,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #accb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #be1 #bjai ,mr4 ,we/]man introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 ! ,judici>y1 ,ov]sight & ,re=m1 ,education & ,labor1 ,rules1 ! ,budget1 ,arm$ ,s]vices1 & ,h\se ,adm9i/ration1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to 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 ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,private-,sector ,heal? ,insurance ,re=ms ,subtitle ,a--,comm]cial ,heal? ,insurance ,provisions ,sec4 #aja4 ,invisible high risk pool re9surance program2 tax on ex*ange plans4 ,sec4 #ajb4 ,*ange 9 p]missible age v>iation 9 heal? insurance premium rates4 ,sec4 #ajc4 ,employ] heal? insurance m&ate repeal4 ,sec4 #ajd4 ,employ] b5efits reports4 ,sec4 #aje4 ,waiv]s = ,/ate innovation4 ,sec4 #ajf4 ,/ate-op]at$ ,ex*anges flexibility = op5 enrollm5t p]iods4 ,sec4 #ajg4 ,enrollm5t p]iods4 ,sec4 #ajh4 ,%ort-t]m limit$ duration insurance4 ,sec4 #aji4 ,promot+ heal? plans t cov] individuals 9 m ?an "o ,/ate4 ,sec4 #aaj4 ,re/or+ ! application ( antitru/ laws to ! bus9ess ( heal? insurance4 ,sec4 #aaa4 ,heal? plans creat$ "u ,,ppaca or (f]$ ?r\gh ,ex*anges to be only heal? plans ,f$]al ,gov]nm5t may make available to ,presid5t1 ,vice ,presid5t1 ,memb]s ( ,congress1 & ,f$]al employees4 ,sec4 #aab4 ,co/-%>+ r$uctions4 ,sec4 #aac4 ,heal? sav+s acc\nts4 ,sec4 #aad4 ,add+ copp] plans to ,ex*anges4 ,sec4 #aae4 ,elim9at+ ,,fehbp eligibility = annuitants4 ,subtitle ,b--,association heal? plans ,sec4 #aba4 ,rules gov]n+ association heal? plans4 ,sec4 #abb4 ,cl>ification ( treatm5t ( s+le employ] arrangem5ts4 ,sec4 #abc4 ,en=cem5t provisions relat+ to association heal? plans4 ,sec4 #abd4 ,coop]ation betwe5 ,f$]al & ,/ate au?orities4 ,sec4 #abe4 ,effective date & transitional & o!r rules4 ,subtitle ,c--,tax-,relat$ ,provisions ,sec4 #aca4 ,premium assi/ance adju/m5t to reflect age4 ,sec4 #acb4 ,repeal ( annual fee on heal? insurance provid]s4 ,sec4 #acc4 ,repeal ( m$ical device excise tax4 ,sec4 #acd4 ,inclusion 9 income ( c]ta9 co/s ( employ]-provid$ cov]age "u heal? plans4 ,sec4 #ace4 ,inclusion ( c]ta9 ov]-!-c\nt] m$ical products z qualifi$ m$ical exp5ses4 ,sec4 #acf4 ,repeal ( limitation on heal? flexible sp5d+ arrangem5ts4 ,sec4 #acg4 ,m$ic>e "p ,d tax d$uction4 ,sec4 #ach4 ,repeal ( net inve/m5t income tax4 ,sec4 #aci4 ,basis = purposes ( det]m9+ ga9 or loss4 ,sec4 #adj4 ,d$uction = qualifi$ *>ity c>e4 ,sec4 #ada4 ,limitation on liability = volunte] heal? c>e pr(essionals4 ,title ,,ii--,m$ic>e & ,m$icaid ,re=ms ,subtitle ,a--,m$ic>e & ,m$icaid ,re=ms ,sec4 #bja4 ,flexible block grant option = ,/ates4 ,sec4 #bjb4 ,m$icaid eligibility det]m9ations4 ,sec4 #bjc4 ,l[]+ safe h>bor ?re%old ) respect to ,/ate taxes on heal? c>e provid]s4 ,sec4 #bjd4 ,income limitations = refundable cr$its = cov]age "u a qualifi$ heal? plan4 ,subtitle ,b--,m$ic>e ,sec4 #bba4 ,(f-campus provid]-bas$ dep>tm5t m$ic>e site neutral paym5t4 ,sec4 #bbb4 ,elim9ation ( ,m$ic>e eligibility = c]ta9 individuals4 ,sec4 #bbc4 ,m$ic>e cov]age ( bad debt4 ,subtitle ,c--,m$ical ,malpractice ,re=m ,sec4 #bca4 ,enc\rag+ spe$y resolution ( claims4 ,sec4 #bcb4 ,comp5sat+ pati5t injury4 ,sec4 #bcc4 ,maximiz+ pati5t recov]y4 ,sec4 #bcd4 ,au?orization ( paym5t ( future damages to claimants 9 heal? c>e lawsuits4 ,sec4 #bce4 ,product liability = heal? c>e provid]s4 ,sec4 #bcf4 ,def9itions4 ,sec4 #bcg4 ,effect on o!r laws4 ,sec4 #bch4 ,rules ( con/ruction4 ,sec4 #bci4 ,effective date4 ,sec4 #bdj4 ,limitation on exp]t witness te/imony4 ,sec4 #bda4 ,communications foll[+ unanticipat$ outcome4 ,sec4 #bdb4 ,exp]t witness qualifications4 ,sec4 #bdc4 ,affidavit ( m]it4 ,sec4 #bdd4 ,notice ( int5t to comm5ce lawsuit4 ,title ,,iii--,prescription drug competition ,subtitle ,a--,elim9at+ ,delays ( ,g5]ic ,drugs & ,biosimil> ,products ,sec4 #cja4 ,actions = delays ( g5]ic drugs & biosimil> biological products4 ,sec4 #cjb4 ,,rems approval process = subsequ5t fil]s4 ,subtitle ,b--,increas+ ,access to ,drugs & ,biosimil> ,products ,sec4 #caa4 ,exp$it$ developm5t & priority review = g5]ic complex drug products4 ,sec4 #cab4 ,increas+ ph>maceutical options to treat an unmet m$ical ne$4 ,sec4 #cac4 ,preemption ( ,/ate b>ri]s to ! sub/itution ( biosimil> products4 ,subtitle ,c--,limit+ ,exclusivity ,p]iods ,delay+ ,competition ,sec4 #cba4 ,limit+ exclusivity p]iods = drugs treat+ r>e diseases & conditions4 ,sec4 #cbb4 ,limit+ exclusivity = biosimil> products4 ,subtitle ,d--,congressional ,review ( ,ag5cy ,rulemak+ ,sec4 #cca4 ,congressional review ( ! ,food & ,drug ,adm9i/ration rulemak+4 ,sec4 #ccb4 ,gov]nm5t ,acc\ntability ,(fice /udy ( rules4 ,subtitle ,e--,m$ic>e ,prescription ,drug ,competition ,sec4 #cda4 ,m$ic>e drug cov]age4 ,sec4 #cdb4 ,,pbm transp>5cy & elim9ation ( ,,dir fees4 ,sec4 #cdc4 ,sunset ( limit on maximum rebate am\nt = s+le s\rce drugs & innovator multiple s\rce drugs4 ,sec4 #cdd4 ,regulation ( manufactur]-sponsor$ copay contributions4 ,sec4 #cde4 ,data report+ to improve ! transp>5cy reg>d+ h[ #cdj;,b hospital cov]$ entities provide c>e = pati5ts4 ,sec4 #cdf4 ,requir+ #cdj;,b drug disc\nt program reports by ,,d% hospital cov]$ entities on l[-income utilization rate ( outpati5t hospital s]vices4 ,title ,,iv--,provid] ,competition ,sec4 #dja4 ,hospital consolidation4 ,sec4 #djb4 ,price transp>5cy4 ,sec4 #djc4 ,repeal+ %>$ sav+s inc5tives f ,m$ic>e %>$ sav+s program4 ,sec4 #djd4 ,repeal ( heal? c>e re=m provisions limit+ ,m$ic>e exception to ! prohibition on c]ta9 physician ref]rals = hospitals4 ,sec4 #dje4 ,advisory gr\p on r$uc+ burd5 ( hospital adm9i/rative requirem5ts4 ,sec4 #djf4 ,au?ority ( ,f$]al ,trade ,commission ov] c]ta9 tax-exempt organizations4 ,title ,v--,digital ,heal? ,c>e ,sec4 #eja4 ,access ( individuals to protect$ heal? in=mation4 ,sec4 #ejb4 ,expansion ( cov]age ( teleheal? s]vices4 ,sec4 #ejc4 ,,/>k & ,,aks exemptions4 ,sec4 #ejd4 ,,/>k te*nical p5alty4 ,i ,private-,sector ,heal? ,insurance ,re=ms ,a ,comm]cial ,heal? ,insurance ,provisions #aja4 ,invisible high risk 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 ,high ,risk ,pool ,re9surance ,program 79 ?is section ref]r$ to z ! ,,ihrpr program74 7b7 ,/ate grants ,"u ! ,,ihrpr 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 high risk 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 high risk 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$]al default qualify+ invisible high risk pool describ$ 9 p>agraph 7#b74 7#b7 ,f$]al default qualify+ invisible high risk pool ,! ,f$]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 high risk 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 #bjbj1 ! ,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 high risk pool ,= purposes ( ?is section1 ! t]m qualify+ invisible high risk 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> #bjbj ?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 #ajb4 ,*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 #bjbj1 z ! ,secret>y may implem5t ?r\gh int]im f9al regulation1 #e to #a = adults 7consi/5t ) section #bgjg7;c774 #ajc4 ,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 #bjbj4 7#b7 ,repeal ( /udy & report ,! am5dm5t made by subsection 7c77#e7 %all take effect on ! date ( ! enactm5t ( ?is ,act4 #ajd4 ,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 #aje4 ,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 #ajf4 ,/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 #ajg4 ,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]iod 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 #ajh4 ,%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 #bjbj4 #aji4 ,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 #bjbj1 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 #aaj4 ,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 #aaa4 ,heal? plans creat$ "u ,,ppaca or (f]$ ?r\gh ,ex*anges to be only heal? plans ,f$]al ,gov]nm5t may make available to ,presid5t1 ,vice ,presid5t1 ,memb]s ( ,congress1 & ,f$]al employees ,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 #aab4 ,co/-%>+ r$uctions 7a7 ,co/-%>+ r$uction 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 ,!re is appropriat$1 f any money 9 ! ,treasury n o!rwise appropriat$1 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 #bjai ?r\gh #bjbb4 7#b7 ,adju/m5ts ,not)/&+ any o!r provision ( law1 paym5ts & o!r actions = adju/m5ts to obligations incurr$ prior to ,decemb] #ca1 #bjbj1 may be made ?r\gh ,decemb] #ca1 #bjba4 7#c7 ,limitation ,am\nts appropriat$ "u p>agraph 7#a7 = ea* ( plan ye>s #bjai ?r\gh #bjbb 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 7b7 ,election ,9 ! case ( an election "u ?is subsection by a ,/ate & a c]tification by ! ,secret>y ( ,heal? & ,human ,s]vices t su* election w n result 9 an increase 9 ,f$]al exp5ditures1 9 lieu ( ! am\nts t w\ld be paid to heal? insurance issu]s 9 su* ,/ate "u section #adjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act1 ! ,secret>y may pay to su* ,/ate an am\nt equal to su* am\nts4 ,prior to su* paym5t1 su* ,/ate %all make su* assurances z ! ,secret>y deems necess>y to ensure t su* ,/ate %all r$i/ribute su* paym5ts to heal? sav+s acc\nts ( individuals-- 7#a7 enroll$ 9 qualifi$ heal? plans 7z def9$ 9 section #cf;,b ( ! ,int]nal ,rev5ue ,code ( #aihf7 (f]$ by su* issu]s1 & 7#b7 ^: income is less ?an #bej p]c5t ( ! ,f$]al pov]ty l9e4 #aac4 ,heal? sav+s acc\nts 7a7 ,no high d$uctible heal? plans requir$ = heal? sav+s acc\nt contributions 7#a7 ,9 g5]al ,section #bbc ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or qualifi$ heal? plan aft] high d$uctible heal? plan ea* place su* t]m appe>s4 7#b7 ,qualifi$ heal? plan def9$ ,section #bbc7;c7 ( su* ,code is am5d$ to read z foll[s3 7c7 ,eligible individual ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,! t]m eligible individual means1 ) respect to any mon?1 any individual if su* individual is cov]$ "u a qualifi$ heal? plan z ( ! #a/ day ( su* mon?4 7#b7 ,qualifi$ heal? plan ,! t]m qualifi$ heal? plan has ! mean+ giv5 su* t]m 9 section #cf;,b4 4 7b7 ,premiums = plans z qualifi$ m$ical exp5ses2 treatm5t ( abortions 7#a7 ,9 g5]al ,section #bbc7;d77#b77;,b7 ( su* ,code is am5d$ to read z foll[s3 7,b7 ,abortions 7i7 ,paym5ts = heal? insurance ) abortion cov]age ,! t]m qualifi$ m$ical exp5se %all n include am\nts paid = insurance t includes cov]age = abortions4 7ii7 ,paym5ts = abortions ,! t]m qualifi$ m$ical exp5se %all n include am\nts paid = an abortion4 7iii7 ,exception ,clauses 7i7 & 7ii7 %all n apply to an abortion1 or to cov]age = an abortion-- 7,i7 if ! pregnancy is ! result ( an act ( rape or ince/1 or 7,,ii7 9 ! case :]e a woman suff]s f a physical disord]1 physical injury1 or physical illness t w\ld1 z c]tifi$ by a physician1 place ! woman 9 dang] ( dea? unless an abortion is p]=m$1 includ+ a life-endang]+ physical condition caus$ by or aris+ f ! pregnancy itself4 4 7#b7 ,con=m+ am5dm5t ,subsection #bbc7;d77#b7 is am5d$ by /rik+ subp>agraph 7,c74 #aad4 ,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 ! plan4 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 #bjbj4 #aae4 ,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 ,b ,association heal? plans #aba4 ,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] ( ! sponsor1 7,b7 ! sponsor1 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 #ejj1jjj1 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 #abb4 ,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 #abc4 ,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 #abd4 ,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$4 4 #abe4 ,effective date & transitional & o!r rules 7a7 ,effective ,date ,! am5dm5ts made by ?is ,act %all take effect #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 ,! ,secret>y ( ,labor %all fir/ issue all regulations necess>y to c>ry out ! am5dm5ts made by ?is ,act )9 #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7b7 ,treatm5t ( ,c]ta9 ,exi/+ ,heal? ,b5efits ,programs 7#a7 ,9 g5]al ,9 any case 9 :i*1 z ( ! date ( ! enactm5t ( ?is ,act1 an arrangem5t is ma9ta9$ 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 subtitle77 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 ,c ,tax-,relat$ ,provisions #aca4 ,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 #ajjjjjjjjjjjj #ajj-accbbbbbbbbbb #acc-aejcdcdcdcdcd #aej-bjjdd4cde4cdf4cdg4cdh4c #bjj-bejd4cd4ce4ce4if4ch4jeg4cih4caj #bej-cjjd4cd4ce4ie4ih4jeh4ceiaj4eajaa4e #cjj-djjd4cd4ce4ie4ih4ceh4ceaj4eaj4eaa4e aa4e 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> #bjbj1 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> #bjbj1 ov] ! rate ( gr[? 9 ! consum] price index = cal5d> ye> #bjbj4 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 = cal5d> ye> #bjah exce$s an am\nt equal to #j4ejd p]c5t ( ! gross dome/ic product = su* cal5d> ye>4 4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjbj4 #acb4 ,repeal ( annual fee on heal? insurance provid]s 7a7 ,9 g5]al ,! ,pati5t ,protection & ,af=dable ,c>e ,act is am5d$ by /rik+ section #ijaj4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to cal5d> ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 #acc4 ,repeal ( m$ical device excise tax 7a7 ,9 g5]al ,*apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ sub*apt] ,e4 7b7 ,con=m+ am5dm5ts 7#a7 ,subsection 7a7 ( section #dbba ( su* ,code is am5d$ by /rik+ ! la/ s5t5ce4 7#b7 ,p>agraph 7#b7 ( section #fdaf7;b7 ( su* ,code is am5d$ by /rik+ ! la/ s5t5ce4 7c7 ,cl]ical am5dm5t ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e4 7d7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ,decemb] #ca1 #bjag4 #acd4 ,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> #bjbj = 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] #bjbj & 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 ,repeal ( employ]-,sponsor$ heal? cov]age excise tax ,! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ section #dihj;,i4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjbj4 #ace4 ,inclusion ( c]ta9 ov]-!-c\nt] m$ical products z qualifi$ m$ical exp5ses 7a7 ,,hsas ,section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 by /rik+ ! la/ s5t5ce ( subp>agraph 7,a7 & ins]t+ ! foll[+3 ,= purposes ( ?is subp>agraph1 am\nts paid = m5/rual c>e products %all be treat$ z paid = m$ical c>e41 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,m5/rual c>e product ,= purposes ( ?is p>agraph1 ! t]m m5/rual c>e product means a tampon1 pad1 l9]1 cup1 sponge1 or simil> product us$ by wom5 ) respect to m5/ruation or o!r g5ital-tract secretions4 4 7b7 ,ar*] ,,msas ,section #bbj7;d77#b77;,a7 ( su* ,code is am5d$ by /rik+ ! la/ s5t5ce & ins]t+ ! foll[+3 ,= purposes ( ?is subp>agraph1 am\nts paid = m5/rual c>e products 7z def9$ 9 section #bbc7;d77#b77;,d77 %all be treat$ z paid = m$ical c>e44 7c7 ,heal? flexible sp5d+ arrangem5ts & heal? reimbursem5t arrangem5ts ,section #ajf ( su* ,code is am5d$ by /rik+ subsection 7f7 & ins]t+ ! foll[+ new subsection3 7f7 ,reimbursem5ts = m5/rual c>e products ,= purposes ( ?is section & section #aje1 exp5ses incurr$ = m5/rual c>e products 7z def9$ 9 section #bbc7;d77#b77;,d77 %all be treat$ z incurr$ = m$ical c>e4 4 7d7 ,effective dates 7#a7 ,di/ributions f heal? sav+s acc\nts ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply to am\nts paid aft] ,decemb] #ca1 #bjbj4 7#b7 ,reimbursem5ts ,! am5dm5t made by subsection 7c7 %all apply to exp5ses incurr$ aft] ,decemb] #ca1 #bjbj4 #acf4 ,repeal ( limitation on heal? flexible sp5d+ arrangem5ts 7a7 ,9 g5]al ,section #abe ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ subsection 7i74 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjah4 #acg4 ,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$uction is all[able ) respect to any co/ tak5 into acc\nt 9 det]m9+ su* paym5t44 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjah4 #ach4 ,repeal ( net inve/m5t income tax 7a7 ,9 g5]al ,subtitle ,a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ *apt] #b;,a4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 #aci4 ,basis = purposes ( det]m9+ ga9 or loss ,no?+ 9 ! ,int]nal ,rev5ue ,code ( #aihf %all be con/ru$ to prev5t ! ,secret>y ( ! ,treasury 7or any designee ( ! ,secret>y7 f provid+ t ! basis = det]m9+ ga9 or loss 7:e!r on ! basis ( co/ or o!rwise7 is adju/$ on ! basis ( inflation4 #adj4 ,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 #ada4 ,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 ,,ii ,m$ic>e & ,m$icaid ,re=ms ,a #bja4 ,flexible block grant option = ,/ates ,title ,,xix ( ! ,social ,security ,act is am5d$-- 7#a7 9 section #aijc 7#db ,u4,s4,c4 #acif;b7-- 7,a7 9 subsection 7a71 9 ! matt] be=e p>agraph 7#a71 by ins]t+ & section #aijc;,a7a7 aft] except z o!rwise provid$ 9 ?is section2 & 7,b7 9 subsection 7d77#a71 by /rik+ to :i* & ins]t+ to :i*1 subject to section #aijc;,a7a712 & 7#b7 by ins]t+ aft] su* section #aijc ! foll[+ new section3 #aijc;,a4 ,flexible block grant option = ,/ates 7a7 ,9 g5]al ,9 ! case ( a ,/ate t elects ! option ( apply+ ?is section = a #aj-;fiscal-ye> p]iod 7beg9n+ no e>li] ?an fiscal ye> #bjbj &1 at ! ,/ate option1 = any succe$+ #aj-;fiscal-ye> p]iod7 & t has a plan approv$ by ! ,secret>y "u subsection 7b7 to c>ry out ! option = su* p]iod-- 7#a7 ! ,/ate %all receive1 in/ead ( am\nts o!rwise payable to ! ,/ate "u ?is title = m$ical assi/ance = block grant individuals )9 ! applicable block grant category 7z def9$ 9 subsection 7f77 = ! ,/ate dur+ ! p]iod 9 :i* ! election is 9 effect1 ! am\nt specifi$ 9 subsection 7d72 7#b7 ! paym5t "u ?is section may only be us$ consi/5t ) ! ,/ate plan "u subsection 7b7 = block grant heal? c>e assi/ance 7z def9$ 9 subsection 7g772 & 7#c7 ) respect to block grant individuals )9 ! applicable block grant category = ! ,/ate = :i* block grant heal? c>e assi/ance is made available "u ?is section1 su* assi/ance %all be in/ead ( m$ical assi/ance o!rwise provid$ to ! individual "u ?is title4 7b7 ,/ate plan = adm9i/]+ block grant option 7#a7 ,9 g5]al ,no paym5t %all be made "u ?is section to a ,/ate pursuant to an election = a #aj-;fiscal-ye> p]iod "u subsection 7a7 unless ! ,/ate has a plan1 approv$ "u p>agraph 7#b71 = su* p]iod t specifies-- 7,a7 ! applicable block grant category ) respect to :i* ! ,/ate w apply ! option "u ?is section = su* p]iod2 7,b7 ! conditions = eligibility ( block grant individuals )9 su* applicable block grant category = block grant heal? c>e assi/ance "u ! option1 :i* %all be in/ead ( o!r conditions = eligibility "u ?is title1 except t 9 ! case ( a ,/ate t has elect$ ! applicable block grant category describ$ 9-- 7i7 p>agraph 7#a7 ( subsection 7f71 ! plan mu/ provide = eligibility = pregnant wom5 & *ildr5 requir$ to be provid$ m$ical assi/ance "u subsections 7a77#aj77;,a77i7 & 7e77#d7 ( section #aijb2 or 7ii7 p>agraph 7#b7 ( subsection 7f71 ! plan mu/ provide = eligibility = pregnant wom5 requir$ to be provid$ m$ical assi/ance "u subsection 7a77#aj77;,a77i72 & 7,c7 ! types ( items & s]vices1 ! am\nt1 duration1 & scope ( su* s]vices1 ! co/-%>+ ) respect to su* s]vices1 & ! me?od = deliv]y ( block grant heal? c>e assi/ance "u ?is section1 :i* %all be in/ead ( ! su* types1 am\nt1 duration1 & scope1 co/-%>+1 & me?ods ( deliv]y = m$ical assi/ance o!rwise requir$ "u ?is title1 except t ! plan mu/ provide = assi/ance =-- 7i7 hospital c>e2 7ii7 surgical c>e & treatm5t2 7iii7 m$ical c>e & treatm5t2 7iv7 ob/etrical & pr5atal c>e & treatm5t2 7v7 prescrib$ drugs1 m$ic9es1 & pro/hetic devices2 7vi7 o!r m$ical supplies & s]vices2 & 7vii7 heal? c>e = *ildr5 "u #ah ye>s ( age4 7#b7 ,review & approval ,a plan describ$ 9 p>agraph 7#a7 %all be deem$ approv$ by ! ,secret>y unless ! ,secret>y det]m9es1 )9 #cj days aft] ! date ( ! ,secret>y's receipt ( ! plan1 t ! plan is incomplete or actu>ially uns\nd &1 ) respect to su* plan & its implem5tation "u ?is section1 ! requirem5ts ( p>agraphs 7#a71 7#aj77;,b71 7#ag71 & 7#bc7 ( section #aijb7;a7 %all n apply4 7c7 ,am\nt ( block grant funds 7#a7 ,= initial fiscal ye> ,! block grant am\nt "u ?is subsection = a ,/ate = ! initial fiscal ye> 9 ! fir/ #aj-;fiscal-ye> p]iod is equal to an am\nt det]m9$ by ! ,secret>y to equal ! p] capita sp5d+ on ! population cov]$ by ! ,/ate plan e/abli%$ 9 subsection 7b7 ( section #aijc;,a4 7#b7 ,= any subsequ5t fiscal ye> ,! block grant am\nt "u ?is section = a ,/ate = ea* succe$+ fiscal ye> 79 any #aj-;fiscal-ye> p]iod7 is equal to ! block grant am\nt "u p>agraph 7#a7 7or ?is p>agraph7 = ! ,/ate = ! previ\s fiscal ye> increas$ by ! annual increase 9 ! consum] price index = all urban consum]s 7all items2 ,u4,s4 city av]age7 = ! fiscal ye> involv$4 7#c7 ,availability ( rollov] funds ,! block grant am\nt "u ?is subsection = a ,/ate = a fiscal ye> %all rema9 available to ! ,/ate = exp5ditures "u ?is section = ! succe$+ fiscal ye> b only if an election is 9 effect "u ?is section = ! ,/ate 9 su* succe$+ fiscal ye>4 7d7 ,f$]al paym5t & ,/ate responsibility ,! ,secret>y %all pay to ea* ,/ate ) an election 9 effect "u ?is section = a fiscal ye>1 f its block grant am\nt "u subsection 7c7 available = su* fiscal ye>1 an am\nt = ea* qu>t] ( su* fiscal ye> equal to ! enhanc$ ,,fmap describ$ 9 ! fir/ s5t5ce ( section #baje7;b7 ( ! total am\nt exp5d$ "u ! ,/ate plan "u ?is section dur+ su* qu>t]1 & ! ,/ate is responsible = ! balance ( funds to c>ry out su* plan4 7e7 ,block grant individual def9$ ,9 ?is section1 ! t]m block grant individual means1 ) respect to a ,/ate = a #aj-;fiscal-ye> p]iod1 an individual :o is )9 an applicable block grant category = ! ,/ate & su* p]iod4 7f7 ,applicable block grant category def9$ ,9 ?is section1 ! t]m applicable block grant category means ) respect to a ,/ate = a #aj-;fiscal-ye> p]iod1 ei!r ( ! foll[+ z specifi$ by ! ,/ate = su* p]iod 9 its plan "u subsection 7b77#a77;,a73 7#a7 ,eld]ly1 bl9d1 disabl$ ,bo? ( ! foll[+ categories3 7,a7 ,eld]ly ,individuals :o are #fe ye>s ( age or old]4 7,b7 ,bl9d & disabl$ ,individuals 7n describ$ 9 ! previ\s subp>agraph7 :o are eligible = m$ical assi/ance "u ?is title on ! basis ( be+ bl9d or disabl$4 7#b7 ,eld]ly1 bl9d1 disabl$1 & o!rs ,all ( ! foll[+ categories3 7,a7 ,eld]ly ,individuals :o are #fe ye>s ( age or old]4 7,b7 ,bl9d & disabl$ ,individuals 7n describ$ 9 ! previ\s subp>agraph7 :o are eligible = m$ical assi/ance "u ?is title on ! basis ( be+ bl9d or disabl$4 7,c7 ,*ildr5 ,individuals 7n describ$ 9 a previ\s subp>agraph7 :o are *ildr5 "u #ai ye>s ( age4 7,d7 ,expansion enrollees ,individuals 7n describ$ 9 a previ\s subp>agraph7 = :om ! am\nts exp5d$ = m$ical assi/ance are subject to an increase or *ange 9 ! ,f$]al m$ical assi/ance p]c5tage "u subsection 7y7 or 7z77#b71 respectively1 ( section #aije4 7,e7 ,o!r noneld]ly1 nondisabl$1 non-expansion adults ,individuals :o are n describ$ 9 any ( ! previ\s subp>agraphs & ^: income does n exce$ #fj p]c5t ( ! pov]ty l9e 7z def9$ 9 section #baaj7;c77#e77 applicable to a family ( ! size involv$4 7g7 ,block grant heal? c>e assi/ance ,9 ?is section1 ! t]m block grant heal? c>e assi/ance means assi/ance = heal?-c>e-relat$ items & m$ical s]vices = block grant individuals )9 ! applicable block grant category = ! ,/ate & #aj-;fiscal-ye> p]iod involv$ :o are l[-income individuals 7z def9$ by ! ,/ate74 7h7 ,audit+ ,z a condition ( receiv+ funds "u ?is section1 a ,/ate %all contract ) an indep5d5t entity to conduct audits ( its exp5ditures made ) respect to activities fund$ "u ?is section = ea* fiscal ye> = :i* ! ,/ate elects to apply ?is section to ensure t su* funds are us$ consi/5t ) ?is section & %all make su* audits available to ! ,secret>y ^u ! reque/ ( ! ,secret>y4 4 #bjb4 ,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 #bjc4 ,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$-- 7#a7 by /rik+ ( fiscal ye>s beg9n+ & ins]t+ ( fiscal ye>s-- 7,i7 beg9n+ 2 & 7#b7 by /rik+ x appe>s4 & ins]t+ ! foll[+3 x appe>s2 7,,ii7 beg9n+ on or aft] ,janu>y #a1 #bjbj1 & be=e ,janu>y #a1 #bjcj1 #d p]c5t %all be sub/itut$ = #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 #bjd4 ,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 7#fj p]c5t 9 ! case ( an individual enroll$ ?r\gh an ,ex*ange utiliz$ by a ,/ate t makes ! election describ$ 9 section #aijc;,a ( ! ,social ,security ,act74 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to taxable ye>s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 ,b ,m$ic>e #bba4 ,(f-campus provid]-bas$ 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 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 #bbb4 ,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 #bbc4 ,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 #bjbj2 & 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 #bjbj2 & 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 #bjbj2 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 #bjbj2 & 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$ical ,malpractice ,re=m #bca4 ,enc\rag+ spe$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 #bcb4 ,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 #bcc4 ,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 #bcd4 ,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 #bce4 ,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 #bcf4 ,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 #bcg4 ,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$]al law4 #bch4 ,rules ( con/ruction 7a7 ,heal? c>e lawsuits ,unless o!rwise specifi$ 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$]al law4 #bci4 ,effective date ,?is subtitle %all apply to any heal? c>e lawsuit br\ght 9 a ,f$]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$4 #bdj4 ,limitation on exp]t witness te/imony 7a7 ,9 g5]al ,no p]son 9 a heal? c>e pr(ession requir+ lic5sure "u ! laws ( a ,/ate %all be compet5t to te/ify 9 any c\rt ( law to e/abli% ! foll[+ facts-- 7#a7 ! recogniz$ /&>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$4 7b7 ,applicability ,! requirem5ts set =? 9 subsection 7a7 %all also apply to exp]t witnesses te/ify+ = ! def5dant z rebuttal witnesses4 7c7 ,waiv] au?ority ,! c\rt may waive ! requirem5ts 9 ?is subsection if x det]m9es t ! appropriate witnesses o!rwise w\ld n be available4 #bda4 ,communications foll[+ unanticipat$ 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 #bdb4 ,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]$4 7c7 ,p[] ( c\rt ,no?+ 9 ?is subsection %all limit ! p[] ( ! trial c\rt 9 a heal? c>e lawsuit to disqualify an exp]t witness on gr\nds o!r ?an ! qualifications set =? "u ?is subsection4 7d7 ,limitation ,an exp]t witness 9 a heal? c>e lawsuit %all n be p]mitt$ 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 #bdc4 ,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 #bdd4 ,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 ,,iii ,prescription drug competition ,a ,elim9at+ ,delays ( ,g5]ic ,drugs & ,biosimil> ,products #cja4 ,actions = delays ( g5]ic drugs & biosimil> biological products 7a7 ,def9itions ,9 ?is section-- 7#a7 ! t]m cov]$ product-- 7,a7 means-- 7i7 any drug approv$ "u subsection 7b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any comb9ation ( a drug or biological product describ$ 9 clause 7i72 or 7iii7 :5 reasonably necess>y to demon/rate sam5ess1 biosimil>ity1 or int]*angeability = purposes ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 z applicable1 any product1 includ+ any device1 t is m>ket$ or int5d$ = use ) su* drug or biological product2 & 7,b7 does n include any drug or biological product t ! ,secret>y has det]m9$ to be curr5tly 9 %ortage & t appe>s on ! drug %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless ! %ortage w n be promptly resolv$-- 7i7 z demon/rat$ by ! fact t ! drug or biological product has be5 9 %ortage = m ?an #f mon?s2 or 7ii7 z o!rwise det]m9$ by ! ,secret>y2 7#b7 ! t]m device has ! mean+ giv5 ! t]m 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#c7 ! t]m eligible product develop] means a p]son t seeks to develop a product = approval pursuant to an application = approval "u subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or = lic5s+ pursuant to an application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 7#d7 ! t]m lic5se hold] means ! hold] ( an application approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or ! hold] ( a lic5se "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a cov]$ product2 7#e7 ! t]m ,,rems means a risk evaluation & mitigation /rategy "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#f7 ! t]m ,,rems ) ,,etasu means a ,,rems t conta9s elem5ts to assure safe use "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 ! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices2 7#h7 ! t]m s+le1 %>$ sy/em ( elem5ts to assure safe use means a s+le1 %>$ sy/em ( elem5ts to assure safe use "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 & 7#i7 ! t]m suffici5t quantities means an am\nt ( a cov]$ product t all[s ! eligible product develop] to-- 7,a7 conduct te/+ to support an application-- 7i7 = approval "u subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 = lic5s+ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 7,b7 fulfill any regulatory requirem5ts relat+ to su* an application = approval or lic5s+4 7b7 ,civil action = failure ,to provide suffici5t quantities ( a cov]$ product 7#a7 ,9 g5]al ,an eligible product develop] may br+ a civil action aga9/ ! lic5se hold] = a cov]$ product seek+ relief "u ?is subsection 9 an appropriate di/rict c\rt ( ! ,unit$ ,/ates alleg+ t ! lic5se hold] has decl9$ to provide suffici5t quantities ( ! cov]$ product to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms4 7#b7 ,elem5ts 7,a7 ,9 g5]al ,to prevail 9 a civil action br\ght "u p>agraph 7#a71 an eligible product develop] %all prove1 by a prepond]ance ( ! evid5ce-- 7i7 t-- 7,i7 ! cov]$ product is n subject to a ,,rems ) ,,etasu2 or 7,,ii7 if ! cov]$ product is subject to a ,,rems ) ,,etasu-- 7aa7 ! eligible product develop] has obta9$ a cov]$ product au?orization f ! ,secret>y 9 accordance ) subp>agraph 7,b72 & 7bb7 ! eligible product develop] has provid$ a copy ( ! cov]$ product au?orization to ! lic5se hold]2 7ii7 t1 z ( ! date on :i* ! civil action is fil$1 ! product develop] has n obta9$ suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7iii7 t ! eligible product develop] has reque/$ to pur*ase suffici5t quantities ( ! cov]$ product f ! lic5se hold]2 & 7iv7 t ! lic5se hold] has n deliv]$ to ! eligible product develop] suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 by ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 & 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 by #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/ = ! cov]$ product2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) subp>agraph 7,b74 7,b7 ,au?orization = cov]$ product subject to a ,,rems ) ,,etasu 7i7 ,reque/ ,an eligible product develop] may submit to ! ,secret>y a writt5 reque/ = ! eligible product develop] to be au?oriz$ to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu4 7ii7 ,au?orization ,n lat] ?an #ij days aft] ! date on :i* a reque/ "u clause 7i7 is receiv$1 ! ,secret>y %all1 by writt5 notice1 au?orize ! eligible product develop] to obta9 suffici5t quantities ( an individual cov]$ product subject to a ,,rems ) ,,etasu = purposes (-- 7,i7 developm5t & te/+ t does n involve human cl9ical trials1 if ! eligible product develop] has agre$ to comply ) any conditions ! ,secret>y det]m9es necess>y2 or 7,,ii7 developm5t & te/+ t involves human cl9ical trials1 if ! eligible product develop] has-- 7aa7 7,,aa7 submitt$ protocols1 in=m$ cons5t docum5ts1 & in=mational mat]ials = te/+ t include protections t provide safety protections comp>able to ^? provid$ by ! ,,rems = ! cov]$ product2 or 7,,bb7 o!rwise satisfi$ ! ,secret>y t su* protections w be provid$2 & 7bb7 met any o!r requirem5ts ! ,secret>y may e/abli%4 7iii7 ,notice ,a cov]$ product au?orization issu$ "u ?is subp>agraph %all /ate t ! provision ( ! cov]$ product by ! lic5se hold] "u ! t]ms ( ! au?orization w n be a violation ( ! ,,rems = ! cov]$ product4 7#c7 ,affirmative def5se ,9 a civil action br\ght "u p>agraph 7#a71 x %all be an affirmative def5se1 on :i* ! def5dant has ! burd5 ( p]suasion by a prepond]ance ( ! evid5ce-- 7,a7 t1 on ! date on :i* ! eligible product develop] reque/$ to pur*ase suffici5t quantities ( ! cov]$ product f ! lic5se hold]-- 7i7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors 0 engag$ 9 ! manufactur+ or comm]cial m>ket+ ( ! cov]$ product2 & 7ii7 nei!r ! lic5se hold] nor any ( its ag5ts1 :olesal]s1 or di/ributors o!rwise _h access to inv5tory ( ! cov]$ product to supply to ! eligible product develop] on comm]cially reasonable1 m>ket-bas$ t]ms2 or 7,b7 t-- 7i7 ! lic5se hold] sells ! cov]$ product ?r\gh ag5ts1 di/ributors1 or :olesal]s2 7ii7 ! lic5se hold] has plac$ no re/rictions1 explicit or implicit1 on its ag5ts1 di/ributors1 or :olesal]s to sell cov]$ products to eligible product develop]s2 & 7iii7 ! cov]$ product c be pur*as$ by ! eligible product develop] 9 suffici5t quantities on comm]cially reasonable1 m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 or :olesal]s ( ! lic5se hold]4 7#d7 ,rem$ies 7,a7 ,9 g5]al ,if an eligible product develop] prevails 9 a civil action br\ght "u p>agraph 7#a71 ! c\rt %all-- 7i7 ord] ! lic5se hold] to provide to ! eligible product develop] )\t delay suffici5t quantities ( ! cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms2 7ii7 aw>d to ! eligible product develop] reasonable attorney fees & co/s ( ! civil action2 & 7iii7 aw>d to ! eligible product develop] a monet>y am\nt suffici5t to det] ! lic5se hold] f fail+ to provide o!r eligible product develop]s ) suffici5t quantities ( a cov]$ product on comm]cially reasonable1 m>ket-bas$ t]ms1 if ! c\rt f9ds1 by a prepond]ance ( ! evid5ce-- 7,i7 t ! lic5se hold] delay$ provid+ suffici5t quantities ( ! cov]$ product to ! eligible product develop] )\t a legitimate bus9ess ju/ification2 or 7,,ii7 t ! lic5se hold] fail$ to comply ) an ord] issu$ "u clause 7i74 7,b7 ,maximum monet>y am\nt ,a monet>y am\nt aw>d$ "u subp>agraph 7,a77iii7 %all n be great] ?an ! rev5ue t ! lic5se hold] e>n$ on ! cov]$ product dur+ ! p]iod-- 7i7 beg9n+ on-- 7,i7 = a cov]$ product t is n subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7,,ii7 = a cov]$ product t is subject to a ,,rems ) ,,etasu1 ! date t is #ca days aft] ! lat] (-- 7aa7 ! date on :i* ! lic5se hold] receiv$ ! reque/2 or 7bb7 ! date on :i* ! lic5se hold] receiv$ a copy ( ! cov]$ product au?orization issu$ by ! ,secret>y 9 accordance ) p>agraph 7#b77;,b72 & 7ii7 end+ on ! date on :i* ! eligible product develop] receiv$ suffici5t quantities ( ! cov]$ product4 7,c7 ,avoidance ( delay ,! c\rt may issue an ord] "u subp>agraph 7,a77i7 be=e conduct+ fur!r proce$+s t may be necess>y to det]m9e :e!r ! eligible product develop] is entitl$ to an aw>d "u clause 7ii7 or 7iii7 ( subp>agraph 7,a71 or ! am\nt ( any su* aw>d4 7c7 ,limitation ( liability ,a lic5se hold] = a cov]$ product %all n be liable = any claim aris+ out ( ! failure ( an eligible product develop] to foll[ adequate safegu>ds to assure safe use ( ! cov]$ product dur+ developm5t or te/+ activities describ$ 9 ?is section1 includ+ transportation1 h&l+1 use1 or disposal ( ! cov]$ product by ! eligible product develop]4 7d7 ,rule ( con/ruction 7#a7 ,def9ition ,9 ?is subsection1 ! t]m antitru/ laws-- 7,a7 has ! mean+ giv5 ! t]m 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab72 & 7,b7 includes section #e ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t su* section applies to unfair me?ods ( competition4 7#b7 ,antitru/ laws ,no?+ 9 ?is section %all be con/ru$ to limit ! op]ation ( any provision ( ! antitru/ laws4 #cjb4 ,,rems approval process = subsequ5t fil]s ,section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is am5d$-- 7#a7 9 subsection 7g77#d77;,b7-- 7,a7 9 clause 7i7 by /rik+ or aft] ! semicolon2 7,b7 9 clause 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7iii7 accommodate diff]5t approv$ risk evaluation & mitigation /rategies = a ref]5ce drug product & a drug t is ! subject ( an abbreviat$ new drug application4 2 & 7#b7 9 subsection 7i77#a71 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,elem5ts to assure safe use1 if requir$ "u subsection 7f7 = ! li/$ drug 9 accordance ) ! foll[+3 7i7 ,subject to clause 7ii71 a drug t is ! subject ( an abbreviat$ new drug application may use-- 7,i7 a s+le1 %>$ sy/em ) ! li/$ drug "u subsection 7f72 or 7,,ii7 a diff]5t1 comp>able aspect ( ! elem5ts to assure safe use "u subsection 7f74 7ii7 ,! ,secret>y may require a drug t is ! subject ( an abbreviat$ new drug application & ! li/$ drug to use a s+le1 %>$ sy/em "u subsection 7f71 if ! ,secret>y det]m9es t no diff]5t1 comp>able aspect ( ! elem5ts to assure safe use c\ld satisfy ! requirem5ts ( subsection 7f74 4 ,b ,increas+ ,access to ,drugs & ,biosimil> ,products #caa4 ,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 #cab4 ,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 #cac4 ,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 ,c ,limit+ ,exclusivity ,p]iods ,delay+ ,competition #cba4 ,limit+ 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 #cbb4 ,limit+ exclusivity = biosimil> products ,p>agraph 7#g7 ( section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 is am5d$ 9 subp>agraph 7,a71 by /rik+ #ab & ins]t+ #e4 ,d ,congressional ,review ( ,ag5cy ,rulemak+ #cca4 ,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$+s "u sub*apt] ) proce$+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 #ccb4 ,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 ,e ,m$ic>e ,prescription ,drug ,competition #cda4 ,m$ic>e drug cov]age ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may alt] ! reimbursem5t me*anism = prescription drugs provid$ ?r\gh ! ,m$ic>e ,"p ,b program by reimburs+ at a rate t1 bas$ on ,,asp#f 9 ! ye> ( implem5tation ( ?is ,act1 gr[s at ,,cpi4 #cdb4 ,,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 #bjbj4 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 #cdc4 ,sunset ( limit on maximum rebate am\nt = s+le s\rce drugs & innovator multiple s\rce drugs ,section #aibg7;c77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,d77 is am5d$ by ins]t+ aft] ,decemb] #ca1 #bjji1 ! foll[+3 & be=e ,decemb] #ca1 #bjbd14 #cdd4 ,regulation ( manufactur]-sponsor$ copay contributions ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may e/abli% a me*anism prohibit+ drug manufactur]s f contribut+ f9ancially to pati5t copays1 & e/abli% a sy/em ( p5aliz+ su* behavior4 #cde4 ,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 #cdf4 ,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$-- 7#a7 9 subp>agraph 7,b77i71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 includ+1 ) respect to su* updates made on or aft] ,janu>y #a1 #bjbj1 by requir+ cov]$ 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 ,,iv ,provid] ,competition #dja4 ,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$ic>e rates appli$ 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$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,x71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,y71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by ins]t+ aft] subp>agraph 7,y7 ! foll[+ new subp>agraph3 7,z7 subject to p>agraph 7#d71 9 ! case ( a hospital 9 an urban area & ) respect to :i* !re is a ,h]f9dahl-,hirs*man ,index 7,,hhi7 ( great] ?an #d1jjj & 9 ! case ( a hospital 9 a rural area & ) respect to :i* !re is ,h]f9dahl-,hirs*man ,index 7,,hhi7 ( great] ?an #e1jjj1 to apply ! reimbursem5t rate ) respect to individuals 7reg>dless ( :e!r su* an individual is entitl$ 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 entitl$ to or enroll$ = b5efits "u ?is title4 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 ! ,,hrr m>ket %>e ( su* hospital 7z det]m9$ "u subp>agraph 7,b77 is less ?an #j4ae4 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 hospital 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 programs "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 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$4 #djb4 ,price transp>5cy ,section #ahff ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc71 z am5d$ by section #dja1 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* 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 ,s]vices ,= purposes ( subsection 7a77#a77;,,aa7 & ?is subsection1 ! ,secret>y %all1 = #bjba & ea* subsequ5t ye>1 publi% a li/ ( ! #ajj 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 #djc4 ,repeal+ %>$ sav+s inc5tives f ,m$ic>e %>$ sav+s program 7a7 ,9 g5]al ,section #ahii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;jjj7 is am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 by /rik+ subp>agraph 7,b72 & 7,b7 by /rik+ su* program-- 7,a7 gr\ps ( provid]s & ins]t+ su* program1 gr\ps ( provid]s 2 7#b7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,c71 by /rik+ t w\ld all[ ! organization to receive & di/ribute paym5ts = %>$ sav+s "u subsection 7d77#b7 to p>ticipat+ provid]s ( s]vices & suppli]s2 & 7,b7 9 subp>agraph 7,e7-- 7i7 by /rik+ ! implem5tation & ins]t+ & ! implem5tation2 & 7ii7 by /rik+ 1 & ! det]m9ation ( paym5ts = %>$ sav+s "u subsection 7d77#b72 7#c7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,a71 by /rik+ except & all t foll[s ?r\gh subp>agraph 7,b77i742 & 7ii7 by /rik+ subp>agraph 7,b72 & 7,b7 by /rik+ p>agraph 7#b72 & 7#d7 9 subsection 7g71 by /rik+ p>agraph 7#d7 & r$esignat+ p>agraphs 7#e7 & 7#f7 z p>agraphs 7#d7 & 7#e71 respectively4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all take effect on ,janu>y #a1 #bjba4 #djd4 ,repeal ( heal? c>e re=m provisions limit+ ,m$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$4 #dje4 ,advisory gr\p on r$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 #djf4 ,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 ,v ,digital ,heal? ,c>e #eja4 ,access ( individuals to protect$ heal? in=mation ,! provisions ( section #afd4ebd ( title #de1 ,code ( ,f$]al ,regulations1 z 9 effect on ! day be=e ! date ( ! enactm5t ( ?is ,act1 %all h ! =ce & effect ( law4 #ejb4 ,expansion ( cov]age ( teleheal? s]vices 7a7 ,cov]$ 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 #ejc4 ,,/>k & ,,aks exemptions ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may exempt value-bas$ arrangem5ts1 alt]native paym5t models1 & te*nologies 7z def9$ by ! ,secret>y7 f any provision ( section #aabh;,b or #ahgg ( ! ,social ,security ,act = purposes ( ma9ta9+1 analyz+1 or transf]r+ electronic heal? records4 #ejd4 ,,/>k te*nical p5alty ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may in/itute a civil monet>y p5alty = te*nical1 nonegregi\s violations ( section #ahgg ( ! ,social ,security ,act 9 lieu ( any p5alty o!rwise applicable = su* violations "u su* section4