,,ii #aaf? ,,congress #b;d ,session ,s4 #dgif ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,octob] #e1 #bjbj,mr4 ,braun introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to address ! high co/s ( heal? c>e s]vices1 prescription drugs1 & heal? insurance cov]age 9 ! ,unit$ ,/ates1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,fair ,c>e ,act ( #bjbj4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,title ,i--,medisave,subtitle ,a--,m$isave ,acc\nts & ,contributions,sec4 #aja4 ,e/abli%m5t ( ,m$isave acc\nts4,sec4 #ajb4 ,consolidation ( ,h,s,as1 ,h,r,as1 ,f,s,as1 & ,m,s,as into ,m$isave acc\nts4,sec4 #ajc4 ,heal? ,reimbursem5t ,arrangem5ts & ,o!r ,acc\nt-,bas$ ,gr\p ,heal? ,plans4,sec4 #ajd4 ,co/-%>+ r$uction paym5ts z eligible contributions4,sec4 #aje4 ,direct prim>y c>e4,subtitle ,b--,assi/ance to ,m$isave ,accounts,sec4 #aaa4 ,support 9 implem5tation4,sec4 #aab4 ,new corporations requir$ to use ,m$isave4,sec4 #aac4 ,f$]al employee heal? b5efits & ,m$isave4,sec4 #aad4 ,grants to ,/ates = consum] assi/ance4,title ,,ii--,improv+ ,private ,heal? ,insurance,subtitle ,a--,ma9ta9+ ,protections = ,pati5ts ) ,preexi/+ ,conditions,sec4 #bja4 ,gu>ante$ availability ( cov]age2 prohibit+ discrim9ation4,subtitle ,b--,exp&+ ,cov]age ,options,sec4 #baa4 ,rules gov]n+ association heal? plans4,sec4 #bab4 ,cl>ification ( treatm5t ( s+le employ] arrangem5ts4,sec4 #bac4 ,en=cem5t provisions relat+ to association heal? plans4,sec4 #bad4 ,coop]ation betwe5 ,f$]al & ,/ate au?orities4,sec4 #bae4 ,effective date & transitional & o!r rules4,sec4 #baf4 ,%ort-t]m limit$ duration insurance4,subtitle ,c--,improv+ ,comm]cial ,heal? ,insurance,sec4 #bba4 ,invisible ,gu>ante$ ,cov]age ,pool ,re9surance ,program2 tax on ex*ange plans4,sec4 #bbb4 ,employ] heal? insurance m&ate repeal4,sec4 #bbc4 ,refundable cr$its = cov]age "u a qualifi$ heal? plan = individuals (f]$ employ]-sponsor$ insurance4,sec4 #bbd4 ,inclusion 9 income ( c]ta9 co/s ( employ]-provid$ cov]age "u heal? plans4,sec4 #bbe4 ,*ange 9 p]missible age v>iation 9 heal? insurance premium rates4,sec4 #bbf4 ,premium assi/ance adju/m5t to reflect age4,sec4 #bbg4 ,premium assi/ance4,sec4 #bbh4 ,add+ copp] plans to ,ex*anges4,sec4 #bbi4 ,copp] & bronze plans4,sec4 #bcj4 ,waiv]s = ,/ate innovation4,sec4 #bca4 ,enrollm5t p]iods4,sec4 #bcb4 ,/ate-op]at$ ,ex*anges flexibility = op5 enrollm5t p]iods4,sec4 #bcc4 ,promot+ heal? plans t cov] individuals 9 m ?an "o ,/ate4,title ,,iii--,competition1 ,transp>5cy & ,accountability,subtitle ,a--,provid] & ,insur] ,competition,sec4 #cja4 ,hospital consolidation4,sec4 #cjb4 ,au?ority ( ,f$]al ,trade ,commission ov] c]ta9 tax-exempt organizations4,sec4 #cjc4 ,re/or+ ! application ( antitru/ laws to ! bus9ess ( heal? insurance4,sec4 #cjd4 ,level+ ! play+ field betwe5 pay]s & provid]s4,sec4 #cje4 ,increas+ transp>5cy by remov+ gag clauses on price & quality in=mation4,sec4 #cjf4 ,bann+ anticompetitive t]ms 9 facility & insurance contracts t limit access to high] quality1 l[] co/ c>e4,sec4 #cjg4 ,repeal+ eligibility ( c]ta9 ,a,c,os4,sec4 #cjh4 ,repeal ( heal? c>e re=m provisions limit+ ,m$ic>e exception to ! prohibition on c]ta9 physician ref]rals = hospitals4,sec4 #cji4 ,alt]native paym5t model = c]ta9 %oppable proc$ures4,subtitle ,b--,price ,transparency,sec4 #cba4 ,price transp>5cy4,sec4 #cbb4 ,price transp>5cy requirem5ts4,sec4 #cbc4 ,designation ( nongov]nm5tal1 nonpr(it transp>5cy organizations to l[] ,am]icans' heal? c>e co/s4,sec4 #cbd4 ,protect+ pati5ts & improv+ ! accuracy ( provid] directory in=mation4,sec4 #cbe4 ,ensur+ enrollee access to co/-%>+ in=mation4,sec4 #cbf4 ,access ( individuals to protect$ heal? in=mation4,sec4 #cbg4 ,timely bills = pati5ts4,sec4 #cbh4 ,advisory gr\p on r$uc+ burd5 ( hospital adm9i/rative requirem5ts4,sec4 #cbi4 ,data report+ to improve ! transp>5cy reg>d+ h[ #cdj;,b hospital cov]$ entities provide c>e = pati5ts4,sec4 #ccj4 ,requir+ #cdj;,b drug disc\nt program reports by ,,d% hospital cov]$ entities on l[-income utilization rate ( outpati5t hospital s]vices4,sec4 #cca4 ,employ] b5efits reports4,sec4 #ccb4 ,gr\p heal? plan report+ requirem5ts4,sec4 #ccc4 ,gov]nm5t ,acc\ntability ,(fice /udy on pr(it- & rev5ue-%>+ 9 heal? c>e4,subtitle ,c--,prescription ,drug ,competition & ,innovation,sec4 #cda4 ,exp$it$ developm5t & priority review = g5]ic complex drug products4,sec4 #cdb4 ,prev5t+ block+ ( g5]ic drugs4,sec4 #cdc4 ,ensur+ timely access to g5]ics4,sec4 #cdd4 ,preemption ( ,/ate b>ri]s to ! sub/itution ( biosimil> products4,sec4 #cde4 ,increas+ ph>maceutical options to treat an unmet m$ical ne$4,sec4 #cdf4 ,provisional approval ( new human drugs4,sec4 #cdg4 ,consolidat+ exclusivity p]iods = drugs treat+ r>e diseases & conditions4,sec4 #cdh4 ,exclusivity p]iod = br& "n biological products4,sec4 #cdi4 ,protect+ access to biological products4,sec4 #cej4 ,/reaml9+ ! transition ( biological products4,sec4 #cea4 ,regulation ( manufactur]-sponsor$ copay contributions4,sec4 #ceb4 ,antitru/ exemption = private heal? insur] issu]s to negotiate :olesale acquisition prices ( prescription drugs pur*as$ f drug manufactur]s4,sec4 #cec4 ,biological product innovation4,sec4 #ced4 ,cl>ify+ ! mean+ ( new *emical entity4,sec4 #cee4 ,prompt approval ( drugs relat$ to safety in=mation4,sec4 #cef4 ,conditions ( use = biosimil> biological products4,sec4 #ceg4 ,education on biological products4,sec4 #ceh4 ,congressional review ( ! ,food & ,drug ,adm9i/ration rulemak+4,sec4 #cei4 ,gov]nm5t ,acc\ntability ,(fice /udy ( rules4,subtitle ,d--,prescription ,drug & ,ph>macy ,b5efit ,manag] ,transparency,sec4 #cfa4 ,pat5t disclosure requirem5ts4,sec4 #cfb4 ,biological product pat5t transp>5cy4,sec4 #cfc4 ,orange ,book mod]nization4,sec4 #cfd4 ,mod]niz+ ! label+ ( c]ta9 g5]ic drugs4,sec4 #cfe4 ,requirem5ts ) respect to prescription drug b5efits4,sec4 #cff4 ,,pbm transp>5cy & elim9ation ( ,,dir fees4,sec4 #cfg4 ,heal? plan ov]sight ( ph>macy b5efit manag] s]vices4,sec4 #cfh4 ,/udy by ,comptroll] ,g5]al ( ,unit$ ,/ates4,subtitle ,e--,m$ic>e & ,m$icaid ,prescription ,drug ,reforms,sec4 #cga4 ,m$ic>e "p ,b rebate by manufactur]s = drugs or biologicals ) prices increas+ fa/] ?an inflation4,sec4 #cgb4 ,m>ket bas$ "p ,b pric+ index4,sec4 #cgc4 ,innovation model te/+ ( ,m$ic>e drug paym5ts4,sec4 #cgd4 ,modification ( maximum rebate am\nt "u ,m$icaid drug rebate program4,subtitle ,f--,m$ical ,malpractice ,reform,sec4 #cha4 ,def9itions4,sec4 #chb4 ,enc\rag+ spe$y resolution ( claims4,sec4 #chc4 ,comp5sat+ pati5t injury4,sec4 #chd4 ,maximiz+ pati5t recov]y4,sec4 #che4 ,au?orization ( paym5t ( future damages to claimants 9 heal? c>e lawsuits4,sec4 #chf4 ,product liability = heal? c>e provid]s4,sec4 #chg4 ,effect on o!r laws4,sec4 #chh4 ,limitation on exp]t witness te/imony4,sec4 #chi4 ,exp]t witness qualifications4,sec4 #cij4 ,communications foll[+ unanticipat$ outcome4,sec4 #cia4 ,affidavit ( m]it4,sec4 #cib4 ,notice ( int5t to comm5ce lawsuit4,sec4 #cic4 ,limitation on liability = volunte] heal? c>e pr(essionals4,sec4 #cid4 ,rules ( con/ruction4,sec4 #cie4 ,effective date4,title ,,iv--,m$ic>e & ,m$icaid ,reforms,subtitle ,a--,m$icaid ,reforms,sec4 #dja4 ,m$icaid paym5t re=m4,sec4 #djb4 ,income limitations = refundable cr$its = cov]age "u a qualifi$ heal? plan4,sec4 #djc4 ,m$icaid eligibility det]m9ations4,sec4 #djd4 ,l[]+ safe h>bor ?re%old ) respect to ,/ate taxes on heal? c>e provid]s4,sec4 #dje4 ,provid+ = ,/ate approval & implem5tation ( specifi$ waiv]s "u ! ,m$icaid program4,sec4 #djf4 ,d$uction = qualifi$ *>ity c>e4,subtitle ,b--,m$ic>e ,reforms,sec4 #daa4 ,(f-campus provid]-bas$ dep>tm5t ,m$ic>e site neutral paym5t4,sec4 #dab4 ,elim9at+ ,,fehbp eligibility = annuitants4,sec4 #dac4 ,elim9ation ( ,m$ic>e eligibility = c]ta9 individuals4,sec4 #dad4 ,m$ic>e "p ,d tax d$uction4,sec4 #dae4 ,repeal ( net inve/m5t income tax4,sec4 #daf4 ,m$ic>e cov]age ( bad debt4,subtitle ,c--,m$ic>e ,*oice & ,competition,sec4 #dba4 ,competitive bidd+ & premiums "u unifi$ ,m$ic>e4,sec4 #dbb4 ,new unifi$ eligibility & enrollm5t rules4,sec4 #dbc4 ,new b5efit /ructure "u unifi$ ,m$ic>e4,sec4 #dbd4 ,late enrollm5t p5alty n to apply = mon?s ( any heal? cov]age4,sec4 #dbe4 ,m$igap re=m4,sec4 #dbf4 ,,aco revision4,sec4 #dbg4 ,prim>y c>e options4,sec4 #dbh4 ,g5]al provisions2 effective date4,subtitle ,d--,teleheal? ,improvem5ts & ,expansion,sec4 #dca4 ,expansion ( cov]age ( teleheal? s]vices4,sec4 #dcb4 ,exp&+ ! use ( teleheal? ?r\gh ! waiv] ( c]ta9 requirem5ts4,sec4 #dcc4 ,exp&+ ! use ( teleheal? = m5tal heal? s]vices4,sec4 #dcd4 ,use ( teleheal? 9 em]g5cy m$ical c>e4,sec4 #dce4 ,improvem5ts to ! process = add+ teleheal? s]vices4,sec4 #dcf4 ,rural heal? cl9ics & ,f$]ally qualifi$ heal? c5t]s4,sec4 #dcg4 ,native ,am]ican heal? facilities4,sec4 #dch4 ,waiv] ( teleheal? re/rictions dur+ national em]g5cies4,sec4 #dci4 ,use ( teleheal? 9 rec]tification = hospice c>e4,sec4 #ddj4 ,cl>ification = fraud & abuse laws reg>d+ te*nologies provid$ to b5efici>ies4,sec4 #dda4 ,/udy & report on increas+ access to teleheal? s]vices 9 ! home4,sec4 #ddb4 ,analysis ( teleheal? waiv]s 9 alt]native paym5t models4,sec4 #ddc4 ,model to all[ additional heal? pr(essionals to furni% teleheal? s]vices4,sec4 #ddd4 ,te/+ ( models to exam9e ! use ( teleheal? "u ! ,m$ic>e program4 ,i ,m$isave ,a ,m$isave ,acc\nts & ,contributions #aja4 ,e/abli%m5t ( ,m$isave acc\nts 7a7 ,9 g5]al ,"p ,,viii ( sub*apt] ,f ( *apt] #a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ecj;,a4 ,m$isave acc\nts 7a7 ,m$isave acc\nt ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,! t]m ,m$isave acc\nt means a tru/ creat$ or organiz$ 9 ! ,unit$ ,/ates z a ,m$isave acc\nt exclusively = ! purpose ( pay+ ! qualifi$ m$ical exp5ses ( ! acc\nt b5efici>y1 b only if ! writt5 gov]n+ in/rum5t creat+ ! tru/ meets ! foll[+ requirem5ts3 7,a7 ,except 9 ! case ( a rollov] contribution describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7e77#e71 no contribution w be accept$-- 7i7 unless x is 9 ca%1 7ii7 to ! ext5t su* contribution1 :5 add$ to previ\s contributions to ! tru/ = ! cal5d> ye>1 exce$s ! limitation am\nt specifi$ 9 subsection 7b77#a71 or 7iii7 to ! ext5t su* contribution1 :5 add$ to ! balance ( ! acc\nt1 exce$s ! limitation am\nt specifi$ 9 subsection 7b77#b74 7,b7 ,! tru/ee is a bank 7z def9$ 9 section #djh7n771 an insurance company 7z def9$ 9 section #haf71 or ano!r p]son :o demon/rates to ! satisfaction ( ! ,secret>y t ! mann] 9 :i* su* p]son w adm9i/] ! tru/ w be consi/5t ) ! requirem5ts ( ?is section4 7,c7 ,no "p ( ! tru/ assets w be inve/$ 9 life insurance contracts4 7,d7 ,! assets ( ! tru/ w n be comm+l$ ) o!r prop]ty except 9 a common tru/ fund or common inve/m5t fund4 7,e7 ,! int]e/ ( an individual 9 ! balance 9 8 acc\nt is non=feitable4 7#b7 ,qualifi$ m$ical exp5ses 7,a7 ,9 g5]al ,! t]m qualifi$ m$ical exp5ses means1 ) respect to an acc\nt b5efici>y1 am\nts paid by su* b5efici>y = m$ical c>e1 b only to ! ext5t su* am\nts are n comp5sat$ = by insurance or o!rwise-- 7i7 =-- 7,i7 su* individual1 7,,ii7 ! sp\se ( su* individual1 7,,iii7 any dep5d5t 7z def9$ 9 section #aeb1 det]m9$ )\t reg>d to subsections 7b77#a71 7b77#b71 & 7d77#a77;,b7 !re(7 ( su* individual1 & 7,,iv7 any individual :o be>s a relation%ip to ! acc\nt b5efici>y t is describ$ 9 subp>agraph 7,c7 or 7,d7 ( section #aeb7;d7 if ! acc\nt b5efici>y is or 0 a dep5d5t ( su* individual = any taxable ye> end+ be=e or ) ! taxable ye> 9 :i* ! individual atta9$ #ah ye>s ( age1 & 7ii7 if1 on ! date su* m$ical c>e 0 provid$1 su* individual1 sp\se or dep5d5t to :om su* c>e 0 provid$ 0 cov]$ "u ! qualifi$ heal? insurance ( ! acc\nt b5efici>y4 7,b7 ,modifi$ def9ition ( m$ical c>e ,= purposes ( subp>agraph 7,a71 ! t]m m$ical c>e has ! mean+ giv5 su* t]m by section #bac7;d71 except t su* t]m includes-- 7i7 a direct prim>y c>e s]vice arrangem5t1 & 7ii7 pr$et]m9$ level ( access to c>e f an integrat$ heal? plan4 7#c7 ,acc\nt b5efici>y ,! t]m acc\nt b5efici>y means ! individual on ^: behalf ! ,m$isave acc\nt 0 e/abli%$4 7#d7 ,c]ta9 rules to apply ,rules simil> to ! foll[+ rules %all apply = purposes ( ?is section3 7,a7 ,section #bai7;d77#b7 7relat+ to no d$uction = rollov]s74 7,b7 ,section #bai7;f77#c7 7relat+ to "t :5 contributions deem$ made74 7,c7 ,except z provid$ 9 section #ajf7;d71 section #bai7;f77#e7 7relat+ to employ] paym5ts74 7,d7 ,section #djh7;g7 7relat+ to community prop]ty laws74 7,e7 ,section #djh7;h7 7relat+ to cu/odial acc\nts74 7b7 ,limitations 7#a7 ,annual limitation 7,a7 ,9 g5]al ,! limitation am\nt specifi$ 9 ?is p>agraph is-- 7i7 #e1jjj 9 ! case ( a qualifi$ heal? plan ) an actu>ial value ( less ?an #dj p]c5t1 7ii7 #d1cjj 9 ! case ( a qualifi$ heal? plan ) an actu>ial value t is #dj p]c5t or m & less ?an #ge p]c5t1 & 7iii7 #c1fjj 9 ! case ( a qualifi$ heal? plan ) an actu>ial value t is #ge p]c5t or m4 7,b7 ,actu>ial value ( qualifi$ heal? plan ,= purposes ( subp>agraph 7,a71 ! actu>ial value ( a qualifi$ heal? plan is ! p]c5tage ( ! total av]age co/s ( cov]$ b5efits "u ! heal? plan4 7#b7 ,acc\nt accumulation limitation ,! limitation am\nt specifi$ 9 ?is p>agraph is #ej1jjj4 7#c7 ,index+ 7,a7 ,9 g5]al ,9 ! case ( any taxable ye> beg9n+ 9 a cal5d> ye> aft] #bjbj1 ea* doll> am\nt conta9$ 9 p>agraph 7#a77;,a7 %all be increas$ by ! m$ical c>e co/ adju/m5t ( su* am\nt = su* cal5d> ye>4 7,b7 ,m$ical c>e co/ adju/m5t ,= purposes ( subp>agraph 7,a71 ! m$ical c>e co/ adju/m5t = any cal5d> ye> is ! p]c5tage 7if any7 by :i*-- 7i7 ! m$ical c>e compon5t ( ! ,c-,,cpi-,u 7z def9$ 9 section #a7;f77#f77 = ,augu/ ( ! prec$+ cal5d> ye>1 exce$s 7ii7 su* compon5t ( ! ,c-,,cpi-,u 7z s def9$7 = ,augu/ ( #bjai4 7,c7 ,r\nd+ 7i7 ,annual limitation ,if any increase 9 a doll> am\nt conta9$ 9 p>agraph 7#a77;,a7 det]m9$ "u subp>agraph 7,a7 is n a multiple ( #ajj1 su* increase %all be r\nd$ to ! ne>e/ multiple ( #ajj4 7ii7 ,acc\nt limitation ,if any increase 9 ! doll> am\nt conta9$ 9 p>agraph 7#b7 det]m9$ "u subp>agraph 7,a7 is n a multiple ( #a1jjj1 su* increase %all be r\nd$ to ! ne>e/ multiple ( #a1jjj4 7#d7 ,coord9ation ) o!r contributions ,! limitation :i* w\ld 7b = ?is p>agraph7 apply "u p>agraphs 7#a7 & 7#b7 to an individual = any taxable ye> %all be r$uc$ 7b n bel[ z]o7 by ! sum (-- 7,a7 ! aggregate am\nt contribut$ to ,m$isave acc\nts ( su* individual :i* is excludable f ! taxpay]'s gross income = su* taxable ye> "u section #ajf7;d71 & 7,b7 ! aggregate am\nt contribut$ to ,m$isave acc\nts ( su* individual = su* taxable ye> "u section #djh7;d77#i74 7#e7 ,deposit ( advance premium tax cr$it ,an acc\nt b5efici>y :o is eligible = an advance paym5t ( ! premium tax cr$it "u section #cf;,b may elect to h ! ,secret>y deposit ! advance paym5t into ! ,m$isave acc\nt ( ! acc\nt b5efici>y4 7c7 ,def9itions & special rules ,= purposes ( ?is section-- 7#a7 ,eligible individual 7,a7 ,9 g5]al ,! t]m eligible individual means1 ) respect to any mon?-- 7i7 any individual :o is cov]$ "u a qualifi$ heal? plan z ( ! #a/ day ( su* mon?2 & 7ii7 any individual ^: h\sehold income is great] ?an #bej p]c5t ( ! ,f$]al pov]ty level-- 7,i7 if su* individual is cov]$ "u a qualifi$ heal? plan ) an actu>ial value n m ?an #hj p]c5t2 or 7,,ii7 if-- 7aa7 su* individual is cov]$ "u a high d$uctible heal? plan z ( ! #a/ day ( su* mon?2 & 7bb7 su* individual is n1 :ile cov]$ "u a high d$uctible heal? plan1 cov]$ "u any heal? plan-- 7,,aa7 :i* is n a high d$uctible heal? plan2 & 7,,bb7 :i* provides cov]age = any b5efit :i* is cov]$ "u ! high d$uctible heal? plan4 7,b7 ,c]ta9 cov]age disreg>d$ ,subp>agraph 7,a7 %all be appli$ )\t reg>d to-- 7i7 cov]age = any b5efit provid$ by p]mitt$ insurance1 & 7ii7 cov]age 7:e!r ?r\gh insurance or o!rwise7 = accid5ts1 disability1 d5tal c>e1 vision c>e1 or long-t]m c>e4 7,c7 ,special rule = individuals eligible = c]ta9 vet]ans b5efits ,an individual %all n fail to be treat$ z an eligible individual = any p]iod m]ely because ! individual receives hospital c>e or m$ical s]vices "u any law adm9i/]$ by ! ,secret>y ( ,vet]ans ,affairs = a s]vice-connect$ disability 7)9 ! mean+ ( section #aja7af7 ( title #ch1 ,unit$ ,/ates ,code74 7#b7 ,qualifi$ heal? plan 7,a7 ,9 g5]al ,! t]m qualifi$ heal? plan means a heal? plan t (f]s heal? insurance cov]age4 ,su* t]m includes entitlem5t to b5efits "u title ,,xviii or title ,,xix ( ! ,social ,security ,act4 7,b7 ,exclusion ( c]ta9 plans ,su* t]m does n include a heal? plan if sub/antially all ( its cov]age is disreg>d$ "u p>agraph 7#a77;,b74 7,c7 ,heal? insurance cov]age ,! t]m heal? insurance cov]age means b5efits consi/+ ( m$ical c>e 7provid$ directly1 ?r\gh insurance or reimbursem5t1 or o!rwise & includ+ items & s]vices paid = z m$ical c>e7 "u any hospital or m$ical s]vice policy or c]tificate1 hospital or m$ical s]vice plan contract1 or heal? ma9t5ance organization contract (f]$ by a heal? insurance issu]4 7,d7 ,heal? insurance issu] ,! t]m heal? insurance issu] means an insurance company1 insurance s]vice1 or insurance organization 7includ+ a heal? ma9t5ance organization7 :i* is lic5s$ to engage 9 ! bus9ess ( insurance 9 a ,/ate & :i* is subject to ,/ate law :i* regulates insurance 7)9 ! mean+ ( section #ead7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aadd7;b77#b7774 7,e7 ,heal? ma9t5ance organization ,! t]m heal? ma9t5ance organization means-- 7i7 a ,f$]ally qualifi$ heal? ma9t5ance organization 7z def9$ 9 section #acja7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;e7a7771 7ii7 an organization recogniz$ "u ,/ate law z a heal? ma9t5ance organization1 or 7iii7 a simil> organization regulat$ "u ,/ate law = solv5cy 9 ! same mann] & to ! same ext5t z su* a heal? ma9t5ance organization4 7#c7 ,p]mitt$ insurance ,! t]m p]mitt$ insurance means-- 7,a7 insurance if sub/antially all ( ! cov]age provid$ "u su* insurance relates to-- 7i7 liabilities incurr$ "u work]s' comp5sation laws1 7ii7 tort liabilities1 7iii7 liabilities relat+ to own]%ip or use ( prop]ty1 or 7iv7 su* o!r simil> liabilities z ! ,secret>y may specify by regulations1 7,b7 insurance = a specifi$ disease or illness1 & 7,c7 insurance pay+ a fix$ am\nt p] day 7or o!r p]iod7 ( hospitalization4 7#d7 ,family cov]age ,! t]m family cov]age means any cov]age o!r ?an self-only cov]age4 7d7 ,tax treatm5t ( acc\nts 7#a7 ,9 g5]al ,a ,m$isave acc\nt is exempt f taxation "u ?is subtitle unless su* acc\nt has ceas$ to be a ,m$isave acc\nt4 ,not)/&+ ! prec$+ s5t5ce1 any ,m$isave acc\nt is subject to ! taxes impos$ by section #eaa 7relat+ to imposition ( tax on unrelat$ bus9ess income ( *>itable1 etc4 organizations74 7#b7 ,acc\nt t]m9ations ,rules simil> to ! rules ( p>agraphs 7#b7 & 7#d7 ( section #djh7;e7 %all apply to ,m$isave acc\nts1 & any am\nt treat$ z di/ribut$ "u su* rules %all be treat$ z n us$ to pay qualifi$ m$ical exp5ses4 7e7 ,tax treatm5t ( di/ributions 7#a7 ,am\nts us$ = qualifi$ m$ical exp5ses ,any am\nt paid or di/ribut$ out ( a ,m$isave acc\nt :i* is us$ exclusively to pay qualifi$ m$ical exp5ses ( any acc\nt b5efici>y %all n be includible 9 gross income4 7#b7 ,inclusion ( am\nts n us$ = qualifi$ m$ical exp5ses ,any am\nt paid or di/ribut$ out ( a ,m$isave acc\nt :i* is n us$ exclusively to pay ! qualifi$ m$ical exp5ses ( ! acc\nt b5efici>y %all be includ$ 9 ! gross income ( su* b5efici>y4 7#c7 ,excess contributions return$ be=e due date ( return 7,a7 ,9 g5]al ,if any excess contribution is contribut$ = a taxable ye> to any ,m$isave acc\nt ( an individual1 p>agraph 7#b7 %all n apply to di/ributions f ! ,m$isave acc\nts ( su* individual 7to ! ext5t su* di/ributions d n exce$ ! aggregate excess contributions to all su* acc\nts ( su* individual = su* ye>7 if-- 7i7 su* di/ribution is receiv$ by ! individual on or be=e ! la/ day prescrib$ by law 7includ+ ext5sions ( "t7 = fil+ su* individual's return = su* taxable ye>1 & 7ii7 su* di/ribution is accompani$ by ! am\nt ( net income attributable to su* excess contribution4 ,any net income describ$ 9 clause 7ii7 %all be includ$ 9 ! gross income ( ! individual = ! taxable ye> 9 :i* x is receiv$4 7,b7 ,excess contribution ,= purposes ( subp>agraph 7,a71 ! t]m excess contribution means any contribution 7o!r ?an a rollov] contribution describ$ 9 p>agraph 7#e77 :i* exce$s ! limitations specifi$ 9 subsection 7b74 7#d7 ,additional tax on di/ributions n us$ = qualifi$ m$ical exp5ses 7,a7 ,9 g5]al ,! tax impos$ by ?is *apt] on ! acc\nt b5efici>y = any taxable ye> 9 :i* !re is a paym5t or di/ribution f a ,m$isave acc\nt ( su* b5efici>y :i* is includible 9 gross income "u p>agraph 7#b7 %all be increas$ by #bj p]c5t ( ! am\nt :i* is s includible4 7,b7 ,exception = disability or dea? ,subp>agraph 7,a7 %all n apply if ! paym5t or di/ribution is made aft] ! acc\nt b5efici>y becomes disabl$ )9 ! mean+ ( section #gb7m77#g7 or dies4 7#e7 ,rollov] contribution 7,a7 ,9 g5]al ,an am\nt is describ$ 9 ?is subp>agraph z a rollov] contribution if x meets ! requirem5ts ( clauses 7i7 & 7ii74 7i7 ,9 g5]al ,p>agraph 7#b7 %all n apply to any am\nt paid or di/ribut$ f a ,m$isave acc\nt to ! acc\nt b5efici>y to ! ext5t ! am\nt receiv$ is paid into a ,m$isave acc\nt = ! b5efit ( su* b5efici>y n lat] ?an ! #fj? day aft] ! day on :i* ! b5efici>y receives ! paym5t or di/ribution4 7ii7 ,limitation ,?is p>agraph %all n apply to any am\nt describ$ 9 clause 7i7 receiv$ by an individual f a ,m$isave acc\nt if1 at any "t dur+ ! #a-ye> p]iod end+ on ! day ( su* receipt1 su* individual receiv$ any o!r am\nt describ$ 9 clause 7i7 f a ,m$isave acc\nt :i* 0 n includible 9 ! individual's gross income because ( ! application ( ?is p>agraph4 7,b7 ,rollov] f ,,fsa1 ,ar*] ,,msa1 & ,,hsa ,an am\nt is describ$ 9 ?is subp>agraph = a cal5d> ye> z a rollov] contribution if ! am\nt is ! rema9+ balance 9 a flexible sp5d+ acc\nt1 ,ar*] ,,msa1 or heal? sav+s acc\nt t is contribut$ to ! ,m$isave acc\nt = a taxable ye> end+ on or be=e "o ye> aft] ! date ( ! enactm5t ( ! ,fair ,c>e ,act ( #bjbj4 7#f7 ,coord9ation ) m$ical exp5se d$uction ,= purposes ( det]m9+ ! am\nt ( ! d$uction "u section #bac1 any paym5t or di/ribution out ( a ,m$isave acc\nt = qualifi$ m$ical exp5ses %all n be treat$ z an exp5se paid = m$ical c>e4 7#g7 ,transf] ( acc\nt incid5t to divorce ,! transf] ( an individual's int]e/ 9 a ,m$isave acc\nt to an individual's sp\se or =m] sp\se "u a divorce or sep>ation in/rum5t describ$ 9 clause 7i7 ( section #aba7;d77#c77;,c7 %all n be consid]$ a taxable transf] made by su* individual not)/&+ any o!r provision ( ?is subtitle1 & su* int]e/ %all1 aft] su* transf]1 be treat$ z a ,m$isave acc\nt ) respect to :i* su* sp\se is ! acc\nt b5efici>y4 7#h7 ,treatm5t aft] dea? ( acc\nt b5efici>y 7,a7 ,treatm5t if designat$ b5efici>y is sp\se ,if ! acc\nt b5efici>y's surviv+ sp\se acquires su* b5efici>y's int]e/ 9 a ,m$isave acc\nt by reason ( be+ ! designat$ b5efici>y ( su* acc\nt at ! dea? ( ! acc\nt b5efici>y1 su* ,m$isave acc\nt %all be treat$ z if ! sp\se 7 ! acc\nt b5efici>y4 7,b7 ,o!r cases 7i7 ,9 g5]al ,if1 by reason ( ! dea? ( ! acc\nt b5efici>y1 any p]son acquires ! acc\nt b5efici>y's int]e/ 9 a ,m$isave acc\nt 9 a case to :i* subp>agraph 7,a7 does n apply-- 7,i7 su* acc\nt %all cease to be a ,m$isave acc\nt z ( ! date ( dea?1 & 7,,ii7 an am\nt equal to ! fair m>ket value ( ! assets 9 su* acc\nt on su* date %all be includible if su* p]son is n ! e/ate ( su* b5efici>y1 9 su* p]son's gross income = ! taxable ye> :i* includes su* date1 or if su* p]son is ! e/ate ( su* b5efici>y1 9 su* b5efici>y's gross income = ! la/ taxable ye> ( su* b5efici>y4 7ii7 ,special rules 7,i7 ,r$uction ( inclusion = pr$ea? exp5ses ,! am\nt includible 9 gross income "u clause 7i7 by any p]son 7o!r ?an ! e/ate7 %all be r$uc$ by ! am\nt ( qualifi$ m$ical exp5ses :i* 7 incurr$ by ! dec$5t be=e ! date ( ! dec$5t's dea? & paid by su* p]son )9 #a ye> aft] su* date4 7,,ii7 ,d$uction = e/ate taxes ,an appropriate d$uction %all be all[$ "u section #fia7;c7 to any p]son 7o!r ?an ! dec$5t or ! dec$5t's sp\se7 ) respect to am\nts includ$ 9 gross income "u clause 7i7 by su* p]son4 7f7 ,reports ,! ,secret>y may require-- 7#a7 ! tru/ee ( a ,m$isave acc\nt to make su* reports reg>d+ su* acc\nt to ! ,secret>y & to ! acc\nt b5efici>y ) respect to contributions1 di/ributions1 ! return ( excess contributions1 & su* o!r matt]s z ! ,secret>y det]m9es appropriate1 & 7#b7 any p]son :o provides an individual ) a qualifi$ heal? plan to make su* reports to ! ,secret>y & to ! acc\nt b5efici>y ) respect to su* plan z ! ,secret>y det]m9es appropriate4 ,! reports requir$ by ?is subsection %all be fil$ at su* "t & 9 su* mann] & furni%$ to su* individuals at su* "t & 9 su* mann] z may be requir$ by ! ,secret>y4 7g7 ,regulations & guidance ,= purposes ( ?is section1 ! ,secret>y %all prescribe su* regulations or o!r guidance z ! ,secret>y det]m9es necess>y or appropriate to c>ry out ?is section1 includ+ regulations or guidance on ! me?ods acceptable to ! ,secret>y = det]m9+ qualifi$ heal? plan actu>ial value4 4 7b7 ,cl]ical am5dm5ts ,! table ( sections = "p ,,viii ( sub*apt] ,f ( *apt] #a ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ecj;,a4 ,m$isave acc\nts4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] "o ye> aft] ! date ( ! enactm5t ( ?is ,act4 #ajb4 ,consolidation ( ,h,s,as1 ,h,r,as1 ,f,s,as1 & ,m,s,as into ,m$isave acc\nts 7a7 ,treatm5t ( employ] paym5ts 7#a7 ,exclusion limit$ to self-fund$ major m$ical plan ( employ]s ,section #aje7;b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ paid1 & ins]t+ paid "u a self-fund$ major m$ical plan ( ! employ]4 7#b7 ,exclusion n applicable to heal? reimbursem5t arrangem5ts ,subsection 7h7 ( su* ,code is am5d$ to read z foll[s3 7h7 ,exclusion n applicable to heal? reimbursem5t arrangem5ts ,subsection 7b7 %all n apply to heal? reimbursem5t arrangem5ts4 4 7#c7 ,repeal ( exclusions f income = ,ar*] ,m,s,as1 ,f,s,as1 & ,h,s,as 7,a7 ,9 g5]al ,section #ajf ( su* ,code is am5d$-- 7i7 by /rik+ subsections 7b71 7d71 & 7e71 & 7ii7 by r$esignat+ subsections 7f7 & 7g7 z subsections 7d7 & 7e71 respectively4 7,b7 ,exclusion f income = ,m$isave acc\nts ,section #ajf ( su* ,code1 z am5d$ by subp>agraph 7,a71 is am5d$ by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,contributions to ,m$isave acc\nts 7#a7 ,9 g5]al ,9 ! case ( an employee :o is an eligible individual 7z def9$ 9 section #ecj;,a7c77#a771 am\nts contribut$ by su* employee's employ] to any ,m$isave acc\nt 7z def9$ 9 section #ecj;,a7a77 ( su* employee %all be treat$ z employ]-provid$ cov]age = m$ical exp5ses "u an accid5t or heal? plan to ! ext5t su* am\nts d n exce$ ! limitations specifi$ 9 clauses 7ii7 & 7iii7 ( section #ecj;,a7a77#a77;,a7 7det]m9$ )\t reg>d to ?is subsection7 :i* is applicable to su* employee = su* taxable ye> unless su* employee is receiv+ & advance paym5t ( ! premium tax cr$it "u section1 !n su* am\nts %all n be treat$ z employ]-provid$ cov]age = m$ical exp5se "u an accid5t or heal? plan & are subject to taxation z p]sonal income4 7#b7 ,no con/ructive receipt ,no am\nt %all be includ$ 9 ! gross income ( any employee solely because ! employee may *oose betwe5 ! contributions ref]r$ to 9 p>agraph 7#a7 & employ] contributions to ano!r heal? plan ( ! employ]4 7#c7 ,special rule = d$uction ( employ] contributions ,any employ] contribution to a ,m$isave acc\nt1 if o!rwise all[able z a d$uction "u ?is *apt]1 %all be all[$ only = ! taxable ye> 9 :i* paid4 7#d7 ,employ] ,m$isave acc\nt contributions requir$ to be %[n on return ,e individual requir$ to file a return "u section #fjab = ! taxable ye> %all include on su* return ! aggregate am\nt contribut$ by employ]s to ! ,m$isave acc\nts ( su* individual or su* individual's sp\se = su* taxable ye>4 7#e7 ,m$isave acc\nt contributions n "p ( ,,cobra cov]age ,p>agraph 7#a7 %all n apply = purposes ( section #dihj;,b4 7#f7 ,cross ref]5ce ,= p5alty on failure by employ] to make comp>able contributions to ! ,m$isave acc\nts ( comp>able employees1 see section #dihj;,g4 4 7#d7 ,di/ribution f c]ta9 retirem5t acc\nts = ,m$isave acc\nt fund+ ,section #djh7;d77#i7 ( su* ,code is am5d$ to read z foll[s3 7#i7 ,di/ribution = ,m$isave acc\nt fund+ 7,a7 ,9 g5]al ,9 ! case ( an individual :o is an eligible individual 7z def9$ 9 section #ecj;,a7c77#a77 & :o elects ! application ( ?is p>agraph = a taxable ye>1 gross income ( ! individual = ! taxable ye> does n include a qualifi$ ,m$isave acc\nt fund+ di/ribution to ! ext5t su* di/ribution is o!rwise includible 9 gross income4 7,b7 ,qualifi$ ,m$isave acc\nt fund+ di/ribution ,= purposes ( ?is p>agraph1 ! t]m qualifi$ ,m$isave acc\nt fund+ di/ribution means a di/ribution f an individual retirem5t plan 7o!r ?an a plan describ$ 9 subsection 7k7 or 7p77 ( ! employee to ! ext5t t-- 7i7 su* di/ribution is contribut$ to ! ,m$isave acc\nt ( ! individual 9 a direct tru/ee-to-tru/ee transf]1 & 7ii7 su* di/ribution-- 7,i7 :5 add$ to previ\s contributions to ! ,m$isave acc\nt = ! cal5d> ye> does n exce$ ! limitation am\nt specifi$ 9 section #ecj;,a7b77#a71 & 7,,ii7 :5 add$ to ! balance ( ! ,m$isave acc\nt1 exce$s ! limitation am\nt specifi$ 9 section #ecj;,a7b77#b74 7,c7 ,"o-"t transf] ,an individual may make an election "u subp>agraph 7,a7 only = "o qualifi$ ,m$isave acc\nt fund+ di/ribution dur+ ! lifetime ( ! individual4 ,su* an election1 once made1 %all be irrevocable4 7,d7 ,application ( section #gb ,not)/&+ section #gb1 9 det]m9+ ! ext5t to :i* an am\nt is treat$ z o!rwise includible 9 gross income = purposes ( subp>agraph 7,a71 ! aggregate am\nt di/ribut$ f an individual retirem5t plan %all be treat$ z includible 9 gross income to ! ext5t t su* am\nt does n exce$ ! aggregate am\nt :i* w\ld h be5 s includible if all am\nts f all individual retirem5t plans 7 di/ribut$4 ,prop] adju/m5ts %all be made 9 apply+ section #gb to o!r di/ributions 9 su* taxable ye> & subsequ5t taxable ye>s4 4 7#e7 ,failure ( employ] to make comp>able contributions 7,a7 ,section #dihj;,g7a7 ( su* ,code is am5d$ by /rik+ heal? sav+s acc\nt & ins]t+ ,m$isave acc\nt4 7,b7 ,section #dihj;,g7c7 ( su* ,code is am5d$ by /rik+ ,ar*] ,m,s,as & heal? sav+s acc\nts & ins]t+ ,m$isave acc\nts4 7#f7 ,w-#b /atem5ts ,section #fjea7;a7 ( su* ,code is am5d$-- 7,a7 by /rik+ p>agraph 7#aa7 & r$esignat+ p>agraphs 7#ab7 ?r\gh 7#ag7 z p>agraphs 7#aa7 ?r\gh 7#af71 respectively1 & 7,b7 by am5d+ p>agraph 7#aa71 z s r$esignat$1 to read z foll[s3 7#aa7 ! am\nt contribut$ to any ,m$isave acc\nt 7z def9$ 9 section #ecj;,a7 ( su* employee or su* employee's sp\se1 4 7b7 ,o!r con=m+ am5dm5ts 7#a7 ,ar*] ,m,s,as ,section #bbj7;a7 ( su* ,code is am5d$ by add+ at ! end ! foll[+3 ,no am\nt is all[$ z a d$uction "u ! prec$+ s5t5ce = any taxable ye> beg9n+ aft] "o ye> aft] ! date ( ! enactm5t ( ! ,fair ,c>e ,act ( #bjbj44 7#b7 ,heal? sav+s acc\nts ,section #bbc7;a7 ( su* ,code is am5d$ by add+ at ! end ! foll[+3 ,no am\nt is all[$ z a d$uction "u ! prec$+ s5t5ce = any taxable ye> beg9n+ aft] "o ye> aft] ! date ( ! enactm5t ( ! ,fair ,c>e ,act ( #bjbj44 7c7 ,rollov] ( ,,fsa1 ,ar*] ,,msa1 ,,hsa to ,m$isave acc\nt ,not)/&+ any o!r provision ( law1 if ! rema9+ balance 9 a heal? flexible sp5d+ arrangem5t1 ,ar*] ,,msa1 or heal? sav+s acc\nt is transf]r$ to a ,m$isave acc\nt be=e ! end ( any taxable ye> end+ on or be=e "o ye> aft] ! date ( ! enactm5t ( ! ,fair ,c>e ,act ( #bjbj1 su* transf] %all be treat$ z a rollov] to ! ,m$isave acc\nt "u section #ecj;,a7e77#e77;,b7 ( ! ,int]nal ,rev5ue ,code ( #aihf & ! di/ribution f ! heal? flexible sp5d+ arrangem5t1 ,ar*] ,,msa1 or heal? sav+s acc\nt %all n be includible 9 gross income4 7d7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] "o ye> aft] ! date ( ! enactm5t ( ?is ,act4 #ajc4 ,heal? ,reimbursem5t ,arrangem5ts & ,o!r ,acc\nt-,bas$ ,gr\p ,heal? ,plans ,! rule publi%$ by ! ,int]nal ,rev5ue ,s]vice1 ! ,employee ,b5efits ,security ,adm9i/ration1 & ! ,heal? & ,human ,s]vices ,dep>tm5t relat+ to ,heal? ,reimbursem5t ,arrangem5ts & ,o!r ,acc\nt-,bas$ ,gr\p ,heal? ,plans 7,june #bj1 #bjai7 %all h ! =ce & effect ( law4 ,heal? ,reimbursem5t ,arrangem5ts z describ$ 9 ?is rule are subject to all sections 9 ?is title4 #ajd4 ,co/-%>+ r$uction paym5ts z eligible contributions 7a7 ,alt]native waiv] = ,/ate innovation ,section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,alt]native waiv] = ,/ate innovation 7#a7 ,9 g5]al ,not)/&+ any prec$+ provision ( ?is section1 a ,/ate may apply to ! ,secret>y = ! waiv] ( any requirem5t ( subsection 7a77#b7 ) respect to heal? insurance cov]age )9 t ,/ate = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb1 if in/ead ( comply+ ) section #adjb ! ,/ate provides = ! di/ribution ( fund+ receiv$ "u p>agraph 7#b7 to ,m$isave acc\nts ( qualify+ individuals ) respect to su* ,/ate4 ,su* application %all be fil$ at su* "t & 9 su* mann] z ! ,secret>y may require1 & %all include su* in=mation z ! ,secret>y may require 7includ+ a #aj-ye> budget plan = su* plan t is budget neutral = ! ,f$]al ,gov]nm5t74 7#b7 ,pass-?r\gh fund+ ,) respect to a ,/ate waiv] "u p>agraph 7#a71 "u :i*1 due to ! /ructure ( su* waiv]1 individuals 9 ! ,/ate w\ld n qualify = co/-%>+ r$uctions "u section #adjb = :i* !y w\ld o!rwise be eligible1 ! ,secret>y %all provide = an alt]native means by :i* an am\nt is transf]r$ to ! ,/ate equal to ! aggregate am\nt ( su* r$uctions t w\ld h be5 paid on behalf ( ! p>ticipants 9 ! ,ex*anges e/abli%$ "u ?is title-- 7,a7 _h ! ,/ate n receiv$ su* waiv]2 7,b7 _h ref]5ces to eligible insur$s "u section #adjb ref]r$ to qualify+ insur$s 7z def9$ 9 section #accb7;f772 7,c7 _h1 aft] application ( clause 7ii71 9 ! case ( a qualify+ insur$ enroll$ 9 ! bronze level ( cov]age-- 7i7 ! p]c5tages specifi$ 9 subclauses 7,i71 7,,ii71 & 7,,iii7 ( section #adjb7;c77#a77;,b7 7 ref]5ces to #hd p]c5t1 #gg p]c5t1 & #fc p]c5t1 respectively2 & 7ii7 ! ref]5ces 9 subp>agraphs 7,a71 7,b71 & 7,c7 ( section #adjb7;c77#b7 to #id p]c5t1 #hg p]c5t1 & #gc p]c5t1 respectively1 7 ref]5ces to #hd p]c5t1 #gg p]c5t1 & #fc p]c5t1 respectively2 & 7,d7 _h1 aft] application ( clause 7ii71 9 ! case ( a qualify+ insur$ enroll$ 9 ! copp] level ( cov]age-- 7i7 ! p]c5tages specifi$ 9 subclauses 7,i71 7,,ii71 & 7,,iii7 ( section #adjb7;c77#a77;,b7 7 ref]5ces to #gd p]c5t1 #fg p]c5t1 & #ec p]c5t1 respectively2 & 7ii7 ! ref]5ces 9 subp>agraphs 7,a71 7,b71 & 7,c7 ( section #adjb7;c77#b7 to #id p]c5t1 #hg p]c5t1 & #gc p]c5t1 respectively1 7 ref]5ces to #gd p]c5t1 #fg p]c5t1 & #ec p]c5t1 respectively4 ,! am\nt transf]r$ pursuant to ! previ\s s5t5ce %all be det]m9$ annually by ! ,secret>y1 tak+ into consid]ation ! exp]i5ce ( o!r ,/ates ) respect to p>ticipation 9 an ,ex*ange & r$uctions provid$ "u su* provisions to resid5ts ( ! o!r ,/ates1 & %all be paid to ! ,/ate = purposes ( implem5t+ su* waiv]4 7#c7 ,waiv] consid]ation & transp>5cy ,! provisions ( p>agraph 7#d7 ( subsection 7a7 %all apply to an application = a waiv] "u p>agraph 7#a7 9 ! same mann] z su* provisions apply ) respect to an application = a waiv] "u subsection 7a77#a71 except t1 = purposes ( ?is p>agraph1 ! provisions ( subsection 7a77#d77;,b77ii7 %all n apply4 7#d7 ,det]m9ations2 t]m ( waiv] ,! provisions ( subsections 7d7 & 7e7 %all apply ) respect to a det]m9ation ) respect to an application "u p>agraph 7#a71 & ) respect to ! t]m ( a waiv] "u su* p>agraph1 9 ! same mann] z su* provisions apply ) respect to a det]m9ation ) respect to an application "u subsection 7a77#a71 & ) respect to ! t]m ( a waiv] "u su* subsection4 7#e7 ,def9itions ,= purposes ( ?is subsection3 7,a7 ,m$isave acc\nt ,! t]m ,m$isave acc\nt has ! mean+ giv5 su* t]m 9 section #ecj;,a7a7 ( ! ,int]nal ,rev5ue ,code ( #aihf4 7,b7 ,qualify+ insur$ ,! t]m qualify+ insur$ means1 ) respect to a ,/ate & a ye>1 an individual-- 7i7 :o is enroll$ 9 a ,m$isave acc\nt2 7ii7 :o is enroll$ = su* ye> 9 a silv]1 bronze1 or copp] level cov]age (f]$ ?r\gh an ,ex*ange2 & 7iii7 ^: h\sehold income is n m ?an #bej p]c5t ( ! ,f$]al pov]ty l9e = a family ( ! size involv$4 4 7b7 ,additional am5dm5ts ,section #adjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjga7 is am5d$ by /rik+ n less ?an #ajj p]c5t b & exce$s #ajj p]c5t b & m ?an #ajj p]c5t b ea* place su* phrases appe>4 7c7 ,con=m+ am5dm5ts ,section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb71 z am5d$ by subsection 7a71 is fur!r am5d$ 9 subsection 7a77#d7-- 7#a7 9 subp>agraph 7,a7 by /rik+ ! p]iod & ins]t+ 1 except 9 ! case ( a waiv] describ$ 9 subsection 7f742 & 7#b7 9 subp>agraph 7,b77ii7 by ins]t+ aft] an application ! foll[+3 7except 9 ! case ( a waiv] describ$ 9 subsection 7f774 7d7 ,appropriation = co/-,%>+ paym5ts ,section #adjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjga7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7g7 ,fund+ 7#a7 ,appropriations ,out ( any funds 9 ! ,treasury n o!rwise appropriat$1 !re is appropriat$ su* sums z may be necess>y to1 subject to p>agraph 7#b71 provide heal? b5efits cov]age ?r\gh paym5t to issu]s 7"u ?is section or ?r\gh advance paym5t by ! ,secret>y ( ! ,treasury "u section #adab7;c77#c77 ( ! am\nts comput$ "u ?is section = ea* ( plan ye>s #bjbb ?r\gh #bjbf4 7#b7 ,adju/m5ts ,not)/&+ any o!r provision ( law1 paym5ts & o!r actions = adju/m5ts to obligations incurr$ prior to ,decemb] #ca1 #bjbb1 may be made ?r\gh ,decemb] #ca1 #bjbb4 7#c7 ,limitation ,am\nts appropriat$ "u p>agraph 7#a7 = ea* ( plan ye>s #bjbb ?r\gh #bjbf are subject to ! requirem5ts & limitations "u sections #ejf & #ejg ( division ,h ( ,public ,law #aae-ca 9 ! same mann] & to ! same ext5t z if su* am\nts = ea* su* ye> 7 appropriat$ "u su* division4 4 #aje4 ,direct prim>y c>e 7a7 ,9 g5]al ,section #bbc7;c77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,treatm5t ( direct prim>y c>e s]vice arrangem5ts 7i7 ,9 g5]al ,a direct prim>y c>e s]vice arrangem5t %all n be treat$ z a heal? plan = purposes ( subp>agraph 7,a77ii74 7ii7 ,direct prim>y c>e s]vice arrangem5t ,= purposes ( ?is p>agraph-- 7,i7 ,9 g5]al ,! t]m direct prim>y c>e s]vice arrangem5t means1 ) respect to any individual1 an arrangem5t "u :i* su* individual is provid$ m$ical c>e 7z def9$ 9 section #bac7;d77 consi/+ solely ( prim>y c>e s]vices provid$ by prim>y c>e practition]s 7z def9$ 9 section #ahcc7x77#b77;,a7 ( ! ,social ,security ,act1 det]m9$ )\t reg>d to clause 7ii7 !re(71 if ! sole comp5sation = su* c>e is a fix$ p]iodic fee4 7,,ii7 ,limitation ,) respect to any individual = any mon?1 su* t]m %all n include any arrangem5t if ! aggregate fees = all direct prim>y c>e s]vice arrangem5ts 7det]m9$ )\t reg>d to ?is subclause7 ) respect to su* individual = su* mon? exce$ #aej 7twice su* doll> am\nt 9 ! case ( an individual ) any direct prim>y c>e s]vice arrangem5t 7z s det]m9$7 t cov]s m ?an "o individual74 7iii7 ,c]ta9 s]vices specifically exclud$ f treatm5t z prim>y c>e s]vices ,= purposes ( ?is p>agraph1 ! t]m prim>y c>e s]vices %all n include-- 7,i7 proc$ures t require ! use ( g5]al ane/hesia1 & 7,,ii7 laboratory s]vices n typically adm9i/]$ 9 an ambulatory prim>y c>e sett+4 ,! ,secret>y1 aft] consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all issue regulations or o!r guidance reg>d+ ! application ( ?is clause4 4 7b7 ,direct prim>y c>e s]vice arrangem5t fees treat$ z m$ical exp5ses ,section #bbc7;d77#b77;,c7 is am5d$ by /rik+ or at ! end ( clause 7iii71 by /rik+ ! p]iod at ! end ( clause 7iv7 & ins]t+ 1 or1 & by add+ at ! end ! foll[+ new clause3 7v7 any direct prim>y c>e s]vice arrangem5t4 4 7c7 ,inflation adju/m5t ,section #bbc7;g77#a7 ( su* ,code is am5d$-- 7#a7 by ins]t+ 1 7c77#a77;,d77ii77,,ii71 aft] 7b77#b71 ea* place su* t]m appe>s1 & 7#b7 9 subp>agraph 7,b71 by ins]t+ & 7iii7 aft] clause 7ii7 9 clause 7i71 by /rik+ & at ! end ( clause 7i71 by /rik+ ! p]iod at ! end ( clause 7ii7 & ins]t+ 1 &1 & by ins]t+ aft] clause 7ii7 ! foll[+ new clause3 7iii7 9 ! case ( ! doll> am\nt 9 subsection 7c77#a77;,d77ii77,,ii7 = taxable ye>s beg9n+ 9 cal5d> ye>s aft] #bjbj1 cal5d> ye> #bjai4 4 7d7 ,report+ ( direct prim>y c>e s]vice arrangem5t fees on ,w-#b ,section #fjea7;a7 ( su* ,code is am5d$ by /rik+ & at ! end ( p>agraph 7#af71 by /rik+ ! p]iod at ! end ( p>agraph 7#ag7 & ins]t+ 1 &1 & by ins]t+ aft] p>agraph 7#ag7 ! foll[+ new p>agraph3 7#ah7 9 ! case ( a direct prim>y c>e s]vice arrangem5t 7z def9$ 9 section #bbc7;c77#a77;,d77ii77 :i* is provid$ 9 connection ) employm5t1 ! aggregate fees = su* arrangem5t = su* employee4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to mon?s beg9n+ aft] ,decemb] #ca1 #bjai1 9 taxable ye>s end+ aft] su* date4 ,b ,assi/ance to ,m$isave ,acc\nts #aaa4 ,support 9 implem5tation 7a7 ,9 g5]al ,9 ! case ( an individual :o makes a contribution to a ,m$isave acc\nt be=e ! end ( ! #a-ye> p]iod beg9n+ on ! date ( ! enactm5t ( ?is ,act1 !re %all be all[$ z a cr$it aga9/ ! tax impos$ by subtitle ,a ( ! ,int]nal ,rev5ue ,code ( #aihf = ! taxable ye> 9 :i* ! contribution is made an am\nt equal to ! aggregate ( #a = e #c contribut$ to ! acc\nt 7o!r ?an a rollov] contribution "u section #ecj;,a7e77#e7 ( su* ,code7 = su* taxable ye>4 7b7 ,limitation ,! aggregate am\nt all[$ to an individual z a cr$it "u subsection 7a7 = all taxable ye>s %all n exce$ #a1jjj4 7c7 ,portion ( cr$it refundable ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,= purposes ( ! ,int]nal ,rev5ue ,code ( #aihf1 9 ! case ( an eligible individual-- 7,a7 ,increase 9 cr$it rate ,subsection 7a7 %all be appli$ by sub/itut+ #a = e #a contribut$ = #a = e #c contribut$4 7,b7 ,cr$it refundable ,! cr$it all[$ "u ?is section %all be treat$ 9 ! same mann] z a cr$it all[$ "u subp>t ,c ( "p ,,iv ( sub*apt] ,a ( *apt] #a ( su* ,code4 7#b7 ,eligible individual 7,a7 ,9 g5]al ,! t]m eligible individual means1 ) respect to any taxable ye>1 a taxpay] ^: h\sehold income = ! taxable ye> does n exce$ #djj p]c5t ( an am\nt equal to ! pov]ty l9e = a family ( ! size involv$4 7,b7 ,m>ri$ c\ples mu/ file jo9t return ,if ! taxpay] is m>ri$ 7)9 ! mean+ ( section #ggjc ( su* ,code7 at ! close ( ! taxable ye>-- 7i7 ! taxpay] %all be treat$ z an eligible individual only if ! taxpay] & ! taxpay]'s sp\se file a jo9t return = ! taxable ye>1 & 7ii7 p>agraph 7#a7 %all be appli$ sep>ately to ea* sp\se4 7#c7 ,family size1 h\sehold income1 modifi$ adju/$ gross income1 pov]ty l9e ,! t]ms family size1 h\sehold income1 modifi$ adju/$ gross income1 & pov]ty l9e h ! mean+ giv5 su* t]ms by section #cf;,b7d7 ( su* ,code4 7d7 ,d5ial ( cr$it to dep5d5ts ,no cr$it %all be all[$ "u ?is section to any individual ) respect to :om a d$uction "u section #aea is all[able to ano!r taxpay] = a taxable ye> beg9n+ 9 ! cal5d> ye> 9 :i* su* individual's taxable ye> beg9s4 #aab4 ,new corporations requir$ to use ,m$isave ,not)/&+ any o!r provision ( law1 a corporation incorporat$ aft] ,decemb] #ca1 #bjba1 may n receive tax b5efits = (f]+ employees heal? insurance4 ,! previ\s s5t5ce %all n apply to ,m$isave contributions (f]$ by su* a corporation4 #aac4 ,f$]al employee heal? b5efits & ,m$isave 7a7 ,9 g5]al ,section #acab7;d77#c77;,d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb7;d77#c77;,d77 is am5d$-- 7#a7 9 ! subp>agraph head+1 by /rik+ ,memb]s ( ,congress & ins]t+ ,presid5t1 ,vice ,presid5t1 ,memb]s ( ,congress1 & ,f$]al employees2 7#b7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i7-- 7,a7 by /rik+ ,memb]s ( ,congress & congressional /aff & ins]t+ ! ,presid5t1 ,vice ,presid5t1 ,memb]s ( ,congress1 & ,f$]al employees2 & 7,b7 by /rik+ a ,memb] ( ,congress or congressional /aff & ins]t+ ! ,presid5t1 ! ,vice ,presid5t1 a ,memb] ( ,congress1 or a ,f$]al employee2 & 7#c7 9 clause 7ii71 by am5d+ subclause 7,,ii7 to read z foll[s3 7,,ii7 ,f$]al employee ,! t]m ,f$]al employee means-- 7aa7 an employee1 z su* t]m is def9$ 9 section #baje ( title #e1 ,unit$ ,/ates ,code2 & 7bb7 includes an individual to :om subsection 7c7 or 7f7 ( su* section #baje p]ta9s 7:e!r or n su* individual satisfies item 7aa774 4 7b7 ,conv]sion to ,m$isave acc\nts ,ea* plan (f]$ "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code1 %all be conv]t$ into a ,m$isave acc\nt deposit & fund$ at ! level ( ! second-lea/ exp5sive silv] plan available ?r\gh ! ,ex*ange :]e ! applicable individual resides4 #aad4 ,grants to ,/ates = consum] assi/ance 7a7 ,9 g5]al ,! ,adm9i/rator %all e/abli% a grant program to provide assi/ance to eligible entities to c>ry out ! activities describ$ 9 subsection 7c7 = ! #e-ye> p]iod beg9n+ on ! date ( ! enactm5t ( ?is section4 7b7 ,application ,an eligible entity %all submit an application to ! ,adm9i/rator 9 su* "t & 9 su* mann] z ! ,adm9i/rator may require1 provid+ t su* application requires a demon/ration ( ! exi/5ce ( a relation%ip )1 or ! ability to e/abli% a relation%ip )1 an employ]1 employee1 self-employ$ individual1 or consum] eligible to enroll 9 a ,m$isave acc\nt4 7c7 ,use ( funds ,an eligible entity receiv+ a grant "u ?is section %all use su* funds to-- 7#a7 di/ribute fair & imp>tial in=mation to consum]s ab\t ,m$isave acc\nts1 includ+ ! availability ( su* acc\nts & h[ su* acc\nts may be utiliz$2 7#b7 conduct activities to raise public aw>5ess ( ,m$isave acc\nts2 7#c7 facilitate enrollm5t 9 ,m$isave acc\nts2 & 7#d7 ref] individuals enroll$ 9 a ,m$isave acc\nt to ! appropriate (ficial1 organization1 or ,/ate ag5cy = ! purpose ( address+ a compla9t1 grievance1 or o!r "q ) respect to su* ,m$isave acc\nt4 7d7 ,am\nt ,! ,adm9i/rator may di/ribute up to #e1jjj1jjj annually = ea* ye> occurr+ dur+ ! p]iod describ$ 9 subsection 7a7 to be divid$ among grant recipi5ts "u ?is section4 7e7 ,report ,n lat] ?an "o ye> aft] ! date on :i* ! la/ ( ! grant p]iods aw>d$ "u ?is section ends1 ! ,adm9i/rator %all submit a report to ! ,congress on ! effectiv5ess ( ! grants provid$ "u ?is section4 7f7 ,def9itions ,9 ?is section3 7#a7 ,adm9i/rator ,! t]m ,adm9i/rator means ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7#b7 ,consum] ,! t]m consum] means an individual enroll$ 91 or seek+ to enroll 91 a ,m$isave acc\nt4 7#c7 ,eligible entity ,! t]m eligible entity includes ! foll[+3 7,a7 ,a ,/ate4 7,b7 ,trade4 7,c7 ,indu/ry4 7,d7 ,pr(essional associations4 7,e7 ,comm]cial fi%+ indu/ry organizations4 7,f7 ,ran*+ & f>m+ organizations4 7,g7 ,community & consum]-focus$ nonpr(it gr\ps4 7,h7 ,*amb]s ( ,comm]ce4 7,i7 ,unions4 7,j7 ,small bus9ess developm5t c5t]s 7z def9$ 9 section #ba ( ! ,small ,bus9ess ,act 7#ae ,u4,s4,c4 #fdh774 7,k7 ,o!r entities capable ( c>ry+ out ! activities describ$ "u subsection 7b74 7#d7 ,m$isave acc\nt ,! t]m ,m$isave acc\nt has ! mean+ giv5 su* t]m 9 section #ecj;,a7a7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7z add$ by section #b7;a774 7#e7 ,/ate ,! t]m ,/ate means ea* ( ! sev]al ,/ates1 ! ,di/rict ( ,columbia1 ea* t]ritory & possession ( ! ,unit$ ,/ates1 & ea* f$]ally recogniz$ ,indian ,tribe4 ,,ii ,improv+ ,private ,heal? ,insurance ,a ,ma9ta9+ ,protections = ,pati5ts ) ,preexi/+ ,conditions #bja4 ,gu>ante$ availability ( cov]age2 prohibit+ discrim9ation 7a7 ,9 g5]al ,subtitle ,c ( title ,i ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia7 is am5d$ by add+ at ! end ! foll[+3 #aif4 ,gu>ante$ availability ( cov]age 7a7 ,gu>ante$ issuance ( cov]age 9 ! individual & gr\p m>ket ,subject to subsections 7b7 ?r\gh 7d71 ea* heal? insurance issu] t (f]s heal? insurance cov]age 9 ! individual or gr\p m>ket 9 a ,/ate mu/ accept e employ] & individual 9 ! ,/ate t applies = su* cov]age4 7b7 ,enrollm5t 7#a7 ,re/riction ,a heal? insurance issu] describ$ 9 subsection 7a7 may re/rict enrollm5t 9 cov]age describ$ 9 su* subsection to op5 or special enrollm5t p]iods4 7#b7 ,e/abli%m5t ,a heal? insurance issu] describ$ 9 subsection 7a7 %all1 9 accordance ) ! regulations promulgat$ "u p>agraph 7#c71 e/abli% special enrollm5t p]iods = qualify+ ev5ts 7"u section #fjc ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd74 7#c7 ,regulations ,! ,secret>y %all promulgate regulations ) respect to enrollm5t p]iods "u p>agraphs 7#a7 & 7#b74 7c7 ,special rules = network plans 7#a7 ,9 g5]al ,9 ! case ( a heal? insurance issu] t (f]s heal? insurance cov]age 9 ! gr\p & individual m>ket ?r\gh a network plan1 ! issu] may-- 7,a7 limit ! employ]s t may apply = su* cov]age to ^? ) eligible individuals :o live1 "w1 or reside 9 ! s]vice area = su* network plan2 & 7,b7 )9 ! s]vice area ( su* plan1 d5y su* cov]age to su* employ]s & individuals if ! issu] has demon/rat$1 if requir$1 to ! applicable ,/ate au?ority t-- 7i7 x w n h ! capacity to deliv] s]vices adequately to enrollees ( any additional gr\ps or any additional individuals because ( its obligations to exi/+ gr\p contract hold]s & enrollees2 & 7ii7 x is apply+ ?is p>agraph uni=mly to all employ]s & individuals )\t reg>d to ! claims exp]i5ce ( ^? individuals1 employ]s & _! employees 7& _! dep5d5ts71 or any heal? /atus-relat$ factor relat+ to su* individuals1 employees1 & dep5d5ts4 7#b7 #ahj-;day susp5sion ^u d5ial ( cov]age ,an issu]1 ^u d5y+ heal? insurance cov]age 9 any s]vice area 9 accordance ) p>agraph 7#a77;,b71 may n (f] cov]age 9 ! gr\p or individual m>ket )9 su* s]vice area = a p]iod ( #ahj days aft] ! date su* cov]age is d5i$4 7d7 ,application ( f9ancial capacity limits 7#a7 ,9 g5]al ,a heal? insurance issu] may d5y heal? insurance cov]age 9 ! gr\p or individual m>ket if ! issu] has demon/rat$1 if requir$1 to ! applicable ,/ate au?ority t-- 7,a7 x does n h ! f9ancial res]ves necess>y to und]write additional cov]age2 & 7,b7 x is apply+ ?is p>agraph uni=mly to all employ]s & individuals 9 ! gr\p or individual m>ket 9 ! ,/ate consi/5t ) applicable ,/ate law & )\t reg>d to ! claims exp]i5ce ( ^? individuals1 employ]s & _! employees 7& _! dep5d5ts7 or any heal? /atus-relat$ factor relat+ to su* individuals1 employees1 & dep5d5ts4 7#b7 #ahj-;day susp5sion ^u d5ial ( cov]age ,a heal? insurance issu] ^u d5y+ heal? insurance cov]age 9 connection ) gr\p heal? plans 9 accordance ) p>agraph 7#a7 9 a ,/ate may n (f] cov]age 9 connection ) gr\p heal? plans 9 ! gr\p or individual m>ket 9 ! ,/ate = a p]iod ( #ahj days aft] ! date su* cov]age is d5i$ or until ! issu] has demon/rat$ to ! applicable ,/ate au?ority1 if requir$ "u applicable ,/ate law1 t ! issu] has suffici5t f9ancial res]ves to und]write additional cov]age1 :i*ev] is lat]4 ,an applicable ,/ate au?ority may provide = ! application ( ?is subsection on a s]vice-area-specific basis4 7e7 ,def9itions ,9 ?is section & 9 sections #aig ?r\gh #aii;,a3 7#a7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 7#b7 ,! t]ms g5etic in=mation1 g5etic te/1 gr\p heal? plan1 gr\p m>ket1 heal? insurance cov]age1 heal? insurance issu]1 gr\p heal? insurance cov]age1 individual heal? insurance cov]age1 individual m>ket1 & und]writ+ purpose h ! mean+s giv5 su* t]ms 9 section #bgia ( ! ,public ,heal? ,s]vice ,act4 #aig4 ,fair heal? insurance premiums 7a7 ,prohibit+ discrim9atory premium rates 7#a7 ,9 g5]al ,) respect to ! premium rate *>g$ by a heal? insurance issu] = heal? insurance cov]age (f]$ 9 ! individual or small gr\p m>ket-- 7,a7 su* rate %all v>y ) respect to ! p>ticul> plan or cov]age involv$ only by-- 7i7 :e!r su* plan or cov]age cov]s an individual or family2 7ii7 rat+ area1 z e/abli%$ 9 accordance ) p>agraph 7#b72 7iii7 age1 except t su* rate %all n v>y by m ?an #e to #a = adults2 & 7iv7 tobacco use1 except t su* rate %all n v>y by m ?an #a4e to #a2 & 7,b7 su* rate %all n v>y ) respect to ! p>ticul> plan or cov]age involv$ by any o!r factor n describ$ 9 subp>agraph 7,a74 7#b7 ,rat+ area 7,a7 ,9 g5]al ,ea* ,/ate %all e/abli% #a or m rat+ areas )9 t ,/ate = purposes ( apply+ ! requirem5ts ( ?is title4 7,b7 ,secret>ial review ,! ,secret>y %all review ! rat+ areas e/abli%$ by ea* ,/ate "u subp>agraph 7,a7 to ensure ! adequacy ( su* areas = purposes ( c>ry+ out ! requirem5ts ( ?is title4 ,if ! ,secret>y det]m9es a ,/ate's rat+ areas are n adequate1 or t a ,/ate does n e/abli% su* areas1 ! ,secret>y may e/abli% rat+ areas = t ,/ate4 7#c7 ,p]missible age b&s ,! ,secret>y1 9 consultation ) ! ,national ,association ( ,insurance ,commission]s1 %all def9e ! p]missible age b&s = rat+ purposes "u p>agraph 7#a77;,a77iii74 7#d7 ,application ( v>iations bas$ on age or tobacco use ,) respect to family cov]age "u a gr\p heal? plan or heal? insurance cov]age1 ! rat+ v>iations p]mitt$ "u clauses 7iii7 & 7iv7 ( p>agraph 7#a77;,a7 %all be appli$ bas$ on ! portion ( ! premium t is attributable to ea* family memb] cov]$ "u ! plan or cov]age4 #aih4 ,prohibit+ discrim9ation aga9/ individual p>ticipants & b5efici>ies bas$ on heal? /atus 7a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age may n e/abli% rules = eligibility 7includ+ cont9u$ eligibility7 ( any individual to enroll "u ! t]ms ( ! plan or cov]age bas$ on any ( ! foll[+ heal? /atus-relat$ factors 9 relation to ! individual or a dep5d5t ( ! individual3 7#a7 ,heal? /atus4 7#b7 ,m$ical condition 7includ+ bo? physical & m5tal illnesses74 7#c7 ,claims exp]i5ce4 7#d7 ,receipt ( heal? c>e4 7#e7 ,m$ical hi/ory4 7#f7 ,g5etic in=mation4 7#g7 ,evid5ce ( insurability 7includ+ conditions aris+ out ( acts ( dome/ic viol5ce74 7#h7 ,disability4 7#i7 ,any o!r heal? /atus-relat$ factor det]m9$ appropriate by ! ,secret>y4 7b7 ,9 premium contributions 7#a7 ,9 g5]al ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 may n require any individual 7z a condition ( enrollm5t or cont9u$ enrollm5t "u ! plan7 to pay a premium or contribution :i* is great] ?an su* premium or contribution = a simil>ly situat$ individual enroll$ 9 ! plan on ! basis ( any heal? /atus-relat$ factor 9 relation to ! individual or to an individual enroll$ "u ! plan z a dep5d5t ( ! individual4 7#b7 ,con/ruction ,no?+ 9 p>agraph 7#a7 %all be con/ru$-- 7,a7 to re/rict ! am\nt t an employ] or individual may be *>g$ = cov]age "u a gr\p heal? plan except z provid$ 9 p>agraph 7#c7 or individual heal? cov]age1 z ! case may be2 or 7,b7 to prev5t a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 f e/abli%+ premium disc\nts or rebates or modify+ o!rwise applicable copaym5ts or d$uctibles 9 return = adh]5ce to programs ( heal? promotion & disease prev5tion4 7#c7 ,no gr\p-bas$ discrim9ation on basis ( g5etic in=mation 7,a7 ,9 g5]al ,= purposes ( ?is section1 a gr\p heal? plan1 & heal? insurance issu] (f]+ gr\p heal? insurance cov]age 9 connection ) a gr\p heal? plan1 may n adju/ premium or contribution am\nts = ! gr\p cov]$ "u su* plan on ! basis ( g5etic in=mation4 7,b7 ,rule ( con/ruction ,no?+ 9 subp>agraph 7,a7 or 9 p>agraphs 7#a7 & 7#b7 ( subsection 7d7 %all be con/ru$ to limit ! ability ( a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age to increase ! premium = an employ] bas$ on ! manife/ation ( a disease or disord] ( an individual :o is enroll$ 9 ! plan4 ,9 su* case1 ! manife/ation ( a disease or disord] 9 "o individual _c also be us$ z g5etic in=mation ab\t o!r gr\p memb]s & to fur!r increase ! premium = ! employ]4 7c7 ,g5etic te/+ 7#a7 ,limitation on reque/+ or requir+ g5etic te/+ ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 %all n reque/ or require an individual or a family memb] ( su* individual to und]go a g5etic te/4 7#b7 ,rule ( con/ruction ,p>agraph 7#a7 %all n be con/ru$ to limit ! au?ority ( a heal? c>e pr(essional :o is provid+ heal? c>e s]vices to an individual to reque/ t su* individual und]go a g5etic te/4 7#c7 ,rule ( con/ruction reg>d+ paym5t 7,a7 ,9 g5]al ,no?+ 9 p>agraph 7#a7 %all be con/ru$ to preclude a gr\p heal? plan1 or a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 f obta9+ & us+ ! results ( a g5etic te/ 9 mak+ a det]m9ation reg>d+ paym5t 7z su* t]m is def9$ = ! purposes ( apply+ ! regulations promulgat$ by ! ,secret>y "u "p ,c ( title ,,xi ( ! ,social ,security ,act & section #bfd ( ?is ,act1 z may be revis$ f "t to "t7 consi/5t ) subsection 7a74 7,b7 ,limitation ,= purposes ( subp>agraph 7,a71 a gr\p heal? plan1 or a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 may reque/ only ! m9imum am\nt ( in=mation necess>y to accompli% ! int5d$ purpose4 7#d7 ,rese>* exception ,not)/&+ p>agraph 7#a71 a gr\p heal? plan1 or a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 may reque/1 b n require1 t a p>ticipant or b5efici>y und]go a g5etic te/ if ea* ( ! foll[+ conditions is met3 7,a7 ,! reque/ is made pursuant to rese>* t complies ) "p #df ( title #de1 ,code ( ,f$]al ,regulations1 or equival5t ,f$]al regulations1 & any applicable ,/ate or local law or regulations = ! protection ( human subjects 9 rese>*4 7,b7 ,! plan or issu] cle>ly indicates to ea* p>ticipant or b5efici>y1 or 9 ! case ( a m9or *ild1 to ! legal gu>dian ( su* b5efici>y1 to :om ! reque/ is made t-- 7i7 compliance ) ! reque/ is volunt>y2 & 7ii7 noncompliance w h no effect on enrollm5t /atus or premium or contribution am\nts4 7,c7 ,no g5etic in=mation collect$ or acquir$ "u ?is p>agraph %all be us$ = und]writ+ purposes4 7,d7 ,! plan or issu] notifies ! ,secret>y 9 writ+ t ! plan or issu] is conduct+ activities pursuant to ! exception provid$ = "u ?is p>agraph1 includ+ a description ( ! activities conduct$4 7,e7 ,! plan or issu] complies ) su* o!r conditions z ! ,secret>y may by regulation require = activities conduct$ "u ?is p>agraph4 7d7 ,prohibition on collection ( g5etic in=mation 7#a7 ,9 g5]al ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 %all n reque/1 require1 or pur*ase g5etic in=mation = und]writ+ purposes4 7#b7 ,prohibition on collection ( g5etic in=mation prior to enrollm5t ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 %all n reque/1 require1 or pur*ase g5etic in=mation ) respect to any individual prior to su* individual's enrollm5t "u ! plan or cov]age 9 connection ) su* enrollm5t4 7#c7 ,incid5tal collection ,if a gr\p heal? plan1 or a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) a gr\p heal? plan1 obta9s g5etic in=mation incid5tal to ! reque/+1 requir+1 or pur*as+ ( o!r in=mation conc]n+ any individual1 su* reque/1 requirem5t1 or pur*ase %all n be consid]$ a violation ( p>agraph 7#b7 if su* reque/1 requirem5t1 or pur*ase is n 9 violation ( p>agraph 7#a74 7e7 ,g5etic in=mation ( a fetus or embryo ,any ref]5ce 9 ?is "p to g5etic in=mation conc]n+ an individual or family memb] ( an individual %all-- 7#a7 ) respect to su* an individual or family memb] ( an individual :o is a pregnant woman1 include g5etic in=mation ( any fetus c>ri$ by su* pregnant woman2 & 7#b7 ) respect to an individual or family memb] utiliz+ an assi/$ reproductive te*nology1 include g5etic in=mation ( any embryo legally held by ! individual or family memb]4 7f7 ,programs ( heal? promotion or disease prev5tion 7#a7 ,g5]al provisions 7,a7 ,g5]al rule ,= purposes ( subsection 7b77#b77;,b71 a program ( heal? promotion or disease prev5tion 7ref]r$ to 9 ?is subsection z a wellness program7 %all be a program (f]$ by an employ] t is design$ to promote heal? or prev5t disease t meets ! applicable requirem5ts ( ?is subsection4 7,b7 ,no conditions bas$ on heal? /atus factor ,if none ( ! conditions = obta9+ a premium disc\nt or rebate or o!r rew>d = p>ticipation 9 a wellness program is bas$ on an individual satisfy+ a /&>d t is relat$ to a heal? /atus factor1 su* wellness program %all n violate ?is section if p>ticipation 9 ! program is made available to all simil>ly situat$ individuals & ! requirem5ts ( p>agraph 7#b7 are compli$ )4 7,c7 ,conditions bas$ on heal? /atus factor ,if any ( ! conditions = obta9+ a premium disc\nt or rebate or o!r rew>d = p>ticipation 9 a wellness program is bas$ on an individual satisfy+ a /&>d t is relat$ to a heal? /atus factor1 su* wellness program %all n violate ?is section if ! requirem5ts ( p>agraph 7#c7 are compli$ )4 7#b7 ,wellness programs n subject to requirem5ts ,if none ( ! conditions = obta9+ a premium disc\nt or rebate or o!r rew>d "u a wellness program z describ$ 9 p>agraph 7#a77;,b7 are bas$ on an individual satisfy+ a /&>d t is relat$ to a heal? /atus factor 7or if su* a wellness program does n provide su* a rew>d71 ! wellness program %all n violate ?is section if p>ticipation 9 ! program is made available to all simil>ly situat$ individuals4 ,! foll[+ programs %all n h to comply ) ! requirem5ts ( p>agraph 7#c7 if p>ticipation 9 ! program is made available to all simil>ly situat$ individuals3 7,a7 ,a program t reimburses all or "p ( ! co/ = memb]%ips 9 a fitness c5t]4 7,b7 ,a diagno/ic te/+ program t provides a rew>d = p>ticipation & does n base any "p ( ! rew>d on outcomes4 7,c7 ,a program t enc\rages prev5tive c>e relat$ to a heal? condition ?r\gh ! waiv] ( ! copaym5t or d$uctible requirem5t "u gr\p heal? plan = ! co/s ( c]ta9 items or s]vices relat$ to a heal? condition 7su* z pr5atal c>e or well-baby visits74 7,d7 ,a program t reimburses individuals = ! co/s ( smok+ cessation programs )\t reg>d to :e!r ! individual quits smok+4 7,e7 ,a program t provides a rew>d to individuals = att5d+ a p]iodic heal? education sem9>4 7#c7 ,wellness programs subject to requirem5ts ,if any ( ! conditions = obta9+ a premium disc\nt1 rebate1 or rew>d "u a wellness program z describ$ 9 p>agraph 7#a77;,c7 is bas$ on an individual satisfy+ a /&>d t is relat$ to a heal? /atus factor1 ! wellness program %all n violate ?is section if ! foll[+ requirem5ts are compli$ )3 7,a7 ,! rew>d = ! wellness program1 toge!r ) ! rew>d = o!r wellness programs ) respect to ! plan t requires satisfaction ( a /&>d relat$ to a heal? /atus factor1 %all n exce$ #cj p]c5t ( ! co/ ( employee-only cov]age "u ! plan4 ,if1 9 addition to employees or individuals1 any class ( dep5d5ts 7su* z sp\ses or sp\ses & dep5d5t *ildr57 may p>ticipate fully 9 ! wellness program1 su* rew>d %all n exce$ #cj p]c5t ( ! co/ ( ! cov]age 9 :i* an employee or individual & any dep5d5ts are enroll$4 ,= purposes ( ?is p>agraph1 ! co/ ( cov]age %all be det]m9$ bas$ on ! total am\nt ( employ] & employee contributions = ! b5efit package "u :i* ! employee is 7or ! employee & any dep5d5ts are7 receiv+ cov]age4 ,a rew>d may be 9 ! =m ( a disc\nt or rebate ( a premium or contribution1 a waiv] ( all or "p ( a co/-%>+ me*anism 7su* z d$uctibles1 copaym5ts1 or co9surance71 ! abs5ce ( a sur*>ge1 or ! value ( a b5efit t w\ld o!rwise n be provid$ "u ! plan4 ,! ,secret>ies ( ,labor1 ,heal? & ,human ,s]vices1 & ! ,treasury may increase ! rew>d available "u ?is subp>agraph to up to #ej p]c5t ( ! co/ ( cov]age if ! ,secret>ies det]m9e t su* an increase is appropriate4 7,b7 ,! wellness program %all be reasonably design$ to promote heal? or prev5t disease4 ,a program complies ) ! prec$+ s5t5ce if ! program has a reasonable *ance ( improv+ ! heal? (1 or prev5t+ disease 91 p>ticipat+ individuals & x is n ov]ly burd5some1 is n a subt]fuge = discrim9at+ bas$ on a heal? /atus factor1 & is n highly suspect 9 ! me?od *os5 to promote heal? or prev5t disease4 7,c7 ,! plan %all give individuals eligible = ! program ! opportunity to qualify = ! rew>d "u ! program at lea/ once ea* ye>4 7,d7 ,! full rew>d "u ! wellness program %all be made available to all simil>ly situat$ individuals4 ,= su* purpose1 among o!r ?+s3 7i7 ,! rew>d is n available to all simil>ly situat$ individuals = a p]iod unless ! wellness program all[s-- 7,i7 = a reasonable alt]native /&>d 7or waiv] ( ! o!rwise applicable /&>d7 = obta9+ ! rew>d = any individual = :om1 = t p]iod1 x is unreasonably difficult due to a m$ical condition to satisfy ! o!rwise applicable /&>d2 & 7,,ii7 = a reasonable alt]native /&>d 7or waiv] ( ! o!rwise applicable /&>d7 = obta9+ ! rew>d = any individual = :om1 = t p]iod1 x is m$ically inadvisable to attempt to satisfy ! o!rwise applicable /&>d4 7ii7 ,if reasonable "u ! circum/ances1 ! plan or issu] may seek v]ification1 su* z a /atem5t f an individual's physician1 t a heal? /atus factor makes x unreasonably difficult or m$ically inadvisable = ! individual to satisfy or attempt to satisfy ! o!rwise applicable /&>d4 7,e7 ,! plan or issu] involv$ %all disclose 9 all plan mat]ials describ+ ! t]ms ( ! wellness program ! availability ( a reasonable alt]native /&>d 7or ! possibility ( waiv] ( ! o!rwise applicable /&>d7 requir$ "u subp>agraph 7,d74 ,if plan mat]ials disclose t su* a program is available1 )\t describ+ its t]ms1 ! disclosure "u ?is subp>agraph %all n be requir$4 #aii4 ,prohibition ( preexi/+ condition exclusions or o!r discrim9ation bas$ on heal? /atus 7a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age may n impose any preexi/+ condition exclusion ) respect to su* plan or cov]age4 7b7 ,def9itions ,= purposes ( ?is section-- 7#a7 ,preexi/+ condition exclusion 7,a7 ,9 g5]al ,! t]m preexi/+ condition exclusion means1 ) respect to cov]age1 a limitation or exclusion ( b5efits relat+ to a condition bas$ on ! fact t ! condition 0 pres5t be=e ! date ( enrollm5t = su* cov]age1 :e!r or n any m$ical advice1 diagnosis1 c>e1 or treatm5t 0 recomm5d$ or receiv$ be=e su* date4 7,b7 ,treatm5t ( g5etic in=mation ,g5etic in=mation %all n be treat$ z a condition describ$ 9 subsection 7a77#a7 9 ! abs5ce ( a diagnosis ( ! condition relat$ to su* in=mation4 7#b7 ,enrollm5t date ,! t]m enrollm5t date means1 ) respect to an individual cov]$ "u a gr\p heal? plan or heal? insurance cov]age1 ! date ( enrollm5t ( ! individual 9 ! plan or cov]age or1 if e>li]1 ! fir/ day ( ! wait+ p]iod = su* enrollm5t4 7#c7 ,late enrollee ,! t]m late enrollee means1 ) respect to cov]age "u a gr\p heal? plan1 a p>ticipant or b5efici>y :o enrolls "u ! plan o!r ?an dur+-- 7,a7 ! fir/ p]iod 9 :i* ! individual is eligible to enroll "u ! plan2 or 7,b7 a special enrollm5t p]iod "u subsection 7f74 7#d7 ,wait+ p]iod ,! t]m wait+ p]iod means1 ) respect to a gr\p heal? plan & an individual :o is a pot5tial p>ticipant or b5efici>y 9 ! plan1 ! p]iod t mu/ pass ) respect to ! individual be=e ! individual is eligible to be cov]$ = b5efits "u ! t]ms ( ! plan4 7c7 ,rules relat+ to cr$it+ previ\s cov]age 7#a7 ,cr$itable cov]age def9$ ,= purposes ( ?is title1 ! t]m cr$itable cov]age means1 ) respect to an individual1 cov]age ( ! individual "u any ( ! foll[+3 7,a7 ,a gr\p heal? plan4 7,b7 ,heal? insurance cov]age4 7,c7 ,"p ,a or "p ,b ( title ,,xviii ( ! ,social ,security ,act4 7,d7 ,title ,,xix ( ! ,social ,security ,act1 o!r ?an cov]age consi/+ solely ( b5efits "u section #aibh4 7,e7 ,*apt] #ee ( title #aj1 ,unit$ ,/ates ,code4 7,f7 ,a m$ical c>e program ( ! ,indian ,heal? ,s]vice or ( a tribal organization4 7,g7 ,a ,/ate heal? b5efits risk pool4 7,h7 ,a heal? plan (f]$ "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code4 7,i7 ,a public heal? plan 7z def9$ 9 regulations74 7,j7 ,a heal? b5efit plan "u section #e7;e7 ( ! ,peace ,corps ,act 7#bb ,u4,s4,c4 #bejd7;e774 ,su* t]m does n include cov]age consi/+ solely ( cov]age ( except$ b5efits 7z def9$ 9 section #bgia7;c774 7#b7 ,n c\nt+ p]iods be=e significant breaks 9 cov]age 7,a7 ,9 g5]al ,a p]iod ( cr$itable cov]age %all n be c\nt$1 ) respect to enrollm5t ( an individual "u a gr\p or individual heal? plan1 if1 aft] su* p]iod & be=e ! enrollm5t date1 !re 0 a #fc-;day p]iod dur+ all ( :i* ! individual 0 n cov]$ "u any cr$itable cov]age4 7,b7 ,wait+ p]iod n treat$ z a break 9 cov]age ,= purposes ( subp>agraph 7,a7 & subsection 7d77#d71 any p]iod t an individual is 9 a wait+ p]iod = any cov]age "u a gr\p or individual heal? plan 7or = gr\p heal? insurance cov]age7 or is 9 an affiliation p]iod 7z def9$ 9 subsection 7g77#b77 %all n be tak5 into acc\nt 9 det]m9+ ! cont9u\s p]iod "u subp>agraph 7,a74 7,c7 ,,taa-eligible individuals ,9 ! case ( plan ye>s beg9n+ be=e ,janu>y #a1 #bjad-- 7i7 ,,taa pre-c]tification p]iod rule ,9 ! case ( a ,,taa-eligible individual1 ! p]iod beg9n+ on ! date ! individual has a ,,taa-relat$ loss ( cov]age & end+ on ! date t is #g days aft] ! date ( ! issuance by ! ,secret>y 7or by any p]son or entity designat$ by ! ,secret>y7 ( a qualifi$ heal? insurance co/s cr$it eligibility c]tificate = su* individual = purposes ( section #gebg ( ! ,int]nal ,rev5ue ,code ( #aihf %all n be tak5 into acc\nt 9 det]m9+ ! cont9u\s p]iod "u subp>agraph 7,a74 7ii7 ,def9itions ,! t]ms ,,taa-eligible individual & ,,taa-relat$ loss ( cov]age h ! mean+s giv5 su* t]ms 9 section #bbje7;b77#d74 7#c7 ,me?od ( cr$it+ cov]age 7,a7 ,/&>d me?od ,except z o!rwise provid$ "u subp>agraph 7,b71 = purposes ( apply+ subsection 7a77#c71 a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 %all c\nt a p]iod ( cr$itable cov]age )\t reg>d to ! specific b5efits cov]$ dur+ ! p]iod4 7,b7 ,election ( alt]native me?od ,a gr\p heal? plan1 or a heal? insurance issu] (f]+ gr\p or individual heal? insurance1 may elect to apply subsection 7a77#c7 bas$ on cov]age ( b5efits )9 ea* ( sev]al classes or categories ( b5efits specifi$ 9 regulations r ?an z provid$ "u subp>agraph 7,a74 ,su* election %all be made on a uni=m basis = all p>ticipants & b5efici>ies4 ,"u su* election a gr\p or individual heal? plan or issu] %all c\nt a p]iod ( cr$itable cov]age ) respect to any class or category ( b5efits if any level ( b5efits is cov]$ )9 su* class or category4 7,c7 ,plan notice ,9 ! case ( an election ) respect to a gr\p heal? plan "u subp>agraph 7,b7 7:e!r or n heal? insurance cov]age is provid$ 9 connection ) su* plan71 ! plan %all-- 7i7 prom95tly /ate 9 any disclosure /atem5ts conc]n+ ! plan1 & /ate to ea* enrollee at ! "t ( enrollm5t "u ! plan1 t ! plan has made su* election2 & 7ii7 include 9 su* /atem5ts a description ( ! effect ( ?is election4 7,d7 ,issu] notice ,9 ! case ( an election "u subp>agraph 7,b7 ) respect to heal? insurance cov]age (f]$ by an issu] 9 ! individual or gr\p m>ket1 ! issu]-- 7i7 %all prom95tly /ate 9 any disclosure /atem5ts conc]n+ ! cov]age1 & to ea* employ] at ! "t ( ! (f] or sale ( ! cov]age1 t ! issu] has made su* election2 & 7ii7 %all include 9 su* /atem5ts a description ( ! effect ( su* election4 7#d7 ,e/abli%m5t ( p]iod ,p]iods ( cr$itable cov]age ) respect to an individual %all be e/abli%$ ?r\gh pres5tation ( c]tifications describ$ 9 subsection 7e7 or 9 su* o!r mann] z may be specifi$ 9 regulations4 7d7 ,exceptions 7#a7 ,exclusion n applicable to c]ta9 newborns ,subject to p>agraph 7#d71 a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 may n impose any preexi/+ condition exclusion 9 ! case ( an individual :o1 z ( ! la/ day ( ! #cj-;day p]iod beg9n+ ) ! date ( bir?1 is cov]$ "u cr$itable cov]age4 7#b7 ,exclusion n applicable to c]ta9 adopt$ *ildr5 ,subject to p>agraph 7#d71 a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 may n impose any preexi/+ condition exclusion 9 ! case ( a *ild :o is adopt$ or plac$ = adoption be=e atta9+ #ah ye>s ( age & :o1 z ( ! la/ day ( ! #cj-;day p]iod beg9n+ on ! date ( ! adoption or placem5t = adoption1 is cov]$ "u cr$itable cov]age4 ,! previ\s s5t5ce %all n apply to cov]age be=e ! date ( su* adoption or placem5t = adoption4 7#c7 ,exclusion n applicable to pregnancy ,a gr\p heal? plan1 & heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 may n impose any preexi/+ condition exclusion relat+ to pregnancy z a preexi/+ condition4 7#d7 ,loss if break 9 cov]age ,p>agraphs 7#a7 & 7#b7 %all no long] apply to an individual aft] ! end ( ! fir/ #fc-;day p]iod dur+ all ( :i* ! individual 0 n cov]$ "u any cr$itable cov]age4 7e7 ,c]tifications & disclosure ( cov]age 7#a7 ,requirem5t = c]tification ( p]iod ( cr$itable cov]age 7,a7 ,9 g5]al ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 %all provide ! c]tification describ$ 9 subp>agraph 7,b7-- 7i7 at ! "t an individual ceases to be cov]$ "u ! plan or o!rwise becomes cov]$ "u a ,,cobra cont9uation provision2 7ii7 9 ! case ( an individual becom+ cov]$ "u su* a provision1 at ! "t ! individual ceases to be cov]$ "u su* provision2 & 7iii7 on ! reque/ on behalf ( an individual made n lat] ?an #bd mon?s aft] ! date ( cessation ( ! cov]age describ$ 9 clause 7i7 or 7ii71 :i*ev] is lat]4 ,! c]tification "u clause 7i7 may be provid$1 to ! ext5t practicable1 at a "t consi/5t ) notices requir$ "u any applicable ,,cobra cont9uation provision4 7,b7 ,c]tification ,! c]tification describ$ 9 ?is subp>agraph is a writt5 c]tification (-- 7i7 ! p]iod ( cr$itable cov]age ( ! individual "u su* plan & ! cov]age 7if any7 "u su* ,,cobra cont9uation provision2 & 7ii7 ! wait+ p]iod 7if any7 7& affiliation p]iod1 if applicable7 impos$ ) respect to ! individual = any cov]age "u su* plan4 7,c7 ,issu] compliance ,to ! ext5t t m$ical c>e "u a gr\p heal? plan consi/s ( gr\p heal? insurance cov]age1 ! plan is deem$ to h satisfi$ ! c]tification requirem5t "u ?is p>agraph if ! heal? insurance issu] (f]+ ! cov]age provides = su* c]tification 9 accordance ) ?is p>agraph4 7#b7 ,disclosure ( in=mation on previ\s b5efits ,9 ! case ( an election describ$ 9 subsection 7c77#c77;,b7 by a gr\p heal? plan or heal? insurance issu]1 if ! plan or issu] enrolls an individual = cov]age "u ! plan & ! individual provides a c]tification ( cov]age ( ! individual "u p>agraph 7#a7-- 7,a7 ^u reque/ ( su* plan or issu]1 ! entity :i* issu$ ! c]tification provid$ by ! individual %all promptly disclose to su* reque/+ plan or issu] in=mation on cov]age ( classes & categories ( heal? b5efits available "u su* entity's plan or cov]age2 & 7,b7 su* entity may *>ge ! reque/+ plan or issu] = ! reasonable co/ ( disclos+ su* in=mation4 7#c7 ,regulations ,! ,secret>y %all e/abli% rules to prev5t an entity's failure to provide in=mation "u p>agraph 7#a7 or 7#b7 ) respect to previ\s cov]age ( an individual f adv]sely affect+ any subsequ5t cov]age ( ! individual "u ano!r gr\p heal? plan or heal? insurance cov]age4 7f7 ,special enrollm5t p]iods 7#a7 ,individuals los+ o!r cov]age ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age 9 connection ) a gr\p heal? plan1 %all p]mit an employee :o is eligible1 b n enroll$1 = cov]age "u ! t]ms ( ! plan 7or a dep5d5t ( su* an employee if ! dep5d5t is eligible1 b n enroll$1 = cov]age "u su* t]ms7 to enroll = cov]age "u ! t]ms ( ! plan if ea* ( ! foll[+ conditions is met3 7,a7 ,! employee or dep5d5t 0 cov]$ "u a gr\p heal? plan or _h heal? insurance cov]age at ! "t cov]age 0 previ\sly (f]$ to ! employee or dep5d5t4 7,b7 ,! employee /at$ 9 writ+ at su* "t t cov]age "u a gr\p heal? plan or heal? insurance cov]age 0 ! reason = decl9+ enrollm5t1 b only if ! plan sponsor or issu] 7if applicable7 requir$ su* a /atem5t at su* "t & provid$ ! employee ) notice ( su* requirem5t 7& ! consequ5ces ( su* requirem5t7 at su* "t4 7,c7 ,! employee's or dep5d5t's cov]age describ$ 9 subp>agraph 7,a7-- 7i7 0 "u a ,,cobra cont9uation provision & ! cov]age "u su* provision 0 exhau/$2 or 7ii7 0 n "u su* a provision & ei!r ! cov]age 0 t]m9at$ z a result ( loss ( eligibility = ! cov]age 7includ+ z a result ( legal sep>ation1 divorce1 dea?1 t]m9ation ( employm5t1 or r$uction 9 ! numb] ( h\rs ( employm5t7 or employ] contributions t[>d su* cov]age 7 t]m9at$4 7,d7 ,"u ! t]ms ( ! plan1 ! employee reque/s su* enrollm5t n lat] ?an #cj days aft] ! date ( exhau/ion ( cov]age describ$ 9 subp>agraph 7,c77i7 or t]m9ation ( cov]age or employ] contribution describ$ 9 subp>agraph 7,c77ii74 7#b7 ,= dep5d5t b5efici>ies 7,a7 ,9 g5]al ,if-- 7i7 a gr\p heal? plan makes cov]age available ) respect to a dep5d5t ( an individual2 7ii7 ! individual is a p>ticipant "u ! plan 7or has met any wait+ p]iod applicable to becom+ a p>ticipant "u ! plan & is eligible to be enroll$ "u ! plan b = a failure to enroll dur+ a previ\s enrollm5t p]iod72 & 7iii7 a p]son becomes su* a dep5d5t ( ! individual ?r\gh m>riage1 bir?1 or adoption or placem5t = adoption1 ! gr\p heal? plan %all provide = a dep5d5t special enrollm5t p]iod describ$ 9 subp>agraph 7,b7 dur+ :i* ! p]son 7or1 if n o!rwise enroll$1 ! individual7 may be enroll$ "u ! plan z a dep5d5t ( ! individual1 & 9 ! case ( ! bir? or adoption ( a *ild1 ! sp\se ( ! individual may be enroll$ z a dep5d5t ( ! individual if su* sp\se is o!rwise eligible = cov]age4 7,b7 ,dep5d5t special enrollm5t p]iod ,a dep5d5t special enrollm5t p]iod "u ?is subp>agraph %all be a p]iod ( n less ?an #cj days & %all beg9 on ! lat] (-- 7i7 ! date dep5d5t cov]age is made available2 or 7ii7 ! date ( ! m>riage1 bir?1 or adoption or placem5t = adoption 7z ! case may be7 describ$ 9 subp>agraph 7,a77iii74 7,c7 ,no wait+ p]iod ,if an individual seeks to enroll a dep5d5t dur+ ! fir/ #cj days ( su* a dep5d5t special enrollm5t p]iod1 ! cov]age ( ! dep5d5t %all become effective-- 7i7 9 ! case ( m>riage1 n lat] ?an ! fir/ day ( ! fir/ mon? beg9n+ aft] ! date ! complet$ reque/ = enrollm5t is receiv$2 7ii7 9 ! case ( a dep5d5t's bir?1 z ( ! date ( su* bir?2 or 7iii7 9 ! case ( a dep5d5t's adoption or placem5t = adoption1 ! date ( su* adoption or placem5t = adoption4 7#c7 ,special rules = application 9 case ( ,m$icaid & ,,*ip 7,a7 ,9 g5]al ,a gr\p heal? plan1 & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age 9 connection ) a gr\p heal? plan1 %all p]mit an employee :o is eligible1 b n enroll$1 = cov]age "u ! t]ms ( ! plan 7or a dep5d5t ( su* an employee if ! dep5d5t is eligible1 b n enroll$1 = cov]age "u su* t]ms7 to enroll = cov]age "u ! t]ms ( ! plan if ei!r ( ! foll[+ conditions is met3 7i7 ,t]m9ation ( ,m$icaid or ,,*ip cov]age ,! employee or dep5d5t is cov]$ "u a ,m$icaid plan "u title ,,xix ( ! ,social ,security ,act or "u a ,/ate *ild heal? plan "u title ,,xxi ( su* ,act & cov]age ( ! employee or dep5d5t "u su* a plan is t]m9at$ z a result ( loss ( eligibility = su* cov]age & ! employee reque/s cov]age "u ! gr\p heal? plan 7or heal? insurance cov]age7 n lat] ?an #fj days aft] ! date ( t]m9ation ( su* cov]age4 7ii7 ,eligibility = employm5t assi/ance "u ,m$icaid or ,,*ip ,! employee or dep5d5t becomes eligible = assi/ance1 ) respect to cov]age "u ! gr\p heal? plan or heal? insurance cov]age1 "u su* ,m$icaid plan or ,/ate *ild heal? plan 7includ+ "u any waiv] or demon/ration project conduct$ "u or 9 relation to su* a plan71 if ! employee reque/s cov]age "u ! gr\p heal? plan or heal? insurance cov]age n lat] ?an #fj days aft] ! date ! employee or dep5d5t is det]m9$ to be eligible = su* assi/ance4 7,b7 ,coord9ation ) ,m$icaid & ,,*ip 7i7 ,outrea* to employees reg>d+ availability ( ,m$icaid & ,,*ip cov]age 7,i7 ,9 g5]al ,ea* employ] t ma9ta9s a gr\p heal? plan 9 a ,/ate t provides m$ical assi/ance "u a ,/ate ,m$icaid plan "u title ,,xix ( ! ,social ,security ,act1 or *ild heal? assi/ance "u a ,/ate *ild heal? plan "u title ,,xxi ( su* ,act1 9 ! =m ( premium assi/ance = ! pur*ase ( cov]age "u a gr\p heal? plan1 %all provide to ea* employee a writt5 notice in=m+ ! employee ( pot5tial opportunities !n curr5tly available 9 ! ,/ate 9 :i* ! employee resides = premium assi/ance "u su* plans = heal? cov]age ( ! employee or ! employee's dep5d5ts4 ,= purposes ( compliance ) ?is subclause1 ! employ] may use any ,/ate-specific model notice develop$ 9 accordance ) section #gja7;f77#c77;,b77i77,,ii7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaha7;f77#c77;,b77i77,,ii774 7,,ii7 ,option to provide concurr5t ) provision ( plan mat]ials to employee ,an employ] may provide ! model notice applicable to ! ,/ate 9 :i* an employee resides concurr5t ) ! furni%+ ( mat]ials notify+ ! employee ( heal? plan eligibility1 concurr5t ) mat]ials provid$ to ! employee 9 connection ) an op5 season or election process conduct$ "u ! plan1 or concurr5t ) ! furni%+ ( ! summ>y plan description z provid$ 9 section #ajd7;b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd4 7ii7 ,disclosure ab\t gr\p heal? plan b5efits to ,/ates = m$icaid & *ip eligible individuals ,9 ! case ( an enrollee 9 a gr\p heal? plan :o is cov]$ "u a ,m$icaid plan ( a ,/ate "u title ,,xix ( ! ,social ,security ,act or "u a ,/ate *ild heal? plan "u title ,,xxi ( su* ,act1 ! plan adm9i/rator ( ! gr\p heal? plan %all disclose to ! ,/ate1 ^u reque/1 in=mation ab\t ! b5efits available "u ! gr\p heal? plan 9 suffici5t specificity1 z det]m9$ "u regulations ( ! ,secret>y ( ,heal? & ,human ,s]vices 9 consultation ) ! ,secret>y t require use ( ! model cov]age coord9ation disclosure =m develop$ "u section #caa7;b77#a77;,c7 ( ! ,*ildr5's ,heal? ,insurance ,reau?orization ,act ( #bjji1 s z to p]mit ! ,/ate to make a det]m9ation 7"u p>agraph 7#b77;,b71 7#c71 or 7#aj7 ( section #baje7;c7 ( ! ,social ,security ,act or o!rwise7 conc]n+ ! co/-effectiv5ess ( ! ,/ate provid+ m$ical or *ild heal? assi/ance ?r\gh premium assi/ance = ! pur*ase ( cov]age "u su* gr\p heal? plan & 9 ord] = ! ,/ate to provide supplem5tal b5efits requir$ "u p>agraph 7#aj77;,e7 ( su* section or o!r au?ority4 7g7 ,use ( ,affiliation ,p]iod by ,h,m,os z ,alt]native to ,preexi/+ ,condition ,exclusion 7#a7 ,9 g5]al ,a heal? ma9t5ance organization :i* (f]s heal? insurance cov]age 9 connection ) a gr\p heal? plan & :i* does n impose any preexi/+ condition exclusion all[$ "u subsection 7a7 ) respect to any p>ticul> cov]age option may impose an affiliation p]iod = su* cov]age option1 b only if-- 7,a7 su* p]iod is appli$ uni=mly )\t reg>d to any heal? /atus-relat$ factors2 & 7,b7 su* p]iod does n exce$ #b mon?s 7or #c mon?s 9 ! case ( a late enrollee74 7#b7 ,affiliation p]iod 7,a7 ,def9$ ,= purposes ( ?is title1 ! t]m affiliation p]iod means a p]iod :i*1 "u ! t]ms ( ! heal? insurance cov]age (f]$ by ! heal? ma9t5ance organization1 mu/ expire be=e ! heal? insurance cov]age becomes effective4 ,! organization is n requir$ to provide heal? c>e s]vices or b5efits dur+ su* p]iod & no premium %all be *>g$ to ! p>ticipant or b5efici>y = any cov]age dur+ ! p]iod4 7,b7 ,beg9n+ ,su* p]iod %all beg9 on ! enrollm5t date4 7,c7 ,runs concurr5tly ) wait+ p]iods ,an affiliation p]iod "u a plan %all run concurr5tly ) any wait+ p]iod "u ! plan4 7#c7 ,alt]native me?ods ,a heal? ma9t5ance organization describ$ 9 p>agraph 7#a7 may use alt]native me?ods1 f ^? describ$ 9 su* p>agraph1 to address adv]se selection z approv$ by ! ,/ate insurance commission] or (ficial or (ficials designat$ by ! ,/ate to en=ce ! requirem5ts ( ?is "p = ! ,/ate involv$ ) respect to su* issu]4 #aii;,a4 ,ext5sion ( dep5d5t cov]age 7a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age t provides dep5d5t cov]age ( *ildr5 %all cont9ue to make su* cov]age available = an adult *ild 7:o is n m>ri$7 until ! *ild turns #bf ye>s ( age4 ,no?+ 9 ?is section %all require a heal? plan or a heal? insurance issu] describ$ 9 ! prec$+ s5t5ce to make cov]age available = a *ild ( a *ild receiv+ dep5d5t cov]age4 7b7 ,regulations ,! ,secret>y %all promulgate regulations to def9e ! dep5d5ts to :i* cov]age %all be made available "u subsection 7a74 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to modify ! def9ition ( dep5d5t z us$ 9 ! ,int]nal ,rev5ue ,code ( #aihf ) respect to ! tax treatm5t ( ! co/ ( cov]age4 #aii;,b4 ,annual limitation on co/-%>+ 7a7 ,9 g5]al 7#a7 #bjad ,! co/-%>+ incurr$ "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age ) respect to self-only cov]age or cov]age o!r ?an self-only cov]age = a plan ye> beg9n+ 9 #bjad %all n exce$ ! doll> am\nts 9 effect "u section #bbc7;c77#b77;,a77ii7 ( ! ,int]nal ,rev5ue ,code ( #aihf = self-only & family cov]age1 respectively1 = taxable ye>s beg9n+ 9 #bjad4 7#b7 #bjae & lat] ,9 ! case ( any plan ye> beg9n+ 9 a cal5d> ye> aft] #bjad1 ! limitation "u ?is p>agraph %all-- 7,a7 9 ! case ( self-only cov]age1 be equal to ! doll> am\nt "u p>agraph 7#a7 = self-only cov]age = plan ye>s beg9n+ 9 #bjad1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage "u subsection 7c7 = ! cal5d> ye>2 & 7,b7 9 ! case ( o!r cov]age1 twice ! am\nt 9 effect "u subp>agraph 7,a74 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7b7 ,co/-,%>+ ,9 ?is section3 7#a7 ,9 g5]al ,! t]m co/-%>+ includes-- 7,a7 d$uctibles1 co9surance1 copaym5ts1 or simil> *>ges2 & 7,b7 any o!r exp5diture requir$ ( an insur$ individual :i* is a qualifi$ m$ical exp5se 7)9 ! mean+ ( section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 ) respect to ess5tial heal? b5efits cov]$ "u ! plan4 7#b7 ,exceptions ,su* t]m does n include premiums1 balance bill+ am\nts = non-network provid]s1 or sp5d+ = non-cov]$ s]vices4 7c7 ,premium adju/m5t p]c5tage ,= purposes ( subsection 7a77#b77;,a71 ! premium adju/m5t p]c5tage = any cal5d> ye> is ! p]c5tage 7if any7 by :i* ! av]age p] capita premium = heal? insurance cov]age 9 ! ,unit$ ,/ates = ! prec$+ cal5d> ye> 7z e/imat$ by ! ,secret>y no lat] ?an ,octob] #a ( su* prec$+ cal5d> ye>7 exce$s su* av]age p] capita premium = #bjac 7z det]m9$ by ! ,secret>y74 #aii;,c4 ,en=cem5t ( c]ta9 heal? insurance requirem5ts 7a7 ,/ate ,en=cem5t 7#a7 ,/ate au?ority ,ea* ,/ate may require t heal? insurance issu]s t issue1 sell1 r5ew1 or (f] heal? insurance cov]age 9 ! ,/ate 9 ! individual or gr\p m>ket meet ! requirem5ts ( ?is "p ) respect to su* issu]s4 7#b7 ,failure to implem5t provisions ,9 ! case ( a det]m9ation by ! ,secret>y t a ,/ate has fail$ to sub/antially en=ce a provision 7or provisions7 ( sections #aif ?r\gh #aii;,a ) respect to heal? insurance issu]s 9 ! ,/ate1 ! ,secret>y %all en=ce su* provision 7or provisions7 "u subsection 7b7 ins(> z !y relate to ! issuance1 sale1 r5ewal1 & (f]+ ( heal? insurance cov]age 9 connection ) gr\p heal? plans or individual heal? insurance cov]age 9 su* ,/ate4 7b7 ,secret>ial ,en=cem5t ,au?ority 7#a7 ,limitation ,! provisions ( ?is subsection %all apply to en=cem5t ( a provision 7or provisions7 describ$ 9 subsection 7a77#b7 only-- 7,a7 z provid$ "u su* subsection2 & 7,b7 ) respect to individual heal? insurance cov]age or gr\p heal? plans t are non-,f$]al gov]nm5tal plans4 7#b7 ,imposition ( p5alties ,9 ! cases describ$ 9 p>agraph 7#a7-- 7,a7 ,9 g5]al ,subject to ! succe$+ provisions ( ?is subsection1 any non-,f$]al gov]nm5tal plan t is a gr\p heal? plan & any heal? insurance issu] t fails to meet a provision ( ?is "p applicable to su* plan or issu] is subject to a civil money p5alty "u ?is subsection4 7,b7 ,liability = p5alty ,9 ! case ( a failure by-- 7i7 a heal? insurance issu]1 ! issu] is liable = su* p5alty2 or 7ii7 a gr\p heal? plan t is a non-,f$]al gov]nm5tal plan :i* is-- 7,i7 sponsor$ by #b or m employ]s1 ! plan is liable = su* p5alty2 or 7,,ii7 n s sponsor$1 ! employ] is liable = su* p5alty4 7,c7 ,am\nt ( p5alty 7i7 ,9 g5]al ,! maximum am\nt ( p5alty impos$ "u ?is p>agraph is #ajj = ea* day = ea* individual ) respect to :i* su* a failure occurs4 7ii7 ,consid]ations 9 imposition ,9 det]m9+ ! am\nt ( any p5alty to be assess$ "u ?is p>agraph1 ! ,secret>y %all take into acc\nt ! previ\s record ( compliance ( ! entity be+ assess$ ) ! applicable provisions ( ?is "p & ! gravity ( ! violation4 7iii7 ,limitations 7,i7 ,p5alty n to apply :]e failure n discov]$ ex]cis+ reasonable dilig5ce ,no civil money p5alty %all be impos$ "u ?is p>agraph on any failure dur+ any p]iod = :i* x is e/abli%$ to ! satisfaction ( ! ,secret>y t none ( ! entities aga9/ :om ! p5alty w\ld be impos$ knew1 or ex]cis+ reasonable dilig5ce w\ld h kn[n1 t su* failure exi/$4 7,,ii7 ,p5alty n to apply to failures correct$ )9 #cj days ,no civil money p5alty %all be impos$ "u ?is p>agraph on any failure if su* failure 0 due to reasonable cause & n to willful neglect1 & su* failure is correct$ dur+ ! #cj-;day p]iod beg9n+ on ! fir/ day any ( ! entities aga9/ :om ! p5alty w\ld be impos$ knew1 or ex]cis+ reasonable dilig5ce w\ld h kn[n1 t su* failure exi/$4 7,d7 ,adm9i/rative review 7i7 ,opportunity = he>+ ,! entity assess$ %all be af=d$ an opportunity = he>+ by ! ,secret>y ^u reque/ made )9 #cj days aft] ! date ( ! issuance ( a notice ( assessm5t4 ,9 su* he>+ ! decision %all be made on ! record pursuant to section #eed ( title #e1 ,unit$ ,/ates ,code4 ,if no he>+ is reque/$1 ! assessm5t %all con/itute a f9al & unappealable ord]4 7ii7 ,he>+ proc$ure ,if a he>+ is reque/$1 ! initial ag5cy decision %all be made by an adm9i/rative law judge1 & su* decision %all become ! f9al ord] unless ! ,secret>y modifies or vacates ! decision4 ,notice ( int5t to modify or vacate ! decision ( ! adm9i/rative law judge %all be issu$ to ! p>ties )9 #cj days aft] ! date ( ! decision ( ! judge4 ,a f9al ord] :i* takes effect "u ?is p>agraph %all be subject to review only z provid$ "u subp>agraph 7,e74 7,e7 ,judicial review 7i7 ,fil+ ( action = review ,any entity aga9/ :om an ord] impos+ a civil money p5alty has be5 ent]$ aft] an ag5cy he>+ "u ?is p>agraph may obta9 review by ! ,unit$ ,/ates di/rict c\rt = any di/rict 9 :i* su* entity is locat$ or ! ,unit$ ,/ates ,di/rict ,c\rt = ! ,di/rict ( ,columbia by fil+ a notice ( appeal 9 su* c\rt )9 #cj days f ! date ( su* ord]1 & simultane\sly s5d+ a copy ( su* notice by regi/]$ mail to ! ,secret>y4 7ii7 ,c]tification ( adm9i/rative record ,! ,secret>y %all promptly c]tify & file 9 su* c\rt ! record ^u :i* ! p5alty 0 impos$4 7iii7 ,/&>d = review ,! f9d+s ( ! ,secret>y %all be set aside only if f\nd to be unsupport$ by sub/antial evid5ce z provid$ by section #gjf7b77;,e7 ( title #e1 ,unit$ ,/ates ,code4 7iv7 ,appeal ,any f9al decision1 ord]1 or judgm5t ( ! di/rict c\rt conc]n+ su* review %all be subject to appeal z provid$ 9 *apt] #hc ( title #bh ( su* ,code4 7,f7 ,failure to pay assessm5t2 ma9t5ance ( action 7i7 ,failure to pay assessm5t ,if any entity fails to pay an assessm5t aft] x has become a f9al & unappealable ord]1 or aft] ! c\rt has ent]$ f9al judgm5t 9 favor ( ! ,secret>y1 ! ,secret>y %all ref] ! matt] to ! ,attorney ,g5]al :o %all recov] ! am\nt assess$ by action 9 ! appropriate ,unit$ ,/ates di/rict c\rt4 7ii7 ,nonreviewability ,9 su* action ! validity & appropriat5ess ( ! f9al ord] impos+ ! p5alty %all n be subject to review4 7,g7 ,paym5t ( p5alties ,except z o!rwise provid$1 p5alties collect$ "u ?is p>agraph %all be paid to ! ,secret>y 7or o!r (fic]7 impos+ ! p5alty & %all be available )\t appropriation & until exp5d$ = ! purpose ( en=c+ ! provisions ) respect to :i* ! p5alty 0 impos$4 7#c7 ,en=cem5t au?ority relat+ to g5etic discrim9ation 7,a7 ,g5]al rule ,9 ! cases describ$ 9 p>agraph 7#a71 not)/&+ ! provisions ( p>agraph 7#b77;,c71 ! succe$+ subp>agraphs ( ?is p>agraph %all apply ) respect to an action "u ?is subsection by ! ,secret>y ) respect to any failure ( a heal? insurance issu] 9 connection ) a gr\p heal? plan1 to meet ! requirem5ts ( subsection 7a77#a77;,f71 7b77#c71 7c71 or 7d7 ( section #aif or section #aig or #aif7;b77#a7 ) respect to g5etic in=mation 9 connection ) ! plan4 7,b7 ,am\nt 7i7 ,9 g5]al ,! am\nt ( ! p5alty impos$ "u ?is p>agraph %all be #ajj = ea* day 9 ! noncompliance p]iod ) respect to ea* p>ticipant or b5efici>y to :om su* failure relates4 7ii7 ,noncompliance p]iod ,= purposes ( ?is p>agraph1 ! t]m noncompliance p]iod means1 ) respect to any failure1 ! p]iod-- 7,i7 beg9n+ on ! date su* failure fir/ occurs2 & 7,,ii7 end+ on ! date ! failure is correct$4 7,c7 ,m9imum p5alties :]e failure discov]$ ,not)/&+ clauses 7i7 & 7ii7 ( subp>agraph 7,d73 7i7 ,9 g5]al ,9 ! case ( #a or m failures ) respect to an individual-- 7,i7 :i* are n correct$ be=e ! date on :i* ! plan receives a notice f ! ,secret>y ( su* violation2 & 7,,ii7 :i* occurr$ or cont9u$ dur+ ! p]iod involv$2 ! am\nt ( p5alty impos$ by subp>agraph 7,a7 by reason ( su* failures ) respect to su* individual %all n be less ?an #b1ejj4 7ii7 ,high] m9imum p5alty :]e violations are m ?an de m9imis ,to ! ext5t violations = :i* any p]son is liable "u ?is p>agraph = any ye> are m ?an de m9imis1 clause 7i7 %all be appli$ by sub/itut+ #ae1jjj = #b1ejj ) respect to su* p]son4 7,d7 ,limitations 7i7 ,p5alty n to apply :]e failure n discov]$ ex]cis+ reasonable dilig5ce ,no p5alty %all be impos$ by subp>agraph 7,a7 on any failure dur+ any p]iod = :i* x is e/abli%$ to ! satisfaction ( ! ,secret>y t ! p]son o!rwise liable = su* p5alty did n "k1 & ex]cis+ reasonable dilig5ce w\ld n h kn[n1 t su* failure exi/$4 7ii7 ,p5alty n to apply to failures correct$ )9 c]ta9 p]iods ,no p5alty %all be impos$ by subp>agraph 7,a7 on any failure if-- 7,i7 su* failure 0 due to reasonable cause & n to willful neglect2 & 7,,ii7 su* failure is correct$ dur+ ! #cj-;day p]iod beg9n+ on ! fir/ date ! p]son o!rwise liable = su* p5alty knew1 or ex]cis+ reasonable dilig5ce w\ld h kn[n1 t su* failure exi/$4 7iii7 ,ov]all limitation = un9t5tional failures ,9 ! case ( failures :i* are due to reasonable cause & n to willful neglect1 ! p5alty impos$ by subp>agraph 7,a7 = failures %all n exce$ ! am\nt equal to ! less] (-- 7,i7 #aj p]c5t ( ! aggregate am\nt paid or incurr$ by ! employ] 7or pr$ecessor employ]7 dur+ ! prec$+ taxable ye> = gr\p heal? plans2 or 7,,ii7 #ejj1jjj4 7,e7 ,waiv] by ,secret>y ,9 ! case ( a failure :i* is due to reasonable cause & n to willful neglect1 ! ,secret>y may waive "p or all ( ! p5alty impos$ by subp>agraph 7,a7 to ! ext5t t ! paym5t ( su* p5alty w\ld be excessive relative to ! failure involv$4 7c7 ,def9itions ,= purposes ( ?is section3 7#a7 ,gov]nm5tal plan ,! t]m gov]nm5tal plan has ! mean+ giv5 su* t]m "u section #c7cb7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd & any ,f$]al gov]nm5tal plan4 7#b7 ,f$]al gov]nm5tal plan ,! t]m #8,f$]al gov]nm5tal plan' means a gov]nm5tal plan e/abli%$ or ma9ta9$ = its employees by ! ,gov]nm5t ( ! ,unit$ ,/ates or by any ag5cy or in/rum5tality ( su* ,gov]nm5t4 7#c7 ,non-,f$]al gov]nm5tal plan ,! t]m non-,f$]al gov]nm5tal plan means a gov]nm5tal plan t is n a ,f$]al gov]nm5tal plan4 4 7b7 ,con=m+ am5dm5t ,! table ( cont5ts "u section #a7;b7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia7 is am5d$ by ins]t+ aft] ! item relat+ to section #aie ! foll[+3 ,sec4 #aif4 ,gu>ante$ availability ( cov]age4 ,sec4 #aig4 ,fair heal? insurance premiums4 ,sec4 #aih4 ,prohibit+ discrim9ation aga9/ individual p>ticipants & b5efici>ies bas$ on heal? /atus4 ,sec4 #aii4 ,prohibition ( preexi/+ condition exclusions or o!r discrim9ation bas$ on heal? /atus4 ,sec4 #aii;,a4 ,ext5sion ( dep5d5t cov]age4 ,sec4 #aii;,b4 ,annual limitation on co/-%>+4 ,sec4 #aii;,c4 ,en=cem5t ( c]ta9 heal? insurance requirem5ts4 4 7c7 ,,erisa & ,,irc ,en=cem5t 7#a7 ,,erisa ,subp>t ,b ( "p #g ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gaf4 ,o!r m>ket re=ms ,sections #aif & #aig ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif %all apply to heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans1 & sections #aih ?r\gh #aii;,b ( su* ,act %all apply to gr\p heal? plans & heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans1 z if includ$ 9 ?is subp>t1 & to ! ext5t t any provision ( ?is "p conflicts ) a provision ( su* section #aif or #aig ) respect to heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans or ( su* section #aih1 #aii1 #aii;,a1 or #aii;,b ) respect to gr\p heal? plans or heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans1 ! provisions ( su* sections #aif ?r\gh #aii;,b %all apply4 4 7#b7 ,,irc ,sub*apt] ,b ( *apt] #ajj ( subtitle ,k ( title #bf ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihaf4 ,o!r m>ket re=ms ,sections #aif & #aig ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif %all apply to heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans1 & sections #aih ?r\gh #aii;,b ( su* ,act %all apply to gr\p heal? plans & heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans1 z if includ$ 9 ?is sub*apt]1 & to ! ext5t t any provision ( ?is *apt] conflicts ) a provision ( su* section #aif or #aig ) respect to heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans or ( su* section #aih1 #aii1 #aii;,a1 or #aii;,b ) respect to gr\p heal? plans or heal? insurance issu]s provid+ heal? insurance cov]age 9 connection ) gr\p heal? plans1 ! provisions ( su* sections #aif ?r\gh #aii;,b %all apply4 4 7d7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date on :i* ! ,supreme ,c\rt ( ! ,unit$ ,/ates issues a decision /rik+ d[n ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh7 9 its entirety4 ,b ,exp&+ ,cov]age ,options #baa4 ,rules gov]n+ association heal? plans 7a7 ,9 ,g5]al ,subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by add+ aft] "p #g ! foll[+ new "p3 #h ,,rules ,,gov]n+ ,,association ,,heal? ,,plans #hja4 ,association heal? plans 7a7 ,9 ,g5]al ,= purposes ( ?is "p1 ! t]m association heal? plan means a gr\p heal? plan ^: sponsor is 7or is deem$ "u ?is "p to be7 describ$ 9 subsection 7b74 7b7 ,sponsor%ip ,! sponsor ( a gr\p heal? plan is describ$ 9 ?is subsection if su* sponsor-- 7#a7 is organiz$ & ma9ta9$ 9 good fai?1 ) a con/itution & bylaws specifically /at+ its purpose & provid+ = p]iodic meet+s on at lea/ an annual basis1 z a bona fide trade association1 a bona fide indu/ry association 7includ+ a rural electric coop]ative association or a rural telephone coop]ative association71 a bona fide pr(essional association1 or a bona fide *amb] ( comm]ce 7or simil> bona fide bus9ess association1 includ+ a corporation or simil> organization t op]ates on a coop]ative basis 7)9 ! mean+ ( section #acha ( ! ,int]nal ,rev5ue ,code ( #aihf771 = sub/antial purposes o!r ?an t ( obta9+ or provid+ m$ical c>e2 7#b7 is e/abli%$ z a p]man5t entity :i* receives ! active support ( its memb]s & requires = memb]%ip paym5t on a p]iodic basis ( dues or paym5ts necess>y to ma9ta9 eligibility = memb]%ip 9 ! sponsor2 & 7#c7 does n condition memb]%ip1 su* dues or paym5ts1 or cov]age "u ! plan on ! basis ( heal? /atus-relat$ factors ) respect to ! employees ( its memb]s 7or affiliat$ memb]s71 or ! dep5d5ts ( su* employees1 & does n condition su* dues or paym5ts on ! basis ( gr\p heal? plan p>ticipation4 ,any sponsor consi/+ ( an association ( entities :i* meet ! requirem5ts ( p>agraphs 7#a71 7#b71 & 7#c7 %all be deem$ to be a sponsor describ$ 9 ?is subsection4 #hjb4 ,c]tification ( association heal? plans 7a7 ,9 ,g5]al ,! applicable au?ority %all prescribe by regulation a proc$ure "u :i*1 subject to subsection 7b71 ! applicable au?ority %all c]tify association heal? plans :i* apply = c]tification z meet+ ! requirem5ts ( ?is "p4 7b7 ,/&>ds ,"u ! proc$ure prescrib$ pursuant to subsection 7a71 9 ! case ( an association heal? plan t provides at lea/ "o b5efit option :i* does n consi/ ( heal? insurance cov]age1 ! applicable au?ority %all c]tify su* plan z meet+ ! requirem5ts ( ?is "p only if ! applicable au?ority is satisfi$ t ! applicable requirem5ts ( ?is "p are met 7or1 ^u ! date on :i* ! plan is to comm5ce op]ations1 w be met7 ) respect to ! plan4 7c7 ,requirem5ts ,applicable to ,c]tifi$ ,plans ,an association heal? plan ) respect to :i* c]tification "u ?is "p is 9 effect %all meet ! applicable requirem5ts ( ?is "p1 effective on ! date ( c]tification 7or1 if lat]1 on ! date on :i* ! plan is to comm5ce op]ations74 7d7 ,requirem5ts = ,cont9u$ ,c]tification ,! applicable au?ority may provide by regulation = cont9u$ c]tification ( association heal? plans "u ?is "p4 7e7 ,class ,c]tification = ,fully ,insur$ ,plans ,! applicable au?ority %all e/abli% a class c]tification proc$ure = association heal? plans "u :i* all b5efits consi/ ( heal? insurance cov]age4 ,"u su* proc$ure1 ! applicable au?ority %all provide = ! grant+ ( c]tification "u ?is "p to ! plans 9 ea* class ( su* association heal? plans ^u appropriate fil+ "u su* proc$ure 9 connection ) plans 9 su* class & paym5t ( ! prescrib$ fee "u section #hjg7;a74 7f7 ,c]tification ( ,self-,insur$ ,association ,heal? ,plans ,an association heal? plan :i* (f]s "o or m b5efit options :i* d n consi/ ( heal? insurance cov]age may be c]tifi$ "u ?is "p only if su* plan consi/s ( any ( ! foll[+3 7#a7 ,a plan :i* (f]$ su* cov]age on ! date ( ! enactm5t ( ?is section4 7#b7 ,a plan "u :i* ! sponsor does n re/rict memb]%ip to "o or m trades & bus9esses or indu/ries & ^: eligible p>ticipat+ employ]s repres5t a broad cross-section ( trades & bus9esses or indu/ries4 7#c7 ,a plan ^: eligible p>ticipat+ employ]s repres5t "o or m trades or bus9esses1 or "o or m indu/ries1 consi/+ ( any ( ! foll[+3 agriculture2 equipm5t & automobile deal]%ips2 b>b]+ & cosmetology2 c]tifi$ public acc\nt+ practices2 *ild c>e2 con/ruction2 dance1 !atrical & or*e/ra productions2 dis9fect+ & pe/ control2 f9ancial s]vices2 fi%+2 food s]vice e/abli%m5ts2 hospitals2 labor organizations2 logg+2 manufactur+ 7metals72 m9+2 m$ical & d5tal practices2 m$ical laboratories2 pr(essional consult+ s]vices2 sanit>y s]vices2 transportation 7local & freight72 w>eh\s+2 :olesal+_/di/ribut+2 or any o!r trade or bus9ess or indu/ry :i* has be5 indicat$ z hav+ av]age or above-av]age risk or heal? claims exp]i5ce by reason ( ,/ate rate fil+s1 d5ials ( cov]age1 propos$ premium rate levels1 or o!r means demon/rat$ by su* plan 9 accordance ) regulations4 #hjc4 ,requirem5ts relat+ to sponsors & bo>ds ( tru/ees 7a7 ,sponsor ,! requirem5ts ( ?is subsection are met ) respect to an association heal? plan if ! sponsor has met 7or is deem$ "u ?is "p to h met7 ! requirem5ts ( section #hja7;b7 = a cont9u\s p]iod ( n less ?an #c ye>s end+ ) ! date ( ! application = c]tification "u ?is "p4 7b7 ,bo>d ( ,tru/ees ,! requirem5ts ( ?is subsection are met ) respect to an association heal? plan if ! foll[+ requirem5ts are met3 7#a7 ,fiscal control ,! plan is op]at$1 pursuant to a tru/ agreem5t1 by a bo>d ( tru/ees :i* has complete fiscal control ov] ! plan & :i* is responsible = all op]ations ( ! plan4 7#b7 ,rules ( op]ation & f9ancial controls ,! bo>d ( tru/ees has 9 effect rules ( op]ation & f9ancial controls1 bas$ on a #c-ye> plan ( op]ation1 adequate to c>ry out ! t]ms ( ! plan & to meet all requirem5ts ( ?is title applicable to ! plan4 7#c7 ,rules gov]n+ relation%ip to p>ticipat+ employ]s & to contractors 7,a7 ,bo>d memb]%ip 7i7 ,9 g5]al ,except z provid$ 9 clauses 7ii7 & 7iii71 ! memb]s ( ! bo>d ( tru/ees are individuals select$ f individuals :o are ! own]s1 (fic]s1 directors1 or employees ( ! p>ticipat+ employ]s or :o are p>tn]s 9 ! p>ticipat+ employ]s & actively p>ticipate 9 ! bus9ess4 7ii7 ,limitation 7,i7 ,g5]al rule ,except z provid$ 9 subclauses 7,,ii7 & 7,,iii71 no su* memb] is an own]1 (fic]1 director1 or employee (1 or p>tn] 91 a contract adm9i/rator or o!r s]vice provid] to ! plan4 7,,ii7 ,limit$ exception = provid]s ( s]vices solely on behalf ( ! sponsor ,(fic]s or employees ( a sponsor :i* is a s]vice provid] 7o!r ?an a contract adm9i/rator7 to ! plan may be memb]s ( ! bo>d if !y con/itute n m ?an #be p]c5t ( ! memb]%ip ( ! bo>d & !y d n provide s]vices to ! plan o!r ?an on behalf ( ! sponsor4 7,,iii7 ,treatm5t ( provid]s ( m$ical c>e ,9 ! case ( a sponsor :i* is an association ^: memb]%ip consi/s prim>ily ( provid]s ( m$ical c>e1 subclause 7,i7 %all n apply 9 ! case ( any s]vice provid] describ$ 9 subclause 7,i7 :o is a provid] ( m$ical c>e "u ! plan4 7iii7 ,c]ta9 plans exclud$ ,clause 7i7 %all n apply to an association heal? plan :i* is 9 exi/5ce on ! date ( ! enactm5t ( ?is section4 7,b7 ,sole au?ority ,! bo>d has sole au?ority "u ! plan to approve applications = p>ticipation 9 ! plan & to contract ) a s]vice provid] to adm9i/] ! day-to-day affairs ( ! plan4 7c7 ,treatm5t ( ,fran*ise ,networks ,9 ! case ( a gr\p heal? plan :i* is e/abli%$ & ma9ta9$ by a fran*is] = a fran*ise network consi/+ ( its fran*isees-- 7#a7 ! requirem5ts ( subsection 7a7 & section #hja7;a7 %all be deem$ met if su* requirem5ts w\ld o!rwise be met if ! fran*is] 7 deem$ to be ! sponsor ref]r$ to 9 section #hja7;b71 su* network 7 deem$ to be an association describ$ 9 section #hja7;b71 & ea* fran*isee 7 deem$ to be a memb] 7( ! association & ! sponsor7 ref]r$ to 9 section #hja7;b72 & 7#b7 ! requirem5ts ( section #hjd7;a77#a7 %all be deem$ met4 ,! ,secret>y may by regulation def9e = purposes ( ?is subsection ! t]ms fran*is]1 fran*ise network1 & fran*isee4 #hjd4 ,p>ticipation & cov]age requirem5ts 7a7 ,cov]$ ,employ]s & ,individuals ,! requirem5ts ( ?is subsection are met ) respect to an association heal? plan if1 "u ! t]ms ( ! plan-- 7#a7 ea* p>ticipat+ employ] mu/ be-- 7,a7 a memb] ( ! sponsor2 7,b7 ! sponsor2 or 7,c7 an affiliat$ memb] ( ! sponsor ) respect to :i* ! requirem5ts ( subsection 7b7 are met1 except t1 9 ! case ( a sponsor :i* is a pr(essional association or o!r individual-bas$ association1 if at lea/ "o ( ! (fic]s1 directors1 or employees ( an employ]1 or at lea/ "o ( ! individuals :o are p>tn]s 9 an employ] & :o actively p>ticipates 9 ! bus9ess1 is a memb] or su* an affiliat$ memb] ( ! sponsor1 p>ticipat+ employ]s may also include su* employ]2 & 7#b7 all individuals comm5c+ cov]age "u ! plan aft] c]tification "u ?is "p mu/ be-- 7,a7 active or retir$ own]s 7includ+ self-employ$ individuals71 (fic]s1 directors1 or employees (1 or p>tn]s 91 p>ticipat+ employ]s2 or 7,b7 ! b5efici>ies ( individuals describ$ 9 subp>agraph 7,a74 7b7 ,cov]age ( ,previ\sly ,un9sur$ ,employees ,9 ! case ( an association heal? plan 9 exi/5ce on ! date ( ! enactm5t ( ?is section1 an affiliat$ memb] ( ! sponsor ( ! plan may be (f]$ cov]age "u ! plan z a p>ticipat+ employ] only if-- 7#a7 ! affiliat$ memb] 0 an affiliat$ memb] on ! date ( c]tification "u ?is "p2 or 7#b7 dur+ ! #ab-mon? p]iod prec$+ ! date ( ! (f]+ ( su* cov]age1 ! affiliat$ memb] has n ma9ta9$ or contribut$ to a gr\p heal? plan ) respect to any ( its employees :o w\ld o!rwise be eligible to p>ticipate 9 su* association heal? plan4 7c7 ,individual ,m>ket ,unaffect$ ,! requirem5ts ( ?is subsection are met ) respect to an association heal? plan if1 "u ! t]ms ( ! plan1 no p>ticipat+ employ] may provide heal? insurance cov]age 9 ! individual m>ket = any employee n cov]$ "u ! plan :i* is simil> to ! cov]age contemporane\sly provid$ to employees ( ! employ] "u ! plan1 if su* exclusion ( ! employee f cov]age "u ! plan is bas$ on a heal? /atus-relat$ factor ) respect to ! employee & su* employee w\ld1 b = su* exclusion on su* basis1 be eligible = cov]age "u ! plan4 7d7 ,prohibition ( ,discrim9ation ,aga9/ ,employ]s & ,employees ,eligible ,to ,p>ticipate ,! requirem5ts ( ?is subsection are met ) respect to an association heal? plan if-- 7#a7 "u ! t]ms ( ! plan1 all employ]s meet+ ! prec$+ requirem5ts ( ?is section are eligible to qualify z p>ticipat+ employ]s = all geographically available cov]age options1 unless1 9 ! case ( any su* employ]1 p>ticipation or contribution requirem5ts ( ! type ref]r$ to 9 section #bgaa ( ! ,public ,heal? ,s]vice ,act are n met2 7#b7 ^u reque/1 any employ] eligible to p>ticipate is furni%$ in=mation reg>d+ all cov]age options available "u ! plan2 & 7#c7 ! applicable requirem5ts ( sections #gja1 #gjb1 & #gjc are met ) respect to ! plan4 #hje4 ,o!r requirem5ts relat+ to plan docum5ts1 contribution rates1 & b5efit options 7a7 ,9 ,g5]al ,! requirem5ts ( ?is section are met ) respect to an association heal? plan if ! foll[+ requirem5ts are met3 7#a7 ,cont5ts ( gov]n+ in/rum5ts ,! in/rum5ts gov]n+ ! plan include a writt5 in/rum5t1 meet+ ! requirem5ts ( an in/rum5t requir$ "u section #djb7;a77#a71 :i*-- 7,a7 provides t ! bo>d ( tru/ees s]ves z ! nam$ fiduci>y requir$ = plans "u section #djb7;a77#a7 & s]ves 9 ! capacity ( a plan adm9i/rator 7ref]r$ to 9 section #c7af77;,a772 7,b7 provides t ! sponsor ( ! plan is to s]ve z plan sponsor 7ref]r$ to 9 section #c7af77;,b772 & 7,c7 incorporates ! requirem5ts ( section #hjf4 7#b7 ,contribution rates mu/ be nondiscrim9atory 7,a7 ,! contribution rates = any p>ticipat+ small employ] d n v>y on ! basis ( any heal? /atus-relat$ factor 9 relation to employees ( su* employ] or _! b5efici>ies & d n v>y on ! basis ( ! type ( bus9ess or indu/ry 9 :i* su* employ] is engag$4 7,b7 ,no?+ 9 ?is title or any o!r provision ( law %all be con/ru$ to preclude an association heal? plan1 or a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) an association heal? plan1 f-- 7i7 sett+ contribution rates bas$ on ! claims exp]i5ce ( ! plan2 or 7ii7 v>y+ contribution rates = small employ]s 9 a ,/ate to ! ext5t t su* rates c\ld v>y us+ ! same me?odology employ$ 9 su* ,/ate = regulat+ premium rates 9 ! small gr\p m>ket ) respect to heal? insurance cov]age (f]$ 9 connection ) bona fide associations 7)9 ! mean+ ( section #bgia7;d77#c7 ( ! ,public ,heal? ,s]vice ,act71 subject to ! requirem5ts ( section #gjb7;b7 relat+ to contribution rates4 7#c7 ,floor = numb] ( cov]$ individuals ) respect to c]ta9 plans ,if any b5efit option "u ! plan does n consi/ ( heal? insurance cov]age1 ! plan has z ( ! beg9n+ ( ! plan ye> n few] ?an #a1jjj p>ticipants & b5efici>ies4 7#d7 ,m>ket+ requirem5ts 7,a7 ,9 g5]al ,if a b5efit option :i* consi/s ( heal? insurance cov]age is (f]$ "u ! plan1 ,/ate-lic5s$ insurance ag5ts %all be us$ to di/ribute to small employ]s cov]age :i* does n consi/ ( heal? insurance cov]age 9 a mann] comp>able to ! mann] 9 :i* su* ag5ts are us$ to di/ribute heal? insurance cov]age4 7,b7 ,/ate-lic5s$ insurance ag5ts ,= purposes ( subp>agraph 7,a71 ! t]m ,/ate-lic5s$ insurance ag5ts means "o or m ag5ts :o are lic5s$ 9 a ,/ate & are subject to ! laws ( su* ,/ate relat+ to lic5sure1 qualification1 te/+1 exam9ation1 & cont9u+ education ( p]sons au?oriz$ to (f]1 sell1 or solicit heal? insurance cov]age 9 su* ,/ate4 7#e7 ,regulatory requirem5ts ,su* o!r requirem5ts z ! applicable au?ority det]m9es are necess>y to c>ry out ! purposes ( ?is "p1 :i* %all be prescrib$ by ! applicable au?ority by regulation4 7b7 ,ability ( ,association ,heal? ,plans ,to ,design ,b5efit ,options ,subject to section #ead7;d71 no?+ 9 ?is "p or any provision ( ,/ate law 7z def9$ 9 section #ead7;c77#a77 %all be con/ru$ to preclude an association heal? plan1 or a heal? insurance issu] (f]+ heal? insurance cov]age 9 connection ) an association heal? plan1 f ex]cis+ its sole discretion 9 select+ ! specific items & s]vices consi/+ ( m$ical c>e to be includ$ z b5efits "u su* plan or cov]age1 except 7subject to section #ead7 9 ! case ( 7#a7 any law to ! ext5t t x is n preempt$ "u section #gca7;a77#a7 ) respect to matt]s gov]n$ by section #gaa1 #gab1 or #gac1 or 7#b7 any law ( ! ,/ate ) :i* fil+ & approval ( a policy type (f]$ by ! plan 0 initially obta9$ to ! ext5t t su* law prohibits an exclusion ( a specific disease f su* cov]age4 #hjf4 ,ma9t5ance ( res]ves & provisions = solv5cy = plans provid+ heal? b5efits 9 addition to heal? insurance cov]age 7a7 ,9 ,g5]al ,! requirem5ts ( ?is section are met ) respect to an association heal? plan if-- 7#a7 ! b5efits "u ! plan consi/ solely ( heal? insurance cov]age2 or 7#b7 if ! plan provides any additional b5efit options :i* d n consi/ ( heal? insurance cov]age1 ! plan-- 7,a7 e/abli%es & ma9ta9s res]ves ) respect to su* additional b5efit options1 9 am\nts recomm5d$ by ! qualifi$ actu>y1 consi/+ (-- 7i7 a res]ve suffici5t = une>n$ contributions2 7ii7 a res]ve suffici5t = b5efit liabilities :i* h be5 incurr$1 :i* h n be5 satisfi$1 & = :i* risk ( loss has n yet be5 transf]r$1 & = expect$ adm9i/rative co/s ) respect to su* b5efit liabilities2 7iii7 a res]ve suffici5t = any o!r obligations ( ! plan2 & 7iv7 a res]ve suffici5t = a m>g9 ( error & o!r fluctuations1 tak+ into acc\nt ! specific circum/ances ( ! plan2 & 7,b7 e/abli%es & ma9ta9s aggregate & specific excess_//op loss insurance & solv5cy indemnification1 ) respect to su* additional b5efit options = :i* risk ( loss has n yet be5 transf]r$1 z foll[s3 7i7 ,! plan %all secure aggregate excess_//op loss insurance = ! plan ) an atta*m5t po9t :i* is n great] ?an #abe p]c5t ( expect$ gross annual claims4 ,! applicable au?ority may by regulation provide = upw>d adju/m5ts 9 ! am\nt ( su* p]c5tage 9 specifi$ circum/ances 9 :i* ! plan specifically provides = & ma9ta9s res]ves 9 excess ( ! am\nts requir$ "u subp>agraph 7,a74 7ii7 ,! plan %all secure specific excess_//op loss insurance = ! plan ) an atta*m5t po9t :i* is at lea/ equal to an am\nt recomm5d$ by ! plan's qualifi$ actu>y4 ,! applicable au?ority may by regulation provide = adju/m5ts 9 ! am\nt ( su* insurance 9 specifi$ circum/ances 9 :i* ! plan specifically provides = & ma9ta9s res]ves 9 excess ( ! am\nts requir$ "u subp>agraph 7,a74 7iii7 ,! plan %all secure indemnification insurance = any claims :i* ! plan is unable to satisfy by reason ( a plan t]m9ation4 ,any p]son issu+ to a plan insurance describ$ 9 clause 7i71 7ii71 or 7iii7 ( subp>agraph 7,b7 %all notify ! ,secret>y ( any failure ( premium paym5t m]it+ cancellation ( ! policy prior to und]tak+ su* a cancellation4 ,any regulations prescrib$ by ! applicable au?ority pursuant to clause 7i7 or 7ii7 ( subp>agraph 7,b7 may all[ = su* adju/m5ts 9 ! requir$ levels ( excess_//op loss insurance z ! qualifi$ actu>y may recomm5d1 tak+ into acc\nt ! specific circum/ances ( ! plan4 7b7 ,m9imum ,surplus 9 ,addition to ,claims ,res]ves ,9 ! case ( any association heal? plan describ$ 9 subsection 7a77#b71 ! requirem5ts ( ?is subsection are met if ! plan e/abli%es & ma9ta9s surplus 9 an am\nt at lea/ equal to-- 7#a7 #ejj1jjj2 or 7#b7 su* great] am\nt 7b n great] ?an #b1jjj1jjj7 z may be set =? 9 regulations prescrib$ by ! applicable au?ority1 consid]+ ! level ( aggregate & specific excess_//op loss insurance provid$ ) respect to su* plan & o!r factors relat$ to solv5cy risk1 su* z ! plan's project$ levels ( p>ticipation or claims1 ! nature ( ! plan's liabilities1 & ! types ( assets available to assure t su* liabilities are met4 7c7 ,additional ,requirem5ts ,9 ! case ( any association heal? plan describ$ 9 subsection 7a77#b71 ! applicable au?ority may provide su* additional requirem5ts relat+ to res]ves1 excess_//op loss insurance1 & indemnification insurance z ! applicable au?ority consid]s appropriate4 ,su* requirem5ts may be provid$ by regulation ) respect to any su* plan or any class ( su* plans4 7d7 ,adju/m5ts = ,excess_/,/op ,loss ,insurance ,! applicable au?ority may provide = adju/m5ts to ! levels ( res]ves o!rwise requir$ "u subsections 7a7 & 7b7 ) respect to any plan or class ( plans to take into acc\nt excess_//op loss insurance provid$ ) respect to su* plan or plans4 7e7 ,alt]native ,means ( ,compliance ,! applicable au?ority may p]mit an association heal? plan describ$ 9 subsection 7a77#b7 to sub/itute1 = all or "p ( ! requirem5ts ( ?is section 7except subsection 7a77#b77;,b77iii771 su* security1 gu>antee1 hold-h>mless arrangem5t1 or o!r f9ancial arrangem5t z ! applicable au?ority det]m9es to be adequate to enable ! plan to fully meet all its f9ancial obligations on a timely basis & is o!rwise no less protective ( ! int]e/s ( p>ticipants & b5efici>ies ?an ! requirem5ts = :i* x is sub/itut$4 ,! applicable au?ority may take into acc\nt1 = purposes ( ?is subsection1 evid5ce provid$ by ! plan or sponsor :i* demon/rates an assumption ( liability ) respect to ! plan4 ,su* evid5ce may be 9 ! =m ( a contract ( indemnification1 li51 bond+1 insurance1 lett] ( cr$it1 rec\rse "u applicable t]ms ( ! plan 9 ! =m ( assessm5ts ( p>ticipat+ employ]s1 security1 or o!r f9ancial arrangem5t4 7f7 ,measures ,to ,ensure ,cont9u$ ,paym5t ( ,b5efits by ,c]ta9 ,plans 9 ,di/ress 7#a7 ,paym5ts by c]ta9 plans to association heal? plan fund 7,a7 ,9 g5]al ,9 ! case ( an association heal? plan describ$ 9 subsection 7a77#b71 ! requirem5ts ( ?is subsection are met if ! plan makes paym5ts into ! ,association ,heal? ,plan ,fund "u ?is subp>agraph :5 !y are due4 ,su* paym5ts %all consi/ ( annual paym5ts 9 ! am\nt ( #e1jjj1 &1 9 addition to su* annual paym5ts1 su* supplem5tal paym5ts z ! ,secret>y may det]m9e to be necess>y "u p>agraph 7#b74 ,paym5ts "u ?is p>agraph are payable to ! ,fund at ! "t det]m9$ by ! ,secret>y4 ,initial paym5ts are due 9 advance ( c]tification "u ?is "p4 ,paym5ts %all cont9ue to accrue until a plan's assets are di/ribut$ pursuant to a t]m9ation proc$ure4 7,b7 ,p5alties = failure to make paym5ts ,if any paym5t is n made by a plan :5 x is due1 a late paym5t *>ge ( n m ?an #ajj p]c5t ( ! paym5t :i* 0 n timely paid %all be payable by ! plan to ! ,fund4 7,c7 ,cont9u$ duty ( ! secret>y ,! ,secret>y %all n cease to c>ry out ! provisions ( p>agraph 7#b7 on acc\nt ( ! failure ( a plan to pay any paym5t :5 due4 7#b7 ,paym5ts by secret>y to cont9ue excess_//op loss insurance cov]age & indemnification insurance cov]age = c]ta9 plans ,9 any case 9 :i* ! applicable au?ority det]m9es t !re is1 or t !re is reason to believe t !re w be3 7,a7 ,a failure to take necess>y corrective actions "u section #hji7;a7 ) respect to an association heal? plan describ$ 9 subsection 7a77#b72 or 7,b7 a t]m9ation ( su* a plan "u section #hji7;b7 or #haj7;b77#h7 7&1 if ! applicable au?ority is n ! ,secret>y1 c]tifies su* det]m9ation to ! ,secret>y71 ! ,secret>y %all det]m9e ! am\nts necess>y to make paym5ts to an insur] 7designat$ by ! ,secret>y7 to ma9ta9 9 =ce excess_//op loss insurance cov]age or indemnification insurance cov]age = su* plan1 if ! ,secret>y det]m9es t !re is a reasonable expectation t1 )\t su* paym5ts1 claims w\ld n be satisfi$ by reason ( t]m9ation ( su* cov]age4 ,! ,secret>y %all1 to ! ext5t provid$ 9 advance 9 appropriation ,acts1 pay su* am\nts s det]m9$ to ! insur] designat$ by ! ,secret>y4 7#c7 ,association heal? plan fund 7,a7 ,9 g5]al ,!re is e/abli%$ on ! books ( ! ,treasury a fund to be kn[n z ! ,association ,heal? ,plan ,fund4 ,! ,fund %all be available = mak+ paym5ts pursuant to p>agraph 7#b74 ,! ,fund %all be cr$it$ ) paym5ts receiv$ pursuant to p>agraph 7#a77;,a71 p5alties receiv$ pursuant to p>agraph 7#a77;,b72 & e>n+s on inve/m5ts ( am\nts ( ! ,fund "u subp>agraph 7,b74 7,b7 ,inve/m5t ,:5ev] ! ,secret>y det]m9es t ! moneys ( ! fund are 9 excess ( curr5t ne$s1 ! ,secret>y may reque/ ! inve/m5t ( su* am\nts z ! ,secret>y det]m9es advisable by ! ,secret>y ( ! ,treasury 9 obligations issu$ or gu>ante$ by ! ,unit$ ,/ates4 7g7 ,excess_/,/op ,loss ,insurance ,= purposes ( ?is section-- 7#a7 ,aggregate excess_//op loss insurance ,! t]m aggregate excess_//op loss insurance means1 9 connection ) an association heal? plan1 a contract-- 7,a7 "u :i* an insur] 7meet+ su* m9imum /&>ds z ! applicable au?ority may prescribe by regulation7 provides = paym5t to ! plan ) respect to aggregate claims "u ! plan 9 excess ( an am\nt or am\nts specifi$ 9 su* contract2 7,b7 :i* is gu>ante$ r5ewable2 & 7,c7 :i* all[s = paym5t ( premiums by any ?ird p>ty on behalf ( ! insur$ plan4 7#b7 ,specific excess_//op loss insurance ,! t]m specific excess_//op loss insurance means1 9 connection ) an association heal? plan1 a contract-- 7,a7 "u :i* an insur] 7meet+ su* m9imum /&>ds z ! applicable au?ority may prescribe by regulation7 provides = paym5t to ! plan ) respect to claims "u ! plan 9 connection ) a cov]$ individual 9 excess ( an am\nt or am\nts specifi$ 9 su* contract 9 connection ) su* cov]$ individual2 7,b7 :i* is gu>ante$ r5ewable2 & 7,c7 :i* all[s = paym5t ( premiums by any ?ird p>ty on behalf ( ! insur$ plan4 7h7 ,indemnification ,insurance ,= purposes ( ?is section1 ! t]m indemnification insurance means1 9 connection ) an association heal? plan1 a contract-- 7#a7 "u :i* an insur] 7meet+ su* m9imum /&>ds z ! applicable au?ority may prescribe by regulation7 provides = paym5t to ! plan ) respect to claims "u ! plan :i* ! plan is unable to satisfy by reason ( a t]m9ation pursuant to section #hji7;b7 7relat+ to m&atory t]m9ation72 7#b7 :i* is gu>ante$ r5ewable & noncancellable = any reason 7except z ! applicable au?ority may prescribe by regulation72 & 7#c7 :i* all[s = paym5t ( premiums by any ?ird p>ty on behalf ( ! insur$ plan4 7i7 ,res]ves ,= purposes ( ?is section1 ! t]m res]ves means1 9 connection ) an association heal? plan1 plan assets :i* meet ! fiduci>y /&>ds "u "p #d & su* additional requirem5ts reg>d+ liquidity z ! applicable au?ority may prescribe by regulation4 7j7 ,solv5cy ,/&>ds ,work+ ,gr\p 7#a7 ,9 g5]al ,)9 #ij days aft] ! date ( ! enactm5t ( ?is section1 ! applicable au?ority %all e/abli% a ,solv5cy ,/&>ds ,work+ ,gr\p4 ,9 prescrib+ ! initial regulations "u ?is section1 ! applicable au?ority %all take into acc\nt ! recomm5dations ( su* ,work+ ,gr\p4 7#b7 ,memb]%ip ,! ,work+ ,gr\p %all consi/ ( n m ?an #ae memb]s appo9t$ by ! applicable au?ority4 ,! applicable au?ority %all include among p]sons invit$ to memb]%ip on ! ,work+ ,gr\p at lea/ "o ( ea* ( ! foll[+3 7,a7 ,a repres5tative ( ! ,national ,association ( ,insurance ,commission]s4 7,b7 ,a repres5tative ( ! ,am]ican ,academy ( ,actu>ies4 7,c7 ,a repres5tative ( ! ,/ate gov]nm5ts1 or _! int]e/s4 7,d7 ,a repres5tative ( exi/+ self-insur$ arrangem5ts1 or _! int]e/s4 7,e7 ,a repres5tative ( associations ( ! type ref]r$ to 9 section #hja7;b77#a71 or _! int]e/s4 7,f7 ,a repres5tative ( multiemploy] plans t are gr\p heal? plans1 or _! int]e/s4 #hjg4 ,requirem5ts = application & relat$ requirem5ts 7a7 ,fil+ ,fee ,"u ! proc$ure prescrib$ pursuant to section #hjb7;a71 an association heal? plan %all pay to ! applicable au?ority at ! "t ( fil+ an application = c]tification "u ?is "p a fil+ fee 9 ! am\nt ( #e1jjj1 :i* %all be available 9 ! case ( ! ,secret>y1 to ! ext5t provid$ 9 appropriation ,acts1 = ! sole purpose ( adm9i/]+ ! c]tification proc$ures applicable ) respect to association heal? plans4 7b7 ,in=mation ,to ,be ,includ$ 9 ,application = ,c]tification ,an application = c]tification "u ?is "p meets ! requirem5ts ( ?is section only if x includes1 9 a mann] & =m :i* %all be prescrib$ by ! applicable au?ority by regulation1 at lea/ ! foll[+ in=mation3 7#a7 ,id5tify+ in=mation ,! names & addresses (-- 7,a7 ! sponsor2 & 7,b7 ! memb]s ( ! bo>d ( tru/ees ( ! plan4 7#b7 ,/ates 9 :i* plan int5ds to d bus9ess ,! ,/ates 9 :i* p>ticipants & b5efici>ies "u ! plan are to be locat$ & ! numb] ( !m expect$ to be locat$ 9 ea* su* ,/ate4 7#c7 ,bond+ requirem5ts ,evid5ce provid$ by ! bo>d ( tru/ees t ! bond+ requirem5ts ( section #dab w be met z ( ! date ( ! application or 7if lat]7 comm5cem5t ( op]ations4 7#d7 ,plan docum5ts ,a copy ( ! docum5ts gov]n+ ! plan 7includ+ any bylaws & tru/ agreem5ts71 ! summ>y plan description1 & o!r mat]ial describ+ ! b5efits t w be provid$ to p>ticipants & b5efici>ies "u ! plan4 7#e7 ,agreem5ts ) s]vice provid]s ,a copy ( any agreem5ts betwe5 ! plan & contract adm9i/rators & o!r s]vice provid]s4 7#f7 ,fund+ report ,9 ! case ( association heal? plans provid+ b5efits options 9 addition to heal? insurance cov]age1 a report sett+ =? in=mation ) respect to su* additional b5efit options det]m9$ z ( a date )9 ! #abj-;day p]iod end+ ) ! date ( ! application1 includ+ ! foll[+3 7,a7 ,res]ves ,a /atem5t1 c]tifi$ by ! bo>d ( tru/ees ( ! plan1 & a /atem5t ( actu>ial op9ion1 sign$ by a qualifi$ actu>y1 t all applicable requirem5ts ( section #hjf are or w be met 9 accordance ) regulations :i* ! applicable au?ority %all prescribe4 7,b7 ,adequacy ( contribution rates ,a /atem5t ( actu>ial op9ion1 sign$ by a qualifi$ actu>y1 :i* sets =? a description ( ! ext5t to :i* contribution rates are adequate to provide = ! paym5t ( all obligations & ! ma9t5ance ( requir$ res]ves "u ! plan = ! #ab-mon? p]iod beg9n+ ) su* date )9 su* #abj-;day p]iod1 tak+ into acc\nt ! expect$ cov]age & exp]i5ce ( ! plan4 ,if ! contribution rates are n fully adequate1 ! /atem5t ( actu>ial op9ion %all indicate ! ext5t to :i* ! rates are inadequate & ! *anges ne$$ to ensure adequacy4 7,c7 ,curr5t & project$ value ( assets & liabilities ,a /atem5t ( actu>ial op9ion sign$ by a qualifi$ actu>y1 :i* sets =? ! curr5t value ( ! assets & liabilities accumulat$ "u ! plan & a projection ( ! assets1 liabilities1 income1 & exp5ses ( ! plan = ! #ab-mon? p]iod ref]r$ to 9 subp>agraph 7,b74 ,! income /atem5t %all id5tify sep>ately ! plan's adm9i/rative exp5ses & claims4 7,d7 ,co/s ( cov]age to be *>g$ & o!r exp5ses ,a /atem5t ( ! co/s ( cov]age to be *>g$1 includ+ an itemization ( am\nts = adm9i/ration1 res]ves1 & o!r exp5ses associat$ ) ! op]ation ( ! plan4 7,e7 ,o!r in=mation ,any o!r in=mation z may be det]m9$ by ! applicable au?ority1 by regulation1 z necess>y to c>ry out ! purposes ( ?is "p4 7c7 ,fil+ ,notice ( ,c]tification ,) ,/ates ,a c]tification grant$ "u ?is "p to an association heal? plan %all n be effective unless writt5 notice ( su* c]tification is fil$ ) ! applicable ,/ate au?ority ( ea* ,/ate 9 :i* at lea/ #be p]c5t ( ! p>ticipants & b5efici>ies "u ! plan are locat$4 ,= purposes ( ?is subsection1 an individual %all be consid]$ to be locat$ 9 ! ,/ate 9 :i* a kn[n address ( su* individual is locat$ or 9 :i* su* individual is employ$4 7d7 ,notice ( ,mat]ial ,*anges ,9 ! case ( any association heal? plan c]tifi$ "u ?is "p1 descriptions ( mat]ial *anges 9 any in=mation :i* 0 requir$ to be submitt$ ) ! application = ! c]tification "u ?is "p %all be fil$ 9 su* =m & mann] z %all be prescrib$ by ! applicable au?ority by regulation4 ,! applicable au?ority may require by regulation prior notice ( mat]ial *anges ) respect to specifi$ matt]s :i* might s]ve z ! basis = susp5sion or revocation ( ! c]tification4 7e7 ,report+ ,requirem5ts = ,c]ta9 ,association ,heal? ,plans ,an association heal? plan c]tifi$ "u ?is "p :i* provides b5efit options 9 addition to heal? insurance cov]age = su* plan ye> %all meet ! requirem5ts ( section #ajc by fil+ an annual report "u su* section :i* %all include in=mation describ$ 9 subsection 7b77#f7 ) respect to ! plan ye> &1 not)/&+ section #ajd7;a77#a77;,a71 %all be fil$ ) ! applicable au?ority n lat] ?an #ij days aft] ! close ( ! plan ye> 7or on su* lat] date z may be prescrib$ by ! applicable au?ority74 ,! applicable au?ority may require by regulation su* int]im reports z x consid]s appropriate4 7f7 ,engagem5t ( ,qualifi$ ,actu>y ,! bo>d ( tru/ees ( ea* association heal? plan :i* provides b5efits options 9 addition to heal? insurance cov]age & :i* is apply+ = c]tification "u ?is "p or is c]tifi$ "u ?is "p %all engage1 on behalf ( all p>ticipants & b5efici>ies1 a qualifi$ actu>y :o %all be responsible = ! prep>ation ( ! mat]ials compris+ in=mation necess>y to be submitt$ by a qualifi$ actu>y "u ?is "p4 ,! qualifi$ actu>y %all utilize su* assumptions & te*niques z are necess>y to enable su* actu>y to =m an op9ion z to :e!r ! cont5ts ( ! matt]s report$ "u ?is "p-- 7#a7 are 9 ! aggregate reasonably relat$ to ! exp]i5ce ( ! plan & to reasonable expectations2 & 7#b7 repres5t su* actu>y's be/ e/imate ( anticipat$ exp]i5ce "u ! plan4 ,! op9ion by ! qualifi$ actu>y %all be made ) respect to1 & %all be made a "p (1 ! annual report4 #hjh4 ,notice requirem5ts = volunt>y t]m9ation ,except z provid$ 9 section #hji7;b71 an association heal? plan :i* is or has be5 c]tifi$ "u ?is "p may t]m9ate 7^u or at any "t aft] cessation ( accruals 9 b5efit liabilities7 only if ! bo>d ( tru/ees1 n less ?an #fj days be=e ! propos$ t]m9ation date-- 7#a7 provides to ! p>ticipants & b5efici>ies a writt5 notice ( int5t to t]m9ate /at+ t su* t]m9ation is int5d$ & ! propos$ t]m9ation date2 7#b7 develops a plan = w9d+ up ! affairs ( ! plan 9 connection ) su* t]m9ation 9 a mann] :i* w result 9 timely paym5t ( all b5efits = :i* ! plan is obligat$2 & 7#c7 submits su* plan 9 writ+ to ! applicable au?ority4 ,actions requir$ "u ?is section %all be tak5 9 su* =m & mann] z may be prescrib$ by ! applicable au?ority by regulation4 #hji4 ,corrective actions & m&atory t]m9ation 7a7 ,actions ,to ,avoid ,depletion ( ,res]ves ,an association heal? plan :i* is c]tifi$ "u ?is "p & :i* provides b5efits o!r ?an heal? insurance cov]age %all cont9ue to meet ! requirem5ts ( section #hjf1 irrespective ( :e!r su* c]tification cont9ues 9 effect4 ,! bo>d ( tru/ees ( su* plan %all det]m9e qu>t]ly :e!r ! requirem5ts ( section #hjf are met4 ,9 any case 9 :i* ! bo>d det]m9es t !re is reason to believe t !re is or w be a failure to meet su* requirem5ts1 or ! applicable au?ority makes su* a det]m9ation & s notifies ! bo>d1 ! bo>d %all imm$iately notify ! qualifi$ actu>y engag$ by ! plan1 & su* actu>y %all1 n lat] ?an ! end ( ! next foll[+ mon?1 make su* recomm5dations to ! bo>d = corrective action z ! actu>y det]m9es necess>y to ensure compliance ) section #hjf4 ,n lat] ?an #cj days aft] receiv+ f ! actu>y recomm5dations = corrective actions1 ! bo>d %all notify ! applicable au?ority 79 su* =m & mann] z ! applicable au?ority may prescribe by regulation7 ( su* recomm5dations ( ! actu>y = corrective action1 toge!r ) a description ( ! actions 7if any7 t ! bo>d has tak5 or plans to take 9 response to su* recomm5dations4 ,! bo>d %all !reaft] report to ! applicable au?ority1 9 su* =m & frequ5cy z ! applicable au?ority may specify to ! bo>d1 reg>d+ corrective action tak5 by ! bo>d until ! requirem5ts ( section #hjf are met4 7b7 ,m&atory ,t]m9ation ,9 any case 9 :i*-- 7#a7 ! applicable au?ority has be5 notifi$ "u subsection 7a7 7or by an issu] ( excess_//op loss insurance or indemnity insurance pursuant to section #hjf7;a77 ( a failure ( an association heal? plan :i* is or has be5 c]tifi$ "u ?is "p & is describ$ 9 section #hjf7;a77#b7 to meet ! requirem5ts ( section #hjf & has n be5 notifi$ by ! bo>d ( tru/ees ( ! plan t corrective action has re/or$ compliance ) su* requirem5ts2 & 7#b7 ! applicable au?ority det]m9es t !re is a reasonable expectation t ! plan w cont9ue to fail to meet ! requirem5ts ( section #hjf1 ! bo>d ( tru/ees ( ! plan %all1 at ! direction ( ! applicable au?ority1 t]m9ate ! plan &1 9 ! c\rse ( ! t]m9ation1 take su* actions z ! applicable au?ority may require1 includ+ satisfy+ any claims ref]r$ to 9 section #hjf7;a77#b77;,b77iii7 & recov]+ = ! plan any liability "u subsection 7a77#b77;,b77iii7 or 7e7 ( section #hjf1 z necess>y to ensure t ! affairs ( ! plan w be1 to ! maximum ext5t possible1 w\nd up 9 a mann] :i* w result 9 timely provision ( all b5efits = :i* ! plan is obligat$4 #haj4 ,tru/ee%ip by ! ,secret>y ( insolv5t association heal? plans provid+ heal? b5efits 9 addition to heal? insurance cov]age 7a7 ,appo9tm5t ( ,secret>y z ,tru/ee = ,insolv5t ,plans ,:5ev] ! ,secret>y det]m9es t an association heal? plan :i* is or has be5 c]tifi$ "u ?is "p & :i* is describ$ 9 section #hjf7;a77#b7 w be unable to provide b5efits :5 due or is o!rwise 9 a f9ancially haz>d\s condition1 z %all be def9$ by ! ,secret>y by regulation1 ! ,secret>y %all1 ^u notice to ! plan1 apply to ! appropriate ,unit$ ,/ates di/rict c\rt = appo9tm5t ( ! ,secret>y z tru/ee to adm9i/] ! plan = ! duration ( ! insolv5cy4 ,! plan may appe> z a p>ty & o!r int]e/$ p]sons may int]v5e 9 ! proce$+s at ! discretion ( ! c\rt4 ,! c\rt %all appo9t su* ,secret>y tru/ee if ! c\rt det]m9es t ! tru/ee%ip is necess>y to protect ! int]e/s ( ! p>ticipants & b5efici>ies or provid]s ( m$ical c>e or to avoid any unreasonable det]ioration ( ! f9ancial condition ( ! plan4 ,! tru/ee%ip ( su* ,secret>y %all cont9ue until ! conditions describ$ 9 ! fir/ s5t5ce ( ?is subsection are rem$i$ or ! plan is t]m9at$4 7b7 ,p[]s z ,tru/ee ,! ,secret>y1 ^u appo9tm5t z tru/ee "u subsection 7a71 %all h ! p[]-- 7#a7 to d any act au?oriz$ by ! plan1 ?is title1 or o!r applicable provisions ( law to be done by ! plan adm9i/rator or any tru/ee ( ! plan2 7#b7 to require ! transf] ( all 7or any "p7 ( ! assets & records ( ! plan to ! ,secret>y z tru/ee2 7#c7 to inve/ any assets ( ! plan :i* ! ,secret>y holds 9 accordance ) ! provisions ( ! plan1 regulations prescrib$ by ! ,secret>y1 & applicable provisions ( law2 7#d7 to require ! sponsor1 ! plan adm9i/rator1 any p>ticipat+ employ]1 & any employee organization repres5t+ plan p>ticipants to furni% any in=mation ) respect to ! plan :i* ! ,secret>y z tru/ee may reasonably ne$ 9 ord] to adm9i/] ! plan2 7#e7 to collect = ! plan any am\nts due ! plan & to recov] reasonable exp5ses ( ! tru/ee%ip2 7#f7 to comm5ce1 prosecute1 or def5d on behalf ( ! plan any suit or proce$+ involv+ ! plan2 7#g7 to issue1 publi%1 or file su* notices1 /atem5ts1 & reports z may be requir$ by ! ,secret>y by regulation or requir$ by any ord] ( ! c\rt2 7#h7 to t]m9ate ! plan 7or provide = its t]m9ation 9 accordance ) section #hji7;b77 & liquidate ! plan assets1 to re/ore ! plan to ! responsibility ( ! sponsor1 or to cont9ue ! tru/ee%ip2 7#i7 to provide = ! enrollm5t ( plan p>ticipants & b5efici>ies "u appropriate cov]age options2 & 7#aj7 to d su* o!r acts z may be necess>y to comply ) ?is title or any ord] ( ! c\rt & to protect ! int]e/s ( plan p>ticipants & b5efici>ies & provid]s ( m$ical c>e4 7c7 ,notice ( ,appo9tm5t ,z soon z practicable aft] ! ,secret>y's appo9tm5t z tru/ee1 ! ,secret>y %all give notice ( su* appo9tm5t to-- 7#a7 ! sponsor & plan adm9i/rator2 7#b7 ea* p>ticipant2 7#c7 ea* p>ticipat+ employ]2 & 7#d7 if applicable1 ea* employee organization :i*1 = purposes ( collective b>ga9+1 repres5ts plan p>ticipants4 7d7 ,additional ,duties ,except to ! ext5t inconsi/5t ) ! provisions ( ?is title1 or z may be o!rwise ord]$ by ! c\rt1 ! ,secret>y1 ^u appo9tm5t z tru/ee "u ?is section1 %all be subject to ! same duties z ^? ( a tru/ee "u section #gjd ( title #aa1 ,unit$ ,/ates ,code1 & %all h ! duties ( a fiduci>y = purposes ( ?is title4 7e7 ,o!r ,proce$+s ,an application by ! ,secret>y "u ?is subsection may be fil$ not)/&+ ! p5d5cy 9 ! same or any o!r c\rt ( any bankruptcy1 mortgage =eclosure1 or equity receiv]%ip proce$+1 or any proce$+ to reorganize1 cons]ve1 or liquidate su* plan or its prop]ty1 or any proce$+ to en=ce a li5 aga9/ prop]ty ( ! plan4 7f7 ,jurisdiction ( ,c\rt 7#a7 ,9 g5]al ,^u ! fil+ ( an application = ! appo9tm5t z tru/ee or ! issuance ( a decree "u ?is section1 ! c\rt to :i* ! application is made %all h exclusive jurisdiction ( ! plan involv$ & its prop]ty :]ev] locat$ ) ! p[]s1 to ! ext5t consi/5t ) ! purposes ( ?is section1 ( a c\rt ( ! ,unit$ ,/ates hav+ jurisdiction ov] cases "u *apt] #aa ( title #aa1 ,unit$ ,/ates ,code4 ,p5d+ an adjudication "u ?is section su* c\rt %all /ay1 & ^u appo9tm5t by x ( ! ,secret>y z tru/ee1 su* c\rt %all cont9ue ! /ay (1 any p5d+ mortgage =eclosure1 equity receiv]%ip1 or o!r proce$+ to reorganize1 cons]ve1 or liquidate ! plan1 ! sponsor1 or prop]ty ( su* plan or sponsor1 & any o!r suit aga9/ any receiv]1 cons]vator1 or tru/ee ( ! plan1 ! sponsor1 or prop]ty ( ! plan or sponsor4 ,p5d+ su* adjudication & ^u ! appo9tm5t by x ( ! ,secret>y z tru/ee1 ! c\rt may /ay any proce$+ to en=ce a li5 aga9/ prop]ty ( ! plan or ! sponsor or any o!r suit aga9/ ! plan or ! sponsor4 7#b7 ,v5ue ,an action "u ?is section may be br\ght 9 ! judicial di/rict :]e ! sponsor or ! plan adm9i/rator resides or does bus9ess or :]e any asset ( ! plan is situat$4 ,a di/rict c\rt 9 :i* su* action is br\ght may issue process ) respect to su* action 9 any o!r judicial di/rict4 7g7 ,p]sonnel ,9 accordance ) regulations :i* %all be prescrib$ by ! ,secret>y1 ! ,secret>y %all appo9t1 reta91 & comp5sate acc\ntants1 actu>ies1 & o!r pr(essional s]vice p]sonnel z may be necess>y 9 connection ) ! ,secret>y's s]vice z tru/ee "u ?is section4 #haa4 ,/ate assessm5t au?ority 7a7 ,9 ,g5]al ,not)/&+ section #ead1 a ,/ate may impose by law a contribution tax on an association heal? plan describ$ 9 section #hjf7;a77#b71 if ! plan comm5c$ op]ations 9 su* ,/ate aft] ! date ( ! enactm5t ( ?is section4 7b7 ,contribution ,tax ,= purposes ( ?is section1 ! t]m contribution tax impos$ by a ,/ate on an association heal? plan means any tax impos$ by su* ,/ate if-- 7#a7 su* tax is comput$ by apply+ a rate to ! am\nt ( premiums or contributions1 ) respect to individuals cov]$ "u ! plan :o are resid5ts ( su* ,/ate1 :i* are receiv$ by ! plan f p>ticipat+ employ]s locat$ 9 su* ,/ate or f su* individuals2 7#b7 ! rate ( su* tax does n exce$ ! rate ( any tax impos$ by su* ,/ate on premiums or contributions receiv$ by insur]s or heal? ma9t5ance organizations = heal? insurance cov]age (f]$ 9 su* ,/ate 9 connection ) a gr\p heal? plan2 7#c7 su* tax is o!rwise nondiscrim9atory2 & 7#d7 ! am\nt ( any su* tax assess$ on ! plan is r$uc$ by ! am\nt ( any tax or assessm5t o!rwise impos$ by ! ,/ate on premiums1 contributions1 or bo? receiv$ by insur]s or heal? ma9t5ance organizations = heal? insurance cov]age1 aggregate excess_//op loss insurance 7z def9$ 9 section #hjf7;g77#a771 specific excess_//op loss insurance 7z def9$ 9 section #hjf7;g77#b771 o!r insurance relat$ to ! provision ( m$ical c>e "u ! plan1 or any comb9ation !re( provid$ by su* insur]s or heal? ma9t5ance organizations 9 su* ,/ate 9 connection ) su* plan4 #hab4 ,def9itions & rules ( con/ruction 7a7 ,def9itions ,= purposes ( ?is "p-- 7#a7 ,gr\p heal? plan ,! t]m gr\p heal? plan has ! mean+ provid$ 9 section #gcc7;a77#a7 7aft] apply+ subsection 7b7 ( ?is section74 7#b7 ,m$ical c>e ,! t]m m$ical c>e has ! mean+ provid$ 9 section #gcc7;a77#b74 7#c7 ,heal? insurance cov]age ,! t]m heal? insurance cov]age has ! mean+ provid$ 9 section #gcc7;b77#a74 7#d7 ,heal? insurance issu] ,! t]m heal? insurance issu] has ! mean+ provid$ 9 section #gcc7;b77#b74 7#e7 ,applicable au?ority ,! t]m applicable au?ority means ! ,secret>y1 except t1 9 connection ) any ex]cise ( ! ,secret>y's au?ority reg>d+ :i* ! ,secret>y is requir$ "u section #ejf7;d7 to consult ) a ,/ate1 su* t]m means ! ,secret>y1 9 consultation ) su* ,/ate4 7#f7 ,heal? /atus-relat$ factor ,! t]m heal? /atus-relat$ factor has ! mean+ provid$ 9 section #gcc7;d77#b74 7#g7 ,individual m>ket 7,a7 ,9 g5]al ,! t]m individual m>ket means ! m>ket = heal? insurance cov]age (f]$ to individuals o!r ?an 9 connection ) a gr\p heal? plan4 7,b7 ,treatm5t ( v small gr\ps 7i7 ,9 g5]al ,subject to clause 7ii71 su* t]m includes cov]age (f]$ 9 connection ) a gr\p heal? plan t has few] ?an #b p>ticipants z curr5t employees or p>ticipants describ$ 9 section #gcb7;d77#c7 on ! fir/ day ( ! plan ye>4 7ii7 ,/ate exception ,clause 7i7 %all n apply 9 ! case ( heal? insurance cov]age (f]$ 9 a ,/ate if su* ,/ate regulates ! cov]age describ$ 9 su* clause 9 ! same mann] & to ! same ext5t z cov]age 9 ! small gr\p m>ket 7z def9$ 9 section #bgia7;e77#e7 ( ! ,public ,heal? ,s]vice ,act7 is regulat$ by su* ,/ate4 7#h7 ,p>ticipat+ employ] ,! t]m p>ticipat+ employ] means1 9 connection ) an association heal? plan1 any employ]1 if any individual :o is an employee ( su* employ]1 a p>tn] 9 su* employ]1 or a self-employ$ individual :o is su* employ] 7or any dep5d5t1 z def9$ "u ! t]ms ( ! plan1 ( su* individual7 is or 0 cov]$ "u su* plan 9 connection ) ! /atus ( su* individual z su* an employee1 p>tn]1 or self-employ$ individual 9 relation to ! plan4 7#i7 ,applicable /ate au?ority ,! t]m applicable ,/ate au?ority means1 ) respect to a heal? insurance issu] 9 a ,/ate1 ! ,/ate insurance commission] or (ficial or (ficials designat$ by ! ,/ate to en=ce ! requirem5ts ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act = ! ,/ate involv$ ) respect to su* issu]4 7#aj7 ,qualifi$ actu>y ,! t]m qualifi$ actu>y means an individual :o is a memb] ( ! ,am]ican ,academy ( ,actu>ies4 7#aa7 ,affiliat$ memb] ,! t]m affiliat$ memb] means1 9 connection ) a sponsor-- 7,a7 a p]son :o is o!rwise eligible to be a memb] ( ! sponsor b :o elects an affiliat$ /atus ) ! sponsor1 7,b7 9 ! case ( a sponsor ) memb]s :i* consi/ ( associations1 a p]son :o is a memb] ( any su* association & elects an affiliat$ /atus ) ! sponsor1 or 7,c7 9 ! case ( an association heal? plan 9 exi/5ce on ! date ( ! enactm5t ( ?is section1 a p]son eligible to be a memb] ( ! sponsor or "o ( its memb] associations4 7#ab7 ,l>ge employ] ,! t]m l>ge employ] means1 9 connection ) a gr\p heal? plan ) respect to a plan ye>1 an employ] :o employ$ an av]age ( at lea/ #ea employees on bus9ess days dur+ ! prec$+ cal5d> ye> & :o employs at lea/ #b employees on ! fir/ day ( ! plan ye>4 7#ac7 ,small employ] ,! t]m small employ] means1 9 connection ) a gr\p heal? plan ) respect to a plan ye>1 an employ] :o is n a l>ge employ]4 7b7 ,rules ( ,con/ruction 7#a7 ,employ]s & employees ,= purposes ( det]m9+ :e!r a plan1 fund1 or program is an employee welf>e b5efit plan :i* is an association heal? plan1 & = purposes ( apply+ ?is title 9 connection ) su* plan1 fund1 or program s det]m9$ to be su* an employee welf>e b5efit plan-- 7,a7 9 ! case ( a p>tn]%ip1 ! t]m employ] 7z def9$ 9 section #c7e77 includes ! p>tn]%ip 9 relation to ! p>tn]s1 & ! t]m employee 7z def9$ 9 section #c7f77 includes any p>tn] 9 relation to ! p>tn]%ip2 & 7,b7 9 ! case ( a self-employ$ individual1 ! t]m employ] 7z def9$ 9 section #c7e77 & ! t]m employee 7z def9$ 9 section #c7f77 %all include su* individual4 7#b7 ,plans1 funds1 & programs treat$ z employee welf>e b5efit plans ,9 ! case ( any plan1 fund1 or program :i* 0 e/abli%$ or is ma9ta9$ = ! purpose ( provid+ m$ical c>e 7?r\gh ! pur*ase ( insurance or o!rwise7 = employees 7or _! dep5d5ts7 cov]$ !reund] & :i* demon/rates to ! ,secret>y t all requirem5ts = c]tification "u ?is "p w\ld be met ) respect to su* plan1 fund1 or program if su* plan1 fund1 or program 7 a gr\p heal? plan1 su* plan1 fund1 or program %all be treat$ = purposes ( ?is title z an employee welf>e b5efit plan on & aft] ! date ( su* demon/ration4 4 7b7 ,con=m+ ,am5dm5ts to ,preemption ,rules 7#a7 ,section #ead7;b77#f7 ( su* ,act 7#bi ,u4,s4,c4 #aadd7;b77#f77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,! prec$+ subp>agraphs ( ?is p>agraph d n apply ) respect to any ,/ate law 9 ! case ( an association heal? plan :i* is c]tifi$ "u "p #h4 4 7#b7 ,section #ead ( su* ,act 7#bi ,u4,s4,c4 #aadd7 is am5d$-- 7,a7 9 subsection 7b77#d71 by /rik+ ,subsection 7a7 & ins]t+ ,subsections 7a7 & 7f72 7,b7 9 subsection 7b77#e71 by /rik+ subsection 7a7 9 subp>agraph 7,a7 & ins]t+ subsection 7a7 ( ?is section & subsections 7a77#b77;,b7 & 7b7 ( section #hje1 & by /rik+ subsection 7a7 9 subp>agraph 7,b7 & ins]t+ subsection 7a7 ( ?is section or subsection 7a77#b77;,b7 or 7b7 ( section #hje2 & 7,c7 by add+ at ! end ! foll[+ new subsection3 7f7 7#a7 ,except z provid$ 9 subsection 7b77#d71 ! provisions ( ?is title %all sup]s$e any & all ,/ate laws ins(> z !y may n[ or h]eaft] preclude1 or h ! effect ( preclud+1 a heal? insurance issu] f (f]+ heal? insurance cov]age 9 connection ) an association heal? plan :i* is c]tifi$ "u "p #h4 7#b7 ,except z provid$ 9 p>agraphs 7#d7 & 7#e7 ( subsection 7b7 ( ?is section-- 7,a7 ,9 any case 9 :i* heal? insurance cov]age ( any policy type is (f]$ "u an association heal? plan c]tifi$ "u "p #h to a p>ticipat+ employ] op]at+ 9 su* ,/ate1 ! provisions ( ?is title %all sup]s$e any & all laws ( su* ,/ate ins(> z !y may preclude a heal? insurance issu] f (f]+ heal? insurance cov]age ( ! same policy type to o!r employ]s op]at+ 9 ! ,/ate :i* are eligible = cov]age "u su* association heal? plan1 :e!r or n su* o!r employ]s are p>ticipat+ employ]s 9 su* plan4 7,b7 ,9 any case 9 :i* heal? insurance cov]age ( any policy type is (f]$ 9 a ,/ate "u an association heal? plan c]tifi$ "u "p #h & ! fil+1 ) ! applicable ,/ate au?ority 7z def9$ 9 section #hab7;a77#i771 ( ! policy =m 9 connection ) su* policy type is approv$ by su* ,/ate au?ority1 ! provisions ( ?is title %all sup]s$e any & all laws ( any o!r ,/ate 9 :i* heal? insurance cov]age ( su* type is (f]$1 ins(> z !y may preclude1 ^u ! fil+ 9 ! same =m & mann] ( su* policy =m ) ! applicable ,/ate au?ority 9 su* o!r ,/ate1 ! approval ( ! fil+ 9 su* o!r ,/ate4 7#c7 ,no?+ 9 subsection 7b77#f77;,e7 or ! prec$+ provisions ( ?is subsection %all be con/ru$1 ) respect to heal? insurance issu]s or heal? insurance cov]age1 to sup]s$e or impair ! law ( any ,/ate-- 7,a7 provid+ solv5cy /&>ds or simil> /&>ds reg>d+ ! adequacy ( insur] capital1 surplus1 res]ves1 or contributions1 or 7,b7 relat+ to prompt paym5t ( claims4 7#d7 ,= additional provisions relat+ to association heal? plans1 see subsections 7a77#b77;,b7 & 7b7 ( section #hje4 7#e7 ,= purposes ( ?is subsection1 ! t]m association heal? plan has ! mean+ provid$ 9 section #hja7;a71 & ! t]ms heal? insurance cov]age1 p>ticipat+ employ]1 & heal? insurance issu] h ! mean+s provid$ su* t]ms 9 section #hab1 respectively4 4 7#c7 ,section #ead7;b77#f77;,a7 ( su* ,act 7#bi ,u4,s4,c4 #aadd7;b77#f77;,a77 is am5d$-- 7,a7 9 clause 7i77,,ii71 by /rik+ & at ! end2 7,b7 9 clause 7ii71 by ins]t+ & :i* does n provide m$ical c>e 7)9 ! mean+ ( section #gcc7;a77#b771 aft] arrangem5t11 & by /rik+ title4 & ins]t+ title1 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7iii7 subject to subp>agraph 7,e71 9 ! case ( any o!r employee welf>e b5efit plan :i* is a multiple employ] welf>e arrangem5t & :i* provides m$ical c>e 7)9 ! mean+ ( section #gcc7;a77#b771 any law ( any ,/ate :i* regulates insurance may apply4 4 7#d7 ,section #ead7;d7 ( su* ,act 7#bi ,u4,s4,c4 #aadd7;d77 is am5d$-- 7,a7 by /rik+ ,no?+ & ins]t+ 7#a7 ,except z provid$ 9 p>agraph 7#b71 no?+2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,no?+ 9 any o!r provision ( law enact$ on or aft] ! date ( ! enactm5t ( ?is p>agraph %all be con/ru$ to alt]1 am5d1 modify1 invalidate1 impair1 or sup]s$e any provision ( ?is title1 except by specific cross-ref]5ce to ! affect$ section4 4 7c7 ,plan ,sponsor ,section #c7af77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #ajb7af77;,b77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,su* t]m also includes a p]son s]v+ z ! sponsor ( an association heal? plan "u "p #h44 7d7 ,disclosure ( ,solv5cy ,protections ,relat$ to ,self-,insur$ & ,fully ,insur$ ,options ,"u ,association ,heal? ,plans ,section #ajb7;b7 ( su* ,act 7#bi ,u4,s4,c4 #ajb7;b77 is am5d$ by add+ at ! end ! foll[+3 ,an association heal? plan %all include 9 its summ>y plan description1 9 connection ) ea* b5efit option1 a description ( ! =m ( solv5cy or gu>antee fund protection secur$ pursuant to ?is ,act or applicable ,/ate law1 if any44 7e7 ,sav+s ,clause ,section #gca7;c7 ( su* ,act is am5d$ by ins]t+ or "p #h aft] ?is "p4 7f7 ,report to ! ,congress ,reg>d+ ,c]tification ( ,self-,insur$ ,association ,heal? ,plans ,n lat] ?an ,janu>y #a1 #bjbb1 ! ,secret>y ( ,labor %all report to ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate ! effect association heal? plans h _h1 if any1 on r$uc+ ! numb] ( un9sur$ individuals4 7g7 ,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 items3 ,"p #h4 ,rules ,gov]n+ ,association ,heal? ,plans #hja4 ,association heal? plans4 #hjb4 ,c]tification ( association heal? plans4 #hjc4 ,requirem5ts relat+ to sponsors & bo>ds ( tru/ees4 #hjd4 ,p>ticipation & cov]age requirem5ts4 #hje4 ,o!r requirem5ts relat+ to plan docum5ts1 contribution rates1 & b5efit options4 #hjf4 ,ma9t5ance ( res]ves & provisions = solv5cy = plans provid+ heal? b5efits 9 addition to heal? insurance cov]age4 #hjg4 ,requirem5ts = application & relat$ requirem5ts4 #hjh4 ,notice requirem5ts = volunt>y t]m9ation4 #hji4 ,corrective actions & m&atory t]m9ation4 #haj4 ,tru/ee%ip by ! ,secret>y ( insolv5t association heal? plans provid+ heal? b5efits 9 addition to heal? insurance cov]age4 #haa4 ,/ate assessm5t au?ority4 #hab4 ,def9itions & rules ( con/ruction4 4 #bab4 ,cl>ification ( treatm5t ( s+le employ] arrangem5ts ,section #c7dj77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajjb7dj77;,b77 is am5d$-- 7#a7 9 clause 7i71 by ins]t+ aft] control gr\p1 ! foll[+3 except t1 9 any case 9 :i* ! b5efit ref]r$ to 9 subp>agraph 7,a7 consi/s ( m$ical c>e 7z def9$ 9 section #hab7;a77#b771 two or m trades or bus9esses1 :e!r or n incorporat$1 %all be deem$ a s+le employ] = any plan ye> ( su* plan1 or any fiscal ye> ( su* o!r arrangem5t1 if su* trades or bus9esses are )9 ! same control gr\p dur+ su* ye> or at any "t dur+ ! prec$+ #a-ye> p]iod12 7#b7 9 clause 7iii71 by /rik+ 7iii7 ! det]m9ation & ins]t+ ! foll[+3 7iii7 7,i7 9 any case 9 :i* ! b5efit ref]r$ to 9 subp>agraph 7,a7 consi/s ( m$ical c>e 7z def9$ 9 section #hab7;a77#b771 ! det]m9ation ( :e!r a trade or bus9ess is "u common control ) ano!r trade or bus9ess %all be det]m9$ "u regulations ( ! ,secret>y apply+ pr9ciples consi/5t & coext5sive ) ! pr9ciples appli$ 9 det]m9+ :e!r employees ( two or m trades or bus9esses are treat$ z employ$ by a s+le employ] "u section #djja7;b71 except t1 = purposes ( ?is p>agraph1 an int]e/ ( great] ?an #be p]c5t may n be requir$ z ! m9imum int]e/ necess>y = common control1 or 7,,ii7 9 any o!r case1 ! det]m9ation 2 7#c7 by r$esignat+ clauses 7iv7 & 7v7 z clauses 7v7 & 7vi71 respectively2 & 7#d7 by ins]t+ aft] clause 7iii7 ! foll[+ new clause3 7iv7 9 any case 9 :i* ! b5efit ref]r$ to 9 subp>agraph 7,a7 consi/s ( m$ical c>e 7z def9$ 9 section #hab7;a77#b771 9 det]m9+1 aft] ! application ( clause 7i71 :e!r b5efits are provid$ to employees ( two or m employ]s1 ! arrangem5t %all be treat$ z hav+ only "o p>ticipat+ employ] if1 aft] ! application ( clause 7i71 ! numb] ( individuals :o are employees & =m] employees ( any "o p>ticipat+ employ] & :o are cov]$ "u ! arrangem5t is great] ?an #ge p]c5t ( ! aggregate numb] ( all individuals :o are employees or =m] employees ( p>ticipat+ employ]s & :o are cov]$ "u ! arrangem5t1 4 #bac4 ,en=cem5t provisions relat+ to association heal? plans 7a7 ,crim9al ,p5alties = ,c]ta9 ,willful ,misrepres5tations ,section #eja ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaca7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7c7 ,any p]son :o willfully falsely repres5ts1 to any employee1 any employee's b5efici>y1 any employ]1 ! ,secret>y1 or any ,/ate1 a plan or o!r arrangem5t e/abli%$ or ma9ta9$ = ! purpose ( (f]+ or provid+ any b5efit describ$ 9 section #c7a7 to employees or _! b5efici>ies z-- 7#a7 be+ an association heal? plan :i* has be5 c]tifi$ "u "p #h2 7#b7 hav+ be5 e/abli%$ or ma9ta9$ "u or pursuant to "o or m collective b>ga9+ agreem5ts :i* are rea*$ pursuant to collective b>ga9+ describ$ 9 section #h7;d7 ( ! ,national ,labor ,relations ,act 7#bi ,u4,s4,c4 #aeh7;d77 or p>agraph ,f\r? ( section #b ( ! ,railway ,labor ,act 7#de ,u4,s4,c4 #aeb1 p>agraph ,f\r?7 or :i* are rea*$ pursuant to labor-managem5t negotiations "u simil> provisions ( ,/ate public employee relations laws2 or 7#c7 be+ a plan or arrangem5t describ$ 9 section #c7dj77;,a77i71 %all1 ^u conviction1 be imprison$ n m ?an #e ye>s1 be f9$ "u title #ah1 ,unit$ ,/ates ,code1 or bo?4 4 7b7 ,cease ,activities ,ord]s ,section #ejb ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aacb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7n7 ,association ,heal? ,plan ,cease & ,desi/ ,ord]s 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ^u application by ! ,secret>y %[+ ! op]ation1 promotion1 or m>ket+ ( an association heal? plan 7or simil> arrangem5t provid+ b5efits consi/+ ( m$ical c>e 7z def9$ 9 section #gcc7;a77#b777 t-- 7,a7 is n c]tifi$ "u "p #h1 is subject "u section #ead7;b77#f7 to ! insurance laws ( any ,/ate 9 :i* ! plan or arrangem5t (f]s or provides b5efits1 & is n lic5s$1 regi/]$1 or o!rwise approv$ "u ! insurance laws ( su* ,/ate2 or 7,b7 is an association heal? plan c]tifi$ "u "p #h & is n op]at+ 9 accordance ) ! requirem5ts "u "p #h = su* c]tification1 a di/rict c\rt ( ! ,unit$ ,/ates %all ent] an ord] requir+ t ! plan or arrangem5t cease activities4 7#b7 ,exception ,p>agraph 7#a7 %all n apply 9 ! case ( an association heal? plan or o!r arrangem5t if ! plan or arrangem5t %[s t-- 7,a7 all b5efits "u x ref]r$ to 9 p>agraph 7#a7 consi/ ( heal? insurance cov]age2 & 7,b7 ) respect to ea* ,/ate 9 :i* ! plan or arrangem5t (f]s or provides b5efits1 ! plan or arrangem5t is op]at+ 9 accordance ) applicable ,/ate laws t are n sup]s$$ "u section #ead4 7#c7 ,additional equitable relief ,! c\rt may grant su* additional equitable relief1 includ+ any relief available "u ?is title1 z x deems necess>y to protect ! int]e/s ( ! public & ( p]sons hav+ claims = b5efits aga9/ ! plan4 4 7c7 ,responsibility = ,claims ,proc$ure ,section #ejc ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aacc7 is am5d$ by ins]t+ 7a7 ,9 g5]al4-- be=e ,9 accordance1 & by add+ at ! end ! foll[+ new subsection3 7b7 ,association ,heal? ,plans ,! t]ms ( ea* association heal? plan :i* is or has be5 c]tifi$ "u "p #h %all require ! bo>d ( tru/ees or ! nam$ fiduci>y 7z applicable7 to ensure t ! requirem5ts ( ?is section are met 9 connection ) claims fil$ "u ! plan4 4 #bad4 ,coop]ation betwe5 ,f$]al & ,/ate au?orities ,section #ejf ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aacf7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7d7 ,consultation ,) ,/ates ,) ,respect to ,association ,heal? ,plans 7#a7 ,agreem5ts ) /ates ,! ,secret>y %all consult ) ! ,/ate recogniz$ "u p>agraph 7#b7 ) respect to an association heal? plan reg>d+ ! ex]cise (-- 7,a7 ! ,secret>y's au?ority "u sections #ejb & #ejd to en=ce ! requirem5ts = c]tification "u "p #h2 & 7,b7 ! ,secret>y's au?ority to c]tify association heal? plans "u "p #h 9 accordance ) regulations ( ! ,secret>y applicable to c]tification "u "p #h4 7#b7 ,recognition ( prim>y domicile /ate ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all ensure t only "o ,/ate w be recogniz$1 ) respect to any p>ticul> association heal? plan1 z ! ,/ate ) :i* consultation is requir$4 ,9 c>ry+ out ?is p>agraph-- 7,a7 9 ! case ( a plan :i* provides heal? insurance cov]age 7z def9$ 9 section #hab7;a77#c771 su* ,/ate %all be ! ,/ate ) :i* fil+ & approval ( a policy type (f]$ by ! plan 0 initially obta9$1 & 7,b7 9 any o!r case1 ! ,secret>y %all take into acc\nt ! places ( resid5ce ( ! p>ticipants & b5efici>ies "u ! plan & ! ,/ate 9 :i* ! tru/ is ma9ta9$4 4 #bae4 ,effective date & transitional & o!r rules 7a7 ,effective ,date ,! am5dm5ts made by ?is ,act %all take effect #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 ,! ,secret>y ( ,labor %all fir/ issue all regulations necess>y to c>ry out ! am5dm5ts made by ?is ,act )9 #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7b7 ,treatm5t ( ,c]ta9 ,exi/+ ,heal? ,b5efits ,programs 7#a7 ,9 g5]al ,9 any case 9 :i*1 z ( ! date ( ! enactm5t ( ?is ,act1 an arrangem5t is ma9ta9$ 9 a ,/ate = ! purpose ( provid+ b5efits consi/+ ( m$ical c>e = ! employees & b5efici>ies ( its p>ticipat+ employ]s1 at lea/ #bjj p>ticipat+ employ]s make contributions to su* arrangem5t1 su* arrangem5t has be5 9 exi/5ce = at lea/ #aj ye>s1 & su* arrangem5t is lic5s$ "u ! laws ( "o or m ,/ates to provide su* b5efits to its p>ticipat+ employ]s1 ^u ! fil+ ) ! applicable au?ority 7z def9$ 9 section #hab7;a77#e7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7z am5d$ by ?is ,act77 by ! arrangem5t ( an application = c]tification ( ! arrangem5t "u "p #h ( subtitle ,b ( title ,i ( su* ,act-- 7,a7 su* arrangem5t %all be deem$ to be a gr\p heal? plan = purposes ( title ,i ( su* ,act2 7,b7 ! requirem5ts ( sections #hja7;a7 & #hjc7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd %all be deem$ met ) respect to su* arrangem5t2 7,c7 ! requirem5ts ( section #hjc7;b7 ( su* ,act %all be deem$ met1 if ! arrangem5t is op]at$ by a bo>d ( directors :i*-- 7i7 is elect$ by ! p>ticipat+ employ]s1 ) ea* employ] hav+ "o vote2 & 7ii7 has complete fiscal control ov] ! arrangem5t & :i* is responsible = all op]ations ( ! arrangem5t2 7,d7 ! requirem5ts ( section #hjd7;a7 ( su* ,act %all be deem$ met ) respect to su* arrangem5t2 & 7,e7 ! arrangem5t may be c]tifi$ by any applicable au?ority ) respect to its op]ations 9 any ,/ate only if x op]ates 9 su* ,/ate on ! date ( c]tification4 ,! provisions ( ?is subsection %all cease to apply ) respect to any su* arrangem5t at su* "t aft] ! date ( ! enactm5t ( ?is ,act z ! applicable requirem5ts ( ?is subsection are n met ) respect to su* arrangem5t4 7#b7 ,def9itions ,= purposes ( ?is subsection1 ! t]ms gr\p heal? plan1 m$ical c>e1 & p>ticipat+ employ] %all h ! mean+s provid$ 9 section #hab ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 except t ! ref]5ce 9 p>agraph 7#g7 ( su* section to an association heal? plan %all be deem$ a ref]5ce to an arrangem5t ref]r$ to 9 ?is subsection4 7c7 ,coord9ation ) exi/+ law ,no?+ 9 ?is ,act %all require plans to become c]tifi$ "u section #hjb ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z am5d$ by ?is ,act1 or require plans t are n c]tifi$ "u su* section to comply ) ! requirem5ts "u "p #h ( su* ,act1 except to ! ext5t provid$ 9 section #hji ( su* ,act4 #baf4 ,%ort-t]m limit$ duration insurance 7a7 ,def9ition ,section #bgia7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,%ort-t]m limit$ duration insurance ,! t]m %ort-t]m limit$ duration insurance means heal? insurance cov]age provid$ pursuant to a contract ) a heal? insurance issu] t has an expiration date specifi$ 9 ! contract 7n tak+ into acc\nt any ext5sions t may be elect$ by ! policyhold] ) or )\t ! issu]'s cons5t7 t is less ?an #ab mon?s aft] ! orig9al effective date ( ! contract4 4 7b7 ,gu>ante$ r5ewability ,section #bgjc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#b7 is am5d$-- 7#a7 9 subsection 7a71 by ins]t+ or (f]s %ort-t]m limit$ duration insurance aft] gr\p m>ket2 & 7#b7 by add+ at ! end ! foll[+3 7f7 ,application to %ort-,t]m limit$ duration insurance 7#a7 ,9 g5]al ,9 apply+ ?is section 9 ! case ( %ort-t]m limit$ duration insurance-- 7,a7 a ref]5ce to heal? insurance cov]age ) respect to su* cov]age (f]$ 9 ! individual m>ket %all be deem$ to include %ort-t]m limit$ duration insurance2 & 7,b7 a ref]5ce to heal? insurance issu] ) respect to heal? insurance cov]age (f]$ 9 ! individual m>ket %all be deem$ to include an issu] ( %ort-t]m limit$ duration insurance4 7#b7 ,special rule = %ort-t]m limit$ duration insurance ,9 ! case ( %ort-t]m limit$ duration insurance1 at ! "t ( application = enrollm5t 9 su* insurance cov]age1 an issu] ( su* insurance may (f] r5ewability ( su* cov]age1 & an individual may decl9e r5ewability ( su* cov]age 9 accordance ) ?is section1 & ! contract betwe5 su* individual & ! heal? insurance issu] %all specify :e!r ! individual opt$ = r5ewability or no r5ewability4 4 7c7 ,applicability ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply ) respect to contracts = %ort-t]m limit$ duration insurance t take effect on or aft] ,janu>y #a1 #bjba4 ,c ,improv+ ,comm]cial ,heal? ,insurance #bba4 ,invisible ,gu>ante$ ,cov]age ,pool ,re9surance ,program2 tax on ex*ange plans 7a7 ,e/abli%m5t ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% ! ,invisible ,gu>ante$ ,cov]age ,pool ,re9surance ,program 79 ?is section ref]r$ to z ! ,,igcpr program74 7b7 ,/ate grants ,"u ! ,,igcpr program1 ! ,secret>y %all1 f am\nts appropriat$ "u subsection 7f7 = a fiscal ye>1 aw>d grants to ,/ates = su* fiscal ye>1 9 am\nts det]m9$ 9 accordance ) ! allocation me?odology specifi$ "u subsection 7d74 ,su* grants %all be us$ = ! purpose ( e/abli%+ or ma9ta9+ a qualify+ ,invisible ,gu>ante$ ,cov]age ,pool = ! ,/ate4 7c7 ,f$]al default 7#a7 ,9 g5]al ,9 ! case ( a ,/ate t does n1 by a date & 9 a mann] specifi$ by ! ,secret>y1 *oose to be aw>d$ a grant "u subsection 7b7 = a fiscal ye> to op]ate a qualify+ ,invisible ,gu>ante$ ,cov]age ,pool = ! ,/ate1 ! ,secret>y %all1 f am\nts appropriat$ "u subsection 7f7 = su* fiscal ye>1 use ! allocation det]m9$ = ! ,/ate "u subsection 7d7 = p>ticipation ( su* ,/ate 9 ! ,f$]al default qualify+ ,invisible ,gu>ante$ ,cov]age ,pool describ$ 9 p>agraph 7#b74 7#b7 ,f$]al default qualify+ ,invisible ,gu>ante$ ,cov]age ,pool ,! ,f$]al default qualify+ high risk pool is1 ) respect to ea* ,/ate t *ooses n to be aw>d$ a grant "u subsection 7b7 ) respect to a fiscal ye> = :i* funds are appropriat$ "u subsection 7f71 an ,invisible ,gu>ante$ ,cov]age ,pool "u :i* heal? insurance issu]s p>ticipat+ 9 ! ,ex*ange ( su* a ,/ate1 ) respect to designat$ individuals :o are enroll$ 9 heal? insurance cov]age & are expect$ to exp]i5ce high] ?an av]age heal? co/s z det]m9$ by ! insur]1 c$e risk to ! pool1 )\t affect+ ! premium paid by ! designat$ individuals or _! t]ms ( cov]age4 ,) respect to su* pool-- 7,a7 high-risk individuals designat$ = cession to ! pool %all be designat$ by ! c$+ issu]2 7,b7 ! premium am\nt ! c$+ issu] %all pay to ! re9surance pool %all be #ij p]c5t ( ! premium paid to ! issu] = ! cov]age2 7,c7 ! c$+ issu] %all reta9 ! same risk "u ! c$$ policies z "u any o!r policy ( ! issu] ) respect to ! fir/ #aj1jjj ( b5efits = ea* c$$ policy involv$ & w n reta9 any risk "u c$$ policies aft] su* fir/ #aj1jjj ( b5efits2 & 7,d7 aft] a c$+ issu]1 ) respect to a c$$ policy1 no long] reta9s risk "u su* policy pursuant to subp>agraph 7,c71 ! negotiat$ rate "u su* policy = items & s]vices %all be payable at ! reimbursem5t rate "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act = su* items & s]vices1 or 9 ! case ( items & s]vices = :i* paym5t is available "u ! policy b n ! ,m$ic>e program1 at a rate det]m9$ by ! ,secret>y4 7d7 ,allocation me?odology ,n lat] ?an ,june #cj1 #bjba1 ! ,secret>y %all specify an allocation me?odology = det]m9+ ! am\nt ( funds appropriat$ "u subsection 7f7 = a fiscal ye> to be allocat$ = ea* ,/ate = purposes ( subsections 7b7 & 7c74 ,su* me?odology %all be bas$ on ! numb] ( resid5ts ( ea* ,/ate & ! g5]al heal? /atus ( su* resid5ts4 7e7 ,qualify+ ,invisible ,gu>ante$ ,cov]age ,pool ,= purposes ( ?is section1 ! t]m qualify+ ,invisible ,gu>ante$ ,cov]age ,pool means1 ) respect to a ,/ate1 a me?od ( designation "u :i* heal? insurance issu]s id5tify individuals :o exp]i5ce high] ?an av]age heal? co/s z det]m9$ by ! ,/ate & are enroll$ 9 heal? insurance cov]age (f]$ 9 ! individual m>ket1 & c$e ! risk ( sp5d+ m ?an #aj1jjj on heal? c>e s]vices = a s+le individual to ! pool )\t affect+ ! premium paid by ! designat$ individuals or _! t]ms ( cov]age4 ,) respect to su* pool1 ! ,/ate1 or an entity op]at+ ! pool on behalf ( ! ,/ate1 %all e/abli%-- 7#a7 ! premium am\nt ! c$+ issu] %all pay to ! re9surance pool2 7#b7 ! applicable atta*m5t po9ts or co9surance p]c5tages if ! c$+ issu] reta9s any portion ( ! risk "u c$$ policies1 except t ! provisions ( subp>agraphs 7,c7 & 7,d7 ( subsection 7c77#b7 %all apply to su* high risk pool 9 ! same mann] z su* clauses apply to ! ,f$]al default high risk pool2 & 7#c7 ! me*anism by :i* high-risk individuals are designat$ = cession to ! pool1 :i* may include a li/ ( designat$ high-co/ heal? conditions4 7f7 ,appropriations ,!re is appropriat$ to ! ,secret>y ( ,heal? & ,human ,s]vices #bjj1jjj1jjj1jjj to c>ry out ?is section = ! p]iod ( fiscal ye> #bjba ?r\gh fiscal ye> #bjbi4 7g7 ,tax on heal? insurance plans sold on ex*anges 7#a7 ,9 g5]al ,*apt] #cd ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new sub*apt]3 ,c ,additional tax on heal? insurance plans sold by insur]s (f]+ plans on ex*anges ,sec4 #ddja4 ,additional tax on heal? insurance plans sold by insur]s (f]+ plans on ex*anges4 #ddja4 ,additional tax on heal? insurance plans sold by insur]s (f]+ plans on ex*anges 7a7 ,imposition ( tax ,!re is impos$ a tax ( #d = ea* policy mon? ( ea* heal? insurance policy sold by insur]s (f]+ plans ?r\gh an ,ex*ange e/abli%$ "u ! ,pati5t ,protection & ,af=dable ,c>e ,act4 7b7 ,liability ,! tax impos$ by subsection 7a7 %all be paid by ! plan sponsor4 4 7#b7 ,con=m+ am5dm5t ,! table ( sub*apt]s = *apt] #cd ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ item3 ,sub*apt] ,c--,additional tax on heal? insurance plans sold by insur]s (f]+ plans on ex*anges 4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to mon?s beg9n+ aft] ! date ( enactm5t ( ?is ,act4 7h7 ,report ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 collaboration ) ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 %all submit to ,congress1 n lat] ?an ,janu>y #a1 #bjbf1 & aga9 #e ye>s !reaft]1 a report on ! /atus ( re9surance pool fund+1 along ) any recomm5dations ) respect to future allocations or fund+ me?ods = su* pool4 #bbb4 ,employ] heal? insurance m&ate repeal 7a7 ,9 g5]al ,*apt] #dc ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ section #dihj;,h4 7b7 ,repeal ( ,relat$ ,report+ ,requirem5ts ,subp>t ,d ( "p ,,iii ( sub*apt] ,a ( *apt] #fa ( su* ,code is am5d$ by /rik+ section #fjef4 7c7 ,con=m+ am5dm5ts 7#a7 ,section #fgbd7;d77#a77;,b7 ( su* ,code is am5d$ by ins]t+ or at ! end ( clause 7xxiii71 by /rik+ or at ! end ( clause 7xxiv71 & by /rik+ clause 7xxv74 7#b7 ,section #fgbd7;d77#b7 ( su* ,code is am5d$ by ins]t+ or at ! end ( subp>agraph 7,,gg7 & by /rik+ subp>agraph 7,,hh74 7#c7 ,! table ( sections = *apt] #dc ( su* ,code is am5d$ by /rik+ ! item relat+ to section #dihj;,h4 7#d7 ,! table ( sections = subp>t ,d ( "p ,,iii ( sub*apt] ,a ( *apt] #fa ( su* ,code is am5d$ by /rik+ ! item relat+ to section #fjef4 7#e7 ,section #aeac ( ! ,pati5t ,protection & ,af=dable ,c>e ,act is am5d$ by /rik+ subsection 7c74 7d7 ,effective date 7#a7 ,9 g5]al ,except z o!rwise provid$ 9 ?is subsection1 ! am5dm5ts made by ?is section %all apply to mon?s & o!r p]iods beg9n+ aft] ,decemb] #ca1 #bjba4 7#b7 ,repeal ( /udy & report ,! am5dm5t made by subsection 7c77#e7 %all take effect on ! date ( ! enactm5t ( ?is ,act4 #bbc4 ,refundable cr$its = cov]age "u a qualifi$ heal? plan = individuals (f]$ employ]-sponsor$ insurance 7a7 ,9 g5]al ,section #cf;,b7c77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 9 subp>agraph 7,b77i71 by ins]t+ or section #ejjj;,a7f77#a77;,b71 & 7#b7 by /rik+ subp>agraph 7,c74 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #bbd4 ,inclusion 9 income ( c]ta9 co/s ( employ]-provid$ cov]age "u heal? plans 7a7 ,9 g5]al ,section #ajf ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,limitation 7#a7 ,9 g5]al ,subsection 7a7 %all n apply to ! ext5t t employ]-provid$ cov]age "u heal? plans = an employee = a taxable ye> exce$s-- 7,a7 #aj1bjj = self-only cov]age1 & 7,b7 #bg1ejj = all o!r cov]age4 7#b7 ,9 g5]al ,9 ! case ( any cal5d> ye> aft] #bjba1 ! doll> am\nts 9 p>agraph 7#a7 %all ea* be increas$ by an am\nt equal to-- 7,a7 su* doll> am\nt1 multipli$ by-- 7,b7 ! co/-(-liv+ adju/m5t det]m9$ "u section #a7;f77#c7 = su* cal5d> ye>1 det]m9$ 7i7 by sub/itut+ cal5d> ye> #bjba = cal5d> ye> #bjaf 9 subp>agraph 7,a77ii7 !re(1 & 7ii7 by sub/itut+ = ! ,c-,,cpi-,u ref]r$ to 9 section #a7;f77#c77;,a7 ! am\nt t su* ,,cpi w\ld h be5 if ! annual p]c5tage increase 9 ,,cpi ) respect to ea* ye> aft] #bjba & be=e #bjca _h be5 "o p]c5tage po9t great]4 7#c7 ,t]ms relat$ to ,,cpi 7,a7 ,annual p]c5tage increase ,= purposes ( subp>agraph 7,b77ii77,,ii71 ! t]m annual p]c5tage increase means ! p]c5tage 7if any7 by :i* ,c-,,cpi-,u = any ye> exce$s ! ,c-,,cpi-,u = ! prior ye>4 7,b7 ,o!r t]ms ,t]ms us$ 9 ?is p>agraph :i* are also us$ 9 section #a7;f77#c7 %all h ! same mean+s z :5 us$ 9 su* section4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjba4 #bbe4 ,*ange 9 p]missible age v>iation 9 heal? insurance premium rates ,section #bgja7;a77#a77;,a77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg7a77#a77;,a77iii77 is am5d$ by ins]t+ aft] 7consi/5t ) section #bgjg7;c77 ! foll[+3 or1 = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 z ! ,secret>y may implem5t ?r\gh int]im f9al regulation1 #e to #a = adults 7consi/5t ) section #bgjg7;c774 #bbf4 ,premium assi/ance adju/m5t to reflect age 7a7 ,modification ( applicable p]c5tage ,section #cf;,b7b77#c77;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 7,a7 ,applicable p]c5tage 7i7 ,9 g5]al ,! applicable p]c5tage = any taxable ye> %all be ! p]c5tage su* t ! applicable p]c5tage = any taxpay] ^: h\sehold income is )9 an income ti] specifi$ 9 ! foll[+ table %all increase1 on a slid+ scale 9 a l9e> mann]1 f ! initial p]c5tage to ! f9al p]c5tage specifi$ 9 su* table = su* income ti] ) respect to a taxpay] ( ! age involv$3 ,9 ! case ( h\sehold income 7express$ z a p]c5t ( ! pov]ty l9e7 )9 ! foll[+ income ti]3,up to ,age #bi;,age #cj-ci;,age #dj-di;,age #ej-ei,ov] ,age #ei;,initial ,f9al ,initial ,f9al ,initial ,f9al ,initial ,f9al ,initial ,f9al ,up to #ajjjjjjjjjjjjajj-accbbbbbbbbbbacc-aejcd 4ccd4ccd4ccd4ccd4caej-bjjd4cf4gd4cf4gd4c f4gd4cf4gd4cf4gbjj-bejf4gf4gf4gg4ff4gh4e f4gh4ef4gh4ebej-cjjf4gf4gg4fg4fh4ci4hh4c i4hh4ci4hcjj-djjf4ggg4fhi4haji4haji4hajd jj-fjjgihajajaeajaeajae 7ii7 ,age det]m9ations 7,i7 ,9 g5]al ,= purposes ( clause 7i71 ! age ( ! taxpay] tak5 into acc\nt "u clause 7i7 ) respect to any taxable ye> is ! age atta9$ by su* taxpay] be=e ! close ( su* taxable ye>4 7,,ii7 ,jo9t returns ,9 ! case ( a jo9t return1 ! age ( ! old] sp\se %all be tak5 into acc\nt "u clause 7i74 7iii7 ,index+ ,9 ! case ( any taxable ye> beg9n+ aft] cal5d> ye> #bjba1 ! initial & f9al p]c5tages conta9$ 9 clause 7i7 %all be adju/$ to reflect-- 7,i7 ! excess 7if any7 ( ! rate ( premium gr[? = ! p]iod beg9n+ ) cal5d> ye> #bjac & end+ ) cal5d> ye> #bjba1 ov] ! rate ( income gr[? = su* p]iod1 & 7,,ii7 9 addition to any adju/m5t "u subclause 7,i71 ! excess 7if any7 ( ! rate ( premium gr[? = cal5d> ye> #bjba1 ov] ! rate ( gr[? 9 ! consum] price index = cal5d> ye> #bjba4 7iv7 ,failsafe ,clause 7iii77,,ii7 %all apply only if ! aggregate am\nt ( premium tax cr$its "u ?is section & co/-%>+ r$uctions "u section #adjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act = ! prec$+ cal5d> ye> exce$s an am\nt equal to #j4ejd p]c5t ( ! gross dome/ic product = su* cal5d> ye>4 4 7b7 ,expansion ( eligibility ,section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 9 subsection 7c77#a77;,a71 by /rik+ #djj & ins]t+ #fjj2 & 7#b7 9 subsection 7f77#b77;,b77i71 by /rik+ #djj ea* place su* ref]5ce appe>s & ins]t+ #fjj 9 ea* su* place4 7c7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjba4 #bbg4 ,premium assi/ance ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ! ,treasury %all calculate ! cr$it all[able "u section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf bas$ on ! taxpay]'s prior ye> tax return & ! ,secret>y ( ,heal? & ,human ,s]vices %all provide = op5 enrollm5t p]iods t end on ,april #ae4 #bbh4 ,add+ copp] plans to ,ex*anges 7a7 ,9 g5]al ,section #acjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7 is am5d$-- 7#a7 9 subsection 7a77#c71 by ins]t+ copp]1 aft] ei!r !2 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,special rule = copp] plans ,a heal? plan 9 ! copp] level ( cov]age 7z describ$ 9 subsection 7d77#a77;,e77 %all be deem$ to meet ! requirem5ts ( ?is subsection4 2 7#c7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,copp] level ,a plan 9 ! copp] level %all provide a level ( cov]age t is design$ to provide b5efits t are actu>ially equival5t to #ej p]c5t ( ! full actu>ial value ( ! b5efits provid$ "u ! plan & w h out-(-pocket limits t are #cj p]c5t high] ?an bronze plans4 2 & 7,b7 9 p>agraph 7#d7-- 7i7 by ins]t+ copp]1 aft] any ref]5ce to a2 & 7ii7 by ins]t+ copp]1 aft] provid+ a2 & 7#d7 9 subsection 7e77#a71 by ins]t+ copp]1 aft] n provid+ a4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 #bbi4 ,copp] & bronze plans ,not)/&+ any o!r provision ( law1 refundable cr$its = cov]age "u a qualifi$ heal? plan & co/-%>+ r$uctions may be us$ to pur*ase bronze & copp] plans4 #bcj4 ,waiv]s = ,/ate innovation 7a7 ,/reaml9+ ! ,/ate ,application ,process ,section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7 is am5d$-- 7#a7 9 subsection 7a77#a77;,c71 by /rik+ ! law & ins]t+ a law or has 9 effect a c]tification2 & 7#b7 9 subsection 7b77#b7-- 7,a7 9 ! p>agraph head+1 by ins]t+ or c]tify aft] law2 7,b7 9 subp>agraph 7,a7-- 7i7 by /rik+ ,a law & ins]t+ ! foll[+3 7i7 ,laws ,a law 2 & 7ii7 by add+ at ! end ! foll[+3 7ii7 ,c]tifications ,a c]tification describ$ 9 ?is p>agraph is a docum5t1 sign$ by ! ,gov]nor ( ! ,/ate1 t c]tifies t su* ,gov]nor has ! au?ority "u exi/+ ,f$]al & ,/ate law to take action "u ?is section1 includ+ implem5tation ( ! ,/ate plan "u subsection 7a77#a77;,b74 2 & 7,c7 9 subp>agraph 7,b7-- 7i7 9 ! subp>agraph head+1 by /rik+ ( opt out2 & 7ii7 by /rik+ may repeal a law & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 8may t]m9ate ! au?ority provid$ "u ! waiv] ) respect to ! ,/ate by-- 7i7 repeal+ a law describ$ 9 subp>agraph 7,a77i72 or 7ii7 t]m9at+ a c]tification describ$ 9 subp>agraph 7,a77ii71 ?r\gh a c]tification = su* t]m9ation sign$ by ! ,gov]nor ( ! ,/ate4 4 7b7 ,provid+ exp$it$ approval ( ,/ate waiv]s ,section #accb7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7;d77 is am5d$-- 7#a7 9 p>agraph 7#a7 by /rik+ #ahj & ins]t+ #ij2 & 7#b7 by add+ at ! end ! foll[+3 7#c7 ,exp$it$ det]m9ation 7,a7 ,9 g5]al ,) respect to any application "u subsection 7a77#a7 submitt$ on or aft] ! date ( ?is p>agraph or any su* application submitt$ prior to su* date ( enactm5t & "u review by ! ,secret>y on su* date ( enactm5t1 ! ,secret>y %all make a det]m9ation on su* application1 us+ ! crit]ia = approval o!rwise applicable "u ?is section1 n lat] ?an #de days aft] ! receipt ( su* application1 & %all all[ ! public notice & comm5t at ! ,/ate & ,f$]al levels describ$ "u subsection 7a77#d7 to occur concurr5tly if su* ,/ate application-- 7i7 is submitt$ 9 response to an urg5t situation1 ) respect to areas 9 ! ,/ate t ! ,secret>y det]m9es are at risk = excessive premium increases or hav+ no heal? plans (f]$ 9 ! applicable heal? insurance m>ket = ! curr5t or foll[+ plan ye>2 or 7ii7 is = a waiv] t is ! same or sub/antially simil> to a waiv] t ! ,secret>y already has approv$ = ano!r ,/ate4 7,b7 ,approval 7i7 ,urg5t situations 7,i7 ,provisional approval ,a waiv] approv$ "u ! exp$it$ det]m9ation process "u subp>agraph 7,a77i7 %all be 9 effect = a p]iod ( #c ye>s1 unless ! ,/ate reque/s a %ort] duration4 7,,ii7 ,full approval ,subject to ! requirem5ts = approval o!rwise applicable "u ?is section1 n lat] ?an #a ye> be=e ! expiration ( a provisional waiv] p]iod describ$ 9 subclause 7,i7 ) respect to an application describ$ 9 subp>agraph 7,a77i71 ! ,secret>y %all make a det]m9ation on :e!r to ext5d ! approval ( su* waiv] = ! full t]m ( ! waiv] reque/$ by ! ,/ate1 = a total approval p]iod n to exce$ #f ye>s4 ,! ,secret>y may reque/ additional in=mation z ! ,secret>y det]m9es appropriate to make su* det]m9ation4 7ii7 ,approval ( same or simil> applications ,an approval ( a waiv] "u subp>agraph 7,a77ii7 %all be subject to ! t]ms ( subsection 7e74 7,c7 ,,gao /udy ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ?is p>agraph1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a review ( all waiv]s approv$ pursuant to an application "u subp>agraph 7,a77ii7 to evaluate :e!r su* waiv]s met ! requirem5ts ( subsection 7b77#a7 & :e!r ! applications %\ld h qualifi$ = su* exp$it$ process4 4 7c7 ,provid+ c]ta9ty = ,/ate-,bas$ re=ms ,section #accb7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7;e77 is am5d$ by /rik+ ,no waiv] & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 8,a waiv] "u ?is section-- 7#a7 %all be 9 effect = a p]iod ( #f ye>s unless ! ,/ate reque/s a %ort] duration2 7#b7 may be r5ew$1 subject to ! ,/ate meet+ ! crit]ia = approval o!rwise applicable "u ?is section1 = unlimit$ additional #f-ye> p]iods ^u application by ! ,/ate2 & 7#c7 may n be susp5d$ or t]m9at$1 9 :ole or 9 "p1 by ! ,secret>y at any "t be=e ! date ( expiration ( ! waiv] p]iod 7includ+ any r5ewal p]iod "u p>agraph 7#b771 unless ! ,secret>y det]m9es t ! ,/ate mat]ially fail$ to comply ) ! t]ms & conditions ( ! waiv]4 4 7d7 ,ensur+ ,pati5t ,access to ,m ,flexible ,heal? ,plans ,section #accb7;b77#a77;,b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7;b77#a77;,b77 is am5d$ by /rik+ at lea/ z af=dable & ins]t+ ( comp>able af=dability1 includ+ = l[-income individuals1 individuals ) s]i\s heal? ne$s1 & o!r vuln]able populations14 7e7 ,applicability ,! am5dm5ts made by ?is ,act to section #accb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjeb7-- 7#a7 ) respect to applications = waiv]s "u su* section #accb submitt$ aft] ! date ( enactm5t ( ?is ,act & applications = su* waiv]s submitt$ prior to su* date ( enactm5t & "u review by ! ,secret>y on ! date ( enactm5t1 %all take effect on ! date ( enactm5t ( ?is ,act2 & 7#b7 ) respect to applications = waiv]s approv$ "u su* section #accb be=e ! date ( enactm5t ( ?is ,act1 %all n require reconsid]ation ( :e!r su* applications meet ! requirem5ts ( su* section #accb1 except t1 at ! reque/ ( a ,/ate1 ! ,secret>y %all recalculate ! am\nt ( fund+ provid$ "u subsection 7a77#c7 ( su* section4 #bca4 ,enrollm5t p]iods 7a7 ,ex*anges ,p>agraph 7#g7 ( section #acaa7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c771 z add$ by section #ajf1 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,enrollm5ts o!r ?an dur+ initial1 op51 & special enrollm5t p]iods ,beg9n+ ) plan ye> #bjba1 an ,ex*ange may provide = enrollm5ts dur+ p]iods 9 addition to op5 enrollm5t p]iods describ$ 9 subp>agraph 7,a7 or p>agraph 7#f7 & special enrollm5t p]iods describ$ 9 p>agraph 7#f74 4 7b7 ,heal? plans ,subp>t ,i ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by add+ at ! end ! foll[+ new section3 #bgaj4 ,enrollm5t outside ( initial1 op51 & special enrollm5t p]iod ,beg9n+ ) plan ye> #bjba1 a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age may provide = enrollm5t 9 su* plan or cov]age dur+ p]iods 9 addition to initial1 op51 or special enrollm5t p]iods4 ,9 ! case t an individual enrolls 9 su* plan or cov]age dur+ a p]iod pursuant to ! previ\s s5t5ce1 ! plan or issu] may *>ge ! individual a "o-"t enrollm5t fee4 4 #bcb4 ,/ate-op]at$ ,ex*anges flexibility = op5 enrollm5t p]iods ,section #acaa7;c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;c77 is am5d$-- 7#a7 9 p>agraph 7#f71 by /rik+ ,! ,secret>y & ins]t+ ,subject to p>agraph 7#g71 ! ,secret>y2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,flexibility = enrollm5t p]iods 7,a7 ,/ate-op]at$ ,ex*anges op5 enrollm5t p]iods ,9 ! case ( an ,ex*ange op]at$ by a ,/ate1 beg9n+ ) plan ye> #bjba1 ! ,ex*ange may provide = op5 enrollm5t p]iods 7aft] ! initial enrollm5t p]iod7 e #ab1 #bd1 or #cf mon?s1 z det]m9$ by ! ,/ate4 4 #bcc4 ,promot+ heal? plans t cov] individuals 9 m ?an "o ,/ate ,!re are appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #aj1jjj1jjj to be made available by ,decemb] #ca1 #bjba1 to ! ,c5t] = ,m$ic>e ,m$icaid ,innovation to fund new rese>* or pilot programs d$icat$ to pursu+ viable me?ods ( enroll+ individuals 9 heal? insurance programs t cross ,/ate l9es4 ,,iii ,competition1 ,transp>5cy & ,acc\ntability ,a ,provid] & ,insur] ,competition #cja4 ,hospital consolidation 7a7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #afj1jjj1jjj to ! ,f$]al ,trade ,commission to hire /aff to inve/igate1 z consi/5t ) ! ,%]man ,antitru/ ,act & o!r relevant ,f$]al laws1 anti-competitive m]g]s & practices "u su* laws to ! ext5t su* m]g]s & practices relate to provid]s ( inpati5t & outpati5t heal? c>e s]vices1 z def9$ by ! ,secret>y ( ,heal? & ,human ,s]vices4 7b7 ,m$ic>e ,advantage rates appli$ to c]ta9 ,,hhi hospitals 7#a7 ,9 g5]al ,section #ahff7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,x71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,y71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by ins]t+ aft] subp>agraph 7,y7 ! foll[+ new subp>agraph3 7,z7 subject to p>agraph 7#d71 9 ! case ( a hospital locat$ 9 a c\nty ^: population d5sity is above ! m$ian population d5sity = all c\nties 9 ! ,unit$ ,/ates ) respect to :i* !re is a ,h]f9dahl-,hirs*man ,index 7,,hhi7 ( great] ?an #d1jjj1 to apply ! av]age reimbursem5t rate ) respect to individuals 7reg>dless ( :e!r su* an individual is entitl$ to or eligible = b5efits "u ?is title1 b exclud+ individuals eligible = m$ical assi/ance "u a ,/ate plan "u title ,,xix7 furni%$ items & s]vices at su* hospital t w\ld be billable "u ?is title = su* items & s]vices if furni%$ by su* hospital to an individual enroll$ "u "p ,c4 2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 7,a7 ,! requirem5t "u p>agraph 7#a77,z7 %all n apply 9 ! case ( a hospital 9 a hospital ref]ral region if-- 7i7 ! ,,hrr m>ket %>e ( su* hospital 7z det]m9$ "u subp>agraph 7,b77 is less ?an #j4ae2 or 7ii7 ! hospital is locat$ 9 a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d774 7,b7 ,= purposes ( subp>agraph 7,a71 ! ,,hrr m>ket %>e ( a hospital 9 a hospital ref]ral region is equal to-- 7i7 ! total rev5ue ( ! hospital1 divid$ by 7ii7 ! total rev5ue ( all hospitals 9 ! hospital ref]ral region4 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjba4 7c7 ,grants = hospital infra/ructure improvem5t 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all c>ry out a grant program "u :i* ! ,secret>y %all provide grants to eligible ,/ates1 9 accordance ) ?is subsection4 7#b7 ,uses ,an eligible ,/ate receiv+ a grant "u ?is subsection may use su* grant to improve ! ,/ate hospital infra/ructure & to supplem5t any o!r funds provid$ = a purpose au?oriz$ "u a ,/ate or local hospital grant program "u ,/ate law4 7#c7 ,eligibility 7,a7 ,9 g5]al ,an eligible ,/ate may receive n m ?an "o grant "u ?is subsection ) respect to ea* qualify+ crit]ion describ$ 9 subp>agraph 7,b7 t is met by ! ,/ate4 7,b7 ,eligible ,/ate ,= purposes ( ?is subsection1 ! t]m eligible ,/ate means a ,/ate t meets any "o or m ( ! foll[+ qualify+ crit]ia3 7i7 ,! ,/ate does n h 9 effect any ,/ate c]tificate ( ne$ law t requires a heal? c>e provid] to provide to a regulatory body a c]tification t ! community ne$s ! s]vices provid$ by ! heal? c>e provid]4 7ii7 ,! ,/ate has 9 effect ,/ate scope ( practice laws t-- 7,i7 all[ advanc$ practice provid]s 7su* z nurse practition]s1 advanc$ practice regi/]$ nurses1 cl9ical nurse speciali/s1 & physician assi/ants7 to evaluate pati5ts2 diagnose1 ord]1 & int]pret diagno/ic te/s2 & initiate & manage treatm5ts2 or 7,,ii7 provide t ! only ju/ification = limit+ ! scope ( practice ( a heal? c>e provid] is safety to ! public4 7iii7 ,! ,/ate does n h 9 effect any ,/ate laws t require manag$ c>e plans to accept into ! network ( su* plan any qualifi$ provid] :o is will+ to accept ! t]ms & conditions ( ! manag$ c>e plan4 7iv7 ,! ,/ate does n h 9 effect any ,c]tificate ( ,public ,advantage laws t cle>ly articulate ! ,/ate's int5t to displace competition 9 favor ( regulation or t violate ,/ate or ,f$]al antitru/ laws4 7v7 ,! ,/ate does n h 9 effect any network adequacy laws regulat+ a heal? plan's ability to deliv] b5efits by provid+ reasonable access to a suffici5t numb] ( 9-network prim>y c>e & specialty physicians1 z well z all heal? c>e s]vices includ$ "u ! t]ms ( an insuree's contract ) a heal? insur]4 7#d7 ,fund+ ,!re is au?oriz$ to be appropriat$ to c>ry out ?is subsection #a1jjj1jjj1jjj = ea* ( ! fiscal ye>s #bjai ?r\gh #bjbh4 ,funds appropriat$ "u ?is p>agraph %all rema9 available until exp5d$4 7d7 ,critical access hospital reimbursem5t rates 7#a7 ,"p ,a ,section #ahad7l77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7l77#a77 is am5d$ by ins]t+ 7or1 = #bjba1 #ajb1 plus #a p]c5tage po9t = ea* subsequ5t ye> ?r\gh #bjbi1 & #aaj = ea* subsequ5t ye> !reaft]7 aft] #aja4 7#b7 ,"p ,b ,section #ahcd7;g77#a7 ( su* ,act 7#db ,u4,s4,c4 #aciem7g77#a77 is am5d$ by ins]t+ 7or1 = #bjba1 #ajb1 plus #a p]c5tage po9t = ea* subsequ5t ye> ?r\gh #bjbi1 & #aaj = ea* subsequ5t ye> !reaft]7 aft] #aja4 #cjb4 ,au?ority ( ,f$]al ,trade ,commission ov] c]ta9 tax-exempt organizations ,section #d ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd7 is am5d$1 9 ! undesignat$ p>agraph relat+ to ! def9ition ( ! t]m ,corporation-- 7#a7 by /rik+ 1 & any & ins]t+ 1 any2 & 7#b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & any organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf t is exempt f taxation "u section #eja7;a7 ( su* ,code4 #cjc4 ,re/or+ ! application ( antitru/ laws to ! bus9ess ( heal? insurance 7a7 ,am5dm5t to ,mc,carran-,f]guson ,act ,section #c ( ! ,act ( ,m>* #i1 #aide 7#ae ,u4,s4,c4 #ajac71 commonly kn[n z ! ,mc,carran-,f]guson ,act1 is am5d$ by add+ at ! end ! foll[+3 7c7 7#a7 ,no?+ conta9$ 9 ?is ,act %all modify1 impair1 or sup]s$e ! op]ation ( any ( ! antitru/ laws ) respect to ! bus9ess ( heal? insurance 7includ+ ! bus9ess ( d5tal insurance & limit$-scope d5tal b5efits74 7#b7 ,p>agraph 7#a7 %all n apply ) respect to mak+ a contract1 or engag+ 9 a comb9ation or conspiracy-- 7,a7 to collect1 compile1 or dissem9ate hi/orical loss data2 7,b7 to det]m9e a loss developm5t factor applicable to hi/orical loss data2 7,c7 to p]=m actu>ial s]vices if su* contract1 comb9ation1 or conspiracy does n involve a re/ra9t ( trade2 or 7,d7 to develop or dissem9ate a /&>d insurance policy =m 7includ+ a /&>d add5dum to an insurance policy =m & /&>d t]m9ology 9 an insurance policy =m7 if su* contract1 comb9ation1 or conspiracy is n to adh]e to su* /&>d =m or require adh]5ce to su* /&>d =m4 7#c7 ,= purposes ( ?is subsection-- 7,a7 ! t]m antitru/ laws has ! mean+ giv5 x 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab71 except t su* t]m includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section #e applies to unfair me?ods ( competition2 7,b7 ! t]m bus9ess ( heal? insurance 7includ+ ! bus9ess ( d5tal insurance & limit$-scope d5tal b5efits7 does n include-- 7i7 ! bus9ess ( life insurance 7includ+ annuities72 or 7ii7 ! bus9ess ( prop]ty or casualty insurance1 includ+ b n limit$ to-- 7,i7 any insurance or b5efits def9$ z except$ b5efits "u p>agraph 7#a71 subp>agraph 7,b7 or 7,c7 ( p>agraph 7#b71 or p>agraph 7#c7 ( section #ihcb7;c7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #ihcb7;c77 :e!r (f]$ sep>ately or 9 comb9ation ) insurance or b5efits describ$ 9 p>agraph 7#b77;,a7 ( su* section2 & 7,,ii7 any o!r l9e ( insurance t is classifi$ z prop]ty or casualty insurance "u ,/ate law2 7,c7 ! t]m hi/orical loss data means in=mation respect+ claims paid1 or res]ves held = claims report$1 by any p]son engag$ 9 ! bus9ess ( insurance2 & 7,d7 ! t]m loss developm5t factor means an adju/m5t to be made to res]ves held = losses incurr$ = claims report$ by any p]son engag$ 9 ! bus9ess ( insurance1 = ! purpose ( br++ su* res]ves to an ultimate paid basis4 4 7b7 ,relat$ provision ,= purposes ( section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t su* section applies to unfair me?ods ( competition1 section #c7;c7 ( ! ,mc,carran-,f]guson ,act %all apply ) respect to ! bus9ess ( heal? insurance )\t reg>d to :e!r su* bus9ess is c>ri$ on = pr(it1 not)/&+ ! def9ition ( ,corporation conta9$ 9 section #d ( ! ,f$]al ,trade ,commission ,act4 #cjd4 ,level+ ! play+ field betwe5 pay]s & provid]s 7a7 ,exemption ,x %all n be a violation ( ! antitru/ laws = "o or m private heal? insur] issu]s or _! designat$ ag5ts to jo9tly negotiate prices ( p>ticul> hospital s]vices ) a hospital provid] ) reg>ds to ! reimbursem5t policies ( ! insur]s = ^? s]vices4 7b7 ,def9itions ,= purposes ( ?is section3 7#a7 ,antitru/ laws ,! t]m antitru/ laws has ! mean+ giv5 x 9 subsection 7a7 ( ! #a/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 except t su* t]m includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t su* section #e applies to unfair me?ods ( competition4 7#b7 ,heal? insurance issu] ,! t]m heal? insurance issu] means an insurance company1 insurance s]vice1 or insurance organization 7includ+ a heal? ma9t5ance organization1 z def9$ 9 subp>agraph 7,c77 :i* is lic5s$ to engage 9 ! bus9ess ( insurance 9 a ,/ate & :i* is subject to ,/ate law :i* regulates insurance 7)9 ! mean+ ( section #ead7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aadd7;b77#b774 ,su* t]m does n include a gr\p heal? plan4 7#c7 ,heal? ma9t5ance organization ,! t]m heal? ma9t5ance organization means-- 7,a7 a ,f$]ally qualifi$ heal? ma9t5ance organization 7z def9$ 9 section #cjj;e7a7 ( title #db ( ! ,unit$ ,/ates ,code71 7,b7 an organization recogniz$ "u ,/ate law z a heal? ma9t5ance organization1 or 7,c7 a simil> organization regulat$ "u ,/ate law = solv5cy 9 ! same mann] & to ! same ext5t z su* a heal? ma9t5ance organization4 7c7 ,effective date ,?is section %all take effect on ! date ( ! enactm5t ( ?is ,act b %all n apply ) respect to conduct t occurs be=e su* date4 #cje4 ,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 ! prec$+ sections1 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 #cjf4 ,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]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 ( ! ,fair ,c>e ,act ( #bjbj1 %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 #cjg4 ,repeal+ eligibility ( c]ta9 ,a,c,os 7a7 ,9 g5]al ,section #ahii7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7b77#a77 is am5d$ by /rik+ subp>agraphs 7,c7 ?r\gh 7,e74 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all take effect on ,janu>y #a1 #bjba4 #cjh4 ,repeal ( heal? c>e re=m provisions limit+ ,m$ic>e exception to ! prohibition on c]ta9 physician ref]rals = hospitals ,sections #fjja & #ajfja ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh2 #abd ,/at4 #fhd1 #ajje7 & section #aajf ( ! ,heal? ,c>e & ,education ,reconciliation ,act ( #bjaj 7,public ,law #aaa-aeb2 #abd ,/at4 #ajdi7 are repeal$ & ! provisions ( law am5d$ by su* sections are re/or$ z if su* sections _h nev] be5 enact$4 #cji4 ,alt]native paym5t model = c]ta9 %oppable proc$ures 7a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia77 may elect1 ) respect to a plan ye>1 to provide a set paym5t am\nt to an enrollee "u su* plan or cov]age = c]ta9 %oppable proc$ures 7z def9$ 9 subsection 7b77 9 accordance ) ! provisions ( ?is section 9 lieu ( o!rwise provid+ cov]age = su* a proc$ure "u su* plan or cov]age1 b only if ! enrollee s agrees to su* set paym5t am\nt4 7b7 ,def9ition ,= purposes ( ?is section1 ! t]m %oppable proc$ure means a proc$ure specifi$ by ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 ) respect to :i* individuals may be expect$ to comp>e prices = su* proc$ure ( heal? c>e provid]s & facilities1 includ+ prim>y & prev5tive s]vices1 pr5atal c>e & *ildbir?1 common surg]ies t c be s*$ul$1 & o!r simil> s]vices4 7c7 ,set paym5t rules ,a set paym5t describ$ 9 subsection 7a7 "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age (f]$ by a heal? insurance issu] %all-- 7#a7 be disclos$ prior to beg9n+ ( ea* plan ye> su* paym5t is 9 effect & %all n v>y dur+ su* plan ye>2 7#b7 be ! same am\nt ) respect to ! same %oppable proc$ure furni%$ 9 a geographic area 7z def9$ by ! ,secret>y72 7#c7 n be less ?an ! m$ian negotiat$ rate = all gr\p heal? plans & heal? insurance cov]age (f]$ 9 su* area = su* proc$ure2 7#d7 be made available to an enroll$ "u su* plan or su* cov]age reg>dless ( ! provid] or facility furni%+ ! %oppable proc$ure2 7#e7 repres5t ! entirety ( ! paym5t obligation ( su* plan or su* issu] ) respect to su* proc$ure2 & 7#f7 may be reta9$ by su* enrollee to ! ext5t t ! am\nt ( su* paym5t exce$s ! am\nt *>g$ by su* provid] or facility = su* proc$ure4 7d7 ,provision ( price in=mation ,ea* heal? c>e provid] & facility t may furni% a %oppable proc$ure dur+ a ye> %all po/ 9 a public area a notice conta9+ ! prices t w be *>g$ by su* provid] ( facility ) respect to ea* su* proc$ure to individuals mak+ paym5t = su* s]vices pursuant to a set paym5t am\nt describ$ 9 subsection 7a74 7e7 ,,ehb waiv] au?ority ,! ,secret>y may waive su* provisions ( section #acjb7;b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;b77 ) respect to a gr\p heal? plan1 heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 & a plan ye> z ! ,secret>y det]m9es necess>y to all[ = ! provision ( set paym5t am\nts describ$ 9 subsection 7a74 ,b ,price ,transp>5cy #cba4 ,price transp>5cy ,section #ahff ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc71 z am5d$ by section #cja1 is fur!r am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 9 subp>agraph 7,y71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,z71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] subp>agraph 7,z7 ! foll[+ new subp>agraph3 7,,aa7 9 ! case ( a hospital1 to comply ) ! requirem5t "u subsection 7l74 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7l7 ,requirem5t relat+ to publi%+ c]ta9 hospital prices 7#a7 ,9 g5]al ,= purposes ( subsection 7a77#a77;,,aa71 ! requirem5t describ$ 9 ?is subsection is1 ) respect to a hospital & ye> 7beg9n+ ) #bjba71 = ! hospital to publicly po/1 ?r\gh ! sy/em e/abli%$ "u p>agraph 7#c71 = ea* common %oppable s]vice includ$ 9 ! li/ publi%$ "u p>agraph 7#b7 = su* ye>1 ! volume-weight$ av]age price *>g$ by ! hospital to-- 7,a7 individuals enroll$ dur+ su* ye> 9 gr\p heal? plans or heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act72 & 7,b7 individuals :o are n enroll$ 9 any heal? insurance cov]age or heal? b5efits plan & individuals :o are enroll$ 9 su* cov]age or plan b su* cov]age or plan does n provide b5efits = ! s]vice4 7#b7 ,common %oppable s]vices ,= purposes ( subsection 7a77#a77;,,aa7 & ?is subsection1 ! ,secret>y %all1 = #bjba & ea* subsequ5t ye>1 publi% a li/ ( ! #ajj common %oppable s]vices t are ! mo/ highly utiliz$ 9 a hospital-bas$ sett+4 7#c7 ,/&>diz$ digital report+ sy/em ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all e/abli% a /&>diz$ digital sy/em = purposes ( p>agraph 7#a74 4 #cbb4 ,price transp>5cy requirem5ts 7a7 ,hospitals ,section #bgah7;e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ah7;e77 is am5d$-- 7#a7 by /rik+ ,ea* hospital & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,ea* hospital 2 7#b7 by ins]t+ 1 9 a ma*9e-readable =mat1 via op5 application program int]faces 7,a,p,is7 aft] a li/2 7#c7 by ins]t+ 1 along ) su* additional in=mation z ! ,secret>y may require ) respect to su* *>ges = purposes ( promot+ public aw>5ess ( hospital pric+ 9 advance ( receiv+ a hospital item or s]vice be=e ! p]iod2 & 7#d7 by add+ at ! end ! foll[+3 7#b7 ,def9ition ( /&>d *>ges ,not)/&+ any o!r provision ( law1 = purposes ( p>agraph 7#a71 ! t]m /&>d *>ges means ! rates hospitals1 includ+ provid]s or entities t contract ) or practice at a hospital1 *>ge = all items & s]vices at a m9imum1 *>gema/] rates1 rates t hospitals negotiate ) ?ird p>ty pay]s across all plans1 includ+ ^? relat$ to a pati5t's specific plan1 disc\nt$ ca% prices1 & o!r rates det]m9$ by ! ,secret>y4 7#c7 ,en=cem5t ,9 addition to any o!r en=cem5t actions or p5alties t may apply "u subsection 7b77#c7 or ano!r provision ( law1 a hospital t fails to provide ! in=mation requir$ by ?is subsection & has n complet$ a corrective action plan to comply ) ! requirem5ts ( su* subsection %all be subject to a civil monet>y p5alty ( an am\nt n to exce$ #cjj p] day t ! violation is ongo+ z det]m9$ by ! ,secret>y4 ,su* p5alty %all be impos$ & collect$ 9 ! same mann] z civil money p5alties "u subsection 7a7 ( section #aabh;,a ( ! ,social ,security ,act are impos$ & collect$4 4 7b7 ,transp>5cy 9 cov]age ,section #acaa7;e77#c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;e77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 9 clause 7vii71 by ins]t+ be=e ! p]iod ! foll[+3 1 includ+1 = all items & s]vices cov]$ "u ! plan1 aggregate in=mation on specific paym5ts ! plan has made to out-(-network heal? c>e provid]s on behalf ( plan enrollees2 7,b7 by designat+ clause 7ix7 z clause 7x72 & 7,c7 by ins]t+ aft] clause 7viii71 ! foll[+3 7ix7 ,in=mation on ! specific negotiat$ paym5t rates betwe5 ! plan & heal? c>e provid]s = all items & s]vices cov]$ "u ! plan4 2 7#b7 9 subp>agraph 7,b7-- 7,a7 9 ! head+1 by /rik+ use & ins]t+ deliv]y me?ods & use2 7,b7 by ins]t+ 1 z applicable1 aft] ,engli% pr(ici5cy2 & 7,c7 by ins]t+ aft] ! second s5t5ce1 ! foll[+3 ,! ,secret>y %all e/abli% /&>ds = electronic deliv]y & access to su* in=mation by individuals1 free ( *>ge1 9 ma*9e readable =mat1 ?r\gh an ,int]net website & via op5 ,a,p,is42 7#c7 9 subp>agraph 7,c7-- 7,a7 9 ! fir/ s5t5ce1 by ins]t+ or out-(-network provid] aft] item or s]vice by a p>ticipat+ provid]2 7,b7 9 ! second s5t5ce1 by /rik+ ?r\gh an ,int]net website & ins]t+ free ( *>ge1 9 ma*9e readable =mat1 ?r\gh an ,int]net website1 & via op5 ,a,p,is1 9 accordance ) /&>ds e/abli%$ by ! ,secret>y12 & 7,c7 by add+ at ! end ! foll[+3 ,su* in=mation %all include specific negotiat$ rates t all[ = comp>ison betwe5 provid]s & across plans1 & relat$ to a pati5t's specific plan1 includ+ aft] an enrollee has exce$$ _! d$uctible responsibility42 & 7#d7 9 subp>agraph 7,d7 by /rik+ subp>agraph 7,a7 & ins]t+ subp>agraphs 7,a71 7,b71 & 7,c74 #cbc4 ,designation ( nongov]nm5tal1 nonpr(it transp>5cy organizations to l[] ,am]icans' heal? c>e co/s 7a7 ,9 g5]al ,subp>t ,c ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 z am5d$ by ! prec$+ sections1 is fur!r am5d$ 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 ( ! ,fair ,c>e ,act ( #bjbj1 %all ent] into contracts ) at lea/ #b nonpr(it entities 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 gr\p heal? plans1 heal? insurance issu]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$ure 7i7 ,tim+ ,! ,secret>y %all issue ! initial set ( regulations "u ?is p>agraph n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,fair ,c>e ,act ( #bjbj4 7ii7 ,au?ority to use int]im f9al proc$ures ,! ,secret>y may make su* initial set ( regulations effective & f9al imm$iately ^u issuance1 on an int]im basis1 & provide = a p]iod ( public comm5t on su* initial set ( regulations aft] ! date ( publication4 7,d7 ,requirem5ts ( entity ,an entity receiv+ ! contract "u ?is section %all-- 7i7 n disclose to ! public any individually id5tifiable heal? in=mation or propriet>y f9ancial in=mation2 7ii7 /rictly limit /aff access to ! data to /aff ) appropriate tra9+1 cle>ance1 & backgr\nd *ecks & require regul> privacy & security tra9+2 7iii7 ma9ta9 effective security /&>ds = transf]r+ data or mak+ data available to au?oriz$ 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$]al privacy law4 7#c7 ,consultation 7,a7 ,advisory committee ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ! ,fair ,c>e ,act ( #bjbj1 ! ,secret>y %all conv5e an ,advisory ,committee 7ref]r$ to 9 ?is section z ! ,committee71 consi/+ ( #ac memb]s1 to advise ! ,secret>y1 a 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 ( ! ,fair ,c>e ,act ( #bjbj1 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 ! entities 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$ entities 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 ! entities aw>d$ contracts "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+ a 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 ,an 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 ,an 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 ea* entity aw>d$ a contract "u subsection 7a74 7,b7 ,/ate data ,an entity aw>d$ a 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 ,an entity aw>d$ a 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 an entity aw>d$ a 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 an entity aw>d$ a 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 ) an entity aw>d$ a 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 an entity aw>d$ a 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 ,an entity aw>d$ a 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 an entity receiv+ a 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$-- 7,a7 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,fair ,c>e ,act ( #bjbj2 7,b7 ! lat] ( #a ye> aft] ! date t is #c ye>s aft] su* date ( enactm5t or ,m>* #a ( ! ye> aft] ! date t is #c ye>s aft] su* date ( enactm5t2 & 7,c7 ,m>* #a ( ea* ye> !reaft]4 7#c7 ,public reports & rese>* ,an entity receiv+ a contract "u subsection 7a7 %all1 9 coord9ation ) au?oriz$ 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 #cbd4 ,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 ! prec$+ sections1 is fur!r am5d$ 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 ( ! ,fair ,c>e ,act ( #bjbj1 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 #cbe4 ,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 ! prec$+ sections1 is fur!r am5d$ 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 #cbf4 ,access ( individuals to protect$ heal? in=mation ,! provisions ( section #afd4ebd ( title #de1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is ,act1 %all h ! =ce & effect ( law4 #cbg4 ,timely bills = pati5ts 7a7 ,9 g5]al 7#a7 ,am5dm5t ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ 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 ! prec$+ sections1 is fur!r am5d$ 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 #cbh4 ,advisory gr\p on r$uc+ burd5 ( hospital adm9i/rative requirem5ts 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e an advisory gr\p to provide1 9 accordance ) ?is section1 recomm5dations on ways ! ,f$]al ,gov]nm5t c\ld r$uce ! burd5 ( adm9i/rative requirem5ts on hospitals4 7b7 ,recomm5dations ,n lat] ?an ,janu>y #a1 #bjbb1 ! advisory bo>d conv5$ "u ?is section %all-- 7#a7 submit to ! ,secret>y ( ,heal? & ,human ,s]vices recomm5dations describ$ "u subsection 7a7 = executive action & any recomm5dations = ,/ate actions = pot5tial consid]ation 9 mak+ grants "u section #b7;c7 to ,/ates2 & 7#b7 submit to ,congress recomm5dations describ$ "u subsection 7a7 = legislative proposals4 7c7 ,memb]%ip ,! advisory bo>d "u ?is section %all consi/ ( ! foll[+ memb]s3 7#a7 ,?ree repres5tatives ( companies t h-- 7,a7 geographically di/ribut$ work=ces2 7,b7 at lea/ #aj1jjj employees2 & 7,c7 no m ?an #aj p]c5t ( su* employees 9 any s+le ,/ate4 7#b7 ,?ree repres5tatives ( heal? insurance issu]s & heal? plans1 consi/+ (-- 7,a7 "o repres5tative ( =-pr(it heal? insurance issu]s & heal? plans ) at lea/ #bj1jjj1jjj enrollees 9 ! employ]-sponsor$ m>ket2 7,b7 "o repres5tative ( non-pr(it heal? insurance issu]s & heal? plans op]at+ 9 at lea/ #e ,/ates2 & 7,c7 "o repres5tative ( non-pr(it heal? insurance issu]s & heal? plans op]at+ 9 a rural ,/ate 7z def9$ by ! ,c5sus ,bureau74 7#c7 ,sev5 public policy exp]ts 9 ! field ( hospital consolidation4 #cbi4 ,data report+ to improve ! transp>5cy reg>d+ h[ #cdj;,b hospital cov]$ entities provide c>e = pati5ts ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,data report+ ,to improve ! transp>5cy reg>d+ h[ hospital cov]$ entities provide c>e = pati5ts 7#a7 ,9 g5]al ,beg9n+ on ! date t is #ad mon?s aft] ! date ( ! enactm5t ( ?is subsection1 & annually !reaft]1 subject to subp>agraph 7,c71 a cov]$ entity describ$ 9 subp>agraph 7,l7 or 7,m7 ( subsection 7a77#d71 unless o!rwise indicat$1 %all report on ! foll[+1 ) respect to ! previ\s ye>1 9 su* a mann] & =m z specifi$ by ! ,secret>y3 7,a7 ,! foll[+ in=mation3 7i7 ,) respect to su* cov]$ entity & ) respect to ea* *ild site ( su* entity 7z ref]5c$ 9 p>agraph 7#aa771 ! numb] & p]c5tage ( individuals :o are disp5s$ or adm9i/]$ drugs t are subject to an agreem5t "u ?is section1 organiz$ by =m ( heal? insurance cov]age ( su* individuals 7includ+ at lea/ by ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! ,m$icaid program "u title ,,xix ( su* ,act1 heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket or a gr\p heal? plan 7z su* t]ms are def9$ 9 section #bgia71 & un9sur$74 7ii7 ,) respect to ea* su* *ild site ( su* entity1 ! total co/s incurr$ at ea* su* site & ! co/ incurr$ at ea* su* site = *>ity c>e z def9$ 9 l9e #bc ( work%eet ,s-#aj to ! ,m$ic>e co/ report or 9 any successor =m4 7,b7 ,! aggregate am\nt ( gross reimbursem5t receiv$ by ea* su* cov]$ entity 7includ+ *ild sites ( su* entity7 describ$ 9 su* subp>agraph 7,l7 or 7,m7 = all drugs pur*as$ t are subject to an agreem5t "u ?is section & ! entity's aggregate acquisition co/ = su* drugs4 7,c7 ,9 ! case ( cov]$ entity describ$ 9 subp>agraph 7,l7 ( subsection 7a77#d71 at ! "t ( application & rec]tification 7& at lea/ annually !reaft]71 ! contract t is ! basis = eligibility "u ! requirem5t "u clause 7i7 ( su* subp>agraph & any modifications to su* contract = purposes ( review by ! ,secret>y4 7,d7 ,) respect to su* cov]$ entity & ) respect to ea* *ild site ( su* entity1 ! "n ( all ?ird-p>ty v5dors or o!r simil> entities t ! cov]$ entity contracts ) to provide s]vices associat$ ) ! program "u ?is section4 7#b7 ,availability ( in=mation 7,a7 ,9 g5]al ,! ,secret>y %all make data report$ by cov]$ entities "u subp>agraphs 7,a71 7,c71 & 7,d7 ( p>agraph 7#a7 available on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 an electronic & se>*able =mat1 :i* may include ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em or a successor to su* sy/em4 7,b7 ,=mat ,data made available "u subp>agraph 7,a7 %all be made available 9 a mann] t %[s ea* category ( data report$ bo? 9 ! aggregate & id5tifi$ by cov]$ entities describ$ 9 subp>agraphs 7,l7 & 7,m7 ( subsection 7a77#d7 & *ild sites ( su* cov]$ entities4 ,9 c>ry+ out ?is p>agraph1 ) respect to data report$ pursuant to p>agraph 7#a77;,c71 ! ,secret>y %all ensure t any propriet>y in=mation %all be r$act$ f contracts submitt$ pursuant to su* p>agraph 7#a77;,c7 be=e po/+ su* data4 7#c7 ,int]im f9al regulations ,! ,secret>y %all issue int]im f9al regulations no lat] ?an ! date t is #f mon?s aft] ! date ( ! enactm5t ( ?is subsection1 to c>ry out ?is subsection & %all f9alize su* regulations prior to ! end ( ! moratorium p]iod to :i* subsection 7a77#aa7 applies4 7#d7 ,reports to ,congress 7,a7 ,,oig report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,(fice ( ! ,inspector ,g5]al %all submit to ,congress a f9al report on ! level ( *>ity c>e provid$ by cov]$ entities describ$ 9 subp>agraphs 7,l7 & 7,m7 ( subsection 7a77#d7 & sep>ately by *ild sites ( su* cov]$ entities1 z report$ 9 p>agraph 7#a77;,a74 7,b7 ,,gao reports 7i7 ,initial report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is subsection1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report-- 7,i7 analyz+ ! ,/ate & local gov]nm5t contracts int5d$ to satisfy ! requirem5t "u subsection 7a77#d77,l77i7 = a cov]$ entity to qualify z an entity describ$ 9 subp>agraph 7,l7 ( subsection 7a77#d72 7,,ii7 assess+ ! am\nt ( c>e su* contracts obligate su* entity to provide to l[-income individuals ineligible = ,m$ic>e "u title ,,xviii ( ! ,social ,security ,act & ,m$icaid "u title ,,xix ( su* ,act2 & 7,,iii7 analyz+ h[ ^! contracts def9e l[-income individuals & :e!r ! ,secret>y reviews su* det]m9ations4 7ii7 ,subsequ5t report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a f9al report on ! in=mation collect$ "u p>agraph 7#a77;,b7 reg>d+ ! diff]5ce betwe5 ! aggregate gross reimbursem5t & aggregate acquisition co/s receiv$ by ea* su* cov]$ entity 7includ+ *ild sites ( su* entity7 = drugs subject to an agreem5t "u ?is section4 4 #ccj4 ,requir+ #cdj;,b drug disc\nt program reports by ,,d% hospital cov]$ entities on l[-income utilization rate ( outpati5t hospital s]vices 7a7 ,9 g5]al ,section #cdj;,b7d77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#b77 is am5d$-- 7#a7 9 subp>agraph 7,b77i71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 includ+1 ) respect to su* updates made on or aft] ,janu>y #a1 #bjba1 by requir+ cov]$ entities describ$ 9 subsection 7a77#d77,l7 to submit 7& to s regul>ly update7 in=mation describ$ 9 subp>agraph 7,c72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,in=mation on l[-income utilization rate ( outpati5t hospital s]vices 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,b77i71 ! in=mation describ$ 9 ?is subp>agraph1 ) respect to a cov]$ entity describ$ 9 subsection 7a77#d77,l7 & an update "u su* subp>agraph 7,b77i71 is-- 7,i7 ! l[-income outpati5t utilization rate ( su* cov]$ entity = ! mo/ rec5t fiscal ye>2 & 7,,ii7 ! l[-income outpati5t utilization rate ( (f-site outpati5t facilities1 cl9ics1 eligible (f-site locations1 & associat$ sites ( su* entity id5tifi$ z *ild sites ( su* entity pursuant to ! id5tification sy/em "u subp>agraph 7,b77iv7 = ! mo/ rec5t fiscal ye>4 7ii7 ,l[-income outpati5t utilization rate def9$ ,9 ?is subp>agraph1 ! t]m l[-income outpati5t utilization rate has ! mean+ giv5 ! t]m l[-income utilization rate "u p>agraph 7#c7 ( section #aibc7;b7 ( ! ,social ,security ,act1 except t-- 7,i7 clauses 7i7 & 7ii7 ( subp>agraph 7,a7 ( su* p>agraph %all be appli$ z if-- 7aa7 ea* ref]5ce to pati5t s]vices 7 a ref]5ce to pati5t s]vices furni%$ on an outpati5t basis2 & 7bb7 = purposes ( clause 7i77,,ii7 ( ?is subp>agraph1 ea* ref]5ce to hospital 7 a ref]5ce to (f-site outpati5t facilities1 cl9ics1 eligible (f-site locations1 & associat$ sites ( ! hospital t are id5tifi$ z *ild sites ( ! hospital pursuant to ! id5tification sy/em "u section #cdj;,b7d77#b77;,b77iv7 ( ! ,public ,heal? ,s]vice ,act2 & 7,,ii7 clauses 7i7 & 7ii7 ( subp>agraph 7,b7 ( su* p>agraph %all be appli$ z if-- 7aa7 ea* ref]5ce to inpati5t hospital s]vices 7 a ref]5ce to outpati5t hospital s]vices2 & 7bb7 = purposes ( clause 7i77,,ii7 ea* ref]5ce to hospital's *>ges 7 a ref]5ce to *>ges ( ! (f-site outpati5t facilities1 cl9ics1 eligible (f-site locations1 & associat$ sites ( ! hospital t are id5tifi$ z *ild sites ( ! hospital pursuant to ! id5tification sy/em "u section #cdj;,b7d77#b77;,b77iv7 ( ! ,public ,heal? ,s]vice ,act4 4 7b7 ,annual reports ,n lat] ?an ,janu>y #a1 #bjba1 & annually !reaft]1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration %all submit to ,congress a report on in=mation submitt$ by cov]$ entities = ! previ\s ye> pursuant to ! am5dm5ts made by subsection 7a74 #cca4 ,employ] b5efits reports 7a7 ,9 g5]al ,subject to subsection 7b71 = ea* plan ye> beg9n+ on or aft] ,janu>y #a1 #bjba1 a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all provide to ea* individual enroll$ 9 su* plan or su* cov]age = su* plan ye> a notification conta9+ ! foll[+3 7#a7 ,! am\nt ! sponsor ( su* gr\p heal? plan exp5d$ ) respect to su* individual "u su* plan = su* plan ye> 7or1 9 ! case ( a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 ! am\nt ! employ] ( su* individual contribut$ = su* cov]age = su* individual = su* plan ye>74 7#b7 ,! am\nt ! sponsor ( su* gr\p heal? plan exp5d$ ) respect to su* individual "u su* plan = ea* previ\s plan ye> 7or1 9 ! case ( a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 ! am\nt ! employ] ( su* individual contribut$ = su* cov]age = su* individual = ea* previ\s plan ye>71 if applicable4 7b7 ,limitation ,subsection 7a7 %all n apply to a gr\p heal? plan1 or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 = a plan ye> if1 = su* plan ye>1 ! numb] ( individuals enroll$ "u su* plan or su* cov]age 0 less ?an #ajj4 7c7 ,p5alty ,9 ! case t ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es t a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance fail$ to provide ! notice requir$ "u subsection 7a71 ! ,secret>y may impose a civil monet>y p5alty on ! sponsor ( su* plan or su* issu]1 z applicable1 9 an am\nt n to exce$ #ajj p] individual enroll$ 9 su* plan or su* cov]age p] day t su* sponsor or issu] fail$ to provide su* notification to su* individual4 7d7 ,def9itions ,9 ?is section1 ! t]ms gr\p heal? plan1 gr\p heal? insurance cov]age1 heal? insurance issu]1 & sponsor h ! mean+ giv5 su* t]ms 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74 #ccb4 ,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 ! prec$+ sections1 is fur!r am5d$ 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 #ccc4 ,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 ,c ,prescription ,drug ,competition & ,innovation #cda4 ,exp$it$ developm5t & priority review = g5]ic complex drug products ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ! foll[+3 #ebd;,b4 ,exp$it$ developm5t & priority review = g5]ic complex drug products 7a7 ,e/abli%m5t ( program ,! ,secret>y %all e/abli% a program to exp$ite ! developm5t (1 & provide priority review "u section #eje7;j7 =1 g5]ic complex drug products4 7b7 ,reque/ = designation ,a sponsor ( a g5]ic complex drug product may reque/ t ! ,secret>y designate su* product = exp$it$ developm5t & priority review "u ?is section4 7c7 ,designation process 7#a7 ,9 g5]al ,n lat] ?an #fj cal5d> days aft] ! receipt ( a reque/ "u subsection 7c71 ! ,secret>y %all det]m9e :e!r ! product t is ! subject ( ! reque/ meets ! crit]ia "u subsection 7e7 to be consid]$ a g5]ic complex drug product4 ,if ! ,secret>y det]m9es t ! product meets ! crit]ia1 ! ,secret>y %all designate ! product = exp$it$ developm5t & priority review4 7#b7 ,review ,review ( a reque/ "u subsection 7b7 %all be und]tak5 by a team t is compos$ ( exp]i5c$ /aff & s5ior manag]s ( ! ,food & ,drug ,adm9i/ration4 7#c7 ,)drawal ,! ,secret>y may n )draw a designation grant$ "u ?is section on ! basis ( ! crit]ia "u subsection 7e7 no long] apply+ because ( ! subsequ5t cle>ance or approval ( any o!r product4 7d7 ,exp$it$ developm5t & priority review ,guidance 7#a7 ,cont5t ,n lat] ?an ,decemb] #ca1 #bjba1 ! ,secret>y %all issue guidance on ! implem5tation ( ?is section4 ,su* guidance %all-- 7,a7 set =? ! process by :i* a p]son may seek a designation "u subsection 7c72 7,b7 provide a template = reque/s "u subsection 7b72 7,c7 id5tify ! crit]ia ! ,secret>y w use 9 evaluat+ a reque/ = designation "u ?is section2 & 7,d7 id5tify ! crit]ia & processes ! ,secret>y w use to exp$ite ! developm5t & review ( products designat$ "u ?is section4 7#b7 ,process ,prior to f9aliz+ ! guidance "u p>agraph 7#a71 ! ,secret>y %all seek public comm5t on a draft v]sion ( t guidance4 7e7 ,g5]ic complex drug product def9$ ,9 ?is section1 ! t]m g5]ic complex drug product means a product t repres5ts a complex !rapy t consi/s ( or includes a drug = approval "u section #eje7;j7 & t-- 7#a7 7,a7 conta9s complex active +r$i5ts 7su* z peptides1 polym]ic comp\nds1 complex mixtures ( active +r$i5ts1 & naturally s\rc$ +r$i5ts72 7,b7 is compos$ ( complex =mulations 7su* z liposomes or colloids72 7,c7 requires a complex r\te ( deliv]y 7su* z locally act+ drugs su* z d]matological products & complex oph?almological products & otic dosage =ms t are =mulat$ z susp5sions1 emulsions1 or gels72 or 7,d7 involves a complex dosage =m 7su* z transd]mals1 met]$ dose inhal]s1 or ext5d$ release injectables72 7#b7 pres5ts z a complex drug-device comb9ation product 7su* z auto injectors or met]$ dose inhal]s72 or 7#c7 is a product t w\ld b5efit f e>ly sci5tific engagem5t due to complexity or unc]ta9ty conc]n+ ! approval pa?way "u section #eje7;j74 4 #cdb4 ,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$1 & %all provide updates to reflect ! mo/ rec5t in=mation available to ! ,secret>y4 #cdc4 ,ensur+ timely access to g5]ics ,section #eje7q7 ( ! ,f$]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$esignat+ clauses 7i7 & 7ii7 z subp>agraphs 7,a7 & 7,b71 respectively1 & adju/+ ! m>g9s accord+ly4 #cdd4 ,preemption ( ,/ate b>ri]s to ! sub/itution ( biosimil> products ,no ,/ate1 or any political subdivision !re(1 may1 "u any circum/ances1 prohibit a ph>macy or ph>maci/ f disp5s+1 9 place ( a biological ref]5ce product1 any biosimil> t ! ,food & ,drug ,adm9i/ration has designat$ z an int]*angeable product = t biological ref]5ce product4 #cde4 ,increas+ ph>maceutical options to treat an unmet m$ical ne$ ,subsection 7b7 ( section #ejf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,unmet m$ical ne$ ,= purposes ( p>agraph 7#a71 a drug %all be deem$ to address an unmet m$ical ne$ = a disease or condition if few] ?an #c available drugs exi/ = ! treatm5t ( su* disease or condition4 4 #cdf4 ,provisional approval ( new human drugs 7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by add+ at ! end ( ! foll[+3 #ebd;,b4 ,provisional approval ( new human drugs 7a7 ,priority review & evaluation ( applications 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a priority review sy/em to evaluate applications submitt$ "u ?is pa?way = provisional approval )9 #ij days ( receipt ( a complet$ application4 7#b7 ,review ( applications dur+ epidemics & p&emics ,9 ! case ( an epidemic or p&emic1 includ+ ) respect to ,,covid-#ai1 ! ,secret>y %all accept & review v>i\s portions ( an application submitt$ "u ! pa?way "u ?is section = provisional approval on a roll+ basis1 & ! review ( any "p ( an application s submitt$ %all be complet$ n lat] ?an #c weeks aft] submission4 7#c7 ,o!r designations ,if a drug submitt$ = review "u ! pa?way "u ?is section is eligible = a special designation by ! ,secret>y "u ?is ,act1 includ+ z a drug = a r>e disease or condition "u section #ebf1 all b5efits ( su* o!r designation %all be available = use "u provisional approval1 includ+ any tax cr$its & waiv+ ( fees "u *apt] ,,vii4 7b7 ,eligibility ,a drug may be eligible = provisional approval "u ?is section if ! ,secret>y det]m9es t ! drug is int5d$ = ! treatm5t1 prev5tion1 or m$ical diagnosis (-- 7#a7 a s]i\s or life-?reat5+ disease or condition = :i* !re is a reasonable likelihood t premature dea? w occur )\t e>ly m$ical int]v5tion = an individual contract+ or be+ diagnos$ ) su* disease or condition2 7#b7 a disease or condition t poses a ?reat ( epidemic or p&emic2 or 7#c7 a disease or condition associat$ ) morbidity t has a sub/antial impact on day-to-day function+4 7c7 ,/&>d ( review = approval 7#a7 ,requirem5ts ,an application = provisional approval "u ?is section may be approv$ only if ! ,secret>y det]m9es t-- 7,a7 !re is sub/antial evid5ce ( safety = ! drug1 su* t !re is evid5ce consi/+ ( adequate & well-controll$ inve/igations1 includ+ cl9ical inve/igations1 by exp]ts qualifi$ by sci5tific tra9+ & exp]i5ce to evaluate ! safety ( ! drug involv$1 on ! basis ( :i* x c\ld fairly & responsibly be conclud$ t ! drug w h ! effect x purports or is repres5t$ to h "u ! conditions ( use prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ or propos$ label+2 & 7,b7 !re is relevant e>ly evid5ce bas$ on adequate & well-controll$ inve/igations1 includ+ e>ly-/age cl9ical inve/igations1 to e/abli% t-- 7i7 ! drug provides a positive !rapeutic outcome2 & 7ii7 ! outcome ( ! drug is consi/5t ) or great] ?an curr5tly m>ket$ on-label !rapies1 ) equal or few] side effects1 if !re are curr5tly m>ket$ on-label !rapies4 7#b7 ,protocols ,! ,secret>y %all promulgate rules t e/abli% ! appropriate protocols = a sponsor ( an application = provisional approval "u ?is section & ! ,commission] to foll[ to enable roll+1 real-"t1 mid-trial submission :ile pres]v+ ! integrity ( ! ongo+ trial & )\t p5aliz+ ! sponsor = mak+ use ( ?is pa?way4 7#c7 ,real _w evid5ce ,! ,secret>y %all all[ ! use ( real _w evid5ce 7z def9$ 9 section #eje;,f7b771 includ+ real _w data us$ to g5]ate real _w evid5ce1 to support an application = provisional approval "u ?is section1 & to fulfill ! foll[-up requirem5ts & support applications = full approval z describ$ "u section #eje or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable4 7#d7 ,use ( sci5tifically sub/antiat$ surrogates 7,a7 ,9 g5]al ,! sponsor ( an application = provisional approval "u ?is section may use sci5tifically sub/antiat$ surrogates to support su* application4 7,b7 ,def9ition ,9 subp>agraph 7,a71 ! t]m sci5tifically sub/antiat$ surrogates means surrogate endpo9ts to pr$ict cl9ical b5efit o!r ?an su* endpo9ts previ\sly validat$ by ! ,secret>y1 bas$ on-- 7i7 epidemiologic1 !rapeutic1 pa?ophysiologic1 or o!r evid5ce2 or 7ii7 an effect on a cl9ical endpo9t o!r ?an survival or irrev]sible morbidity ( int]e/4 7d7 ,transp>5cy & pati5t monitor+ requirem5ts 7#a7 ,regi/ries 7,a7 ,9 g5]al ,! sponsor ( a drug provisionally approv$ "u ?is section %all require t all pati5ts :o use su* drug p>ticipate 9 an obs]vational regi/ry & cons5t to ! sponsor's collection1 & submission to ! regi/ry1 ( data relat$ to ! pati5t's use ( su* drug until su* drug receives full approval "u section #eje or section #cea ( ! ,public ,heal? ,s]vice ,act1 or ! provisional approval is resc9d$4 7,b7 ,requirem5ts = regi/ries ,an obs]vational regi/ry describ$ 9 subp>agraph 7,a7 may be run by a ?ird p>ty1 su* z a gov]nm5t1 = pr(it1 or non-pr(it organization1 & %all track all pati5ts :o use ! provisionally approv$ drug4 7,c7 ,accessibility ,an obs]vational regi/ry describ$ 9 subp>agraph 7,a7 %all be easily accessible =-- 7i7 all pati5ts :o are p>ticipat+ 9 any regi/ry relat$ to a provisionally approv$ drug t all[s = easy1 unre/rict$ 7or transp>5t7 access = su* pati5ts to _! pati5t data & relat$ in=mation reg>d+ _! usage ( ! provisionally approv$ drug2 & 7ii7 approv$ rese>*]s & m$ical pr(essionals :o may access data ma9ta9$ 9 ! regi/ry1 :i* access %all be = public heal? rese>* & only 9 a de-id5tifi$1 aggregat$ mann]4 7#b7 ,fund+ ,an obs]vational regi/ry "u ?is subsection %all be ma9ta9$1 z applicable-- 7,a7 by ! sponsor ( ! drug provisionally approv$ "u ?is section t is ! subject ( ! regi/ry2 7,b7 by a ?ird p>ty1 su* z a gov]nm5t1 = pr(it1 or nonpr(it organization2 or 7,c7 ! ,f$]al ,gov]nm5t1 9 ! case ( any drug s approv$ t is int5d$ to treat a disease or condition associat$ ) an epidemic or p&emic4 7#c7 ,sponsor requirem5ts 7,a7 ,9 g5]al ,= any drug application provisionally approv$ "u ?is section1 ! ,secret>y %all notify ! sponsor ( ! exact data su* sponsor is requir$ to submit to an obs]vational regi/ry4 7,b7 ,annual review ( ! regi/ry2 p5alties ,! ,secret>y %all conduct an annual review ( obs]vational regi/ries e/abli%$ "u ?is subsection4 ,if1 at su* an annual review1 less ?an #ij p]c5t ( pati5ts are p>ticipat+ 9 an obs]vational regi/ry ) respect to a drug approv$ "u ?is section1 ! ,secret>y %all issue to ! sponsor ( su* drug a civil monet>y p5alty ( n m ?an #ajj1jjj4 ,if a violation ( ?is section is n correct$ )9 ! #cj-;day p]iod foll[+ notification1 ! sponsor %all1 9 addition to any p5alty "u ?is subp>agraph be subject to a civil monet>y p5alty ( n m ?an #aj1jjj = ea* day ( ! violation aft] su* p]iod until ! violation is correct$4 ,if application pati5t p>ticipation 9 an obs]vational regi/ry is n at or above #ij p]c5t )9 #f mon?s ( issuance ( su* p5alty1 ! provisional approval %all be )drawn4 7#d7 ,annual report to ,congress ,! ,secret>y %all submit an annual report to ,congress on all drugs grant$ provisional approval "u ?is section4 ,su* report %all include-- 7,a7 ! numb] ( pati5ts treat$ ) ea* su* drug1 & ! numb] ( pati5ts track$ 9 an obs]vational regi/ry ) respect to ea* su* drug2 7,b7 a discussion ( ! m9imum am\nt ( data requir$ 9 ! regi/ries1 includ+ pati5t treatm5ts & uses1 l5g? ( use1 side effects enc\nt]$1 relevant biom>k]s or sci5tifically sub/antiat$ surrogates1 scan results1 cause ( dea? & h[ long ! pati5t liv$1 & adv]se drug effects2 7,c7 a li/ ( all su* drugs = :i* an application = full approval "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 or an application = an ext5sion ( provisional approval "u ?is section1 has be5 submitt$2 & 7,d7 a li/ ( all applications d5i$ provisional approval "u ?is section1 toge!r ) an explanation = ! decisions to d5y ea* su* application4 7e7 ,)drawal ( provisional approval 7#a7 ,9 g5]al ,! ,secret>y %all )draw provisional approval "u ?is section if !re are a significant numb] ( pati5ts :o exp]i5ce s]i\s adv]se effects1 comp>$ to ! o!r curr5tly m>ket$ on-label !rapies t are available = ! applicable disease or condition4 7#b7 ,effect ( )drawal ,if a provisional approval is )drawn "u ?is subsection1 ! sponsor may n make ! drug available to any new pati5ts1 b may be all[$ to cont9ue to make su* drug available to pati5ts :o />t$ tak+ ! drug prior to ! date ( )drawal1 = z long a p]iod z dictat$ by pati5t ne$1 z det]m9$ by ! ,secret>y4 7f7 ,transp>5cy ,any sci5tific1 m$ical1 academic1 or heal? c>e j\rnal publi%+ an article expla9+1 releas+1 convey+ or ann\nc+ rese>* f9d+s :i* 7 fund$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all be prohibit$ f publi%+ su* rese>* unless-- 7#a7 su* article convey+ rese>* f9d+s is made publicly available on ! j\rnal's int]net website )\t a paywall or *>ge n lat] ?an #c mon?s aft] ! date on :i* su* article 0 fir/ provid$ to subscrib]s ( su* j\rnal 7or fir/ made available = pur*ase72 & 7#b7 ! article's au?or or rese>*] or au?or's in/itution 7or1 9 ! case ( multiple au?ors1 rese>*]s1 or in/itutions1 all su* au?ors1 rese>*]s1 or in/itutions7 receiv$ less ?an #cj p]c5t ( fund+ = su* rese>* f ! ,dep>tm5t ( ,heal? & ,human ,s]vices ?r\gh\t ! p]iod ( "t ! rese>* 0 conduct$4 7g7 ,in=m$ cons5t ,prior to receiv+ a drug provisionally approv$ "u ?is section1 ! sponsor ( ! drug %all receive f ea* pati5t1 or ! pati5t's repres5tative1 in=m$ cons5t1 ?r\gh a sign$ in=m$ cons5t =m1 ackn[l$g+ t su* pati5t und]/&s t ! drug did n und]go ! usual process = full approval ( a drug by ! ,food & ,drug ,adm9i/ration1 & t su* pati5t is will+ to accept ! risks involv$ 9 tak+ su* drug4 7h7 ,po/m>ket controls & label+ 7#a7 ,,fda annual review ( regi/ry data ,! ,secret>y %all annually review ! data made available ?r\gh ! obs]vational regi/ries "u subsection 7d7 & make a det]m9ation reg>d+ :e!r ! side effect pr(ile ( any drug approv$ "u ?is pa?way does n support ! b5efit provid$1 or ! data %[s ! b5efit is less ?an ! b5efits (f]$ ?r\gh o!r1 fully approv$ drugs4 7#b7 ,label+ ,! sponsor ( ! provisionally approv$ drug %all ensure t all label+ & promotional mat]ials = ! drug be> ! /atem5t provisionally approv$ by ! ,,fda p5d+ a full demon/ration ( effectiv5ess "u application numb] 7specify+ ! application numb] assign$ by ! ,secret>y 9 place ( ! blank74 ,all promotional1 educational & m>ket+ mat]ials = provisionally approv$ products %all be review$ & approv$ by ! ,secret>y be=e su* mat]ials are di/ribut$4 7#c7 ,rescission ( provisional approval ,if ! ,secret>y det]m9es t ! side effect pr(ile ( any drug includ$ 9 su* obs]vational regi/ries does n support ! b5efit provid$ by su* drug1 or t ! data %[s t ! b5efit is less ?an ! b5efits (f]$ ?r\gh o!r1 fully approv$ drugs1 ! ,secret>y %all resc9d su* provisional approval4 7i7 ,duration ( provisional approval2 requirem5t ,to br+ drug to m>ket 7#a7 ,duration2 r5ewals ,! p]iod ( provisional approval = a drug approv$ "u ?is section is effective = a #b-ye> p]iod4 ,! sponsor may reque/ r5ewal = provisional approval /atus = up to #c subsequ5t #b-ye> p]iods by ! ,secret>y4 ,provisional approval /atus ) respect to a drug %all n exce$ a total ( #f ye>s f ! initial date ! sponsor 0 aw>d$ provisional approval /atus4 7#b7 ,m>ket+ requirem5t ,if any drug t receives provisional approval /atus "u ?is section is n br\ght to m>ket )9 #ahj days ( ! approval1 su* approval %all be resc9d$4 7j7 ,limitation on liability ,) respect to any claim "u ,/ate law alleg+ t a drug sold or o!rwise made available pursuant to a grant ( provisional approval "u ?is section is unsafe or ineffective1 no liability 9 a cause ( action %all lie aga9/ a sponsor or manufactur]1 unless ! relevant conduct con/itutes reckless or willful misconduct1 gross neglig5ce1 or an int5tional tort "u any applicable ,/ate law4 7k7 ,apply+ = full approval 7#a7 ,9 g5]al ,except z provid$ "u p>agraph 7#b71 ! sponsor ( a drug grant$ provisional approval pursuant to ?is section may1 at any po9t1 submit an application = full approval ( su* drug "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable4 7#b7 ,effect ( recession on approval & automatic approval 7,a7 ,9 g5]al ,! sponsor ( a drug grant$ provisional approval pursuant to ?is section t has be5 resc9d$ "u subsection 7h77#c71 may submit an application = full approval ( su* drug "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act at any "t4 7,b7 ,automatic approval ,su* full approval may be aw>d$ at any "t = any drug grant$ provisional approval pursuant to ?is section if ! sponsor ( ! drug e/abli%es a #ae p]c5t improvem5t 9 an important endpo9t1 includ+ surrogate endpo9ts n validat$ by ! ,food & ,drug ,adm9i/ration1 comp>$ to a /&>d drug4 7#c7 ,real-"t epidemic & p&emic vacc9e approval 7,a7 ,9 g5]al ,9 ! case ( a vacc9e develop$ 9 response to an epidemic or p&emic1 includ+ ,,covid-#ai1 ! ,secret>y %all %>e data in=mation reg>d+ ! approval ( ! vacc9e ) ! ,advisory ,committee on ,immunization ,practices ( ! ,c5t]s = ,disease ,control & ,prev5tion z ! review ne>s completion4 7,b7 ,evaluation ,any vacc9e t has be5 approv$ by ! ,secret>y = an epidemic or p&emic-relat$ disease1 includ+ ,,covid-#ai1 %all be evaluat$ by ! ,advisory ,committee on ,immunization ,practices ( ! ,c5t]s = ,disease ,control & ,prev5tion n lat] ?an #a week aft] ! date ( submission to ! ,advisory ,committee by ! ,secret>y ( ! vacc9e4 7l7 ,pati5t advocate g5]al ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ! ,promis+ ,pa?way ,act1 ! ,secret>y %all e/abli% )9 ! ,(fice ( ! ,commission]1 ! position ( ,pati5t ,advocate ,g5]al1 :o %all provide assi/ance to pati5ts & _! families :o use drugs "u evaluation 9 ?is pa?way or drugs review$ or approv$ "u section #eje or section #cea ( ! ,public ,heal? ,s]vice ,act4 ,su* assi/ance %all include provid+ bi-in=mational communication ab\t ma9ta9+ pati5t heal?1 deliv]y ( prop] in=m$ cons5t1 p>ticipat+ 9 cl9ical inve/igations1 complet+ requir$ docum5tation 9 ord] to p>ticipate 9 ! applicable programs1 & provid+ o!r in=mation4 4 7b7 ,con=m+ am5dm5t ,section #eje7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;a77 is am5d$ by ins]t+ 1 or !re is 9 effect a provisional approval "u section #ebd;,b ) respect to su* drug be=e ! p]iod4 7c7 ,reimbursem5t 7#a7 ,private heal? insur]s ,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 ,treatm5t ( c]ta9 drugs ,a gr\p heal? plan or heal? insurance issu] ( gr\p or individual heal? insurance cov]age %all n d5y cov]age ( any drug provisionally approv$ "u section #ebd;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act on ! basis ( su* drug be+ exp]im5tal4 ,9 det]m9+ cov]age "u ! applicable plan or cov]age1 a gr\p heal? plan or heal? insurance issu] %all treat a drug provisionally approv$ "u su* section 9 ! same mann] z su* plan or cov]age w\ld treat a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ?is ,act4 ,no?+ 9 ?is subsection %all be con/ru$ to require a gr\p heal? plan or heal? insurance issu] to cov] any specific drug provisionally approv$ "u su* section #ebd;,b4 4 7#b7 ,f$]al heal? c>e programs ,! requirem5t "u subsection 7e7 ( section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7z add$ by p>agraph 7#a77 %all apply ) respect to cov]age det]m9ations "u a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 9 ! same mann] su* requirem5t applies "u su* subsection 7e74 7#c7 ,con=m+ am5dm5t ,section #aibg7k77#b77;,a77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b77;,a77i77 is am5d$-- 7,a7 by /rik+ or :i* & ins]t+ 1 :i*2 & 7,b7 by ins]t+ 1 or :i* is provisionally approv$ "u section #ebd;,b ( su* ,act be=e ! semicolon4 #cdg4 ,consolidat+ exclusivity p]iods = drugs treat+ r>e diseases & conditions 7a7 ,9 g5]al ,subsection 7a7 ( section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$ to read z foll[s3 7a7 ,exclusivity 7#a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 if ! ,secret>y approves an application fil$ pursuant to section #eje1 or issues a lic5se "u section #cea ( ! ,public ,heal? ,s]vice ,act1 = a drug designat$ "u section #ebf = a r>e disease or condition1 ! ,secret>y may n approve an application fil$ pursuant to section #eje1 or issue a lic5se "u section #cea ( ! ,public ,heal? ,s]vice ,act1 = ! same drug = ! same disease or condition = a p]son :o is n ! hold] ( su* approv$ application or ( su* lic5se until ! expiration ( ! exclusivity p]iod describ$ 9 p>agraph 7#b74 7#b7 ,exclusivity p]iod describ$ ,! exclusivity p]iod describ$ 9 ?is p>agraph1 ) respect to a drug designat$ "u section #ebf = a r>e disease or condition1 is-- 7,a7 a s+le #g-ye> p]iod ( exclusivity ) respect to ! fir/ designation ( su* drug "u su* section = t r>e disease or condition2 or 7,b7 9 ! case ( a drug t has previ\sly receiv$ a p]iod ( exclusivity "u p>agraph 7#a71 a s+le #c-ye> p]iod ( exclusivity ) respect to any subsequ5t designation ( su* drug "u su* section = any o!r r>e disease or condition4 7#c7 ,limitation ,9 ! case ( a drug t has receiv$ two p]iods ( exclusivity pursuant to p>agraph 7#a71 no additional exclusivity p]iod "u ?is section is available ) respect to su* drug1 reg>dless ( :e!r su* drug has be5 designat$ "u section #ebf = a r>e disease or condition t is di/9ct f ! r>e disease or condition = :i* su* exclusivity p]iods 7 grant$4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #eje7;j77#e77;,b77iv77,,ii77dd77,,aa7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$ by /rik+ #g-ye> p]iod & ins]t+ exclusivity p]iod4 7#b7 ,section #eje;,a7b77#a77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$ by /rik+ r ?an sev5 ye>s2 & ins]t+ 1 or ?ree ye>s & six mon?s1 r ?an sev5 ye>s or ?ree ye>s1 respectively24 7#c7 ,section #eje;,a7c77#a77;,a77ii7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$ by /rik+ r ?an sev5 ye>s2 & ins]t+ 1 or ?ree ye>s & six mon?s1 r ?an sev5 ye>s or ?ree ye>s1 respectively24 7#d7 ,section #eje;,e7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$ by /rik+ #g-ye> p]iod & ins]t+ exclusivity p]iods4 7#e7 ,section #ebg7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$ by /rik+ ! #g-ye> p]iod & ins]t+ any exclusivity p]iod4 7#f7 ,section #cea7m77#b77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is am5d$ by /rik+ r ?an #g ye>s & ins]t+ or #c ye>s & #f mon?s1 r ?an #g ye>s or #c ye>s1 respectively4 7#g7 ,section #cea7m77#c77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is am5d$ by /rik+ r ?an #g ye>s & ins]t+ or #c ye>s & #f mon?s1 r ?an #g ye>s or #c ye>s1 respectively4 #cdh4 ,exclusivity p]iod = br& "n biological products 7a7 ,9 g5]al ,section #cea7k77#g77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#g77;,a77 is am5d$ by /rik+ #ab ye>s & ins]t+ #e ye>s4 7b7 ,con=m+ *anges ,p>agraphs 7#b77;,a7 & 7#c77;,a7 ( section #cea7m7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7m77 is am5d$ by /rik+ #ab ye>s ea* place x appe>s & ins]t+ #e ye>s4 7c7 ,applicability ,?is ,act & ! am5dm5ts made by ?is ,act apply only ) respect to a biological product = :i* ! ref]5ce product 7z su* t]m is us$ 9 section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb77 is lic5s$ "u subsection 7a7 ( su* section on or aft] ! date ( enactm5t ( ?is ,act4 #cdi4 ,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 #cej4 ,/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 #cea4 ,regulation ( manufactur]-sponsor$ copay contributions ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may e/abli% a me*anism to regulate drug manufactur]s' f9ancial contributions to pati5t out-(-pocket co/s1 su* z drug co-pays4 #ceb4 ,antitru/ exemption = private heal? insur] issu]s to negotiate :olesale acquisition prices ( prescription drugs pur*as$ f drug manufactur]s 7a7 ,exemption ,x %all n be a violation ( ! antitru/ laws = "o or m private heal? insur] issu]s or _! designat$ ag5ts to jo9tly negotiate :olesale acquisition prices ( a prescription drug ) a manufactur] ( a prescription drug ) reg>ds to ! reimbursem5t policies ( ! insur]s ( ! manufactur]'s drugs s long z no "o s+le :olesale acquisition price is jo9tly det]m9$ betwe5 ! insurance issu]s or _! designat$ ag5ts4 7b7 ,def9itions ,= purposes ( ?is section3 7#a7 ,antitru/ laws ,! t]m antitru/ laws has ! mean+ giv5 x 9 subsection 7a7 ( ! #a/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 except t su* t]m includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t su* section #e applies to unfair me?ods ( competition4 7#b7 ,heal? insurance issu] ,! t]m heal? insurance issu] means an insurance company1 insurance s]vice1 or insurance organization 7includ+ a heal? ma9t5ance organization1 z def9$ 9 subp>agraph 7,c77 :i* is lic5s$ to engage 9 ! bus9ess ( insurance 9 a ,/ate & :i* is subject to ,/ate law :i* regulates insurance 7)9 ! mean+ ( section #ead7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aadd7;b77#b7774 ,su* t]m does n include a gr\p heal? plan4 7#c7 ,heal? ma9t5ance organization ,! t]m heal? ma9t5ance organization means-- 7,a7 a ,f$]ally qualifi$ heal? ma9t5ance organization 7z def9$ 9 section #cjj;e7a7 ( title #db ( ! ,unit$ ,/ates ,code71 7,b7 an organization recogniz$ "u ,/ate law z a heal? ma9t5ance organization1 or 7,c7 a simil> organization regulat$ "u ,/ate law = solv5cy 9 ! same mann] & to ! same ext5t z su* a heal? ma9t5ance organization4 7#d7 ,manufactur] ,! t]m manufactur] means anyone :o is engag$ 9 manufactur+1 prep>+1 propagat+1 comp\nd+1 process+1 packag+1 repackag+1 or label+ ( a prescription drug4 7#e7 ,prescription drug ,! t]m prescription drug means any human drug requir$ by ,f$]al law or regulation to be disp5s$ only by a prescription1 includ+ f9i%$ dosage =ms & active +r$i5ts subject to section #ejc7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b774 7c7 ,effective date ,?is section %all take effect on ! date ( ! enactm5t ( ?is ,act b %all n apply ) respect to conduct t occurs be=e su* date4 #cec4 ,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$71 %all apply ) respect to a biological product subject to regulation "u ?is section4 4 #ced4 ,cl>ify+ ! mean+ ( new *emical entity 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]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 #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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$-- 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 #cee4 ,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 #cef4 ,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 #ceg4 ,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$ical education programs t advance ! education ( su* provid]s on ! prescrib+ (1 & relevant cl9ical consid]ations ) respect to1 biological products1 includ+ biosimil> biological products & int]*angeable biosimil> biological products4 4 #ceh4 ,congressional review ( ! ,food & ,drug ,adm9i/ration rulemak+ 7a7 ,congressional review ,"p ,i ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 #aj ,congressional ,review ( ,food & ,drug ,adm9i/ration ,rulemak+ ,sec4 #ibj4 ,applicability4 #iba4 ,congressional review4 #ibb4 ,congressional approval proc$ure = major rules4 #ibc4 ,congressional disapproval proc$ure = nonmajor rules4 #ibd4 ,def9itions4 #ibe4 ,judicial review4 #ibf4 ,exemption = monet>y policy4 #ibg4 ,effective date ( c]ta9 rules4 #ibh4 ,regulatory cut-g requirem5t4 #ibi4 ,review ( rules curr5tly 9 effect4 #ibj4 ,applicability ,?is *apt] applies 9 lieu ( *apt] #h ) respect to ! ,food & ,drug ,adm9i/ration4 #iba4 ,congressional review 7a7 7#a7 7,a7 ,be=e a rule may take effect1 ! ,food & ,drug ,adm9i/ration %all satisfy ! requirem5ts ( section #ibh & %all publi% 9 ! ,f$]al ,regi/] a li/ ( in=mation on :i* ! rule is bas$1 includ+ data1 sci5tific & economic /udies1 & co/-b5efit analyses1 & id5tify h[ ! public c access su* in=mation onl9e1 & %all submit to ea* ,h\se ( ! ,congress & to ! ,comptroll] ,g5]al a report conta9+-- 7i7 a copy ( ! rule2 7ii7 a concise g5]al /atem5t relat+ to ! rule2 7iii7 a classification ( ! rule z a major or nonmajor rule1 includ+ an explanation ( ! classification specifically address+ ea* crit]ia = a major rule conta9$ )9 sections #ibd7b77;,a71 #ibd7b77;,b71 & #ibd7b77;,c72 7iv7 a li/ ( any o!r relat$ regulatory actions int5d$ to implem5t ! same /atutory provision or regulatory objective z well z ! individual & aggregate economic effects ( ^? actions2 & 7v7 ! propos$ effective date ( ! rule4 7,b7 ,on ! date ( ! submission ( ! report "u subp>agraph 7,a71 ! ,food & ,drug ,adm9i/ration %all submit to ! ,comptroll] ,g5]al & make available to ea* ,h\se ( ,congress-- 7i7 a complete copy ( ! co/-b5efit analysis ( ! rule1 if any1 includ+ an analysis ( any jobs add$ or lo/1 diff]5tiat+ betwe5 public & private sector jobs2 7ii7 ! ,food & ,drug ,adm9i/ration's actions pursuant to sections #fjc1 #fjd1 #fje1 #fjg1 & #fji ( ?is title2 7iii7 ! ,food & ,drug ,adm9i/ration's actions pursuant to sections #bjb1 #bjc1 #bjd1 & #bje ( ! ,unfund$ ,m&ates ,re=m ,act ( #aiie2 & 7iv7 any o!r relevant in=mation or requirem5ts "u any o!r ,act & any relevant ,executive ord]s4 7,c7 ,^u receipt ( a report submitt$ "u subp>agraph 7,a71 ea* ,h\se %all provide copies ( ! report to ! *airman & rank+ memb] ( ea* /&+ committee ) jurisdiction "u ! rules ( ! ,h\se ( ,repres5tatives or ! ,s5ate to report a bill to am5d ! provision ( law "u :i* ! rule is issu$4 7#b7 7,a7 ,! ,comptroll] ,g5]al %all provide a report on ea* major rule to ! committees ( jurisdiction by ! end ( #ae cal5d> days aft] ! submission or publication date4 ,! report ( ! ,comptroll] ,g5]al %all include an assessm5t ( ! ,food & ,drug ,adm9i/ration's compliance ) proc$ural /eps requir$ by p>agraph 7#a77;,b7 & an assessm5t ( :e!r ! major rule imposes any new limits or m&ates on private-sector activity4 7,b7 ,! ,food & ,drug ,adm9i/ration %all coop]ate ) ! ,comptroll] ,g5]al by provid+ in=mation relevant to ! ,comptroll] ,g5]al's report "u subp>agraph 7,a74 7#c7 ,a major rule relat+ to a report submitt$ "u p>agraph 7#a7 %all take effect ^u enactm5t ( a jo9t resolution ( approval describ$ 9 section #ibb or z provid$ = 9 ! rule foll[+ enactm5t ( a jo9t resolution ( approval describ$ 9 section #ibb1 :i*ev] is lat]4 7#d7 ,a nonmajor rule %all take effect z provid$ by section #ibc aft] submission to ,congress "u p>agraph 7#a74 7#e7 ,if a jo9t resolution ( approval relat+ to a major rule is n enact$ )9 ! p]iod provid$ 9 subsection 7b77#b71 !n a jo9t resolution ( approval relat+ to ! same rule may n be consid]$ "u ?is *apt] 9 ! same ,congress by ei!r ! ,h\se ( ,repres5tatives or ! ,s5ate4 7b7 7#a7 ,a major rule %all n take effect unless ! ,congress enacts a jo9t resolution ( approval describ$ "u section #ibb4 7#b7 ,if a jo9t resolution describ$ 9 subsection 7a7 is n enact$ into law by ! end ( #gj session days or legislative days1 z applicable1 beg9n+ on ! date on :i* ! report ref]r$ to 9 section #iba7;a77#a77;,a7 is receiv$ by ,congress 7exclud+ days ei!r ,h\se ( ,congress is adj\rn$ = m ?an #c days dur+ a session ( ,congress71 !n ! rule describ$ 9 t resolution %all be deem$ n to be approv$ & su* rule %all n take effect4 7c7 7#a7 ,not)/&+ any o!r provision ( ?is section 7except subject to p>agraph 7#c771 a major rule may take effect = "o #ij-;cal5d>-day p]iod if ! ,presid5t makes a det]m9ation "u p>agraph 7#b7 & submits writt5 notice ( su* det]m9ation to ! ,congress4 7#b7 ,p>agraph 7#a7 applies to a det]m9ation made by ! ,presid5t by ,executive ord] t ! major rule %\ld take effect because su* rule is-- 7,a7 necess>y because ( an imm95t ?reat to heal? or safety or o!r em]g5cy2 7,b7 necess>y = ! en=cem5t ( crim9al laws2 7,c7 necess>y = national security2 or 7,d7 issu$ pursuant to any /atute implem5t+ an int]national trade agreem5t4 7#c7 ,an ex]cise by ! ,presid5t ( ! au?ority "u ?is subsection %all h no effect on ! proc$ures "u section #ibb4 7d7 7#a7 ,9 addition to ! opportunity = review o!rwise provid$ "u ?is *apt]1 9 ! case ( any rule = :i* a report 0 submitt$ 9 accordance ) subsection 7a77#a77;,a7 dur+ ! p]iod beg9n+ on ! date occurr+-- 7,a7 9 ! case ( ! ,s5ate1 #fj session days2 or 7,b7 9 ! case ( ! ,h\se ( ,repres5tatives1 #fj legislative days1 be=e ! date ! ,congress is s*$ul$ to adj\rn a session ( ,congress ?r\gh ! date on :i* ! same or succe$+ ,congress fir/ conv5es its next session1 sections #ibb & #ibc %all apply to su* rule 9 ! succe$+ session ( ,congress4 7#b7 7,a7 ,9 apply+ sections #ibb & #ibc = purposes ( su* additional review1 a rule describ$ "u p>agraph 7#a7 %all be treat$ z ?\gh-- 7i7 su* rule 7 publi%$ 9 ! ,f$]al ,regi/] on-- 7,i7 9 ! case ( ! ,s5ate1 ! #ae? session day2 or 7,,ii7 9 ! case ( ! ,h\se ( ,repres5tatives1 ! #ae? legislative day1 aft] ! succe$+ session ( ,congress fir/ conv5es2 & 7ii7 a report on su* rule 7 submitt$ to ,congress "u subsection 7a77#a7 on su* date4 7,b7 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect ! requirem5t "u subsection 7a77#a7 t a report %all be submitt$ to ,congress be=e a rule c take effect4 7#c7 ,a rule describ$ "u p>agraph 7#a7 %all take effect z o!rwise provid$ by law 7includ+ o!r subsections ( ?is section74 #ibb4 ,congressional approval proc$ure = major rules 7a7 7#a7 ,= purposes ( ?is section1 ! t]m jo9t resolution means only a jo9t resolution address+ a report classify+ a rule z major pursuant to section #iba7;a77#a77;,a77iii7 t-- 7,a7 be>s no preamble2 7,b7 be>s ! foll[+ title 7) blanks fill$ z appropriate73 ,approv+ ! rule submitt$ by relat+ to 42 7,c7 includes aft] its resolv+ clause only ! foll[+ 7) blanks fill$ z appropriate73 ,t ,congress approves ! rule submitt$ by relat+ to 42 & 7,d7 is introduc$ pursuant to p>agraph 7#b74 7#b7 ,aft] a ,h\se ( ,congress receives a report classify+ a rule z major pursuant to section #iba7;a77#a77;,a77iii71 ! majority lead] ( t ,h\se 7or 8 or h] respective designee7 %all introduce 7by reque/1 if appropriate7 a jo9t resolution describ$ 9 p>agraph 7#a7-- 7,a7 9 ! case ( ! ,h\se ( ,repres5tatives1 )9 #c legislative days2 & 7,b7 9 ! case ( ! ,s5ate1 )9 #c session days4 7#c7 ,a jo9t resolution describ$ 9 p>agraph 7#a7 %all n be subject to am5dm5t at any /age ( proce$+4 7b7 ,a jo9t resolution describ$ 9 subsection 7a7 %all be ref]r$ 9 ea* ,h\se ( ,congress to ! committees hav+ jurisdiction ov] ! provision ( law "u :i* ! rule is issu$4 7c7 ,9 ! ,s5ate1 if ! committee or committees to :i* a jo9t resolution describ$ 9 subsection 7a7 has be5 ref]r$ h n report$ x at ! end ( #ae session days aft] its introduction1 su* committee or committees %all be automatically dis*>g$ f fur!r consid]ation ( ! resolution & x %all be plac$ on ! cal5d>4 ,a vote on f9al passage ( ! resolution %all be tak5 on or be=e ! close ( ! #ae? session day aft] ! resolution is report$ by ! committee or committees to :i* x 0 ref]r$1 or aft] su* committee or committees h be5 dis*>g$ f fur!r consid]ation ( ! resolution4 7d7 7#a7 ,9 ! ,s5ate1 :5 ! committee or committees to :i* a jo9t resolution is ref]r$ h report$1 or :5 a committee or committees are dis*>g$ 7"u subsection 7c77 f fur!r consid]ation ( a jo9t resolution describ$ 9 subsection 7a71 x is at any "t !reaft] 9 ord] 7ev5 ?\gh a previ\s motion to ! same effect has be5 disagre$ to7 = a motion to proce$ to ! consid]ation ( ! jo9t resolution1 & all po9ts ( ord] aga9/ ! jo9t resolution 7& aga9/ consid]ation ( ! jo9t resolution7 are waiv$4 ,! motion is n subject to am5dm5t1 or to a motion to po/pone1 or to a motion to proce$ to ! consid]ation ( o!r bus9ess4 ,a motion to reconsid] ! vote by :i* ! motion is agre$ to or disagre$ to %all n be 9 ord]4 ,if a motion to proce$ to ! consid]ation ( ! jo9t resolution is agre$ to1 ! jo9t resolution %all rema9 ! unf9i%$ bus9ess ( ! ,s5ate until dispos$ (4 7#b7 ,9 ! ,s5ate1 debate on ! jo9t resolution1 & on all debatable motions & appeals 9 connection !re)1 %all be limit$ to n m ?an #b h\rs1 :i* %all be divid$ equally betwe5 ^? favor+ & ^? oppos+ ! jo9t resolution4 ,a motion to fur!r limit debate is 9 ord] & n debatable4 ,an am5dm5t to1 or a motion to po/pone1 or a motion to proce$ to ! consid]ation ( o!r bus9ess1 or a motion to recommit ! jo9t resolution is n 9 ord]4 7#c7 ,9 ! ,s5ate1 imm$iately foll[+ ! conclusion ( ! debate on a jo9t resolution describ$ 9 subsection 7a71 & a s+le quorum call at ! conclusion ( ! debate if reque/$ 9 accordance ) ! rules ( ! ,s5ate1 ! vote on f9al passage ( ! jo9t resolution %all occur4 7#d7 ,appeals f ! decisions ( ! ,*air relat+ to ! application ( ! rules ( ! ,s5ate to ! proc$ure relat+ to a jo9t resolution describ$ 9 subsection 7a7 %all be decid$ )\t debate4 7e7 ,9 ! ,h\se ( ,repres5tatives1 if any committee to :i* a jo9t resolution describ$ 9 subsection 7a7 has be5 ref]r$ has n report$ x to ! ,h\se at ! end ( #ae legislative days aft] its introduction1 su* committee %all be dis*>g$ f fur!r consid]ation ( ! jo9t resolution1 & x %all be plac$ on ! appropriate cal5d>4 ,on ! second & f\r? ,?ursdays ( ea* mon? x %all be 9 ord] at any "t = ! ,speak] to recognize a ,memb] :o favors passage ( a jo9t resolution t has appe>$ on ! cal5d> = at lea/ #e legislative days to call up t jo9t resolution = imm$iate consid]ation 9 ! ,h\se )\t int]v5tion ( any po9t ( ord]4 ,:5 s call$ up a jo9t resolution %all be consid]$ z read & %all be debatable = #a h\r equally divid$ & controll$ by ! propon5t & an oppon5t1 & ! previ\s "q %all be consid]$ z ord]$ to its passage )\t int]v5+ motion4 ,x %all n be 9 ord] to reconsid] ! vote on passage4 ,if a vote on f9al passage ( ! jo9t resolution has n be5 tak5 by ! ?ird ,?ursday on :i* ! ,speak] may recognize a ,memb] "u ?is subsection1 su* vote %all be tak5 on t day4 7f7 7#a7 ,if1 be=e pass+ a jo9t resolution describ$ 9 subsection 7a71 "o ,h\se receives f ! o!r a jo9t resolution hav+ ! same text1 !n-- 7,a7 ! jo9t resolution ( ! o!r ,h\se %all n be ref]r$ to a committee2 & 7,b7 ! proc$ure 9 ! receiv+ ,h\se %all be ! same z if no jo9t resolution _h be5 receiv$ f ! o!r ,h\se until ! vote on passage1 :5 ! jo9t resolution receiv$ f ! o!r ,h\se %all supplant ! jo9t resolution ( ! receiv+ ,h\se4 7#b7 ,?is subsection %all n apply to ! ,h\se ( ,repres5tatives if ! jo9t resolution receiv$ f ! ,s5ate is a rev5ue measure4 7g7 ,if ei!r ,h\se has n tak5 a vote on f9al passage ( ! jo9t resolution by ! la/ day ( ! p]iod describ$ 9 section #iba7;b77#b71 !n su* vote %all be tak5 on t day4 7h7 ,?is section & section #ibc are enact$ by ,congress-- 7#a7 z an ex]cise ( ! rulemak+ p[] ( ! ,s5ate & ,h\se ( ,repres5tatives1 respectively1 & z su* is deem$ to be "p ( ! rules ( ea* ,h\se1 respectively1 b applicable only ) respect to ! proc$ure to be foll[$ 9 t ,h\se 9 ! case ( a jo9t resolution describ$ 9 subsection 7a7 & sup]s$+ o!r rules only :]e explicitly s2 & 7#b7 ) full recognition ( ! ,con/itutional "r ( ei!r ,h\se to *ange ! rules 7s f> z !y relate to ! proc$ure ( t ,h\se7 at any "t1 9 ! same mann] & to ! same ext5t z 9 ! case ( any o!r rule ( t ,h\se4 #ibc4 ,congressional disapproval proc$ure = nonmajor rules 7a7 ,= purposes ( ?is section1 ! t]m jo9t resolution means only a jo9t resolution introduc$ 9 ! p]iod beg9n+ on ! date on :i* ! report ref]r$ to 9 section #iba7;a77#a77;,a7 is receiv$ by ,congress & end+ #fj days !reaft] 7exclud+ days ei!r ,h\se ( ,congress is adj\rn$ = m ?an #c days dur+ a session ( ,congress71 ! matt] aft] ! resolv+ clause ( :i* is z foll[s3 ,t ,congress disapproves ! nonmajor rule submitt$ by ! relat+ to 1 & su* rule %all h no =ce or effect4 7,! blank spaces be+ appropriately fill$ 974 7b7 ,a jo9t resolution describ$ 9 subsection 7a7 %all be ref]r$ to ! committees 9 ea* ,h\se ( ,congress ) jurisdiction4 7c7 ,9 ! ,s5ate1 if ! committee to :i* is ref]r$ a jo9t resolution describ$ 9 subsection 7a7 has n report$ su* jo9t resolution 7or an id5tical jo9t resolution7 at ! end ( #ae session days aft] ! date ( introduction ( ! jo9t resolution1 su* committee may be dis*>g$ f fur!r consid]ation ( su* jo9t resolution ^u a petition support$ 9 writ+ by #cj ,memb]s ( ! ,s5ate1 & su* jo9t resolution %all be plac$ on ! cal5d>4 7d7 7#a7 ,9 ! ,s5ate1 :5 ! committee to :i* a jo9t resolution is ref]r$ has report$1 or :5 a committee is dis*>g$ 7"u subsection 7c77 f fur!r consid]ation ( a jo9t resolution describ$ 9 subsection 7a71 x is at any "t !reaft] 9 ord] 7ev5 ?\gh a previ\s motion to ! same effect has be5 disagre$ to7 = a motion to proce$ to ! consid]ation ( ! jo9t resolution1 & all po9ts ( ord] aga9/ ! jo9t resolution 7& aga9/ consid]ation ( ! jo9t resolution7 are waiv$4 ,! motion is n subject to am5dm5t1 or to a motion to po/pone1 or to a motion to proce$ to ! consid]ation ( o!r bus9ess4 ,a motion to reconsid] ! vote by :i* ! motion is agre$ to or disagre$ to %all n be 9 ord]4 ,if a motion to proce$ to ! consid]ation ( ! jo9t resolution is agre$ to1 ! jo9t resolution %all rema9 ! unf9i%$ bus9ess ( ! ,s5ate until dispos$ (4 7#b7 ,9 ! ,s5ate1 debate on ! jo9t resolution1 & on all debatable motions & appeals 9 connection !re)1 %all be limit$ to n m ?an #aj h\rs1 :i* %all be divid$ equally betwe5 ^? favor+ & ^? oppos+ ! jo9t resolution4 ,a motion to fur!r limit debate is 9 ord] & n debatable4 ,an am5dm5t to1 or a motion to po/pone1 or a motion to proce$ to ! consid]ation ( o!r bus9ess1 or a motion to recommit ! jo9t resolution is n 9 ord]4 7#c7 ,9 ! ,s5ate1 imm$iately foll[+ ! conclusion ( ! debate on a jo9t resolution describ$ 9 subsection 7a71 & a s+le quorum call at ! conclusion ( ! debate if reque/$ 9 accordance ) ! rules ( ! ,s5ate1 ! vote on f9al passage ( ! jo9t resolution %all occur4 7#d7 ,appeals f ! decisions ( ! ,*air relat+ to ! application ( ! rules ( ! ,s5ate to ! proc$ure relat+ to a jo9t resolution describ$ 9 subsection 7a7 %all be decid$ )\t debate4 7e7 ,9 ! ,s5ate1 ! proc$ure specifi$ 9 subsection 7c7 or 7d7 %all n apply to ! consid]ation ( a jo9t resolution respect+ a nonmajor rule-- 7#a7 aft] ! expiration ( ! #fj session days beg9n+ ) ! applicable submission or publication date2 or 7#b7 if ! report "u section #iba7;a77#a77;,a7 0 submitt$ dur+ ! p]iod ref]r$ to 9 section #iba7;d77#a71 aft] ! expiration ( ! #fj session days beg9n+ on ! #ae? session day aft] ! succe$+ session ( ,congress fir/ conv5es4 7f7 ,if1 be=e ! passage by "o ,h\se ( a jo9t resolution ( t ,h\se describ$ 9 subsection 7a71 t ,h\se receives f ! o!r ,h\se a jo9t resolution describ$ 9 subsection 7a71 !n ! foll[+ proc$ures %all apply3 7#a7 ,! jo9t resolution ( ! o!r ,h\se %all n be ref]r$ to a committee4 7#b7 ,) respect to a jo9t resolution describ$ 9 subsection 7a7 ( ! ,h\se receiv+ ! jo9t resolution-- 7,a7 ! proc$ure 9 t ,h\se %all be ! same z if no jo9t resolution _h be5 receiv$ f ! o!r ,h\se2 b 7,b7 ! vote on f9al passage %all be on ! jo9t resolution ( ! o!r ,h\se4 #ibd4 ,def9itions ,= purposes ( ?is *apt]3 7#a7 ,! t]m major rule means any rule ( ! ,food & ,drug ,adm9i/ration1 includ+ an int]im f9al rule1 t ! ,adm9i/rator ( ! ,(fice ( ,in=mation & ,regulatory ,affairs ( ! ,(fice ( ,managem5t & ,budget f9ds has result$ 9 or is likely to result 9-- 7,a7 an annual co/ on ! economy ( #ajj1jjj1jjj or m1 adju/$ annually = inflation2 7,b7 a major increase 9 co/s or prices = consum]s1 individual indu/ries1 ,f$]al1 ,/ate1 or local gov]nm5t ag5cies1 or geographic regions2 or 7,c7 significant adv]se effects on competition1 employm5t1 inve/m5t1 productivity1 innovation1 or on ! ability ( ,unit$ ,/ates-bas$ ent]prises to compete ) =eign-bas$ ent]prises 9 dome/ic & export m>kets4 7#b7 ,! t]m nonmajor rule means any rule ( ! ,food & ,drug ,adm9i/ration t is n a major rule4 7#c7 ,! t]m rule has ! mean+ giv5 su* t]m 9 section #eea1 except t su* t]m does n include-- 7,a7 any rule ( p>ticul> applicability2 7,b7 any rule relat+ to ag5cy managem5t or p]sonnel2 or 7,c7 any rule ( ag5cy organization1 proc$ure1 or practice t does n sub/antially affect ! rights or obligations ( non-ag5cy p>ties4 7#d7 ,! t]m submission date or publication date1 except z o!rwise provid$ 9 ?is *apt]1 means-- 7,a7 9 ! case ( a major rule1 ! date on :i* ! ,congress receives ! report submitt$ "u section #iba7;a77#a72 & 7,b7 9 ! case ( a nonmajor rule1 ! lat] (-- 7i7 ! date on :i* ! ,congress receives ! report submitt$ "u section #iba7;a77#a72 & 7ii7 ! date on :i* ! nonmajor rule is publi%$ 9 ! ,f$]al ,regi/]1 if s publi%$4 #ibe4 ,judicial review 7a7 ,no det]m9ation1 f9d+1 action1 or omission "u ?is *apt] %all be subject to judicial review4 7b7 ,not)/&+ subsection 7a71 a c\rt may det]m9e :e!r ! ,food & ,drug ,adm9i/ration has complet$ ! necess>y requirem5ts "u ?is *apt] = a rule to take effect4 7c7 ,! enactm5t ( a jo9t resolution ( approval "u section #ibb %all n be int]pret$ to s]ve z a grant or modification ( /atutory au?ority by ,congress = ! promulgation ( a rule1 %all n ext+ui% or affect any claim1 :e!r sub/antive or proc$ural1 aga9/ any alleg$ defect 9 a rule1 & %all n =m "p ( ! record be=e ! c\rt 9 any judicial proce$+ conc]n+ a rule except = purposes ( det]m9+ :e!r or n ! rule is 9 effect4 #ibf4 ,exemption = monet>y policy ,no?+ 9 ?is *apt] %all apply to rules t conc]n monet>y policy propos$ or implem5t$ by ! ,bo>d ( ,gov]nors ( ! ,f$]al ,res]ve ,sy/em or ! ,f$]al ,op5 ,m>ket ,committee4 #ibg4 ,effective date ( c]ta9 rules ,not)/&+ section #iba1 any rule o!r ?an a major rule :i* ! ,food & ,drug ,adm9i/ration = good cause f9ds 7& incorporates ! f9d+ & a brief /atem5t ( reasons !re=e 9 ! rule issu$7 t notice & public proc$ure !reon are impracticable1 unnecess>y1 or contr>y to ! public int]e/1 %all take effect at su* "t z ! ,food & ,drug ,adm9i/ration det]m9es4 #ibh4 ,regulatory cut-g requirem5t ,9 mak+ any new rule1 ! ,food & ,drug ,adm9i/ration %all id5tify a rule or rules t may be am5d$ or repeal$ to completely (fset any annual co/s ( ! new rule to ! ,unit$ ,/ates economy4 ,be=e ! new rule may take effect1 ! ,food & ,drug ,adm9i/ration %all make ea* su* repeal or am5dm5t4 ,9 mak+ su* an am5dm5t or repeal1 ! ,food & ,drug ,adm9i/ration %all comply ) ! requirem5ts ( sub*apt] ,,ii ( *apt] #e1 b ! ,food & ,drug ,adm9i/ration may consolidate proce$+s "u sub*apt] ,,ii 7( *apt] #e7 ) proce$+s on ! new rule4 #ibi4 ,review ( rules curr5tly 9 effect 7a7 ,annual review ,beg9n+ on ! date t is #f mon?s aft] ! date ( enactm5t ( ?is section & annually !reaft] = ! #i ye>s foll[+1 ! ,food & ,drug ,adm9i/ration %all designate n less ?an #aj p]c5t ( eligible rules made by ! ,food & ,drug ,adm9i/ration = review1 & %all submit a report includ+ ea* su* eligible rule 9 ! same mann] z a report "u section #iba7;a77#a74 ,section #iba1 section #ibb1 & section #ibc %all apply to ea* su* rule1 subject to subsection 7c7 ( ?is section4 ,no eligible rule previ\sly designat$ may be designat$ aga94 7b7 ,sunset = eligible rules n ext5d$ ,beg9n+ aft] ! date t is #aj ye>s aft] ! date ( enactm5t ( ?is section1 if ,congress has n enact$ a jo9t resolution ( approval = t eligible rule1 t eligible rule %all n cont9ue 9 effect4 7c7 ,consolidation2 sev]ability ,9 apply+ sections #iba1 #ibb1 & #ibc to eligible rules "u ?is section1 ! foll[+ %all apply3 7#a7 ,! words take effect %all be read z cont9ue 9 effect4 7#b7 ,except z provid$ 9 p>agraph 7#c71 a s+le jo9t resolution ( approval %all apply to all eligible rules 9 a report designat$ = a ye>1 & ! matt] aft] ! resolv+ clause ( t jo9t resolution is z foll[s3 ,t ,congress approves ! rules submitt$ by ! = ! ye> 4 7,! blank spaces be+ appropriately fill$ 974 7#c7 ,x %all be 9 ord] to consid] any am5dm5t t provides = specific conditions on :i* ! approval ( a p>ticul> eligible rule includ$ 9 ! jo9t resolution is cont+5t4 7#d7 ,a memb] ( ei!r ,h\se may move t a sep>ate jo9t resolution be requir$ = a specifi$ rule4 7d7 ,def9ition ,9 ?is section1 ! t]m eligible rule means a rule t is 9 effect z ( ! date ( enactm5t ( ?is section4 4 7b7 ,budget>y effects ( rules subject to section #ibb ( title #e1 ,unit$ ,/ates ,code ,section #beg7;b77#b7 ( ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,budget>y effects ( rules subject to section #ibb ( title #e1 ,unit$ ,/ates ,code ,any rules subject to ! congressional approval proc$ure set =? 9 section #ibb ( *apt] #h ( title #e1 ,unit$ ,/ates ,code1 affect+ budget au?ority1 outlays1 or receipts %all be assum$ to be effective unless x is n approv$ 9 accordance ) su* section4 4 7c7 ,gov]nm5t ,acc\ntability ,(fice /udy ( rules 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to det]m9e1 z ( ! date ( ! enactm5t ( ?is ,act-- 7,a7 h[ _m rules 7z su* t]m is def9$ 9 section #ibd ( title #e1 ,unit$ ,/ates ,code7 ( ! ,food & ,drug ,adm9i/ration 7 9 effect2 7,b7 h[ _m major rules 7z su* t]m is def9$ 9 section #ibd ( title #e1 ,unit$ ,/ates ,code7 ( ! ,food & ,drug ,adm9i/ration 7 9 effect2 & 7,c7 ! total e/imat$ economic co/ impos$ by all su* rules4 7#b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ,congress t conta9s ! f9d+s ( ! /udy conduct$ "u p>agraph 7#a74 7d7 ,effective date ,subsections 7a7 & 7b71 & ! am5dm5ts made by su* sections1 %all take effect beg9n+ on ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #cei4 ,gov]nm5t ,acc\ntability ,(fice /udy ( rules 7a7 ,9 g5]al ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy to det]m9e1 z ( ! date ( ! enactm5t ( ?is ,act-- 7#a7 h[ _m rules 7z su* t]m is def9$ 9 section #hjd ( title #e1 ,unit$ ,/ates ,code7 7 9 effect2 7#b7 h[ _m major rules 7z su* t]m is def9$ 9 section #hjd ( title #e1 ,unit$ ,/ates ,code7 7 9 effect2 & 7#c7 ! total e/imat$ economic co/ impos$ by all su* rules4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ,congress t conta9s ! f9d+s ( ! /udy conduct$ "u subsection 7a74 ,d ,prescription ,drug & ,ph>macy ,b5efit ,manag] ,transp>5cy #cfa4 ,pat5t disclosure requirem5ts 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 ( ?is subsection1 )9 #cj 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 approv$ "u section #cea ( ! ,,phsa ,n lat] ?an #cj days aft] ! date ( enactm5t ( ! ,fair ,c>e ,act ( #bjbj1 ! 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 #bjba1 ! 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 #bjba1 %all submit a li/ ( ea* pat5t requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c774 7,c7 ,updates ,! hold] ( a biological product lic5se approv$ "u subsection 7a7 or 7k7 %all submit to ! ,secret>y a li/ t includes-- 7i7 any pat5t fir/ requir$ to be disclos$ 7z describ$ 9 p>agraph 7#c77 aft] ! submission "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>agraph ) respect to ! biological product subsequ5tly det]m9$ to be invalid or un5=ceable1 )9 #cj days ( a det]m9ation ( pat5t invalidity4 7#b7 ,publication ( in=mation 7,a7 ,9 g5]al ,)9 #a ye> ( ! date ( enactm5t ( ! ,fair ,c>e ,act ( #bjbj1 ! ,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 #bjba2 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$2 7vi7 any p]iod ( any exclusivity "u subsection 7k77#g77;,a7 or subsection 7k77#g77;,b7 ( ?is section or section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & any ext5sion ( su* p]iod 9 accordance ) subsection 7m7 ( ?is section ) respect to ea* su* biological product1 & ! date on :i* su* exclusivity expires2 7vii7 in=mation reg>d+ any det]m9ation relat$ to 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 ,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 #bjba1 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 ,re/riction on claims ( pat5t infr+em5t ,section #bga7;e7 ( title #ce1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,! own] ( a pat5t t %\ld h be5 includ$ 9 ! li/ describ$ 9 section #cea7o77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7o77#a771 includ+ any updates requir$ "u subp>agraph 7,c7 ( t section1 b 0 n timely includ$ 9 su* li/1 may n br+ an action "u ?is section = infr+em5t ( ! pat5t4 4 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 #cfb4 ,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 ( ! ,fair ,c>e ,act ( #bjbj1 )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 ( ! ,fair ,c>e ,act ( #bjbj1 ! 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 ( ! ,fair ,c>e ,act ( #bjbj1 ! ,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 ( ! ,fair ,c>e ,act ( #bjbj1 ! ,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 #cfc4 ,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 ! prec$+ sections1 is am5d$ 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 #cfd4 ,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 ( ! ,fair ,c>e ,act ( #bjbj & 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 #cfe4 ,requirem5ts ) respect to prescription drug b5efits 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 ,requirem5ts ) respect to prescription drug b5efits ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all n1 & %all ensure t any entity t provides ph>macy b5efits managem5t s]vices "u a contract ) any su* heal? plan or heal? insurance cov]age does n1 receive f a drug manufactur] a r$uction 9 price or o!r remun]ation ) respect to any prescription drug receiv$ by an enrollee 9 ! plan or cov]age & cov]$ by ! plan or cov]age1 unless-- 7#a7 any su* r$uction 9 price is reflect$ at ! po9t ( sale to ! enrollee2 & 7#b7 any su* o!r remun]ation is a flat fee-bas$ s]vice fee t a manufactur] ( prescription drugs pays to a ph>macy b5efit manag] = s]vices r5d]$ to ! manufactur] t relate to arrangem5ts by ! ph>macy b5efit manag] to provide ph>macy b5efit managem5t s]vices to a heal? plan or heal? insurance issu]1 if c]ta9 conditions e/abli%$ by ! ,secret>y are met1 includ+ requirem5ts t ! fees are transp>5t to ! heal? plan or heal? insurance issu]4 4 7b7 ,effective date ,section #bgbi;,a ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a71 %all take effect on ,janu>y #a1 #bjba4 #cff4 ,,pbm transp>5cy & elim9ation ( ,,dir fees 7a7 ,prohibit+ m$ic>e ,,pdp sponsors & ,,ma-,,pd organizations f retroactively r$uc+ paym5t on clean claims submitt$ by ph>macies 7#a7 ,9 g5]al ,section #ahfj;,d-#ab7;b77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#d77;,a77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iv7 ,prohibit+ retroactive r$uctions 9 paym5ts on clean claims ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all provide t aft] ! date ( receipt ( a clean claim submitt$ by a ph>macy1 ! ,,pdp sponsor 7or an ag5t ( ! ,,pdp sponsor7 may n retroactively r$uce paym5t on su* claim directly or indirectly ?r\gh aggregat$ effective rate or o!rwise except 9 ! case su* claim is f\nd to n be a clean claim 7su* z 9 ! case ( a claim lack+ requir$ sub/antiat+ docum5tation7 dur+ ! c\rse ( a r\t9e audit z p]mitt$ pursuant to writt5 agreem5t betwe5 ! ,,pdp sponsor 7or su* an ag5t7 & su* ph>macy4 ,! previ\s s5t5ce %all n prohibit any retroactive increase 9 paym5t to a ph>macy pursuant to a writt5 agreem5t betwe5 a ,,pdp sponsor 7or an ag5t ( su* sponsor7 & su* ph>macy4 4 7#b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to contracts ent]$ into on or aft] ,janu>y #a1 #bjba4 7b7 ,elim9ation ( ,,dir fees 7#a7 ,ph>macy b5efits manag] /&>ds "u ! ,m$ic>e program = prescription drug plans & ,,ma-,,pd plans 7,a7 ,9 g5]al ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,ph>macy b5efits manag] transp>5cy requirem5ts ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor or ) an ,,ma organization (f]+ an ,,ma-,,pd plan "u "p ,c %all provide t ! sponsor or organization1 respectively1 may n ent] into a contract ) any ph>macy b5efits manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm7 to manage ! prescription drug cov]age provid$ "u su* plan1 or to control ! co/s ( ! prescription drug cov]age "u su* plan1 unless ! ,,pbm adh]es to ! foll[+ crit]ia :5 h&l+ p]sonally id5tifiable utilization & claims data or o!r s5sitive pati5t data3 7,a7 ,! ,,pbm may n transmit any p]sonally id5tifiable utilization1 protect$ heal? in=mation1 or claims data1 ) respect to a plan enrollee1 to a ph>macy own$ by a ,,pbm if ! plan enrollee has n volunt>ily elect$ 9 writ+ or via secure electronic means to fill t p>ticul> prescription at ! ,,pbm-own$ ph>macy4 7,b7 ,! ,,pbm may n require t a plan enrollee use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm1 or provide an inc5tive to a plan enrollee to enc\rage ! enrollee to use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm1 if ! inc5tive is applicable only to su* ph>macies4 4 7,b7 ,regul> update ( prescription drug pric+ /&>d ,p>agraph 7#f7 ( section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ to read z foll[s3 7#f7 ,regul> update ( prescription drug pric+ /&>d 7,a7 ,9 g5]al ,if ! ,,pdp sponsor ( a prescription drug plan 7or ,,ma organization (f]+ an ,,ma-,,pd plan7 uses a /&>d = reimbursem5t 7z describ$ 9 subp>agraph 7,b77 ( ph>macies bas$ on ! co/ ( a drug1 ea* contract ent]$ into ) su* sponsor "u ?is "p 7or organization "u "p ,c7 ) respect to ! plan %all provide t ! sponsor 7or organization7 %all-- 7i7 update su* /&>d n less frequ5tly ?an once e #g days1 beg9n+ ) an initial update on ,janu>y #a ( ea* ye>1 to accurately reflect ! m>ket price ( acquir+ ! drug2 7ii7 disclose to applicable ph>macies & ! contract+ entities ( su* ph>macies ! s\rces us$ = mak+ any su* update imm$iately )\t requirem5t ( reque/2 7iii7 if ! s\rce = su* a /&>d = reimbursem5t is n publicly available1 disclose to ! applicable ph>macies & ! respective contract+ entities ( su* ph>macies all individual drug prices to be s updat$ 9 advance ( ! use ( su* prices = ! reimbursem5t ( claims2 7iv7 e/abli% a process to appeal1 inve/igate1 & resolve disputes reg>d+ individual drug prices t are less ?an ! ph>macy acquisition price = su* drug1 :i* mu/ be adjudicat$ )9 #g days ( ! ph>macy fil+ its appeal2 & 7v7 provide all su* pric+ data 9 an 4xml spread%eet =mat or a comp>able easily accessible & complete spread%eet =mat4 7,b7 ,prescription drug pric+ /&>d def9$ ,= purposes ( subp>agraph 7,a71 a /&>d = reimbursem5t ( a ph>macy is any me?odology or =mula = v>y+ ! pric+ ( a drug or drugs dur+ ! t]m ( ! ph>macy reimbursem5t contract t is bas$ on ! co/ ( ! drug involv$1 includ+ drug pric+ ref]5ces & am\nts t are bas$ ^u av]age :olesale price1 :olesale av]age co/1 av]age manufactur] price1 av]age sales price1 maximum all[able co/ 7,,mac71 or o!r co/s1 :e!r publicly available or n4 4 7,c7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 7#b7 ,regul> update ( prescription drug pric+ /&>d "u ,,tric>e retail ph>macy program ,section #ajgd;g7d7 ( title #aj1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,to ! ext5t practicable1 ) respect to ! ,,tric>e retail ph>macy program describ$ 9 subsection 7a77#b77;,e77ii71 ! ,secret>y %all ensure t a contract ent]$ into ) a ,,tric>e manag$ c>e support contractor includes requirem5ts describ$ 9 section #ahfj;,d-#ab7;b77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#f77 to ensure ! provision ( in=mation reg>d+ ! pric+ /&>d = prescription drugs4 4 7#c7 ,prescription drug transp>5cy 9 ! ,f$]al ,employees ,heal? ,b5efits program 7,a7 ,9 g5]al ,section #hijb ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new subsections3 7p7 ,a contract may n be made or a plan approv$ "u ?is *apt] "u :i* a c>ri] has an agreem5t ) a ph>macy b5efits manag] 79 ?is subsection ref]r$ to z a ,,pbm7 to manage prescription drug cov]age or to control ! co/s ( ! prescription drug cov]age unless ! c>ri] & ,,pbm adh]e to ! foll[+ crit]ia3 7#a7 ,! ,,pbm may n transmit any p]sonally id5tifiable utilization1 protect$ heal? in=mation1 or claims data ) respect to an individual enroll$ "u su* contract or plan to a ph>macy own$ by ! ,,pbm if ! individual has n volunt>ily elect$ 9 writ+ or via secure electronic means to fill t p>ticul> prescription at su* a ph>macy4 7#b7 ,! ,,pbm may n require t an individual enroll$ "u su* contract or plan use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm or provide an inc5tive to a plan enrollee to enc\rage ! enrollee to use a retail ph>macy1 mail ord] ph>macy1 specialty ph>macy1 or o!r ph>macy entity provid+ ph>macy s]vices 9 :i* ! ,,pbm has an own]%ip int]e/ or t has an own]%ip int]e/ 9 ! ,,pbm1 if ! inc5tive is applicable only to su* ph>macies4 7q7 7#a7 ,if a contract made or plan approv$ "u ?is *apt] provides = a /&>d = reimbursem5t 7z describ$ 9 p>agraph 7#b77 ) respect to a prescription drug plan1 su* contract or plan %all provide t ! applicable c>ri]-- 7,a7 update su* /&>d n less frequ5tly ?an once e #g days1 beg9n+ ) an initial update on ,janu>y #a ( ea* ye>1 to accurately reflect ! m>ket price ( acquir+ ! drug2 7,b7 disclose to applicable ph>macies & ! contract+ entities ( su* ph>macies ! s\rces us$ = mak+ any su* update imm$iately )\t requirem5t ( reque/2 7,c7 if ! s\rce = su* a /&>d = reimbursem5t is n publicly available1 disclose to ! applicable ph>macies & contract+ entities ( su* ph>macies all individual drug prices to be s updat$ 9 advance ( ! use ( su* prices = ! reimbursem5t ( claims2 7,d7 e/abli% a process to appeal1 inve/igate1 & resolve disputes reg>d+ individual drug prices t are less ?an ! ph>macy acquisition price = su* drug1 :i* mu/ be adjudicat$ )9 #g days ( ! ph>macy fil+ its appeal2 & 7,e7 provide all su* pric+ data 9 an 4xml spread%eet =mat or a comp>able easily accessible & complete spread%eet =mat4 7#b7 ,= purposes ( p>agraph 7#a71 a /&>d = reimbursem5t ( a ph>macy is any me?odology or =mula = v>y+ ! pric+ ( a drug or drugs dur+ ! t]m ( ! ph>macy reimbursem5t contract t is bas$ on ! co/ ( ! drug involv$1 includ+ drug pric+ ref]5ces & am\nts t are bas$ ^u av]age :olesale price1 :olesale av]age co/1 av]age manufactur] price1 av]age sales price1 maximum all[able co/1 or o!r co/s1 :e!r publicly available or n4 4 7,b7 ,application ,! am5dm5t made by subp>agraph 7,a7 %all apply to any contract ent]$ into "u section #hijb ( title #e1 ,unit$ ,/ates ,code1 on or aft] ! date ( enactm5t ( ?is section4 #cfg4 ,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 ! prec$+ sections1 is fur!r am5d$ 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 ( ! ,fair ,c>e ,act ( #bjbj1 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>macy4 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 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 4 #cfh4 ,/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 ,e ,m$ic>e & ,m$icaid ,prescription ,drug ,re=ms #cga4 ,m$ic>e "p ,b rebate by manufactur]s = drugs or biologicals ) prices increas+ fa/] ?an inflation 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,rebate by manufactur]s = drugs or biologicals ) prices increas+ fa/] ?an inflation 7#a7 ,requirem5ts 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #f mon?s aft] ! end ( ea* rebate p]iod 7z def9$ 9 p>agraph 7#b77;,a77 beg9n+ on or aft] ,janu>y #a1 #bjba1 ! ,secret>y %all1 = ea* rebatable drug 7z def9$ 9 p>agraph 7#b77;,b771 report to ea* manufactur] ( su* rebatable drug ! foll[+ = su* rebate p]iod3 7i7 ,in=mation on ! total numb] ( units ( ! bill+ & paym5t code describ$ 9 subp>agraph 7,a77i7 ( p>agraph 7#c7 ) respect to su* rebatable drug & rebate p]iod4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age sales price increase describ$ 9 subp>agraph 7,a77ii7 ( su* p>agraph = su* rebatable drug & rebate p]iod4 7iii7 ,! rebate am\nt specifi$ "u su* p>agraph = su* rebatable drug & rebate p]iod4 7,b7 ,manufactur] rebate 7i7 ,9 g5]al ,subject to clause 7ii71 = ea* rebate p]iod beg9n+ on or aft] ,janu>y #a1 #bjba1 ! manufactur] ( a rebatable drug %all1 = su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation & rebate am\nt pursuant to subp>agraph 7,a7 = su* rebate p]iod1 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* rebate p]iod4 7ii7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u ?is subp>agraph ) respect to a rebatable drug t is li/$ on ! drug %ortage li/ ma9ta9$ by ! ,food & ,drug ,adm9i/ration pursuant to section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,c7 ,reque/ = reconsid]ation ,! ,secret>y %all e/abli% proc$ures "u :i* a manufactur] ( a rebatable drug may reque/ a reconsid]ation by ! ,secret>y ( ! rebate am\nt specifi$ "u p>agraph 7#c7 = su* rebatable drug & rebate p]iod1 z report$ to ! manufactur] pursuant to subp>agraph 7,a77iii74 7#b7 ,rebate p]iod & rebatable drug def9$ ,9 ?is subsection3 7,a7 ,rebate p]iod ,! t]m rebate p]iod means a cal5d> qu>t] beg9n+ on or aft] ,janu>y #a1 #bjba4 7,b7 ,rebatable drug ,! t]m rebatable drug means a s+le s\rce drug or biological 7o!r ?an a biosimil> biological product7-- 7i7 describ$ 9 section #ahdb7o77#a77;,c7 = :i* ! paym5t am\nt is provid$ "u ?is section2 or 7ii7 = :i* paym5t is made sep>ately "u section #ahcc7;i7 or section #ahcc7t7 & = :i* ! paym5t am\nt is calculat$ bas$ on ! paym5t am\nt "u ?is section4 7#c7 ,rebate am\nt 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! am\nt specifi$ 9 ?is p>agraph = a rebatable drug assign$ to a bill+ & paym5t code = a rebate p]iod is1 subject to p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraph 7,b71 ! total numb] ( units ( ! bill+ & paym5t code = su* rebatable drug furni%$ dur+ ! rebate p]iod2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! am\nt det]m9$ "u subsection 7b77#d7 = su* rebatable drug dur+ ! rebate p]iod2 exce$s 7,,ii7 ! inflation-adju/$ base paym5t am\nt det]m9$ "u subp>agraph 7,c7 ( ?is p>agraph = su* rebatable drug dur+ ! rebate p]iod4 7,b7 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( units ( ! bill+ & paym5t code = rebatable drugs furni%$ dur+ a rebate p]iod %all n include units ) respect to :i* ! manufactur] provides a disc\nt "u ! program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or a rebate "u section #aibg4 7,c7 ,det]m9ation ( inflation-adju/$ paym5t am\nt ,! inflation-adju/$ paym5t am\nt det]m9$ "u ?is subp>agraph = a rebatable drug = a rebate p]iod is-- 7i7 ! am\nt det]m9$ "u subsection 7b77#d7 = su* rebatable drug 9 ! paym5t am\nt b5*m>k qu>t] 7z def9$ 9 subp>agraph 7,d772 increas$ by 7ii7 ! p]c5tage by :i* ! rebate p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,f77 = ! rebate p]iod exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,e774 7,d7 ,paym5t am\nt b5*m>k qu>t] ,! t]m paym5t am\nt b5*m>k qu>t] means ! cal5d> qu>t] beg9n+ ,july #a1 #bjai4 7,e7 ,b5*m>k p]iod cpi-u ,! t]m b5*m>k p]iod ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,july #bjai4 7,f7 ,rebate p]iod cpi-u ,! t]m rebate p]iod ,,cpi-,u means1 ) respect to a rebate p]iod1 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! la/ mon? ( ! cal5d> qu>t] t is two cal5d> qu>t]s prior to ! rebate p]iod4 7#d7 ,application to new drugs ,9 ! case ( a rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjai1 ! foll[+ %all apply3 7,a7 ,dur+ initial p]iod ,= qu>t]s dur+ ! initial p]iod 9 :i* ! paym5t am\nt = su* drug is det]m9$ us+ ! me?odology describ$ 9 subsection 7c77#d7-- 7i7 clause 7ii77,i7 ( p>agraph 7#c77;,a7 %all be appli$ z if ! ref]5ce to ! am\nt det]m9$ "u subsection 7b77#d71 7 a ref]5ce to ! :olesale acquisition co/ applicable "u subsection 7c77#d72 7ii7 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$-- 7,i7 z if ! ref]5ce to ! am\nt det]m9$ "u subsection 7b77#d71 7 a ref]5ce to ! :olesale acquisition co/ applicable "u subsection 7c77#d72 & 7,,ii7 z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! fir/ full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$2 & 7iii7 clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#d77;,e7 z if ! ref]5ce to ,july #bjai "u su* p>agraph 7 a ref]5ce to ! fir/ mon? ( ! fir/ full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$4 7,b7 ,aft] initial p]iod ,= qu>t]s beg9n+ aft] su* initial p]iod-- 7i7 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! fir/ full cal5d> qu>t] = :i* ! ,secret>y is able to compute an av]age sales price = ! rebatable drug2 & 7ii7 clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#d77;,e7 z if ! ref]5ce to ,july #bjai "u su* p>agraph 7 a ref]5ce to ! fir/ mon? ( ! fir/ full cal5d> qu>t] = :i* ! ,secret>y is able to compute an av]age sales price = ! rebatable drug4 7#e7 ,rebate deposits ,am\nts paid z rebates "u p>agraph 7#a77;,b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#f7 ,en=cem5t 7,a7 ,civil money p5alty 7i7 ,9 g5]al ,! ,secret>y %all impose a civil money p5alty on a manufactur] t fails to comply ) ! requirem5ts "u p>agraph 7#a77;,b7 ) respect to provid+ a rebate = a rebatable drug = a rebate p]iod = ea* su* failure 9 an am\nt equal to ! sum (-- 7,i7 ! rebate am\nt specifi$ pursuant to p>agraph 7#c7 = su* drug = su* rebate p]iod2 & 7,,ii7 #be p]c5t ( su* am\nt4 7ii7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7,b7 ,no paym5t = manufactur]s :o fail to pay p5alty ,if ! manufactur] ( a rebatable drug fails to pay a civil money p5alty "u subp>agraph 7,a7 ) respect to ! failure to provide a rebate = a rebatable drug = a rebate p]iod by a date specifi$ by ! ,secret>y aft] ! imposition ( su* p5alty1 no paym5t %all be available "u ?is "p = su* rebatable drug = cal5d> qu>t]s beg9n+ on or aft] su* date until ! ,secret>y det]m9es ! manufactur] has paid ! p5alty due "u su* subp>agraph4 4 7b7 ,implem5tation ,section #ahdg;,a7g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;g77 is am5d$-- 7#a7 9 p>agraph 7#d71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 det]m9ation ( ! rebate am\nt = a rebatable drug "u p>agraph 7#c7 ( subsection 7h71 includ+ ) respect to a new drug pursuant to p>agraph 7#d7 ( su* subsection1 includ+-- 7,a7 a decision by ! ,secret>y ) respect to a reque/ = reconsid]ation "u p>agraph 7#a77;,c72 & 7,b7 ! det]m9ation (-- 7i7 ! total numb] ( units ( ! bill+ & paym5t code "u p>agraph 7#c77;,a77i72 & 7ii7 ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,c74 4 7c7 ,con=m+ am5dm5t to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is am5d$ by ins]t+ or subsection 7h7 aft] section #aibg4 #cgb4 ,m>ket bas$ "p ,b pric+ index ,not)/&+ any provision ( "p ,b ( title ,,xviii ( ! ,social ,security ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices may make paym5ts = drugs payable "u su* "p bas$ on an int]national pric+ index4 ,9 us+ su* an index1 ! ,secret>y %all take into acc\nt :e!r ! m>ket ( ea* c\ntry includ$ 9 su* index is a price-controll$ or free m>ket & give m weight "u su* index to c\ntries ) m>ket-bas$ drug policies4 #cgc4 ,innovation model te/+ ( ,m$ic>e drug paym5ts ,not)/&+ any provision ( section #aaae;,a1 ! ,secret>y ( ,heal? & ,human ,s]vices may1 "u su* section1 te/ a model to integrate b5efits provid$ = drugs "u p>ts ,a1 ,b1 & ,d ( title ,,xviii ( ! ,social ,security ,act4 #cgd4 ,modification ( maximum rebate am\nt "u ,m$icaid drug rebate program 7a7 ,9 g5]al ,subp>agraph 7,d7 ( section #aibg7;c77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77 is am5d$ to read z foll[s3 7,d7 ,maximum rebate am\nt 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 9 no case %all ! sum ( ! am\nts appli$ "u p>agraph 7#a77;,a77ii7 & ?is p>agraph ) respect to ea* dosage =m & /r5g? ( a s+le s\rce drug or an innovator multiple s\rce drug = a rebate p]iod exce$-- 7,i7 = rebate p]iods beg9n+ aft] ,decemb] #ca1 #bjji1 & be=e ,septemb] #cj1 #bjbb1 #ajj p]c5t ( ! av]age manufactur] price ( ! drug2 & 7,,ii7 = rebate p]iods beg9n+ on or aft] ,octob] #a1 #bjbb1 #abe p]c5t ( ! av]age manufactur] price ( ! drug4 7ii7 ,no maximum am\nt = drugs if ,,amp increases outpace inflation 7,i7 ,9 g5]al ,if ! av]age manufactur] price ) respect to ea* dosage =m & /r5g? ( a s+le s\rce drug or an innovator multiple s\rce drug increases on or aft] ,octob] #a1 #bjba1 & su* increas$ av]age manufactur] price exce$s ! inflation-adju/$ av]age manufactur] price det]m9$ ) respect to su* drug "u subclause 7,,ii7 = ! rebate p]iod1 clause 7i7 %all n apply & !re %all be no limitation on ! sum ( ! am\nts appli$ "u p>agraph 7#a77;,a77ii7 & ?is p>agraph = ! rebate p]iod ) respect to ea* dosage =m & /r5g? ( ! s+le s\rce drug or innovator multiple s\rce drug4 7,,ii7 ,inflation-adju/$ av]age manufactur] price def9$ ,9 ?is clause1 ! t]m inflation-adju/$ av]age manufactur] price means1 ) respect to a s+le s\rce drug or an innovator multiple s\rce drug & a rebate p]iod1 ! av]age manufactur] price = ea* dosage =m & /r5g? ( ! drug = ! cal5d> qu>t] beg9n+ ,july #a1 #aiij 7)\t reg>d to :e!r or n ! drug has be5 sold or transf]r$ to an entity1 includ+ a division or subsidi>y ( ! manufactur]1 aft] ! #a/ day ( su* qu>t]71 increas$ by ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! mon? be=e ! mon? 9 :i* ! rebate p]iod beg9s exce$s su* index = ,septemb] #aiij4 4 7b7 ,treatm5t ( subsequ5tly approv$ drugs ,section #aibg7;c77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,b77 is am5d$ by ins]t+ & clause 7ii77,,ii7 ( subp>agraph 7,d7 aft] clause 7ii77,,ii7 ( subp>agraph 7,a74 7c7 ,te*nical am5dm5ts ,section #aibg7;c77#c77;,c77ii77,,iv7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#i7;c77#c77;,c77ii77,,iv77 is am5d$-- 7#a7 by /rik+ subp>agraph 7,a7 & ins]t+ p>agraph 7#c77;,a72 & 7#b7 by /rik+ ?is subp>agraph & ins]t+ p>agraph 7#c77;,c74 ,f ,m$ical ,malpractice ,re=m #cha4 ,def9itions ,9 ?is ,act3 7#a7 ,alt]native dispute resolution sy/em2 ,,adr ,! t]m alt]native dispute resolution sy/em or ,,adr means a sy/em t provides = ! resolution ( heal? c>e lawsuits 9 a mann] o!r ?an ?r\gh a civil action br\ght 9 a ,/ate or ,f$]al c\rt4 7#b7 ,claimant ,! t]m claimant means any p]son :o br+s a heal? c>e lawsuit1 includ+ a p]son :o ass]ts or claims a "r to legal or equitable contribution1 indemnity1 or subrogation1 aris+ out ( a heal? c>e liability claim or action1 & any p]son on ^: behalf su* a claim is ass]t$ or su* an action is br\ght1 :e!r deceas$1 incompet5t1 or a m9or4 7#c7 ,collat]al s\rce b5efits ,! t]m collat]al s\rce b5efits means any am\nt paid or reasonably likely to be paid 9 ! future to or on behalf ( ! claimant1 or any s]vice1 product1 or o!r b5efit provid$ or reasonably likely to be provid$ 9 ! future to or on behalf ( ! claimant1 z a result ( ! injury or wrongful dea?1 pursuant to-- 7,a7 any ,/ate or ,f$]al heal?1 sickness1 income-disability1 accid5t1 or work]s' comp5sation law2 7,b7 any heal?1 sickness1 income-disability1 or accid5t insurance t provides heal? b5efits or income-disability cov]age2 7,c7 any contract or agreem5t ( any gr\p1 organization1 p>tn]%ip1 or corporation to provide1 pay =1 or reimburse ! co/ ( m$ical1 hospital1 d5tal1 or income-disability b5efits2 & 7,d7 any o!r publicly or privately fund$ program4 7#d7 ,cont+5t fee ,! t]m cont+5t fee includes all comp5sation to any p]son or p]sons :i* is payable only if a recov]y is effect$ on behalf ( "o or m claimants4 7#e7 ,economic damages ,! t]m economic damages means objectively v]ifiable monet>y losses incurr$ z a result ( ! provision or use ( 7or failure to provide or use7 heal? c>e s]vices or m$ical products1 su* z pa/ & future m$ical exp5ses1 loss ( pa/ & future e>n+s1 co/ ( obta9+ dome/ic s]vices1 loss ( employm5t1 & loss ( bus9ess or employm5t opportunities1 unless o!rwise def9$ "u applicable ,/ate law4 ,9 no circum/ances %all damages = heal? c>e s]vices or m$ical products exce$ ! am\nt actually paid or incurr$ by or on behalf ( ! claimant4 7#f7 ,future damages ,! t]m future damages means any damages t are incurr$ aft] ! date ( judgm5t1 settlem5t1 or o!r resolution 7includ+ m$iation1 or any o!r =m ( alt]native dispute resolution74 7#g7 ,heal? c>e lawsuit ,! t]m heal? c>e lawsuit means any heal? c>e liability claim conc]n+ ! provision ( goods or s]vices = :i* cov]age 0 provid$ 9 :ole or 9 "p via a ,f$]al program1 subsidy or tax b5efit1 or any heal? c>e liability action conc]n+ ! provision ( goods or s]vices = :i* cov]age 0 provid$ 9 :ole or 9 "p via a ,f$]al program1 subsidy or tax b5efit1 br\ght 9 a ,/ate or ,f$]al c\rt or pursuant to an alt]native dispute resolution sy/em1 aga9/ a heal? c>e provid] reg>dless ( ! !ory ( liability on :i* ! claim is bas$1 or ! numb] ( claimants1 pla9tiffs1 def5dants1 or o!r p>ties1 or ! numb] ( claims or causes ( action1 9 :i* ! claimant alleges a heal? c>e liability claim4 ,su* t]m does n include a claim or action :i* is bas$ on crim9al liability2 :i* seeks civil f9es or p5alties paid to ,f$]al1 ,/ate1 or local gov]nm5t2 or :i* is gr\nd$ 9 antitru/4 7#h7 ,heal? c>e liability action ,! t]m heal? c>e liability action means a civil action br\ght 9 a ,/ate or ,f$]al c\rt or pursuant to an alt]native dispute resolution sy/em1 aga9/ a heal? c>e provid] reg>dless ( ! !ory ( liability on :i* ! claim is bas$1 or ! numb] ( pla9tiffs1 def5dants1 or o!r p>ties1 or ! numb] ( causes ( action1 9 :i* ! claimant alleges a heal? c>e liability claim4 7#i7 ,heal? c>e liability claim ,! t]m heal? c>e liability claim means a dem& by any p]son1 :e!r or n pursuant to ,,adr1 aga9/ a heal? c>e provid]1 includ+1 b n limit$ to1 ?ird-p>ty claims1 cross-claims1 c\nt]-claims1 or contribution claims1 :i* are bas$ ^u ! provision or use ( 7or ! failure to provide or use7 heal? c>e s]vices or m$ical products1 reg>dless ( ! !ory ( liability on :i* ! claim is bas$1 or ! numb] ( pla9tiffs1 def5dants1 or o!r p>ties1 or ! numb] ( causes ( action4 7#aj7 ,heal? c>e provid] ,! t]m heal? c>e provid] means any p]son or entity requir$ by ,/ate or ,f$]al laws or regulations to be lic5s$1 regi/]$1 or c]tifi$ to provide heal? c>e s]vices1 & be+ ei!r s lic5s$1 regi/]$1 or c]tifi$1 or exempt$ f su* requirem5t by o!r /atute or regulation1 z well z any o!r individual or entity def9$ z a heal? c>e provid]1 heal? c>e pr(essional1 or heal? c>e in/itution "u ,/ate law4 7#aa7 ,heal? c>e s]vices ,! t]m heal? c>e s]vices means ! provision ( any goods or s]vices 7includ+ safety1 pr(essional1 or adm9i/rative s]vices directly relat$ to heal? c>e7 by a heal? c>e provid]1 or by any individual work+ "u ! sup]vision ( a heal? c>e provid]1 t relates to ! diagnosis1 prev5tion1 or treatm5t ( any human disease or impairm5t1 or ! assessm5t or c>e ( ! heal? ( human be+s4 7#ab7 ,m$ical product ,! t]m m$ical product means a drug1 device1 or biological product int5d$ = humans1 & ! t]ms drug1 device1 & biological product h ! mean+s giv5 su* t]ms 9 sections #bja7;g77#a7 & #bja7;h7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7 & 7h77 & section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a771 respectively1 includ+ any compon5t or raw mat]ial us$ !re91 b exclud+ heal? c>e s]vices4 7#ac7 ,noneconomic damages ,! t]m noneconomic damages means damages = physical & emotional pa91 suff]+1 inconv5i5ce1 physical impairm5t1 m5tal angui%1 disfigurem5t1 loss ( enjoym5t ( life1 loss ( society & companion%ip1 loss ( consortium 7o!r ?an loss ( dome/ic s]vice71 h$onic damages1 injury to reputation1 & all o!r nonpecuni>y losses ( any k9d or nature incurr$ z a result ( ! provision or use ( 7or failure to provide or use7 heal? c>e s]vices or m$ical products1 unless o!rwise def9$ "u applicable ,/ate law4 7#ad7 ,recov]y ,! t]m recov]y means ! net sum recov]$ aft] d$uct+ any disbursem5ts or co/s incurr$ 9 connection ) prosecution or settlem5t ( ! claim1 includ+ all co/s paid or advanc$ by any p]son4 ,co/s ( heal? c>e incurr$ by ! pla9tiff & ! attorneys' (fice ov]head co/s or *>ges = legal s]vices are n d$uctible disbursem5ts or co/s = su* purpose4 7#ae7 ,repres5tative ,! t]m repres5tative means a legal gu>dian1 attorney1 p]son designat$ to make decisions on behalf ( a pati5t "u a m$ical p[] ( attorney1 or any p]son recogniz$ 9 law or cu/om z a pati5t's ag5t4 7#af7 ,/ate ,! t]m ,/ate means ea* ( ! sev]al ,/ates1 ! ,di/rict ( ,columbia1 ! ,commonweal? ( ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ,am]ican ,samoa1 ! ,nor!rn ,m>iana ,isl&s1 ! ,tru/ ,t]ritory ( ! ,pacific ,isl&s1 & any o!r t]ritory or possession ( ! ,unit$ ,/ates1 or any political subdivision !re(4 #chb4 ,enc\rag+ spe$y resolution ( claims 7a7 ,/atute ( limitations 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! "t = ! comm5cem5t ( a heal? c>e lawsuit %all be1 :i*ev] occurs fir/ ( ! foll[+3 7,a7 ,?ree ye>s aft] ! date ( ! occurr5ce ( ! brea* or tort4 7,b7 ,?ree ye>s aft] ! date ! m$ical or heal? c>e treatm5t t is ! subject ( ! claim is complet$4 7,c7 ,"o ye> aft] ! claimant discov]s1 or ?r\gh ! use ( reasonable dilig5ce %\ld h discov]$1 ! injury4 7#b7 ,toll+ ,9 no ev5t %all ! "t = comm5cem5t ( a heal? c>e lawsuit exce$ #c ye>s aft] ! date ( ! occurr5ce ( ! brea* or tort or #c ye>s aft] ! date ! m$ical or heal? c>e treatm5t t is ! subject ( ! claim is complet$ 7:i*ev] occurs fir/7 unless toll$ = any ( ! foll[+-- 7,a7 ^u pro( ( fraud2 7,b7 int5tional concealm5t2 or 7,c7 ! pres5ce ( a =eign body1 :i* has no !rapeutic or diagno/ic purpose or effect1 9 ! p]son ( ! injur$ p]son4 7#c7 ,actions by a m9or ,actions by a m9or %all be comm5c$ )9 #c ye>s aft] ! date ( ! occurr5ce ( ! brea* or tort or #c ye>s aft] ! date ( ! m$ical or heal? c>e treatm5t t is ! subject ( ! claim is complet$ 7:i*ev] occurs fir/7 except t actions by a m9or "u ! full age ( #f ye>s %all be comm5c$ )9 #c ye>s aft] ! date ( ! occurr5ce ( ! brea* or tort1 #c ye>s aft] ! date ( ! m$ical or heal? c>e treatm5t t is ! subject ( ! claim is complet$1 or #a ye> aft] ! injury is discov]$1 or ?r\gh ! use ( reasonable dilig5ce %\ld h be5 discov]$1 or prior to ! m9or's #h? bir?day1 :i*ev] provides a long] p]iod4 ,su* "t limitation %all be toll$ = m9ors = any p]iod dur+ :i* a p>5t or gu>dian & a heal? c>e provid] h committ$ fraud or collusion 9 ! failure to br+ an action on behalf ( ! injur$ m9or4 7b7 ,/ate flexibility ,no provision ( subsection 7a7 %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t-- 7#a7 specifies a "t p]iod ( less ?an #c ye>s aft] ! date ( injury or less ?an #a ye> aft] ! claimant discov]s1 or ?r\gh ! use ( reasonable dilig5ce %\ld h discov]$1 ! injury1 = ! fil+ ( a heal? c>e lawsuit2 7#b7 t specifies a diff]5t "t p]iod = ! fil+ ( lawsuits by a m9or2 7#c7 t trigg]s ! "t p]iod bas$ on ! date ( ! alleg$ neglig5ce2 or 7#d7 e/abli%es a /atute ( repose = ! fil+ ( a heal? c>e lawsuit4 #chc4 ,comp5sat+ pati5t injury 7a7 ,unlimit$ am\nt ( damages = actual economic losses 9 heal? c>e lawsuits ,9 any heal? c>e lawsuit1 no?+ 9 ?is ,act %all limit a claimant's recov]y ( ! full am\nt ( ! available economic damages1 not)/&+ ! limitation 9 subsection 7b74 7b7 ,additional noneconomic damages ,9 any heal? c>e lawsuit1 ! am\nt ( noneconomic damages1 if available1 %all n exce$ #bej1jjj1 reg>dless ( ! numb] ( p>ties aga9/ :om ! action is br\ght or ! numb] ( sep>ate claims or actions br\ght ) respect to ! same injury4 7c7 ,no disc\nt ( aw>d = noneconomic damages ,= purposes ( apply+ ! limitation 9 subsection 7b71 future noneconomic damages %all n be disc\nt$ to pres5t value4 ,! jury %all n be in=m$ ab\t ! maximum aw>d = noneconomic damages4 ,an aw>d = noneconomic damages 9 excess ( #bej1jjj %all be r$uc$ ei!r be=e ! entry ( judgm5t1 or by am5dm5t ( ! judgm5t aft] entry ( judgm5t1 & su* r$uction %all be made be=e acc\nt+ = any o!r r$uction 9 damages requir$ by law4 ,if sep>ate aw>ds are r5d]$ = pa/ & future noneconomic damages & ! comb9$ aw>ds exce$ #bej1jjj1 ! future noneconomic damages %all be r$uc$ fir/4 7d7 ,fair %>e rule ,9 any heal? c>e lawsuit1 ea* p>ty %all be liable = t p>ty's sev]al %>e ( any damages only & n = ! %>e ( any o!r p]son4 ,ea* p>ty %all be liable only = ! am\nt ( damages allocat$ to su* p>ty 9 direct proportion to su* p>ty's p]c5tage ( responsibility4 ,:5ev] a judgm5t ( liability is r5d]$ z to any p>ty1 a sep>ate judgm5t %all be r5d]$ aga9/ ea* su* p>ty = ! am\nt allocat$ to su* p>ty4 ,= purposes ( ?is section1 ! tri] ( fact %all det]m9e ! proportion ( responsibility ( ea* p>ty = ! claimant's h>m4 7e7 ,/ate flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t specifies a p>ticul> monet>y am\nt ( economic or noneconomic damages 7or ! total am\nt ( damages7 t may be aw>d$ 9 a heal? c>e lawsuit1 reg>dless ( :e!r su* monet>y am\nt is great] or less] ?an is provid$ = "u ?is section4 #chd4 ,maximiz+ pati5t recov]y 7a7 ,c\rt sup]vision ( %>e ( damages actually paid to claimants ,9 any heal? c>e lawsuit1 ! c\rt %all sup]vise ! arrangem5ts = paym5t ( damages to protect aga9/ conflicts ( int]e/ t may h ! effect ( r$uc+ ! am\nt ( damages aw>d$ t are actually paid to claimants4 ,9 p>ticul>1 9 any heal? c>e lawsuit 9 :i* ! attorney = a p>ty claims a f9ancial /ake 9 ! outcome by virtue ( a cont+5t fee1 ! c\rt %all h ! p[] to re/rict ! paym5t ( a claimant's damage recov]y to su* attorney1 & to r$irect su* damages to ! claimant bas$ ^u ! int]e/s ( ju/ice & pr9ciples ( equity4 ,9 no ev5t %all ! total ( all cont+5t fees = repres5t+ all claimants 9 a heal? c>e lawsuit exce$ ! foll[+ limits3 7#a7 ,=ty p]c5t ( ! fir/ #ej1jjj recov]$ by ! claimant7s74 7#b7 ,?irty-?ree & "o-?ird p]c5t ( ! next #ej1jjj recov]$ by ! claimant7s74 7#c7 ,tw5ty-five p]c5t ( ! next #ejj1jjj recov]$ by ! claimant7s74 7#d7 ,fifte5 p]c5t ( any am\nt by :i* ! recov]y by ! claimant7s7 is 9 excess ( #fjj1jjj4 7b7 ,applicability ,! limitations 9 ?is section %all apply :e!r ! recov]y is by judgm5t1 settlem5t1 m$iation1 arbitration1 or any o!r =m ( alt]native dispute resolution4 ,9 a heal? c>e lawsuit involv+ a m9or or incompet5t p]son1 a c\rt reta9s ! au?ority to au?orize or approve a fee t is less ?an ! maximum p]mitt$ "u ?is section4 ,! requirem5t = c\rt sup]vision 9 ! fir/ two s5t5ces ( subsection 7a7 applies only 9 civil actions4 7c7 ,/ate flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t specifies a less] p]c5tage or less] total value ( damages :i* may be claim$ by an attorney repres5t+ a claimant 9 a heal? c>e lawsuit4 #che4 ,au?orization ( paym5t ( future damages to claimants 9 heal? c>e lawsuits 7a7 ,9 g5]al ,9 any heal? c>e lawsuit1 if an aw>d ( future damages1 )\t r$uction to pres5t value1 equal+ or exce$+ #ej1jjj is made aga9/ a p>ty ) suffici5t insurance or o!r assets to fund a p]iodic paym5t ( su* a judgm5t1 ! c\rt %all1 at ! reque/ ( any p>ty1 ent] a judgm5t ord]+ t ! future damages be paid by p]iodic paym5ts1 9 accordance ) ! ,uni=m ,p]iodic ,paym5t ( ,judgm5ts ,act promulgat$ by ! ,national ,conf]5ce ( ,commission]s on ,uni=m ,/ate ,laws4 7b7 ,applicability ,?is section applies to all actions :i* h n be5 fir/ set = trial or retrial be=e ! effective date ( ?is ,act4 7c7 ,/ate ,flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t specifies p]iodic paym5ts = future damages at any am\nt o!r ?an #ej1jjj or t m&ates su* paym5ts abs5t ! reque/ ( ei!r p>ty4 #chf4 ,product liability = heal? c>e provid]s ,a heal? c>e provid] :o prescribes1 or :o disp5ses pursuant to a prescription1 a m$ical product approv$1 lic5s$1 or cle>$ by ! ,food & ,drug ,adm9i/ration %all n be nam$ z a p>ty to a product liability lawsuit involv+ su* product & %all n be liable to a claimant 9 a class action lawsuit aga9/ ! manufactur]1 di/ributor1 or sell] ( su* product4 #chg4 ,effect on o!r laws 7a7 ,vacc9e injury 7#a7 ,to ! ext5t t title ,,xxi ( ! ,public ,heal? ,s]vice ,act e/abli%es a ,f$]al rule ( law applicable to a civil action br\ght = a vacc9e-relat$ injury or dea?-- 7,a7 ?is ,act does n affect ! application ( ! rule ( law to su* an action2 & 7,b7 any rule ( law prescrib$ by ?is subtitle 9 conflict ) a rule ( law ( su* title ,,xxi %all n apply to su* action4 7#b7 ,if !re is an aspect ( a civil action br\ght = a vacc9e-relat$ injury or dea? to :i* a ,f$]al rule ( law "u title ,,xxi ( ! ,public ,heal? ,s]vice ,act does n apply1 !n ?is subtitle or o!rwise applicable law 7z det]m9$ "u ?is subtitle7 w apply to su* aspect ( su* action4 7b7 ,o!r ,f$]al law ,except z provid$ 9 ?is section1 no?+ 9 ?is subtitle %all be deem$ to affect any def5se available to a def5dant 9 a heal? c>e lawsuit or action "u any o!r provision ( ,f$]al law4 #chh4 ,limitation on exp]t witness te/imony 7a7 ,9 g5]al ,no p]son 9 a heal? c>e pr(ession requir+ lic5sure "u ! laws ( a ,/ate %all be compet5t to te/ify 9 any c\rt ( law to e/abli% ! foll[+ facts-- 7#a7 ! recogniz$ /&>d ( acceptable pr(essional practice & ! specialty !re(1 if any1 t ! def5dant practices1 :i* %all be ! type ( acceptable pr(essional practice recogniz$ 9 ! def5dant's community or 9 a community simil> to ! def5dant's community t 0 9 place at ! "t ! alleg$ injury or wrongful action occurr$2 7#b7 t ! def5dant act$ ) less ?an or fail$ to act ) ord9>y & reasonable c>e 9 accordance ) ! recogniz$ /&>d2 & 7#c7 t z a proximate result ( ! def5dant's neglig5t act or omission1 ! claimant suff]$ injuries :i* w\ld n o!rwise h occurr$1 unless ! p]son 0 lic5s$ to practice1 9 ! ,/ate or a contigu\s bord]+ ,/ate1 a pr(ession or specialty :i* w\ld make ! p]son's exp]t te/imony relevant to ! issues 9 ! case & _h practic$ ?is pr(ession or specialty 9 "o ( ^! ,/ates dur+ ! ye> prec$+ ! date t ! alleg$ injury or wrongful act occurr$4 7b7 ,applicability ,! requirem5ts set =? 9 subsection 7a7 %all also apply to exp]t witnesses te/ify+ = ! def5dant z rebuttal witnesses4 7c7 ,waiv] au?ority ,! c\rt may waive ! requirem5ts 9 ?is subsection if x det]m9es t ! appropriate witnesses o!rwise w\ld n be available4 #chi4 ,exp]t witness qualifications 7a7 ,9 g5]al ,9 any heal? c>e lawsuit1 an individual %all n give exp]t te/imony on ! appropriate /&>d ( practice or c>e involv$ unless ! individual is lic5s$ z a heal? pr(essional 9 "o or m ,/ates & ! individual meets ! foll[+ crit]ia3 7#a7 ,if ! p>ty aga9/ :om or on ^: behalf ! te/imony is to be (f]$ is or claims to be a speciali/1 ! exp]t witness %all specialize at ! "t ( ! occurr5ce t is ! basis = ! lawsuit 9 ! same specialty or claim$ specialty z ! p>ty aga9/ :om or on ^: behalf ! te/imony is to be (f]$4 ,if ! p>ty aga9/ :om or on ^: behalf ! te/imony is to be (f]$ is or claims to be a speciali/ :o is bo>d c]tifi$1 ! exp]t witness %all be a speciali/ :o is bo>d c]tifi$ 9 t specialty or claim$ specialty4 7#b7 ,dur+ ! #a-ye> p]iod imm$iately prec$+ ! occurr5ce ( ! action t gave rise to ! lawsuit1 ! exp]t witness %all h devot$ a majority ( ! individual's pr(essional "t to "o or m ( ! foll[+3 7,a7 ,! active cl9ical practice ( ! same heal? pr(ession z ! def5dant &1 if ! def5dant is or claims to be a speciali/1 9 ! same specialty or claim$ specialty4 7,b7 ,! in/ruction ( /ud5ts 9 an accr$it$ heal? pr(essional s*ool or accr$it$ resid5cy or cl9ical rese>* program 9 ! same heal? pr(ession z ! def5dant &1 if ! def5dant is or claims to be a speciali/1 9 an accr$it$ heal? pr(essional s*ool or accr$it$ resid5cy or cl9ical rese>* program 9 ! same specialty or claim$ specialty4 7#c7 ,if ! def5dant is a g5]al practition]1 ! exp]t witness %all h devot$ a majority ( ! witness's pr(essional "t 9 ! #a-ye> p]iod prec$+ ! occurr5ce ( ! action giv+ rise to ! lawsuit to "o or m ( ! foll[+3 7,a7 ,active cl9ical practice z a g5]al practition]4 7,b7 ,in/ruction ( /ud5ts 9 an accr$it$ heal? pr(essional s*ool or accr$it$ resid5cy or cl9ical rese>* program 9 ! same heal? pr(ession z ! def5dant4 7b7 ,lawsuits aga9/ entities ,if ! def5dant 9 a heal? c>e lawsuit is an entity t employs a p]son aga9/ :om or on ^: behalf ! te/imony is (f]$1 ! provisions ( subsection 7a7 apply z if ! p]son 7 ! p>ty or def5dant aga9/ :om or on ^: behalf ! te/imony is (f]$4 7c7 ,p[] ( c\rt ,no?+ 9 ?is section %all limit ! p[] ( ! trial c\rt 9 a heal? c>e lawsuit to disqualify an exp]t witness on gr\nds o!r ?an ! qualifications set =? "u ?is subsection4 7d7 ,limitation ,an exp]t witness 9 a heal? c>e lawsuit %all n be p]mitt$ to te/ify if ! fee ( ! witness is 9 any way cont+5t on ! outcome ( ! lawsuit4 7e7 ,/ate flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t places additional qualification requirem5ts ^u any individual te/ify+ z an exp]t witness4 #cij4 ,communications foll[+ unanticipat$ outcome 7a7 ,provid] communications ,9 any heal? c>e liability action1 any & all /atem5ts1 affirmations1 ge/ures1 or conduct express+ apology1 fault1 sympa?y1 commis]ation1 condol5ce1 compassion1 or a g5]al s5se ( b5evol5ce :i* are made by a heal? c>e provid] or an employee ( a heal? c>e provid] to ! pati5t1 a relative ( ! pati5t1 or a repres5tative ( ! pati5t & :i* relate to ! discom=t1 pa91 suff]+1 injury1 or dea? ( ! pati5t z ! result ( ! unanticipat$ outcome ( m$ical c>e %all be inadmissible = any purpose z evid5ce ( an admission ( liability or z evid5ce ( an admission aga9/ int]e/4 7b7 ,/ate flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t makes additional communications inadmissible z evid5ce ( an admission ( liability or z evid5ce ( an admission aga9/ int]e/4 #cia4 ,affidavit ( m]it 7a7 ,requir$ fil+ ,subject to subsection 7b71 ! pla9tiff 9 a heal? c>e lawsuit alleg+ neglig5ce or1 if ! pla9tiff is repres5t$ by an attorney1 ! pla9tiff's attorney %all file simultane\sly ) ! heal? c>e lawsuit an affidavit ( m]it sign$ by a heal? pr(essional :o meets ! requirem5ts = an exp]t witness "u section #bdb ( ?is ,act4 ,! affidavit ( m]it %all c]tify t ! heal? pr(essional has review$ ! notice & all m$ical records suppli$ to him or h] by ! pla9tiff's attorney conc]n+ ! allegations conta9$ 9 ! notice & %all conta9 a /atem5t ( ea* ( ! foll[+3 7#a7 ,! applicable /&>d ( practice or c>e4 7#b7 ,! heal? pr(essional's op9ion t ! applicable /&>d ( practice or c>e 0 brea*$ by ! heal? pr(essional or heal? facility receiv+ ! notice4 7#c7 ,! actions t %\ld h be5 tak5 or omitt$ by ! heal? pr(essional or heal? facility 9 ord] to h compli$ ) ! applicable /&>d ( practice or c>e4 7#d7 ,! mann] 9 :i* ! brea* ( ! /&>d ( practice or c>e 0 ! proximate cause ( ! injury alleg$ 9 ! notice4 7#e7 ,a li/+ ( ! m$ical records review$4 7b7 ,fil+ ext5sion ,^u motion ( a p>ty = good cause %[n1 ! c\rt 9 :i* ! compla9t is fil$ may grant ! pla9tiff or1 if ! pla9tiff is repres5t$ by an attorney1 ! pla9tiff's attorney an additional #bh days 9 :i* to file ! affidavit requir$ "u subsection 7a74 7c7 ,/ate flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t e/abli%es additional requirem5ts = ! fil+ ( an affidavit ( m]it or simil> pre-litigation docum5tation4 #cib4 ,notice ( int5t to comm5ce lawsuit 7a7 ,advance notice ,a p]son %all n comm5ce a heal? c>e lawsuit aga9/ a heal? c>e provid] unless ! p]son has giv5 ! heal? c>e provid] #ij days writt5 notice be=e ! action is comm5c$4 7b7 ,exceptions ,a heal? c>e lawsuit aga9/ a heal? c>e provid] fil$ )9 #f mon?s ( ! /atute ( limitations expir+ z to any claimant1 or )9 #a ye> ( ! /atute ( repose expir+ z to any claimant1 %all be exempt f compliance ) ?is section4 7c7 ,/ate flexibility ,no provision ( ?is section %all be con/ru$ to preempt any ,/ate law 7:e!r effective be=e1 on1 or aft] ! date ( ! enactm5t ( ?is ,act7 t e/abli%es a diff]5t "t p]iod = ! fil+ ( writt5 notice4 #cic4 ,limitation on liability = volunte] heal? c>e pr(essionals 7a7 ,9 g5]al ,title ,,ii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bjb et seq47 is am5d$ by ins]t+ aft] section #bbd ! foll[+3 #bbd;,a4 ,limitation on liability = volunte] heal? c>e pr(essionals 7a7 ,limitation on liability ,a physician %all n be liable "u ,f$]al or ,/ate law 9 any civil action = any h>m caus$ by an act or omission ( su* physician1 or att5d+ m$ical p]sonnel support+ su* physician1 if su* act or omission-- 7#a7 occurs 9 ! c\rse ( furni%+ qualifi$ *>ity c>e 7z su* t]m is def9$ 9 section #aii;,b ( ! ,int]nal ,rev5ue ,code ( #aihf72 & 7#b7 0 n grossly neglig5t4 7b7 ,preemption ,?is section preempts ! laws ( a ,/ate or any political subdivision ( a ,/ate to ! ext5t t su* laws are inconsi/5t ) ?is section1 unless su* laws provide great] protection f liability = a def5dant4 7c7 ,def9itions ,9 ?is section3 7#a7 ,physician ,! t]m physician has ! mean+ giv5 su* t]m by section #ahfa7r7 ( ! ,social ,security ,act4 7#b7 ,att5d+ m$ical p]sonnel ,! t]m att5d+ m$ical p]sonnel means an individual :o is lic5s$ to directly support a physician 9 furni%+ m$ical s]vices4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply to any claim fil$ to ! ext5t t x is ) respect to acts or omissions occurr+ aft] ! date ( ! enactm5t ( ?is ,act4 #cid4 ,rules ( con/ruction 7a7 ,heal? c>e lawsuits ,unless o!rwise specifi$ 9 ?is subtitle1 ! provisions gov]n+ heal? c>e lawsuits set =? 9 ?is subtitle preempt1 subject to subsections 7b7 & 7c71 ,/ate law to ! ext5t t ,/ate law prev5ts ! application ( any provisions ( law e/abli%$ by or "u ?is subtitle4 ,! provisions gov]n+ heal? c>e lawsuits set =? 9 ?is subtitle sup]s$e *apt] #aga ( title #bh1 ,unit$ ,/ates ,code1 to ! ext5t t su* *apt]-- 7#a7 provides = a great] am\nt ( damages or cont+5t fees1 a long] p]iod 9 :i* a heal? c>e lawsuit may be comm5c$1 or a r$uc$ applicability or scope ( p]iodic paym5t ( future damages1 ?an provid$ 9 ?is subtitle2 or 7#b7 prohibits ! introduction ( evid5ce reg>d+ collat]al s\rce b5efits1 or m&ates or p]mits subrogation or a li5 on collat]al s\rce b5efits4 7b7 ,protection ( ,/ates' rights & o!r laws ,any issue t is n gov]n$ by any provision ( law e/abli%$ by or "u ?is subtitle 7includ+ ,/ate /&>ds ( neglig5ce7 %all be gov]n$ by o!rwise applicable ,/ate or ,f$]al law4 7c7 ,/ate ,flexibility ,no provision ( ?is subtitle %all be con/ru$ to preempt any def5se available to a p>ty 9 a heal? c>e lawsuit "u any o!r provision ( ,/ate or ,f$]al law4 #cie4 ,effective date ,?is subtitle %all apply to any heal? c>e lawsuit br\ght 9 a ,f$]al or ,/ate c\rt1 or subject to an alt]native dispute resolution sy/em1 t is initiat$ on or aft] ! date ( ! enactm5t ( ?is subtitle1 except t any heal? c>e lawsuit aris+ f an injury occurr+ prior to ! date ( ! enactm5t ( ?is subtitle %all be gov]n$ by ! applicable /atute ( limitations provisions 9 effect at ! "t ! cause ( action accru$4 ,,iv ,m$ic>e & ,m$icaid ,re=ms ,a ,m$icaid ,re=ms #dja4 ,m$icaid paym5t re=m 7a7 ,9 g5]al ,title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is am5d$ by ins]t+ aft] section #aijc ! foll[+ section3 #aijc;,a4 ,re=m$ paym5t to ,/ates 7a7 ,re=m$ paym5t sy/em 7#a7 ,9 g5]al ,= qu>t]s beg9n+ on or aft] ! implem5tation date 7z def9$ 9 subsection 7k77#a771 9 ! case ( a ,/ate t elects 79 a "t & mann] specifi$ by ! ,secret>y7 to apply ?is section1 9 lieu ( am\nts o!rwise payable to su* ,/ate "u ?is title 7includ+ any paym5ts attributable to section #aibc71 except z o!rwise provid$ 9 ?is section1 ! am\nt payable to su* ,/ate %all be equal to ! sum ( ! foll[+3 7,a7 ,adju/$ aggregate b5efici>y-bas$ am\nt ,! aggregate b5efici>y-bas$ am\nt specifi$ 9 subsection 7b7 = ! qu>t] & ! ,/ate1 adju/$ "u subsection 7e74 7,b7 ,*ronic c>e quality bonus ,! am\nt 7if any7 ( ! *ronic c>e quality bonus paym5t specifi$ 9 subsection 7f7 = ! qu>t] = ! ,/ate4 7#b7 ,requirem5t ( ,/ate %>e 7,a7 ,9 g5]al ,a ,/ate %all make1 f non-,f$]al funds1 exp5ditures 9 an am\nt equal to its ,/ate %>e 7z det]m9$ "u subp>agraph 7,b77 = a qu>t] = items1 s]vices1 & o!r co/s = :i*1 b = p>agraph 7#a71 ,f$]al funds w\ld h be5 payable "u ?is title4 7,b7 ,/ate %>e ,! ,/ate %>e = a ,/ate = a qu>t] 9 a fiscal ye> is equal to ! product (-- 7i7 ! aggregate b5efici>y-bas$ am\nt specifi$ 9 subsection 7b7 = ! qu>t] & ! ,/ate2 & 7ii7 ! ratio (-- 7,i7 ! ,/ate p]c5tage describ$ 9 subp>agraph 7,d77ii7 = su* ,/ate & fiscal ye>2 to 7,,ii7 ! ,f$]al p]c5tage describ$ 9 subp>agraph 7,d77i7 = su* ,/ate & fiscal ye>4 7,c7 ,nonpaym5t = failure to pay /ate %>e 7i7 ,9 g5]al ,if a ,/ate fails to exp5d ! am\nt requir$ "u subp>agraph 7,a7 = a qu>t] 9 a fiscal ye>1 ! am\nt payable to ! ,/ate "u p>agraph 7#a7 %all be r$uc$ by ! product ( ! am\nt by :i* ! ,/ate paym5t is less ?an ! ,/ate %>e & ! ratio (-- 7,i7 ! ,f$]al p]c5tage describ$ 9 subp>agraph 7,d77i7 = su* ,/ate & fiscal ye>2 to 7,,ii7 ! ,/ate p]c5tage describ$ 9 subp>agraph 7,d77ii7 = su* ,/ate & fiscal ye>4 7ii7 ,grace p]iod ,a ,/ate %all n be consid]$ to h fail$ to provide paym5t ( its requir$ ,/ate %>e = a qu>t] "u subp>agraph 7,a7 if ! aggregate ,/ate paym5t t[>ds ! ,/ate's requir$ ,/ate %>e = ! #d-qu>t] p]iod beg9n+ ) su* qu>t] exce$s ! requir$ ,/ate %>e am\nt = su* #d-qu>t] p]iod4 7,d7 ,f$]al & ,/ate p]c5tages ,9 ?is p>agraph1 ) respect to a ,/ate & a fiscal ye>3 7i7 ,f$]al p]c5tage ,! ,f$]al p]c5tage describ$ 9 ?is clause is #ge p]c5t or1 if high]1 ! ,f$]al m$ical assi/ance p]c5tage = su* ,/ate = su* fiscal ye>4 7ii7 ,/ate p]c5tage ,! ,/ate p]c5tage describ$ 9 ?is clause is #ajj p]c5t m9us ! ,f$]al p]c5tage describ$ 9 clause 7i74 7,e7 ,rules = cr$it+ t[>d ,/ate %>e 7i7 ,g5]al limitation to mat*able exp5ditures ,a paym5t = exp5ditures %all n be c\nt$ t[>d ! ,/ate %>e "u subp>agraph 7,a7 unless ,f$]al paym5ts may be us$ = su* exp5ditures consi/5t ) p>agraph 7#c77;,b74 7ii7 ,fur!r limitations on all[able exp5ditures ,a paym5t = exp5ditures %all n be c\nt$ t[>ds ! ,/ate %>e "u subp>agraph 7,a7 if ! exp5diture is = any ( ! foll[+3 7,i7 ,abortion ,exp5ditures = an abortion4 7,,ii7 ,int]gov]nm5tal transf]s ,an exp5diture t is attributable to an int]gov]nm5tal transf]4 7,,iii7 ,c]tifi$ public exp5ditures ,an exp5diture t is attributable to c]tifi$ public exp5ditures4 7iii7 ,cr$it+ fraud & abuse recov]ies ,am\nts recov]$ by a ,/ate ?r\gh ! op]ation ( its ,m$icaid fraud & abuse control unit describ$ 9 section #aijc7q7 %all be fully c\nt$ t[>d ! ,/ate %>e "u subp>agraph 7,a74 7,f7 ,con/ruction ,no?+ 9 ! p>agraph %all be con/ru$ z prev5t+ a ,/ate f exp5d+1 f non-,f$]al funds1 an am\nt "u ?is title 9 excess ( ! am\nt ( ! ,/ate %>e4 7,g7 ,det]m9ation bas$ ^u submitt$ claims ,9 apply+ ?is p>agraph ) respect to exp5ditures ( a ,/ate = a qu>t]1 ! det]m9ation ( ! exp5ditures = su* ,/ate = su* qu>t] %all be made aft] ! end ( ! p]iod 7:i*1 z ( ! date ( ! enactm5t ( ?is section1 is #b ye>s7 = :i* ! ,secret>y accepts claims = paym5t "u ?is title ) respect to su* qu>t]4 7#c7 ,use ( ,f$]al paym5ts 7,a7 ,application ( ,m$icaid limitations ,a ,/ate may only use ,f$]al paym5ts receiv$ "u subsection 7a7 = exp5ditures = :i* ,f$]al funds w\ld h be5 payable "u ?is title b = ?is section4 7,b7 ,limitation = c]ta9 eligibles 7i7 ,application ( #ajj p]c5t f$]al pov]ty l9e limit on eligibility ,subject to clause 7iii71 a ,/ate may n use su* ,f$]al paym5ts to provide m$ical assi/ance = an individual :o has an income 7z det]m9$ "u clause 7ii77 t exce$s #ajj p]c5t ( ! pov]ty l9e 7z def9$ 9 section #baaj7;c77#e77 applicable to a family ( ! size involv$4 7ii7 ,det]m9ation ( income us+ modifi$ adju/$ gross income )\t any #e p]c5t increase ,9 det]m9+ income = purposes ( clause 7i7 "u section #aijb7;e77#ad7 7relat+ to modifi$ adju/$ gross income71 ! foll[+ rules %all apply3 7,i7 ,application ( sp5d d[n ,! ,/ate %all take into acc\nt ! co/s incurr$ = m$ical c>e or = any o!r type ( rem$ial c>e recogniz$ "u ,/ate law 9 ! same mann] & to ! same ext5t t su* ,/ate takes su* co/s into acc\nt = purposes ( section #aijb7;a77#ag74 7,,ii7 ,disreg>d ( #e p]c5t increase ,subp>agraph 7,i7 ( section #aijb7;e77#ad7 7relat+ to a #e p]c5t r$uction7 %all n apply4 7iii7 ,exception ,clause 7i7 %all n apply to an individual :o is-- 7,i7 a woman describ$ 9 clause 7i7 ( section #aijc7v77#d77;,a72 7,,ii7 a *ild :o is an individual describ$ 9 clause 7i7 ( section #aije7;a72 7,,iii7 enroll$ 9 a ,/ate plan "u ?is title z ( ! date ( ! enactm5t ( ?is section = ! p]iod ( cont9u\s enrollm5t2 or 7,,iv7 describ$ 9 section #aijb7;e77#ad77;,d7 7relat+ to modifi$ adju/$ gross income74 7iv7 ,cl>ification relat$ to community sp\se ,no?+ 9 ?is subp>agraph %all sup]s$e ! application ( section #aibd 7relat$ to community sp\se income & assets74 7#d7 ,exceptions = pass-?r\gh paym5ts 7,a7 ,9 g5]al ,p>agraph 7#a7 %all n apply1 & am\nts %all cont9ue to be payable "u ?is title 7& n "u subsection 7a771 9 ! case ( ! foll[+ paym5ts 7& relat$ adm9i/rative co/s & exp5ditures73 7i7 ,paym5ts to t]ritories ,paym5ts to a ,/ate o!r ?an ! #ej ,/ates & ! ,di/rict ( ,columbia4 7ii7 ,m$ic>e co/-%>+ ,paym5ts attributable to ,m$ic>e co/-%>+ "u section #aije7p74 7iii7 ,p$iatric vacc9es ,paym5ts attributable to section #aibh4 7iv7 ,em]g5cy s]vices = c]ta9 individuals ,paym5ts = treatm5t ( em]g5cy m$ical conditions attributable to ! application ( section #aijc7v77#b74 7v7 ,indian heal? c>e facilities ,paym5ts = m$ical assi/ance describ$ 9 ! ?ird s5t5ce ( section #aije7;b74 7vi7 ,employ]-sponsor$ insurance 7,,esi7 ,paym5ts = m$ical assi/ance attributable to paym5ts to employ]s = employ]-sponsor$ heal? b5efits cov]age4 7vii7 ,o!r populations ) limit$ b5efit cov]age ,o!r paym5ts t are det]m9$ by ! ,secret>y to be relat$ to a specifi$ population = :i* ! m$ical assi/ance "u ?is title is limit$ & does n include any inpati5t1 nurs+ facility1 or long-t]m c>e s]vices4 7,b7 ,c]ta9 exp5ses ,p>agraph 7#a7 %all n apply1 & am\nts %all cont9ue to be payable "u ?is title 7& n "u subsection 7a771 9 ! case ( ! foll[+3 7i7 ,adm9i/ration ( m$ic>e prescription drug b5efit ,exp5ditures describ$ 9 section #aice7;b7 7relat+ to adm9i/ration ( ! ,m$ic>e prescription drug b5efit74 7ii7 ,paym5ts = ,,hit bonuses ,paym5ts "u section #aijc7;a77#c77;,f7 7relat+ to paym5ts to enc\rage ! adoption & use ( c]tifi$ ,,ehr te*nology74 7iii7 ,paym5ts = design1 developm5t1 & in/allation ( ,,mmis & eligibility sy/ems ,paym5ts "u subp>agraphs 7,a77i7 & 7,h77i7 ( section #aijc7;a77#c7 = exp5ditures = design1 developm5t1 & in/allation ( ! ,m$icaid managem5t in=mation sy/ems & me*aniz$ v]ification & in=mation retrieval sy/ems 7relat$ to eligibility74 7#e7 ,paym5t ( am\nts 7,a7 ,9 g5]al ,except z ! ,secret>y may o!rwise provide1 am\nts %all be payable to a ,/ate "u subsection 7a7 9 ! same mann] z am\nts are payable "u subsection 7d7 ( section #aijc to a ,/ate "u subsection 7a7 ( su* section4 7,b7 ,in=mation & =ms 7i7 ,submission ,z a condition ( receiv+ paym5t "u subsection 7a71 a ,/ate %all submit su* in=mation1 9 su* =m1 & mann]1 z ! ,secret>y %all specify1 includ+ in=mation necess>y to make ! computations "u subsections 7c77#b77;,c7 & 7e74 7ii7 ,uni=m report+ ,! ,secret>y %all develop su* =ms z may be ne$$ to assure a sy/em ( uni=m report+ ( su* in=mation across ,/ates4 7,c7 ,requir$ report+ ( in=mation on m$ical loss ratios = manag$ c>e ,! in=mation requir$ to be report$ "u subp>agraph 7,b77i7 %all include in=mation on ! m$ical loss ratio ) respect to cov]age provid$ "u ea* ,m$icaid manag$ c>e plan ) a contract ) ! ,/ate "u section #aijc7m7 or #aicb4 7b7 ,aggregate b5efici>y-,bas$ am\nt 7#a7 ,9 g5]al ,! aggregate b5efici>y-bas$ am\nt specifi$ 9 ?is subsection = a ,/ate = a qu>t] is equal to ! sum ( ! products1 = ea* ( ! categories ( ,m$icaid b5efici>ies specifi$ 9 p>agraph 7#b71 ( ! foll[+3 7,a7 ,b5efici>y-bas$ qu>t]ly am\nt ,! b5efici>y-bas$ qu>t]ly am\nt = su* category comput$ "u subsection 7c7 = su* ,/ate = su* qu>t]4 7,b7 ,numb] ( individuals 9 category ,subject to subsection 7d71 ! av]age numb] ( ,m$icaid b5efici>ies enroll$ 9 su* category 9 ! ,/ate 9 su* qu>t]4 7#b7 ,categories ,! categories specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,eld]ly ,a category ( ,m$icaid b5efici>ies :o are #fe ye>s ( age or old]4 7,b7 ,bl9d or disabl$ ,a category ( ,m$icaid b5efici>ies n describ$ 9 subp>agraph 7,a7 :o are describ$ 9 section #aicg7;a77#b77;,b77ii74 7,c7 ,*ildr5 ,a category ( ,m$icaid b5efici>ies n describ$ 9 subp>agraph 7,b7 :o are "u #ba ye>s ( age4 7,d7 ,o!r adults ,a category ( any ,m$icaid b5efici>ies :o are n describ$ 9 a previ\s subp>agraph ( ?is p>agraph4 7c7 ,computation ( p] b5efici>y1 p] category qu>t]ly am\nt 7#a7 ,9 g5]al ,= a ,/ate1 = ea* category ( b5efici>y = a qu>t]-- 7,a7 ,fir/ re=m ye> ,= qu>t]s 9 ! fir/ re=m ye> 7z def9$ 9 subsection 7k77#b771 ! b5efici>y-bas$ qu>t]ly am\nt is equal to #a_/d ( ! base av]age p] b5efici>y ,f$]al paym5ts = su* ,/ate = su* category det]m9$ "u p>agraph 7#b71 increas$ by a factor t reflects ! sum ( ! foll[+3 7i7 ,hi/orical m$ical c>e compon5t ( ,,cpi ?r\gh previ\s re=m ye> ,! p]c5tage increase 9 ! hi/orical m$ical c>e compon5t ( ! ,consum] ,price ,index = all urban consum]s 7,u4,s4 city av]age7 f ! midpo9t ( ! base fiscal ye> 7z def9$ 9 p>agraph 7#f77 to ! midpo9t ( ! fiscal ye> prec$+ ! fir/ re=m ye>4 7ii7 ,project$ m$ical c>e compon5t ( ,,cpi = ! fir/ re=m ye> ,! p]c5tage increase 9 ! project$ m$ical c>e compon5t ( ! ,consum] ,price ,index = all urban consum]s 7,u4,s4 city av]age7 f ! midpo9t ( ! previ\s fiscal ye> ref]r$ to 9 clause 7i7 to ! midpo9t ( ! fir/ re=m ye>4 7,b7 ,second & ?ird re=m ye>s ,! b5efici>y-bas$ qu>t]ly am\nt = a ,/ate = a category = qu>t]s 9 ! second re=m ye> or ! ?ird re=m ye> is equal to ! b5efici>y-bas$ qu>t]ly am\nt "u ?is p>agraph = su* ,/ate & category = ! previ\s re=m ye> increas$ by ! p] b5efici>y p]c5tage increase 7z def9$ 9 subp>agraph 7,e77 = su* category & re=m ye>4 7,c7 ,f\r? ?r\gh t5? re=m ye>s ,! b5efici>y-bas$ qu>t]ly am\nt = a ,/ate = a category = qu>t]s 9 a re=m ye> beg9n+ ) ! f\r? re=m ye> & end+ ) ! t5? re=m ye> is-- 7i7 9 ! case ( a ,/ate t is a high p] b5efici>y ,/ate or a l[ p] b5efici>y ,/ate 7z def9$ 9 p>agraph 7#d77;,b77iii77 = ! category1 ! am\nt det]m9$ "u clause 7i7 or 7ii7 ( p>agraph 7#d77;,b7 = su* ,/ate1 category1 & re=m ye>2 or 7ii7 9 ! case ( any o!r ,/ate1 ! b5efici>y-bas$ qu>t]ly am\nt "u ?is p>agraph = su* ,/ate & category = ! previ\s re=m ye> increas$ by ! p] b5efici>y p]c5tage increase = su* category & re=m ye>4 7,d7 ,elev5? re=m ye> & subsequ5t re=m ye>s ,! b5efici>y-bas$ qu>t]ly am\nt = a ,/ate = a category = qu>t]s 9 a re=m ye> beg9n+ ) ! elev5? re=m ye> is equal to ! b5efici>y-bas$ qu>t]ly am\nt "u ?is p>agraph = su* ,/ate & category = ! previ\s re=m ye> increas$ by ! p] b5efici>y p]c5tage increase = su* category & re=m ye>4 7,e7 ,annual p]c5tage increase beg9n+ ) second re=m ye> ,= purposes ( ?is subsection1 ! t]m p] b5efici>y p]c5tage increase means1 = a re=m ye>1 ! sum (-- 7i7 ! project$ p]c5tage *ange 9 nom9al gross dome/ic product f ! midpo9t ( ! previ\s re=m ye> to ! midpo9t ( ! re=m ye> = :i* ! p]c5tage increase is be+ appli$2 & 7ii7 "o p]c5tage po9t4 7#b7 ,base p] b5efici>y1 p] category am\nt = ea* ,/ate 7,a7 ,av]age p] category 7i7 ,9 g5]al ,! ,secret>y %all det]m9e1 consi/5t ) ?is p>agraph & p>agraph 7#c71 a base p] b5efici>y1 p] category am\nt = ea* ( ! #ej ,/ates & ! ,di/rict ( ,columbia equal to ! av]age am\nt1 p] ,m$icaid b5efici>y1 ( ,f$]al paym5ts "u ?is title1 includ+ paym5ts attributable to disproportionate %>e hospital paym5ts "u section #aibc1 = ea* ( ! categories ( b5efici>ies "u subsection 7b77#b7 = ! base fiscal ye> = ea* ( ! #ej ,/ates & ! ,di/rict ( ,columbia4 7ii7 ,be/ available data ,! det]m9ation "u clause 7i7 %all initially be e/imat$ by ! ,secret>y1 bas$ ^u ! be/ available data at ! "t ! det]m9ation is made4 7iii7 ,updates ,! det]m9ation "u clause 7i7 %all be updat$ by ! ,secret>y on an annual basis bas$ ^u improv$ data4 ,! ,secret>y %all adju/ ! am\nts "u subsection 7a77#a77;,a7 to reflect *anges 9 ! am\nts s det]m9$ bas$ on su* updates4 7,b7 ,exclusion ( pass-?r\gh paym5ts ,9 comput+ base p] b5efici>y1 p] category am\nts "u subp>agraph 7,a77i7 ! ,secret>y %all exclude paym5ts describ$ 9 subsection 7a77#d74 7,c7 ,/&>dization 7i7 ,9 g5]al ,9 comput+ ea* su* am\nt1 ! ,secret>y %all /&>dize ! am\nt 9 ord] to remove ! v>iation attributable to ! foll[+3 7,i7 ,risk factors ,su* risk factors z age1 heal? & disability /atus 7includ+ high co/ m$ical conditions71 g5d]1 in/itutional /atus1 & su* o!r factors z ! ,secret>y det]m9es to be appropriate1 s z to ensure actu>ial equival5ce4 7,,ii7 ,geographic ,v>iations 9 co/s on a c\nty-by-c\nty basis4 7ii7 ,me?od ( /&>dization 7,i7 ,consultation 9 developm5t ( risk /&>dization ,9 develop+ ! me?odology = risk /&>dization = purposes ( clause 7i77,i71 ! ,secret>y %all consult ) ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission1 ! ,m$ic>e ,paym5t ,advisory ,commission1 & ! ,national ,association ( ,m$icaid ,directors4 7,,ii7 ,me?od = risk /&>dization ,9 c>ry+ out clause 7i77,i71 ! ,secret>y may apply ! hi]>*al condition category me?odology "u section #ahec7;a77#a77;,c74 ,if ! ,secret>y uses su* me?odology1 ! ,secret>y %all adju/ ! application ( su* me?odology to take into acc\nt ! diff]5ces 9 s]vices provid$ "u ?is title comp>$ to title ,,xviii1 su* z ! cov]age ( long t]m c>e1 pregnancy1 & p$iatric s]vices4 7,,iii7 ,me?od = geographic /&>dization ,! ,secret>y %all apply ! /&>dization "u clause 7i77,,ii7 9 a mann] simil> to t appli$ "u section #ahec7;c77#d77;,a77iii74 7iii7 ,application on a national1 budget neutral basis ,! /&>dization "u clause 7i7 %all be design$ & implem5t$ on a uni=m national basis & %all be budget neutral s z to n result 9 any aggregate *ange 9 paym5ts "u subsection 7a74 7iv7 ,response to new risk ,subject to clause 7iii71 ! ,secret>y may adju/ ! /&>dization "u clause 7i7 to respond promptly to new in/ances ( communicable diseases & o!r public heal? haz>ds4 7v7 ,ref]5ce to application ( risk adju/m5t ,= rules relat$ to ! application ( risk adju/m5t to am\nts "u subsection 7a77#a77;,a71 see subsection 7e74 7,d7 ,adju/m5t = tempor>y ,,fmap increases ,9 comput+ ea* base p] b5efici>y1 p] category am\nts "u subp>agraph 7,a77i7 ! ,secret>y %all disreg>d portions ( paym5ts t are attributable to a tempor>y increase 9 ! ,f$]al mat*+ rates1 includ+ ^? attributable to ! foll[+3 7i7 ,,ppaca disa/] ,,fmap ,section #aije7;aa74 7ii7 ,,arra ,section #ejja ( ! ,am]ican ,recov]y & ,re9ve/m5t ,act ( #bjji 7#db ,u4,s4,c4 #acif;d note74 7iii7 ,extraord9>y employ] p5sion contribution ,section #fad ( ! ,*ildr5's ,heal? ,insurance ,program ,reau?orization ,act ( #bjji 7#db ,u4,s4,c4 #acif;d note74 7#c7 ,allocation ( nonm$ical assi/ance paym5ts ,! ,secret>y %all e/abli% rules = ! allocation ( paym5ts "u ?is title 7o!r ?an ^? paym5ts describ$ 9 p>agraph 7#a7 or 7#e7 ( section #aijc7;a7 & includ+ su* paym5ts attributable to section #aibc7-- 7,a7 among diff]5t categories ( b5efici>ies2 & 7,b7 betwe5 paym5ts includ$ "u subsection 7a77#a7 & paym5ts describ$ 9 subsection 7a77#d74 7#d7 ,transition to a corridor ar\nd ! national av]age 7,a7 ,det]m9ation ( national av]age base p] b5efici>y1 p] category am\nt ,subject to subp>agraph 7,c71 ! ,secret>y %all det]m9e a national av]age base p] b5efici>y1 p] category am\nt equal to ! av]age ( ! base p] b5efici>y1 p] category am\nts = ea* ( ! #ej ,/ates & ! ,di/rict ( ,columbia det]m9$ "u p>agraph 7#b71 weight$ by ! av]age numb] ( b5efici>ies 9 ea* su* category & ,/ate z det]m9$ by ! ,secret>y consi/5t ) subsection 7d7 = ! base fiscal ye>4 7,b7 ,transition adju/m5t 7i7 ,high p] b5efici>y /ates ,9 ! case ( a high p] b5efici>y ,/ate 7z def9$ 9 clause 7iii77,i77 = a category1 ! b5efici>y-bas$ qu>t]ly am\nt = su* ,/ate & category = a qu>t] 9 a re=m ye> 7beg9n+ ) ! f\r? re=m ye> & end+ ) ! t5? re=m ye>7 is equal to ! sum (-- 7,i7 ! product ( ! ,/ate-specific factor = su* re=m ye> 7z def9$ 9 clause 7iv77 & ! b5efici>y-bas$ qu>t]ly am\nt t w\ld o!rwise be det]m9$ "u p>agraph 7#a7 = su* ,/ate & category if ! ,/ate 7 a ,/ate describ$ 9 clause 7ii7 ( p>agraph 7#a77;,c71 in/ead ( a ,/ate describ$ 9 clause 7i7 ( su* p>agraph2 & 7,,ii7 ! product ( #a m9us ! ,/ate-specific factor = su* re=m ye> & ! b5efici>y-bas$ qu>t]ly am\nt t w\ld o!rwise be det]m9$ "u p>agraph 7#a7 = a ,/ate & category if ! base p] b5efici>y1 p] category am\nt det]m9$ "u p>agraph 7#b7 = ! ,/ate & category 7 equal to #aaj p]c5t ( ! national av]age base p] b5efici>y1 p] category am\nt det]m9$ "u subp>agraph 7,a7 = su* category4 7ii7 ,l[ p] b5efici>y /ates ,9 ! case ( a l[ p] b5efici>y ,/ate 7z def9$ 9 clause 7iii77,,ii77 = a category1 ! b5efici>y-bas$ qu>t]ly am\nt = su* ,/ate & category = a qu>t] 9 a re=m ye> 7beg9n+ ) ! f\r? re=m ye> & end+ ) ! t5? re=m ye>7 is equal to ! sum (-- 7,i7 ! product ( ! ,/ate-specific factor = su* re=m ye> & ! b5efici>y-bas$ qu>t]ly am\nt t w\ld o!rwise be det]m9$ "u p>agraph 7#a7 = su* ,/ate & category if ! ,/ate 7 a ,/ate describ$ 9 clause 7ii7 ( p>agraph 7#a77;,c71 in/ead ( a ,/ate describ$ 9 clause 7i7 ( su* p>agraph2 & 7,,ii7 ! product ( #a m9us ! ,/ate-specific factor = su* re=m ye> & ! b5efici>y-bas$ qu>t]ly am\nt t w\ld o!rwise be det]m9$ "u p>agraph 7#a7 = a ,/ate & category if ! base p] b5efici>y1 p] category am\nt det]m9$ "u p>agraph 7#b7 = ! ,/ate & category 7 equal to #ij p]c5t ( ! national av]age base p] b5efici>y1 p] category am\nt det]m9$ "u subp>agraph 7,a7 = su* category4 7iii7 ,high & l[ p] b5efici>y ,/ates def9$ ,9 ?is subp>agraph3 7,i7 ,high p] b5efici>y ,/ate ,! t]m high p] b5efici>y ,/ate means1 ) respect to a category1 a ,/ate = :i* ! base p] b5efici>y1 p] category am\nt det]m9$ "u p>agraph 7#b7 = su* category is great] ?an #aaj p]c5t ( ! national av]age base p] b5efici>y1 p] category am\nt det]m9$ "u subp>agraph 7,a7 = su* category4 7,,ii7 ,l[ p] b5efici>y ,/ate ,! t]m l[ p] b5efici>y ,/ate means1 ) respect to a category1 a ,/ate = :i* ! base p] b5efici>y1 p] category am\nt det]m9$ "u p>agraph 7#b7 = su* category is less ?an #ij p]c5t ( ! national av]age base p] b5efici>y1 p] category am\nt det]m9$ "u subp>agraph 7,a7 = su* category4 7iv7 ,/ate-specific factor ,9 ?is subp>agraph1 ! t]m ,/ate-specific factor means-- 7,i7 = ! f\r? re=m ye>1 #g_/h2 & 7,,ii7 = a subsequ5t re=m ye>1 ! ,/ate-specific factor "u ?is clause = ! previ\s re=m ye> m9us #a_/h4 7,c7 ,no additional exp5ditures 7i7 ,det]m9ation ( increase 9 ,f$]al exp5ditures ,= ea* category = ea* re=m ye> 7beg9n+ ) ! f\r? re=m ye> & end+ ) ! t5? re=m ye>71 ! ,secret>y %all det]m9e :e!r ! application ( ?is p>agraph-- 7,i7 to ! category = ! re=m ye> w result 9 an aggregate increase 9 ! aggregate ,f$]al exp5ditures "u subsection 7a72 & 7,,ii7 to all ! categories = ! re=m ye> w result 9 a net aggregate increase 9 ! aggregate ,f$]al exp5ditures "u subsection 7a74 7ii7 ,adju/m5t ,if ! ,secret>y det]m9es "u clause 7i77,,ii7 t ! application ( ?is p>agraph to all ! categories = a re=m ye> w result 9 a net aggregate increase 9 ! aggregate ,f$]al exp5ditures "u subsection 7a71 ! ,secret>y %all r$uce ! national av]age base p] b5efici>y1 p] category am\nt comput$ "u subp>agraph 7,a7 = ea* ( ! categories det]m9$ "u clause 7i77,i7 = :i* !re w be an aggregate increase 9 ! aggregate ,f$]al exp5ditures "u subsection 7a7 by su* uni=m p]c5tage z w ensure t !re is no net aggregate ,f$]al exp5diture increase describ$ 9 clause 7i77,,ii7 = ! re=m ye>4 7#e7 ,reports on p] b5efici>y rates2 appeals 7,a7 ,report to /ates ,n lat] ?an #h mon?s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all submit to ea* ,/ate ! ,secret>y's initial det]m9ation (-- 7i7 ! base p] b5efici>y1 p] category am\nts "u p>agraph 7#b7 = su* ,/ate2 & 7ii7 ! national av]age base p] b5efici>y1 p] category am\nts "u p>agraph 7#d77;,a74 7,b7 ,opportunity to appeal ,n lat] ?an #c mon?s aft] ! date a ,/ate receives notice ( ! ,secret>y's initial det]m9ation ( su* base p] b5efici>y1 p] category am\nts = su* ,/ate "u subp>agraph 7,a77i71 ! ,/ate may file ) ! ,secret>y1 9 a =m & mann] specifi$ by ! ,secret>y1 an appeal ( su* det]m9ation4 7,c7 ,det]m9ation on appeal ,n lat] ?an #c mon?s aft] receiv+ su* an appeal1 ! ,secret>y %all make a f9al det]m9ation on su* am\nts = su* ,/ate4 ,if no su* appeal is receiv$ = a ,/ate1 ! ,secret>y's initial det]m9ation "u subp>agraph 7,a77i7 %all become f9al4 7#f7 ,base fiscal ye> def9$ ,9 ?is section1 ! t]m base fiscal ye> means ! late/ fiscal ye>1 end+ be=e ! date ( ! enactm5t ( ?is section1 = :i* ! ,secret>y det]m9es t adequate data are available to make ! computations requir$ "u ?is subsection4 7d7 ,n c\nt+ individuals ,to acc\nt = exclud$ paym5ts ,"u rules specifi$ by ! ,secret>y1 individuals %all n be c\nt$ z ,m$icaid b5efici>ies = purposes ( subsection 7b77#a77;,b7 & subsection 7c77#b77;,a7 to ! ext5t t su* individuals-- 7#a7 are receiv+ m$ical assi/ance = :i* paym5ts describ$ "u subsection 7a77#d77;,a7 are made2 or 7#b7 w\ld n h be5 eligible to enroll "u ! ,/ate plan 7or waiv] ( su* plan7 9 ! ,/ate 9 :i* su* individual is s enroll$ if ! rules = eligibility = enrollm5t "u su* plan 7or waiv]7 7 ! same z su* rules = eligibility 9 effect z ( ,janu>y #a1 #bjji4 7e7 ,risk ,adju/m5t 7#a7 ,9 g5]al ,! am\nt "u subsection 7a77#a77;,a7 %all be adju/$ "u ?is subsection 9 an appropriate mann]1 specifi$ by ! ,secret>y & consi/5t ) p>agraph 7#b71 to take into acc\nt-- 7,a7 ! factors describ$ 9 subsection 7c77#b77;,c77i77,i7 )9 a category ( b5efici>ies2 & 7,b7 v>iations 9 co/s on a c\nty-by-c\nty basis = m$ical assi/ance & adm9i/rative exp5ses4 7#b7 ,me?od ( adju/m5t 7,a7 ,9 g5]al ,! adju/m5ts "u p>agraph 7#a7 %all be made 9 a mann] simil> to ! mann] 9 :i* simil> adju/m5ts are made "u subsection 7c77#b77;,c7 & consi/5t ) ! requirem5ts ( clause 7iii7 ( su* subsection & subp>agraph 7,b74 7,b7 ,biannual update ( risk adju/m5t me?odology ,9 apply+ clause 7i77,i7 ( subsection 7c77#b77;,c7 = purposes ( subp>agraph 7,a71 ! ,secret>y %all1 9 consultation ) ! entities describ$ 9 clause 7ii77,i7 ( su* subsection1 update ! risk adju/m5t me?odology appli$ z appropriate n less (t5 ?an e #b ye>s4 7f7 ,*ronic c>e quality bonus paym5ts 7#a7 ,det]m9ation ( bonus paym5ts ,if ! ,secret>y det]m9es t1 bas$ on ! reports "u p>agraph 7#e71 ) respect to categories ( *ronic disease = :i* *ronic c>e p]=mance t>gets _h be5 e/abli%$ "u p>agraph 7#c7 = ea* category ( ,m$icaid b5efici>ies specifi$ "u subsection 7b77#b7 su* t>gets h be5 met by a ,/ate = a re=m ye>1 ! ,secret>y %all make an additional paym5t to su* ,/ate 9 ! am\nt specifi$ 9 p>agraph 7#f7 = ea* qu>t] 9 ! succe$+ re=m ye>4 ,su* paym5ts %all be made 9 a mann] specifi$ by ! ,secret>y & may only be us$ consi/5t ) subsection 7a77#c74 7#b7 ,id5tification ( categories ( *ronic disease ,! ,secret>y %all det]m9e ! categories ( *ronic disease = :i* bonus paym5ts may be available "u ?is subsection = ea* category ( ,m$icaid b5efici>ies4 7#c7 ,adoption ( quality measurem5t sy/em & id5tification ( p]=mance t>gets 7,a7 ,sy/em & data ,) respect to ! categories ( *ronic disease "u p>agraph 7#b71 ! ,secret>y %all adopt a quality measurem5t sy/em t uses data describ$ 9 p>agraph 7#d7 & is simil> to ! ,five-,/> ,quality ,rat+ ,sy/em us$ to indicate ! p]=mance ( ,m$ic>e ,advantage plans "u "p ,c ( title ,,xviii4 7,b7 ,t>gets ,us+ su* sy/em & data1 ! ,secret>y %all e/abli% = ea* re=m ye> ! *ronic c>e p]=mance t>gets = purposes ( ! paym5ts "u p>agraph 7#a74 ,su* p]=mance t>gets %all be e/abli%$ 9 consultation ) ,/ates1 associations repres5t+ individuals ) *ronic illnesses1 entities provid+ treatm5t to su* individuals = su* *ronic illnesses1 & o!r /akehold]s1 includ+ ! ,national ,association ( ,m$icaid ,directors & ! ,national ,gov]nors ,association4 7#d7 ,data to be us$ ,! data to be us$ "u p>agraph 7#c7 %all include-- 7,a7 data collect$ ?r\gh me?ods su* z-- 7i7 ! ,heal?c>e ,effectiv5ess ,data & ,in=mation ,set 7also kn[n z ,,h$is7 7or an appropriate successor p]=mance measurem5t tool72 7ii7 ! ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems 7also kn[n z ,,cahps7 7or an appropriate successor p]=mance measurem5t tool72 & 7iii7 ! ,heal? ,outcomes ,survey 7also kn[n z ,,hos7 7or an appropriate successor p]=mance measurem5t tool72 & 7,b7 o!r data collect$ by ! ,/ate4 7#e7 ,reports 7,a7 ,9 g5]al ,ea* ,/ate %all collect1 analyze1 & report to ! ,secret>y1 at a frequ5cy & 9 a mann] to be e/abli%$ by ! ,secret>y1 data describ$ 9 p>agraph 7#d7 t p]mit ! ,secret>y to monitor ! ,/ate's p]=mance relative to ! *ronic c>e p]=mance t>gets e/abli%$ "u p>agraph 7#c74 7,b7 ,review & v]ification ,! ,secret>y may review ! data collect$ by ! ,/ate "u subp>agraph 7,a7 to v]ify ! ,/ate's analysis ( su* data ) respect to ! p]=mance t>gets "u p>agraph 7#c74 7#f7 ,am\nt ( bonus paym5ts 7,a7 ,9 g5]al ,subject to subp>agraphs 7,b7 & 7,c71 ) respect to ea* category ( ,m$icaid b5efici>ies1 9 ! case ( a ,/ate t ! ,secret>y det]m9es1 bas$ on ! *ronic c>e p]=mance t>gets set "u p>agraph 7#c7 = a re=m ye> = su* category1 p]=ms-- 7i7 9 ! top five ,/ates 9 su* category1 subject to subp>agraph 7,c77ii71 ! am\nt ( ! bonus = ea* qu>t] 9 ! succe$+ re=m ye> %all be #aj p]c5t ( ! paym5t am\nt o!rwise paid to ! ,/ate "u subsection 7a7 = individuals enroll$ "u ! plan )9 su* category2 7ii7 9 ! next five ,/ates 9 su* category1 subject to subp>agraph 7,c77ii71 ! am\nt ( ! bonus = ea* su* qu>t] %all be #e p]c5t ( ! paym5t am\nt o!rwise paid to ! ,/ate "u subsection 7a7 = individuals enroll$ "u ! plan )9 su* category2 7iii7 9 ! next five ,/ates 9 su* category1 subject to clauses 7i7 & 7iii7 ( subp>agraph 7,c71 ! am\nt ( ! bonus = ea* su* qu>t] %all be #c p]c5t ( ! paym5t am\nt o!rwise paid to ! ,/ate "u subsection 7a7 = individuals enroll$ "u ! plan )9 su* category2 7iv7 9 ! next five ,/ates 9 su* category1 subject to clauses 7i7 & 7iii7 ( subp>agraph 7,c71 ! am\nt ( ! bonus = ea* su* qu>t] %all be #b p]c5t ( ! paym5t am\nt o!rwise paid to ! ,/ate "u subsection 7a7 = individuals enroll$ "u ! plan )9 su* category2 & 7v7 9 ! next five ,/ates 9 su* category1 subject to clauses 7i7 & 7iii7 ( subp>agraph 7,c71 ! am\nt ( ! bonus = ea* su* qu>t] %all be #a p]c5t ( ! paym5t am\nt o!rwise paid to ! ,/ate "u subsection 7a7 = individuals enroll$ "u ! plan )9 su* category4 7,b7 ,aggregate annual limit = ea* category ( ,m$icaid b5efici>ies 7i7 ,9 g5]al ,9 no case may ! aggregate am\nt ( bonuses "u ?is subsection = qu>t]s 9 a re=m ye> = a category ( ,m$icaid b5efici>ies exce$ ! limit specifi$ 9 clause 7ii7 = ! re=m ye>4 7ii7 ,limit ,! limit specifi$ 9 ?is clause-- 7,i7 = ! second re=m ye> is equal to #bej1jjj1jjj2 or 7,,ii7 = a subsequ5t re=m ye> is equal to ! limit specifi$ 9 ?is clause = ! previ\s re=m ye> increas$ by ! p] b5efici>y p]c5tage increase det]m9$ "u p>agraph 7#a77;,e7 ( subsection 7c74 7,c7 ,limitation & proration ( bonuses bas$ on application ( aggregate limit 7i7 ,no bonus = ?ird or subsequ5t ti]s unless aggregate limit n rea*$ on fir/ two ti]s ,no bonus %all be payable "u clause 7iii71 7iv71 or 7v7 ( subp>agraph 7,a7 = a category ( ,m$icaid b5efici>ies = a qu>t] 9 a re=m ye> unless ! aggregate am\nt ( bonuses "u clauses 7i7 & 7ii7 ( su* subp>agraph = su* category & re=m ye> is less ?an ! limit specifi$ 9 subp>agraph 7,b77ii7 = ! re=m ye>4 7ii7 ,proration = fir/ two ti]s ,if ! aggregate am\nt ( bonuses "u clauses 7i7 & 7ii7 ( subp>agraph 7,a7 = a category ( ,m$icaid b5efici>ies = qu>t]s 9 a re=m ye> exce$s ! limit specifi$ 9 subp>agraph 7,b77ii7 = ! re=m ye>1 ! am\nt ( ea* su* bonus %all be prorat$ 9 a mann] s ! aggregate am\nt ( su* bonuses is equal to su* limit4 7iii7 ,proration = next ?ree ti]s ,if ! aggregate am\nt ( bonuses "u clauses 7i7 & 7ii7 ( subp>agraph 7,a7 = a category ( ,m$icaid b5efici>ies = qu>t]s 9 a re=m ye> is less ?an ! limit specifi$ 9 subp>agraph 7,b77ii7 = ! re=m ye>1 b ! aggregate am\nt ( bonuses "u clauses 7i7 ?r\gh 7v7 ( subp>agraph 7,a7 = ! category & su* qu>t]s 9 ! re=m ye> exce$s ! limit specifi$ 9 subp>agraph 7,b77ii7 = ! re=m ye>1 ! am\nt ( ea* bonus 9 clauses 7iii71 7iv71 & 7v7 ( subp>agraph 7,a7 %all be prorat$ 9 a mann] s ! aggregate am\nt ( all ! bonuses "u subp>agraph 7,a7 is equal to su* limit4 7g7 ,/ate option = receiv+ ,m$ic>e paym5ts = full-,b5efit dual eligible individuals 7#a7 ,9 g5]al ,"u ?is subsection a ,/ate may elect = qu>t]s beg9n+ on or aft] ! implem5tation date 9 a re=m ye> to receive paym5t f ! ,secret>y "u p>agraph 7#c74 ,z a condition ( receiv+ su* paym5t1 ! ,/ate %all agree to provide to full-b5efit dual eligible individuals eligible = m$ical assi/ance "u ! ,/ate plan-- 7,a7 ! m$ical assi/ance to :i* su* eligible individuals w\ld o!rwise be entitl$ "u ?is title2 & 7,b7 any items & s]vices :i* su* eligible individuals w\ld o!rwise receive "u title ,,xviii4 7#b7 ,provid] paym5t requirem5t 7,a7 ,9 g5]al ,a ,/ate elect+ ! option "u ?is subsection %all provide paym5t to heal? c>e provid]s = ! items & s]vices describ$ "u p>agraph 7#a77;,b7 at a rate t is n less ?an ! rate at :i* paym5ts w\ld be made to su* provid]s = su* items & s]vices "u title ,,xviii4 7,b7 ,flexibility 9 paym5t me?ods ,no?+ 9 subp>agraph 7,a7 %all be con/ru$ z prev5t+ a ,/ate f us+ alt]native paym5t me?odologies 7su* z bundl$ paym5ts or ! use ( acc\ntable c>e organizations 7z su* t]m is us$ 9 section #ahii77 = purposes ( mak+ paym5ts to heal? c>e provid]s = items & s]vices provid$ to dual eligible individuals 9 ! ,/ate "u ! option "u ?is subsection4 7#c7 ,paym5ts to ,/ates 9 lieu ( ,m$ic>e paym5ts ,) respect to a full-b5efit dual eligible individual1 9 ! case ( a ,/ate t elects ! option "u p>agraph 7#a7 = qu>t]s 9 a re=m ye>-- 7,a7 ! ,secret>y %all n make any paym5t "u title ,,xviii = items & s]vices furni%$ to su* individual = su* qu>t]s2 & 7,b7 ! ,secret>y %all pay to ! ,/ate1 9 addition to ! am\nts paid to su* ,/ate "u subsection 7a71 ! am\nt t ! ,secret>y w\ld1 b = ?is subsection1 o!rwise pay "u title ,,xviii = items & s]vices furni%$ to su* an individual 9 su* ,/ate = su* qu>t]s4 7#d7 ,full-b5efit dual eligible individual def9$ ,9 ?is subsection1 ! t]m full-b5efit dual eligible individual means an individual :o meets ! requirem5ts ( section #aice7;c77#f77;,a77ii74 7h7 ,audits ,! ,secret>y %all conduct su* audits on ! numb] & classification ( ,m$icaid b5efici>ies "u su* subsections & exp5ditures "u ?is section z may be necess>y to ensure appropriate paym5ts "u ?is section4 7i7 ,treatm5t ( waiv]s 7#a7 ,no impact on curr5t waiv]s ,9 ! case ( a waiv] ( requirem5ts ( ?is title pursuant to section #aaae or o!r law t is 9 effect z ( ! date ( ! enactm5t ( ?is section1 no?+ 9 ?is section %all be con/ru$ to affect su* waiv] = ! p]iod ( ! waiv] z approv$ z ( su* date4 7#b7 ,application ( budget neutrality to subsequ5t waiv]s & r5ewals tak+ section into acc\nt ,9 ! case ( a waiv] ( requirem5ts ( ?is title pursuant to section #aaae or o!r law t is approv$ or r5ew$ aft] ! date ( ! enactm5t ( ?is section1 to ! ext5t t su* approval or r5ewal is condition$ ^u a demon/ration ( budget neutrality1 budget neutrality %all be det]m9$ tak+ into acc\nt ! application ( ?is section4 7j7 ,report to ,congress ,n lat] ?an ,janu>y #a ( ! second re=m ye>1 ! ,secret>y %all submit to ,congress a report on ! implem5tation ( ?is section4 7k7 ,def9itions ,9 ?is section3 7#a7 ,implem5tation date ,! t]m implem5tation date means-- 7,a7 ,july #a1 #bjba1 if ?is section is enact$ on or be=e ,july #a1 #bjbj2 or 7,b7 ,july #a1 #bjbb1 if ?is section is enact$ aft] ,july #a1 #bjbj4 7#b7 ,re=m ye>s 7,a7 ,! t]m re=m ye> means a fiscal ye> beg9n+ ) ! fir/ re=m ye>4 7,b7 ,! t]m fir/ re=m ye> means ! fiscal ye> 9 :i* ! implem5tation date occurs4 7,c7 ,! t]ms second1 ?ird1 & successive simil> t]ms mean1 ) respect to a re=m ye>1 ! second1 ?ird1 or successive re=m ye>1 respectively1 succe$+ ! fir/ re=m ye>4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,cont9u$ application ( clawback provisions 7,a7 ,cont9u$ application ,subsections 7a7 & 7c77#a77;,c7 ( section #aice ( su* ,act 7#db ,u4,s4,c4 #acifu-#e7 are ea* am5d$ by ins]t+ or #aijc;,a7a7 aft] #aijc7;a74 7,b7 ,te*nical am5dm5t ,section #aice7;d77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7;d77#a77 is am5d$ by ins]t+ except z provid$ 9 section #aijc;,a7g7 aft] any o!r provision ( ?is title4 7#b7 ,paym5t rules "u section #aijc 7,a7 ,section #aijc7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7a77 is am5d$1 9 ! matt] be=e p>agraph 7#a71 by ins]t+ & section #aijc;,a aft] except z o!rwise provid$ 9 ?is section4 7,b7 ,section #aijc7;d7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7d77 is am5d$-- 7i7 9 p>agraph 7#a71 by ins]t+ & "u section #aijc;,a aft] subsections 7a7 & 7b72 7ii7 9 p>agraph 7#b7-- 7,i7 9 subp>agraph 7,a71 by ins]t+ or section #aijc;,a aft] 0 made "u ?is section2 & 7,,ii7 9 subp>agraph 7,b71 by ins]t+ or section #aijc;,a aft] "u subsection 7a72 7iii7 9 p>agraph 7#d7-- 7,i7 by /rik+ "u ?is subsection & ins]t+ 1 ) respect to ?is section or section #aijc;,a1 "u ?is subsection2 & 7,,ii7 by /rik+ "u ?is section & ins]t+ "u ! respective section2 & 7iv7 9 p>agraph 7#e71 by ins]t+ or section #aijc;,a aft] ov]paym5t "u ?is section4 7#c7 ,con=m+ waiv] au?ority ,section #aaae7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae7;a77#b77;,a77 is am5d$ by /rik+ or #aijc & ins]t+ #aijc1 or #aijc;,a4 7#d7 ,report on additional con=m+ am5dm5ts ne$$ ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report t includes a description ( any additional te*nical & con=m+ am5dm5ts to law t are requir$ to prop]ly c>ry out ?is ,act4 #djb4 ,income limitations = refundable cr$its = cov]age "u a qualifi$ heal? plan 7a7 ,9 g5]al ,subp>agraphs 7,a7 & 7,b7 ( section #cf;,b7c77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf are am5d$ by ins]t+ aft] #ajj p]c5t ea* place su* t]m appe>s ! foll[+3 7or1 9 ! case ( a taxpay] enroll$ ?r\gh an ,ex*ange utiliz$ by su* ,/ate t makes ! election describ$ 9 section #aijc;,a ( ! ,social ,security ,act1 ! p]c5tage e/abli%$ by su* ,/ate "u "p ,a ( title ,,iv ( su* ,act = purposes ( eligibility "u title ,,xix ( su* ,act z ( ,janu>y #a1 #bjji74 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to taxable ye>s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #djc4 ,m$icaid eligibility det]m9ations 7a7 ,/ate flexibility ,to use contractors ,to make eligibility det]m9ations on behalf ( ,/ate ,section #aijb7;a77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#e77 is am5d$ by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 b su* det]m9ations ( eligibility may be made1 at ! option ( a ,/ate1 "u a contract ) ano!r ,/ate or local ag5cy or a contractor s long z ! contract does n provide inc5tives = ! ag5cy or contractor to delay eligibility det]m9ations or to d5y eligibility = individuals o!rwise eligible = m$ical assi/ance4 7b7 ,frequ5cy ( eligibility r$et]m9ations ,section #aijb7;e77#ad7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7e77#ad77 is am5d$ by add+ at ! end ! foll[+3 7,l7 ,frequ5cy ( eligibility r$et]m9ations ,beg9n+ on ,octob] #a1 #bjai1 & not)/&+ subp>agraph 7,h71 9 ! case ( an individual ^: eligibility = m$ical assi/ance "u ! ,/ate plan "u ?is title 7or a waiv] ( su* plan7 is det]m9$ bas$ on ! application ( modifi$ adju/$ gross income "u subp>agraph 7,a7 & :o is s eligible on ! basis ( clause 7i77,,viii71 7ii77,,xx71 or 7ii77,,xxiii7 ( subsection 7a77#aj77;,a71 at ! option ( ! ,/ate1 ! ,/ate plan may provide t ! individual's eligibility %all be r$et]m9$ e #f mon?s 7or su* %ort] numb] ( mon?s z ! ,/ate may elect74 4 #djd4 ,l[]+ safe h>bor ?re%old ) respect to ,/ate taxes on heal? c>e provid]s ,section #aijc7w77#d77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7w77#d77;,c77ii77 is am5d$-- 7#a7 by /rik+ ( fiscal ye>s beg9n+ & ins]t+ ( fiscal ye>s-- 7,i7 beg9n+ 2 & 7#b7 by /rik+ x appe>s4 & ins]t+ ! foll[+3 x appe>s2 7,,ii7 beg9n+ on or aft] ,janu>y #a1 #bjba1 & be=e ,janu>y #a1 #bjcj1 #d p]c5t %all be sub/itut$ = #f p]c5t ea* place x appe>s2 7,,iii7 beg9n+ on or aft] ,janu>y #a1 #bjcj1 & be=e ,janu>y #a1 #bjce1 #c p]c5t %all be sub/itut$ = #f p]c5t ea* place x appe>s2 7,,iv7 beg9n+ on or aft] ,janu>y #a1 #bjce1 & be=e ,janu>y #a1 #bjdj1 #b p]c5t %all be sub/itut$ = #f p]c5t ea* place x appe>s2 7,v7 beg9n+ on or aft] ,janu>y #a1 #bjdj1 & be=e ,janu>y #a1 #bjde1 #a p]c5t %all be sub/itut$ = #f p]c5t ea* place x appe>s2 & 7,,vi7 beg9n+ on or aft] ,janu>y #a1 #bjde1 #j p]c5t %all be sub/itut$ = #f p]c5t ea* place x appe>s4 4 #dje4 ,provid+ = ,/ate approval & implem5tation ( specifi$ waiv]s "u ! ,m$icaid program ,section #aaae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae7 is am5d$-- 7#a7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a71 by /rik+ ,an application & ins]t+ ,subject to p>agraph 7#d71 an application2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 7,a7 ,an exp]im5tal1 pilot1 or demon/ration project und]tak5 "u subsection 7a7 may be approv$ or r5ew$ by a ,/ate if su* project is describ$ 9 subp>agraph 7,b74 7,b7 ,an exp]im5tal1 pilot1 or demon/ration project is describ$ 9 ?is subp>agraph if su* project provides = a waiv] ( requirem5ts ) respect to a ,/ate plan 7or a waiv] ( su* plan7 "u title ,,xix su* t-- 7i7 individuals enroll$ "u su* plan 7or su* waiv]7 may elect to p>ticipate 9 su* project ) respect to a ye>2 & 7ii7 su* individuals :o elect to s p>ticipate are furni%$ ) prim>y c>e s]vices 7z describ$ 9 section #bbc7;c77#a77;,d77ii77,i7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 ?r\gh a direct prim>y c>e s]vice arrangem5t 7z def9$ 9 su* section74 7,c7 ,= purposes ( a ,/ate's approval or r5ewal ( an exp]im5tal1 pilot1 or demon/ration project "u subp>agraph 7,a71 ea* ref]5ce to ! ,secret>y 9 subsection 7a7 %all be deem$ to be a ref]5ce to ! ,/ate4 2 & 7#b7 9 subsection 7e71 by ins]t+ 7o!r ?an su* a project t is describ$ 9 p>agraph 7#d77;,b77 be=e ! p]iod at ! end4 #djf4 ,d$uction = qualifi$ *>ity c>e 7a7 ,9 g5]al ,"p ,,vi ( sub*apt] ,b ( *apt] #a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #aii;,b4 ,qualifi$ *>ity c>e 7a7 ,9 g5]al ,!re %all be all[$ z a d$uction = ! taxable ye> an am\nt equal to-- 7#a7 9 ! case ( a direct prim>y c>e physician1 an am\nt equal to ! sum (-- 7,a7 ! fee 7z publi%$ on a publicly available website ( su* physician7 = physicians' s]vices t are qualifi$ *>ity c>e furni%$ by su* taxpay] dur+ su* ye>1 & 7,b7 = ea* visit by a pati5t to su* physician dur+ :i* qualifi$ *>ity c>e is furni%$1 half ( s mu* ( ! l[e/ subscription fee ( su* physician t is attributable to a mon?1 & 7#b7 9 ! case ( any o!r individual1 ! unreimburs$ ,m$ic>e-bas$ value ( qualifi$ *>ity c>e furni%$ by su* taxpay] dur+ su* ye>4 7b7 ,def9itions ,= purposes ( ?is section3 7#a7 ,unreimburs$ m$ic>e-bas$ value ,! t]m unreimburs$ ,m$ic>e-bas$ value means1 ) respect to physicians' s]vices1 ! am\nt payable = su* s]vices "u ! physician fee s*$ule e/abli%$ "u section #ahdh ( ! ,social ,security ,act4 7#b7 ,qualifi$ *>ity c>e ,! t]m qualifi$ *>ity c>e means physicians' s]vices t are furni%$-- 7,a7 )\t expectation ( reimbursem5t1 & 7,b7 to an individual enroll$-- 7i7 "u a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or a waiv] ( su* plan71 or 7ii7 "u a ,/ate *ild heal? plan "u title ,,xxi ( ! ,social ,security ,act 7or a waiv] ( su* plan74 7#c7 ,direct prim>y c>e physician ,! t]m direct prim>y c>e physician means a physician 7z def9$ 9 section #ahfa7r7 ( ! ,social ,security ,act7 :o provides prim>y c>e-- 7,a7 to individuals :o h paid a p]iodic subscription fee1 & 7,b7 9 ex*ange = a fee t is publi%$ on a publicly available website ( su* physician4 7#d7 ,physicians' s]vices ,! t]m physicians s]vices' has ! mean+ giv5 su* t]m by section #ahfa7q7 ( ! ,social ,security ,act4 7c7 ,limitation ,! am\nt all[$ z a d$uction "u subsection 7a7 = a taxable ye> %all n exce$ ! gross receipts attributable to physicians' s]vices furni%$ by ! taxpay] dur+ ! taxable ye>4 4 7b7 ,cl]ical am5dm5t ,! table ( sections = "p ,,vi ( sub*apt] ,b ( *apt] #a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #aii;,b4 ,qualifi$ *>ity c>e4 4 ,b ,m$ic>e ,re=ms #daa4 ,(f-campus provid]-bas$ dep>tm5t ,m$ic>e site neutral paym5t 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,(f-,campus provid]-,bas$ dep>tm5t ,m$ic>e site neutral paym5t 7#a7 ,9 g5]al ,) respect to items & s]vices furni%$ 9 an (f-campus provid]-bas$ dep>tm5t1 paym5t "u ?is section = su* items & s]vices %all be ! am\nt det]m9$ "u ! fee s*$ule "u section #ahdh = su* items & s]vices furni%$ if furni%$ 9 a physician (fice sett+4 7#b7 ,(f-campus provid]-bas$ dep>tm5t ,= purposes ( ?is subsection1 ! t]m (f-campus provid]-bas$ dep>tm5t has su* mean+ z specifi$ by ! ,secret>y4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjba4 #dab4 ,elim9at+ ,,fehbp eligibility = annuitants ,section #hije7;b7 ( title #e1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,an & ins]t+ ,consi/5t ) ! la/ s5t5ce ( ?is subsection1 an2 & 7#b7 by add+ at ! end ! foll[+3 4 ,an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 by reason ( section #bbf or #bbf;,a ( su* ,act 7#db ,u4,s4,c4 #dbf1 #dbf-a71 or o!rwise eligible to enroll "u su* "p pursuant to section #ahah or #ahah;,a ( su* ,act 7#db ,u4,s4,c4 #acie;i-#b1 #acie;i-#b;a71 & :o fir/ becomes an annuitant aft] ! date ( enactm5t ( ?is s5t5ce may n cont9ue enrollm5t 9 any heal? b5efits plan "u ?is *apt]44 #dac4 ,elim9ation ( ,m$ic>e eligibility = c]ta9 individuals 7a7 ,enrollm5t prohibition 7#a7 ,"p ,b ,section #ahcf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieo7 is am5d$ by /rik+ ! p]iod at ! end & ins]t+ 1 except t an individual :o atta9s age #fe on or aft] ,janu>y #a1 #bjcj1 & is an individual :o1 ^u atta9+ su* age1 has e>n$ #aj1jjj1jjj or m 9 lifetime wages1 %all n be eligible to s enroll44 7#b7 ,"p ,d ,section #ahfj;,d-#a7;a77#c77;,a7 ( su* ,act 7#db ,u4,s4,c4 #aciew-#aja7;a77#c77;,a77 is am5d$ by /rik+ ! p]iod at ! end & ins]t+ 1 exclud+ an individual :o1 ^u atta9+ age #fe1 has e>n$ #aj1jjj1jjj or m 9 lifetime wages44 7b7 ,m$igap ,section #ahhb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciess7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7aa7 ,additional limitation on newly eligible b5efici>ies 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( ?is section1 on or aft] ,janu>y #a1 #bjcj1 a m$ic>e supplem5tal policy may n be sold or issu$ to a t>get$ newly eligible ,m$ic>e b5efici>y4 7#b7 ,t>get$ newly eligible ,m$ic>e b5efici>y ,= purposes ( ?is subsection1 ! t]m t>get$ newly eligible ,m$ic>e b5efici>y means an individual :o1 ^u atta9+ ! age ( #fe1 has e>n$ #aj1jjj1jjj or m 9 lifetime wages4 4 #dad4 ,m$ic>e "p ,d tax d$uction 7a7 ,9 g5]al ,section #aci;,a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+3 ,?is section %all n be tak5 into acc\nt = purposes ( det]m9+ :e!r any d$uction is all[able ) respect to any co/ tak5 into acc\nt 9 det]m9+ su* paym5t44 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjah4 #dae4 ,repeal ( net inve/m5t income tax 7a7 ,9 g5]al ,subtitle ,a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ *apt] #b;,a4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 #daf4 ,m$ic>e cov]age ( bad debt ,section #ahfa7v77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie7v77#a77 is am5d$-- 7#a7 9 subp>agraph 7,t7-- 7,a7 9 clause 7iv71 by /rik+ & at ! end2 7,b7 9 clause 7v7-- 7i7 by /rik+ dur+ fiscal ye> & ins]t+ dur+ fiscal ye>s2 7ii7 by /rik+ or a subsequ5t fiscal ye> & ins]t+ ?r\gh #bjba2 & 7iii7 by /rik+ ! p]iod at ! end & ins]t+ 1 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7vi7 = co/ report+ p]iods beg9n+ dur+ fiscal ye> #bjba or a subsequ5t fiscal ye>1 by ! p]c5t applicable = co/ report+ p]iods beg9n+ dur+ ! previ\s fiscal ye>1 increas$ 7?r\gh fiscal ye> #bjbd7 by #aj p]c5tage po9ts4 2 7#b7 9 subp>agraph 7,v7-- 7,a7 9 clause 7i7-- 7i7 9 subclause 7,,iii71 by /rik+ & at ! end2 7ii7 9 subclause 7,,iv7-- 7,i7 by /rik+ dur+ fiscal ye> & ins]t+ dur+ fiscal ye>s #bjae ?r\gh #bjba2 & 7,,ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subclause3 7,v7 = co/ report+ p]iods beg9n+ dur+ fiscal ye> #bjba or a subsequ5t fiscal ye>1 ! p]c5t applicable = co/ report+ p]iods beg9n+ dur+ ! previ\s fiscal ye>1 increas$ 7?r\gh fiscal ye> #bjbd7 by #aj p]c5tage po9ts4 2 & 7,b7 9 clause 7ii7-- 7i7 9 subclause 7,,iii71 by /rik+ & at ! end2 & 7ii7 9 subclause 7,,iv7-- 7,i7 by /rik+ a subsequ5t fiscal ye> & ins]t+ fiscal ye>s #bjae ?r\gh #bjba2 7,,ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+ new subclause3 7,v7 = co/ report+ p]iods beg9n+ dur+ fiscal ye> #bjba or a subsequ5t fiscal ye>1 %all be r$uc$ by ! p]c5t applicable = co/ report+ p]iods beg9n+ dur+ ! previ\s fiscal ye>1 increas$ 7?r\gh fiscal ye> #bjbd7 by #aj p]c5tage po9ts4 2 & 7#c7 9 subp>agraph 7,w77i7-- 7,a7 9 subclause 7,,ii71 by /rik+ & at ! end2 7,b7 9 subclause 7,,iii7-- 7i7 by /rik+ dur+ a subsequ5t fiscal ye> & ins]t+ dur+ fiscal ye>s #bjae ?r\gh #bjba2 & 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new subclause3 7,,iv7 = co/ report+ p]iods beg9n+ dur+ fiscal ye> #bjba or a subsequ5t fiscal ye>1 by ! p]c5t applicable = co/ report+ p]iods beg9n+ dur+ ! previ\s fiscal ye>1 increas$ 7?r\gh fiscal ye> #bjbd7 by #aj p]c5tage po9ts4 4 ,c ,m$ic>e ,*oice & ,competition #dba4 ,competitive bidd+ & premiums "u unifi$ ,m$ic>e 7a7 ,9 g5]al ,"p ,e ( title ,,xviii ( ! ,social ,security ,act1 z add$ by section #aja & am5d$ by section #ajc1 is fur!r am5d$ by add+ at ! end ! foll[+3 #c ,competitive bidd+ & premiums #ahfj;,e-#ca4 ,application ( competitive bidd+ 9 enrollm5t 7a7 ,9 g5]al ,not)/&+ any o!r provision ( ?is title1 ! ,secret>y %all1 beg9n+ ) plan ye> #bjba1 e/abli% a me?od :]eby individuals enroll+ "u ?is title s enroll ?r\gh an onl9e process design$ to highlight enrollm5t options = su* individuals & all[ su* individuals to comp>e co/s ( enrollm5t 9 su* options4 7b7 ,enrollm5t options ,= purposes ( subsection 7a71 ! ,secret>y %all make ! foll[+ options available to individuals = enrollm5t "u ?is title3 7#a7 ,traditional fee-=-s]vice cov]age4 7#b7 provid]-l$ risk-be>+ plans 7also kn[n z ,a,c,os74 7#c7 ,m$ic>e ,advantage plans4 7c7 ,m$ic>e advantage plan actu>ial value requirem5t ,ea* ,m$ic>e ,advantage plan (f]$ ?r\gh ! process describ$ 9 subsection 7a7 %all h an actu>ial value equal to traditional fee-=-s]vice cov]age "u p>ts ,a & ,b4 7d7 ,,ma direct deposit ( c]ta9 rebates ,9 ! case ( an ,m$ic>e ,advantage plan ) a bid = a ye> t involves a premium diff]5tial betwe5 su* bid & ! b5*m>k = su* ye> & plan1 su* plan %all provide = a direct deposit ( su* diff]5tial if ! applicable enrollee 9 su* plan does n elect any supplem5tal cov]age "u su* plan4 7e7 ,enrollm5t 9 prescription drug cov]age ,z "p ( ! me?od describ$ 9 subsection 7a71 ! ,secret>y %all e/abli% a process to all[ an individual to enroll 9 prescription drug cov]age4 ,9 ! case ( an individual :o enrolls 9 a ,m$ic>e ,advantage plan1 su* cov]age %all be provid$ "u su* plan4 ,9 a case ( an individual :o enrolls 9 an ,,aco1 su* cov]age %all be provid$ "u su* network4 ,9 ! case ( an individual :o enrolls "u traditional fee-=-s]vice cov]age1 su* drug cov]age %all be provid$ ?r\gh a prescription drug plan4 7f7 ,supplem5tal b5efits 7#a7 ,,ma plans ,an ,,ma plan is all[$ to (f] two diff]5t packages ( supplem5tal b5efits 7^! packages are available only to individuals :o select su* plans74 7#b7 ,a,c,os ,a,c,os may limit supplem5tal options = _! enrollees to ,m$igap plans ) contractual ties4 7#c7 ,fee-=-s]vice ,fee-=-s]vice individuals may select supplem5tal cov]age f ,m$igap policies4 #ahfj;,e-#cb4 ,competition 7a7 ,bid areas ,m>ket areas us$ = bid submissions = ,m$ic>e ,advantage plans1 ,a,c,os1 & = calculation p] p]son fee-=-s]vices co/s %all be metropolitan /ati/ical regions plus associat$ regions4 7b7 ,premiums ,m$ic>e paym5t b5*m>k by m>ket area %all be calculat$ bas$ on weight$ av]age 7by enrollm5t 9 previ\s ye>7 ( ! premium bids f ,,ma plans1 ,a,c,os1 & ! p] p]son co/s ( fee-=-s]vice1 less ! /atutory "p ,b premium4 7c7 ,b5efici>y responsibility ,b5efici>ies %all pay ! diff]5ce betwe5 ,m$ic>e paym5t & requir$ premium ( ! plan !y *oose1 & get #ajj p]c5t ( ! sav+s by *oos+ a plan ) a premium bel[ ! b5*m>k4 7d7 ,transition ,= b5efici>ies :o are 9 fee-=-s]vice at ! "t ( ! enactm5t ( ?is section1 !re %all be a limit on ! am\nt ( a premium increase all[able by ye> ( no m ?an #bj p] mon? comp>$ to :at su* premium w\ld h o!rwise be5 if ?is subp>t _h n be5 enact$ = ea* ye> ?r\gh ! fif? ye>4 7e7 ,multiye> contracts ,a ,m$ic>e ,advantage plan may (f] to b5efici>ies multiye> contracts ) gu>ante$ premiums ov] su* ye>s1 be>+ ! risk ( any *ange 9 paym5ts f ! ,secret>y 9 subsequ5t ye>s4 ,a b5efici>y enroll+ "u su* a contract %all be exempt f ! me?od describ$ 9 subsection 7a74 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #ahec7;a77#a77;,a7 ( ! ,social ,security ,act is am5d$ by /rik+ & section #ahei7;e77#d7 & ins]t+ 1 section #ahei7;e77#d71 & subp>t #c ( "p ,e4 7#b7 ,section #ahec7;j7 ( su* ,act is am5d$ by ins]t+ & subp>t #c ( "p ,e aft] subsection 7o74 7#c7 ,section #ahed ( su* ,act is am5d$-- 7,a7 9 subsection 7a71 aft] ! head+1 by ins]t+ ,subject to subp>t #c ( "p ,e32 7,b7 9 subsection 7b71 aft] ! head+1 by ins]t+ ,subject to subp>t #c ( "p ,e32 7,c7 9 subsection 7d71 aft] ! head+1 by ins]t+ ,subject to subp>t #c ( "p ,e32 & 7,d7 9 subsection 7e71 aft] ! head+1 by ins]t+ ,subject to subp>t #c ( "p ,e34 #dbb4 ,new unifi$ eligibility & enrollm5t rules 7a7 ,9 g5]al ,title ,,xviii ( ! ,social ,security ,act is am5d$-- 7#a7 by r$esignat+ "p ,e z "p ,f2 & 7#b7 by ins]t+ aft] "p ,d ! foll[+ new "p3 ,e ,m$ic>e ) ,*oice & ,competition #a ,opt-,out & auto-,enrollm5t #ahfj;,e-#aa4 ,"p ,a opt-out & ,,ma auto-enrollm5t 7a7 ,p]mitt+ individuals ,to opt out ( "p ,a cov]age )\t los+ social security b5efits 7#a7 ,9 g5]al ,! ,secret>y %all e/abli%-- 7,a7 a process by :i* an individual o!rwise entitl$ to b5efits "u "p ,a may elect 7at a "t & 9 a mann] specifi$ "u ! process7 to waive su* entitlem5t2 & 7,b7 a process by :i* an individual :o elects to waive su* entitlem5t may revoke 7at a "t & 9 a mann] specifi$ "u ! process7 su* waiv]4 ,! process "u subp>agraph 7,b7 %all be coord9at$ ) ! enrollm5t process "u section #ahcg = "p ,b4 7#b7 ,application ( late enrollm5t p5alty ,an individual :o revokes a waiv] "u p>agraph 7#a77;,b7 %all be subject to a late enrollm5t p5alty z appli$ "u section #ahfj;,e-#cb7;c77#b77;,c74 7#c7 ,no impact on title ,,ii b5efits ,not)/&+ any o!r provision ( law1 an election ( an individual to waive entitlem5t to b5efits "u "p ,a "u p>agraph 7#a77;,a7 %all n result 9 any loss ( b5efits "u title ,,ii4 7#d7 ,deem$ opt-out 7,a7 ,an election ( an individual to waive entitlem5t to b5efits "u "p ,a "u p>agraph 7#a77;,a7 is also deem$ ! fil+ ( a notice ( t]m9ation ( b5efits "u "p ,b pursuant to section #ahch7;b77#a74 7,b7 ,! t]m9ation ( b5efits "u "p ,b pursuant to section #ahch7;b7 is also deem$ to be a waiv] ( any entitlem5t to b5efits "u "p ,a4 7b7 ,special op5 enrollm5t p]iod )\t late enrollm5t p5alty = curr5t "p ,a only or "p ,b only enrollees ,not)/&+ any o!r provision ( law1 9 ! case ( an individual :o z ( ! g5]al effective date1 is entitl$ to b5efits "u "p ,a b n enroll$ "u "p ,b1 or :o is enroll$ "u "p ,b b n entitl$ to b5efits 7or enroll$7 "u "p ,a1 beg9n+ z ( su* date1 su* individual %all be deem$ to be enroll$ "u "p ,b or "p ,a1 respectively1 unless su* individual elects to be enroll$ 7or entitl$ to b5efits7 "u nei!r ( su* p>ts dur+ a special op5 enrollm5t p]iod specifi$ by ! ,secret>y4 ,no increase 9 ! mon?ly premium ( an individual pursuant to section #ahci7;b7 or section #ahah7;c7 %all be effect$ 9 ! case ( any su* individual :o is deem$ enroll$ "u "p ,b or "p ,a pursuant to ! previ\s s5t5ce ) respect to any p]iod prior to ! date ( su* enrollm5t4 7c7 ,auto enrollm5t ( dual eligible individuals "u ,m$ic>e ,advantage plans 7#a7 ,9 g5]al ,except 9 ! case ( a ,/ate t has elect$ ! ma9t5ance ( ef=t option describ$ 9 section #aidd7;b77#b71 9 ! case ( an individual describ$ 9 subp>agraph 7,a77ii7 ( section #aice7;c77#f7 7tak+ into acc\nt ! application ( subp>agraph 7,b7 ( su* section71 ! ,secret>y %all e/abli% a process = ! enrollm5t 9 an ,,ma-,,pd plan t is a manag$ c>e plan "u "p ,c t has a mon?ly b5efici>y premium t does n exce$ ! premium assi/ance available "u section #ahfj;,e-#da7;b77#a77;,a74 ,if !re is m ?an "o su* plan available1 ! ,secret>y %all enroll su* an individual on a r&om basis among all su* plans 9 ! ,,pdp region4 7#b7 ,"r to dis5roll ,no?+ 9 p>agraph 7#a7 %all prev5t su* an individual f decl9+ enrollm5t 9 any su* plan 7& !reby obta9+ cov]age "u ,m$ic>e fee-=-s]vice7 or f *ang+ enrollm5t 9 su* a plan to ano!r ,,ma-,,pd plan4 #ahfj;,e-#ab4 ,coord9ation ) "p ,d 7a7 ,deem$ enrollm5t "u "p ,d 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% a process t1 beg9n+ z ( ! g5]al effective date1 provides = ! enrollm5t 9 a prescription drug plan t has a mon?ly base b5efici>y premium t does n exce$ ! weight$ av]age ( premiums = su* plans t provide /&>d prescription drug cov]age 7z def9$ 9 section #ahfj;,d-#b7;b77 ) respect to ! area involv$ 7on a r&om basis among all su* plans 9 ! applicable ,,pdp region7 ( ea* ,m$ic>e enrollee 7z def9$ 9 section #ahfj;,e-#ea7 :o-- 7,a7 fail$ to enroll 9 su* a prescription drug plan dur+ ! applicable enrollm5t or cov]age election p]iod "u section #ahfj;,d-#a7;b72 & 7,b7 fail$ to elect n to enroll 9 su* a prescription drug plan dur+ an applicable opt-out p]iod describ$ 9 p>agraph 7#b74 ,no?+ 9 ! previ\s s5t5ce %all prev5t su* an individual f decl9+ or *ang+ su* enrollm5t4 ,su* process %all be c>ri$ out 9 ! same mann] z ! process describ$ 9 section #ahfj;,d-#a7;b77#a77;,c74 7#b7 ,opt-out p]iods ,! process "u p>agraph 7#a7 %all provide = ! opportunity to make an election describ$ 9 subp>agraph 7,b7 ( su* p>agraph dur+ an opt-out p]iod t is coord9at$ ) ! relevant enrollm5t or cov]age election p]iod "u section #ahfj;,d-#a4 7#c7 ,late enrollm5t p5alties ,9 ! case ( an individual :o makes an election describ$ 9 p>agraph 7#a77;,b7 & !n enrolls 9 a prescription drug plan1 ! late enrollm5t p5alty "u section #ahfj;,d-#ac7;b7 %all apply to ! mon?ly b5efici>y premium ( su* individual1 except t 9 apply+ su* section1 any ref]5ce to ! initial enrollm5t p]iod ( su* individual %all be deem$ to be a ref]5ce to ! opt-out p]iod "u p>agraph 7#b7 dur+ :i* ! individual elect$ n to enroll 9 a prescription drug plan4 7#d7 ,no late enrollm5t p5alty = curr5t fee-=-s]vice b5efici>ies )\t drug cov]age ,9 ! case ( an individual :o is a ,m$ic>e enrollee be=e ! date ( enactm5t ( ?is section & :o 0 n enroll$ "u a prescription drug plan be=e be+ enroll$ "u su* a plan pursuant to p>agraph 7#a71 !re %all be no increase 9 ! base b5efici>y premium ( an individual "u section #ahfj;,d-#ac by a late enrollm5t p5alty "u subsection 7b7 ( su* section ) respect to any p]iod prior to ! date ( su* enrollm5t4 7b7 ,ref]5ce to requir$ prescription drug cov]age "u "p ,c ,= provision requir+ cov]age "u ,,ma plans to include prescription drug cov]age1 see section #ahfj;,e-#bf4 4 7b7 ,limitation on ,m$icaid b5efits = full-,b5efit dual eligible individuals ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7ll7 ,limitation on b5efits = full-,b5efit dual eligible individuals ,effective z ( ! g5]al effective date 7z specifi$ 9 section #ahfj;,e-#fb71 except 9 ! case ( a ,/ate :i* has elect$ ! option describ$ 9 section #aidd7;b77#b71 9 ! case ( an individual describ$ 9 subp>agraph 7,a77ii7 ( section #aice7;c77#f7 7tak+ into acc\nt ! application ( subp>agraph 7,b7 ( su* section71 not)/&+ any o!r provision ( law1 m$ical assi/ance %all n be available "u ?is title = any items & s]vices = :i* paym5t may be made "u title ,,xviii4 4 7c7 ,m$icaid ma9t5ance ( ef=t & alt]natives ,title ,,xix ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #aidc ! foll[+ new section3 #aidd4 ,ma9t5ance ( ef=t options = full-b5efit dual eligible individuals 7a7 ,9 g5]al ,effective z ( ! g5]al effective date 7z specifi$ 9 section #ahfj;,e-#fb71 a ,/ate %all elect1 9 a =m & mann] specifi$ by ! ,secret>y1 a ma9t5ance ( ef=t option describ$ 9 subsection 7b74 ,9 ! case ( a ,/ate t fails to make su* an election1 ! ,/ate %all be deem$ to h elect$ ! option describ$ 9 subsection 7b77#c74 7b7 ,ma9t5ance ( ef=t options describ$ ,! foll[+ are ma9t5ance ( ef=t options describ$ 9 ?is subsection = a ,/ate1 :i* %all apply to all individuals describ$ 9 subp>agraph 7,a77ii7 ( section #aice7;c77#f7 7tak+ into acc\nt ! application ( subp>agraph 7,b7 ( su* section7 = su* ,/ate3 7#a7 ,enrollm5t ( dual eligibles 9 compreh5sive ,m$icaid manag$ c>e plan 7,a7 ,9 g5]al ,! ,/ate enrolls all su* individuals 9 a compreh5sive ,m$icaid manag$ c>e plan (f]$ by a manag$ c>e entity "u section #aicb4 7,b7 ,paym5t ( subsidy am\nt to ,/ate ,9 ! case ( a ,/ate t elects ! option "u ?is p>agraph ) respect to an individual1 ! ,secret>y e/abli%$ "u section #ahfj;,e-#ea %all pay to ! ,/ate ! same am\nt t ! individual w\ld be entitl$ to h paid z an income-relat$ premium subsidy "u section #ahfj;,e-#da7;b77#a77;,a7 plus ! am\nt t ! ,secret>y e/imates w\ld h be5 paid ) respect to ! individual "u "p ,d 7includ+ ! actu>ial value ( subsidy paym5ts "u sections #ahfj;,d-#ac & #ahfj;,d-#ad74 ,su* paym5t %all be made 9 appropriate "p f ! ,f$]al ,hospital ,insurance ,tru/ ,fund "u section #ahag & ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda4 7,c7 ,relation to "p ,d rules ,9 ! case ( a ,/ate t has elect$ ! option "u ?is p>agraph1 not)/&+ any o!r provision ( law-- 7i7 ! cov]age provid$ "u ?is option %all be 9 lieu ( any cov]age t may o!rwise be provid$ "u "p ,d2 & 7ii7 ! paym5t to ! ,/ate "u subp>agraph 7,b7 %all be 9 lieu ( any paym5ts o!rwise made ) respect to su* individual "u su* "p4 7#b7 ,o!r innovative alt]natives 7,a7 ,9 g5]al ,! ,/ate submits to ! ,secret>y1 & has approv$ by ! ,secret>y1 an innovative alt]native proposal relat+ to coord9at+ cov]age ( su* individuals "u ,m$ic>e & ! ,/ate plan "u title ,,xix4 7,b7 ,process = review ,) respect to proposals submitt$ to ! ,secret>y "u subp>agraph 7,a71 ! ,secret>y %all approve su* a proposal if ! ,/ate demon/rates ) respect to ! proposal t-- 7i7 !re w\ld be no increas$ co/ to ! ,f$]al ,gov]nm5t if x 7 approv$2 & 7ii7 !re w\ld be no r$uction 9 ! quality ( c>e provid$ to su* individuals if ! proposal 7 approv$4 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #bbf ,section #bbf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #dbf7 is am5d$-- 7,a7 9 subsection 7a71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 1 subject to section #ahfj;,e-#aa7;a7 aft] individual :o2 7,b7 9 subsection 7b71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 1 subject to section #ahfj;,e-#aa7;a7 aft] individual :o2 & 7,c7 9 subsection 7c71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 1 subject to section #ahfj;,e-#aa7;a7 aft] subsection 7a74 7#b7 ,section #bbf;,a ,section #bbf;,a7a7 ( su* ,act 7#db ,u4,s4,c4 #dbf-a7;a77 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ & subject to section #ahfj;,e-#aa7;a7 aft] or title ,,xviii4 7#c7 ,section #aicb ,section #aicb7;a77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7;a77#b77;,b77 is am5d$ by /rik+ ,a ,/ate & ins]t+ ,except 9 ! case ( a ,/ate t has elect$ ! ma9t5ance ( ef=t option describ$ 9 section #aidd7;b77#b71 a ,/ate4 #dbc4 ,new b5efit /ructure "u unifi$ ,m$ic>e 7a7 ,9 g5]al ,"p ,e ( title ,,xviii ( ! ,social ,security ,act1 z add$ by section #bea1 is am5d$ by add+ at ! end ! foll[+3 #b ,out-(-,pocket limit #ahfj;,e-#ba4 ,out-(-pocket limit 7a7 ,9 g5]al ,beg9n+ ) #bjba1 9 ! case ( a ,m$ic>e enrollee1 if ! am\nt ( ! out-(-pocket co/-%>+ ( su* enrollee = a cal5d> ye> equals or exce$s ! cata/rophic limit "u subsection 7b7 = t ye>-- 7#a7 ! enrollee %all n be responsible = additional out-(-pocket co/-%>+ incurr$ dur+ t ye>2 & 7#b7 ! ,secret>y %all e/abli% proc$ures "u :i* ! ,secret>y %all1 9 appropriate "p f ! ,"p ,a ,m$ic>e ,,ffs ,acc\nt "u section #ahag & ! ,"p ,b ,m$ic>e ,,ffs ,acc\nt "u section #ahda-- 7,a7 pay on behalf ( ! enrollee ! am\nt ( ! additional out-(-pocket co/-%>+ describ$ 9 p>agraph 7#a7 attributable to d$uctibles & co9surance describ$ 9 subsection 7c77#a72 & 7,b7 reimburse ! enrollee ! am\nt ( ! additional out-(-pocket co/-%>+ describ$ 9 p>agraph 7#a7 attributable to d$uctibles & co9surance describ$ 9 subsection 7c77#b74 7b7 ,cata/rophic limit ,! am\nt ( ! cata/rophic limit "u ?is subsection = a ye> %all be ! doll> am\nt 9 effect "u section #bbc7;c77#b77;,a77ii7 ( ! ,int]nal ,rev5ue ,code ( #aihf = self-only cov]age = taxable ye>s beg9n+ 9 su* ye>4 7c7 ,out-(-,pocket co/-,%>+ def9$ ,9 ?is section1 ! t]m out-(-pocket co/-%>+ means1 ) respect to an individual1 ! am\nt ( co/s incurr$ by ! individual t are attributable to-- 7#a7 d$uctibles & co9surance impos$ "u "p ,a or "p ,b2 & 7#b7 d$uctibles & co9surance impos$ "u /&>d prescription drug cov]age pursuant to section #ahfj;,d-#b7;b7 or alt]native prescription drug cov]age pursuant to section #ahfj;,d-#b7;c7 (f]$ by a prescription drug plan4 4 7b7 ,application ( out-(-,pocket limit to ,,ma-,,pd plans 7#a7 ,9 g5]al ,section #aheb7;a77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#a77;,b77 is am5d$-- 7,a7 9 clause 7i71 by /rik+ clause 7iii7 & ins]t+ clauses 7iii7 & 7vi72 & 7,b7 by add+ at ! end ! foll[+ new clause3 7vi7 ,out-(-pocket limit ,! provisions ( section #ahfj;,e-#ba-- 7,i7 %all apply to individuals enroll$ "u an ,,ma-,,pd plan 9 ! same mann] z su* provisions apply to ,m$ic>e enrollees "u su* section1 except t 9 lieu ( ! application ( subsection 7a77#b7 ( su* section ! ,,ma-,,pd plan %all e/abli% proc$ures to provide = paym5t ( any additional out-(-pocket co/-%>+ describ$ 9 subsection 7a77#a7 ( su* section incurr$ by individuals enroll$ "u ! ,,ma-,,pd plan2 & 7,,ii7 z appli$ "u subclause 7,i71 may n be waiv$ by application ( ?is subp>agraph4 ,9 apply+ subsection 7b7 ( section #ahfj;,e-#ba pursuant to ! previ\s s5t5ce1 an ,,ma-,,pd plan may sub/itute a doll> am\nt t is less ?an ! doll> am\nt specifi$ "u su* subsection4 4 7#b7 ,exempt+ ,,ma-,,pd plans (f]+ alt]native prescription drug cov]age f "p ,d d$uctible & out-(-pocket limit requirem5ts ,section #ahfj;,d-#b7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is am5d$-- 7,a7 9 p>agraph 7#b71 by /rik+ ,! d$uctible & ins]t+ ,9 ! case ( a prescription drug plan1 ! d$uctible2 & 7,b7 9 p>agraph 7#c71 by /rik+ ,! cov]age provides & ins]t+ ,9 ! case ( a prescription drug plan1 ! cov]age provides4 7c7 ,prescription drug plans requir$ ,to report enrollees' out-(-,pocket co/-,%>+ ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,out-(-pocket co/-%>+ reports ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all require t1 ) respect to ea* claim submitt$ = items or s]vices furni%$ to an individual enroll$ "u ! plan pursuant to ! contract1 ! sponsor submits to ! ,secret>y in=mation on ! am\nt ( out-(-pocket co/-%>+ 7z def9$ 9 section #ahfj;,e-#bc7;c77 applicable to su* enrollee = su* items or s]vices4 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #ahac ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;e7 is am5d$-- 7,a7 9 subsection 7a71 by ins]t+ ,subject to subp>t #b ( "p ,e3 be=e p>agraph 7#a72 & 7,b7 9 subsection 7b71 by ins]t+ ,subject to subp>t #b ( "p ,e3 be=e p>agraph 7#a74 7#b7 ,section #ahcc ( su* ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7,a7 9 subsection 7a71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ & subp>t #b ( "p ,e aft] succe$+ provisions ( ?is section2 7,b7 9 subsection 7b71 9 ! fir/ s5t5ce1 by /rik+ ,be=e apply+ & ins]t+ ,subject to subp>t #b ( "p ,e1 be=e apply+2 7,c7 9 subsection 7c77#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ subject to subp>t #b ( "p ,e1 aft] ?is "p12 7,d7 9 subsection 7f71 by /rik+ ,9 e/abli%+ & ins]t+ ,subject to subp>t #b ( "p ,e1 9 e/abli%+2 & 7,e7 9 subsection 7g77#a71 by ins]t+ & subp>t #b ( "p ,e & p>agraphs 7#d7 & 7#e74 7#c7 ,section #ahhb7;a77#b7 ( su* ,act is am5d$ by /rik+ ,no m$ic>e & ins]t+ ,subject to section #ahfj;,e-#bd7;c71 no m$ic>e4 #dbd4 ,late enrollm5t p5alty n to apply = mon?s ( any heal? cov]age 7a7 ,9 g5]al ,section #ahci7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acier7 is am5d$ 9 ! second s5t5ce1 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or mon?s dur+ :i* ! individual has any o!r heal? cov]age4 7b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all apply = mon?s ( cov]age beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #dbe4 ,m$igap re=m ,not)/&+ any provision ( section #ahhb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciess71 z ( ! date ( ! enactm5t ( ?is ,act1 no policy may be (f]$ "u su* section t does n provide gu>ante$ cov]age 7)\t reg>d to an individual's preexi/+ conditions1 if any7 to all individuals eligible to enroll "u su* policy4 #dbf4 ,,aco revision 7a7 ,enrollm5t ,enrollm5t 9 su* an ,,aco "u su* title %all be bas$ on ! me?od e/abli%$ "u "p ,e ( su* title4 ,su* a network %all be> full risk 9 ! ev5t paym5ts "u su* title d n equal or exce$ liabilities "u su* network4 7b7 ,direction ( paym5t ,an ,,aco may direct t any paym5ts "u su* title be made to a c5traliz$ entity r ?an to an individual provid] or suppli]4 7c7 ,bids ,! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% a process :]eby su* networks compete us+ a bidd+ process simil> to t describ$ 9 "p ,e ( su* title = ,m$ic>e ,advantage plans4 #dbg4 ,prim>y c>e options 7a7 ,selection ( prim>y c>e physician ,! ,secret>y %all e/abli% a me*anism "u :i* an individual enroll$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act may select su* individual's prim>y c>e physician4 ,su* an individual %all n be liable = m ?an #e = ea* visit to su* select$ physician4 7b7 ,paym5t to physician ,a physician select$ "u subsection 7a7 %all receive a mon?ly fee 9 lieu ( any o!r paym5t "u su* "p ,b = evaluation & monitor+ ( su* individual4 ,! ,secret>y %all provide a li/ ( /&>diz$ b5efits t are includ$ 9 su* paym5t1 includ+ telephone & email communications1 (fice visits1 prev5tive c>e1 & vacc9ations4 #dbh4 ,g5]al provisions2 effective date ,"p ,e ( title ,,xviii ( ! ,social ,security ,act1 z ins]t$ by section #aja7;a77#b7 & z previ\sly am5d$1 is fur!r am5d$ by add+ at ! end ! foll[+ new subp>t3 #e4 ,g5]al provisions #ahfj;,e-#ea4 ,applicability2 def9itions 7a7 ,9 g5]al ,! provisions ( ?is ,act are sup]s$$ to ! ext5t inconsi/5t ) ! provisions ( ?is "p4 7b7 ,t]m9ology ,= purposes ( ?is "p3 7#a7 ,m$ic>e enrollee 7,a7 ,9 g5]al ,! t]m ,m$ic>e enrollee means-- 7i7 an individual entitl$ to 7or enroll$ = b5efits7 "u "p ,a & enroll$ "u "p ,b2 & 7ii7 except z o!rwise specifi$1 an individual describ$ 9 section #ahfj;,e-#aa7;a77#c74 7,b7 ,treatm5t ,any ref]5ce 9 ?is ,act 7or any o!r ,act7 9 effect be=e ! date ( ! enactm5t ( ?is "p1 to an individual entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b %all be deem$ a ref]5ce to a ,m$ic>e enrollee4 7#b7 ,m$ic>e fee-=-s]vice ,! t]m ,m$ic>e fee-=-s]vice means ! orig9al ,m$ic>e fee-=-s]vice program "u p>ts ,a & ,b1 z modifi$ by ?is "p1 & does n include "p ,c or "p ,d4 7#c7 ,m$ic>e fee-=-s]vice enrollee ,! t]m ,m$ic>e fee-=-s]vice enrollee means a ,m$ic>e enrollee :o is n enroll$ "u a ,m$ic>e ,advantage plan "u "p ,c4 #ahfj;,e-#fa4 ,g5]al effective date ,except z o!rwise specifi$1 ! provisions ( ?is "p %all apply to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjba1 & to plan ye>s beg9n+ on or aft] su* date 7ref]r$ to 9 ?is title z ! g5]al effective date74 4 ,d ,teleheal? ,improvem5ts & ,expansion #dca4 ,expansion ( cov]age ( teleheal? s]vices 7a7 ,cov]$ s]vices ,section #ahcd7m77#d77;,f77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,f77i77 is am5d$-- 7#a7 by /rik+ & (fice & ins]t+ (fice2 & 7#b7 by ins]t+3 respiratory s]vices1 audiology s]vices 7z def9$ 9 section #ahfa7ll771 outpati5t !rapy s]vices 7includ+ physical !rapy1 occupational !rapy1 & spee*-language pa?ology s]vices7 aft] ! ,secret>y7714 7b7 ,provid]s ,subsection 7m7 ( section #ahcd ( su* ,act 7#db ,u4,s4,c4 #aciem7 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ or a practition] 7describ$ 9 section #ahdb7;b77#ah77;,c77 & ins]t+ 1 a practition] 7describ$ 9 section #ahdb7;b77#ah77;,c771 or an applicable pr(essional 7z def9$ 9 p>agraph 7#d77;,g772 7#b7 by /rik+ physician or practition] ea* "t x appe>s 9 su* subsection & ins]t+ physician1 practition]1 or applicable pr(essional2 7#c7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! head+1 by /rik+ ,physician & practition] & ins]t+ ,physician1 practition]1 & applicable pr(essional2 & 7,b7 by /rik+ physicians or practition]s & ins]t+ physicians1 practition]s1 or applicable pr(essionals2 & 7#d7 9 p>agraph 7#d71 by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,applicable pr(essional ,! t]m applicable pr(essional means1 ) respect to s]vices furni%$ on or aft] ! date t is #f mon?s aft] ! date ( ! enactm5t ( ?is subp>agraph1 a c]tifi$ diabetes educator or lic5s$-- 7i7 respiratory !rapi/2 7ii7 audiologi/2 7iii7 occupational !rapi/2 7iv7 physical !rapi/2 or 7v7 spee* language pa?ologi/4 4 7c7 ,home-,bas$ monitor+ s]vices = conge/ive he>t failure & *ronic ob/ructive pulmon>y disease 7#a7 ,cov]age ( remote pati5t monitor+ s]vices = c]ta9 *ronic heal? conditions 7,a7 ,9 g5]al ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$-- 7i7 9 subp>agraph 7,,gg71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,,hh71 by ins]t+ & at ! end2 & 7iii7 by ins]t+ aft] subp>agraph 7,,hh7 ! foll[+ new subp>agraph3 7,,ii7 applicable remote pati5t monitor+ s]vices 7z def9$ 9 p>agraph 7#a77;,a7 ( subsection 7iii772 4 7#b7 ,s]vices describ$ ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7kkk7 ,remote ,pati5t ,monitor+ ,s]vices = ,*ronic ,heal? ,conditions 7#a7 7,a7 ,! t]m applicable remote pati5t monitor+ s]vices means remote pati5t monitor+ s]vices 7z def9$ 9 subp>agraph 7,b77 furni%$ to provide = ! monitor+1 evaluation1 & managem5t ( an individual ) a cov]$ *ronic condition 7z def9$ 9 p>agraph 7#b771 ins(> z su* s]vices are = ! managem5t ( su* *ronic condition4 7,b7 ,! t]m remote pati5t monitor+ s]vices means s]vices furni%$ ?r\gh remote pati5t monitor+ te*nology 7z def9$ 9 subp>agraph 7,c774 7,c7 ,! t]m remote pati5t monitor+ te*nology means a coord9at$ sy/em t uses "o or m home-bas$ or mobile monitor+ devices t automatically transmit vital sign data or in=mation on activities ( daily liv+ & may include responses to assessm5t que/ions collect$ on ! devices wirelessly or ?r\gh a telecommunications connection to a s]v] t complies ) ! ,f$]al regulations 7conc]n+ ! privacy ( individually id5tifiable heal? in=mation7 promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 z "p ( an e/abli%$ plan ( c>e = t pati5t t includes ! review & int]pretation ( t data by a heal? c>e pr(essional4 7#b7 ,= purposes ( p>agraph 7#a71 ! t]m cov]$ *ronic heal? condition means applicable conditions 7z def9$ 9 & appli$ "u section #ahhf7q77#e77 :5 "u *ronic c>e managem5t 7id5tifi$ z ( ,july #a1 #bjae1 by ,,hcpcs code #iidij 7& z subsequ5tly modifi$ by ! ,secret>y774 7#c7 7,a7 ,paym5t may be made "u ?is "p = applicable remote pati5t monitor+ s]vices provid$ to an individual dur+ a p]iod ( up to #ij days & su* additional p]iod z provid$ = "u subp>agraph 7,b74 7,b7 ,! #ij-;day p]iod describ$ 9 subp>agraph 7,a71 ) respect to an individual1 may be r5ew$ by ! physician :o provides *ronic c>e managem5t to su* individual if ! individual cont9ues to qualify = su* managem5t4 4 7#c7 ,paym5t "u ! physician fee s*$ule ,section #ahdh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7 is am5d$-- 7,a7 9 subsection 7c7-- 7i7 9 p>agraph 7#b77;,b7-- 7,i7 9 clause 7ii77,,ii71 by /rik+ & 7v7 & ins]t+ 7v71 & 7vii72 & 7,,ii7 by add+ at ! end ! foll[+ new clause3 7vii7 ,budget>y treatm5t ( c]ta9 s]vices ,! additional exp5ditures attributable to s]vices describ$ 9 section #ahfa7s77#b77;,,ii7 %all n be tak5 into acc\nt 9 apply+ clause 7ii77,,ii74 2 & 7ii7 by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,treatm5t ( applicable remote pati5t monitor+ s]vices 7,a7 ,9 det]m9+ relative value units = applicable remote pati5t monitor+ s]vices 7z def9$ 9 section #ahfa7;iii77#a77;,a771 ! ,secret>y1 9 consultation ) appropriate physician gr\ps1 practition] gr\ps1 & suppli] gr\ps1 %all take into consid]ation-- 7i7 physician or practition] res\rces1 includ+ physician or practition] "t & ! level ( int5sity ( s]vices provid$1 bas$ on-- 7,i7 ! frequ5cy ( evaluation necess>y to manage ! individual be+ furni%$ ! s]vices2 7,,ii7 ! complexity ( ! evaluation1 includ+ ! in=mation t mu/ be obta9$1 review$1 & analyz$2 & 7,,iii7 ! numb] ( possible diagnoses & ! numb] ( managem5t options t mu/ be consid]$2 7ii7 practice exp5se co/s associat$ ) su* s]vices1 includ+ ! direct co/s associat$ ) in/allation & in=mation transmission1 co/s ( remote pati5t monitor+ te*nology 7includ+ equipm5t & s(tw>e71 device deliv]y co/s1 & res\rce co/s necess>y = pati5t monitor+ & foll[up 7b n includ+ co/s ( any relat$ item or non-physician s]vice o!rwise reimburs$ "u ?is title72 & 7iii7 malpractice exp5se res\rces4 7,b7 ,us+ ! relative value units det]m9$ 9 subp>agraph 7,a71 ! ,secret>y %all provide = sep>ate paym5t = su* s]vices & %all n adju/ ! relative value units assign$ to o!r s]vices t might o!rwise h be5 det]m9$ to include su* sep>ately paid remote pati5t monitor+ s]vices4 2 & 7,b7 9 subsection 7j77#c71 by ins]t+ 7#b77;,,ii71 aft] heal? risk assessm5t714 #dcb4 ,exp&+ ! use ( teleheal? ?r\gh ! waiv] ( c]ta9 requirem5ts 7a7 ,9 g5]al ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is am5d$-- 7#a7 9 p>agraph 7#d77;,c77i71 by /rik+ & 7#g7 & ins]t+ 7#g71 & 7#h72 & 7#b7 by add+ at ! end ! foll[+3 7#h7 ,au?ority to waive requirem5ts & limitations if c]ta9 conditions met 7,a7 ,9 g5]al ,not)/&+ ! prec$+ provisions ( ?is subsection1 9 ! case ( teleheal? s]vices furni%$ on or aft] ,janu>y #a1 #bjba1 ! ,secret>y may waive any re/riction applicable to paym5t = teleheal? s]vices "u ?is subsection t is describ$ 9 subp>agraph 7,b71 b only if ! ,secret>y det]m9es t su* waiv] w\ld n d5y or limit ! cov]age or provision ( b5efits "u ?is title1 &-- 7i7 ! ,secret>y det]m9es t ! waiv] is expect$ to r$uce sp5d+ "u ?is title )\t r$uc+ ! quality ( c>e or improve ! quality ( pati5t c>e )\t increas+ sp5d+2 or 7ii7 ! waiv] w\ld apply to teleheal? s]vices furni%$ 9 orig9at+ sites locat$ 9 a high-ne$ heal? pr(essional %ortage area 7z designat$ pursuant to section #ccb7;a77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;e7a77#a77;,a7774 7,b7 ,re/rictions describ$ ,= purposes ( ?is p>agraph1 re/rictions applicable to paym5t = teleheal? s]vices "u p>agraph 7#a7 are-- 7i7 requirem5ts relat+ to qualifications = an orig9at+ site "u p>agraph 7#d77;,c77ii72 7ii7 any geographic limitations "u p>agraph 7#d77;,c77i7 7o!r ?an applicable ,/ate law requirem5ts1 includ+ ,/ate lic5sure requirem5ts72 7iii7 any limitation on ! type ( te*nology us$ to furni% teleheal? s]vices2 7iv7 any limitation on ! type ( provid] ( s]vices or suppli] :o may furni% teleheal? s]vices 7o!r ?an ! requirem5t t ! provid] ( s]vices or suppli] is enroll$ "u ?is title72 7v7 any limitation on specific s]vices designat$ z teleheal? s]vices pursuant to ?is subsection 7provid$ ! ,secret>y det]m9es t su* s]vices are cl9ically appropriate to furni% remotely72 or 7vi7 any o!r limitation relat+ to ! furni%+ ( teleheal? s]vices "u ?is title id5tifi$ by ! ,secret>y4 7,c7 ,public comm5t ,! ,secret>y %all e/abli% a process by :i* /akehold]s may 7on at lea/ an annual basis7 provide public comm5t = waiv]s "u ?is p>agraph4 7,d7 ,p]iodic review ( waiv]s ,! ,secret>y %all p]iodically1 b n m (t5 ?an e #c ye>s1 reassess ea* waiv] "u ?is p>agraph to det]m9e :e!r ! waiv] cont9ues to meet ! conditions applicable "u subp>agraph 7,a74 4 7b7 ,po/+ ( in=mation ,n lat] ?an #b ye>s aft] ! date on :i* a waiv] "u section #ahcd7m77#h7 ( ! ,social ,security ,act1 z add$ by subsection 7a71 fir/ becomes effective1 & at lea/ bi5nially !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all po/ on ! int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-- 7#a7 ! numb] ( ,m$ic>e b5efici>ies receiv+ teleheal? s]vices by reason ( ea* waiv] "u su* section2 7#b7 ! impact ( su* waiv]s on exp5ditures & utilization "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 & 7#c7 o!r outcomes1 z det]m9$ appropriate by ! ,secret>y4 #dcc4 ,exp&+ ! use ( teleheal? = m5tal heal? s]vices 7a7 ,9 g5]al ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m771 z am5d$ by ! prec$+ sections1 is am5d$-- 7#a7 9 p>agraph 7#d77;,c77i71 by /rik+ & 7#h7 & ins]t+ 7#h71 & 7#i72 & 7#b7 by add+ at ! end ! foll[+3 7#i7 ,treatm5t ( m5tal heal? s]vices furni%$ ?r\gh teleheal? ,! geographic requirem5ts describ$ 9 p>agraph 7#d77;,c77i7 7o!r ?an applicable ,/ate law requirem5ts1 includ+ ,/ate lic5sure requirem5ts7 %all n apply ) respect to teleheal? s]vices t are m5tal heal? s]vices 7z det]m9$ by ! ,secret>y7 furni%$ on or aft] ,janu>y #a1 #bjba1 to an eligible teleheal? individual at an orig9at+ site describ$ 9 p>agraph 7#d77;,c77ii7 7o!r ?an an orig9at+ site describ$ 9 subclause 7,,ix7 ( su* p>agraph74 4 7b7 ,inclusion ( ! home z an orig9at+ site ,section #ahcd7m77#d77;,c77ii77,x7 ( su* ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c77ii77,x77 is am5d$ by /rik+ p>agraph 7#g7 & ins]t+ p>agraphs 7#g7 & 7#i74 7c7 ,additional s]vices ,z "p ( ! implem5tation ( ! am5dm5ts made by ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all consid] :e!r additional s]vices %\ld be add$ to ! s]vices specifi$ 9 p>agraph 7#d77;,f77i7 ( section #ahcd7m7 ( su* ,act 7#db ,u4,s4,c4 #aciem7 = au?oriz$ paym5t "u p>agraph 7#a7 ( su* section4 #dcd4 ,use ( teleheal? 9 em]g5cy m$ical c>e 7a7 ,9 g5]al ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m771 z am5d$ by ! prec$+ sections1 is am5d$-- 7#a7 9 p>agraph 7#d77;,c77i71 by /rik+ & 7#i7 & ins]t+ 7#i71 & 7#aj72 & 7#b7 by add+ at ! end ! foll[+3 7#aj7 ,treatm5t ( em]g5cy m$ical c>e furni%$ ?r\gh teleheal? ,! geographic requirem5ts describ$ 9 p>agraph 7#d77;,c77i7 7o!r ?an applicable ,/ate law requirem5ts1 includ+ ,/ate lic5sure requirem5ts7 %all n apply ) respect to teleheal? s]vices t are s]vices = em]g5cy m$ical c>e 7z det]m9$ by ! ,secret>y7 furni%$ on or aft] ,janu>y #a1 #bjba1 to an eligible teleheal? individual at an orig9at+ site describ$ 9 subclause 7,,ii71 7,v71 or 7,,vii7 ( p>agraph 7#d77;,c77ii74 4 7b7 ,additional s]vices ,z "p ( ! implem5tation ( ! am5dm5ts made by ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all consid] :e!r additional s]vices %\ld be add$ to ! s]vices specifi$ 9 p>agraph 7#d77;,f77i7 ( section #ahcd7m7 ( su* ,act 7#db ,u4,s4,c4 #aciem7 = au?oriz$ paym5t "u p>agraph 7#a7 ( su* section4 #dce4 ,improvem5ts to ! process = add+ teleheal? s]vices ,! ,secret>y %all und]take a review ( ! process e/abli%$ pursuant to section #ahcd7m77#d77;,f77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,f77ii771 & bas$ on ! results ( su* review-- 7#a7 implem5t revisions to ! process s t ! crit]ia to add s]vices prioritizes1 z appropriate1 improv$ access to c>e ?r\gh teleheal? s]vices2 & 7#b7 provide cl>ification on :at reque/s to add teleheal? s]vices "u su* process %\ld include4 #dcf4 ,rural heal? cl9ics & ,f$]ally qualifi$ heal? c5t]s 7a7 ,expansion ( orig9at+ sites ,section #ahcd7m77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c771 z am5d$ by ! prec$+ sections1 is am5d$-- 7#a7 9 clause 7i71 by /rik+ & 7#aj7 & ins]t+ & 7#aj71 & subject to clause 7iii712 & 7#b7 by add+ at ! end ! foll[+ new clause3 7iii7 ,rural heal? cl9ics & ,f$]ally qualifi$ heal? c5t]s ,! t]m orig9at+ site %all also include any ,f$]ally qualifi$ heal? c5t] & any rural heal? cl9ic 7z su* t]ms are def9$ 9 section #ahfa7;aa77 at :i* ! eligible teleheal? individual is locat$ at ! "t ! s]vice is furni%$ via a telecommunications sy/em1 :e!r or n ! individual is locat$ 9 an area describ$ 9 clause 7i71 ins(> z su* sites are n o!rwise includ$ 9 ! def9ition ( orig9at+ site "u su* clause1 subject to applicable ,/ate law requirem5ts1 includ+ ,/ate lic5sure requirem5ts4 4 7b7 ,expansion ( di/ant sites ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is am5d$-- 7#a7 9 ! fir/ s5t5ce ( p>agraph 7#a7-- 7,a7 by /rik+ or a practition] 7describ$ 9 section #ahdb7;b77#ah77;,c77 & ins]t+ 1 a practition] 7describ$ 9 section #ahdb7;b77#ah77;,c771 a ,f$]ally qualifi$ heal? c5t]1 or a rural heal? cl9ic2 & 7,b7 by /rik+ or practition] & ins]t+ 1 practition]1 ,f$]ally qualifi$ heal? c5t]1 or rural heal? cl9ic2 7#b7 9 p>agraph 7#b77;,a7-- 7,a7 by ins]t+ or to a ,f$]ally qualifi$ heal? c5t] or rural heal? cl9ic t s]ves z a di/ant site aft] a di/ant site2 & 7,b7 by /rik+ su* physician or practition] & ins]t+ su* physician1 practition]1 ,f$]ally qualifi$ heal? c5t]1 or rural heal? cl9ic2 & 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ & includes a ,f$]ally qualifi$ heal? c5t] or rural heal? cl9ic t furni%es a teleheal? s]vice to an eligible individual be=e ! p]iod at ! end2 & 7,b7 9 subp>agraph 7,f71 by add+ at ! end ! foll[+ new clause3 7iii7 ,inclusion ( rural heal? cl9ic s]vices & ,f$]ally qualifi$ heal? c5t] s]vices furni%$ us+ teleheal? ,= purposes ( ?is subp>agraph1 ! t]m teleheal? s]vices includes a rural heal? cl9ic s]vice or ,f$]ally qualifi$ heal? c5t] s]vice t is furni%$ us+ teleheal? to ! ext5t t paym5t codes correspond+ to s]vices id5tifi$ by ! ,secret>y "u clause 7i7 or 7ii7 are li/$ on ! correspond+ claim = su* rural heal? cl9ic s]vice or ,f$]ally qualifi$ heal? c5t] s]vice4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to s]vices furni%$ on or aft] ,janu>y #a1 #bjba4 #dcg4 ,native ,am]ican heal? facilities 7a7 ,9 g5]al ,section #ahcd7m77#d77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,c771 z am5d$ by ! prec$+ sections1 is am5d$-- 7#a7 9 clause 7i71 by /rik+ clause 7iii7 & ins]t+ clauses 7iii7 & 7iv72 & 7#b7 by add+ at ! end ! foll[+ new clause3 7iv7 ,native ,am]ican heal? facilities ,! orig9at+ site requirem5ts describ$ 9 clauses 7i7 & 7ii7 %all n apply ) respect to a facility ( ! ,indian ,heal? ,s]vice1 :e!r op]at$ by su* ,s]vice1 or by an ,indian tribe 7z t t]m is def9$ 9 section #d ( ! ,indian ,heal? ,c>e ,improvem5t ,act 7#be ,u4,s4,c4 #afjc77 or a tribal organization 7z t t]m is def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #ecjd771 or a facility ( ! ,native ,hawaiian heal? c>e sy/ems au?oriz$ "u ! ,native ,hawaiian ,heal? ,c>e ,improvem5t ,act 7#db ,u4,s4,c4 #aagja et seq474 4 7b7 ,no orig9at+ site facility fee = new sites ,section #ahcd7m77#b77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#b77;,b77i77 is am5d$1 9 ! matt] prec$+ subclause 7,i71 by ins]t+ 7o!r ?an an orig9at+ site t is only describ$ 9 clause 7iv7 ( p>agraph 7#d77;,c71 & does n meet ! requirem5t = an orig9at+ site "u clause 7i7 ( su* p>agraph7 aft] ! orig9at+ site4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to s]vices furni%$ on or aft] ,janu>y #a1 #bjba4 #dch4 ,waiv] ( teleheal? re/rictions dur+ national em]g5cies ,section #aace7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;b77 is am5d$-- 7#a7 9 p>agraph 7#f71 by /rik+ & aft] ! semicolon2 7#b7 9 p>agraph 7#g71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#h7 requirem5ts = paym5t = teleheal? s]vices "u section #ahcd7m74 4 #dci4 ,use ( teleheal? 9 rec]tification = hospice c>e 7a7 ,9 g5]al ,section #ahad7;a77#g77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77 is am5d$ by ins]t+ 7includ+ ?r\gh use ( teleheal?1 not)/&+ ! requirem5ts 9 section #ahcd7m77#d77;,c77 aft] face-to-face enc\nt]4 7b7 ,,gao report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ,congress evaluat+ ! impact ( ! am5dm5t made by subsection 7a7 on-- 7#a7 ! numb] & p]c5tage ( b5efici>ies rec]tifi$ = ! ,m$ic>e hospice b5efit at #ahj days & = subsequ5t b5efit p]iods2 7#b7 ! appropriat5ess = hospice c>e ( ! pati5ts rec]tifi$ ?r\gh ! use ( teleheal?2 & 7#c7 any o!r factors det]m9$ appropriate by ! ,comptroll] ,g5]al4 #ddj4 ,cl>ification = fraud & abuse laws reg>d+ te*nologies provid$ to b5efici>ies ,section #aabh;,a7i77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7i77#f77 is am5d$-- 7#a7 9 subp>agraph 7,i71 by /rik+ 2 or & ins]t+ a semicolon2 7#b7 9 subp>agraph 7,j71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,k7 ! provision ( te*nologies 7z def9$ by ! ,secret>y7 on or aft] ! date ( ! enactm5t ( ?is subp>agraph1 by a provid] ( s]vices or suppli] 7z su* t]ms are def9$ = purposes ( title ,,xviii7 directly to an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii1 enroll$ "u "p ,b ( su* title1 or bo?1 = ! purpose ( furni%+ teleheal? s]vices1 remote pati5t monitor+ s]vices1 or o!r s]vices furni%$ ?r\gh ! use ( te*nology 7z def9$ by ! ,secret>y71 if-- 7i7 ! te*nologies are n (f]$ z "p ( any adv]tisem5t or solicitation2 & 7ii7 ! provision ( ! te*nologies meets any o!r requirem5ts set =? 9 regulations promulgat$ by ! ,secret>y4 4 #dda4 ,/udy & report on increas+ access to teleheal? s]vices 9 ! home 7a7 ,med,p,a,c /udy ,! ,m$ic>e ,paym5t ,advisory ,commission 79 ?is section ref]r$ to z ! ,commission7 %all conduct a /udy on increas+ access "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 to teleheal? s]vices 9 ! home4 ,su* /udy %all include an analysis ( ! foll[+3 7#a7 ,h[ diff]5t pay]s all[ ! home to be an orig9at+ site = teleheal? s]vices4 7#b7 ,p>ticul> types ( teleheal? s]vices or subgr\ps ( b5efici>ies ) respect to :i* all[+ ! home to be an orig9at+ site "u ! ,m$ic>e program w\ld be suitable4 7b7 ,report ,n lat] ?an #bd mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,commission %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,commission det]m9es appropriate4 #ddb4 ,analysis ( teleheal? waiv]s 9 alt]native paym5t models ,! second s5t5ce ( section #aaae;,a7g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7g77 is am5d$ by ins]t+ an analysis ( waiv]s "u section 7d77#a7 relat$ to teleheal? & ! impact on quality & sp5d+ "u ! applicable titles ( su* waiv]s1 aft] subsection 7c714 #ddc4 ,model to all[ additional heal? pr(essionals to furni% teleheal? s]vices ,section #aaae;,a7b77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b77 is am5d$ by add+ at ! end ! foll[+ new clause3 7xxviii7 ,all[+ heal? pr(essionals :o are n o!rwise eligible "u section #ahcd7m7 to furni% teleheal? s]vices to furni% su* s]vices4 4 #ddd4 ,te/+ ( models to exam9e ! use ( teleheal? "u ! ,m$ic>e program ,section #aaae;,a7b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,te/+ models to exam9e use ( teleheal? "u ,m$ic>e ,! ,secret>y %all consid] te/+ "u ?is subsection models to exam9e ! use ( teleheal? "u title ,,xviii4 4