secret>y4 ,! ,secret>y %all include en=cem5t t]ms 9 any contract ) an organization *os5 "u ?is section1 to ensure ! timely transf] ( all data to a new entity 9 ! ev5t ( contract t]m9ation4 7d7 ,receiv+ heal? in=mation 7#a7 ,requirem5ts 7,a7 ,9 g5]al ,an applicable self-insur$ gr\p heal? plan %all1 ?r\gh its heal? insurance issu]1 ?ird-p>ty adm9i/rator1 ph>macy b5efit manag]1 or o!r entity designat$ by ! gr\p heal? plan1 electronically submit all claims data ) respect to ! plan1 pursuant to subp>agraph 7,b74 7,b7 ,scope ( in=mation & =mat ( submission ,! entity aw>d$ ! contract "u subsection 7a71 9 consultation ) ! ,committee describ$ 9 subsection 7b77#c71 & pursuant to ! privacy & security requirem5ts ( subsection 7b77#b71 %all-- 7i7 specify ! data elem5ts requir$ to be submitt$ "u subp>agraph 7,a71 :i* %all include all data relat$ to transactions describ$ 9 subp>agraphs 7,a7 & 7,e7 ( section #aagc7;a77#b7 ( ! ,social ,security ,act1 includ+ all data elem5ts normally pres5t 9 su* transactions :5 adjudicat$1 & enrollm5t in=mation2 7ii7 specify ! =m & mann] = su* submissions1 & ! hi/orical p]iod to be includ$ 9 ! initial submission2 & 7iii7 (f] an automat$ submission option to m9imize adm9i/rative burd5s = entities requir$ to submit data4 7,c7 ,de-id5tification ( data ,! entity aw>d$ ! contract "u subsection 7a7 %all-- 7i7 e/abli% a process "u :i* data is de-id5tifi$ 9 accordance ) section #afd4ead7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 :ile reta9+ ! ability to l9k data longitud9ally = ! purposes ( rese>* on co/ & quality1 & ! ability to complete risk adju/m5t & geographic analysis2 7ii7 ensure t any ?ird-p>ty subcontractors :o p]=m ! de-id5tification process describ$ 9 clause 7i7 reta9 ! m9imum necess>y in=mation to p]=m su* a process1 & adh]e to effective security & encryption practices 9 data /orage & transmission2 7iii7 /ore claims & o!r data collect$ "u ?is subsection only 9 de-id5tifi$ =m1 9 accordance ) section #afd4ead7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7iv7 ensure t data is encrypt$1 9 accordance ) ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif4 7#b7 ,applicable self-insur$ gr\p heal? plan ,= purposes ( p>agraph 7#a71 a self-insur$ gr\p heal? plan is an applicable self-insur$ gr\p heal? plan if su* plan is self-adm9i/]$1 or is adm9i/]$ by a heal? insurance issu] or ?ird-p>ty adm9i/rator t meets "o or bo? ( ! foll[+ crit]ia3 7,a7 ,adm9i/]s heal? b5efits = m ?an #ej1jjj enrollees4 7,b7 ,is "o ( ! #e l>ge/ adm9i/rators or issu]s ( self-insur$ gr\p heal? plans 9 a ,/ate 9 :i* su* adm9i/rator op]ates1 z measur$ by ! numb] ( enrollees4 7#c7 ,issu]s & ?ird-p>ty adm9i/rators ,9 ! case ( a heal? insurance issu] or ?ird-p>ty adm9i/rator t is requir$ "u ?is subsection to submit claims data ) respect to an applicable self-insur$ gr\p heal? plan1 su* issu] or adm9i/rator %all submit claims data ) respect to all self-insur$ gr\p heal? plans t ! issu] or adm9i/rator adm9i/]s1 includ+ su* plans t are n applicable self-insur$ gr\p heal? plans1 z describ$ 9 p>agraph 7#b74 7#d7 ,receiv+ o!r in=mation 7,a7 ,m$ic>e data ,! entity aw>d$ ! contract "u subsection 7a7 %all ma9ta9 active c]tification z a qualifi$ entity pursuant to section #ahgd7;e7 ( ! ,social ,security ,act = ! t]m ( ! contract aw>d$ "u subsection 7a74 7,b7 ,/ate data ,! entity aw>d$ ! contract "u subsection 7a7 %all collect data f ,/ate all-pay] claims databases t seek access to ! database e/abli%$ "u ?is section4 7#e7 ,availability ( data ,an entity requir$ to submit data "u ?is subsection may n place any re/rictions on ! use ( su* data by au?oriz$ us]s4 7e7 ,uses ( in=mation 7#a7 ,9 g5]al ,! entity aw>d$ ! contract "u subsection 7a7 %all make ! database available to us]s :o are au?oriz$ "u ?is subsection1 at co/1 & reports & analyses bas$ on ! data available to ! public ) no *>ge4 7#b7 ,au?orization ( us]s 7,a7 ,9 g5]al ,an entity may reque/ au?orization by ! entity aw>d$ ! contract "u subsection 7a7 = access to ! database 9 accordance ) ?is p>agraph4 7,b7 ,application ,an entity desir+ au?orization "u ?is p>agraph %all submit to ! entity aw>d$ ! contract an application = su* access1 :i* %all include-- 7i7 9 ! case ( an entity reque/+ access = rese>* purposes-- 7,i7 a description ( ! uses & me?odologies = evaluat+ heal? sy/em p]=mance us+ su* data2 & 7,,ii7 docum5tation ( approval ( ! rese>* by an in/itutional review bo>d1 if applicable = a p>ticul> plan ( rese>*2 or 7ii7 9 ! case ( an entity su* z an employ]1 heal? insurance issu]1 ?ird-p>ty adm9i/rator1 or heal? c>e provid]1 reque/+ access = ! purpose ( quality improvem5t or co/-conta9m5t1 a description ( ! int5d$ uses = su* data4 7,c7 ,requirem5ts 7i7 ,rese>* ,^u approval ( an application = rese>* purposes "u subp>agraph 7,b77i71 ! au?oriz$ us] %all ent] into a data use & confid5tiality agreem5t ) ! entity aw>d$ ! contract "u subsection 7a71 :i* %all include a prohibition on attempts to reid5tify & disclose protect$ heal? in=mation & propriet>y f9ancial in=mation4 7ii7 ,quality improvem5t & co/-conta9m5t ,9 consultation ) ! ,committee describ$ 9 subsection 7b77#c71 ! ,secret>y %all1 ?r\gh rulemak+1 e/abli% ! =m & mann] 9 :i* au?oriz$ us]s describ$ 9 subp>agraph 7,b77ii7 may access data4 ,data provid$ to su* au?oriz$ us]s %all be provid$ 9 a =m & mann] su* t us]s may n obta9 individually id5tifiable price in=mation ) respect to direct competitors4 ,^u approval1 su* au?oriz$ us] %all ent] into a data use & confid5tiality agreem5t ) ! entity4 7iii7 ,cu/omiz$ reports ,employ]s & employ] organizations may reque/ cu/omiz$ reports f ! entity aw>d$ ! contract "u subsection 7a71 at co/1 subject to ! requirem5ts ( ?is section ) respect to privacy1 security1 & propriet>y f9ancial in=mation4 7iv7 ,non-cu/omiz$ reports ,! entity aw>d$ ! contract "u subsection 7a71 9 consultation ) ! ,committee1 %all make available to all au?oriz$ us]s aggregate data sets1 free ( *>ge4 7f7 ,fund+ 7#a7 ,initial fund+ ,!re are au?oriz$ to be appropriat$1 & !re are appropriat$1 out ( monies 9 ! ,treasury n o!rwise appropriat$1 #bj1jjj1jjj = fiscal ye> #bjbj1 = ! implem5tation ( ! initial contract & e/abli%m5t ( ! database "u ?is section4 7#b7 ,ongo+ fund+ ,!re are au?oriz$ to be appropriat$ #ae1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 = purposes ( c>ry+ out ?is section 7o!r ?an ! grant program "u subsection 7h774 7g7 ,annual report 7#a7 ,submission ,n lat] ?an ,m>* #a1 #bjba1 & ,m>* #a ( ea* ye> !reaft]1 ! entity receiv+ ! contract "u subsection 7a7 %all submit to ,congress1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ,heal? & ,human ,s]vices1 & publi% onl9e = access by ! g5]al public1 a report conta9+ a description (-- 7,a7 tr5ds 9 ! price1 utilization1 & total sp5d+ on heal? c>e s]vices1 includ+ a geographic analysis ( diff]5ces 9 su* tr5ds2 7,b7 limitations 9 ! data set2 7,c7 progress t[>ds ! objectives ( ?is section2 & 7,d7 ! p]=mance by ! entity ( ! duties requir$ "u su* contract4 7#b7 ,public reports & rese>* ,! entity receiv+ a contract "u subsection 7a7 %all1 9 coord9ation ) au?oriz$ us]s1 make analyses & rese>* available to ! public on an ongo+ basis to promote ! objectives ( ?is section4 7h7 ,grants to ,/ates 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 may aw>d grants to ,/ates = ! purpose ( e/abli%+ & ma9ta9+ ,/ate all-pay] claims databases t improve transp>5cy ( data 9 ord] to meet ! goals ( subsection 7a77#a74 7#b7 ,requirem5t ,to be eligible to receive ! fund+ "u p>agraph 7#a71 a ,/ate %all submit data to ! database z describ$ 9 subsection 7b77#a77;,c71 us+ ! =mat describ$ 9 subsection 7d77#a74 7#c7 ,fund+ ,!re is au?oriz$ to be appropriat$ #ajj1jjj1jjj = ! p]iod ( fiscal ye>s #bjbj ?r\gh #bjbi = ! purpose ( aw>d+ grants to ,/ates "u ?is subsection4 7i7 ,exemption f public disclosure 7#a7 ,9 g5]al ,claims data provid$ to ! database1 & ! database itself %all n be consid]$ public records & %all be exempt f public disclosure requirem5ts4 7#b7 ,re/rictions on uses = c]ta9 proce$+s ,data disclos$ to au?oriz$ us]s %all n be subject to discov]y or admission z public in=mation1 or evid5ce 9 judicial or adm9i/rative proce$+s )\t cons5t ( ! affect$ p>ties4 7j7 ,def9itions 7#a7 ,protect$ heal? in=mation ,! t]m protect$ heal? in=mation has ! mean+ giv5 su* t]m 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#b7 ,propriet>y f9ancial in=mation ,! t]m propriet>y f9ancial in=mation means data t w\ld disclose ! t]ms ( a specific contract betwe5 an individual heal? c>e provid] or facility & a specific gr\p heal? plan1 ,m$icaid manag$ c>e organization or o!r manag$ c>e entity1 or heal? insurance issu] (f]+ gr\p or individual cov]age4 7k7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect or modify en=cem5t ( ! privacy1 security1 or brea* notification rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7or successor regulations74 4 7b7 ,,gao report 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on-- 7,a7 ! p]=mance ( ! entity aw>d$ a contract "u section #gce7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z add$ by subsection 7a71 "u su* contract2 7,b7 ! privacy & security ( ! in=mation report$ to ! entity2 & 7,c7 ! co/s incurr$ by su* entity 9 p]=m+ su* duties4 7#b7 ,reports ,n lat] ?an #b ye>s aft] ! effective date ( ! fir/ contract ent]$ into "u section #gce7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z add$ by subsection 7a71 & aga9 n lat] ?an #d ye>s aft] su* effective date1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u p>agraph 7#a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 7c7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by ins]t+ aft] ! item relat+ to section #gcd ! foll[+ new item3 ,sec4 #gce4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s4 4 #cjd4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 z am5d$ by sections #cja & #cjb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,c4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation 7a7 ,network /atus ( provid]s 7#a7 ,9 g5]al ,beg9n+ on ! date t is "o ye> aft] ! date ( enactm5t ( ?is section1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all-- 7,a7 e/abli% bus9ess processes to ensure t all enrollees 9 su* plan or cov]age receive pro( ( a heal? c>e provid]'s network /atus-- 7i7 ?r\gh a writt5 electronic communication f ! plan or issu] to ! enrollee1 z soon z practicable & n lat] ?an #a bus9ess day aft] a telephone inquiry is made by su* enrollee = su* in=mation2 & 7ii7 9 real-"t ?r\gh an onl9e heal? c>e provid] directory se>* tool ma9ta9$ by ! plan or issu]2 & 7,b7 include 9 any pr9t directory a disclosure t ! in=mation includ$ 9 ! directory is accurate z ( ! date ( ! la/ data update & t enrollees or prospective enrollees %\ld consult ! gr\p heal? plan or issu]'s electronic provid] directory on its website or call a specifi$ cu/om] s]vice telephone numb] to obta9 ! mo/ curr5t provid] directory in=mation4 7#b7 ,gr\p heal? plan & heal? insurance issu] bus9ess processes ,beg9n+ on ! date t is "o ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all e/abli% bus9ess processes to-- 7,a7 v]ify & update1 at lea/ once e #ij days1 ! provid] directory in=mation = all provid]s includ$ 9 ! onl9e heal? c>e provid] directory se>* tool describ$ 9 p>agraph 7#a77;,a77ii72 & 7,b7 remove any provid] f su* onl9e directory se>* tool if su* provid] has n v]ifi$ ! directory in=mation )9 ! previ\s #f mon?s or ! plan or issu] has be5 unable to v]ify ! provid]'s network p>ticipation4 7b7 ,co/-,%>+ limitations 7#a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n apply1 & %all ensure t no provid] applies co/-%>+ to an enrollee = treatm5t or s]vices provid$ by a heal? c>e provid] 9 excess ( ! normal co/-%>+ appli$ = 9-network c>e 7includ+ any balance bill issu$ by ! heal? c>e provid] involv$71 if su* enrollee1 or heal? c>e provid] ref]r+ su* enrollee1 demon/rates 7bas$ on ! electronic in=mation describ$ 9 subsection 7a77#a77;,a77i7 or a copy ( ! onl9e provid] directory describ$ 9 subsection 7a77#a77;,a77ii7 on ! date ! enrollee attempt$ to obta9 ! provid]'s network /atus7 t ! enrollee reli$ on ! in=mation describ$ 9 subsection 7a77#a71 if ! provid]'s network /atus or directory in=mation on su* directory 0 incorrect at ! "t ! treatm5t or s]vices involv$ 0 provid$4 7#b7 ,refunds to enrollees ,if a heal? c>e provid] submits a bill to an enrollee 9 violation ( p>agraph 7#a71 & ! enrollee pays su* bill1 ! provid] %all reimburse ! enrollee = ! full am\nt paid by ! enrollee 9 excess ( ! 9-network co/-%>+ am\nt = ! treatm5t or s]vices involv$1 plus int]e/1 at an int]e/ rate det]m9$ by ! ,secret>y4 7c7 ,provid] bus9ess processes ,a heal? c>e provid] %all h 9 place bus9ess processes to ensure ! timely provision ( provid] directory in=mation to a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age to support compliance by su* plans or issu]s ) subsection 7a77#a74 ,su* provid]s %all submit provid] directory in=mation to a plan or issu]s1 at a m9imum-- 7#a7 :5 ! provid] beg9s a network agreem5t ) a plan or ) an issu] ) respect to c]ta9 cov]age2 7#b7 :5 ! provid] t]m9ates a network agreem5t ) a plan or ) an issu] ) respect to c]ta9 cov]age2 7#c7 :5 !re are mat]ial *anges to ! cont5t ( provid] directory in=mation describ$ 9 subsection 7a77#a72 & 7#d7 e #ij days ?r\gh\t ! duration ( ! network agreem5t ) a plan or issu]4 7d7 ,en=cem5t 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a heal? c>e provid] t violates a requirem5t "u subsection 7c7 or takes actions t prev5t a gr\p heal? plan or heal? insurance issu] f comply+ ) subsection 7a77#a7 or 7b7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7#b7 ,safe h>bor ,! ,secret>y may waive ! p5alty describ$ "u p>agraph 7#a7 ) respect to a heal? c>e provid] t unkn[+ly violates subsection 7b77#a7 ) respect to an enrollee if su* provid] resc9ds ! bill involv$ &1 if applicable1 reimburses ! enrollee )9 #cj days ( ! date on :i* ! provid] bill$ ! enrollee 9 violation ( su* subsection4 7#c7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7e7 ,sav+s clause ,no?+ 9 ?is section %all prohibit a provid] f requir+ 9 ! t]ms ( a contract1 or contract t]m9ation1 ) a gr\p heal? plan or heal? insurance issu]-- 7#a7 t ! plan or issu] remove1 at ! "t ( t]m9ation ( su* contract1 ! provid] f a directory ( ! plan or issu] describ$ 9 subsection 7a77#a72 or 7#b7 t ! plan or issu] be> f9ancial responsibility1 includ+ "u subsection 7b71 = provid+ inaccurate network /atus in=mation to an enrollee4 7f7 ,def9ition ,= purposes ( ?is section1 ! t]m provid] directory in=mation includes ! names1 addresses1 specialty1 & telephone numb]s ( individual heal? c>e provid]s1 & ! names1 addresses1 & telephone numb]s ( ea* m$ical gr\p1 cl9ic1 or facility contract$ to p>ticipate 9 any ( ! networks ( ! gr\p heal? plan or heal? insurance cov]age involv$4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to preempt any provision ( ,/ate law relat+ to heal? c>e provid] directories or network adequacy4 4 #cje4 ,timely bills = pati5ts 7a7 ,9 g5]al 7#a7 ,am5dm5t ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#g4 ,timely bills = pati5ts 7a7 ,9 g5]al ,! ,secret>y %all require-- 7#a7 heal? c>e facilities1 or 9 ! case ( practition]s provid+ s]vices outside ( su* a facility1 practition]s1 to provide to pati5ts a li/ ( s]vices r5d]$ dur+ ! visit to su* facility or practition]1 &1 9 ! case ( a facility1 ! "n ( ! provid] = ea* su* s]vice1 ^u dis*>ge or by po/al or electronic communication z soon z practicable & n lat] ?an #e cal5d> days aft] dis*>ge2 & 7#b7 heal? c>e facilities & practition]s to s5d all adjudicat$ bills to ! pati5t z soon z practicable1 b n lat] ?an #de cal5d> days aft] dis*>ge4 7b7 ,paym5t aft] bill+ ,no pati5t may be requir$ to pay a bill = heal? c>e s]vices any e>li] ?an #cj cal5d> days aft] receipt ( a bill = su* s]vices4 7c7 ,effect ( violation 7#a7 ,notification & refund requirem5ts 7,a7 ,provid] li/s ,if a facility or practition] fails to provide a pati5t a li/ z requir$ "u subsection 7a77#a71 su* facility or practition] %all report su* failure to ! ,secret>y4 7,b7 ,bill+ ,if a facility or practition] bills a pati5t aft] ! #de-;cal5d>-day p]iod describ$ 9 subsection 7a77#b71 su* facility or practition] %all-- 7i7 report su* bill to ! ,secret>y2 & 7ii7 refund ! pati5t = ! full am\nt paid 9 response to su* bill ) int]e/1 at a rate det]m9$ by ! ,secret>y4 7#b7 ,civil monet>y p5alties 7,a7 ,9 g5]al ,! ,secret>y may impose civil monet>y p5alties ( up to #aj1jjj a day on any facility or practition] t-- 7i7 fails to provide a li/ requir$ "u subsection 7a77#a7 m ?an #aj times1 beg9n+ on ! date ( su* t5? failure2 7ii7 submits m ?an #aj bills outside ( ! p]iod describ$ 9 subsection 7a77#b71 beg9n+ on ! date on :i* su* facility or practition] s5ds ! t5? su* bill2 7iii7 fails to report to ! ,secret>y any failure to provide li/s z requir$ "u p>agraph 7#a77;,a71 beg9n+ on ! date t is #de cal5d> days aft] dis*>ge2 or 7iv7 fails to s5d any bill z requir$ "u subsection 7a77#b71 beg9n+ on ! date t is #de cal5d> days aft] ! date ( dis*>ge or visit1 z applicable4 7,b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#c7 ,safe h>bor ,! ,secret>y may exempt a practition] or facility f ! p5alties "u p>agraph 7#b77;,a7 or ext5d ! p]iod ( "t specifi$ "u subsection 7a77#b7 = compliance ) su* subsection if a practition] or facility-- 7,a7 makes a good fai? attempt to s5d a bill )9 #cj days b is unable to d s because ( an incorrect address2 or 7,b7 exp]i5ces ext5uat+ circum/ances 7z def9$ by ! ,secret>y71 su* z a hurricane or cyb]attack1 t may reasonably delay deliv]y ( a timely bill4 4 7#b7 ,rulemak+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all promulgate f9al regulations to def9e ! t]m ext5uat+ circum/ance = purposes ( section #cii,v-#g7;c77#c77;,b7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by p>agraph 7#a74 7b7 ,gr\p heal? plan & heal? insurance issu] requirem5ts ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa71 z am5d$ by section #cjd1 is fur!r am5d$ by add+ to ! end ! foll[+3 #bgbi;,d4 ,timely bills = pati5ts 7a7 ,9 g5]al ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all h 9 place bus9ess practices ) respect to 9-network facilities & practition]s to ensure t claims are adjudicat$ 9 ord] to facilitate facility & practition] compliance ) ! requirem5ts "u section #cii,v-#g7;a74 7b7 ,cl>ification ,no?+ 9 subsection 7a7 prohibits a provid] & a gr\p heal? plan or heal? insurance issu] f e/abli%+ 9 a contract ! timel9e = submission by ei!r p>ty to ! o!r p>ty ( bill+ in=mation1 adjudication1 s5d+ ( remittance in=mation1 or any o!r coord9ation requir$ betwe5 ! provid] & ! plan or issu] necess>y = meet+ ! deadl9e describ$ 9 section #cii,v-#g7;a77#b74 4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect #f mon?s aft] ! date ( enactm5t ( ?is ,act4 #cjf4 ,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 seq471 z am5d$ by section #cje1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,e4 ,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 ( ! ,l[] ,heal? ,c>e ,co/s ,act1 n less frequ5tly ?an once p] plan qu>t]1 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 ! plan sponsor 7z def9$ 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd7 ( su* gr\p heal? plan or heal? insurance cov]age 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 ,prescription drug transactions ) ph>macies indep5d5t ( ! issu] or ph>macy b5efits manag] ,if ! ph>macy t disp5ses a prescription drug to an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age is n :olly or p>tially own$ by su* plan1 su* issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 su* plan1 issu]1 or entity %all n *>ge ! plan1 issu]1 or enrollee a price = su* prescription drug t exce$s ! price paid to ! ph>macy1 exclud+ p5alties paid by ph>macies to su* plan1 issu]1 or entity4 7#b7 ,intra-company prescription drug transactions ,if ! mail ord]1 specialty1 or retail ph>macy t disp5ses a prescription drug to an enrollee 9 a gr\p heal? plan or heal? insurance cov]age is :olly or p>tially own$ by su* heal? insurance issu] or an entity provid+ ph>macy b5efit managem5t s]vices "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! price *>g$ = su* drug by su* ph>macy to su* gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age may n exce$ ! less] (-- 7,a7 ! :olesale acquisition co/ ( ! drug paid by ! ph>macy1 plus cle>ly docum5t$ disp5s+ co/s1 includ+ ph>macy pr(it2 or 7,b7 ! m$ian price *>g$ to ! gr\p heal? plan or heal? insurance issu] :5 ! same drug is disp5s$ to enrollees 9 ! plan or cov]age by o!r simil>ly situat$ ph>macies n :olly or p>tially own$ by ! heal? insurance issu] or entity provid+ ph>macy b5efits managem5t s]vices1 z describ$ 9 p>agraph 7#a74 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 ! gr\p heal? plan4 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 #ij 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>4 7e7 ,en=cem5t 7#a7 ,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#b7 ,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#c7 ,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 7f7 ,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 ,act4 4 #cjg4 ,gov]nm5t ,acc\ntability ,(fice /udy on pr(it- & rev5ue-%>+ 9 heal? c>e 7a7 ,/udy ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to-- 7#a7 describe :at is kn[n ab\t pr(it- & rev5ue-%>+ relation%ips 9 ! comm]cial heal? c>e m>kets1 includ+ ^? relation%ips t-- 7,a7 involve "o or m-- 7i7 physician gr\ps t practice )9 a hospital includ$ 9 ! pr(it- or rev5ue-%>+ relation%ip1 or ref] pati5ts to su* hospital2 7ii7 laboratory1 radiology1 or ph>macy s]vices t are deliv]$ to privately insur$ pati5ts ( su* hospital2 7iii7 surgical s]vices2 7iv7 hospitals or gr\p pur*as+ organizations2 or 7v7 rehabilitation or physical !rapy facilities or s]vices2 & 7,b7 include rev5ue- or pr(it-%>+ :e!r ?r\gh a jo9t v5ture1 managem5t or pr(essional s]vices agreem5t1 or o!r =m ( ga9-%>+ contract2 7#b7 describe ,f$]al ov]sight ( su* relation%ips1 includ+ au?orities ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,f$]al ,trade ,commission to review su* relation%ips & _! pot5tial to increase co/s = pati5ts1 & id5tify limitations 9 su* ov]sight2 & 7#c7 z appropriate1 make recomm5dations to improve ,f$]al ov]sight ( su* relation%ips4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all prep>e & submit a report on ! /udy conduct$ "u subsection 7a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,education & ,labor & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 #cjh4 ,disclosure ( direct & indirect comp5sation = brok]s & consultants to employ]-sponsor$ heal? plans & enrollees 9 plans on ! individual m>ket 7a7 ,gr\p heal? plans ,section #djh7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77 is am5d$-- 7#a7 by /rik+ 7#b7 ,contract+ or mak+ & ins]t+ 7#b77;,a7 ,contract+ or mak+2 & 7#b7 by add+ at ! end ! foll[+3 7,b7 7i7 ,no contract or arrangem5t = s]vices betwe5 a cov]$ plan & a cov]$ s]vice provid]1 & no ext5sion or r5ewal ( su* a contract or arrangem5t1 is reasonable )9 ! mean+ ( ?is p>agraph unless ! requirem5ts ( ?is clause are met4 7ii7 7,i7 ,= purposes ( ?is subp>agraph3 7aa7 ,! t]m cov]$ plan means a gr\p heal? plan z def9$ section #gcc7;a74 7bb7 ,! t]m cov]$ s]vice provid] means a s]vice provid] t ent]s into a contract or arrangem5t ) ! cov]$ plan & reasonably expects #a1jjj 7or su* am\nt z ! ,secret>y may e/abli% 9 regulations to acc\nt = inflation s9ce ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 z appropriate7 or m 9 comp5sation1 direct or indirect1 to be receiv$ 9 connection ) provid+ "o or m ( ! foll[+ s]vices1 pursuant to ! contract or arrangem5t1 reg>dless ( :e!r su* s]vices w be p]=m$1 or su* comp5sation receiv$1 by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor3 7,,aa7 ,brok]age s]vices1 = :i* ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive indirect comp5sation or direct comp5sation describ$ 9 item 7dd71 provid$ to a cov]$ plan ) respect to selection ( insurance products 7includ+ vision & d5tal71 recordkeep+ s]vices1 m$ical managem5t v5dor1 b5efits adm9i/ration 7includ+ vision & d5tal71 /op-loss insurance1 ph>macy b5efit managem5t s]vices1 wellness s]vices1 transp>5cy tools & v5dors1 gr\p pur*as+ organization pref]r$ v5dor panels1 disease managem5t v5dors & products1 compliance s]vices1 employee assi/ance programs1 or ?ird-p>ty adm9i/ration s]vices4 7,,bb7 ,consult+1 = :i* ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive indirect comp5sation or direct comp5sation describ$ 9 item 7dd71 relat$ to ! developm5t or implem5tation ( plan design1 insurance or insurance product selection 7includ+ vision & d5tal71 recordkeep+1 m$ical managem5t1 b5efits adm9i/ration selection 7includ+ vision & d5tal71 /op-loss insurance1 ph>macy b5efit managem5t s]vices1 wellness design & managem5t s]vices1 transp>5cy tools1 gr\p pur*as+ organization agreem5ts & s]vices1 p>ticipation 9 & s]vices f pref]r$ v5dor panels1 disease managem5t1 compliance s]vices1 employee assi/ance programs1 or ?ird-p>ty adm9i/ration s]vices4 7cc7 ,! t]m affiliate1 ) respect to a cov]$ s]vice provid]1 means an entity t directly or indirectly 7?r\gh "o or m int]m$i>ies7 controls1 is controll$ by1 or is "u common control )1 su* provid]1 or is an (fic]1 director1 or employee (1 or p>tn] 91 su* provid]4 7dd7 7,,aa7 ,! t]m comp5sation means any?+ ( monet>y value1 b does n include non-monet>y comp5sation valu$ at #bej 7or su* am\nt z ! ,secret>y may e/abli% 9 regulations to acc\nt = inflation s9ce ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 z appropriate7 or less1 9 ! aggregate1 dur+ ! t]m ( ! contract or arrangem5t4 7,,bb7 ,! t]m direct comp5sation means comp5sation receiv$ directly f a cov]$ plan4 7,,cc7 ,! t]m indirect comp5sation means comp5sation receiv$ f any s\rce o!r ?an ! cov]$ plan1 ! plan sponsor1 ! cov]$ s]vice provid]1 or an affiliate4 ,comp5sation receiv$ f a subcontractor is indirect comp5sation1 unless x is receiv$ 9 connection ) s]vices p]=m$ "u a contract or arrangem5t ) a subcontractor4 7ee7 ,! t]m responsible plan fiduci>y means a fiduci>y ) au?ority to cause ! cov]$ plan to ent] into1 or ext5d or r5ew1 ! contract or arrangem5t4 7ff7 ,! t]m subcontractor means any p]son or entity 7or an affiliate ( su* p]son or entity7 t is n an affiliate ( ! cov]$ s]vice provid] & t1 pursuant to a contract or arrangem5t ) ! cov]$ s]vice provid] or an affiliate1 reasonably expects to receive #a1jjj 7or su* am\nt z ! ,secret>y may e/abli% 9 regulations to acc\nt = inflation s9ce ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 z appropriate7 or m 9 comp5sation = p]=m+ "o or m s]vices describ$ 9 item 7bb7 "u a contract or arrangem5t ) ! cov]$ plan4 7,,ii7 ,= purposes ( ?is subp>agraph1 a description ( comp5sation or co/ may be express$ z a monet>y am\nt1 =mula1 or a p] capita *>ge = ea* enrollee or1 if ! comp5sation or co/ _c reasonably be express$ 9 su* t]ms1 by any o!r reasonable me?od1 includ+ a disclosure t additional comp5sation may be e>n$ b may n be calculat$ at ! "t ( contract if su* a disclosure includes a description ( ! circum/ances "u :i* ! additional comp5sation may be e>n$ & a reasonable & good fai? e/imate if ! cov]$ s]vice provid] _c o!rwise readily describe comp5sation or co/ & expla9s ! me?odology & assumptions us$ to prep>e su* e/imate4 ,any su* description %all conta9 suffici5t in=mation to p]mit evaluation ( ! reasonabl5ess ( ! comp5sation or co/4 7,,iii7 ,no p]son or entity is a cov]$ s]vice provid] )9 ! mean+ ( subclause 7,i77bb7 solely on ! basis ( provid+ s]vices z an affiliate or a subcontractor t is p]=m+ "o or m ( ! s]vices describ$ 9 subitem 7,,aa7 or 7,,bb7 ( su* subclause "u ! contract or arrangem5t ) ! cov]$ plan4 7iii7 ,a cov]$ s]vice provid] %all disclose to a responsible plan fiduci>y1 9 writ+1 ! foll[+3 7,i7 ,a description ( ! s]vices to be provid$ to ! cov]$ plan pursuant to ! contract or arrangem5t4 7,,ii7 ,if applicable1 a /atem5t t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor w provide1 or reasonably expects to provide1 s]vices pursuant to ! contract or arrangem5t directly to ! cov]$ plan z a fiduci>y 7)9 ! mean+ ( section #c7ba774 7,,iii7 ,a description ( all direct comp5sation1 ei!r 9 ! aggregate or by s]vice1 t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive 9 connection ) ! s]vices describ$ 9 subclause 7,i74 7,,iv7 7aa7 ,a description ( all indirect comp5sation t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive 9 connection ) ! s]vices describ$ 9 subclause 7,i7-- 7,,aa7 includ+ comp5sation f a v5dor to a brok]age firm bas$ on a /ructure ( inc5tives n solely relat$ to ! contract ) ! cov]$ plan2 & 7,,bb7 n includ+ comp5sation receiv$ by an employee f an employ] on acc\nt ( "w p]=m$ by ! employee4 7bb7 ,a description ( ! arrangem5t betwe5 ! pay] & ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor1 z applicable1 pursuant to :i* su* indirect comp5sation is paid4 7cc7 ,id5tification ( ! s]vices = :i* ! indirect comp5sation w be receiv$1 if applicable4 7dd7 ,id5tification ( ! pay] ( ! indirect comp5sation4 7,v7 ,a description ( any comp5sation t w be paid among ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor1 9 connection ) ! s]vices describ$ 9 subclause 7,i7 if su* comp5sation is set on a transaction basis 7su* z commissions1 f9d]'s fees1 or o!r simil> inc5tive comp5sation bas$ on bus9ess plac$ or reta9$71 includ+ id5tification ( ! s]vices = :i* su* comp5sation w be paid & id5tification ( ! pay]s & recipi5ts ( su* comp5sation 7includ+ ! /atus ( a pay] or recipi5t z an affiliate or a subcontractor71 reg>dless ( :e!r su* comp5sation also is disclos$ pursuant to subclause 7,,iii7 or 7,,iv74 7,,vi7 ,a description ( any comp5sation t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive 9 connection ) t]m9ation ( ! contract or arrangem5t1 & h[ any prepaid am\nts w be calculat$ & refund$ ^u su* t]m9ation4 7iv7 ,a cov]$ s]vice provid] %all disclose to a responsible plan fiduci>y1 9 writ+ a description ( ! mann] 9 :i* ! comp5sation describ$ 9 clause 7iii71 z applicable1 w be receiv$4 7v7 7,i7 ,a cov]$ s]vice provid] %all disclose ! in=mation requir$ "u clauses 7iii7 & 7iv7 to ! responsible plan fiduci>y n lat] ?an ! date t is reasonably 9 advance ( ! date on :i* ! contract or arrangem5t is ent]$ into1 & ext5d$ or r5ew$4 7,,ii7 ,a cov]$ s]vice provid] %all disclose any *ange to ! in=mation requir$ "u clauses 7iii7 & 7iv7 z soon z practicable1 b n lat] ?an #fj days f ! date on :i* ! cov]$ s]vice provid] is in=m$ ( su* *ange1 unless su* disclosure is preclud$ due to extraord9>y circum/ances beyond ! cov]$ s]vice provid]'s control1 9 :i* case ! in=mation %all be disclos$ z soon z practicable4 7vi7 7,i7 ,^u ! writt5 reque/ ( ! responsible plan fiduci>y or cov]$ plan adm9i/rator1 a cov]$ s]vice provid] %all furni% any o!r in=mation relat+ to ! comp5sation receiv$ 9 connection ) ! contract or arrangem5t t is requir$ = ! cov]$ plan to comply ) ! report+ & disclosure requirem5ts "u ?is ,act4 7,,ii7 ,! cov]$ s]vice provid] %all disclose ! in=mation requir$ "u clause 7iii77,i7 reasonably 9 advance ( ! date ^u :i* su* responsible plan fiduci>y or cov]$ plan adm9i/rator /ates t x is requir$ to comply ) ! applicable report+ or disclosure requirem5t1 unless su* disclosure is preclud$ due to extraord9>y circum/ances beyond ! cov]$ s]vice provid]'s control1 9 :i* case ! in=mation %all be disclos$ z soon z practicable4 7vii7 ,no contract or arrangem5t w fail to be reasonable "u ?is subp>agraph solely because ! cov]$ s]vice provid]1 act+ 9 good fai? & ) reasonable dilig5ce1 makes an error or omission 9 disclos+ ! in=mation requir$ pursuant to clause 7iii7 7or a *ange to su* in=mation disclos$ pursuant to clause 7v77,,ii77 or clause 7vi71 provid$ t ! cov]$ s]vice provid] discloses ! correct in=mation to ! responsible plan fiduci>y z soon z practicable1 b n lat] ?an #cj days f ! date on :i* ! cov]$ s]vice provid] kn[s ( su* error or omission4 7viii7 7,i7 ,pursuant to subsection 7a71 subp>agraphs 7,c7 & 7,d7 ( section #djf7;a77#a7 %all n apply to a responsible plan fiduci>y1 n)/&+ any failure by a cov]$ s]vice provid] to disclose in=mation requir$ "u clause 7iii71 if ! foll[+ conditions are met3 7aa7 ,! responsible plan fiduci>y did n "k t ! cov]$ s]vice provid] fail$ or w\ld fail to make requir$ disclosures & reasonably believ$ t ! cov]$ s]vice provid] disclos$ ! in=mation requir$ to be disclos$4 7bb7 ,! responsible plan fiduci>y1 ^u discov]+ t ! cov]$ s]vice provid] fail$ to disclose ! requir$ in=mation1 reque/s 9 writ+ t ! cov]$ s]vice provid] furni% su* in=mation4 7cc7 ,if ! cov]$ s]vice provid] fails to comply ) a writt5 reque/ describ$ 9 subclause 7,,ii7 )9 #ij days ( ! reque/1 ! responsible plan fiduci>y notifies ! ,secret>y ( ! cov]$ s]vice provid]'s failure1 9 accordance ) subclauses 7,,ii7 & 7,,iii74 7,,ii7 ,a notice describ$ 9 subclause 7,i77cc7 %all conta9-- 7aa7 ! "n ( ! cov]$ plan2 7bb7 ! plan numb] us$ = ! annual report on ! cov]$ plan2 7cc7 ! plan sponsor's "n1 address1 & employ] id5tification numb]2 7dd7 ! "n1 address1 & telephone numb] ( ! responsible plan fiduci>y2 7ee7 ! "n1 address1 phone numb]1 &1 if kn[n1 employ] id5tification numb] ( ! cov]$ s]vice provid]2 7ff7 a description ( ! s]vices provid$ to ! cov]$ plan2 7gg7 a description ( ! in=mation t ! cov]$ s]vice provid] fail$ to disclose2 7hh7 ! date on :i* su* in=mation 0 reque/$ 9 writ+ f ! cov]$ s]vice provid]2 & 7ii7 a /atem5t z to :e!r ! cov]$ s]vice provid] cont9ues to provide s]vices to ! plan4 7,,iii7 ,a notice describ$ 9 subclause 7,i77cc7 %all be fil$ ) ! ,dep>tm5t n lat] ?an #cj days foll[+ ! e>li] (-- 7aa7 ! cov]$ s]vice provid]'s refusal to furni% ! in=mation reque/$ by ! writt5 reque/ describ$ 9 subclause 7,i77bb72 or 7bb7 #ij days aft] ! writt5 reque/ ref]r$ to 9 subclause 7,i77cc7 is made4 7,,iv7 ,if ! cov]$ s]vice provid] fails to comply ) ! writt5 reque/ "u subclause 7,i77bb7 )9 #ij days ( su* reque/1 ! responsible plan fiduci>y %all det]m9e :e!r to t]m9ate or cont9ue ! contract or arrangem5t "u section #djd4 ,if ! reque/$ in=mation relates to future s]vices & is n disclos$ promptly aft] ! end ( ! #ij-;day p]iod1 ! responsible plan fiduci>y %all t]m9ate ! contract or arrangem5t z exp$iti\sly z possible1 consi/5t ) su* duty ( prud5ce4 7ix7 ,no?+ 9 ?is subp>agraph %all be con/ru$ to sup]s$e any provision ( ,/ate law t gov]ns disclosures by p>ties t provide ! s]vices describ$ 9 ?is section1 except to ! ext5t t su* law prev5ts ! application ( a requirem5t ( ?is section4 4 7b7 ,applicability ( exi/+ regulations ,no?+ 9 ! am5dm5ts made by subsection 7a7 %all be con/ru$ to affect ! applicability ( section #beej4djh;b-#b ( title #bi1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ) respect to any applicable entity o!r ?an a cov]$ plan or a cov]$ s]vice provid] 7z def9$ 9 section #djh7;b77#b77;,b77ii7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z am5d$ by subsection 7a774 7c7 ,individual m>ket cov]age ,subp>t #a ( "p ,b ( title ,,xvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#da et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgdf4 ,disclosure to enrollees ( individual m>ket cov]age 7a7 ,9 g5]al ,a heal? insurance issu] (f]+ individual heal? insurance cov]age %all make disclosures to enrollees 9 su* cov]age1 z describ$ 9 subsection 7b71 & reports to ! ,secret>y1 z describ$ 9 subsection 7c71 reg>d+ direct or indirect comp5sation provid$ to an ag5t or brok] associat$ ) enroll+ individuals 9 su* cov]age4 7b7 ,disclosure ,a heal? insurance issu] describ$ 9 subsection 7a7 %all disclose to an enrollee ! am\nt ( direct or indirect comp5sation provid$ to an ag5t or brok] = s]vices provid$ by su* ag5t or brok] associat$ ) plan selection & enrollm5t4 ,su* disclosure %all be-- 7#a7 made prior to ! individual f9aliz+ plan selection2 & 7#b7 includ$ on any docum5tation confirm+ ! individual's enrollm5t4 7c7 ,report+ ,a heal? insurance issu] describ$ 9 subsection 7a7 %all report to ! ,secret>y any direct or indirect comp5sation provid$ to an ag5t or brok] associat$ ) enroll+ individuals 9 su* cov]age4 7d7 ,rulemak+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all f9alize1 ?r\gh notice-&-comm5t rulemak+1 ! =m & mann] 9 :i* issu]s describ$ 9 subsection 7a7 are requir$ to make ! disclosures describ$ 9 subsection 7b7 & ! reports describ$ 9 subsection 7c74 4 7d7 ,transition rule ,no contract execut$ prior to ! effective date describ$ 9 subsection 7e7 by a gr\p heal? plan subject to ! requirem5ts ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7z am5d$ by subsection 7a77 or by a heal? insurance issu] subject to ! requirem5ts ( section #bgdf ( ! ,public ,heal? ,s]vice ,act 7z add$ by subsection 7c77 %all be subject to ! requirem5ts ( su* section #djh7;b77#b77;,b7 or su* section #bgdf1 z applicable4 7e7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7c7 %all take effect #b ye>s aft] ! date ( enactm5t ( ?is ,act4 #cji4 ,ensur+ enrollee access to co/-%>+ in=mation 7a7 ,9 g5]al ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 z am5d$ by section #cjf1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,f4 ,provision ( co/-%>+ in=mation 7a7 ,provid] disclosures ,a provid] t is 9-network ) respect to a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide to an enrollee 9 ! plan or cov]age :o submits a reque/ = ! in=mation describ$ 9 p>agraph 7#a7 or 7#b71 toge!r ) accurate & complete in=mation ab\t ! enrollee's cov]age "u ! applicable plan or cov]age-- 7#a7 z soon z practicable & n lat] ?an #b bus9ess days aft] ! enrollee reque/s su* in=mation1 a good fai? e/imate ( ! expect$ enrollee co/-%>+ = ! provision ( a p>ticul> heal? c>e s]vice 7includ+ any s]vice t is reasonably expect$ to be provid$ 9 conjunction ) su* specific s]vice72 & 7#b7 z soon z practicable & n lat] ?an #b bus9ess days aft] an enrollee reque/s su* in=mation1 ! contact in=mation = any ancill>y provid]s = a s*$ul$ heal? c>e s]vice4 7b7 ,insur] disclosures ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide an enrollee 9 ! plan or cov]age ) a good fai? e/imate ( ! enrollee's co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 = :i* ! enrollee w\ld be responsible = pay+ ) respect to a specific heal? c>e s]vice 7includ+ any s]vice t is reasonably expect$ to be provid$ 9 conjunction ) su* specific s]vice71 z soon z practicable & n lat] ?an #b bus9ess days aft] receiv+ a reque/ = su* in=mation by an enrollee4 7c7 ,en=cem5t 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a heal? c>e provid] t violates a requirem5t "u subsection 7a7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7#b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 4 7b7 ,effective date ,section #bgbi;,g ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 #caj4 ,/r5g!n+ p>ity 9 m5tal heal? & sub/ance use disord] b5efits ,section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#h7 ,compliance requirem5ts 7,a7 ,nonquantitative treatm5t limitation 7nqtl7 requirem5ts ,9 ! case ( a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age t provides bo? m$ical & surgical b5efits & m5tal heal? or sub/ance use disord] b5efits1 ! plan or cov]age %all p]=m comp>ative analyses ab\t ! design & application ( nonquantitative treatm5t limitations 7ref]r$ to 9 ?is p>agraph z ! ,,nqtl7 9 accordance ) ! foll[+ process1 & make available to ! ,secret>y ^u reque/ )9 #fj days beg9n+ ,janu>y #a1 #bjbj1 & )9 #cj days beg9n+ ,janu>y #a1 #bjba1 ! foll[+ in=mation3 7i7 ,! specific plan or cov]age language reg>d+ ! ,,nqtl1 t applies to su* plan or cov]age1 & a description ( all m5tal heal? or sub/ance use disord] & m$ical_/surgical s]vices to :i* x applies 9 ea* respective b5efits classification4 7ii7 ,! factors us$ to det]m9e t an ,,nqtl w apply to m5tal heal? or sub/ance use disord] b5efits & m$ical_/surgical b5efits4 7iii7 ,! evid5ti>y /&>d 7bo? id5tifi$ & deid5tifi$7 = ! factors id5tifi$ 9 clause 7ii7 & any o!r evid5ce reli$ ^u to design & apply ! ,,nqtl to m5tal heal? or sub/ance use disord] b5efits & m$ical_/surgical b5efits4 7iv7 ,! comp>ative analyses demon/rat+ t ! processes & /rategies us$ to design ! ,,nqtl1 z writt5 & 9 op]ation1 & ! z writt5 processes & /rategies us$ to apply ! ,,nqtl = m5tal heal? or sub/ance use disord] b5efits are comp>able to1 & are appli$ no m /r+5tly ?an1 ! processes & /rategies us$ to design ! ,,nqtl1 z writt5 & 9 op]ation1 & ! z writt5 processes & /rategies us$ to apply ! ,,nqtl to m$ical_/surgical b5efits4 7v7 ,a disclosure ( ! specific f9d+s & conclusions rea*$ by ! plan or cov]age t ! results ( ! analyses describ$ 9 ?is subp>agraph indicate t ! plan or cov]age is 9 compliance ) ?is section4 7,b7 ,secret>y reque/ process 7i7 ,submission ^u compla9t ,! ,secret>y %all reque/ t a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age submit ! comp>ative analyses describ$ 9 subp>agraph 7,a7 if ! ,secret>y has receiv$ any compla9ts f plan p>ticipants or p>ticipat+ provid]s ab\t su* a plan or cov]age t involve m5tal heal? or sub/ance use disord] b5efits4 7ii7 ,r&om submissions ,! ,secret>y %all reque/ ! comp>ative analyses describ$ 9 subp>agraph 7,a7 f no few] ?an #ej plans or cov]ages select$ at r&om1 annually1 & su* plans or cov]ages %all n-- 7,i7 be ! same plans or cov]ages = :i* ! comp>ative analyses are reque/$ "u clause 7i72 7,,ii7 be ! same plan or cov]age be+ inve/igat$ by ! ,dep>tm5t reg>d+ ,n,q,t,ls or t has be5 inve/igat$ by ! ,dep>tm5t reg>d+ ,n,q,t,ls )9 ! la/ #e ye>s2 & 7,,iii7 be ! same plan or cov]age t has be5 select$ "u clause 7i7 or 7ii7 )9 ! la/ #e ye>s4 7iii7 ,additional in=mation ,9 in/ances 9 :i* ! ,secret>y has conclud$ t ! plan or cov]age has n submitt$ suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses describ$ 9 subp>agraph 7,a71 z reque/$ "u clauses 7i7 & 7ii71 ! ,secret>y %all specify to ! plan or cov]age ! in=mation ! plan or cov]age mu/ submit to be responsive to ! reque/ "u clauses 7i7 & 7ii7 = ! ,secret>y to review ! comp>ative analyses describ$ 9 subp>agraph 7,a7 = compliance ) ?is section4 7iv7 ,requir$ action ,9 in/ances 9 :i* ! ,secret>y has review$ ! comp>ative analyses describ$ 9 subp>agraph 7,a71 z reque/$ "u clauses 7i7 & 7ii71 & det]m9$ t ! plan or cov]age is n 9 compliance ) ?is section1 ! ,secret>y %all specify to ! plan or cov]age ! actions ! plan or cov]age mu/ take to be 9 compliance ) ?is section4 ,docum5ts or communications produc$ 9 connection ) ! ,secret>y's recomm5dations to ! plan or cov]age %all n be subject to disclosure pursuant to section #eeb ( title #e1 ,unit$ ,/ates ,code4 7v7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 & annually !reaft]1 ! ,secret>y %all submit to ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report t conta9s-- 7,i7 ea* ( ! comp>ative analyses reque/$ "u clauses 7i7 & 7ii71 except t ! id5tity ( ea* plan or cov]age & any contract$ entity ( a plan or cov]age %all be r$act$2 7,,ii7 ! ,secret>y's conclusions z to :e!r ea* plan or cov]age submitt$ suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses reque/$ "u clauses 7i7 & 7ii7 = compliance ) ?is section2 7,,iii7 = ea* plan or cov]age t did submit suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses reque/$ "u clause 7i71 ! ,secret>y's conclusions z to :e!r & :y ! plan or cov]age is 9 compliance ) ?is section2 7,,iv7 ! ,secret>y's specifications describ$ 9 clause 7iii7 = ea* plan or cov]age t ! ,secret>y det]m9$ did n submit suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses reque/$ "u clauses 7i7 & 7ii7 = compliance ) ?is section2 & 7,v7 ! ,secret>y's specifications describ$ 9 clause 7iv7 ( ! actions ea* plan or cov]age t ! ,secret>y det]m9$ is n 9 compliance ) ?is section mu/ take to be 9 compliance ) ?is section1 includ+ ! reason :y ! ,secret>y det]m9$ ! plan or cov]age is n 9 compliance4 7,c7 ,compliance program guidance docum5t update process 7i7 ,9 g5]al ,! ,secret>y %all include select in/ances ( noncompliance t ! ,secret>y discov]s ^u review+ ! comp>ative analyses reque/$ "u clauses 7i7 & 7ii7 ( subp>agraph 7,b7 9 ! compliance program guidance docum5t describ$ 9 section #bgbf7;a77#f71 z x is updat$ e #b ye>s1 except t all in/ances %all be deid5tifi$ & su* in/ances %all n disclose any protect$ heal? in=mation or individually id5tifiable in=mation4 7ii7 ,guidance & regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all f9alize any draft or int]im guidance & regulations relat+ to m5tal heal? p>ity "u ?is section4 7iii7 ,/ate ,any in/ances ( noncompliance ! ,secret>y discov]s ^u review+ ! comp>ative analyses reque/$ "u clauses 7i7 & 7ii7 ( subp>agraph 7,b7 %all be %>$ ) a ,/ate = cov]age (f]$ by a heal? insurance issu] 9 ! gr\p m>ket1 9 accordance ) section #bgbf7;a77#f77;,b77iii77,,ii74 4 #caa4 ,te*nical am5dm5ts 7a7 ,,erisa ,section #gae ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;d7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7,b7 by /rik+ 7z s am5d$74 7b7 ,,irc ,section #ihae ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7,b7 by /rik+ 7z s am5d$74 7c7 ,applicability ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect z ?\gh includ$ 9 ! enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh74 #cab4 ,?ird-p>ty adm9i/rators ,any obligation on a ?ird-p>ty adm9i/rator "u ?is ,act 7includ+ ! am5dm5ts 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 ,,iv ,improv+ ,public ,heal? #dja4 ,improv+ aw>5ess ( disease prev5tion ,! ,public ,heal? ,s]vice ,act is am5d$ by /rik+ section #cac ( su* ,act 7#db ,u4,s4,c4 #bde7 & ins]t+ ! foll[+3 #cac4 ,public aw>5ess campaign on ! importance ( vacc9ations 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r (fices & ag5cies1 z appropriate1 %all aw>d competitive grants to "o or m public or private entities to c>ry out a national1 evid5ce-bas$ campaign to increase aw>5ess & k ( ! safety & effectiv5ess ( vacc9es = ! prev5tion & control ( diseases1 combat mis9=mation ab\t vacc9es1 & dissem9ate sci5tific & evid5ce-bas$ vacc9e-relat$ in=mation1 ) ! goal ( increas+ rates ( vacc9ation across all ages1 z applicable1 p>ticul>ly 9 communities ) l[ rates ( vacc9ation1 to r$uce & elim9ate vacc9e-prev5table diseases4 7b7 ,consultation ,9 c>ry+ out ! campaign "u ?is section1 ! ,secret>y %all consult ) appropriate public heal? & m$ical exp]ts1 includ+ ! ,national ,academy ( ,m$ic9e & m$ical & public heal? associations & nonpr(it organizations1 9 ! developm5t1 implem5tation1 & evaluation ( ! evid5ce-bas$ public aw>5ess campaign4 7c7 ,requirem5ts ,! campaign "u ?is section %all-- 7#a7 be a national1 evid5ce-bas$ initiative2 7#b7 include ! developm5t ( res\rces = communities ) l[ rates ( vacc9ation1 includ+ culturally & l+ui/ically appropriate res\rces1 z applicable2 7#c7 include ! dissem9ation ( vacc9e in=mation & communication res\rces to public heal? dep>tm5ts1 heal? c>e provid]s1 & heal? c>e facilities1 includ+ su* provid]s & facilities t provide pr5atal & p$iatric c>e2 7#d7 be complem5t>y to1 & coord9at$ )1 any o!r ,f$]al1 ,/ate1 or local ef=ts1 z appropriate2 & 7#e7 assess ! effectiv5ess ( communication /rategies to increase rates ( vacc9ation4 7d7 ,additional activities ,! campaign "u ?is section may-- 7#a7 include ! use ( television1 radio1 ! int]net1 & o!r m$ia & telecommunications te*nologies2 7#b7 be focus$ to address specific ne$s ( communities & populations ) l[ rates ( vacc9ation2 & 7#c7 include ! dissem9ation ( sci5tific & evid5ce-bas$ vacc9e-relat$ in=mation1 su* z-- 7,a7 advancem5ts 9 evid5ce-bas$ rese>* relat$ to diseases t may be prev5t$ by vacc9es & vacc9e developm5t2 7,b7 in=mation on vacc9ations = individuals & communities1 includ+ individuals = :om vacc9es are n recomm5d$ by ! ,advisory ,committee = ,immunization ,practices1 & ! effects ( l[ vacc9ation rates )9 a community on su* individuals2 7,c7 in=mation on diseases t may be prev5t$ by vacc9es2 & 7,d7 in=mation on vacc9e safety & ! sy/ems 9 place to monitor vacc9e safety4 7e7 ,evaluation ,! ,secret>y %all-- 7#a7 e/abli% b5*m>ks & metrics to quantitatively measure & evaluate ! aw>5ess campaign "u ?is section2 7#b7 conduct qualitative assessm5ts reg>d+ ! aw>5ess campaign "u ?is section2 & 7#c7 prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives an evaluation ( ! aw>5ess campaign "u ?is section4 7f7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section & section #cag7k7 su* sums z may be necess>y = fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djb4 ,grants to address vacc9e-prev5table diseases ,section #cag7k77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b7k77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subp>agraph 7,d71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7,e7 plann+1 implem5tation1 & evaluation ( activities to address vacc9e-prev5table diseases1 includ+ activities to-- 7i7 id5tify communities at high risk ( outbreaks relat$ to vacc9e-prev5table diseases1 includ+ ?r\gh improv$ data collection & analysis2 7ii7 pilot innovative approa*es to improve vacc9ation rates 9 communities & among populations ) l[ rates ( vacc9ation2 7iii7 r$uce b>ri]s to access+ vacc9es & evid5ce-bas$ in=mation ab\t ! heal? effects ( vacc9es2 7iv7 p>tn] ) community organizations & heal? c>e provid]s to develop & deliv] evid5ce-bas$ int]v5tions1 includ+ culturally & l+ui/ically appropriate int]v5tions1 to increase vacc9ation rates2 7v7 improve deliv]y ( evid5ce-bas$ vacc9e-relat$ in=mation to p>5ts & o!rs2 & 7vi7 improve ! ability ( ,/ate1 local1 tribal1 & t]ritorial public heal? dep>tm5ts to engage communities at high risk = outbreaks relat$ to vacc9e-prev5table diseases2 & 7,f7 rese>* relat$ to /rategies = improv+ aw>5ess ( sci5tific & evid5ce-bas$ vacc9e-relat$ in=mation1 includ+ = communities ) l[ rates ( vacc9ation1 9 ord] to und]/& b>ri]s to vacc9ation1 improve vacc9ation rates1 & assess ! public heal? outcomes ( su* /rategies4 4 #djc4 ,guide on evid5ce-bas$ /rategies = public heal? dep>tm5t obesity prev5tion programs 7a7 ,developm5t & dissem9ation ( an evid5ce-,bas$ /rategies guide ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 %all-- 7#a7 develop a guide on evid5ce-bas$ /rategies = ,/ate1 t]ritorial1 & local heal? dep>tm5ts to use to build & ma9ta9 effective obesity prev5tion & r$uction programs1 &1 9 consultation ) /akehold]s t h exp]tise 9 ,tribal heal?1 a guide on su* evid5ce-bas$ /rategies ) respect to ,indian ,tribes & ,tribal organizations = su* ,indian ,tribes & ,tribal organizations to use = su* purpose1 bo? ( :i* guides %all-- 7,a7 describe an integrat$ program /ructure = implem5t+ int]v5tions prov5 to be effective 9 prev5t+ & r$uc+ ! incid5ce ( obesity2 & 7,b7 recomm5d-- 7i7 optimal res\rces1 includ+ /aff+ & infra/ructure1 = promot+ nutrition & obesity prev5tion & r$uction2 & 7ii7 /rategies = effective obesity prev5tion programs = ,/ate & local heal? dep>tm5ts1 ,indian ,tribes1 & ,tribal organizations1 includ+ /rategies relat$ to-- 7,i7 ! application ( evid5ce-bas$ & evid5ce-in=m$ practices to prev5t & r$uce obesity rates2 7,,ii7 ! developm5t1 implem5tation1 & evaluation ( obesity prev5tion & r$uction /rategies = specific communities & populations2 7,,iii7 demon/rat$ k ( obesity prev5tion practices t r$uce associat$ prev5table diseases1 heal? conditions1 dea?1 & heal? c>e co/s2 7,,iv7 be/ practices = ! coord9ation ( ef=ts to prev5t & r$uce obesity & relat$ *ronic diseases2 7,v7 address+ ! und]ly+ risk factors & social det]m9ants ( heal? t impact obesity rates2 & 7,,vi7 int]discipl9>y coord9ation betwe5 relevant public heal? (ficials specializ+ 9 fields su* z nutrition1 physical activity1 epidemiology1 communications1 & policy implem5tation1 & collaboration betwe5 public heal? (ficials & community-bas$ organizations2 & 7#b7 dissem9ate ! guides & curr5t rese>*1 evid5ce-bas$ practices1 tools1 & educational mat]ials relat$ to obesity prev5tion1 consi/5t ) ! guide1 to ,/ate & local heal? dep>tm5ts1 ,indian ,tribes1 & ,tribal organizations4 7b7 ,te*nical assi/ance ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all provide te*nical assi/ance to ,/ate & local heal? dep>tm5ts1 ,indian ,tribes1 & ,tribal organizations to support su* heal? dep>tm5ts 9 implem5t+ ! guide develop$ "u subsection 7a77#a74 7c7 ,indian ,tribes2 ,tribal organizations ,! t]ms ,indian ,tribe & ,tribal organization h ! mean+s giv5 ! t]ms ,indian tribe & tribal organization1 respectively1 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #ecjd74 #djd4 ,exp&+ capacity = heal? outcomes ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ccj,m 7#db ,u4,s4,c4 #bed;c-#ai7 ! foll[+3 #ccj,n4 ,exp&+ capacity = heal? outcomes 7a7 ,def9itions ,9 ?is section3 7#a7 ,eligible entity ,! t]m eligible entity means an entity provid+ heal? c>e s]vices 9 rural areas1 fronti] areas1 heal? pr(essional %ortage areas1 or m$ically und]s]v$ areas1 or to m$ically und]s]v$ populations or ,native ,am]icans1 includ+ ,indian tribes or tribal organizations4 7#b7 ,heal? pr(essional %ortage area ,! t]m heal? pr(essional %ortage area means a heal? pr(essional %ortage area designat$ "u section #ccb4 7#c7 ,indian tribe ,! t]ms ,indian tribe & tribal organization h ! mean+s giv5 su* t]ms 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act4 7#d7 ,m$ically und]s]v$ population ,! t]m m$ically und]s]v$ population has ! mean+ giv5 ! t]m 9 section #ccj7;b77#c74 7#e7 ,native ,am]icans ,! t]m ,native ,am]icans has ! mean+ giv5 su* t]m 9 section #gcf & includes ,indian tribes & tribal organizations4 7#f7 ,te*nology-enabl$ collaborative le>n+ & capacity build+ model ,! t]m te*nology-enabl$ collaborative le>n+ & capacity build+ model means a di/ance heal? education model t connects speciali/s ) multiple o!r heal? c>e pr(essionals ?r\gh simultane\s int]active videoconf]5c+ = ! purpose ( facilitat+ case-bas$ le>n+1 dissem9at+ be/ practices1 & evaluat+ outcomes4 7b7 ,program e/abli%$ ,! ,secret>y %all1 z appropriate1 aw>d grants to evaluate1 develop1 &1 z appropriate1 exp& ! use ( te*nology-enabl$ collaborative le>n+ & capacity build+ models1 to increase access to heal? c>e s]vices1 su* z ^? to address *ronic diseases & conditions1 m5tal heal?1 sub/ance use disord]s1 pr5atal & mat]nal heal?1 p$iatric c>e1 pa9 managem5t1 palliative c>e1 & o!r specialty c>e 9 m$ically und]s]v$ areas & = m$ically und]s]v$ populations4 7c7 ,use ( funds 7#a7 ,9 g5]al ,grants aw>d$ "u subsection 7b7 %all be us$ =-- 7,a7 ! developm5t & acquisition ( in/ructional programm+1 & ! tra9+ ( heal? c>e provid]s & o!r pr(essionals t provide or assi/ 9 ! provision ( s]vices ?r\gh su* models2 7,b7 in=mation collection & evaluation activities to /udy ! impact ( su* models on pati5t outcomes & heal? c>e provid]s1 & to id5tify be/ practices = ! expansion & use ( su* models2 or 7,c7 o!r activities consi/5t ) a*iev+ ! objectives ( ! grants aw>d$ "u ?is section1 z det]m9$ by ! ,secret>y4 7#b7 ,o!r uses ,9 addition to any ( ! uses "u p>agraph 7#a71 grants aw>d$ "u subsection 7b7 may be us$ =-- 7,a7 equipm5t to support ! use & expansion ( te*nology-enabl$ collaborative le>n+ & capacity build+ models1 includ+ = h>dw>e & s(tw>e t enables di/ance le>n+1 heal? c>e provid] support1 & ! secure ex*ange ( electronic heal? in=mation2 or 7,b7 support = heal? c>e provid]s & o!r pr(essionals t provide or assi/ 9 ! provision ( s]vices ?r\gh su* models4 7d7 ,l5g? ( grants ,grants aw>d$ "u subsection 7b7 %all be = a p]iod ( up to #e ye>s4 7e7 ,application ,an eligible entity t seeks to receive a grant "u subsection 7b7 %all submit to ! ,secret>y an application1 at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 ,su* application crit]ia %all include an assessm5t ( ! effect ( te*nology-enabl$ collaborative le>n+ & capacity build+ models on pati5t outcomes & heal? c>e provid]s4 7f7 ,te*nical assi/ance ,! ,secret>y %all provide 7ei!r directly ?r\gh ! ,dep>tm5t ( ,heal? & ,human ,s]vices or by contract7 te*nical assi/ance to eligible entities1 includ+ recipi5ts ( grants "u subsection 7b71 on ! developm5t1 use1 & evaluation ( te*nology-enabl$ collaborative le>n+ & capacity build+ models 9 ord] to exp& access to heal? c>e s]vices provid$ by su* entities1 includ+ = m$ically und]s]v$ areas & to m$ically und]s]v$ populations4 7g7 ,report by ,secret>y ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & po/ on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 a report includ+1 at m9imum-- 7#a7 a description ( any new & cont9u+ grants aw>d$ to entities "u subsection 7b7 & ! specific purpose & am\nts ( su* grants2 7#b7 an ov]view (-- 7,a7 ! evaluations conduct$ "u subsections 7b7 or 7f72 & 7,b7 te*nical assi/ance provid$ "u subsection 7f72 & 7#c7 a description ( any significant f9d+s or developm5ts 9 pati5t outcomes & heal? c>e provid]s & be/ practices = eligible entities exp&+1 us+1 or evaluat+ te*nology-enabl$ collaborative le>n+ & capacity build+ models4 7h7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 #dje4 ,public heal? data sy/em mod]nization ,subtitle ,c ( title ,,xxviii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is am5d$ by add+ at ! end ! foll[+3 #bhbb4 ,public heal? data sy/em mod]nization grants 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all-- 7#a7 aw>d grants to ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts = ! expansion & mod]nization ( public heal? data sy/ems1 to assi/ public heal? dep>tm5ts 9-- 7,a7 assess+ curr5t data infra/ructure capabilities & gaps to improve & increase consi/5cy 9 data collection1 /orage1 analysis1 &1 z appropriate1 to improve dissem9ation ( public heal?-relat$ in=mation2 7,b7 improv+ secure public heal? data collection1 transmission1 ex*ange1 ma9t5ance1 & analysis2 7,c7 simplify+ & support+ report+ by heal? c>e provid]s1 z applicable1 pursuant to ,/ate law1 includ+ ?r\gh ! use ( heal? in=mation te*nology1 to ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts1 includ+ public heal? (ficials 9 multiple jurisdictions )9 su* ,/ate1 z appropriate2 7,d7 enhanc+ int]op]ability ( public heal? data sy/ems 7includ+ sy/ems creat$ or access$ by public heal? dep>tm5ts7 ) heal? in=mation te*nology1 includ+ c]tifi$ heal? in=mation te*nology2 7,e7 support+ e>li] disease & heal? condition detection1 su* z ?r\gh ne> real-"t data monitor+1 to support rapid public heal? responses2 & 7,f7 support+ activities )9 ! applicable jurisdiction relat$ to ! expansion & mod]nization ( electronic case report+2 7#b7 z appropriate1 conduct activities relat$ to ! int]op]ability & improvem5t ( applicable public heal? data sy/ems us$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 &1 9 coord9ation ) ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 ! designation ( data & te*nology /&>ds = heal? in=mation sy/ems ( ! public heal? infra/ructure ) def]5ce giv5 to /&>ds publi%$ by /&>ds developm5t organizations & volunt>y cons5sus-bas$ /&>ds bodies2 & 7#c7 develop & utilize public-private p>tn]%ips = te*nical assi/ance & relat$ implem5tation support = ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts1 & ! ,c5t]s = ,disease ,control & ,prev5tion1 on ! expansion & mod]nization ( electronic case report+ & public heal? data sy/ems1 z applicable4 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! ,secret>y may n aw>d a grant "u subsection 7a77#a7 unless ! applicant supports /&>ds endors$ by ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology pursuant to section #cjja7;c77#a7 or adopt$ by ! ,secret>y "u section #cjjd4 7#b7 ,waiv] ,! ,secret>y may waive ! requirem5t "u p>agraph 7#a7 ) respect to an applicant if ! ,secret>y det]m9es t ! activities "u subsection 7a7 _c o!rwise be c>ri$ out )9 ! applicable jurisdiction4 7#c7 ,application ,a ,/ate1 local1 ,tribal1 or t]ritorial heal? dep>tm5t apply+ = a grant "u ?is section %all submit an application to ! ,secret>y at su* "t & 9 su* mann] z ! ,secret>y may require4 ,su* application %all include in=mation describ+-- 7,a7 ! activities t w be support$ by ! grant2 & 7,b7 h[ ! mod]nization ( su* public heal? data sy/ems w support or impact ! public heal? infra/ructure ( ! heal? dep>tm5t1 includ+ a description ( rema9+ gaps1 if any1 & ! actions ne$$ to address su* gaps4 7c7 ,use ( funds ,an entity receiv+ a grant "u ?is section may use am\nts receiv$ "u su* grant = "o or bo? ( ! foll[+3 7#a7 ,c>ry+ out activities describ$ 9 subsection 7a77#a7 to support public heal? data sy/ems 7includ+ electronic case report+71 :i* may include support =1 & tra9+ (1 pr(essionals ) exp]tise 9 contribut+ to & us+ su* sy/ems 7includ+ public heal? data sci5ti/s74 7#b7 ,develop+ & dissem9at+ in=mation relat$ to ! use & importance ( public heal? data4 7d7 ,/rategy & implem5tation plan ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a coord9at$ /rategy & an accompany+ implem5tation plan t id5tifies & demon/rates ! /eps ! ,secret>y w c>ry out to-- 7#a7 update & improve applicable public heal? data sy/ems us$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7#b7 c>ry out ! activities describ$ 9 ?is section to support ! improvem5t ( ,/ate1 local1 ,tribal1 & t]ritorial public heal? data sy/ems4 7e7 ,consultation ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all consult ) ,/ate1 local1 ,tribal1 & t]ritorial heal? dep>tm5ts1 pr(essional m$ical & public heal? associations1 associations repres5t+ hospitals or o!r heal? c>e entities1 heal? in=mation te*nology exp]ts1 & o!r appropriate entities reg>d+ ! plan & grant program to mod]nize public heal? data sy/ems pursuant to ?is section4 ,su* activities may include ! provision ( te*nical assi/ance relat$ to ! ex*ange ( in=mation by su* public heal? data sy/ems us$ by relevant heal? c>e & public heal? entities at ! local1 ,/ate1 ,f$]al1 ,tribal1 & t]ritorial levels4 7f7 ,report to ,congress ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives t includes-- 7#a7 a description ( any b>ri]s to-- 7,a7 public heal? au?orities implem5t+ electronic case report+ & int]op]able public heal? data sy/ems2 or 7,b7 ! ex*ange ( in=mation pursuant to electronic case report+2 7#b7 an assessm5t ( ! pot5tial public heal? impact ( implem5t+ electronic case report+ & int]op]able public heal? data sy/ems2 & 7#c7 a description ( ! activities c>ri$ out pursuant to ?is section4 7g7 ,electronic case report+ ,9 ?is section1 ! t]m electronic case report+ means ! automat$ id5tification1 g5]ation1 & bilat]al ex*ange ( reports ( heal? ev5ts among electronic heal? record or heal? in=mation te*nology sy/ems & public heal? au?orities4 7h7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ su* sums z may be necess>y = fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djf4 ,innovation = mat]nal heal? 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 9 consultation ) exp]ts repres5t+ a v>iety ( cl9ical specialties1 ,/ate1 tribal1 or local public heal? (ficials1 rese>*]s1 epidemiologi/s1 /ati/icians1 & community organizations1 %all e/abli% a program to aw>d competitive grants to eligible entities = ! purpose (-- 7#a7 id5tify+1 develop+1 or dissem9at+ be/ practices to improve mat]nal heal? c>e quality & outcomes1 elim9ate prev5table mat]nal mortality & sev]e mat]nal morbidity1 & improve infant heal? outcomes1 :i* may include-- 7,a7 in=mation on evid5ce-bas$ practices to improve ! quality & safety ( mat]nal heal? c>e 9 hospitals & o!r heal? c>e sett+s ( a ,/ate or heal? c>e sy/em1 includ+ by address+ topics commonly associat$ ) heal? complications or risks relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e2 7,b7 be/ practices = improv+ mat]nal heal? c>e bas$ on data f9d+s & reviews conduct$ by a ,/ate mat]nal mortality review committee t address topics ( relevance to common complications or heal? risks relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e2 & 7,c7 in=mation on address+ det]m9ants ( heal? t impact mat]nal heal? outcomes = wom5 be=e1 dur+1 & aft] pregnancy2 7#b7 collaborat+ ) ,/ate mat]nal mortality review committees to id5tify issues = ! developm5t & implem5tation ( evid5ce-bas$ practices to improve mat]nal heal? outcomes & r$uce prev5table mat]nal mortality & sev]e mat]nal morbidity2 7#c7 provid+ te*nical assi/ance & support+ ! implem5tation ( be/ practices id5tifi$ 9 p>agraph 7#a7 to entities provid+ heal? c>e s]vices to pregnant & po/p>tum wom52 & 7#d7 id5tify+1 develop+1 & evaluat+ new models ( c>e t improve mat]nal & infant heal? outcomes1 :i* may include ! integration ( community-bas$ s]vices & cl9ical c>e4 7b7 ,eligible entities ,to be eligible = a grant "u subsection 7a71 an entity %all-- 7#a7 submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require2 & 7#b7 demon/rate 9 su* application t ! entity has a demon/rat$ exp]tise 9 data-driv5 mat]nal safety & quality improvem5t initiatives 9 ! areas ( ob/etrics & gynecology or mat]nal heal?4 7c7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 #djg4 ,tra9+ = heal? c>e provid]s ,title ,,vii ( ! ,public ,heal? ,s]vice ,act is am5d$ by /rik+ section #gfc 7#db ,u4,s4,c4 #bidp7 & ins]t+ ! foll[+3 #gfc4 ,tra9+ = heal? c>e provid]s 7a7 ,grant program ,! ,secret>y %all e/abli% a program to aw>d grants to accr$it$ s*ools ( allopa?ic m$ic9e1 o/eopa?ic m$ic9e1 & nurs+1 & o!r heal? pr(essional tra9+ programs = ! tra9+ ( heal? c>e pr(essionals to r$uce & prev5t discrim9ation 7includ+ tra9+ relat$ to implicit biases7 9 ! provision ( heal? c>e s]vices relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e4 7b7 ,eligibility ,to be eligible = a grant "u subsection 7a71 an entity describ$ 9 su* subsection %all submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7c7 ,report+ requirem5t ,ea* entity aw>d$ a grant "u ?is section %all p]iodically submit to ! ,secret>y a report on ! /atus ( activities conduct$ us+ ! grant1 includ+ a description ( ! impact ( su* tra9+ on pati5t outcomes1 z applicable4 7d7 ,be/ practices ,! ,secret>y may id5tify & dissem9ate be/ practices = ! tra9+ ( heal? c>e pr(essionals to r$uce & prev5t discrim9ation 7includ+ tra9+ relat$ to implicit biases7 9 ! provision ( heal? c>e s]vices relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e4 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djh4 ,/udy on tra9+ to r$uce & prev5t discrim9ation ,n lat] ?an #b ye>s aft] date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 ?r\gh a contract ) an indep5d5t rese>* organization1 /udy & make recomm5dations = accr$it$ s*ools ( allopa?ic m$ic9e1 o/eopa?ic m$ic9e1 & nurs+1 & o!r heal? pr(essional tra9+ programs on be/ practices relat$ to tra9+ to r$uce & prev5t discrim9ation1 includ+ tra9+ relat$ to implicit biases1 9 ! provision ( heal? c>e s]vices relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e4 #dji4 ,p]9atal quality collaboratives ,section #cag,k7a77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;a77#b77 is am5d$ by add+ at ! end ! foll[+3 7,e7 7i7 ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r (fices & ag5cies1 z appropriate1 %all e/abli% or cont9ue a competitive grant program = ! e/abli%m5t or support ( p]9atal quality collaboratives to improve p]9atal c>e & p]9atal heal? outcomes = pregnant & po/p>tum wom5 & _! infants4 ,a ,/ate or ,indian ,tribe may use funds receiv$ ?r\gh su* grant to-- 7,i7 support ! use ( evid5ce-bas$ or evid5ce-in=m$ practices to improve outcomes = mat]nal & infant heal?2 7,,ii7 "w ) cl9ical teams2 exp]ts2 ,/ate1 local1 &1 z appropriate1 tribal public heal? (ficials2 & /akehold]s1 includ+ pati5ts & families1 to id5tify1 develop1 or dissem9ate be/ practices to improve p]9atal c>e & outcomes2 & 7,,iii7 employ /rategies t provide opportunities = heal? c>e pr(essionals & cl9ical teams to collaborate across heal? c>e sett+s & discipl9es1 includ+ prim>y c>e & m5tal heal?1 z appropriate1 to improve mat]nal & infant heal? outcomes1 :i* may include ! use ( data to provide timely fe$back across hospital & cl9ical teams to in=m responses1 & to provide support & tra9+ to hospital & cl9ical teams = quality improvem5t1 z appropriate4 7ii7 ,to be eligible = a grant "u clause 7i71 an entity %all submit to ! ,secret>y an application 9 su* =m & mann] & conta9+ su* in=mation z ! ,secret>y may require4 4 #daj4 ,integrat$ s]vices = pregnant & po/p>tum wom5 7a7 ,grants ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ccj,n ( su* ,act1 z add$ by section #djd1 ! foll[+3 #ccj,o4 ,integrat$ s]vices = pregnant & po/p>tum wom5 7a7 ,9 g5]al ,! ,secret>y may aw>d grants = ! purpose ( e/abli%+ or op]at+ evid5ce-bas$ or innovative1 evid5ce-in=m$ programs to deliv] integrat$ heal? c>e s]vices to pregnant & po/p>tum wom5 to optimize ! heal? ( wom5 & _! infants1 includ+ to r$uce adv]se mat]nal heal? outcomes1 pregnancy-relat$ dea?s1 & relat$ heal? disp>ities 7includ+ su* disp>ities associat$ ) racial & e?nic m9ority populations71 & z appropriate1 by address+ issues rese>*$ "u subsection 7b77#b7 ( section #cag,k4 7b7 ,integrat$ s]vices = pregnant & po/p>tum wom5 7#a7 ,eligibility ,to be eligible to receive a grant "u subsection 7a71 a ,/ate or ,indian ,tribe 7z def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act7 %all "w ) relevant /akehold]s t coord9ate c>e 7includ+ coord9at+ res\rces & ref]rals = heal? c>e & social s]vices7 to develop & c>ry out ! program1 includ+-- 7,a7 ,/ate1 tribal1 & local ag5cies responsible = ,m$icaid1 public heal?1 social s]vices1 m5tal heal?1 & sub/ance use disord] treatm5t & s]vices2 7,b7 heal? c>e provid]s :o s]ve pregnant wom52 & 7,c7 community-bas$ heal? organizations & heal? work]s1 includ+ provid]s ( home visit+ s]vices & individuals repres5t+ communities ) disproportionately high rates ( mat]nal mortality & sev]e mat]nal morbidity1 & includ+ ^? repres5t+ racial & e?nicity m9ority populations4 7#b7 ,t]ms 7,a7 ,limitation ,! ,secret>y may aw>d a grant "u subsection 7a7 to up to #aj ,/ates4 7,b7 ,p]iod ,a grant aw>d$ "u subsection 7a7 %all be made = a p]iod ( #e ye>s4 7,c7 ,prioritization ,9 aw>d+ grants "u subsection 7a71 ! ,secret>y %all prioritize applications f ,/ates or ,indian ,tribes ) ! highe/ rates ( mat]nal mortality & sev]e mat]nal morbidity1 & %all consid] heal? disp>ities relat$ to mat]nal mortality & sev]e mat]nal morbidity1 includ+ su* disp>ities associat$ ) racial & e?nic m9ority populations4 7,d7 ,evaluation ,! ,secret>y %all require grantees to evaluate ! outcomes ( ! programs support$ "u ! grant4 7c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 7b7 ,report on grant outcomes & dissem9ation ( be/ practices 7#a7 ,report ,n lat] ?an ,april #a1 #bjbe1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t describes-- 7,a7 ! outcomes ( ! activities support$ by ! grants aw>d$ "u ! am5dm5ts made by ?is section on mat]nal & *ild heal?2 7,b7 be/ practices & models ( c>e us$ by recipi5ts ( grants "u su* am5dm5ts2 & 7,c7 ob/acles id5tifi$ by recipi5ts ( grants "u su* am5dm5ts1 & /rategies us$ by su* recipi5ts to deliv] c>e1 improve mat]nal & *ild heal?1 & r$uce heal? disp>ities4 7#b7 ,dissem9ation ( be/ practices ,n lat] ?an ,octob] #a1 #bjbe1 ! ,secret>y ( ,heal? & ,human ,s]vices %all dissem9ate in=mation on be/ practices & models ( c>e us$ by recipi5ts ( grants "u ! am5dm5ts made by ?is section 7includ+ be/ practices & models ( c>e relat+ to ! r$uction ( heal? disp>ities1 includ+ su* disp>ities associat$ ) racial & e?nic m9ority populations1 9 rates ( mat]nal mortality & sev]e mat]nal morbidity7 to relevant /akehold]s1 :i* may include heal? provid]s1 m$ical s*ools1 nurs+ s*ools1 relevant ,/ate1 tribal1 & local ag5cies1 & ! g5]al public4 #daa4 ,ext5sion = community heal? c5t]s1 ! ,national ,heal? ,s]vice ,corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs 7a7 ,community heal? c5t]s fund+ ,section #ajejc7;b77#a77;,f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is am5d$ by /rik+ fiscal ye> #bjai & ins]t+ ea* ( fiscal ye>s #bjai ?r\gh #bjbd4 7b7 ,national ,heal? ,s]vice ,corps ,section #ajejc7;b77#b77;,f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77;,f77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 7c7 ,tea*+ ,heal? ,c5t]s t op]ate ,graduate ,m$ical ,education ,programs ,section #cdj;,h7g77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 7d7 ,application ( provisions ,am\nts appropriat$ pursuant to ?is section = ea* ( fiscal ye>s #bjai ?r\gh #bjbd %all be subject to ! requirem5ts conta9$ 9 ,public ,law #aae-bde = funds = programs au?oriz$ "u sections #ccj ?r\gh #cdj ( ! ,public ,heal? ,s]vice ,act4 7e7 ,con=m+ am5dm5ts ,p>agraph 7#d7 ( section #cjad7;h7 ( title #ah1 ,unit$ ,/ates ,code1 z am5d$ by section #ejija ( ,public ,law #aae-abc1 is am5d$ by /rik+ & section #ejija7;e7 ( ! ,advanc+ ,*ronic ,c>e1 ,ext5d]s1 & ,social ,s]vices ,act & ins]t+ 1 section #ejija7;e7 ( ! ,advanc+ ,*ronic ,c>e1 ,ext5d]s1 & ,social ,s]vices ,act1 & section #daa7;d7 ( ! ,l[] ,heal? ,c>e ,co/s ,act4 #dab4 ,o!r programs 7a7 ,type ,i ,section #ccj;,b7b77#b77;,d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77;,d77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 7b7 ,indians ,subp>agraph 7,d7 ( section #ccj;,c7c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77;,d77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 ,v ,improv+ ! ,ex*ange ( ,heal? ,in=mation #eja4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation 7a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$ by ins]t+ aft] section #bgae;,a ! foll[+3 #bgae;,b4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all make available = access1 ex*ange1 or use )\t special ef=t1 ?r\gh application programm+ int]faces 7or successor te*nology or /&>ds71 ! in=mation describ$ 9 subsection 7b71 9 ! mann] describ$ 9 subsection 7b7 & o!rwise consi/5t ) ?is section4 7b7 ,in=mation ,! foll[+ in=mation is requir$ to be made available1 9 su* =m & mann] z ! ,secret>y may specify1 z describ$ 9 subsection 7a73 7#a7 ,hi/orical claims1 provid] enc\nt]1 & paym5t data = ea* enrollee1 :i* %all-- 7,a7 include adjudicat$ m$ical & prescription drug claims & equival5t enc\nt]s1 includ+ all data elem5ts conta9$ 9 su* transactions-- 7i7 t 7 adjudicat$ by ! gr\p heal? plan or heal? insurance issu] dur+ ! previ\s #e ye>s or ! enrollee's entire p]iod ( enrollm5t 9 ! applicable plan or cov]age if su* p]iod is less ?an #e ye>s2 7ii7 t involve b5efits manag$ by any ?ird p>ty1 su* z a ph>macy b5efits manag] or radiology b5efits manag] t manages b5efits or adjudicates claims on behalf ( ! plan or cov]age2 & 7iii7 f any o!r heal? plan or heal? insurance cov]age issu$ or adm9i/]$ by ! same insurance issu]1 9 :i* ! same enrollee 0 enroll$ dur+ ! previ\s #e ye>s2 & 7,b7 be available-- 7i7 9 a s+le1 longitud9al =mat t is easy to und]/& & secure1 & t may update automatically1 includ+ by us+ ! /&>ds adopt$ = implem5tation ( section #cjja7;c77#e77;,d77iv72 7ii7 z soon z practicable1 & 9 no case lat] ?an ! p]iod ( "t det]m9$ by ! ,secret>y1 aft] ! claim is adjudicat$ or ! data is receiv$ by ! heal? plan or heal? insurance issu]2 & 7iii7 to ! enrollee1 & any provid]s or ?ird-p>ty applications or s]vices au?oriz$ by ! enrollee1 = #e ye>s aft] ! end date ( ! enrollee's enrollm5t 9 ! plan or 9 any cov]age (f]$ by ! heal? insurance issu]4 7#b7 ,id5tify+ directory in=mation = all 9-network provid]s1 includ+ facilities & practition]s1 t p>ticipate 9 ! plan or cov]age1 :i* %all-- 7,a7 include-- 7i7 ! national provid] id5tifi] = 9-network facilities & practition]s2 & 7ii7 ! "n1 address1 phone numb]1 & specialty = ea* su* facility & practition]1 bas$ on ! mo/ rec5t int]action betwe5 ! plan or cov]age & t facility or practition]2 7,b7 be capable ( return+ a li/ ( p>ticipat+ 9-network facilities & practition]s1 9 a giv5 specialty or at a p>ticul> facility type1 )9 a specifi$ geographic radius2 & 7,c7 be capable ( return+ ! network /atus1 :5 pres5t$ ) id5tifi]s = a giv5 enrollee & facility or practition]4 7#c7 ,e/imat$ pati5t out-(-pocket co/s1 includ+ co/s expect$ to be incurr$ ?r\gh a d$uctible1 copaym5t1 co9surance1 or o!r =m ( co/-%>+1 =-- 7,a7 a designat$ set ( common s]vices or episodes ( c>e1 to be e/abli%$ by ! ,secret>y ?r\gh rulemak+1 includ+1 at a m9imum-- 7i7 9 ! case ( s]vices provid$ by a hospital1 ! #ajj mo/ common diagnosis-relat$ gr\ps1 z us$ 9 ! ,m$ic>e ,inpati5t ,prospective ,pati5t ,sy/em 7or successor episode-bas$ reimbursem5t me?odology7 at t hospital1 bas$ on claims data adjudicat$ by ! gr\p heal? plan or heal? insurance issu]2 7ii7 9 ! case ( s]vices provid$ 9 an outpati5t sett+1 includ+ radiology1 lab te/s1 & outpati5t surgical proc$ures1 any s]vice r5d]$ by ! facility or practition]1 & reimburs$ by ! heal? plan or heal? insurance issu]2 & 7iii7 9 ! case ( po/-acute c>e1 includ+ home heal? provid]s1 skill$ nurs+ facilities1 inpati5t rehabilitation facilities1 & long-t]m c>e hospitals1 ! pati5t out-(-pocket co/s = an episode ( c>e1 z ! ,secret>y may det]m9e1 :i* p]mits us]s to reasonably comp>e co/s across diff]5t facility & s]vice types2 & 7,b7 all prescription drugs curr5tly includ$ on any ti] ( ! =mul>y ( ! plan or cov]age4 7c7 ,availability & access ,! application programm+ int]faces1 includ+ all data requir$ to be made available ?r\gh su* int]faces1 %all-- 7#a7 be made available by ! applicable gr\p heal? plan or heal? insurance issu]1 at no *>ge1 to-- 7,a7 enrollees 9 ! gr\p heal? plan or heal? insurance cov]age2 7,b7 ?ird p>ties au?oriz$ by ! enrollee2 7,c7 facilities & practition]s :o are "u contract ) ! plan or cov]age2 & 7,d7 bus9ess associates ( su* facilities & practition]s1 z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7#b7 be available to enrollees 9 ! gr\p heal? plan or heal? insurance cov]age1 & to ?ird-p>ty applications or s]vices facilitat+ su* access by enrollees1 dur+ ! enrollm5t process & = a m9imum ( #e ye>s aft] ! end date ( ! enrollee's enrollm5t 9 ! plan or 9 any cov]age (f]$ by ! heal? insurance issu]2 7#c7 p]mit p]si/5t access by ?ird-p>ty applications or s]vices au?oriz$ by ! enrollee1 = a reasonable p]iod ( "t1 consi/5t ) curr5t security practices2 7#d7 employ ! applicable cont5t1 vocabul>y1 & te*nical /&>ds1 includ+1 z appropriate1 su* /&>ds adopt$ by ! ,secret>y pursuant to title ,,xxx2 & 7#e7 employ security & au!ntication /&>ds1 z ! ,secret>y det]m9es appropriate4 7d7 ,rule ( con/ruction reg>d+ privacy ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations "u ! privacy1 security1 & brea* notification rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act 7or successor regulations71 "u "p #b ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations71 "u section #ddd ( ! ,g5]al ,education ,provisions ,act 7#bj ,u4,s4,c4 #abcb;g7 7commonly ref]r$ to z ! ,family ,educational ,rights & ,privacy ,act ( #aigd71 "u ! am5dm5ts made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act1 or "u ,/ate privacy law4 4 7b7 ,effective date ,section #bgae;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect #a ye> aft] ! date ( enactm5t ( ?is ,act4 #ejb4 ,recognition ( security practices ,"p #a ( subtitle ,d ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agica et seq47 is am5d$ by add+ at ! end ! foll[+3 #acdab4 ,recognition ( security practices 7a7 ,9 g5]al ,consi/5t ) ! au?ority ( ! ,secret>y "u sections #aagf & #aagg ( ! ,social ,security ,act1 :5 mak+ det]m9ations relat+ to f9es "u section #acdaj1 decreas+ ! l5g? & ext5t ( an audit "u section #acdaa1 or rem$ies o!rwise agre$ to by ! ,secret>y1 ! ,secret>y %all consid] :e!r ! entity or bus9ess associate _h1 = n less ?an ! previ\s #ab mon?s1 recogniz$ security practices 9 place t may-- 7#a7 mitigate f9es "u section #acdaj2 7#b7 result 9 ! e>ly1 favorable t]m9ation ( an audit "u section #acdaa2 & 7#c7 limit ! rem$ies t w\ld o!rwise be agre$ to 9 any agreem5t betwe5 ! entity or bus9ess associate & ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7b7 ,additional consid]ation ,at ! election ( ! entity or bus9ess associate1 ! ,secret>y may provide fur!r consid]ation to an entity or bus9ess associate t c adequately demon/rate t su* recogniz$ security practices 7 9 place1 z det]m9$ by ! ,secret>y4 7c7 ,def9ition & miscellane\s provisions 7#a7 ,recogniz$ security practices ,! t]m recogniz$ security practices means ! /&>ds1 guidel9es1 be/ practices1 me?odologies1 proc$ures1 & processes develop$ "u section #b7;c77#ae7 ( ! ,national ,in/itute ( ,/&>ds & ,te*nology ,act1 ! approa*es promulgat$ "u section #dje7;d7 ( ! ,cyb]security ,in=mation ,%>+ ,act ( #bjae1 & any o!r program or processes t are equival5t to su* requirem5ts z may be develop$ ?r\gh regulations4 ,su* practices %all be det]m9$ by ! entity or bus9ess associate1 except :]e additional consid]ation is reque/$ "u subsection 7b74 7#b7 ,limitation ,no?+ 9 ?is section %all be con/ru$ z provid+ ! ,secret>y au?ority to-- 7,a7 increase f9es "u section #acdaj1 or ! l5g?1 ext5t or quantity ( audits "u section #acdaa1 due to a lack ( compliance ) ! recogniz$ security practices2 or 7,b7 m&ate1 direct1 or condition ! aw>d ( any ,f$]al grant1 contract1 or pur*ase1 on compliance ) su* recogniz$ security practices4 7#c7 ,no liability = nonp>ticipation ,no?+ 9 ?is section %all be con/ru$ to subject an entity or bus9ess associate to liability = elect+ n to engage 9 ! recogniz$ security practices def9$ by ?is section4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! ,secret>y's au?ority to en=ce ! ,,hipaa ,security rule 7"p #afj ( title #de1 ,code ( ,f$]al ,regulations1 & subp>ts ,a & ,c ( "p #afd ( su* title71 or to sup]s$e or conflict ) an entity or bus9ess associate's obligations "u ! ,,hipaa ,security rule4 4 #ejc4 ,,gao /udy on ! privacy & security risks ( electronic transmission ( individually id5tifiable heal? in=mation to & f entities n cov]$ by ! ,heal? ,insurance ,portability & ,acc\ntability ,act 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to-- 7#a7 describe ! roles ( ,f$]al ag5cies & ! private sector ) respect to protect+ ! privacy & security ( individually id5tifiable heal? in=mation transmitt$ electronically to & f entities n cov]$ by ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note72 7#b7 id5tify rec5t developm5ts reg>d+ ! use ( application programm+ int]faces to access individually id5tifiable heal? in=mation1 & implications = ! privacy & security ( su* in=mation2 7#c7 id5tify practices 9 ! private sector1 su* z t]ms & conditions = use1 relat+ to ! privacy1 disclosure1 & second>y uses ( individually id5tifiable heal? in=mation transmitt$ electronically to or f entities1 select$ by an individual1 t are n subject to ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif2 & 7#d7 id5tify /eps ! public & private sectors c take to improve ! private & secure access to & availability ( individually id5tifiable heal? in=mation4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conc]n+ ! f9d+s ( ! /udy conduct$ "u subsection 7a74 #ejd4 ,te*nical corrections 7a7 ,9 g5]al ,section #cjbb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,application ( au?orities "u ,inspector ,g5]al ,act ( #aigh ,9 c>ry+ out ?is subsection1 ! ,inspector ,g5]al %all h ! same au?orities z provid$ "u section #f ( ! ,inspector ,g5]al ,act ( #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all take effect z if includ$ 9 ! enactm5t ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee74 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,l[] ,heal? ,c>e ,co/s ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,end+ surprise m$ical bills,sec4 #aja4 ,protect+ pati5ts aga9/ out-(-network d$uctibles 9 em]g5cies4,sec4 #ajb4 ,protection aga9/ surprise bills4,sec4 #ajc4 ,b5*m>k = paym5t4,sec4 #ajd4 ,effective date4,sec4 #aje4 ,end+ surprise air ambulance bills4,sec4 #ajf4 ,report4,,title ,,ii--,r$uc+ ! prices ( prescription drugs,sec4 #bja4 ,biological product pat5t transp>5cy4,sec4 #bjb4 ,orange ,book mod]nization4,sec4 #bjc4 ,ensur+ timely access to g5]ics4,sec4 #bjd4 ,protect+ access to biological products4,sec4 #bje4 ,prev5t+ block+ ( g5]ic drugs4,sec4 #bjf4 ,education on biological products4,sec4 #bjg4 ,biological product innovation4,sec4 #bjh4 ,cl>ify+ ! mean+ ( new *emical entity4,sec4 #bji4 ,/reaml9+ ! transition ( biological products4,sec4 #baj4 ,orphan drug cl>ification4,sec4 #baa4 ,prompt approval ( drugs relat$ to safety in=mation4,sec4 #bab4 ,conditions ( use = biosimil> biological products4,sec4 #bac4 ,mod]niz+ ! label+ ( c]ta9 g5]ic drugs4,sec4 #bad4 ,actions = delays ( g5]ic drugs & biosimil> biological products4,sec4 #bae4 ,r$uc+ ! price ( prescription drugs4,,title ,,iii--,improv+ transp>5cy 9 heal? care,sec4 #cja4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation4,sec4 #cjb4 ,bann+ anticompetitive t]ms 9 facility & insurance contracts t limit access to high] quality1 l[] co/ c>e4,sec4 #cjc4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s4,sec4 #cjd4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation4,sec4 #cje4 ,timely bills = pati5ts4,sec4 #cjf4 ,heal? plan ov]sight ( ph>macy b5efit manag] s]vices4,sec4 #cjg4 ,gov]nm5t ,acc\ntability ,(fice /udy on pr(it- & rev5ue-%>+ 9 heal? c>e4,sec4 #cjh4 ,disclosure ( direct & indirect comp5sation = brok]s & consultants to employ]-sponsor$ heal? plans & enrollees 9 plans on ! individual m>ket4,sec4 #cji4 ,ensur+ enrollee access to co/-%>+ in=mation4,sec4 #caj4 ,/r5g!n+ p>ity 9 m5tal heal? & sub/ance use disord] b5efits4,sec4 #caa4 ,te*nical am5dm5ts4,sec4 #cab4 ,?ird-p>ty adm9i/rators4,sec4 #cac4 ,gr\p heal? plan report+ requirem5ts4,sec4 #cad4 ,/udy by ,comptroll] ,g5]al ( ,unit$ ,/ates4,,title ,,iv--,improv+ public health,sec4 #dja4 ,improv+ aw>5ess ( disease prev5tion4,sec4 #djb4 ,grants to address vacc9e-prev5table diseases4,sec4 #djc4 ,guide on evid5ce-bas$ /rategies = public heal? dep>tm5t obesity prev5tion programs4,sec4 #djd4 ,exp&+ capacity = heal? outcomes4,sec4 #dje4 ,public heal? data sy/em mod]nization4,sec4 #djf4 ,innovation = mat]nal heal?4,sec4 #djg4 ,tra9+ = heal? c>e provid]s4,sec4 #djh4 ,/udy on tra9+ to r$uce & prev5t discrim9ation4,sec4 #dji4 ,p]9atal quality collaboratives4,sec4 #daj4 ,integrat$ s]vices = pregnant & po/p>tum wom54,sec4 #daa4 ,ext5sion = community heal? c5t]s1 ! national heal? s]vice corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs4,sec4 #dab4 ,o!r programs4,sec4 #dac4 ,native ,am]ican suicide prev5tion4,sec4 #dad4 ,m9imum age ( sale ( tobacco products4,sec4 #dae4 ,sale ( tobacco products to individuals "u ! age ( #ba4,,title ,v--,improv+ ! ex*ange ( heal? information,sec4 #eja4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation4,sec4 #ejb4 ,recognition ( security practices4,sec4 #ejc4 ,,gao /udy on ! privacy & security risks ( electronic transmission ( individually id5tifiable heal? in=mation to & f entities n cov]$ by ! ,heal? ,insurance ,portability & ,acc\ntability ,act4,sec4 #ejd4 ,te*nical corrections4,sec4 #eje4 ,public meet+4 ,i ,end+ surprise m$ical bills #aja4 ,protect+ pati5ts aga9/ out-(-network d$uctibles 9 em]g5cies ,section #bgai;,a7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ or a free/&+ em]g5cy room aft] hospital2 & 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7ii77,i71 by ins]t+ or free/&+ em]g5cy room aft] em]g5cy dep>tm5t2 & 7ii7 9 subp>agraph 7,c77ii77,,ii71 by add+1 a d$uctible1 aft] 7express$ z2 & 7#b7 9 p>agraph 7#b77;,b7-- 7,a7 9 clause 7i7-- 7i7 by ins]t+ or free/&+ em]g5cy room aft] hospital2 & 7ii7 by ins]t+ or free/&+ em]g5cy room aft] em]g5cy dep>tm5t2 & 7,b7 9 clause 7ii71 by ins]t+ or free/&+ em]g5cy room aft] hospital4 #ajb4 ,protection aga9/ surprise bills 7a7 ,,phsa ,section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is am5d$ by add+ at ! end ! foll[+3 7e7 ,out-(-network ancill>y s]vices 7#a7 ,cov]age ( s]vices ,subject to subsection 7h71 9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives out-(-network ancill>y s]vices at an 9-network facility1 includ+ any ref]rals = diagno/ic s]vices1 & su* s]vices w\ld be cov]$ "u su* plan or cov]age if provid$ 9-network-- 7,a7 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to su* s]vices %all be ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by an 9-network practition]1 & any co9surance or d$uctible %all be bas$ on 9-network rates2 & 7,b7 am\nts paid t[>d su* co/-%>+ %all be c\nt$ t[>ds ! 9-network d$uctible & 9-network out-(-pocket maximum am\nt1 z applicable1 "u ! plan or cov]age = ! plan ye>4 7#b7 ,notice be=e provid+ non-em]g5cy s]vices ,subject to subsection 7h71 9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives out-(-network1 non-em]g5cy s]vices t are n ancill>y s]vices1 f an out-(-network provid] at an 9-network facility1 & su* s]vices w\ld be cov]$ "u su* plan or cov]age if provid$ 9-network1 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to su* s]vices %all be ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by an 9-network practition]1 & any co9surance or d$uctible %all be bas$ on 9-network rates1 unless1 z soon z practicable1 & 9 no case lat] ?an #dh h\rs prior to provid+ non-em]g5cy s]vices t are n ancill>y s]vices-- 7,a7 ! 9-network facility provides to ! enrollee :o is s*$ul$ to receive su* s]vices notice t-- 7i7 is provid$ 9 pap] or electronic =m 7& includ+ electronic notification :5ev] practicable72 7ii7 /ates t su* s]vice w be provid$ out-(-network2 7iii7 includes ! e/imat$ am\nt t su* practition] or facility may *>ge ! enrollee = su* s]vices2 & 7iv7 provides ! option to affirmatively cons5t to receiv+ su* s]vices f su* practition] or facility2 7,b7 su* enrollee signs su* notice cons5t+ to receive su* s]vices f an out-(-network provid] at an 9-network facility1 & ackn[l$g+ t ! out-(-network s]vices may be cov]$ at an out-(-network co/-%>+ am\nt1 requir+ high] co/-%>+ obligations ( ! enrollee ?an if ! s]vice 7 provid$ by an 9-network practition] or facility2 & 7,c7 su* facility ma9ta9s docum5tation ( ! enrollee's signature or confirmation ( receipt ( su* in=mation "u subp>agraph 7,b7 9 ! enrollee's pati5t record = #b ye>s aft] ! date ( s]vices4 7#c7 ,def9ition ,= purposes ( ?is subsection1 ! t]m facility has ! mean+ giv5 ! t]m heal? c>e facility 9 section #bgbi;,a7c74 7f7 ,cov]age ( out-(-network s]vices = enrollees admitt$ aft] em]g5cy s]vices 7#a7 ,protection = enrollees admitt$ to ! hospital = em]g5cy s]vices prior to /abilization ,9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives em]g5cy s]vices1 or mat]nal c>e = a woman 9 labor1 9 ! em]g5cy dep>tm5t ( an out-(-network facility & has n be5 /abiliz$ 7)9 ! mean+ ( subsection 7b77#b77;,c771 if ! pati5t is subsequ5tly admitt$ to ! out-(-network facility = c>e1 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to any out-(-network s]vices provid$ to ! enrollee prior to be+ /able & 9 a condition to receive in=mation "u 7#b71 is ! same requirem5t t w\ld apply z "u subsection 7b77#b77;,c77ii77,,ii74 7#b7 ,notice & cons5t 7,a7 ,9 g5]al ,subject to subsection 7h71 9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives em]g5cy s]vices1 or mat]nal c>e = a woman 9 labor1 9 ! em]g5cy dep>tm5t ( an out-(-network facility & has be5 /abiliz$ 7)9 ! mean+ ( subsection 7b77#b77;,c771 if ! pati5t is subsequ5tly admitt$ to ! out-(-network facility = c>e1 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to any out-(-network s]vices is ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by an 9-network provid]1 unless ! enrollee1 once /able & 9 a condition to receive su* in=mation1 includ+ hav+ suffici5t m5tal capacity-- 7i7 has be5 provid$ by ! facility1 prior to ! provision ( any po/-/abilization1 out-(-network s]vice at su* facility1 )-- 7,i7 pap] or electronic notification t ! practition] or facility is an out-(-network heal? c>e provid] & ! out-(-network rate ( ! provid]1 z applicable1 & ! option to affirmatively cons5t to receiv+ s]vices f su* practition] or facility2 & 7,,ii7 ! e/imat$ am\nt t su* provid] may *>ge ! p>ticipant1 b5efici>y1 or enrollee = su* s]vices involv$2 7ii7 has be5 provid$ by ! plan or cov]age1 prior to ! provision ( any po/-/abilization1 out-(-network s]vice at su* facility1 )-- 7,i7 pap] or electronic notification 7& includ+ electronic notification :5ev] practicable7 t ! practition] or facility is an out-(-network heal? c>e provid]1 & ! option to affirmatively cons5t to receiv+ s]vices f su* practition] or facility2 7,,ii7 a li/ ( 9-network practition]s or facilities 9 ! relevant geographic area t c\ld provide ! same s]vices1 & an option = a ref]ral to su* provid]s2 & 7,,iii7 in=mation ab\t :e!r prior au?orization or o!r c>e managem5t limitations may be requir$ 9 advance ( receiv+ 9-network s]vices at ! facility2 7iii7 has ackn[l$g$1 9 writ+1 t ! out-(-network s]vices provid$ aft] ! individual has be5 /abiliz$ may n be cov]$ or may be cov]$ at an out-(-network co/-%>+ am\nt1 requir+ high] co/-%>+ obligations ( ! enrollee ?an if ! s]vice 7 provid$ at an 9-network facility4 7,b7 ,requirem5ts ( notice ,! notice "u subp>agraph 7,a7 %all be 9 a =mat det]m9$ by ! ,secret>y to give a reasonable layp]son cle> compreh5sion ( ! t]ms ( ! agreem5t1 includ+ all possible f9ancial responsibilities1 includ+ ! requirem5ts t ! notice-- 7i7 does n exce$ "o page 9 l5g?2 7ii7 is readily id5tifiable = its purpose & z a contract ( cons5t2 7iii7 cle>ly /ates t cons5t to pot5tial out-(-network *>ges is optional & t ! enrollee has ! *oice to transf] to an 9-network facility2 7iv7 includes an e/imate ( ! am\nt t su* provid] w *>ge ! p>ticipant1 b5efici>y1 or enrollee = su* s]vices involv$2 & 7v7 be available 9 ! #ae mo/ common languages 9 ! facility's geographic area1 ) ! facility mak+ a good fai? ef=t to provide oral notice 9 ! enrollee's prim>y language if x is n "o ( su* #ae languages4 7,c7 ,ma9t5ance ( records ,a facility %all ma9ta9 docum5tation ( notice giv5 to an enrollee pursuant to ?is subsection & ! enrollee's confirmation ( receipt ( su* in=mation 9 ! enrollee's pati5t record = #b ye>s aft] ! date ( s]vices4 7#c7 ,rulemak+ ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all issue regulations to c>ry out ?is subsection1 :i* %all include cl>ification on h[ to det]m9e :e!r an individual is /abiliz$ & ! tim+ ( ! notice requir$ "u ?is p>agraph4 7g7 ,prohibition on bill+ m ?an an 9-network rate "u c]ta9 circum/ances 7#a7 ,9 g5]al ,a facility or practition] furni%+-- 7,a7 em]g5cy s]vices1 z def9$ 9 subsection 7b77#b71 reg>dless ( ! ,/ate 9 :i* ! pati5t resides2 7,b7 out-(-network s]vices at an 9-network facility describ$ 9 subsection 7e77#a72 7,c7 out-(-network s]vices at an 9-network facility describ$ 9 subsection 7e77#b71 :]e ! notice & cons5t = receiv+ su* s]vices out-(-network did n meet ! requirem5t ( su* subsection2 7,d7 s]vices furni%$ by an out-(-network provid] aft] an enrollee has be5 admitt$ to ! hospital = em]g5cy s]vices b prior to /abilization1 z describ$ 9 subsection 7f77#a72 or 7,e7 out-(-network s]vices furni%$ aft] ! enrollee has be5 /abiliz$ 7)9 ! mean+ ( subsection 7b77#b77;,c771 :]e ! notice & option = receiv+ c>e at an alt]nate facility requir$ "u subsection 7f77#b7 h n be5 provid$ to ! enrollee & ! enrollee did n give cons5t "u subsection 7f77#c71 may n bill an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age = am\nts beyond ! co/-%>+ am\nt t w\ld apply "u subsection 7b77#a77;,c77ii77,,ii71 7e77#a71 7e77#b71 or 7f71 z applicable4 7#b7 ,notice ,a facility furni%+ s]vices describ$ 9 p>agraph 7#a7 %all provide enrollees 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age ) a "o-page notice1 9 #af-po9t font1 ^u intake at ! em]g5cy room or be+ admitt$ at ! facility ( ! prohibition on balance bill+ "u p>agraph 7#a7 & :o to contact = rec\rse if !y are s5t a balance bill 9 violation ( su* p>agraph4 ,! facility %all be responsible = obta9+ ! signature f ! enrollee on su* notice4 ,! ,secret>y %all issue regulations )9 #f mon?s ( ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act on ! requirem5ts = ! notice "u ?is p>agraph4 7h7 ,ma9ta9+ ,/ate surprise bill+ protections 7#a7 ,9 g5]al ,no?+ 9 ?is section %all prev5t a ,/ate f e/abli%+ or cont9u+ 9 effect1 ) respect to heal? insurance issu]s1 facilities1 or practition]s1 an alt]nate me?od "u ,/ate law = det]m9+ ! appropriate comp5sation = s]vices describ$ 9 subsection 7b71 7e71 or 7f74 7#b7 ,additional application ,9 ! case ( gr\p heal? plans or gr\p or individual heal? insurance cov]age (f]$ 9 a ,/ate t has n e/abli%$ an alt]nate me?od describ$ 9 p>agraph 7#a71 su* z arbitration or a b5*m>k1 or = s]vices describ$ 9 subsection 7b71 7e71 or 7f7 t are n cov]$ by su* ,/ate's alt]nate me?od describ$ 9 p>agraph 7#a71 ! provisions ( ?is section %all apply4 7#c7 ,self-insur$ plans ,subsections 7b71 7e71 & 7f7 %all apply to a self-insur$ gr\p heal? plan t is n subject to ,/ate insurance regulation4 7i7 ,def9itions ,9 ?is section3 7#a7 ,9-network ,! t]m 9-network1 ) respect to a gr\p heal? plan or heal? insurance cov]age means a provid] t has a contractual relation%ip ) ! plan4 7#b7 ,enrollee ,! t]m enrollee1 ) respect to heal? insurance cov]age or a gr\p heal? plan1 includes a p>ticipant1 dep5d5t1 or b5efici>y4 7#c7 ,ancill>y s]vices ,! t]m ancill>y s]vices means non-em]g5cy c>e t is-- 7,a7 provid$ by ane/hesiologi/s1 pa?ologi/s1 em]g5cy m$ic9e provid]s1 int5sivi/s1 radiologi/s1 neonatologi/s1 hospitali/s1 & assi/ant surgeons1 :e!r ! c>e is provid$ by a physician or non-physician practition]2 7,b7 a diagno/ic s]vice 7includ+ radiology & lab s]vices72 or 7,c7 provid$ by su* o!r specialty practition] n typically select$ by ! pati5ts receiv+ ! c>e1 :i* ! ,secret>y may add p]iodically to su* def9ition ?r\gh rulemak+4 4 7b7 ,en=cem5t ( balance bill+ prohibitions ,"p ,c ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgie4 ,en=cem5t ( balance bill+ prohibitions 7a7 ,9 g5]al ,subject to subsection 7b71 a facility or practition] t violates a requirem5t "u section #bgai;,a7g77#a7 or fails to provide notice or obta9 cons5t z requir$ "u subsection 7e77#b7 or 7f77#b7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7c7 ,safe h>bor 7#a7 ,9 g5]al ,! ,secret>y %all waive ! p5alties describ$ "u subsection 7a7 ) respect to a facility or1 practition] :o does n kn[+ly violate1 & %\ld n h reasonably kn[n x violat$1 section #bgai;,a7g77#a7 ) respect to an enrollee1 if su* facility or practition]1 )9 #cj days ( ! violation1 )draws ! bill t 0 9 violation ( section #bgai;,a7g77#a71 &1 z applicable1 reimburses ! gr\p heal? plan1 heal? insurance issu]1 or enrollee1 9 an am\nt equal to ! diff]5ce betwe5 ! am\nt bill$ & ! am\nt all[$ to be bill$ "u section #bgai;,a7g77#a71 plus int]e/1 at an int]e/ rate det]m9$ by ! ,secret>y4 7#b7 ,h>d%ip exemption ,! ,secret>y may e/abli% a h>d%ip exemption to ! p5alties "u ?is section4 7#c7 ,/ate en=cem5t ,! ,secret>y %all waive p5alties "u ?is section ) respect to a facility or practition] t has already be5 subject to en=cem5t action "u ,/ate law = a violation describ$ 9 subsection 7a74 4 7c7 ,application to gr&fa!r$ plans ,section #abea7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjaa7;a77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,application ( additional provisions ,subsections 7b7 ?r\gh 7h7 ( section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 %all apply to gr&fa!r$ heal? plans = plan ye>s beg9n+ ) ! second plan ye> t beg9s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act4 4 7d7 ,cov]age "u ,f$]al ,employees ,heal? ,b5efits ,program ,section #hijd ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7c7 ,any heal? b5efits plan (f]$ "u ?is *apt] %all be treat$ z a gr\p heal? plan or gr\p or individual heal? insurance cov]age = purposes ( subsections 7e7 ?r\gh 7g7 ( section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 7except = p>agraph 7#c7 ( su* subsection 7g774 4 #ajc4 ,b5*m>k = paym5t 7a7 ,9 g5]al ,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 ,b5*m>k = paym5t 7a7 ,e/abli%m5t ( b5*m>k ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all pay provid]s1 includ+ facilities & practition]s1 furni%+ s]vices = :i* su* facilities & practition]s are prohibit$ "u section #bgai;,a7g7 f bill+ enrollees = am\nts beyond ! co/-%>+ am\nt t w\ld apply "u subsection 7b77#a77;,c77ii77,,ii71 7e71 or 7f7 ( section #bgai;,a1! m$ian 9-network rate = su* s]vices provid$ to enrollees1 us+ a me?odology det]m9$ "u subsection 7b7 = ! same or simil> s]vices (f]$ by ! gr\p heal? plan or heal? insurance issu] 9 t geographic region4 ,su* paym5t %all be made 9 a timely fa%ion 9 ord] to ensure compliance ) sections #cii,v-#g & #bgbi;,d4 7b7 ,m$ian 9-network rate 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m m$ian 9-network rate means1 ) respect to heal? c>e s]vices cov]$ by a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! m$ian contract$ rate "u ! applicable plan or cov]age recogniz$ "u ! plan or cov]age z ! total maximum paym5t = ! s]vice m9us ! 9-network co/-%>+ = su* s]vice "u ! plan or cov]age1 = ! same or a simil> s]vice t is provid$ by a provid] 9 ! same or simil> specialty & 9 ! geographic region 9 :i* ! s]vice is furni%$4 7#b7 ,rulemak+ 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all1 ?r\gh rulemak+1 det]m9e ! me?odology a gr\p heal? plan or heal? insurance issu] is requir$ to use to det]m9e ! m$ian 9-network rate describ$ 9 p>agraph 7#a71 diff]5tiat+ by bus9ess l9e1 ! in=mation ! plan or issu] %all %>e ) ! out-(-network provid] involv$ :5 mak+ su* a det]m9ation1 & ! geographic regions appli$ = purposes ( ?is subsection4 ,su* rulemak+ %all take into acc\nt paym5ts t are made by heal? insurance issu]s t are n on a fee-=-s]vice basis4 7,b7 ,geographic regions ,9 e/abli%+ geographic regions "u subp>agraph 7,a71 ! ,secret>y %all consid] adequate access to s]vices 9 rural areas & heal? pr(essional %ortage areas1 z def9$ 9 section #ccb4 ,! ,secret>y %all consult ) ! ,national ,association ( ,insurance ,commission]s 9 e/abli%+ ! geographic regions4 ,! ,secret>y %all update ! geographic regions p]iodically1 z appropriate1 tak+ into acc\nt ! f9d+s ( ! report "u section #ajf ( ! ,l[] ,heal? ,c>e ,co/s ,act4 7#c7 ,c]ta9 insur]s ,if a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age does n h suffici5t in=mation to calculate a m$ian 9-network rate = ?is s]vice or provid] type1 or am\nt (1 claims = s]vices 7z det]m9$ by ! applicable ,/ate au?ority1 9 ! case ( heal? insurance cov]age1 or by ! ,secret>y ( ,labor1 9 ! case ( a self-insur$ gr\p heal? plan7 cov]$ "u ! li/ ( out-(-network s]vices set by ! ,/ate au?ority or ,secret>y ( ,labor1 z applicable1 9 a p>ticul> geographic area1 su* plan or issu] %all demon/rate t x w use a database free ( conflicts ( int]e/ t has suffici5t in=mation reflect+ all[$ am\nts paid to individual heal? c>e provid]s = relevant s]vices provid$ 9 ! applicable geographic region1 & t su* plan or issu] w use t database to det]m9e a m$ian 9-network rate4 ,! gr\p heal? plan or heal? insurance issu] %all cov] ! co/ ( access+ ! database4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all prev5t a gr\p heal? plan or heal? insurance issu] f e/abli%+ sep>ate calculations ( a m$ian 9-network rate "u p>agraph 7#a7 = s]vices deliv]$ 9 nonhospital facilities1 includ+ free/&+ em]g5cy rooms4 7c7 ,facility ,= purposes ( ?is section1 ! t]m heal? c>e facility or facility includes hospitals1 hospital outpati5t dep>tm5ts1 critical access hospitals1 ambulatory surg]y c5t]s1 laboratories1 radiology cl9ics1 free/&+ em]g5cy rooms1 & any o!r facility t provides s]vices t are cov]$ "u a gr\p heal? plan or heal? insurance cov]age1 includ+ sett+s ( c>e subject to section #bgai;,a7b74 4 7b7 ,non-,f$]al gov]nm5tal plans ,section #bgbb7;a77#b77;,e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ba7;a77#b77;,e77 is am5d$ by ins]t+ 1 except t su* election %all be available ) respect to section #bgbi;,a be=e ! p]iod4 #ajd4 ,effective date ,! am5dm5ts made by sections #aja1 #ajb1 & #ajc %all take effect beg9n+ 9 ! second plan ye> t beg9s aft] ! date ( enactm5t ( ?is ,act4 #aje4 ,end+ surprise air ambulance bills 7a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgai;,a 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 ! foll[+3 #bgai;,b4 ,end+ surprise air ambulance bills 7a7 ,9 g5]al ,9 ! case ( an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age :o receives air ambulance s]vices f an out-(-network provid]1 if su* s]vices w\ld be cov]$ if provid$ by an 9-network provid]-- 7#a7 ! co/-%>+ requirem5t 7express$ z a copaym5t am\nt1 co9surance rate1 or d$uctible7 ) respect to su* s]vices %all be ! same requirem5t t w\ld apply if su* s]vices 7 provid$ by an 9-network practition]1 & any co9surance or d$uctible %all be bas$ on 9-network rates2 & 7#b7 su* co/-%>+ am\nts %all be c\nt$ t[>ds ! 9-network d$uctible & 9-network out-(-pocket maximum am\nt "u ! plan or cov]age = ! plan ye>4 7b7 ,paym5t rate ,a gr\p heal? plan or heal? insurance issu] %all pay = air ambulance s]vices = purposes ( subsection 7a7 at ! m$ian 9-network z def9$ 9 subsection 7c74 7c7 ,m$ian 9-network rate 7#a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m m$ian 9-network rate means1 ) respect to air ambulance s]vices cov]$ by a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! m$ian contract$ rate "u ! applicable plan or cov]age recogniz$ "u ! plan or cov]age z ! total maximum paym5t = ! s]vice1 m9us ! 9-network co/-%>+ = su* s]vice "u ! plan or cov]age1 = ! same or a simil> s]vice t is provid$ by a provid] 9 ! same or simil> specialty1 & 9 ! geographic region 9 :i* ! s]vice is furni%$4 7#b7 ,rulemak+ 7,a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all1 ?r\gh rulemak+1 det]m9e ! me?odology a gr\p heal? plan or heal? insurance issu] is requir$ to use to det]m9e ! m$ian 9-network rate describ$ 9 p>agraph 7#a71 ! in=mation ! plan or issu] %all %>e ) ! out-(-network provid] involv$ :5 mak+ su* a det]m9ation1 & ! geographic regions appli$ = purposes ( ?is subsection4 ,su* rulemak+ %all take into acc\nt paym5ts t are made by issu]s t are n on a fee-=-s]vice basis4 7,b7 ,geographic regions ,9 e/abli%+ geographic regions z describ$ 9 subp>agraph 7,a71 ! ,secret>y %all consid] adequate access to s]vices 9 rural areas4 ,! ,secret>y %all consult ) ! ,national ,association ( ,insurance ,commission]s 9 e/abli%+ ! geographic regions4 ,! ,secret>y %all update ! geographic regions p]iodically1 z appropriate1 tak+ into acc\nt ! f9d+s ( ! report "u section #ajf ( ! ,l[] ,heal? ,c>e ,co/s ,act4 7#c7 ,c]ta9 insur]s ,if a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age does n h suffici5t in=mation to calculate a m$ian 9-network rate = ?is s]vice or provid] type1 or am\nt (1 claims = s]vices 7z det]m9$ by ! applicable ,/ate au?ority1 9 ! case ( heal? insurance cov]age1 or by ! ,secret>y ( ,labor1 9 ! case ( a self-insur$ gr\p heal? plan7 cov]$ "u ! li/ ( out-(-network s]vices set by ! ,/ate au?ority or ,secret>y ( ,labor1 z applicable1 9 a p>ticul> geographic area1 su* plan or issu] %all demon/rate t x w use a database free ( conflicts ( int]e/ t has suffici5t in=mation reflect+ all[$ am\nts paid to individual heal? c>e provid]s = relevant s]vices provid$ 9 ! applicable geographic region1 & t su* plan or issu] w use t database to det]m9e a m$ian 9-network rate4 ,! gr\p heal? plan or heal? insurance issu] %all cov] ! co/ ( access+ ! database4 7#d7 ,cl>ification ,= purposes ( ?is subsection1 ! ,secret>y may def9e geographic regions t are diff]5t f ! geographic regions id5tifi$ = purposes ( section #bgbi;,a7b7 to ensure t an adequate numb] ( air ambulance s]vices are 9-network 9 ea* geographic region s t a m$ian 9-network rate = air ambulance s]vices may be calculat$ = ea* su* region4 7d7 ,co/-%>+ limitation ,an air ambulance s]vice provid] may n bill an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age = am\nts beyond ! co/-%>+ am\nt t applies "u subsection 7a74 7e7 ,en=cem5t 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 an air ambulance s]vice provid] t violates subsection 7d7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7#b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#c7 ,safe h>bor ,! ,secret>y %all waive ! p5alties describ$ "u p>agraph 7#a7 ) respect to a air ambulance s]vice provid] :o unkn[+ly violates subsection 7d7 ) respect to an enrollee1 if su* air ambulance s]vice provid] )9 #cj days ( ! violation1 )draws ! bill t 0 9 violation ( subsection 7d71 &1 z applicable1 reimburses ! gr\p heal? plan1 heal? insurance issu]1 or enrollee1 z applicable1 9 an am\nt equal to ! am\nt bill$ 9 violation ( subsection 7d71 plus int]e/1 at an int]e/ rate det]m9$ by ! ,secret>y4 4 7b7 ,effective date ,section #bgai;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #ajf4 ,report ,n lat] ?an #a ye> aft] ! effective date describ$ 9 section #ajd1 & annually = ! foll[+ #d ye>s1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,f$]al ,trade ,commission & ! ,attorney ,g5]al1 %all-- 7#a7 conduct a /udy on-- 7,a7 ! effects ( ! am5dm5ts made by sections #aja1 #ajb1 #ajc1 & #aje1 includ+ any patt]ns ( v]tical or horizontal integration ( heal? c>e facilities1 provid]s1 gr\p heal? plans1 or heal? insurance issu]s2 7,b7 ! effects ( ! am5dm5ts made by sections #aja1 #ajb1 #ajc1 & #aje on ov]all heal? c>e co/s2 7,c7 ! effects ( ! am5dm5ts made by sections #aja1 #ajb1 #ajc1 & #aje on access to s]vices1 includ+ specialty s]vices1 9 rural areas & heal? pr(essional %ortage areas z def9$ 9 section #ccb2 & 7,d7 recomm5dations1 made 9 consultation ) ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 = effective en=cem5t ( #bgbi;,a ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #ajc1 includ+ pot5tial *all5ges to address+ anti-competitive consolidation by heal? c>e facilities1 provid]s1 gr\p heal? plans1 or heal? insurance issu]s2 & 7#b7 submit a report on su* /udy to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation1 ! ,committee on ,f9ance1 & ! ,committee on ! ,judici>y ( ! ,s5ate & ! ,committee on ,education & ,labor1 ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,ways & ,means1 & ! ,committee on ! ,judici>y ( ! ,h\se ( ,repres5tatives4 ,,ii ,r$uc+ ! prices ( prescription drugs #bja4 ,biological product pat5t transp>5cy 7a7 ,9 g5]al ,section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is am5d$ by add+ at ! end ! foll[+3 7o7 ,additional requirem5ts ) respect to pat5ts 7#a7 ,approv$ application hold] li/+ requirem5ts 7,a7 ,9 g5]al ,beg9n+ on ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 )9 #fj days ( approval ( an application "u subsection 7a7 or 7k71 ! hold] ( su* approv$ application %all submit to ! ,secret>y a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7,b7 ,previ\sly approv$ or lic5s$ biological products 7i7 ,products lic5s$ "u section #cea ( ! ,,phsa ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! hold] ( a biological product lic5se t 0 approv$ "u subsection 7a7 or 7k7 be=e ! date ( enactm5t ( su* ,act %all submit to ! ,secret>y a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7ii7 ,products approv$ "u section #eje ( ! ,,ffdca ,n lat] ?an #cj days aft] ,m>* #bc1 #bjbj1 ! hold] ( an approv$ application = a biological product "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act t is deem$ to be a lic5se = ! biological product "u ?is section on ,m>* #bc1 #bjbj1 %all submit to ! ,secret>y a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7,c7 ,updates ,! hold] ( a biological product lic5se t is ! subject ( an application "u subsection 7a7 or 7k7 %all submit to ! ,secret>y a li/ t includes-- 7i7 any pat5t n previ\sly requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c77 "u subp>agraph 7,a7 or 7,b71 z applicable1 )9 #cj days ( ! e>li] (-- 7,i7 ! date ( issuance ( su* pat5t by ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice2 or 7,,ii7 ! date ( approval ( a supplem5tal application = ! biological product2 & 7ii7 any pat5t1 or any claim ) respect to a pat5t1 includ$ on ! li/ pursuant to ?is p>agraph1 t ! ,pat5t ,trial & ,appeal ,bo>d ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice det]m9es 9 a writt5 decision to cancel z unpat5table1 )9 #cj days ( su* decision4 7#b7 ,publication ( in=mation 7,a7 ,9 g5]al ,)9 #a ye> ( ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all publi% & make available to ! public a s+le1 easily se>*able li/ t includes-- 7i7 ! (ficial & propriet>y "n ( ea* biological product lic5s$1 or deem$ to be lic5s$1 "u subsection 7a7 or 7k72 7ii7 ) respect to ea* biological product describ$ 9 clause 7i71 ea* pat5t submitt$ 9 accordance ) p>agraph 7#a72 7iii7 ! date ( lic5sure & application numb] = ea* su* biological product2 7iv7 ! m>ket+ /atus1 dosage =m1 r\te ( adm9i/ration1 /r5g?1 &1 if applicable1 ref]5ce product1 = ea* su* biological product2 7v7 ! lic5sure /atus = ea* su* biological product1 includ+ :e!r ! lic5se at ! "t ( li/+ is approv$1 )drawn1 or revok$2 7vi7 ) respect to ea* su* biological product1 any p]iod ( exclusivity "u p>agraph 7#f71 7#g77;,a71 or 7#g77;,b7 ( subsection 7k7 ( ?is section or section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & any ext5sion ( su* p]iod 9 accordance ) subsection 7m7 ( ?is section1 = :i* ! ,secret>y has det]m9$ su* biological product to be eligible1 & ! date on :i* su* exclusivity expires2 7vii7 any det]m9ation ( biosimil>ity or int]*angeability = ea* su* biological product2 & 7viii7 in=mation reg>d+ approv$ indications = ea* su* biological product1 9 su* mann] z ! ,secret>y det]m9es appropriate4 7,b7 ,updates ,e #cj days aft] ! publication ( ! fir/ li/ "u subp>agraph 7,a71 ! ,secret>y %all revise ! li/ to include-- 7i7 7,i7 ea* biological product lic5s$ "u subsection 7a7 or 7k7 dur+ ! #cj-;day p]iod2 & 7,,ii7 ) respect to ea* biological product describ$ 9 subclause 7,i71 ! in=mation describ$ 9 clauses 7i7 ?r\gh 7viii7 ( subp>agraph 7,a72 & 7ii7 any updates to in=mation previ\sly publi%$ 9 accordance ) subp>agraph 7,a74 7,c7 ,noncompliance ,beg9n+ #ah mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y1 9 consultation ) ! ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice1 %all publi% & make available to ! public a li/ ( any hold]s ( biological product lic5ses1 & ! correspond+ biological product or products1 t fail$ to submit in=mation z requir$ "u p>agraph 7#a71 includ+ any updates requir$ "u p>agraph 7#a77;,c71 9 su* mann] & =mat z ! ,secret>y det]m9es appropriate4 ,if in=mation requir$ "u p>agraph 7#a7 is submitt$ foll[+ publication ( su* li/1 ! ,secret>y %all remove su* hold]s ( su* biological product lic5ses f ! public li/ 9 a reasonable p]iod ( "t4 7#c7 ,pat5ts requir$ to be disclos$ ,9 ?is section1 a pat5t requir$ to be disclos$ is any pat5t = :i* ! hold] ( a biological product lic5se approv$ "u subsection 7a7 or 7k71 or a biological product application approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & deem$ to be a lic5se = a biological product "u ?is section on ,m>* #bc1 #bjbj1 believes a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ by ! hold]1 or by a pat5t own] t has grant$ an exclusive lic5se to ! hold] ) respect to ! biological product t is ! subject ( su* lic5se1 if a p]son n lic5s$ by ! own] engag$ 9 ! mak+1 us+1 (f]+ to sell1 sell+1 or import+ into ! ,unit$ ,/ates ( ! biological product t is ! subject ( su* lic5se4 4 7b7 ,disclosure ( pat5ts ,section #cea7l77#c77;,a77i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is am5d$ by ins]t+ includ$ 9 ! li/ provid$ by ! ref]5ce product sponsor "u subsection 7o77#a7 aft] a li/ ( pat5ts4 7c7 ,review & ,report on ,noncompliance ,n lat] ?an #cj mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all-- 7#a7 solicit public comm5ts reg>d+ appropriate rem$ies1 9 addition to ! publication ( ! li/ "u subsection 7o77#b77;,c7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z add$ by subsection 7a71 ) respect to hold]s ( biological product lic5ses :o fail to timely submit in=mation z requir$ "u subsection 7o77#a7 ( su* section #cea1 includ+ any updates requir$ "u subp>agraph 7,c7 ( su* subsection 7o77#a72 & 7#b7 submit to ,congress an evaluation ( comm5ts receiv$ "u p>agraph 7#a7 & ! recomm5dations ( ! ,secret>y conc]n+ appropriate rem$ies4 7d7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices may promulgate regulations to c>ry out subsection 7o7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z add$ by subsection 7a74 7e7 ,rule ( con/ruction ,no?+ 9 ?is ,act1 includ+ an am5dm5t made by ?is ,act1 %all be con/ru$ to require or all[ ! ,secret>y ( ,heal? & ,human ,s]vices to delay ! lic5s+ ( a biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 #bjb4 ,orange ,book mod]nization 7a7 ,submission ( pat5t in=mation = br& "n drugs 7#a7 ,9 g5]al ,p>agraph 7#a7 ( section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is am5d$ to read z foll[s3 7b7 7#a7 7,a7 ,any p]son may file ) ! ,secret>y an application ) respect to any drug subject to ! provisions ( subsection 7a74 ,su* p]sons %all submit to ! ,secret>y z "p ( ! application-- 7i7 full reports ( inve/igations :i* h be5 made to %[ :e!r or n su* drug is safe = use & :e!r su* drug is effective 9 use2 7ii7 a full li/ ( ! articles us$ z compon5ts ( su* drug2 7iii7 a full /atem5t ( ! composition ( su* drug2 7iv7 a full description ( ! me?ods us$ 91 & ! facilities & controls us$ =1 ! manufacture1 process+1 & pack+ ( su* drug2 7v7 su* samples ( su* drug & ( ! articles us$ z compon5ts !re( z ! ,secret>y may require2 7vi7 specim5s ( ! label+ propos$ to be us$ = su* drug2 7vii7 any assessm5ts requir$ "u section #eje;,b2 & 7viii7 ! pat5t numb] & expiration date1 ( ea* pat5t = :i* a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ if a p]son n lic5s$ by ! own] engag$ 9 ! manufacture1 use1 or sale ( ! drug1 & t-- 7,i7 claims ! drug = :i* ! applicant submitt$ ! application & is a drug sub/ance pat5t or a drug product pat5t2 or 7,,ii7 claims ! me?od ( us+ ! drug = :i* approval is s\ght or has be5 grant$ 9 ! application4 7,b7 ,if an application is fil$ "u ?is subsection = a drug1 & a pat5t ( ! type describ$ 9 subp>agraph 7,a77viii7 t claims su* drug or a me?od ( us+ su* drug is issu$ aft] ! fil+ date1 ! applicant %all am5d ! application to include su* pat5t in=mation4 4 7#b7 ,guidance ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal? & ) repres5tatives ( ! drug manufactur+ indu/ry1 review & develop guidance1 z appropriate1 on ! inclusion ( wom5 & m9orities 9 cl9ical trials requir$ "u subsection 7b77#a77;,a77i7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 z am5d$ by p>agraph 7#a74 7b7 ,con=m+ *anges to requirem5ts = subsequ5t submission ( pat5t in=mation ,section #eje7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#b77 is am5d$-- 7#a7 by ins]t+ be=e ! fir/ s5t5ce ! foll[+3 ,n lat] ?an #cj days aft] ! date ( approval ( an application "u subsection 7b71 ! hold] ( ! approv$ application %all file ) ! ,secret>y ! pat5t numb] & ! expiration date ( any pat5t describ$ 9 subclause 7,i7 or 7,,ii7 ( subsection 7b77#a77;,a77viii71 except t a pat5t t is id5tifi$ z claim+ a me?od ( us+ su* drug %all be fil$ only if ! pat5t claims a me?od ( use approv$ 9 ! application4 ,! hold] ( ! approv$ application %all file ) ! ,secret>y ! pat5t numb] & ! expiration date ( any pat5t describ$ 9 subclause 7,i7 or 7,,ii7 ( subsection 7b77#a77;,a77viii7 t is issu$ aft] ! date ( approval ( ! application1 n lat] ?an #cj days aft] ! date ( issuance ( ! pat5t1 except t a pat5t t claims a me?od ( us+ su* drug %all be fil$ only if approval = su* use has be5 grant$ 9 ! application42 7#b7 by ins]t+ aft] ! pat5t numb] & ! expiration date ( any pat5t :i* ! foll[+3 fulfills ! crit]ia 9 subsection 7b7 &2 7#c7 by ins]t+ aft] ! ?ird s5t5ce 7z am5d$ by p>agraph 7#a77 ! foll[+3 ,pat5t in=mation t is n ! type ( pat5t in=mation requir$ by subsection 7b77#a77;,a77viii7 %all n be submitt$ "u ?is p>agraph42 & 7#d7 by ins]t+ aft] c\ld n file pat5t in=mation "u subsection 7b7 because no pat5t ! foll[+3 ( ! type requir$ to be submitt$ 9 subsection 7b77#a77;,a77viii74 7c7 ,li/+ ( exclusivities ,subp>agraph 7,a7 ( section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7iv7 ,= ea* drug includ$ on ! li/1 ! ,secret>y %all specify any exclusivity p]iod t is applicable1 = :i* ! ,secret>y has det]m9$ ! expiration date1 & = :i* su* p]iod has n yet expir$ "u-- 7,i7 clause 7ii71 7iii71 or 7iv7 ( subsection 7c77#c77;,e7 ( ?is section2 7,,ii7 clause 7iv7 or 7v7 ( p>agraph 7#e77;,b7 ( ?is subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 ( p>agraph 7#e77;,f7 ( ?is subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 7,,vi7 section #ebg7;a72 or 7,,vii7 subsection 7u7 4 7d7 ,orange book updates ) respect to invalidat$ pat5ts 7#a7 ,9 g5]al 7,a7 ,am5dm5ts ,section #eje7;j77#g77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a771 z am5d$ by subsection 7c71 is fur!r am5d$ by add+ at ! end ! foll[+3 7v7 ,9 ! case ( a li/$ drug = :i* ! li/ "u clause 7i7 includes a pat5t = su* drug1 & :]e ! ,"u ,secret>y ( ,comm]ce = ,intellectual ,prop]ty & ,director ( ! ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice h cancell$ any claim ( ! pat5t pursuant to a decision by ! ,pat5t ,trial & ,appeal ,bo>d 9 an int] p>tes review conduct$ "u *apt] #ca ( title #ce1 ,unit$ ,/ates ,code1 or a po/-grant review conduct$ "u *apt] #cb ( t title1 & f :i* no appeal has be5 tak51 or c be tak51 ! hold] ( ! applicable approv$ application %all notify ! ,secret>y1 9 writ+1 )9 #ad days ( su* cancellation1 &1 if ! pat5t has be5 deem$ :olly inop]ative or invalid1 or if a pat5t claim has be5 cancell$1 ! revisions requir$ "u clause 7iii7 %all include /rik+ ! pat5t or in=mation reg>d+ su* pat5t claim f ! li/ ) respect to su* drug1 z applicable1 except t ! ,secret>y %all n remove a pat5t f ! li/ be=e ! expiration ( any #ahj-;day exclusivity p]iod "u p>agraph 7#e77;,b77iv7 t relies on a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 ) respect to su* pat5t4 4 7,b7 ,application ,! am5dm5t made by subp>agraph 7,a7 %all n apply ) respect to any det]m9ation ) respect to a pat5t or pat5t claim t is made prior to ! date ( enactm5t ( ?is ,act4 7#b7 ,no effect on fir/ applicant exclusivity p]iod ,section #eje7;j77#e77;,b77iv77,i71 z am5d$ by section #bje1 is am5d$ by add+ at ! end ! foll[+3 ,?is subclause %all apply ev5 if a pat5t is /rick5 f ! li/ "u p>agraph 7#g77;,a71 pursuant to p>agraph 7#g77;,a77v71 provid$ t1 at ! "t t ! fir/ applicant submitt$ an application "u ?is subsection conta9+ a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv71 ! pat5t t 0 ! subject ( su* c]tification 0 includ$ 9 su* li/ ) respect to ! li/$ drug44 #bjc4 ,ensur+ timely access to g5]ics ,section #eje7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a77i71 by ins]t+ 1 #aj4ca1 aft] #aj4cj2 7,b7 9 subp>agraph 7,e7-- 7i7 by /rik+ application & & ins]t+ application or2 7ii7 by /rik+ ,if ! ,secret>y & ins]t+ ! foll[+3 7i7 ,9 g5]al ,if ! ,secret>y 2 & 7iii7 by /rik+ ! second s5t5ce & ins]t+ ! foll[+3 7ii7 ,prim>y purpose ( delay+ 7,i7 ,9 g5]al ,9 det]m9+ :e!r a petition 0 submitt$ ) ! prim>y purpose ( delay+ an application1 ! ,secret>y may consid] ! foll[+ factors3 7aa7 ,:e!r ! petition 0 submitt$ 9 accordance ) p>agraph 7#b77;,b71 bas$ on :5 ! petition] knew or reasonably %\ld h kn[n ! relevant in=mation reli$ ^u to =m ! basis ( su* petition4 7bb7 ,:e!r ! petition] has submitt$ multiple or s]ial petitions or supplem5ts to petitions rais+ issues t reasonably c\ld h be5 kn[n to ! petition] at ! "t ( submission ( ! e>li] petition or petitions4 7cc7 ,:e!r ! petition 0 submitt$ close 9 "t to a kn[n1 fir/ date ^u :i* an application "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act c\ld be approv$4 7dd7 ,:e!r ! petition 0 submitt$ )\t relevant data or in=mation 9 support ( ! sci5tific positions =m+ ! basis ( su* petition4 7ee7 ,:e!r ! petition raises ! same or sub/antially simil> issues z a prior petition to :i* ! ,secret>y has respond$ sub/antively already1 includ+ if ! subsequ5t submission foll[s su* response f ! ,secret>y closely 9 "t4 7ff7 ,:e!r ! petition reque/s *ang+ ! applicable /&>ds t o!r applicants are requir$ to meet1 includ+ reque/+ te/+1 data1 or label+ /&>ds t are m on]\s or rigor\s ?an ! /&>ds ! ,secret>y has det]m9$ to be applicable to ! li/$ drug1 ref]5ce product1 or petition]'s v]sion ( ! same drug4 7gg7 ,! petition]'s record ( submitt+ petitions to ! ,food & ,drug ,adm9i/ration t h be5 det]m9$ by ! ,secret>y to h be5 submitt$ ) ! prim>y purpose ( delay4 7hh7 ,o!r relevant & appropriate factors1 :i* ! ,secret>y %all describe 9 guidance4 7,,ii7 ,guidance ,! ,secret>y may issue or update guidance1 z appropriate1 to describe factors ! ,secret>y consid]s 9 accordance ) subclause 7,,ii74 2 7,c7 by add+ at ! end ! foll[+3 7iii7 ,ref]ral to ! ,f$]al ,trade ,commission ,! ,secret>y %all e/abli% proc$ures = ref]r+ to ! ,f$]al ,trade ,commission any petition or supplem5t to a petition t ! ,secret>y det]m9es 0 submitt$ ) ! prim>y purpose ( delay+ approval ( an application4 ,su* proc$ures %all include notification to ! petition] by ! ,secret>y4 2 7,d7 by /rik+ subp>agraph 7,f72 7,e7 by r$esignat+ subp>agraphs 7,g7 ?r\gh 7,i7 z subp>agraphs 7,f7 ?r\gh 7,h71 respectively2 & 7,f7 9 subp>agraph 7,h71 z s r$esignat$1 by /rik+ submission ( ?is petition & ins]t+ submission ( ?is docum5t2 7#b7 9 p>agraph 7#b7-- 7,a7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,c7 z subp>agraphs 7,c7 ?r\gh 7,e71 respectively2 7,b7 by ins]t+ be=e subp>agraph 7,c71 z s r$esignat$1 ! foll[+3 7,a7 ,9 g5]al ,a p]son %all submit a petition to ! ,secret>y "u p>agraph 7#a7 be=e fil+ a civil action 9 :i* ! p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act4 ,su* petition & any supplem5t to su* a petition %all describe all in=mation & argum5ts t =m ! basis ( ! relief reque/$ 9 any civil action describ$ 9 ! previ\s s5t5ce4 7,b7 ,timely submission ( citiz5 petition ,a petition & any supplem5t to a petition %all be submitt$ )9 #fj days aft] ! p]son knew1 or reasonably %\ld h kn[n1 ! in=mation t =ms ! basis ( ! reque/ made 9 ! petition or supplem5t4 2 7,c7 9 subp>agraph 7,c71 z s r$esignat$-- 7i7 9 ! head+1 by /rik+ )9 #aej days2 7ii7 9 clause 7i71 by /rik+ dur+ ! #aej-;day p]iod ref]r$ to 9 p>agraph 7#a77;,f712 & 7iii7 by am5d+ clause 7ii7 to read z foll[s3 7ii7 on or aft] ! date t is #aea days aft] ! date ( submission ( ! petition1 ! ,secret>y approves or has approv$ ! application t is ! subject ( ! petition )\t hav+ made su* a f9al decision4 2 7,d7 by am5d+ subp>agraph 7,d71 z s r$esignat$1 to read z foll[s3 7,d7 ,dismissal ( c]ta9 civil actions 7i7 ,petition ,if a p]son files a civil action aga9/ ! ,secret>y 9 :i* a p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act )\t comply+ ) ! requirem5ts ( subp>agraph 7,a71 ! c\rt %all dismiss )\t prejudice ! action = failure to exhau/ adm9i/rative rem$ies4 7ii7 ,timel9ess ,if a p]son files a civil action aga9/ ! ,secret>y 9 :i* a p]son seeks to set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act )\t comply+ ) ! requirem5ts ( subp>agraph 7,b71 ! c\rt %all dismiss ) prejudice ! action = failure to timely file a petition4 7iii7 ,f9al response ,if a civil action is fil$ aga9/ ! ,secret>y ) respect to any issue rais$ 9 a petition timely fil$ "u p>agraph 7#a7 9 :i* ! petition] reque/s t ! ,secret>y take any =m ( action t c\ld1 if tak51 set aside1 delay1 resc9d1 )draw1 or prev5t submission1 review1 or approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( ?is section or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act be=e ! ,secret>y has tak5 f9al ag5cy action on ! petition )9 ! mean+ ( subp>agraph 7,c71 ! c\rt %all dismiss )\t prejudice ! action = failure to exhau/ adm9i/rative rem$ies4 2 & 7,e7 9 clause 7iii7 ( subp>agraph 7,e71 z s r$esignat$1 by /rik+ z def9$ "u subp>agraph 7#b77;,a7 & ins]t+ )9 ! mean+ ( subp>agraph 7,c72 & 7#c7 9 p>agraph 7#d7-- 7,a7 by /rik+ ,exceptions & all t foll[s ?r\gh ,?is subsection does & ins]t+ ,exceptions4--,?is subsection does2 7,b7 by /rik+ subp>agraph 7,b72 & 7,c7 by r$esignat+ clauses 7i7 & 7ii7 z subp>agraphs 7,a7 & 7,b71 respectively1 & adju/+ ! m>g9s accord+ly4 #bjd4 ,protect+ access to biological products ,section #cea7k77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is am5d$ by add+ at ! end ! foll[+3 7,d7 ,deem$ lic5ses 7i7 ,no additional exclusivity ?r\gh deem+ ,an approv$ application t is deem$ to be a lic5se = a biological product "u ?is section pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji %all n be treat$ z hav+ be5 fir/ lic5s$ "u subsection 7a7 = purposes ( subp>agraphs 7,a7 & 7,b74 7ii7 ,application ( limitations on exclusivity ,subp>agraph 7,c7 %all apply ) respect to a ref]5ce product ref]r$ to 9 su* subp>agraph t 0 ! subject ( an approv$ application t 0 deem$ to be a lic5se pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji4 7iii7 ,applicability ,! exclusivity p]iods describ$ 9 section #ebg1 section #eje;,a7b77#a77;,a77ii71 & section #eje;,a7c77#a77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act %all cont9ue to apply to a biological product aft] an approv$ application = ! biological product is deem$ to be a lic5se = ! biological product "u subsection 7a7 pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji4 4 #bje4 ,prev5t+ block+ ( g5]ic drugs 7a7 ,9 g5]al ,section #eje7;j77#e77;,b77iv77,i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77,i77 is am5d$-- 7#a7 by /rik+ #ahj days aft] ! date & ins]t+ 8#ahj days aft] ! e>li] ( ! foll[+3 7aa7 ,! date 2 & 7#b7 by add+ at ! end ! foll[+3 7bb7 ,! date on :i* all ( ! foll[+ conditions are fir/ met1 provid$ no application submitt$ by any fir/ applicant is approv$ on or be=e su* date3 7,,aa7 ,an application = ! drug submitt$ by an applicant o!r ?an a fir/ applicant has receiv$ t5tative approval & c\ld receive approval1 if no fir/ applicant 7 eligible = #ahj-;day exclusivity "u ?is clause1 & su* applicant has n ent]$ into an agreem5t t w\ld prev5t comm]cial m>ket+ ^u approval & has submitt$ a notification to ! ,secret>y docum5t+ t x has n ent]$ into an agreem5t t w\ld prev5t comm]cial m>ket+4 7,,bb7 ,?irty-?ree mon?s h pass$ s9ce ! date ( submission ( an application = ! drug by "o fir/ applicant1 if !re is only "o fir/ applicant1 or1 9 ! case ( m ?an "o fir/ applicant1 #cc mon?s h pass$ s9ce ! date ( submission ( all su* applications4 7,,cc7 ,approval ( an application = ! drug submitt$ by at lea/ "o fir/ applicant w\ld n be preclud$ "u clause 7iii74 4 7b7 ,in=mation ,n lat] ?an #fj days ( ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all publi%1 z appropriate & available1 in=mation suffici5t to all[ applicants to assess :e!r ! conditions describ$ 9 subitems 7,,aa7 ?r\gh 7,,cc7 ( section #eje7;j77#e77;,b77iv77,i77bb7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z am5d$ by subsection 7a77 h be5 or w be satisfi$ = all applications :]e ! exclusivity p]iod "u 7iv77,i7 ( section #eje7;j77#e77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z s am5d$7 has n expir$1 & %all provide updates to reflect ! mo/ rec5t in=mation available to ! ,secret>y4 #bjf4 ,education on biological products ,subp>t #a ( "p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$ by add+ at ! end ! foll[+3 #ceb;,a4 ,education on biological products 7a7 ,int]net website 7#a7 ,9 g5]al ,! ,secret>y may ma9ta9 & op]ate an int]net website to provide educational mat]ials = heal? c>e provid]s1 pati5ts1 & c>egiv]s1 reg>d+ ! mean+ ( ! t]ms1 & ! /&>ds = review & lic5s+ (1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 7#b7 ,cont5t ,educational mat]ials provid$ "u p>agraph 7#a7 may include-- 7,a7 explanations ( key /atutory & regulatory t]ms1 includ+ biosimil> & int]*angeable1 & cl>ification reg>d+ ! use ( int]*angeable biosimil> biological products2 7,b7 in=mation relat$ to developm5t programs = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products & relevant cl9ical consid]ations = prescrib]s1 :i* may include1 z appropriate & applicable1 in=mation relat$ to ! comp>ability ( su* biological products2 7,c7 an explanation ( ! process = report+ adv]se ev5ts = biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products2 & 7,d7 an explanation ( ! relation%ip betwe5 biosimil> biological products & int]*angeable biosimil> biological products lic5s$ "u section #cea7k7 & ref]5ce products 7z def9$ 9 section #cea7;i771 includ+ ! /&>ds = review & lic5s+ ( ea* su* type ( biological product4 7#c7 ,=mat ,! educational mat]ials provid$ "u p>agraph 7#a7 may be-- 7,a7 9 =mats su* z web9>s1 cont9u+ m$ical education modules1 videos1 fact %eets1 infographics1 /akehold] toolkits1 or o!r =mats z appropriate & applicable2 & 7,b7 tailor$ = ! unique ne$s ( heal? c>e provid]s1 pati5ts1 c>egiv]s1 & o!r audi5ces1 z ! ,secret>y det]m9es appropriate4 7#d7 ,o!r in=mation ,9 addition to ! in=mation describ$ 9 p>agraph 7#b71 ! ,secret>y %all cont9ue to publi% ! foll[+ in=mation3 7,a7 ,! action package ( ea* biological product lic5s$ "u subsection 7a7 or 7k74 7,b7 ,! summ>y review ( ea* biological product lic5s$ "u subsection 7a7 or 7k74 7#e7 ,confid5tial & trade secret in=mation ,?is subsection does n au?orize ! disclosure ( any trade secret1 confid5tial comm]cial or f9ancial in=mation1 or o!r matt] describ$ 9 section #eeb7;b7 ( title #e4 7b7 ,cont9u+ education ,! ,secret>y %all advance education & aw>5ess among heal? c>e provid]s reg>d+ biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products1 z appropriate1 includ+ by develop+ or improv+ cont9u+ m$ical education programs t advance ! education ( su* provid]s on ! prescrib+ (1 & relevant cl9ical consid]ations ) respect to1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 4 #bjg4 ,biological product innovation ,section #cea7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;j77 is am5d$-- 7#a7 by /rik+ except t a product & ins]t+ 8except t-- 7#a7 a product 2 7#b7 by /rik+ ,act4 & ins]t+ ,act2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#b7 no requirem5t "u su* ,act reg>d+ an (ficial comp5dium 7z def9$ 9 section #bja7;j7 ( su* ,act71 or o!r ref]5ce 9 su* ,act to an (ficial comp5dium 7z s def9$71 %all apply ) respect to a biological product subject to regulation "u ?is section4 4 #bjh4 ,cl>ify+ ! mean+ ( new *emical entity 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$-- 7#a7 9 section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 9 subsection 7c77#c77;,e71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 ea* place x appe>s & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,b7 9 subsection 7j77#e77;,f71 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 ea* place x appe>s & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7,c7 9 subsection 7l77#b77;,a7-- 7i7 by am5d+ clause 7i7 to read z foll[s3 7i7 n lat] ?an #cj days aft] ! date ( approval ( su* applications-- 7,i7 = a drug1 no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 ( :i* has be5 approv$ 9 any o!r application "u ?is section2 or 7,,ii7 = a biological product1 no active +r$i5t ( :i* has be5 approv$ 9 any o!r application "u section #cea ( ! ,public ,heal? ,s]vice ,act2 & 2 & 7ii7 9 clause 7ii71 by ins]t+ or biological product be=e ! p]iod2 7,d7 by am5d+ subsection 7s7 to read z foll[s3 7s7 ,ref]ral to advisory committee ,! ,secret>y %all-- 7#a7 ref] a drug or biological product to a ,food & ,drug ,adm9i/ration advisory committee = review at a meet+ ( su* advisory committee prior to ! approval ( su* drug or biological if x is-- 7,a7 a drug1 no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 ( :i* has be5 approv$ 9 any o!r application "u ?is section2 or 7,b7 a biological product1 no active +r$i5t ( :i* has be5 approv$ 9 any o!r application "u section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7#b7 if ! ,secret>y does n ref] a drug or biological product describ$ 9 p>agraph 7#a7 to a ,food & ,drug ,adm9i/ration advisory committee prior to su* approval1 provide 9 ! action lett] on ! application = ! drug or biological product a summ>y ( ! reasons :y ! ,secret>y did n ref] ! drug or biological product to an advisory committee prior to approval4 2 & 7,e7 9 subsection 7u77#a71 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 & 7ii7 by /rik+ same active +r$i5t & ins]t+ same active moiety2 7#b7 9 section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f771 by /rik+ active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 ea* place x appe>s & ins]t+ active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations772 7#c7 9 section #ebd7;a77#d7 7#ba ,u4,s4,c4 #cfjn7a77#d771 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 is =-- 7i7 a human drug1 no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 ( :i* has be5 approv$ 9 any o!r application "u section #eje7;b77#a72 or 7ii7 a biological product1 no active +r$i5t ( :i* has be5 approv$ 9 any o!r application "u section #cea ( ! ,public ,heal? ,s]vice ,act4 2 7#d7 9 section #ebi7;a77#d7 7#ba ,u4,s4,c4 #ba ,u4,s4,c4 #cfj;ff7a77#d771 by /rik+ subp>agraphs 7,a7 & 7,b7 & ins]t+ ! foll[+3 7,a7 is = a drug or biological product t is = ! prev5tion or treatm5t ( a r>e p$iatric disease2 7,b7 7i7 is = su* a drug-- 7,i7 t conta9s no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 t has be5 previ\sly approv$ 9 any o!r application "u subsection 7b77#a71 7b77#b71 or 7j7 ( section #eje2 & 7,,ii7 t is ! subject ( an application submitt$ "u section #eje7;b77#a72 or 7ii7 or is = su* a biological product-- 7,i7 t conta9s no active +r$i5t t has be5 previ\sly approv$ 9 any o!r application "u section #cea7;a7 or #cea7k7 ( ! ,public ,heal? ,s]vice ,act2 & 7,,ii7 t is ! subject ( an application submitt$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 2 & 7#e7 9 section #efe;,a7a77#d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d771 by am5d+ subp>agraph 7,d7 to read z foll[s3 7,d7 is =-- 7i7 a human drug1 no active moiety 7z def9$ by ! ,secret>y 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations77 ( :i* has be5 approv$ 9 any o!r application "u section #eje7;b77#a72 or 7ii7 a biological product1 no active +r$i5t ( :i* has be5 approv$ 9 any o!r application "u section #cea ( ! ,public ,heal? ,s]vice ,act4 4 7b7 ,te*nical corrections ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq7 is am5d$-- 7#a7 9 section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 9 subsection 7c77#c77;,e71 by repeal+ clause 7i72 & 7,b7 9 subsection 7j77#e77;,f71 by repeal+ clause 7i72 & 7#b7 9 section #eje;,a7c77#a77;,a77i77,,ii7 7#ba ,u4,s4,c4 #cee;a7c77#a77;,a77i771 by /rik+ 7c77#c77;,d7 & ins]t+ 7c77#c77;,e74 #bji4 ,/reaml9+ ! transition ( biological products ,section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh7 is am5d$ by add+ at ! end ! foll[+3 ,) respect to an application = a biological product submitt$ "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 ) a fil+ date t is n lat] ?an ,septemb] #bc1 #bjai1 & t does n receive f9al approval on or be=e ,m>* #bc1 #bjbj1 su* application %all be deem$ to be )drawn & ! ,secret>y %all refund ! fee paid "u section #gcf7;a77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#a77;,b774 ,not)/&+ any su* )drawal ( ! drug application1 ! ,secret>y %all consid] any previ\sly conduct$ sci5tific review & accel]ate review ( any su* subsequ5t application ) respect to su* biological product "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 ,! ,secret>y %all provide additional assi/ance to ! sponsor or manufactur] ( su* application44 #baj4 ,orphan drug cl>ification ,section #ebg7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7c77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,applicability ,?is subsection applies to any drug designat$ "u section #ebf = :i* an application 0 approv$ "u section #eje ( ?is ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act aft] ! date ( enactm5t ( ! ,,fda ,reau?orization ,act ( #bjag1 reg>dless ( ! date ( on :i* su* drug 0 designat$ "u section #ebf4 4 #baa4 ,prompt approval ( drugs relat$ to safety in=mation ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$ by add+ at ! end ! foll[+3 7z7 ,prompt ,approval ( ,drugs ,:5 safety in=mation ,is ,add$ to ,label+ 7#a7 ,g5]al rule ,a drug = :i* an application has be5 submitt$ or approv$ "u subsection 7b77#b7 or 7j7 %all n be consid]$ ineligible = approval "u ?is section or misbr&$ "u section #ejb on ! basis t ! label+ ( ! drug omits safety in=mation1 includ+ contra9dications1 w>n+s1 precautions1 dos+1 adm9i/ration1 or o!r in=mation p]ta9+ to safety1 :5 ! omitt$ safety in=mation is protect$ by exclusivity "u clause 7iii7 or 7iv7 ( subsection 7j77#e77;,f71 clause 7iii7 or 7iv7 ( subsection 7c77#c77;,e71 or section #ebg7;a71 or by an ext5sion ( su* exclusivity "u section #eje;,a or #eje;,e4 7#b7 ,label+ ,not)/&+ clauses 7iii7 & 7iv7 ( subsection 7j77#e77;,f71 clauses 7iii7 & 7iv7 ( subsection 7c77#c77;,e71 or section #ebg1 ! ,secret>y %all require t ! label+ ( a drug approv$ pursuant to an application submitt$ "u subsection 7b77#b7 or 7j7 t omits safety in=mation describ$ 9 p>agraph 7#a7 include a /atem5t ( any appropriate safety in=mation t ! ,secret>y consid]s necess>y to assure safe use4 7#c7 ,availability & scope ( exclusivity ,?is subsection does n affect-- 7,a7 ! availability or scope ( exclusivity or an ext5sion ( exclusivity describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #eje;,a7o77#c72 7,b7 ! "q ( ! eligibility = approval "u ?is section ( any application describ$ 9 subsection 7b77#b7 or 7j7 t omits any o!r aspect ( label+ protect$ by exclusivity "u-- 7i7 clause 7iii7 or 7iv7 ( subsection 7j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 ( subsection 7c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,c7 except z expressly provid$ 9 p>agraphs 7#a7 & 7#b71 ! op]ation ( ?is section or section #ebg4 4 #bab4 ,conditions ( use = biosimil> biological products ,section #cea7k77#b77;,a77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii7 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,,iii7 may include in=mation to %[ t ! conditions ( use prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ propos$ = ! biological product h be5 previ\sly approv$ = ! ref]5ce product4 4 #bac4 ,mod]niz+ ! label+ ( c]ta9 g5]ic drugs ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejc;,c ! foll[+3 #ejc;,d4 ,process to update label+ = c]ta9 drugs 7a7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m cov]$ drug means a drug approv$ "u section #eje7;c7-- 7,a7 = :i* !re are no unexpir$ pat5ts includ$ 9 ! li/ "u section #eje7;j77#g7 & no unexpir$ p]iod ( exclusivity2 7,b7 = :i* ! approval ( ! application has be5 )drawn = reasons o!r ?an safety or effectiv5ess2 & 7,c7 = :i*1 ) respect to ! label+-- 7i7 new sci5tific evid5ce is available reg>d+ ! conditions ( use ( ! drug2 7ii7 !re is a relevant accept$ use 9 cl9ical practice t is n reflect$ 9 ! approv$ label+2 or 7iii7 ! label+ ( su* drug does n reflect curr5t legal & regulatory requirem5ts4 7#b7 ,! t]m p]iod ( exclusivity1 ) respect to a drug approv$ "u section #eje7;c71 means any p]iod ( exclusivity "u clause 7ii71 7iii71 or 7iv7 ( section #eje7;c77#c77;,e71 clause 7ii71 7iii71 or 7iv7 ( section #eje7;j77#e77;,f71 or section #eje;,a1 #eje;,e1 or #ebg4 7#c7 ,! t]m g5]ic v]sion means a drug approv$ "u section #eje7;j7 ^: ref]5ce drug is a cov]$ drug4 7#d7 ,! t]m relevant accept$ use means a use = a drug 9 cl9ical practice t is support$ by sci5tific evid5ce t appe>s to ! ,secret>y to meet ! /&>ds = approval "u section #eje4 7#e7 ,! t]m select$ drug means a cov]$ drug = :i* ! ,secret>y has det]m9$ ?r\gh ! process "u subsection 7c7 t ! label+ %\ld be *ang$4 7b7 ,id5tification ( cov]$ drugs ,! ,secret>y may id5tify cov]$ drugs = :i* label+ updates w\ld provide a public heal? b5efit4 ,to assi/ 9 id5tify+ cov]$ drugs1 ! ,secret>y may d "o or bo? ( ! foll[+3 7#a7 ,ent] into coop]ative agreem5ts or contracts ) public or private entities to review ! available sci5tific evid5ce conc]n+ su* drugs4 7#b7 ,seek public input conc]n+ su* drugs1 includ+ input on :e!r !re is a relevant accept$ use 9 cl9ical practice t is n reflect$ 9 ! approv$ label+ ( su* drugs or :e!r new sci5tific evid5ce is available reg>d+ ! conditions ( use = su* drug1 by-- 7,a7 hold+ "o or m public meet+s2 7,b7 op5+ a public docket = ! submission ( public comm5ts2 or 7,c7 o!r means1 z ! ,secret>y det]m9es appropriate4 7c7 ,selection ( drugs = updat+ ,if ! ,secret>y det]m9es1 ) respect to a cov]$ drug1 t ! available sci5tific evid5ce meets ! /&>ds "u section #eje = add+ or modify+ in=mation to ! label+ or provid+ supplem5tal in=mation to ! label+ reg>d+ ! use ( ! cov]$ drug1 ! ,secret>y may initiate ! process "u subsection 7d74 7d7 ,initiation ( ! process ( updat+ ,if ! ,secret>y det]m9es t label+ *anges are appropriate = a select$ drug pursuant to subsection 7c71 ! ,secret>y %all provide notice to ! hold]s ( approv$ applications = a g5]ic v]sion ( su* drug t-- 7#a7 summ>izes ! f9d+s support+ ! det]m9ation ( ! ,secret>y t ! available sci5tific evid5ce meets ! /&>ds "u section #eje = add+ or modify+ in=mation or provid+ supplem5tal in=mation to ! label+ ( ! cov]$ drug pursuant to subsection 7c72 7#b7 provides a cle> /atem5t reg>d+ ! additional1 modifi$1 or supplem5tal in=mation = su* label+1 accord+ to ! det]m9ation by ! ,secret>y 7includ+1 z applicable1 modifications to add ! relevant accept$ use to ! label+ ( ! drug z an additional indication = ! drug72 & 7#c7 /ates :e!r ! /atem5t "u p>agraph 7#b7 applies to ! select$ drug z a class ( cov]$ drugs or only to a specific drug product4 7e7 ,response to notification ,)9 #cj days ( receipt ( notification provid$ by ! ,secret>y pursuant to subsection 7d71 ! hold] ( an approv$ application = a g5]ic v]sion ( ! select$ drug %all-- 7#a7 agree to *ange ! approv$ label+ to reflect ! additional1 modifi$1 or supplem5tal in=mation ! ,secret>y has det]m9$ to be appropriate2 or 7#b7 notify ! ,secret>y t ! hold] ( ! approv$ application does n believe t ! reque/$ label+ *anges are w>rant$ & submit a /atem5t detail+ ! reasons :y su* *anges are n w>rant$4 7f7 ,review ( application hold]'s response 7#a7 ,9 g5]al ,^u receipt ( ! application hold]'s response1 ! ,secret>y %all promptly review ea* /atem5t receiv$ "u subsection 7e77#b7 & det]m9e :i* label+ *anges pursuant to ! ,secret>y's notice "u subsection 7d7 are appropriate1 if any4 ,if ! ,secret>y disagrees ) ! reasons :y su* label+ *anges are n w>rant$1 ! ,secret>y %all provide opportunity = discussions ) ! application hold]s to rea* agreem5t on :e!r ! label+ = ! cov]$ drug %\ld be updat$ to reflect curr5t sci5tific evid5ce1 & if s1 ! cont5t ( su* label+ *anges4 7#b7 ,*anges to label+ ,aft] consid]+ all responses f ! hold] ( an approv$ application "u p>agraph 7#a7 or 7#b7 ( subsection 7e71 & any discussion "u p>agraph 7#a71 ! ,secret>y may ord] su* hold] to make ! label+ *anges ! ,secret>y det]m9es are appropriate4 ,su* hold] ( an approv$ application %all-- 7,a7 update its pap] label+ = ! drug at ! next pr9t+ ( t label+2 7,b7 update any electronic label+ = ! drug )9 #cj days2 & 7,c7 submit ! revis$ label+ ?r\gh ! =m1 ,supplem5t--,*anges ,be+ ,effect$4 7g7 ,violation ,if ! hold] ( an approv$ application = ! g5]ic v]sion ( ! select$ drug does n comply ) ! requirem5ts ( subsection 7f77#b71 su* g5]ic v]sion ( ! select$ drug %all be deem$ to be misbr&$ "u section #ejb4 7h7 ,limitations2 g5]ic drugs 7#a7 ,9 g5]al ,) respect to any label+ *ange requir$ "u ?is section1 ! g5]ic v]sion %all be deem$ to h ! same conditions ( use & ! same label+ z a ref]5ce drug = purposes ( clauses 7i7 & 7v7 ( section #eje7;j77#b77;,a74 ,any label+ *ange s requir$ %all n h any legal effect = ! applicant t is diff]5t ?an ! legal effect t w\ld h result$ if a supplem5tal application _h be5 submitt$ & approv$ to con=m ! label+ ( ! g5]ic v]sion to a *ange 9 ! label+ ( ! ref]5ce drug4 7#b7 ,supplem5tal applications ,*anges to label+ made 9 accordance ) ?is p>agraph %all n be eligible = an exclusivity p]iod "u ?is ,act4 7i7 ,drug product classes ,9 ! case ( a select$ drug = :i* ! label+ *anges ord]$ by ! ,secret>y "u subsection 7d77#b7 are requir$ = a class ( cov]$ drugs1 su* label+ *anges %all be made = g5]ic v]sions ( su* drug 9 t class4 7j7 ,rules ( con/ruction 7#a7 ,approval /&>ds ,?is section %all n be con/ru$ z alt]+ ! applicability ( ! /&>ds = approval ( an application "u section #eje4 ,no ord] %all be issu$ "u ?is subsection unless ! evid5ce support+ ! *ang$ label+ meets ! /&>ds = approval applicable to any *ange to label+ "u section #eje4 7#b7 ,removal ( in=mation ,no?+ 9 ?is section %all be con/ru$ to give ! ,secret>y additional au?ority to remove approv$ indications = drugs1 o!r ?an ! au?ority describ$ 9 ?is section4 7k7 ,reports ,n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act & e #d ye>s !reaft]1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report t-- 7#a7 describes ! actions ( ! ,secret>y "u ?is section1 includ+-- 7,a7 ! numb] ( cov]$ drugs & description ( ! types ( drugs ! ,secret>y has select$ = label+ *anges & ! rationale = su* recomm5d$ *anges2 & 7,b7 ! numb] ( times ! ,secret>y ent]$ into discussions conc]n+ a disagreem5t ) an application hold] or hold]s & a summ>y ( ! decision reg>d+ a label+ *ange1 if any2 & 7#b7 includes any recomm5dations ( ! ,secret>y = modify+ ! program "u ?is section4 4 #bad4 ,actions = delays ( g5]ic drugs & biosimil> biological products 7a7 ,def9itions ,9 ?is section-- 7#a7 ! t]m comm]cially reasonable1 m>ket-bas$ t]ms means-- 7,a7 a nondiscrim9atory price = ! sale ( ! cov]$ product at or bel[1 b n great] ?an1 ! mo/ rec5t :olesale acquisition co/ = ! drug1 z def9$ 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a s*$ule = deliv]y t results 9 ! transf] ( ! cov]$ product to ! eligible product develop] consi/5t ) ! tim+ "u subsection 7b77#b77;,a77iv72 & 7,c7 no additional conditions are impos$ on ! sale ( ! cov]$ product2 7#b7 ! t]m cov]$ product-- 7,a7 means-- 7i7 any drug approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any comb9ation ( a drug or biological product describ$ 9 clause 7i72 or 7iii7 :5 reasonably necess>y to support approval ( an application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z applicable1 or o!rwise meet ! requirem5ts = approval "u ei!r su* section1 any product1 includ+ any device1 t is m>ket$ or int5d$ = use ) su* a drug or biological product2 & 7,b7 does n include any drug or biological product t appe>s on ! drug %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 ! drug or biological product has be5 on ! drug %ortage li/ 9 effect "u su* section #ejf;,e cont9u\sly = m ?an #f mon?s2 or 7ii7 ! ,secret>y det]m9es t inclusion ( ! drug or biological product z a cov]$ product is likely to contribute to alleviat+ or prev5t+ a %ortage4 7#c7 ! t]m device has ! mean+ giv5 ! t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 ! t]m eligible product develop] means a p]son t seeks to develop a product = approval pursuant to an application = approval "u subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or = lic5s+ pursuant to an application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 ! t]m lic5se hold] means ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ! hold] ( a lic5se "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a cov]$ product2 7#f7 ! t]m ,,rems means a risk evaluation & mitigation /rategy "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 ! t]m ,,rems ) ,,etasu means a ,,rems t conta9s elem5ts to assure safe use "u section #eje-a7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices2 7#i7 ! t]m s+le1 %>$ sy/em ( elem5ts to assure safe use means a s+le1 %>$ sy/em ( elem5ts to assure safe use "u section #eje-a7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 & 7#aj7 ! t]m suffici5t quantities means an am\nt ( a cov]$ product t ! eligible product develop] det]m9es all[s x to-- 7,a7 conduct te/+ to support an application "u-- 7i7 subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 7,b7 fulfill any regulatory requirem5ts relat+ to approval ( su* an application4 7b7 ,civil action = failure ,to provide suffici5t quantities ( a cov]$ product 7#a7 ,9 g5]al ,an eligible product develop] may br+ a civil action aga9/ ! lic5se hold] = a cov]$ product seek+ relief "u ?is subsection 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates alleg+ t ! lic5se hold] has decl9$ to provide suffici5t quantities ( ! cov]$ product to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms4 7#b7 ,elem5ts 7,a7 ,9 g5]al ,to prevail 9 a civil action br\ght "u p>agraph 7#a71 an eligible product develop] %all prove1 by a prepond]ance ( ! evid5ce-- 7i7 t-- 7,i7 ! cov]$ product is n subject to a ,,rems ) ,,etasu2 or 7,,ii7 if ! cov]$ product is subject to a ,,rems ) ,,etasu-- 7aa7 ! eligible product develop] has obta9$ a cov]$ product au?orization f ! ,secret>y 9 accordance ) subp>agraph 7,b72 & 7bb7 ! eligible product develop] has provid$ a copy ( ! cov]$ product au?orization to ! lic5se hold]2 7ii7 t1 z ( ! date on :i* ! civil action is fil$1 ! product develop] has n obta9$ suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7iii7 t ! eligible product develop] has submitt$ a writt5 reque/ to pur*ase suffici5t quantities ( ! cov]$ product to ! lic5se hold]1 & su* reque/-- 7,i7 0 s5t to a nam$ corporate (fic] ( ! lic5se hold]2 7,,ii7 0 made by c]tifi$ or regi/]$ mail ) return receipt reque/$2 7,,iii7 specifi$ an individual z ! po9t ( contact = ! lic5se hold] to direct communications relat$ to ! sale ( ! cov]$ product to ! eligible product develop] & a means = electronic & writt5 communications ) t individual2 & 7,,iv7 specifi$ an address to :i* ! cov]$ product 0 to be %ipp$ ^u rea*+ an agreem5t to transf] ! cov]$ product2 & 7iv7 t ! lic5se hold] has n deliv]$ to ! eligible product develop] suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 & 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) subp>agraph 7,b74 7,b7 ,au?orization = cov]$ product subject to a ,,rems ) ,,etasu 7i7 ,reque/ ,an eligible product develop] may submit to ! ,secret>y a writt5 reque/ = ! eligible product develop] to be au?oriz$ to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu4 7ii7 ,au?orization ,n lat] ?an #abj days aft] ! date on :i* a reque/ "u clause 7i7 is receiv$1 ! ,secret>y %all1 by writt5 notice1 au?orize ! eligible product develop] to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu = purposes (-- 7,i7 developm5t & te/+ t does n involve human cl9ical trials1 if ! eligible product develop] has agre$ to comply ) any conditions ! ,secret>y det]m9es necess>y2 or 7,,ii7 developm5t & te/+ t involves human cl9ical trials1 if ! eligible product develop] has-- 7aa7 7,,aa7 submitt$ protocols1 in=m$ cons5t docum5ts1 & in=mational mat]ials = te/+ t include protections t provide safety protections comp>able to ^? provid$ by ! ,,rems = ! cov]$ product2 or 7,,bb7 o!rwise satisfi$ ! ,secret>y t su* protections w be provid$2 & 7bb7 met any o!r requirem5ts ! ,secret>y may e/abli%4 7iii7 ,notice ,a cov]$ product au?orization issu$ "u ?is subp>agraph %all /ate t ! provision ( ! cov]$ product by ! lic5se hold] "u ! t]ms ( ! au?orization w n be a violation ( ! ,,rems = ! cov]$ product4 7#c7 ,affirmative def5se ,9 a civil action br\ght "u p>agraph 7#a71 x %all be an affirmative def5se1 on :i* ! def5dant has ! burd5 ( p]suasion by a prepond]ance ( ! evid5ce-- 7,a7 t1 on ! date on :i* ! eligible product develop] reque/$ to pur*ase suffici5t quantities ( ! cov]$ product f ! lic5se hold]-- 7i7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors 0 engag$ 9 ! manufactur+ or comm]cial m>ket+ ( ! cov]$ product2 & 7ii7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors o!rwise _h access to inv5tory ( ! cov]$ product to supply to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms2 7,b7 t-- 7i7 ! lic5se hold] sells ! cov]$ product ?r\gh ag5ts1 di/ributors1 or :olesal]s2 7ii7 ! lic5se hold] has plac$ no re/rictions1 explicit or implicit1 on its ag5ts1 di/ributors1 or :olesal]s to sell cov]$ products to eligible product develop]s2 & 7iii7 ! cov]$ product c be pur*as$ by ! eligible product develop] 9 suffici5t quantities on comm]cially reasonable1 m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 or :olesal]s ( ! lic5se hold]2 or 7,c7 t ! lic5se hold] made an (f] to ! individual specifi$ pursuant to p>agraph 7#b77;,a77iii77,,iii71 by a means ( communication 7electronic1 writt51 or bo?7 specifi$ pursuant to su* p>agraph1 to sell suffici5t quantities ( ! cov]$ product to ! eligible product develop] at comm]cially reasonable m>ket-bas$ t]ms-- 7i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ad days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product1 & ! eligible product develop] did n accept su* (f] by ! date t is #g days aft] ! date on :i* ! eligible product develop] receiv$ su* (f] f ! lic5se hold]2 or 7ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by ! date t is #bj days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product1 & ! eligible product develop] did n accept su* (f] by ! date t is #aj days aft] ! date on :i* ! eligible product develop] receiv$ su* (f] f ! lic5se hold]4 7#d7 ,rem$ies 7,a7 ,9 g5]al ,if an eligible product develop] prevails 9 a civil action br\ght "u p>agraph 7#a71 ! c\rt %all-- 7i7 ord] ! lic5se hold] to provide to ! eligible product develop] )\t delay suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7ii7 aw>d to ! eligible product develop] reasonable attorney's fees & co/s ( ! civil action2 & 7iii7 aw>d to ! eligible product develop] a monet>y am\nt suffici5t to det] ! lic5se hold] f fail+ to provide eligible product develop]s ) suffici5t quantities ( a cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms1 if ! c\rt f9ds1 by a prepond]ance ( ! evid5ce-- 7,i7 t ! lic5se hold] delay$ provid+ suffici5t quantities ( ! cov]$ product to ! eligible product develop] )\t a legitimate bus9ess ju/ification2 or 7,,ii7 t ! lic5se hold] fail$ to comply ) an ord] issu$ "u clause 7i74 7,b7 ,maximum monet>y am\nt ,a monet>y am\nt aw>d$ "u subp>agraph 7,a77iii7 %all n be great] ?an ! rev5ue t ! lic5se hold] e>n$ on ! cov]$ product dur+ ! p]iod-- 7i7 beg9n+ on-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) p>agraph 7#b77;,b72 & 7ii7 end+ on ! date on :i* ! eligible product develop] receiv$ suffici5t quantities ( ! cov]$ product4 7,c7 ,avoidance ( delay ,! c\rt may issue an ord] "u subp>agraph 7,a77i7 be=e conduct+ fur!r proce$+s t may be necess>y to det]m9e :e!r ! eligible product develop] is entitl$ to an aw>d "u clause 7ii7 or 7iii7 ( subp>agraph 7,a71 or ! am\nt ( any su* aw>d4 7c7 ,limitation ( liability ,a lic5se hold] = a cov]$ product %all n be liable = any claim "u ,f$]al1 ,/ate1 or local law aris+ out ( ! failure ( an eligible product develop] to foll[ adequate safegu>ds to assure safe use ( ! cov]$ product dur+ developm5t or te/+ activities describ$ 9 ?is section1 includ+ transportation1 h&l+1 use1 or disposal ( ! cov]$ product by ! eligible product develop]4 7d7 ,no violation ( ,,rems ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7l7 ,provision ( samples n a violation ( /rategy ,! provision ( samples ( a cov]$ product to an eligible product develop] 7z ^? t]ms are def9$ 9 section #bad7;a7 ( ! ,l[] ,heal? ,c>e ,co/s ,act7 %all n be consid]$ a violation ( ! requirem5ts ( any risk evaluation & mitigation /rategy t may be 9 place "u ?is section = su* drug4 4 7e7 ,rule ( con/ruction 7#a7 ,def9ition ,9 ?is subsection1 ! t]m antitru/ laws-- 7,a7 has ! mean+ giv5 ! t]m 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab72 & 7,b7 includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section applies to unfair me?ods ( competition4 7#b7 ,antitru/ laws ,no?+ 9 ?is section %all be con/ru$ to limit ! op]ation ( any provision ( ! antitru/ laws4 7f7 ,,rems approval process = subsequ5t fil]s ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 z am5d$ by subsection 7d71 is fur!r am5d$-- 7#a7 9 subsection 7g77#d77;,b7-- 7,a7 9 clause 7i7 by /rik+ or aft] ! semicolon2 7,b7 9 clause 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7iii7 accommodate diff]5t1 comp>able aspects ( ! elem5ts to assure safe use = a drug t is ! subject ( an application "u section #eje7;j71 & ! applicable li/$ drug4 2 7#b7 9 subsection 7i77#a71 by /rik+ subp>agraph 7,c7 & ins]t+ ! foll[+3 7,c7 7i7 ,elem5ts to assure safe use1 if requir$ "u subsection 7f7 = ! li/$ drug1 :i*1 subject to clause 7ii71 = a drug t is ! subject ( an application "u section #eje7;j7 may use-- 7,i7 a s+le1 %>$ sy/em ) ! li/$ drug "u subsection 7f72 or 7,,ii7 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f74 7ii7 ,! ,secret>y may require a drug t is ! subject ( an application "u section #eje7;j7 & ! li/$ drug to use a s+le1 %>$ sy/em "u subsection 7f71 if ! ,secret>y det]m9es t no diff]5t1 comp>able aspect ( ! elem5ts to assure safe use c\ld satisfy ! requirem5ts ( subsection 7f74 2 7#c7 9 subsection 7i71 by add+ at ! end ! foll[+3 7#c7 ,%>$ ,,rems ,if ! ,secret>y approves1 9 accordance ) p>agraph 7#a77;,c77i77,,ii71 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f7 = a drug t is ! subject ( an abbreviat$ new drug application "u section #eje7;j71 ! ,secret>y may require t su* diff]5t comp>able aspect ( ! elem5ts to assure safe use c be us$ ) respect to any o!r drug t is ! subject ( an application "u section #eje7;j7 or #eje7;b7 t ref]5ces ! same li/$ drug4 2 & 7#d7 by add+ at ! end ! foll[+3 7m7 ,sep>ate ,,rems ,:5 us$ 9 ?is section1 ! t]ms diff]5t1 comp>able aspect ( ! elem5ts to assure safe use or diff]5t1 comp>able approv$ risk evaluation & mitigation /rategies means a risk evaluation & mitigation /rategy = a drug t is ! subject ( an application "u section #eje7;j7 t uses diff]5t me?ods or op]ational means ?an ! /rategy requir$ "u subsection 7a7 = ! applicable li/$ drug1 or o!r application "u section #eje7;j7 ) ! same su* li/$ drug1 b a*ieves ! same level ( safety z su* /rategy4 4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section1 ! am5dm5ts made by ?is section1 or 9 section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 %all be con/ru$ z-- 7#a7 prohibit+ a lic5se hold] f provid+ an eligible product develop] access to a cov]$ product 9 ! abs5ce ( an au?orization "u ?is section2 or 7#b7 9 any way negat+ ! applicability ( a ,,rems ) ,,etasu1 z o!rwise requir$ "u su* section #eje-a1 ) respect to su* cov]$ product4 #bae4 ,r$uc+ ! price ( prescription drugs ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,drug ,price ,report+2 ,drug ,value ,fund #cii,,oo4 ,report+ on ju/ification = drug price increases 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! lic5se issu$ "u section #cea ( ?is ,act2 or 7,b7 :o is responsible = sett+ ! price = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m p] mon? supply1 or p] a c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 7,i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7,,ii7 commonly adm9i/]$ by hospitals 7z det]m9$ by ! ,secret>y72 & 7ii7 n designat$ by ! ,secret>y z a vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or "u a ,/ate ,m$icaid plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y = ea* price increase ( a qualify+ drug t w result 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7,a7 #aj p]c5t or m ov] a #ab-mon? p]iod2 or 7,b7 #be p]c5t or m ov] a #cf-mon? p]iod4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase4 7c7 ,cont5ts ,a report "u subsection 7b7 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug on ! plann$ effective date ( su* price increase2 7,b7 a ju/ification =1 & description (1 ea* manufactur]'s price increase t w occur dur+ ! #ab-mon? p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,c7 ! id5tity ( ! initial develop] ( ! drug2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 7,e7 ! curr5t li/ price ( ! drug2 7,f7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 & 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 7,g7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,h7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is us$ =-- 7i7 basic & precl9ical rese>*2 7ii7 cl9ical rese>*2 7iii7 new drug developm5t2 7iv7 pursu+ new or exp&$ indications = su* drug ?r\gh supplem5tal applications "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act2 & 7v7 c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ ^? "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,i7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,j7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur]-- 7i7 = ! #ab-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,a72 or 7ii7 = ! #cf-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,b72 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation-- 7i7 = !#ab-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,a72 or 7ii7 = ! #cf-mon? p]iod prec$+ ! date ( ! report1 9 ! case ( a report bas$ on an increase describ$ 9 subsection 7b77#a77;,b72 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate1 z specifi$ ?r\gh notice & comm5t rulemak+4 7d7 ,civil p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section %all be subject to a civil p5alty ( #ajj1jjj = ea* day on :i* ! violation cont9ues4 7e7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 n lat] ?an #cj days aft] ! submission ( a report "u subsection 7b71 ! ,secret>y %all po/ ! report on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#b7 ,=mat ,9 develop+ ! =mat ( su* report = public po/+1 ! ,secret>y %all consult /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back on ! cont5t & =mat f consum] advocates & readability exp]ts to ensure su* public reports are us]-fri5dly to ! public & are writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,trade secrets & confid5tial in=mation ,9 c>ry+ out ?is section ! ,secret>y %all en=ce curr5t law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 4 #cii,,oo-#a4 ,use ( civil p5alty am\nts ,! ,secret>y %all1 )\t fur!r appropriation1 collect civil p5alties "u section #cii,,oo & use ! funds d]iv$ f su* civil p5alties1 9 addition to any o!r am\nts available to ! ,secret>y1 to c>ry out activities describ$ 9 ?is "p & to improve consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ,congress1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is easy to f9d1 use1 & und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #cii,,oo2 & 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section4 7b7 ,trade secrets & confid5tial in=mation ,9 c>ry+ out ?is section ! ,secret>y %all en=ce curr5t law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 4 ,,iii ,improv+ transp>5cy 9 heal? c>e #cja4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 z am5d$ by section #ajc1 is am5d$ by add+ at ! end ! foll[+3 #bgbi;,b4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation 7a7 ,increas+ price & quality transp>5cy = plan sponsors & gr\p & individual m>ket & consum]s 7#a7 ,gr\p heal? plans ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age may n ent] into an agreem5t ) a heal? c>e provid]1 network or association ( provid]s1 ?ird-p>ty adm9i/rator1 or o!r s]vice provid] (f]+ access to a network ( provid]s t w\ld directly or indirectly re/rict a gr\p heal? plan or heal? insurance issu] f-- 7,a7 provid+ provid]-specific co/ or quality ( c>e in=mation1 ?r\gh a consum] engagem5t tool or any o!r means1 to ref]r+ provid]s1 ! plan sponsor1 enrollees1 or eligible enrollees ( ! plan or cov]age2 7,b7 electronically access+ de-id5tifi$ claims & enc\nt] data = ea* enrollee 9 ! plan or cov]age1 ^u reque/ & consi/5t ) ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij1 ) respect to ! applicable heal? plan or heal? insurance cov]age1 includ+1 on a p] claim basis-- 7i7 f9ancial in=mation1 su* z ! all[$ am\nt1 or any o!r claim-relat$ f9ancial obligations includ$ 9 ! provid] contract2 7ii7 provid] in=mation1 includ+ "n & cl9ical designation2 7iii7 s]vice codes2 or 7iv7 any o!r data elem5t normally includ$ 9 claim or enc\nt] transactions :5 receiv$ by a plan or issu]2 or 7,c7 %>+ data describ$ 9 subp>agraph 7,a7 or 7,b7 ) a bus9ess associate z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 consi/5t ) ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij4 7#b7 ,individual heal? insurance cov]age ,a heal? insurance issu] (f]+ individual heal? insurance cov]age may n ent] into an agreem5t ) a heal? c>e provid]1 network or association ( provid]s1 or o!r s]vice provid] (f]+ access to a network ( provid]s t w\ld directly or indirectly re/rict ! heal? insurance issu] f-- 7,a7 provid+ provid]-specific price or quality ( c>e in=mation1 ?r\gh a consum] engagem5t tool or any o!r means1 to ref]r+ provid]s1 enrollees1 or eligible enrollees ( ! plan or cov]age2 or 7,b7 %>+1 = plan design1 plan adm9i/ration1 & plan1 f9ancial1 legal1 & quality improvem5t activities1 data describ$ 9 subp>agraph 7,a7 ) a bus9ess associate z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations71 consi/5t ) ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij4 7#c7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 p>agraph 7#a77;,a7 or 7#b77;,a7 prev5ts a heal? c>e provid]1 network or association ( provid]s1 or o!r s]vice provid] f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation describ$ 9 su* p>agraphs 7#a7 & 7#b74 7#d7 ,atte/ation ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all annually submit to1 z applicable1 ! applicable au?ority describ$ 9 section #bgbc or ! ,secret>y ( ,labor1 an atte/ation t su* plan or issu] is 9 compliance ) ! requirem5ts ( ?is subsection4 7#e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to o!rwise limit gr\p heal? plan1 plan sponsor1 or heal? insurance issu] access to data curr5tly p]mitt$ "u ! privacy regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act1 ! am5dm5ts to ?is ,act made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh1 & ! ,am]icans ) ,disabilities ,act ( #aiij4 4 #cjb4 ,bann+ anticompetitive t]ms 9 facility & insurance contracts t limit access to high] quality1 l[] co/ c>e 7a7 ,9 g5]al ,section #bgbi;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #cja1 is am5d$ by add+ at ! end ! foll[+3 7b7 ,protect+ ,heal? ,plans ,network ,design ,flexibility 7#a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n ent] into an agreem5t ) a provid]1 network or association ( provid]s1 or o!r s]vice provid] (f]+ access to a network ( s]vice provid]s if su* agreem5t1 directly or indirectly-- 7,a7 re/ricts ! gr\p heal? plan or heal? insurance issu] f-- 7i7 direct+ or /e]+ enrollees to o!r heal? c>e provid]s2 or 7ii7 (f]+ inc5tives to enc\rage enrollees to utilize specific heal? c>e provid]s2 or 7,b7 requires ! gr\p heal? plan or heal? insurance issu] to ent] into any additional contract ) an affiliate ( ! provid]1 su* z an affiliate ( ! provid]1 z a condition ( ent]+ into a contract ) su* provid]2 7,c7 requires ! gr\p heal? plan or heal? insurance issu] to agree to paym5t rates or o!r t]ms = any affiliate n p>ty to ! contract ( ! provid] involv$2 or 7,d7 re/ricts o!r gr\p heal? plans or heal? insurance issu]s n p>ty to ! contract f pay+ a l[] rate = items or s]vices ?an ! contract+ plan or issu] pays = su* items or s]vices4 7#b7 ,additional requirem5t = self-insur$ plans ,a self-insur$ gr\p heal? plan %all n ent] into an agreem5t ) a provid]1 network or association ( provid]s1 ?ird-p>ty adm9i/rator1 or o!r s]vice provid] (f]+ access to a network ( provid]s if su* agreem5t directly or indirectly requires ! gr\p heal? plan to c]tify1 atte/1 or o!rwise confirm 9 writ+ t ! gr\p heal? plan is b\nd by re/rictive contract+ t]ms betwe5 ! s]vice provid] & a ?ird-p>ty adm9i/rator t ! gr\p heal? plan is n p>ty to1 )\t a disclosure t su* t]ms exi/4 7#c7 ,exception = c]ta9 gr\p model issu]s ,p>agraph 7#a77;,a7 %all n apply to a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age ) respect to-- 7,a7 a heal? ma9t5ance organization 7z def9$ 9 section #bgia7;b77#c771 if su* heal? ma9t5ance organization op]ates prim>ily ?r\gh exclusive contracts ) multi-specialty physician gr\ps1 nor to any arrangem5t betwe5 su* a heal? ma9t5ance organization & its affiliates2 or 7,b7 a value-bas$ network arrangem5t1 su* z an exclusive provid] network1 acc\ntable c>e organization1 c5t] ( excell5ce1 a provid] sponsor$ heal? insurance issu] t op]ates prim>ily ?r\gh align$ multi-specialty physician gr\p practices or integrat$ heal? sy/ems1 or su* o!r simil> network arrangem5ts z det]m9$ by ! ,secret>y ?r\gh rulemak+4 7#d7 ,atte/ation ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all annually submit to1 z applicable1 ! applicable au?ority describ$ 9 section #bgbc or ! ,secret>y ( ,labor1 an atte/ation t su* plan or issu] is 9 compliance ) ! requirem5ts ( ?is subsection4 7c7 ,ma9t5ance ( exi/+ ,,hipaa1 ,,g9a1 & ,,ada protections ,no?+ 9 ?is section %all modify1 r$uce1 or elim9ate ! exi/+ privacy protections & /&>ds provid$ by reason ( ,/ate & ,f$]al law1 includ+ ! requirem5ts ( p>ts #afj & #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7d7 ,regulations ,! ,secret>y1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 %all promulgate regulations to c>ry out ?is section4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit network design or co/ or quality initiatives by a gr\p heal? plan or heal? insurance issu]1 includ+ acc\ntable c>e organizations1 exclusive provid] organizations1 networks t ti] provid]s by co/ or quality or /e] enrollees to c5t]s ( excell5ce1 or o!r pay-=-p]=mance programs4 7f7 ,cl>ification ) respect to antitru/ laws ,compliance ) ?is section does n con/itute compliance ) ! antitru/ laws1 z def9$ 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a774 4 7b7 ,effective date ,section #bgbi;,b ( ! ,public ,heal? ,s]vice ,act 7z add$ by section #cja & am5d$ by subsection 7a77 %all apply ) respect to any contract ent]$ into on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 ,) respect to an applicable contract t is 9 effect on ! date ( enactm5t ( ?is ,act1 su* section #bgbi;,b %all apply on ! e>li] ( ! date ( r5ewal ( su* contract or #c ye>s aft] su* date ( enactm5t4 #cjc4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s 7a7 ,9 g5]al ,subp>t ,c ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 z am5d$ by section #ajb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgif4 ,designation ( a nongov]nm5tal1 nonpr(it transp>5cy organization to l[] ,am]icans' heal? c>e co/s 7a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 %all ent] into a contract ) a nonpr(it entity to support ! e/abli%m5t & ma9t5ance ( a database t receives & utilizes heal? c>e claims in=mation & relat$ in=mation & issues reports t are available to ! public & au?oriz$ us]s1 & are submitt$ to ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! database e/abli%$ "u subsection 7a7 %all-- 7,a7 improve transp>5cy by us+ de-id5tifi$ heal? c>e data to-- 7i7 in=m pati5ts ab\t ! co/1 quality1 & value ( _! c>e2 7ii7 assi/ provid]s & hospitals1 z !y "w ) pati5ts1 to make in=m$ *oices ab\t c>e2 7iii7 enable provid]s1 hospitals1 & communities to improve s]vices & outcomes = pati5ts by b5*m>k+ _! p]=mance aga9/ t ( o!r provid]s1 hospitals1 & communities2 7iv7 enable pur*as]s1 includ+ employ]s1 employee organizations1 & heal? plans1 to develop value-bas$ pur*as+ models1 improve quality1 & r$uce ! co/ ( heal? c>e & insurance cov]age = enrollees2 7v7 enable employ]s & employee organizations to evaluate network design & con/ruction1 & ! co/ ( c>e = enrollees2 7vi7 facilitate ,/ate-l$ initiatives to l[] heal? c>e co/s & improve quality2 & 7vii7 promote competition bas$ on quality & co/2 7,b7 collect m$ical claims1 prescription drug claims1 & remittance data consi/5t ) ! protections & requirem5ts ( subsection 7d72 7,c7 be e/abli%$ 9 su* a mann] t all[s ! data collect$ pursuant to subp>agraph 7,b7 to be %>$ ) any ,/ate all-pay] claims database or regional database op]at$ ) au?orization f ,/ates1 at co/1 us+ a /&>diz$ =mat1 if su* ,/ate or regional database also submits claims data to ! database e/abli%$ "u ?is section2 & 7,d7 be available to-- 7i7 ! ,director ( ! ,congressional ,budget ,(fice1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission1 & ! ,executive ,director ( ! ,m$icaid & ,,*ip ,paym5t ,advisory ,commission1 ^u reque/1 subject to ! privacy & security requirem5ts ( au?oriz$ us]s "u subsection 7e77#b72 & 7ii7 au?oriz$ us]s1 includ+ employ]s1 employee organizations1 provid]s1 rese>*]s1 & policymak]s1 subject to subsection 7e74 7#b7 ,privacy & security2 brea* notifications 7,a7 ,regulations 7i7 ,9 g5]al ,! ,secret>y %all issue regulations prescrib+ ! ext5t to :i*1 & ! mann] 9 :i*1 ! foll[+ rules 7& any successors ( su* rules7 %all apply to ! activities "u ?is section ( an entity receiv+ a contract "u subsection 7a73 7,i7 ,! ,privacy ,rule "u "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,,ii7 ,! ,security ,rule "u "p #afj & subp>ts ,a & ,c ( "p #afd ( su* title #de 7or any successor regulations74 7,,iii7 ,! ,brea* ,notification ,rule "u "p #afj & subp>ts ,a & ,d ( "p #afd ( su* title #de 7or any successor regulations74 7ii7 ,supplem5tal regulations ,9 ord] to ensure data privacy & security & ! notification ( brea*es1 ! ,secret>y may issue su* supplem5tal regulations on ! subjects ( ! rules li/$ "u clause 7i7 z ! ,secret>y det]m9es appropriate to address diff]5ces betwe5 ! activities describ$ by ?is section & ! activities cov]$ by su* rules4 7,b7 ,en=cem5t ,section #aagf ( ,social ,security ,act %all apply ) respect to a violation ( ?is p>agraph 9 ! same mann] su* section #aagf applies to a violation ( "p ,c ( title ,,xi ( ! ,social ,security ,act1 & ! ,secret>y may include 9 ! regulations promulgat$ "u ?is section provisions to apply su* section to ?is p>agraph4 7,c7 ,proc$ure 7i7 ,tim+ ,! ,secret>y %all issue ! initial set ( regulations "u ?is p>agraph n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act4 7ii7 ,au?ority to use int]im f9al proc$ures ,! ,secret>y may make su* initial set ( regulations effective & f9al imm$iately ^u issuance1 on an int]im basis1 & provide = a p]iod ( public comm5t on su* initial set ( regulations aft] ! date ( publication4 7,d7 ,requirem5ts ( entity ,! entity receiv+ ! contract "u ?is section %all-- 7i7 n disclose to ! public any individually id5tifiable heal? in=mation or propriet>y f9ancial in=mation2 7ii7 /rictly limit /aff access to ! data to /aff ) appropriate tra9+1 cle>ance1 & backgr\nd *ecks & require regul> privacy & security tra9+2 7iii7 ma9ta9 effective security /&>ds = transf]r+ data or mak+ data available to au?oriz$ us]s2 7iv7 develop a process = provid+ access to data to au?oriz$ us]s1 9 a secure mann] t ma9ta9s privacy & confid5tiality ( data2 & 7v7 adh]e to curr5t be/ security practices ) respect to ! managem5t & use ( su* data = heal? s]vices rese>*1 9 accordance ) applicable ,f$]al privacy law 7#c7 ,consultation 7,a7 ,advisory committee ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all conv5e an ,advisory ,committee 7ref]r$ to 9 ?is section z ! ,committee71 consi/+ ( #ac memb]s1 to advise ! ,secret>y1 ! contract+ entity1 & ,congress on ! e/abli%m5t1 op]ations1 & use ( ! database e/abli%$ "u ?is section4 7,b7 ,memb]%ip 7i7 ,appo9tm5t ,9 accordance ) clause 7ii71 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor & ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 appo9t memb]s to ! ,committee :o h di/+ui%$ !mselves 9 ! fields ( heal? s]vices rese>*1 heal? economics1 heal? in=matics1 or ! gov]nance ( ,/ate all-pay] claims databases1 or :o repres5t organizations likely to submit data to or use ! database1 includ+ pati5ts1 employ]s1 or employee organizations t sponsor gr\p heal? plans1 heal? c>e provid]s1 heal? insurance issu]s1 or ?ird-p>ty adm9i/rators ( gr\p heal? plans4 ,su* memb]s %all s]ve #c-ye> t]ms on a /agg]$ basis4 ,vacancies on ! ,committee %all be fill$ by appo9tm5t consi/5t ) ?is subsection n lat] ?an #c mon?s aft] ! vacancy arises4 7ii7 ,composition ,9 accordance ) clause 7i7-- 7,i7 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor1 %all appo9t to ! ,committee-- 7aa7 #a memb] select$ by ! ,secret>y1 9 coord9ation ) ! ,secret>y ( ,labor1 to s]ve z ! *air ( ! ,committee2 7bb7 ! ,assi/ant ,secret>y = ,plann+ & ,evaluation ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 or a designee ( su* ,assi/ant ,secret>y2 7cc7 #a repres5tative ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7dd7 #a repres5tative ( ! ,ag5cy = ,heal? ,rese>* & ,quality2 7ee7 #a repres5tative ( ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ) exp]tise 9 data privacy & security2 7ff7 #a repres5tative ( ! ,national ,c5t] = ,heal? ,/ati/ics2 & 7gg7 #a repres5tative ( ! ,employee ,b5efits & ,security ,adm9i/ration ( ! ,dep>tm5t ( ,labor2 & 7,,ii7 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all appo9t to ! ,committee-- 7aa7 #a repres5tative ( an employ] t sponsors a gr\p heal? plan2 7bb7 #a repres5tative ( an employee organization t sponsors a gr\p heal? plan2 7cc7 #a academic rese>*] ) exp]tise 9 heal? economics or heal? s]vices rese>*2 7dd7 #a consum] advocate2 & 7ee7 #b additional memb]s4 7,c7 ,duties ,! ,committee %all-- 7i7 advise ! ,secret>y on ! managem5t ( ! contract "u subsection 7a72 7ii7 assi/ & advise ! entity receiv+ ! contract "u subsection 7a7 9 e/abli%+-- 7,i7 ! scope & =mat ( ! data to be submitt$ "u subsection 7d72 7,,ii7 be/ practices ) respect to de-id5tification ( data1 z appropriate2 7,,iii7 ! appropriate uses ( data by au?oriz$ us]s1 includ+ develop+ /&>ds = ! approval ( reque/s by organizations to access & use ! data2 & 7,,iv7 ! appropriate =mats & me?ods = mak+ reports & analyses bas$ on ! database to ! public2 7iii7 conduct an annual review ( :e!r data 0 us$ accord+ to ! appropriate uses z describ$ 9 clause 7ii77,,ii71 & advise ! designat$ entity on us+ ! data = au?oriz$ purposes2 7iv7 report1 z appropriate1 to ! ,secret>y & ,congress on ! op]ation ( ! database & opportunities to bett] a*ieve ! objectives ( ?is section2 7v7 e/abli% additional re/rictions on rese>*]s :o receive comp5sation f entities describ$ 9 subsection 7e77#b77;,b77ii71 9 ord] to protect propriet>y f9ancial in=mation2 & 7vi7 e/abli% objectives = rese>* & public report+4 7#d7 ,/ate requirem5ts ,a ,/ate may require heal? insurance issu]s & o!r pay]s to submit claims data to ! database e/abli%$ "u ?is section1 provid$ t su* data is submitt$ to ! entity aw>d$ ! contract "u ?is section 9 a =m & mann] e/abli%$ by ! ,secret>y1 & pursuant to subsection 7d77#d77;,b74 7#e7 ,sanctions ,! ,secret>y %all take appropriate action to sanction us]s :o attempt to re-id5tify data access$ pursuant to p>agraph 7#a77;,d74 7c7 ,contract requirem5ts 7#a7 ,competitive proc$ures ,! ,secret>y %all ent] into ! contract "u subsection 7a7 us+ full & op5 competition proc$ures pursuant to *apt] #cc ( title #da1 ,unit$ ,/ates ,code4 7#b7 ,eligible entities ,to be eligible to ent] into a contract describ$ 9 subsection 7a71 an entity %all-- 7,a7 be a private nonpr(it entity gov]n$ by a bo>d t includes repres5tatives ( ! academic rese>* community & individuals ) exp]tise 9 employ]-sponsor$ insurance1 rese>* us+ heal? c>e claims data & actu>ial analysis2 7,b7 conduct its bus9ess 9 an op5 & transp>5t mann] t provides ! opportunity = public comm5t on its activities2 & 7,c7 agree to comply ) any requirem5ts impos$ "u ! rulemak+ describ$ 9 subsection 7d77#d77;,a74 7#c7 ,consid]ations ,9 aw>d+ ! contract "u subsection 7a71 ! ,secret>y %all consid] an entity's exp]i5ce 9-- 7,a7 heal? c>e claims data collection1 aggregation1 quality assurance1 analysis1 & security2 7,b7 support+ academic rese>* on heal? co/s1 sp5d+1 & utilization = & by privately insur$ pati5ts2 7,c7 work+ ) l>ge heal? insurance issu]s & ?ird-p>ty adm9i/rators to assemble a national claims database2 7,d7 effectively collaborat+ ) & engag+ /akehold]s to develop reports2 7,e7 meet+ budgets & timel9es1 includ+ 9 connection ) report g5]ation2 & 7,f7 facilitat+ ! creation (1 or support+1 ,/ate all-pay] claims databases4 7#d7 ,contract t]m ,a contract aw>d$ "u ?is section %all be = a p]iod ( #e ye>s1 & may be r5ew$ aft] a subsequ5t competitive bidd+ process "u ?is section4 7#e7 ,transition ( contract ,if ! ,secret>y1 foll[+ a competitive process at ! end ( ! contract p]iod1 selects a new entity to ma9ta9 ! database1 all data %all be transf]r$ to ! new entity accord+ to a s*$ule & process to be det]m9$ by ! ,secret>y4 ,^u t]m9ation ( a contract1 no entity may keep data held by ! database or disclose su* data to any entity o!r ?an ! entity s designat$ by ! ,secret>y4 ,! ,secret>y %all include en=cem5t t]ms 9 any contract ) an organization *os5 "u ?is section1 to ensure ! timely transf] ( all data1 & any associat$ code or algori?ms1 to a new entity 9 ! ev5t ( contract t]m9ation4 7d7 ,receiv+ heal? in=mation 7#a7 ,requirem5ts 7,a7 ,9 g5]al ,! ,secret>y ( ,labor %all ensure t ! applicable self-insur$ gr\p heal? plan1 ?r\gh its ?ird-p>ty adm9i/rator1 ph>macy b5efit manag]1 or o!r entity designat$ by ! gr\p heal? plan1 z applicable1 electronically submits all claims data ) respect to ! plan1 pursuant to subp>agraph 7,b74 7,b7 ,scope ( in=mation & =mat ( submission ,! entity aw>d$ ! contract "u subsection 7a71 9 consultation ) ! ,committee describ$ 9 subsection 7b77#c71 & pursuant to ! privacy & security requirem5ts ( subsection 7b77#b71 %all-- 7i7 specify ! data elem5ts requir$ to be submitt$ "u subp>agraph 7,a71 :i* %all include all data relat$ to transactions describ$ 9 subp>agraphs 7,a7 & 7,e7 ( section #aagc7;a77#b7 ( ! ,social ,security ,act1 includ+ all data elem5ts normally pres5t 9 su* transactions :5 adjudicat$1 & enrollm5t in=mation2 7ii7 specify ! =m & mann] = su* submissions1 & ! hi/orical p]iod to be includ$ 9 ! initial submission2 & 7iii7 (f] an automat$ submission option to m9imize adm9i/rative burd5s = entities requir$ to submit data4 7,c7 ,de-id5tification ( data ,! entity aw>d$ ! contract "u subsection 7a7 %all-- 7i7 e/abli% a process "u :i* data is de-id5tifi$ consi/5t ) ! de-id5tification requirem5ts "u section #afd4ead ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 :ile reta9+ ! ability to l9k data longitud9ally = ! purposes ( rese>* on co/ & quality1 & ! ability to complete risk adju/m5t & geographic analysis2 7ii7 ensure t any ?ird-p>ty subcontractors :o p]=m ! de-id5tification process describ$ 9 clause 7i7 reta9 only ! m9imum necess>y in=mation to p]=m su* a process1 & adh]e to effective security & encryption practices 9 data /orage & transmission2 7iii7 /ore claims & o!r data collect$ "u ?is subsection only 9 de-id5tifi$ =m1 9 accordance ) section #afd4ead ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations72 & 7iv7 ensure t individually id5tifiable data is encrypt$1 9 accordance ) guidance issu$ by ! ,secret>y "u section #acdjb7;h77#b7 ( ! ,,hite* ,act4 7#b7 ,applicable self-insur$ gr\p heal? plan ,= purposes ( p>agraph 7#a71 a self-insur$ gr\p heal? plan is an applicable self-insur$ gr\p heal? plan if su* plan is self-adm9i/]$1 or is adm9i/]$ by a ?ird-p>ty plan adm9i/rator t meets #a or bo? ( ! foll[+ crit]ia3 7,a7 ,adm9i/]s heal?1 m$ical1 or ph>macy b5efits = m ?an #ej1jjj enrollees4 7,b7 ,is "o ( ! #e l>ge/ adm9i/rators or issu]s ( self-insur$ gr\p heal? plans 9 a ,/ate 9 :i* su* adm9i/rator op]ates1 z measur$ by ! aggregate numb] ( enrollees 9 plans adm9i/]$ by su* adm9i/rator 9 su* ,/ate1 z det]m9$ by ! ,secret>y4 7#c7 ,?ird-p>ty adm9i/rators ,9 ! case ( a ?ird-p>ty adm9i/rator t is requir$ "u ?is subsection to submit claims data ) respect to an applicable self-insur$ gr\p heal? plan1 su* adm9i/rator %all submit claims data ) respect to all self-insur$ gr\p heal? plans t ! adm9i/rator adm9i/]s1 includ+ su* plans t are n applicable self-insur$ gr\p heal? plans1 z describ$ 9 p>agraph 7#b74 7#d7 ,receiv+ o!r in=mation 7,a7 ,m$ic>e data ,! ,secret>y1 ?r\gh rulemak+1 %all ensure t ! data made available to su* entity is available to qualifi$ entities "u section #ahgd7;e7 ( ! ,social ,security ,act is made available to ! entity aw>d$ a contract "u subsection 7a74 7,b7 ,/ate data ,! entity aw>d$ ! contract "u subsection 7a7 %all collect data f ,/ate all pay] claims databases t seek access to ! database e/abli%$ "u ?is section4 7#e7 ,availability ( data ,an entity requir$ to submit data "u ?is subsection may n place any re/rictions on ! use ( su* data by au?oriz$ us]s4 7e7 ,uses ( in=mation 7#a7 ,9 g5]al ,! entity aw>d$ ! contract "u subsection 7a7 %all make ! database available to us]s :o are au?oriz$ "u ?is subsection1 at co/1 & reports & analyses bas$ on ! data available to ! public ) no *>ge4 7#b7 ,au?orization ( us]s 7,a7 ,9 g5]al ,an entity may reque/ au?orization by ! entity aw>d$ ! contract "u subsection 7a7 = access to ! database 9 accordance ) ?is p>agraph4 7,b7 ,application ,an entity desir+ au?orization "u ?is p>agraph %all submit to ! entity aw>d$ ! contract an application = su* access1 :i* %all include-- 7i7 9 ! case ( an entity reque/+ access = rese>* purposes-- 7,i7 a description ( ! uses & me?odologies = evaluat+ heal? sy/em p]=mance us+ su* data2 & 7,,ii7 docum5tation ( approval ( ! rese>* by an in/itutional review bo>d1 if applicable = a p>ticul> plan ( rese>*2 or 7ii7 9 ! case ( an entity su* z an employ]1 heal? insurance issu]1 ?ird-p>ty adm9i/rator1 or heal? c>e provid]1 reque/+ access = ! purpose ( quality improvem5t or co/-conta9m5t1 a description ( ! int5d$ uses = su* data4 7,c7 ,requirem5ts 7i7 ,rese>* ,^u approval ( an application = rese>* purposes "u subp>agraph 7,b77i71 ! au?oriz$ us] %all ent] into a data use & confid5tiality agreem5t ) ! entity aw>d$ ! contract "u subsection 7a71 :i* %all include a prohibition on attempts to reid5tify & disclose individually id5tifiable heal? in=mation & propriet>y f9ancial in=mation4 7ii7 ,quality improvem5t & co/-conta9m5t ,9 consultation ) ! ,committee describ$ 9 subsection 7b77#c71 ! ,secret>y %all1 ?r\gh rulemak+1 e/abli% ! =m & mann] 9 :i* au?oriz$ us]s describ$ 9 subp>agraph 7,b77ii7 may access data4 ,data provid$ to su* au?oriz$ us]s %all be provid$ 9 a =m & mann] su* t us]s may n obta9 individually id5tifiable price in=mation ) respect to direct competitors4 ,^u approval1 su* au?oriz$ us] %all ent] into a data use & confid5tiality agreem5t ) ! entity4 7iii7 ,cu/omiz$ reports ,employ]s & employ] organizations may reque/ cu/omiz$ reports f ! entity aw>d$ ! contract "u subsection 7a71 at co/1 subject to ! requirem5ts ( ?is section ) respect to privacy1 security1 & propriet>y f9ancial in=mation4 7iv7 ,non-cu/omiz$ reports ,! entity aw>d$ ! contract "u subsection 7a71 9 consultation ) ! ,committee1 %all make available to all au?oriz$ us]s aggregate data sets1 free ( *>ge4 7f7 ,fund+ 7#a7 ,initial fund+ ,!re are au?oriz$ to be appropriat$1 & !re are appropriat$1 out ( monies 9 ! ,treasury n o!rwise appropriat$1 #bj1jjj1jjj = fiscal ye> #bjbj1 = ! implem5tation ( ! initial contract & e/abli%m5t ( ! database "u ?is section4 7#b7 ,ongo+ fund+ ,!re are au?oriz$ to be appropriat$ #ae1jjj1jjj = ea* ( fiscal ye>s #bjba ?r\gh #bjbe1 = purposes ( c>ry+ out ?is section 7o!r ?an ! grant program "u subsection 7h774 7g7 ,annual report 7#a7 ,submission ,on ea* ( ! dates describ$ 9 p>agraph 7#b71 ! entity receiv+ ! contract "u subsection 7a7 %all submit to ,congress1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,secret>y ( ,labor & publi% onl9e = access by ! g5]al public1 a report conta9+ a description (-- 7,a7 tr5ds 9 ! price1 utilization1 & total sp5d+ on heal? c>e s]vices1 includ+ a geographic analysis ( diff]5ces 9 su* tr5ds2 7,b7 limitations 9 ! data set2 7,c7 progress t[>ds ! objectives ( ?is section2 & 7,d7 ! p]=mance by ! entity ( ! duties requir$ "u su* contract4 7#b7 ,dates describ$ ,! reports describ$ 9 p>agraph 7#a7 %all be submitt$-- 7,a7 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act2 7,b7 ! lat] ( #a ye> aft] ! date t is #c ye>s aft] su* date ( enactm5t or ,m>* #a ( ! ye> aft] ! date t is #c ye>s aft] su* date ( enactm5t2 & 7,c7 ,m>* #a ( ea* ye> !reaft]4 7#c7 ,public reports & rese>* ,! entity receiv+ a contract "u subsection 7a7 %all1 9 coord9ation ) au?oriz$ us]s1 make analyses & rese>* available to ! public on an ongo+ basis to promote ! objectives ( ?is section4 7h7 ,grants to ,/ates 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor1 may aw>d grants to ,/ates = ! purpose ( e/abli%+ & ma9ta9+ ,/ate all-pay] claims databases t improve transp>5cy ( data 9 ord] to meet ! goals ( subsection 7a77#a74 7#b7 ,requirem5t ,to be eligible to receive ! fund+ "u p>agraph 7#a71 a ,/ate %all submit data to ! database z describ$ 9 subsection 7b77#a77;,c71 us+ ! =mat describ$ 9 subsection 7d77#a74 7#c7 ,fund+ ,!re is au?oriz$ to be appropriat$ #ajj1jjj1jjj = ! p]iod ( fiscal ye>s #bjbj ?r\gh #bjbi = ! purpose ( aw>d+ grants to ,/ates "u ?is subsection4 7i7 ,exemption f public disclosure 7#a7 ,9 g5]al ,claims data provid$ to ! database1 & ! database itself %all n be consid]$ public records & %all be exempt f public disclosure requirem5ts4 7#b7 ,re/rictions on uses = c]ta9 proce$+s ,data disclos$ to au?oriz$ us]s %all n be subject to discov]y or admission z public in=mation1 or evid5ce 9 judicial or adm9i/rative proce$+s )\t cons5t ( ! affect$ p>ties4 7j7 ,def9itions 7#a7 ,individually id5tifiable heal? in=mation ,! t]m individually id5tifiable heal? in=mation has ! mean+ giv5 su* t]m 9 section #aaga7f7 ( ! ,social ,security ,act4 7#b7 ,propriet>y f9ancial in=mation ,! t]m propriet>y f9ancial in=mation means data t w\ld disclose ! t]ms ( a specific contract betwe5 an individual heal? c>e provid] or facility & a specific gr\p heal? plan1 ,m$icaid manag$ c>e organization or o!r manag$ c>e entity1 or heal? insurance issu] (f]+ gr\p or individual cov]age4 7k7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to affect or modify en=cem5t ( ! privacy1 security1 or brea* notification rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7or successor regulations74 4 7b7 ,,gao report 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on-- 7,a7 ! p]=mance ( ! entity aw>d$ a contract "u section #bgie7;a7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 "u su* contract2 7,b7 ! privacy & security ( ! in=mation report$ to ! entity2 & 7,c7 ! co/s incurr$ by su* entity 9 p]=m+ su* duties4 7#b7 ,reports ,n lat] ?an #b ye>s aft] ! effective date ( ! fir/ contract ent]$ into "u section #bgie7;a7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 & aga9 n lat] ?an #d ye>s aft] su* effective date1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u p>agraph 7#a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 #cjd4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation 7a7 ,9 g5]al ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 z am5d$ by sections #cja & #cjb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,c4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation 7a7 ,network /atus ( provid]s 7#a7 ,9 g5]al ,beg9n+ on ! date t is "o ye> aft] ! date ( enactm5t ( ?is section1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all-- 7,a7 e/abli% bus9ess processes to ensure t all enrollees 9 su* plan or cov]age receive pro( ( a heal? c>e provid]'s network /atus1 bas$ on :at a plan or issu] kn[s or c\ld reasonably "k-- 7i7 ?r\gh a writt5 electronic communication f ! plan or issu] to ! enrollee1 z soon z practicable & n lat] ?an #a bus9ess day aft] a telephone inquiry is made by su* enrollee = su* in=mation2 7ii7 ?r\gh an oral confirmation1 docum5t$ by su* issu] or cov]age1 & kept 9 ! enrollee's file = a m9imum ( #b ye>s2 & 7iii7 9 real-"t ?r\gh an onl9e heal? c>e provid] directory se>* tool ma9ta9$ by ! plan or issu]2 & 7,b7 include 9 any pr9t directory a disclosure t ! in=mation includ$ 9 ! directory is accurate z ( ! date ( ! la/ data update & t enrollees or prospective enrollees %\ld consult ! gr\p heal? plan or issu]'s electronic provid] directory on its website or call a specifi$ cu/om] s]vice telephone numb] to obta9 ! mo/ curr5t provid] directory in=mation4 7#b7 ,gr\p heal? plan & heal? insurance issu] bus9ess processes ,beg9n+ on ! date t is "o ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all e/abli% bus9ess processes to-- 7,a7 v]ify & update1 at lea/ once e #ij days1 ! provid] directory in=mation = all provid]s includ$ 9 ! onl9e heal? c>e provid] directory se>* tool describ$ 9 p>agraph 7#a77;,a77iii72 & 7,b7 remove any provid] f su* onl9e directory se>* tool if su* provid] has n v]ifi$ ! directory in=mation )9 ! previ\s #f mon?s or ! plan or issu] has be5 unable to v]ify ! provid]'s network p>ticipation4 7b7 ,co/-%>+ limitations 7#a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n apply1 & %all ensure t no provid] applies co/-%>+ to an enrollee = treatm5t or s]vices provid$ by a heal? c>e provid] 9 excess ( ! normal co/-%>+ appli$ = 9-network c>e 7includ+ any balance bill issu$ by ! heal? c>e provid] involv$71 if su* enrollee1 or heal? c>e provid] ref]r+ su* enrollee1 demon/rates 7bas$ on ! electronic1 writt5 in=mation describ$ 9 subsection 7a77#a77;,a77i71 ! oral confirmation describ$ 9 subsection 7a77#a77;,a77ii71 or a copy ( ! onl9e provid] directory describ$ 9 subsection 7a77#a77;,a77iii7 on ! date ! enrollee attempt$ to obta9 ! provid]'s network /atus7 t ! enrollee reli$ on ! in=mation describ$ 9 subsection 7a77#a71 if ! provid]'s network /atus or directory in=mation on su* directory 0 incorrect at ! "t ! treatm5t or s]vices involv$ 0 provid$4 7#b7 ,refunds to enrollees ,if a heal? c>e provid] submits a bill to an enrollee 9 violation ( p>agraph 7#a71 & ! enrollee pays su* bill1 ! provid] %all reimburse ! enrollee = ! full am\nt paid by ! enrollee 9 excess ( ! 9-network co/-%>+ am\nt = ! treatm5t or s]vices involv$1 plus int]e/1 at an int]e/ rate det]m9$ by ! ,secret>y4 7c7 ,provid] bus9ess processes ,a heal? c>e provid] %all h 9 place bus9ess processes to ensure ! timely provision ( provid] directory in=mation to a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age to support compliance by su* plans or issu]s ) subsection 7a77#a74 ,su* provid]s %all submit provid] directory in=mation to a plan or issu]s1 at a m9imum-- 7#a7 :5 ! provid] beg9s a network agreem5t ) a plan or ) an issu] ) respect to c]ta9 cov]age2 7#b7 :5 ! provid] t]m9ates a network agreem5t ) a plan or ) an issu] ) respect to c]ta9 cov]age2 7#c7 :5 !re are mat]ial *anges to ! cont5t ( provid] directory in=mation describ$ 9 subsection 7a77#a72 & 7#d7 e #ij days ?r\gh\t ! duration ( ! network agreem5t ) a plan or issu]4 7d7 ,en=cem5t 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a heal? c>e provid] t violates a requirem5t "u subsection 7c7 or takes actions t prev5t a gr\p heal? plan or heal? insurance issu] f comply+ ) subsection 7a77#a7 or 7b7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7#b7 ,safe h>bor ,! ,secret>y may waive ! p5alty describ$ "u p>agraph 7#a7 ) respect to a heal? c>e provid] t unkn[+ly violates subsection 7b77#a7 ) respect to an enrollee if su* provid] resc9ds ! bill involv$ &1 if applicable1 reimburses ! enrollee )9 #cj days ( ! date on :i* ! provid] bill$ ! enrollee 9 violation ( su* subsection4 7#c7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7e7 ,sav+s clause ,no?+ 9 ?is section %all prohibit a provid] f requir+ 9 ! t]ms ( a contract1 or contract t]m9ation1 ) a gr\p heal? plan or heal? insurance issu]-- 7#a7 t ! plan or issu] remove1 at ! "t ( t]m9ation ( su* contract1 ! provid] f a directory ( ! plan or issu] describ$ 9 subsection 7a77#a72 or 7#b7 t ! plan or issu] be> f9ancial responsibility1 includ+ "u subsection 7b71 = provid+ inaccurate network /atus in=mation to an enrollee4 7f7 ,def9ition ,= purposes ( ?is section1 ! t]m provid] directory in=mation includes ! names1 addresses1 specialty1 & telephone numb]s ( individual heal? c>e provid]s1 & ! names1 addresses1 & telephone numb]s ( ea* m$ical gr\p1 cl9ic1 or facility contract$ to p>ticipate 9 any ( ! networks ( ! gr\p heal? plan or heal? insurance cov]age involv$4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to preempt any provision ( ,/ate law relat+ to heal? c>e provid] directories or network adequacy4 4 7b7 ,effective date ,section #bgbi;,c ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect ) respect to plan ye>s beg9n+ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 #cje4 ,timely bills = pati5ts 7a7 ,9 g5]al 7#a7 ,am5dm5t ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+3 #cii,v-#g4 ,timely bills = pati5ts 7a7 ,9 g5]al ,! ,secret>y %all require-- 7#a7 heal? c>e facilities1 or 9 ! case ( practition]s provid+ s]vices outside ( su* a facility1 practition]s1 to provide to pati5ts a li/ ( s]vices r5d]$ dur+ ! visit to su* facility or practition]1 &1 9 ! case ( a facility1 ! "n ( ! provid] = ea* su* s]vice1 ^u dis*>ge or end ( ! visit or by po/al or electronic communication z soon z practicable & n lat] ?an #e cal5d> days aft] dis*>ge or date ( visit2 & 7#b7 heal? c>e facilities & practition]s to furni% all adjudicat$ bills to ! pati5t z soon z practicable1 b n lat] ?an #de cal5d> days aft] dis*>ge or date ( visit4 7b7 ,paym5t aft] bill+ ,no pati5t may be requir$ to pay a bill = heal? c>e s]vices any e>li] ?an #ce days aft] ! po/m>k date ( a bill = su* s]vices4 7c7 ,effect ( violation 7#a7 ,notification & refund requirem5ts 7,a7 ,provid] li/s ,if a facility or practition] fails to provide a pati5t a li/ z requir$ "u subsection 7a77#a71 su* facility or practition] %all report su* failure to ! ,secret>y4 7,b7 ,bill+ ,if a facility or practition] bills a pati5t aft] ! #de-;cal5d>-day p]iod describ$ 9 subsection 7a77#b71 su* facility or practition] %all-- 7i7 report su* bill to ! ,secret>y2 & 7ii7 refund ! pati5t = ! full am\nt paid 9 response to su* bill ) int]e/1 at a rate det]m9$ by ! ,secret>y4 7#b7 ,civil monet>y p5alties 7,a7 ,9 g5]al ,! ,secret>y may impose civil monet>y p5alties ( up to #aj1jjj a day on any facility or practition] t-- 7i7 fails to provide a li/ requir$ "u subsection 7a77#a7 m ?an #aj times1 beg9n+ on ! date ( su* t5? failure2 7ii7 submits m ?an #aj bills outside ( ! p]iod describ$ 9 subsection 7a77#b71 beg9n+ on ! date on :i* su* facility or practition] s5ds ! t5? su* bill2 7iii7 fails to report to ! ,secret>y any failure to provide li/s z requir$ "u p>agraph 7#a77;,a71 beg9n+ on ! date t is #de cal5d> days aft] dis*>ge or visit2 or 7iv7 fails to s5d any bill z requir$ "u subsection 7a77#b71 beg9n+ on ! date t is #de cal5d> days aft] ! date ( dis*>ge or visit1 z applicable4 7,b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#c7 ,safe h>bor ,! ,secret>y may exempt a practition] or facility f ! p5alties "u p>agraph 7#b77;,a7 or ext5d ! p]iod ( "t specifi$ "u subsection 7a77#b7 = compliance ) su* subsection if a practition] or facility-- 7,a7 makes a good-fai? attempt to s5d a bill )9 #cj days b is unable to d s because ( an incorrect address2 or 7,b7 exp]i5ces ext5uat+ circum/ances 7z def9$ by ! ,secret>y71 su* z a hurricane or cyb]attack1 t may reasonably delay deliv]y ( a timely bill4 4 7#b7 ,rulemak+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all promulgate f9al regulations to def9e ! t]m ext5uat+ circum/ance = purposes ( section #cii,v-#g7;c77#c77;,b7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by p>agraph 7#a74 7b7 ,gr\p heal? plan & heal? insurance issu] requirem5ts ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa71 z am5d$ by section #cjd1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,d4 ,timely bills = pati5ts 7a7 ,9 g5]al ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all h 9 place bus9ess practices ) respect to 9-network facilities & practition]s to ensure t claims are adjudicat$ 9 ord] to facilitate facility & practition] compliance ) ! requirem5ts "u section #cii,v-#g7;a74 7b7 ,cl>ification ,no?+ 9 subsection 7a7 prohibits a provid] & a gr\p heal? plan or heal? insurance issu] f e/abli%+ 9 a contract ! timel9e = submission by ei!r p>ty to ! o!r p>ty ( bill+ in=mation1 adjudication1 s5d+ ( remittance in=mation1 or any o!r coord9ation requir$ betwe5 ! provid] & ! plan or issu] necess>y = meet+ ! deadl9e describ$ 9 section #cii,v-#g7;a77#b74 4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect #f mon?s aft] ! date ( enactm5t ( ?is ,act4 #cjf4 ,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 seq471 z am5d$ by section #cje7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,e4 ,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 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 ( ! ,l[] ,heal? ,c>e ,co/s ,act1 n less frequ5tly ?an once e #f 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 ! plan sponsor 7z def9$ 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd7 ( su* gr\p heal? plan or heal? insurance cov]age 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* #c or m drugs are includ$ on ! =mul>y ( su* plan or cov]age-- 7,i7 ! am\nt receiv$1 or expect$ to be receiv$1 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+1 aft] d$uct+ rebates1 price concessions1 alt]native disc\nts or o!r remun]ation f drug manufactur]s1 by ! heal? plan or heal? insurance cov]age on t category or class ( drugs2 & 7,,iii7 ! net price p] c\rse ( treatm5t or #cj-;day supply 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>ty1 o!r ?an ! plan sponsor1 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#a71 except t su* issu] or entity may n re/rict disclosure ( su* report to gov]nm5tal ag5cies pursuant to an inve/igation or en=cem5t action4 7,c7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ( plan sponsors :o are drug manufactur]s1 drug :olesal]s1 or o!r direct p>ticipants 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7c7 ,limitations on spread pric+ 7#a7 ,prescription drug transactions ) ph>macies indep5d5t ( ! issu] or ph>macy b5efits manag] ,if ! ph>macy t disp5ses a prescription drug to an enrollee 9 a gr\p heal? plan or gr\p or individual heal? insurance cov]age is n :olly or p>tially-own$ by su* plan1 su* issu]1 or an entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 su* plan1 issu]1 or entity %all n *>ge ! plan1 issu]1 or enrollee a price = su* prescription drug t exce$s ! price paid to ! ph>macy1 exclud+ p5alties paid by ph>macies to su* plan1 issu]1 or entity4 7#b7 ,intra-company prescription drug transactions ,if ! mail ord]1 specialty1 or retail ph>macy t disp5ses a prescription drug to an enrollee 9 a gr\p heal? plan or heal? insurance cov]age is :olly or p>tially own$ by1 & submits claims to1 su* heal? insurance issu] or an entity provid+ ph>macy b5efit managem5t s]vices "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age1 ! price *>g$ = su* drug by su* ph>macy to su* gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age may n exce$ ! less] (-- 7,a7 ! am\nt paid to ! ph>macy = acquisition ( ! drug2 or 7,b7 ! m$ian price *>g$ to ! gr\p heal? plan or heal? insurance issu] :5 ! same drug is disp5s$ to enrollees 9 ! plan or cov]age by o!r simil>ly-situat$ ph>macies n :olly or p>tially own$ by ! heal? insurance issu] or entity provid+ ph>macy b5efits managem5t s]vices1 z describ$ 9 p>agraph 7#a74 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 report e #f mon?s 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] c\rse ( treatm5t or #cj-;day supply ) 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] c\rse ( treatm5t or #cj-;day supply1 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] c\rse ( treatm5t or #cj-;day supply1 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] c\rse ( treatm5t or #cj-;day supply1 = 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 ! gr\p heal? plan4 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 #ij 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]+ 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 subsection 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 7#e7 ,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 paym5ts to entities (f]+ ph>macy b5efits managem5t s]vices = bona fide s]vices us+ a fee /ructure n contemplat$ by ?is section1 provid$ t su* fees are transp>5t to gr\p heal? plans & heal? insurance issu]s4 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 sectionb#ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 4 #cjg4 ,gov]nm5t ,acc\ntability ,(fice /udy on pr(it- & rev5ue-%>+ 9 heal? c>e 7a7 ,/udy ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to-- 7#a7 describe :at is kn[n ab\t pr(it- & rev5ue-%>+ relation%ips 9 ! comm]cial heal? c>e m>kets1 includ+ ^? relation%ips t-- 7,a7 involve "o or m-- 7i7 physician gr\ps t practice )9 a hospital includ$ 9 ! pr(it- or rev5ue-%>+ relation%ip1 or ref] pati5ts to su* hospital2 7ii7 laboratory1 radiology1 or ph>macy s]vices t are deliv]$ to privately insur$ pati5ts ( su* hospital2 7iii7 surgical s]vices2 7iv7 hospitals or gr\p pur*as+ organizations2 or 7v7 rehabilitation or physical !rapy facilities or s]vices2 & 7,b7 include rev5ue- or pr(it-%>+ :e!r ?r\gh a jo9t v5ture1 managem5t or pr(essional s]vices agreem5t1 or o!r =m ( ga9-%>+ contract2 7#b7 describe ,f$]al ov]sight ( su* relation%ips1 includ+ au?orities ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,f$]al ,trade ,commission to review su* relation%ips & _! pot5tial to increase co/s = pati5ts1 & id5tify limitations 9 su* ov]sight2 & 7#c7 z appropriate1 make recomm5dations to improve ,f$]al ov]sight ( su* relation%ips4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all prep>e & submit a report on ! /udy conduct$ "u subsection 7a7 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,education & ,labor & ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 #cjh4 ,disclosure ( direct & indirect comp5sation = brok]s & consultants to employ]-sponsor$ heal? plans & enrollees 9 plans on ! individual m>ket 7a7 ,gr\p heal? plans ,section #djh7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77 is am5d$-- 7#a7 by /rik+ 7#b7 ,contract+ or mak+ & ins]t+ 7#b77;,a7 ,contract+ or mak+2 & 7#b7 by add+ at ! end ! foll[+3 7,b7 7i7 ,no contract or arrangem5t = s]vices betwe5 a cov]$ plan & a cov]$ s]vice provid]1 & no ext5sion or r5ewal ( su* a contract or arrangem5t1 is reasonable )9 ! mean+ ( ?is p>agraph unless ! requirem5ts ( ?is clause are met4 7ii7 7,i7 ,= purposes ( ?is subp>agraph3 7aa7 ,! t]m cov]$ plan means a gr\p heal? plan z def9$ section #gcc7;a74 7bb7 ,! t]m cov]$ s]vice provid] means a s]vice provid] t ent]s into a contract or arrangem5t ) ! cov]$ plan & reasonably expects #a1jjj 7or su* am\nt z ! ,secret>y may e/abli% 9 regulations to acc\nt = inflation s9ce ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 z appropriate7 or m 9 comp5sation1 direct or indirect1 to be receiv$ 9 connection ) provid+ "o or m ( ! foll[+ s]vices1 pursuant to ! contract or arrangem5t1 reg>dless ( :e!r su* s]vices w be p]=m$1 or su* comp5sation receiv$1 by ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor3 7,,aa7 ,brok]age s]vices1 = :i* ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive indirect comp5sation or direct comp5sation describ$ 9 item 7dd71 provid$ to a cov]$ plan ) respect to selection ( insurance products 7includ+ vision & d5tal71 recordkeep+ s]vices1 m$ical managem5t v5dor1 b5efits adm9i/ration 7includ+ vision & d5tal71 /op-loss insurance1 ph>macy b5efit managem5t s]vices1 wellness s]vices1 transp>5cy tools & v5dors1 gr\p pur*as+ organization pref]r$ v5dor panels1 disease managem5t v5dors & products1 compliance s]vices1 employee assi/ance programs1 or ?ird p>ty adm9i/ration s]vices4 7,,bb7 ,consult+1 = :i* ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive indirect comp5sation or direct comp5sation describ$ 9 item 7dd71 relat$ to ! developm5t or implem5tation ( plan design1 insurance or insurance product selection 7includ+ vision & d5tal71 recordkeep+1 m$ical managem5t1 b5efits adm9i/ration selection 7includ+ vision & d5tal71 /op-loss insurance1 ph>macy b5efit managem5t s]vices1 wellness design & managem5t s]vices1 transp>5cy tools1 gr\p pur*as+ organization agreem5ts & s]vices1 p>ticipation 9 & s]vices f pref]r$ v5dor panels1 disease managem5t1 compliance s]vices1 employee assi/ance programs1 or ?ird p>ty adm9i/ration s]vices4 7cc7 ,! t]m affiliate1 ) respect to a cov]$ s]vice provid]1 means an entity t directly or indirectly 7?r\gh "o or m int]m$i>ies7 controls1 is controll$ by1 or is "u common control )1 su* provid]1 or is an (fic]1 director1 or employee (1 or p>tn] 91 su* provid]4 7dd7 7,,aa7 ,! t]m comp5sation means any?+ ( monet>y value1 b does n include non-monet>y comp5sation valu$ at #bej 7or su* am\nt z ! ,secret>y may e/abli% 9 regulations to acc\nt = inflation s9ce ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 z appropriate7 or less1 9 ! aggregate1 dur+ ! t]m ( ! contract or arrangem5t4 7,,bb7 ,! t]m direct comp5sation means comp5sation receiv$ directly f a cov]$ plan4 7,,cc7 ,! t]m indirect comp5sation means comp5sation receiv$ f any s\rce o!r ?an ! cov]$ plan1 ! plan sponsor1 ! cov]$ s]vice provid]1 or an affiliate4 ,comp5sation receiv$ f a subcontractor is indirect comp5sation1 unless x is receiv$ 9 connection ) s]vices p]=m$ "u a contract or arrangem5t ) a subcontractor4 7ee7 ,! t]m responsible plan fiduci>y means a fiduci>y ) au?ority to cause ! cov]$ plan to ent] into1 or ext5d or r5ew1 ! contract or arrangem5t4 7ff7 ,! t]m subcontractor means any p]son or entity 7or an affiliate ( su* p]son or entity7 t is n an affiliate ( ! cov]$ s]vice provid] & t1 pursuant to a contract or arrangem5t ) ! cov]$ s]vice provid] or an affiliate1 reasonably expects to receive #a1jjj 7or su* am\nt z ! ,secret>y may e/abli% 9 regulations to acc\nt = inflation s9ce ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 z appropriate7 or m 9 comp5sation = p]=m+ "o or m s]vices describ$ 9 item 7bb7 "u a contract or arrangem5t ) ! cov]$ plan4 7,,ii7 ,= purposes ( ?is subp>agraph1 a description ( comp5sation or co/ may be express$ z a monet>y am\nt1 =mula1 or a p] capita *>ge = ea* enrollee or1 if ! comp5sation or co/ _c reasonably be express$ 9 su* t]ms1 by any o!r reasonable me?od1 includ+ a disclosure t additional comp5sation may be e>n$ b may n be calculat$ at ! "t ( contract if su* a disclosure includes a description ( ! circum/ances "u :i* ! additional comp5sation may be e>n$ & a reasonable & good fai? e/imate if ! cov]$ s]vice provid] _c o!rwise readily describe comp5sation or co/ & expla9s ! me?odology & assumptions us$ to prep>e su* e/imate4 ,any su* description %all conta9 suffici5t in=mation to p]mit evaluation ( ! reasonabl5ess ( ! comp5sation or co/4 7,,iii7 ,no p]son or entity is a cov]$ s]vice provid] )9 ! mean+ ( subclause 7,i77bb7 solely on ! basis ( provid+ s]vices z an affiliate or a subcontractor t is p]=m+ "o or m ( ! s]vices describ$ 9 subitem 7,,aa7 or 7,,bb7 ( su* subclause "u ! contract or arrangem5t ) ! cov]$ plan4 7iii7 ,a cov]$ s]vice provid] %all disclose to a responsible plan fiduci>y1 9 writ+1 ! foll[+3 7,i7 ,a description ( ! s]vices to be provid$ to ! cov]$ plan pursuant to ! contract or arrangem5t4 7,,ii7 ,if applicable1 a /atem5t t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor w provide1 or reasonably expects to provide1 s]vices pursuant to ! contract or arrangem5t directly to ! cov]$ plan z a fiduci>y 7)9 ! mean+ ( section #c7ba774 7,,iii7 ,a description ( all direct comp5sation1 ei!r 9 ! aggregate or by s]vice1 t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive 9 connection ) ! s]vices describ$ 9 subclause 7,i74 7,,iv7 7aa7 ,a description ( all indirect comp5sation t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive 9 connection ) ! s]vices describ$ 9 subclause 7,i7-- 7,,aa7 includ+ comp5sation f a v5dor to a brok]age firm bas$ on a /ructure ( inc5tives n solely relat$ to ! contract ) ! cov]$ plan2 & 7,,bb7 n includ+ comp5sation receiv$ by an employee f an employ] on acc\nt ( "w p]=m$ by ! employee4 7bb7 ,a description ( ! arrangem5t betwe5 ! pay] & ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor1 z applicable1 pursuant to :i* su* indirect comp5sation is paid4 7cc7 ,id5tification ( ! s]vices = :i* ! indirect comp5sation w be receiv$1 if applicable4 7dd7 ,id5tification ( ! pay] ( ! indirect comp5sation4 7,v7 ,a description ( any comp5sation t w be paid among ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor1 9 connection ) ! s]vices describ$ 9 subclause 7,i7 if su* comp5sation is set on a transaction basis 7su* z commissions1 f9d]'s fees1 or o!r simil> inc5tive comp5sation bas$ on bus9ess plac$ or reta9$71 includ+ id5tification ( ! s]vices = :i* su* comp5sation w be paid & id5tification ( ! pay]s & recipi5ts ( su* comp5sation 7includ+ ! /atus ( a pay] or recipi5t z an affiliate or a subcontractor71 reg>dless ( :e!r su* comp5sation also is disclos$ pursuant to subclause 7,,iii7 or 7,,iv74 7,,vi7 ,a description ( any comp5sation t ! cov]$ s]vice provid]1 an affiliate1 or a subcontractor reasonably expects to receive 9 connection ) t]m9ation ( ! contract or arrangem5t1 & h[ any prepaid am\nts w be calculat$ & refund$ ^u su* t]m9ation4 7iv7 ,a cov]$ s]vice provid] %all disclose to a responsible plan fiduci>y1 9 writ+ a description ( ! mann] 9 :i* ! comp5sation describ$ 9 clause 7iii71 z applicable1 w be receiv$4 7v7 7,i7 ,a cov]$ s]vice provid] %all disclose ! in=mation requir$ "u clauses 7iii7 & 7iv7 to ! responsible plan fiduci>y n lat] ?an ! date t is reasonably 9 advance ( ! date on :i* ! contract or arrangem5t is ent]$ into1 & ext5d$ or r5ew$4 7,,ii7 ,a cov]$ s]vice provid] %all disclose any *ange to ! in=mation requir$ "u clause 7iii7 & 7iv7 z soon z practicable1 b n lat] ?an #fj days f ! date on :i* ! cov]$ s]vice provid] is in=m$ ( su* *ange1 unless su* disclosure is preclud$ due to extraord9>y circum/ances beyond ! cov]$ s]vice provid]'s control1 9 :i* case ! in=mation %all be disclos$ z soon z practicable4 7vi7 7,i7 ,^u ! writt5 reque/ ( ! responsible plan fiduci>y or cov]$ plan adm9i/rator1 a cov]$ s]vice provid] %all furni% any o!r in=mation relat+ to ! comp5sation receiv$ 9 connection ) ! contract or arrangem5t t is requir$ = ! cov]$ plan to comply ) ! report+ & disclosure requirem5ts "u ?is ,act4 7,,ii7 ,! cov]$ s]vice provid] %all disclose ! in=mation requir$ "u clause 7iii77,i7 reasonably 9 advance ( ! date ^u :i* su* responsible plan fiduci>y or cov]$ plan adm9i/rator /ates t x is requir$ to comply ) ! applicable report+ or disclosure requirem5t1 unless su* disclosure is preclud$ due to extraord9>y circum/ances beyond ! cov]$ s]vice provid]'s control1 9 :i* case ! in=mation %all be disclos$ z soon z practicable4 7vii7 ,no contract or arrangem5t w fail to be reasonable "u ?is subp>agraph solely because ! cov]$ s]vice provid]1 act+ 9 good fai? & ) reasonable dilig5ce1 makes an error or omission 9 disclos+ ! in=mation requir$ pursuant to clause 7iii7 7or a *ange to su* in=mation disclos$ pursuant to clause 7v77,,ii77 or clause 7vi71 provid$ t ! cov]$ s]vice provid] discloses ! correct in=mation to ! responsible plan fiduci>y z soon z practicable1 b n lat] ?an #cj days f ! date on :i* ! cov]$ s]vice provid] kn[s ( su* error or omission4 7viii7 7,i7 ,pursuant to subsection 7a71 subp>agraphs 7,c7 & 7,d7 ( section #djf7;a77#a7 %all n apply to a responsible plan fiduci>y1 not)/&+ any failure by a cov]$ s]vice provid] to disclose in=mation requir$ "u clause 7iii71 if ! foll[+ conditions are met3 7aa7 ,! responsible plan fiduci>y did n "k t ! cov]$ s]vice provid] fail$ or w\ld fail to make requir$ disclosures & reasonably believ$ t ! cov]$ s]vice provid] disclos$ ! in=mation requir$ to be disclos$4 7bb7 ,! responsible plan fiduci>y1 ^u discov]+ t ! cov]$ s]vice provid] fail$ to disclose ! requir$ in=mation1 reque/s 9 writ+ t ! cov]$ s]vice provid] furni% su* in=mation4 7cc7 ,if ! cov]$ s]vice provid] fails to comply ) a writt5 reque/ describ$ 9 subclause 7,,ii7 )9 #ij days ( ! reque/1 ! responsible plan fiduci>y notifies ! ,secret>y ( ! cov]$ s]vice provid]'s failure1 9 accordance ) subclauses 7,,ii7 & 7,,iii74 7,,ii7 ,a notice describ$ 9 subclause 7,i77cc7 %all conta9-- 7aa7 ! "n ( ! cov]$ plan2 7bb7 ! plan numb] us$ = ! annual report on ! cov]$ plan2 7cc7 ! plan sponsor's "n1 address1 & employ] id5tification numb]2 7dd7 ! "n1 address1 & telephone numb] ( ! responsible plan fiduci>y2 7ee7 ! "n1 address1 phone numb]1 &1 if kn[n1 employ] id5tification numb] ( ! cov]$ s]vice provid]2 7ff7 a description ( ! s]vices provid$ to ! cov]$ plan2 7gg7 a description ( ! in=mation t ! cov]$ s]vice provid] fail$ to disclose2 7hh7 ! date on :i* su* in=mation 0 reque/$ 9 writ+ f ! cov]$ s]vice provid]2 & 7ii7 a /atem5t z to :e!r ! cov]$ s]vice provid] cont9ues to provide s]vices to ! plan4 7,,iii7 ,a notice describ$ 9 subclause 7,i77cc7 %all be fil$ ) ! ,dep>tm5t n lat] ?an #cj days foll[+ ! e>li] (-- 7aa7 ,! cov]$ s]vice provid]'s refusal to furni% ! in=mation reque/$ by ! writt5 reque/ describ$ 9 subclause 7,i77bb72 or 7bb7 #ij days aft] ! writt5 reque/ ref]r$ to 9 subclause 7,i77cc7 is made4 7,,iv7 ,if ! cov]$ s]vice provid] fails to comply ) ! writt5 reque/ "u subclause 7,i77bb7 )9 #ij days ( su* reque/1 ! responsible plan fiduci>y %all det]m9e :e!r to t]m9ate or cont9ue ! contract or arrangem5t "u section #djd4 ,if ! reque/$ in=mation relates to future s]vices & is n disclos$ promptly aft] ! end ( ! #ij-;day p]iod1 ! responsible plan fiduci>y %all t]m9ate ! contract or arrangem5t z exp$iti\sly z possible1 consi/5t ) su* duty ( prud5ce4 7ix7 ,no?+ 9 ?is subp>agraph %all be con/ru$ to sup]s$e any provision ( ,/ate law t gov]ns disclosures by p>ties t provide ! s]vices describ$ 9 ?is section1 except to ! ext5t t su* law prev5ts ! application ( a requirem5t ( ?is section4 4 7b7 ,applicability ( exi/+ regulations ,no?+ 9 ! am5dm5ts made by subsection 7a7 %all be con/ru$ to affect ! applicability ( section #beej4djh;b-#b ( title #bi1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ) respect to any applicable entity o!r ?an a cov]$ plan or a cov]$ s]vice provid] 7z def9$ 9 section #djh7;b77#b77;,b77ii7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z am5d$ by subsection 7a774 7c7 ,individual m>ket cov]age ,subp>t #a ( "p ,b ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#da et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgdf4 ,disclosure to enrollees ( individual m>ket cov]age 7a7 ,9 g5]al ,a heal? insurance issu] (f]+ individual heal? insurance cov]age %all make disclosures to enrollees 9 su* cov]age1 z describ$ 9 subsection 7b71 & reports to ! ,secret>y1 z describ$ 9 subsection 7c71 reg>d+ direct or indirect comp5sation provid$ to an ag5t or brok] associat$ ) enroll+ individuals 9 su* cov]age4 7b7 ,disclosure ,a heal? insurance issu] describ$ 9 subsection 7a7 %all disclose to an enrollee ! am\nt ( direct or indirect comp5sation provid$ to an ag5t or brok] = s]vices provid$ by su* ag5t or brok] associat$ ) plan selection & enrollm5t4 ,su* disclosure %all be-- 7#a7 made prior to ! individual f9aliz+ plan selection2 & 7#b7 includ$ on any docum5tation confirm+ ! individual's enrollm5t4 7c7 ,report+ ,a heal? insurance issu] describ$ 9 subsection 7a7 %all annually report to ! ,secret>y1 prior to ! beg9n+ ( op5 enrollm5t1 any direct or indirect comp5sation provid$ to an ag5t or brok] associat$ ) enroll+ individuals 9 su* cov]age4 7d7 ,rulemak+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y %all f9alize1 ?r\gh notice-&-comm5t rulemak+1 ! =m & mann] 9 :i* issu]s describ$ 9 subsection 7a7 are requir$ to make ! disclosures describ$ 9 subsection 7b7 & ! reports describ$ 9 subsection 7c74 4 7d7 ,transition rule ,no contract execut$ prior to ! effective date describ$ 9 subsection 7e7 by a gr\p heal? plan subject to ! requirem5ts ( section #djh7;b77#b77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7z am5d$ by subsection 7a77 or by a heal? insurance issu] subject to ! requirem5ts ( section #bgdf ( ! ,public ,heal? ,s]vice ,act 7z add$ by subsection 7c77 %all be subject to ! requirem5ts ( su* section #djh7 b77#b77;,b7 or su* section #bgdf1 z applicable4 7e7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7c7 %all take effect #b ye>s aft] ! date ( enactm5t ( ?is ,act4 #cji4 ,ensur+ enrollee access to co/-%>+ in=mation 7a7 ,9 g5]al ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 z am5d$ by section #cjf1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgbi;,f4 ,provision ( co/-%>+ in=mation 7a7 ,provid] disclosures ,a provid] t is 9-network ) respect to a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide to an enrollee 9 ! plan or cov]age :o submits a reque/ = ! in=mation describ$ 9 p>agraph 7#a7 or 7#b71 toge!r ) accurate & complete in=mation ab\t ! enrollee's cov]age "u ! applicable plan or cov]age-- 7#a7 z soon z practicable & n lat] ?an #b bus9ess days aft] ! enrollee reque/s su* in=mation1 a good fai? e/imate ( ! expect$ enrollee co/-%>+ = ! provision ( a p>ticul> heal? c>e s]vice 7includ+ any s]vice t is reasonably expect$ to be provid$ 9 conjunction ) su* specific s]vice72 & 7#b7 z soon z practicable & n lat] ?an #b bus9ess days aft] an enrollee reque/s su* in=mation1 ! contact in=mation = any ancill>y provid]s = a s*$ul$ heal? c>e s]vice4 7b7 ,insur] disclosures ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide an enrollee 9 ! plan or cov]age ) a good fai? e/imate ( ! enrollee's co/-%>+ 7includ+ d$uctibles1 copaym5ts1 & co9surance7 = :i* ! enrollee w\ld be responsible = pay+ ) respect to a specific heal? c>e s]vice 7includ+ any s]vice t is reasonably expect$ to be provid$ 9 conjunction ) su* specific s]vice71 z soon z practicable & n lat] ?an #b bus9ess days aft] a reque/ = su* in=mation by an enrollee4 7c7 ,en=cem5t 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 a heal? c>e provid] t violates a requirem5t "u subsection 7a7 %all be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* act con/itut+ su* violation4 7#b7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section1 %all apply to civil money p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a ( ! ,social ,security ,act4 4 7b7 ,effective date ,section #bgbi;,g ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all apply ) respect to plan ye>s beg9n+ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 #caj4 ,/r5g!n+ p>ity 9 m5tal heal? & sub/ance use disord] b5efits ,section #bgbf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#h7 ,compliance requirem5ts 7,a7 ,nonquantitative treatm5t limitation 7nqtl7 requirem5ts ,9 ! case ( a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age t provides bo? m$ical & surgical b5efits & m5tal heal? or sub/ance use disord] b5efits & t imposes nonquantitative treatm5t limitations 7ref]r$ to 9 ?is section z ,,nqtl7 on m5tal heal? or sub/ance use disord] b5efits1 ! plan or issu] (f]+ heal? insurance cov]age 9 connection ) su* a plan1 %all p]=m comp>ative analyses ( ! design & application ( ,n,q,t,ls 9 accordance ) ! foll[+ process1 & make available to ! applicable ,/ate au?ority 7or1 z applicable1 to ! ,secret>y ( ,labor ) respect to gr\p heal? plans or ! ,secret>y ( ,heal? & ,human ,s]vices ) respect to heal? insurance cov]age71 ^u reque/ )9 #fj days beg9n+ #f mon?s aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! foll[+ in=mation3 7i7 ,! specific plan or cov]age t]ms reg>d+ ! ,,nqtl1 t applies to su* plan or cov]age1 & a description ( all m5tal heal? or sub/ance use disord] & m$ical or surgical b5efits to :i* x applies 9 ea* respective b5efits classification4 7ii7 ,! factors us$ to det]m9e t ! ,,nqtl w apply to m5tal heal? or sub/ance use disord] b5efits & m$ical or surgical b5efits4 7iii7 ,! evid5ti>y /&>ds us$ = ! factors id5tifi$ 9 clause 7ii71 :5 applicable1 provid$ t e factor %all be def9$ & any o!r s\rce or evid5ce reli$ ^u to design & apply ! ,,nqtl to m5tal heal? or sub/ance use disord] b5efits & m$ical or surgical b5efits4 7iv7 ,! comp>ative analyses demon/rat+ t ! processes1 /rategies1 evid5ti>y /&>ds1 & o!r factors us$ to design ! ,,nqtl1 z writt51 & ! op]ation processes & /rategies z writt5 & 9 op]ation t are us$ to apply ! ,,nqtl = m5tal heal? or sub/ance use disord] b5efits are comp>able to1 & are appli$ no m /r+5tly ?an1 ! processes1 /rategies1 evid5ti>y /&>ds1 & o!r factors us$ to design ! ,,nqtl1 z writt51 & ! op]ation processes & /rategies z writt5 & 9 op]ation t are us$ to apply ! ,,nqtl to m$ical or surgical b5efits4 7v7 ,a disclosure ( ! specific f9d+s & conclusions rea*$ by ! plan or cov]age t ! results ( ! analyses describ$ 9 ?is subp>agraph indicate t ! plan or cov]age is 9 compliance ) ?is section4 7,b7 ,secret>y reque/ process 7i7 ,submission ^u reque/ ,) respect to gr\p heal? plans or heal? insurance cov]age = :i* ! ,secret>y is en=c+ ?is section 9 accordance ) section #bgbc1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,labor & ! ,secret>y ( ,treasury1 %all reque/ t a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age submit ! comp>ative analyses describ$ 9 subp>agraph 7,a7 = plans t involve pot5tial violations ( ?is section conc]n+ ,n,q,t,ls & any o!r in/ances 9 :i* ! ,secret>y det]m9es appropriate4 ,! ,secret>y %all reque/ n few] ?an #bj su* analyses p] ye>4 7ii7 ,additional in=mation ,9 in/ances 9 :i* ! ,secret>y has conclud$ t ! plan or cov]age has n submitt$ suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses describ$ 9 subp>agraph 7,a71 z reque/$ "u clause 7i71 ! ,secret>y %all specify to ! plan or cov]age ! in=mation ! plan or cov]age mu/ submit to be responsive to ! reque/ "u clause 7i7 = ! ,secret>y to review ! comp>ative analyses describ$ 9 subp>agraph7,a7 = compliance ) ?is section4 ,no?+ 9 ?is p>agraph %all require ! ,secret>y to conclude t a plan is 9 compliance ) ?is section solely bas$ ^u ! inspection ( ! comp>ative analyses describ$ 9 subp>agraph 7,a71 z reque/$ "u clause 7i74 7iii7 ,requir$ action ,9 in/ances 9 :i* ! ,secret>y has review$ ! comp>ative analyses describ$ 9 subp>agraph 7,a71 z reque/$ "u clause 7i71 & det]m9$ t ! plan or cov]age is n 9 compliance ) ?is section1 ! plan or cov]age %all specify to ! ,secret>y ! actions ! plan or cov]age w take to be 9 compliance ) ?is section4 ,docum5ts or communications produc$ 9 connection ) ! ,secret>y's recomm5dations to ! plan or cov]age %all n be subject to disclosure pursuant to section #eeb ( title #e1 ,unit$ ,/ates ,code4 7iv7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 & annually !reaft]1 ! ,secret>y %all submit to ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report t conta9s-- 7,i7 a summ>y ( ! comp>ative analyses reque/$ "u clause 7i71 except t ! id5tity ( ea* plan or cov]age & any contract$ entity ( a plan or cov]age %all be r$act$2 7,,ii7 ! ,secret>y's conclusions z to :e!r ea* plan or cov]age submitt$ suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses reque/$ "u clause 7i7 = compliance ) ?is section2 7,,iii7 = ea* plan or cov]age t did submit suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses reque/$ "u clause 7i71 ! ,secret>y's conclusions z to :e!r & :y ! plan or cov]age is 9 compliance ) ! disclosure requirem5ts "u ?is section2 7,,iv7 ! ,secret>y's specifications describ$ 9 clause 7ii7 = ea* plan or cov]age t ! ,secret>y det]m9$ did n submit suffici5t in=mation = ! ,secret>y to review ! comp>ative analyses reque/$ "u clause 7i7 = compliance ) ?is section2 & 7,v7 ! ,secret>y's specifications describ$ 9 clause 7iii7 ( ! actions ea* plan or cov]age t ! ,secret>y det]m9$ is n 9 compliance ) ?is section mu/ take to be 9 compliance ) ?is section1 includ+ ! reason :y ! ,secret>y det]m9$ ! plan or cov]age is n 9 compliance4 7,c7 ,compliance program guidance docum5t update process 7i7 ,9 g5]al ,! ,secret>y %all include select in/ances ( noncompliance t ! ,secret>y discov]s ^u review+ ! comp>ative analyses reque/$ "u subp>agraph 7,b77i7 9 ! compliance program guidance docum5t describ$ 9 section #bgbf7;a77#f71 z x is updat$ e #b ye>s1 except t all in/ances %all be deid5tifi$ & su* in/ances %all n disclose any protect$ heal? in=mation or individually id5tifiable in=mation4 7ii7 ,guidance & regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all f9alize any draft or int]im guidance & regulations relat+ to m5tal heal? p>ity "u ?is section4 7iii7 ,/ate ,! ,secret>y %all %>e in=mation on f9d+s ( compliance & noncompliance discov]$ ^u review+ ! comp>ative analyses reque/$ "u subp>agraph 7,b77i7 %all be %>$ ) ! ,/ate :]e ! gr\p heal? plan is locat$ or ! ,/ate :]e ! heal? insurance issu] is lic5s$ to d bus9ess = cov]age (f]$ by a heal? insurance issu] 9 ! gr\p m>ket1 9 accordance ) section #bgbf7;a77#f77;,b77iii77,,ii74 4 #caa4 ,te*nical am5dm5ts 7a7 ,,erisa ,section #gae ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;d7 is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7,b7 by /rik+ 7z s am5d$74 7b7 ,,irc ,section #ihae ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 9 subsection 7a77#a71 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7#b7 9 subsection 7b7-- 7,a7 by /rik+ 7z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act7 & ins]t+ 7includ+ any subsequ5t am5dm5ts to su* "p72 & 7,b7 by /rik+ 7z s am5d$74 7c7 ,applicability ,! am5dm5ts made by subsections 7a7 & 7b7 %all take effect z ?\gh includ$ 9 ! enactm5t ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh74 #cab4 ,?ird-p>ty adm9i/rators ,any obligation on a ?ird-p>ty adm9i/rator "u ?is ,act 7includ+ ! am5dm5ts 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 #cac4 ,gr\p heal? plan report+ requirem5ts ,"p ,c ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 z am5d$ by section #cjc1 is fur!r am5d$ by add+ at ! end ! foll[+3 #bgig4 ,gr\p heal? plan report+ 7a7 ,9 g5]al ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all submit to ! ,secret>y1 n lat] ?an ,m>* #a ( ea* ye>1 ! foll[+ in=mation ) respect to ! heal? plan 9 ! previ\s plan ye>3 7#a7 ,! beg9n+ & end dates ( ! plan ye>4 7#b7 ,! numb] ( enrollees4 7#c7 ,ea* ,/ate 9 :i* ! plan is (f]$4 7#d7 ,! #ej br& prescription drugs mo/ frequ5tly disp5s$ by ph>macies = claims paid by ! issu]1 & ! total numb] ( paid claims = ea* su* drug4 7#e7 ,! #ej mo/ co/ly prescription drugs ) respect to ! plan by total annual sp5d+1 & ! annual am\nt sp5t by ! plan = ea* su* drug4 7#f7 ,! #ej prescription drugs ) ! greate/ increase 9 plan exp5ditures ov] ! plan ye> prec$+ ! plan ye> t is ! subject ( ! report1 &1 = ea* su* drug1 ! *ange 9 am\nts exp5d$ by ! plan 9 ea* su* plan ye>4 7#g7 ,total sp5d+ on heal? c>e s]vices by su* gr\p heal? plan1 brok5 d[n by-- 7,a7 ! type ( co/s1 includ+-- 7i7 hospital co/s2 7ii7 heal? c>e provid] & cl9ical s]vice co/s2 7iii7 co/s = prescription drugs2 & 7iv7 o!r m$ical co/s2 & 7,b7 sp5d+ on prescription drugs by-- 7i7 ! heal? plan2 & 7ii7 ! enrollees4 7#h7 ,! av]age mon?ly premium-- 7,a7 paid by employ]s on behalf ( enrollees2 & 7,b7 paid by enrollees4 7#i7 ,any impact on premiums by rebates1 fees1 & any o!r remun]ation paid by drug manufactur]s to ! plan or its adm9i/rators or s]vice provid]s1 ) respect to prescription drugs prescrib$ to enrollees 9 ! plan1 includ+-- 7,a7 ! am\nts s paid = ea* !rapeutic class ( drugs2 & 7,b7 ! am\nts s paid = ea* ( ! #be drugs t yield$ ! highe/ am\nt ( rebates & o!r remun]ation "u ! plan f drug manufactur]s dur+ ! plan ye>4 7#aj7 ,any r$uction 9 premiums & out-(-pocket co/s associat$ ) rebates1 fees1 or o!r remun]ation describ$ 9 p>agraph 7#i74 7b7 ,report ,n lat] ?an #ah mon?s aft] ! date on :i* ! fir/ report is requir$ "u subsection 7a7 & biannually !reaft]1 ! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y ( ,plann+ & ,evaluation & 9 coord9ation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all make available on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices a report on prescription drug reimbursem5ts "u gr\p heal? plans1 prescription drug pric+ tr5ds1 & ! role ( prescription drug co/s 9 contribut+ to premium increases or decreases "u su* plans1 aggregat$ 9 su* a way z no drug or plan specific in=mation w be made public4 7c7 ,privacy protections ,no confid5tial or trade secret in=mation submitt$ to ! ,secret>y "u subsection 7a7 %all be includ$ 9 ! report "u subsection 7b74 4 #cad4 ,/udy by ,comptroll] ,g5]al ( ,unit$ ,/ates 7a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all1 9 consultation ) appropriate /akehold]s1 conduct a /udy on ! role ( ph>macy b5efit manag]s4 7b7 ,p]missible exam9ation ,9 conduct+ ! /udy requir$ "u subsection 7a71 ! ,comptroll] ,g5]al may exam9e v>i\s qualitative & quantitative aspects ( ! role ( ph>macy b5efit manag]s1 su* z ! foll[+3 7#a7 ,! role t ph>macy b5efit manag]s play 9 ! ph>maceutical supply *a94 7#b7 ,! /ate ( competition among ph>macy b5efit manag]s1 includ+ ! m>ket %>e = ! ,nation's l>ge/ ph>macy b5efit manag]s4 7#c7 ,! use ( rebates & fees by ph>macy b5efit manag]s1 includ+-- 7,a7 ! ext5t to :i* rebates are pass$ on to heal? plans & :e!r su* rebates are pass$ on to individuals enroll$ 9 su* plans2 7,b7 ! ext5t to :i* rebates are kept by su* ph>macy b5efit manag]s2 & 7,c7 ! role ( any fees *>g$ by su* ph>macy b5efit manag]s4 7#d7 ,:e!r ph>macy b5efit manag]s /ructure _! =mul>ies 9 favor ( high-rebate prescription drugs ov] l[]-co/1 l[]-rebate alt]natives4 7#e7 ,! av]age prior au?orization approval "t = ph>macy b5efit manag]s4 7#f7 ,factors affect+ ! use ( /ep !rapy by ph>macy b5efit manag]s4 7c7 ,report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a71 includ+ policy recomm5dations4 ,,iv ,improv+ public heal? #dja4 ,improv+ aw>5ess ( disease prev5tion ,! ,public ,heal? ,s]vice ,act is am5d$ by /rik+ section #cac ( su* ,act 7#db ,u4,s4,c4 #bde7 & ins]t+ ! foll[+3 #cac4 ,public aw>5ess campaign on ! importance ( vacc9ations 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r (fices & ag5cies1 z appropriate1 %all aw>d competitive grants to "o or m public or private entities to c>ry out a national1 evid5ce-bas$ campaign to increase aw>5ess & k ( ! safety & effectiv5ess ( vacc9es = ! prev5tion & control ( diseases1 combat mis9=mation ab\t vacc9es1 & dissem9ate sci5tific & evid5ce-bas$ vacc9e-relat$ in=mation1 ) ! goal ( increas+ rates ( vacc9ation across all ages1 z applicable1 p>ticul>ly 9 communities ) l[ rates ( vacc9ation1 to r$uce & elim9ate vacc9e-prev5table diseases4 7b7 ,consultation ,9 c>ry+ out ! campaign "u ?is section1 ! ,secret>y %all consult ) appropriate public heal? & m$ical exp]ts1 includ+ ! ,national ,academy ( ,m$ic9e & m$ical & public heal? associations & nonpr(it organizations1 9 ! developm5t1 implem5tation1 & evaluation ( ! evid5ce-bas$ public aw>5ess campaign4 7c7 ,requirem5ts ,! campaign "u ?is section %all-- 7#a7 be a national1 evid5ce-bas$ initiative2 7#b7 include ! developm5t ( res\rces = communities ) l[ rates ( vacc9ation1 includ+ culturally- & l+ui/ically-appropriate res\rces1 z applicable2 7#c7 include ! dissem9ation ( vacc9e in=mation & communication res\rces to public heal? dep>tm5ts1 heal? c>e provid]s1 & heal? c>e facilities1 includ+ su* provid]s & facilities t provide pr5atal & p$iatric c>e2 7#d7 be complem5t>y to1 & coord9at$ )1 any o!r ,f$]al1 ,/ate1 local1 or ,tribal ef=ts1 z appropriate2 & 7#e7 assess ! effectiv5ess ( communication /rategies to increase rates ( vacc9ation4 7d7 ,additional activities ,! campaign "u ?is section may-- 7#a7 include ! use ( television1 radio1 ! int]net1 & o!r m$ia & telecommunications te*nologies2 7#b7 be focus$ to address specific ne$s ( communities & populations ) l[ rates ( vacc9ation2 & 7#c7 include ! dissem9ation ( sci5tific & evid5ce-bas$ vacc9e-relat$ in=mation1 su* z-- 7,a7 advancem5ts 9 evid5ce-bas$ rese>* relat$ to diseases t may be prev5t$ by vacc9es & vacc9e developm5t2 7,b7 in=mation on vacc9ations = individuals & communities1 includ+ individuals = :om vacc9es are n recomm5d$ by ! ,advisory ,committee = ,immunization ,practices1 & ! effects ( l[ vacc9ation rates )9 a community on su* individuals2 7,c7 in=mation on diseases t may be prev5t$ by vacc9es2 & 7,d7 in=mation on vacc9e safety & ! sy/ems 9 place to monitor vacc9e safety4 7e7 ,evaluation ,! ,secret>y %all-- 7#a7 e/abli% b5*m>ks & metrics to quantitatively measure & evaluate ! aw>5ess campaign "u ?is section2 7#b7 conduct qualitative assessm5ts reg>d+ ! aw>5ess campaign "u ?is section2 & 7#c7 prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives an evaluation ( ! aw>5ess campaign "u ?is section4 7f7 ,supplem5t n supplant ,funds appropriat$ "u ?is section %all be us$ to supplem5t & n supplant o!r ,f$]al1 ,/ate1 & local public funds provid$ = activities describ$ 9 ?is section4 7g7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section & section #cag7k7 su* sums z may be necess>y = fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djb4 ,grants to address vacc9e-prev5table diseases 7a7 ,9 g5]al ,section #cag7k77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b7k77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subp>agraph 7,d71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7,e7 plann+1 implem5tation1 & evaluation ( activities to address vacc9e-prev5table diseases1 includ+ activities to-- 7i7 id5tify communities at high risk ( outbreaks relat$ to vacc9e-prev5table diseases1 includ+ ?r\gh improv$ data collection & analysis2 7ii7 pilot innovative approa*es to improve vacc9ation rates 9 communities & among populations ) l[ rates ( vacc9ation2 7iii7 r$uce b>ri]s to access+ vacc9es & evid5ce-bas$ in=mation ab\t ! heal? effects ( vacc9es2 7iv7 p>tn] ) community organizations & heal? c>e provid]s to develop & deliv] evid5ce-bas$ int]v5tions1 includ+ culturally- & l+ui/ically-appropriate int]v5tions1 to increase vacc9ation rates2 7v7 improve deliv]y ( evid5ce-bas$ vacc9e-relat$ in=mation to p>5ts & o!rs2 & 7vi7 improve ! ability ( ,/ate1 local1 tribal1 & t]ritorial public heal? dep>tm5ts to engage communities at high risk = outbreaks relat$ to vacc9e-prev5table diseases2 & 7,f7 rese>* relat$ to /rategies = improv+ aw>5ess ( sci5tific & evid5ce-bas$ vacc9e-relat$ in=mation1 includ+ = communities ) l[ rates ( vacc9ation1 9 ord] to und]/& b>ri]s to vacc9ation1 improve vacc9ation rates1 & assess ! public heal? outcomes ( su* /rategies4 4 7b7 ,supplem5tal grant funds ,section #ccj7;d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;b7 is am5d$-- 7#a7 9 subp>agraph 7,f71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,g71 by /rik+ ! p]iod & & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,h7 improv+ access to recomm5d$ immunizations4 4 #djc4 ,guide on evid5ce-bas$ /rategies = public heal? dep>tm5t obesity prev5tion programs 7a7 ,developm5t & dissem9ation ( an evid5ce-bas$ /rategies guide ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 %all-- 7#a7 develop a guide on evid5ce-bas$ /rategies = ,/ate1 t]ritorial1 & local heal? dep>tm5ts to use to build & ma9ta9 effective obesity prev5tion & r$uction programs1 &1 9 consultation ) ,indian ,tribes & ,tribal organizations1 a guide on su* evid5ce-bas$ /rategies ) respect to ,indian ,tribes & ,tribal organizations = su* ,indian ,tribes & ,tribal organizations to use = su* purpose1 bo? ( :i* guides %all-- 7,a7 describe an integrat$ program /ructure = implem5t+ int]v5tions prov5 to be effective 9 prev5t+ & r$uc+ ! incid5ce ( obesity2 & 7,b7 recomm5d-- 7i7 optimal res\rces1 includ+ /aff+ & infra/ructure1 = promot+ nutrition & obesity prev5tion & r$uction2 & 7ii7 /rategies = effective obesity prev5tion programs = ,/ate1 t]ritorial1 & local heal? dep>tm5ts1 ,indian ,tribes1 & ,tribal organizations1 includ+ /rategies relat$ to-- 7,i7 ! application ( evid5ce-bas$ & evid5ce-in=m$ practices to prev5t & r$uce obesity rates2 7,,ii7 ! developm5t1 implem5tation1 & evaluation ( obesity prev5tion & r$uction /rategies = specific communities & populations2 7,,iii7 demon/rat$ k ( obesity prev5tion practices t r$uce associat$ prev5table diseases1 heal? conditions1 dea?1 & heal? c>e co/s2 7,,iv7 be/ practices = ! coord9ation ( ef=ts to prev5t & r$uce obesity & relat$ *ronic diseases2 7,v7 address+ ! und]ly+ risk factors & social det]m9ants ( heal? t impact obesity rates2 & 7,,vi7 int]discipl9>y coord9ation betwe5 relevant public heal? (ficials specializ+ 9 fields su* z nutrition1 physical activity1 epidemiology1 communications1 & policy implem5tation1 & collaboration betwe5 public heal? (ficials1 community-bas$ organizations1 & o!rs1 z appropriate2 & 7#b7 dissem9ate ! guides & curr5t rese>*1 evid5ce-bas$ practices1 tools1 & educational mat]ials relat$ to obesity prev5tion1 consi/5t ) ! guide1 to ,/ate1 t]ritorial1 & local heal? dep>tm5ts1 ,indian ,tribes1 & ,tribal organizations4 7b7 ,te*nical assi/ance ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all provide te*nical assi/ance to ,/ate1 t]ritorial1 & local heal? dep>tm5ts1 ,indian ,tribes1 & ,tribal organizations to support su* heal? dep>tm5ts 9 implem5t+ ! guide develop$ "u subsection 7a77#a74 7c7 ,indian ,tribes2 ,tribal organizations ,! t]ms ,indian ,tribe & ,tribal organization h ! mean+s giv5 ! t]ms ,indian tribe & tribal organization1 respectively1 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #ecjd74 #djd4 ,exp&+ capacity = heal? outcomes ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ccj,m 7#db ,u4,s4,c4 #bed;c-#ai7 ! foll[+3 #ccj,n4 ,exp&+ capacity = heal? outcomes 7a7 ,def9itions ,9 ?is section3 7#a7 ,eligible entity ,! t]m eligible entity means an entity provid+ heal? c>e s]vices 9 rural areas1 fronti] areas1 heal? pr(essional %ortage areas1 or m$ically und]s]v$ areas1 or to m$ically und]s]v$ populations or ,native ,am]icans1 includ+ ,indian tribes or tribal organizations4 7#b7 ,heal? pr(essional %ortage area ,! t]m heal? pr(essional %ortage area means a heal? pr(essional %ortage area designat$ "u section #ccb4 7#c7 ,indian tribe ,! t]ms ,indian tribe & tribal organization h ! mean+s giv5 su* t]ms 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act4 7#d7 ,m$ically und]s]v$ population ,! t]m m$ically und]s]v$ population has ! mean+ giv5 ! t]m 9 section #ccj7;b77#c74 7#e7 ,native ,am]icans ,! t]m ,native ,am]icans has ! mean+ giv5 su* t]m 9 section #gcf & includes ,indian tribes & tribal organizations4 7#f7 ,te*nology-enabl$ collaborative le>n+ & capacity build+ model ,! t]m te*nology-enabl$ collaborative le>n+ & capacity build+ model means a di/ance heal? education model t connects heal? c>e pr(essionals1 & p>ticul>ly speciali/s1 ) multiple o!r heal? c>e pr(essionals ?r\gh simultane\s int]active videoconf]5c+ = ! purpose ( facilitat+ case-bas$ le>n+1 dissem9at+ be/ practices1 & evaluat+ outcomes4 7b7 ,program e/abli%$ ,! ,secret>y %all1 z appropriate1 aw>d grants to evaluate1 develop1 &1 z appropriate1 exp& ! use ( te*nology-enabl$ collaborative le>n+ & capacity build+ models1 to increase access to heal? c>e s]vices1 su* z ^? to address *ronic diseases & conditions1 m5tal heal?1 sub/ance use disord]s1 pr5atal & mat]nal heal?1 p$iatric c>e1 pa9 managem5t1 palliative c>e1 & o!r specialty c>e 9 rural areas1 fronti] areas1 heal? pr(essional %ortage areas1 or m$ically und]s]v$ areas & = m$ically und]s]v$ populations or ,native ,am]icans1 includ+ ,indian ,tribes & ,tribal organizations4 7c7 ,use ( funds 7#a7 ,9 g5]al ,grants aw>d$ "u subsection 7b7 %all be us$ =-- 7,a7 ! developm5t & acquisition ( in/ructional programm+1 & ! tra9+ ( heal? c>e provid]s & o!r pr(essionals t provide or assi/ 9 ! provision ( s]vices ?r\gh su* models2 7,b7 in=mation collection & evaluation activities to /udy ! impact ( su* models on pati5t outcomes & heal? c>e provid]s1 & to id5tify be/ practices = ! expansion & use ( su* models2 or 7,c7 o!r activities consi/5t ) a*iev+ ! objectives ( ! grants aw>d$ "u ?is section1 z det]m9$ by ! ,secret>y4 7#b7 ,o!r uses ,9 addition to any ( ! uses "u p>agraph 7#a71 grants aw>d$ "u subsection 7b7 may be us$ =-- 7,a7 equipm5t to support ! use & expansion ( te*nology-enabl$ collaborative le>n+ & capacity build+ models1 includ+ = h>dw>e & s(tw>e t enables di/ance le>n+1 heal? c>e provid] support1 & ! secure ex*ange ( electronic heal? in=mation2 or 7,b7 support = heal? c>e provid]s & o!r pr(essionals t provide or assi/ 9 ! provision ( s]vices ?r\gh su* models4 7d7 ,l5g? ( grants ,grants aw>d$ "u subsection 7b7 %all be = a p]iod ( up to #e ye>s4 7e7 ,application ,an eligible entity t seeks to receive a grant "u subsection 7b7 %all submit to ! ,secret>y an application1 at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 ,su* application crit]ia %all include an assessm5t ( ! effect ( te*nology-enabl$ collaborative le>n+ & capacity build+ models on pati5t outcomes & heal? c>e provid]s4 7f7 ,access to broadb& ,9 adm9i/]+ grants "u ?is section1 ! ,secret>y may coord9ate ) o!r ag5cies to ensure t fund+ opportunities are available to support access to reliable1 high-spe$ int]net = grantees4 7g7 ,te*nical assi/ance ,! ,secret>y %all provide 7ei!r directly ?r\gh ! ,dep>tm5t ( ,heal? & ,human ,s]vices or by contract7 te*nical assi/ance to eligible entities1 includ+ recipi5ts ( grants "u subsection 7b71 on ! developm5t1 use1 & evaluation ( te*nology-enabl$ collaborative le>n+ & capacity build+ models 9 ord] to exp& access to heal? c>e s]vices provid$ by su* entities1 includ+ = m$ically und]s]v$ areas & to m$ically und]s]v$ populations or ,native ,am]icans1 includ+ ,indian tribes & ,tribal organizations4 7h7 ,rese>* & evaluation ,! ,secret>y1 9 consultation ) /akehold]s ) appropriate exp]tise 9 su* models1 %all develop a /rategic plan to rese>* & evaluate ! evid5ce = su* models4 ,! ,secret>y %all use su* plan to in=m ! activities c>ri$ out "u ?is section4 7i7 ,report by ,secret>y ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 & po/ on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 a report includ+1 at m9imum-- 7#a7 a description ( any new & cont9u+ grants aw>d$ to entities "u subsection 7b7 & ! specific purpose & am\nts ( su* grants2 7#b7 an ov]view (-- 7,a7 ! evaluations conduct$ "u subsections 7b7 or 7f72 & 7,b7 te*nical assi/ance provid$ "u subsection 7g72 & 7#c7 a description ( any significant f9d+s or developm5ts 9 pati5t outcomes & heal? c>e provid]s & be/ practices = eligible entities exp&+1 us+1 or evaluat+ te*nology-enabl$ collaborative le>n+ & capacity build+ models1 includ+ ?r\gh ! activities describ$ 9 subsection 7g74 7j7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 #dje4 ,public heal? data sy/em mod]nization ,subtitle ,c ( title ,,xxviii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is am5d$ by add+ at ! end ! foll[+3 #bhbb4 ,public heal? data sy/em mod]nization grants 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all-- 7#a7 aw>d grants to ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts = ! expansion & mod]nization ( public heal? data sy/ems1 to assi/ public heal? dep>tm5ts 9-- 7,a7 assess+ curr5t data infra/ructure capabilities & gaps to improve & increase consi/5cy 9 data collection1 /orage1 analysis1 &1 z appropriate1 to improve dissem9ation ( public heal?-relat$ in=mation2 7,b7 improv+ secure public heal? data collection1 transmission1 ex*ange1 ma9t5ance1 & analysis2 7,c7 simplify+ & support+ report+ by heal? c>e provid]s1 z applicable1 pursuant to ,/ate law1 includ+ ?r\gh ! use ( heal? in=mation te*nology1 to ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts1 includ+ public heal? (ficials 9 multiple jurisdictions )9 su* ,/ate1 z appropriate2 7,d7 enhanc+ int]op]ability ( public heal? data sy/ems 7includ+ sy/ems creat$ or access$ by public heal? dep>tm5ts7 ) heal? in=mation te*nology1 includ+ heal? in=mation te*nology c]tifi$ "u section #cjja7;c77#e72 7,e7 support+ e>li] disease & heal? condition detection1 su* z ?r\gh ne> real-"t data monitor+1 to support rapid public heal? responses2 & 7,f7 support+ activities )9 ! applicable jurisdiction relat$ to ! expansion & mod]nization ( electronic case report+2 7#b7 z appropriate1 conduct activities relat$ to ! int]op]ability & improvem5t ( applicable public heal? data sy/ems us$ by ! ,c5t]s = ,disease ,control & ,prev5tion1 &1 9 coord9ation ) ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 ! designation ( data & te*nology /&>ds = heal? in=mation sy/ems ( ! public heal? infra/ructure ) def]5ce giv5 to /&>ds publi%$ by /&>ds developm5t organizations & volunt>y cons5sus-bas$ /&>ds bodies2 & 7#c7 develop & utilize public-private p>tn]%ips = te*nical assi/ance & relat$ implem5tation support = ,/ate1 local1 ,tribal1 & t]ritorial public heal? dep>tm5ts1 & ! ,c5t]s = ,disease ,control & ,prev5tion1 on ! expansion & mod]nization ( electronic case report+ & public heal? data sy/ems1 z applicable4 7b7 ,requirem5ts 7#a7 ,9 g5]al ,! ,secret>y may n aw>d a grant "u subsection 7a77#a7 unless ! applicant uses or agrees to use /&>ds recogniz$ by ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology pursuant to section #cjja7;c77#a7 or adopt$ by ! ,secret>y "u section #cjjd4 7#b7 ,waiv] ,! ,secret>y may waive ! requirem5t "u p>agraph 7#a7 ) respect to an applicant if ! ,secret>y det]m9es t ! activities "u subsection 7a7 _c o!rwise be c>ri$ out )9 ! applicable jurisdiction4 7#c7 ,application ,a ,/ate1 local1 ,tribal1 or t]ritorial heal? dep>tm5t apply+ = a grant "u ?is section %all submit an application to ! ,secret>y at su* "t & 9 su* mann] z ! ,secret>y may require4 ,su* application %all include in=mation describ+-- 7,a7 ! activities t w be support$ by ! grant2 & 7,b7 h[ ! mod]nization ( su* public heal? data sy/ems w support or impact ! public heal? infra/ructure ( ! heal? dep>tm5t1 includ+ a description ( rema9+ gaps1 if any1 & ! actions ne$$ to address su* gaps4 7c7 ,use ( funds ,an entity receiv+ a grant "u ?is section may use am\nts receiv$ "u su* grant = "o or bo? ( ! foll[+3 7#a7 ,c>ry+ out activities describ$ 9 subsection 7a77#a7 to support public heal? data sy/ems 7includ+ electronic case report+71 :i* may include support =1 & tra9+ (1 pr(essionals ) exp]tise 9 contribut+ to & us+ su* sy/ems 7includ+ public heal? data sci5ti/s74 7#b7 ,develop+ & dissem9at+ in=mation relat$ to ! use & importance ( public heal? data4 7d7 ,/rategy & implem5tation plan ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a coord9at$ /rategy & an accompany+ implem5tation plan t id5tifies & demon/rates ! /eps ! ,secret>y w c>ry out to-- 7#a7 update & improve applicable public heal? data sy/ems us$ by ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7#b7 c>ry out ! activities describ$ 9 ?is section to support ! improvem5t ( ,/ate1 local1 ,tribal1 & t]ritorial public heal? data sy/ems4 7e7 ,consultation ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all consult ) ,/ate1 local1 ,tribal1 & t]ritorial heal? dep>tm5ts1 pr(essional m$ical & public heal? associations1 associations repres5t+ hospitals or o!r heal? c>e entities1 heal? in=mation te*nology exp]ts1 & o!r appropriate entities reg>d+ ! plan & grant program to mod]nize public heal? data sy/ems pursuant to ?is section4 ,su* activities may include ! provision ( te*nical assi/ance relat$ to ! ex*ange ( in=mation by su* public heal? data sy/ems us$ by relevant heal? c>e & public heal? entities at ! local1 ,/ate1 ,f$]al1 ,tribal1 & t]ritorial levels4 7f7 ,report to ,congress ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all submit a report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives t includes-- 7#a7 a description ( any b>ri]s to-- 7,a7 public heal? au?orities implem5t+ int]op]able public heal? data sy/ems & electronic case report+2 7,b7 ! ex*ange ( in=mation pursuant to electronic case report+2 or 7,c7 report+ by heal? c>e provid]s us+ su* public heal? data sy/ems1 z appropriate1 & pursuant to ,/ate law2 7#b7 an assessm5t ( ! pot5tial public heal? impact ( implem5t+ electronic case report+ & int]op]able public heal? data sy/ems2 & 7#c7 a description ( ! activities c>ri$ out pursuant to ?is section4 7g7 ,electronic case report+ ,9 ?is section1 ! t]m electronic case report+ means ! automat$ id5tification1 g5]ation1 & bilat]al ex*ange ( reports ( heal? ev5ts among electronic heal? record or heal? in=mation te*nology sy/ems & public heal? au?orities4 7h7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ su* sums z may be necess>y = fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djf4 ,innovation = mat]nal heal? ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ccj,n ( su* ,act1 z add$ by section #djd1 ! foll[+3 #ccj,o4 ,innovation = mat]nal heal? 7a7 ,9 g5]al ,! ,secret>y1 9 consultation ) exp]ts repres5t+ a v>iety ( cl9ical specialties1 ,/ate1 tribal1 or local public heal? (ficials1 rese>*]s1 epidemiologi/s1 /ati/icians1 & community organizations1 %all e/abli% or cont9ue a program to aw>d competitive grants to eligible entities = ! purpose (-- 7#a7 id5tify+1 develop+1 or dissem9at+ be/ practices to improve mat]nal heal? c>e quality & outcomes1 elim9ate prev5table mat]nal mortality & sev]e mat]nal morbidity1 & improve infant heal? outcomes1 :i* may include-- 7,a7 in=mation on evid5ce-bas$ practices to improve ! quality & safety ( mat]nal heal? c>e 9 hospitals & o!r heal? c>e sett+s ( a ,/ate or heal? c>e sy/em1 includ+ by address+ topics commonly associat$ ) heal? complications or risks relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e2 7,b7 be/ practices = improv+ mat]nal heal? c>e bas$ on data f9d+s & reviews conduct$ by a ,/ate mat]nal mortality review committee t address topics ( relevance to common complications or heal? risks relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e2 & 7,c7 in=mation on address+ det]m9ants ( heal? t impact mat]nal heal? outcomes = wom5 be=e1 dur+1 & aft] pregnancy2 7#b7 collaborat+ ) ,/ate mat]nal mortality review committees to id5tify issues = ! developm5t & implem5tation ( evid5ce-bas$ practices to improve mat]nal heal? outcomes & r$uce prev5table mat]nal mortality & sev]e mat]nal morbidity2 7#c7 provid+ te*nical assi/ance & support+ ! implem5tation ( be/ practices id5tifi$ 9 p>agraph 7#a7 to entities provid+ heal? c>e s]vices to pregnant & po/p>tum wom52 & 7#d7 id5tify+1 develop+1 & evaluat+ new models ( c>e t improve mat]nal & infant heal? outcomes1 :i* may include ! integration ( community-bas$ s]vices & cl9ical c>e4 7b7 ,eligible entities ,to be eligible = a grant "u subsection 7a71 an entity %all-- 7#a7 submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require2 & 7#b7 demon/rate 9 su* application t ! entity is capable ( c>ry+ out data-driv5 mat]nal safety & quality improvem5t initiatives 9 ! areas ( ob/etrics & gynecology or mat]nal heal?4 7c7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djg4 ,tra9+ = heal? c>e provid]s ,title ,,vii ( ! ,public ,heal? ,s]vice ,act is am5d$ by /rik+ section #gfc 7#db ,u4,s4,c4 #bidp7 & ins]t+ ! foll[+3 #gfc4 ,tra9+ = heal? c>e provid]s 7a7 ,grant program ,! ,secret>y %all e/abli% a program to aw>d grants to accr$it$ s*ools ( allopa?ic m$ic9e1 o/eopa?ic m$ic9e1 & nurs+1 & o!r heal? pr(essional tra9+ programs = ! tra9+ ( heal? c>e pr(essionals to r$uce & prev5t discrim9ation 7includ+ tra9+ relat$ to implicit biases7 9 ! provision ( heal? c>e s]vices relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e4 7b7 ,eligibility ,to be eligible = a grant "u subsection 7a71 an entity describ$ 9 su* subsection %all submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7c7 ,report+ requirem5t ,ea* entity aw>d$ a grant "u ?is section %all p]iodically submit to ! ,secret>y a report on ! /atus ( activities conduct$ us+ ! grant1 includ+ a description ( ! impact ( su* tra9+ on pati5t outcomes1 z applicable4 7d7 ,be/ practices ,! ,secret>y may id5tify & dissem9ate be/ practices = ! tra9+ ( heal? c>e pr(essionals to r$uce & prev5t discrim9ation 7includ+ tra9+ relat$ to implicit biases7 9 ! provision ( heal? c>e s]vices relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e4 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 #djh4 ,/udy on tra9+ to r$uce & prev5t discrim9ation ,n lat] ?an #b ye>s aft] date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all1 ?r\gh a contract ) an indep5d5t rese>* organization1 conduct a /udy & make recomm5dations = accr$it$ s*ools ( allopa?ic m$ic9e1 o/eopa?ic m$ic9e1 & nurs+1 & o!r heal? pr(essional tra9+ programs on be/ practices relat$ to tra9+ to r$uce & prev5t discrim9ation1 includ+ tra9+ relat$ to implicit biases1 9 ! provision ( heal? c>e s]vices relat$ to pr5atal c>e1 labor c>e1 bir?+1 & po/p>tum c>e4 #dji4 ,p]9atal quality collaboratives ,section #cag,k7a77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;a77#b77 is am5d$ by add+ at ! end ! foll[+3 7,e7 7i7 ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r (fices & ag5cies1 z appropriate1 %all e/abli% or cont9ue a competitive grant program = ! e/abli%m5t or support ( p]9atal quality collaboratives to improve p]9atal c>e & p]9atal heal? outcomes = pregnant & po/p>tum wom5 & _! infants4 ,a ,/ate1 ,indian ,tribe1 or ,tribal organization may use funds receiv$ ?r\gh su* grant to-- 7,i7 support ! use ( evid5ce-bas$ or evid5ce-in=m$ practices to improve outcomes = mat]nal & infant heal?2 7,,ii7 "w ) cl9ical teams2 exp]ts2 ,/ate1 local1 &1 z appropriate1 tribal public heal? (ficials2 & /akehold]s1 includ+ pati5ts & families1 to id5tify1 develop1 or dissem9ate be/ practices to improve p]9atal c>e & outcomes2 & 7,,iii7 employ /rategies t provide opportunities = heal? c>e pr(essionals & cl9ical teams to collaborate across heal? c>e sett+s & discipl9es1 includ+ prim>y c>e & m5tal heal?1 z appropriate1 to improve mat]nal & infant heal? outcomes1 :i* may include ! use ( data to provide timely fe$back across hospital & cl9ical teams to in=m responses1 & to provide support & tra9+ to hospital & cl9ical teams = quality improvem5t1 z appropriate4 7ii7 ,to be eligible = a grant "u clause 7i71 an entity %all submit to ! ,secret>y an application 9 su* =m & mann] & conta9+ su* in=mation z ! ,secret>y may require4 4 #daj4 ,integrat$ s]vices = pregnant & po/p>tum wom5 7a7 ,grants ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #ccj,o ( su* ,act1 z add$ by section #djf1 ! foll[+3 #ccj,p4 ,integrat$ s]vices = pregnant & po/p>tum wom5 7a7 ,9 g5]al ,! ,secret>y may aw>d grants = ! purpose ( e/abli%+ or op]at+ evid5ce-bas$ or innovative1 evid5ce-in=m$ programs to deliv] integrat$ heal? c>e s]vices to pregnant & po/p>tum wom5 to optimize ! heal? ( wom5 & _! infants1 includ+ to r$uce adv]se mat]nal heal? outcomes1 pregnancy-relat$ dea?s1 & relat$ heal? disp>ities 7includ+ su* disp>ities associat$ ) racial & e?nic m9ority populations71 &1 z appropriate1 by address+ issues rese>*$ "u subsection 7b77#b7 ( section #cag,k4 7b7 ,integrat$ s]vices = pregnant & po/p>tum wom5 7#a7 ,eligibility ,to be eligible to receive a grant "u subsection 7a71 a ,/ate1 ,indian ,tribe1 or ,tribal organization 7z su* t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act7 %all "w ) relevant /akehold]s t coord9ate c>e 7includ+ coord9at+ res\rces & ref]rals = heal? c>e & social s]vices7 to develop & c>ry out ! program1 includ+-- 7,a7 ,/ate1 ,tribal1 & local ag5cies responsible = ,m$icaid1 public heal?1 social s]vices1 m5tal heal?1 & sub/ance use disord] treatm5t & s]vices2 7,b7 heal? c>e provid]s :o s]ve pregnant & po/p>tum wom52 & 7,c7 community-bas$ heal? organizations & heal? work]s1 includ+ provid]s ( home visit+ s]vices & individuals repres5t+ communities ) disproportionately high rates ( mat]nal mortality & sev]e mat]nal morbidity1 & includ+ ^? repres5t+ racial & e?nicity m9ority populations4 7#b7 ,t]ms 7,a7 ,p]iod ,a grant aw>d$ "u subsection 7a7 %all be made = a p]iod ( #e ye>s4 ,any supplem5tal aw>d made to a grantee "u subsection 7a7 may be made = a p]iod ( less ?an #e ye>s4 7,b7 ,pref]5ce ,9 aw>d+ grants "u subsection 7a71 ! ,secret>y %all-- 7i7 give pref]5ce to ,/ates1 ,indian ,tribes1 & ,tribal organizations t h ! highe/ rates ( mat]nal mortality & sev]e mat]nal morbidity relative to o!r su* ,/ates1 ,indian ,tribes1 or ,tribal organizations1 respectively2 & 7ii7 %all consid] heal? disp>ities relat$ to mat]nal mortality & sev]e mat]nal morbidity1 includ+ su* disp>ities associat$ ) racial & e?nic m9ority populations4 7,c7 ,priority ,9 aw>d+ grants "u subsection 7a71 ! ,secret>y %all give priority to applications f up to #ae entities describ$ 9 subp>agraph 7,b77i74 7,d7 ,evaluation ,! ,secret>y %all require grantees to evaluate ! outcomes ( ! programs support$ "u ! grant4 7c7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section su* sums z may be necess>y = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 4 7b7 ,report on grant outcomes & dissem9ation ( be/ practices 7#a7 ,report ,n lat] ?an ,febru>y #a1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t describes-- 7,a7 ! outcomes ( ! activities support$ by ! grants aw>d$ "u ! am5dm5ts made by ?is section on mat]nal & *ild heal?2 7,b7 be/ practices & models ( c>e us$ by recipi5ts ( grants "u su* am5dm5ts2 & 7,c7 ob/acles id5tifi$ by recipi5ts ( grants "u su* am5dm5ts1 & /rategies us$ by su* recipi5ts to deliv] c>e1 improve mat]nal & *ild heal?1 & r$uce heal? disp>ities4 7#b7 ,dissem9ation ( be/ practices ,n lat] ?an ,augu/ #a1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all dissem9ate in=mation on be/ practices & models ( c>e us$ by recipi5ts ( grants "u ! am5dm5ts made by ?is section 7includ+ be/ practices & models ( c>e relat+ to ! r$uction ( heal? disp>ities1 includ+ su* disp>ities associat$ ) racial & e?nic m9ority populations1 9 rates ( mat]nal mortality & sev]e mat]nal morbidity7 to relevant /akehold]s1 :i* may include heal? provid]s1 m$ical s*ools1 nurs+ s*ools1 relevant ,/ate1 tribal1 & local ag5cies1 & ! g5]al public4 #daa4 ,ext5sion = community heal? c5t]s1 ! national heal? s]vice corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs 7a7 ,community heal? c5t]s ,section #ajejc7;b77#a77;,f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is am5d$ by /rik+ fiscal ye> #bjai & ins]t+ ea* ( fiscal ye>s #bjai ?r\gh #bjbd4 7b7 ,national ,heal? ,s]vice ,corps ,section #ajejc7;b77#b77;,f7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77;,f77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 7c7 ,tea*+ ,heal? ,c5t]s t op]ate ,graduate ,m$ical ,education ,programs ,section #cdj;,h7g77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 7d7 ,application ( provisions ,am\nts appropriat$ pursuant to ?is section = ea* ( fiscal ye>s #bjai ?r\gh #bjbd %all be subject to ! requirem5ts conta9$ 9 ,public ,law #aae-bde = funds = programs au?oriz$ "u sections #ccj ?r\gh #cdj ( ! ,public ,heal? ,s]vice ,act4 7e7 ,con=m+ am5dm5ts ,p>agraph 7#d7 ( section #cjad7;h7 ( title #ah1 ,unit$ ,/ates ,code1 z am5d$ by section #ejija ( ,public ,law #aae-abc1 is am5d$ by /rik+ & section #ejija7;e7 ( ! ,advanc+ ,*ronic ,c>e1 ,ext5d]s1 & ,social ,s]vices ,act & ins]t+ 1 section #ejija7;e7 ( ! ,advanc+ ,*ronic ,c>e1 ,ext5d]s1 & ,social ,s]vices ,act1 & section #daa7;d7 ( ! ,l[] ,heal? ,c>e ,co/s ,act4 #dab4 ,o!r programs 7a7 ,type ,i ,section #ccj;,b7b77#b77;,d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77;,d77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 7b7 ,indians ,subp>agraph 7,d7 ( section #ccj;,c7c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77;,d77 is am5d$ by /rik+ & #bjai & ins]t+ ?r\gh #bjbd4 #dac4 ,native ,am]ican suicide prev5tion ,section #ebj;,e7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cf7;b7 is am5d$ by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,consultation ,a ,/ate apply+ = a grant or coop]ative agreem5t "u ?is section %all1 9 ! developm5t & implem5tation ( a /atewide e>ly int]v5tion /rategy1 consult or conf] ) entities describ$ 9 p>agraph 7#a77;,c7 9 su* ,/ate4 4 #dad4 ,m9imum age ( sale ( tobacco products 7a7 ,9 g5]al ,section #ijf7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chg;f7d77 is am5d$-- 7#a7 9 p>agraph 7#c77;,a77ii71 by /rik+ #ah ye>s & ins]t+ #ba ye>s2 & 7#b7 by add+ at ! end ! foll[+3 7#e7 ,m9imum age ( sale ,x %all be unlawful = any retail] to sell a tobacco product to any p]son y\ng] ?an #ba ye>s ( age4 4 7b7 ,regulations ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all publi% 9 ! ,f$]al ,regi/] a f9al rule to update ! regulations issu$ "u *apt] ,,ix ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chg et seq47 z appropriate1 only to c>ry out ! am5dm5ts made by subsection 7a71 includ+ updat+ ! relevant age v]ification requirem5ts "u "p #aadj ( title #ba1 ,code ( ,f$]al ,regulations to require age v]ification = individuals "u ! age ( #cj4 ,su* f9al rule %all-- 7#a7 take full effect n lat] ?an #ij days aft] ! date on :i* su* f9al rule is publi%$2 & 7#b7 be deem$ to be 9 compliance ) all applicable provisions ( *apt] #e ( title #e1 ,unit$ ,/ates ,code & all o!r provisions ( law relat+ to rulemak+ proc$ures4 7c7 ,notification ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all provide writt5 notification to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives reg>d+ ! progress ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices t[>ds promulgat+ ! f9al rule "u subsection 7b74 ,if1 #ahj days aft] ! date ( enactm5t ( ?is ,act1 su* rule has n be5 promulgat$ 9 accordance ) subsection 7b71 ! ,secret>y %all provide a writt5 notification & a ju/ification = ! delay 9 rulemak+ to su* committees4 7d7 ,p5alties = violations 7#a7 ,9 g5]al ,section #ajc7q77#b7 ( ! ,family ,smok+ ,prev5tion & ,tobacco ,control ,act 7,public ,law #aaa-ca7 is am5d$-- 7,a7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ section #ijf7;d77#e7 or ( aft] violations (2 & 7,b7 9 subp>agraph 7,c71 by ins]t+ section #ijf7;d77#e7 or ( aft] a retail] (4 7#b7 ,repeat$ violations ,section #cjc7;f77#h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#h77 is am5d$ by ins]t+ section #ijf7;d77#e7 or ( aft] repeat$ violations (4 7#c7 ,misbr&$ products ,section #ijc7;a77#g77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #chg;c7 is am5d$ by ins]t+ section #ijf7;d77#e7 or ( aft] violation (4 #dae4 ,sale ( tobacco products to individuals "u ! age ( #ba 7a7 ,9 g5]al ,section #aibf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#bf7 is am5d$-- 7#a7 9 ! head+-- 7,a7 by /rik+ ,/ate law reg>d+2 & 7,b7 by /rik+ #ah & ins]t+ #ba2 7#b7 by /rik+ subsections 7a7 & 7d72 7#c7 by r$esignat+ subsections 7b7 & 7c7 z subsections 7a7 & 7b71 respectively2 7#d7 by am5d+ subsection 7a71 z s r$esignat$1 to read z foll[s3 7a7 ,9 g5]al ,a fund+ agreem5t = a grant "u section #aiba is t ! ,/ate involv$ w-- 7#a7 annually conduct r&om1 unann\nc$ inspections to ensure t retail]s d n sell tobacco products to individuals "u ! age ( #ba2 & 7#b7 annually submit to ! ,secret>y a report describ+-- 7,a7 ! activities c>ri$ out by ! ,/ate to ensure t retail]s d n sell tobacco products to individuals "u ! age ( #ba2 7,b7 ! ext5t ( success ! ,/ate has a*iev$ 9 ensur+ t retail]s d n sell tobacco products to individuals "u ! age ( #ba2 & 7,c7 ! /rategies to be utiliz$ by ! ,/ate to ensure t retail]s d n sell tobacco products to individuals "u ! age ( #ba dur+ ! fiscal ye> = :i* ! grant is s\ght4 2 7#e7 9 subsection 7b71 z s r$esignat$-- 7,a7 by /rik+ p>agraphs 7#a71 7#b71 7#c71 & 7#d72 7,b7 by /rik+ ,be=e mak+ & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,be=e mak+ 2 7,c7 by /rik+ = ! fir/ applicable fiscal ye> or any subsequ5t fiscal ye>2 7,d7 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7a72 7,e7 by /rik+ equal to-- & ins]t+ up to #aj p]c5t ( ! am\nt det]m9$ "u section #aicc = ! ,/ate = ! applicable fiscal ye>42 & 7,f7 by add+ at ! end ! foll[+3 7#b7 ,limitation 7,a7 ,9 g5]al ,a ,/ate %all n h funds )held pursuant to p>agraph 7#a7 if su* ,/ate = :i* ! ,secret>y has made a det]m9ation ( noncompliance "u su* p>agraph-- 7i7 c]tifies to ! ,secret>y by ,may #a ( ! fiscal ye> = :i* ! funds are appropriat$1 consi/5t ) subp>agraph 7,b71 t ! ,/ate w commit additional ,/ate funds1 9 accordance ) p>agraph 7#a71 to ensure t retail]s d n sell tobacco products to individuals "u #ba ye>s ( age2 7ii7 agrees to comply ) a negotiat$ agreem5t = a corrective action plan t is approv$ by ! ,secret>y & c>ri$ out 9 accordance ) guidel9es issu$ by ! ,secret>y2 or 7iii7 is a t]ritory t receives less ?an #a1jjj1jjj = a fiscal ye> "u section #aiba4 7,b7 ,c]tification 7i7 ,9 g5]al ,! am\nt ( funds to be committ$ by a ,/ate pursuant to subp>agraph 7,a77i7 %all be equal to #a p]c5t ( su* ,/ate's sub/ance abuse allocation det]m9$ "u section #aicc = ea* p]c5tage po9t by :i* ! ,/ate misses ! retail] compliance rate goal e/abli%$ by ! ,secret>y4 7ii7 ,/ate exp5ditures ,= a fiscal ye> 9 :i* a ,/ate commits funds z describ$ 9 clause 7i71 su* ,/ate %all ma9ta9 ,/ate exp5ditures = tobacco prev5tion programs & = compliance activities at a level t is n less ?an ! level ( su* exp5ditures ma9ta9$ by ! ,/ate = ! prec$+ fiscal ye>1 plus ! additional funds = tobacco compliance activities requir$ "u clause 7i74 ,! ,/ate %all submit a report to ! ,secret>y on all ,/ate obligations ( funds = su* fiscal ye> & all ,/ate exp5ditures = ! prec$+ fiscal ye> = tobacco prev5tion & compliance activities by program activity by ,july #ca ( su* fiscal ye>4 7iii7 ,discretion ,! ,secret>y %all ex]cise discretion 9 en=c+ ! tim+ ( ! ,/ate obligation ( ! additional funds requir$ by ! c]tification describ$ 9 subp>agraph 7,a77i7 z late z ,july #ca ( su* fiscal ye>4 7,c7 ,failure to c]tify ,if a ,/ate describ$ 9 subp>agraph 7,a7 fails to c]tify to ! ,secret>y pursuant to subp>agraph 7,a77i7 or ent] into1 or comply )1 a negotiat$ agreem5t "u subp>agraph 7,a77ii71 ! ,secret>y may take action pursuant to p>agraph 7#a74 2 & 7#f7 by add+ at ! end ! foll[+3 7c7 ,implem5tation ( report+ requirem5ts 7#a7 ,transition p]iod ,! ,secret>y %all-- 7,a7 n )hold am\nts "u subsection 7b7 = ! #c-ye> p]iod imm$iately foll[+ ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act2 & 7,b7 use discretion 9 ex]cis+ its au?ority "u subsection 7b7 dur+ ! #b-ye> p]iod imm$iately foll[+ ! #c-ye> p]iod describ$ 9 subp>agraph 7,a71 to all[ = a transition p]iod = implem5tation ( ! report+ requirem5ts "u subsection 7a77#b74 7#b7 ,regulations or guidance ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,l[] ,heal? ,c>e ,co/s ,act ! ,secret>y %all update regulations "u "p #if ( title #de1 ,code ( ,f$]al ,regulations or guidance on ! retail] compliance rate goal "u subsection 7b71 ! use ( funds provid$ "u section #aiba = purposes ( meet+ ! requirem5ts ( ?is section1 & report+ requirem5ts "u subsection 7a77#b74 7#c7 ,coord9ation ,! ,secret>y %all ensure ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use coord9ates1 z appropriate1 ) ! ,commission] ( ,food & ,drugs 9 provid+ te*nical assi/ance "u ?is section to ,/ates1 relat$ to ensur+ retail]s d n sell tobacco products to individuals "u ! age ( #ba1 t is consi/5t ) applicable regulations issu$ by ! ,food & ,drug ,adm9i/ration4 7d7 ,transitional grants 7#a7 ,9 g5]al ,! ,secret>y %all aw>d grants "u ?is subsection to ea* ,/ate t receives fund+ "u section #aiba to ensure compliance ( ea* su* ,/ate ) ?is section4 7#b7 ,use ( funds ,a ,/ate receiv+ a grant "u ?is subsection-- 7,a7 %all use am\nts receiv$ "u su* grant = activities to plan = or ensure compliance 9 ! ,/ate ) subsection 7a72 & 7,b7 9 ! case ( a ,/ate = :i* ! ,secret>y has made a det]m9ation "u subsection 7b7 t ! ,/ate is prep>$ to meet1 or has met1 ! requirem5ts ( subsection 7a71 may use su* funds = tobacco cessation activities1 /rategies to prev5t ! use ( tobacco products by individuals "u ! age ( #ba1 or all[able uses "u section #aiba4 7#c7 ,supplem5t n supplant ,grants "u ?is subsection %all be us$ to supplem5t & n supplant o!r ,f$]al1 ,/ate1 & local public funds provid$ = activities "u p>agraph 7#b74 7#d7 ,au?orization ( appropriations ,to c>ry out ?is subsection1 !re are au?oriz$ to be appropriat$ #ah1ehj1gij = ea* ( fiscal ye>s #bjbj ?r\gh #bjbd4 7#e7 ,sunset ,?is subsection %all h no =ce or effect aft] ,septemb] #cj1 #bjbd4 7e7 ,te*nical assi/ance ,! ,secret>y %all provide te*nical assi/ance to ,/ates relat$ to ! activities requir$ "u ?is section4 4 7b7 ,report to ,congress ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! /atus ( implem5t+ ! requirem5ts ( section #aibf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx-#bf71 z am5d$ by subsection 7a71 & a description ( any te*nical assi/ance provid$ "u subsection 7e7 ( su* section1 includ+ ! numb] ( meet+s reque/$ & held relat$ to te*nical assi/ance4 7c7 ,con=m+ am5dm5t ,section #bab ( division ,d ( ! ,consolidat$ ,appropriations ,act1 #bjaj 7,public ,law #aaa-aag7 is repeal$4 ,v ,improv+ ! ex*ange ( heal? in=mation #eja4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation 7a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$ by ins]t+ aft] section #bgae;,a ! foll[+3 #bgae;,b4 ,requirem5t to provide heal? claims1 network1 & co/ in=mation 7a7 ,9 g5]al ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all make available = access1 ex*ange1 & use )\t special ef=t1 ?r\gh application programm+ int]faces 7or successor te*nology or /&>ds71 ! in=mation describ$ 9 subsection 7b71 9 ! mann] describ$ 9 subsection 7b7 & o!rwise consi/5t ) ?is section4 7b7 ,in=mation ,! foll[+ in=mation is requir$ to be made available1 z ! ,secret>y may specify3 7#a7 ,hi/orical claims1 provid] enc\nt]1 & paym5t data = ea* enrollee1 :i* %all-- 7,a7 include adjudicat$ m$ical & prescription drug claims & equival5t enc\nt]s1 includ+ all data elem5ts conta9$ 9 su* transactions-- 7i7 t 7 adjudicat$ by ! gr\p heal? plan or heal? insurance issu] dur+ ! previ\s #e ye>s or ! enrollee's entire p]iod ( enrollm5t 9 ! applicable plan or cov]age if su* p]iod is less ?an ! previ\s #e ye>s2 7ii7 t involve b5efits manag$ by any ?ird p>ty1 su* z a ph>macy b5efits manag] or radiology b5efits manag] t manages b5efits or adjudicates claims on behalf ( ! plan or cov]age2 & 7iii7 f any o!r heal? plan or heal? insurance cov]age (f]$ by ! same insurance issu]1 9 :i* ! same enrollee 0 enroll$ dur+ ! previ\s #e ye>s2 & 7,b7 be available to an enrollee or =m] enrollee1 ! enrollee's provid]s1 & any ?ird-p>ty applications or s]vices au?oriz$ by ! enrollee-- 7i7 ?r\gh ! application programm+ int]faces 7or successor te*nology or /&>ds7 z requir$ by ?is p>agraph1 9 a s+le1 longitud9al =mat t is easy to und]/&1 secure1 & t may update automatically2 7ii7 z soon z practicable1 & 9 no case lat] ?an ! p]iod ( "t det]m9$ by ! ,secret>y1 aft] ! claim is adjudicat$ or ! data is receiv$ by ! heal? plan or heal? insurance issu]2 & 7iii7 to ! enrollee1 =m] enrollee1 & any provid]s or ?ird-p>ty applications or s]vices au?oriz$ by ! enrollee1 = #e ye>s aft] ! end date ( ! enrollee's enrollm5t 9 ! plan or 9 any cov]age (f]$ by ! heal? insurance issu]4 7#b7 ,id5tify+ directory in=mation = all 9-network provid]s1 includ+ facilities & practition]s1 t p>ticipate 9 ! plan or cov]age1 :i* %all-- 7,a7 include-- 7i7 ! national provid] id5tifi] = 9-network facilities & practition]s2 & 7ii7 ! "n1 address1 phone numb]1 & specialty = ea* su* facility & practition]1 bas$ on ! mo/ rec5t int]action betwe5 ! plan or cov]age & t facility or practition]2 7,b7 be capable ( return+ ! in=mation necess>y to e/abli% a li/ ( p>ticipat+ 9-network facilities & practition]s1 9 a giv5 specialty or at a p>ticul> facility type1 )9 a specifi$ geographic radius2 & 7,c7 be capable ( return+ ! network /atus1 :5 pres5t$ ) id5tifi]s = a giv5 enrollee & facility or practition]4 7#c7 ,e/imat$ enrollee out-(-pocket co/s1 includ+ co/s expect$ to be incurr$ ?r\gh a d$uctible1 co-paym5t1 co9surance1 or o!r =m ( co/-%>+1 =-- 7,a7 a designat$ set ( common s]vices or episodes ( c>e1 to be e/abli%$ by ! ,secret>y ?r\gh rulemak+1 includ+1 at a m9imum-- 7i7 9 ! case ( s]vices provid$ by a hospital1 ! #ajj mo/ common diagnosis-relat$ gr\ps1 z us$ 9 ! ,m$ic>e ,inpati5t ,prospective ,pati5t ,sy/em 7or successor episode-bas$ reimbursem5t me?odology7 at t hospital1 bas$ on claims data adjudicat$ by ! gr\p heal? plan or heal? insurance issu]2 7ii7 9 ! case ( s]vices provid$ 9 an out-pati5t sett+1 includ+ radiology1 lab te/s1 & out-pati5t surgical proc$ures1 any s]vice r5d]$ by ! facility or practition]1 & reimburs$ by ! heal? plan or heal? insurance issu]2 & 7iii7 9 ! case ( po/-acute c>e1 includ+ home heal? provid]s1 skill$ nurs+ facilities1 inpati5t rehabilitation facilities1 & long-t]m c>e hospitals1 ! pati5t out-(-pocket co/s = an episode ( c>e1 z ! ,secret>y may det]m9e1 :i* p]mits us]s to reasonably comp>e co/s across diff]5t facility & s]vice types2 & 7,b7 all prescription drugs curr5tly includ$ on any ti] ( ! =mul>y ( ! plan or cov]age4 7#d7 ,a li/ ( ! categories ( provid]s ( ancill>y s]vices1 z def9$ 9 section #bgai7;,a77i77#c71 = :i* ! plan or cov]age has no 9-network provid]s4 7c7 ,availability & access ,subject to all applicable ,f$]al & ,/ate privacy1 security1 & brea* notification laws1 ! application programm+ int]faces1 includ+ all data requir$ to be made available ?r\gh su* int]faces1 %all-- 7#a7 be made available by ! applicable gr\p heal? plan or heal? insurance issu]1 at no *>ge1 to-- 7,a7 enrollees & prospective enrollees 9 ! gr\p heal? plan or heal? insurance cov]age2 7,b7 ?ird p>ties au?oriz$ by ! enrollee2 7,c7 facilities & practition]s :o are "u contract ) ! plan or cov]age2 & 7,d7 bus9ess associates ( su* facilities & practition]s1 z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7#b7 be available to enrollees 9 ! gr\p heal? plan or heal? insurance cov]age1 & to ?ird-p>ty applications or s]vices facilitat+ su* access by enrollees1 dur+ ! enrollm5t process & = a m9imum ( #e ye>s aft] ! end date ( ! enrollee's enrollm5t 9 ! plan or 9 any cov]age (f]$ by ! heal? insurance issu]2 7#c7 p]mit p]si/5t access by ?ird p>ty applications or s]vices au?oriz$ by ! enrollee1 = a reasonable p]iod ( "t1 consi/5t ) ! requirem5ts ( ! ,,hipaa ,security rule 7"p #afj ( title #de ,code ( ,f$]al ,regulations & subp>ts ,a & ,c ( "p #afd ( su* title72 7#d7 employ ! applicable cont5t1 vocabul>y1 & te*nical /&>ds1 z det]m9$ by ! ,secret>y pursuant to title ,,xxx2 & 7#e7 employ security & au!ntication /&>ds1 z ! ,secret>y det]m9es appropriate4 7d7 ,rule ( con/ruction reg>d+ privacy ,no?+ 9 ?is section %all be con/ru$ to alt] exi/+ obligations ( a cov]$ entity or bus9ess associate "u ! privacy1 security1 & brea* notification rules promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act or section #acdjb ( ! ,,hite* ,act1 or to alt] ! ,secret>y's exi/+ au?ority to modify su* rules1 "u "p #b ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations71 "u section #ddd ( ! ,g5]al ,education ,provisions ,act 7#bj ,u4,s4,c4 #abcb;g7 7commonly ref]r$ to z ! ,family ,educational ,rights & ,privacy ,act ( #aigd71 "u ! am5dm5ts made by ! ,g5etic ,in=mation ,nondiscrim9ation ,act1 or "u ,/ate privacy law4 4 7b7 ,effective date ,section #bgae;,b ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 #ejb4 ,recognition ( security practices ,"p #a ( subtitle ,d ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agica et seq47 is am5d$ by add+ at ! end ! foll[+3 #acdab4 ,recognition ( security practices 7a7 ,9 g5]al ,consi/5t ) ! au?ority ( ! ,secret>y "u sections #aagf & #aagg ( ! ,social ,security ,act1 :5 mak+ det]m9ations relat+ to f9es "u section #acdaj1 decreas+ ! l5g? & ext5t ( an audit "u section #acdaa1 or rem$ies o!rwise agre$ to by ! ,secret>y1 ! ,secret>y %all consid] :e!r ! cov]$ entity or bus9ess associate has adequately demon/rat$ t x _h1 = n less ?an ! previ\s #ab mon?s1 recogniz$ security practices 9 place t may-- 7#a7 mitigate f9es "u section #acdaj2 7#b7 result 9 ! e>ly1 favorable t]m9ation ( an audit "u section #acdaa2 & 7#c7 mitigate ! rem$ies t w\ld o!rwise be agre$ to 9 any agreem5t ) respect to resolv+ pot5tial violations ( ! ,,hipaa ,security rule 7"p #afj ( title #de ,code ( ,f$]al ,regulations & subp>ts ,a & ,c ( "p #afd ( su* title7 betwe5 ! cov]$ entity or bus9ess associate & ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7b7 ,def9ition & miscellane\s provisions 7#a7 ,recogniz$ security practices ,! t]m recogniz$ security practices means ! /&>ds1 guidel9es1 be/ practices1 me?odologies1 proc$ures1 & processes develop$ "u section #b7;c77#ae7 ( ! ,national ,in/itute ( ,/&>ds & ,te*nology ,act1 ! approa*es promulgat$ "u section #dje7;d7 ( ! ,cyb]security ,act ( #bjae1 & o!r programs & processes t address cyb]security & t are develop$1 recogniz$1 or promulgat$ ?r\gh regulations "u o!r /atutory au?orities4 ,su* practices %all be det]m9$ by ! cov]$ entity or bus9ess associate4 7#b7 ,limitation ,no?+ 9 ?is section %all be con/ru$ z provid+ ! ,secret>y au?ority to increase f9es "u section #acdaj1 or ! l5g?1 ext5t or quantity ( audits "u section #acdaa1 due to a lack ( compliance ) ! recogniz$ security practices4 7#c7 ,no liability = nonp>ticipation ,subject to p>agraph 7#d71 no?+ 9 ?is section %all be con/ru$ to subject a cov]$ entity or bus9ess associate to liability = elect+ n to engage 9 ! recogniz$ security practices def9$ by ?is section4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to limit ! ,secret>y's au?ority to en=ce ! ,,hipaa ,security rule 7"p #afj ( title #de ,code ( ,f$]al ,regulations & subp>ts ,a & ,c ( "p #afd ( su* title71 or to sup]s$e or conflict ) an entity or bus9ess associate's obligations "u ! ,,hipaa ,security rule4 4 #ejc4 ,,gao /udy on ! privacy & security risks ( electronic transmission ( individually id5tifiable heal? in=mation to & f entities n cov]$ by ! ,heal? ,insurance ,portability & ,acc\ntability ,act 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to-- 7#a7 describe ! roles ( ,f$]al ag5cies & ! private sector ) respect to protect+ ! privacy & security ( individually id5tifiable heal? in=mation transmitt$ electronically to & f entities n cov]$ by ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note72 7#b7 id5tify rec5t developm5ts reg>d+ ! use ( application programm+ int]faces to access individually id5tifiable heal? in=mation1 & implications = ! privacy & security ( su* in=mation2 7#c7 id5tify practices 9 ! private sector1 su* z t]ms & conditions = use1 relat+ to ! privacy1 disclosure1 & second>y uses ( individually id5tifiable heal? in=mation transmitt$ electronically to or f entities1 select$ by an individual1 t are n subject to ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif2 & 7#d7 id5tify /eps ! public & private sectors c take to improve ! private & secure access to & availability ( individually id5tifiable heal? in=mation4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conc]n+ ! f9d+s ( ! /udy conduct$ "u subsection 7a74 #ejd4 ,te*nical corrections 7a7 ,9 g5]al ,section #cjbb7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,application ( au?orities "u ,inspector ,g5]al ,act ( #aigh ,9 c>ry+ out ?is subsection1 ! ,inspector ,g5]al %all h ! same au?orities z provid$ "u section #f ( ! ,inspector ,g5]al ,act ( #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all take effect z if includ$ 9 ! enactm5t ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee74 #eje4 ,public meet+ 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a public meet+ = purposes ( discuss+ & provid+ input on pati5t-mat*+ metrics = ! purpose ( enabl+ int]op]ability & ! ex*ange ( heal? in=mation across heal? c>e organizations4 7b7 ,exp]ts ,! public meet+ "u ?is section may include-- 7#a7 repres5tatives ( relevant ,f$]al ag5cies 7includ+ repres5tatives f ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology72 7#b7 ,/ate1 local1 ,tribal1 & t]ritorial public heal? (ficials2 7#c7 /akehold]s ) exp]tise 9 heal? in=mation ex*ange2 7#d7 /akehold]s ) exp]tise 9 capabilities relevant to pati5t mat*+1 su* z exp]ts 9 in=matics & data analytics2 7#e7 /akehold]s affect$ by record-mat*+ 7includ+ pati5ts1 hospitals1 heal? sy/ems1 pay]s1 heal? in=mation ex*anges1 & prescription drug monitor+ programs72 & 7#f7 o!r repres5tatives1 z ! ,secret>y det]m9es appropriate4 7c7 ,topics ,su* public meet+ %all include a discussion (-- 7#a7 /&>ds & processes = assess+ ! accuracy ( pati5t-mat*+ algori?ms2 7#b7 p]=mance metrics = heal? c>e provid]s pur*as+ pati5t-mat*+ te*nology & algori?m develop]s2 7#c7 ! developm5t ( b5*m>ks = ! accuracy ( pati5t-mat*+ algori?ms2 7#d7 consid]ations = ,/ate1 local1 ,tribal1 & t]ritorial capabilities & infra/ructure relat$ to data ex*ange1 int]op]ability1 & mat*+ pati5t records2 7#e7 opportunities = ! incorporation ( innovative te*nologies to improve pati5t mat*+2 & 7#f7 privacy & security protections4 ,july #h1 #bjai,report$ ) an am5dm5t