,,ii #aai? ,,congress #b;d ,session ,s4 #edif ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,septemb] #bd1 #bjbf,mr4 ,w>n] introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to exp& access to & l[] ! co/ ( heal? c>e4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,heal? = ! ,commonweal? ?r\gh ,af=dability1 ,re=m1 & ,expansion ,act ( #bjbf or ! ,heal? ,,c>e ,act ( #bjbf4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,re/or+ heal? c>e & l[]+ costs,sec4 #aja4 ,repeal ( reconciliation heal? provisions4,sec4 #ajb4 ,p]man5t ext5sion ( enhanc$ tax cr$it4,sec4 #ajc4 ,promot+ consum] outrea* & education4,,title ,,ii--,pa?way to univ]sal coverage,sec4 #bja4 ,e/abli%m5t ( heal? plan4,sec4 #bjb4 ,availability ( plan4,sec4 #bjc4 ,af=dability4,sec4 #bjd4 ,p>ticipat+ provid]s4,sec4 #bje4 ,provid] paym5t rates4,sec4 #bjf4 ,no effect on ,m$ic>e b5efits or ,m$ic>e tru/ funds4,,title ,,iii--,/r5g!n+ ,medicaid,sec4 #cja4 ,increas$ ,,fmap = m$ical assi/ance to newly eligible individuals4,sec4 #cjb4 ,support+ ,/ate ,m$icaid programs ?r\gh economic d[nturns4,,title ,,iv--,l[]+ drug costs,sec4 #dja4 ,exp&+ ,m$ic>e drug price negotiation4,sec4 #djb4 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket4,sec4 #djc4 ,e/abli%+ an out-(-pocket limit on exp5ditures = prescription drugs "u gr\p heal? plans & gr\p & individual heal? insurance cov]age4,sec4 #djd4 ,requirem5ts ) respect to co/-%>+ = insul9 products4,,title ,v--,ensur+ quality heal? insurance & remov+ b>ri]s to care,sec4 #eja4 ,requir$ exceptions process = m$ication /ep !rapy protocols4,sec4 #ejb4 ,e/abli%+ requirem5ts ) respect to ! use ( prior au?orization "u ,m$ic>e ,advantage plans4,sec4 #ejc4 ,special enrollm5t p]iod = provid] t]m9ations4,sec4 #ejd4 ,provid+ cov]age = he>+ c>e "u ! ,m$ic>e program4,,title ,,vi--,l[]+ ! co/ ( care,sec4 #fja4 ,/r5g!n+ hospital price transp>5cy4,sec4 #fjb4 ,cl9ical diagno/ic laboratory price transp>5cy4,sec4 #fjc4 ,imag+ s]vices price transp>5cy4,sec4 #fjd4 ,ambulatory surgical c5t] price transp>5cy4,sec4 #fje4 ,/r5g!n+ heal? cov]age transp>5cy requirem5ts4,sec4 #fjf4 ,increas+ gr\p heal? plan access to heal? data4,sec4 #fjg4 ,ov]sight ( adm9i/rative s]vice provid]s4,sec4 #fjh4 ,/ate preemption only 9 ev5t ( conflict4,sec4 #fji4 ,requirem5t = explanation ( b5efits4,sec4 #faj4 ,transp>5cy 9 bill+4,sec4 #faa4 ,te*nical am5dm5ts4,sec4 #fab4 ,implem5tation & en=cem5t fund+4,,title ,,vii--,re=m+ ,p,b,ms & ,protect+ ,pharmacies,sec4 #gja4 ,ensur+ accurate paym5ts to ph>macies "u ,m$icaid4,sec4 #gjb4 ,prev5t+ ! use ( abusive spread pric+ 9 ,m$icaid4 ,i ,re/or+ heal? c>e & l[]+ co/s #aja4 ,repeal ( reconciliation heal? provisions 7a7 ,9 g5]al ,except z provid$ 9 subsection 7b71 subtitle ,b ( title ,,vii ( ! ,act titl$ ,an ,act to provide = reconciliation pursuant to title ,,ii ( ,h4 ,con4 ,res4 #ad 7,public ,law #aai-ba7 is repeal$ & any law or regulation ref]r$ to 9 su* subtitle %all be appli$ z if su* subtitle & ! am5dm5ts made by su* subtitle _h n be5 enact$4 7b7 ,exceptions ,subsection 7a7 %all n apply to ! provisions ( & am5dm5ts made by sections #gabjb1 #gacjf1 & #gadja ( su* ,act4 7c7 ,rescission 7#a7 ,,obbba implem5tation fund+ ,! unobligat$ am\nts appropriat$ "u ! foll[+ provisions ( ! ,act titl$ ,an ,act to provide = reconciliation pursuant to title ,,ii ( ,h4 ,con4 ,res4 #ad 7,public ,law #aai-ba7 are h]eby resc9d$3 7,a7 ,section #gaaja7;b74 7,b7 ,section #gaajg7;c74 7,c7 ,section #gaaji7;c74 7,d7 ,section #gaaaj7;b74 7,e7 ,section #gaaab7;e74 7,f7 ,section #gaaac7;c74 7,g7 ,section #gaaae7;c74 7,h7 ,section #gaaaf7;e74 7,i7 ,section #gaaah7;b74 7,j7 ,subsections 7e7 & 7f7 ( section #gaaai4 7,k7 ,section #gaabj7;c74 7,l7 ,section #gaaba7;b74 7#b7 ,title ,,xix fund+ ,! unobligat$ am\nts appropriat$ "u section #aijb7uu77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7uu77#c771 z repeal$ by subsection 7a71 are h]eby resc9d$4 #ajb4 ,p]man5t ext5sion ( enhanc$ tax cr$it 7a7 ,9 g5]al ,subp>agraph 7,a7 ( section #cf;,b7c77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ b does n exce$ #djj p]c5t4 7b7 ,applicable p]c5tages 7#a7 ,9 g5]al ,subp>agraph 7,a7 ( section #cf;,b7b77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 7,a7 ,applicable p]c5tage ,! applicable p]c5tage = any taxable ye> %all be ! p]c5tage su* t ! applicable p]c5tage = any taxpay] ^: h\sehold income is )9 an income ti] specifi$ 9 ! foll[+ table %all increase1 on a slid+ scale 9 a l9e> mann]1 f ! initial premium p]c5tage to ! f9al premium p]c5tage specifi$ 9 su* table = su* income ti]3 ,9 ! case ( h\sehold income 7express$ z a p]c5t ( pov]ty l9e7 )9 ! foll[+ income ti]3,! initial premium p]c5tage is--,! f9al premium p]c5tage is--,up to #aej p]c5t#jjaej p]c5t up to #bjj p]c5t#jb4jbjj p]c5t up to #bej p]c5t#b4jd4jbej p]c5t up to #cjj p]c5t#d4jf4jcjj p]c5t up to #djj p]c5t#f4jh4edjj p]c5t & high]#h4eh4e4 4 7#b7 ,con=m+ am5dm5ts relat+ to af=dability ( cov]age 7,a7 ,p>agraph 7#a7 ( section #cf;,b7c7 ( su* ,code is am5d$ by /rik+ subp>agraph 7,e74 7,b7 ,subp>agraph 7,c7 ( section #cf;,b7c77#b7 ( su* ,code is am5d$ by /rik+ clause 7iv74 7,c7 ,p>agraph 7#d7 ( section #cf;,b7c7 ( su* ,code is am5d$ by /rik+ subp>agraph 7,f74 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjbf4 #ajc4 ,promot+ consum] outrea* & education 7a7 ,9 g5]al ,section #acaa7;i7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjca7;i77 is am5d$-- 7#a7 9 p>agraph 7#b71 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,selection ( recipi5ts ,9 ! case ( an ,ex*ange e/abli%$ & op]at$ by ! ,secret>y )9 a ,/ate pursuant to section #acba7;c71 9 aw>d+ grants "u p>agraph 7#a71 ! ,ex*ange %all-- 7i7 select entities to receive su* grants bas$ on an entity's demon/rat$ capacity to c>ry out ea* ( ! duties specifi$ 9 p>agraph 7#c72 7ii7 n take into acc\nt :e!r or n ! entity has demon/rat$ h[ ! entity w provide in=mation to individuals relat+ to gr\p heal? plans (f]$ by a gr\p or association ( employ]s or %ort-t]m limit$ duration insurance 7z def9$ by ! ,secret>y = purposes ( section #bgia7;b77#e7 ( ! ,public ,heal? ,s]vice ,act72 & 7iii7 ensure t1 ea* ye>1 ! ,ex*ange aw>ds su* a grant to-- 7,i7 at lea/ "o entity describ$ 9 ?is p>agraph t is a community & consum]-focus$ nonpr(it gr\p2 & 7,,ii7 at lea/ "o entity describ$ 9 subp>agraph 7,b71 :i* may include ano!r community & consum]-focus$ nonpr(it gr\p 9 addition to any su* gr\p aw>d$ a grant pursuant to subclause 7,i74 ,9 aw>d+ su* grants1 an ,ex*ange may consid] an entity's record ) respect to wa/e1 fraud1 & abuse = purposes ( ma9ta9+ ! integrity ( su* ,ex*ange4 2 7#b7 9 p>agraph 7#c7-- 7,a7 by am5d+ subp>agraph 7,c7 to read z foll[s3 7,c7 facilitate enrollm5t1 includ+ ) respect to individuals ) limit$ ,engli% pr(ici5cy & individuals ) *ronic illnesses1 9 qualifi$ heal? plans1 ,/ate ,m$icaid plans "u title ,,xix ( ! ,social ,security ,act1 & ,/ate *ild heal? plans "u title ,,xxi ( su* ,act2 2 7,b7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7,c7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 7,d7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 provide ref]rals to community-bas$ organizations t address social ne$s relat$ to heal? outcomes4 2 & 7,e7 by add+ at ! end ! foll[+ flu% text3 ,! duties specifi$ 9 ! prec$+ s5t5ce may be c>ri$ out by su* a navigator at any "t dur+ a ye>4 2 7#c7 9 p>agraph 7#d77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ n2 7,b7 9 clause 7i7-- 7i7 by ins]t+ n be=e be2 & 7ii7 by /rik+ 2 or & ins]t+ a semicolon2 7,c7 9 clause 7ii7-- 7i7 by ins]t+ n be=e receive2 & 7ii7 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,d7 by add+ at ! end ! foll[+ new clauses3 7iii7 ma9ta9 physical pres5ce 9 ! ,/ate ( ! ,ex*ange s z to all[ 9-p]son assi/ance to consum]s2 & 7iv7 receive opioid specific education & tra9+ t ensures ! navigator c be/ educate individuals on qualifi$ heal? plans (f]$ ?r\gh an ,ex*ange1 specifically cov]age "u su* plans = opioid heal? c>e treatm5t4 2 & 7#d7 9 p>agraph 7#f7-- 7,a7 by /rik+ ,grants "u & ins]t+ ! foll[+3 7,a7 ,/ate ex*anges ,grants "u 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,f$]al ex*anges ,= purposes ( c>ry+ out ?is subsection1 ) respect to an ,ex*ange e/abli%$ & op]at$ by ! ,secret>y )9 a ,/ate pursuant to section #acba7;c71 ! ,secret>y %all obligate #ajj1jjj1jjj out ( am\nts collect$ ?r\gh ! us] fees on p>ticipat+ heal? insurance issu]s pursuant to section #aef4ej ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 = fiscal ye> #bjbg & ea* subsequ5t fiscal ye>4 ,su* am\nt = a fiscal ye> %all rema9 available until exp5d$4 4 7b7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbg4 ,,ii ,pa?way to univ]sal cov]age #bja4 ,e/abli%m5t ( heal? plan 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is title z ! ,secret>y7 %all e/abli% a coord9at$ & l[-co/ heal? plan 7ref]r$ to 9 ?is title z ! heal? plan7 to provide access to quality heal? c>e = enrollees4 7b7 ,individual m>ket availability ,! ,secret>y %all make ! heal? plan available 9 ! individual m>ket = plan ye> #bjbh & ea* subsequ5t plan ye>4 7c7 ,rulemak+ ,! ,secret>y may promulgate su* regulations z may be necess>y to c>ry out ?is title4 7d7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ su* sums z may be necess>y to c>ry out ?is title4 #bjb4 ,availability ( plan 7a7 ,eligibility ,an individual %all be eligible to enroll 9 ! heal? plan if su* individual1 = ! entire p]iod = :i* enrollm5t is s\ght-- 7#a7 is a qualifi$ individual )9 ! mean+ ( section #acab ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjcb72 7#b7 is n eligible = b5efits "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 & 7#c7 is n o!rwise eligible =1 or has be5 o!rwise (f]$1 employ]-sponsor$ heal? c>e cov]age4 7b7 ,ex*anges ,! heal? plan %all be made available ?r\gh ! ,ex*anges1 includ+ ! ,small ,bus9ess ,heal? ,options ,program ,ex*ange4 #bjc4 ,af=dability ,! ,secret>y %all ensure t cov]age options = ! heal? plan are n m co/ly ?an comp>able options (f]$ on ! ,ex*ange 9 ! applicable m>ket4 #bjd4 ,p>ticipat+ provid]s 7a7 ,requirem5t ,to p>ticipate 9 ord] ,to be enroll$ "u ,m$ic>e ,beg9n+ ,janu>y #a1 #bjbh1 ! ,secret>y may require a heal? c>e provid] enroll$ "u ! ,m$ic>e program "u section #ahff7;j7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7j77 to be a p>ticipat+ provid] "u ! heal? plan4 7b7 ,requirem5t ,to p>ticipate 9 ord] ,to p>ticipate 9 ,m$icaid ,beg9n+ ,janu>y #a1 #bjbh1 ! ,secret>y may require a heal? c>e provid] "u a ,/ate ,m$icaid plan "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 to also be a p>ticipat+ provid] "u ! heal? plan4 #bje4 ,provid] paym5t rates ,! ,secret>y %all set competitive provid] paym5t rates "u ! heal? plan us+ ! be/ in=mation publicly available & data o!rwise accessible to ! ,secret>y4 ,! ,secret>y %all give consid]ation to exi/+ provid] paym5t rates = comm]cial heal? plans & provid] co/s to deliv] c>e1 giv+ special consid]ation to increas$ co/s = provid]s to deliv] c>e 9 rural & m$ically und]s]v$ areas4 #bjf4 ,no effect on ,m$ic>e b5efits or ,m$ic>e tru/ funds ,no?+ 9 ?is title %all-- 7#a7 affect ! b5efits available "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq472 or 7#b7 impact ! ,f$]al ,hospital ,insurance ,tru/ ,fund "u section #ahag ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;i7 or ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet7 7includ+ ! ,m$ic>e ,prescription ,drug ,acc\nt )9 su* ,tru/ ,fund74 ,,iii ,/r5g!n+ ,m$icaid #cja4 ,increas$ ,,fmap = m$ical assi/ance to newly eligible individuals 7a7 ,9 g5]al ,section #aije ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is am5d$-- 7#a7 9 subsection 7y77#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ #bjad1 #bjae1 & #bjaf & ins]t+ ea* ( ! fir/ #c consecutive #ab-mon? p]iods 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 7,b7 9 subp>agraph 7,b71 by /rik+ #bjag & ins]t+ ! f\r? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 7,c7 9 subp>agraph 7,c71 by /rik+ #bjah & ins]t+ ! fif? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 7,d7 9 subp>agraph 7,d71 by /rik+ #bjai & ins]t+ ! six? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals2 & 7,e7 9 subp>agraph 7,e71 by /rik+ #bjbj & ea* ye> !reaft] & ins]t+ ! sev5? consecutive #ab-mon? p]iod 9 :i* ! ,/ate provides m$ical assi/ance to newly eligible individuals & ea* su* p]iod !reaft]2 & 7#b7 9 subsection 7z77#b77;,b77i77,,ii71 by ins]t+ 7z 9 effect on ! day be=e ! enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf7 aft] subsection 7y77#a74 7b7 ,retroactive application ,! am5dm5ts made by subsection 7a77#a7 %all take effect z if includ$ 9 ! enactm5t ( ,public ,law #aaa-adh & %all apply to am\nts exp5d$ by any ,/ate = m$ical assi/ance = newly eligible individuals describ$ 9 subclause 7,,viii7 ( section #aijb7;a77#aj77;,a77i7 ( ! ,social ,security ,act "u a ,/ate ,m$icaid plan 7or a waiv] ( su* plan7 dur+ ! p]iod be=e ! date ( enactm5t ( ?is ,act4 #cjb4 ,support+ ,/ate ,m$icaid programs ?r\gh economic d[nturns 7a7 ,9 g5]al ,section #aije ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is am5d$-- 7#a7 9 subsection 7b71 by /rik+ & 7ii7 & ins]t+ 7ii71 & 7ll72 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7ll7 ,increas$ ,,fmap dur+ economic d[nturns 7#a7 ,9 g5]al ,if a fiscal qu>t] t beg9s on or aft] ,janu>y #a1 #bjbf1 is an economic d[nturn qu>t] 7z def9$ 9 p>agraph 7#b77 ) respect to a ,/ate1 !n ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = ea* ,/ate = su* qu>t] "u subsection 7b7 %all be equal to ! p]c5tage det]m9$ = ! ,/ate & qu>t] "u p>agraph 7#c74 7#b7 ,economic d[nturn qu>t] 7,a7 ,9 g5]al 7i7 ,9 g5]al ,9 ?is subsection1 ! t]m economic d[nturn qu>t] means1 ) respect to a ,/ate1 a fiscal qu>t] dur+ :i* ! ,/ate's unemploym5t rate = ! qu>t] exce$s ! p]c5tage det]m9$ = ! ,/ate & qu>t] "u clause 7ii74 7ii7 ,?re%old p]c5tage ,! p]c5tage det]m9$ "u ?is clause = a ,/ate & fiscal qu>t] is ! p]c5tage equal to ! l[] (-- 7,i7 ! ,/ate unemploym5t rate at ! #bj? p]c5tile ( ! di/ribution ( ! ,/ate's qu>t]ly unemploym5t rates = ! #fj-qu>t] p]iod prec$+ ! qu>t] involv$1 increas$ by #a p]c5tage po9t2 & 7,,ii7 ! ,/ate's av]age qu>t]ly unemploym5t rate = ! #ab-qu>t] p]iod prec$+ ! qu>t] involv$1 increas$ by #a p]c5tage po9t4 7,b7 ,unemploym5t data 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 = purposes ( det]m9+ unemploym5t rates = a ,/ate & a qu>t] "u ?is p>agraph1 ! ,secret>y %all use data f ! ,local ,area ,unemploym5t ,/ati/ics f ! ,bureau ( ,labor ,/ati/ics4 7ii7 ,application to c]ta9 t]ritories ,9 ! case ( ! ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 ,am]ican ,samoa1 or any o!r jurisdiction = :i* suitable data f ! ,local ,area ,unemploym5t ,/ati/ics f ! ,bureau ( ,labor ,/ati/ics are unavailable1 ! ,secret>y %all use data f ! ,u-#c unemploym5t measure ( ! ,bureau ( ,labor ,/ati/ics to make any necess>y det]m9ations "u subp>agraph 7,a74 7#c7 ,increas$ ,,fmap dur+ economic d[nturn qu>t] 7,a7 ,9 g5]al ,dur+ a fiscal qu>t] t is an economic d[nturn qu>t] ) respect to a ,/ate1 ! ,f$]al m$ical assi/ance p]c5tage = ! ,/ate & qu>t] det]m9$ "u subsection 7b7 %all be equal to-- 7i7 ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = ! ,/ate & qu>t] "u subsection 7b7 )\t reg>d to ?is subsection2 increas$ by 7ii7 ! numb] ( p]c5tage po9ts 7r\nd$ to ! ne>e/ t5? ( a p]c5tage po9t7 equal to ! product (-- 7,i7 ! numb] ( p]c5tage po9ts 7r\nd$ to ! ne>e/ t5? ( a p]c5tage po9t7 by :i* ! unemploym5t rate = ! ,/ate & qu>t] exce$s ! p]c5tage det]m9$ = ! ,/ate & qu>t] "u p>agraph 7#b77;,a77ii72 & 7,,ii7 #d4h4 7,b7 ,rules ( application ,! foll[+ rules %all apply ) respect to ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = a ,/ate & an economic d[nturn qu>t] "u ?is subsection3 7i7 ,scope ( application ,su* ,f$]al m$ical assi/ance p]c5tage %all n apply = purposes (-- 7,i7 disproportionate %>e hospital paym5ts describ$ 9 section #aibc2 7,,ii7 paym5ts "u "p ,d ( title ,,iv2 or 7,,iii7 any paym5ts "u ?is title t are bas$ on a ,f$]al m$ical assi/ance p]c5tage det]m9$ = a ,/ate "u subsection 7aa7 7b only to ! ext5t t su* ,f$]al m$ical assi/ance p]c5tage is high] ?an ! economic recov]y ,,fmap74 7ii7 ,limitation ,9 no case %all-- 7,i7 ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = a ,/ate & qu>t] pursuant to ?is subsection exce$ #ie p]c5t2 or 7,,ii7 any increase to ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = a ,/ate & qu>t] pursuant to ?is subsection result 9 ! application ( a ,f$]al m$ical assi/ance p]c5tage t exce$s #ie p]c5t4 7iii7 ,application to ,,*ip ,not)/&+ ! fir/ s5t5ce ( section #baje7;b71 ! application ( ?is subsection may result 9 ! enhanc$ ,,fmap ( a ,/ate = a fiscal ye> "u su* section exce$+ #he p]c5t1 b 9 no case may ! application ( ?is subsection be=e application ( ! second s5t5ce ( su* section result 9 ! enhanc$ ,,fmap ( ! ,/ate exce$+ #ie p]c5t4 7#d7 ,advance paym5t2 retrospective adju/m5t 7,a7 ,9 g5]al ,prior to ! beg9n+ ( ! second fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is subsection1 & ea* subsequ5t fiscal qu>t]1 ! ,secret>y %all1 ) respect to ea* ,/ate-- 7i7 make an initial det]m9ation1 bas$ on ! projections made = ! ,/ate & qu>t] "u subp>agraph 7,b71 z to-- 7,i7 :e!r ! application ( ?is subsection is expect$ to result 9 ! application ( a high] ,f$]al m$ical assi/ance p]c5tage = ! ,/ate & qu>t] ?an ! p]c5tage t w\ld o!rwise apply )\t reg>d to ?is subsection2 & 7,,ii7 if ! application ( ?is subsection is expect$ to result 9 su* a high] ,f$]al m$ical assi/ance p]c5tage = ! ,/ate & qu>t]1 :at su* high] p]c5tage is expect$ to be2 & 7ii7 if ! ,secret>y det]m9es "u clause 7i7 t ! application ( ?is subsection is expect$ to result 9 ! application ( a high] ,f$]al m$ical assi/ance p]c5tage = ! ,/ate & qu>t] ?an ! p]c5tage t w\ld o!rwise apply )\t reg>d to ?is subsection-- 7,i7 apply su* high] ,f$]al m$ical assi/ance p]c5tage ( ! ,/ate = purposes ( mak+ paym5ts to ! ,/ate = am\nts exp5d$ dur+ su* qu>t] z m$ical assi/ance "u ! ,/ate plan2 & 7,,ii7 take into acc\nt su* high] ,f$]al m$ical assi/ance p]c5tage ( ! ,/ate = purposes ( calculat+ ! enhanc$ ,,fmap = ! ,/ate & qu>t] "u section #baje7;b74 7,b7 ,projection ( ,/ate unemploym5t rates ,prior to ! beg9n+ ( ! second fiscal qu>t] t beg9s aft] ! date ( enactm5t ( ?is subsection1 & ea* subsequ5t fiscal qu>t]1 ! ,secret>y1 act+ ?r\gh ! ,*ief ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all1 us+ ! mo/ rec5tly available data describ$ 9 p>agraph 7#b77;,b71 make projections ) respect to-- 7i7 ! unemploym5t rates = ea* ,/ate = su* qu>t]2 7ii7 ! ?re%old p]c5tages describ$ 9 p>agraph 7#b77;,a77ii7 = ea* ,/ate = su* qu>t]2 & 7iii7 ! national unemploym5t rate = su* qu>t]4 7,c7 ,retrospective adju/m5t ,z soon z practicable aft] f9al unemploym5t data becomes available = a fiscal qu>t] = :i* ! ,secret>y made an initial det]m9ation "u ?is p>agraph1 ! ,secret>y %all1 ) respect to ea* ,/ate-- 7i7 make a f9al det]m9ation ) respect to ! application ( ?is subsection = purposes ( det]m9+ ! ,f$]al m$ical assi/ance p]c5tage & enhanc$ ,,fmap ( ! ,/ate = ! qu>t]2 & 7ii7 9 accordance ) section #aijc7;d77#b7 & section #baje7;e71 r$uce or increase ! am\nt payable to ! ,/ate "u section #aijc7;a7 or section #baje = a subsequ5t fiscal qu>t] to ! ext5t ( any ov]paym5t or und]paym5t "u ei!r su* section :i* ! ,secret>y det]m9es 0 made z a result ( an incorrect initial det]m9ation "u subp>agraph 7,a77i7 ) respect to ! application ( ?is subsection = purposes ( det]m9+ ! ,f$]al m$ical assi/ance p]c5tage & enhanc$ ,,fmap ( ! ,/ate = su* prior fiscal qu>t]4 7#e7 ,retrospective application ( ov]-!-limit ,,fmap increases 7,a7 ,9 g5]al ,if a ,/ate has excess p]c5tage po9ts ) respect to an economic d[nturn qu>t] & an applicable ,,fmap 7z det]m9$ "u subp>agraph 7,b771 ! ,/ate may elect to apply su* excess p]c5tage po9ts to increase su* applicable ,,fmap = "o or m qu>t]s dur+ ! look-back p]iod = ! ,/ate & economic d[nturn qu>t] 9 accordance ) ?is p>agraph4 7,b7 ,excess p]c5tage po9ts ,= purposes ( ?is p>agraph1 ! numb] ( excess p]c5tage po9ts = a ,/ate1 economic d[nturn qu>t]1 & an applicable ,,fmap %all be equal to ! numb] ( p]c5tage po9ts by :i*-- 7i7 ! applicable ,,fmap = ! ,/ate & qu>t] 7aft] application ( p>agraph 7#c7 b )\t reg>d to subp>agraph 7,b77ii7 ( su* p>agraph72 exce$s 7ii7 #ie p]c5t4 7,c7 ,effect ( application ( excess p]c5tage po9ts ,if a ,/ate elects to apply excess p]c5tage po9ts to an applicable ,,fmap to a qu>t] dur+ a look-back p]iod "u ?is p>agraph1 ! ,secret>y %all det]m9e ! additional am\nt ( paym5t "u section #aijc7;a7 to :i* ! ,/ate w\ld h be5 entitl$ = su* qu>t] if ! applicable ,,fmap 7z s increas$7 _h be5 9 effect = su* qu>t]1 & %all treat su* additional am\nt z an und]paym5t = su* qu>t]4 7,d7 ,di/ribution ( excess p]c5tage po9ts ,a ,/ate t has excess p]c5tage po9ts ) respect to an economic d[nturn qu>t] & applicable ,,fmap may elect to divide su* po9ts among m ?an #a qu>t] dur+ ! look-back p]iod = su* ,/ate & qu>t] provid$ t no excess p]c5tage po9t 7or fraction ( an excess p]c5tage po9t7 is appli$ to ! applicable ,,fmap ( m ?an #a qu>t]4 7,e7 ,limitations 7i7 ,no increases ov] #ajj p]c5t ,a ,/ate may n increase an applicable ,,fmap = any qu>t] dur+ a look-back p]iod "u ?is p>agraph if su* increase w\ld result 9 ! applicable ,,fmap = su* qu>t] exce$+ #ajj p]c5t4 7ii7 ,scope ( application ,any increase to an applicable ,,fmap ( a ,/ate = a fiscal qu>t] "u ?is p>agraph-- 7,i7 %all only apply ) respect to paym5ts = am\nts exp5d$ by ! ,/ate = m$ical assi/ance = s]vices furni%$ dur+ su* qu>t] to :i* su* applicable ,,fmap is applicable2 & 7,,ii7 %all n apply ) respect to paym5ts describ$ 9 p>agraph 7#c77;,b77i74 7,f7 ,def9itions ,9 ?is p>agraph3 7i7 ,applicable ,,fmap ,! t]m applicable ,,fmap means1 ) respect to a ,/ate & fiscal qu>t]-- 7,i7 ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = ! ,/ate & qu>t] "u subsection 7b72 7,,ii7 ! ,f$]al m$ical assi/ance p]c5tage applicable "u subsection 7y72 7,,iii7 ! ,f$]al m$ical assi/ance p]c5tage applicable "u subsection 7z77#b72 7,,iv7 ! ,f$]al m$ical assi/ance p]c5tage det]m9$ = ! ,/ate & qu>t] "u subsection 7ff72 or 7,v7 ! enhanc$ ,,fmap det]m9$ = ! ,/ate & qu>t] "u section #baje7;b74 7ii7 ,look-back p]iod ,! t]m look-back p]iod means1 ) respect to a ,/ate & a fiscal qu>t] t is an economic d[nturn qu>t] = ! ,/ate1 ! p]iod ( #d fiscal qu>t]s t ends ) ! f\r? qu>t] :i* prec$es ! mo/ rec5t fiscal qu>t]s t 0 n an economic d[nturn qu>t] = ! ,/ate4 7#f7 ,requirem5t = all ,/ates ,?is subsection %all n apply to a ,/ate ) respect to a fiscal qu>t]1 if-- 7,a7 eligibility /&>ds1 me?odologies1 or proc$ures "u ! ,/ate plan or a waiv] ( su* plan are m re/rictive dur+ su* qu>t] ?an ! eligibility /&>ds1 me?odologies1 or proc$ures1 respectively1 "u su* plan 7or waiv]7 z 9 effect on ! la/ day ( ! mo/ rec5t fiscal qu>t] t 0 n an economic d[nturn qu>t] = ! ,/ate2 7,b7 ! am\nt ( any premium impos$ by ! ,/ate pursuant to section #aiaf or #aiaf;,a dur+ su* qu>t]1 ) respect to an individual enroll$ "u su* plan 7or waiv]71 exce$s ! am\nt ( su* premium z ( ! date describ$ 9 subp>agraph 7,a72 or 7,c7 ! ,/ate fails to provide t an individual :o is enroll$ = b5efits "u su* plan 7or waiv]7 z ( ! date describ$ 9 subp>agraph 7,a7 or enrolls = b5efits "u su* plan 7or waiv]7 dur+ ! p]iod beg9n+ ) su* date & end+ ) ! day be=e ! fir/ day ( ! next qu>t] t is n an economic d[nturn qu>t] = ! ,/ate %all be treat$ z eligible = su* b5efits = n less ?an #ab mon?s aft] su* date or 7if lat]7 ! date t su* individual s enrolls unless ! individual reque/s a volunt>y t]m9ation ( eligibility or ! individual ceases to be a resid5t ( ! ,/ate4 4 7b7 ,exclusion ( economic d[nturn ,,fmap increases f t]ritorial caps2 special rule = ,,*ip allotm5ts 7#a7 ,exclusion f t]ritorial caps ,section #aajh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acjh7 is am5d$-- 7,a7 9 subsection 7f71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ subsections 7g7 & 7h7 & ins]t+ subsections 7g71 7h71 & 7j72 & 7,b7 by add+ at ! end ! foll[+3 7j7 ,exclusion f caps ( am\nts attributable to economic d[nturn ,,fmap ,any paym5t made to a t]ritory = a fiscal ye> 9 :i* ! ,f$]al m$ical assi/ance p]c5tage = ! t]ritory is det]m9$ "u section #aije7ll7 %all n be tak5 into acc\nt = purposes ( apply+ paym5t limits "u subsections 7f7 & 7g7 to ! ext5t t su* paym5t exce$s ! am\nt ( ! paym5t t w\ld h be5 made to ! t]ritory = ! ye> if ! ,f$]al m$ical assi/ance p]c5tage = ! t]ritory _h be5 det]m9$ )\t reg>d to su* section4 4 7#b7 ,,*ip allotm5ts ,section #bajd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;dd7m77 is am5d$-- 7,a7 9 p>agraph 7#b77;,b71 9 ! matt] prec$+ clause 7i71 by /rik+ p>agraphs 7#e71 7#g71 & 7#ab7 & ins]t+ p>agraphs 7#e71 7#g71 7#ab71 & 7#ac72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#ac7 ,special rule = adju/+ allotm5ts dur+ fiscal ye>s ) economic d[nturn qu>t]s 7,a7 ,9 g5]al ,if a fiscal qu>t] is det]m9$ "u section #aije7ll7 to be an economic d[nturn qu>t] ) respect to a ,/ate !n1 z soon z practicable aft] su* det]m9ation1 ! ,secret>y %all increase ! allotm5t = ! ,/ate & ! fiscal ye> 9 :i* su* fiscal qu>t] occurs 9 accordance ) subp>agraph 7,b74 7,b7 ,am\nt ( increase 7i7 ,9 g5]al ,! am\nt ( an increase to ! allotm5t ( a ,/ate describ$ 9 subp>agraph 7,a7 = a fiscal ye> %all be equal to ! am\nt by :i* ,f$]al paym5ts made to ! ,/ate = ! prec$+ fiscal ye> "u ?is title w\ld h be5 increas$ 7)\t reg>d to :e!r su* paym5ts w\ld exce$ ! am\nt ( ! ,/ate's allotm5t = su* prec$+ fiscal ye>7 if ! enhanc$ ,,fmap det]m9$ = ! ,/ate = su* prec$+ fiscal ye> _h be5 increas$ to ! same ext5t t ! ,/ate's enhanc$ ,,fmap = ! fiscal ye> involv$ is expect$ to be increas$ z a result ( ! application ( section #aije7ll7 relative to ! enhanc$ ,,fmap t w\ld apply to ! ,/ate = ! fiscal ye> involv$ )\t ! application ( su* section4 7ii7 ,inclusion ( project$ increases ,9 increas+ ! allotm5t ( a ,/ate = a fiscal ye> "u ?is p>agraph1 ! ,secret>y may base ! calculation ( su* increase on projections made by ! ,secret>y ) respect to-- 7,i7 ! numb] ( fiscal qu>t]s dur+ su* fiscal ye> t w be economic d[nturn qu>t]s2 & 7,,ii7 ! effect t ! application ( section #aije7ll7 is expect$ to h on ! enhanc$ ,,fmap ( ! ,/ate = su* fiscal ye>4 7,c7 ,disreg>d ( increas$ paym5ts = purposes ( future allotm5ts ,any ,f$]al paym5t made to a ,/ate "u ?is title = a fiscal ye> 9 :i* ! ,f$]al m$ical assi/ance p]c5tage = ! ,/ate is det]m9$ "u section #aije7ll7 %all be disreg>d$ :5 det]m9+ ! allotm5t ( ! ,/ate = any subsequ5t ye>1 includ+ = purposes ( apply+ ?is p>agraph1 to ! ext5t t su* paym5t exce$s ! am\nt ( ! paym5t t w\ld h be5 made to ! ,/ate = ! ye> if ! ,f$]al m$ical assi/ance p]c5tage = ! ,/ate & ye> _h be5 det]m9$ )\t reg>d to su* section4 4 ,,iv ,l[]+ drug co/s #dja4 ,exp&+ ,m$ic>e ,drug price negotiation 7a7 ,9 g5]al ,section #aaib7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7;a77 is am5d$-- 7#a7 9 p>agraph 7#c71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#d7-- 7,a7 by /rik+ or a subsequ5t ye>2 & 7,b7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#e7 ) respect to ! initial price applicability ye> #bjcj1 #cj negotiation-eligible drugs describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7d77#a7 ) respect to su* ye> 7or1 all 7if su* numb] is less ?an #cj7 su* negotiation-eligible drugs ) respect to su* ye>72 7#f7 ) respect to ! initial price applicability ye> #bjca1 #dj negotiation-eligible drugs describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7d77#a7 ) respect to su* ye> 7or1 all 7if su* numb] is less ?an #dj7 su* negotiation-eligible drugs ) respect to su* ye>72 & 7#g7 ) respect to ! initial price applicability ye> #bjcb or a subsequ5t ye>1 #ej negotiation-eligible drugs describ$ 9 subp>agraph 7,a7 or 7,b7 ( subsection 7d77#a74 4 7b7 ,expansion ( def9ition ( maximum fair price eligible individual ,section #aaia7;c77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f7c77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ 1 or a p>ticipant1 b5efici>y1 or enrollee :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or disp5s$ aft] su* select$ drug2 & 7#b7 9 subp>agraph 7,b71 by ins]t+ 1 or a p>ticipant1 b5efici>y1 or enrollee :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or adm9i/]$ aft] su* select$ drug4 7c7 ,application ( adm9i/rative proc$ures to new maximum fair price eligible individuals ,section #aaif7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#e7;a77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 maximum fair price eligible individuals n describ$ 9 subp>agraph 7,a7 or 7,b74 4 7d7 ,heal? insur] agreem5ts ,"p ,e ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f et seq47 is am5d$-- 7#a7 by r$esignat+ sections #aaig & #aaih z sections #aaih & #aaii1 respectively2 & 7#b7 by ins]t+ aft] section #aaif ! foll[+ new section3 #aaig4 ,volunt>y p>ticipation by o!r heal? plans 7a7 ,agreem5t ,to p>ticipate "u program 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 "u ! program "u ?is "p ! ,secret>y %all be treat$ z hav+ 9 effect an agreem5t ) a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod-- 7,a7 9 ! case su* select$ drug furni%$ or disp5s$ at a ph>macy or by mail ord] s]vice if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or disp5s$2 & 7,b7 9 ! case su* select$ drug furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli] if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,opt+ out ( agreem5t ,! ,secret>y %all n be treat$ z hav+ 9 effect an agreem5t "u ! program "u ?is "p ) a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod if su* a plan or issu] affirmatively elects1 ?r\gh a process specifi$ by ! ,secret>y1 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 7b7 ,publication ( election ,) respect to ea* price applicability p]iod & ea* select$ drug ) respect to su* p]iod1 ! ,secret>y1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury1 z applicable1 %all make public a li/ ( ea* gr\p heal? plan & ea* heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 ) respect to :i* cov]age is provid$ "u su* plan or cov]age = su* drug1 t has elect$ "u subsection 7a7 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 4 7e7 ,application to gr\p heal? plans & heal? insurance cov]age 7#a7 ,,phsa ,"p ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #bgii;,a-#ab4 ,drug ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod = :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply-- 7,a7 9 ! case ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to su* plan or cov]age1 & to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ "u su* plan or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to p>ticipants1 b5efici>ies1 & enrollees enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 9 ! case ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to su* plan or cov]age1 & to ! p>ticipants1 b5efici>ies1 & enrollees enroll$ "u su* plan or cov]age1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y1 to p>ticipants1 b5efici>ies1 & enrollees entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 su* p>ticipants1 b5efici>ies1 & enrollees s enroll$ 9 su* plans & cov]age1 & su* hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ 9 su* plans & cov]age4 7b7 ,notification reg>d+ nonp>ticipation 9 ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all publicly disclose1 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y1 any election made "u section #aaig ( ! ,social ,security ,act by su* plan or issu] to n p>ticipate 9 ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7#b7 ,,erisa 7,a7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gbg4 ,drug ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y ( ,heal? & ,human ,s]vices "u ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod = :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 9 ! case ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to su* plan or cov]age1 & to ! p>ticipants & b5efici>ies enroll$ "u su* plan or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to p>ticipants & b5efici>ies enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 9 ! case ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! gr\p heal? plan or cov]age (f]$ by an issu]1 to ! p>ticipants & b5efici>ies enroll$ "u su* plans or cov]age1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y ( ,heal? & ,human ,s]vices1 to p>ticipants & b5efici>ies entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 & su* p>ticipants & b5efici>ies s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,application to retiree & c]ta9 small gr\p heal? plans ,section #gcb7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaia;a7a77 is am5d$ by /rik+ & #gbf & ins]t+ #gbf1 & #gbg4 7,c7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( su* ,act is am5d$ by ins]t+ aft] ! item relat+ to section #gbf ! foll[+ new item3 ,sec4 #gbg4 ,drug ,price ,negotiation ,program & application ( maximum fair prices4 4 7#c7 ,,irc 7,a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihbg4 ,drug ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y ( ,heal? & ,human ,s]vices "u ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod = :i* cov]age is provid$ "u su* plan-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plan1 & to ! p>ticipants & b5efici>ies enroll$ "u su* plan dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to p>ticipants & b5efici>ies enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 if cov]age ( su* select$ drug is provid$ "u su* plan if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plan1 to ! p>ticipants & b5efici>ies enroll$ "u su* plan1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y ( ,heal? & ,human ,s]vices1 to p>ticipants & b5efici>ies entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan %all apply any co/-%>+ responsibilities "u su* plan1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan & su* p>ticipants & b5efici>ies s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,drug ,price ,negotiation ,program ,a gr\p heal? plan %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan to n p>ticipate 9 ! ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,application to retiree & c]ta9 small gr\p heal? plans ,section #ihca7;a77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or #ihbg aft] section #ihbf4 7,c7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbg4 ,drug ,price ,negotiation ,program & application ( maximum fair prices4 4 #djb4 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket 7a7 ,"p ,b drugs 7#a7 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket ,section #ahdg;,a7i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7i77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a77i71 by /rik+ units & ins]t+ bill+ units2 7,b7 9 p>agraph 7#b77;,a71 by /rik+ = :i* paym5t is made "u ?is "p & ins]t+ t w\ld be payable "u ?is "p if su* drug 7 furni%$ to an individual enroll$ "u ?is "p2 & 7,c7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a77i71 by /rik+ units & ins]t+ bill+ units2 & 7ii7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,total numb] ( bill+ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( bill+ units ) respect to a "p ,b rebatable drug is det]m9$ z foll[s3 7i7 ,det]m9e ! total numb] ( units equal to-- 7,i7 ! total numb] ( units1 z report$ "u subsection 7c77#a77;,b71 = ea* ,national ,drug ,code ( su* drug dur+ ! cal5d> qu>t] t is #b cal5d> qu>t]s prior to ! cal5d> qu>t] z describ$ 9 subp>agraph 7,a71 m9us 7,,ii7 ! total numb] ( units ) respect to ea* ,national ,drug ,code ( su* drug = :i* paym5t 0 made "u a ,/ate plan "u title ,,xix 7or waiv] ( su* plan71 z report$ by ,/ates "u section #aibg7;b77#b77;,a7 = ! rebate p]iod t is ! same cal5d> qu>t] z describ$ 9 subclause 7,i74 7ii7 ,conv]t ! units det]m9$ "u clause 7i7 to bill+ units = ! bill+ & paym5t code ( su* drug1 us+ a me?odology simil> to ! me?odology us$ "u ?is section1 by divid+ ! units det]m9$ "u clause 7i7 = ea* ,national ,drug ,code ( su* drug by ! bill+ unit = ! bill+ & paym5t code ( su* drug4 7iii7 ,compute ! sum ( ! bill+ units = ea* ,national ,drug ,code ( su* drug 9 clause 7ii74 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to cal5d> qu>t]s beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 7b7 ,cov]$ "p ,d drugs 7#a7 ,application ( prescription drug inflation rebates to drugs furni%$ 9 ! comm]cial m>ket ,section #ahfj;,d-#ad;,b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;b7 is am5d$-- 7,a7 9 subsection 7b7-- 7i7 9 p>agraph 7#a7-- 7,i7 9 subp>agraph 7,a77i71 by /rik+ ! total numb] ( units & all t foll[s ?r\gh ! semicolon & ins]t+ ! foll[+3 ! total numb] ( units t are us$ to calculate ! av]age manufactur] price ( su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug1 z report$ by ! manufactur] ( su* drug "u section #aibg = ea* mon?1 ) respect to su* p]iod22 & 7,,ii7 by /rik+ subp>agraph 7,b7 & ins]t+ ! foll[+3 7,b7 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! ,secret>y %all exclude f ! total numb] ( units = a dosage =m & /r5g? ) respect to a "p ,d rebatable drug1 ) respect to an applicable p]iod1 ! foll[+3 7i7 ,units ( ea* dosage =m & /r5g? ( su* "p ,d rebatable drug = :i* paym5t 0 made "u a ,/ate plan "u title ,,xix 7or waiv] ( su* plan71 z report$ by ,/ates "u section #aibg7;b77#b77;,a74 7ii7 ,units ( ea* dosage =m & /r5g? ( su* "p ,d rebatable drug = :i* a rebate is paid "u section #ahdg;,a7i74 7iii7 ,beg9n+ ) plan ye> #bjbh1 units ( ea* dosage =m & /r5g? ( su* "p ,d rebatable drug = :i* ! manufactur] provides a disc\nt "u ! program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act4 2 & 7ii7 9 p>agraph 7#f71 by /rik+ in=mation & all t foll[s ?r\gh rebatable cov]$ "p ,d drug disp5s$ & ins]t+ ! foll[+3 ,,amp reports4--,! ,secret>y %all provide = a me?od & process "u :i*1 9 ! case ( a manufactur] ( a "p ,d rebatable drug t submits revisions to in=mation submitt$ "u section #aibg by ! manufactur] ) respect to su* drug2 & 7,b7 by /rik+ subsection 7d7 & ins]t+ ! foll[+3 7d7 ,in=mation ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all use in=mation submitt$ by manufactur]s "u section #aibg7;b77#c7 & in=mation submitt$ by ,/ates "u section #aibg7;b77#b77;,a74 4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all apply ) respect to applicable p]iods 7z def9$ 9 section #ahfj;,d-#ad;,b7g77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad;b7g77#g777 beg9n+ aft] ! date ( ! enactm5t ( ?is ,act4 #djc4 ,e/abli%+ an out-(-pocket limit on exp5ditures = prescription drugs "u gr\p heal? plans & gr\p & individual heal? insurance cov]age 7a7 ,,phsa ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$-- 7#a7 9 section #bgjg1 by add+ at ! end ! foll[+ new subsection3 7e7 ,sunset ,! prec$+ provisions ( ?is section %all n apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh4 2 & 7#b7 9 "p ,d1 z am5d$ by section #dja1 by add+ at ! end ! foll[+ new section3 #bgii;,a-#ac4 ,compreh5sive cov]age 7a7 ,cov]age = ess5tial heal? b5efits package ,a heal? insurance issu] t (f]s heal? insurance cov]age 9 ! individual or small gr\p m>ket %all ensure t su* cov]age includes ! ess5tial heal? b5efits package requir$ "u section #acjb7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 7b7 ,co/-,%>+ limitation 7#a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all ensure t-- 7,a7 any annual co/-%>+ impos$ "u ! plan or cov]age 7includ+ any su* co/-%>+ s impos$ ) respect to prescription drugs7 does n exce$ ! doll> am\nts specifi$ 9 p>agraph 7#b72 & 7,b7 any annual co/-%>+ impos$ "u ! plan or cov]age ) respect to prescription drugs does n exce$ ! doll> am\nts specifi$ 9 p>agraph 7#c74 7#b7 ,limitation on ov]all out-(-pocket co/-%>+ ,= purposes ( p>agraph 7#a77;,a71 ! doll> am\nts specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,) respect to self-only cov]age-- 7i7 = plan ye>s beg9n+ 9 #bjbh1 ! doll> am\nt 9 effect "u section #acjb7;c77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act = su* cov]age = plan ye>s beg9n+ 9 #bjad1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage specifi$ 9 p>agraph 7#d7 ( su* section = ! cal5d> ye>2 & 7ii7 = plan ye>s beg9n+ 9 #bjbi or a subsequ5t ye>1 ! doll> am\nt 9 effect "u ?is subp>agraph = plan ye>s beg9n+ 9 #bjbg1 increas$ by an am\nt equal to ! product ( t am\nt ! premium adju/m5t p]c5tage specifi$ 9 p>agraph 7#d7 = ! cal5d> ye>4 7,b7 ,) respect to cov]age o!r ?an self-only cov]age1 = plan ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 twice ! am\nt 9 effect "u subp>agraph 7,a7 = su* plan ye>4 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#c7 ,limitation on prescription drug out-(-pocket co/-%>+ ,= purposes ( p>agraph 7#a77;,b71 ! doll> am\nts specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,) respect to self-only cov]age-- 7i7 = plan ye>s beg9n+ 9 #bjbh1 #b1jjj2 & 7ii7 = plan ye>s beg9n+ 9 #bjbi or a subsequ5t ye>1 ! doll> am\nt 9 effect "u ?is subp>agraph = plan ye>s beg9n+ 9 #bjbh1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage "u p>agraph 7#d7 = ! cal5d> ye>4 7,b7 ,) respect to cov]age o!r ?an self-only cov]age1 = plan ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 twice ! am\nt 9 effect "u subp>agraph 7,a7 = su* plan ye>4 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#d7 ,premium adju/m5t p]c5tage ,= purposes ( p>agraphs 7#b77;,a77ii7 & 7#c77;,a77ii71 ! premium adju/m5t p]c5tage = any cal5d> ye> is ! p]c5tage 7if any7 by :i* ! av]age p] capita premium = heal? insurance cov]age 9 ! ,unit$ ,/ates = ! prec$+ cal5d> ye> 7z e/imat$ by ! ,secret>y no lat] ?an ,octob] #a ( su* prec$+ cal5d> ye>7 exce$s su* av]age p] capita premium = #bjbf 7z det]m9$ by ! ,secret>y74 7#e7 ,co/-%>+ ,9 ?is section3 7,a7 ,9 g5]al ,! t]m co/-%>+ includes-- 7i7 d$uctibles1 co9surance1 copaym5ts1 or simil> *>ges2 & 7ii7 any o!r exp5diture requir$ ( an insur$ individual :i* is a qualifi$ m$ical exp5se 7)9 ! mean+ ( section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 ) respect to ess5tial heal? b5efits cov]$ "u ! plan or cov]age4 7,b7 ,exceptions ,su* t]m does n include premiums1 balance bill+ am\nts = non-network provid]s1 or sp5d+ = non-cov]$ s]vices4 7#f7 ,implem5tation ,! ,secret>y may implem5t ! provisions ( ?is subsection by subregulatory guidance1 int]im f9al rule1 or o!rwise4 7c7 ,*ild-,only plans ,if a heal? insurance issu] (f]s heal? insurance cov]age 9 any level ( cov]age specifi$ "u section #acjb7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act1 ! issu] %all also (f] su* cov]age 9 t level z a plan 9 :i* ! only enrollees are individuals :o1 z ( ! beg9n+ ( a plan ye>1 h n atta9$ ! age ( #ba4 7d7 ,d5tal only ,?is section %all n apply to a plan describ$ 9 section #acaa7;d77#b77;,b77ii7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 4 7b7 ,,erisa 7#a7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe et seq471 z am5d$ by section #dja1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #gbh4 ,compreh5sive cov]age 7a7 ,cov]age = ess5tial heal? b5efits package ,a heal? insurance issu] t (f]s heal? insurance cov]age 9 ! small gr\p m>ket %all ensure t su* cov]age includes ! ess5tial heal? b5efits package requir$ "u section #acjb7;a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 7b7 ,co/-,%>+ limitation 7#a7 ,9 g5]al ,a gr\p heal? plan & a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all ensure t-- 7,a7 any annual co/-%>+ impos$ "u ! plan or cov]age 7includ+ any su* co/-%>+ s impos$ ) respect to prescription drugs7 does n exce$ ! doll> am\nts specifi$ 9 p>agraph 7#b72 & 7,b7 any annual co/-%>+ impos$ "u ! plan or cov]age ) respect to prescription drugs does n exce$ ! doll> am\nts specifi$ 9 p>agraph 7#c74 7#b7 ,limitation on ov]all out-(-pocket co/-%>+ ,= purposes ( p>agraph 7#a77;,a71 ! doll> am\nts specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,) respect to self-only cov]age-- 7i7 = plan ye>s beg9n+ 9 #bjbh1 ! doll> am\nt 9 effect "u section #acjb7;c77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act = su* cov]age = plan ye>s beg9n+ 9 #bjad1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage specifi$ 9 p>agraph 7#d7 ( su* section = ! cal5d> ye>2 & 7ii7 = plan ye>s beg9n+ 9 #bjbi or a subsequ5t ye>1 ! doll> am\nt 9 effect "u ?is subp>agraph = plan ye>s beg9n+ 9 #bjbh1 increas$ by an am\nt equal to ! product ( t am\nt ! premium adju/m5t p]c5tage specifi$ 9 p>agraph 7#d7 = ! cal5d> ye>4 7,b7 ,) respect to cov]age o!r ?an self-only cov]age1 = plan ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 twice ! am\nt 9 effect "u subp>agraph 7,a7 = su* plan ye>4 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#c7 ,limitation on prescription drug out-(-pocket co/-%>+ ,= purposes ( p>agraph 7#a77;,b71 ! doll> am\nts specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,) respect to self-only cov]age-- 7i7 = plan ye>s beg9n+ 9 #bjbh1 #b1jjj2 & 7ii7 = plan ye>s beg9n+ 9 #bjbi or a subsequ5t ye>1 ! doll> am\nt 9 effect "u ?is subp>agraph = plan ye>s beg9n+ 9 #bjbh1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage "u p>agraph 7#d7 = ! cal5d> ye>4 7,b7 ,) respect to cov]age o!r ?an self-only cov]age1 = plan ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 twice ! am\nt 9 effect "u subp>agraph 7,a7 = su* plan ye>4 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#d7 ,premium adju/m5t p]c5tage ,= purposes ( p>agraphs 7#b77;,a77ii7 & 7#c77;,a77ii71 ! premium adju/m5t p]c5tage = any cal5d> ye> is ! p]c5tage 7if any7 by :i* ! av]age p] capita premium = heal? insurance cov]age 9 ! ,unit$ ,/ates = ! prec$+ cal5d> ye> 7z e/imat$ by ! ,secret>y no lat] ?an ,octob] #a ( su* prec$+ cal5d> ye>7 exce$s su* av]age p] capita premium = #bjbg 7z det]m9$ by ! ,secret>y74 7#e7 ,co/-%>+ ,9 ?is section3 7,a7 ,9 g5]al ,! t]m co/-%>+ includes-- 7i7 d$uctibles1 co9surance1 copaym5ts1 or simil> *>ges2 & 7ii7 any o!r exp5diture requir$ ( an insur$ individual :i* is a qualifi$ m$ical exp5se 7)9 ! mean+ ( section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 ) respect to ess5tial heal? b5efits cov]$ "u ! plan or cov]age4 7,b7 ,exceptions ,su* t]m does n include premiums1 balance bill+ am\nts = non-network provid]s1 or sp5d+ = non-cov]$ s]vices4 7#f7 ,implem5tation ,! ,secret>y may implem5t ! provisions ( ?is subsection by subregulatory guidance1 int]im f9al rule1 or o!rwise4 7c7 ,*ild-,only plans ,if a heal? insurance issu] (f]s heal? insurance cov]age 9 any level ( cov]age specifi$ "u section #acjb7;d7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act1 ! issu] %all also (f] su* cov]age 9 t level z a plan 9 :i* ! only enrollees are individuals :o1 z ( ! beg9n+ ( a plan ye>1 h n atta9$ ! age ( #ba4 7d7 ,d5tal only ,?is section %all n apply to a plan describ$ 9 section #acaa7;d77#b77;,b77ii7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( su* ,act1 z am5d$ by section #dja1 is fur!r am5d$ by ins]t+ aft] ! item relat+ to section #gbg ! foll[+ new item3 ,sec4 #gbh4 ,compreh5sive cov]age4 4 7c7 ,,irc 7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #dja1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #ihbh4 ,compreh5sive cov]age 7a7 ,co/-,%>+ limitation 7#a7 ,9 g5]al ,a gr\p heal? plan %all ensure t-- 7,a7 any annual co/-%>+ impos$ "u ! plan 7includ+ any su* co/-%>+ s impos$ ) respect to prescription drugs7 does n exce$ ! doll> am\nts specifi$ 9 p>agraph 7#b72 & 7,b7 any annual co/-%>+ impos$ "u ! plan ) respect to prescription drugs does n exce$ ! doll> am\nts specifi$ 9 p>agraph 7#c74 7#b7 ,limitation on ov]all out-(-pocket co/-%>+ ,= purposes ( p>agraph 7#a77;,a71 ! doll> am\nts specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,) respect to self-only cov]age-- 7i7 = plan ye>s beg9n+ 9 #bjbh1 ! doll> am\nt 9 effect "u section #acjb7;c77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act = su* cov]age = plan ye>s beg9n+ 9 #bjad1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage specifi$ 9 p>agraph 7#d7 ( su* section = ! cal5d> ye>2 & 7ii7 = plan ye>s beg9n+ 9 #bjbi or a subsequ5t ye>1 ! doll> am\nt 9 effect "u ?is subp>agraph = plan ye>s beg9n+ 9 #bjbh1 increas$ by an am\nt equal to ! product ( t am\nt ! premium adju/m5t p]c5tage specifi$ 9 p>agraph 7#d7 = ! cal5d> ye>4 7,b7 ,) respect to cov]age o!r ?an self-only cov]age1 = plan ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 twice ! am\nt 9 effect "u subp>agraph 7,a7 = su* plan ye>4 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#c7 ,limitation on prescription drug out-(-pocket co/-%>+ ,= purposes ( p>agraph 7#a77;,b71 ! doll> am\nts specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,) respect to self-only cov]age-- 7i7 = plan ye>s beg9n+ 9 #bjbh1 #b1jjj2 & 7ii7 = plan ye>s beg9n+ 9 #bjbi or a subsequ5t ye>1 ! doll> am\nt 9 effect "u ?is subp>agraph = plan ye>s beg9n+ 9 #bjbh1 increas$ by an am\nt equal to ! product ( t am\nt & ! premium adju/m5t p]c5tage "u p>agraph 7#d7 = ! cal5d> ye>4 7,b7 ,) respect to cov]age o!r ?an self-only cov]age1 = plan ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 twice ! am\nt 9 effect "u subp>agraph 7,a7 = su* plan ye>4 ,if ! am\nt ( any increase "u subp>agraph 7,a7 is n a multiple ( #ej1 su* increase %all be r\nd$ to ! next l[e/ multiple ( #ej4 7#d7 ,premium adju/m5t p]c5tage ,= purposes ( p>agraphs 7#b77;,a77ii7 & 7#c77;,a77ii71 ! premium adju/m5t p]c5tage = any cal5d> ye> is ! p]c5tage 7if any7 by :i* ! av]age p] capita premium = heal? insurance cov]age 9 ! ,unit$ ,/ates = ! prec$+ cal5d> ye> 7z e/imat$ by ! ,secret>y no lat] ?an ,octob] #a ( su* prec$+ cal5d> ye>7 exce$s su* av]age p] capita premium = #bjbf 7z det]m9$ by ! ,secret>y74 7#e7 ,co/-%>+ ,9 ?is section3 7,a7 ,9 g5]al ,! t]m co/-%>+ includes-- 7i7 d$uctibles1 co9surance1 copaym5ts1 or simil> *>ges2 & 7ii7 any o!r exp5diture requir$ ( an insur$ individual :i* is a qualifi$ m$ical exp5se 7)9 ! mean+ ( section #bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf7 ) respect to ess5tial heal? b5efits cov]$ "u ! plan4 7,b7 ,exceptions ,su* t]m does n include premiums1 balance bill+ am\nts = non-network provid]s1 or sp5d+ = non-cov]$ s]vices4 7#f7 ,implem5tation ,! ,secret>y may implem5t ! provisions ( ?is subsection by subregulatory guidance1 int]im f9al rule1 or o!rwise4 7b7 ,d5tal only ,?is section %all n apply to a plan describ$ 9 section #acaa7;d77#b77;,b77ii7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #dja1 is fur!r am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbh4 ,compreh5sive cov]age4 4 7d7 ,con=m+ am5dm5ts ,! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh7 is am5d$-- 7#a7 9 section #acjb-- 7,a7 9 subsection 7a77#b71 by ins]t+ ) respect to plan ye>s beg9n+ be=e ,janu>y #a1 #bjbg1 be=e limits co/-%>+2 & 7,b7 9 subsection 7e77#a77;,b77i7-- 7i7 by ins]t+ 7or1 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 9 effect "u section #bgii;,a-#ac7;b77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act7 aft] subsection 7c77#a72 & 7ii7 by ins]t+ & except1 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 9 ! case ( an individual :o has incurr$ co/-%>+ exp5ses ) respect to prescription drugs 9 an am\nt equal to ! annual limitation 9 effect "u section #bgii;,a-#ac7;b77#a77;,b7 ( su* ,act1 = b5efits consi/+ ( prescription drugs aft] section #bgac2 & 7#b7 9 section #adjb7;c77#a77;,a71 by ins]t+ 7or1 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 ! applicable out-(-pocket limit "u section #bgii;,a-#ac7;b77#a77;,a7 ( ! ,public ,heal? ,s]vice ,act7 aft] section #acjb7;c77#a74 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh4 #djd4 ,requirem5ts ) respect to co/-%>+ = insul9 products 7a7 ,,phsa ,"p ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 z am5d$ by section #djc1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #bgii;,a-#ad4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all provide cov]age ( select$ insul9 products1 & ) respect to su* products1 %all n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ 9 excess ( ! less] (1 p] #cj-;day supply-- 7,a7 #ce2 or 7,b7 ! am\nt equal to #be p]c5t ( ! negotiat$ price ( ! select$ insul9 product net ( all price concessions receiv$ by or on behalf ( ! plan or cov]age1 includ+ price concessions receiv$ by or on behalf ( ?ird-p>ty entities provid+ s]vices to ! plan or cov]age1 su* z ph>macy b5efit managem5t s]vices4 7b7 ,def9itions ,9 ?is section3 7#a7 ,select$ insul9 products ,! t]m select$ insul9 products means at lea/ "o ( ea* dosage =m 7su* z vial1 pump1 or inhal] dosage =ms7 ( ea* diff]5t type 7su* z rapid-act+1 %ort-act+1 int]m$iate-act+1 long-act+1 ultra long-act+1 & premix$7 ( insul9 7z def9$ bel[71 :5 available1 z select$ by ! gr\p heal? plan or heal? insurance issu]4 7#b7 ,insul9 def9$ ,! t]m insul9 means insul9 t is lic5s$ "u subsection 7a7 or 7k7 ( section #cea & cont9ues to be m>ket$ "u su* section4 7c7 ,out-(-,network provid]s ,no?+ 9 ?is section requires a plan or issu] t has a network ( provid]s to provide b5efits = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]1 or precludes a plan or issu] t has a network ( provid]s f impos+ high] co/-%>+ ?an ! levels specifi$ 9 subsection 7a7 = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]4 7d7 ,rule ( con/ruction ,subsection 7a7 %all n be con/ru$ to require cov]age (1 or prev5t a gr\p heal? plan or heal? insurance cov]age f impos+ co/-%>+ o!r ?an ! levels specifi$ 9 subsection 7a7 on1 insul9 products t are n select$ insul9 products1 to ! ext5t t su* cov]age is n o!rwise requir$ & su* co/-%>+ is o!rwise p]mitt$ "u ,f$]al & applicable ,/ate law4 7e7 ,application ( co/-,%>+ t[>ds d$uctibles & out-(-,pocket maximums ,any co/-%>+ paym5ts made pursuant to subsection 7a77#b7 %all be c\nt$ t[>d any d$uctible or out-(-pocket maximum t applies "u ! plan or cov]age4 4 7b7 ,,erisa 7#a7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe et seq471 z am5d$ by section #djc1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #gbi4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all provide cov]age ( select$ insul9 products1 & ) respect to su* products1 %all n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ 9 excess ( ! less] (1 p] #cj-;day supply-- 7,a7 #ce2 or 7,b7 ! am\nt equal to #be p]c5t ( ! negotiat$ price ( ! select$ insul9 product net ( all price concessions receiv$ by or on behalf ( ! plan or cov]age1 includ+ price concessions receiv$ by or on behalf ( ?ird-p>ty entities provid+ s]vices to ! plan or cov]age1 su* z ph>macy b5efit managem5t s]vices4 7b7 ,def9itions ,9 ?is section3 7#a7 ,select$ insul9 products ,! t]m select$ insul9 products means at lea/ "o ( ea* dosage =m 7su* z vial1 pump1 or inhal] dosage =ms7 ( ea* diff]5t type 7su* z rapid-act+1 %ort-act+1 int]m$iate-act+1 long-act+1 ultra long-act+1 & premix$7 ( insul9 7z def9$ bel[71 :5 available1 z select$ by ! gr\p heal? plan or heal? insurance issu]4 7#b7 ,insul9 def9$ ,! t]m insul9 means insul9 t is lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & cont9ues to be m>ket$ "u su* section4 7c7 ,out-(-,network provid]s ,no?+ 9 ?is section requires a plan or issu] t has a network ( provid]s to provide b5efits = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]1 or precludes a plan or issu] t has a network ( provid]s f impos+ high] co/-%>+ ?an ! levels specifi$ 9 subsection 7a7 = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]4 7d7 ,rule ( con/ruction ,subsection 7a7 %all n be con/ru$ to require cov]age (1 or prev5t a gr\p heal? plan or heal? insurance cov]age f impos+ co/-%>+ o!r ?an ! levels specifi$ 9 subsection 7a7 on1 insul9 products t are n select$ insul9 products1 to ! ext5t t su* cov]age is n o!rwise requir$ & su* co/-%>+ is o!rwise p]mitt$ "u ,f$]al & applicable ,/ate law4 7e7 ,application ( co/-,%>+ t[>ds d$uctibles & out-(-,pocket maximums ,any co/-%>+ paym5ts made pursuant to subsection 7a77#b7 %all be c\nt$ t[>d any d$uctible or out-(-pocket maximum t applies "u ! plan or cov]age4 4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( su* ,act is am5d$ by ins]t+ aft] ! item relat+ to section #gbh 7z ins]t$ by section #djc7 ! foll[+ new item3 ,sec4 #gbi4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products4 4 7c7 ,,irc 7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #djc1 is fur!r am5d$ by add+ at ! end ! foll[+ new section3 #ihbi4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 a gr\p heal? plan %all provide cov]age ( select$ insul9 products1 & ) respect to su* products1 %all n-- 7#a7 apply any d$uctible2 or 7#b7 impose any co/-%>+ 9 excess ( ! less] (1 p] #cj-;day supply-- 7,a7 #ce2 or 7,b7 ! am\nt equal to #be p]c5t ( ! negotiat$ price ( ! select$ insul9 product net ( all price concessions receiv$ by or on behalf ( ! plan1 includ+ price concessions receiv$ by or on behalf ( ?ird-p>ty entities provid+ s]vices to ! plan1 su* z ph>macy b5efit managem5t s]vices4 7b7 ,def9itions ,9 ?is section3 7#a7 ,select$ insul9 products ,! t]m select$ insul9 products means at lea/ "o ( ea* dosage =m 7su* z vial1 pump1 or inhal] dosage =ms7 ( ea* diff]5t type 7su* z rapid-act+1 %ort-act+1 int]m$iate-act+1 long-act+1 ultra long-act+1 & premix$7 ( insul9 7z def9$ bel[71 :5 available1 z select$ by ! gr\p heal? plan4 7#b7 ,insul9 def9$ ,! t]m insul9 means insul9 t is lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & cont9ues to be m>ket$ "u su* section4 7c7 ,out-(-,network provid]s ,no?+ 9 ?is section requires a plan t has a network ( provid]s to provide b5efits = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]1 or precludes a plan t has a network ( provid]s f impos+ high] co/-%>+ ?an ! levels specifi$ 9 subsection 7a7 = select$ insul9 products describ$ 9 ?is section t are deliv]$ by an out-(-network provid]4 7d7 ,rule ( con/ruction ,subsection 7a7 %all n be con/ru$ to require cov]age (1 or prev5t a gr\p heal? plan f impos+ co/-%>+ o!r ?an ! levels specifi$ 9 subsection 7a7 on1 insul9 products t are n select$ insul9 products1 to ! ext5t t su* cov]age is n o!rwise requir$ & su* co/-%>+ is o!rwise p]mitt$ "u ,f$]al & applicable ,/ate law4 7e7 ,application ( co/-,%>+ t[>ds d$uctibles & out-(-,pocket maximums ,any co/-%>+ paym5ts made pursuant to subsection 7a77#b7 %all be c\nt$ t[>d any d$uctible or out-(-pocket maximum t applies "u ! plan4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #djc1 is fur!r am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbi4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products4 4 7d7 ,no effect on o!r co/-,%>+ ,section #acjb7;d77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;d77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,special rule relat+ to insul9 cov]age ,! exemption ( cov]age ( select$ insul9 products 7z def9$ 9 section #bgii;,a-#ad7;b7 ( ! ,public ,heal? ,s]vice ,act7 f ! application ( any d$uctible pursuant to section #bgii;,a-#ad7;a77#a7 ( su* ,act1 section #gbi7;a77#a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihbi7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf %all n be consid]$ :5 det]m9+ ! actu>ial value ( a qualifi$ heal? plan "u ?is subsection4 4 7e7 ,cov]age ( c]ta9 insul9 products "u cata/rophic plans ,section #acjb7;e7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,cov]age ( c]ta9 insul9 products 7,a7 ,9 g5]al ,not)/&+ p>agraph 7#a77;,b77i71 a heal? plan describ$ 9 p>agraph 7#a7 %all provide cov]age ( select$ insul9 products1 9 accordance ) section #bgii;,a-#ad ( ! ,public ,heal? ,s]vice ,act1 = a plan ye> be=e an enroll$ individual has incurr$ co/-%>+ exp5ses 9 an am\nt equal to ! annual limitation 9 effect "u subsection 7c77#a7 = ! plan ye>4 7,b7 ,t]m9ology ,= purposes ( subp>agraph 7,a7-- 7i7 ! t]m select$ insul9 products has ! mean+ giv5 su* t]m 9 section #bgii;,a-#ad7;b7 ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 ! requirem5ts ( section #bgii;,a-#ad ( su* ,act %all be appli$ by deem+ ea* ref]5ce 9 su* section to individual heal? insurance cov]age to be a ref]5ce to a plan describ$ 9 p>agraph 7#a74 4 ,v ,ensur+ quality heal? insurance & remov+ b>ri]s to c>e #eja4 ,requir$ exceptions process = m$ication /ep !rapy protocols 7a7 ,requir$ exceptions process = m$ication /ep !rapy protocols ,! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by ins]t+ aft] section #gac ( su* ,act 7#bi ,u4,s4,c4 #aahe;b7 ! foll[+ new section3 #gac;,a4 ,requir$ exceptions process = m$ication /ep !rapy protocols 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ cov]age (f]$ 9 connection ) su* a plan t provides cov]age ( a prescription drug pursuant to a m$ication /ep !rapy protocol1 ! plan or issu] %all-- 7#a7 implem5t a cle>1 prompt1 & transp>5t process = a p>ticipant or b5efici>y 7or ! prescrib+ heal? c>e provid] 7ref]r$ to 9 ?is section z ! prescrib]7 on behalf ( ! p>ticipant or b5efici>y7 to reque/ an exception to su* m$ication /ep !rapy protocol1 pursuant to subsection 7b72 & 7#b7 :]e ! p>ticipant or b5efici>y or prescrib]'s reque/ = an exception to ! m$ication /ep !rapy protocols satisfies ! crit]ia & requirem5ts ( subsection 7b71 cov] ! reque/$ drug 9 accordance ) ! t]ms e/abli%$ by ! plan or cov]age = pati5t co/-%>+ rates or am\nts at ! beg9n+ ( ! plan ye>4 7b7 ,circum/ances = exception approval ,! circum/ances requir+ an exception to a m$ication /ep !rapy protocol1 pursuant to a reque/ "u subsection 7a71 are any ( ! foll[+3 7#a7 ,any treatm5ts o!rwise requir$ "u ! protocol1 or treatm5ts 9 ! same ph>macological class or hav+ ! same me*anism ( action1 includ+ treatm5ts provid$ prior to ! effective date ( ! p>ticipant's or b5efici>y's cov]age "u ! plan or cov]age1 h be5 ineffective 9 ! treatm5t ( ! disease or condition ( ! p>ticipant or b5efici>y1 :5 prescrib$ consi/5t ) cl9ical indications1 cl9ical guidel9es1 or o!r pe]-review$ evid5ce1 bas$ on ! prescrib+ heal? c>e pr(essional's judgem5t or relevant in=mation provid$ by ! p>ticipant or b5efici>y 7includ+ ! m$ical records ( ! p>ticipant or b5efici>y74 7#b7 ,delay ( effective treatm5t w\ld lead to sev]e or irrev]sible consequ5ces1 or wors5 disease progression or a comorbidity & ! treatm5t o!rwise requir$ "u ! protocol is reasonably expect$ by ! prescrib] to be ineffective bas$ ^u ! docum5t$ physical or m5tal *>act]i/ics ( ! p>ticipant or b5efici>y & ! kn[n *>act]i/ics ( su* treatm5t4 7#c7 ,any treatm5ts o!rwise requir$ "u ! protocol are contra9dicat$ = ! p>ticipant or b5efici>y or h caus$1 or are likely to cause1 bas$ on cl9ical1 pe]-review$ evid5ce1 an adv]se reaction or o!r physical or m5tal h>m to ! p>ticipant or b5efici>y4 7#d7 ,any treatm5t o!rwise requir$ "u ! protocol has prev5t$1 w prev5t1 or is likely to prev5t a p>ticipant or b5efici>y f a*iev+ or ma9ta9+ reasonable & safe functional ability 9 p]=m+ occupational responsibilities or activities ( daily liv+ 7z def9$ 9 section #dda4eje ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations774 7#e7 ,! p>ticipant or b5efici>y is /able = 8 or h] disease or condition on ! prescription drug or drugs select$ by ! prescrib] & has previ\sly receiv$ approval = cov]age ( ! relevant drug or drugs = ! disease or condition by any public or private heal? plan4 7#f7 ,o!r circum/ances1 z det]m9$ by ! ,secret>y4 7c7 ,requirem5t ( a cle> process 7#a7 ,9 g5]al ,! process requir$ by subsection 7a7 %all-- 7,a7 provide ! prescrib] or p>ticipant or b5efici>y an opportunity to pres5t su* prescrib]'s cl9ical rationale & relevant m$ical in=mation = ! gr\p heal? plan or heal? insurance issu] to evaluate su* reque/ = exception2 7,b7 develop & use a /&>d =m & in/ructions = ! reque/ ( an exception "u subsection 7b71 available 9 pap] & electronic =ms1 & all[ = submission ( su* =m by pap] & electronic means2 7,c7 provide bo? pap] & electronic means = ! submission ( reque/s = additional in=mation2 7,d7 cle>ly set =? all requir$ in=mation & ! specific crit]ia t w be us$ to det]m9e :e!r an exception is w>rant$1 :i* may require disclosure (-- 7i7 ! m$ical hi/ory or o!r heal? records ( ! p>ticipant or b5efici>y demon/rat+ t ! p>ticipant or b5efici>y seek+ an exception-- 7,i7 has tri$ o!r drugs includ$ 9 ! drug !rapy class )\t success2 or 7,,ii7 has tak5 ! reque/$ drug = a cl9ically appropriate am\nt ( "t to e/abli% /ability1 9 relation to ! condition be+ treat$ & prescription guidel9es giv5 by ! prescrib+ physician2 or 7ii7 o!r cl9ical in=mation t may be relevant to conduct+ ! exception review2 7,e7 n require ! submission ( any in=mation or support+ docum5tation beyond :at is /rictly necess>y 7z det]m9$ by ! ,secret>y7 to det]m9e :e!r a circum/ance li/$ 9 subsection 7b7 exi/s2 7,f7 cle>ly outl9e conditions "u :i* an exception reque/ w>rants exp$it$ resolution f ! gr\p heal? plan or heal? insurance issu]1 pursuant to subsection 7d77#b72 & 7,g7 all[ a repres5tative ( a p>ticipant or b5efici>y1 :i* may include a designat$ ?ird-p>ty advocate1 to act on behalf ( ! p>ticipant or b5efici>y4 7#b7 ,availability ( process in=mation ,! gr\p heal? plan or heal? insurance issu] %all make in=mation reg>d+ ! process requir$ "u subsection 7a7 readily available 9 ! relevant plan mat]ials1 includ+ ! summ>y ( b5efits &1 if available1 on ! website ( ! gr\p heal? plan or heal? insurance issu]4 ,su* in=mation %all include-- 7,a7 ! requirem5ts = reque/+ an exception to a m$ication /ep !rapy protocol pursuant to ?is section2 & 7,b7 any =ms1 support+ in=mation1 & contact in=mation1 z appropriate4 7d7 ,tim+ = det]m9ation ( exception ,! process requir$ "u subsection 7a77#a7 %all provide = ! disposition ( reque/s receiv$ "u su* p>agraph 9 accordance ) ! foll[+3 7#a7 ,subject to p>agraph 7#b71 n lat] ?an #gb h\rs aft] receiv+ an initial exception reque/1 ! plan or issu] %all respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib] ) ei!r a det]m9ation ( exception eligibility or a reque/ = additional requir$ in=mation /rictly necess>y to make a det]m9ation ( :e!r ! conditions specifi$ 9 subsection 7b7 are met4 ,! plan or issu] %all respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib]1 ) a det]m9ation ( exception eligibility no lat] ?an #gb h\rs aft] receipt ( ! additional requir$ in=mation4 7#b7 ,9 ! case ( a reque/ "u circum/ances 9 :i* ! applicable m$ication /ep !rapy protocol may s]i\sly jeop>dize ! life or heal? ( ! p>ticipant or b5efici>y1 may jeop>dize ! ability ( ! p>ticipant or b5efici>y to rega9 maximum function1 or may subject ! p>ticipant or b5efici>y to sev]e pa9 t _c be adequately manag$ )\t ! treatm5t t is ! subject ( ! reque/1 ! plan or issu] %all conduct a review ( ! reque/ & respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib]1 ) ei!r a det]m9ation ( exception eligibility or a reque/ = additional requir$ in=mation /rictly necess>y to make a det]m9ation ( :e!r ! conditions specifi$ 9 subsection 7b7 are met1 9 accordance ) ! foll[+3 7,a7 ,if ! plan or issu] c make a det]m9ation ( exception eligibility )\t additional in=mation1 su* det]m9ation %all be made on an exp$it$ basis1 & no lat] ?an #bd h\rs aft] receipt ( su* reque/4 7,b7 ,if ! plan or issu] requires additional in=mation be=e mak+ a det]m9ation ( exception eligibility1 ! plan or issu] %all respond to ! p>ticipant or b5efici>y &1 if applicable1 ! reque/+ prescrib]1 ) a reque/ = su* in=mation )9 #bd h\rs ( ! reque/ = a det]m9ation1 & %all respond ) a det]m9ation ( exception eligibility z quickly z ! condition or disease requires1 & no lat] ?an #bd h\rs aft] receipt ( ! additional requir$ in=mation4 7e7 ,duration ( a grant ,if an exception to a m$ication /ep !rapy protocol is grant$ "u ?is section to a p>ticipant or b5efici>y1 cov]age = ! reque/$ drug %all rema9 9 effect ) respect to su* p>ticipant or b5efici>y = n less ?an #a ye>4 7f7 ,m$ication /ep !rapy protocol ,9 ?is section1 ! t]m m$ication /ep !rapy protocol means a drug !rapy utilization managem5t protocol or program "u :i* a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age ( prescription drugs requires a p>ticipant or b5efici>y to try an alt]native pref]r$ prescription drug or drugs be=e ! plan or heal? insurance issu] approves cov]age = ! non-pref]r$ drug !rapy prescrib$4 7g7 ,cl>ification ,?is section %all apply ) respect to any gr\p heal? plan or heal? insurance cov]age (f]$ 9 connection ) su* a plan t provides cov]age ( a prescription drug pursuant to a policy t meets ! def9ition ( ! t]m m$ication /ep !rapy protocol 9 subsection 7f71 reg>dless ( :e!r su* policy is describ$ by su* gr\p heal? plan or heal? insurance cov]age z a /ep !rapy protocol4 7h7 ,report+ 7#a7 ,report+ to ! ,secret>y ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 & n lat] ?an ,octob] #a ( ea* ye> !reaft]1 ea* gr\p heal? plan & heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all report to ! ,secret>y1 9 su* mann] z ! ,secret>y %all require1 ! foll[+3 7,a7 ,! numb] ( /ep !rapy exception reque/s receiv$ = ea* exception circum/ance describ$ 9 p>agraphs 7#a7 ?r\gh 7#f7 ( subsection 7b71 & ! numb]s ( su* reque/s = ea* su* circum/ance t 7-- 7i7 approv$2 7ii7 d5i$1 & ! reasons = ! d5ials2 7iii7 initially d5i$ & appeal$2 & 7iv7 initially d5i$ & !n subsequ5tly rev]s$ by int]nal appeals or ext]nal reviews4 7,b7 ,! numb] ( times a plan or issu] reque/$ additional in=mation 9 response to a /ep !rapy exception reque/1 by exception circum/ance describ$ 9 p>agraphs 7#a7 ?r\gh 7#f7 ( subsection 7b74 7,c7 ,! numb] ( exception reque/s submitt$ by p>ticipants or b5efici>ies1 & ! numb] ( exception reque/s submitt$ by prescrib]s1 by m$ical specialty4 7,d7 ,! m$ical conditions = :i* p>ticipants & b5efici>ies 7 grant$ exceptions due to ! likelihood t swit*+ f a prescription drug w likely cause an adv]se reaction by1 or physical or m5tal h>m to1 ! p>ticipant or b5efici>y1 z describ$ 9 subsection 7b77#c74 7,e7 ,! entities responsible = provid+ ph>macy b5efit managem5t s]vices = ! gr\p heal? plan or heal? insurance cov]age4 7#b7 ,in=mation ,a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all n ent] into a contract ) a ?ird-p>ty adm9i/rator or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! plan or cov]age t prev5ts ! plan or issu] f obta9+ f ! ?ird-p>ty adm9i/rator or ! entity provid+ ph>macy b5efit managem5t s]vices any in=mation ne$$ = ! plan or issu] to comply ) ! report+ requirem5ts "u p>agraph 7#a74 7#c7 ,reports to ,congress ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 & n lat] ?an ,octob] #a ( ea* ye> !reaft]1 ! ,secret>y %all submit to ,congress1 & make publicly available1 a report t conta9s a summ>y & analysis ( ! in=mation report$ "u p>agraph 7#a71 includ+ an analysis (1 ) respect to reque/s = exceptions "u ?is section1 approvals1 & d5ials1 includ+ ! reasons = d5ials2 appeals & ext]nal reviews2 & tr5ds1 if any1 9 exception reque/s by m$ical specialty or m$ical condition4 4 7b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is am5d$ by ins]t+ aft] ! item relat+ to section #gac ! foll[+ new item3 ,sec4 #gac;,a4 ,requir$ exceptions process = m$ication /ep !rapy protocols4 4 7c7 ,effective date 7#a7 ,9 g5]al ,! am5dm5t made by subsection 7a7 applies ) respect to plan ye>s beg9n+ ) ! fir/ plan ye> t beg9s at lea/ #f mon?s aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,regulations ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,labor %all issue f9al regulations1 ?r\gh notice & comm5t rulemak+1 to implem5t ! provisions ( section #gac;,a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 z add$ by subsection 7a74 #ejb4 ,e/abli%+ requirem5ts ) respect to ! use ( prior au?orization "u ,m$ic>e ,advantage plans 7a7 ,9 g5]al ,section #aheb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7o7 ,prior au?orization requirem5ts 7#a7 ,9 g5]al ,9 ! case ( a ,m$ic>e ,advantage plan t imposes any prior au?orization requirem5t ) respect to any applicable item or s]vice 7z def9$ 9 p>agraph 7#e77 dur+ a plan ye>1 su* plan %all-- 7,a7 beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbi-- 7i7 e/abli% ! electronic prior au?orization program describ$ 9 p>agraph 7#b72 & 7ii7 meet ! enrollee protection /&>ds specifi$ pursuant to p>agraph 7#d72 & 7,b7 beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 meet ! transp>5cy requirem5ts specifi$ 9 p>agraph 7#c74 7#b7 ,electronic prior au?orization program 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,a71 ! electronic prior au?orization program describ$ 9 ?is p>agraph is a program t provides = ! secure electronic transmission (-- 7i7 a prior au?orization reque/ f a provid] or suppli] to a ,m$ic>e ,advantage plan ) respect to an applicable item or s]vice to be furni%$ to an individual & a response1 9 accordance ) ?is p>agraph1 f su* plan to su* provid] or suppli]2 & 7ii7 any support+ docum5tation relat+ to su* reque/ or response4 7,b7 ,electronic transmission 7i7 ,exclusions ,= purposes ( ?is p>agraph1 a facsimile1 a propriet>y pay] portal t does n meet /&>ds specifi$ by ! ,secret>y1 or an electronic =m %all n be treat$ z an electronic transmission describ$ 9 subp>agraph 7,a74 7ii7 ,/&>ds ,an electronic transmission describ$ 9 subp>agraph 7,a7 %all comply ) applicable te*nical /&>ds & o!r requirem5ts to promote ! /&>dization & /reaml9+ ( electronic transactions adopt$ by ! ,secret>y4 7#c7 ,transp>5cy requirem5ts 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! transp>5cy requirem5ts specifi$ 9 ?is p>agraph are1 ) respect to a ,m$ic>e ,advantage plan1 ! foll[+3 7i7 ,! plan1 annually & 9 a mann] specifi$ by ! ,secret>y1 %all submit to ! ,secret>y ! foll[+ in=mation3 7,i7 ,a li/ ( all applicable items & s]vices t 7 subject to a prior au?orization requirem5t "u ! plan dur+ ! previ\s plan ye>4 7,,ii7 ,! p]c5tage & numb] ( specifi$ reque/s 7z def9$ 9 subp>agraph 7,f77 approv$ dur+ ! previ\s plan ye> by ! plan 9 an initial det]m9ation & ! p]c5tage & numb] ( specifi$ reque/s d5i$ dur+ su* plan ye> by su* plan 9 an initial det]m9ation 7bo? 9 ! aggregate & categoriz$ by ea* item & s]vice74 7,,iii7 ,! p]c5tage & numb] ( specifi$ reque/s t 7 d5i$ dur+ ! previ\s plan ye> by ! plan 9 an initial det]m9ation & t 7 subsequ5tly appeal$4 7,,iv7 ,! numb] ( appeals ( specifi$ reque/s resolv$ dur+ ! prec$+ plan ye>1 & ! p]c5tage & numb] ( su* resolv$ appeals t result$ 9 approval ( ! furni%+ ( ! item or s]vice t 0 ! subject ( su* reque/1 categoriz$ by ea* applicable item & s]vice & categoriz$ by ea* level ( appeal 7includ+ judicial review74 7,v7 ,! p]c5tage & numb] ( specifi$ reque/s t 7 d5i$1 & ! p]c5tage & numb] ( specifi$ reque/s t 7 approv$1 by ! plan dur+ ! previ\s plan ye> ?r\gh ! utilization ( decision support te*nology1 artificial intellig5ce te*nology1 ma*9e-le>n+ te*nology1 cl9ical decision-mak+ te*nology1 or any o!r te*nology specifi$ by ! ,secret>y4 7,,vi7 ,! av]age & ! m$ian am\nt ( "t 79 h\rs7 t elaps$ dur+ ! previ\s plan ye> betwe5 ! submission ( a specifi$ reque/ to ! plan & a det]m9ation by ! plan ) respect to su* reque/ = ea* su* item & s]vice1 exclud+ any su* reque/s t 7 n submitt$ ) ! m$ical or o!r docum5tation requir$ to be submitt$ by ! plan4 7,,vii7 ,! p]c5tage & numb] ( specifi$ reque/s t 7 exclud$ f ! calculation describ$ 9 subclause 7,,vi7 bas$ on ! plan's det]m9ation t su* reque/s 7 n submitt$ ) ! m$ical or o!r docum5tation requir$ to be submitt$ by ! plan4 7,,viii7 ,in=mation on ea* occurr5ce dur+ ! previ\s plan ye> 9 :i*1 dur+ a surgical or m$ical proc$ure involv+ ! furni%+ ( an applicable item or s]vice ) respect to :i* su* plan _h approv$ a prior au?orization reque/1 ! provid] or suppli] furni%+ su* item or s]vice det]m9$ t a diff]5t or additional item or s]vice 0 m$ically necess>y1 includ+ a specification ( :e!r su* plan subsequ5tly approv$ ! furni%+ ( su* diff]5t or additional item or s]vice4 7,,ix7 ,a disclosure & description ( any te*nology describ$ 9 subclause 7,v7 t ! plan utiliz$ dur+ ! previ\s plan ye> 9 mak+ det]m9ations ) respect to specifi$ reque/s4 7,x7 ,! numb] ( grievances 7z describ$ 9 subsection 7f77 receiv$ by su* plan dur+ ! previ\s plan ye> t 7 relat$ to a prior au?orization requirem5t4 7,,xi7 ,su* o!r in=mation z ! ,secret>y det]m9es appropriate4 7ii7 ,! plan %all provide-- 7,i7 to ea* provid] or suppli] :o seeks to ent] into a contract ) su* plan to furni% applicable items & s]vices "u su* plan1 ! li/ describ$ 9 clause 7i77,i7 & any policies or proc$ures us$ by ! plan = mak+ det]m9ations ) respect to prior au?orization reque/s2 7,,ii7 to ea* su* provid] & suppli] t ent]s into su* a contract1 access to ! crit]ia us$ by ! plan = mak+ su* det]m9ations & an itemization ( ! m$ical or o!r docum5tation requir$ to be submitt$ by a provid] or suppli] ) respect to su* a reque/2 & 7,,iii7 to an enrollee ( ! plan1 ^u reque/1 access to ! crit]ia us$ by ! plan = mak+ det]m9ations ) respect to prior au?orization reque/s = an item or s]vice4 7,b7 ,option = plan to provide c]ta9 additional in=mation ,z "p ( ! in=mation describ$ 9 subp>agraph 7,a77i7 provid$ to ! ,secret>y dur+ a plan ye>1 a ,m$ic>e ,advantage plan may elect to include in=mation reg>d+ ! p]c5tage & numb] ( specifi$ reque/s made ) respect to an individual & an item or s]vice t 7 d5i$ by ! plan dur+ ! prec$+ plan ye> 9 an initial det]m9ation bas$ on su* reque/s fail+ to demon/rate t su* individuals met ! cl9ical crit]ia e/abli%$ by su* plan to receive su* items or s]vices4 7,c7 ,regulations ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 e/abli% requirem5ts = ,m$ic>e ,advantage plans reg>d+ ! provision (-- 7i7 access to crit]ia describ$ 9 subp>agraph 7,a77ii77,,ii7 to provid]s ( s]vices & suppli]s 9 accordance ) su* subp>agraph2 & 7ii7 access to su* crit]ia to enrollees 9 accordance ) subp>agraph 7,a77ii77,,iii74 7,d7 ,publication ( in=mation ,! ,secret>y %all publi% in=mation describ$ 9 subp>agraph 7,a77i7 & subp>agraph 7,b7 on a public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 ,su* in=mation %all be s publi%$ on an individual plan level & may 9 addition be aggregat$ 9 su* mann] z det]m9$ appropriate by ! ,secret>y4 7,e7 ,med,pac report ,n lat] ?an #c ye>s aft] ! date in=mation is fir/ submitt$ "u subp>agraph 7,a77i71 ! ,m$ic>e ,paym5t ,advisory ,commission %all submit to ,congress a report on su* in=mation t includes a descriptive analysis ( ! use ( prior au?orization4 ,z appropriate1 ! ,commission %\ld report on /ati/ics includ+ ! frequ5cy ( appeals & ov]turn$ decisions4 ,! ,commission %all provide recomm5dations1 z appropriate1 on any improvem5t t %\ld be made to ! electronic prior au?orization programs ( ,m$ic>e ,advantage plans4 7,f7 ,specifi$ reque/ def9$ ,= purposes ( ?is p>agraph1 ! t]m specifi$ reque/ means a prior au?orization reque/ made ) respect to an applicable item or s]vice4 7#d7 ,enrollee protection /&>ds ,= purposes ( p>agraph 7#a77;,a77ii71 ) respect to ! use ( prior au?orization by ,m$ic>e ,advantage plans = applicable items & s]vices1 ! enrollee protection /&>ds specifi$ 9 ?is p>agraph are-- 7,a7 ! adoption ( transp>5t prior au?orization programs develop$ 9 consultation ) enrollees & ) provid]s & suppli]s ) contracts 9 effect ) su* plans = furni%+ su* items & s]vices "u su* plans2 7,b7 all[+ = ! waiv] or modification ( prior au?orization requirem5ts bas$ on ! p]=mance ( su* provid]s & suppli]s 9 demon/rat+ compliance ) su* requirem5ts1 su* z adh]5ce to evid5ce-bas$ m$ical guidel9es & o!r quality crit]ia2 & 7,c7 conduct+ annual reviews ( su* items & s]vices = :i* prior au?orization requirem5ts are impos$ "u su* plans ?r\gh a process t takes into acc\nt input f enrollees & f provid]s & suppli]s ) su* contracts 9 effect & is bas$ on consid]ation ( prior au?orization data f previ\s plan ye>s & analyses ( curr5t cov]age crit]ia4 7#e7 ,applicable item or s]vice def9$ ,= purposes ( ?is subsection1 ! t]m applicable item or s]vice means1 ) respect to a ,m$ic>e ,advantage plan1 any item or s]vice = :i* b5efits are available "u su* plan1 o!r ?an a cov]$ "p ,d drug4 7#f7 ,reports to ,congress 7,a7 ,,gao ,n lat] ?an ,janu>y #a1 #bjcc1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ an evaluation ( ! implem5tation ( ! requirem5ts ( ?is subsection & an analysis ( issues 9 implem5t+ su* requirem5ts fac$ by ,m$ic>e ,advantage plans4 7,b7 ,,hhs 7i7 ,! ,secret>y ,n lat] ?an ! end ( ! fif? plan ye> beg9n+ aft] ! date ( ! enactm5t ( ?is subsection1 & bi5nially !reaft] ?r\gh ! date t is #aj ye>s aft] su* date ( enactm5t1 ! ,secret>y %all submit to ,congress a report conta9+ a description ( ! in=mation submitt$ "u p>agraph 7#c77;,a77i7 dur+-- 7,i7 9 ! case ( ! fir/ su* report1 ! f\r? plan ye> beg9n+ aft] ! date ( ! enactm5t ( ?is subsection2 & 7,,ii7 9 ! case ( a subsequ5t report1 ! #b plan ye>s prec$+ ! ye> ( ! submission ( su* report4 7ii7 ,,cms ,n lat] ?an ,janu>y #a1 #bjbi1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology %all submit to ,congress & publi% on ! int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices a report t-- 7,i7 def9es ! t]m real-"t decision & details h[ ! def9ition = su* t]m may be updat$ bas$ on any te*nological advances2 7,,ii7 us+ ! data submitt$ to ! ,secret>y "u p>agraph 7#c77;,a77i71 details a process = real-"t decisions = r\t9ely approv$ items & s]vices = purposes ( ! electronic prior au?orization program describ$ 9 p>agraph 7#b72 & 7,,iii7 includes an analysis (-- 7aa7 items & s]vices t are r\t9ely approv$2 7bb7 items & s]vices id5tifi$ 9 item 7aa7 t c\ld be eligible = real-"t decisions2 7cc7 :e!r e/abli%+ real-"t decisions = su* items & s]vices c\ld-- 7,,aa7 improve enrollee access to b5efits "u ?is "p2 7,,bb7 produce op]ational effici5cies = provid]s & suppli]s & ,m$ic>e ,advantage plans2 & 7,,cc7 r$uce heal? disp>ities = ,m$ic>e ,advantage enrollees 9 rural & l[-income communities2 & 7dd7 h[ det]m9ations ( r\t9ely approv$ items & s]vices made solely ?r\gh automation & artificial intellig5ce by ,m$ic>e ,advantage plans impact pati5t access1 includ+ disp>ities 9 access = rural & l[-income b5efici>ies4 4 7b7 ,provid+ ! ,secret>y au?ority ,to en=ce timely responses = all prior au?orization reque/s submitt$ "u "p ,c ,section #aheb7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;g77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a71 by ins]t+ & 9 accordance ) any timeframe e/abli%$ by ! ,secret>y "u p>agraph 7#f7 aft] p>agraph 7#c72 7#b7 9 p>agraph 7#c77;,b77iii71 by ins]t+ 7) respect to prior au?orization reque/s submitt$ on or aft] ! fir/ day ( ! ?ird plan ye> beg9n+ aft] ! date ( ! enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 any timeframe e/abli%$ by ! ,secret>y "u p>agraph 7#f77 aft] #gb h\rs2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,timeframe = response to prior au?orization reque/s ,subject to p>agraph 7#c71 ! ,secret>y may e/abli%1 = purposes ( an organization det]m9ation made ) respect to a prior au?orization reque/ = an item or s]vice to be furni%$ to an individual1 timeframes1 su* z #bd h\rs1 = ! organization to notify ! enrollee 7& ! physician involv$1 z appropriate7 ( su* det]m9ation =-- 7,a7 a reque/ = exp$it$ det]m9ation describ$ 9 p>agraph 7#c77;,a72 7,b7 a real "t decision = r\t9ely approv$ items & s]vices2 & 7,c7 any o!r prior au?orization reque/4 4 #ejc4 ,special enrollm5t p]iod = provid] t]m9ations ,section #ahea7;e77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;e77#d77 is am5d$-- 7#a7 by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,e72 & 7#b7 by ins]t+ aft] subp>agraph 7,c7 ! foll[+ new subp>agraph3 7,d7 ! individual demon/rates or ! ,secret>y or organization det]m9es t ! individual is assign$ to1 curr5tly receiv+ c>e f1 or has receiv$ c>e 9 ! previ\s #c mon?s f1 a provid] ( s]vices or suppli] t is t]m9at$ f ! provid] network ( ! plan2 4 #ejd4 ,provid+ cov]age = he>+ c>e "u ! ,m$ic>e program 7a7 ,provision ( audiology s]vices by qualifi$ audiologi/s & qualifi$ he>+ aid pr(essionals 7#a7 ,9 g5]al ,section #ahfa7ll7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ll77 is am5d$-- 7,a7 9 p>agraph 7#c7-- 7i7 by ins]t+ 7&1 beg9n+ ,janu>y #a1 #bjbh1 su* aural rehabilitation & treatm5t s]vices7 aft] assessm5t s]vices2 7ii7 by ins]t+ 1 &1 beg9n+ on ,janu>y #a1 #bjbh1 su* he>+ assessm5t s]vices furni%$ by a qualifi$ he>+ aid pr(essional1 aft] by a qualifi$ audiologi/2 & 7iii7 by /rik+ ! audiologi/ & ins]t+ ! audiologi/ or qualifi$ he>+ aid pr(essional2 & 7,b7 9 p>agraph 7#d71 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,! t]m qualifi$ he>+ aid pr(essional means1 ) respect to he>+ assessm5t s]vices describ$ 9 p>agraph 7#c71 an individual :o-- 7i7 is lic5s$ or regi/]$ z a he>+ aid disp5s]1 he>+ aid speciali/1 he>+ in/rum5t disp5s]1 or relat$ pr(essional by ! ,/ate 9 :i* ! individual furni%es su* s]vices2 & 7ii7 meets su* o!r requirem5ts z ! ,secret>y det]m9es appropriate 7includ+ requirem5ts relat+ to educational c]tifications or accr$itations71 tak+ into acc\nt any additional requirem5ts = he>+ aid speciali/s1 he>+ aid disp5s]s1 & he>+ in/rum5t disp5s]s e/abli%$ by ,m$ic>e ,advantage organizations "u "p ,c1 ,/ate plans 7or waiv]s ( su* plans7 "u title ,,xix1 & ! gr\p heal? plans & heal? insurance issu]s 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act74 4 7#b7 ,paym5t = qualifi$ he>+ aid pr(essionals ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7 by /rik+ & be=e 7,,hh72 & 7,b7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 & 7,,ii7 ) respect to he>+ assessm5t s]vices 7z describ$ 9 p>agraph 7#c7 ( section #ahfa7ll77 furni%$ by a qualifi$ he>+ aid pr(essional 7z def9$ 9 p>agraph 7#d77;,c7 ( su* section71 ! am\nts paid %all be equal to #hj p]c5t ( ! less] ( ! actual *>ge = su* s]vices or #he p]c5t ( ! am\nt = su* s]vices det]m9$ "u ! paym5t basis det]m9$ "u section #ahdh4 7b7 ,cov]age ( he>+ aids 7#a7 ,inclusion ( he>+ aids z pro/hetic devices ,section #ahfa7s77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#h77 is am5d$ by ins]t+ 1 & includ+ he>+ aids 7z describ$ 9 section #ahcd7;h77#g77 furni%$ on or aft] ,janu>y #a1 #bjbh1 to individuals diagnos$ ) mod]ately sev]e1 sev]e1 or pr(\nd he>+ loss be=e ! semicolon at ! end4 7#b7 ,paym5t limitations = he>+ aids ,section #ahcd7;h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77 is am5d$ by add+ at ! end ! foll[+ new p>agraphs3 7#f7 ,paym5t only on an assignm5t-relat$ basis ,paym5t = he>+ aids = :i* paym5t may be made "u ?is "p may be made only on an assignm5t-relat$ basis4 ,! provisions ( section #ahdb7;b77#ah77;,b7 %all apply to he>+ aids 9 ! same mann] z !y apply to s]vices furni%$ by a practition] describ$ 9 subsection 7b77#ah77;,c74 7#g7 ,limitations = he>+ aids ,paym5t may be made "u ?is "p ) respect to an individual1 ) respect to he>+ aids furni%$ on or aft] ,janu>y #a1 #bjbh-- 7,a7 n m ?an once p] e> dur+ a #e-ye> p]iod2 7,b7 only = types ( su* he>+ aids t are det]m9$ appropriate by ! ,secret>y2 & 7,c7 only if furni%$ pursuant to a writt5 ord] ( a physician1 qualifi$ audiologi/ 7z def9$ 9 section #ahfa7ll77#d771 qualifi$ he>+ aid pr(essional 7z s def9$71 physician assi/ant1 nurse practition]1 or cl9ical nurse speciali/4 4 7#c7 ,application ( competitive acquisition 7,a7 ,9 g5]al ,section #ahcd7;h77#a77;,h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,h77 is am5d$-- 7i7 9 ! head]1 by ins]t+ & he>+ aids aft] or?otics2 7ii7 9 ! matt] prec$+ clause 7i71 by ins]t+ 1 or ( he>+ aids describ$ 9 p>agraph 7#b77;,e7 ( su* section1 aft] #bjaa12 & 7iii7 9 clause 7i71 by ins]t+ or su* he>+ aids aft] su* or?otics4 7,b7 ,con=m+ am5dm5t 7i7 ,9 g5]al ,section #ahdg7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,he>+ aids ,he>+ aids describ$ 9 section #ahfa7s77#h7 = :i* paym5t w\ld o!rwise be made "u section #ahcd7;h74 4 7ii7 ,exemption ( c]ta9 items f competitive acquisition ,section #ahdg7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,c]ta9 he>+ aids ,^? items & s]vices describ$ 9 p>agraph 7#b77;,e7 if furni%$ by a physician or o!r practition] 7z def9$ by ! ,secret>y7 to ! physician's or practition]'s own pati5ts z "p ( ! physician's or practition]'s pr(essional s]vice4 4 7#d7 ,inclusion ( qualifi$ audiologi/s & qualifi$ he>+ aid pr(essionals z c]ta9 practition]s to receive paym5t on an assignm5t-relat$ basis ,section #ahdb7;b77#ah77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#ah77;,c771 is am5d$ by add+ at ! end ! foll[+ new clauses3 7ix7 ,beg9n+ on ,janu>y #a1 #bjbh1 a qualifi$ audiologi/ 7z def9$ 9 section #ahfa7ll77#d77;,b774 7x7 ,a qualifi$ he>+ aid pr(essional 7z def9$ 9 section #ahfa7ll77#d77;,c774 4 7c7 ,exclusion modification ,section #ahfb7;a77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#g77 is am5d$ by ins]t+ 7except su* he>+ aids or exam9ations !re= z describ$ 9 & o!rwise all[$ "u section #ahfa7s77#h77 aft] he>+ aids or exam9ations !re=4 7d7 ,inclusion z except$ m$ical treatm5t ,section #ahba7;b77#e77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;i-#e7;b77#e77;,a77 is am5d$-- 7#a7 9 clause 7ii71 by /rik+ or2 7#b7 9 clause 7iii71 by /rik+ ! p]iod & ins]t+ 1 or2 & 7#c7 by add+ at ! end ! foll[+ new clause3 7iv7 consi/+ ( audiology s]vices describ$ 9 subsection 7ll77#c7 ( section #ahfa1 or he>+ aids describ$ 9 subsection 7s77#h7 ( su* section1 t are payable "u "p ,b z a result ( ! am5dm5ts made by ! ,heal? ,,c>e ,act ( #bjbf4 4 7e7 ,rural heal? cl9ics & ,f$]ally qualifi$ heal? c5t]s 7#a7 ,cl>ify+ cov]age ( audiology s]vices z physicians' s]vices ,section #ahfa7;aa77#a77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa77#a77;,a77 is am5d$ by ins]t+ 7includ+ audiology s]vices 7z def9$ 9 subsection 7ll77#c777 aft] physicians' s]vices4 7#b7 ,inclusion ( qualifi$ audiologi/s & qualifi$ he>+ aid pr(essionals z ,,rhc & ,,fqhc practition]s ,section #ahfa7;aa77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7aa77#a77;,b77 is am5d$ by ins]t+ or by a qualifi$ audiologi/ or a qualifi$ he>+ aid pr(essional 7z su* t]ms are def9$ 9 subsection 7ll771 aft] 7z def9$ 9 subsection 7hh77#a7714 7#c7 ,tempor>y paym5t rates = c]ta9 s]vices "u ! ,,rhc ,,air & ,,fqhc ,,pps 7,a7 ,,air ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7i7 9 subsection 7a77#c77;,a71 by ins]t+ 7:i* %all1 9 ! case ( audiology s]vices 7z def9$ 9 section #ahfa7ll77#c771 9 lieu ( any limits on reasonable *>ges o!rwise applicable1 be bas$ on ! rates payable = su* s]vices "u ! paym5t basis det]m9$ "u section #ahdh until su* "t z ! ,secret>y det]m9es suffici5t data has be5 collect$ to o!rwise apply su* limits 7or ,janu>y #a1 #bjcd1 if no su* det]m9ation has be5 made z ( su* date77 aft] may prescribe 9 regulations2 & 7ii7 by add+ at ! end ! foll[+ new subsection3 7ee7 ,disreg>d ( co/s attributable to c]ta9 s]vices f calculation ( ,,rhc ,,air ,paym5ts = rural heal? cl9ic s]vices o!r ?an audiology s]vices 7z def9$ 9 section #ahfa7ll77#c77 "u ! me?odology = all-inclusive rates 7e/abli%$ by ! ,secret>y7 "u subsection 7a77#c7 %all n take into acc\nt ! co/s ( su* s]vices :ile rates = su* s]vices are bas$ on rates payable = su* s]vices "u ! paym5t basis e/abli%$ "u section #ahdh4 4 7,b7 ,,pps ,section #ahcd7o7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,tempor>y paym5t rates bas$ on ,,pfs = c]ta9 s]vices ,! ,secret>y %all1 9 e/abli%+ paym5t rates = audiology s]vices 7z def9$ 9 section #ahfa7ll77#c77 t are ,f$]ally qualifi$ heal? c5t] s]vices "u ! prospective paym5t sy/em e/abli%$ "u ?is subsection1 9 lieu ( ! rates o!rwise applicable "u su* sy/em1 base su* rates on rates payable = su* s]vices "u ! paym5t basis e/abli%$ "u section #ahdh until su* "t z ! ,secret>y det]m9es suffici5t data has be5 collect$ to o!rwise e/abli% rates = su* s]vices "u su* sy/em 7or ,janu>y #a1 #bjcd1 if no su* det]m9ation has be5 made z ( su* date74 ,paym5ts = ,f$]ally qualifi$ heal? c5t] s]vices o!r ?an su* audiology s]vices "u su* sy/em %all n take into acc\nt ! co/s ( su* s]vices :ile rates = su* s]vices are bas$ on rates payable = su* s]vices "u ! paym5t basis e/abli%$ "u section #ahdh4 4 7f7 ,implem5tation 7#a7 ,9 g5]al ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,secret>y ( ,heal? & ,human ,s]vices = fiscal ye> #bjbg1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #cgj1jjj1jjj1 to rema9 available until exp5d$1 = purposes ( implem5t+ ! am5dm5ts made by ?is section dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjbg1 & end+ on ,septemb] #cj1 #bjcf4 7#b7 ,program in/ruction ,! ,secret>y ( ,heal? & ,human ,s]vices %all implem5t ! provisions (1 & ! am5dm5ts made by1 ?is section = #bjbg & #bjbh by program in/ruction4 ,,vi ,l[]+ ! co/ ( c>e #fja4 ,/r5g!n+ hospital price transp>5cy ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgah 7#db ,u4,s4,c4 #cjj;gg-#ah7 ! foll[+3 #bgah;,a4 ,provid] price transp>5cy 7a7 ,def9itions ,9 ?is section3 7#a7 ,applicable imag+ s]vice provid] ,! t]m applicable imag+ provid] means a provid] ( s]vices or suppli] :o furni%es any imag+ s]vices to pati5ts1 includ+ an indep5d5t diagno/ic te/+ facility1 an outpati5t diagno/ic facility1 & any o!r imag+ c5t] designat$ by ! ,secret>y1 except t su* t]m does n include an imag+ s]vice provid] ) respect to :i* /&>d *>ges = specifi$ imag+ s]vice provid] s]vices furni%$ by su* s]vice provid] are made available by a hospital pursuant to subsection 7b7 or specifi$ ambulatory surgical c5t] pursuant to subsection 7e74 7#b7 ,applicable laboratory ,! t]m applicable laboratory means a laboratory z su* t]m is def9$ 9 section #dic4b1 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation71 except t su* t]m does n include a laboratory ) respect to :i* /&>d *>ges = specifi$ cl9ical diagno/ic laboratory te/s furni%$ by su* laboratory are made available by a hospital pursuant to subsection 7b7 or specifi$ ambulatory surgical c5t] pursuant to subsection 7e74 7#c7 ,disc\nt$ ca% price 7,a7 ,9 g5]al ,! t]m disc\nt$ ca% price means ! m9imum *>ge express$ z a doll> am\nt1 subject to subp>agraph 7,b71 t ! applicable s]vice provid] subject to ?is section accepts f an individual :o pays ca%1 or ca% equival5t1 = a furni%$ item or s]vice1 )\t reg>d to heal? insurance cov]age1 z paym5t 9 full4 7,b7 ,exclusions ,= purposes ( subp>agraph 7,a71 ! m9imum *>ge describ$ 9 su* subp>agraph1 ) respect to a furni%$ item or s]vice1 z applicable1 %all be calculat$ )\t tak+ into acc\nt any f9ancial assi/ance1 includ+ assi/ance attributable to *>ity c>e 79 ! case ( a hospital1 z su* t]m is us$ = purposes ( hospital co/ report+ "u title ,,xviii ( ! ,social ,security ,act71 or ?ird-p>ty assi/ance = su* item or s]vice4 7#d7 ,extraord9>y collection actions ,! t]m extraord9>y collection action has ! mean+ giv5 su* t]m = purposes ( section #eja7r7 ( ! ,int]nal ,rev5ue ,code ( #aihf4 7#e7 ,gross *>ge ,! t]m gross *>ge means ! *>ge = an individual item or s]vice t is reflect$ on a hospital's *>gema/] or simil> li/ ( prices facilitat$ by any o!r provid]1 z def9$ by ! ,secret>y1 abs5t any disc\nts4 7#f7 ,hospital ,! t]m hospital means an in/itution 9 any ,/ate 9 :i* ,/ate or applicable local law provides = ! lic5s+ ( hospitals1 t is lic5s$ z a hospital pursuant to su* law or is approv$1 by ! ag5cy ( su* ,/ate or locality responsible = lic5s+ hospitals1 z meet+ ! /&>ds e/abli%$ = su* lic5s+4 ,= purposes ( ?is p>agraph1 ! t]m ,/ate includes ea* ( ! sev]al ,/ates1 ! ,di/rict ( ,columbia1 ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ,am]ican ,samoa1 & ! ,nor!rn ,m>iana ,isl&s4 7#g7 ,pay]-specific negotiat$ *>ge ,! t]m pay]-specific negotiat$ *>ge means ! *>ge t a hospital has negotiat$ ) a ?ird-p>ty pay] = an item or s]vice4 7#h7 ,%oppable s]vice ,! t]m %oppable s]vice means a s]vice t c be s*$ul$ by a heal?c>e consum] 9 advance4 ,su* s]vices are r\t9ely provid$ 9 non-urg5t situations t d n require imm$iate action or att5tion to ! pati5t1 ?us all[+ pati5ts to price %op & s*$ule a s]vice at a "t t is conv5i5t = !m4 7#i7 ,specifi$ ambulatory surgical c5t] ,! t]m specifi$ ambulatory surgical c5t] means any di/9ct entity t op]ates exclusively = ! purpose ( provid+ surgical s]vices to pati5ts n requir+ hospitalization & 9 :i* ! expect$ duration ( s]vices w\ld n exce$ #bd h\rs foll[+ an admission1 except t su* t]m does n include a surgical c5t] ) respect to :i* /&>d *>ges = specifi$ ambulatory surgical c5t] s]vices furni%$ by su* surgical c5t] are made available by a hospital pursuant to subsection 7b74 7#aj7 ,specifi$ cl9ical diagno/ic laboratory te/ ,! t]m specifi$ cl9ical diagno/ic laboratory te/ means any cl9ical diagno/ic laboratory te/ or s]vice t is provid$ by ! applicable laboratory1 exclud+ advanc$ diagno/ic laboratory te/s 7z def9$ 9 section #ahcd;,a7d77#e7 ( ! ,social ,security ,act74 7#aa7 ,specifi$ imag+ s]vice ,! t]m specifi$ imag+ s]vice has ! mean+ giv5 to ! t]m radiology & c]ta9 o!r imag+ s]vices = purposes ( section #daa4cea ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations74 7#ab7 ,?ird p>ty pay] ,! t]m ?ird p>ty pay] means an entity t is1 by /atute1 contract1 or agreem5t1 legally responsible = paym5t ( a claim = a heal? c>e item or s]vice4 7b7 ,hospital price transp>5cy 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 ea* hospital %all1 9 accordance ) a me?od & =mat e/abli%$ by ! ,secret>y "u p>agraph 7#c71 on a qu>t]ly basis 7if !re h be5 any *anges to ! /&>d *>ges describ$ 9 subp>agraph 7#b77 compile & make publicly available on an int]net website 7)\t subscription & free ( *>ge7-- 7,a7 all ( ! hospital's /&>d *>ges = ea* item & s]vice furni%$ by su* hospital 9 a ma*9e-readable =mat 7or a successor te*nology specifi$ by ! ,secret>y72 7,b7 all ( ! hospital's /&>d *>ges 9 a consum]-fri5dly =mat 7z specifi$ by ! ,secret>y71 t includes-- 7i7 z _m ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vices t are furni%$ by ! hospital1 & z _m additional hospital-select$ %oppable s]vices 7or all su* additional s]vices1 if su* hospital furni%es few] ?an #cjj %oppable s]vices7 z may be necess>y = a comb9$ total ( at lea/ #cjj %oppable s]vices ?r\gh ! ,janu>y #a describ$ 9 ?is subp>agraph1 aft] :i* ! hospital %all include all %oppable s]vices t ! hospital furni%es2 & 7ii7 ) respect to ea* ,c5t]s = ,m$ic>e ,m$icaid ,s]vices-specifi$ %oppable s]vice t is n furni%$ by ! hospital1 an indication t su* s]vice is n s furni%$2 & 7,c7 ! "n & bus9ess address = ea* p]son or entity t1 ) respect to ! hospital-- 7i7 has an own]%ip or inve/m5t int]e/2 7ii7 has a controll+ int]e/2 7iii7 is a managem5t s]vices organization2 or 7iv7 is a significant equity inve/or4 7#b7 ,/&>d *>ges def9$ ,= purposes ( p>agraph 7#a71 ! t]m /&>d *>ges means ! foll[+3 7,a7 ,a pla9 language description ( ea* item & s]vice1 accompani$ by any applicable bill+ codes1 includ+ modifi]s1 us+ commonly recogniz$ bill+ code sets1 includ+-- 7i7 ! ,diagnosis ,relat$ ,gr\p2 7ii7 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code2 7iii7 ! ,national ,drug ,code2 & 7iv7 o!r applicable id5tifi]s z det]m9$ by ! ,secret>y 7or successor code sets74 7,b7 ,! gross *>ge1 express$ z a doll> am\nt1 = ea* su* item or s]vice1 :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+4 7,c7 ,! disc\nt$ ca% price4 7,d7 ,! pay]-specific negotiat$ *>ges1 express$ z a doll> am\nt & cle>ly associat$ ) ! "n ( ! applicable ?ird-p>ty pay] & "n ( ea* plan1 t apply to ea* su* item or s]vice :5 provid$ 91 z applicable1 ! inpati5t sett+ & outpati5t dep>tm5t sett+4 ,if ! *>ges are bas$ on an algori?m1 p]c5tage ( ano!r am\nt1 or o!r =mula or crit]ia1 ! hospital %all also disclose su* algori?m1 p]c5tage1 =mula1 or crit]ia z set =? 9 its contract & any o!r in=mation necess>y to det]m9e ! negotiat$ *>ge z a doll> am\nt4 7,e7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges = ea* su* item or s]vice1 express$ z a non-z]o doll> am\nt4 7,f7 ,! am\nt ( any facility fee1 z def9$ by ! ,secret>y1 or add-on *>ges t w be "p ( ! f9al paym5t am\nt1 9 addition to any in=mation t might help ! pati5t und]/& :5 a facility fee or add-on *>ge may apply & h[ to avoid su* *>ges4 7,g7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges = an item or s]vice1 except in=mation t is duplicative ( any o!r report+ requirem5t "u ?is subsection4 ,9 ! case ( /&>d *>ges = an item or s]vice includ$ z "p ( a bundl$1 p] diem1 episodic1 or o!r simil> arrangem5t1 ! in=mation describ$ 9 ?is subp>agraph %all be made available z det]m9$ appropriate by ! ,secret>y4 7#c7 ,uni=m me?od & =mat ,! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = hospitals to use 9 compil+ & mak+ public in=mation describ$ 9 p>agraph 7#a74 ,su* me?od & =mat %all-- 7,a7 include a ma*9e-readable =mat 7or successor te*nology specifi$ by ! ,secret>y7 conta9+ ! in=mation describ$ 9 p>agraph 7#b7 = all items & s]vices furni%$ by ea* hospital2 7,b7 meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* *>ges2 & 7,c7 be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#d7 ,no deem$ compliance ,hospitals may (f] a price e/imator tool1 b ! availability ( su* a price e/imator tool %all n be consid]$ to deem compliance ) or o!rwise vitiate ! requirem5ts ( p>agraph 7#a77;,b7 or any o!r requirem5ts ( ?is subsection4 7#e7 ,monitor+ compliance ,! ,secret>y %all1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 ,su* process %all ensure t ea* hospital's compliance ) ?is subsection is review$ n less frequ5tly ?an once e ye>4 7#f7 ,atte/ation ,a s5ior (ficial f ea* hospital 7! ,*ief ,executive ,(fic]1 ,*ief ,f9ancial ,(fic]1 or an (ficial ( equival5t s5iority7 %all atte/ to ! accuracy & complet5ess ( ! disclosures1 & any o!r atte/ations z requir$ by ! ,secret>y1 made 9 accordance ) ! hospital price transp>5cy requirem5ts bas$ on crit]ia e/abli%$ by ! ,secret>y4 7#g7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( a hospital t fails to comply ) ! requirem5ts ( ?is subsection1 n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s1 ! ,secret>y %all notify su* hospital ( su* det]m9ation1 :i* %all include a reque/ = a corrective action plan if applicable to comply ) su* requirem5ts4 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,9 addition to any o!r en=cem5t actions or p5alties t may apply "u ano!r provision ( law1 a hospital t has receiv$ a reque/ = a corrective action plan "u subp>agraph 7,a7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #ij days aft] su* reque/ is made %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ on ! day ! hospital 0 fir/ out ( compliance1 z det]m9$ by ! ,secret>y7 dur+ :i* su* failure 0 ongo+4 ,su* am\nt %all n exce$-- 7,i7 9 ! case ( a specifi$ hospital ) #cj or few] b$s1 #cjj p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #djj p] day72 7,,ii7 9 ! case ( a specifi$ hospital ) m ?an #cj b$s b few] ?an #aja b$s1 #ab4ej p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #ae p] b$ p] day72 7,,iii7 9 ! case ( a specifi$ hospital ) m ?an #ajj b$s b few] ?an #bja b$s1 #ag4ej p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #bj p] b$ p] day72 7,,iv7 9 ! case ( a specifi$ hospital ) m ?an #bjj b$s b few] ?an #eja b$s1 #bj p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #be p] b$ p] day72 & 7,v7 9 ! case ( a specifi$ hospital ) m ?an #ejj b$s1 #be p] b$ p] day 7or1 9 ! case ( su* a hospital t has be5 noncompliant ) su* requirem5ts = a #a-ye> p]iod or long]1 beg9n+ ) ! fir/ day foll[+ su* #a-ye> p]iod1 #ce p] b$ p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to hospitals t fail to comply 9 #bjbh or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase-- 7,i7 ! limitation on ! p] day am\nt ( any p5alty applicable to a hospital "u clause 7i77,i72 7,,ii7 ! limitations on ! p] b$ p] day am\nt ( any p5alty applicable "u any ( subclauses 7,,ii7 ?r\gh 7,v7 ( clause 7i72 & 7,,iii7 ! limitation on ! increase ( any p5alty appli$ "u clause 7iii7 pursuant to ! am\nts specifi$ 9 subclause 7,,ii7 ( su* clause4 7iii7 ,p]si/5t noncompliance 7,i7 ,9 g5]al ,9 ! case ( a hospital t ! ,secret>y has det]m9$ to be noncompliant ) ! provisions ( ?is subsection two or m times dur+ a #a-ye> p]iod 7z det]m9$ by ! ,secret>y71 ! ,secret>y may increase any p5alty o!rwise applicable "u ?is subp>agraph by ! am\nt specifi$ 9 subclause 7,,ii7 ) respect to su* hospital & may require su* hospital to complete su* additional corrective actions plans z ! ,secret>y may specify4 7,,ii7 ,specifi$ am\nt ,= purposes ( subclause 7,i71 ! am\nt specifi$ 9 ?is subclause is1 ) respect to a hospital-- 7aa7 ) m ?an #cj b$s b few] ?an #aja b$s1 an am\nt t is n less ?an #ejj1jjj & n m ?an #a1jjj1jjj2 7bb7 ) m ?an #ajj b$s b few] ?an #cja b$s1 an am\nt t is great] ?an #a1jjj1jjj & n m ?an #b1jjj1jjj2 7cc7 ) m ?an #cjj b$s b few] ?an #eja b$s1 an am\nt t is great] ?an #b1jjj1jjj & n m ?an #d1jjj1jjj2 & 7dd7 ) m ?an #ejj b$s1 an am\nt t is n less ?an #e1jjj1jjj & n m ?an #aj1jjj1jjj4 7iv7 ,provision ( te*nical assi/ance ,! ,secret>y may1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is section to hospitals reque/+ su* assi/ance4 7v7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7,c7 ,no au?ority to waive or r$uce p5alty ,! ,secret>y %all n grant or ext5d any waiv]1 delay1 toll+1 or o!r mitigation ( a civil monet>y p5alty = fail+ to comply ) ! requirem5ts ( ?is subsection except :]e ! ,secret>y det]m9es t impos+ ! maximum civil monet>y p5alty1 includ+ p5alties = p]si/5t noncompliance1 w disrupt hospital op]ations 9 a mann] t impacts pati5t c>e4 ,! ,secret>y may reque/ docum5tation 9 su* =m & mann] z ! ,secret>y may require 9 ord] to evaluate impact on hospital op]ations4 7,d7 ,prohibition on extraord9>y collection ,9 addition to civil monet>y p5alties applicable "u subp>agraph 7,b7 & any o!r en=cem5t actions or p5alties t may apply "u any o!r provision ( law1 = a hospital t has receiv$ a reque/ = a corrective action plan "u subp>agraph 7,a7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #ij days aft] su* reque/1 t hospital or any o!r p]son or entity collect+ on behalf ( ! hospital %all-- 7i7 n take any extraord9>y collection actions aga9/ any pati5t or pati5t gu>antor = debt incurr$ by any pati5t on ! date or dates ( s]vice :5 ! hospital 0 n 9 compliance ) ! requirem5ts ( ?is subsection2 7ii7 cease any extraord9>y collection actions t h begun aga9/ any pati5t or pati5t gu>antor = debt incurr$ by any pati5t on ! date or dates ( s]vice :5 ! hospital 0 n 9 compliance ) ! requirem5ts ( ?is subsection2 & 7iii7 n take any extraord9>y collection actions aga9/ any pati5t or pati5t gu>antor = debt incurr$ by any pati5t on ! date or dates ( s]vice :5 ! hospital 0 n 9 compliance ) ! requirem5ts ( ?is subsection aft] ! hospital comes back into compliance ) ! requirem5ts ( ?is subsection4 7#h7 ,rulemak+ 7,a7 ,9 g5]al ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,own]%ip in=mation ,9 promulgat+ regulations "u ?is p>agraph1 ! ,secret>y %all def9e ! individuals & organizations t mu/ be disclos$ "u p>agraph 7#a77;,c7 9 a mann] t h>monizes disclosure requirem5ts ) requirem5ts e/abli%$ "u section #aabd ( ! ,social ,security ,act & prioritizes ! disclosure ( individuals & organizations ^: own]%ip or managem5t relation%ip ) a hospital impacts op]ational1 f9ancial1 or cl9ical decision mak+ = su* hospital4 4 #fjb4 ,cl9ical diagno/ic laboratory price transp>5cy ,section #bgah;,a ( ! ,public ,heal? ,s]vice ,act1 z add$ by section #fja1 is am5d$ by add+ at ! end ! foll[+3 7c7 ,cl9ical diagno/ic laboratory price transp>5cy 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 an applicable laboratory %all1 on a qu>t]ly basis 7if !re h be5 any *anges to ! /&>d *>ges describ$ 9 p>agraph 7#b77 compile & make publicly available on an int]net website 7)\t subscription & free ( *>ge7-- 7,a7 ! /&>d *>ges describ$ 9 p>agraph 7#b7 ) respect to ea* specifi$ cl9ical diagno/ic laboratory te/ t su* laboratory s furni%es2 & 7,b7 ! "n & bus9ess address = ea* p]son or entity t1 ) respect to ! laboratory-- 7i7 has an own]%ip or inve/m5t int]e/2 7ii7 has a controll+ int]e/2 7iii7 is a managem5t s]vices organization2 or 7iv7 is a significant equity inve/or4 7#b7 ,/&>d *>ges def9$ ,= purposes ( p>agraph 7#a71 ! t]m /&>d *>ges means1 ) respect to an applicable laboratory & a specifi$ cl9ical diagno/ic laboratory te/1 ! foll[+3 7,a7 ,a pla9 language description ( ea* item or s]vice1 accompani$ by any applicable bill+ codes 7includ+ modifi]s t mat]ially *ange ! price = insur]s or provid]s1 & t mat]ially *ange out-(-pocket co/s = consum]s7 us+ commonly recogniz$ bill+ code sets1 includ+-- 7i7 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code2 7ii7 ! ,national ,drug ,code2 or 7iii7 o!r applicable id5tifi] z det]m9$ by ! ,secret>y 7or successor code sets74 7,b7 ,! gross *>ge express$ z a doll> am\nt1 = ea* su* te/4 7,c7 ,! disc\nt$ ca% price4 7,d7 ,! pay]-specific negotiat$ *>ges1 express$ z a doll> am\nt & cle>ly associat$ ) ! "n ( ! applicable ?ird-p>ty pay] & "n ( ea* plan1 t apply to ea* su* te/4 ,if ! *>ges are bas$ on an algori?m1 p]c5tage ( ano!r am\nt1 or o!r =mula or crit]ia1 ! applicable laboratory also %all disclose su* algori?m1 p]c5tage1 =mula1 or crit]ia z set =? 9 its contract & any o!r in=mation necess>y to det]m9e ! negotiat$ *>ge z a doll> am\nt4 7,e7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges = ea* su* item or s]vice1 express$ z a non-z]o doll> am\nt4 7,f7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges = an item or s]vice1 except in=mation t is duplicative ( any o!r report+ requirem5t "u ?is section4 ,9 ! case ( /&>d *>ges = an item or s]vice includ$ z "p ( a bundl$1 p] diem1 episodic1 or o!r simil> arrangem5t1 ! in=mation describ$ 9 ?is subp>agraph %all be made available z det]m9$ appropriate by ! ,secret>y4 7#c7 ,uni=m me?od & =mat ,! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = applicable laboratories to use 9 compil+ & mak+ public in=mation pursuant to p>agraph 7#a74 ,su* me?od & =mat %all-- 7,a7 include a ma*9e-readable =mat 7or a successor te*nology specifi$ by ! ,secret>y7 conta9+ ! in=mation describ$ 9 p>agraph 7#b7 = all specifi$ cl9ical diagno/ic laboratory te/s furni%$ by ea* laboratory & ! own]%ip in=mation describ$ 9 p>agraph 7#a77;,b72 7,b7 meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* in=mation2 & 7,c7 be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#d7 ,monitor+ compliance ,! ,secret>y %all1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 ,su* process %all ensure t ea* applicable laboratory's compliance ) ?is subsection is review$ n less frequ5tly ?an once e ye>4 7#e7 ,inclusion ( ancill>y s]vices ,any *>ge = a specifi$ cl9ical diagno/ic laboratory te/ furni%$ by an applicable laboratory made publicly available 9 accordance ) p>agraph 7#a7 %all include ! *>ge = any ancill>y item or s]vice 7su* z specim5 collection s]vices1 specim5 transport1 c5trifugation1 aliquot+1 label+1 requisition process+1 & /&>d result report+ s]vices7 t w\ld cu/om>ily & r\t9ely be furni%$ by su* laboratory z "p ( su* te/1 z specifi$ by ! ,secret>y4 7#f7 ,atte/ation ,a s5ior (ficial f ea* cl9ical diagno/ic laboratory 7! ,*ief ,executive ,(fic]1 ,*ief ,f9ancial ,(fic]1 or an (ficial ( equival5t s5iority7 %all atte/ to ! accuracy & complet5ess ( ! disclosures1 & any o!r atte/ations z requir$ by ! ,secret>y1 made 9 accordance ) ! cl9ical laboratory price transp>5cy requirem5ts bas$ on crit]ia e/abli%$ by ! ,secret>y4 7#g7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( an applicable laboratory t fails to comply ) ! requirem5ts ( ?is subsection-- 7i7 ! ,secret>y %all notify su* laboratory ( su* failure n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s2 & 7ii7 ^u reque/ ( ! ,secret>y1 su* laboratory %all submit to ! ,secret>y1 n lat] ?an #de days aft] ! date ( su* reque/1 a corrective action plan to comply ) su* requirem5ts4 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,an applicable laboratory t has receiv$ a notification "u subp>agraph 7,a77i7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #ij days aft] su* notification 7or1 9 ! case ( an applicable laboratory t has submitt$ a corrective action plan describ$ 9 subp>agraph 7,a77ii7 9 response to a reque/ s describ$1 by ! date t is #ij days aft] su* submission7 %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* laboratory 0 n comply+ ) su* requirem5ts7 dur+ :i* su* failure is ongo+ 7n to exce$ #cjj p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to an applicable laboratory t fails to comply ) ! requirem5ts ( ?is subsection 9 #bjbh or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase ! limitation on ! p] day am\nt ( any p5alty applicable to an applicable laboratory "u clause 7i74 7iii7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7iv7 ,no au?ority to waive or r$uce p5alty ,! ,secret>y %all n grant or ext5d any waiv]1 delay1 toll+1 or o!r mitigation ( a civil monet>y p5alty = fail+ to comply ) ! requirem5ts ( ?is subsection except :]e ! ,secret>y det]m9es t impos+ ! maximum civil monet>y p5alty w disrupt applicable laboratory op]ations 9 a mann] t impacts pati5t c>e4 ,! ,secret>y may reque/ docum5tation 9 su* =m & mann] z ! ,secret>y may require 9 ord] to evaluate impact on applicable laboratory op]ations4 7#h7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is subsection to applicable laboratories reque/+ su* assi/ance4 7#i7 ,rulemak+ 7,a7 ,9 g5]al ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,own]%ip in=mation ,9 promulgat+ regulations "u ?is p>agraph1 ! ,secret>y %all def9e ! individuals & organizations t mu/ be disclos$ "u p>agraph 7#a77;,b7 9 a mann] t h>monizes disclosure requirem5ts ) requirem5ts e/abli%$ "u section #aabd ( ! ,social ,security ,act & prioritizes ! disclosure ( individuals & organizations ^: own]%ip or managem5t relation%ip ) a laboratory impacts op]ational1 f9ancial1 or cl9ical decision mak+ = su* laboratory4 4 #fjc4 ,imag+ s]vices price transp>5cy ,section #bgah;,a ( ! ,public ,heal? ,s]vice ,act1 z am5d$ by section #fjb1 is fur!r am5d$ by add+ at ! end ! foll[+3 7d7 ,imag+ s]vices price transp>5cy 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 ea* applicable imag+ s]vice provid] %all1 on a qu>t]ly basis 7if !re h be5 any *anges to ! /&>d *>ges describ$ 9 p>agraph 7#b77 compile & make publicly available on an int]net website 7)\t subscription & free ( *>ge7-- 7,a7 ! /&>d *>ges describ$ 9 p>agraph 7#b7 ) respect to ea* su* specifi$ imag+ s]vice provid$ by su* provid]2 & 7,b7 ! "n & bus9ess address = ea* p]son or entity t1 ) respect to ! imag+ s]vices provid]-- 7i7 has an own]%ip or inve/m5t int]e/2 7ii7 has a controll+ int]e/2 7iii7 is a managem5t s]vices organization2 or 7iv7 is a significant equity inve/or4 7#b7 ,/&>d *>ges def9$ ,= purposes ( p>agraph 7#a71 ! t]m /&>d *>ges1 ) respect to an applicable imag+ s]vice provid] & a specifi$ imag+ s]vice1 means ! foll[+3 7,a7 ,a pla9 language description ( ea* item or s]vice1 accompani$ by any applicable bill+ codes 7includ+ modifi]s t mat]ially *ange ! price = insur]s or provid]s1 & t mat]ially *ange out-(-pocket co/s = consum]s7 us+ commonly recogniz$ bill+ code sets1 includ+-- 7i7 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code2 7ii7 ! ,national ,drug ,code2 or 7iii7 o!r applicable id5tifi] z det]m9$ by ! ,secret>y 7or successor code sets74 7,b7 ,! gross *>ge express$ z a doll> am\nt1 = ea* su* item or s]vice4 7,c7 ,! disc\nt$ ca% price4 7,d7 ,! pay]-specific negotiat$ *>ges1 express$ z a doll> am\nt & cle>ly associat$ ) ! "n ( ! applicable ?ird-p>ty pay] & "n ( ea* plan1 t apply to ea* su* s]vice4 ,if ! *>ges are bas$ on an algori?m1 p]c5tage ( ano!r am\nt1 or o!r =mula or crit]ia1 ! provid] or suppli] also %all disclose su* algori?m1 p]c5tage1 =mula1 or crit]ia z set =? 9 its contract & any o!r in=mation necess>y to det]m9e ! negotiat$ *>ge z a doll> am\nt4 7,e7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges = ea* su* item or s]vice1 express$ z a non-z]o doll> am\nt4 7,f7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges & prices = an item or s]vice1 except in=mation t is duplicative ( any o!r report+ requirem5t "u ?is subsection4 ,9 ! case ( /&>d *>ges = an item or s]vice includ$ z "p ( a bundl$1 p] diem1 episodic1 or o!r simil> arrangem5t1 ! in=mation describ$ 9 ?is subp>agraph %all be made available z det]m9$ appropriate by ! ,secret>y4 7#c7 ,uni=m me?od & =mat ,! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = applicable imag+ s]vice provid]s to use 9 mak+ public in=mation describ$ 9 p>agraph 7#a74 ,any su* me?od & =mat %all-- 7,a7 include a ma*9e-readable =mat 7z specifi$ by ! ,secret>y7 conta9+ ! in=mation describ$ 9 p>agraph 7#b7 = all specifi$ imag+ s]vices furni%$ by ea* applicable imag+ s]vice provid] & own]%ip in=mation describ$ 9 p>agraph 7#a77;,b72 7,b7 meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* in=mation2 & 7,c7 be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#d7 ,monitor+ compliance ,! ,secret>y %all1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 7#e7 ,atte/ation ,a s5ior (ficial f ea* specifi$ imag+ s]vice provid] 7! ,*ief ,executive ,(fic]1 ,*ief ,f9ancial ,(fic]1 or an (ficial ( equival5t s5iority7 %all atte/ to ! accuracy & complet5ess ( ! disclosures1 & any o!r atte/ations z requir$ by ! ,secret>y1 made 9 accordance ) ! imag+ s]vice provid] price transp>5cy requirem5ts bas$ on crit]ia e/abli%$ by ! ,secret>y4 7#f7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( a specifi$ imag+ s]vice provid] t fails to comply ) ! requirem5ts ( ?is subsection-- 7i7 ! ,secret>y %all notify su* imag+ s]vice provid] ( su* failure n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s2 & 7ii7 ^u reque/ ( ! ,secret>y1 su* imag+ s]vice provid] %all submit to ! ,secret>y1 n lat] ?an #de days aft] ! date ( su* reque/1 a corrective action plan to comply ) su* requirem5ts4 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,a specifi$ imag+ s]vice provid] t has receiv$ a notification "u subp>agraph 7,a77i7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #ij days aft] su* notification 7or1 9 ! case ( a specifi$ imag+ s]vice provid] t has submitt$ a corrective action plan describ$ 9 subp>agraph 7,a77ii7 9 response to a reque/ s describ$1 by ! date t is #ij days aft] su* submission7 %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* imag+ s]vice provid] 0 n comply+ ) su* requirem5ts7 dur+ :i* su* failure is ongo+ 7n to exce$ #cjj p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to a specifi$ imag+ s]vice provid] t fails to comply ) ! requirem5ts ( ?is subsection 9 #bjbh or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase ! limitation on ! p] day am\nt ( any p5alty applicable to a specifi$ imag+ s]vice provid] "u clause 7i74 7iii7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7iv7 ,no au?ority to waive or r$uce p5alty ,! ,secret>y %all n grant or ext5d any waiv]1 delay1 toll+1 or o!r mitigation ( a civil monet>y p5alty = fail+ to comply ) ! requirem5ts ( ?is subsection except :]e ! ,secret>y det]m9es t impos+ ! maximum civil monet>y p5alty w disrupt specifi$ imag+ s]vice provid] op]ations 9 a mann] t impacts pati5t c>e4 ,! ,secret>y may reque/ docum5tation 9 su* =m & mann] z ! ,secret>y may require 9 ord] to evaluate impact on specifi$ imag+ s]vice provid] op]ations4 7#g7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is subsection to provid]s ( s]vices & suppli]s reque/+ su* assi/ance4 7#h7 ,rulemak+ 7,a7 ,9 g5]al ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,own]%ip in=mation ,9 promulgat+ regulations "u ?is p>agraph1 ! ,secret>y %all def9e ! individuals & organizations t mu/ be disclos$ "u p>agraph 7#a77;,b7 9 a mann] t h>monizes disclosure requirem5ts ) requirem5ts e/abli%$ "u section #aabd ( ! ,social ,security ,act & prioritizes ! disclosure ( individuals & organizations ^: own]%ip or managem5t relation%ip ) an imag+ s]vice provid] impacts op]ational1 f9ancial1 or cl9ical decision mak+ = su* imag+ s]vice provid]4 4 #fjd4 ,ambulatory surgical c5t] price transp>5cy ,section #bgah;,a ( ! ,public ,heal? ,s]vice ,act1 z am5d$ by section #fjc1 is fur!r am5d$ by add+ at ! end ! foll[+3 7e7 ,ambulatory surgical c5t] price transp>5cy 7#a7 ,9 g5]al ,beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 ea* specifi$ ambulatory surgical c5t] %all1 on a qu>t]ly basis 7if !re h be5 any *anges to ! /&>d *>ges describ$ 9 p>agraph 7#b771 compile & make publicly available on an int]net website 7)\t subscription & free ( *>ge7-- 7,a7 ! /&>d *>ges describ$ 9 p>agraph 7#b7 ) respect to ea* specifi$ s]vice furni%$ by su* surgical c5t]2 & 7,b7 ! "n & bus9ess address = ea* p]son or entity t1 ) respect to ! ambulatory surgical c5t]-- 7i7 has an own]%ip or inve/m5t int]e/2 7ii7 has a controll+ int]e/2 7iii7 is a managem5t s]vices organization2 or 7iv7 is a significant equity inve/or4 7#b7 ,/&>d *>ges def9$ ,= purposes ( p>agraph 7#a71 ! t]m /&>d *>ges ) respect to /&>d *>ges & prices made public by a specifi$ ambulatory surgical c5t] means ! foll[+3 7,a7 ,a pla9 language description ( ea* item or s]vice1 accompani$ by any applicable bill+ codes 7includ+ modifi]s t mat]ially *ange ! price = insur]s or provid]s1 & t mat]ially *ange out-(-pocket co/s = consum]s7 us+ commonly recogniz$ bill+ code sets1 includ+-- 7i7 ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code2 7ii7 ! ,national ,drug ,code2 or 7iii7 o!r applicable id5tifi] z det]m9$ by ! ,secret>y 7or successor code sets74 7,b7 ,! gross *>ge1 express$ z a doll> am\nt1 = ea* su* item or s]vice4 7,c7 ,! disc\nt$ ca% price4 7,d7 ,! pay]-specific negotiat$ *>ges1 express$ z a doll> am\nt & cle>ly associat$ ) ! "n ( ! applicable ?ird p>ty pay] & "n ( ea* plan1 t apply to ea* su* item or s]vice4 ,if ! *>ges are bas$ on an algori?m1 p]c5tage ( ano!r am\nt1 or o!r =mula or crit]ia1 ! ambulatory surgical c5t] also %all disclose su* algori?m1 p]c5tage1 =mula1 or crit]ia z set =? 9 its contract & any o!r in=mation necess>y to det]m9e ! negotiat$ *>ge z a doll> am\nt4 7,e7 ,! de-id5tifi$ maximum & m9imum negotiat$ *>ges = ea* su* item or s]vice1 express$ z a non-z]o doll> am\nt4 7,f7 ,any o!r additional in=mation ! ,secret>y may require = ! purpose ( improv+ ! accuracy (1 or enabl+ consum]s to easily und]/& & comp>e1 /&>d *>ges & prices = an item or s]vice4 ,9 ! case ( /&>d *>ges = an item or s]vice includ$ z "p ( a bundl$1 p] diem1 episodic1 or o!r simil> arrangem5t1 ! in=mation describ$ 9 ?is subp>agraph %all be made available z det]m9$ appropriate by ! ,secret>y4 7#c7 ,uni=m me?od & =mat ,! ,secret>y %all e/abli% a /&>d1 uni=m me?od & =mat = specifi$ ambulatory surgical c5t]s to use 9 compil+ & mak+ public in=mation pursuant to p>agraph 7#a74 ,su* me?od & =mat %all-- 7,a7 include a ma*9e-readable =mat 7or a successor te*nology specifi$ by ! ,secret>y7 conta9+ ! in=mation describ$ 9 p>agraph 7#b7 = all specifi$ s]vices furni%$ by ea* ambulatory surgical c5t] & = ! own]%ip in=mation describ$ 9 p>agraph 7#a77;,b72 7,b7 meet su* /&>ds z det]m9$ appropriate by ! ,secret>y 9 ord] to ensure ! accessibility & usability ( su* *>ges2 & 7,c7 be updat$ z det]m9$ appropriate by ! ,secret>y1 9 consultation ) /akehold]s4 7#d7 ,monitor+ compliance ,! ,secret>y %all1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 e/abli% a process to monitor compliance ) ?is subsection4 ,su* process %all ensure t ea* specifi$ ambulatory surgical c5t]'s compliance ) ?is subsection is review$ n less frequ5tly ?an once e ye>4 7#e7 ,atte/ation ,a s5ior (ficial f ea* specifi$ ambulatory surgical c5t] 7! ,*ief ,executive ,(fic]1 ,*ief ,f9ancial ,(fic]1 or an (ficial ( equival5t s5iority7 %all atte/ to ! accuracy & complet5ess ( ! disclosures1 & any o!r atte/ations z requir$ by ! ,secret>y1 made 9 accordance ) ! ambulatory c5t] price transp>5cy requirem5ts bas$ on crit]ia e/abli%$ by ! ,secret>y4 7#f7 ,en=cem5t 7,a7 ,9 g5]al ,9 ! case ( a specifi$ ambulatory surgical c5t] t fails to comply ) ! requirem5ts ( ?is subsection-- 7i7 ! ,secret>y %all notify su* ambulatory surgical c5t] ( su* failure n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s2 & 7ii7 ^u reque/ ( ! ,secret>y1 su* ambulatory surgical c5t] %all submit to ! ,secret>y1 n lat] ?an #de days aft] ! date ( su* reque/1 a corrective action plan to comply ) su* requirem5ts4 7,b7 ,civil monet>y p5alty 7i7 ,9 g5]al ,a specifi$ ambulatory surgical c5t] t has receiv$ a notification "u subp>agraph 7,a77i7 & fails to comply ) ! requirem5ts ( ?is subsection by ! date t is #ij days aft] su* notification 7or1 9 ! case ( a specifi$ ambulatory surgical c5t] t has submitt$ a corrective action plan describ$ 9 subp>agraph 7,a77ii7 9 response to a reque/ s describ$1 by ! date t is #ij days aft] su* submission7 %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ ) ! day on :i* ! ,secret>y fir/ det]m9$ t su* ambulatory surgical c5t] 0 n comply+ ) su* requirem5ts7 dur+ :i* su* failure is ongo+ 7n to exce$ #cjj p] day74 7ii7 ,increase au?ority ,9 apply+ ?is subp>agraph ) respect to a specifi$ ambulatory surgical c5t] t fails to comply ) ! requirem5ts ( ?is subsection 9 #bjbh or a subsequ5t ye>1 ! ,secret>y may ?r\gh notice & comm5t rulemak+ increase ! limitation on ! p] day am\nt ( any p5alty applicable to a specifi$ ambulatory surgical c5t] "u clause 7i74 7iii7 ,application ( c]ta9 provisions ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b7 ( su* section7 %all apply to a civil monet>y p5alty impos$ "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil monet>y p5alty impos$ "u subsection 7a7 ( su* section4 7iv7 ,no au?ority to waive or r$uce p5alty ,! ,secret>y %all n grant or ext5d any waiv]1 delay1 toll+1 or o!r mitigation ( a civil monet>y p5alty = fail+ to comply ) ! requirem5ts ( ?is subsection except :]e ! ,secret>y det]m9es t impos+ ! maximum civil monet>y p5alty w disrupt specifi$ ambulatory surgical c5t] op]ations 9 a mann] t impacts pati5t c>e4 ,! ,secret>y may reque/ docum5tation 9 su* =m & mann] z ! ,secret>y may require 9 ord] to evaluate impact on specifi$ ambulatory surgical c5t] op]ations4 7#g7 ,provision ( te*nical assi/ance ,! ,secret>y %all1 to ! ext5t practicable1 provide te*nical assi/ance relat+ to compliance ) ! provisions ( ?is subsection to specifi$ ambulatory surgical c5t]s reque/+ su* assi/ance4 7#h7 ,rulemak+ 7,a7 ,9 g5]al ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7,b7 ,own]%ip in=mation ,9 promulgat+ regulations "u ?is p>agraph1 ! ,secret>y %all def9e ! individuals & organizations t mu/ be disclos$ "u p>agraph 7#a77;,b7 9 a mann] t h>monizes disclosure requirem5ts ) requirem5ts e/abli%$ "u section #aabd ( ! ,social ,security ,act & prioritizes ! disclosure ( individuals & organizations ^: own]%ip or managem5t relation%ip ) an ambulatory surgical c5t] impacts op]ational1 f9ancial1 or cl9ical decision mak+ = su* ambulatory surgical c5t]4 7f7 ,cont9u$ applicability ( ,/ate law ,! provisions ( ?is section %all n sup]s$e any provision ( ,/ate law t e/abli%es1 implem5ts1 or cont9ues 9 effect any requirem5t or prohibition relat$ to heal? c>e price transp>5cy1 except to ! ext5t t su* requirem5t or prohibition prev5ts ! application ( a requirem5t or prohibition ( ?is section4 4 #fje4 ,/r5g!n+ heal? cov]age transp>5cy requirem5ts 7a7 ,transp>5cy 9 cov]age ,section #bgae;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ae;a7 is am5d$-- 7#a7 by /rik+ ,a ,gr\p heal? & ins]t+ ! foll[+3 7a7 ,9 g5]al ,a gr\p heal? 2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,additional transp>5cy requirem5ts 7#a7 ,specifi$ in=mation requir$ 7,a7 ,9 g5]al ,a gr\p heal? plan or heal? insurance issu] (f]+ cov]age 9 ! individual or gr\p m>ket %all provide to ea* p>ticipant1 b5efici>y1 or enrollee1 at ! "t ( enrollm5t 9 ! plan or cov]age1 ! in=mation describ$ 9 subp>agraph 7,b74 7,b7 ,in=mation requir$ ,= purposes ( subp>agraph 7,a71 ! in=mation specifi$ 9 ?is subp>agraph is1 ) respect to b5efits available "u ! plan or cov]age = an item or s]vice furni%$ by a heal? c>e provid]1 ! foll[+ 7or o!r in=mation z det]m9$ appropriate by ! ,secret>y73 7i7 ,if su* provid] is an 9-network provid] ) respect to su* item or s]vice1 ! 9-network rate 7z def9$ 9 p>agraph 7#e77 = su* item or s]vice4 7ii7 ,if su* provid] is n describ$ 9 clause 7i71 ! out-(-network all[$ am\nt 7z su* t]m is def9$ = purposes ( section #adg4baj7;a77#b77xvii7 ( title #de1 ,code ( ,f$]al ,regulations7 = su* item or s]vice t ! plan or cov]age w pay )\t reg>d to ! am\nt 9 clause 7iii74 7iii7 ,! am\nt ( co/-%>+ liability 7includ+ d$uctibles1 copaym5ts1 & co9surance7 t ! individual w incur = su* item or s]vice bas$ on ! in=mation available to ! plan or cov]age at ! "t ! reque/ is made 7:i*1 9 ! case su* item or s]vice is to be furni%$ by a provid] describ$ 9 clause 7ii71 %all be calculat$ us+ ! maximum am\nt describ$ 9 su* clause74 7iv7 ,! accumulat$ am\nts ) respect to any d$uctible or out-(-pocket maximum "u ! plan or cov]age reflect$ 9 ! plan's or cov]age's records at ! "t ! reque/ is made 7brok5 d[n1 9 ! case sep>ate d$uctibles or maximums apply to sep>ate individuals enroll$ 9 ! plan or cov]age1 by su* sep>ate d$uctibles or maximums1 9 addition to any cumulative d$uctible or maximum74 7v7 ,9 ! case su* plan or cov]age imposes any frequ5cy or volume limitations ) respect to su* item or s]vice 7exclud+ m$ical necessity det]m9ations71 ! am\nt t su* individual has accru$ t[>ds su* limitation ) respect to su* item or s]vice reflect$ 9 ! plan's or cov]age's records at ! "t ! reque/ is made4 7vi7 ,in=mation ab\t any utilization managem5t requirem5ts1 su* z prior au?orization1 concurr5t review1 /ep !rapy1 fail fir/1 or simil> requirem5ts applicable to cov]age ( su* item or s]vice "u su* plan or cov]age1 includ+ in=mation reg>d+ utilization managem5t practices & det]m9ations1 includ+ aggregate in=mation relat$ to approval & d5ial rates1 associat$ timel9es1 & appeals1 z det]m9$ appropriate by ! ,secret>y4 7,c7 ,self-s]vice tool ,= purposes ( subp>agraph 7,a71 a self-s]vice tool e/abli%$ by a heal? plan meets ! requirem5ts ( ?is subp>agraph if su* tool-- 7i7 is bas$ on an int]net website2 7ii7 provides = real-"t responses to reque/s describ$ 9 su* subp>agraph2 7iii7 is updat$ 9 a mann] su* t ! in=mation is accurate bas$ on ! in=mation available to ! plan or cov]age at ! "t ! reque/ is made2 7iv7 all[s su* a reque/ to be made = in=mation ) respect to an item or s]vice furni%$ by-- 7,i7 a specific provid] t is an 9-network provid] ) respect to su* item or s]vice2 or 7,,ii7 all provid]s t are 9-network provid]s ) respect to su* plan or cov]age & su* item or s]vice2 7v7 provides t su* a reque/ may be made = in=mation ) respect to an item or s]vice ?r\gh use (-- 7,i7 ! bill+ code = su* item or s]vice2 or 7,,ii7 ?r\gh use ( a descriptive t]m = su* item or s]vice2 & 7vi7 is made available 9 pla9 language1 )\t subscription or o!r fee4 7,d7 ,nonduplication ,a gr\p heal? plan or heal? insurance issu]s %all be deem$ to be 9 compliance ) ?is p>agraph if su* plan or issu] has a tool 9 place "u section #bgii;,a-#d4 7#b7 ,rate & paym5t in=mation 7,a7 ,9 g5]al ,beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 & e qu>t] !reaft] 7if !re h be5 any *anges to ! rate & paym5t in=mation describ$ 9 subp>agraphs 7,b7 & 7,c71 ea* gr\p heal? plan or heal? insurance issu] (f]+ cov]age 9 ! gr\p or individual m>ket %all make available to ! public1 ! rate & paym5t in=mation describ$ 9 subp>agraph 7,b7 9 accordance ) subp>agraph 7,c774 7,b7 ,rate & paym5t in=mation describ$ ,= purposes ( subp>agraph 7,a71 ! rate & paym5t in=mation describ$ 9 ?is subp>agraph is1 ) respect to a plan or cov]age1 ! foll[+3 7i7 ,) respect to ea* item or s]vice = :i* b5efits are available "u su* plan or cov]age1 exclud+ ^? includ$ 9 clause 7ii71 id5tifi$ by ,,cpt1 ,,hcpcs1 ,,drg1 or o!r applicable nationally recogniz$ id5tifi]1 includ+ any applicable code modifi]s1 & accompani$ by a pla9 language description ( ! item or s]vice1 ! 9-network rate 7express$ z a doll> am\nt or p]c5tage ( *>ges1 unless o!rwise specifi$ by ! ,secret>y71 includ+ ! individual & total am\nts = any bundl$ rates1 9 effect z ( ! date ( ! submission ( su* in=mation ) ea* provid] 7id5tifi$ by national provid] id5tifi]7 t is an 9-network provid] ) respect to su* item or s]vice1 o!r ?an su* a rate 9 effect ) a provid] t an issu] has det]m9$ bas$ on factors det]m9$ by ! ,secret>y 7su* z m$ical specialty7 t x is unlikely t ! provid] w\ld be reimburs$ = ! item or s]vice4 7ii7 ,) respect to ea* drug & biologic 7id5tifi$ by ,national ,drug ,code1 ,j-code1 or o!r commonly recogniz$ bill+ code us$ = drugs7 = :i* b5efits are available "u su* plan or cov]age1 ! 9-network rate 7express$ z a doll> am\nt or p]c5tage ( *>ges1 unless o!rwise specifi$ by ! ,secret>y7 9 effect z ( ! fir/ day ( ! qu>t] 9 :i* su* in=mation is made public ) ea* ph>macy or o!r prescription drug disp5s] t is an 9-network ph>macy or o!r prescription drug disp5s] ) respect to su* drug4 7iii7 ,) respect to ea* item or s]vice = :i* b5efits are available "u su* plan or cov]age 7express$ z a doll> am\nt71 id5tifi$ by ,,cpt1 ,,drg1 ,,hcpcs1 or o!r applicable nationally recogniz$ id5tifi]1 includ+ any applicable code modifi]s1 & accompani$ by a brief description ( ! item or s]vice1 ! am\nt bill$ or *>g$ by ! provid]1 & ! am\nt all[$ by ! plan or cov]age1 = ea* su* item or s]vice furni%$ dur+ a repres5tative lookback w9d[ e/abli%$ by ! ,secret>y by ea* provid] t 0 an out-(-network provid] ) respect to su* item or s]vice1 brok5 d[n by ea* su* provid] 7id5tifi$ by national provid] id5tifi]71 o!r ?an items & s]vices ) respect to :i* n few] ?an #aa claims = su* item or s]vice 7 submitt$ to su* plan dur+ su* p]iod4 7,c7 ,mann] ( submission ,rate & paym5t in=mation requir$ to be submitt$ & made available "u ?is p>agraph %all be s submitt$ & s made available z foll[s3 7i7 ,in=mation %all be conta9$ 9 at lea/ #c sep>ate ma*9e-readable files correspond+ to ! in=mation describ$ 9 ea* ( clauses 7i7 ?r\gh 7iii7 ( subp>agraph 7,b7 t meet su* requirem5ts z specifi$ by ! ,secret>y ?r\gh rulemak+1 9 consultation ) ! ,secret>ies ( ,labor & ! ,treasury1 to apply comp>able requirem5ts to gr\p heal? plans & heal? insurance cov]age & to entities provid+ b5efit managem5t or o!r ?ird-p>ty adm9i/ration s]vices on a contractual basis ) a gr\p heal? plan or cov]age4 7ii7 ,requirem5ts specifi$ by ! ,secret>y ?r\gh rulemak+ 7or subregulatory guidance7 %all ensure ! foll[+3 7,i7 ,su* files are made available 9 a widely available =mat t all[s = in=mation conta9$ 9 su* files to be comp>$ across plans & cov]age & are freely accessible to individuals at no co/ & )\t ! ne$ to e/abli% a us] acc\nt or provide o!r cr$5tials4 7,,ii7 ,ea* su* file includes ea* ( ! foll[+ data elem5ts3 7aa7 ,a num]ical id5tifi] = ! gr\p heal? plan or heal? insurance issu] 7su* z a ,heal? ,insurance ,ov]sight ,sy/em id5tifi]74 7bb7 ,a pla9-language description ( ! item or s]vice 7includ+1 = drugs1 ! propriet>y & nonpropriet>y "n assign$74 7cc7 ,! bill+ code1 includ+ any applicable modifi]s1 associat$ ) su* item or s]vice1 includ+ ! ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code1 diagnosis-relat$ gr\p1 national drug code1 or o!r commonly recogniz$ code set4 7dd7 ,! place ( s]vice code4 7ee7 ,! ,national ,provid] ,id5tifi] & provid] ,tax ,id5tification ,numb]4 7iii7 ,! rate & paym5t in=mation disclos$ "u clauses 7i7 ?r\gh 7iii7 ( subp>agraph 7,b7 %all be sep>ately del9eat$ = ea* item or s]vice1 reg>dless ( :e!r su* item or s]vice is reimburs$ z a "p ( a bundle1 episode1 or o!r gr\p+ ( items & s]vices4 7iv7 ,an (fic] or executive ( compet5t au?ority %all atte/ to ! accuracy & complet5ess ( in=mation submitt$ & made available "u ?is subp>agraph4 ,9 ! case ( a plan or cov]age t relies on a ?ird-p>ty adm9i/rator or o!r s]vice provid] to compile ! in=mation submitt$ & made available "u ?is subp>agraph1 su* plan or cov]age may satisfy ! requirem5t "u ?is clause by obta9+ su* an atte/ation f ! ?ird-p>ty adm9i/rator or o!r s]vice provid]4 ,su* atte/ation %all be subject to en=cem5t "u p>agraph 7#f74 7#c7 ,own]%ip in=mation ,beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 & e qu>t] !reaft] 7if !re h be5 any *anges 9 ! requir$ in=mation71 ea* gr\p heal? plan or heal? insurance issu] (f]+ cov]age 9 ! individual or gr\p m>ket %all submit to ! ,secret>y1 ! applicable ,/ate au?ority1 & make available to ! public1 ! "n & bus9ess address ( ea* p]son or entity t1 ) respect to su* plan or cov]age-- 7,a7 has an own]%ip or inve/m5t int]e/2 7,b7 has a controll+ int]e/2 7,c7 is a managem5t s]vices organization2 or 7,d7 is a significant equity inve/or4 7#d7 ,en=cem5t 7,a7 ,9 g5]al ,ea* ye>1 ! ,secret>y %all audit ! ma*9e-readable files requir$ by p>agraph 7#b77;,b7 po/$ by n few] ?an #ej gr\p heal? plans or heal? insurance issu]s = compliance ) =mat & accessibility /&>ds4 7,b7 ,notification & reque/ = corrective action ,9 ! case ( a gr\p heal? plan or heal? insurance issu] t fails to comply ) ! requirem5ts ( ?is p>agraph1 n lat] ?an #cj days aft] ! date on :i* ! ,secret>y det]m9es su* failure exi/s1 ! ,secret>y %all submit to su* plan or issu] a notification ( su* det]m9ation1 :i* %all include a reque/ = a corrective action plan to comply ) su* requirem5ts4 7,c7 ,civil monet>y p5alty ,a plan or issu] t has receiv$ a reque/ = a corrective action plan "u subp>agraph 7,b7 & fails to comply ) ! requirem5ts ( ?is p>agraph by ! date t is #cj days aft] su* reque/ is made %all be subject to a civil monet>y p5alty ( an am\nt specifi$ by ! ,secret>y = ea* day 7beg9n+ ) ! day on :i* su* heal? plan or heal? insurance issu] 0 fail+ to comply ) su* p>agraph7 dur+ :i* su* failure 0 ongo+4 ,su* am\nt %all n exce$ #cjj p] p>ticipant1 b5efici>y1 or cov]$ individual p] day or #aj1jjj1jjj1 :i*ev] is less]4 7#e7 ,def9itions ,9 ?is subsection3 7,a7 ,9-network provid] ,! t]m 9-network provid] has ! mean+ giv5 su* t]m 9 section #ed4ihae-bgae;,a#a7;a77#b77xii7 ( title #bf1 ,code ( ,f$]al ,regulations4 7,b7 ,9-network rate ,! t]m 9-network rate means1 ) respect to a heal? plan & an item or s]vice furni%$ by a provid] t is a p>ticipat+ provid] ) respect to su* plan & item or s]vice1 ! contract$ rate 9 effect betwe5 su* plan & su* provid] = su* item or s]vice4 ,if ! rate is bas$ on an algori?m1 p]c5tage ( ano!r am\nt1 or o!r =mula or crit]ia1 ! heal? plan also %all disclose su* algori?m1 p]c5tage1 =mula1 or crit]ia z set =? 9 its contract & any o!r t]ms1 s*$ules1 exhibits1 data1 or o!r in=mation ref]5c$ 9 any su* contract z %all be requir$ to det]m9e & disclose ! negotiat$ rate4 7#f7 ,rulemak+ 7,a7 ,9 g5]al ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 ,! ,secret>y may implem5t ! mann] ( submission ( data describ$ 9 p>agraph 7#b77;,c7 ?r\gh subregulatory guidance4 7,b7 ,regulations ,regulations promulgat$ pursuant to ?is subsection %all provide ! foll[+3 7i7 ,! ,secret>y %all annually audit ! ma*9e-readable files requir$ by p>agraph 7#b77;,b7 po/$ by n few] ?an #ej gr\p heal? plans or heal? insurance issu]s = compliance ) =mat & accessibility /&>ds4 7ii7 ,! ,secret>y ( ,labor %all annually audit ! ma*9e-readable files requir$ by p>agraph 7#b77;,b7 po/$ by n few] ?an #bej gr\p heal? plans or s]vice provid]s furni%+ ?ird-p>ty adm9i/rator s]vices to a gr\p heal? plan = compliance ) =mat & accessibility /&>ds4 7iii7 ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 conjunction ) ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 %all annually issue a report to ,congress t includes f9d+s1 conclusions1 & en=cem5t actions tak5 bas$ on audits ( ! ma*9e-readable files4 ,su* report %all be provid$ no lat] ?an ,july #a foll[+ ! cal5d> ye> dur+ :i* ! audits 7 complet$4 ,! ,secret>y ( ,heal? & ,human ,s]vices %all make su* report to ,congress accessible to ! public4 4 7b7 ,effective date 7#a7 ,9 g5]al ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply beg9n+ ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf4 7#b7 ,cont9u$ applicability ( rules = previ\s ye>s ,no?+ 9 ! am5dm5ts made by ?is section may be con/ru$ z affect+ ! applicability ( ! rule entitl$ ,transp>5cy 9 ,cov]age publi%$ by ! ,dep>tm5t ( ! ,treasury1 ! ,dep>tm5t ( ,labor1 & ! ,dep>tm5t ( ,heal? & ,human ,s]vices on ,novemb] #ab1 #bjbj 7#he ,f$4 ,reg4 #gbaeh71 or am5dm5ts made to su* rule t are applicable be=e ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf4 #fjf4 ,increas+ gr\p heal? plan access to heal? data 7a7 ,gr\p heal? plan access to in=mation 7#a7 ,9 g5]al ,section #bgii;,a-#i ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aai7 is am5d$ by add+ at ! end ! foll[+3 7#a7 ,gr\p ,heal? ,plan ,access to ,in=mation 7,a7 ,9 g5]al ,no contract or arrangem5t = s]vices1 & no ext5sion or r5ewal ( su* contract or arrangem5t1 betwe5 a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan 7z su* t]ms are def9$ 9 subp>agraph 7,f77 & a heal? c>e provid] 7:i* = purposes ( ?is subp>agraph1 includes a heal? c>e facility71 network or association ( provid]s1 s]vice provid] (f]+ access to a network ( provid]s1 ?ird-p>ty adm9i/rator1 heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or ph>macy b5efit manag]1 or any entity act+ z an int]m$i>y betwe5 ! gr\p heal? plan & ! heal? c>e provid]1 network association ( provid]s1 s]vice provid] (f]+ access to a network or association ( provid]s 7includ+ a lic5s$ heal? insurance issu] or ?ird-p>ty adm9i/rator71 or ph>macy b5efit manag] 7collectively ref]r$ to 9 ?is subsection z ,cov]$ ,s]vice ,provid]s71 is reasonable )9 ! mean+ ( ?is subsection unless su* contract or arrangem5t-- 7i7 all[s ! responsible plan fiduci>y 7z t t]m is def9$ 9 section #djh7;b77#b77;,b77ii77,i77ee77 access to all claims & enc\nt] in=mation or data1 & any docum5tation support+ claim paym5ts1 includ+1 b n limit$ to1 m$ical records & policy docum5ts1 or in=mation or data describ$ 9 subsection 7a77#a77;,b7 to-- 7,i7 comply ) applicable law2 & 7,,ii7 det]m9e ! accuracy or reasonabl5ess ( claims paym5t2 & 7ii7 does n-- 7,i7 unreasonably limit or delay access1 z det]m9$ by ! ,secret>y b 9 any ev5t n long] ?an #ae days1 aft] a reque/ = access by a plan fiduci>y to su* in=mation or data2 7,,ii7 limit ! volume ( claims & enc\nt] in=mation or data t ! gr\p heal? plan1 ! plan sponsor1 ! plan adm9i/rator1 or a bus9ess associate ( su* plan may access dur+ an audit or pursuant to any reque/ = su* in=mation or data2 7,,iii7 limit ! disclosure ( pric+ t]ms = value-bas$ paym5t arrangem5ts or capitat$ paym5t arrangem5ts1 includ+-- 7aa7 paym5t calculations & =mulas2 7bb7 quality measures2 7cc7 contract t]ms2 7dd7 paym5t am\nts2 7ee7 measurem5t p]iods = all inc5tives2 & 7ff7 o!r paym5t me?odologies us$ by an entity1 includ+ a heal? c>e provid] 7includ+ a heal? c>e facility71 network or association ( provid]s1 s]vice provid] (f]+ access to a network ( provid]s1 ?ird-p>ty adm9i/rator1 or ph>macy b5efit manag]2 7,,iv7 limit ! disclosure ( ov]paym5ts & ov]paym5t recov]y t]ms2 7,v7 limit ! "r ( ! gr\p heal? plan1 ! plan sponsor1 or ! plan adm9i/rator ( su* plan to select an auditor or def9e audit scope or frequ5cy2 7,,vi7 o!rwise limit or unduly delay ! gr\p heal? plan1 ! plan sponsor1 ! plan adm9i/rator1 or a bus9ess associate ( su* plan f access+ claims & enc\nt] in=mation or data2 7,,vii7 limit ! disclosure ( fees *>g$ to ! gr\p heal? plan relat$ to plan adm9i/ration & claims process+1 includ+ r5egotiation fees1 access fees1 repric+ fees1 or enhanc$ review fees2 7,,viii7 limit ! "r ( ! gr\p heal? plan1 ! plan sponsor1 or ! plan adm9i/rator to reque/ action on any suspect claim paym5ts2 7,,ix7 limit public disclosure ( de-id5tifi$ or aggregate in=mation2 7,x7 limit ! disclosure (1 ) respect to a provid] t files claims "u su* plan1 :e!r a ,cov]$ ,s]vice ,provid]-- 7aa7 has an own]%ip or inve/m5t int]e/2 7bb7 has a controll+ int]e/2 7cc7 is a managem5t s]vices organization2 or 7dd7 is a significant equity inve/or2 or 7,,xi7 limit ! disclosure ( ! "n & address ( ea* p]son or entity t1 ) respect to ! heal? plan s]vice provid]-- 7aa7 has an own]%ip or inve/m5t int]e/2 7bb7 has a controll+ int]e/2 or 7cc7 is a significant equity inve/or4 7,b7 ,mann] ( provid+ in=mation or data 7i7 ,9 g5]al ,a ,cov]$ ,s]vice ,provid] %all provide in=mation or data "u ?is subsection 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a77 & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 ,a ,cov]$ ,s]vice ,provid] %all n be requir$ to disclose in=mation or data "u ?is subsection t c\ld reasonably id5tify a p>ticipant or b5efici>y ?r\gh individually id5tifiable heal? in=mation 7z su* t]m is def9$ "u ,,hipaa privacy regulations74 7ii7 ,additional requirem5ts ,9 c>ry+ out ?is subsection1 a ,cov]$ ,s]vice ,provid] %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation74 7iii7 ,rule ( con/ruction 7,i7 ,9 g5]al ,no?+ 9 ?is subsection %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7,,ii7 ,civil rights laws ,no?+ 9 ?is subsection %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7iv7 ,writt5 notice ,ea* plan ye>1 a ,cov]$ ,s]vice ,provid] %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t t ,cov]$ ,s]vice ,provid]s respond to reque/s to submit in=mation or data "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7v7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is subsection %all prev5t a ,cov]$ ,s]vice ,provid] f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation or data describ$ 9 p>agraph 7#a71 except t su* ,provid] may n re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury4 7vi7 ,limitation ,?is p>agraph %all n be con/ru$ to abridge or limit ! disclosure requirem5ts "u ?is subsection or to impose additional privacy or security requirem5ts on ,cov]$ ,s]vice ,provid]s or plan sponsors4 7,c7 ,limitation on disclosure ,a gr\p heal? plan receiv+ in=mation or data "u ?is subsection may disclose su* in=mation only 9 a mann] t is consi/5t ) ,,hipaa & ! privacy & security regulations promulgat$ !reund]1 reg>dless ( _! direct or indirect applicability to ! plan or any entities t c\ld be or are bus9ess associates4 ,a gr\p heal? plan 7& any bus9ess associate or o!r entity act+ on behalf ( su* plan7 may use su* in=mation or data only = purposes ( plan adm9i/ration & may n sell1 lic5se1 or o!rwise comm]cially exploit su* in=mation or data or provide su* in=mation or data to any ?ird p>ty t may take su* action4 7,d7 ,requirem5ts ( in=mation ,in=mation made available "u ?is subsection %all con=m to ! foll[+ /&>ds3 7i7 ,all claims f a heal?c>e provid] %all be made to ! gr\p heal? plan 9 accordance ) transaction /&>ds adopt$ by regulation "u ,,hipaa1 z foll[s3 7,i7 ,in/itutional1 pr(essional1 & d5tal claims %all be 9 ,,asc ,x#ab,n #hcg;,d =mat or any subsequ5t /&>d z e/abli%$ by ! ,secret>y4 7,,ii7 ,ph>macy claims %all be 9 ! ,national ,c\ncil = ,prescription ,drug ,programs 7,,ncpdp7 =mat or any subsequ5t /&>d z e/abli%$ by ! ,secret>y4 7,,iii7 ,! files %all be unmodifi$ copies ( ! files s5t f ! provid]1 or1 ^u reque/1 deliv]$ 9 a ma*9e readable =mat4 ,9 ! ev5t t pap] claims are s5t by ! provid]1 !y %all be conv]t$ to ! appropriate /&>d electronic =mat4 ,files %all be accessible to ! plan at no co/ to ! gr\p heal? plan4 7ii7 ,all claim paym5t 7or ,,eft1 electronic funds transf]7 & electronic remittance advice 7,,era7 notices s5t by a ,cov]$ ,s]vice ,provid] %all be made available to ! gr\p heal? plan z ,,asc ,x#ab,n #hce files 7or any o!r =mat z id5tifi$ by ! ,secret>y7 9 accordance ) /&>ds adopt$ by regulation "u ,,hipaa4 ,! files %all be unmodifi$ copies ( ! files s5t by ! ,cov]$ ,s]vice ,provid] to ! heal?c>e provid]4 ,files %all be accessible at no co/ to ! gr\p heal? plan4 7iii7 ,! contractual t]ms conta9+ paym5t calculations & =mulas1 pric+ me?odologies1 & o!r in=mation us$ to det]m9e ! doll> value ( reimbursem5t1 9 a =mat z specifi$ by ! ,secret>y4 7iv7 ,all non-claim co/s %all be itemiz$ & made available to ! gr\p heal? plan z reque/$ ?r\gh a web-bas$ portal1 ?r\gh an application program int]face 7,,api71 ?r\gh a d[nloadable ,comma-,sep>at$ ,value 7,,csv7 file1 &1 z appropriate1 ?r\gh o!r d[nloadable ma*9e-readable file types4 7,e7 ,implem5tation ,! ,secret>y %all implem5t ?is subsection ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 7,f7 ,def9itions 7i7 ,9 g5]al ,! provisions ( sections #djh & #daj ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd %all apply ) respect to t]ms us$ "u ?is subsection4 7ii7 ,specifi$ l>ge employ] ,9 ?is subsection1 ! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ej employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7iii7 ,specifi$ l>ge plan ,9 ?is subsection1 ! t]m specifi$ l>ge plan means a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd t _h an av]age ( at lea/ #ej p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 4 7#b7 ,civil en=cem5t 7,a7 ,civil en=cem5t ,subsection 7c7 ( section #ejb ( su* ,act 7#bi ,u4,s4,c4 #aacb7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ac7 7,a7 ,9 ! case ( an agreem5t betwe5 a gr\p heal? plan 7z def9$ 9 section #gcc7;a771 ! plan sponsor ( su* plan 7z def9$ 9 section #c7af77;,b771 or ! plan adm9i/rator ( su* plan 7z def9$ 9 section #c7af77;,a77 & a heal? c>e provid] 7:i*1 = purposes ( ?is p>agraph1 includes a heal? c>e facility71 network or association ( provid]s1 s]vice provid] (f]+ access to a network or association ( provid]s1 ?ird-p>ty adm9i/rator1 or ph>macy b5efit manag]1 t violates ! provisions ( section #gbd7;b71 ! ,secret>y may assess a civil p5alty aga9/ su* provid]1 network or association1 s]vice provid] (f]+ access to a network or association ( provid]s1 ?ird-p>ty adm9i/rator1 ph>macy b5efit manag]1 or o!r s]vice provid] 9 ! am\nt ( up to #aj1jjj = ea* day dur+ :i* su* violation cont9ues4 ,su* p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7,b7 ,no?+ 9 subp>agraph 7,a7 %all be con/ru$ to p]mit ! ,secret>y to regulate heal? c>e provid]s act+ 9 _! capacity z m$ical organizations furni%+ items & s]vices to pati5ts4 4 7,b7 ,exi/+ provisions void ,section #daj ( su* ,act 7#bi ,u4,s4,c4 #aaaj7 is am5d$ by add+ at ! end ! foll[+3 7c7 ,any provision 9 an agreem5t or in/rum5t %all be void z aga9/ public policy if su* provision-- 7#a7 unduly delays or limits a gr\p heal? plan 7z def9$ 9 section #gcc7;a771 ! plan sponsor ( su* plan 7z def9$ 9 section #c7af77;,b771 or ! plan adm9i/rator ( su* plan 7z def9$ 9 section #c7af77;,a77 f access+ ! claims & enc\nt] in=mation or data describ$ 9 section #gbd7;b77#a77;,b72 or 7#b7 violates ! requirem5ts ( section #djh7;b77#b77;,c74 4 7,c7 ,te*nical am5dm5ts ,section #djh7;b77#b77;,b7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77 is am5d$-- 7i7 9 clause 7i71 by /rik+ ?is clause & ins]t+ ?is p>agraph2 & 7ii7 by add+ at ! end ! foll[+3 7xi7 ,a contract or arrangem5t %all n be reasonable "u ?is subp>agraph if x fails to comply ) section #gbd7;b74 4 7b7 ,updat$ atte/ation = price & quality in=mation ,section #bgii;,a-#i7;a77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aai7;a77#d77 is am5d$ to read z foll[s3 7#d7 ,atte/ation 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all annually submit to ! ,secret>y an atte/ation t su* plan or issu] ( su* cov]age is 9 compliance ) ! requirem5ts ( ?is subsection4 ,su* atte/ation %all also include a /atem5t v]ify+ t-- 7i7 ! in=mation or data describ$ "u subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a7 is available ^u reque/ & provid$ to ! gr\p heal? plan1 ! plan sponsor1 ! plan adm9i/rator1 or ! bus9ess associate ( su* plan1 or ! issu]1 z applicable1 9 a timely mann]2 & 7ii7 !re are no t]ms 9 ! agreem5t "u su* p>agraph 7#a7 t directly or indirectly re/rict or unduly delay a gr\p heal? plan1 ! plan sponsor1 ! plan adm9i/rator1 a bus9ess associate ( su* plan1 or ! issu] f audit+1 review+1 or o!rwise access+ su* in=mation4 7,b7 ,limitation on submission ,a gr\p heal? plan or issu] (f]+ gr\p heal? insurance cov]age may n ent] into an agreem5t ) a ?ird-p>ty adm9i/rator or o!r s]vice provid] to submit ! atte/ation requir$ "u subp>agraph 7,a74 7,c7 ,exception ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is unable to obta9 ! in=mation or data ne$$ to submit ! atte/ation requir$ "u subp>agraph 7,a71 su* plan or issu] may submit a writt5 /atem5t 9 lieu ( su* atte/ation t includes-- 7i7 an explanation ( :y su* plan or issu] 0 unsuccessful 9 obta9+ su* in=mation or data1 includ+ :e!r su* plan1 ! plan sponsor1 or ! plan adm9i/rator or issu] 0 limit$ or prev5t$ f audit+1 review+1 or o!rwise access+ su* in=mation or data2 7ii7 a description ( ! ef=ts made by ! gr\p heal? plan1 ! plan sponsor1 or ! plan adm9i/rator to remove any gag clause provisions f ! agreem5t "u p>agraph 7#a72 & 7iii7 a description ( any response by ! ?ird-p>ty adm9i/rator or o!r s]vice provid] ) respect to ef=ts to comply ) ! atte/ation requirem5t "u subp>agraph 7,a71 includ+ ! "n ( ! ?ird-p>ty adm9i/rator or o!r s]vice provid]4 4 7c7 ,effective date ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply ) respect to a plan beg9n+ ) ! fir/ plan ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act4 #fjg4 ,ov]sight ( adm9i/rative s]vice provid]s 7a7 ,,phsa am5dm5t ,"p ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 z am5d$ by section #djd1 is am5d$ by add+ at ! end ! foll[+3 #bgii;,a-#ae4 ,ov]sight ( adm9i/rative s]vice provid]s 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 no agreem5t betwe5 a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan 7z su* t]ms are def9$ 9 section #bgii;,a-#aa7;f77 or a heal? insurance issu] (f]+ individual or gr\p heal? cov]age 7t makes an election subject to subsection 7b77#e77 & a heal? insurance issu] t is op]at+ z a ?ird-p>ty adm9i/rator1 a heal? c>e provid]1 network or association ( provid]s1 ?ird-p>ty adm9i/rator1 s]vice provid] (f]+ access to a network ( provid]s1 ph>macy b5efit manag]s1 or any o!r ?ird p>ty 7ea* ref]r$ to 9 ?is section z a heal? plan s]vice provid]7 is p]missible if su* agreem5t limits 7or delays beyond ! applicable report+ p]iod describ$ 9 subsection 7b77#a77 ! disclosure ( in=mation to su* gr\p heal? plans & heal? insurance issu]s 9 a mann] t prev5ts any heal? plan s]vice provid] f provid+ ! in=mation describ$ 9 subsection 7b74 7b7 ,requir$ disclosures 7#a7 ,cont5ts & frequ5cy ,) respect to plan ye>s beg9n+ on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ?is section1 n less frequ5tly ?an qu>t]ly1 a heal? plan s]vice provid] %all provide to ! gr\p heal? or ! heal? insurance issu] (f]+ individual or gr\p heal? insurance cov]age ! foll[+ in=mation at no co/ to ! plan or issu]3 7,a7 ,! in=mation describ$ 9 section #bgii;,a-#i7;a77#a77;,b7 7#db ,u4,s4,c4 #cjj;gg-#aai7;a77#a77;,b774 7,b7 ,any contractual & subcontractual calculation me?odologies1 pric+ or fee s*$ules1 or o!r =mulae us$ to det]m9e reimbursem5t am\nts to provid]s & subcontractors1 includ+ me?odologies1 s*$ules1 fee /ructures1 & any appli$ adju/m5ts or modifi]s1 ) su* in=mation provid$ 9 a mann] suffici5tly detail$ to enable ! gr\p heal? plan or issu] to accurately assess1 v]ify1 & ensure compliance ) ! t]ms ( any contractual & subcontractual agreem5t gov]n+ ! reimbursem5t am\nts4 7,c7 ,! total am\nt receiv$ or expect$ to be receiv$ by ! heal? plan s]vice provid] or its subcontractors 9 provid] or suppli] rebates1 fees1 alt]native disc\nts1 & all o!r remun]ation includ+ am\nts held 9 escr[ or v>iance acc\nts t has be5 paid or is to be paid = claims incurr$ & adm9i/rative s]vices includ+ data sales or network paym5ts4 7,d7 ,! total am\nt paid or expect$ to be paid by ! heal? plan s]vice provid] to its subcontractors 9 rebates1 fees1 contractual arrangem5ts1 & all o!r remun]ation = adm9i/rative & o!r s]vices4 7,e7 ,all paym5t data1 calculation me?odologies1 & reconciliation in=mation relat$ to alt]native comp5sation arrangem5ts1 includ+ acc\ntable c>e organizations1 value-bas$ programs1 %>$ sav+s programs1 inc5tive comp5sation1 bundl$ paym5ts1 capitation arrangem5ts1 p]=mance paym5ts1 & any o!r reimbursem5t or paym5t models1 :]e ! gr\p heal? plan paid fees1 incurr$ obligations1 or made paym5ts 9 connection ) ! gr\p heal? plan or issu] relat$ to su* arrangem5ts4 7,f7 ,:e!r1 ) respect to a provid] t files claims "u su* plan or cov]age1 ! heal? plan s]vice provid]-- 7i7 has an own]%ip or inve/m5t int]e/2 7ii7 has a controll+ int]e/2 7iii7 is a managem5t s]vices organization2 or 7iv7 is a significant equity inve/or4 7,g7 ,! "n & bus9ess address = ea* p]son or entity t1 ) respect to ! heal? plan s]vice provid]-- 7i7 has an own]%ip or inve/m5t int]e/2 7ii7 has a controll+ int]e/2 or 7iii7 is a significant equity inve/or4 7#b7 ,mann] ( provid+ in=mation or data 7,a7 ,9 g5]al ,a heal? plan s]vice provid] %all provide in=mation or data "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a77 & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts ,9 c>ry+ out ?is subsection1 a heal? plan s]vice provid] %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation74 7,c7 ,rule ( con/ruction 7i7 ,9 g5]al ,no?+ 9 ?is subsection %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,civil rights laws ,no?+ 9 ?is subsection %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 a heal? plan s]vice provid] %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = heal? plan s]vice provid]s to submit in=mation or data "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is subsection %all prev5t a heal? plan s]vice provid] f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation or data describ$ 9 p>agraph 7#a71 except t su* provid] may n re/rict disclosures "u subsection 7b77#a7 to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury4 7,f7 ,limitation ,?is p>agraph %all n be con/ru$ to abridge or limit ! disclosure requirem5ts "u ?is subsection or to impose additional privacy or security requirem5ts on heal? plan s]vice provid]s or plan sponsors4 7#c7 ,disclosure & r$isclosure 7,a7 ,9 g5]al ,a gr\p heal? plan or heal? insurance issu] (f]+ individual or gr\p cov]age receiv+ in=mation "u p>agraph 7#a7 may disclose su* in=mation only-- 7i7 to ! entity f :i* ! in=mation 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations72 or 7ii7 z p]mitt$ by ! ,,hipaa ,privacy ,rule 7#de ,,cfr "p #afj & subp>ts ,a & ,e ( "p #afd74 7,b7 ,availability ( in=mation ,to ! ext5t ! in=mation requir$ by ?is subsection is made available to ! heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 ! heal? insurance issu] %all make su* in=mation available1 at ! same "t1 9 ! same =mat1 & at no co/1 to ! gr\p heal? plan4 7,c7 ,limitation on use ( in=mation ,a gr\p heal? plan or heal? insurance issu] 7& any bus9ess associate or o!r entity act+ on behalf ( su* plan7 may use in=mation or data "u ?is p>agraph only = purposes ( plan adm9i/ration & may n sell1 lic5se1 or o!rwise comm]cially exploit su* in=mation or data or provide su* in=mation or data to any ?ird p>ty t may take su* action4 7,d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to prev5t a gr\p heal? plan1 a heal? insurance issu]1 or a heal? plan s]vice provid] provid+ s]vices ) respect to su* a plan1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation describ$ 9 p>agraph 7#a71 except t su* plan or entity may n re/rict disclosure ( su* in=mation to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 ! ,dep>tm5t ( ! ,treasury1 or ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates4 7,e7 ,failure to provide ,! obligation to provide in=mation pursuant to ?is subsection %all exi/ not)/&+ ! pres5ce ( any =mal data-%>+ agreem5t betwe5 ! p>ties4 ,failure to provide ! requir$ in=mation z specifi$ %all con/itute a violation ( ?is ,act & ! ,secret>y %all initiate en=cem5t action "u section #bgbc7;b7 7#db ,u4,s4,c4 #cjj;gg-#bb7;b77 )9 #ij days ( becom+ aw>e ( a violation ( ?is section1 except t no?+ 9 ?is section %all be con/ru$ to limit ! ,secret>y's exi/+ au?ority "u ?is ,act4 7#d7 ,data =mat /&>ds ,all data & in=mation provid$ pursuant to ?is subsection %all comply ) ! foll[+ /&>ds3 7,a7 ,all claims f a heal?c>e provid] %all be made to ! gr\p heal? plan 9 accordance ) /&>ds adopt$ "u ,,hipaa z describ$ 9 subp>t ,k ( "p #afb ( title #de1 ,code ( ,f$]al ,regulations1 z foll[s3 7i7 ,in/itutional1 pr(essional1 & d5tal claims & adju/m5ts to ^! claims %all be provid$ to ! gr\p heal? plan or heal? insurance issu] 9 ! ,,asc ,x#ab,n #hcg =mat4 7ii7 ,prescription drug claims %all be 9 ! ,national ,c\ncil = ,prescription ,drug ,programs 7,,ncpdp7 =mat4 7iii7 ,! files %all be unmodifi$ copies ( ! files s5t f ! provid]4 ,9 ! ev5t t pap] claims are s5t by ! provid]1 !y %all be conv]t$ to ! appropriate /&>d electronic =mat4 ,su* data %all be provid$ at no co/ to ! gr\p heal? plan4 7,b7 ,all claim paym5t 7or ,,eft1 electronic funds transf]7 & electronic remittance advice 7,,era7 in=mation s5t by a heal? plan s]vice provid] %all be provid$ to ! gr\p heal? plan or heal? insurance issu] 9 ! ,,asc ,x#ab,n #hce =mat1 9 accordance ) /&>ds & op]at+ rules adopt$ "u ,,hipaa at subp>t ,p ( "p #afb ( title #de1 ,code ( ,f$]al ,regulations1 unmodifi$ f ! =m 9 :i* x 0 transmitt$ to ! heal?c>e provid]4 ,su* in=mation %all be provid$ at no co/ to ! gr\p heal? plan4 7,c7 ,! ,secret>y may modify ! /&>ds set =? 9 ?is p>agraph z necess>y to align ) any *anges adopt$ by ! ,secret>y pursuant to ! au?ority provid$ "u section #aagc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#b74 7#e7 ,opt-9 = heal? insurance cov]age ,9 ! case ( a heal? insurance issu] (f]+ cov]age 9 ! individual or gr\p m>ket1 su* issu] may1 on an annual basis1 = plan ye>s beg9n+ on or aft] ! effective date ( ?is section1 elect to require a heal? plan s]vice provid] to submit to su* issu] a report t includes all ( ! in=mation describ$ 9 p>agraph 7#a74 7c7 ,prohibit$ contractual provisions ,any provision 9 an agreem5t t unduly delays or limits a gr\p heal? plan or issu]'s access to in=mation describ$ 9 ?is section or t re/ricts ! =mat or tim+ ( ! provision ( su* in=mation 9 a mann] t is inconsi/5t ) ! requirem5ts ( ?is section %all be prohibit$ &1 if a gr\p heal? plan or issu] ent]s into su* agreem5t1 %all be deem$ void z aga9/ public policy4 7d7 ,regulations ,! ,secret>y %all implem5t ?is section ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 4 7b7 ,p5alty ,section #bgbc7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#bb7;b77 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,en=cem5t au?ority relat+ to heal? plan s]vice provid]s ,not)/&+ any provisions to ! contr>y1 ! ,secret>y may assess a p5alty aga9/ a heal? plan s]vice provid]1 z def9$ 9 section #bgii;,a-#ae7;a71 ( #ajj1jjj p] day = ea* violation ( su* section1 pursuant to sub/antially simil> processes & proc$ures z ^? set =? 9 section #bgbc7;b77#b77;,d7 ?r\gh 7,g74 4 7c7 ,,erisa am5dm5ts 7#a7 ,9 g5]al ,section #ejb7;c7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aacb7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ad7 ,! ,secret>y may assess a civil p5alty aga9/ any p]son ( #ajj1jjj p] day = ea* violation by any p]son ( section #bgii;,a-#ae ( ! ,public ,heal? ,s]vice ,act4 4 7#b7 ,te*nical am5dm5t ,p>agraph 7#f7 ( section #ejb7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aacb7;a77 is am5d$ by /rik+ or 7#i7 & ins]t+ 7#i71 7#ac71 or 7#ad74 #fjh4 ,/ate preemption only 9 ev5t ( conflict ,! provisions ( section #bgah;,a ( ! ,public ,heal? ,s]vice ,act 7z add$ & am5d$ by ?is ,act7 %all n be con/ru$ to sup]s$e any provision ( ,/ate law :i* e/abli%es1 implem5ts1 or cont9ues 9 effect any requirem5t or prohibition relat$ to heal? c>e price transp>5cy1 includ+ = hospitals1 cl9ical diagno/ic laboratories1 provid] ( specifi$ imag+ s]vices1 & ambulatory surgical c5t]s 7z su* t]ms are def9$ 9 section #bgah;,a7a7 ( ! ,public ,heal? ,s]vice ,act71 except to ! ext5t t su* requirem5t or prohibition prev5ts ! application ( a requirem5t or prohibition ( su* sections 7or su* am5dm5ts74 ,no?+ 9 ?is section %all be con/ru$ to affect gr\p heal? plans e/abli%$ "u ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or alt] ! application ( section #ead ( su* ,act 7#bi ,u4,s4,c4 #aadd74 #fji4 ,requirem5t = explanation ( b5efits 7a7 ,advanc$ explanation ( b5efits ,section #bgii;,a-#a7;f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa7;f77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ subp>agraph 7,c7 & ins]t+ ! foll[+3 7,c7 ,a good fai? e/imate ( ! am\nt ! plan or cov]age is responsible = pay+ = items & s]vices includ$ 9 ! e/imate describ$ 9 subp>agraph 7,b71 includ+ a pla9 language description ( ea* item or s]vice & all applicable bill+ codes = ea* item or s]vice1 includ+ modifi]s1 us+ /&>d & commonly recogniz$ bill+ code sets t are cle>ly id5tifi$4 2 & 7,b7 by add+ at ! end ! foll[+3 7,i7 ,a notification t ! recipi5t may be held h>mless1 9 c]ta9 circum/ances1 if ! in=mation 9 ! advanc$ explanation ( b5efits does n mat* ! am\nt ! recipi5t is bill$4 2 & 7#b7 by add+ at ! end ! foll[+3 7#c7 ,hold h>mless 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #a ye> aft] ! date on :i* ! ,secret>y implem5ts ?is section1 a p>ticipant1 b5efici>y1 or enrollee %all be held h>mless = any am\nt t is sub/antially 9 excess 7z def9$ by ! ,secret>y 9 a mann] consi/5t ) ! process describ$ 9 section #bgii;,b-#g7 ( ! e/imate g5]at$ by ! advanc$ explanation ( b5efits4 7,b7 ,no pati5t responsibility = excess *>ges ,a gr\p heal? plan or a heal? insurance issu] 9 ! gr\p or individual m>ket %all n hold a p>ticipant1 b5efici>y1 or enrollee responsible = excess *>ges describ$ 9 ?is p>agraph if su* excess is ! result ( cov]age or paym5t det]m9ations t diff] f projections made 9 ! advanc$ explanation ( b5efits at ! "t su* explanation 0 g5]at$4 7,c7 ,sub/antial excess ,a p>ticipant1 b5efici>y1 or enrollee %all n be held h>mless = excess am\nts if su* am\nts reflect ! co/ ( m$ically necess>y items or s]vices furni%$ bas$ on un=ese5 circum/ances t c\ld n h reasonably be5 anticipat$ by ! provid] or facility at ! "t ! good fai? e/imate 0 g5]at$ or by ! plan or issu] at ! "t ! advanc$ explanation ( b5efits 0 g5]at$4 4 7b7 ,good fai? e/imates ,section #bgii;,b-#f ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#acf7 is am5d$-- 7#a7 by /rik+ ,ea* heal? c>e & ins]t+ ! foll[+3 7a7 ,9 g5]al ,ea* heal? c>e 2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,hold h>mless 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #a ye> aft] ! date on :i* ! ,secret>y implem5ts section #bgii;,a-#a7;f71 if an individual enroll$ 9 a gr\p heal? plan or heal? insurance cov]age 7& seeks to h a claim = an item or s]vice submitt$ to su* plan or cov]age7 is responsible = any am\nt t is sub/antially 9 excess 7z def9$ by ! ,secret>y 9 a mann] consi/5t ! process describ$ 9 section #bgii;,b-#g7 ( ! e/imate g5]at$ 9 ! advanc$ explanation ( b5efits describ$ 9 section #bgii;,a-#a7;f7 because ! f9al *>ges = items & s]vices 7 sub/antially 9 excess ( ! good fai? e/imate provid$ to ! plan or cov]age "u ?is section1 a provid] %all n bill ! pati5t = am\nts sub/antially 9 excess ( ! advanc$ explanation ( b5efits4 7#b7 ,sub/antial excess ,an individual seek+ to h a claim = an item or s]vice cov]$ by a gr\p heal? plan or heal? insurance cov]age %all n be held h>mless = excess am\nts if su* am\nts reflect ! co/ ( m$ically necess>y items or s]vices furni%$ bas$ on un=ese5 circum/ances t c\ld n h reasonably be5 anticipat$ by ! provid] or facility at ! "t ! good fai? e/imate 0 g5]at$ or by ! plan or issu] at ! "t ! advanc$ explanation ( b5efits 0 g5]at$4 4 7c7 ,explanation ( b5efits ,section #bgii;,a-#a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa7 is am5d$ by add+ at ! end ! foll[+3 7g7 ,explanation ( b5efits 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on ,janu>y #a ( ! ye> t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ! ,heal? ,,c>e ,act ( #bjbf1 ea* gr\p heal? plan1 or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all1 )9 #de days ( receiv+ ! in=mation necess>y to decide a claim = paym5t 7z def9$ by ! ,secret>y7 = an item or s]vice "u ! plan or cov]age = :i* liability "u ! plan or cov]age has be5 det]m9$1 provide to ! p>ticipant1 b5efici>y1 or enrollee 7?r\gh mail or electronic means1 z reque/$ by ! p>ticipant1 b5efici>y1 or enrollee7 a notification 79 cle> & und]/&able language & utiliz+ sub/antially ! same =mat z ! advanc$ explanation ( b5efits requir$ by subsection 7f7 to enable comp>ison :5 an advanc$ explanation ( b5efits is provid$7 includ+ ! foll[+3 7,a7 ,:e!r or n ! provid] or facility is a p>ticipat+ provid] or a p>ticipat+ facility ) respect to ! plan or cov]age ) respect to ! furni%+ ( su* item or s]vice4 7,b7 ,an itemiz$ explanation ( b5efits t includes ! foll[+3 7i7 ,a pla9 language description ( ea* item or s]vice4 7ii7 ,all applicable bill+ codes = ea* item or s]vice1 includ+ modifi]s1 us+ /&>d & commonly recogniz$ bill+ code sets t are cle>ly id5tifi$4 7iii7 ,! am\nt ! plan or cov]age is responsible = pay+ = ea* item or s]vice4 7iv7 ,! am\nt ( any co/-%>+ = :i* ! p>ticipant1 b5efici>y1 or enrollee is responsible = ea* item or s]vice 7z ( ! date ( su* notification74 7v7 ,! am\nt t ! p>ticipant1 b5efici>y1 or enrollee has incurr$ t[>d meet+ ! limit ( ! f9ancial responsibility 7includ+ ) respect to d$uctibles & out-(-pocket maximums7 "u ! plan or cov]age 7z ( ! date ( su* notification74 7vi7 ,! type ( site ( ea* item or s]vice1 includ+ (fice1 facility1 or em]g5cy room4 7vii7 ,if applicable1 a description ( any discrepancies t exi/ betwe5 ! s]vices outl9$ 9 a pati5t's advanc$ explanation ( b5efits & ! explanation ( b5efits4 7viii7 ,! am\nt ( any facility fee or o!r pati5t *>ges t 7 add$ to ! f9al paym5t am\nt1 toge!r ) a pla9 language explanation ( ! fee1 if applicable4 7,c7 ,if ! provid] or facility is a p>ticipat+ provid] or facility ) respect to ! plan or cov]age ) respect to ! furni%+ ( su* item or s]vice1 ! contract$ rate "u su* plan or cov]age = su* item or s]vice4 7,d7 ,! *>ges submitt$ by ! provid] or facility = ea* item or s]vice4 7,e7 ,in=mation p]ta9+ to plan type1 z def9$ ! ,secret>y4 7#b7 ,=mat ,if applicable1 ! notification describ$ 9 p>agraph 7#a7 may be provid$ 9 conjunction )1 or z "p (1 a notice ( a claim det]m9ation or o!r communication requir$ by section #bgai7;a7 7#db ,u4,s4,c4 #cjj;gg-#ai7;a771 or regulations !reund]4 7h7 ,regulations ,! ,secret>y %all implem5t ?is section ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 4 #faj4 ,transp>5cy 9 bill+ 7a7 ,9 g5]al ,"p ,e ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aca et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgii;,b-#aj4 ,pati5t access to complete bill+ in=mation 7a7 ,requirem5ts 7#a7 ,notice ( "r ( access to itemiz$ bills2 ,9 g5]al ,a heal? c>e provid] or heal? c>e facility t reque/s paym5t f an individual = provid+ a heal? c>e item or s]vice to ! pati5t %all include ) su* reque/ a writt5 notice ( ! individual's "r to reque/ an itemiz$ bill z "p ( ! individual's designat$ record set "u section #afd4ebd ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation74 7#b7 ,requir$ in=mation ,a notice "u p>agraph 7#a7 %all provide-- 7,a7 a phone numb] & int]net website :]e an individual c make a reque/ = access to _! itemiz$ bill2 7,b7 in=mation ab\t ! availability ( language-assi/ance s]vices = individuals ) limit$ ,engli% pr(ici5cy 7,,lep72 & 7,c7 in=mation ab\t ! heal? c>e provid]'s or heal? c>e facility's *>ity c>e policies & in/ructions on h[ to apply = *>ity c>e4 7#c7 ,collections actions 7,a7 ,9 g5]al ,a heal? c>e provid] or heal? c>e facility %all n bill or take any collections actions aga9/ an individual-- 7i7 = any provid$ heal? c>e item or s]vice unless ! heal? c>e provid] or heal? c>e facility has compli$ ) p>agraph 7#a7 or section #acdje7;e77#d7 ( ! ,,hite* ,act2 or 7ii7 ) respect to any items or s]vices = :i* ! am\nt appe>+ on an itemiz$ bill describ$ above 9 p>agraph 7#a7 exce$s ! am\nt disclos$ pursuant to ,f$]al heal? c>e price transp>5cy regulations1 includ+ "p #ahj ( title #de1 ,code ( ,f$]al ,regulations1 or provid$ 9 a good fai? e/imate t complies ) section #bgii;,b-#f ( ?is ,act & section #adi4faj ( title #de1 ,code ( ,f$]al ,regulations1 or ano!r good fai? e/imate provid$ by a heal? c>e entity cov]$ "u ?is section b n o!rwise cov]$ "u su* section #bgii;,b-#f1 unless ! provid] or facility docum5ts t ! additional items or s]vices 7 m$ically necess>y due to un=ese5 complications or a pati5t-initiat$ *ange1 & c\ld n reasonably h be5 anticipat$4 7,b7 ,provid] requirem5t ,if a provid] fails to provide a docum5tation z requir$ "u subp>agraph 7,a77ii7 9 ! case ( items or s]vices1 ! good fai? e/imate describ$ 9 su* subp>agraph ) respect to su* items or s]vices %all be b9d+4 7b7 ,failure ,to comply 7#a7 ,p5alties ,! ,secret>y %all impose p5alties on any heal? c>e provid] or heal? c>e facility t fails to comply ) ! requirem5ts ( ?is section 9 an am\nt n to exce$ #aj1jjj = ea* in/ance ( failure to comply4 7#b7 ,presumption 9 favor ( individual ,if a heal? c>e provid] or heal? c>e facility fails to comply ) ! requirem5ts ( ?is section1 ! presumption %all be t *>ges 7 sub/antially 9 excess ( ! good fai? e/imate1 z set =? 9 section #bgii;,b-#f1 = ! purpose ( any pati5t-provid] dispute1 includ+ 9 accordance ) section #bgii;,b-#g & regulations promulgat$ !reund]4 7c7 ,regulations ,! ,secret>y %all implem5t ?is section ?r\gh notice & comm5t rulemak+ 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 4 7b7 ,/&>ds = access+ itemiz$ bills ,section #acdje7;e7 ( ! ,,hite* ,act 7#db ,u4,s4,c4 #agice7;e77 is am5d$-- 7#a7 9 p>agraph 7#b71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end1 ! foll[+3 7#d7 if ! individual makes a reque/ only = an itemiz$ copy ( a bill = s]vices provid$1 ! cov]$ entity or bus9ess associate %all-- 7,a7 make su* protect$ heal? in=mation available )9 #cj days ( su* reque/2 7,b7 n impose any fee = provid+ su* individual a copy ( _! in=mation2 & 7,c7 include 9 su* itemiz$ bill1 a pla9 language description ( ea* di/9ct heal? c>e item or s]vice1 all applicable bill+ codes = ea* di/9ct item or s]vice1 includ+ modifi]s1 us+ /&>d & commonly recogniz$ bill+ code sets1 ! price & bill$ am\nt1 if diff]5t1 ( ea* di/9ct item or s]vice4 4 #faa4 ,te*nical am5dm5ts 7a7 ,,erisa ,section #gae7;a77#a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aahe;d7a77#a77 is am5d$ by ins]t+ & p>ts ,d & ,e ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7z am5d$ by title ,,vi ! ,heal? ,,c>e ,act ( #bjbf7 aft] ,af=dable ,c>e ,act74 7b7 ,int]nal ,rev5ue ,code ,section #ihae7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ & p>ts ,d & ,e ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7z am5d$ by title ,,vi ( ! ,heal? ,,c>e ,act ( #bjbf7 aft] ,af=dable ,c>e ,act74 #fab4 ,implem5tation & en=cem5t fund+ 7a7 ,appropriation = ,secret>y ( ,labor ,!re are au?oriz$ to be appropriat$1 su* sums z may be necess>y = fiscal ye> #bjbg1 & ea* subsequ5t fiscal ye>1 to enable ! ,secret>y ( ,labor to c>ry out ?is ,act & ! am5dm5ts made by ?is ,act1 includ+ en=cem5t activities4 7b7 ,appropriation = ! ,secret>y ( ,heal? & ,human ,s]vices ,!re are au?oriz$ to be appropriat$1 su* sums z may be necess>y = fiscal ye> #bjbg1 & ea* subsequ5t fiscal ye>1 to enable ! ,secret>y ( ,heal? & ,human ,s]vices to c>ry out ! am5dm5ts made by ?is ,act1 includ+ implem5tation & en=cem5t activities4 ,,vii ,re=m+ ,p,b,ms & ,protect+ ,ph>macies #gja4 ,ensur+ accurate paym5ts to ph>macies "u ,m$icaid 7a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a7-- 7,a7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7,b7 by /rik+ & aft] ! semicolon at ! end ( clause 7i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,det]m9+ ph>macy actual acquisition co/s ,! ,secret>y %all conduct a survey ( retail community ph>macy drug prices & applicable non-retail ph>macy drug prices to det]m9e national av]age drug acquisition co/ b5*m>ks 7z su* t]m is def9$ by ! ,secret>y7 z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 7ii7 ) respect to applicable non-retail ph>macies-- 7,i7 ! det]m9ation ( survey prices1 sep>ate f ! survey prices describ$ 9 clause 7i71 ( ! non-retail national av]age drug acquisition co/ = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 7,,ii7 at ! discretion ( ! ,secret>y1 = ea* type ( applicable non-retail ph>macy1 ! det]m9ation ( survey prices1 sep>ate f ! survey prices describ$ 9 clause 7i7 or subclause 7,i7 ( ?is clause1 ( ! national av]age drug acquisition co/ = su* type ( ph>macy = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 2 7#b7 9 subp>agraph 7,b7 ( p>agraph 7#a71 by /rik+ subp>agraph 7,a77ii7 & ins]t+ subp>agraph 7,a77iii72 7#c7 9 subp>agraph 7,d7 ( p>agraph 7#a71 by /rik+ clauses 7ii7 & 7iii7 & ins]t+ ! foll[+3 7ii7 ,! v5dor mu/ update ! ,secret>y no less (t5 ?an mon?ly on ! survey prices = cov]$ outpati5t drugs4 7iii7 ,! v5dor mu/ diff]5tiate1 9 collect+ & report+ survey data1 = all co/ in=mation collect$1 :e!r a ph>macy is a retail community ph>macy or an applicable non-retail ph>macy1 includ+ :e!r su* ph>macy is an affiliate 7z def9$ 9 subsection 7k77#ac771 &1 9 ! case ( an applicable non-retail ph>macy1 :i* type ( applicable non-retail ph>macy x is us+ ! relevant ph>macy type indicators includ$ 9 ! guidance requir$ by subsection 7d77#b7 ( section #gja ( ! ,heal? ,,c>e ,act ( #bjbf4 2 7#d7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,9 ord] to meet ! requirem5t ( section #aijb7;a77#ed71 a ,/ate %all require t any retail community ph>macy or applicable non-retail ph>macy 9 ! ,/ate t receives any paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 rebate1 or o!r price concession relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 rebate1 or o!r price concession is receiv$ f ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d77 directly or f a ph>macy b5efit manag] or ano!r entity t has a contract ) ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z s def9$71 %all respond to surveys conduct$ "u ?is p>agraph4 7,g7 ,survey in=mation ,in=mation on national drug acquisition prices obta9$ "u ?is p>agraph %all be made publicly available 9 a =m & mann] to be det]m9$ by ! ,secret>y & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate to ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ me?odology & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,in=mation on price concessions to ph>macies1 includ+ disc\nts1 rebates1 & o!r price concessions1 to ! ext5t t su* in=mation may be publicly releas$ & has be5 collect$ by ! ,secret>y z "p ( ! survey4 7,h7 ,p5alties 7i7 ,9 g5]al ,subject to clauses 7ii71 7iii71 & 7iv71 ! ,secret>y %all en=ce ! provisions ( ?is p>agraph ) respect to a ph>macy ?r\gh ! e/abli%m5t ( civil money p5alties applicable to a retail community ph>macy or an applicable non-retail ph>macy4 7ii7 ,basis = p5alties ,! ,secret>y %all impose a civil money p5alty e/abli%$ "u ?is subp>agraph on a retail community ph>macy or applicable non-retail ph>macy if-- 7,i7 ! retail ph>macy or applicable non-retail ph>macy refuses or o!rwise fails to respond to a reque/ = in=mation ab\t prices 9 connection ) a survey "u ?is subsection2 7,,ii7 kn[+ly provides false in=mation 9 response to su* a survey2 or 7,,iii7 o!rwise fails to comply ) ! requirem5ts e/abli%$ "u ?is p>agraph4 7iii7 ,p>amet]s = p5alties 7,i7 ,9 g5]al ,a civil money p5alty e/abli%$ "u ?is subp>agraph may be assess$ ) respect to ea* violation1 & ) respect to ea* non-compliant retail community ph>macy 7includ+ a ph>macy t is "p ( a *a97 or non-compliant applicable non-retail ph>macy 7includ+ a ph>macy t is "p ( a *a971 9 an am\nt n to exce$ #ajj1jjj = ea* su* violation4 7,,ii7 ,consid]ations ,9 det]m9+ ! am\nt ( a civil money p5alty impos$ "u ?is subp>agraph1 ! ,secret>y may consid] ! size1 bus9ess /ructure1 & type ( ph>macy involv$1 z well z ! type ( violation & o!r relevant factors1 z det]m9$ appropriate by ! ,secret>y4 7iv7 ,rule ( application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil money p5alty or proce$+ "u section #aabh;,a7a74 7,i7 ,limitation on use ( applicable non-retail ph>macy pric+ in=mation ,no ,/ate %all use pric+ in=mation report$ by applicable non-retail ph>macies "u subp>agraph 7,a77ii7 to develop or in=m paym5t me?odologies = retail community ph>macies4 2 7#e7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ paym5t rates & me?odologies = det]m9+ +r$i5t co/ reimbursem5t "u manag$ c>e entities or o!r specifi$ entities 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d771 aft] "u ?is title2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ & ! basis = su* disp5s+ fees be=e ! semicolon2 7#f7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 7#g7 by ins]t+ aft] p>agraph 7#c7 ! foll[+ new p>agraph3 7#d7 ,ov]sight 7,a7 ,9 g5]al ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct p]iodic /udies ( ! survey data report$ "u ?is subsection1 z appropriate1 includ+ ) respect to sub/antial v>iations 9 acquisition co/s or o!r applicable co/s1 z well z ) respect to h[ int]nal transf] prices & relat$ p>ty transactions may influ5ce ! co/s report$ by ph>macies t are affiliates 7z def9$ 9 subsection 7k77#ac77 or are own$ by1 controll$ by1 or relat$ "u a common own]%ip /ructure ) a :olesal]1 di/ributor1 or o!r entity t acquires cov]$ outpati5t drugs relative to co/s report$ by ph>macies n affiliat$ ) su* entities4 ,! ,inspector ,g5]al %all provide p]iodic updates to ,congress on ! results ( su* /udies1 z appropriate1 9 a mann] t does n disclose trade secrets or o!r propriet>y in=mation4 7,b7 ,appropriation ,!re is appropriat$ to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #e1jjj1jjj = fiscal ye> #bjbg1 to rema9 available until exp5d$1 to c>ry out ?is p>agraph4 2 & 7#h7 9 p>agraph 7#e71 z s r$esignat$-- 7,a7 by ins]t+ 1 & #i1jjj1jjj = fiscal ye> #bjbg & ea* fiscal ye> !reaft]1 aft] #bjaj2 & 7,b7 by ins]t+ ,funds appropriat$ "u ?is p>agraph = fiscal ye> #bjbg & any subsequ5t fiscal ye> %all rema9 available until exp5d$4 aft] ! p]iod4 7b7 ,def9itions ,section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,9 ! section & ins]t+ ,9 ?is section2 & 7#b7 by add+ at ! end ! foll[+ new p>agraphs3 7#ab7 ,applicable non-retail ph>macy ,! t]m applicable non-retail ph>macy means a ph>macy t is lic5s$ z a ph>macy by ! ,/ate & t is n a retail community ph>macy1 includ+ a ph>macy t disp5ses prescription m$ications to pati5ts prim>ily ?r\gh mail & specialty ph>macies4 ,su* t]m does n include nurs+ home ph>macies1 long-t]m c>e facility ph>macies1 hospital ph>macies1 cl9ics1 *>itable or n-=-pr(it ph>macies1 gov]nm5t ph>macies1 or l[ disp5s+ ph>macies 7z def9$ by ! ,secret>y74 7#ac7 ,affiliate ,! t]m affiliate means any entity t is own$ by1 controll$ by1 or relat$ "u a common own]%ip /ructure ) a ph>macy b5efit manag] or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d774 4 7c7 ,effective date 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! am5dm5ts made by ?is section %all take effect on ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #f mon?s aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,delay$ application to applicable non-retail ph>macies ,! ph>macy survey requirem5ts e/abli%$ by ! am5dm5ts to section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 made by ?is section %all apply to retail community ph>macies beg9n+ on ! effective date describ$ 9 p>agraph 7#a71 b %all n apply to applicable non-retail ph>macies until ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,id5tification ( applicable non-,retail ph>macies 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbh1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) /akehold]s z appropriate1 publi% guidance specify+ ph>macies t meet ! def9ition ( applicable non-retail ph>macies 7z su* t]m is def9$ 9 subsection 7k77#ab7 ( section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 z add$ by subsection 7b771 & t w be subject to ! survey requirem5ts "u subsection 7f77#a7 ( su* section1 z am5d$ by subsection 7a74 7#b7 ,inclusion ( ph>macy type indicators ,! guidance publi%$ "u p>agraph 7#a7 %all include ph>macy type indicators to di/+ui% betwe5 diff]5t types ( applicable non-retail ph>macies1 su* z ph>macies t disp5se prescriptions prim>ily ?r\gh ! mail & ph>macies t disp5se prescriptions t require special h&l+ or di/ribution4 ,an applicable non-retail ph>macy may be id5tifi$ ?r\gh multiple ph>macy type indicators4 7e7 ,implem5tation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 7#b7 ,nonapplication ( ,adm9i/rative ,proc$ure ,act ,implem5tation ( ! am5dm5ts made by ?is section %all be exempt f ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code4 7f7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any data collection und]tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f771 z am5d$ by ?is section4 #gjb4 ,prev5t+ ! use ( abusive spread pric+ 9 ,m$icaid 7a7 ,9 g5]al ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7#a7 9 subsection 7e71 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,transp>5t prescription drug pass-?r\gh pric+ requir$ 7,a7 ,9 g5]al ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm71 or a contract betwe5 ! ,/ate & a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d7 & collectively ref]r$ to 9 ?is p>agraph z ! entity7 t includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs disp5s$ to individuals enroll$ ) ! entity1 %all require t paym5t = su* drugs & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or entity1 is bas$ on a transp>5t prescription drug pass-?r\gh pric+ model "u :i*-- 7i7 any paym5t made by ! entity or ! ,,pbm 7z applicable7 = su* a drug-- 7,i7 is limit$ to-- 7aa7 +r$i5t co/2 & 7bb7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate w\ld pay if ! ,/ate 7 mak+ ! paym5t directly 9 accordance ) ! ,/ate plan2 7,,ii7 is pass$ ?r\gh 9 its entirety 7except z r$uc$ "u ,f$]al or ,/ate laws & regulations 9 response to in/ances ( wa/e1 fraud1 or abuse7 by ! entity or ,,pbm to ! ph>macy or provid] t disp5ses ! drug2 & 7,,iii7 is made 9 a mann] t is consi/5t ) sections #ddg4ejb1 #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 z if su* requirem5ts appli$ directly to ! entity or ! ,,pbm1 except t any paym5t by ! entity or ! ,,pbm = ! +r$i5t co/ ( su* drug pur*as$ by a cov]$ entity 7z def9$ 9 subsection 7a77#e77;,b77 may exce$ ! actual acquisition co/ 7z def9$ 9 #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation7 = su* drug if-- 7aa7 su* drug 0 subject to an agreem5t "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 7bb7 su* paym5t = ! +r$i5t co/ ( su* drug does n exce$ ! maximum paym5t t w\ld h be5 made by ! entity or ! ,,pbm = ! +r$i5t co/ ( su* drug if su* drug _h n be5 pur*as$ by su* cov]$ entity2 & 7cc7 su* cov]$ entity reports to ! ,secret>y 79 a =m & mann] specifi$ by ! ,secret>y71 on an annual basis & ) respect to paym5ts = ! +r$i5t co/s ( su* drugs s pur*as$ by su* cov]$ entity t are 9 excess ( ! actual acquisition co/s = su* drugs1 ! aggregate am\nt ( su* excess2 7ii7 paym5t to ! entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! entity or ,,pbm is limit$ to an adm9i/rative fee t reflects ! fair m>ket value 7z def9$ by ! ,secret>y7 ( su* s]vices2 7iii7 ! entity or ! ,,pbm 7z applicable7 makes available to ! ,/ate1 & ! ,secret>y ^u reque/ 9 a =m & mann] specifi$ by ! ,secret>y1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices 7z describ$ 9 clause 7ii77 incurr$1 receiv$1 or made by ! entity or ! ,,pbm1 brok5 d[n 7z specifi$ by ! ,secret>y71 to ! ext5t su* co/s & paym5ts are attributable to an individual cov]$ outpati5t drug1 by ea* su* drug1 includ+ any +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees 7z describ$ 9 clause 7ii771 po/-sale & po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all o!r remun]ation1 z def9$ by ! ,secret>y2 & 7iv7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! entity or ! ,,pbm 7z applicable7 t exce$s ! am\nt paid to ! ph>macies or provid]s on behalf ( ! ,/ate or entity1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts1 z def9$ by ! ,secret>y 7aft] all[+ = an adm9i/rative fee z describ$ 9 clause 7ii771 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 7,b7 ,publication ( in=mation ,! ,secret>y %all publi%1 n less frequ5tly ?an on an annual basis & 9 a mann] t does n disclose ! id5tity ( a p>ticul> cov]$ entity or organization1 in=mation receiv$ by ! ,secret>y pursuant to subp>agraph 7,a77iii77,,iii7 t is brok5 out by ,/ate & by ea* ( ! foll[+ categories ( cov]$ entity )9 ea* su* ,/ate3 7i7 ,cov]$ entities describ$ 9 subp>agraph 7,a7 ( section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act4 7ii7 ,cov]$ entities describ$ 9 subp>agraphs 7,b7 ?r\gh 7,k7 ( su* section4 7iii7 ,cov]$ entities describ$ 9 subp>agraph 7,l7 ( su* section4 7iv7 ,cov]$ entities describ$ 9 subp>agraph 7,m7 ( su* section4 7v7 ,cov]$ entities describ$ 9 subp>agraph 7,n7 ( su* section4 7vi7 ,cov]$ entities describ$ 9 subp>agraph 7,o7 ( su* section4 2 & 7#b7 9 subsection 7k71 z am5d$ by section #gja7;b71 by add+ at ! end ! foll[+ new p>agraph3 7#ad7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any p]son or entity t1 ei!r directly or ?r\gh an int]m$i>y1 acts z a price negotiator or gr\p pur*as] on behalf ( a ,/ate1 manag$ c>e entity 7z def9$ 9 section #aijc7m77#i77;,d771 or o!r specifi$ entity 7z s def9$71 or manages ! prescription drug b5efits provid$ by a ,/ate1 manag$ c>e entity1 or o!r specifi$ entity1 includ+ ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! manag+ ( appeals or grievances relat$ to ! prescription drug b5efits1 contract+ ) ph>macies1 controll+ ! co/ ( cov]$ outpati5t drugs1 or ! provision ( s]vices relat$ !reto4 ,su* t]m includes any p]son or entity t acts z a price negotiator 7) reg>d to paym5t am\nts to ph>macies & provid]s = a cov]$ outpati5t drug or ! net co/ ( ! drug7 or gr\p pur*as] on behalf ( a ,/ate1 manag$ c>e entity1 or o!r specifi$ entity or t c>ries out #a or m ( ! o!r activities describ$ 9 ! prec$+ s5t5ce1 irrespective ( :e!r su* p]son or entity calls itself a ph>macy b5efit manag]4 4 7b7 ,con=m+ am5dm5ts ,section #aijc7m7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$-- 7#a7 9 p>agraph 7#b77;,a77xiii7-- 7,a7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,,iv7 if ! contract includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs1 ! entity %all comply ) ! requirem5ts ( section #aibg7;e77#f72 & 7,c7 by mov+ ! m>g9 #b ems to ! left2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,no paym5t %all be made "u ?is title to a ,/ate ) respect to exp5ditures incurr$ by ! ,/ate = paym5t = s]vices provid$ by an o!r specifi$ entity 7z def9$ 9 p>agraph 7#i77;,d77iii77 unless su* s]vices are provid$ 9 accordance ) a contract betwe5 ! ,/ate & su* entity :i* satisfies ! requirem5ts ( p>agraph 7#b77;,a77xiii74 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to contracts betwe5 ,/ates & manag$ c>e entities1 o!r specifi$ entities1 or ph>macy b5efit manag]s t h an effective date beg9n+ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,implem5tation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 7#b7 ,nonapplication ( adm9i/rative proc$ure act ,implem5tation ( ! am5dm5ts made by ?is section %all be exempt f ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code4 7e7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any data collection und]tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e771 z am5d$ by ?is section4