,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #bdeb ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #a1 #bjai,ms4 ,de,lauro 7= h]self1 ,ms4 ,s*ak[sky1 ,mr4 ,k5n$y1 ,mr4 ,clay1 ,ms4 ,norton1 ,mr4 ,grijalva1 ,mr4 ,c>bajal1 ,mrs4 ,trahan1 ,mr4 ,ryan1 ,ms4 ,jackson ,lee1 ,mr4 ,?ompson ( ,mississippi1 ,ms4 ,roybal-,all>d1 ,ms4 ,mc,collum1 ,ms4 ,moore1 ,mr4 ,ru%1 & ,mr4 ,higg9s ( ,new ,york7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,ways & ,means1 & 9 addition to ! ,committees on ,en]gy & ,comm]ce1 ,education & ,labor1 ! ,judici>y1 ,natural ,res\rces1 & ,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 am5d ! ,social ,security ,act to e/abli% a ,m$ic>e = ,am]ica heal? program to provide = compreh5sive heal? cov]age = all ,am]icans4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,m$ic>e = ,am]ica ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,transition+ to & ,e/abli%+ ,m$ic>e = ,am]ica ,subtitle ,a--,transitional public heal? option ,sec4 #aja4 ,e/abli%m5t4 ,sec4 #ajb4 ,eligibility4 ,sec4 #ajc4 ,b5efits4 ,sec4 #ajd4 ,premiums4 ,sec4 #aje4 ,provid]s & reimbursem5t rates4 ,sec4 #ajf4 ,acc\nt2 fund+4 ,subtitle ,b--,m$ic>e = ,am]ica ,sec4 #aaa4 ,e/abli%m5t & adm9i/ration ( ,m$ic>e = ,am]ica4 ,sec4 #aab4 ,modifications to & coord9ation ) exi/+ ,f$]al heal? programs4 ,subtitle ,c--,t>get$ ,re=ms ,sec4 #aba4 ,no surprise bill+4 ,sec4 #abb4 ,limitation on removal ( ,m$ic>e ,advantage provid]s by ,,ma organizations4 ,sec4 #abc4 ,network adequacy4 ,sec4 #abd4 ,elim9at+ ! #bd-mon? wait+ p]iod = ,m$ic>e cov]age = individuals ) disabilities4 ,sec4 #abe4 ,elim9at+ ! wait+ p]iod = individuals on ,/ate ,m$icaid wait+ li/s4 ,sec4 #abf4 ,employ] heal? plan options4 ,sec4 #abg4 ,prohibition on /ep !rapy & prior au?orization "u gr\p heal? plans4 ,sec4 #abh4 ,m$ic>e outpati5t obs]vation s]vices4 ,sec4 #abi4 ,abortion cov]age4 ,sec4 #acj4 ,applicability ( m5tal heal? p>ity4 ,sec4 #aca4 ,/ud5t loan =giv5ess = heal? c>e provid]s p>ticipat+ 9 ,m$ic>e = ,am]ica4 ,sec4 #acb4 ,cl>ification ( ! def9ition ( p$iatric m$ical necessity 9 qualify+ gr\p cov]age4 ,sec4 #acc4 ,safe /aff+ requirem5ts4 ,sec4 #acd4 ,enhancem5ts = r$uc$ co/-%>+4 ,sec4 #ace4 ,repeal ( bonus paym5ts = ,m$ic>e ,advantage plans4 ,title ,,ii--,,tax ,,provisions ,sec4 #bja4 ,sunset ( ,public ,law #aae-ig4 ,sec4 #bjb4 ,surtax4 ,sec4 #bjc4 ,basis ( prop]ty acquir$ f a dec$5t4 ,sec4 #bjd4 ,m$ic>e payroll tax4 ,sec4 #bje4 ,net inve/m5t income tax4 ,sec4 #bjf4 ,t]m9ation ( d$uction = contributions to heal? sav+s acc\nts4 ,sec4 #bjg4 ,increase 9 excise tax on small cig>s & cig>ettes & o!r tobacco products4 ,sec4 #bjh4 ,excise tax on alcohol4 ,sec4 #bji4 ,tax on sug>$ dr9ks4 ,sec4 #baj4 ,repeal ( excise tax on high-co/ employ]-sponsor$ heal? cov]age4 ,title ,,iii--,,drug-,,relat$ ,,provisions ,sec4 #cja4 ,e/abli%m5t ( ! ,prescription ,drug & ,m$ical ,device ,review ,bo>d4 ,sec4 #cjb4 ,memb]%ip2 /aff4 ,sec4 #cjc4 ,prohibition aga9/ excessive price4 ,sec4 #cjd4 ,en=cem5t provisions4 ,sec4 #cje4 ,au?ority4 ,sec4 #cjf4 ,regulations4 ,sec4 #cjg4 ,report to ,f$]al ag5cies4 ,sec4 #cjh4 ,def9itions4 ,sec4 #cji4 ,moratorium on direct-to-consum] drug adv]tis+4 ,sec4 #caj4 ,report+ on ju/ification = drug price increases4 ,title ,,iv--,outcomes & ,report+ ,sec4 #dja4 ,s5se ( ,congress4 ,sec4 #djb4 ,evaluation ( bill's outcome4 ,i ,transition+ to & ,e/abli%+ ,m$ic>e = ,am]ica ,a ,transitional public heal? option #aja4 ,e/abli%m5t ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subtitle ref]r$ to z ! ,secret>y7 %all e/abli% a public heal? plan option t is (f]$ 9 ! individual m>ket ?r\gh ! ,f$]al & ,/ate ,ex*anges "u title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act to eligible individuals = plan ye>s #bjba & #bjbb 9 accordance ) ?is subtitle4 #ajb4 ,eligibility ,subject to subsection 7b71 an individual is eligible to enroll 9 su* public heal? plan option if ! individual is o!rwise eligible to pur*ase individual heal? insurance cov]age ?r\gh an ,ex*ange & ! individual resides 9 a rat+ area 9 :i* ! ,secret>y makes ! public heal? plan option available4 #ajc4 ,b5efits 7a7 ,9 g5]al ,! public heal? plan option %all be a qualifi$ heal? plan )9 ! mean+ ( section #acja7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjba7;a77 t-- 7#a7 meets all requirem5ts applicable to qualifi$ heal? plans "u subtitle ,d ( title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7o!r ?an ! requirem5t "u section #acja7;a77#a77;,c77ii7 ( su* ,act 7#db ,u4,s4,c4 #ahjba7;a77#a77;,c77ii777 & title ,,xxvii ( ! ,public ,heal? ,s]vice ,act2 7#b7 provides cov]age ( ! ess5tial heal? b5efits describ$ 9 section #acjb7;b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;b772 7#c7 provides silv] & gold-level cov]age describ$ 9 section #acjb7;d77#a77;,c7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;d77#a77;,c772 & 7#d7 provides cov]age ( compreh5sive reproductive heal? s]vices1 includ+ abortion4 7b7 ,preemption ,not)/&+ section #acjc7;a77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbc7;a77#a77-- 7#a7 a ,/ate may n prohibit ! public heal? plan option f (f]+ ! cov]age describ$ 9 subsection 7a77#d72 & 7#b7 no ,/ate law t w\ld prohibit su* a plan f (f]+ su* cov]age %all apply to su* plan4 #ajd4 ,premiums 7a7 ,9 g5]al ,! ,secret>y %all e/abli% premium rates = ! public heal? plan option t-- 7#a7 are adju/$ bas$ on ! applicable rat+ area2 7#b7 are at a level suffici5t to fully f9ance-- 7,a7 ! co/s ( heal? b5efits provid$ by su* plans2 & 7,b7 adm9i/rative co/s relat$ to op]at+ ! plans2 7#c7 comply ) ! requirem5ts "u section #bgja ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg72 & 7#d7 ensure t no individual or h\sehold w pay m ?an #h p]c5t ( adju/$ gross mon?ly income t[>d ! mon?ly premium4 7b7 ,f$]al subsidies ,f$]al subsidies %all be provid$ to ensure t ! premium %all be-- 7#a7 z]o 9 ! case ( an individual ^: annual h\sehold income is bel[ #bjj p]c5t ( ! pov]ty l9e2 7#b7 det]m9$ by a l9e> slid+ scale1 9 ! case ( an individual ^: h\sehold income is at lea/ #bjj p]c5t ( ! pov]ty l9e1 b n m ?an #fjj p]c5t ( ! pov]ty l9e2 & 7#c7 no individual or h\sehold above #fjj p]c5t ( pov]ty level w pay m ?an #h p]c5t ( adju/$ gross mon?ly income t[>d su* mon?ly premium4 #aje4 ,provid]s & reimbursem5t rates 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a rate s*$ule = reimburs+ types ( heal? c>e provid]s furni%+ items & s]vices "u ! public heal? insurance plan option at rates bas$ on rates appli$ = su* items & s]vices "u title ,,xviii ( ! ,social ,security ,act1 z ( ! date ( ! enactm5t ( ?is ,act1 t are necess>y to ma9ta9 network adequacy4 ,! ,secret>y %all e/abli% a rate s*$ule = items & s]vices n curr5tly cov]$ "u title ,,xviii ( ! ,social ,security ,act1 su* z d5tal1 vision1 & he>+ b5efits1 well *ild visits1 & reproductive heal? s]vices1 at a level to ensure adequate access to provid]s4 7b7 ,p>ticipat+ provid]s 7#a7 ,9 g5]al ,a heal? c>e provid] t is a p>ticipat+ provid] ( s]vices or suppli] "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act or "u ! ,m$icaid program "u title ,,xix ( su* ,act on ! date ( enactm5t ( ?is title %all be a p>ticipat+ provid] = ! public heal? insurance plan option4 7#b7 ,additional provid]s ,! ,secret>y %all e/abli% a process to all[ heal? c>e provid]s n describ$ 9 p>agraph 7#a7 to become p>ticipat+ provid]s = ! public heal? insurance plan option4 7#c7 ,cl>ification ,not)/&+ any o!r provision ( law1 heal? c>e provid]s may n be prohibit$ f p>ticipat+ 9 ! public heal? insurance option = reasons o!r ?an _! ability to provide cov]$ s]vices4 ,heal? c>e provid]s & in/itutions are prohibit$ f d5y+ cov]$ individuals access to any cov]$ b5efits & s]vices because ( _! religi\s objections4 7c7 ,prescription drugs ,! ,secret>y %all apply ! provisions ( section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i77 to prescription drugs "u ! public heal? plan option 9 ! same mann] z su* provisions apply ) respect to applicable cov]$ "p ,d drugs "u su* section4 #ajf4 ,acc\nt2 fund+ 7a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates an acc\nt = ! receipts & disbursem5ts attributable to ! op]ation ( ! public heal? plan option4 7b7 ,appropriation ,!re is appropriat$ to ! acc\nt e/abli%$ "u subsection 7a71 out ( any funds 9 ! ,treasury n o!rwise obligat$1 su* sums z may be necess>y to be us$ by ! ,secret>y = purposes ( c>ry+ out ?is "p4 7c7 ,prohibition ( ,/ate imposition ( taxes ,section #ahed7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bd7;g77 %all apply to receipts & disbursem5ts describ$ 9 subsection 7a7 9 ! same mann] z su* section applies to paym5ts or premiums describ$ 9 su* section4 7d7 ,cl>ification ,any provision ( law re/rict+ ! use ( ,f$]al funds ) respect to any reproductive heal? s]vice %all n apply to funds appropriat$ "u subsection 7b7 or ) respect to ! acc\nt "u subsection 7a74 ,b ,m$ic>e = ,am]ica #aaa4 ,e/abli%m5t & adm9i/ration ( ,m$ic>e = ,am]ica ,! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new title3 ,,xxii ,,m$ic>e ,,= ,,am]ica ,a ,,compreh5sive ,,heal? ,,cov]age #bbja4 ,e/abli%m5t ,! ,secret>y %all e/abli% a public heal? insurance program1 to be kn[n z ,m$ic>e = ,am]ica1 :i* %all = cal5d> ye> #bjbc & ea* subsequ5t cal5d> ye> provide compreh5sive heal? b5efits 9 accordance ) ?is "p to individuals enroll$ = cov]age "u ?is title4 #bbjb4 ,eligibility2 automatic enrollm5t 7a7 ,eligible individuals ,= purposes ( ?is title1 e individual :o is-- 7#a7 a resid5t ( ! ,unit$ ,/ates or a t]ritory ( ! ,unit$ ,/ates2 7#b7 an individual :o is lawfully pres5t1 z def9$ 9 section #aeb4b ( title #de ( ! ,code ( ,f$]al ,regulations2 or 7#c7 an individual :o w\ld be eligible = cov]age "u a ,/ate ,m$icaid plan pursuant to section #aijc7v7 7z su* section 0 9 effect z ( ! date ( ! enactm5t ( ?is title71 is entitl$ to b5efits = heal? c>e s]vices "u ?is title4 ,! ,secret>y %all promulgate a rule t provides crit]ia = apply+ ?is subsection1 includ+ det]m9+ resid5cy = eligibility purposes "u ?is title4 ,no?+ 9 ?is title %all preclude a ,/ate f us+ ,/ate funds to provide = an individual's heal? cov]age :o is n eligible "u ?is subsection4 7b7 ,enrollm5ts ,subject to subsection 7c73 7#a7 ,9 g5]al ,beg9n+ 9 #bjbc1 ! ,secret>y %all provide a me*anism = ! enrollm5t ( individuals entitl$ to b5efits "u ?is title &1 9 conjunction ) su* enrollm5t1 ! issuance ( a ,m$ic>e = ,am]ica c>d :i* may be us$ = purposes ( id5tification & process+ ( claims = b5efits "u ?is title4 ,! c>d %all n use ! individual's social security numb] z an id5tifi]4 ,z a condition ( p>ticipation 9 ! program1 p>ticipat+ provid]s %all facilitate enrollm5t z specifi$ by ! ,secret>y4 ,! ,/ate entities responsible = enroll+ individuals 9 ! ,m$icaid program "u title ,,xix & ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi %all s]ve z ! enroll+ entity = ,m$ic>e = ,am]ica )9 ea* ,/ate4 7#b7 ,automatic enrollm5ts ,! me*anism provid$ "u p>agraph 7#a7 %all1 subject to p>agraph 7#d71 provide1 = plan ye>s1 = ! foll[+ automatic enrollm5ts "u ,m$ic>e = ,am]ica3 7,a7 ,enrollm5t at bir? ,= plan ye>s 7beg9n+ ) plan ye> #bjbc71 a process1 e/abli%$ by ! ,secret>y 9 consultation ) ! ,commission] ( ,social ,security1 = ! automatic enrollm5t ( eligible individuals born dur+ su* plan ye>4 7,b7 ,curr5t m$ic>e b5efici>ies 7i7 ,curr5t m$ic>e b5efici>ies ,= plan ye>s 7beg9n+ ) plan ye> #bjbc71 a process e/abli%$ by ! ,secret>y = ! automatic enrollm5t ( all individuals :o are enroll$ = b5efits "u "p ,a or ,b ( title ,,xviii 7o!r ?an individuals :o are enroll$ = su* b5efits & receiv+ b5efits "u title ,,xix74 7ii7 ,cont9u+ population ,= plan ye>s 7beg9n+ ) plan ye> #bjbc71 a process e/abli%$ by ! ,secret>y = ! automatic enrollm5t ( eligible individuals :o atta9 ! age ( #fe dur+ su* plan ye>4 7iii7 ,duals ,= plan ye>s 7beg9n+ ) plan ye> #bjbe71 a process e/abli%$ by ! ,secret>y = ! automatic enrollm5t ( eligible individuals :o are enroll$ = b5efits "u "p ,a or ,b ( title ,,xviii & receiv+ b5efits "u title ,,xix4 7,c7 ,o!r individuals )\t qualifi$ heal? cov]age ,= plan ye>s 7beg9n+ ) plan ye> #bjbc71 a process e/abli%$ by ! ,secret>y = ! automatic enrollm5t ( eligible individuals :o are n enroll$ 9 o!r qualifi$ heal? cov]age 7z def9$ 9 p>agraph 7#d77;,b77 = su* plan ye>4 7#c7 ,o!r enrollm5ts ,! me*anism provid$ "u p>agraph 7#a7 %all provide = ! foll[+3 7,a7 ,9 g5]al ,enrollm5t p]iods & processes = ea* plan ye> 7beg9n+ ) plan ye> #bjbc7 = enrollm5t "u ,m$ic>e = ,am]ica ( any eligible individual n o!rwise describ$ 9 p>agraph 7#b74 7,b7 ,small employ]s 7i7 ,9 g5]al ,= plan ye>s 7beg9n+ ) plan ye> #bjbc71 a process & me?odology "u :i* a small employ]1 z def9$ 9 section #abf7;d77#c7 ( ! ,m$ic>e = ,am]ica ,act1 may provide = ! enrollm5t ( ! employees ( su* employ] "u ,m$ic>e = ,am]ica4 ,= purposes ( ?is subp>agraph1 ! t]m small employ] means any employ] = any cal5d> ye> if ! annual payroll ( su* employ] = ! prec$+ cal5d> ye> does n exce$ #b1jjj1jjj or has few] ?an #ajj employees4 7ii7 ,requirem5t ,small employ]s %all ei!r provide cov]age z def9$ )9 ! mean+ ( section #bgia7;d77#h7 ( ! ,public ,heal? ,s]vice ,act or facilitate ! enrollm5t ( _! employees into ,m$ic>e = ,am]ica4 ,small employ]s facilitat+ enrollm5t into ,m$ic>e = ,am]ica w n be subject to a m&atory employ] contribution4 7iii7 ,au?ority ,! ,secret>y may set /&>ds = det]m9+ :e!r employ]s are und]tak+ any actions to affect ! risk pool )9 ,m$ic>e = ,am]ica by induc+ individuals to decl9e cov]age "u a qualify+ employ]-sponsor$ plan & in/ead to enroll 9 ,m$ic>e = ,am]ica4 ,an employ] violat+ su* /&>ds %all be treat$ z n meet+ ! requirem5ts ( qualifi$ heal? cov]age4 7,c7 ,l>ge employ]s ,= plan ye>s 7beg9n+ ) plan ye> #bjbg71 ! ,secret>y %all provide = a process & me?odology "u :i* a l>ge employ] may provide = ! enrollm5t ( ! employees ( su* employ] "u ,m$ic>e = ,am]ica4 ,= purposes ( ! prec$+ s5t5ce1 ! t]m l>ge employ] means an employ] ) at lea/ #ajj employees or ^: annual payroll exce$s #b1jjj1jjj4 7,d7 ,memb]s ( ,congress & ,_! ,/aff ,beg9n+ = plan ye> #bjbc1 ,memb]s ( ,congress & _! /aff1 subject to p>agraph 7#d71 %all be enroll$ 9 ,m$ic>e = ,am]ica4 7#d7 ,opt out = individuals enroll$ "u qualifi$ heal? cov]age 7,a7 ,9 g5]al ,! me*anism provid$ "u p>agraph 7#a7 %all provide1 ) respect to a plan ye>1 = a process t enables individuals :o are enroll$ 9 qualifi$ heal? cov]age = su* plan ye> to opt out ( cov]age "u ,m$ic>e = ,am]ica = su* ye>4 7,b7 ,qualifi$ heal? cov]age def9$ ,= purposes ( ?is section1 ! t]m qualifi$ heal? cov]age means cov]age "u any ( ! foll[+3 7i7 ,= plan ye>s #bjbc & #bjbd3 7,i7 ,qualifi$ employ] cov]age1 z def9$ 9 section #abf ( ! ,m$ic>e = ,am]ica ,act4 7,,ii7 ,m$ical cov]age "u *apt] #ee ( title #aj1 ,unit$ ,/ates ,code1 includ+ cov]age "u ! ,,tric>e program4 7,,iii7 ,a heal? c>e program "u *apt] #ag or #ah ( title #ch1 ,unit$ ,/ates ,code1 z det]m9$ by ! ,secret>y ( ,vet]ans ,affairs1 9 coord9ation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y4 7,,iv7 ,! heal? b5efit program "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code4 7,v7 ,m$ical b5efits & s]vices provid$ by or ?r\gh ! ,indian ,heal? ,s]vice4 7,,vi7 ,! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act4 7,,vii7 ,! ,,*ip program "u title ,,xxi ( ! ,social ,security ,act4 7ii7 ,= plan ye>s #bjbe & #bjbf3 7,i7 ,cov]age describ$ 9 subclause 7,i71 7,,ii71 7,,iii71 7,,iv71 or 7,v7 ( clause 7i74 7,,ii7 ,cov]age describ$ 9 subclause 7,,vi7 ( clause 7i71 b only ) respect to cov]age t is n = individuals describ$ 9 subclause 7,,viii7 ( section #aijb7;a77#aj77;,a77i7 or :o are also enroll$ = b5efits "u title ,,xviii4 7iii7 ,= ea* subsequ5t plan ye>1 cov]age describ$ 9 subclause 7,i71 7,,ii71 7,,iii71 7,,iv71 or 7,v7 ( clause 7i74 7c7 ,waiv] ,! ,secret>y %all e/abli% a process "u :i* ! ,secret>y may grant waiv]s to ,/ates = additional "t be=e populations describ$ 9 a previ\s subsection ( ?is section ( su* ,/ate are automatically enroll$ "u ,m$ic>e = ,am]ica s long z ! ,/ate c demon/rate sub/antial progress has be5 made 9 transition+ ^! populations4 #bbjc4 ,b5efits 7a7 ,9 g5]al ,m$ic>e = ,am]ica %all1 9 accordance ) ?is section1 provide cov]age = all ! b5efits1 z det]m9$ to be m$ically necess>y1 z cov]$ & def9$ "u p>ts ,a & ,b ( title ,,xviii & title ,,xix z ( ! date ( ! enactm5t ( ?is title1 includ+ ! foll[+3 7#a7 ,ambulatory pati5t s]vices4 7#b7 ,em]g5cy c>e & urg5t c>e s]vices4 7#c7 ,hospitalization4 7#d7 ,mat]nity & newborn c>e4 7#e7 ,behavioral heal? s]vices1 includ+ m5tal heal?1 sub/ance use disord] s]vices1 & int5sive home & community bas$ s]vices4 7#f7 ,prescription drugs approv$ by ! ,food & ,drug ,adm9i/ration4 7#g7 ,rehabilitative & habilitative s]vices & devices1 includ+ ! foll[+3 7,a7 ,physical !rapy4 7,b7 ,spee* !rapy4 7,c7 ,occupational !rapy4 7#h7 ,laboratory s]vices4 7#i7 ,prev5tive & wellness s]vices & *ronic disease managem5t4 7#aj7 ,p$iatric s]vices1 all s]vices t w\ld o!rwise be cov]able "u e>ly & p]iodic scre5+1 diagno/ic1 & treatm5t "u ! ,m$icaid program "u title ,,xix & s]vices o!rwise includ$ "u ! mat]nal1 infant1 & e>ly *ildhood home visit+ program "u section #eaa1 z ( ! date ( ! enactm5t ( ?is title4 7#aa7 ,d5tal c>e1 at a m9imum ! s]vices necess>y to prev5t disease & promote oral heal?1 re/ore oral /ructures to heal? & function1 & treat em]g5cy conditions1 nightgu>ds1 m\?gu>ds1 & d5tures4 7#ab7 ,he>+ heal? s]vices includ+ aids & exams4 7#ac7 ,vision s]vices4 7#ad7 ,home & community bas$ long-t]m s]vices & supports4 7#ae7 ,*iropractic s]vices4 7#af7 ,durable m$ical equipm5t 7z def9$ = purposes ( title ,,xix71 includ+ ! foll[+3 7,a7 ,:eel*airs & accessories4 7,b7 ,walk+ aides su* z walk]s1 canes1 & crut*es4 7,c7 ,ba?room equipm5t su* z commodes & safety equipm5t4 7,d7 ,inhalation !rapy equipm5t su* z nebuliz]s4 7,e7 ,hospital b$s & accessories4 7,f7 ,o!r devices su* z ,cont9u\s ,positive ,airway ,pressure 7,,cpap7 ma*9es1 apnea monitors1 & v5tilators4 7,g7 ,insul9 pumps & glucomet]s4 7,h7 ,brea/ pumps4 7,i7 ,lymph$ema compression treatm5t items4 7,j7 ,wigs = m$ical conditions4 7,k7 ,augm5tative & alt]native communication devices1 includ+ dual-use devices4 7,l7 ,oxyg54 7,m7 ,or?otic & pro/hetic devices4 7,n7 ,disposable m$ical supplies4 7#ag7 ,family plann+1 includ+ ! foll[+3 7,a7 ,reproductive heal? exams4 7,b7 ,pati5t c\nsel+ & education relat$ to family plann+4 7,c7 ,abortion4 7,d7 ,scre5+1 te/+1 treatm5t1 & pre- & po/-te/ c\nsel+ = sexually transmitt$ diseases & ,,hiv4 7,e7 ,contraceptives includ+ pill1 pat*1 m$ication1 condom1 implant1 or o!r devices us$ to prev5t pregnancy4 7,f7 ,volunt>y /]ilization = b5efici>ies ov] ! age ( #ba4 7,g7 ,inf]tility treatm5t4 7#ah7 ,g5d]-confirm+ m$ical proc$ures & treatm5t4 7#ai7 ,scre5+1 te/+1 treatm5t1 & pre- & po/-te/ c\nsel+ = sexually transmitt$ diseases & ,,hiv4 7#bj7 ,diet>y & nutrition c\nsel+4 7#ba7 ,m$ically necess>y food & vitam9s = dige/ive & inh]it$ metabolic disord]s4 7#bb7 ,nurs+ facilities4 7#bc7 ,acupuncture4 7#bd7 ,digital heal? !rapeutics1 z approv$ by ! ,c5t] = ,heal?c>e & ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation4 7#be7 ,teleheal?4 7#bf7 ,non-em]g5cy m$ical transportation4 7#bg7 ,c>e coord9ation1 includ+ s]vices def9$ 9 section #ddj4afi ( title #db1 ,code ( ,f$]al ,regulations4 7#bh7 ,palliative c>e4 7#bi7 ,any additional b5efit or s]vice n includ$ 9 ?is section t is cov]able by any ,/ate plan 7or waiv] ( su* ,/ate plan7 "u title ,,xix on ! date ( ! enactm5t ( ?is title4 7b7 ,updates ,b5efits cov]able "u ,m$ic>e = ,am]ica %all be updat$ 9 accordance ) ! ,national ,cov]age ,det]m9ation process t _h1 z ( ! date be=e ! date ( ! enactm5t ( ?is title1 appli$ ) respect to b5efits cov]$ "u title ,,xviii4 7c7 ,implem5t+ policies ,! ,secret>y %all e/abli% paym5t models1 quality measures1 & o!r implem5t+ policies t provide fur!r access to ! cov]age "u ?is title4 ,= purposes ( ! previ\s s5t5ce1 ! ,secret>y %all consult ) /akehold]s1 includ+ ^? cov]+ p$iatrics1 disabilities1 & s5iors4 7d7 ,prohibition aga9/ duplicat+ cov]age 7#a7 ,9 g5]al ,x is unlawful = a private heal? insur] 7o!r ?an an insur] ) respect to a ,m$ic>e ,advantage = ,am]ica plan "u "p ,c ( ?is title or qualifi$ employ]-bas$ cov]age7 to sell heal? insurance cov]age t duplicates ! b5efits provid$ "u ,m$ic>e = ,am]ica "u ?is "p4 7#b7 ,con/ruction ,no?+ 9 p>agraph 7#a7 %all be con/ru$ z prohibit+ ! sale ( heal? insurance cov]age = any additional b5efits n cov]$ by ?is "p1 ins(> z ! cov]age satisfies ! conditions ( p>agraphs 7#c7 & 7#d74 ,no?+ %all preclude employ]s meet+ ! requirem5ts "u section #abf ( ! ,m$ic>e = ,am]ica ,act f provid+ supplem5tal cov]age "u ?is section to _! employees4 7#c7 ,application ( protections ,= purposes ( p>agraph 7#b71 heal? insurance cov]age = any additional b5efits mu/ satisfy ! foll[+ conditions3 7,a7 ,! provisions ( section #bgah ( ! ,public ,heal? ,s]vice ,act1 relat+ to a m$ical loss ratio4 7,b7 ,! provisions ( section #bgjb ( ! ,public ,heal? ,s]vice ,act1 relat+ to gu>ante$ issue4 7,c7 ,! provisions ( section #bgja ( ! ,public ,heal? ,s]vice ,act1 relat+ to community rat+4 7,d7 ,! provisions ( section #bgjd ( ! ,public ,heal? ,s]vice ,act1 relat+ to ! ban on pre-exi/+ conditions exclusions4 7#d7 ,no fees to brok]s ,= purposes ( p>agraph 7#b71 ! condition describ$ 9 ?is p>agraph is t heal? insurance cov]age describ$ 9 su* p>agraph does n pay fees to insurance brok]s4 7e7 ,/ates may provide additional b5efits ,individual ,/ates may provide additional b5efits = ! resid5ts ( su* ,/ates at ! exp5se ( ! ,/ate4 7f7 ,prohibition aga9/ /ep !rapy & prior au?orization ,items & s]vices cov]$ "u ,m$ic>e = ,am]ica %all be cov]$ )\t any ne$ = any prior au?orization det]m9ation & )\t any limitation appli$ ?r\gh ! use ( /ep !rapy protocols4 #bbjd4 ,premiums 7a7 ,9 g5]al 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ea* individual enroll$ = b5efits "u ?is title = a ye> %all pay mon?ly community-rat$ premiums = su* ye> 9 an am\nt det]m9$ by ! ,secret>y 9 accordance ) subsection 7b74 7#b7 ,gr&fa!r$ ,m$ic>e b5efici>ies ,9 ! case ( an individual enroll$ "u "p ,b ( title ,,xviii z ( ! date ( ! enactm5t ( ?is "p1 ! premium appli$ "u ?is section = su* individual = b5efits "u ?is title %all be ! less] (-- 7,a7 ! premium o!rwise applicable to su* individual "u su* title ,,xviii if ?is title _h n be5 enact$2 or 7,b7 ! premium t w\ld be appli$ to su* individual "u ?is title )\t ! application ( ?is p>agraph4 7b7 ,premium contribution bas$ on income ,! am\nt ( a mon?ly premium1 ) respect to a plan ye> 7beg9n+ ) #bjbc71 "u ?is section %all be e/abli%$ by ! ,secret>y 9 accordance ) ! foll[+3 7#a7 ,su* premium %all be det]m9$ su* t ! collective premiums = ! plan ye> are ) respect to ! co/s ( heal? b5efits provid$ "u ?is title = su* ye> & relat$ adm9i/rative co/s4 7#b7 ,premiums %all v>y by family composition only4 7#c7 ,f$]al subsidies %all be provid$ to ensure t ! premium %all be-- 7,a7 z]o 9 ! case ( an individual ^: annual h\sehold income is bel[ #bjj p]c5t ( ! pov]ty l9e2 7,b7 det]m9$ by a l9e> slid+ scale1 9 ! case ( an individual ^: h\sehold income is at lea/ #bjj p]c5t ( ! pov]ty l9e1 b n m ?an #fjj p]c5t ( ! pov]ty l9e2 & 7,c7 no individual or h\sehold w pay m ?an #h p]c5t ( adju/$ gross mon?ly income t[>d su* premium4 7#d7 ,= an individual ^: employ] w be mak+ a firm-wide contribution "u ?is title 9 lieu ( (f]+ employ]-sponsor$ insurance 7z specifi$ 9 section #abf7;b77#a77;,b7 ( ! ,m$ic>e = ,am]ica ,act71 su* individual %all pay a premium 9 accordance ) ?is subsection4 7#e7 ,= an individual :o has opt$ out ( _! employ]-sponsor$ insurance 9 ord] to enroll 9 ,m$ic>e = ,am]ica z specifi$ 9 section #abf7;c7 ( su* ,act1 ! individual %all pay ! less] (-- 7,a7 ! premium describ$ 9 ?is subsection2 or 7,b7 ! am\nt ow$ aft] ! am\nt ( employ] contribution 7z specifi$ 9 section #abf7;b77#a77;,b7 ( ! ,m$ic>e = ,am]ica ,act7 is subtract$ f ! premium e/abli%$ by ! ,secret>y ( ,heal? & ,human ,s]vices z describ$ 9 p>agraph 7#a71 :i*ev] is less4 7c7 ,deposits ,am\nts paid "u ?is section = cov]age "u ?is title %all be deposit$ 9 ! ,treasury to ! cr$it ( ! ,tru/ ,fund e/abli%$ "u section #bbjf4 7d7 ,appeals = c]ta9 m$ic>e gr&fa!r$ population ,9 calculat+ premiums = purposes ( subsection 7a77#b73 7#a7 ,any individual t 0 subject to a late enrollm5t p5alty "u "p ,b ( title ,,xviii %all h ! "r to appeal ! assessm5t ( ! p5alty = good fai? enrollm5t mi/akes4 7#b7 ,! ,secret>y1 9 consultation ) ! ,commission] ( ,social ,security1 %all develop & publi% a =mal application = reque/+ an action ( ! ,secret>y "u p>agraph 7#a7 to correct or elim9ate ! effects ( an error1 misrepres5tation1 or inaction describ$ 9 su* p>agraph & det]m9e & publi% specific timel9es = timely resolution ( su* a reque/4 7#c7 ,! ,secret>y %all also require t all su* det]m9ations ) respect to su* reque/s %all be rea*$ )9 #ae bus9ess days ( ! submission ( su* application4 ,all det]m9ations %all be 9 writ+ ?r\gh a /&>d decision notice :i* %all include an explanation ( ! reasons = ! det]m9ation4 7#d7 ,! ,commission] ( ,social ,security %all ent] into contracts ) indep5d5t review organizations 9 accordance ) ?is subsection = ! purpose ( review+ & det]m9+ individual appeals ( det]m9ations "u p>agraph 7#c7 ) respect to an application relat+ to enrollm5t "u "p ,a or "p ,b4 7#e7 ,an individual :o receives an adv]se det]m9ation "u p>agraph 7#c7 may appeal to an indep5d5t review organization designat$ by ! ,commission4 ,any su* appeal mu/ be s5t to ! indep5d5t review organization )9 #ij days ( ! date ! individual receiv$ ! det]m9ation to be eligible = review4 ,! indep5d5t review organization %all review & rea* a det]m9ation ( ! review 9 writ+ )9 #de days ( ! receipt ( any su* appeal4 7#f7 ,! ,secret>y ( ! ,treasury may n ent] into a contract "u p>agraph 7#d7 ) an indep5d5t review organization-- 7,a7 unless ! organization has /aff t has ! appropriate k (1 & exp]i5ce )1 ! eligibility & coord9ation ( b5efits rules & regulations "u ?is title2 & 7,b7 to ! ext5t ! organization is a fiscal int]m$i>y "u section #ahaf1 a c>ri] "u section #ahdb1 or a ,m$ic>e adm9i/rative contractor "u section #ahgd;,a4 7#g7 ,! ,secret>y %all provide = access by indep5d5t review organizations conduct+ appeal det]m9ations "u ?is subsection1 to ! database ( ! ,coord9ation ( ,b5efits ,contractor ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices z necess>y 9 ord] to conduct ! duties ( su* organizations to det]m9e appeals pursuant to ?is subsection4 #bbje4 ,paym5t ( b5efits2 co/-%>+2 out-(-pocket limits 7a7 ,paym5t ( b5efits2 co/-,%>+ ,!re %all be paid1 9 ! case ( ea* individual :o is enroll$ "u ,m$ic>e = ,am]ica & incurs exp5ses = items & s]vices ) respect to :i* b5efits are payable "u ?is "p1 subject to subsection 7c71 #hj p]c5t ( ! reimbursem5t rates e/abli%$ pursuant to section #bbjf = su* items & s]vices1 except t = ! foll[+ s]vices1 ! am\nts paid "u ?is section %all be equal to #ajj p]c5t ( ! reimbursem5t rates e/abli%$ pursuant to section #bbjf = su* items & s]vices3 7#a7 ,,usptf recomm5d$ prev5tive & *ronic disease s]vices4 7#b7 ,long-t]m s]vices & supports4 7#c7 ,g5]ic drugs1 & prescription drugs if m$ically necess>y4 7#d7 ,all s]vices = individuals :o are m$ically frail or o!rwise h special m$ical ne$s1 7includ+ *ildr5 ) s]i\s emotional di/urbance & adults ) s]i\s m5tal illness71 individuals ) *ronic sub/ance use disord]s1 or individuals ) s]i\s & complex m$ical conditions 7su* z epilepsy & ,,hiv71 individuals ) a physical1 intellectual or developm5tal disability t significantly impairs _! ability to p]=m "o or m activities ( daily liv+4 7#e7 ,pregnancy relat$ s]vices4 7#f7 ,em]g5cy s]vices4 7#g7 ,s]vices = *ildr5 "u age #ba4 ,! ,secret>y %all e/abli% a default mon?ly paym5t plan "u ! ,m$ic>e = ,am]ica b5efits package to ensure ! paym5t ow$ by ! individual enroll$ "u ,m$ic>e = ,am]ica is spread-out ev5ly ?r\gh\t ! ye>4 7b7 ,d$uctible ,!re %all be no d$uctible "u ,m$ic>e = ,am]ica4 7c7 ,maximum out-(-,pocket limit 7#a7 ,9 g5]al ,! cov]age "u ,m$ic>e %all provide b5efits1 aft] ! eligible individual has incurr$ out-(-pocket exp5ses = items & s]vices ) respect to :i* b5efits are payable "u ?is "p 9 a ye> equal to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#b71 ) co/-%>+ t is equal to #j4 7#b7 ,annual out-(-pocket ?re%old 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 subject to subp>agraphs 7,b7 & 7,c71 ! annual out-(-pocket ?re%old specifi$ 9 ?is p>agraph is a ?re%old t %all be det]m9$ on a l9e> slid+ scale = h\sehold income t is at lea/ #bjj p]c5t ( ! pov]ty l9e1 b n m ?an #fjj p]c5t ( ! pov]ty l9e1 & t %all n exce$-- 7i7 ) respect to an individual1 #c1ejj2 or 7ii7 ) respect to a h\sehold1 #e1jjj4 ,individuals or h\seholds ) income above #fjj p]c5t ( ! ,f$]al pov]ty l9e %all h _! annual out-(-pocket ?re%old capp$ at #c1ejj & #e1jjj respectively4 7,b7 ,index+ ,9 ! case ( plan ye>s beg9n+ aft] #bjba1 ! ?re%old describ$ 9 subp>agraph 7,a7 7z 9 effect = ! prec$+ plan ye> aft] application ( ?is subp>agraph7 %all be increas$ by ! p]c5tage increase ov] ! previ\s ye> 9 ! m$ical c>e exp5diture category ( ! ,consum] ,price ,index = ,all ,urban ,consum]s 7,unit$ ,/ates city av]age71 publi%$ by ! ,bureau ( ,labor ,/ati/ics4 7,c7 ,exception ,= purposes ( p>agraph 7#a71 ! annual out-(-pocket ?re%old = individuals & h\seholds ) annual income bel[ #bjj p]c5t ( ! ,f$]al pov]ty l9e is #j4 7d7 ,no lifetime or annual limits ,!re %all be no lifetime or annual limits = any s]vices or b5efits cov]able "u ,m$ic>e = ,am]ica4 7e7 ,no balance bill+ ,no provid] may impose a *>ge to an enroll$ individual = cov]able s]vices = :i* b5efits are provid$ "u ?is "p 9 an am\nt high] ?an ! reimbursem5t rate = su* s]vices "u section #bbjf & may n impose a *>ge to su* individual = su* s]vice o!r ?an ) respect to ! o!r co/-%>+ describ$ 9 ?is section4 7f7 ,no private contract+ ,a heal? c>e provid] or heal? c>e in/itution are prohibit$ f ent]+ into a private contract ) an individual enroll$ "u ,m$ic>e = ,am]ica = any item or s]vice cov]able "u ,m$ic>e = ,am]ica4 7g7 ,limitations on ! ,use ( ,flexible ,sav+s ,acc\nts ,flexible ,sav+s ,acc\nts %all only be us$ = b5efits & s]vices n cov]$ by ,m$ic>e = ,am]ica4 #bbjf4 ,provid]s network & reimbursem5t rates 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a rate s*$ule = reimburs+ types ( heal? c>e provid]s furni%+ items & s]vices "u ,m$ic>e = ,am]ica at rates t are consi/5t ) subsection 7b7 & are necess>y to ma9ta9 network adequacy4 7b7 ,rates 7#a7 ,9 g5]al ,except z provid$ 9 p>agraphs 7#b7 & 7#c71 ! ,secret>y %all e/abli% rates = b5efits & s]vices to be provid$ to heal? c>e provid]s & suppli]s furni%+ "u ,m$ic>e = ,am]ica bas$ on rates t w\ld be appli$ 7includ+ z comput$1 updat$1 & adju/$7 "u title ,,xviii or title ,,xix1 :i*ev] is high]1 = su* type ( heal? c>e provid]s & suppli]s & item & s]vice if su* title rema9$ 9 effect &1 9 ! case ( a type ( provid] & suppli] or item or s]vice cov]able "u ,m$ic>e = ,am]ica b n o!rwise cov]able "u title ,,xviii or title ,,xix1 %all provide = rates t ensure adequate access to c>e4 7#b7 ,exceptions ,= purposes ( ?is section1 9 apply+ p>agraph 7#a7 ! ,secret>y %all ensure t rates to hospitals = inpati5t s]vices or outpati5t s]vices furni%$ "u ,m$ic>e = ,am]ica are at lea/ #aaj p]c5t ( su* rates on av]age or 9 ! aggregate = furni%+ su* inpati5t or outpati5t s]vices o!rwise appli$ "u title ,,xviii or title ,,xix1 :i*ev] is high]1 except t = hospitals s]v+ und]s]v$ areas z specifi$ by ! ,secret>y1 su* rates are increas$ z necess>y to ensure adequate access to c>e4 7#c7 ,application ,9 apply+ rates "u title ,,xviii & title ,,xix1 z applicable1 = purposes ( ?is "p1 ! foll[+ %all apply3 7,a7 ,! ,secret>y %all provide = site-neutral paym5ts = items & s]vices furni%$ 9 an outpati5t hospital & physician (fice1 ! rate ( paym5t = su* s]vice %all be ! same4 7,b7 ,! ,secret>y %all provide = a me*anism to provide paym5ts = direct & indirect co/s ( graduate m$ical education programs )\t any cap on ! numb] ( resid5cy positions = :i* paym5t may be made1 includ+ paym5ts to hospitals = su* programs & to eligible facilities = programs = population heal?-bas$ resid5cies & = nurse practition] po/-lic5sure cl9ical tra9+1 resid5cy1 & fell[%ip programs4 7,c7 ,! ,secret>y %all increase ! av]age relative value ( prim>y c>e & o!r m5tal & behavioral heal? & cognitive s]vices by n less ?an #cj p]c5t 9 ord] to ensure adequate access to inpati5t & outpati5t c>e4 7,d7 ,z a condition ( p>ticipation 9 ! program1 p>ticipat+ provid]s %all accept ,m$ic>e = ,am]ica rates paid by employ]-sponsor$ insurance plans & ,m$ic>e ,advantage = ,am]ica plans4 7,e7 ,! ,secret>y %all semiannually review if ! rates paid by ,m$ic>e = ,am]ica are creat+ b>ri]s to c>e4 ,! ,secret>y %all h ! au?ority to raise rates z necess>y to ensure adequate access to c>e4 7#d7 ,increas$ ,f$]al mat* = m$icaid & ! *ildr5's heal? insurance program = ye>s #bjbc ?r\gh #bjbg ,! ,secret>y ( ,heal? & ,human ,s]vices %all pay ! diff]5ce betwe5 ! ,m$ic>e = ,am]ica rates & ! ,m$icaid & ,,*ip rates dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjbc1 & end+ on ,decemb] #ca1 #bjbg4 7c7 ,p>ticipat+ provid]s 7#a7 ,9 g5]al ,a heal? c>e provid] t is a p>ticipat+ provid] ( s]vices or suppli] "u ! ,m$ic>e program "u title ,,xviii or ! ,m$icaid program "u title ,,xix on ! date ( enactm5t ( ?is title %all rema9 a p>ticipat+ provid] = ,m$ic>e = ,am]ica4 7#b7 ,additional provid]s ,! ,secret>y %all e/abli% a process to all[ heal? c>e provid]s n describ$ 9 p>agraph 7#a7 to become p>ticipat+ provid]s = ,m$ic>e = ,am]ica4 7d7 ,prescription drugs 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y %all1 = plan ye>s beg9n+ on or aft] ! date ( ! enactm5t ( ?is title1 negotiate ) ph>maceutical manufactur]s ! prices 7includ+ disc\nts1 rebates1 & o!r price concessions7 t may be *>g$ to ,m$ic>e = ,am]ica & ,,ma = ,am]ica organizations dur+ a negotiat$ price p]iod 7z specifi$ by ! ,secret>y7 = cov]$ drugs = ,m$ic>e = ,am]ica enrollees4 ,9 negotiat+ su* prices "u ?is section1 ! ,secret>y %all take into acc\nt ! foll[+ factors3 7,a7 ,! comp>ative cl9ical effectiv5ess & co/ effectiv5ess1 :5 available f an imp>tial s\rce1 ( su* drug4 7,b7 ,! budget>y impact ( provid+ cov]age ( su* drug4 7,c7 ,! numb] ( simil>ly effective drugs or alt]native treatm5t regim5s = ea* approv$ use ( su* drug4 7,d7 ,! associat$ f9ancial burd5 on pati5ts t utilize su* drug4 7,e7 ,! associat$ unmet pati5t ne$ = su* drug4 7,f7 ,! total rev5ues f global sales obta9$ by ! manufactur] = su* drug & ! associat$ inve/m5t 9 rese>* & developm5t ( su* drug by ! manufactur]4 7#b7 ,f9alization ( negotiat$ price ,! negotiat$ price ( ea* cov]$ drug = a negotiat$ price p]iod %all be f9aliz$ n lat] ?an #cj days be=e ! fir/ plan ye> 9 su* negotiat$ price p]iod4 7#c7 ,competitive lic5s+ au?ority 7,a7 ,9 g5]al ,not)/&+ any exclusivity "u clause 7iii7 or 7iv7 ( section #eje7;j77#e77;,f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 clause 7iii7 or 7iv7 ( section #eje7;c77#c77;,e7 ( su* ,act1 section #cea7k77#g77;,a7 ( ! ,public ,heal? ,s]vice ,act1 or section #ebg7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 or by an ext5sion ( su* exclusivity "u section #eje;,a ( su* ,act or section #eje;,e ( su* ,act1 & any o!r provision ( law t provides = m>ket exclusivity 7or ext5sion ( m>ket exclusivity7 ) respect to a drug1 9 ! case t ! ,secret>y is unable to successfully negotiate an appropriate price = a cov]$ drug = a negotiat$ price p]iod1 ! ,secret>y %all au?orize ! use ( any pat5t1 cl9ical trial data1 or o!r exclusivity grant$ by ! ,f$]al ,gov]nm5t ) respect to su* drug z ! ,secret>y det]m9es appropriate = purposes ( manufactur+ su* drug = sale "u ,m$ic>e = ,am]ica4 ,any entity mak+ use ( a competitive lic5se to use pat5t1 cl9ical trial data1 or o!r exclusivity "u ?is section %all provide to ! manufactur] hold+ su* exclusivity reasonable comp5sation1 z det]m9$ by ! ,secret>y bas$ on ! foll[+ factors3 7i7 ,! risk-adju/$ value ( any ,f$]al ,gov]nm5t subsidies & inve/m5ts 9 rese>* & developm5t us$ to support ! developm5t ( su* drug4 7ii7 ,! risk-adju/$ value ( any inve/m5t made by su* manufactur] 9 ! rese>* & developm5t ( su* drug4 7iii7 ,! impact ( ! price1 includ+ lic5se comp5sation paym5ts1 on meet+ ! m$ical ne$ ( all pati5ts4 7iv7 ,! relation%ip betwe5 ! price ( su* drug1 includ+ comp5sation paym5ts1 & ! heal? b5efits ( su* drug4 7v7 ,o!r relevant factors det]m9$ appropriate by ! ,secret>y to provide reasonable comp5sation4 7,b7 ,reasonable comp5sation ,! manufactur] describ$ 9 subp>agraph 7,a7 may seek recov]y aga9/ ! ,unit$ ,/ates 9 ! ,unit$ ,/ates ,c\rt ( ,f$]al ,claims4 7,c7 ,int]im p]iod 7i7 ,9 g5]al ,until #a ye> aft] a drug describ$ 9 subp>agraph 7,a7 is approv$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act & is provid$ "u lic5se issu$ by ! ,secret>y "u su* subp>agraph1 ,m$ic>e = ,am]ica %all n pay m = su* drug ?an ! av]age ( ! prices available1 dur+ ! mo/ rec5t #ab-mon? p]iod = :i* data is available prior to ! beg9n+ ( su* negotiat$ price p]iod1 f ! manufactur] to any :olesal]1 retail]1 provid]1 heal? ma9t5ance organization1 nonpr(it entity1 or gov]nm5tal entity 9 ! t5 ,,oecd 7,organization = ,economic ,coop]ation & ,developm5t7 c\ntries t h ! l>ge/ gross dome/ic product ) a p] capita income t is n less ?an half ! p] capita income ( ! ,unit$ ,/ates or ! price e/abli%$ by ! ,prescription ,drug & ,m$ical ,device ,review ,bo>d e/abli%$ "u title ,,iii ( ! ,m$ic>e = ,am]ica ,act ( #bjai4 7ii7 ,f$]al program lic5s+ ,if su* drug is n made available at ! price det]m9$1 ! ,secret>y %all au?orize su* entities to use any pat5t1 cl9ical trial data1 or o!r exclusivity grant$ by ! ,f$]al ,gov]nm5t ) respect to su* drug z ! ,secret>y det]m9es appropriate = purposes ( manufactur+ su* drug = sale "u any ,f$]al program1 includ+ ^? provid$ by ,m$ic>e = ,am]ica1 ,vet]ans ,affairs1 ! ,dep>tm5t ( ,def5se1 & ! ,coa/ ,gu>d4 7,d7 ,au?orization = secret>y to procure drugs directly 7i7 ,9 g5]al ,! ,secret>y may procure a drug manufactur$ pursuant to a competitive lic5se "u subp>agraph 7,a7 = purposes ( ?is "p or pursuant to a ,f$]al program lic5se "u subp>agraph 7,c77ii7 = purposes ( a ,f$]al program directly f ! entity manufactur+ ! drug pursuant to su* a lic5se4 7ii7 ,cl>ification reg>d+ application ( buy am]ican act ,9 ! case :]e ! ,secret>y procures a drug "u ?is subp>agraph1 ! provisions ( *apt] #hc ( title #da1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! ,buy ,am]ican ,act71 %all apply4 7,e7 ,priority = u4s4 manufactur]s 9 au?oriz+ competitive lic5ses ,9 au?oriz+ a competitive lic5se "u ?is p>agraph1 ! ,secret>y-- 7i7 %all give pref]5ce to entities t ! ,secret>y det]m9es h ! highe/ safety & security /&>ds2 & 7ii7 may give priority to entities t w manufacture su* drug 9 ! ,unit$ ,/ates4 7#d7 ,,fda review ( lic5s$ drug applications ,! ,secret>y %all prioritize review ( applications "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = drugs lic5s$ "u p>agraph 7#c77;,a74 7#e7 ,prohibition ( anticompetitive behavior ,no drug manufactur] may engage 9 anticompetitive behavior ) ano!r manufactur] t may int]f]e ) ! issuance & implem5tation ( a competitive lic5se or run contr>y to public policy4 7#f7 ,requir$ report+ ,! ,secret>y may require ph>maceutical manufactur]s to disclose to ! ,secret>y su* in=mation t ! ,secret>y det]m9es necess>y = purposes ( c>ry+ out ?is subsection4 7#g7 ,cl>ification ,no?+ 9 ?is subsection %all be con/ru$ z prev5t+ ,m$ic>e = ,am]ica obta9+ a disc\nt or r$uction ( ! price = a cov]$ drug bel[ ! price negotiat$ by ! ,secret>y4 7#h7 ,value or co/-effectiv5ess assessm5ts ,! use ( ,quality-,adju/$ ,life ,ye>s1 ,disability-,adju/$ ,life ,ye>s1 or o!r simil> me*anisms is prohibit$ = use 9 value or co/-effectiv5ess assessm5ts = purposes ( ?is subsection4 7#i7 ,cl>ification ,!re %all be no =mul>y "u ,m$ic>e = ,am]ica4 #bbjg4 ,tru/ fund2 fund+ 7a7 ,tru/ fund ,!re %all be e/abli%$ a unifi$ ,m$ic>e ,tru/ ,fund 9 :i* funds provid$ "u ?is title are deposit$ & f :i* exp5ditures "u ?is title are made4 ,! ,tru/ ,fund %all consi/ ( su* gifts & beque/s z may be made & su* am\nts z may be deposit$ 91 or appropriat$ to1 su* ,tru/ ,fund z provid$ 9 ?is ,act4 7b7 ,fund+ 7#a7 ,taxes ,!re are h]eby appropriat$ to ! ,tru/ ,fund = ea* fiscal ye> beg9n+ ) fiscal ye> #bjbc1 out ( any moneys 9 ! ,treasury n o!rwise appropriat$1 am\nts equival5t to #ajj p]c5t ( ! net increase 9 rev5ues to ! ,treasury :i* is attributable to ! am5dm5ts made by title ,,ii ( ! ,m$ic>e = ,am]ica ,act & premiums collect$ "u ?is title4 ,! am\nts appropriat$ by ! prec$+ s5t5ce %all be transf]r$ f "t to "t 7b n less frequ5tly ?an mon?ly7 f ! g5]al fund 9 ! ,treasury to ! ,tru/ ,fund1 su* am\nts to be det]m9$ on ! basis ( e/imates by ! ,secret>y ( ! ,treasury ( ! taxes paid to or deposit$ into ! ,treasury2 & prop] adju/m5ts %all be made 9 am\nts subsequ5tly transf]r$ to ! ext5t prior e/imates 7 9 excess ( or 7 less ?an ! am\nts t %\ld h be5 s transf]r$4 7#b7 ,curr5t program receipts ,not)/&+ any o!r provision ( law1 !re are h]eby appropriat$ to ! ,tru/ ,fund = ea* fiscal ye>1 beg9n+ ) fiscal ye> #bjbc1 ! am\nts t w\ld o!rwise h be5 appropriat$ to c>ry out ! foll[+ programs3 7,a7 ,! ,m$ic>e program "u title ,,xviii4 7,b7 ,! ,m$icaid program "u title ,,xix1 beg9n+ z ( #bjbg4 7#c7 ,additional appropriations ,additional sums are au?oriz$ to be appropriat$ annually z ne$$ to ma9ta9 maximum quality1 effici5cy1 & access "u ?is "p4 7#d7 ,m$icaid ma9t5ance ( ef=t paym5ts ,!re %all be transf]r$ to ! ,tru/ ,fund ! ma9t5ance ( ef=t paym5ts made "u section #bbji4 7c7 ,re/rictions %all n apply ,any o!r provision ( law 9 effect on ! date ( enactm5t ( ?is title re/rict+ ! use ( ,f$]al funds = any reproductive heal? s]vice1 includ+ abortion1 %all n apply to monies 9 ! ,tru/ ,fund4 7d7 ,incorporation ( provisions ,! provisions ( subsections 7b7 ?r\gh 7i7 ( section #ahag %all apply to ! ,tru/ ,fund "u ?is section 9 ! same mann] z su* provisions appli$ to ! ,f$]al ,hospital ,insurance ,tru/ ,fund "u su* section #ahag1 except t1 = purposes ( apply+ su* subsections to ?is section1 ! ,bo>d ( ,tru/ees ( ! ,tru/ ,fund %all mean ! ,secret>y4 7e7 ,transf] ( funds ,any am\nts rema9+ 9 ! ,f$]al ,hospital ,insurance ,tru/ ,fund "u section #ahag or ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda aft] ! paym5t ( claims = items & s]vices furni%$ "u title ,,xviii h be5 complet$1 %all be transf]r$ into ! ,tru/ ,fund "u ?is section4 #bbjh4 ,adm9i/rative provisions 7a7 ,c5t] = heal? c>e ,beg9n+ #bjbc1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all be r5am$ ! ,c5t] = ,heal? ,c>e & all ref]5ces 9 law & regulation to su* ,c5t]s %all be deem$ a ref]5ce to su* ,c5t]4 ,all p[]s1 duties1 & responsibilities ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all be transf]r$ to ! ,c5t] = ,heal? ,c>e4 7b7 ,au?ority ,! ,secret>y %all h ! au?ority to issue int]im f9al rules ) respect to any provision 9 ?is "p4 7c7 ,adm9i/rative law judges 7#a7 ,9 g5]al ,! ,c5t] = ,heal? ,c>e is n au?oriz$ to appo9t adm9i/rative law judges1 9 accordance ) pages #aadbj ?r\gh #aadii ( title #gj ( ! ,f$]al ,regi/] 7,m>* #h1 #bjje74 7#b7 ,tim+ ,"u ?is title1 adm9i/rative law judges mu/ issue a decision )9 #ij days ( receipt ( a he>+ reque/1 z specifi$ 9 subsections 7a7 & 7c7 ( section #dje4ajaf ( title #b1 ,code ( ,f$]al ,regulations4 7d7 ,cov]age det]m9ations appeals 7#a7 ,individuals may appeal a cov]age det]m9ation "u ?is title be=e ! individual obta9s ! s]vice or item t is ! subject ( ! appeal4 ,individuals %all cont9ue to receive ! s]vice or item if an appeal is fil$ be=e ! provision ( ! s]vice or item is t]m9at$4 7#b7 ,! ,secret>y %all elim9ate ! r$et]m9ation by a ,m$ic>e adm9i/rative contractor f ! appeals process "u ! ,m$ic>e program = b5efici>ies4 7e7 ,private "r ( action 7#a7 ,9 g5]al ,an applicant or recipi5t d5i$ a "r conf]r$ by ?is title may br+ a civil action seek+ any rem$y available 9 law or equity to rem$y t violation4 ,/ate c\rts & di/rict c\rts ( ! ,unit$ ,/ates %all h concurr5t jurisdiction ( su* actions4 7#b7 ,"r def9$ ,rights are creat$ by any provision ( ?is title t-- 7,a7 prescribes1 e/abli%es1 or conf]s a b5efit or protection 9 favor ( ! individual or individuals seek+ to en=ce ! provision2 or 7,b7 prescribes1 e/abli%es1 or imposes a duty or obligation on a p]son or entity to act or conduct op]ations 9 a mann] t b5efits ! individual or individuals seek+ to en=ce ! provision4 7#c7 ,reasonable attorney fees ,9 any action or proce$+ to en=ce ?is title1 ! c\rt may aw>d reasonable attorneys' fees & litigation co/s 7includ+ exp]t fees7 reasonably incurr$ aga9/ ! def5dant or def5dants4 7#d7 ,appeal ,any civil action br\ght "u ?is section %all be subject to appeal z provid$ 9 sections #abia & #abib ( title #bh ( ! ,unit$ ,/ates ,code4 7#e7 ,cont9u$ application ( o!r laws ,no?+ 9 ?is title 7or an am5dm5t made by ?is title7 %all be con/ru$ to invalidate or limit ! rights1 rem$ies1 proc$ures1 or legal /&>ds available to individuals aggriev$ "u section #aigi ( ! ,revis$ ,/atutes 7#db ,u4,s4,c4 #aihc71 or to sup]s$e ,/ate laws causes ( action4 7f7 ,non-,discrim9ation 7#a7 ,9 g5]al ,except z o!rwise provid$ = 9 ?is title1 an individual %all n1 on ! gr\nd prohibit$ "u title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d et seq471 title ,,ix ( ! ,education ,am5dm5ts ( #aigb 7#bj ,u4,s4,c4 #afha et seq471 ! ,age ,discrim9ation ,act ( #aige 7#db ,u4,s4,c4 #faja et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 or section #aeeg ( ! ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 be exclud$ f p>ticipation 91 be d5i$ ! b5efits (1 or be subject$ to discrim9ation "u1 any heal? program or activity1 any "p ( :i* is receiv+ ,f$]al f9ancial assi/ance1 includ+ cr$its1 subsidies1 or contracts ( insurance1 or "u any program or activity t is adm9i/]$ by an ,executive ,ag5cy or any entity e/abli%$ "u ?is title 7or am5dm5ts7 or any employ]-sponsor$ insurance4 ,! en=cem5t me*anisms provid$ = & available "u su* title ,,vi1 title ,,ix1 section #gid1 ,age ,discrim9ation ,act1 or su* section #aeeg %all apply = purposes ( violations ( ?is subsection4 7#b7 ,cont9u$ application ( laws ,no?+ 9 ?is title 7or an am5dm5t made by ?is title7 %all be con/ru$ to invalidate or limit ! rights1 rem$ies1 proc$ures1 or legal /&>ds available to individuals aggriev$ "u title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d et seq471 title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e et seq471 title ,,ix ( ! ,education ,am5dm5ts ( #aigb 7#bj ,u4,s4,c4 #afha et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 ! ,age ,discrim9ation ,act ( #aige 7#db ,u4,s4,c4 #faa et seq471 or section #aeeg ( ! ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf7 or to sup]s$e ,/ate laws t provide additional protections aga9/ discrim9ation on any basis describ$ 9 p>agraph 7#a74 7#c7 ,heal? c>e provid]s ,heal? c>e provid]s may n be prohibit$ f p>ticipat+ 9 ! ,m$ic>e = ,am]ica = reasons o!r ?an _! ability to provide cov]$ s]vices4 ,heal? c>e provid]s & in/itutions are prohibit$ f d5y+ cov]$ individuals access to cov]$ b5efits & s]vices because ( _! religi\s objections4 ,?is subsection sup]c$es any provision ( law t all[s = consci5ce protection4 7#d7 ,regulations ,! ,secret>y may promulgate regulations to implem5t ?is subsection4 #bbji4 ,ma9t5ance ( ef=t requirem5t 7a7 ,9 g5]al ,a ,/ate is n eligible = paym5t "u any program specifi$ 9 subsection 7c7 = a cal5d> qu>t] 9 a plan ye> beg9n+ aft] #bjbg unless ! ,/ate makes to ! ,secret>y = transf] to ! unifi$ ,m$ic>e ,tru/ ,fund "u section #bbjg ! ma9t5ance ( ef=t paym5t applicable to su* ,/ate & plan ye> "u subsection 7b74 ,! ,secret>y %all ext5d su* a waiv] 7includ+ ! availability ( ,f$]al f9ancial p>ticipation "u su* waiv]7 = su* p]iod z may be requir$ = a ,/ate to meet ! requirem5t ( ! previ\s s5t5ce4 7b7 ,ma9t5ance ( ef=t paym5ts ,= purposes ( ?is section1 a ma9t5ance ( ef=t paym5t ) respect to a ,/ate & plan ye> is-- 7#a7 = plan ye> #bjbh & a ,/ate1 a paym5t 9 an am\nt equal to ! total am\nt ( exp5ditures ( ! ,/ate = m$ical assi/ance "u title ,,xix & *ild heal? assi/ance "u title ,,xxi includ+ adm9i/rative co/s = ! plan ye> be=e ! date ( ! enactm5t ( ?is title2 7#b7 = plan ye> #bjbi & ea* subsequ5t plan ye> be=e plan ye> #bjcc-- 7,a7 9 ! case ( a ,/ate t is a ,,ppaca expansion ,/ate1 ! paym5t am\nt appli$ "u ?is subsection = ! previ\s plan ye>1 increas$ by gr[? 9 ,,gdp p] capita plus #j4d p]c5t2 & 7,b7 9 ! case ( a ,/ate t is n a ,,ppaca expansion ,/ate1 ! paym5t am\nt appli$ "u ?is subsection = ! previ\s plan ye>1 increas$ by gr[? 9 ,,gdp p] capita plus #j4g p]c5t2 & 7#c7 beg9n+ 9 #bjcc1 = ea* subsequ5t plan ye>1 ) respect to any ,/ate1 ! paym5t am\nt appli$ "u ?is subsection = ! previ\s ye>1 increas$ by gr[? 9 ,,gdp p] capita plus #j4g p]c5t4 7c7 ,programs specifi$ ,= purposes ( ?is section1 ! programs specifi$ 9 ?is subsection are ea* ( ! foll[+3 7#a7 ,block grants = community m5tal heal? s]vices "u subp>t ,i ( "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,block grants & programs = social s]vices & eld] ju/ice "u title ,,xx4 7#c7 ,mat]nal & *ild heal? s]vices block grants "u title ,v4 7#d7 ,block grants = prev5tion & treatm5t ( sub/ance abuse "u subp>t ,,ii ( "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act4 7#e7 ,/ate ,t>get$ ,response to ,opioid ,crisis ,grant ,community ,s]vices ,block ,grant4 7#f7 ,grants "u section #ccj ( ! ,public ,heal? ,s]vice ,act4 7#g7 ,ryan ,:ite ,,hiv_/,,aids ,program grants "u title ,,xxvi ( ! ,public ,heal? ,s]vice ,act4 #bbaj4 ,application ( title ,,xviii provisions ,except z specifi$ o!rwise 9 ?is title1 9 implem5t+ ,m$ic>e = ,am]ica1 ! ,secret>y %all to ! greate/ ext5t practicable apply ! foll[+ provisions ( title ,,xviii to ! program "u ?is title1 b5efits cov]$ "u ?is title1 individuals entitl$ to b5efits "u ?is title1 & provid]s ( s]vices & suppli]s p>ticipat+ "u ! program "u ?is title 9 a simil> mann] z su* provisions appli$ to ! program "u title ,,xviii1 b5efits cov]$ "u su* title1 individuals entitl$ to b5efits or enroll$ "u su* title1 & provid]s ( s]vices & suppli]s p>ticipat+ "u ! program "u su* title3 7#a7 ,section #ahja4 7#b7 ,section #ahje4 7#c7 ,section #ahjf4 7#d7 ,section #ahjg4 7#e7 ,section #ahji4 7#f7 ,section #ahad4 7#g7 ,section #ahae4 7#h7 ,section #ahaf4 7#i7 ,section #ahah4 7#aj7 ,section #ahah;,a4 7#aa7 ,section #ahai4 7#ab7 ,section #ahbj4 7#ac7 ,section #ahcd4 7#ad7 ,section #ahcd;,a4 7#ae7 ,section #ahdc4 7#af7 ,section #ahdf4 7#ag7 ,section #ahdg4 7#ah7 ,section #ahea4 7#ai7 ,section #aheb4 7#bj7 ,section #ahee4 7#ba7 ,section #ahef4 7#bb7 ,section #aheg4 7#bc7 ,section #aheh4 7#bd7 ,section #ahfa4 7#be7 ,section #ahfc4 7#bf7 ,section #ahfd4 7#bg7 ,section #ahff;,b4 7#bh7 ,section #ahff;,c4 7#bi7 ,section #ahff;,e4 7#cj7 ,section #ahfg4 7#ca7 ,section #ahfh4 7#cb7 ,section #ahfi4 7#cc7 ,section #ahga4 7#cd7 ,section #ahgd;,a4 7#ce7 ,section #ahhj4 7#cf7 ,section #ahha4 7#cg7 ,section #ahha;,a4 7#ch7 ,section #ahia4 7#ci7 ,section #ahid4 7#dj7 ,section #ahie4 7#da7 ,section #ahif4 ,b ,home & ,community ,bas$ ,long-,t]m ,s]vices & ,supports #bbca4 ,home & community bas$ long-t]m s]vices & supports b5efit ,all individuals enroll$ "u ,m$ic>e = ,am]ica "u ?is title %all h cov]age = home & community bas$ long-t]m s]vices & supports b5efits4 ,no?+ 9 ?is "p %all be con/ru$ to limit an enrollee's entitlem5t to any o!r b5efit t is cov]$ pursuant to section #bbjc1 includ+ nurs+ facility b5efits4 #bbcb4 ,eligibility 7a7 ,eligible individuals ,an individual :o is eligible = home & community bas$ long-t]m s]vices & supports b5efits "u ?is "p is an individual :o satisfies ea* ( ! foll[+3 7#a7 ,! individual is eligible = ,m$ic>e = ,am]ica4 7#b7 ,! individual is det]m9$ by a lic5s$ heal? c>e practition] to be unable to p]=m1 )\t sub/antial assi/ance1 at lea/ "o ,activity ( ,daily ,liv+ z describ$ 9 section #ggjb;,b7c77#b77;,b7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 or to require sub/antial assi/ance ) "o or m ( ! foll[+ areas3 7,a7 ,communication4 7,b7 ,social int]action4 7,c7 ,le>n+4 7,d7 ,self-c>e4 7,e7 ,self-managem5t4 7,f7 ,impairm5ts t affect ! p]son's capacity = social or economic p>ticipation4 7b7 ,cl>ification ,"u ?is "p1 9 ! case ( an individual describ$ 9 subsection 7a7 :o exp]i5ces p]iods 9 :i* _! functional capacity *anges or improves1 su* individual %all cont9ue to h access to b5efits "u ?is "p z ne$$4 ,if su* an individual's functional capacity improves to a po9t 9 :i* ! individual no long] requires home & community bas$ long-t]m s]vices & supports1 or requires few] s]vices1 ! individual %all be able to imm$iately & seamlessly resume receiv+ all ne$$ s]vices if & :5 _! functional ne$s recur4 ,eligibility = s]vices %all be ma9ta9$ if1 )\t ! s]vices1 ! individual w\ld h r$uc$ functional capacity4 ,:5 assess+ functional impairm5t1 ! individual w be assess$ )\t reg>d to any curr5t s]vices or ! ameliorative effects ( o!r mitigat+ measures describ$ 9 section #c7d77;,e77i77,i7 ( ! ,am]icans ,) ,disabilities ,act ( #aiij4 7c7 ,b5efits 7#a7 ,def9ition ,= purposes ( ?is title1 ! t]m home & community bas$ long-t]m s]vices & supports b5efit means ! daily liv+ supports ne$$ by eligible individuals 9 ord] to live1 "w1 & p>ticipate 9 _! communities1 & includes all home & community bas$ s]vices & supports cov]able z ( ! date ( ! enactm5t ( ?is title1 "u any ,/ate plan or waiv] "u title ,,xix1 includ+-- 7,a7 home heal? aides & homemak]s2 7,b7 direct support pr(essionals & p]sonal att5dant c>e s]vices2 7,c7 hospice2 7,d7 nurs+ c>e2 7,e7 m$ical social s]vices2 7,f7 c>e coord9ation1 includ+ case managem5t1 fiscal int]m$i>y1 & support brok]age s]vices2 7,g7 %ort-t]m inpati5t c>e1 includ+ respite c>e & c>e = pa9 control2 7,h7 behavioral heal? home & community bas$ long-t]m s]vices & supports1 includ+ ass]tive community treatm5t2 pe] support s]vices2 int5sive c>e coord9ation1 includ+ case managem5t2 support$ employm5t2 & support$ h\s+ wrap>\nd2 7,i7 private-duty nurs+2 7,j7 respite s]vices provid$ 9 ! individual's home or broad] community2 & 7,k7 transitional s]vices to support an individual's transition f an in/itutional sett+ to ! community4 7#b7 ,non-application ,! provisions ( sections #dbd4bb7;a77#a77;i7 & #dbd4bb7;a77#a77;ii7 ( title #db ( ! ,code ( ,f$]al ,regulations does n apply 9 ! case ( ! b5efit describ$ 9 p>agraph 7#a77;,a74 7d7 ,home & ,community ,bas$ ,long-,t]m ,s]vices & ,supports ,work=ce ,developm5t 7#a7 ,9 g5]al ,! ,secret>y %all ensure t ! numb] ( individuals 9 ! home & community bas$ long-t]m s]vices & supports work=ce is adequate to ensure community integration = all b5efici>ies "u ,m$ic>e = ,am]ica4 ,9 s do+1 ! ,secret>y may consid] a wide range ( factors1 includ+ paym5t rates = direct c>e work]s1 c>e] pipel9es & cr$5tial+1 work] rights1 & ! impact ( national labor policies4 7#b7 ,self-direct$ model ,all eligible individuals %all be default$ into a self-direct$ c>e option 7z def9$ by ! ,secret>y74 ,! ,secret>y mu/ consult ) eligible individuals1 c>egiv]s1 work]s & _! repres5tatives1 includ+ unions1 & /ate entities responsible = adm9i/]+ ! ,,ltss b5efit to e/abli% ?is model4 7#c7 ,community fir/ ,! b5efit "u ?is "p %all be arrang$ = & provid$ ) a community fir/ presumption & eligible individuals %all be provid$ home & community bas$ long-t]m s]vices & support available "u ?is section1 reg>dless ( type or level ( disability or s]vice ne$4 ,no eligible individual may be ref]r$ to an in/itution )\t fir/ be+ (f]$ &1 if *os51 provid$ home & community bas$ long-t]m s]vices & supports4 ,individuals 9 an in/itution on ! effective date ( ! bill1 & at lea/ annually or ^u any *ange 9 condition !reaft]1 %all be in=m$ (1 & if *os51 provid$ ) home & community bas$ long-t]m s]vices & supports4 7e7 ,adm9i/ration ( ,s]vices & ,supports ,/ate entities responsible = adm9i/]+ home & community bas$ long-t]m s]vices & support b5efits "u any ,/ate plan or waiv] "u title ,,xix z ( ! date ( ! enactm5t ( ?is title %all cont9ue to adm9i/] ! b5efits & s]vices cov]able "u ?is section4 7f7 ,coord9ation ) o!r ,f$]al b5efits 7#a7 ,rule ( con/ruction ,no?+ 9 ?is "p %all be con/ru$ z prohibit+ b5efits paid "u ?is "p f be+ us$ to comp5sate a c>egiv] :o provides community liv+ assi/ance s]vices & supports to a dep5d5t relative = provid+ community liv+ assi/ance s]vices & supports to an eligible individual "u ?is "p4 7#b7 ,dep5d5t relative def9$ ,! t]m dep5d5t relative means a *ild1 gr&*ild1 niece1 nephew1 p>5t1 gr&p>5t1 sibl+1 aunt1 or uncle 7( su* c>egiv] or 8 or h] sp\se or dome/ic p>tn]72 su* c>egiv]'s sp\se or dome/ic p>tn]1 if su* *ild1 gr&*ild1 niece1 nephew1 p>5t1 gr&p>5t1 sibl+1 aunt1 uncle1 sp\se1 or dome/ic p>tn] is an eligible individual4 7#c7 ,supplem5t n supplant ,b5efits receiv$ "u ?is "p by a c>egiv] %all supplem5t1 b n supplant1 o!r b5efits = :i* ! individual is eligible "u any o!r f$]ally fund$ program t provides b5efits or assi/ance4 7#d7 ,disreg>d ,! b5efit paid "u ?is "p %all be disreg>d$ = purposes ( det]m9+ or cont9u+ ! eligibility ( ! individual or ! sp\se ( ! individual = receipt ( b5efits "u any o!r ,f$]al1 ,/ate1 or locally fund$ assi/ance program1 includ+ b5efits paid "u title ,,ii or ,,xvi1 "u ! laws adm9i/]$ by ! ,secret>y ( ,vet]ans ,affairs1 "u l[-income h\s+ assi/ance programs1 "u ! supplem5tal nutrition assi/ance program e/abli%$ "u ! ,food & ,nutrition ,act ( #bjjh1 or "u programs adm9i/]$ by ,/ate vocational rehabilitation ag5cies4 7#e7 ,regulations ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all promulgate su* regulations z are necess>y to c>ry out ?is "p & to prev5t fraud & abuse ) respect to ! b5efits "u ?is "p4 ,c ,,m$ic>e ,,advantage ,,= ,,am]ica #bbba4 ,all private plans 7a7 ,9 g5]al ,= plan ye>s beg9n+ ) plan ye> #bjbc1 a heal? insurance issu] may (f] heal? insurance cov]age 9 ! individual m>ket only if su* issu] has ent]$ into a contract ) ! ,secret>y "u subsection 7b7 to (f] su* cov]age4 7b7 ,agreem5ts ,! ,secret>y %all ent] into an agreem5t ) an ,,ma = ,am]ica sponsor to (f] ,,ma = ,am]ica plans "u ?is "p = ! cov]age ( individuals enroll$ "u ,m$ic>e = ,am]ica :o elect to receive b5efits "u "p ,a ?r\gh su* a plan4 7c7 ,,ma = ,am]ica plan2 ,,ma = ,am]ica sponsor ,= purposes ( ?is "p3 7#a7 ,,ma = ,am]ica plan ,an ,,ma = ,am]ica plan is a ,m$ic>e ,advantage plan "u "p ,c ( title ,,xviii1 except su* plan %all provide cov]age = individuals enroll$ "u ,m$ic>e = ,am]ica "u "p ,a ( ?is title1 ) respect to at lea/ ! b5efits cov]$ "u su* "p ,a4 7#b7 ,,ma = ,am]ica sponsor ,an ,,ma = ,am]ica sponsor is a sponsor ( an ,,ma = ,am]ica plan4 #bbbb4 ,application ( ,m$ic>e ,advantage provisions ,= purposes ( apply+ ?is "p1 except z o!rwise specifi$ "u ?is "p1 ! provisions ( "p ,c ( title ,,xviii1 z 9 effect z ( ! date ( ! enactm5t ( ?is title %all apply ) respect to an ,,ma = ,am]ica sponsor1 ,,ma = ,am]ica plan1 individuals eligible = cov]age "u ?is "p1 individuals enroll$ "u su* plan1 & b5efits cov]$ "u "p ,a 9 a simil> mann] & to a simil> ext5t z su* provisions appli$ to an ,,ma organization1 ,,ma plan1 individuals eligible = "u "p ,c ( su* title1 individuals enroll$ "u an ,,ma plan1 & b5efits cov]$ "u fee-=-s]vice ,m$ic>e z ( su* date4 #bbbc4 ,m$ic>e ,advantage = ,am]ica paym5t rates ,! rates = ,m$ic>e ,advantage = ,am]ica plans %all be equal to ! rates paid by ,m$ic>e = ,am]ica4 ,! ,adm9i/rator ( ! ,c5t] = ,heal?c>e %all pay ,m$ic>e ,advantage = ,am]ica plans #ie p]c5t ( av]age ,m$ic>e = ,am]ica co/s 9 ea* c\nty4 #bbbd4 ,sep>ate premium = ,m$ic>e ,advantage = ,am]ica plans furni%+ supplem5tal b5efits ,no?+ 9 ?is "p %all preclude an individual f *oos+ a ,m$ic>e ,advantage = ,am]ica plan :i* requires ! individual to pay an additional1 sep>ate am\nt because ( supplem5tal b5efits or because x is a m exp5sive plan4 ,9 su* case ! individual enroll$ "u su* plan w\ld be responsible = a sep>ate mon?ly premium4 #bbbe4 ,prescription drug pric+ "u ,m$ic>e ,advantage = ,am]ica plans ,m$ic>e ,advantage = ,am]ica plans1 = prescription drugs1 %all pay no m ?an ! price negotiat$ "u ,m$ic>e = ,am]ica4 #bbbf4 ,ban on pay+ brok]s' fees ,m$ic>e ,advantage = ,am]ica plans may n pay fees to insurance brok]s4 #bbbg4 ,cl>ification on ,m$ic>e ,advantage employ] gr\p waiv] plans & ! ,m$ic>e second>y pay] requirem5t ,su* plans %all be exempt f ! ,,msp ,requirem5t1 & no?+ 9 ?is section %all be con/ru$ z prohibit+ su* plans f contribut+ to ! paym5t ( premiums & co/-%>+4 #bbbh4 ,ref]5ces ,beg9n+ 9 #bjbc1 all ref]5ces 9 law & regulation to ,m$ic>e ,advantage %all be deem$ a ref]5ce to ,m$ic>e ,advantage = ,am]ica4 4 #aab4 ,modifications to & coord9ation ) exi/+ ,f$]al heal? programs 7a7 ,m$ic>e1 ,m$icaid1 & ,/ate *ildr5's heal? insurance program 7,,s*ip7 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 subject to p>agraphs 7#b7 & 7#c7 & section #bbjb7;c7 ( ! ,social ,security ,act1 z add$ by section #aaa-- 7,a7 no b5efits %all be available "u title ,,xviii ( ! ,social ,security ,act = any item or s]vice furni%$-- 7i7 beg9n+ on or aft] ,janu>y #a1 #bjbc 7except 9 ! case ( an individual enroll$ "u su* title & title ,,xix ( su* ,act72 & 7ii7 beg9n+ on or aft] ,janu>y #a1 #bjbe1 ) respect to all individuals1 includ+ individuals enroll$ "u su* title & title ,,xix ( su* ,act2 7,b7 no individual is entitl$ to m$ical assi/ance "u a ,/ate plan approv$ "u title ,,xix ( su* ,act-- 7i7 = any item or s]vice furni%$ on or aft] ,janu>y #a1 #bjbe1 9 ! case ( an individual enroll$ "u su* title & title ,,xviii ( ! ,social ,security ,act or an individual describ$ 9 subclause 7,,viii7 ( section #aijb7;a77#aj77;,a77i72 & 7ii7 = any item or s]vice furni%$ on or aft] ,janu>y #a1 #bjbg2 7,c7 no individual is entitl$ to m$ical assi/ance "u a ,/ate *ild heal? plan "u title ,,xxi ( su* ,act = any item or s]vice furni%$ on or aft] ,janu>y #a1 #bjbe2 & 7,d7 no paym5t %all be made to a ,/ate "u section #aijc7;a7 or #baje7;a7 ( su* ,act ) respect to m$ical assi/ance or *ild heal? assi/ance-- 7i7 = any item or s]vice furni%$ on or aft] ,janu>y #a1 #bjbe1 9 ! case ( an individual enroll$ "u su* title & title ,,xviii ( ! ,social ,security ,act or an individual describ$ 9 subclause 7,,viii7 ( section #aijb7;a77#aj77;,a77i72 & 7ii7 = any item or s]vice furni%$ on or aft] ,janu>y #a1 #bjbg4 7#b7 ,transition ,9 ! case ( inpati5t hospital s]vices & ext5d$ c>e s]vices dur+ a cont9u\s p]iod ( /ay :i* began be=e ,janu>y #a1 #bjbe1 = ,m$ic>e & #bjbg = ,m$icaid or ,,*ip1 & :i* _h n end$ z ( su* date1 = :i* b5efits are provid$ "u title ,,xviii ( ! ,social ,security ,act1 "u a ,/ate plan "u title ,,xix ( su* ,act1 or "u a ,/ate *ild heal? plan "u title ,,xxi su* ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all provide = cont9uation ( b5efits "u su* title or plan until ! end ( ! p]iod ( /ay4 7b7 ,o!r ,f$]al heal? programs 7#a7 ,f$]al employees heal? b5efits program ,no?+ 9 ?is ,act1 or ! am5dm5ts made by ?is ,act1 %all affect b5efits made available "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,,tric>e ,no?+ 9 ?is ,act1 or ! am5dm5ts made by ?is ,act1 %all affect b5efits made available "u sections #ajgi & #ajhf ( title #aj1 ,unit$ ,/ates ,code4 7#c7 ,treatm5t ( b5efits = vet]ans & ,native ,am]icans 7,a7 ,9 g5]al ,no?+ 9 ?is ,act1 or ! am5dm5ts made by ?is ,act1 %all affect ! eligibility ( vet]ans = ! m$ical b5efits & s]vices provid$ "u title #ch1 ,unit$ ,/ates ,code1 or ( ,indians = ! m$ical b5efits & s]vices provid$ by or ?r\gh ! ,indian ,heal? ,s]vice4 7,b7 ,reevaluation ,no reevaluation ( ! ,indian ,heal? ,s]vice %all be und]tak5 )\t consultation ) tribal lead]s & /akehold]s4 7,c7 ,supplem5tal ,indian ,heal? ,s]vices allocation ,! ,secret>y %all annually det]m9e ! ne$ to provide an allotm5t ( supplem5tal funds to ,indian ,heal? ,s]vices1 includ+ paym5ts to provid]s1 heal? pr(essional education1 adm9i/rative exp5ses1 & prev5tion & public heal? activities4 7#d7 ,enrollee *oice ,no?+ 9 ?is ,act %all preclude individuals enroll$ 9 ! ,f$]al ,employees ,heal? ,b5efits ,program or ,,tric>e or individuals receiv+ b5efits provid$ "u title1 #ch1 ,unit$ ,/ates ,code or ! ,indian ,heal? ,s]vice f enroll+ 9 ,m$ic>e = ,am]ica4 ,enrollees %all be entitl$ to ! employ] contribution z e/abli%$ "u section #abf7;c7 ( su* ,act4 7c7 ,sunset ( provisions relat$ to ! ,/ate ex*anges ,effective ,janu>y #a1 #bjbb1 ! ,f$]al & ,/ate ,ex*anges e/abli%$ pursuant to title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh7 %all t]m9ate1 & any o!r provision ( law t relies ^u p>ticipation 9 or enrollm5t ?r\gh su* an ,ex*ange1 includ+ su* provisions ( ! ,int]nal ,rev5ue ,code ( #aihf1 %all cease to h =ce or effect4 7d7 ,sev]ability ,e provision 9 ?is ,act & e application ( ! provisions 9 ?is ,act are sev]able f ea* o!r z a matt] ( ,f$]al law4 ,if any application ( any provision 9 ?is ,act to any p]son or gr\p ( p]sons or circum/ances is f\nd by a c\rt to be invalid1 ! rema9d] ( ?is ,act & ! application ( ! ,act's provisions to all o!r p]sons & circum/ances may n be affect$4 ,c ,t>get$ ,re=ms #aba4 ,no surprise bill+ 7a7 ,surprise bill def9$ ,= purposes ( ?is section ! t]m surprise bill-- 7#a7 means a bill = heal? c>e s]vices1 o!r ?an em]g5cy s]vices1 receiv$ by an insur$ = s]vices r5d]$ by an out-(-network heal? c>e provid]1 :]e su* s]vices 7 r5d]$ by su* out-(-network provid] at an 9-network facility1 dur+ a s]vice or proc$ure p]=m$ by an 9-network provid] or dur+ a s]vice or proc$ure previ\sly approv$ or au?oriz$ by ! heal? c>ri] & ! insur$ did n kn[+ly elect to obta9 su* s]vices f su* out-(-network provid]2 & 7#b7 does n include a bill = heal? c>e s]vices receiv$ by an insur$ :5 an 9-network heal? c>e provid] 0 available to r5d] su* s]vices & ! insur$ kn[+ly elect$ to obta9 su* s]vices f ano!r heal? c>e provid] :o 0 out-(-network4 7b7 ,no non-p>ticipat+ heal? c>e provid] %all require prior au?orization = r5d]+ em]g5cy s]vices to an insur$4 7c7 ,no heal? c>ri] %all impose1 = em]g5cy s]vices r5d]$ to an insur$ by an out-(-network heal? c>e provid]1 a co9surance1 copaym5t1 d$uctible or o!r out-(-pocket exp5se t is great] ?an ! co9surance1 copaym5t1 d$uctible or o!r out-(-pocket exp5se t w\ld be impos$ if su* em]g5cy s]vices 7 r5d]$ by an 9-network heal? c>e provid]4 7d7 ,paym5t ,am\nt ,if em]g5cy s]vices 7 r5d]$ to an insur$ by an out-(-network heal? c>e provid]1 su* heal? c>e provid] may bill ! heal? c>ri] directly & ! heal? c>ri] %all reimburse su* heal? c>e provid] ! greate/ ( ! foll[+ am\nts3 7#a7 ,! am\nt payable "u ,m$ic>e = ,am]ica = su* s]vices if r5d]$ by a heal? c>e provid] p>ticipat+ 9 ,m$ic>e = ,am]ica4 7#b7 ,! arbitrat$ am\nt betwe5 ! qualify+ heal? plan & ! non-p>ticipat+ provid]4 7e7 ,no?+ 9 ?is section %all be con/ru$ to prohibit ! qualify+ heal? plan & ! non-p>ticipat+ heal? c>e provid] f agree+ to a great] reimbursem5t am\nt4 7f7 ,non-,em]g5cy s]vices ,) respect to a surprise bill1 ! foll[+ applies3 7#a7 ,an individual enroll$ 9 ! qualify+ heal? plan %all only be requir$ to pay ! applicable co9surance t w\ld be impos$ = su* heal? c>e s]vices if su* s]vices 7 r5d]$ by a p>ticipat+ heal? c>e provid]4 7#b7 ,! qualify+ heal? plan %all reimburse ! non-p>ticipat+ heal? c>e provid] or individual enroll$ 9 su* heal? plan1 z applicable1 = heal? c>e s]vices r5d]$ at ! qualify+ heal? plane rate z paym5t 9 full1 unless ! heal? plan & ! non-p>ticipat+ heal? c>e provid] agree o!rwise4 7g7 ,if heal? c>e s]vices 7 r5d]$ to an individual enroll$ 9 qualify+ heal? cov]age by a non-p>ticipat+ heal? c>e provid] & ! qualify+ heal? plan fail$ to in=m su* enrollee1 if su* enrollee 0 requir$ to be in=m$1 ( ! network /atus ( su* non-p>ticipat+ heal? c>e provid]1 ! qualify+ heal? plan %all n impose co9surance exp5se t is great] ?an ! maximum out-(-pocket exp5se t w\ld be impos$ if su* s]vices 7 r5d]$ by a qualify+ heal? c>e provid]4 7h7 ,em]g5cy s]vices 7#a7 ,no prior au?orization ,a heal? c>e provid] n p>ticipat+ 9 ,m$ic>e = ,am]ica may n require prior au?orization = r5d]+ em]g5cy s]vices to an individual enroll$ "u ,m$ic>e = ,am]ica4 7#b7 ,out-(-pocket exp5ses ,a heal? c>e provid] n p>ticipat+ 9 ,m$ic>e = ,am]ica may n impose1 = em]g5cy s]vices r5d]$ to an individual enroll$ 9 ,m$ic>e = ,am]ica1 a co9surance1 copaym5t1 or o!r out-(-pocket exp5se t is great] ?an ! co9surance or maximum out-(-pocket exp5se t w\ld be impos$ if su* em]g5cy s]vices 7 r5d]$ by a ,m$ic>e = ,am]ica p>ticipat+ provid]4 7#c7 ,paym5t am\nt ,if em]g5cy s]vices are r5d]$ to an individual enroll$ 9 ,m$ic>e = ,am]ica by a heal? c>e provid] n p>ticipat+ 9 ,m$ic>e = ,am]ica1 su* heal? c>e provid] may bill ,m$ic>e = ,am]ica directly & ,m$ic>e = ,am]ica %all reimburse su* heal? c>e provid] ! greate/ ( ! foll[+ am\nts3 7,a7 ,! am\nt payable "u ,m$ic>e = ,am]ica = su* s]vices if r5d]$ by a heal? c>e provid] p>ticipat+ 9 ,m$ic>e = ,am]ica4 7,b7 ,! arbitrat$ am\nt betwe5 ! ,secret>y ( ,heal? & ,human ,s]vices & ! provid]1 det]m9$ by an arbitration process e/abli%$ by ! ,secret>y4 7i7 ,non-,em]g5cy s]vices ,) respect to a surprise bill1 ! foll[+ applies3 7#a7 ,an individual enroll$ 9 qualify+ cov]age 7z def9$ 9 section #bbjb7;b77#d77;,b7 ( ! ,social ,security ,act7 %all only be requir$ to pay ! applicable co9surance t w\ld be impos$ = su* heal? c>e s]vices if su* s]vices 7 r5d]$ by a heal? c>e provid] p>ticipat+ 9 ,m$ic>e = ,am]ica4 7#b7 ,! ,secret>y ( ,heal? & ,human ,s]vices %all reimburse ! non-p>ticipat+ heal? c>e provid] or individual enroll$ 9 su* heal? plan1 z applicable1 = heal? c>e s]vices r5d]$ at rate payable "u ,m$ic>e = ,am]ica z paym5t 9 full1 unless ! ,secret>y & ! non-p>ticipat+ heal? c>e provid] agree o!rwise4 7#c7 ,if heal? c>e s]vices 7 r5d]$ to an individual enroll$ 9 ,m$ic>e = ,am]ica by a heal? c>e provid] n p>ticipat+ 9 ,m$ic>e = ,am]ica & ! ,secret>y ( ,heal? & ,human ,s]vices fail$ to in=m su* enrollee1 if su* enrollee 0 requir$ to be in=m$1 ( ! network /atus ( su* non-p>ticipat+ heal? c>e provid]1 ! ,secret>y %all n impose a co9surance exp5se t is great] ?an ! maximum out-(-pocket exp5se t w\ld be impos$ if su* s]vices 7 r5d]$ by a provid] p>ticipat+ 9 ,m$ic>e = ,am]ica4 #abb4 ,limitation on removal ( ,m$ic>e ,advantage provid]s by ,,ma organizations 7a7 ,limitation ,section #aheb7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,limitation on removal ( provid]s f ma plans by ma organizations 7,a7 ,removal ( provid]s ) cause ,beg9n+ ) plan ye> #bjbj1 except z provid$ 9 subp>agraph 7,c71 an ,,ma organization (f]+ an ,,ma plan may only remove a provid] ( s]vices or a suppli] f a network ( su* plan if ! organization has cause to remove su* provid] or suppli]4 7,b7 ,cause to remove provid]s 7i7 ,9 g5]al ,an ,,ma organization (f]+ an ,,ma plan has cause to remove a provid] ( s]vices or a suppli] f a network ( su* plan if ! ,secret>y det]m9es t ! provid] or suppli] is-- 7,i7 m$ically neglig5t2 7,,ii7 9 violation ( any legal or contractual requirem5t applicable to ! provid] or suppli] act+ )9 ! lawful scope ( practice1 includ+ any p>ticipation or o!r requirem5t applicable to su* provid] or suppli] "u ?is title or "u any contractual t]m = su* plan2 or 7,,iii7 o!rwise unfit to furni% items & s]vices 9 accordance ) requirem5ts ( ?is title4 7ii7 ,consid]ation ( co/ to ma organizations ,= purposes ( subp>agraph 7,a71 co/ to an ,,ma organization (f]+ an ,,ma plan due to ! p>ticipation ( a provid] ( s]vices or suppli] 9 a network ( su* plan does n con/itute cause = ! ,,ma organization to remove su* provid] or suppli] f ! network mid-ye>1 & su* co/ may n be consid]$ z a factor 9 favor ( a det]m9ation t su* organization has cause to remove ! provid]4 7,c7 ,exception ,) respect to ea* upcom+ plan ye>1 beg9n+ ) plan ye> #bjbj an ,,ma organization (f]+ an ,,ma plan may only remove a provid] ( s]vices or suppli] f a network ( su* plan = reasons n specifi$ 9 subp>agraph 7,b77i7 be=e ! date t is #fj days be=e ! fir/ day ( ! annual coord9at$ election p]iod = su* plan ye> "u section #ahea7;e77#c74 7,d7 ,notice & appeal process 7i7 ,9 g5]al ,any removal ( a provid] ( s]vices or suppli] f a network ( an ,,ma plan may occur only aft] ! completion ( a fair notice & appeal process t ! ,secret>y %all e/abli% by regulation4 ,su* process %all require ! ,,ma organization to provide to su* provid] or suppli] & to ! ,secret>y an explanation ( ! reason or reasons = ! removal4 ,! ,secret>y %all make ?is in=mation publicly available4 7ii7 ,application 7,i7 ,application ( new process ,9 ! case ( a removal ( a provid] ( s]vices or suppli] f a network ( an ,,ma plan occurr+ on or aft] ! effective date publi%$ 9 a f9al rule = su* fair notice & appeal process1 su* process %all apply 9 lieu ( ! process = ! t]m9ation or susp5sion ( a provid] contract "u section #dbb4bjb7;a7 ( title #db1 ,code ( ,f$]al ,regulations4 7,,ii7 ,cont9uation ( old process ,9 ! case ( a removal ( a provid] ( s]vices or suppli] f a network ( an ,,ma plan occurr+ be=e su* effective date1 ! process = ! t]m9ation or susp5sion ( a provid] contract "u section #dbb4bjb7;a7 ( title #db1 ,code ( ,f$]al ,regulations1 %all apply4 7,e7 ,p>ticipant notice & protection 7i7 ,notice to p>ticipants ( provid] removal ,n less ?an #fj days be=e ! date on :i* a provid] ( s]vices or suppli] is remov$ f a network ( an ,,ma plan1 ! ,,ma organization (f]+ su* plan %all provide writt5 notification ( ! removal to ea* individual enroll$ 9 su* plan receiv+ items or s]vices f ! provid] or suppli] dur+ ! plan ye> 9 effect on ! date ( removal or dur+ ! previ\s plan ye>4 ,su* notification %all include at ! m9imum-- 7,i7 ! names & telephone numb]s ( available 9-network provid]s ( s]vices & suppli]s (f]+ items & s]vices t are ! same or simil> to ! items & s]vices (f]$ by ! remov$ provid] or suppli]2 7,,ii7 in=mation reg>d+ ! options available to an individual enroll$ 9 su* plan to reque/ ! cont9uation ( m$ical treatm5t or !rapy ) ! remov$ provid] or suppli]2 & 7,,iii7 "o or m cu/om] s]vice telephone numb]s t an individual enroll$ 9 su* plan may access to obta9 in=mation reg>d+ *anges to ! network ( ! plan4 7ii7 ,annual notice ( *ange ,9 addition to provid+ ! notification ( removal z requir$ "u clause 7i71 ! ,,ma organization (f]+ su* ,,ma plan %all include su* notification 9 ! annual notice ( *ange = ! ,,ma plan = ! upcom+ plan ye>4 7iii7 ,cont9uity ( c>e ,9 any case 9 :i* a provid] ( s]vices or suppli] is remov$ f a network ( an ,,ma plan1 su* plan %all ensure t ! removal satisfies ! cont9uity ( c>e requirem5ts "u p>agraph 7#a77;,a7 ) respect to ea* individual enroll$ 9 su* plan receiv+ items or s]vices f ! provid] or suppli] dur+ ! plan ye> 9 effect on ! date ( removal or dur+ ! previ\s plan ye>4 7,f7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ z affect+ ! ability ( a provid] ( s]vices or suppli] to decl9e to p>ticipate 9 a network ( an ,,ma plan4 7#h7 ,transp>5cy 9 measures us$ by ma organizations to e/abli% or modify provid] networks 7,a7 ,9 g5]al ,beg9n+ ) plan ye> #bjbj1 an ,,ma organization (f]+ an ,,ma plan %all publi% & make accessible ! in=mation describ$ 9 subp>agraph 7,b7-- 7i7 9 ! annual bid in=mation submitt$ by ! ,,ma organization ) respect to ! ,,ma plan "u section #ahed2 & 7ii7 on ! ,int]net ,web ,site = ! ,,ma plan4 7,b7 ,in=mation describ$ ,! in=mation describ$ 9 ?is subp>agraph is ! foll[+3 7i7 ,in=mation reg>d+ ! measures us$ by ! ,,ma organization to e/abli% or modify ! provid] network ( ! ,,ma plan1 includ+ measures ( ! quality & effici5cy ( provid]s4 ,su* in=mation %all include ! specifications1 me?odology1 & sample size ( su* measures4 7ii7 ,o!r in=mation relat$ to ! e/abli%m5t or modification ( su* provid] network t ! ,secret>y det]m9es appropriate4 7,c7 ,limitation ,! in=mation describ$ 9 subp>agraph 7,b7 %all n include any individually id5tifiable in=mation ( any provid] or suppli] ( s]vices4 4 7b7 ,en=cem5t 7#a7 ,sanctions = noncompliance ,section #aheg7;g77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;g77#a77 is am5d$-- 7,a7 9 subp>agraph 7,j71 by /rik+ or2 7,b7 by r$esignat+ subp>agraph 7,k7 z subp>agraph 7,l72 7,c7 by ins]t+ aft] subp>agraph 7,j7 ! foll[+ new subp>agraph3 7,k7 fails to comply ) section #aheb7;d77#g7 or #aheb7;d77#h72 or 2 & 7,d7 9 subp>agraph 7,l7 7z s r$esignat$71 by /rik+ ?r\gh 7,j7 & ins]t+ ?r\gh 7,k74 7#b7 ,sanctions n applicable to "p ,d ,title ,,xviii ( ! ,social ,security ,act is am5d$-- 7,a7 9 section #ahfj;,d-#ab7;b77#c77;,e7 7#db ,u4,s4,c4 #aciew-#aab7;b77#c77;,e771 by /rik+ p>agraph 7#a77;,f7 & ins]t+ p>agraphs 7#a77;,f7 & 7#a77,k72 & 7,b7 9 section #ahid7;e77#f77;,b7 7#db ,u4,s4,c4 #acie;eee7e77#f77;,b771 by ins]t+ 7o!r ?an p>agraph 7#a77,k7 ( su* section7 aft] #aheg7;g77#a74 7c7 ,m$ic>e advantage plan comp>e tool ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all take su* measures z are necess>y to ensure t ! ,m$ic>e ,advantage ,comp>e ,tool takes into acc\nt ! pref]5ces & utilization ne$s ( su* individuals4 #abc4 ,network adequacy 7a7 ,9 g5]al ,section #aheb7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is am5d$ by add+ at ! end ! foll[+3 7#i7 ,network adequacy requirem5ts ,beg9n+ 9 plan ye> #bjai1 not)/&+ any o!r provision ( law1 ! foll[+ %all apply3 7,a7 ,provid] availability ,:5 e/abli%+ a plan network1 a ,m$ic>e ,advantage organization (f]+ an ,,ma plan %all1 among o!r factors det]m9$ by ! ,secret>y1 consid] ! foll[+3 7i7 ,! anticipat$ enrollm5t 9 ! plan4 7ii7 ,! expect$ types ( s]vices provid$ & utilization ( s]vices by enrollees "u ! plan4 7iii7 ,! numb] & types ( provid]s ne$$ to provide su* s]vices4 7iv7 ,! numb] ( network provid]s :o are n accept+ new pati5ts4 7v7 ,! location ( provid]s & enrollees1 tak+ into acc\nt geographic disbursem5t4 7vi7 ,! full-"t equival5t availability ( a provid] to provide su* s]vices4 7,b7 ,provision ( c>e 9 a timely mann] ,a ,m$ic>e ,advantage organization (f]+ an ,,ma plan %all ensure t provid]s are able to provide s]vices 9 a timely mann]1 z def9$ by ! ,secret>y1 "u ! plan4 7,c7 ,application ( network access adequacy /&>ds ,9 apply+ ! network access adequacy /&>ds pursuant to p>agraph 7#a71 ! ,secret>y %all seek input f pati5t advocacy gr\ps1 provid]s ( s]vices & suppli]s1 & ,,ma plans "u ?is "p4 7,d7 ,c]tification ,ea* plan ye>1 a ,m$ic>e ,advantage organization %all c]tify to ! ,secret>y1 ) respect to ea* ,,ma plan (f]$ by ! organization1 t ! provid]s1 includ+ speciali/s & subspeciali/s1 9 ! plan network are able to provide ! s]vices requir$ "u ! organization's contract ) ! ,secret>y "u section #aheg ) respect to ! (f]+ ( su* plan & to meet ! ne$s ( ! enrollees )9 ! plan s]vice area dur+ ! ye>4 7,e7 ,annual report+ ,ea* plan ye>1 a ,m$ic>e ,advantage organization %all report to ! ,secret>y1 & make public ! foll[+ ) respect to ea* ,,ma plan (f]$ by ! organization3 7i7 ,av]age wait "t ,! av]age wait "t = prim>y & specialty c>e = enrollees "u ! plan4 7ii7 ,utilization ( out ( network provid]s ,! utilization ( out-(-network provid]s "u ! plan4 7iii7 ,av]age co/ p] pati5t ,! av]age annual sp5d+ p] pati5t = prim>y & specialty c>e = enrollees "u ! plan4 7,f7 ,c]tification ,9 advance ( ! annual1 coord9at$ election p]iod "u section #ahea7;e77#c71 a ,m$ic>e ,advantage organization %all c]tify to ! ,secret>y ! accuracy ( provid] directories = ea* plan (f]$ by ! organization4 7,g7 ,network review ,! ,secret>y %all ensure t ! network ( ea* ,,ma plan (f]$ by a ,m$ic>e ,advantage organization meets ! network adequacy guidel9es e/abli%$ "u ?is p>agraph & "u section #dbb4aab7;a77#d7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation to su* section7 at lea/ once e #c ye>s or :5 a mat]ial *ange 9 network occurs4 7,h7 ,au?ority ,! ,secret>y %all h ! au?ority to /op any fur!r enrollm5t 9 a ,m$ic>e ,advantage plan if !re is a patt]n ( excessive violations ( ?is p>agraph4 4 7b7 ,en=cem5t ,section #aheg7;g77#a77,k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;g77#a77,k771 z add$ by section #b7;b71 is am5d$ by /rik+ or #aheb7;d77#h7 & ins]t+ 1 #aheb7;d77#h71 or #aheb7;d77#i74 #abd4 ,elim9at+ ! #bd-mon? wait+ p]iod = ,m$ic>e cov]age = individuals ) disabilities 7a7 ,9 g5]al ,section #bbf7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #dbf7;b77 is am5d$-- 7#a7 9 p>agraph 7#b77;,a71 by /rik+ 1 & has = #bd cal5d> mon?s be5 entitl$ to12 7#b7 9 p>agraph 7#b77;,b71 by /rik+ 1 & has be5 = n less ?an #bd mon?s12 7#c7 9 p>agraph 7#b77;,c77ii71 by /rik+ 1 includ+ ! requirem5t t he has be5 entitl$ to ! specifi$ b5efits = #bd mon?s12 7#d7 9 ! fir/ s5t5ce1 by /rik+ = ea* mon? beg9n+ ) ! lat] ( 7,i7 ,july #aigc or 7,,ii7 ! tw5ty-fif? mon? ( 8 entitlem5t or /atus z a qualifi$ railroad retirem5t b5efici>y describ$ 9 p>agraph 7#b71 & & ins]t+ = ea* mon? = :i* ! individual meets ! requirem5ts ( p>agraph 7#b71 beg9n+ ) ! mon? foll[+ ! mon? 9 :i* ! individual meets ! requirem5ts ( su* p>agraph1 &2 & 7#e7 9 ! second s5t5ce1 by /rik+ ! tw5ty-fif? mon? ( 8 entitlem5t & all t foll[s ?r\gh p>agraph 7#b77;,c7 &4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #bbf ,section #bbf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #dbf7 is am5d$ by-- 7,a7 /rik+ subsections 7e77#a77;,b71 7f71 & 7h72 & 7,b7 r$esignat+ subsections 7g7 & 7i7 z subsections 7f7 & 7g71 respectively4 7#b7 ,m$ic>e description ,section #ahaa7b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;c7#b77 is am5d$ by /rik+ h be5 entitl$ = n less ?an #bd mon?s & ins]t+ are entitl$4 7#c7 ,m$ic>e cov]age ,section #ahcg7;g77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciep7g77#a77 is am5d$ by /rik+ #be? mon? ( & ins]t+ mon? foll[+ ! fir/ mon? (4 7#d7 ,railroad retirem5t sy/em ,section #g7;d77#b77;ii7 ( ! ,railroad ,retirem5t ,act ( #aigd 7#de ,u4,s4,c4 #bca;f7d77#b77;ii77 is am5d$-- 7,a7 by /rik+ has be5 entitl$ to an annuity & ins]t+ is entitl$ to an annuity2 7,b7 by /rik+ 1 = n less ?an #bd mon?s2 & 7,c7 by /rik+ c\ld h be5 entitl$ = #bd cal5d> mon?s1 &4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to insurance b5efits "u title ,,xviii ( ! ,social ,security ,act ) respect to items & s]vices furni%$ 9 mon?s beg9n+ aft] ! date ( enactm5t ( ?is ,act4 #abe4 ,elim9at+ ! wait+ p]iod = individuals on ,/ate ,m$icaid wait+ li/s ,! ,secret>y ( ,heal? & ,human ,s]vices is appropriat$ su* sums z are necess>y to facilitate enrollm5t1 n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act1 all eligible individuals :o1 z ( ! date ( ! enactm5t ( ?is ,act1 are on ,/ate ,m$icaid wait+ li/s or ,/ate ,m$icaid waiv] wait+ li/s4 #abf4 ,employ] heal? plan options 7a7 ,def9ition ,a qualify+ employ]-sponsor$ plan is-- 7#a7 a gov]nm5tal plan 7)9 ! mean+ ( section #bgia7;d77#h7 ( ! ,public ,heal? ,s]vice ,act72 or 7#b7 any o!r plan or cov]age t meets ! crit]ia "u subsection 7b71 includes vision1 d5tal1 & he>+ b5efits1 & provides heal? cov]age t is equival5t to an actu>ial value ( at lea/ #hj p]c5t ( ! cov]age provid$ "u title ,,xxii ( ! ,social ,security ,act & makes a premium contribution ( at lea/ #gj p]c5t4 ,su* plan %all require a premium contribution f ! employ] ( at lea/ #gj p]c5t reg>dless ( :e!r cov]age is = s+le1 sp\sal1 or dep5d5t c>e4 7b7 ,obligation ,l>ge employ]s %all1 ) respect to any full-"t employee ( su* employ]-- 7#a7 (f] a qualify+ employ]-sponsor$ plan to su* employee1 9 accordance ) subsection 7a72 or 7#b7 make a contribution ( #h p]c5t ( _! annual payroll to ! ,m$ic>e ,tru/ ,fund "u title ,,xxii ( ! ,social ,security ,act4 7c7 ,employee *oice ,an employee may opt out ( a qualify+ employ]-sponsor$ plan z satisfi$ by subsection 7b77#a7 9 ord] to enroll 9 ,m$ic>e = ,am]ica4 ,! employ] %all make a contribution equal to ! contribution x %all make 9 ord] to meet ! requirem5ts e/abli%$ by subsection 7a77#a7 or 7a77#b74 ,! ,secret>y ( ,heal? & ,human ,s]vices %all h au?ority to set /&>ds = det]m9+ :e!r employ]s or insur]s are und]tak+ any actions to affect ! risk pool )9 ,m$ic>e = ,am]ica by induc+ individuals to decl9e cov]age "u a qualify+ employ]-sponsor$ plan & in/ead to enroll 9 ,m$ic>e = ,am]ica4 ,an employ] violat+ su* /&>ds %all be treat$ z n meet+ ! requirem5ts ( subsection 7a74 7d7 ,employee ,education on ,heal? ,cov]age ,options ,l>ge employ]s %all dissem9ate to employees su* publicly available in=mation on cov]age options "u ,m$ic>e = ,am]ica z ! ,secret>y deems appropriate1 includ+ contact in=mation = assi/ance4 7e7 ,special rules 7#a7 ,annual payroll ,= purposes ( ?is p>agraph1 ! t]m annual payroll means1 ) respect to any employ] = any cal5d> ye>1 ! aggregate wages paid by ! employ] dur+ su* cal5d> ye>4 7#b7 ,aggregation rules ,relat$ employ]s & pr$ecessors %all be treat$ z a s+le employ] = purposes ( ?is subsection4 7#c7 ,r$uction = "p-"t employees ,9 ! case ( a "p-"t employee1 ! employ] contribution requirem5ts ( p>agraph 7#a7 %all be treat$ z satisfi$ if ! employ] contribution ) respect to su* employee is n less ?an ! "p-"t employm5t ratio ( ! contribution requir$ "u p>agraph 7#a74 7#d7 ,rules relat$ to "p-"t employm5t ,= purposes ( ?is subsection-- 7,a7 ,"p-"t employee ,! t]m "p-"t employee means1 ) respect to any mon?1 an employee :o works on av]age few] ?an #cj h\rs p] week4 7,b7 ,"p-"t employm5t ratio ,! t]m "p-"t employm5t ratio means1 ) respect to a "p-"t employee ( an employ] 9 a mon?1 a fraction-- 7i7 ! num]ator ( :i* is ! numb] ( h\rs 9 ! employee's normal "w week2 & 7ii7 ! d5om9ator ( :i* is #cj h\rs4 7,c7 ,special rules ,"u rules prescrib$ by ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 9 ! case ( an employee = an employ] ^: def9$ "w week = full-"t employees is less ?an #cj h\rs1 any ref]5ce 9 ?is subsection to #cj h\rs is deem$ a ref]5ce to ! numb] ( h\rs 9 ! "w week s def9$4 7,d7 ,conv]sion to h\rs ( employm5t ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y ( ! ,treasury1 %all e/abli% rules = ! conv]sion ( comp5sation to h\rs ( employm5t1 = purposes ( ?is subsection 9 ! case ( employees t receive comp5sation on a sal>i$ basis1 or on ! basis ( a commission1 or o!r cont+5t or bonus basis1 r ?an bas$ on an h\rly wage4 7f7 ,tim+ & mann] ,ea* employ] t makes a f9ancial contribution "u subsection 7b77#b7 & 7c7 "u ?is section 7o!r ?an ) respect to cov]age "u a gr\p heal? plan7 %all pay su* contribution 9 a =m & mann]1 specifi$ by ! ,secret>y ( ! ,treasury1 bas$ ^u ! =m & mann] 9 :i* employ] excise taxes are requir$ to be paid "u section #caaa ( ! ,int]nal ,rev5ue ,code ( #aihf4 7g7 ,non-,discrim9ation 7#a7 ,9 g5]al ,except z o!rwise provid$ = 9 ?is title 7or an am5dm5t made by ?is title71 an individual %all n1 on ! gr\nd prohibit$ "u title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d et seq471 title ,,ix ( ! ,education ,am5dm5ts ( #aigb 7#bj ,u4,s4,c4 #afha et seq471 ! ,age ,discrim9ation ,act ( #aige 7#db ,u4,s4,c4 #faja et seq471 or section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 be exclud$ f p>ticipation 91 be d5i$ ! b5efits (1 or be subject$ to discrim9ation "u1 any heal? program or activity1 any "p ( :i* is receiv+ ,f$]al f9ancial assi/ance1 includ+ cr$its1 subsidies1 or contracts ( insurance1 or "u any program or activity t is adm9i/]$ by an ,executive ,ag5cy or any entity e/abli%$ "u ?is title 7or am5dm5ts7 or any employ]-sponsor$ insurance4 7#b7 ,cont9u$ application ( laws ,no?+ 9 ?is title 7or an am5dm5t made by ?is title7 %all be con/ru$ to invalidate or limit ! rights1 rem$ies1 proc$ures1 or legal /&>ds available to individuals aggriev$ "u title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d et seq471 title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e et seq471 title ,,ix ( ! ,education ,am5dm5ts ( #aigb 7#bj ,u4,s4,c4 #afha et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 or ! ,age ,discrim9ation ,act ( #aige 7#db ,u4,s4,c4 #faa et seq471 or to sup]s$e ,/ate laws t provide additional protections aga9/ discrim9ation on any basis describ$ 9 p>agraph 7#a74 7#c7 ,limitation ,a gr\p heal? plan may n e/abli% rules relat+ to ! heal? insurance cov]age eligibility 7includ+ cont9u$ eligibility7 or contribution requirem5ts ( any full-"t employee "u ! t]ms ( ! plan t h ! effect ( discrim9at+ 9 favor ( high]-wage employees4 7#d7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 conjunction ) ! ,secret>y ( ,labor1 may promulgate regulations to implem5t ?is subsection4 #abg4 ,prohibition on /ep !rapy & prior au?orization "u gr\p heal? plans ,section #bgai;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7e7 ,prohibition aga9/ /ep !rapy & prior au?orization ,beg9n+ ) ! fir/ plan ye> foll[+ ! date ( ! enactm5t ( ?is subsection1 a gr\p heal? plan may n require a prior au?orization det]m9ation = cov]age ( any b5efit "u su* plan & may n apply treatm5t limitations ?r\gh ! use ( /ep !rapy protocols4 4 #abh4 ,m$ic>e outpati5t obs]vation s]vices ,section #ahfa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7i77 is am5d$ by add+ at ! end ! foll[+3 ,= purposes ( ?is subsection1 an individual receiv+ outpati5t obs]vation s]vices %all be deem$ to be an inpati5t dur+ su* p]iod1 & ! date su* individual ceases receiv+ su* s]vices %all be deem$ ! hospital dis*>ge date 7unless su* individual is admitt$ z a hospital inpati5t at ! end ( su* p]iod74 #abi4 ,abortion cov]age ,not)/&+ any o!r provision ( law1 ,f$]al funds may be us$ to provide = abortion s]vices "u any heal? program or activity4 #acj4 ,applicability ( m5tal heal? p>ity ,section #bgbf ( ! ,public ,heal? ,s]vice ,act %all apply to all heal? cov]age 9 ! same mann] & to ! same ext5t z su* section applies to heal? insurance issu]s & gr\p heal? plans "u title ,,xxvii ( su* ,act4 #aca4 ,/ud5t loan =giv5ess = heal? c>e provid]s p>ticipat+ 9 ,m$ic>e = ,am]ica 7a7 ,9 g5]al ,beg9n+ on ! date aft] ! date ( ! enactm5t ( ?is ,act1 aft] ! conclusion ( ea* plan ye>1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 conjunction ) ! ,secret>y ( ,education1 %all cancel ! applicable p]c5t specifi$ 9 subsection 7b7 ( ! total am\nt due on any eligible ,f$]al ,loan made #bj ye>s prior to date ( enactm5t & any date aft] ! date ( enactm5t ( ?is ,act = a borr[] :o is a ,m$ic>e = ,am]ica p>ticipat+ provid] & submits an employm5t c]tification =m describ$ 9 subsection 7d74 7b7 ,applicable p]c5t ,= purposes ( subsection 7a71 ! applicable p]c5t is #aj p]c5t ( any eligible ,f$]al ,loan = ea* ye> ! heal? c>e provid] p>ticipates 9 ,m$ic>e = ,am]ica4 7c7 ,def9itions ,9 ?is section3 7#a7 ,eligible ,f$]al loan ,! t]m eligible ,f$]al loan means any loan made "u "p ,d ( title ,,iv ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajhg;a74 7#b7 ,heal? c>e provid] ,! t]m heal? c>e provid] means a physician1 physician assi/ant1 regi/]$ nurse1 nurse practition]1 advanc$ practice nurse1 lic5s$ practical nurse1 psy*ologi/1 m5tal heal? c\nselor1 m>riage & family !rapi/1 direct c>e work]1 heal? social work]1 d5ti/1 d5tal hygi5i/1 ph>maci/1 physical !rapi/1 occupational !rapi/1 or any o!r heal? c>e provid] specifi$ by ! ,secret>y ( ,heal? & ,human ,s]vices if ! ,secret>y det]m9es su* specification = purposes ( ?is section is necess>y to ensure work=ce adequacy4 7#c7 ,m$ic>e = am]ica p>ticipat+ provid] ,! t]m ,m$ic>e = ,am]ica p>ticipat+ provid] means a heal? c>e provid] t meets ! def9ition ( su* t]m "u section #aje or works at a p>ticipat+ provid] or entity z def9$ "u section #aje4 7d7 ,employm5t ,c]tification ,=m 7#a7 ,9 g5]al ,9 ord] to receive loan cancellation "u ?is p>agraph1 a borr[] %all submit to ! ,secret>y ( ,education an employm5t c]tification =m t is develop$ by ! ,secret>y ( ,education & includes self-c]tification ( employm5t & a sep>ate "p = employ] c]tification t indicates ! dates ( employm5t4 7#b7 ,def]m5t ,if a borr[] submits to ! ,secret>y ( ,education ! employm5t c]tification =m describ$ 9 p>agraph 7#a71 dur+ ! p]iod 9 :i* ! borr[] is employ$ z a ,m$ic>e = ,am]ica p>ticipat+ provid] = :i* loan cancellation is eligible "u ?is section1 ! borr[]'s eligible ,f$]al ,direct ,loan %all be plac$ 9 def]m5t4 7e7 ,int]e/ cancel$ ,if a portion ( a loan is cancel$ "u ?is section = any ye>1 ! entire am\nt ( int]e/ on su* loan t accrues = su* ye> %all be cancel$4 7f7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices & ,secret>y ( ,education may promulgate regulations to implem5t ?is section4 #acb4 ,cl>ification ( ! def9ition ( p$iatric m$ical necessity 9 qualify+ gr\p cov]age 7a7 ,def9ition ,! foll[+ def9ition ( p$iatric m$ical necessity %all be incorporat$ into b5efit /&>ds ( all plans subject to ! requirem5ts ( section #acjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7 & all gr\p plans by #bjbc4 7b7 ,developm5t ( def9ition ,p$iatric m$ical necessity1 or p$iatric m$ically necess>y c>e1 %all be def9$ z heal? c>e int]v5tions t are evid5ce bas$1 evid5ce in=m$1 or bas$ on cons5sus advisory op9ion & t are recomm5d$ by recogniz$ heal? c>e pr(essionals1 to promote optimal gr[? & developm5t 9 a *ild & to prev5t1 detect1 diagnose1 treat1 ameliorate1 or palliate ! effects ( physical1 g5etic1 cong5ital1 developm5tal1 behavioral1 or m5tal conditions1 injuries1 or disabilities4 7c7 ,updates to def9ition ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) exp]ts 9 ! field ( p$iatric c>e & key /akehold]s1 includ+ pati5t & family gr\ps1 %all review & update ?is def9ition on a bi5nial basis1 consi/5t ) up-to-date /&>ds ( p$iatric heal?c>e practice t are bas$ on-- 7#a7 ! views ( p$iatric heal?c>e provid]s & exp]ts practic+ 9 relevant cl9ical areas2 7#b7 recomm5dations ( m$ical-specialty societies1 o!r p$iatric heal?c>e provid] organizations1 & family & pati5t gr\ps1 & 7#c7 cr$ible sci5tific evid5ce publi%$ 9 pe]-review$ lit]ature t is g5]ally recogniz$ by ! relevant heal? c>e provid] community4 #acc4 ,safe /aff+ requirem5ts 7a7 ,m9imum direct c>e regi/]$ nurse /aff+ requirem5ts ,! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq47 is am5d$ by add+ at ! end ! foll[+ new title3 ,,xxxiv ,m9imum ,direct ,c>e ,regi/]$ ,nurse ,/aff+ ,requirem5t #cdja4 ,m9imum nurse /aff+ requirem5t 7a7 ,/aff+ plan 7#a7 ,9 g5]al ,a hospital %all implem5t a /aff+ plan t-- 7,a7 provides adequate1 appropriate1 & quality deliv]y ( heal? c>e s]vices & protects pati5t safety2 & 7,b7 is consi/5t ) ! requirem5ts ( ?is title4 7#b7 ,effective dates 7,a7 ,implem5tation ( /aff+ plan ,subject to subp>agraph 7,b71 ! requirem5ts "u p>agraph 7#a7 %all take effect on a date to be det]m9$ by ! ,secret>y1 b n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is title4 7,b7 ,application ( m9imum direct c>e regi/]$ nurse-to-pati5t ratios ,! requirem5ts "u subsection 7b7 %all take effect z soon z practicable1 z det]m9$ by ! ,secret>y1 b n lat] ?an-- 7i7 #bjbc2 & 7ii7 9 ! case ( a hospital 9 a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d7 ( ! ,social ,security ,act71 #bjbe4 7b7 ,m9imum direct c>e regi/]$ nurse-to-,pati5t ratios 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#d7 & o!r provisions ( ?is section1 a hospital's /aff+ plan %all provide t1 at all times dur+ ea* %ift )9 a unit ( ! hospital1 & ) a full complem5t ( ancill>y & support /aff1 a direct c>e regi/]$ nurse may be assign$ to n m ?an ! foll[+ numb] ( pati5ts 9 t unit3 7,a7 ,"o pati5t 9 trauma em]g5cy units4 7,b7 ,"o pati5t 9 op]at+ room units1 provid$ t a m9imum ( #a additional p]son s]ves z a scrub assi/ant 9 su* unit4 7,c7 ,two pati5ts 9 critical c>e units1 includ+ neonatal int5sive c>e units1 em]g5cy critical c>e & int5sive c>e units1 labor & deliv]y units1 coron>y c>e units1 acute respiratory c>e units1 po/ane/hesia units1 & burn units4 7,d7 ,?ree pati5ts 9 em]g5cy room units1 p$iatrics units1 /epd[n units1 telemetry units1 antep>tum units1 & comb9$ labor1 deliv]1 & po/p>tum units4 7,e7 ,f\r pati5ts 9 m$ical-surgical units1 int]m$iate c>e nurs]y units1 acute c>e psy*iatric units1 & o!r specialty c>e units4 7,f7 ,five pati5ts 9 rehabilitation units & skill$ nurs+ units4 7,g7 ,six pati5ts 9 po/p>tum 7#c c\plets7 units & well-baby nurs]y units4 7#b7 ,simil> units ) diff]5t names ,! ,secret>y may apply m9imum direct c>e regi/]$ nurse-to-pati5t ratios e/abli%$ 9 p>agraph 7#a7 = a hospital unit ref]r$ to 9 su* p>agraph to a type ( hospital unit n ref]r$ to 9 su* p>agraph if su* type ( hospital unit provides a level ( c>e to pati5ts ^: ne$s are simil> to ! ne$s ( pati5ts c>$ = 9 ! hospital unit ref]r$ to 9 su* p>agraph4 7#c7 ,application ( ratios to hospital nurs+ practice /&>ds 7,a7 ,9 g5]al ,a pati5t assignm5t may be includ$ 9 ! calculation ( ! direct c>e regi/]$ nurse-to-pati5t ratios requir$ 9 ?is subsection only if c>e is provid$ by a direct c>e regi/]$ nurse & ! provision ( c>e to ! p>ticul> pati5t is )9 t direct c>e regi/]$ nurse's compet5ce4 7,b7 ,demon/ration ( unit-specific compet5ce ,a hospital %all n assign a direct c>e regi/]$ nurse to a hospital unit unless t hospital det]m9es t ! direct c>e regi/]$ nurse has demon/rat$ curr5t compet5ce 9 provid+ c>e 9 t unit1 & has also receiv$ ori5tation to t hospital's unit suffici5t to provide compet5t c>e to pati5ts 9 t unit4 7,c7 ,duties ( ! assign$ direct c>e regi/]$ nurse ,ea* pati5t %all be assign$ to a direct c>e regi/]$ nurse :o %all directly provide ! assessm5t1 plann+1 sup]vision1 implem5tation1 & evaluation ( ! nurs+ c>e provid$ to ! pati5t at lea/ e %ift & has ! responsibility = ! provision ( c>e to a p>ticul> pati5t )9 8 or h] scope ( practice4 7,d7 ,nurse adm9i/rators & sup]visors ,a regi/]$ nurse :o is a nurse adm9i/rator1 nurse sup]visor1 nurse manag]1 *>ge nurse1 case manag]1 or any o!r hospital adm9i/rator or sup]visor1 %all n be includ$ 9 ! calculation ( ! direct c>e regi/]$ nurse-to-pati5t ratio unless t nurse has a curr5t & active direct pati5t c>e assignm5t & provides direct pati5t c>e 9 compliance ) ! requirem5ts ( ?is section1 includ+ compet5cy requirem5ts4 ,! exemption 9 ?is subsection %all apply only dur+ ! h\rs 9 :i* ! individual regi/]$ nurse has ! pr9cipal responsibility ( provid+ direct pati5t c>e & has no additional job duties z w\ld a direct c>e regi/]$ nurse4 7,e7 ,o!r p]sonnel ,o!r p]sonnel may p]=m pati5t c>e tasks bas$ on _! tra9+ & demon/rat$ skill b may n p]=m or assi/ 9 direct c>e regi/]$ nurse functions unless au?oriz$ to d 9 accordance ) ,/ate scope ( practice laws & regulations4 7,f7 ,tempor>y nurs+ p]sonnel ,a hospital %all n assign any nurs+ p]sonnel f tempor>y nurs+ ag5cies pati5t c>e to any hospital unit )\t su* p]sonnel hav+ demon/rat$ compet5ce on ! assign$ unit & receiv$ ori5tation to t hospital's unit suffici5t to provide compet5t c>e to pati5ts 9 t unit4 7,g7 ,ancill>y & additional /aff+ ,! ne$ = additional /aff+ ( direct c>e regi/]$ nurses1 lic5s$ vocational or practical nurses1 lic5s$ psy*iatric te*nicians1 c]tifi$ nurs+ or pati5t c>e assi/ants1 or o!r lic5s$ or unlic5s$ ancill>y /aff above ! m9imum regi/]$ nurse-to-pati5t ratios %all be bas$ on ! assessm5t ( ! individual pati5t's nurs+ c>e requirem5t1 ! individual pati5t's nurs+ c>e plan1 & acuity level4 7#d7 ,re/rictions 7,a7 ,prohibition aga9/ av]ag+ ,a hospital %all n av]age ! numb] ( pati5ts & ! total numb] ( direct c>e regi/]$ nurses assign$ to pati5ts 9 a hospital unit dur+ any #a %ift or ov] any p]iod ( "t = purposes ( meet+ ! requirem5ts "u ?is subsection4 7,b7 ,prohibition aga9/ imposition ( m&atory ov]time requirem5ts ,a hospital %all n impose m&atory ov]time requirem5ts to meet ! hospital unit direct c>e regi/]$ nurse-to-pati5t ratios requir$ "u ?is subsection4 7,c7 ,relief dur+ r\t9e abs5ces ,a hospital %all ensure t only a direct c>e regi/]$ nurse :o has demon/rat$ curr5t compet5ce to ! hospital 9 provid+ c>e on a p>ticul> unit & has also receiv$ ori5tation to t hospital's unit suffici5t to provide compet5t c>e to pati5ts 9 t unit may relieve ano!r direct c>e regi/]$ nurse dur+ breaks1 meals1 & o!r r\t9e1 expect$ abs5ces f a hospital unit4 7,d7 ,application ( direct c>e regi/]$ nurse-to-pati5t ratios 9 pati5t-acuity adju/able units ,pati5ts %all be c>$ = only on units or pati5t c>e areas :]e ! direct c>e regi/]$ nurse-to-pati5t ratios meet ! level ( int5sity1 type ( c>e1 & ! individual requirem5ts & ne$s ( ea* pati5t4 ,not)/&+ p>agraph 7#b71 hospitals t provide pati5t c>e 9 units or pati5t c>e areas t are acuity adaptable or acuity adju/able %all apply ! direct c>e regi/]$ nurse-to-pati5t ratio requir$ 9 ?is section = ! highe/ pati5t acuity level or level ( c>e 9 t unit or pati5t c>e area1 & %all comply ) all o!r requirem5ts ( ?is section4 7,e7 ,use ( video monitors ,a hospital %all n employ video monitors or any =m ( electronic visualization ( a pati5t z a sub/itute = ! direct obs]vation requir$ = pati5t assessm5t by ! direct c>e regi/]$ nurse or requir$ = pati5t protection4 ,video monitors or any =m ( electronic visualization ( a pati5t %all n be includ$ 9 ! calculation ( ! direct c>e regi/]$ nurse-to-pati5t ratio requir$ 9 ?is subsection & %all n replace ! requirem5t ( p>agraph 7#c77;,d7 t ea* pati5t %all be assign$ to a direct c>e regi/]$ nurse :o %all directly provide ! assessm5t1 plann+1 sup]vision1 implem5tation1 & evaluation ( ! nurs+ c>e provid$ to ! pati5t at lea/ e %ift & h ! responsibility = ! provision ( c>e to a p>ticul> pati5t )9 8 or h] scope ( practice4 7,f7 ,use ( o!r te*nology ,a hospital %all n employ te*nology t sub/itutes = ! assign$ regi/]$ nurse's pr(essional judgm5t 9 assessm5t1 plann+1 implem5tation1 & evaluation ( c>e4 7#e7 ,adju/m5t ( ratios 7,a7 ,9 g5]al ,if necess>y to protect pati5t safety1 ! ,secret>y may prescribe regulations t-- 7i7 increase m9imum direct c>e regi/]$ nurse-to-pati5t ratios "u ?is subsection to r$uce ! numb] ( pati5ts t may be assign$ to ea* direct c>e nurse2 or 7ii7 add m9imum direct c>e regi/]$ nurse-to-pati5t ratios = units n ref]r$ to 9 p>agraphs 7#a7 & 7#b74 7,b7 ,consultation ,su* regulations %all be prescrib$ aft] consultation ) affect$ hospitals & regi/]$ nurses4 7#f7 ,ancill>y & additional /aff+ 7,a7 ,9 g5]al ,! ,secret>y may prescribe regulations requir+ additional /aff+ ( direct c>e regi/]$ nurses1 lic5s$ vocational or practice nurses1 lic5s$ psy*iatric te*nicians1 c]tifi$ nurs+ or pati5t c>e assi/ants1 or o!r lic5s$ or unlic5s$ ancill>y /aff above ! m9imum regi/]$ nurse-to-pati5t ratios t is bas$ on ! assessm5t ( ! individual pati5t's nurs+ c>e ne$s1 ! individual pati5t's nurs+ c>e plan1 & acuity level4 7,b7 ,consultation ,su* regulations %all be prescrib$ aft] consultation ) affect$ hospitals1 regi/]$ nurses1 & ancill>y /aff4 7#g7 ,relation%ip to ,/ate-impos$ ratios ,no?+ 9 ?is title %all preempt ,/ate /&>ds t ! ,secret>y det]m9es to be z /r+5t z ,f$]al requirem5ts = a /aff+ plan e/abli%$ "u ?is title4 ,m9imum direct c>e regi/]$ nurse-to-pati5t ratios e/abli%$ "u ?is subsection %all n preempt ,/ate requirem5ts t ! ,secret>y det]m9es are z /r+5t z to ,f$]al requirem5ts = direct c>e regi/]$ nurse-to-pati5t ratios e/abli%$ "u ?is title4 7#h7 ,exemption 9 em]g5cies ,! requirem5ts e/abli%$ "u ?is subsection %all n apply dur+ a /ate ( em]g5cy if a hospital is reque/$ or expect$ to provide an exceptional level ( em]g5cy or o!r m$ical s]vices4 ,if a hospital seeks to apply ! exemption "u ?is p>agraph 9 response to a compla9t fil$ aga9/ ! hospital = a violation ( ! provisions ( ?is title1 ! hospital mu/ demon/rate t prompt & dilig5t ef=ts 7 made to ma9ta9 requir$ /aff+ levels4 ,! ,secret>y %all issue guidance to hospitals t describes situations t con/itute a /ate ( em]g5cy = purposes ( ! exemption "u ?is p>agraph & %all e/abli% necess>y p5alties = violations ( ?is p>agraph consi/5t ) section #cdjf4 7c7 ,developm5t & reevaluation ( /aff+ plan 7#a7 ,consid]ations 9 developm5t ( plan ,9 develop+ ! /aff+ plan1 a hospital %all provide = direct c>e regi/]$ nurse-to-pati5t ratios above ! m9imum direct c>e regi/]$ nurse-to-pati5t ratios requir$ "u subsection 7b7 if appropriate bas$ ^u consid]ation (1 at a m9imum1 ! foll[+ factors3 7,a7 ,! numb] ( pati5ts on a p>ticul> unit on a %ift-by-%ift basis4 7,b7 ,! acuity level & nurs+ c>e plan ( pati5ts on a p>ticul> unit on a %ift-by-%ift basis4 7,c7 ,! anticipat$ admissions1 dis*>ges1 & transf]s ( pati5ts dur+ ea* %ift t impacts direct pati5t c>e4 7,d7 ,specializ$ exp]i5ce requir$ ( direct c>e regi/]$ nurses on a p>ticul> unit4 7,e7 ,/aff+ levels & s]vices provid$ by lic5s$ vocational or practical nurses1 lic5s$ psy*iatric te*nicians1 c]tifi$ nurse assi/ants1 or o!r ancill>y /aff 9 meet+ direct pati5t c>e ne$s n requir$ by a direct c>e regi/]$ nurse4 7,f7 ,! level ( famili>ity ) hospital practices1 policies1 & proc$ures by tempor>y ag5cy direct c>e regi/]$ nurses us$ dur+ a %ift4 7,g7 ,ob/acles to effici5cy 9 ! deliv]y ( pati5t c>e pres5t$ by physical lay\t4 7#b7 ,docum5tation ( /aff+ ,a hospital %all specify ! sy/em us$ to docum5t actual /aff+ 9 ea* unit = ea* %ift4 7#c7 ,annual reevaluation ( plan 7,a7 ,9 g5]al ,a hospital %all annually evaluate its /aff+ plan 9 ea* unit 9 relation to actual pati5t c>e requirem5ts4 7,b7 ,update ,a hospital %all update its /aff+ plan to ! ext5t appropriate bas$ on su* evaluation4 7#d7 ,transp>5cy 7,a7 ,9 g5]al ,any /aff+ plan or me?od us$ to create & evaluate acuity-level & adopt$ by a hospital "u ?is section %all be transp>5t 9 all respects1 includ+ disclosure ( detail$ docum5tation ( ! me?odology us$ to det]m9e nurs+ /aff+1 id5tify+ ea* factor1 assumption1 & value us$ 9 apply+ su* me?odology4 7,b7 ,public availability ,! ,secret>y %all e/abli% proc$ures to provide t ! docum5tation submitt$ "u subsection 7d7 is available = public inspection 9 its entirety4 7#e7 ,regi/]$ nurse p>ticipation ,a /aff+ plan ( a hospital-- 7,a7 %all be develop$ & subsequ5t reevaluations %all be conduct$ "u ?is subsection on ! basis ( input f direct c>e regi/]$ nurses at ! hospital f ea* unit or pati5t c>e area2 & 7,b7 :]e su* nurses are repres5t$ ?r\gh collective b>ga9+1 %all require b>ga9+ ) ! applicable recogniz$ or c]tifi$ collective b>ga9+ repres5tative ( su* nurses4 ,no?+ 9 ?is title %all be con/ru$ to p]mit conduct prohibit$ "u ! ,national ,labor ,relations ,act or *apt] #ga ( title #e1 ,unit$ ,/ates ,code4 7#f7 ,/aff+ committees ,if a hospital ma9ta9s a /aff+ committee1 !n ! committee %all include at lea/ "o regi/]$ nurse f ea* hospital unit & %all be compos$ ( at lea/ #ej p]c5t direct c>e regi/]$ nurses4 ,! /aff+ committee %all include mean+ful repres5tation ( o!r direct c>e nonmanagem5t /aff4 ,direct c>e regi/]$ nurses :o s]ve on ! committee %all be select$ by o!r direct c>e regi/]$ nurses f _! unit4 ,o!r direct c>e nonmanagem5t /aff %all be select$ by o!r direct c>e nonmanagem5t /aff4 ,p>ticipation on /aff+ committees %all be consid]$ a "p ( ! employee's regul>ly s*$ul$ workweek4 7d7 ,submission ( plan to secret>y ,a hospital %all submit to ! ,secret>y its /aff+ plan & any annual updates "u subsection 7c77#c77;,b74 ,a f$]ally op]at$ hospital may submit its /aff+ plan ?r\gh ! dep>tm5t or ag5cy op]at+ ! hospital4 #cdjb4 ,po/+1 records1 & audits 7a7 ,po/+ requirem5ts ,9 ea* unit1 a hospital %all po/ a uni=m notice 9 a =m specifi$ by ! ,secret>y 9 regulation t-- 7#a7 expla9s requirem5ts impos$ "u section #cdja2 7#b7 includes actual direct c>e regi/]$ nurse-to-pati5t ratios dur+ ea* %ift2 7#c7 includes ! actual numb] & titles ( direct c>e regi/]$ nurses assign$ dur+ ea* %ift2 & 7#d7 is visible1 conspicu\s1 & accessible to /aff1 pati5ts1 & ! public4 7b7 ,records 7#a7 ,ma9t5ance ( records ,ea* hospital %all ma9ta9 accurate records ( actual direct c>e regi/]$ nurse-to-pati5t ratios 9 ea* unit = ea* %ift = no less ?an #c ye>s4 ,su* records %all include-- 7,a7 ! numb] ( pati5ts 9 ea* unit2 7,b7 ! id5tity & duty h\rs (-- 7i7 ea* direct c>e regi/]$ nurse assign$ to ea* pati5t 9 ea* unit 9 ea* %ift2 & 7ii7 ancill>y /aff :o are "u ! coord9ation ( ! direct c>e regi/]$ nurse2 7,c7 c]tification t ea* nurse receiv$ re/ & meal breaks & ! id5tity & duty h\rs ( ea* direct c>e regi/]$ nurse :o provid$ su* relief2 & 7,d7 a copy ( ea* notice po/$ "u subsection 7a74 7#b7 ,availability ( records ,ea* hospital %all make its records ma9ta9$ "u p>agraph 7#a7 available to-- 7,a7 ! ,secret>y2 7,b7 regi/]$ nurses & _! collective b>ga9+ repres5tatives 7if any72 & 7,c7 ! public "u regulations e/abli%$ by ! ,secret>y1 or 9 ! case ( a f$]ally op]at$ hospital1 "u section #eeb ( title #e1 ,unit$ ,/ates ,code 7commonly kn[n z ! ,fre$om ( ,in=mation ,act74 7c7 ,audits ,! ,secret>y %all conduct p]iodic audits to ensure-- 7#a7 implem5tation ( ! /aff+ plan 9 accordance ) ?is title2 & 7#b7 accuracy 9 records ma9ta9$ "u ?is section4 #cdjc4 ,m9imum direct c>e lic5s$ practical nurse /aff+ requirem5ts 7a7 ,e/abli%m5t ,a hospital's /aff+ plan %all comply ) m9imum direct c>e lic5s$ practical nurse /aff+ requirem5ts t ! ,secret>y e/abli%es = units 9 hospitals4 ,su* /aff+ requirem5ts %all be e/abli%$ n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is title1 & %all be bas$ on ! /udy conduct$ "u subsection 7b74 7b7 ,/udy ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is title1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 %all complete a /udy ( lic5s$ practical nurse /aff+ & its effects on pati5t c>e 9 hospitals4 ,! ,director may contract ) a qualifi$ entity or organization to c>ry out su* /udy "u ?is p>agraph4 ,! ,director %all consult ) lic5s$ practical nurses & organizations repres5t+ lic5s$ practical nurses reg>d+ ! design & conduct ( ! /udy4 7c7 ,application ( regi/]$ nurse provisions to lic5s$ practical nurse /aff+ requirem5ts ,p>agraphs 7#b71 7#d77;,a71 7#d77;,b71 7#d77;,c71 & 7#f7 ( section #cdja7;b71 p>agraphs 7#a71 7#b71 7#c71 & 7#d7 ( section #cdja7;c71 & section #cdjb %all apply to ! e/abli%m5t & application ( direct c>e lic5s$ practical nurse /aff+ requirem5ts "u ?is section pursuant to ! additional /aff+ requirem5ts "u subsection 7b77#c77;,g7 ( section #cdja & 9 ! same mann] t !y apply to ! e/abli%m5t & application ( direct c>e regi/]$ nurse-to-pati5t ratios "u sections #cdja & #cdjb4 7d7 ,effective date ,! requirem5ts ( ?is section %all take effect z soon z practicable1 z det]m9$ by ! ,secret>y1 b n lat] ?an-- 7#a7 #b ye>s aft] ! date ( ! enactm5t ( ?is title2 & 7#b7 9 ! case ( a hospital 9 a rural area 7z def9$ 9 section #ahhf7;d77#b77;,d7 ( ! ,social ,security ,act71 #d ye>s aft] ! date ( ! enactm5t ( ?is title4 7e7 ,/udy ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is title1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality %all complete a /udy ( regi/]$ & practical nurse /aff+ requirem5ts 9 cl9ics & o!r outpati5t sett+s1 & its effects on pati5t c>e 9 outpati5t sett+s4 ,! ,director may contract ) a qualifi$ entity or organization to c>ry out su* /udy "u ?is subsection4 ,! ,director %all consult ) regi/]$ nurses & lic5s$ practice nurses work+ 9 outpati5t sett+s1 includ+ pr(essional nurs+ associations & labor organizations repres5t+ bo? regi/]$ & practice nurses work+ 9 outpati5t sett+s reg>d+ ! design & conduct ( ! /udy4 #cdjd4 ,:i/lebl[] & pati5t protections 7a7 ,pr(essional obligation & rights ,all nurses h a duty & "r to act bas$ on _! pr(essional judgm5t 9 accordance ) ,/ate nurs+ laws & regulations ( ! ,/ate 9 :i* ! direct nurs+ c>e is be+ p]=m$ & to provide c>e 9 ! exclusive int]e/s ( ! pati5ts & to act z ! pati5t's advocate4 7b7 ,acceptance ( pati5t c>e assignm5ts ,! nurse is responsible = provid+ compet5t1 safe1 !rapeutic1 & effective nurs+ c>e to assign$ pati5ts4 ,be=e accept+ a pati5t assignm5t1 a nurse %all-- 7#a7 h ! necess>y pr(essional k1 judgm5t1 skills1 & ability to provide ! requir$ c>e2 7#b7 det]m9e us+ pr(essional judgm5t 9 accordance ) ,/ate nurs+ laws & regulations ( ! ,/ate 9 :i* ! direct nurs+ c>e is be+ p]=m$ :e!r ! nurse is compet5t to p]=m ! nurs+ c>e requir$2 & 7#c7 det]m9e :e!r acceptance ( a pati5t assignm5t w\ld expose ! pati5t or nurse to risk ( h>m4 7c7 ,objection to or refusal ( assignm5t ,a nurse may object to1 or refuse to p>ticipate 91 any activity1 policy1 practice1 assignm5t1 or task if 9 good fai?-- 7#a7 ! nurse reasonably believes x to be 9 violation ( section #cdja or #cdjc2 or 7#b7 ! nurse is n prep>$ by education1 tra9+1 or exp]i5ce to fulfill ! assignm5t )\t compromis+ ! safety ( any pati5t or jeop>diz+ ! lic5se ( ! nurse4 7d7 ,retaliation = objection to or refusal ( assignm5t b>r$ 7#a7 ,no dis*>ge1 discrim9ation1 or retaliation ,no hospital %all dis*>ge1 retaliate1 discrim9ate1 or o!rwise take adv]se action 9 any mann] ) respect to any aspect ( a nurse's employm5t 7z def9$ 9 section #cdjg71 includ+ dis*>ge1 promotion1 comp5sation1 or t]ms1 conditions1 or privileges ( employm5t1 bas$ on ! nurse's refusal ( a "w assignm5t "u subsection 7c74 7#b7 ,no fil+ ( compla9t ,no hospital %all file a compla9t or a report aga9/ a nurse ) a ,/ate pr(essional discipl9>y ag5cy because ( ! nurse's refusal ( a "w assignm5t "u subsection 7c74 7e7 ,cause ( action ,any nurse1 collective b>ga9+ repres5tative1 or legal repres5tative ( any nurse :o has be5 dis*>g$1 discrim9at$ aga9/1 or retaliat$ aga9/ 9 violation ( subsection 7d77#a7 or aga9/ :om a compla9t or report has be5 fil$ 9 violation ( subsection 7d77#b7 may 7)\t reg>d to :e!r a compla9t has be5 fil$ "u subsection 7f7 ( ?is section or subsection 7b7 ( section #cdjf7 br+ a cause ( action 9 a ,unit$ ,/ates di/rict c\rt4 ,a nurse :o prevails on ! cause ( action %all be entitl$ to "o or m ( ! foll[+3 7#a7 ,re9/atem5t4 7#b7 ,reimbursem5t ( lo/ wages1 comp5sation1 & b5efits4 7#c7 ,attorneys' fees4 7#d7 ,c\rt co/s4 7#e7 ,o!r damages4 7f7 ,compla9t to secret>y ,a nurse1 pati5t1 collective b>ga9+ repres5tative1 or o!r individual may file a compla9t ) ! ,secret>y aga9/ a hospital t violates ! provisions ( ?is title4 ,= any compla9t fil$1 ! ,secret>y %all-- 7#a7 receive & inve/igate ! compla9t2 7#b7 det]m9e :e!r a violation ( ?is title z alleg$ 9 ! compla9t has occurr$2 & 7#c7 if su* a violation has occurr$1 issue an ord] t ! compla9+ nurse or individual %all n suff] any dis*>ge1 retaliation1 discrim9ation1 or o!r adv]se action prohibit$ by subsection 7d7 or subsection 7h74 7g7 ,toll-,free telephone numb] 7#a7 ,9 g5]al ,! ,secret>y %all provide = ! e/abli%m5t ( a toll-free telephone hotl9e to provide in=mation reg>d+ ! requirem5ts "u sections #cdja ?r\gh #cdjc & to receive reports ( violations ( su* section4 7#b7 ,notice to pati5ts ,a hospital %all provide ea* pati5t admitt$ to ! hospital = inpati5t c>e ) ! hotl9e describ$ 9 p>agraph 7#a71 & %all give notice to ea* pati5t t su* hotl9e may be us$ to report inadequate /aff+ or c>e4 7h7 ,protection = report+ 7#a7 ,prohibition on retaliation or discrim9ation ,a hospital %all n discrim9ate or retaliate 9 any mann] aga9/ any pati5t1 employee1 or contract employee ( ! hospital1 or any o!r individual1 on ! basis t su* individual1 9 good fai?1 individually or 9 conjunction ) ano!r p]son or p]sons1 has pres5t$ a grievance or compla9t1 or has initiat$ or coop]at$ 9 any inve/igation or proce$+ ( any gov]nm5tal entity1 regulatory ag5cy1 or private accr$itation body1 made a civil claim or dem&1 or fil$ an action relat+ to ! c>e1 s]vices1 or conditions ( ! hospital or ( any affiliat$ or relat$ facilities4 7#b7 ,good fai? def9$ ,= purposes ( ?is subsection1 an individual %all be deem$ to be act+ 9 good fai? if ! individual reasonably believes-- 7,a7 ! in=mation report$ or disclos$ is true2 & 7,b7 a violation ( ?is title has occurr$ or may occur4 7i7 ,prohibition on int]f]5ce ) rights 7#a7 ,ex]cise ( rights ,x %all be unlawful = any hospital to-- 7,a7 int]f]e )1 re/ra91 or d5y ! ex]cise1 or attempt to ex]cise1 by any p]son ( any "r provid$ or protect$ "u ?is title2 or 7,b7 co]ce or intimidate any p]son reg>d+ ! ex]cise or attempt to ex]cise su* "r4 7#b7 ,opposition to unlawful policies or practices ,x %all be unlawful = any hospital to discrim9ate or retaliate aga9/ any p]son = oppos+ any hospital policy1 practice1 or actions :i* are alleg$ to violate1 brea*1 or fail to comply ) any provision ( ?is title4 7#c7 ,prohibition on int]f]5ce ) protect$ communications ,a hospital 7or an individual repres5t+ a hospital7 %all n make1 adopt1 or en=ce any rule1 regulation1 policy1 or practice :i* 9 any mann] directly or indirectly prohibits1 imp$es1 or disc\rages a direct c>e nurse f1 or intimidates1 co]ces1 or induces a direct c>e nurse reg>d+1 engag+ 9 free spee* activities or disclos+ in=mation z provid$ "u ?is title4 7#d7 ,prohibition on int]f]5ce ) collective action ,a hospital 7or an individual repres5t+ a hospital7 %all n 9 any way int]f]e ) ! rights ( nurses to organize1 b>ga9 collectively1 & engage 9 conc]t$ activity "u section #g ( ! ,national ,labor ,relations ,act 7#bi ,u4,s4,c4 #aeg74 7j7 ,notice ,a hospital %all po/ 9 an appropriate location 9 ea* unit a conspicu\s notice 9 a =m specifi$ by ! ,secret>y t-- 7#a7 expla9s ! rights ( nurses1 pati5ts1 & o!r individuals "u ?is section2 7#b7 includes a /atem5t t a nurse1 pati5t1 or o!r individual may file a compla9t ) ! ,secret>y aga9/ a hospital t violates ! provisions ( ?is title2 & 7#c7 provides in/ructions on h[ to file su* a compla9t4 7k7 ,effective date 7#a7 ,refusal2 retaliation2 cause ( action 7,a7 ,9 g5]al ,subsections 7c7 ?r\gh 7e7 %all apply to objections & refusals occurr+ on or aft] ! effective date ( ! provision ( ?is title to :i* ! objection or refusal relates4 7,b7 ,exception ,subsection 7c77#b7 %all n apply to objections or refusals 9 any hospital be=e ! requirem5ts ( section #cdja7;a7 or #cdjc7;a71 z applicable1 apply to t hospital4 7#b7 ,protections = report+ ,subsection 7h77#a7 %all apply to actions occurr+ on or aft] ! effective date ( ! provision to :i* ! violation relates1 except t su* subsection %all apply to initiation1 coop]ation1 or p>ticipation 9 an inve/igation or proce$+ on or aft] ! date ( enactm5t ( ?is title4 7#c7 ,notice ,subsection 7j7 %all take effect #ah mon?s aft] ! date ( enactm5t ( ?is title4 #cdje4 ,en=cem5t 7a7 ,9 g5]al ,! ,secret>y %all en=ce ! requirem5ts & prohibitions ( ?is title 9 accordance ) ?is section4 7b7 ,proc$ures = receiv+ & inve/igat+ compla9ts ,! ,secret>y %all e/abli% proc$ures "u :i*-- 7#a7 any p]son may file a compla9t alleg+ t a hospital has violat$ a requirem5t or a prohibition ( ?is title2 & 7#b7 su* compla9ts %all be inve/igat$ by ! ,secret>y4 7c7 ,rem$ies ,if ! ,secret>y det]m9es t a hospital has violat$ a requirem5t ( ?is title1 ! ,secret>y-- 7#a7 %all require ! facility to e/abli% a corrective action plan to prev5t ! recurr5ce ( su* violation2 & 7#b7 may impose civil money p5alties1 z describ$ 9 subsection 7d74 7d7 ,civil p5alties 7#a7 ,9 g5]al ,9 addition to any o!r p5alties prescrib$ by law1 ! ,secret>y may impose civil p5alties z foll[s3 7,a7 ,hospital liability ,! ,secret>y may impose on a hospital f\nd to be 9 violation ( ?is title a civil money p5alty (-- 7i7 n m ?an #be1jjj = ! fir/ kn[+ violation ( ?is title by su* hospital2 & 7ii7 n m ?an #ej1jjj = any subsequ5t kn[+ violation ( ?is title by su* hospital4 7,b7 ,individual liability ,! ,secret>y may impose on an individual :o-- 7i7 is employ$ by a hospital f\nd by ! ,secret>y to h violat$ ?is title2 & 7ii7 kn[+ly violates ?is title1 a civil money p5alty ( n m ?an #bj1jjj = ea* su* violation by ! individual4 7#b7 ,proc$ures ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply ) respect to a civil money p5alty or proce$+ "u ?is subsection 9 ! same mann] z su* provisions apply ) respect to a civil money p5alty or proce$+ "u su* section #aabh;,a4 7e7 ,public notice ( violations 7#a7 ,int]net website ,! ,secret>y %all publi% on ! int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! names ( hospitals on :i* a civil money p5alty has be5 impos$ "u ?is section1 ! violation = :i* su* p5alty 0 impos$1 & su* additional in=mation z ! ,secret>y det]m9es appropriate4 7#b7 ,*ange ( own]%ip ,) respect to a hospital t _h a *ange ( own]%ip1 z det]m9$ by ! ,secret>y1 p5alties impos$ on ! hospital :ile "u previ\s own]%ip %all no long] be publi%$ by ! ,secret>y pursuant to p>agraph 7#a7 aft] ! #a-ye> p]iod beg9n+ on ! date ( *ange ( own]%ip4 7f7 ,use ( funds ,funds collect$ by ! ,secret>y pursuant to ?is section are au?oriz$ to be appropriat$ to c>ry out ?is title4 #cdjf4 ,def9itions ,= purposes ( ?is title3 7#a7 ,acuity level ,! t]m acuity level means ! det]m9ation1 us+ a hospital acuity measurem5t tool t has be5 develop$ & e/abli%$ 9 coord9ation ) direct c>e regi/]$ nurses & made transp>5t pursuant to section #cdja7;c77#d71 ( nurs+ c>e requirem5ts1 bas$ on ! assign$ direct c>e regi/]$ nurse's pr(essional judgm5t (-- 7,a7 ! sev]ity & complexity ( an individual pati5t's illness or injury2 7,b7 ! ne$ = specializ$ equipm5t2 & 7,c7 ! int5sity ( nurs+ int]v5tions requir$4 7#b7 ,compet5ce ,! t]m compet5ce or compet5t means ! satisfactory application ( ! duties & responsibilities ( a regi/]$ nurse 9 provid+ nurs+ c>e to specific pati5t populations & = acuity levels = ea* pati5t c>e unit or area pursuant to ! ,/ate nurs+ laws & regulations ( ! ,/ate 9 :i* ! direct nurs+ c>e is be+ p]=m$4 7#c7 ,direct c>e lic5s$ practical nurse ,! t]m direct c>e lic5s$ practical nurse means an individual :o has be5 grant$ a lic5se by at lea/ "o ,/ate to practice z a lic5s$ practical nurse or a lic5s$ vocational nurse & :o provides b$side c>e = "o or m pati5ts4 7#d7 ,direct c>e regi/]$ nurse ,! t]m direct c>e regi/]$ nurse means an individual :o has be5 grant$ a lic5se by at lea/ "o ,/ate to practice z a regi/]$ nurse & :o provides b$side c>e = "o or m pati5ts4 7#e7 ,employm5t ,! t]m employm5t includes ! provision ( s]vices "u a contract or o!r arrangem5t4 7#f7 ,hospital ,! t]m hospital has ! mean+ giv5 t t]m 9 section #ahfa7;e7 ( ! ,social ,security ,act4 7#g7 ,nurse ,! t]m nurse means any direct c>e regi/]$ nurse or direct c>e lic5s$ practice nurse 7z ! case may be71 reg>dless ( :e!r or n ! nurse is an employee4 7#h7 ,nurs+ c>e plan ,! t]m nurs+ c>e plan means a plan develop$ by ! assign$ direct c>e regi/]$ nurse 79 accordance ) nurs+ law 9 ! ,/ate 9 :i* ! nurs+ c>e is p]=m$7 t indicates ! nurs+ c>e to be giv5 to individual pati5ts t-- 7,a7 consid]s ! acuity level ( ! pati5t2 7,b7 is develop$ 9 coord9ation ) ! pati5t1 ! pati5t's family1 or o!r repres5tatives :5 appropriate1 & /aff ( o!r discipl9es involv$ 9 ! c>e ( ! pati5t2 7,c7 reflects all elem5ts ( ! nurs+ process2 & 7,d7 recomm5ds ! numb] & skill mix ( additional lic5s$ & unlic5s$ direct c>e /aff ne$$ to fully implem5t ! nurs+ c>e plan4 7#i7 ,pr(essional judgm5t ,! t]m pr(essional judgm5t means1 9 accordance ) ,/ate nurs+ laws & regulations ( ! ,/ate 9 :i* ! direct nurs+ c>e is be+ p]=m$1 ! direct c>e regi/]$ nurse's application ( k1 exp]tise1 & exp]i5ce 9 conduct+ a compreh5sive nurs+ assessm5t ( ea* pati5t & 9 mak+ indep5d5t decisions ab\t pati5t c>e includ+ ! ne$ = additional /aff4 7#aj7 ,/aff+ plan ,! t]m /aff+ plan means a /aff+ plan requir$ "u section #cdja4 7#aa7 ,/ate ( em]g5cy ,! t]m /ate ( em]g5cy-- 7,a7 means a /ate ( em]g5cy t is an unpr$ictable or unavoidable occurr5ce at an uns*$ul$ or unpr$ictable int]val1 relat+ to heal? c>e deliv]y & requir+ imm$iate m$ical int]v5tions & c>e2 & 7,b7 does n include a /ate ( em]g5cy t results f a labor dispute 9 ! heal? c>e indu/ry or consi/5t und]/aff+4 #cdjg4 ,rule ( con/ruction ,no?+ 9 ?is title %all be con/ru$ to au?orize disclosure ( private & confid5tial pati5t in=mation1 if su* disclosure is n au?oriz$ or requir$ by o!r applicable law4 4 7b7 ,recomm5dations to congress ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report conta9+ recomm5dations = ensur+ t suffici5t numb]s ( nurses are available to meet ! requirem5ts impos$ by title ,,xxxiv ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a74 7c7 ,report by ,,hrsa 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 9 consultation ) ! ,national ,heal? ,c>e ,work=ce ,commission1 %all submit to ,congress a report reg>d+ ! relation%ip betwe5 nurse /aff+ levels & nurse ret5tion 9 hospitals4 7#b7 ,updat$ report ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 9 consultation ) ! ,national ,heal? ,c>e ,work=ce ,commission1 %all submit to ,congress an update ( ! report submitt$ "u p>agraph 7#a74 7d7 ,en=cem5t ( requirem5ts ?r\gh ,f$]al programs 7#a7 ,m$ic>e program ,section #ahff7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7a77#a77 is am5d$-- 7,a7 9 subp>agraph 7,x71 by /rik+ 1 & & ins]t+ a comma2 7,b7 9 subp>agraph 7,y71 by /rik+ ! p]iod at ! end & ins]t+ 1 &2 & 7,c7 by ins]t+ aft] subp>agraph 7,y7 ! foll[+ new subp>agraph3 7,z7 9 ! case ( a hospital1 to comply ) ! provisions ( title ,,xxxiv ( ! ,public ,heal? ,s]vice ,act4 4 7#b7 ,m$icaid program ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is am5d$-- 7,a7 by /rik+ & at ! end ( p>agraph 7#hb72 7,b7 by /rik+ ! p]iod at ! end ( p>agraph 7#hc7 & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#hc7 ! foll[+ new p>agraph3 7#hd7 provide t any hospital t receives a paym5t "u su* plan comply ) ! provisions ( title ,,xxxiv ( ! ,public ,heal? ,s]vice ,act 7relat+ to m9imum direct c>e regi/]$ nurse /aff+ requirem5ts74 4 7e7 ,nurs+ homes ,no lat] ?an "o ye> aft] enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all promulgate a rule = m9imum /aff+ /&>ds = skill$ nurs+ facilities "u ! ,m$ic>e program & = nurs+ facilities "u ! ,m$icaid program t align ) ! /&>ds set 9 ?is section4 #acd4 ,enhancem5ts = r$uc$ co/-%>+ 7a7 ,9 g5]al ,section #adjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjga7 is am5d$-- 7#a7 9 subsection 7b77#a71 by /rik+ silv] & ins]t+ gold2 7#b7 by am5d+ subsection 7c77#a77;,b7 to read z foll[s3 7,b7 ,coord9ation ) actu>ial limits ,! ,secret>y %all ensure ! r$uction "u ?is p>agraph %all n result 9 ! plan's %>e ( ! total all[$ co/s ( b5efits provid$ "u ! plan becom+ less ?an-- 7i7 #ie p]c5t 9 ! case ( an eligible insur$ describ$ 9 p>agraph 7#b77;,a72 7ii7 #ij p]c5t 9 ! case ( an eligible insur$ describ$ 9 p>agraph 7#b77;,b72 & 7iii7 #he p]c5t 9 ! case ( an eligible insur$ describ$ 9 p>agraph 7#b77;,c74 2 & 7#c7 by am5d+ subsection 7c77#b7 to read z foll[s3 7#b7 ,additional r$uction ,! ,secret>y %all e/abli% proc$ures "u :i* ! issu] ( a qualifi$ heal? plan to :i* ?is section applies %all fur!r r$uce co/-%>+ "u ! plan 9 a mann] suffici5t to-- 7,a7 9 ! case ( an eligible insur$ ^: h\sehold income is n less ?an #ajj p]c5t b n m ?an #bjj p]c5t ( ! pov]ty l9e = a family ( ! size involv$1 increase ! plan's %>e ( ! total all[$ co/s ( b5efits provid$ "u ! plan to #ie p]c5t ( su* co/s2 7,b7 9 ! case ( an eligible insur$ ^: h\sehold income is m ?an #bjj p]c5t b n m ?an #cjj p]c5t ( ! pov]ty l9e = a family ( ! size involv$1 increase ! plan's %>e ( ! total all[$ co/s ( b5efits provid$ "u ! plan to #ij p]c5t ( su* co/s2 & 7,c7 9 ! case ( an eligible insur$ ^: h\sehold income is m ?an #cjj p]c5t b n m ?an #djj p]c5t ( ! pov]ty l9e = a family ( ! size involv$1 increase ! plan's %>e ( ! total all[$ co/s ( b5efits provid$ "u ! plan to #he p]c5t ( su* co/s4 4 7b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply to plan ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 7c7 ,fund+ ,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+ ,out ( any funds 9 ! ,treasury n o!rwise appropriat$1 !re are appropriat$ to ! ,secret>y su* sums z may be necess>y = paym5ts "u ?is section4 4 #ace4 ,repeal ( bonus paym5ts = ,m$ic>e ,advantage plans ,section #ahec7o7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7o77 is repeal$4 ,,ii ,,tax ,,provisions #bja4 ,sunset ( ,public ,law #aae-ig 7a7 ,9 g5]al ,all provisions (1 & am5dm5ts made by1 ,public ,law #aae-ig %all n apply to cal5d>1 taxable1 plan1 or limitation ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 7b7 ,application ( c]ta9 laws ,! ,int]nal ,rev5ue ,code ( #aihf %all be appli$ & adm9i/]$ to ye>s describ$ 9 subsection 7a7 z if ! provisions & am5dm5ts describ$ 9 subsection 7a7 _h nev] be5 enact$4 #bjb4 ,surtax ,!re is h]eby impos$ a tax ( #e p]c5t on ! adju/$ gross income ( ea* taxpay] to ! ext5t su* income exce$s #ejj1jjj4 #bjc4 ,basis ( prop]ty acquir$ f a dec$5t 7a7 ,9 g5]al ,section #ajad ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ p]son1 be & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 p]son1 be ! basis 9 ! h&s ( ! dec$5t44 7b7 ,effective date ,! am5dm5ts made by ?is section to prop]ty acquir$ or pass$ aft] ! date ( enactm5t ( ?is ,act4 #bjd4 ,m$ic>e payroll tax 7a7 ,9 g5]al ,section #caja7;b77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #j4i p]c5t & ins]t+ #d p]c5t4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to taxable ye>s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #bje4 ,net inve/m5t income tax 7a7 ,9 g5]al ,section #adaa7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #c4h p]c5t ea* place su* t]m appe>s & ins]t+ #f4i p]c5t4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to taxable ye>s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #bjf4 ,t]m9ation ( d$uction = contributions to heal? sav+s acc\nts ,section #bbc7;b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,t]m9ation ( d$uction ,not)/&+ any o!r provision ( ?is subsection1 ! mon?ly limitation = any mon? beg9n+ aft] ,decemb] #ca1 #bjbc1 is z]o4 4 #bjg4 ,increase 9 excise tax on small cig>s & cig>ettes & o!r tobacco products 7a7 ,small cig>s ,section #egja7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #ej4cc & ins]t+ #ajj4ff4 7b7 ,cig>ettes ,section #egja7;b7 ( su* ,code is am5d$-- 7#a7 by /rik+ #ej4cc 9 p>agraph 7#a7 & ins]t+ #ajj4ff2 & 7#b7 by /rik+ #aje4fi 9 p>agraph 7#b7 & ins]t+ #baa4ch4 7c7 ,pipe tobacco ,section #egja7;f7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #b4hcaa c5ts & ins]t+ #ej4jj4 7d7 ,roll-,y\r-,own tobacco ,section #egja7;g7 ( su* ,code is am5d$ by /rik+ #bd4gh & ins]t+ #di4ef4 7e7 ,l>ge cig>s ,p>agraph 7#b7 ( section #egja7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #eb4ge p]c5t & all t foll[s ?r\gh ! p]iod & ins]t+ #bd4gh p] p\nd 7& a proportionate tax at ! l rate on all fractional p>ts ( a p\nd7 b n less ?an #e4jcc c5ts p] cig>44 7f7 ,smokeless tobacco 7#a7 ,9 g5]al ,section #egja7;e7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7,a7 9 p>agraph 7#a71 by /rik+ #a4ea & ins]t+ #bh4jd2 7,b7 9 p>agraph 7#b71 by /rik+ #ej4cc c5ts & ins]t+ #ab4db2 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,smokeless tobacco sold 9 discrete s+le-use units ,on discrete s+le-use units1 #ajg4fe p] ea* #a1jjj s+le-use units4 4 7#b7 ,discrete s+le-use unit ,section #egjb7m7 ( su* ,code is am5d$-- 7,a7 9 p>agraph 7#a71 by /rik+ or *ew+ tobacco & ins]t+ *ew+ tobacco1 discrete s+le-use unit2 7,b7 9 p>agraphs 7#b7 & 7#c71 by ins]t+ t is n a discrete s+le-use unit be=e ! p]iod 9 ea* su* p>agraph2 & 7,c7 by add+ at ! end ! foll[+3 7#d7 ,discrete s+le-use unit ,! t]m discrete s+le-use unit means any product conta9+ tobacco t-- 7,a7 is n int5d$ to be smok$2 & 7,b7 is 9 ! =m ( a loz5ge1 tablet1 pill1 p\*1 dissolvable /rip1 or o!r discrete s+le-use or s+le-dose unit 4 #bjh4 ,excise tax on alcohol 7a7 ,di/ill$ spirits ,section #ejja7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #ac4ej & ins]t+ #af4jj4 7b7 ,w9e 7#a7 ,section #ejda7;b77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #a4jg p] w9e gallon & ins]t+ #af4jj p] pro( gallon4 7#b7 ,section #ejda7;b77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #a4eg p] w9e gallon & ins]t+ #af4jj p] pro( gallon4 7#c7 ,section #ejda7;b77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #c4ae p] w9e gallon & ins]t+ #af4jj p] pro( gallon4 7#d7 ,section #ejda7;b77#d7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #c4dj p] w9e gallon & ins]t+ #af4jj p] pro( gallon4 7#e7 ,section #ejda7;b77#e7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #c4cj p] w9e gallon & ins]t+ #af4jj p] pro( gallon4 7#f7 ,section #ejda7;b77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #bb4f c5ts p] w9e gallon & ins]t+ #af4jj p] pro( gallon4 7c7 ,be] ,section #ejea7;,b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #ah = p] b>rel & ins]t+ #af p] pro( gallon4 #bji4 ,tax on sug>$ dr9ks 7a7 ,9 g5]al ,sub*apt] ,d ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ aft] "p ,i ! foll[+ new "p3 ,,ii ,sug>-,sweet5$ bev]ages ,sec4 #daga4 ,imposition ( tax4 ,sec4 #dagb4 ,def9itions4 ,sec4 #dagc4 ,special rules4 #daga4 ,imposition ( tax 7a7 ,9 g5]al ,!re is h]eby impos$ a tax on ! sale or transf] ( any specifi$ sug>-sweet5$ bev]age product by ! manufactur]1 produc]1 or import] !re(4 7b7 ,rate ( tax ,! rate ( tax impos$ "u subsection 7a7 %all be equal to "o c5t p] #d4b grams ( caloric sweet5] conta9$ 9 su* specifi$ sug>-sweet5$ bev]age product4 7c7 ,p]sons liable = tax ,! manufactur]1 produc]1 or import] ref]r$ to 9 subsection 7a7 %all be liable = ! tax impos$ by su* subsection4 #dagb4 ,def9itions 7a7 ,specifi$ sug>-,sweet5$ bev]age product ,= purposes ( ?is "p-- 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m specifi$ sug>-sweet5$ bev]age product means-- 7,a7 any liquid int5d$ = human consumption :i* conta9s a caloric sweet5]1 & 7,b7 any liquid1 or solid mixture ( +r$i5ts1 :i*-- 7i7 conta9s a caloric sweet5]1 & 7ii7 is int5d$ = use z an +r$i5t 9 a liquid describ$ 9 subp>agraph 7,a74 7#b7 ,exceptions ,! foll[+ %all n be treat$ z liquids describ$ 9 p>agraph 7#a77;,a73 7,a7 ,any liquid ! prim>y +r$i5ts ( :i* are milk or soy1 rice1 or simil> plant-bas$ milk sub/itute4 7,b7 ,any liquid compos$ entirely ( "o or m ( ! foll[+3 7i7 ,! orig9al liquid result+ f ! press+ ( fruit or vegetables4 7ii7 ,! liquid result+ f ! recon/itution ( fruit or vegetable juice conc5trate4 7iii7 ,! liquid result+ f ! re/oration ( wat] to dehydrat$ fruit or vegetable juice4 7,c7 ,infant =mula4 7,d7 ,any liquid products manufactur$ = use z-- 7i7 an oral nutritional !rapy = p]sons :o _c absorb or metabolize diet>y nutri5ts f food or bev]ages1 7ii7 a s\rce ( necess>y nutrition us$ due to a m$ical condition1 or 7iii7 an oral electrolyte solution = infants & *ildr5 =mulat$ to prev5t dehydration due to illness4 7,e7 ,any liquid ) respect to :i* tax is impos$ "u *apt] #ea 7relat+ to di/ill$ spirits1 w9es1 & be]7 or "u section #gfeb by reason ( ! tax impos$ "u *apt] #ea be+ impos$ on l articles ( dome/ic manufacture4 7b7 ,caloric sweet5] ,= purposes ( ?is "p1 ! t]m caloric sweet5] means monosac*>ides1 disac*>ides1 & high-fructose corn syrup4 #dagc4 ,special rules 7a7 ,sweet5] tax$ only once ,9 ! case ( any specifi$ sug>-sweet5$ bev]age product :i* is manufactur$ or produc$ by includ+ "o or m o!r specifi$ sug>-sweet5$ bev]age products1 no tax %all be impos$ "u ?is section on any caloric sweet5] conta9$ 9 ! result+ specifi$ sug>-sweet5$ bev]age product if tax 0 previ\sly impos$ "u ?is section on su* caloric sweet5] :5 conta9$ 9 ! specifi$ sug>-sweet5$ bev]age product s includ$4 7b7 ,inflation adju/m5t ,9 ! case ( any sale aft] ,decemb] #ca1 #bjae1 ! "o c5t am\nt 9 section #daga7;b7 %all be increas$ by an am\nt equal to-- 7#a7 su* am\nt1 multipli$ by 7#b7 ! co/-(-liv+ adju/m5t det]m9$ "u section #a7;f77#c7 = ! cal5d> ye> 9 :i* su* sale occurs1 det]m9$ by sub/itut+ cal5d> ye> #bjad = cal5d> ye> #aiib 9 subp>agraph 7,b7 !re(4 ,any increase det]m9$ "u ?is subsection %all be r\nd$ to ! ne>e/ multiple ( "o-t5? ( a c5t4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #dbba7;a7 is am5d$ by add+ at ! end ! foll[+3 ,p>agraphs 7#a71 7#d71 7#e71 & 7#f7 %all n apply to ! tax impos$ "u section #daga44 7#b7 ,! table ( p>ts = sub*apt] ,d ( *apt] #cb ( su* ,code is am5d$ by ins]t+ aft] ! item relat+ to "p ,i ! foll[+ new item3 ,"p ,,ii--,sug>-,sweet5$ bev]ages 4 7c7 ,effective date 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! am5dm5ts made by ?is section %all take effect on ! date ( ! enactm5t ( ?is ,act4 7#b7 ,excise tax ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 #baj4 ,repeal ( excise tax on high-co/ employ]-sponsor$ heal? cov]age 7a7 ,9 g5]al ,*apt] #dc ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ section #dihj;,i4 7b7 ,con=m+ am5dm5t ,section #fjea ( su* ,code is am5d$-- 7#a7 9 p>agraph 7#ad7 ( subsection 7a71 by /rik+ section #dihj;,i7d77#a7 & ins]t+ subsection 7g71 & 7#b7 by add+ at ! end ! foll[+3 7g7 ,applicable employ]-,sponsor$ cov]age ,= purposes ( subsection 7a77#ad7-- 7#a7 ,9 g5]al ,! t]m applicable employ]-sponsor$ cov]age means1 ) respect to any employee1 cov]age "u any gr\p heal? plan made available to ! employee by an employ] :i* is excludable f ! employee's gross income "u section #ajf1 or w\ld be s excludable if x 7 employ]-provid$ cov]age 7)9 ! mean+ ( su* section #ajf74 7#b7 ,exceptions ,! t]m applicable employ]-sponsor$ cov]age %all n include-- 7,a7 any cov]age 7:e!r ?r\gh insurance or o!rwise7 describ$ 9 section #ihcb7;c77#a7 7o!r ?an subp>agraph 7,g7 !re(7 or = long-t]m c>e2 7,b7 any cov]age "u a sep>ate policy1 c]tificate1 or contract ( insurance :i* provides b5efits sub/antially all ( :i* are = treatm5t ( ! m\? 7includ+ any organ or /ructure )9 ! m\?7 or = treatm5t ( ! eye2 or 7,c7 any cov]age describ$ 9 section #ihcb7;c77#c7 ! paym5t = :i* is n excludable f gross income & = :i* a d$uction "u section #afb7l7 is n all[able4 7#c7 ,cov]age includes employee paid portion ,cov]age %all be treat$ z applicable employ]-sponsor$ cov]age )\t reg>d to :e!r ! employ] or employee pays = ! cov]age4 7#d7 ,gov]nm5tal plans includ$ ,applicable employ]-sponsor$ cov]age %all include cov]age "u any gr\p heal? plan e/abli%$ & ma9ta9$ prim>ily = its civilian employees by ! ,gov]nm5t ( ! ,unit$ ,/ates1 by ! gov]nm5t ( any ,/ate or political subdivision !re(1 or by any ag5cy or in/rum5tality ( any su* gov]nm5t4 7#e7 ,co/ ( cov]age 7,a7 ,heal? ,,fsas ,9 ! case ( applicable employ]-sponsor$ cov]age consi/+ ( cov]age "u a flexible sp5d+ arrangem5t 7z def9$ 9 section #bbje7;g771 ! co/ ( ! cov]age %all be equal to ! am\nt det]m9$ "u rules simil> to ! rules ( section #dihj;,b7f77#d7 ) respect to any reimbursem5t "u ! arrangem5t r$uc$ by ! contributions describ$ 9 subsection 7a77#ad77;,b74 7,b7 ,ar*] msas & hsas ,9 ! case ( applicable employ]-sponsor$ cov]age consi/+ ( cov]age "u an arrangem5t "u :i* ! employ] makes contributions describ$ 9 subsection 7b7 or 7d7 ( section #ajf1 ! co/ ( ! cov]age %all be equal to ! am\nt ( employ] contributions "u ! arrangem5t until ! t]m9ation ( ,h,s,as z describ$ "u section #bjf ( su* ,act4 7,c7 ,allocation on a mon?ly basis ,if co/ is det]m9$ on o!r ?an a mon?ly basis1 ! co/ %all be allocat$ to mon?s 9 a taxable p]iod on su* basis z ! ,secret>y may prescribe4 4 7c7 ,cl]ical am5dm5t ,! table ( sections = *apt] #dc ( su* ,code is am5d$ by /rik+ ! item relat+ to section #dihj;,i4 7d7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjai4 ,,iii ,,drug-,,relat$ ,,provisions #cja4 ,e/abli%m5t ( ! ,prescription ,drug & ,m$ical ,device ,review ,bo>d ,!re is e/abli%$ 9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices a bo>d to be kn[n z ! ,prescription ,drug & ,m$ical ,device ,price ,review ,bo>d 79 ?is ,act ref]r$ to z ! ,bo>d74 #cjb4 ,memb]%ip2 /aff 7a7 ,memb]s ,! ,bo>d %all be compos$ ( ! memb]s z foll[s3 7#a7 ,! ,assi/ant ,secret>y = ,plann+ & ,evaluation ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7or ! ,assi/ant ,secret>y's designee74 7#b7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices or1 beg9n+ ) #bjbb1 ! ,adm9i/rator ( ! ,c5t] = ,heal? ,c>e 7or ! ,adm9i/rator's designee74 7#c7 ,! ,assi/ant ,director = ! ,heal? ,s]vices ,division ( ! ,f$]al ,bureau ( ,prisons 7or ! ,assi/ant ,director's designee74 7#d7 ,! ,secret>y ( ,def5se 7or ! ,secret>y's designee74 7#e7 ,! ,secret>y ( ,vet]ans ,affairs 7or ! ,secret>y's designee74 7#f7 ,! ,commission] ( ,food & ,drugs 7or ! ,commission]'s designee74 7#g7 ,! ,director ( ! ,national ,in/itutes ( ,heal? 7or ! ,director's designee74 7b7 ,*airp]son ,! ,bo>d %all designate #a memb] ( ! ,bo>d to s]ve z ! *airp]son4 7c7 ,director & /aff 7#a7 ,director ,! ,bo>d %all h a director :o %all be appo9t$ by ! *airp]son ( ! ,bo>d1 subject to rules prescrib$ by ! ,bo>d4 7#b7 ,/aff ,! director may appo9t & fix ! pay ( su* additional p]sonnel z ! *airp]son consid]s appropriate1 subject to rules prescrib$ by ! ,bo>d4 7#c7 ,applicability ( c]ta9 civil s]vice laws ,! director & /aff ( ! ,bo>d %all be appo9t$ subject to ! provisions ( title #e1 ,unit$ ,/ates ,code1 gov]n+ appo9tm5ts 9 ! competitive s]vice1 & %all be paid 9 accordance ) ! requirem5ts ( *apt] #ea & sub*apt] ,,iii ( *apt] #ec ( su* title relat+ to classification & ,g5]al ,s*$ule pay rates2 except t an individual s appo9t$ may n receive pay 9 excess ( ! maximum annual rate ( basic pay payable = grade ,,gs-#ae ( ! ,g5]al ,s*$ule4 7d7 ,assi/ance = ! bo>d ,subject to section #cjf7;g71 9 c>ry+ out ?is title1 ! ,bo>d-- 7#a7 may seek assi/ance f outside exp]ts 9 ! fields ( consum] advocacy1 m$ic9e1 ph>macology1 ph>macy1 & prescription drug reimbursem5t2 & 7#b7 %all e/abli% & ma9ta9 an advisory gr\p & a /akehold] gr\p = purposes ( seek+ su* assi/ance4 7e7 ,initial meet+ ,! ,bo>d %all hold its initial meet+ n lat] ?an #ij days aft] ! date ( ! enactm5t ( ?is ,act4 7f7 ,bann$ individuals 7#a7 ,drug company lobbyi/s ,no =m] regi/]$ drug manufactur] lobbyi/-- 7,a7 may be appo9t$ to ! position ( ,director ( ! ,(fice2 or 7,b7 may be employ$ by ! ,(fice dur+ ! #f-ye> p]iod beg9n+ on ! date on :i* ! regi/]$ lobbyi/ t]m9ates its regi/ration 9 accordance ) section #d7;d7 ( ! ,lobby+ ,disclosure ,act ( #aiie 7#b ,u4,s4,c4 #afjc7;d77 or ! ag5t t]m9ates its /atus1 z applicable4 7#b7 ,s5ior executives ( law-break+ companies ,no =m] s5ior executive ( a cov]$ entity-- 7,a7 may be appo9t$ to ! position ( ,director ( ! ,(fice2 or 7,b7 may be employ$ by ! ,(fice dur+ ! #f-ye> p]iod beg9n+ on ! lat] (-- 7i7 ! date ( ! settlem5t2 & 7ii7 ! date on :i* ! en=cem5t action has conclud$4 7#c7 ,cov]$ entity ,! t]m cov]$ entity means any entity t is-- 7,a7 a drug manufactur]2 & 7,b7 7i7 op]at+ "u ,f$]al settlem5t1 includ+ a ,f$]al cons5t decree2 or 7ii7 ! subject ( an en=cem5t action 9 a c\rt ( ! ,unit$ ,/ates or by an ag5cy4 #cjc4 ,prohibition aga9/ excessive price 7a7 ,prohibition ,beg9n+ on ! effective date ( ! regulation requir$ by subsection 7b71 ! manufactur] ( a prescription drug or m$ical device %all n *>ge an excessive price1 z det]m9$ pursuant to su* regulation1 = su* drug or device4 7b7 ,=mula ,! ,bo>d %all by regulation prescribe a =mula = det]m9+ :e!r ! av]age manufactur] price ( su* drug or device ov] an annual qu>t] is an excessive price4 7c7 ,det]m9ation ( excessive price ,if ! ,bo>d det]m9es1 on its own initiative or 9 response to a petition submitt$ "u subsection 7d71 t ! manufactur] ( a prescription drug or m$ical device *>ges an excessive price = su* drug or device 9 violation ( subsection 7a7-- 7#a7 ! ,bo>d %all give ! manufactur]-- 7,a7 notice ( su* violation2 & 7,b7 subject to subsection 7d71 a p]iod to correct su* violation2 & 7#b7 if ! manufactur] fails to correct ! violation by ! end ( su* p]iod1 ! manufactur] %all be subject to section #cjd1 section #aibg7;c77#b77;,e7 ( ! ,social ,security ,act 7z add$ by subsection 7c7 ( section #cjd71 & section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf1 z add$ by subsection 7d7 ( section #cjd4 7d7 ,petitions ,any p]son may petition ! ,bo>d to make a det]m9ation "u subsection 7c7 reg>d+ ! pric+ ( a prescription drug or m$ical device4 ,n lat] ?an #ij days aft] ! date ( receipt ( su* a petition1 ! ,bo>d %all-- 7#a7 make a det]m9ation "u subsection 7c7 reg>d+ su* pric+2 or 7#b7 decl9e to make su* a det]m9ation4 7e7 ,cont9u+ violation ,! ,bo>d %all n be requir$ to give a manufactur] an opportunity to correct a violation1 z describ$ 9 subsection 7c77#a77;,b71 be=e ! manufactur] becomes subject to ! provisions describ$ 9 subsection 7c77#b7 = su* violation1 if-- 7#a7 ! ,bo>d has already provid$ su* an opportunity to correct to ! manufactur]2 & 7#b7 ! ,bo>d f9ds t ! violation ( subsection 7a7 is a cont9uation ( an e>li] violation ) respect to :i* su* an opportunity 0 provid$4 7f7 ,consid]ations ,! =mula requir$ by subsection 7a7 %all at a m9imum take into consid]ation-- 7#a7 ! av]age manufactur] price ( ! prescription drug or m$ical device ov] ! respective annual qu>t] or qu>t]s2 7#b7 ! av]age manufactur] price ( o!r prescription drugs or m$ical devices 9 ! same !rapeutic class ov] ! same qu>t] or qu>t]s2 7#c7 ! av]age price at :i* ! prescription drug or m$ical device & o!r prescription drugs & m$ical devices 9 ! same !rapeutic class h be5 sold by manufactur]s 9 c\ntries o!r ?an ! ,unit$ ,/ates2 7#d7 ! co/s associat$ ) produc+ & m>ket+ ! prescription drug or m$ical device1 ! value ( ! drug or device to pati5ts :]e suffici5t data is available to det]m9e su* value1 ! total ,f$]al inve/m5t 9 ! developm5t ( ! drug or device1 ! size ( ! pati5t population receiv+ ! drug or device1 & o!r factors det]m9ative z to ! true co/ ( production2 & 7#e7 :e!r ! price ( ! prescription drug or m$ical device increas$ dur+ any annual qu>t] by a p]c5tage t is m ?an #b p]c5t great] ?an ! ,,cpi increase p]c5tage 7z def9$ 9 section #bae7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #dae77 = ! respective annual qu>t]4 7g7 ,value or co/-,effectiv5ess assessm5ts ,! use ( ,quality-,adju/$ ,life ,ye>s1 ,disability-,adju/$ ,life ,ye>s1 or o!r simil> me*anisms is prohibit$ = use 9 value or co/-effectiv5ess assessm5ts = purposes ( ?is section4 #cjd4 ,en=cem5t provisions 7a7 ,r$uc$ pat5t t]m ,if ! ,bo>d f9ds t ! manufactur] ( a prescription drug or m$ical device1 :o is also an own] ( a pat5t = su* drug or device1 *>g$ an excessive price = su* drug or device 9 violation ( section #cjc7;a71 ! ,bo>d may-- 7#a7 r$uce ! t]m1 by n m ?an #e ye>s1 ( any pat5t issu$ "u title #ce1 ,unit$ ,/ates ,code1 relat+ to su* drug or device2 or 7#b7 if ! t]m ( ea* pat5t = su* drug or device has expir$1 r$uce ! t]m1 by n m ?an #e ye>s1 ( ano!r pat5t own$ by ! pat5t own] relat+ to a prescription drug or m$ical device4 7b7 ,civil p5alties ,if ! ,bo>d det]m9es "u section #cjc7;c7 t a manufactur] ( a prescription drug or m$ical device *>g$ an excessive price = a prescription drug or m$ical device 9 violation ( section #cjc7;a71 ! ,bo>d may impose a civil p5alty on ! manufactur] ( n m ?an #aj p]c5t ( ! manufactur]'s gross sales ( ! drug or device dur+ ! p]iod beg9n+ on ! date on :i* an excessive price is fir/ *>g$ & end+ on ! date on :i* ! manufactur] ceases to *>ge an excessive price4 7c7 ,tax on excess prescription drug & m$ical device pr(its 7#a7 ,det]m9ation ( am\nt ,if ! ,bo>d det]m9es "u section #cjc7;a7 t a manufactur]1 produc]1 or import] ( a prescription drug or m$ical device *>g$ an excessive price = su* prescription drug or m$ical device dur+ a taxable ye>1 ! ,bo>d may det]m9e "u ?is p>agraph a reasonable price = su* drug or device = su* taxable ye>4 7#b7 ,imposition ( tax 7,a7 ,9 g5]al ,! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ aft] section #daia ! foll[+ new section3 #daib4 ,excessive prescription drug & m$ical device price 7a7 ,9 g5]al ,!re is h]eby impos$ on ! sale ( any prescription drug or m$ical device by ! manufactur]1 produc]1 or import] a tax equal to ! diff]5ce betwe5 ! price at :i* su* drug or device is s sold & ! reasonable price det]m9$ by ! ,prescription ,drug & ,m$ical ,device ,price ,review ,bo>d "u section #cjc7;c77#a7 ( ! ,m$ic>e = ,am]ica ,act = su* drug or device = ! taxable ye> = sales aft] ! det]m9ation4 7b7 ,prescription drug or m$ical device ,= purposes ( ?is section1 ! t]m prescription drug or m$ical device means any prescription drug 7z def9$ 9 section #ijjh ( ! ,pati5t ,protection & ,af=dable ,c>e ,act7 or device 7z def9$ 9 section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 int5d$ = humans4 4 7,b7 ,cl]ical am5dm5t ,! table ( p>ts = *apt] #cb ( su* ,code is am5d$-- 7i7 9 ! item relat+ to sub*apt] ,e1 by /rik+ ,m$ical & ins]t+ ,drugs & m$ical2 & 7ii7 by ins]t+ aft] ! item relat+ to section #daia ! foll[+ new item3 ,sec4 #daib4 ,excessive prescription drug & m$ical device price4 4 7#c7 ,effective date ,?is subsection & ! am5dm5ts made by ?is subsection %all apply ) respect to sales aft] ,decemb] #ca1 #bjai4 #cje4 ,au?ority 7a7 ,obta9+ (ficial data ,! *airp]son ( ! ,bo>d may secure directly f any ,f$]al ag5cy in=mation necess>y to enable ! ,bo>d to c>ry out its duties4 ,^u reque/ ( ! *airp]son1 ! head ( ! ag5cy %all furni% su* in=mation to ! ,bo>d to ! ext5t su* in=mation is n prohibit$ f disclosure by law4 7b7 ,mails ,! ,bo>d may use ! ,unit$ ,/ates mails 9 ! same mann] & "u ! same conditions z o!r ,f$]al ag5cies4 7c7 ,adm9i/rative support s]vices ,^u ! reque/ ( ! *airp]son ( ! ,bo>d1 ! ,adm9i/rator ( ,g5]al ,s]vices %all provide to ! ,bo>d1 on a reimbursable basis1 ! adm9i/rative support s]vices necess>y = ! ,bo>d to c>ry out its duties4 7d7 ,contract au?ority ,! ,bo>d may contract ) & comp5sate gov]nm5t & private ag5cies or p]sons = ! purpose ( conduct+ rese>*1 surveys1 & o!r s]vices necess>y to enable ! ,bo>d to c>ry out its duties4 7e7 ,inve/igations ,! ,bo>d may make su* inve/igations z x consid]s necess>y to det]m9e :e!r !re is or may be a violation ( any regulation promulgat$ "u ?is ,act & may require or p]mit any p]son to file ) x a /atem5t 9 writ+1 "u oa? or o!rwise z ! ,bo>d %all det]m9e1 z to all ! facts & circum/ances conc]n+ ! matt] to be inve/igat$4 7f7 ,subpo5a p[] 7#a7 ,9 g5]al ,! ,bo>d may issue subpo5as requir+ ! att5dance & te/imony ( witnesses & ! production ( any evid5ce relat+ to any matt] "u inve/igation by ! ,bo>d4 ,! att5dance ( witnesses & ! production ( evid5ce may be requir$ f any place )9 ! ,unit$ ,/ates at any designat$ place ( he>+ )9 ! ,unit$ ,/ates4 7#b7 ,failure to obey a subpo5a ,if a p]son refuses to obey a subpo5a issu$ "u p>agraph 7#a71 ! ,bo>d may apply to a ,unit$ ,/ates di/rict c\rt = an ord] requir+ t p]son to appe> be=e ! ,bo>d to give te/imony1 produce evid5ce1 or bo?1 relat+ to ! matt] "u inve/igation4 ,! application may be made )9 ! judicial di/rict :]e ! he>+ is conduct$ or :]e t p]son is f\nd1 resides1 or transacts bus9ess4 ,any failure to obey ! ord] ( ! c\rt may be puni%$ by ! c\rt z civil contempt4 7#c7 ,s]vice ( subpo5as ,! subpo5as ( ! ,bo>d %all be s]v$ 9 ! mann] provid$ = subpo5as issu$ by a ,unit$ ,/ates di/rict c\rt "u ! ,f$]al ,rules ( ,civil ,proc$ure = ! ,unit$ ,/ates di/rict c\rts4 7#d7 ,s]vice ( process ,all process ( any c\rt to :i* application is made "u p>agraph 7#b7 may be s]v$ 9 ! judicial di/rict 9 :i* ! p]son requir$ to be s]v$ resides or may be f\nd4 7#e7 ,notice ,^u issu+ any subpo5a "u ?is subsection1 ! ,bo>d %all give notice ( su* issuance to ! appropriate committees ( ,congress1 includ+ ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,appropriations ( ! ,s5ate4 7g7 ,confid5tiality ,"u ?is title1 ! ,secret>y %all en=ce applicable law conc]n+ a trade secret or confid5tial in=mation subject to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah4 #cjf4 ,regulations 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! initial meet+ held "u section #cjb7;e71 ! ,bo>d %all issue f9al regulations to c>ry out ?is ,act4 7b7 ,notice & comm5t requirem5t ,! regulations develop$ "u subsection 7a7 %all be issu$ 9 accordance ) ! notice & comm5t proc$ures e/abli%$ "u section #eec ( title #e1 ,unit$ ,/ates ,code4 #cjg4 ,report to ,f$]al ag5cies ,n lat] ?an #a ye> aft] ! effective date ( ! regulations "u section #cjf & annually !reaft]1 ! ,bo>d %all submit to ea* ,f$]al ag5cy t disp5ses or makes paym5ts = ! disp5s+ ( prescription drugs or m$ical devices a report conta9+ a li/ ( ea* prescription drug & m$ical device = :i* an excessive price 0 *>g$ dur+ ! prec$+ cal5d> ye>1 z det]m9$ by ! ,bo>d "u section #cjc4 ,! ,secret>y %all make ?is report publicly available4 #cjh4 ,def9itions ,9 ?is title3 7#a7 ,affiliate ,! t]m affiliate means1 ) respect to a manufactur]1 any entity t controls1 is controll$ by1 or is "u common control ) su* manufactur]4 7#b7 ,av]age manufactur] price ,! t]m av]age manufactur] price means ! av]age price *>g$ by ! manufactur] ( a prescription drug or m$ical device1 z applicable1 = sales ( ! drug or device by ! manufactur] 9 ! ,unit$ ,/ates ov] ! respective annual qu>t]4 7#c7 ,m$ical device ,! t]m m$ical device means a device 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba774 7#d7 ,prescription drug ,! t]m prescription drug means a drug 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 t is subject to section #ejc7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cec7;b77#a774 7#e7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! lic5se issu$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 :o is responsible = sett+ ! price = ! drug4 7#f7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 #cji4 ,moratorium on direct-to-consum] drug adv]tis+ ,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is am5d$-- 7#a7 9 section #cja 7#ba ,u4,s4,c4 #cca71 by add+ at ! end ! foll[+3 7eee7 ,! conduct ( direct-to-consum] adv]tis+ ( a drug 9 violation ( section #ejf;,j4 2 & 7#b7 9 *apt] ,v1 by ins]t+ aft] section #ejf;,i 7#ba ,u4,s4,c4 #cef;f7 ! foll[+3 #ejf;,j4 ,direct-to-consum] drug adv]tis+ 7a7 ,prohibitions 7#a7 ,fir/ ?ree ye>s 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 no p]son %all conduct direct-to-consum] adv]tis+ ( a drug = :i* an application is submitt$ "u section #eje7;b7 be=e ! end ( ! #c-ye> p]iod beg9n+ on ! date ( ! approval ( su* application4 7,b7 ,waiv] ,! ,secret>y may waive ! application ( subp>agraph 7,a7 to a drug dur+ ! ?ird ye> ( ! #c-ye> p]iod describ$ 9 su* subp>agraph if-- 7i7 ! sponsor ( ! drug submits an application to ! ,secret>y pursuant to subp>agraph 7,c72 & 7ii7 ! ,secret>y1 aft] consid]+ ! application & any accompany+ mat]ials1 det]m9es t direct-to-consum] adv]tis+ ( ! drug w\ld h an affirmative value to public heal?4 7,c7 ,application = waiv] ,to seek a waiv] "u subp>agraph 7,b71 ! sponsor ( a drug %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7#b7 ,subsequ5t ye>s ,! ,secret>y may prohibit direct-to-consum] adv]tis+ ( a drug dur+ ! p]iod beg9n+ at ! end ( ! #c-ye> p]iod describ$ 9 p>agraph 7#a77;,a7 if ! ,secret>y det]m9es t ! drug has significant adv]se heal? effects bas$ on po/-approval /udies1 risk-b5efit analyses1 adv]se ev5t reports1 ! sci5tific lit]ature1 any cl9ical or obs]vational /udies1 or any o!r appropriate res\rce4 7b7 ,regulations ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all revise ! regulations promulgat$ "u ?is ,act gov]n+ drug adv]tisem5ts to ! ext5t necess>y to implem5t ?is section4 7c7 ,rule ( con/ruction ,?is section %all n be con/ru$ to dim9i% ! au?ority ( ! ,secret>y to prohibit or regulate direct-to-consum] adv]tis+ ( drugs "u o!r provisions ( law4 4 #caj4 ,report+ on ju/ification = drug price increases ,title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq47 is am5d$ by add+ at ! end ! foll[+3 ,w ,drug ,price ,report+2 ,drug ,value ,fund #cii,,oo4 ,report+ on ju/ification = drug price increases 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! lic5se issu$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 :o is responsible = sett+ ! price = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ?is ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m p] mon? supply or p] a c\rse ( treatm5t t la/s less ?an a mon? & is-- 7i7 7,i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7,,ii7 commonly adm9i/]$ by hospitals 7z det]m9$ by ! ,secret>y72 7ii7 n designat$ z a drug = a r>e disease or condition "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7iii7 n designat$ by ! ,secret>y z a vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or "u a ,/ate ,m$icaid plan "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y = ea* price increase ( a qualify+ drug t w result 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7,a7 #aj p]c5t or m ov] a #ab-mon? p]iod2 or 7,b7 #be p]c5t or m ov] a #cf-mon? p]iod4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase4 7c7 ,cont5ts ,a report "u subsection 7b7 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug on ! plann$ effective date ( su* price increase2 7,b7 a ju/ification =1 & description (1 ea* manufactur]'s price increase t w occur dur+ ! #ab-mon? p]iod describ$ 9 subsection 7b77#a77;,a7 or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,b71 z applicable2 7,c7 ! id5tity ( ! initial develop] ( ! drug2 7,d7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 7,e7 ! curr5t li/ price ( ! drug2 7,f7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 & 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 7,g7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,h7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is us$ =-- 7i7 basic & precl9ical rese>*2 7ii7 cl9ical rese>*2 7iii7 new drug developm5t2 7iv7 pursu+ new or exp&$ indications = su* drug ?r\gh supplem5tal applications "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 & 7v7 c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ ^? "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,i7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,j7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #ab- & #cf-mon? p]iods prec$+ ! submission ( ! report2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #ab- & #cf-mon? p]iods prec$+ ! submission ( ! report2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate4 7d7 ,civil p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section %all be subject to a civil p5alty ( #ajj1jjj = ea* day on :i* ! violation cont9ues4 7e7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#c71 n lat] ?an #cj days aft] ! submission ( a report "u subsection 7b71 ! ,secret>y %all po/ ! report on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#b7 ,=mat ,9 develop+ ! =mat ( su* report = public po/+1 ! ,secret>y %all consult /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back on ! cont5t & =mat f consum] advocates & readability exp]ts to ensure su* public reports are us]-fri5dly to ! public & are writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,trade secrets & confid5tial in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 #cii,,oo-#a4 ,use ( civil p5alty am\nts ,! ,secret>y %all1 )\t fur!r appropriation1 collect civil p5alties "u section #cii,,oo & use ! funds d]iv$ f su* civil p5alties1 9 addition to any o!r am\nts available to ! ,secret>y1 to c>ry out activities describ$ 9 ?is "p & to improve consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ,congress1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is easy to use & und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #cii,,oo2 & 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section4 7b7 ,trade secrets & confid5tial in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 4 ,,iv ,outcomes & ,report+ #dja4 ,s5se ( ,congress ,x is ! s5se ( ,congress t ,m$ic>e = ,am]ica w h a significant impact on ! heal? & well-be+ ( ! ,unit$ ,/ates population & ! social det]m9ants ( ! heal? ( b5efici>ies ( ,m$ic>e = ,am]ica4 #djb4 ,evaluation ( bill's outcome 7a7 ,9 g5]al ,to assess ! impact ( ?is ,act on ! heal? ( ! population1 n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all all[ = analysis ( adm9i/rative records t h remov$ all p]sonally id5tifiable in=mation f ! ,c5t] = ,heal? ,c>e to exi/+ population surveys conduct$ by ! ,f$]al ,gov]nm5t & f$]ally support$ surveys4 7b7 ,,cdc & ,,nih ,! ,directors ( ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,national ,in/itutes ( ,heal? %all solicit a compreh5sive1 longitud9al /udy to evaluate any diff]5tial individual impact on cov]age expansion bas$ on-- 7#a7 race & e?nicity2 7#b7 socioeconomic /atus2 or 7#c7 heal? /atus4 7c7 ,report ,t5 ye>s aft] ! date ( ! enactm5t ( ?is ,act & e t5 ye>s !reaft]1 ! ,secret>y %all submit a report to ! ,h\se ,committee on ,en]gy & ,comm]ce & ! ,s5ate ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions reg>d+ impact ( ?is ,act on ! heal? ( ! ,unit$ ,/ates population bas$ on ! results ( subsection 7b7 contributions f all o!r relevant ag5cies4