,,ii #aaf? ,,congress #a/ ,session ,s4 #c ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #c1 #bjai,mr4 ,c>d9 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to br+ /ability to ! individual insurance m>ket1 make insurance cov]age m af=dable1 l[] prescription drug prices1 & improve ,m$icaid4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,keep+ ,heal? ,insurance ,af=dable ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,,title ,i--,m>ketplace /ability & security ,sec4 #aja4 ,public heal? insurance option4 ,,title ,,ii--,heal? c>e f9ancial assi/ance ,sec4 #bja4 ,increase 9 eligibility = premium assi/ance tax cr$its4 ,,title ,,iii--,drug ,pric+ ,sec4 #cja4 ,requir+ drug manufactur]s to provide drug rebates = drugs disp5s$ to l[-income individuals4 ,sec4 #cjb4 ,negotiation ( prices = ,m$ic>e prescription drugs4 ,sec4 #cjc4 ,gu>ante$ prescription drug b5efits4 ,sec4 #cjd4 ,full reimbursem5t = qualifi$ retiree prescription drug plans4 ,i ,m>ketplace /ability & security #aja4 ,public heal? insurance option 7a7 ,9 g5]al ,"p #c ( subtitle ,d ( title ,i ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7,public ,law #aaa-adh7 is am5d$ by add+ at ! end ! foll[+ new section3 #acbe4 ,public heal? insurance option 7a7 ,e/abli%m5t & adm9i/ration ( a public heal? insurance option 7#a7 ,e/abli%m5t ,= ye>s beg9n+ ) #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all provide = ! (f]+ ?r\gh ,ex*anges e/abli%$ "u ?is title ( a heal? b5efits plan 79 ?is ,act ref]r$ to z ! public heal? insurance option7 t ensures *oice1 competition1 & /ability ( af=dable1 high-quality cov]age ?r\gh\t ! ,unit$ ,/ates 9 accordance ) ?is section4 ,9 design+ ! option1 ! ,secret>y's prim>y responsibility is to create a l[-co/ plan )\t compromis+ quality or access to c>e4 7#b7 ,(f]+ ?r\gh ,ex*anges 7,a7 ,exclusive to ,ex*anges ,! public heal? insurance option %all be made available only ?r\gh ,ex*anges e/abli%$ "u ?is title4 7,b7 ,ensur+ a level play+ field ,consi/5t ) ?is section1 ! public heal? insurance option %all comply ) requirem5ts t are applicable "u ?is title to heal? b5efits plans (f]$ ?r\gh su* ,ex*anges1 includ+ requirem5ts relat$ to b5efits1 b5efit levels1 provid] networks1 notices1 consum] protections1 & co/ %>+4 7,c7 ,provision ( b5efit levels ,! public heal? insurance option-- 7i7 %all (f] bronze1 silv]1 & gold plans2 & 7ii7 may (f] plat9um plans4 7#c7 ,adm9i/rative contract+ ,! ,secret>y may ent] into contracts = ! purpose ( p]=m+ adm9i/rative functions 7includ+ functions describ$ 9 subsection 7a77#d7 ( section #ahgd;,a ( ! ,social ,security ,act7 ) respect to ! public heal? insurance option 9 ! same mann] z ! ,secret>y may ent] into contracts "u subsection 7a77#a7 ( su* section4 ,! ,secret>y has ! same au?ority ) respect to ! public heal? insurance option z ! ,secret>y has "u subsections 7a77#a7 & 7b7 ( section #ahgd;,a ( ! ,social ,security ,act ) respect to title ,,xviii ( su* ,act4 ,contracts "u ?is subsection %all n involve ! transf] ( insurance risk to su* entity4 7#d7 ,ombudsman ,! ,secret>y %all e/abli% an (fice ( ! ombudsman = ! public heal? insurance option :i* %all h duties ) respect to ! public heal? insurance option simil> to ! duties ( ! ,m$ic>e ,b5efici>y ,ombudsman "u section #ahjh7;c77#b7 ( ! ,social ,security ,act4 ,9 addition1 su* (fice %all "w ) ,/ates to ensure t in=mation & notice is provid$ t ! public heal? insurance option is "o ( ! heal? plans available ?r\gh an ,ex*ange4 7#e7 ,data collection ,! ,secret>y %all collect su* data z may be requir$ to e/abli% premiums & paym5t rates = ! public heal? insurance option & = o!r purposes "u ?is section1 includ+ to improve quality & to r$uce racial1 e?nic1 & o!r disp>ities 9 heal? & heal? c>e4 7#f7 ,access to ,f$]al c\rts ,! provisions ( ,m$ic>e 7& relat$ provisions ( title ,,ii ( ! ,social ,security ,act7 relat+ to access ( ,m$ic>e b5efici>ies to ,f$]al c\rts = ! en=cem5t ( rights "u ,m$ic>e1 includ+ ) respect to am\nts 9 controv]sy1 %all apply to ! public heal? insurance option & individuals enroll$ "u su* option "u ?is title 9 ! same mann] z su* provisions apply to ,m$ic>e & ,m$ic>e b5efici>ies4 7b7 ,premiums & f9anc+ 7#a7 ,e/abli%m5t ( premiums 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% geographically adju/$ premium rates = ! public heal? insurance option-- 7i7 9 a mann] t complies ) ! premium rules "u p>agraph 7#c72 & 7ii7 at a level suffici5t to fully f9ance ! co/s (-- 7,i7 heal? b5efits provid$ by ! public heal? insurance option2 & 7,,ii7 adm9i/rative co/s relat$ to op]at+ ! public heal? insurance option4 7,b7 ,cont+5cy m>g9 ,9 e/abli%+ premium rates "u subp>agraph 7,a71 ! ,secret>y %all include an appropriate am\nt = a cont+5cy m>g94 7#b7 ,acc\nt 7,a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury ( ! ,unit$ ,/ates an acc\nt = ! receipts & disbursem5ts attributable to ! op]ation ( ! public heal? insurance option1 includ+ ! />t-up fund+ "u subp>agraph 7,b74 ,section #ahed7;g7 ( ! ,social ,security ,act %all apply to receipts describ$ 9 ! previ\s s5t5ce 9 ! same mann] z su* section applies to paym5ts or premiums describ$ 9 su* section4 7,b7 ,/>t-up fund+ 7i7 ,9 g5]al ,9 ord] to provide = ! e/abli%m5t ( ! public heal? insurance option !re is h]eby appropriat$ to ! ,secret>y1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 #b1jjj1jjj1jjj4 ,9 ord] to provide = initial claims res]ves be=e ! collection ( premiums1 !re is h]eby appropriat$ to ! ,secret>y1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 su* sums z necess>y to cov] #ij days wor? ( claims res]ves bas$ on project$ enrollm5t4 7ii7 ,amortization ( />t-up fund+ ,! ,secret>y %all provide = ! repaym5t ( ! />tup fund+ provid$ "u clause 7i7 to ! ,treasury 9 an amortiz$ mann] ov] ! #aj-ye> p]iod beg9n+ ) #bjbj4 7iii7 ,limitation on fund+ ,no?+ 9 ?is subsection %all be con/ru$ z au?oriz+ any additional appropriations to ! acc\nt1 o!r ?an su* am\nts z are o!rwise provid$ ) respect to o!r heal? b5efits plans p>ticipat+ "u ! ,ex*ange involv$4 7#c7 ,insurance rat+ rules ,! premium rate *>g$ = ! public heal? insurance option may n v>y except z provid$ "u section #bgja ( ! ,public ,heal? ,s]vice ,act4 7c7 ,paym5t rates = items & s]vices 7#a7 ,rates e/abli%$ by ,secret>y 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% paym5t rates = ! public heal? insurance option = s]vices & heal? c>e provid]s consi/5t ) ?is subsection & may *ange su* paym5t rates 9 accordance ) subsection 7d74 7,b7 ,initial paym5t rules 7i7 ,9 g5]al ,dur+ #bjbj1 #bjba1 & #bjbb1 ! ,secret>y %all set ! paym5t rates "u ?is subsection = s]vices & provid]s describ$ 9 subp>agraph 7,a7 equal to ! paym5t rates = equival5t s]vices & provid]s "u p>ts ,a & ,b ( ,m$ic>e1 subject to clause 7ii71 p>agraph 7#d71 & subsection 7d74 7ii7 ,exceptions ,! ,secret>y may det]m9e ! ext5t to :i* ,m$ic>e adju/m5ts applicable to base paym5t rates "u p>ts ,a & ,b ( ,m$ic>e = graduate m$ical education & disproportionate %>e hospitals %all apply "u ?is section4 7,c7 ,= new s]vices ,! ,secret>y %all modify paym5t rates describ$ 9 subp>agraph 7,b7 9 ord] to accommodate paym5ts = s]vices1 su* z well-*ild visits1 t are n o!rwise cov]$ "u ,m$ic>e4 7,d7 ,prescription drugs ,paym5t rates "u ?is subsection = prescription drugs t are n paid = "u "p ,a or "p ,b ( ,m$ic>e %all be at rates negotiat$ by ! ,secret>y4 7#b7 ,subsequ5t p]iods2 provid] network 7,a7 ,subsequ5t p]iods ,beg9n+ ) #bjbc & = subsequ5t ye>s1 ! ,secret>y %all cont9ue to use an adm9i/rative process to set su* rates 9 ord] to promote paym5t accuracy1 to ensure adequate b5efici>y access to provid]s1 & to promote af=dability & ! effici5t deliv]y ( m$ical c>e consi/5t ) subsection 7a77#a74 ,su* rates %all n be set at levels expect$ to increase av]age m$ical co/s p] enrollee cov]$ "u ! public heal? insurance option beyond :at w\ld be expect$ if ! process "u p>agraph 7#a77;,b7 7 cont9u$1 z c]tifi$ by ! ,(fice ( ! ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,b7 ,e/abli%m5t ( a provid] network ,heal? c>e provid]s p>ticipat+ "u ,m$ic>e are p>ticipat+ provid]s 9 ! public heal? insurance option unless !y opt out 9 a process e/abli%$ by ! ,secret>y4 7#c7 ,adm9i/rative process = sett+ rates ,*apt] #e ( title #e1 ,unit$ ,/ates ,code %all apply to ! process = ! initial e/abli%m5t ( paym5t rates "u ?is subsection b n to ! specific me?odology = e/abli%+ su* rates or ! calculation ( su* rates4 7#d7 ,con/ruction ,no?+ 9 ?is section %all be con/ru$ z limit+ ! ,secret>y's au?ority to correct = paym5ts t are excessive or defici5t1 tak+ into acc\nt ! provisions ( subsection 7a77#a7 & any appropriate adju/m5ts bas$ on ! demographic *>act]i/ics ( enrollees cov]$ "u ! public heal? insurance option1 b 9 no case %all ! correction ( paym5ts "u ?is p>agraph result 9 a level ( exp5ditures p] enrollee t exce$s ! level ( exp5ditures t w\ld h occurr$ "u p>agraph 7#a77;,b71 z c]tifi$ by ! ,(fice ( ! ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7#e7 ,con/ruction ,no?+ 9 ?is section %all be con/ru$ z affect+ ! au?ority ( ! ,secret>y to e/abli% paym5t rates1 includ+ paym5ts to provide = ! m effici5t deliv]y ( s]vices1 su* z ! initiatives provid$ = "u subsection 7d74 7#f7 ,limitations on review ,!re %all be no adm9i/rative or judicial review ( a paym5t rate or me?odology e/abli%$ "u ?is subsection or "u subsection 7d74 7d7 ,mod]niz$ paym5t initiatives & deliv]y sy/em re=m 7#a7 ,9 g5]al ,= plan ye>s beg9n+ ) #bjbj1 ! ,secret>y may utilize innovative paym5t me*anisms & policies to det]m9e paym5ts = items & s]vices "u ! public heal? insurance option4 ,! paym5t me*anisms & policies "u ?is subsection may include pati5t-c5t]$ m$ical home & o!r c>e managem5t paym5ts1 acc\ntable c>e organizations1 value-bas$ pur*as+1 bundl+ ( s]vices1 diff]5tial paym5t rates1 p]=mance or utilization bas$ paym5ts1 p>tial capitation1 & direct contract+ ) provid]s4 ,paym5t rates "u su* paym5t me*anisms & policies %all n be set at levels expect$ to increase av]age m$ical co/s p] enrollee cov]$ "u ! public heal? insurance option beyond :at w\ld be expect$ if ! process "u subsection 7c77#a77;,b7 7 cont9u$1 z c]tifi$ by ! ,(fice ( ! ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7#b7 ,requirem5ts = innovative paym5ts ,! ,secret>y %all design & implem5t ! paym5t me*anisms & policies "u ?is subsection 9 a mann] t-- 7,a7 seeks to-- 7i7 improve heal? outcomes2 7ii7 r$uce heal? disp>ities 7includ+ racial1 e?nic1 & o!r disp>ities72 7iii7 provide effici5t & af=dable c>e2 7iv7 address geographic v>iation 9 ! provision ( heal? s]vices2 or 7v7 prev5t or manage *ronic illness2 & 7,b7 promotes c>e t is integrat$1 pati5t-c5t]$1 high-quality1 & effici5t4 7#c7 ,enc\rag+ ! use ( high value s]vices ,to ! ext5t all[$ by ! b5efit /&>ds appli$ to all heal? b5efits plans p>ticipat+ "u ! ,ex*ange involv$1 ! public heal? insurance option may modify co/ %>+ & paym5t rates to enc\rage ! use ( s]vices t promote heal? & value4 7#d7 ,non-uni=mity p]mitt$ ,no?+ 9 ?is section %all prev5t ! ,secret>y f v>y+ paym5ts bas$ on diff]5t paym5t /ructure models 7su* z acc\ntable c>e organizations & m$ical homes7 "u ! public heal? insurance option = diff]5t geographic areas4 7e7 ,provid] p>ticipation 7#a7 ,9 g5]al ,! ,secret>y %all e/abli% conditions ( p>ticipation = heal? c>e provid]s "u ! public heal? insurance option4 7#b7 ,lic5sure or c]tification ,! ,secret>y %all n all[ a heal? c>e provid] to p>ticipate 9 ! public heal? insurance option unless su* provid] is appropriately lic5s$ or c]tifi$ "u ,/ate law4 7#c7 ,paym5t t]ms = provid]s 7,a7 ,physicians ,! ,secret>y %all provide = ! annual p>ticipation ( physicians "u ! public heal? insurance option1 = :i* paym5t may be made = s]vices furni%$ dur+ ! ye>1 9 "o ( #b classes3 7i7 ,pref]r$ physicians ,^? physicians :o agree to accept ! paym5t rate e/abli%$ "u ?is section 7)\t reg>d to co/-%>+7 z ! paym5t 9 full4 7ii7 ,p>ticipat+1 non-pref]r$ physicians ,^? physicians :o agree n to impose *>ges 79 relation to ! paym5t rate describ$ 9 subsection 7c7 = su* physicians7 t exce$ ! ratio p]mitt$ "u section #ahdh7;g77#b77;,c7 ( ! ,social ,security ,act4 7,b7 ,o!r provid]s ,! ,secret>y %all provide = ! p>ticipation 7on an annual or o!r basis specifi$ by ! ,secret>y7 ( heal? c>e provid]s 7o!r ?an physicians7 "u ! public heal? insurance option "u :i* paym5t %all only be available if ! provid] agrees to accept ! paym5t rate e/abli%$ "u subsection 7c7 7)\t reg>d to co/-%>+7 z ! paym5t 9 full4 7#d7 ,exclusion ( c]ta9 provid]s ,! ,secret>y %all exclude f p>ticipation "u ! public heal? insurance option a heal? c>e provid] t is exclud$ f p>ticipation 9 a ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b7f7 ( ! ,social ,security ,act74 7f7 ,application ( fraud & abuse provisions ,provisions ( law 7o!r ?an crim9al law provisions7 id5tifi$ by ! ,secret>y by regulation1 9 consultation ) ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 t impose sanctions ) respect to wa/e1 fraud1 & abuse "u ,m$ic>e1 su* z ! ,false ,claims ,act 7#ca ,u4,s4,c4 #cgbi et seq471 %all also apply to ! public heal? insurance option4 7g7 ,m$ic>e def9$ ,= purposes ( ?is section1 ! t]m ,m$ic>e means ! heal? insurance programs "u title ,,xviii ( ! ,social ,security ,act4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,treatm5t z qualifi$ heal? plan ,section #acja7;a77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act is am5d$-- 7,a7 9 ! head+1 by ins]t+ 1 ! public heal? insurance option1 be=e &2 & 7,b7 by ins]t+ ! public heal? insurance option "u section #acbe1 be=e & a multi-,/ate plan4 7#b7 ,level play+ field ,section #acbd7;a7 ( su* ,act is am5d$ by ins]t+ ! public heal? insurance option "u section #acbe1 be=e or a multi-,/ate qualifi$ heal? plan4 ,,ii ,heal? c>e f9ancial assi/ance #bja4 ,increase 9 eligibility = premium assi/ance tax cr$its 7a7 ,9 g5]al ,subp>agraph 7,a7 ( section #cf;,b7c77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #djj p]c5t & ins]t+ #fjj p]c5t4 7b7 ,con=m+ am5dm5t ,! table conta9$ 9 clause 7i7 ( section #cf;,b7b77#c77;,a77i7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #djj & ins]t+ #fjj4 7c7 ,reconciliation ( cr$it & advance cr$it ,clause 7i7 ( section #cf;,b7f77#b77;,b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7#a7 by /rik+ ,9 ! case ( & all t foll[s ?r\gh ! am\nt ( & ins]t+ ,! am\nt (2 & 7#b7 by /rik+ b less ?an #djj 9 ! table4 7d7 ,effective date ,! am5dm5ts made by ?is section %all apply to taxable ye>s beg9n+ aft] ,decemb] #ca1 #bjah4 ,,iii ,drug ,pric+ #cja4 ,requir+ drug manufactur]s to provide drug rebates = drugs disp5s$ to l[-income individuals 7a7 ,9 g5]al ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7#a7 9 subsection 7e77#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & subsection 7f7 aft] ?is subsection2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7f7 ,prescription drug rebate agreem5t = rebate eligible individuals 7#a7 ,requirem5t 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 9 ?is "p1 ! t]m cov]$ "p ,d drug does n include any drug or biological product t is manufactur$ by a manufactur] t has n ent]$ into & h 9 effect a rebate agreem5t describ$ 9 p>agraph 7#b74 7,b7 #bjbj plan ye> requirem5t ,any drug or biological product manufactur$ by a manufactur] t decl9es to ent] into a rebate agreem5t describ$ 9 p>agraph 7#b7 = ! p]iod beg9n+ on ,janu>y #a1 #bjbj1 & end+ on ,decemb] #ca1 #bjbj1 %all n be includ$ z a cov]$ "p ,d drug = ! subsequ5t plan ye>4 7#b7 ,rebate agreem5t ,a rebate agreem5t "u ?is subsection %all require ! manufactur] to provide to ! ,secret>y a rebate = ea* rebate p]iod 7z def9$ 9 p>agraph 7#f77;,b77 end+ aft] ,decemb] #ca1 #bjai1 9 ! am\nt specifi$ 9 p>agraph 7#c7 = any cov]$ "p ,d drug ( ! manufactur] disp5s$ aft] ,decemb] #ca1 #bjai1 to any rebate eligible individual 7z def9$ 9 p>agraph 7#f77;,a77 = :i* paym5t 0 made by a ,,pdp sponsor or ,,ma organization "u ?is "p = su* p]iod1 includ+ paym5ts pass$ ?r\gh ! l[-income & re9surance subsidies "u sections #ahfj;,d-#ad & #ahfj;,d-#ae7;b71 respectively4 ,su* rebate %all be paid by ! manufactur] to ! ,secret>y n lat] ?an #cj days aft] ! date ( receipt ( ! in=mation describ$ 9 section #ahfj;,d-#ab7;b77#h71 includ+ z su* section is appli$ "u section #aheg7;f77#c71 or #cj days aft] ! receipt ( in=mation "u subp>agraph 7,d7 ( p>agraph 7#c71 z det]m9$ by ! ,secret>y4 ,ins(> z n inconsi/5t ) ?is subsection1 ! ,secret>y %all e/abli% t]ms & conditions ( su* agreem5t relat+ to compliance1 p5alties1 & program evaluations1 inve/igations1 & audits t are simil> to ! t]ms & conditions = rebate agreem5ts "u p>agraphs 7#c7 & 7#d7 ( section #aibg7;b74 7#c7 ,rebate = rebate eligible ,m$ic>e drug plan enrollees 7,a7 ,9 g5]al ,! am\nt ( ! rebate specifi$ "u ?is p>agraph = a manufactur] = a rebate p]iod1 ) respect to ea* dosage =m & /r5g? ( any cov]$ "p ,d drug provid$ by su* manufactur] & disp5s$ to a rebate eligible individual1 %all be equal to ! product (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? ( ! drug s provid$ & disp5s$ = :i* paym5t 0 made by a ,,pdp sponsor or an ,,ma organization "u ?is "p = ! rebate p]iod1 includ+ paym5ts pass$ ?r\gh ! l[-income & re9surance subsidies "u sections #ahfj;,d-#ad & #ahfj;,d-#ae7;b71 respectively2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! ,m$icaid rebate am\nt 7z def9$ 9 subp>agraph 7,b77 = su* =m1 /r5g?1 & p]iod1 exce$s 7,,ii7 ! av]age ,m$ic>e drug program rebate eligible rebate am\nt 7z def9$ 9 subp>agraph 7,c77 = su* =m1 /r5g?1 & p]iod4 7,b7 ,m$icaid rebate am\nt ,= purposes ( ?is p>agraph1 ! t]m ,m$icaid rebate am\nt means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ "p ,d drug provid$ by ! manufactur] = a rebate p]iod-- 7i7 9 ! case ( a s+le s\rce drug or an innovator multiple s\rce drug1 ! am\nt specifi$ 9 p>agraph 7#a77;,a77ii77,,ii7 or 7#b77;,c7 ( section #aibg7;c7 plus ! am\nt1 if any1 specifi$ 9 subp>agraph 7,a77ii7 ( p>agraph 7#b7 ( su* section1 = su* =m1 /r5g?1 & p]iod2 or 7ii7 9 ! case ( any o!r cov]$ outpati5t drug1 ! am\nt specifi$ 9 p>agraph 7#c77;,a77i7 ( su* section = su* =m1 /r5g?1 & p]iod4 7,c7 ,av]age ,m$ic>e drug program rebate eligible rebate am\nt ,= purposes ( ?is subsection1 ! t]m av]age ,m$ic>e drug program rebate eligible rebate am\nt means1 ) respect to ea* dosage =m & /r5g? ( a cov]$ "p ,d drug provid$ by a manufactur] = a rebate p]iod1 ! sum1 = all ,,pdp sponsors "u "p ,d & ,,ma organizations adm9i/]+ an ,,ma-,,pd plan "u "p ,c1 (-- 7i7 ! product1 = ea* su* sponsor or organization1 (-- 7,i7 ! sum ( all rebates1 disc\nts1 or o!r price concessions 7n tak+ into acc\nt any rebate provid$ "u p>agraph 7#b7 or any disc\nts "u ! program "u section #ahfj;,d-#ad;,a7 = su* dosage =m & /r5g? ( ! drug disp5s$1 calculat$ on a p]-unit basis1 b only to ! ext5t t any su* rebate1 disc\nt1 or o!r price concession applies equally to drugs disp5s$ to rebate eligible ,m$ic>e drug plan enrollees & drugs disp5s$ to ,,pdp & ,,ma-,,pd enrollees :o are n rebate eligible individuals2 & 7,,ii7 ! numb] ( ! units ( su* dosage & /r5g? ( ! drug disp5s$ dur+ ! rebate p]iod to rebate eligible individuals enroll$ 9 ! prescription drug plans adm9i/]$ by ! ,,pdp sponsor or ! ,,ma-,,pd plans adm9i/]$ by ! ,,ma organization2 divid$ by 7ii7 ! total numb] ( units ( su* dosage & /r5g? ( ! drug disp5s$ dur+ ! rebate p]iod to rebate eligible individuals enroll$ 9 all prescription drug plans adm9i/]$ by ,,pdp sponsors & all ,,ma-,,pd plans adm9i/]$ by ,,ma organizations4 7,d7 ,use ( e/imates ,! ,secret>y may e/abli% a me?odology = e/imat+ ! av]age ,m$ic>e drug program rebate eligible rebate am\nts = ea* rebate p]iod bas$ on bid & utilization in=mation "u ?is "p & may use ^! e/imates z ! basis = det]m9+ ! rebates "u ?is section4 ,if ! ,secret>y elects to e/imate ! av]age ,m$ic>e drug program rebate eligible rebate am\nts1 ! ,secret>y %all e/abli% a reconciliation process = adju/+ manufactur] rebate paym5ts n lat] ?an #c mon?s aft] ! date t manufactur]s receive ! in=mation collect$ "u section #ahfj;,d-#ab7;b77#h77;,b74 7#d7 ,l5g? ( agreem5t ,! provisions ( p>agraph 7#d7 ( section #aibg7;b7 7o!r ?an clauses 7iv7 & 7v7 ( subp>agraph 7,b77 %all apply to rebate agreem5ts "u ?is subsection 9 ! same mann] z su* p>agraph applies to a rebate agreem5t "u su* section4 7#e7 ,o!r t]ms & conditions ,! ,secret>y %all e/abli% o!r t]ms & conditions ( ! rebate agreem5t "u ?is subsection1 includ+ t]ms & conditions relat$ to compliance1 t are consi/5t ) ?is subsection4 7#f7 ,def9itions ,9 ?is subsection & section #ahfj;,d-#ab7;b77#h73 7,a7 ,rebate eligible individual ,! t]m rebate eligible individual means-- 7i7 a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77;,a772 7ii7 a ,m$icaid b5efici>y treat$ z a subsidy eligible individual "u clause 7v7 ( section #ahfj;,d-#ad7;a77#c77;,b72 & 7iii7 any "p ,d eligible individual n describ$ 9 clause 7i7 or 7ii7 :o is det]m9$ = purposes ( ! ,/ate plan "u title ,,xix to be eligible = m$ical assi/ance "u clause 7i71 7iii71 or 7iv7 ( section #aijb7;a77#aj77;,e74 7,b7 ,rebate p]iod ,! t]m rebate p]iod has ! mean+ giv5 su* t]m 9 section #aibg7k77#h74 4 7b7 ,report+ requirem5t = ! det]m9ation & paym5t ( rebates by manufactur]s relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees 7#a7 ,requirem5ts = ,,pdp sponsors ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,report+ requirem5t = ! det]m9ation & paym5t ( rebates by manufactur]s relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees 7,a7 ,9 g5]al ,= purposes ( ! rebate "u section #ahfj;,d-#b7;f7 = contract ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan %all require t ! sponsor comply ) subp>agraphs 7,b7 & 7,c74 7,b7 ,report =m & cont5ts ,n lat] ?an a date specifi$ by ! ,secret>y1 a ,,pdp sponsor ( a prescription drug plan "u ?is "p %all report to ea* manufactur]-- 7i7 in=mation 7by ,national ,drug ,code numb]7 on ! total numb] ( units ( ea* dosage1 =m1 & /r5g? ( ea* drug ( su* manufactur] disp5s$ to rebate eligible ,m$ic>e drug plan enrollees "u any prescription drug plan op]at$ by ! ,,pdp sponsor dur+ ! rebate p]iod2 7ii7 in=mation on ! price disc\nts1 price concessions1 & rebates = su* drugs = su* =m1 /r5g?1 & p]iod2 7iii7 in=mation on ! ext5t to :i* su* price disc\nts1 price concessions1 & rebates apply equally to rebate eligible ,m$ic>e drug plan enrollees & ,,pdp enrollees :o are n rebate eligible ,m$ic>e drug plan enrollees2 & 7iv7 any additional in=mation t ! ,secret>y det]m9es is necess>y to enable ! ,secret>y to calculate ! av]age ,m$ic>e drug program rebate eligible rebate am\nt 7z def9$ 9 p>agraph 7#c77;,c7 ( su* section71 & to det]m9e ! am\nt ( ! rebate requir$ "u ?is section1 = su* =m1 /r5g?1 & p]iod4 ,su* report %all be 9 a =m consi/5t ) a /&>d report+ =mat e/abli%$ by ! ,secret>y4 7,c7 ,submission to ,secret>y ,ea* ,,pdp sponsor %all promptly transmit a copy ( ! in=mation report$ "u subp>agraph 7,b7 to ! ,secret>y = ! purpose ( audit ov]sight & evaluation4 7,d7 ,confid5tiality ( in=mation ,! provisions ( subp>agraph 7,d7 ( section #aibg7;b77#c71 relat+ to confid5tiality ( in=mation1 %all apply to in=mation report$ by ,,pdp sponsors "u ?is p>agraph 9 ! same mann] t su* provisions apply to in=mation disclos$ by manufactur]s or :olesal]s "u su* section1 except-- 7i7 t any ref]5ce to ?is section 9 clause 7i7 ( su* subp>agraph %all be treat$ z be+ a ref]5ce to ?is section2 7ii7 ! ref]5ce to ! ,director ( ! ,congressional ,budget ,(fice 9 clause 7iii7 ( su* subp>agraph %all be treat$ z includ+ a ref]5ce to ! ,m$ic>e ,paym5t ,advisory ,commission2 & 7iii7 clause 7iv7 ( su* subp>agraph %all n apply4 7,e7 ,ov]sight ,in=mation report$ "u ?is p>agraph may be us$ by ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices = ! /atutorily au?oriz$ purposes ( audit1 inve/igation1 & evaluations4 7,f7 ,p5alties = failure to provide timely in=mation & provision ( false in=mation ,9 ! case ( a ,,pdp sponsor-- 7i7 t fails to provide in=mation requir$ "u subp>agraph 7,b7 on a timely basis1 ! sponsor is subject to a civil money p5alty 9 ! am\nt ( #aj1jjj = ea* day 9 :i* su* in=mation has n be5 provid$2 or 7ii7 t kn[+ly 7z def9$ 9 section #aabh;,a7i77 provides false in=mation "u su* subp>agraph1 ! sponsor is subject to a civil money p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil money p5alties are 9 addition to o!r p5alties z may be prescrib$ by law4 ,! 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 p5alty or proce$+ "u section #aabh;,a7a74 4 7#b7 ,application to ,,ma organizations ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,report+ requirem5t relat$ to rebate = rebate eligible ,m$ic>e drug plan enrollees ,section #ahfj;,d-#ab7;b77#h74 4 7c7 ,deposit ( rebates into ,m$ic>e ,prescription ,drug ,acc\nt ,section #ahfj;,d-#af7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaf7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,rebate = rebate eligible ,m$ic>e drug plan enrollees ,am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f7 %all be deposit$ into ! ,acc\nt4 4 7d7 ,exclusion f det]m9ation ( be/ price & av]age manufactur] price "u ,m$icaid 7#a7 ,exclusion f be/ price det]m9ation ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is am5d$ by ins]t+ & am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f7 aft] ?is section4 7#b7 ,exclusion f av]age manufactur] price det]m9ation ,section #aibg7k77#a77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i77 is am5d$-- 7,a7 9 subclause 7,,iv71 by /rik+ & aft] ! semicolon2 7,b7 9 subclause 7,v71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,vi7 am\nts paid "u a rebate agreem5t "u section #ahfj;,d-#b7;f74 4 #cjb4 ,negotiation ( prices = ,m$ic>e prescription drugs ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by /rik+ subsection 7i7 7relat+ to non9t]f]5ce7 & ins]t+ ! foll[+3 7i7 ,negotiation2 no national =mul>y or price /ructure 7#a7 ,negotiation ( prices ) manufactur]s ,9 ord] to ensure t b5efici>ies enroll$ "u prescription drug plans & ,,ma-,,pd plans pay ! l[e/ possible price1 ! ,secret>y %all h & ex]cise au?ority simil> to t ( o!r ,f$]al entities t pur*ase prescription drugs 9 bulk to negotiate contracts ) manufactur]s ( cov]$ "p ,d drugs1 consi/5t ) ! requirem5ts & 9 fur!rance ( ! goals ( provid+ quality c>e & conta9+ co/s "u ?is "p4 7#b7 ,no national =mul>y or price /ructure ,9 ord] to promote competition "u ?is "p & 9 c>ry+ out ?is "p1 ! ,secret>y may n require a p>ticul> =mul>y or in/itute a price /ructure = ! reimbursem5t ( cov]$ "p ,d drugs4 4 #cjc4 ,gu>ante$ prescription drug b5efits 7a7 ,9 g5]al ,section #ahfj;,d-#c ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajc7 is am5d$ to read z foll[s3 #ahfj;,d-#c4 ,access to a *oice ( qualifi$ prescription drug cov]age 7a7 ,assur+ access to a *oice ( cov]age 7#a7 ,*oice ( at lea/ ?ree plans 9 ea* area ,beg9n+ on ,janu>y #a1 #bjba1 ! ,secret>y %all ensure t ea* "p ,d eligible individual has available1 consi/5t ) p>agraph 7#b71 a *oice ( enrollm5t 9-- 7,a7 a nationwide prescription drug plan (f]$ by ! ,secret>y 9 accordance ) subsection 7b72 & 7,b7 at lea/ #b qualify+ plans 7z def9$ 9 p>agraph 7#c77 9 ! area 9 :i* ! individual resides1 at lea/ "o ( :i* is a prescription drug plan4 7#b7 ,requirem5t = diff]5t plan sponsors ,! requirem5t 9 p>agraph 7#a77;,b7 is n satisfi$ ) respect to an area if only "o entity (f]s all ! qualify+ plans 9 ! area4 7#c7 ,qualify+ plan def9$ ,= purposes ( ?is section1 ! t]m qualify+ plan means-- 7,a7 a prescription drug plan2 7,b7 an ,,ma-,,pd plan describ$ 9 section #ahea7;a77#b77;,a77i7 t provides-- 7i7 basic prescription drug cov]age2 or 7ii7 qualifi$ prescription drug cov]age t provides supplem5tal prescription drug cov]age s long z !re is no ,,ma mon?ly supplem5tal b5efici>y premium appli$ "u ! plan1 due to ! application ( a cr$it aga9/ su* premium ( a rebate "u section #ahed7;b77#a77;,c72 or 7,c7 a nationwide prescription drug plan (f]$ by ! ,secret>y 9 accordance ) subsection 7b74 7b7 ,,hhs z ,,pdp sponsor = a nationwide prescription drug plan 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all take su* /eps z may be necess>y to qualify & s]ve z a ,,pdp sponsor & to (f] a prescription drug plan t (f]s basic prescription drug cov]age ?r\gh\t ! ,unit$ ,/ates4 ,su* a plan %all be 9 addition to1 & n 9 lieu (1 o!r prescription drug plans (f]$ "u ?is "p4 7#b7 ,premium2 solv5cy2 au?orities ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y-- 7,a7 %all e/abli% a premium 9 ! am\nt ( #cg = mon?s 9 #bjba &1 = mon?s 9 subsequ5t ye>s1 9 ! am\nt specifi$ 9 ?is p>agraph = mon?s 9 ! previ\s ye> increas$ by ! annual p]c5tage increase describ$ 9 section #ahfj;,d-#b7;b77#f7 7relat+ to gr[? 9 ,m$ic>e prescription drug co/s p] b5efici>y7 = ! ye> involv$2 7,b7 is deem$ to h met any applicable solv5cy & capital adequacy /&>ds2 & 7,c7 %all ex]cise su* au?orities 7includ+ ! use ( regional or o!r ph>maceutical b5efit manag]s7 z ! ,secret>y det]m9es necess>y to (f] ! prescription drug plan 9 ! same or a comp>able mann] z is ! case = prescription drug plans (f]$ by private ,,pdp sponsors4 7c7 ,flexibility 9 risk assum$ ,9 ord] to ensure access pursuant to subsection 7a7 9 an area ! ,secret>y may approve limit$ risk plans "u section #ahfj;,d-#aa7;f7 = ! area4 4 7b7 ,con=m+ am5dm5t ,section #ahfj;,d-#aa7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;g77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ,?is subsection %all n apply on or aft] ,janu>y #a1 #bjba4 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 #cjd4 ,full reimbursem5t = qualifi$ retiree prescription drug plans 7a7 ,elim9ation ( true ,out-(-,pocket limitation ,section #ahfj;,d-#b7;b77#d77;,c77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77;,c77iii77 is am5d$-- 7#a7 9 subclause 7,,iii71 by /rik+ or at ! end2 7#b7 9 subclause 7,,iv71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+ new subclause3 7,v7 "u a qualifi$ retiree prescription drug plan 7z def9$ 9 section #ahfj;,d-#bb7;a77#b774 4 7b7 ,equalization ( subsidies ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices %all provide = su* increase 9 ! special subsidy paym5t am\nts "u section #ahfj;,d-#bb7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#c77 z may be appropriate to provide = paym5ts 9 ! aggregate equival5t to ! paym5ts t w\ld h be5 made "u section #ahfj;,d-#ae ( su* ,act 7#db ,u4,s4,c4 #aciew-#aae7 if ! individuals 7 n enroll$ 9 a qualifi$ retiree prescription drug plan4 ,9 mak+ su* computation1 ! ,secret>y %all n take into acc\nt ! application ( ! am5dm5ts made by section #abjb ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7,public ,law #ajh-agc2 #aag ,/at4 #bdhj74 7c7 ,effective date ,?is section1 & ! am5dm5ts made by ?is section1 %all take effect on ,janu>y #a1 #bjba4