,i #aag? ,,congress #b;d ,session ,h4 ,r4 #gdig ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #aa1 #bjbb,ms4 ,slotk9 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ,education & ,labor1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to provide = l[] prices = drugs ?r\gh drug price negotiation1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,make ,m$ic9e ,af=dable ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,title ,i--,l[]+ ,prices ,?r\gh ,drug ,price ,negotiation,sec4 #aja4 ,provid+ = l[] prices = c]ta9 high-pric$ s+le s\rce drugs4,sec4 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods4,sec4 #ajc4 ,fund+4,title ,,ii--,prescription ,drug ,inflation ,rebates,sec4 #bja4 ,m$ic>e "p ,b rebate by manufactur]s4,sec4 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s4,title ,,iii--,"p ,d ,improvem5ts & ,maximum ,out-(-,pocket ,cap = ,m$ic>e ,beneficiaries,sec4 #cja4 ,m$ic>e "p ,d b5efit r$esign4,sec4 #cjb4 ,maximum mon?ly cap on co/-%>+ paym5ts "u prescription drug plans & ,,ma-,,pd plans4,title ,,iv--,repeal ( ,c]ta9 ,prescription ,drug ,rebate ,rule,sec4 #dja4 ,prohibit+ implem5tation ( rule relat+ to elim9at+ ! anti-kickback /atute safe h>bor protection = prescription drug rebates4,title ,v--,miscellaneous,sec4 #eja4 ,appropriate co/-%>+ = c]ta9 insul9 products "u ,m$ic>e "p ,d4,sec4 #ejb4 ,cov]age ( adult vacc9es recomm5d$ by ! ,advisory ,committee on ,immunization ,practices "u ,m$ic>e "p ,d4,sec4 #ejc4 ,paym5t = biosimil> biological products dur+ initial p]iod4,sec4 #ejd4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = c]ta9 biosimil> biological products4,sec4 #eje4 ,improv+ access to adult vacc9es "u ,m$icaid & ,,*ip4,title ,,vi--,additional ,insul9 ,policies,sec4 #fja4 ,,erisa requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products4,sec4 #fjb4 ,public ,heal? ,s]vice ,act requirem5ts ) respect to co/-%>+ = insul9 products4,sec4 #fjc4 ,,irc requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products4 ,i ,l[]+ ,prices ,?r\gh ,drug ,price ,negotiation #aja4 ,provid+ = l[] prices = c]ta9 high-pric$ s+le s\rce drugs 7a7 ,program ,to l[] prices = c]ta9 high-,pric$ s+le s\rce drugs ,title ,,xi ( ! ,social ,security ,act is am5d$ by add+ aft] section #aahd 7#db ,u4,s4,c4 #acbj;e-#c7 ! foll[+ new "p3 ,e ,price ,negotiation ,program to ,l[] ,prices = ,c]ta9 ,high-,pric$ ,s+le ,s\rce ,drugs #aaia4 ,e/abli%m5t ( program 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a ,drug ,price ,negotiation ,program 79 ?is "p ref]r$ to z ! program74 ,"u ! program1 ) respect to ea* price applicability p]iod1 ! ,secret>y %all-- 7#a7 publi% a li/ ( negotiation-eligible drugs & select$ drugs 9 accordance ) section #aaib2 7#b7 ent] into agreem5ts ) manufactur]s ( select$ drugs ) respect to su* p]iod1 9 accordance ) section #aaic2 7#c7 negotiate &1 if applicable1 r5egotiate maximum fair prices = su* select$ drugs1 9 accordance ) section #aaid2 & 7#d7 c>ry out ! adm9i/rative duties describ$ 9 section #aaif4 7b7 ,def9itions relat+ to tim+ ,= purposes ( ?is "p3 7#a7 ,initial price applicability ye> ,! t]m initial price applicability ye> means a ye> 7beg9n+ ) #bjbe74 7#b7 ,price applicability p]iod ,! t]m price applicability p]iod means1 ) respect to a qualify+ s+le s\rce drug1 ! p]iod beg9n+ ) ! fir/ initial price applicability ye> ) respect to :i* su* drug is a select$ drug & end+ ) ! la/ ye> dur+ :i* ! drug is a select$ drug4 7#c7 ,select$ drug publication date ,! t]m select$ drug publication date means1 ) respect to ea* initial price applicability ye>1 ,febru>y #a ( ! ye> t beg9s #b ye>s prior to su* ye>4 7#d7 ,negotiation p]iod ,! t]m negotiation p]iod means1 ) respect to an initial price applicability ye> ) respect to a select$ drug1 ! p]iod-- 7,a7 beg9n+ on ! soon] (-- 7i7 ! date on :i* ! manufactur] ( ! drug & ! ,secret>y ent] into an agreem5t "u section #aaic ) respect to su* drug2 or 7ii7 ,febru>y #bh foll[+ ! select$ drug publication date ) respect to su* select$ drug2 & 7,b7 end+ on ,novemb] #a ( ! ye> t beg9s #b ye>s prior to ! initial price applicability ye>4 7c7 ,o!r def9itions ,= purposes ( ?is "p3 7#a7 ,maximum fair price eligible individual ,! t]m maximum fair price eligible individual means1 ) respect to a select$ drug-- 7,a7 9 ! case su* drug is disp5s$ to ! individual at a ph>macy1 by a mail ord] s]vice1 or by ano!r disp5s]1 an individual :o is enroll$ "u a prescription drug plan "u "p ,d ( title ,,xviii or an ,,ma-,,pd plan "u "p ,c ( su* title if cov]age is provid$ "u su* plan = su* select$ drug2 & 7,b7 9 ! case su* drug is furni%$ or adm9i/]$ to ! individual by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 an individual :o is enroll$ "u "p ,b ( title ,,xviii1 includ+ an individual :o is enroll$ "u an ,,ma plan "u "p ,c ( su* title1 if su* select$ drug is cov]$ "u su* "p4 7#b7 ,maximum fair price ,! t]m maximum fair price means1 ) respect to a ye> dur+ a price applicability p]iod & ) respect to a select$ drug 7z def9$ 9 section #aaib7;c77 ) respect to su* p]iod1 ! price publi%$ pursuant to section #aaie 9 ! ,f$]al ,regi/] = su* drug & ye>4 7#c7 ,unit ,! t]m unit means1 ) respect to a drug or biological1 ! l[e/ id5tifiable am\nt 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! drug or biological t is disp5s$ or furni%$4 ,! det]m9ation ( a unit1 ) respect to a drug or biological1 pursuant to ?is p>agraph %all n be subject to adm9i/rative or judicial review4 7#d7 ,total exp5ditures ,! t]m total exp5ditures includes1 9 ! case ( exp5ditures ) respect to "p ,d ( title ,,xviii1 +r$i5t co/s1 disp5s+ fees1 sales tax1 & if applicable1 vacc9e adm9i/ration fees4 ,! t]m total exp5ditures excludes1 9 ! case ( exp5ditures ) respect to "p ,b ( su* title1 exp5ditures = a drug or biological t are bundl$ or packag$ into ! paym5t = ano!r s]vice4 #aaib4 ,selection ( negotiation-eligible drugs z select$ drugs 7a7 ,9 g5]al ,n lat] ?an ! select$ drug publication date ) respect to an initial price applicability ye>1 9 accordance ) subsection 7b71 ! ,secret>y %all select & publi% 9 ! ,f$]al ,regi/] a li/ (-- 7#a7 7,a7 ) respect to ! initial price applicability ye> #bjbe1 n m ?an #aj negotiation-eligible drugs describ$ 9 subp>agraph 7,a77i7 ( subsection 7d77#a71 b n subp>agraph 7,b7 ( su* subsection1 ) respect to su* ye>2 7,b7 ) respect to ! initial price applicability ye> #bjbf1 n m ?an #ae negotiation-eligible drugs describ$ 9 subp>agraph 7,a77i7 ( subsection 7d77#a71 b n subp>agraph 7,b7 ( su* subsection1 ) respect to su* ye>2 7,c7 ) respect to ! initial price applicability ye> #bjbg1 n m ?an #ae negotiation-eligible drugs describ$ 9 subp>agraph 7,a7 ( subsection 7d77#a71 b n subp>agraph 7,b7 ( su* subsection1 ) respect to su* ye>2 & 7,d7 ) respect to ! initial price applicability ye> #bjbh or a subsequ5t ye>1 n m ?an #bj negotiation-eligible drugs describ$ 9 subp>agraph 7,a7 ( subsection 7d77#a71 b n subp>agraph 7,b7 ( su* subsection1 ) respect to su* ye>2 & 7#b7 all negotiation-eligible drugs describ$ 9 subp>agraph 7,b7 ( su* subsection ) respect to su* ye>4 ,subject to subsection 7c77#b7 & section #aaid7;f77#e71 ea* drug publi%$ on ! li/ pursuant to ! previ\s s5t5ce %all be subject to ! negotiation process "u section #aaid = ! negotiation p]iod ) respect to su* initial price applicability ye> 7& ! r5egotiation process "u su* section z applicable = any subsequ5t ye> dur+ ! applicable price applicability p]iod74 7b7 ,selection ( drugs 7#a7 ,9 g5]al ,9 c>ry+ out subsection 7a77#a71 subject to p>agraph 7#b71 ! ,secret>y %all1 ) respect to an initial price applicability ye>-- 7,a7 rank a comb9$ li/ ( negotiation-eligible drugs describ$ 9 subsection 7d77#a77;,a7 accord+ to ! total exp5ditures = su* drugs "u p>ts ,b & ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t p]iod ( #ab mon?s prior to ! select$ drug publication date 7b end+ n lat] ?an ,octob] #ca ( ! ye> prior to ! ye> ( su* drug publication date71 ) respect to su* ye>1 = :i* data are available1 ) ! negotiation-eligible drugs ) ! highe/ total exp5ditures be+ rank$ ! highe/2 & 7,b7 select f su* rank$ comb9$ li/ = inclusion on ! publi%$ li/ describ$ 9 subsection 7a7 ) respect to su* ye> ! negotiation-eligible drugs ) ! highe/ su* rank+s4 7#b7 ,high sp5d "p ,d drugs = #bjbe & #bjbf ,) respect to ! initial price applicability ye> #bjbe & ) respect to ! initial price applicability ye> #bjbf1 ! ,secret>y %all apply p>agraph 7#a7 z if ! ref]5ce to negotiation-eligible drugs describ$ 9 subsection 7d77#a77;,a7 7 a ref]5ce to negotiation-eligible drugs describ$ 9 subsection 7d77#a77;,a77i7 & z if ! ref]5ce to total exp5ditures = su* drugs "u p>ts ,b & ,d ( title ,,xviii 7 a ref]5ce to total exp5ditures = su* drugs "u "p ,d ( title ,,xviii4 7c7 ,select$ drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 consi/5t ) subsection 7e77#b7 & subject to p>agraph 7#b71 ea* negotiation-eligible drug includ$ on ! li/ publi%$ "u subsection 7a7 ) respect to an initial price applicability ye> %all be ref]r$ to z a select$ drug ) respect to su* ye> & ea* subsequ5t ye> beg9n+ be=e ! fir/ ye> t beg9s aft] ! date on :i* ! ,secret>y det]m9es at lea/ "o drug or biological product-- 7,a7 is approv$ or lic5s$ 7z applicable7-- 7i7 "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act us+ su* drug z ! li/$ drug2 or 7ii7 "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act us+ su* drug z ! ref]5ce product2 & 7,b7 is m>ket$ pursuant to su* approval or lic5sure4 7#b7 ,cl>ification ,a negotiation-eligible drug-- 7,a7 t is includ$ on ! li/ publi%$ "u subsection 7a7 ) respect to an initial price applicability ye>2 & 7,b7 = :i* ! ,secret>y makes a det]m9ation describ$ 9 p>agraph 7#a7 be=e or dur+ ! negotiation p]iod ) respect to su* initial price applicability ye>1 %all n be subject to ! negotiation process "u section #aaid ) respect to su* negotiation p]iod & %all cont9ue to be consid]$ a select$ drug "u ?is "p ) respect to ! numb] ( negotiation-eligible drugs publi%$ on ! li/ "u subsection 7a7 ) respect to su* initial price applicability ye>4 7d7 ,negotiation-,eligible drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 subject to p>agraph 7#b71 ! t]m negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug1 z def9$ 9 subsection 7e71 t is describ$ 9 ei!r ( ! foll[+ subp>agraphs 7or1 ) respect to ! initial price applicability ye> #bjbe or #bjbf1 t is describ$ 9 subp>agraph 7,a77i7 or 7,b773 7,a7 ,high sp5d drugs ,! qualify+ s+le s\rce drug is1 det]m9$ 9 accordance ) subsection 7e77#b7-- 7i7 among ! #ej qualify+ s+le s\rce drugs ) ! highe/ total exp5ditures "u "p ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y 9 accordance ) p>agraph 7#c71 dur+ ! mo/ rec5t p]iod = :i* data are available ( at lea/ #ab mon?s prior to ! select$ drug publication date 7b end+ no lat] ?an ,octob] #ca ( ! ye> prior to ! ye> ( su* drug publication date71 ) respect to su* ye>2 or 7ii7 among ! #ej qualify+ s+le s\rce drugs ) ! highe/ total exp5ditures "u "p ,b ( title ,,xviii1 z det]m9$ by ! ,secret>y 9 accordance ) p>agraph 7#c71 dur+ su* mo/ rec5t p]iod1 z describ$ 9 clause 7i74 7,b7 ,insul9 ,! qualify+ s+le s\rce drug is describ$ 9 subsection 7e77#a77;,c74 7#b7 ,exception = small biote* drugs 7,a7 ,9 g5]al ,subject to subp>agraph 7,c71 ! t]m negotiation-eligible drug %all n include1 ) respect to ! initial price applicability ye>s #bjbe1 #bjbf1 & #bjbg1 a qualify+ s+le s\rce drug t meets ei!r ( ! foll[+3 7i7 ,"p ,d drugs ,! total exp5ditures = ! qualify+ s+le s\rce drug "u "p ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y 9 accordance ) p>agraph 7#c71 dur+ #bjba-- 7,i7 are equal to or less ?an #a p]c5t ( ! total exp5ditures "u su* "p ,d1 z s det]m9$1 = all cov]$ "p ,d drugs dur+ su* ye>2 & 7,,ii7 are equal to at lea/ #hj p]c5t ( ! total exp5ditures "u su* "p ,d1 z s det]m9$1 = all cov]$ "p ,d drugs = :i* ! manufactur] ( ! drug has an agreem5t 9 effect "u section #ahfj;,d-#ad;,a dur+ su* ye>4 7ii7 ,"p ,b drugs ,! total exp5ditures = ! qualify+ s+le s\rce drug "u "p ,b ( title ,,xviii1 z det]m9$ by ! ,secret>y 9 accordance ) p>agraph 7#c71 dur+ #bjba-- 7,i7 are equal to or less ?an #a p]c5t ( ! total exp5ditures "u su* "p ,b1 z s det]m9$1 = all qualify+ s+le s\rce drugs cov]$ "u su* "p ,b dur+ su* ye>2 & 7,,ii7 are equal to at lea/ #hj p]c5t ( ! total exp5ditures "u su* "p ,b1 z s det]m9$1 = all qualify+ s+le s\rce drugs ( ! manufactur] t are cov]$ "u su* "p ,b dur+ su* ye>4 7,b7 ,cl>ifications relat+ to manufactur]s 7i7 ,aggregation rule ,all p]sons treat$ z a s+le employ] "u subsection 7a7 or 7b7 ( section #eb ( ! ,int]nal ,rev5ue ,code ( #aihf %all be treat$ z "o manufactur] = purposes ( ?is p>agraph4 7ii7 ,limitation ,a qualify+ s+le s\rce drug describ$ 9 subp>agraph 7,a7 %all n include a qualify+ s+le s\rce drug ( a manufactur] if su* manufactur] is acquir$ aft] #bjba by ano!r manufactur] t does n meet ! def9ition ( a specifi$ manufactur] "u section #ahfj;,d-#ad;,c7g77#d77;,b77ii71 effective at ! beg9n+ ( ! plan ye> imm$iately foll[+ su* acquisition or1 9 ! case ( an acquisition be=e #bjbd1 effective ,janu>y #a1 #bjbd4 7,c7 ,drugs n includ$ z small biote* drugs ,! foll[+ %all n be consid]$ a qualify+ s+le s\rce drug describ$ 9 subp>agraph 7,a73 7i7 ,a vacc9e t is lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act & is m>ket$ pursuant to su* section4 7ii7 ,a new =mulation1 su* z an ext5d$ release =mulation1 ( a qualify+ s+le s\rce drug4 7iii7 ,a qualify+ s+le s\rce drug describ$ 9 subsection 7e77#a77;,c74 7#c7 ,cl>ifications & det]m9ations 7,a7 ,previ\sly select$ drugs & small biote* drugs exclud$ ,9 apply+ clauses 7i7 & 7ii7 ( p>agraph 7#a77;,a71 ! ,secret>y %all n consid] or c\nt-- 7i7 drugs t are already select$ drugs2 & 7ii7 = initial price applicability ye>s #bjbe1 #bjbf1 & #bjbg1 qualify+ s+le s\rce drugs describ$ 9 p>agraph 7#b77;,a74 7,b7 ,use ( data ,9 det]m9+ :e!r a qualify+ s+le s\rce drug satisfies any ( ! crit]ia describ$ 9 p>agraph 7#a7 or 7#b71 ! ,secret>y %all use data t is aggregat$ across dosage =ms & /r5g?s ( ! drug1 includ+ new =mulations ( ! drug1 su* z an ext5d$ release =mulation1 & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7#d7 ,publication ,n lat] ?an ! select$ drug publication date ) respect to an initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] a li/ ( negotiation-eligible drugs ) respect to su* select$ drug publication date4 7e7 ,qualify+ s+le s\rce drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m qualify+ s+le s\rce drug means1 ) respect to an initial price applicability ye>1 subject to p>agraphs 7#b7 & 7#c71 a cov]$ "p ,d drug 7z def9$ 9 section #ahfj;,d-#b7;e77 t is describ$ 9 any ( ! foll[+ or a drug or biological product cov]$ "u "p ,b ( title ,,xviii t is describ$ 9 any ( ! foll[+3 7,a7 ,drug products ,a drug-- 7i7 t is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & is m>ket$ pursuant to su* approval2 7ii7 = :i*1 z ( ! select$ drug publication date ) respect to su* initial price applicability ye>1 at lea/ #g ye>s w h elaps$ s9ce ! date ( su* approval2 & 7iii7 t is n ! li/$ drug = any drug t is approv$ & m>ket$ "u section #eje7;j7 ( su* ,act4 7,b7 ,biological products ,a biological product-- 7i7 t is lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act & is m>ket$ "u section #cea ( su* ,act2 7ii7 = :i*1 z ( ! select$ drug publication date ) respect to su* initial price applicability ye>1 at lea/ #aa ye>s w h elaps$ s9ce ! date ( su* lic5sure2 & 7iii7 t is n ! ref]5ce product = any biological product t is lic5s$ & m>ket$ "u section #cea7k7 ( su* ,act4 7,c7 ,insul9 product ,any insul9 product t is approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act & m>ket$ pursuant to su* approval or lic5sure1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & is m>ket$ pursuant to su* section1 reg>dless ( :e!r su* insul9 product w\ld be describ$ 9 subp>agraph 7,a7 or 7,b74 7#b7 ,treatm5t ( au?oriz$ g5]ic drugs 7,a7 ,9 g5]al ,9 ! case ( a qualify+ s+le s\rce drug describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a7 t is ! li/$ drug 7z su* t]m is us$ 9 section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 or ! ref]5ce product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act71 ) respect to an au?oriz$ g5]ic drug1 9 apply+ ! provisions ( ?is "p1 su* au?oriz$ g5]ic drug & su* li/$ drug or ref]5ce product %all be treat$ z ! same qualify+ s+le s\rce drug4 7,b7 ,au?oriz$ g5]ic drug def9$ ,= purposes ( ?is p>agraph1 ! t]m au?oriz$ g5]ic drug means-- 7i7 9 ! case ( a drug1 an au?oriz$ g5]ic drug 7z su* t]m is def9$ 9 section #eje7t77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act72 & 7ii7 9 ! case ( a biological product1 a ref]5ce product 7z su* t]m is def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act7 t-- 7,i7 has be5 lic5s$ "u section #cea7;a7 ( su* ,act2 & 7,,ii7 is m>ket$1 sold1 or di/ribut$ directly or indirectly to retail class ( trade "u a diff]5t label+1 packag+ 7o!r ?an repackag+ z ! ref]5ce product 9 bli/] packs1 unit doses1 or simil> packag+ = use 9 in/itutions71 product code1 label] code1 trade "n1 or trade m>k ?an ! ref]5ce product4 7#c7 ,exclusions ,9 ?is "p1 ! t]m qualify+ s+le s\rce drug does n include any ( ! foll[+3 7,a7 ,c]ta9 orphan drugs ,a drug t is designat$ z a drug = only "o r>e disease or condition "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & = :i* ! only approv$ indication 7or indications7 is = su* disease or condition4 7,b7 ,l[ sp5d ,m$ic>e drugs ,a drug or biological product 7o!r ?an an insul9 product describ$ 9 p>agraph 7#a77;,c77 ) respect to :i* ! total exp5ditures "u p>ts ,b & ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t p]iod = :i* data are available ( at lea/ #ab mon?s prior to ! select$ drug publication date 7b end+ no lat] ?an ,octob] #ca ( ! ye> prior to ! ye> ( su* drug publication date71 ) respect to su* ye> is less ?an-- 7i7 ) respect to #bjba1 #bjj1jjj1jjj2 or 7ii7 ) respect to a subsequ5t ye>1 ! doll> am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye> increas$ by ! annual p]c5tage increase 9 ! consum] price index 7all items2 ,u4,s4 city av]age7 z ( ,decemb] ( su* previ\s ye>4 7f7 ,no adm9i/rative or judicial review ( det]m9ations & selections ,! det]m9ation ( negotiation-eligible drugs "u subsection 7d7 & ! selection ( drugs "u ?is section are n subject to adm9i/rative or judicial review4 #aaic4 ,manufactur] agreem5ts 7a7 ,9 g5]al ,= purposes ( section #aaia7;a77#b71 ! ,secret>y %all ent] into agreem5ts ) manufactur]s ( select$ drugs ) respect to a price applicability p]iod1 by n lat] ?an ,febru>y #bh foll[+ ! select$ drug publication date ) respect to su* select$ drug1 "u :i*-- 7#a7 dur+ ! negotiation p]iod = ! initial price applicability ye> = ! select$ drug1 ! ,secret>y & manufactur]1 9 accordance ) section #aaid1 negotiate to det]m9e 7&1 by n lat] ?an ! la/ date ( su* p]iod1 agree to7 a maximum fair price = su* select$ drug ( ! manufactur] 9 ord] = ! manufactur] to provide access to su* price-- 7,a7 to maximum fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are disp5s$ su* drug 7& to ph>macies1 mail ord] s]vices1 & o!r disp5s]s1 ) respect to su* maximum fair price eligible individuals :o are disp5s$ su* drugs7 dur+1 subject to subp>agraph 7#b71 ! price applicability p]iod2 & 7,b7 to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s ) respect to maximum fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( su* section & are furni%$ or adm9i/]$ su* drug dur+1 subject to subp>agraph 7#b71 ! price applicability p]iod2 7#b7 ! ,secret>y & ! manufactur] %all1 9 accordance ) section #aaid1 r5egotiate 7&1 by n lat] ?an ! la/ date ( su* p]iod1 agree to7 ! maximum fair price = su* drug1 9 ord] = ! manufactur] to provide access to su* maximum fair price 7z s r5egotiat$7-- 7,a7 to maximum fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are disp5s$ su* drug 7& to ph>macies1 mail ord] s]vices1 & o!r disp5s]s1 ) respect to su* maximum fair price eligible individuals :o are disp5s$ su* drugs7 dur+ any ye> dur+ ! price applicability p]iod 7beg9n+ aft] su* r5egotiation7 ) respect to su* select$ drug2 & 7,b7 to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s ) respect to maximum fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( su* section & are furni%$ or adm9i/]$ su* drug dur+ any ye> describ$ 9 subp>agraph 7,a72 7#c7 access to ! maximum fair price 7includ+ z r5egotiat$ pursuant to p>agraph 7#b771 ) respect to su* a select$ drug1 %all be provid$ by ! manufactur] to-- 7,a7 maximum fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ! ph>macy1 mail ord] s]vice1 or o!r disp5s] at ! po9t-(-sale ( su* drug 7& %all be provid$ by ! manufactur] to ! ph>macy1 mail ord] s]vice1 or o!r disp5s]1 ) respect to su* maximum fair price eligible individuals :o are disp5s$ su* drugs71 z describ$ 9 p>agraph 7#a77;,a7 or 7#b77;,a71 z applicable2 & 7,b7 hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s ) respect to maximum fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( su* section & are furni%$ or adm9i/]$ su* drug1 z describ$ 9 p>agraph 7#a77;,b7 or 7#b77;,b71 z applicable2 7#d7 ! manufactur]1 subject to subsection 7d71 submits to ! ,secret>y1 ?r\gh an onl9e portal e/abli%$ by ! ,secret>y or o!r =m & mann] specifi$ by ! ,secret>y1 = ! negotiation p]iod = ! price applicability p]iod 7&1 if applicable1 be=e any p]iod ( r5egotiation pursuant to section #aaid7;f77 ) respect to su* drug-- 7,a7 in=mation on ! non-,f$]al av]age manufactur] price = ! drug = ! applicable ye> or p]iod2 & 7,b7 all o!r in=mation t ! ,secret>y requires to c>ry out ! negotiation 7or r5egotiation process7 "u ?is "p1 includ+ in=mation describ$ 9 section #aaid7;e77#a72 & 7#e7 ! manufactur] complies ) requirem5ts impos$ by ! ,secret>y = purposes ( adm9i/]+ ! program1 includ+ ) respect to ! duties describ$ 9 section #aaif4 7b7 ,agreem5t 9 effect until drug is no long] a select$ drug ,an agreem5t ent]$ into "u ?is section %all be effective1 ) respect to a select$ drug1 until su* drug is no long] consid]$ a select$ drug "u section #aaib7;c74 7c7 ,confid5tiality ( in=mation ,in=mation submitt$ to ! ,secret>y "u ?is "p by a manufactur] ( a select$ drug t is propriet>y in=mation ( su* manufactur] 7z det]m9$ by ! ,secret>y7 %all be us$ only by ! ,secret>y or disclos$ to & us$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates or ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( c>ry+ out ?is "p4 7d7 ,implem5tation = #bjbe & #bjbf ,not)/&+ any o!r provision ( ?is "p1 ! ,secret>y %all implem5t ?is section = #bjbe & #bjbf by program in/ruction or o!rwise4 #aaid4 ,negotiation & r5egotiation process 7a7 ,9 g5]al ,= purposes ( ?is "p1 "u an agreem5t "u section #aaic betwe5 ! ,secret>y & a manufactur] ( a select$ drug1 ) respect to ! p]iod = :i* su* agreem5t is 9 effect & 9 accordance ) subsections 7b71 7c71 & 7d71 ! ,secret>y & ! manufactur]-- 7#a7 %all dur+ ! negotiation p]iod ) respect to su* drug1 9 accordance ) ?is section1 negotiate a maximum fair price = su* drug = ! purpose describ$ 9 section #aaic7;a77#a72 & 7#b7 r5egotiate1 9 accordance ) ! process specifi$ pursuant to subsection 7f71 su* maximum fair price = su* drug if su* drug is a r5egotiation-eligible drug "u su* subsection4 7b7 ,negotiation process requirem5ts 7#a7 ,me?odology & process ,! ,secret>y %all develop & use a consi/5t me?odology & process1 9 accordance ) p>agraph 7#b71 = negotiations "u subsection 7a7 t aims to a*ieve ! l[e/ maximum fair price = ea* select$ drug4 7#b7 ,specific elem5ts ( negotiation process ,z "p ( ! negotiation process "u ?is section1 ) respect to a select$ drug & ! negotiation p]iod ) respect to ! initial price applicability ye> ) respect to su* drug1 ! foll[+ %all apply3 7,a7 ,submission ( in=mation ,n lat] ?an ,m>* #a ( ! ye> ( ! select$ drug publication date1 ) respect to ! select$ drug1 ! manufactur] ( ! drug %all submit to ! ,secret>y1 9 accordance ) section #aaic7;a77#d71 ! in=mation describ$ 9 su* section4 7,b7 ,initial (f] by ,secret>y ,n lat] ?an ! ,june #a foll[+ ! select$ drug publication date1 ! ,secret>y %all provide ! manufactur] ( a select$ drug ) a writt5 initial (f] t conta9s ! ,secret>y's proposal = ! maximum fair price ( ! drug & a li/ ( ! consid]ations describ$ 9 section #aaid7;e7 t 7 us$ 9 develop+ su* (f]4 7,c7 ,response to initial (f] 7i7 ,9 g5]al ,n lat] ?an #cj days aft] ! date ( receipt ( an initial (f] "u subp>agraph 7,b71 ! manufactur] %all ei!r accept su* (f] or propose a c\nt](f] to su* (f]4 7ii7 ,c\nt](f] requirem5ts ,if a manufactur] proposes a c\nt](f]1 su* c\nt](f]-- 7,i7 %all be 9 writ+2 & 7,,ii7 %all be ju/ifi$ bas$ on ! factors describ$ 9 subsection 7e74 7,d7 ,response to c\nt](f] ,aft] receiv+ a c\nt](f] "u subp>agraph 7,c71 ! ,secret>y %all respond 9 writ+ to su* c\nt](f]4 7,e7 ,deadl9e ,all negotiations %all end prior to ! fir/ day ( ,novemb] foll[+ ! select$ drug publication date1 ) respect to ! initial price applicability ye>4 7,f7 ,limitations on (f] am\nt ,9 negotiat+ ! maximum fair price ( a select$ drug1 ) respect to an initial price applicability ye> = ! select$ drug1 &1 z applicable1 9 r5egotiat+ ! maximum fair price = su* drug1 ) respect to a subsequ5t ye> dur+ ! price applicability p]iod = su* drug1 ! ,secret>y %all n (f] 7or agree to a c\nt](f] =7 a maximum fair price = ! select$ drug t-- 7i7 exce$s ! ceil+ det]m9$ "u subsection 7c7 = ! select$ drug & ye>2 or 7ii7 z applicable1 is less ?an ! floor det]m9$ "u subsection 7d7 = ! select$ drug & ye>4 7,g7 ,treatm5t ( det]m9ation ,! e/abli%m5t ( a maximum fair price "u ?is section is n subject to adm9i/rative or judicial review4 7c7 ,ceil+ = maximum fair price 7#a7 ,9 g5]al ,! maximum fair price negotiat$ "u ?is section = a select$ drug1 ) respect to ! fir/ ye> ( ! price applicability p]iod ) respect to su* drug1 %all n exce$ ! applicable p]c5t describ$ 9 p>agraph 7#b71 ) respect to su* drug1 ( ! foll[+3 7,a7 ,initial price applicability ye> #bjbe ,9 ! case ( a select$ drug ) respect to :i* su* initial price applicability ye> is #bjbe1 ! av]age ( ! non-,f$]al av]age manufactur] price = su* drug = ! fir/ #c cal5d> qu>t]s ( #bjba 7or1 9 ! case t !re is n a non-,f$]al av]age manufactur] price available = su* drug = any ( su* fir/ #c cal5d> qu>t]s ( #bjba1 = ! fir/ full ye> foll[+ ! m>ket entry = su* drug71 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 f ,septemb] #bjba 7or su* fir/ full ye> foll[+ ! m>ket entry71 z applicable1 to ! ye> prior to ! select$ drug publication date ) respect to su* initial price applicability ye>4 7,b7 ,initial price applicability ye> #bjbf & subsequ5t ye>s ,9 ! case ( a select$ drug ) respect to :i* su* initial price applicability ye> is #bjbf or a subsequ5t ye>1 ! l[] (-- 7i7 ! av]age ( ! non-,f$]al av]age manufactur] price = su* drug = ! fir/ #c cal5d> qu>t]s ( #bjba 7or1 9 ! case t !re is n a non-,f$]al av]age manufactur] price available = su* drug = any ( su* fir/ #c cal5d> qu>t]s ( #bjba1 = ! fir/ full ye> foll[+ ! m>ket entry = su* drug71 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 f ,septemb] #bjba 7or su* fir/ full ye> foll[+ ! m>ket entry71 z applicable1 to ! ye> prior to ! select$ drug publication date ) respect to su* initial price applicability ye>2 or 7ii7 ! non-,f$]al av]age manufactur] price = su* drug = ! ye> prior to ! select$ drug publication date ) respect to su* initial price applicability ye>4 7#b7 ,applicable p]c5t describ$ ,= purposes ( p>agraph 7#a71 ! applicable p]c5t describ$ 9 ?is p>agraph is ! foll[+3 7,a7 ,%ort-monopoly drugs ,) respect to a select$ drug 7o!r ?an a po/-exclusivity drug & a long-monopoly drug71 #ge p]c5t4 7,b7 ,po/-exclusivity drugs ,) respect to a po/-exclusivity drug1 #fe p]c5t4 7,c7 ,long-monopoly drugs ,) respect to a long-monopoly drug1 #dj p]c5t4 7#c7 ,po/-exclusivity drug def9$ 7,a7 ,9 g5]al ,9 ?is "p1 subject to subp>agraph 7,b71 ! t]m po/-exclusivity drug means1 ) respect to an initial price applicability ye>1 a select$ drug = :i* at lea/ #ab ye>s1 b few] ?an #af ye>s1 h elaps$ s9ce ! date ( approval ( su* drug "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or s9ce ! date ( lic5sure ( su* drug "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 z applicable4 7,b7 ,exclusions ,! t]m po/-exclusivity drug %all n include any ( ! foll[+3 7i7 ,a vacc9e t is lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act & m>ket$ pursuant to su* section4 7ii7 ,a select$ drug t _h an agreem5t "u ?is "p ) ! ,secret>y prior to ! initial price applicability ye> #bjcj4 7,c7 ,cl>ification ,no?+ 9 subp>agraph 7,b77ii7 %all limit ! transition ( a select$ drug describ$ 9 p>agraph 7#b77;,a7 to a long-monopoly drug if ! select$ drug meets ! def9ition ( a long-monopoly drug4 7#d7 ,long-monopoly drug def9$ 7,a7 ,9 g5]al ,9 ?is "p1 subject to subp>agraph 7,b71 ! t]m long-monopoly drug means1 ) respect to an initial price applicability ye>1 a select$ drug = :i* at lea/ #af ye>s h elaps$ s9ce ! date ( approval ( su* drug "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or s9ce ! date ( lic5sure ( su* drug "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 z applicable4 7,b7 ,exclusion ,! t]m long-monopoly drug %all n include a vacc9e t is lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act & m>ket$ pursuant to su* section4 7#e7 ,non-,f$]al av]age manufactur] price ,9 ?is "p1 ! t]m non-,f$]al av]age manufactur] price has ! mean+ giv5 su* t]m 9 section #habf7;h77#e7 ( title #ch1 ,unit$ ,/ates ,code4 7d7 ,tempor>y floor = small biote* drugs ,9 ! case ( a select$ drug t is a qualify+ s+le s\rce drug describ$ 9 section #aaib7;d77#b7 & ) respect to :i* ! fir/ initial price applicability ye> ( ! price applicability p]iod ) respect to su* drug is #bjbh or #bjbi1 ! maximum fair price negotiat$ "u ?is section = su* drug = su* initial price applicability ye> may n be less ?an #ff p]c5t ( ! av]age ( ! non-,f$]al av]age manufactur] price = su* drug 7z def9$ & appli$ 9 subsection 7c77#d77 = ! fir/ #c cal5d> qu>t]s ( #bjba 7or1 9 ! case t !re is n a non-,f$]al av]age manufactur] price available = su* drug = any ( su* fir/ #c cal5d> qu>t]s ( #bjba1 = ! fir/ full ye> foll[+ ! m>ket entry = su* drug71 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,unit$ ,/ates city av]age7 f ,septemb] #bjba 7or su* fir/ full ye> foll[+ ! m>ket entry71 z applicable1 to ! ye> prior to ! select$ drug publication date ) respect to ! initial price applicability ye>4 7e7 ,consid]ations ,= purposes ( negotiat+ ! maximum fair price ( a select$ drug "u ?is "p ) ! manufactur] ( ! drug1 ! ,secret>y %all consid] ! foll[+ factors 7&1 ) respect to po/-exclusivity drugs & long-monopoly drugs1 %all n consid] factors o!r ?an ^? describ$ 9 subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#a773 7#a7 ,manufactur]-specific in=mation ,! foll[+ in=mation1 ) respect to su* select$ drug1 includ+ z submitt$ by ! manufactur]3 7,a7 ,rese>* & developm5t co/s ( ! manufactur] = ! drug & ! ext5t to :i* ! manufactur] has rec\p$ rese>* & developm5t co/s4 7,b7 ,m>ket data = ! drug1 includ+ ! di/ribution ( sales across diff]5t programs & pur*as]s & project$ future rev5ues = ! drug4 7,c7 ,unit co/s ( production & di/ribution ( ! drug4 7,d7 ,prior ,f$]al f9ancial support = novel !rapeutic discov]y & developm5t ) respect to ! drug4 7,e7 ,data on pat5ts & on exi/+ & p5d+ exclusivity = ! drug4 7,f7 ,national sales data = ! drug4 7,g7 ,in=mation on cl9ical trials = ! drug4 7#b7 ,in=mation on unmet m$ical ne$s & alt]native treatm5ts ,! foll[+ in=mation1 ) respect to su* select$ drug3 7,a7 ,! ext5t to :i* ! drug repres5ts a !rapeutic advance z comp>$ to exi/+ !rapeutic alt]natives &1 to ! ext5t su* in=mation is available1 ! co/s ( su* exi/+ !rapeutic alt]natives4 7,b7 ,in=mation on approval by ! ,food & ,drug ,adm9i/ration ( alt]native drug products or biological products4 7,c7 ,in=mation on comp>ative effectiv5ess analysis = su* products1 tak+ into consid]ation ! effects ( su* products on specific populations1 su* z individuals ) disabilities1 ! eld]ly1 ! t]m9ally ill1 *ildr51 & o!r pati5t populations4 7,d7 ,! ext5t to :i* ! drug addresses unmet m$ical ne$s = a condition = :i* treatm5t or diagnosis is n address$ adequately by available !rapy4 ,9 consid]+ in=mation describ$ 9 subp>agraph 7,c71 ! ,secret>y %all n use evid5ce or f9d+s f comp>ative cl9ical effectiv5ess rese>* 9 a mann] t treats ext5d+ ! life ( an eld]ly1 disabl$1 or t]m9ally ill individual z ( l[] value ?an ext5d+ ! life ( an individual :o is y\ng]1 nondisabl$1 or n t]m9ally ill4 7#c7 ,additional in=mation ,in=mation submitt$ to ! ,secret>y1 9 accordance ) a process specifi$ by ! ,secret>y1 by o!r p>ties t are affect$ by ! e/abli%m5t ( a maximum fair price = ! select$ drug4 7f7 ,r5egotiation process 7#a7 ,9 g5]al ,9 ! case ( a r5egotiation-eligible drug 7z def9$ 9 p>agraph 7#b77 t is select$ "u p>agraph 7#c71 ! ,secret>y %all provide = a process ( r5egotiation 7= ye>s 7beg9n+ ) #bjbg7 dur+ ! price applicability p]iod1 ) respect to su* drug7 ( ! maximum fair price = su* drug consi/5t ) p>agraph 7#d74 7#b7 ,r5egotiation-eligible drug def9$ ,9 ?is section1 ! t]m r5egotiation-eligible drug means a select$ drug t is any ( ! foll[+3 7,a7 ,addition ( new indication ,a select$ drug = :i* a new indication is add$ to ! drug4 7,b7 ,*ange ( /atus to a po/-exclusivity drug ,a select$ drug t is describ$ 9 section #aaib7;d77#a77;,a7 t-- 7i7 is n a po/-exclusivity drug or a long-monopoly drug2 & 7ii7 = :i* !re is a *ange 9 /atus to t ( a po/-exclusivity drug4 7,c7 ,*ange ( /atus to a long-monopoly drug ,a select$ drug t is describ$ 9 section #aaib7;d77#a77;,a7 t-- 7i7 is n a long-monopoly drug2 & 7ii7 = :i* !re is a *ange 9 /atus to t ( a long-monopoly drug4 7,d7 ,mat]ial *anges ,a select$ drug = :i* ! ,secret>y det]m9es !re has be5 a mat]ial *ange ( factors describ$ 9 p>agraph 7#a7 or 7#b7 ( subsection 7e74 7#c7 ,selection ( drugs = r5egotiation ,ea* ye> ! ,secret>y %all select among r5egotiation-eligible drugs = r5egotiation z foll[s3 7,a7 ,all po/-exclusivity negotiation-eligible drugs ,! ,secret>y %all select all r5egotiation-eligible drugs describ$ 9 p>agraph 7#b77;,b74 7,b7 ,all long-monopoly negotiation-eligible drugs ,! ,secret>y %all select all r5egotiation-eligible drugs describ$ 9 p>agraph 7#b77;,c74 7,c7 ,rema9+ drugs ,among ! rema9+ r5egotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,d7 ( p>agraph 7#b71 ! ,secret>y %all select r5egotiation-eligible drugs = :i* ! ,secret>y expects r5egotiation is likely to result 9 a significant *ange 9 ! maximum fair price o!rwise negotiat$4 7#d7 ,r5egotiation process ,! ,secret>y %all specify ! process = r5egotiation ( maximum fair prices ) ! manufactur] ( a r5egotiation-eligible drug select$ = r5egotiation "u ?is subsection4 ,su* process %all1 to ! ext5t practicable1 be consi/5t ) ! me?odology & process e/abli%$ "u subsection 7b7 & 9 accordance ) subsections 7c7 & 7d71 & = purposes ( apply+ subsections 7c7 & 7d71 ! ref]5ce to ! fir/ initial price applicability ye> ( ! price applicability p]iod ) respect to su* drug %all be treat$ z ! fir/ initial price applicability ye> ( su* p]iod = :i* ! maximum fair price e/abli%$ pursuant to su* r5egotiation applies1 includ+ = apply+ subsection 7c77#b77;,b7 9 ! case ( r5egotiation-eligible drugs describ$ 9 p>agraph 7#c77;,a7 ( ?is subsection & subsection 7c77#b77;,c7 9 ! case ( r5egotiation-eligible drugs describ$ 9 p>agraph 7#c77;,b7 ( ?is subsection4 7#e7 ,cl>ification ,a r5egotiation-eligible drug = :i* ! ,secret>y makes a det]m9ation describ$ 9 section #aaib7;c77#a7 be=e or dur+ ! p]iod ( r5egotiation %all n be subject to ! r5egotiation process "u ?is section4 7#f7 ,no adm9i/rative or judicial review ,! det]m9ation ( r5egotiation-eligible drugs "u p>agraph 7#b7 & ! selection ( r5egotiation-eligible drugs "u p>agraph 7#c7 are n subject to adm9i/rative or judicial review4 7g7 ,reque/ = in=mation ,= purposes ( negotiat+ &1 z applicable1 r5egotiat+ 7includ+ = purposes ( det]m9+ :e!r to r5egotiate7 ! maximum fair price ( a select$ drug "u ?is "p ) ! manufactur] ( ! drug1 ) respect to a price applicability p]iod1 & o!r relevant data = purposes ( ?is section-- 7#a7 ! ,secret>y %all1 n lat] ?an ! select$ drug publication date ) respect to ! initial price applicability ye> ( su* p]iod1 reque/ drug pric+ in=mation f ! manufactur] ( su* select$ drug1 includ+ in=mation describ$ 9 subsection 7e77#a72 & 7#b7 by n lat] ?an ,m>* #a foll[+ ! select$ drug publication date1 ! manufactur] ( su* select$ drug %all submit to ! ,secret>y su* reque/$ in=mation 9 su* =m & mann] z ! ,secret>y requires4 ,! ,secret>y %all reque/1 f ! manufactur] or o!rs1 all additional in=mation ne$$ to c>ry out ! negotiation & r5egotiation process "u ?is section4 7h7 ,cl>ification ,9 no case %all ! maximum fair price negotiat$ "u ?is section = a select$ drug t is a qualify+ s+le s\rce drug describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #aaib7;e77#a7 apply be=e-- 7#a7 9 ! case ! select$ drug is a qualify+ s+le s\rce drug describ$ 9 su* subp>agraph 7,a71 ! date t is #i ye>s aft] ! date on :i* ! drug 0 approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7#b7 9 ! case ! select$ drug is a qualify+ s+le s\rce drug describ$ 9 su* subp>agraph 7,b71 ! date t is #ac ye>s aft] ! date on :i* ! drug 0 lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 7i7 ,implem5tation = #bjbe & #bjbf ,not)/&+ any o!r provision ( ?is "p1 ! ,secret>y %all implem5t ?is section = #bjbe & #bjbf by program in/ruction or o!rwise4 #aaie4 ,publication ( maximum fair prices 7a7 ,9 g5]al ,) respect to an initial price applicability ye> & a select$ drug ) respect to su* ye>-- 7#a7 n lat] ?an ,novemb] #ae ( ! ye> t is #b ye>s prior to su* initial price applicability ye>1 ! ,secret>y %all publi% on ,,cms4gov ! maximum fair price = su* drug negotiat$ "u ?is "p ) ! manufactur] ( su* drug2 7#b7 n lat] ?an ,novemb] #cj ( ! ye> t is #b ye>s prior to su* initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! maximum fair price = su* drug describ$ 9 p>agraph 7#a72 & 7#c7 n lat] ?an ,m>* #a ( ! ye> prior to su* initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/]1 subject to section #aaic7;c7 & bas$ on ! consid]ations z describ$ 9 section #aaid7;e71 ! explanation = ! maximum fair price = su* drug describ$ 9 p>agraphs 7#a7 & 7#b74 7b7 ,updates 7#a7 ,subsequ5t ye> maximum fair prices ,= a select$ drug1 = ea* ye> subsequ5t to fir/ initial price applicability ye> ( ! price applicability p]iod ) respect to su* drug1 ) respect to :i* an agreem5t = su* drug is 9 effect "u section #aaic1 n lat] ?an ,novemb] #cj ( ! ye> t is #b ye>s prior to su* subsequ5t ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! maximum fair price applicable to su* drug & ye>1 :i* %all be-- 7,a7 subject to subp>agraph 7,b71 ! am\nt equal to ! maximum fair price publi%$ = su* drug = ! previ\s ye>1 increas$ by ! annual p]c5tage increase 9 ! consum] price index = all urban consum]s 7all items2 ,u4,s4 city av]age7 z ( ,septemb] ( su* previ\s ye>2 or 7,b7 9 ! case ! maximum fair price = su* drug 0 r5egotiat$1 = ! fir/ ye> = :i* su* price z s r5egotiat$ applies1 su* r5egotiat$ maximum fair price4 7#b7 ,prices negotiat$ aft] deadl9e ,9 ! case ( a select$ drug ) respect to an initial price applicability ye> = :i* ! maximum fair price is det]m9$ "u ?is "p aft] ! date ( publication "u ?is section1 ! ,secret>y %all publi% su* maximum fair price 9 ! ,f$]al ,regi/] by n lat] ?an #cj days aft] ! date su* maximum price is s det]m9$4 #aaif4 ,adm9i/rative duties2 coord9ation provisions 7a7 ,adm9i/rative duties 7#a7 ,9 g5]al ,= purposes ( section #aaia1 ! adm9i/rative duties describ$ 9 ?is section are ! foll[+3 7,a7 ,! e/abli%m5t ( proc$ures to ensure t ! maximum fair price = a select$ drug is appli$ be=e-- 7i7 any cov]age or f9ancial assi/ance "u o!r heal? b5efit plans or programs t provide cov]age or f9ancial assi/ance = ! pur*ase or provision ( prescription drug cov]age on behalf ( maximum fair price eligible individuals2 & 7ii7 any o!r disc\nts4 7,b7 ,! e/abli%m5t ( proc$ures to compute & apply ! maximum fair price across diff]5t /r5g?s & dosage =ms ( a select$ drug & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7,c7 ,! e/abli%m5t ( proc$ures to c>ry out ! provisions ( ?is "p1 z applicable1 ) respect to-- 7i7 maximum fair price eligible individuals :o are enroll$ "u a prescription drug plan "u "p ,d ( title ,,xviii or an ,,ma-,,pd plan "u "p ,c ( su* title2 & 7ii7 maximum fair price eligible individuals :o are enroll$ "u "p ,b ( su* title1 includ+ :o are enroll$ "u an ,,ma plan "u "p ,c ( su* title4 7,d7 ,! e/abli%m5t ( a negotiation process & r5egotiation process 9 accordance ) section #aaid1 includ+ a process = acquir+ in=mation describ$ 9 subsection 7e7 ( su* section4 7,e7 ,! e/abli%m5t ( an onl9e portal :i* manufactur]s %all be requir$ to use to submit in=mation describ$ 9 section #aaid7;b77#b77;,a74 7,f7 ,! %>+ ) ! ,secret>y ( ! ,treasury ( su* in=mation z is necess>y to det]m9e ! tax impos$ by section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf 7relat+ to en=cem5t ( ?is "p74 7,g7 ,! e/abli%m5t ( an atte/ation & v]ification process = purposes ( apply+ section #aaib7;d77#b77;,b74 7#b7 ,monitor+ compliance ,! ,secret>y %all monitor compliance by a manufactur] ) ! t]ms ( an agreem5t "u section #aaic1 includ+ by e/abli%+ a me*anism ?r\gh :i* violations ( su* t]ms %all be report$4 7b7 ,implem5tation = #bjbe & #bjbf ,not)/&+ any o!r provision ( ?is "p1 ! ,secret>y %all implem5t ?is section = #bjbe & #bjbf by program in/ruction or o!rwise4 #aaig4 ,civil monet>y p5alty 7a7 ,violations relat+ to (f]+ ( maximum fair price ,any manufactur] ( a select$ drug t has ent]$ into an agreem5t "u section #aaic1 ) respect to a ye> dur+ ! price applicability p]iod ) respect to su* drug1 t does n provide access to a price t is n m ?an ! maximum fair price 7or a less] price7 = su* drug = su* ye>-- 7#a7 to a maximum fair price eligible individual :o ) respect to su* drug is describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & :o is disp5s$ su* drug dur+ su* ye> 7& to ph>macies1 mail ord] s]vices1 & o!r disp5s]s1 ) respect to su* maximum fair price eligible individuals :o are disp5s$ su* drugs72 or 7#b7 to a hospital1 physician1 or o!r provid] ( s]vices or suppli] ) respect to maximum fair price eligible individuals :o ) respect to su* drug is describ$ 9 subp>agraph 7,b7 ( su* section & is furni%$ or adm9i/]$ su* drug by su* hospital1 physician1 or provid] or suppli] dur+ su* ye>1 %all be subject to a civil monet>y p5alty equal to t5 times ! am\nt equal to ! product ( ! numb] ( units ( su* drug s furni%$1 disp5s$1 or adm9i/]$ dur+ su* ye> & ! diff]5ce betwe5 ! price = su* drug made available = su* ye> by su* manufactur] ) respect to su* individual or hospital1 physician1 provid] ( s]vices1 or suppli] & ! maximum fair price = su* drug = su* ye>4 7b7 ,violations ( c]ta9 t]ms ( agreem5t ,any manufactur] ( a select$ drug t has ent]$ into an agreem5t "u section #aaic1 ) respect to a ye> dur+ ! price applicability p]iod ) respect to su* drug1 t is 9 violation ( a requirem5t impos$ pursuant to section #aaic7;a77#e71 includ+ ! requirem5t to submit in=mation pursuant to section #aaic7;a77#d71 %all be subject to a civil monet>y p5alty equal to #a1jjj1jjj = ea* day ( su* violation4 7c7 ,false in=mation ,any manufactur] t kn[+ly provides false in=mation = ! atte/ation process or v]ification process e/abli%$ pursuant to section #aaif7;a77#a77;,h71 %all be subject to a civil monet>y p5alty equal to #ajj1jjj1jjj = ea* item ( su* false in=mation4 7d7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is section 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 4 7b7 ,application ( maximum fair prices & con=m+ am5dm5ts 7#a7 ,"u ,m$ic>e 7,a7 ,application to paym5ts "u "p ,b ,section #ahdg;,a7b77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#a77;,b77 is am5d$ by ins]t+ or 9 ! case ( su* a drug or biological t is a select$ drug 7z ref]r$ to 9 section #aaib7;c771 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 #ajf p]c5t ( ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 applicable = su* drug & a ye> dur+ su* p]iod aft] p>agraph 7#d74 7,b7 ,application "u ,,ma ( co/-%>+ = "p ,b drugs bas$ (f ( negotiat$ price ,section #aheb7;a77#a77;,b77iv7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#a77;,b77iv77 is am5d$-- 7i7 by r$esignat+ subclause 7,,vii7 z subclause 7,,viii72 & 7ii7 by ins]t+ aft] subclause 7,,vi7 ! foll[+ subclause3 7,,vii7 ,a drug or biological t is a select$ drug 7z ref]r$ to 9 section #aaib7;c774 4 7,c7 ,exception to "p ,d non-int]f]5ce ,section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i77 is am5d$-- 7i7 9 p>agraph 7#a71 by /rik+ & at ! end2 7ii7 9 p>agraph 7#b71 by /rik+ or in/itute a price /ructure = ! reimbursem5t ( cov]$ "p ,d drugs & ins]t+ = cov]$ "p ,d drugs2 &2 & 7iii7 by add+ at ! end ! foll[+3 7#c7 may n in/itute a price /ructure = ! reimbursem5t ( cov]$ "p ,d drugs1 except z provid$ "u "p ,e ( title ,,xi4 4 7,d7 ,application z negotiat$ price "u "p ,d ,section #ahfj;,d-#b7;d77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;d77#a77 is am5d$-- 7i7 9 subp>agraph 7,b71 by ins]t+ 1 subject to subp>agraph 7,d71 aft] negotiat$ prices2 & 7ii7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,application ( maximum fair price = select$ drugs ,9 apply+ ?is section1 9 ! case ( a cov]$ "p ,d drug t is a select$ drug 7z ref]r$ to 9 section #aaib7;c771 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 ! negotiat$ prices us$ = paym5t 7z describ$ 9 ?is subsection7 %all be no great] ?an ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug & = ea* ye> dur+ su* p]iod plus any disp5s+ fees = su* drug4 4 7,e7 ,cov]age ( select$ drugs ,section #ahfj;,d-#d7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,i7 ,requir$ inclusion ( select$ drugs ,= #bjbe & ea* subsequ5t ye>1 ! ,,pdp sponsor (f]+ a prescription drug plan %all include ea* cov]$ "p ,d drug t is a select$ drug "u section #aaib = :i* an agreem5t = su* drug is 9 effect "u section #aaic ) respect to ! ye>4 4 7,f7 ,in=mation f prescription drug plans & ,,ma-,,pd plans requir$ 7i7 ,prescription drug plans ,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 ,provision ( in=mation relat$ to maximum fair prices ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all require ! sponsor to provide in=mation to ! ,secret>y z reque/$ by ! ,secret>y 9 accordance ) section #aaid7;g74 4 7ii7 ,,ma-,,pd plans ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,provision ( in=mation relat$ to maximum fair prices ,section #ahfj;,d-#ab7;b77#h74 4 7#b7 ,drug price negotiation program prices includ$ 9 be/ price ,section #aibg7;c77#a77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77 is am5d$-- 7,a7 9 clause 7i77,,vi71 by /rik+ any prices *>g$ & ins]t+ subject to clause 7ii77,v71 any prices *>g$2 & 7,b7 9 clause 7ii7-- 7i7 9 subclause 7,,iii71 by /rik+ at ! end 2 &2 7ii7 9 subclause 7,,iv71 by /rik+ at ! end ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subclause3 7,v7 9 ! case ( a rebate p]iod & a cov]$ outpati5t drug t is a select$ drug 7z ref]r$ to 9 section #aaib7;c77 dur+ su* rebate p]iod1 %all be inclusive ( ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug ) respect to su* p]iod4 4 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods 7a7 ,9 g5]al ,*apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new sub*apt]3 ,e ,o!r items ,sec4 #daib4 ,select$ drugs dur+ noncompliance p]iods4 #daib4 ,select$ drugs dur+ noncompliance p]iods 7a7 ,9 g5]al ,!re is h]eby impos$ on ! sale by ! manufactur]1 produc]1 or import] ( any select$ drug dur+ a day describ$ 9 subsection 7b7 a tax 9 an am\nt su* t ! applicable p]c5tage is equal to ! ratio (-- 7#a7 su* tax1 divid$ by 7#b7 ! sum ( su* tax & ! price = :i* s sold4 7b7 ,noncompliance p]iods ,a day is describ$ 9 ?is subsection ) respect to a select$ drug if x is a day dur+ "o ( ! foll[+ p]iods3 7#a7 ,! p]iod beg9n+ on ! ,m>* #a/ imm$iately foll[+ ! select$ drug publication date & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has 9 place an agreem5t describ$ 9 subsection 7a7 ( section #aaic ( ! ,social ,security ,act ) respect to su* drug4 7#b7 ,! p]iod beg9n+ on ! ,novemb] #bnd imm$iately foll[+ ! ,m>* #a/ describ$ 9 p>agraph 7#a7 & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug & ! ,secret>y h agre$ to a maximum fair price "u su* agreem5t4 7#c7 ,9 ! case ( a select$ drug ) respect to :i* ! ,secret>y ( ,heal? & ,human ,s]vices has specifi$ a r5egotiation p]iod "u su* agreem5t1 ! p]iod beg9n+ on ! fir/ date aft] ! la/ date ( su* r5egotiation p]iod & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has agre$ to a r5egotiat$ maximum fair price "u su* agreem5t4 7#d7 ,) respect to in=mation t is requir$ to be submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices "u su* agreem5t1 ! p]iod beg9n+ on ! date on :i* su* ,secret>y c]tifies t su* in=mation is ov]due & end+ on ! date t su* in=mation is s submitt$4 7c7 ,applicable p]c5tage ,= purposes ( ?is section1 ! t]m applicable p]c5tage means-- 7#a7 9 ! case ( sales ( a select$ drug dur+ ! fir/ #ij days describ$ 9 subsection 7b7 ) respect to su* drug1 #fe p]c5t1 7#b7 9 ! case ( sales ( su* drug dur+ ! #ia/ day ?r\gh ! #ahj? day describ$ 9 subsection 7b7 ) respect to su* drug1 #ge p]c5t1 7#c7 9 ! case ( sales ( su* drug dur+ ! #aha/ day ?r\gh ! #bgj? day describ$ 9 subsection 7b7 ) respect to su* drug1 #he p]c5t1 & 7#d7 9 ! case ( sales ( su* drug dur+ any subsequ5t day1 #ie p]c5t4 7d7 ,select$ drug ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,! t]m select$ drug means any select$ drug 7)9 ! mean+ ( section #aaib ( ! ,social ,security ,act7 :i* is manufactur$ or produc$ 9 ! ,unit$ ,/ates or ent]$ into ! ,unit$ ,/ates = consumption1 use1 or w>eh\s+4 7#b7 ,unit$ ,/ates ,! t]m ,unit$ ,/ates has ! mean+ giv5 su* t]m by section #dfab7;a77#d74 7#c7 ,coord9ation ) rules = possessions ( ! ,unit$ ,/ates ,rules simil> to ! rules ( p>agraphs 7#b7 & 7#d7 ( section #dacb7;c7 %all apply = purposes ( ?is section4 7e7 ,o!r def9itions ,= purposes ( ?is section1 ! t]ms select$ drug publication date & maximum fair price h ! mean+ giv5 su* t]ms 9 section #aaia ( ! ,social ,security ,act4 7f7 ,anti-,abuse rule ,9 ! case ( a sale :i* 0 tim$ = ! purpose ( avoid+ ! tax impos$ by ?is section1 ! ,secret>y may treat su* sale z occurr+ dur+ a day describ$ 9 subsection 7b74 4 7b7 ,no d$uction = excise tax paym5ts ,section #bge7;a77#f7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or by section #daib be=e ! p]iod at ! end4 7c7 ,c]ta9 exemptions f tax n applicable 7#a7 ,section #dbba7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+3 ,9 ! case ( ! tax impos$ by section #daib1 p>agraphs 7#c71 7#d71 7#e71 & 7#f7 %all n apply44 7#b7 ,section #fdaf7;b77#b7 ( su* ,code is am5d$ by add+ at ! end ! foll[+3 ,9 ! case ( ! tax impos$ by section #daib1 subp>agraphs 7,b71 7,c71 7,d71 & 7,e7 %all n apply44 7d7 ,cl]ical am5dm5t ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sub*apt] ,e4 ,o!r items 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 #ajc4 ,fund+ ,9 addition to am\nts o!rwise available1 !re is appropriat$ = fiscal ye> #bjbb1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 to rema9 available until exp5d$-- 7#a7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbb2 7#b7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbc2 7#c7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbd2 7#d7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbe2 7#e7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbf2 7#f7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbg2 7#g7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbh2 7#h7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjbi2 7#i7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjcj2 & 7#aj7 #cjj1jjj1jjj to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is "p 9 fiscal ye> #bjca4 ,,ii ,prescription ,drug ,inflation ,rebates #bja4 ,m$ic>e "p ,b rebate by manufactur]s 7a7 ,9 g5]al ,section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7#a7 by r$esignat+ subsection 7h7 z subsection 7i7 & by ins]t+ aft] subsection 7g7 ! foll[+ subsection3 7h7 ,rebate by manufactur]s = s+le s\rce drugs & biologicals ) prices increas+ fa/] ?an inflation 7#a7 ,requirem5ts 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #f mon?s aft] ! end ( ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjbc1 ! ,secret>y %all1 = ea* "p ,b rebatable drug1 report to ea* manufactur] ( su* "p ,b rebatable drug ! foll[+ = su* cal5d> qu>t]3 7i7 ,in=mation on ! total numb] ( bill+ units ( ! bill+ & paym5t code describ$ 9 subp>agraph 7,a77i7 ( p>agraph 7#c7 ) respect to su* drug & cal5d> qu>t]4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age sales price increase describ$ 9 subp>agraph 7,a77ii7 ( su* p>agraph = su* drug & cal5d> qu>t]4 7iii7 ,! rebate am\nt specifi$ "u su* p>agraph = su* "p ,b rebatable drug & cal5d> qu>t]4 7,b7 ,manufactur] requirem5t ,= ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjbc1 ! manufactur] ( a "p ,b rebatable drug %all1 = su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation describ$ 9 subp>agraph 7,a7 = su* cal5d> qu>t]1 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* cal5d> qu>t]4 7#b7 ,"p ,b rebatable drug def9$ 7,a7 ,9 g5]al ,9 ?is subsection1 ! t]m "p ,b rebatable drug means a s+le s\rce drug or biological 7z def9$ 9 subp>agraph 7,d7 ( subsection 7c77#f771 includ+ a biosimil> biological product 7z def9$ 9 subp>agraph 7,h7 ( su* subsection7 b exclud+ a qualify+ biosimil> biological product 7z def9$ 9 subsection 7b77#h77;,b77iii771 t w\ld be payable "u ?is "p if su* drug 7 furni%$ to an individual enroll$ "u ?is "p1 except su* t]m %all n include su* a drug or biological-- 7i7 if1 z det]m9$ by ! ,secret>y1 ! av]age total all[$ *>ges = su* drug or biological "u ?is "p = a ye> p] individual t uses su* a drug or biological are less ?an1 subject to subp>agraph 7,b71 #ajj2 or 7ii7 t is a vacc9e describ$ 9 subp>agraph 7,a7 or 7,b7 ( section #ahfa7s77#aj74 7,b7 ,increase ,! doll> am\nt appli$ "u subp>agraph 7,a77i7-- 7i7 = #bjbd1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbc1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is clause 7or clause 7i77 = ! previ\s ye> 7)\t application ( subp>agraph 7,c771 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>4 7,c7 ,r\nd+ ,any doll> am\nt det]m9$ "u subp>agraph 7,b7 t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 7#c7 ,rebate am\nt 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a71 ! am\nt specifi$ 9 ?is p>agraph = a "p ,b rebatable drug assign$ to a bill+ & paym5t code = a cal5d> qu>t] is1 subject to subp>agraphs 7,b7 & 7,g7 & p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 ! total numb] ( bill+ units det]m9$ "u subp>agraph 7,b7 = ! bill+ & paym5t code ( su* drug2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! am\nt equal to-- 7aa7 9 ! case ( a "p ,b rebatable drug describ$ 9 p>agraph 7#a77;,b7 ( section #ahdg;,a7b71 #ajf p]c5t ( ! am\nt det]m9$ "u p>agraph 7#d7 ( su* section = su* drug dur+ ! cal5d> qu>t]2 or 7bb7 9 ! case ( a "p ,b rebatable drug describ$ 9 p>agraph 7#a77;,c7 ( su* section1 ! paym5t am\nt "u su* p>agraph = su* drug dur+ ! cal5d> qu>t]2 exce$s 7,,ii7 ! inflation-adju/$ paym5t am\nt det]m9$ "u subp>agraph 7,c7 = su* "p ,b rebatable drug dur+ ! cal5d> qu>t]4 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;,b7 = ea* ,national ,drug ,code ( su* drug dur+ ! cal5d> qu>t] t is two 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 7,c7 ,det]m9ation ( inflation-adju/$ paym5t am\nt ,! inflation-adju/$ paym5t am\nt det]m9$ "u ?is subp>agraph = a "p ,b rebatable drug = a cal5d> qu>t] is-- 7i7 ! paym5t am\nt = ! bill+ & paym5t code = su* drug 9 ! paym5t am\nt b5*m>k qu>t] 7z def9$ 9 subp>agraph 7,d772 increas$ by 7ii7 ! p]c5tage by :i* ! rebate p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,f77 = ! cal5d> qu>t] exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subp>agraph 7,e774 7,d7 ,paym5t am\nt b5*m>k qu>t] ,! t]m paym5t am\nt b5*m>k qu>t] means ! cal5d> qu>t] imm$iately prior to ! cal5d> qu>t] beg9n+ ,octob] #a1 #bjba4 7,e7 ,b5*m>k p]iod ,,cpi-,u ,! t]m b5*m>k p]iod ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! la/ mon? ( ! cal5d> qu>t] beg9n+ ,octob] #a1 #bjba4 7,f7 ,rebate p]iod ,,cpi-,u ,! t]m rebate p]iod ,,cpi-,u means1 ) respect to a cal5d> qu>t] describ$ 9 subp>agraph 7,c71 ! great] ( ! b5*m>k p]iod ,,cpi-,u & ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! fir/ mon? ( ! cal5d> qu>t] t is two cal5d> qu>t]s prior to su* describ$ cal5d> qu>t]4 7,g7 ,exemption = %ortages & sev]e supply *a9 disruptions ,! ,secret>y %all r$uce or waive ! am\nt "u subp>agraph 7,a7 ) respect to a "p ,b rebatable drug t is describ$ z curr5tly 9 %ortage on ! %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( a biosimil> biological product1 :5 ! ,secret>y det]m9es !re are sev]e supply *a9 disruptions4 7#d7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,9 ! case ( a "p ,b rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,m>* #a1 #bjba1 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! ?ird full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$ & clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#c77;,e7 z if ! ref]5ce to ! la/ mon? ( ! cal5d> qu>t] imm$iately prior to ! cal5d> qu>t] beg9n+ ,octob] #a1 #bjba "u su* p>agraph 7 a ref]5ce to ! fir/ mon? ( ! fir/ full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$4 7,b7 ,timel9e = provision ( rebates = subsequ5tly approv$ drugs ,9 ! case ( a "p ,b rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,m>* #a1 #bjba1 p>agraph 7#a77;,b7 %all be appli$ z if ! ref]5ce to ,july #a1 #bjbc "u su* p>agraph 7 a ref]5ce to ! lat] ( ! #f? full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$ or ,july #a1 #bjbc4 7,c7 ,select$ drugs ,9 ! case ( a "p ,b rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 = a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 9 ! case su* drug is det]m9$ 7pursuant to su* section #aaib7;c77 to no long] be a select$ drug1 beg9n+ ! fir/ cal5d> qu>t] aft] ! price applicability p]iod ) respect to su* drug1 clause 7i7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k qu>t] 7 def9$ "u p>agraph 7#c77;,d7 z ! cal5d> qu>t] beg9n+ ,janu>y #a ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* select$ drug & clause 7ii7 ( p>agraph 7#c77;,c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u p>agraph 7#c77;,e7 z if ! ref]5ce to ! la/ mon? ( ! cal5d> qu>t] imm$iately prior to ! cal5d> qu>t] beg9n+ ,octob] #a1 #bjba "u su* p>agraph 7 a ref]5ce to ! ,m>* ( ! ye> prec$+ su* la/ ye>4 7#e7 ,application to b5efici>y co9surance ,9 ! case ( a "p ,b rebatable drug1 if ! paym5t am\nt describ$ 9 p>agraph 7#c77;,a77ii77,i7 7or1 9 ! case ( a "p ,b rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c771 ! paym5t am\nt describ$ 9 subsection 7b77#a77;,b7 = su* drug7 = a cal5d> qu>t] exce$s ! inflation adju/$ paym5t = su* qu>t]-- 7,a7 9 comput+ ! am\nt ( any co9surance applicable "u ?is "p to an individual to :om su* drug is furni%$1 ! computation ( su* co9surance %all be equal to #bj p]c5t ( ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c77;,c7 = su* "p ,b rebatable drug2 & 7,b7 ! am\nt ( su* co9surance = su* cal5d> qu>t]1 z comput$ "u subp>agraph 7,a71 %all be appli$ z a p]c5t1 z det]m9$ by ! ,secret>y1 to ! paym5t am\nt t w\ld o!rwise apply "u subp>agraph 7,b7 or 7,c7 ( subsection 7b77#a74 7#f7 ,rebate deposits ,am\nts paid z rebates "u p>agraph 7#a77;,b7 %all be deposit$ into ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 7#g7 ,civil money p5alty ,if a manufactur] ( a "p ,b rebatable drug has fail$ to comply ) ! requirem5ts "u p>agraph 7#a77;,b7 = su* drug = a cal5d> qu>t]1 ! manufactur] %all be subject to1 9 accordance ) a process e/abli%$ by ! ,secret>y pursuant to regulations1 a civil money p5alty 9 an am\nt equal to at lea/ #abe p]c5t ( ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* cal5d> qu>t]4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 2 & 7#b7 9 subsection 7i71 z r$esignat$ by p>agraph 7#a7-- 7,a7 9 p>agraph 7#d71 by /rik+ at ! end &2 7,b7 9 p>agraph 7#e71 by /rik+ at ! end ! p]iod & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+ new p>agraphs3 7#f7 ! det]m9ation ( units "u subsection 7h72 7#g7 ! det]m9ation ( :e!r a drug is a "p ,b rebatable drug "u subsection 7h72 7#h7 ! calculation ( ! rebate am\nt "u subsection 7h72 7#i7 ! computation ( co9surance "u subsection 7h77#e72 & 7#aj7 ! computation ( am\nts paid "u section #ahcc7;a77#a77;,,ee74 4 7b7 ,am\nts payable2 co/-,%>+ ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 9 subp>agraph 7,g71 by ins]t+ 1 subject to subsection 7i77#i71 aft] ! am\nts paid2 7,b7 9 subp>agraph 7,s71 by /rik+ ) respect to & ins]t+ subject to subp>agraph 7,,ee71 ) respect to2 7,c7 by /rik+ & 7,,dd7 & ins]t+ 7,,dd72 & 7,d7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,ee7 ) respect to a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahdg;,a7h77 = :i* ! paym5t am\nt = a cal5d> qu>t] "u p>agraph 7#c77;,a77ii77,i7 ( su* section 7or1 9 ! case ( a "p ,b rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 = :i*1 ! paym5t am\nt describ$ 9 section #ahdg;,a7b77#a77;,b77 = su* drug = su* qu>t] exce$s ! inflation-adju/$ paym5t "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* qu>t]1 ! am\nts paid %all be equal to ! p]c5t ( ! paym5t am\nt "u p>agraph 7#c77;,a77ii77,i7 ( su* section or section #ahdg;,a7b77#a77;,b71 z applicable1 t equals ! diff]5ce betwe5 7i7 #ajj p]c5t1 & 7ii7 ! p]c5t appli$ "u section #ahdg;,a7h77#e77;,b72 7#b7 9 subsection 7i71 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,9 ! case ( a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahdg;,a7h77 = :i* paym5t "u ?is subsection is n packag$ into a paym5t = a s]vice furni%$ on or aft] ,july #a1 #bjbc1 "u ! revis$ paym5t sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahdg;,a7h77#e7 & p>agraph 7#a77;,,ee7 ( subsection 7a71 %all1 z det]m9$ appropriate by ! ,secret>y1 apply "u ?is subsection 9 ! same mann] z su* provisions ( section #ahdg;,a7h77#e7 & subsection 7a7 apply "u su* section & subsection4 2 & 7#c7 9 subsection 7t77#h71 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,"p ,b rebatable drugs ,9 ! case ( a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahdg;,a7h71 except if su* drug does n h a copaym5t am\nt z a result ( application ( subp>agraph 7,e77 = :i* paym5t "u ?is "p is n packag$ into a paym5t = a cov]$ ,,opd s]vice 7or gr\p ( s]vices7 furni%$ on or aft] ,july #a1 #bjbc1 & ! paym5t = su* drug "u ?is subsection is ! same z ! am\nt = a cal5d> qu>t] "u p>agraph 7#c77;,a77ii77,i7 ( section #ahdg;,a7h71 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( ! copaym5t am\nt & ! am\nt ( paym5t o!rwise applicable "u ?is subsection 7o!r ?an ! application ( ! limitation describ$ 9 subp>agraph 7,c771 ! provisions ( section #ahdg;,a7h77#e7 & p>agraph 7#a77;,,ee7 ( subsection 7a71 %all1 z det]m9$ appropriate by ! ,secret>y1 apply "u ?is subsection 9 ! same mann] z su* provisions ( section #ahdg;,a7h77#e7 & subsection 7a7 apply "u su* section & subsection4 4 7c7 ,con=m+ am5dm5ts 7#a7 ,to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is am5d$ by ins]t+ subsection 7h7 or be=e section #aibg4 7#b7 ,exclud+ "p ,b drug inflation rebate f be/ price ,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+ or section #ahdg;,a7h7 aft] ?is section4 7#c7 ,coord9ation ) ,m$icaid rebate in=mation disclosure ,section #aibg7;b77#c77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i77 is am5d$ by ins]t+ & ! rebate aft] ! paym5t am\nt4 7#d7 ,exclud+ "p ,b drug inflation rebates f av]age manufactur] price ,section #aibg7k77#a77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i771 z previ\sly am5d$1 is fur!r am5d$-- 7,a7 9 subclause 7,,iv71 by /rik+ &2 7,b7 9 subclause 7,v71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,c7 by add+ at ! end ! foll[+ new subclause3 7,,vi7 rebates paid by manufactur]s "u section #ahdg;,a7h72 & 4 7d7 ,fund+ ,9 addition to am\nts o!rwise available1 !re are appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #ab1ejj1jjj = fiscal ye> #bjbb & #g1ejj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjca1 to rema9 available until exp5d$1 to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is section4 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s 7a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,a 7#db ,u4,s4,c4 #aciew-#aad;a7 ! foll[+ new section3 #ahfj;,d-#ad;,b4 ,manufactur] rebate = c]ta9 drugs ) prices increas+ fa/] ?an inflation 7a7 ,requirem5ts 7#a7 ,secret>ial provision ( in=mation ,n lat] ?an #i mon?s aft] ! end ( ea* applicable ye> 7z def9$ 9 subsection 7g77#g771 subject to p>agraph 7#c71 ! ,secret>y %all1 = ea* "p ,d rebatable drug1 report to ea* manufactur] ( su* "p ,d rebatable drug ! foll[+ = su* ye>3 7,a7 ,! am\nt 7if any7 ( ! excess annual manufactur] price increase describ$ 9 subsection 7b77#a77;,a77ii7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7,b7 ,! rebate am\nt specifi$ "u subsection 7b7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7#b7 ,manufactur] requirem5ts ,= ea* applicable ye>1 ! manufactur] ( a "p ,d rebatable drug1 = ea* dosage =m & /r5g? ) respect to su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation describ$ 9 p>agraph 7#a7 = su* ye>1 %all provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 subsection 7b7 = su* dosage =m & /r5g? ) respect to su* drug = su* ye>4 7#c7 ,transition rule = report+ ,! ,secret>y may1 = ea* rebatable cov]$ "p ,d drug1 delay ! timeframe = report+ ! in=mation & rebate am\nt describ$ 9 subp>agraphs 7,a7 & 7,b7 ( su* p>agraph = ! applicable ye> ( #bjbc until n lat] ?an ,septemb] #cj1 #bjbe4 7b7 ,rebate am\nt 7#a7 ,9 g5]al 7,a7 ,calculation ,= purposes ( ?is section1 ! am\nt specifi$ 9 ?is subsection = a dosage =m & /r5g? ) respect to a "p ,d rebatable drug & applicable ye> is1 subject to subp>agraph 7,c71 p>agraph 7#e77;,b71 & p>agraph 7#f71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraph 7,b7 ( ?is p>agraph1 ! 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* ye>2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! annual manufactur] price 7z det]m9$ 9 p>agraph 7#b77 paid = su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug = ! ye>2 exce$s 7,,ii7 ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c7 = su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug = ! ye>4 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 ye>1 ! 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;,a7h74 7,c7 ,exemption = %ortages & sev]e supply *a9 disruptions ,! ,secret>y %all r$uce or waive ! am\nt "u subp>agraph 7,a7 ) respect to a "p ,d rebatable drug t is describ$ z curr5tly 9 %ortage on ! %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( a g5]ic drug1 :5 ! ,secret>y det]m9es !re are sev]e supply *a9 disruptions4 7#b7 ,det]m9ation ( annual manufactur] price ,! annual manufactur] price det]m9$ "u ?is p>agraph = a dosage =m & /r5g?1 ) respect to a "p ,d rebatable drug & an applicable ye>1 is ! sum ( ! products (-- 7,a7 ! av]age manufactur] price 7z def9$ 9 subsection 7g77#f77 ( su* dosage =m & /r5g?1 z calculat$ = a unit ( su* drug1 ) respect to ea* ( ! cal5d> qu>t]s ( su* ye>2 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? report$ "u section #aibg ) respect to ea* su* cal5d> qu>t] ( su* ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? report$ "u section #aibg ) respect to su* ye>1 z det]m9$ by ! ,secret>y4 7#c7 ,det]m9ation ( inflation-adju/$ paym5t am\nt ,! inflation-adju/$ paym5t am\nt det]m9$ "u ?is p>agraph = a dosage =m & /r5g? ) respect to a "p ,d rebatable drug = an applicable ye>1 subject to p>agraph 7#e71 is-- 7,a7 ! b5*m>k ye> manufactur] price det]m9$ "u p>agraph 7#d7 = su* dosage =m & /r5g? ) respect to su* drug & ye>2 increas$ by 7,b7 ! p]c5tage by :i* ! applicable ye> ,,cpi-,u 7z def9$ 9 subsection 7g77#e77 = ! ye> exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subsection 7g77#d774 7#d7 ,det]m9ation ( b5*m>k ye> manufactur] price ,! b5*m>k ye> manufactur] price det]m9$ "u ?is p>agraph = a dosage =m & /r5g?1 ) respect to a "p ,d rebatable drug & an applicable ye>1 is ! sum ( ! products (-- 7,a7 ! av]age manufactur] price 7z def9$ 9 subsection 7g77#f77 ( su* dosage =m & /r5g?1 z calculat$ = a unit ( su* drug1 ) respect to ea* ( ! cal5d> qu>t]s ( ! paym5t am\nt b5*m>k ye> 7z def9$ 9 subsection 7g77#c772 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units report$ "u section #aibg ( su* dosage =m & /r5g? ) respect to ea* su* cal5d> qu>t] ( su* paym5t am\nt b5*m>k ye>2 to 7ii7 ! total numb] ( units report$ "u section #aibg ( su* dosage =m & /r5g? ) respect to su* paym5t am\nt b5*m>k ye>4 7#e7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,9 ! case ( a "p ,d rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,octob] #a1 #bjba1 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#d7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k ye> 7 def9$ "u subsection 7g77#c7 z ! fir/ cal5d> ye> beg9n+ aft] ! day on :i* ! drug 0 fir/ m>ket$ by any manufactur] & subp>agraph 7,b7 ( p>agraph 7#c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u subsection 7g77#d7 z if ! ref]5ce to ! mon? imm$iately prior to ,octob] #bjba "u su* subsection 7 a ref]5ce to ,janu>y ( ! fir/ ye> beg9n+ aft] ! date on :i* ! drug 0 fir/ m>ket$ by any manufactur]4 7,b7 ,treatm5t ( new =mulations 7i7 ,9 g5]al ,9 ! case ( a "p ,d rebatable drug t is a l9e ext5sion ( a "p ,d rebatable drug t is an oral solid dosage =m1 ! ,secret>y %all e/abli% a =mula = det]m9+ ! rebate am\nt "u p>agraph 7#a7 & ! inflation adju/$ paym5t am\nt "u p>agraph 7#c7 ) respect to su* "p ,d rebatable drug & an applicable ye>1 consi/5t ) ! =mula appli$ "u subsection 7c77#b77;,c7 ( section #aibg = det]m9+ a rebate obligation = a rebate p]iod "u su* section4 7ii7 ,l9e ext5sion def9$ ,9 ?is subp>agraph1 ! t]m l9e ext5sion means1 ) respect to a "p ,d rebatable drug1 a new =mulation ( ! drug1 su* z an ext5d$ release =mulation1 b does n include an abuse-det]r5t =mulation ( ! drug 7z det]m9$ by ! ,secret>y71 reg>dless ( :e!r su* abuse-det]r5t =mulation is an ext5d$ release =mulation4 7,c7 ,select$ drugs ,9 ! case ( a "p ,d rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 = a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 9 ! case su* drug is det]m9$ 7pursuant to su* section #aaib7;c77 to no long] be a select$ drug1 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod ) respect to su* drug1 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#d7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k ye> 7 def9$ "u subsection 7g77#c7 z ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* select$ drug & subp>agraph 7,b7 ( p>agraph 7#c7 %all be appli$ z if ! t]m b5*m>k p]iod ,,cpi-,u 7 def9$ "u subsection 7g77#d7 z if ! ref]5ce to ! mon? imm$iately prior to ,octob] #a1 #bjba "u su* subsection 7 a ref]5ce to ,janu>y ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* drug4 7#f7 ,reconciliation 9 case ( revis$ ,,amp reports ,! ,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* drug1 ! ,secret>y det]m9es1 pursuant to su* revisions1 adju/m5ts1 if any1 to ! calculation ( ! am\nt specifi$ 9 ?is subsection = a dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & an applicable ye> & reconciles any ov]paym5ts or und]paym5ts 9 am\nts paid z rebates "u ?is subsection4 ,any id5tifi$ und]paym5t %all be rectifi$ by ! manufactur] n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( in=mation on su* und]paym5t4 7c7 ,rebate deposits ,am\nts paid z rebates "u subsection 7b7 %all be deposit$ into ! ,m$ic>e ,prescription ,drug ,acc\nt 9 ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund e/abli%$ "u section #ahda4 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 7e7 ,civil money p5alty ,if a manufactur] ( a "p ,d rebatable drug has fail$ to comply ) ! requirem5t "u subsection 7a77#b7 ) respect to su* drug = an applicable ye>1 ! manufactur] %all be subject to1 9 accordance ) a process e/abli%$ by ! ,secret>y pursuant to regulations1 a civil money p5alty 9 an am\nt equal to #abe p]c5t ( ! am\nt specifi$ 9 subsection 7b7 = su* drug = su* ye>4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 7) respect to am\nts ( p5alties or additional assessm5ts7 & 7b77 %all apply to a civil money p5alty "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7f7 ,no adm9i/rative or judicial review ,!re %all be no adm9i/rative or judicial review ( ! foll[+3 7#a7 ,! det]m9ation ( units "u ?is section4 7#b7 ,! det]m9ation ( :e!r a drug is a "p ,d rebatable drug "u ?is section4 7#c7 ,! calculation ( ! rebate am\nt "u ?is section4 7g7 ,def9itions ,9 ?is section3 7#a7 ,"p ,d rebatable drug 7,a7 ,9 g5]al ,! t]m "p ,d rebatable drug means a drug or biological t w\ld 7)\t application ( ?is section7 be a cov]$ "p ,d drug1 except su* t]m %all1 ) respect to an applicable ye>1 n include su* a drug or biological if ! av]age annual total co/ "u ?is "p = su* ye> p] individual :o uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 is less ?an1 subject to subp>agraph 7,b71 #ajj1 z det]m9$ by ! ,secret>y us+ ! mo/ rec5t data available or1 if data is n available1 z e/imat$ by ! ,secret>y4 7,b7 ,increase ,! doll> am\nt appli$ "u subp>agraph 7,a7-- 7i7 = #bjbd1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbc1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod beg9n+ ) ,janu>y ( #bjbc2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod beg9n+ ) ,janu>y ( ! previ\s ye>4 ,any doll> am\nt specifi$ "u ?is subp>agraph t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 7#b7 ,unit ,! t]m unit means1 ) respect to a "p ,d rebatable drug1 ! l[e/ disp5sable am\nt 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! "p ,d rebatable drug1 z report$ "u section #aibg4 7#c7 ,paym5t am\nt b5*m>k ye> ,! t]m paym5t am\nt b5*m>k ye> means ! ye> end+ 9 ! mon? imm$iately prior to ,octob] #a1 #bjba4 7#d7 ,b5*m>k p]iod ,,cpi-,u ,! t]m b5*m>k p]iod ,,cpi-,u means ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! mon? imm$iately prior to ,octob] #bjba4 7#e7 ,applicable ye> ,,cpi-,u ,! t]m applicable ye> ,,cpi-,u means1 ) respect to an applicable ye>1 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ,janu>y ( su* ye>4 7#f7 ,av]age manufactur] price ,! t]m av]age manufactur] price has ! mean+1 ) respect to a "p ,d rebatable drug ( a manufactur]1 giv5 su* t]m 9 section #aibg7k77#a71 ) respect to a cov]$ outpati5t drug ( a manufactur] = a rebate p]iod "u section #aibg4 7#g7 ,applicable ye> ,! t]m applicable ye> means a cal5d> ye> beg9n+ ) #bjbc4 7h7 ,implem5tation = #bjbc & #bjbd ,not)/&+ any o!r provision ( ?is section1 ! ,secret>y %all implem5t ?is section = #bjbc & #bjbd by program in/ruction or o!rwise4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c771 z am5d$ by section #bja7;c77#a71 is fur!r am5d$ by /rik+ subsection 7h7 or section #aibg & ins]t+ subsection 7h71 section #aibg1 or section #ahfj;,d-#ad;,b4 7#b7 ,exclud+ "p ,d drug inflation rebate f be/ price ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i771 z am5d$ by section #bja7;c77#b71 is fur!r am5d$ by /rik+ or section #ahdg;,a7h7 & ins]t+ 1 section #ahdg;,a7h71 or section #ahfj;,d-#ad;,b4 7#c7 ,coord9ation ) ,m$icaid rebate in=mation disclosure ,section #aibg7;b77#c77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i771 z am5d$ by section #bja7;c77#c71 is fur!r am5d$ by /rik+ or to c>ry out section #ahdg;,b & ins]t+ or to c>ry out section #ahdg;,b or section #ahfj;,d-#ad;,b4 7#d7 ,exclud+ "p ,d drug inflation rebates f av]age manufactur] price ,section #aibg7k77#a77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i771 z previ\sly am5d$1 is fur!r am5d$ by add+ at ! end ! foll[+ new subclause3 7,,vii7 rebates paid by manufactur]s "u section #ahfj;,d-#ad;,b4 4 7c7 ,fund+ ,9 addition to am\nts o!rwise available1 !re are appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #ab1ejj1jjj = fiscal ye> #bjbb & #g1ejj1jjj = ea* ( fiscal ye>s #bjbc ?r\gh #bjca1 to rema9 available until exp5d$1 to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is section4 ,,iii ,"p ,d ,improvem5ts & ,maximum ,out-(-,pocket ,cap = ,m$ic>e ,b5efici>ies #cja4 ,m$ic>e "p ,d b5efit r$esign 7a7 ,b5efit /ructure r$esign ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbd & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbd & ea* subsequ5t ye> aft] p>agraph 7#c72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbd1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ ?r\gh #bjbc2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbd1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjai ?r\gh #bjbc2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjbc2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbd1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjbc2 & 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i7-- 7,i7 by r$esignat+ subclauses 7,i7 & 7,,ii7 z items 7aa7 & 7bb71 respectively1 & mov+ ! m>g9 ( ea* su* r$esignat$ item #b ems to ! "r2 7,,ii7 9 ! matt] prec$+ item 7aa71 z r$esignat$ by subclause 7,i71 by /rik+ is equal to ! great] (-- & ins]t+ 8is equal to-- 7,i7 = a ye> prec$+ #bjbd1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbd & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii7-- 7,i7 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 & 7,,ii7 by add+ at ! end ! foll[+ new s5t5ce3 ,! ,secret>y %all cont9ue to calculate ! doll> am\nts specifi$ 9 clause 7i77,i77aa71 includ+ ) ! adju/m5t "u ?is clause1 aft] #bjbc = purposes ( section #ahfj;,d-#ad7;a77#a77;,d77iii742 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 9 subclause 7,v71 by /rik+ or at ! end2 7,,ii7 9 subclause 7,,vi7-- 7aa7 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjba ?r\gh #bjbc2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbd1 is equal to #b1jjj2 or 7,,viii7 = a subsequ5t ye>1 is equal to ! am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = ! ye> involv$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ &1 = a ye> prec$+ #bjbd1 = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( ye>s #bjaa ?r\gh #bjbc1 9 apply+4 7b7 ,re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 by /rik+ equal to #hj p]c5t & ins]t+ 8equal to-- 7,a7 = a ye> prec$+ #bjbd1 #hj p]c5t 2 7,b7 9 subp>agraph 7,a71 z add$ by subp>agraph 7,a71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 = #bjbd & ea* subsequ5t ye>1 ! sum (-- 7i7 an am\nt equal to #bj p]c5t ( su* all[able re9surance co/s attributable to t portion ( gross prescription drug co/s z specifi$ 9 p>agraph 7#c7 incurr$ 9 ! cov]age ye> aft] su* individual has incurr$ co/s t exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 ) respect to applicable drugs 7z def9$ 9 section #ahfj;,d-#ad;,c7g77#b772 & 7ii7 an am\nt equal to #dj p]c5t ( su* all[able re9surance co/s attributable to t portion ( gross prescription drug co/s z specifi$ 9 p>agraph 7#c7 incurr$ 9 ! cov]age ye> aft] su* individual has incurr$ co/s t exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b7 ) respect to cov]$ "p ,d drugs t are n applicable drugs 7z s def9$74 2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ ,,co/s4--,= purposes & ins]t+ ,co/s4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 = purposes 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,inclusion ( manufactur] disc\nts on applicable drugs ,= purposes ( apply+ subp>agraph 7,a71 ! t]m all[able re9surance co/s %all include ! portion ( ! negotiat$ price 7z def9$ 9 section #ahfj;,d-#ad;,c7g77#f77 ( an applicable drug 7z def9$ 9 section #ahfj;,d-#ad;,c7g77#b77 t 0 paid by a manufactur] "u ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c4 2 & 7#c7 9 p>agraph 7#c7-- 7,a7 9 ! fir/ s5t5ce1 by /rik+ ,= purposes & ins]t+ ,subject to p>agraph 7#b77;,b71 = purposes2 & 7,b7 9 ! second s5t5ce1 by ins]t+ 7or1 ) respect to #bjbd & subsequ5t ye>s1 9 ! case ( an applicable drug1 z def9$ 9 section #ahfj;,d-#ad;,c7g77#b71 by a manufactur]7 aft] by ! individual or "u ! plan4 7c7 ,r$uc$ co/-,%>+2 b5efici>y premium p]c5tage 7#a7 ,co/-%>+ 7,a7 ,9 g5]al ,section #ahfj;,d-#b7;b77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b77;,a77 is am5d$-- 7i7 9 ! subp>agraph head]1 by /rik+ #be p]c5t co9surance & ins]t+ ,co9surance2 7ii7 9 clause 7i71 by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #bc p]c5t7 aft] #be p]c5t2 & 7iii7 9 clause 7ii71 by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #bc p]c5t7 aft] #be p]c5t4 7,b7 ,con=m+ am5dm5t ,section #ahfj;,d-#ad7;a77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#b77;,d77 is am5d$ by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 in/ead ( co9surance ( #bc p]c5t7 aft] in/ead ( co9surance ( #be p]c5t4 7#b7 ,b5efici>y premium p]c5tage 7,a7 ,9 g5]al ,section #ahfj;,d-#ac7;a77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aac7;a77#c77;,a77 is am5d$ by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #bc4e p]c5t7 aft] #be4e p]c5t4 7,b7 ,con=m+ am5dm5ts 7i7 ,section #ahfj;,d-#aa7;g77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;g77#f77 is am5d$ by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #bc4e p]c5t7 aft] #be4e p]c5t4 7ii7 ,section #ahfj;,d-#ac7;a77#g77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aac7;a77#g77;,b77i77 is am5d$-- 7,i7 9 subclause 7,i71 by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #bc4e p]c5t7 aft] #be4e p]c5t2 & 7,,ii7 9 subclause 7,,ii71 by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #bc4e p]c5t7 aft] #be4e p]c5t4 7iii7 ,section #ahfj;,d-#ae7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;a77 is am5d$ by ins]t+ 7or1 = #bjbd & ea* subsequ5t ye>1 #gf4e p]c5t7 aft] #gd4e p]c5t4 7d7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja ?r\gh #db ,u4,s4,c4 #aciew-#aec71 z am5d$ by section #bjb1 is fur!r am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,b ! foll[+ new sections3 #ahfj;,d-#ad;,c4 ,manufactur] disc\nt program 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a manufactur] disc\nt program 79 ?is section ref]r$ to z ! program74 ,"u ! program1 ! ,secret>y %all ent] into agreem5ts describ$ 9 subsection 7b7 ) manufactur]s & provide = ! p]=mance ( ! duties describ$ 9 subsection 7c74 ,! ,secret>y %all e/abli% a model agreem5t = use "u ! program by n lat] ?an ,janu>y #a1 #bjbc1 9 consultation ) manufactur]s1 & all[ = comm5t on su* model agreem5t4 7b7 ,t]ms ( agreem5t 7#a7 ,9 g5]al 7,a7 ,agreem5t ,an agreem5t "u ?is section %all require ! manufactur] to provide1 9 accordance ) ?is section1 disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ to applicable b5efici>ies on or aft] ,janu>y #a1 #bjbd4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+-- 7i7 ! application ( a co9surance ( #bc p]c5t ( ! negotiat$ price1 z appli$ "u p>agraph 7#b77;,a7 ( section #ahfj;,d-#b7;b71 = co/s describ$ 9 su* p>agraph2 or 7ii7 ! application ( ! copaym5t am\nt describ$ 9 p>agraph 7#d77;,a7 ( su* section1 ) respect to co/s describ$ 9 su* p>agraph4 7,c7 ,tim+ ( agreem5t 7i7 ,special rule = #bjbd ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to ! p]iod beg9n+ on ,janu>y #a1 #bjbd1 & end+ on ,decemb] #ca1 #bjbd1 ! manufactur] %all ent] into su* agreem5t n lat] ?an #cj days aft] ! date ( ! e/abli%m5t ( a model agreem5t "u subsection 7a74 7ii7 #bjbe & subsequ5t ye>s ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to plan ye> #bjbe or a subsequ5t plan ye>1 ! manufactur] %all ent] into su* agreem5t n lat] ?an a cal5d> qu>t] or semi-annual deadl9e e/abli%$ by ! ,secret>y4 7#b7 ,provision ( appropriate data ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all collect & h available appropriate data1 z det]m9$ by ! ,secret>y1 to ensure t x c demon/rate to ! ,secret>y compliance ) ! requirem5ts "u ! program4 7#c7 ,compliance ) requirem5ts = adm9i/ration ( program ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all comply ) requirem5ts impos$ by ! ,secret>y or a ?ird p>ty ) a contract "u subsection 7d77#c71 z applicable1 = purposes ( adm9i/]+ ! program1 includ+ any det]m9ation "u subp>agraph 7,a7 ( subsection 7c77#a7 or proc$ures e/abli%$ "u su* subsection 7c77#a74 7#d7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section %all be effective = an initial p]iod ( n less ?an #ab mon?s & %all be automatically r5ew$ = a p]iod ( n less ?an #a ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ! ,secret>y ,! ,secret>y %all provide = t]m9ation ( an agreem5t "u ?is section = a kn[+ & willful violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice to ! manufactur] ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 & su* he>+ %all take place prior to ! effective date ( ! t]m9ation ) suffici5t "t = su* effective date to be repeal$ if ! ,secret>y det]m9es appropriate4 7ii7 ,by a manufactur] ,a manufactur] may t]m9ate an agreem5t "u ?is section = any reason4 ,any su* t]m9ation %all be effective1 ) respect to a plan ye>-- 7,i7 if ! t]m9ation occurs be=e ,janu>y #ca ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #ca ( a plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7iii7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is subp>agraph %all n affect disc\nts = applicable drugs ( ! manufactur] t are due "u ! agreem5t be=e ! effective date ( its t]m9ation4 7iv7 ,notice to ?ird p>ty ,! ,secret>y %all provide notice ( su* t]m9ation to a ?ird p>ty ) a contract "u subsection 7d77#c7 )9 n less ?an #cj days be=e ! effective date ( su* t]m9ation4 7c7 ,duties describ$ ,! duties describ$ 9 ?is subsection are ! foll[+3 7#a7 ,adm9i/ration ( program ,adm9i/]+ ! program1 includ+-- 7,a7 ! det]m9ation ( ! am\nt ( ! disc\nt$ price ( an applicable drug ( a manufactur]2 7,b7 ! e/abli%m5t ( proc$ures to ensure t1 n lat] ?an ! applicable numb] ( cal5d> days aft] ! disp5s+ ( an applicable drug by a ph>macy or mail ord] s]vice1 ! ph>macy or mail ord] s]vice is reimburs$ = an am\nt equal to ! diff]5ce betwe5-- 7i7 ! negotiat$ price ( ! applicable drug2 & 7ii7 ! disc\nt$ price ( ! applicable drug2 7,c7 ! e/abli%m5t ( proc$ures to ensure t ! disc\nt$ price = an applicable drug "u ?is section is appli$ be=e any cov]age or f9ancial assi/ance "u o!r heal? b5efit plans or programs t provide cov]age or f9ancial assi/ance = ! pur*ase or provision ( prescription drug cov]age on behalf ( applicable b5efici>ies z specifi$ by ! ,secret>y2 & 7,d7 provid+ a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 applicable b5efici>ies1 & ! ?ird p>ty ) a contract "u subsection 7d77#c74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,secret>y %all monitor compliance by a manufactur] ) ! t]ms ( an agreem5t "u ?is section4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7d77#c7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u subsection 7e74 7#c7 ,collection ( data f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans & ,,ma-,,pd plans 9 a timeframe t all[s = disc\nt$ prices to be provid$ = applicable drugs "u ?is section4 7d7 ,adm9i/ration 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! ,secret>y %all provide = ! implem5tation ( ?is section1 includ+ ! p]=mance ( ! duties describ$ 9 subsection 7c74 7#b7 ,limitation ,9 provid+ = ! implem5tation ( ?is section1 ! ,secret>y %all n receive or di/ribute any funds ( a manufactur] "u ! program4 7#c7 ,contract ) ?ird p>ties ,! ,secret>y %all ent] into a contract ) #a or m ?ird p>ties to adm9i/] ! requirem5ts e/abli%$ by ! ,secret>y 9 ord] to c>ry out ?is section4 ,at a m9imum1 ! contract ) a ?ird p>ty "u ! prec$+ s5t5ce %all require t ! ?ird p>ty-- 7,a7 receive & transmit in=mation betwe5 ! ,secret>y1 manufactur]s1 & o!r individuals or entities ! ,secret>y det]m9es appropriate2 7,b7 receive1 di/ribute1 or facilitate ! di/ribution ( funds ( manufactur]s to appropriate individuals or entities 9 ord] to meet ! obligations ( manufactur]s "u agreem5ts "u ?is section2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is section1 z necess>y = ! manufactur] to fulfill its obligations "u ?is section2 & 7,d7 p]mit manufactur]s to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ by ! ?ird p>ty to det]m9e disc\nts = applicable drugs ( ! manufactur] "u ! program4 7#d7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#c7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is section4 7#e7 ,implem5tation ,! ,secret>y %all implem5t ! program "u ?is section = #bjbd & #bjbe by program in/ruction or o!rwise4 7e7 ,en=cem5t 7#a7 ,audits ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all be subject to p]iodic audit by ! ,secret>y4 7#b7 ,civil money p5alty 7,a7 ,9 g5]al ,a manufactur] t fails to provide disc\nt$ prices = applicable drugs ( ! manufactur] disp5s$ to applicable b5efici>ies 9 accordance ) su* agreem5t %all be subject to a civil money p5alty = ea* su* failure 9 an am\nt ! ,secret>y det]m9es is equal to ! sum (-- 7i7 ! am\nt t ! manufactur] w\ld h paid ) respect to su* disc\nts "u ! agreem5t1 :i* w !n be us$ to pay ! disc\nts :i* ! manufactur] _h fail$ to provide2 & 7ii7 #be p]c5t ( su* am\nt4 7,b7 ,application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7f7 ,cl>ification reg>d+ availability ( o!r cov]$ "p ,d drugs ,no?+ 9 ?is section %all prev5t an applicable b5efici>y f pur*as+ a cov]$ "p ,d drug t is n an applicable drug 7includ+ a g5]ic drug or a drug t is n on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 974 7g7 ,def9itions ,9 ?is section3 7#a7 ,applicable b5efici>y ,! t]m applicable b5efici>y means an individual :o1 on ! date ( disp5s+ a cov]$ "p ,d drug-- 7,a7 is enroll$ 9 a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is n enroll$ 9 a qualifi$ retiree prescription drug plan2 & 7,c7 has incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c7 z if clause 7iii7 ( su* section includ$ a ref]5ce to co/s reimburs$ ?r\gh insurance1 a gr\p heal? plan1 or c]ta9 o!r ?ird-p>ty paym5t arrangem5ts1 = cov]$ "p ,d drugs 9 ! ye> t exce$-- 7i7 9 ! case ( an individual n describ$ 9 clause 7ii7 or 7iii71 ! annual d$uctible = su* ye>1 z specifi$ 9 section #ahfj;,d-#b7;b77#a72 7ii7 9 ! case ( a subsidy eligible individual describ$ 9 section #ahfj;,d-#ad7;a77#a71 ! annual d$uctible = su* ye>1 z specifi$ 9 subp>agraph 7,b7 ( su* section2 & 7iii7 9 ! case ( a subsidy eligible individual describ$ 9 section #ahfj;,d-#ad7;a77#b71 ! annual d$uctible = su* ye>1 z specifi$ 9 subp>agraph 7,b7 ( su* section4 7#b7 ,applicable drug ,! t]m applicable drug1 ) respect to an applicable b5efici>y-- 7,a7 means a cov]$ "p ,d drug-- 7i7 approv$ "u a new drug application "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or1 9 ! case ( a biologic product1 lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 7,i7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan uses a =mul>y1 :i* is on ! =mul>y ( ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 7,,ii7 if ! ,,pdp sponsor ( ! prescription drug plan or ! ,,ma organization (f]+ ! ,,ma-,,pd plan does n use a =mul>y1 = :i* b5efits are available "u ! prescription drug plan or ,,ma-,,pd plan t ! applicable b5efici>y is enroll$ 92 or 7,,iii7 is provid$ ?r\gh an exception or appeal2 & 7,b7 does n include a select$ drug 7z ref]r$ to "u section #aaib7;c77 dur+ a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b77 ) respect to su* drug4 7#c7 ,applicable numb] ( cal5d> days ,! t]m applicable numb] ( cal5d> days means-- 7,a7 ) respect to claims = reimbursem5t submitt$ electronically1 #ad days2 & 7,b7 ) respect to claims = reimbursem5t submitt$ o!rwise1 #cj days4 7#d7 ,disc\nt$ price 7,a7 ,9 g5]al ,! t]m disc\nt$ price means1 subject to subp>agraphs 7,b7 & 7,c71 ) respect to an applicable drug ( a manufactur] disp5s$ dur+ a ye> to an applicable b5efici>y-- 7i7 :o has n incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>1 #ij p]c5t ( ! negotiat$ price ( su* drug2 & 7ii7 :o has incurr$ su* co/s1 z s det]m9$1 9 ! ye> t are equal to or exce$ su* ?re%old = ! ye>1 #hj p]c5t ( ! negotiat$ price ( su* drug4 7,b7 ,phase-9 = c]ta9 drugs disp5s$ to ,,lis b5efici>ies 7i7 ,9 g5]al ,9 ! case ( an applicable drug ( a specifi$ manufactur] 7z def9$ 9 clause 7ii77 t is m>ket$ z ( ! date ( enactm5t ( ?is subp>agraph & disp5s$ = an applicable b5efici>y :o is a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c771 ! t]m disc\nt$ price means ! specifi$ ,,lis p]c5t 7z def9$ 9 clause 7iii77 ( ! negotiat$ price ( ! applicable drug ( ! manufactur]4 7ii7 ,specifi$ manufactur] 7,i7 ,9 g5]al ,9 ?is subp>agraph1 subject to subclause 7,,ii71 ! t]m specifi$ manufactur] means a manufactur] ( an applicable drug = :i*1 9 #bjba-- 7aa7 ! manufactur] _h a cov]age gap disc\nt agreem5t "u section #ahfj;,d-#ad;,a2 7bb7 ! total exp5ditures = all ( ! specifi$ drugs ( ! manufactur] cov]$ by su* agreem5t or agreem5ts = su* ye> & cov]$ "u ?is "p dur+ su* ye> repres5t$ less ?an #a4j p]c5t ( ! total exp5ditures "u ?is "p = all cov]$ ,"p ,d drugs dur+ su* ye>2 & 7cc7 ! total exp5ditures = all ( ! specifi$ drugs ( ! manufactur] t are s+le s\rce drugs & biological products cov]$ "u "p ,b dur+ su* ye> repres5t$ less ?an #a4j p]c5t ( ! total exp5ditures "u "p ,b = all drugs or biological products cov]$ "u su* "p dur+ su* ye>4 7,,ii7 ,specifi$ drugs 7aa7 ,9 g5]al ,= purposes ( ?is clause1 ! t]m specifi$ drug means1 ) respect to a specifi$ manufactur]1 = #bjba1 an applicable drug t is produc$1 prep>$1 propagat$1 comp\nd$1 conv]t$1 or process$ by ! manufactur]4 7bb7 ,aggregation rule ,all p]sons treat$ z a s+le employ] "u subsection 7a7 or 7b7 ( section #eb ( ! ,int]nal ,rev5ue ,code ( #aihf %all be treat$ z "o manufactur] = purposes ( ?is subp>agraph4 ,= purposes ( mak+ a det]m9ation pursuant to ! previ\s s5t5ce1 an agreem5t "u ?is section %all require t a manufactur] provide & atte/ to su* in=mation z specifi$ by ! ,secret>y z necess>y4 7,,iii7 ,limitation ,! t]m specifi$ manufactur] %all n include a manufactur] describ$ 9 subclause 7,i7 if su* manufactur] is acquir$ aft] #bjba by ano!r manufactur] t is n a specifi$ manufactur]1 effective at ! beg9n+ ( ! plan ye> imm$iately foll[+ su* acquisition or1 9 ! case ( an acquisition be=e #bjbd1 effective ,janu>y #a1 #bjbd4 7iii7 ,specifi$ ,,lis p]c5t ,9 ?is subp>agraph1 ! specifi$ ,,lis p]c5t means1 ) respect to a ye>-- 7,i7 = an applicable drug disp5s$ = an applicable b5efici>y describ$ 9 clause 7i7 :o has n incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>-- 7aa7 = #bjbd1 #ii p]c5t2 7bb7 = #bjbe1 #ih p]c5t2 7cc7 = #bjbf1 #ie p]c5t2 7dd7 = #bjbg1 #ib p]c5t2 & 7ee7 = #bjbh & ea* subsequ5t ye>1 #ij p]c5t2 & 7,,ii7 = an applicable drug disp5s$ = an applicable b5efici>y describ$ 9 clause 7i7 :o has incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>-- 7aa7 = #bjbd1 #ii p]c5t2 7bb7 = #bjbe1 #ih p]c5t2 7cc7 = #bjbf1 #ie p]c5t2 7dd7 = #bjbg1 #ib p]c5t2 7ee7 = #bjbh1 #ij p]c5t2 7ff7 = #bjbi1 #he p]c5t2 & 7gg7 = #bjcj & ea* subsequ5t ye>1 #hj p]c5t4 7,c7 ,phase-9 = specifi$ small manufactur]s 7i7 ,9 g5]al ,9 ! case ( an applicable drug ( a specifi$ small manufactur] 7z def9$ 9 clause 7ii77 t is m>ket$ z ( ! date ( enactm5t ( ?is subp>agraph & disp5s$ = an applicable b5efici>y1 ! t]m disc\nt$ price means ! specifi$ small manufactur] p]c5t 7z def9$ 9 clause 7iii77 ( ! negotiat$ price ( ! applicable drug ( ! manufactur]4 7ii7 ,specifi$ small manufactur] 7,i7 ,9 g5]al ,9 ?is subp>agraph1 subject to subclause 7,,iii71 ! t]m specifi$ small manufactur] means a manufactur] ( an applicable drug = :i*1 9 #bjba-- 7aa7 ! manufactur] is a specifi$ manufactur] 7z def9$ 9 subp>agraph 7,b77ii772 & 7bb7 ! total exp5ditures "u "p ,d = any "o ( ! specifi$ small manufactur] drugs ( ! manufactur] t are cov]$ by ! agreem5t or agreem5ts "u section #ahfj;,d-#ad;,a ( su* manufactur] = su* ye> & cov]$ "u ?is "p dur+ su* ye> are equal to or m ?an #hj p]c5t ( ! total exp5ditures "u ?is "p = all specifi$ small manufactur] drugs ( ! manufactur] t are cov]$ by su* agreem5t or agreem5ts = su* ye> & cov]$ "u ?is "p dur+ su* ye>4 7,,ii7 ,specifi$ small manufactur] drugs 7aa7 ,9 g5]al ,= purposes ( ?is clause1 ! t]m specifi$ small manufactur] drugs means1 ) respect to a specifi$ small manufactur]1 = #bjba1 an applicable drug t is produc$1 prep>$1 propagat$1 comp\nd$1 conv]t$1 or process$ by ! manufactur]4 7bb7 ,aggregation rule ,all p]sons treat$ z a s+le employ] "u subsection 7a7 or 7b7 ( section #eb ( ! ,int]nal ,rev5ue ,code ( #aihf %all be treat$ z "o manufactur] = purposes ( ?is subp>agraph4 ,= purposes ( mak+ a det]m9ation pursuant to ! previ\s s5t5ce1 an agreem5t "u ?is section %all require t a manufactur] provide & atte/ to su* in=mation z specifi$ by ! ,secret>y z necess>y4 7,,iii7 ,limitation ,! t]m specifi$ small manufactur] %all n include a manufactur] describ$ 9 subclause 7,i7 if su* manufactur] is acquir$ aft] #bjba by ano!r manufactur] t is n a specifi$ small manufactur]1 effective at ! beg9n+ ( ! plan ye> imm$iately foll[+ su* acquisition or1 9 ! case ( an acquisition be=e #bjbd1 effective ,janu>y #a1 #bjbd4 7iii7 ,specifi$ small manufactur] p]c5t ,9 ?is subp>agraph1 ! t]m specifi$ small manufactur] p]c5t means1 ) respect to a ye>-- 7,i7 = an applicable drug disp5s$ = an applicable b5efici>y :o has n incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>-- 7aa7 = #bjbd1 #ii p]c5t2 7bb7 = #bjbe1 #ih p]c5t2 7cc7 = #bjbf1 #ie p]c5t2 7dd7 = #bjbg1 #ib p]c5t2 & 7ee7 = #bjbh & ea* subsequ5t ye>1 #ij p]c5t2 & 7,,ii7 = an applicable drug disp5s$ = an applicable b5efici>y :o has incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>-- 7aa7 = #bjbd1 #ii p]c5t2 7bb7 = #bjbe1 #ih p]c5t2 7cc7 = #bjbf1 #ie p]c5t2 7dd7 = #bjbg1 #ib p]c5t2 7ee7 = #bjbh1 #ij p]c5t2 7ff7 = #bjbi1 #he p]c5t2 & 7gg7 = #bjcj & ea* subsequ5t ye>1 #hj p]c5t4 7,d7 ,total exp5ditures ,= purposes ( ?is p>agraph1 ! t]m total exp5ditures includes1 9 ! case ( exp5ditures ) respect to "p ,d1 +r$i5t co/s1 disp5s+ fees1 sales tax1 &1 if applicable1 vacc9e adm9i/ration fees4 ,! t]m total exp5ditures excludes1 9 ! case ( exp5ditures ) respect to "p ,b1 exp5ditures = a drug or biological t are bundl$ or packag$ into ! paym5t = ano!r s]vice4 7,e7 ,special case = c]ta9 claims 7i7 ,claims spann+ d$uctible ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall above ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price "u ?is section on only ! portion ( ! negotiat$ price ( ! applicable drug t falls above su* annual d$uctible4 7ii7 ,claims spann+ out-(-pocket ?re%old ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall entirely bel[ or entirely above ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price-- 7,i7 9 accordance ) subp>agraph 7,a77i7 on ! portion ( ! negotiat$ price ( ! applicable drug t falls bel[ su* ?re%old2 & 7,,ii7 9 accordance ) subp>agraph 7,a77ii7 on ! portion ( su* price ( su* drug t falls at or above su* ?re%old4 7#e7 ,manufactur] ,! t]m manufactur] means any entity :i* is engag$ 9 ! production1 prep>ation1 propagation1 comp\nd+1 conv]sion1 or process+ ( prescription drug products1 ei!r directly or indirectly by extraction f sub/ances ( natural orig91 or indep5d5tly by means ( *emical syn!sis1 or by a comb9ation ( extraction & *emical syn!sis4 ,su* t]m does n include a :olesale di/ributor ( drugs or a retail ph>macy lic5s$ "u ,/ate law4 7#f7 ,negotiat$ price ,! t]m negotiat$ price has ! mean+ giv5 su* t]m 9 section #dbc4ajj ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 &1 ) respect to an applicable drug1 su* negotiat$ price %all include any disp5s+ fee &1 if applicable1 any vacc9e adm9i/ration fee = ! applicable drug4 7#g7 ,qualifi$ retiree prescription drug plan ,! t]m qualifi$ retiree prescription drug plan has ! mean+ giv5 su* t]m 9 section #ahfj;,d-#bb7;a77#b74 #ahfj;,d-#ad;,d4 ,select$ drug subsidy program ,) respect to cov]$ "p ,d drugs t w\ld be applicable drugs 7z def9$ 9 section #ahfj;,d-#ad;,c7g77#b77 b = ! application ( subp>agraph 7,b7 ( su* section1 ! ,secret>y %all provide a process :]eby1 9 ! case ( an applicable b5efici>y 7z def9$ 9 section #ahfj;,d-#ad;,c7g77#a77 :o1 ) respect to a ye>1 is enroll$ 9 a prescription drug plan or is enroll$ 9 an ,,ma-,,pd plan1 has n incurr$ co/s t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i71 & is disp5s$ su* a drug ! ,secret>y 7p]iodically & on a timely basis7 provides ! ,,pdp sponsor or ! ,,ma organization (f]+ ! plan1 a subsidy ) respect to su* drug t is equal to #aj p]c5t ( ! negotiat$ price 7z def9$ 9 section #ahfj;,d-#ad;,c7g77#f77 ( su* drug4 4 7#b7 ,sunset ( ,m$ic>e cov]age gap disc\nt program ,section #ahfj;,d-#ad;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is am5d$-- 7,a7 9 subsection 7a71 9 ! fir/ s5t5ce1 by /rik+ ,! ,secret>y & ins]t+ ,subject to subsection 7h71 ! ,secret>y2 & 7,b7 by add+ at ! end ! foll[+ new subsection3 7h7 ,sunset ( program 7#a7 ,9 g5]al ,! program %all n apply ) respect to applicable drugs disp5s$ on or aft] ,janu>y #a1 #bjbd1 &1 subject to p>agraph 7#b71 agreem5ts "u ?is section %all be t]m9at$ z ( su* date4 7#b7 ,cont9u$ application = applicable drugs disp5s$ prior to sunset ,! provisions ( ?is section 7includ+ all responsibilities & duties7 %all cont9ue to apply on & aft] ,janu>y #a1 #bjbd1 ) respect to applicable drugs disp5s$ prior to su* date4 4 7#c7 ,inclusion ( actu>ial value ( manufactur] disc\nts 9 bids ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ 8assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c subtract$ f ! actu>ial value to produce su* bid2 & 2 & 7,b7 9 subsection 7c77#a77;,c7-- 7i7 by /rik+ an actu>ial valuation ( ! re9surance & ins]t+ 8an actu>ial valuation (-- 7i7 ! re9surance 2 7ii7 9 clause 7i71 z ins]t$ by clause 7i7 ( ?is subp>agraph1 by add+ & at ! end2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c2 4 7e7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or1 = a ye> prec$+ #bjbd1 an increase 9 ! initial2 7,b7 9 subsection 7c77#a77;,c7-- 7i7 9 ! subp>agraph head+1 by /rik+ at initial cov]age limit2 & 7ii7 by ins]t+ = a ye> prec$+ #bjbd or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbd & ea* subsequ5t ye> aft] subsection 7b77#c7 = ! ye> ea* place x appe>s2 & 7,c7 9 subsection 7d77#a77;,a71 by /rik+ or an initial & ins]t+ or1 = a ye> prec$+ #bjbd1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbd1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbd1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbd1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbd1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is am5d$ by /rik+ section #ahfj;,d-#b7;b77#d77;,b77i7 & ins]t+ section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is am5d$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbd1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ by subp>agraph 7,a7 ( ?is p>agraph1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7ii7 = #bjbd & ea* subsequ5t ye>1 any disc\nt provid$ pursuant to section #ahfj;,d-#ad;,c4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is am5d$-- 7,a7 by ins]t+ = a ye> be=e #bjbd aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7#g7 ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is am5d$-- 7,a7 9 subsection 7a7-- 7i7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 p>ticipate 9-- 7,a7 = #bjaa ?r\gh #bjbc1 ! ,m$ic>e cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 2 7ii7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 h ent]$ into & h 9 effect-- 7,a7 = #bjaa ?r\gh #bjbc1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,a ) ! ,secret>y2 & 7,b7 = #bjbd & ea* subsequ5t ye>1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,c ) ! ,secret>y2 & 2 & 7iii7 by /rik+ p>agraph 7#c7 & ins]t+ ! foll[+3 7#c7 h ent]$ into & h 9 effect1 "u t]ms & conditions specifi$ by ! ,secret>y-- 7,a7 = #bjaa ?r\gh #bjbc1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbd & ea* subsequ5t ye>1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( section #ahfj;,d-#ad;,c4 2 & 7,b7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,effective date ,p>agraphs 7#a77;,a71 7#b77;,a71 & 7#c77;,a7 ( subsection 7a7 %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjaa1 & be=e ,janu>y #a1 #bjbd1 & p>agraphs 7#a77;,b71 7#b77;,b71 & 7#c77;,b7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjbd4 4 7#h7 ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7,a7 9 subsection 7c77#a77;,c77i77,,vi71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or "u ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 & 7,b7 9 subsection 7k77#a77;,b77i77,v71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or "u section #ahfj;,d-#ad;,c4 7f7 ,implem5tation = #bjbd & #bjbe ,not)/&+ any o!r provision ( ?is section1 ! ,secret>y %all implem5t ?is section1 includ+ ! am5dm5ts made by ?is section1 = #bjbd & #bjbe by program in/ruction or o!rwise4 7g7 ,fund+ ,9 addition to am\nts o!rwise available1 !re are appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #dd1jjj1jjj = fiscal ye> #bjbb1 #ch1jjj1jjj = fiscal ye> #bjbc1 & #cb1jjj1jjj = ea* ( fiscal ye>s #bjbd ?r\gh #bjca1 to rema9 available until exp5d$1 to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is section4 #cjb4 ,maximum mon?ly cap on co/-%>+ paym5ts "u prescription drug plans & ,,ma-,,pd plans 7a7 ,9 g5]al ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b771 z am5d$ by section #cja1 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & 7,d7 & ins]t+ 1 7,d71 & 7,e72 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,maximum mon?ly cap on co/-%>+ paym5ts 7i7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 ea* ,,pdp sponsor (f]+ a prescription drug plan & ea* ,,ma organization (f]+ an ,,ma-,,pd plan %all provide to any enrollee ( su* plan1 includ+ an enrollee :o is a subsidy eligible individual 7z def9$ 9 p>agraph 7#c7 ( section #ahfj;,d-#ad7;a771 ! option to elect ) respect to a plan ye> to pay co/-%>+ "u ! plan 9 mon?ly am\nts t are capp$ 9 accordance ) ?is subp>agraph4 7ii7 ,det]m9ation ( maximum mon?ly cap ,= ea* mon? 9 ! plan ye> = :i* an enrollee 9 a prescription drug plan or an ,,ma-,,pd plan has made an election pursuant to clause 7i71 ! ,,pdp sponsor or ,,ma organization %all det]m9e a maximum mon?ly cap 7z def9$ 9 clause 7iv77 = su* enrollee4 7iii7 ,b5efici>y mon?ly paym5ts ,) respect to an enrollee :o has made an election pursuant to clause 7i71 = ea* mon? describ$ 9 clause 7ii71 ! ,,pdp sponsor or ,,ma organization %all bill su* enrollee an am\nt 7n to exce$ ! maximum mon?ly cap7 = ! out-(-pocket co/s ( su* enrollee 9 su* mon?4 7iv7 ,maximum mon?ly cap def9$ ,9 ?is subp>agraph1 ! t]m maximum mon?ly cap means1 ) respect to an enrollee-- 7,i7 = ! fir/ mon? = :i* ! enrollee has made an election pursuant to clause 7i71 an am\nt det]m9$ by calculat+-- 7aa7 ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 m9us ! incurr$ co/s ( ! enrollee z describ$ 9 p>agraph 7#d77;,c72 divid$ by 7bb7 ! numb] ( mon?s rema9+ 9 ! plan ye>2 & 7,,ii7 = a subsequ5t mon?1 an am\nt det]m9$ by calculat+-- 7aa7 ! sum ( any rema9+ out-(-pocket co/s ow$ by ! enrollee f a previ\s mon? t h n yet be5 bill$ to ! enrollee & any additional out-(-pocket co/s incurr$ by ! enrollee2 divid$ by 7bb7 ! numb] ( mon?s rema9+ 9 ! plan ye>4 7v7 ,additional requirem5ts ,! foll[+ requirem5ts %all apply ) respect to ! option to make an election pursuant to clause 7i7 "u ?is subp>agraph3 7,i7 ,secret>ial responsibilities ,! ,secret>y %all provide in=mation to "p ,d eligible individuals on ! option to make su* election ?r\gh educational mat]ials1 includ+ ?r\gh ! notices provid$ "u section #ahjd7;a74 7,,ii7 ,tim+ ( election ,an enrollee 9 a prescription drug plan or an ,,ma-,,pd plan may make su* an election-- 7aa7 prior to ! beg9n+ ( ! plan ye>2 or 7bb7 9 any mon? dur+ ! plan ye>4 7,,iii7 ,,pdp sponsor & ma organization responsibilities ,ea* ,,pdp sponsor (f]+ a prescription drug plan or ,,ma organization (f]+ an ,,ma-,,pd plan-- 7aa7 may n limit ! option = an enrollee to make su* an election to c]ta9 cov]$ "p ,d drugs2 7bb7 %all1 prior to ! plan ye>1 notify prospective enrollees ( ! option to make su* an election 9 promotional mat]ials2 7cc7 %all include in=mation on su* option 9 enrollee educational mat]ials2 7dd7 %all h 9 place a me*anism to notify a ph>macy dur+ ! plan ye> :5 an enrollee incurs out-(-pocket co/s ) respect to cov]$ "p ,d drugs t make x likely ! enrollee may b5efit f mak+ su* an election2 7ee7 %all provide t a ph>macy1 aft] receiv+ a notification describ$ 9 item 7dd7 ) respect to an enrollee1 in=ms ! enrollee ( su* notification2 7ff7 %all ensure t su* an election by an enrollee has no effect on ! am\nt paid to ph>macies 7or ! tim+ ( su* paym5ts7 ) respect to cov]$ "p ,d drugs disp5s$ to ! enrollee2 & 7gg7 %all h 9 place a f9ancial reconciliation process to correct inaccuracies 9 paym5ts made by an enrollee "u ?is subp>agraph ) respect to cov]$ "p ,d drugs dur+ ! plan ye>4 7,,iv7 ,failure to pay am\nt bill$ ,if an enrollee fails to pay ! am\nt bill$ = a mon? z requir$ "u ?is subp>agraph1 ! election ( ! enrollee pursuant to clause 7i7 %all be t]m9at$ & ! enrollee %all pay ! co/-%>+ o!rwise applicable = any cov]$ "p ,d drugs subsequ5tly disp5s$ to ! enrollee up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b74 7,v7 ,cl>ification reg>d+ pa/ due am\nts ,no?+ 9 ?is subp>agraph %all be con/ru$ z prohibit+ a ,,pdp sponsor or an ,,ma organization f bill+ an enrollee = an am\nt ow$ "u ?is subp>agraph4 7,,vi7 ,treatm5t ( unsettl$ balances ,any unsettl$ balances ) respect to am\nts ow$ "u ?is subp>agraph %all be treat$ z plan losses & ! ,secret>y %all n be liable = any su* balances outside ( ^? assum$ z losses e/imat$ 9 plan bids4 2 & 7#b7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,c71 by /rik+ 9 subp>agraph 7,e7 & ins]t+ 9 subp>agraph 7,e7 & subject to subp>agraph 7,f72 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,inclusion ( co/s paid "u maximum mon?ly cap option ,9 apply+ subp>agraph 7,a71 ) respect to an enrollee :o has made an election pursuant to clause 7i7 ( p>agraph 7#b77;,e71 co/s %all be treat$ z incurr$ if su* co/s are paid by a ,,pdp sponsor or an ,,ma organization "u ! option provid$ "u su* p>agraph4 4 7b7 ,application to alt]native prescription drug cov]age ,section #ahfj;,d-#b7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,same maximum mon?ly cap on co/-%>+ ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbe1 ! maximum mon?ly cap on co/-%>+ paym5ts "u ! option provid$ "u subsection 7b77#b77;,e7 %all apply to su* cov]age4 4 7c7 ,implem5tation = #bjbe ,! ,secret>y %all implem5t ?is section1 includ+ ! am5dm5ts made by ?is section1 = #bjbe by program in/ruction or o!rwise4 7d7 ,fund+ ,9 addition to am\nts o!rwise available1 !re are appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #a1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 to rema9 available until exp5d$1 to c>ry out ! provisions (1 includ+ ! am5dm5ts made by1 ?is section4 ,,iv ,repeal ( ,c]ta9 ,prescription ,drug ,rebate ,rule #dja4 ,prohibit+ implem5tation ( rule relat+ to elim9at+ ! anti-kickback /atute safe h>bor protection = prescription drug rebates ,beg9n+ ,janu>y #a1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all n implem5t1 adm9i/]1 or en=ce ! provisions ( ! f9al rule publi%$ by ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices on ,novemb] #cj1 #bjbj1 & titl$ ,fraud & ,abuse2 ,removal ( ,safe ,h>bor ,protection = ,rebates ,involv+ ,prescription ,ph>maceuticals & ,creation ( ,new ,safe ,h>bor ,protection = ,c]ta9 ,po9t-(-,sale ,r$uctions 9 ,price on ,prescription ,ph>maceuticals & ,c]ta9 ,ph>macy ,b5efit ,manag] ,s]vice ,fees 7#he ,f$4 ,reg4 #gffff74 ,v ,miscellane\s #eja4 ,appropriate co/-%>+ = c]ta9 insul9 products "u ,m$ic>e "p ,d 7a7 ,9 g5]al ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ ,! cov]age & ins]t+ ,subject to p>agraph 7#h71 ! cov]age2 7,b7 9 p>agraph 7#b77;,a71 by /rik+ & 7,d7 & ins]t+ & 7,d7 & p>agraph 7#h72 7,c7 9 p>agraph 7#c77;,a71 by /rik+ & 7#d7 & ins]t+ 7#d71 & 7#h72 7,d7 9 p>agraph 7#d77;,a77i71 by /rik+ ,! cov]age & ins]t+ ,subject to p>agraph 7#h71 ! cov]age2 & 7,e7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,treatm5t ( co/-%>+ = c]ta9 insul9 products 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 ! foll[+ %all apply ) respect to insul9 products 7z def9$ 9 subp>agraph 7,b773 7i7 ,no application ( d$uctible ,! d$uctible "u p>agraph 7#a7 %all n apply ) respect to su* insul9 products4 7ii7 ,application ( co/-%>+ 7,i7 ,plan ye> #bjbc ,= plan ye> #bjbc1 ! cov]age provides b5efits = su* insul9 products1 reg>dless ( :e!r an individual has rea*$ ! initial cov]age limit "u p>agraph 7#c7 or ! out-(-pocket ?re%old "u p>agraph 7#d71 ) co/-%>+ t is equal to ! applicable copaym5t am\nt4 7,,ii7 ,plan ye> #bjbd & subsequ5t plan ye>s ,= plan ye> #bjbd & subsequ5t plan ye>s1 ! cov]age provides b5efits = su* insul9 products1 prior to an individual rea*+ ! out-(-pocket ?re%old "u p>agraph 7#d71 ) co/-%>+ t is equal to ! applicable copaym5t am\nt4 7,,iii7 ,applicable copaym5t am\nt ,= purposes ( ?is clause1 ! t]m applicable copaym5t am\nt means1 ) respect to an insul9 product "u a prescription drug plan or an ,,ma-,,pd plan1 an am\nt t is n m ?an #ce4 7,b7 ,insul9 product ,= purposes ( ?is p>agraph1 ! t]m insul9 product means an insul9 product t is approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act & m>ket$ pursuant to su* approval or lic5sure1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & m>ket$ pursuant to su* section4 2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,treatm5t ( co/-%>+ = insul9 products ,! cov]age is provid$ 9 accordance ) subsection 7b77#h74 4 7b7 ,con=m+ am5dm5ts to co/-,%>+ = l[-,income individuals ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,d77iii71 by add+ at ! end ! foll[+ new s5t5ce3 ,= plan ye> #bjbc & subsequ5t plan ye>s1 ! copaym5t am\nt applicable "u ! prec$+ s5t5ce to an insul9 product 7z def9$ 9 section #ahfj;,d-#b7;b77#h77;,b77 furni%$ to ! individual may n exce$ ! applicable copaym5t am\nt = ! product "u ! prescription drug plan or ,,ma-,,pd plan 9 :i* ! individual is enroll$42 & 7,b7 9 subp>agraph 7,e71 by ins]t+ ! foll[+ be=e ! p]iod at ! end or "u section #ahfj;,d-#b7;b77#h7 9 ! case ( an insul9 product 7z def9$ 9 subp>agraph 7,b7 ( su* section72 & 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,d71 by add+ at ! end ! foll[+ new s5t5ce3 ,= plan ye> #bjbc & subsequ5t plan ye>s1 ! am\nt ( ! co9surance applicable "u ! prec$+ s5t5ce to an insul9 product 7z def9$ 9 section #ahfj;,d-#b7;b77#h77;,b77 furni%$ to ! individual may n exce$ ! applicable copaym5t am\nt = ! product "u ! prescription drug plan or ,,ma-,,pd plan 9 :i* ! individual is enroll$42 & 7,b7 9 subp>agraph 7,e71 by add+ at ! end ! foll[+ new s5t5ce3 ,= plan ye> #bjbc1 ! am\nt ( ! copaym5t or co9surance applicable "u ! prec$+ s5t5ce to an insul9 product 7z def9$ 9 section #ahfj;,d-#b7;b77#h77;,b77 furni%$ to ! individual may n exce$ ! applicable copaym5t am\nt = ! product "u ! prescription drug plan or ,,ma-,,pd plan 9 :i* ! individual is enroll$44 7c7 ,implem5tation ,! ,secret>y %all implem5t ?is section = plan ye>s #bjbc & #bjbd by program in/ruction or o!rwise4 #ejb4 ,cov]age ( adult vacc9es recomm5d$ by ! ,advisory ,committee on ,immunization ,practices "u ,m$ic>e "p ,d 7a7 ,ensur+ treatm5t ( co/-,%>+ is consi/5t ) treatm5t ( vacc9es "u m$ic>e "p b ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb71 z am5d$ by section #eja1 is fur!r am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ p>agraph 7#h7 & ins]t+ p>agraphs 7#h7 & 7#i72 7,b7 9 p>agraph 7#b77;,a71 by /rik+ p>agraph 7#h7 & ins]t+ p>agraphs 7#h7 & 7#i72 7,c7 9 p>agraph 7#c77;,a71 by /rik+ & 7#h7 & ins]t+ 7#h71 & 7#i72 7,d7 9 p>agraph 7#d77;,a77i71 by /rik+ p>agraph 7#h7 & ins]t+ p>agraphs 7#h7 & 7#i72 & 7,e7 by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,treatm5t ( co/-%>+ = adult vacc9es recomm5d$ by ! advisory committee on immunization practices consi/5t ) treatm5t ( vacc9es "u "p b 7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbd1 ! foll[+ %all apply ) respect to an adult vacc9e recomm5d$ by ! ,advisory ,committee on ,immunization ,practices 7z def9$ 9 subp>agraph 7,b773 7i7 ,no application ( d$uctible ,! d$uctible "u p>agraph 7#a7 %all n apply ) respect to su* vacc9e4 7ii7 ,no application ( co9surance or any o!r co/-%>+ ,!re %all be no co9surance or o!r co/-%>+ "u ?is "p ) respect to su* vacc9e1 reg>dless ( :e!r = co/s bel[1 at1 or above ! initial cov]age limit "u p>agraph 7#c7 or ! out-(-pocket ?re%old "u p>agraph 7#d74 7,b7 ,adult vacc9es recomm5d$ by ! advisory committee on immunization practices ,= purposes ( ?is p>agraph1 ! t]m adult vacc9e recomm5d$ by ! ,advisory ,committee on ,immunization ,practices means a cov]$ "p ,d drug t is a vacc9e lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act = use by adult populations & adm9i/]$ 9 accordance ) recomm5dations ( ! ,advisory ,committee on ,immunization ,practices ( ! ,c5t]s = ,disease ,control & ,prev5tion4 2 & 7#b7 9 subsection 7c71 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,treatm5t ( co/-%>+ = adult vacc9es recomm5d$ by ! advisory committee on immunization practices ,! cov]age is 9 accordance ) subsection 7b77#i74 4 7b7 ,con=m+ am5dm5ts to co/-,%>+ = l[-,income individuals ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 z am5d$ by section #eja1 is fur!r am5d$-- 7#a7 9 p>agraph 7#a77;,d71 9 ea* ( clauses 7ii7 & 7iii71 by /rik+ ,9 ! case & ins]t+ ,subject to p>agraph 7#f71 9 ! case2 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,b71 by /rik+ ,a r$uction & ins]t+ ,subject to p>agraph 7#f71 a r$uction2 7,b7 9 subp>agraph 7,d71 by /rik+ ,! sub/itution & ins]t+ ,subject to p>agraph 7#f71 ! sub/itution2 & 7,c7 9 subp>agraph 7,e71 by /rik+ subsection 7c7 & ins]t+ p>agraph 7#f7 & subsection 7c72 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,no application ( co/-%>+ = adult vacc9es recomm5d$ by ! advisory committee on immunization practices ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbd1 !re %all be no co/-%>+ "u ?is section1 includ+ no annual d$uctible applicable "u ?is section1 ) respect to an adult vacc9e recomm5d$ by ! ,advisory ,committee on ,immunization ,practices 7z def9$ 9 subp>agraph 7,b7 ( su* section74 4 7c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ z limit+ cov]age "u "p ,d ( title ,,xviii ( ! ,social ,security ,act = vacc9es t are n recomm5d$ by ! ,advisory ,committee on ,immunization ,practices4 7d7 ,implem5tation = #bjbd ,! ,secret>y %all implem5t ?is section1 includ+ ! am5dm5ts made by ?is section1 = #bjbd by program in/ruction or o!rwise4 #ejc4 ,paym5t = biosimil> biological products dur+ initial p]iod ,section #ahdg;,a7c77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#d77 is am5d$-- 7#a7 9 ea* ( subp>agraphs 7,a7 & 7,b71 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii71 respectively1 & mov+ su* subclauses #b ems to ! "r2 7#b7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii7 & mov+ su* clauses #b ems to ! "r2 7#c7 by /rik+ unavailable4--,9 ! case & ins]t+ 8unavailable4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 ! case 2 & 7#d7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,limitation on paym5t am\nt = biosimil> biological products dur+ initial p]iod ,9 ! case ( a biosimil> biological product furni%$ on or aft] ,july #a1 #bjbc1 dur+ ! initial p]iod describ$ 9 subp>agraph 7,a7 ) respect to ! biosimil> biological product1 ! am\nt payable "u ?is section = ! biosimil> biological product is ! less] ( ! foll[+3 7i7 ,! am\nt det]m9$ "u clause 7ii7 ( su* subp>agraph = ! biosimil> biological product4 7ii7 ,! am\nt det]m9$ "u subsection 7b77#a77;,b7 = ! ref]5ce biological product4 4 #ejd4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = c]ta9 biosimil> biological products ,section #ahdg;,a7b77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#h77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & mov+ ! m>g9 ( ea* su* r$esignat$ clause #b ems to ! "r2 7#b7 by /rik+ product4--,! am\nt & ins]t+ ! foll[+3 8product4-- 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! am\nt 2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,tempor>y paym5t increase 7i7 ,9 g5]al ,9 ! case ( a qualify+ biosimil> biological product t is furni%$ dur+ ! applicable #e-ye> p]iod = su* product1 ! am\nt specifi$ 9 ?is p>agraph = su* product ) respect to su* p]iod is ! sum det]m9$ "u subp>agraph 7,a71 except t clause 7ii7 ( su* subp>agraph %all be appli$ by sub/itut+ #h p]c5t = #f p]c5t4 7ii7 ,applicable #e-ye> p]iod ,= purposes ( clause 7i71 ! applicable #e-ye> p]iod = a qualify+ biosimil> biological product is-- 7,i7 9 ! case ( su* a product = :i* paym5t 0 made "u ?is p>agraph z ( ,m>* #ca1 #bjbb1 ! #e-ye> p]iod beg9n+ on ,april #a1 #bjbb2 & 7,,ii7 9 ! case ( su* a product = :i* paym5t is fir/ made "u ?is p>agraph dur+ a cal5d> qu>t] dur+ ! p]iod beg9n+ ,april #a1 #bjbb1 & end+ ,m>* #ca1 #bjbg1 ! #e-ye> p]iod beg9n+ on ! fir/ day ( su* cal5d> qu>t] dur+ :i* su* paym5t is fir/ made4 7iii7 ,qualify+ biosimil> biological product def9$ ,= purposes ( ?is subp>agraph1 ! t]m qualify+ biosimil> biological product means a biosimil> biological product describ$ 9 p>agraph 7#a77;,c7 ) respect to :i*-- 7,i7 9 ! case ( a product describ$ 9 clause 7ii77,i71 ! av]age sales price "u p>agraph 7#h77;,a77i7 = a cal5d> qu>t] dur+ ! #e-ye> p]iod describ$ 9 su* clause is n m ?an ! av]age sales price "u p>agraph 7#d77;,a7 = su* qu>t] = ! ref]5ce biological product2 & 7,,ii7 9 ! case ( a product describ$ 9 clause 7ii77,,ii71 ! av]age sales price "u p>agraph 7#h77;,a77i7 = a cal5d> qu>t] dur+ ! #e-ye> p]iod describ$ 9 su* clause is n m ?an ! av]age sales price "u p>agraph 7#d77;,a7 = su* qu>t] = ! ref]5ce biological product4 4 #eje4 ,improv+ access to adult vacc9es "u ,m$icaid & ,,*ip 7a7 ,m$icaid 7#a7 ,requir+ cov]age ( adult vacc9ations 7,a7 ,9 g5]al ,section #aijb7;a77#aj77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77 is am5d$ 9 ! matt] prec$+ clause 7i7 by ins]t+ 7#ac77;,b71 aft] 7#e714 7,b7 ,m$ically ne$y ,section #aijb7;a77#aj77;,c77iv7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,c77iv77 is am5d$ by ins]t+ 1 7#ac77;,b71 aft] 7#e74 7#b7 ,no co/-%>+ = vacc9ations 7,a7 ,g5]al co/-%>+ limitations ,section #aiaf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifo7 is am5d$-- 7i7 9 subsection 7a77#b7-- 7,i7 9 subp>agraph 7,g71 by ins]t+ a comma aft] ,/ate plan2 7,,ii7 9 subp>agraph 7,h71 by /rik+ 2 or & ins]t+ a comma2 7,,iii7 9 subp>agraph 7,i71 by /rik+ 2 & & ins]t+ 1 or2 & 7,,iv7 by add+ at ! end ! foll[+ new subp>agraph3 7,j7 vacc9es describ$ 9 section #aije7;a77#ac77;,b7 & ! adm9i/ration ( su* vacc9es2 & 2 & 7ii7 9 subsection 7b77#b7-- 7,i7 9 subp>agraph 7,g71 by ins]t+ a comma aft] ,/ate plan2 7,,ii7 9 subp>agraph 7,h71 by /rik+ 2 or & ins]t+ a comma2 7,,iii7 9 subp>agraph 7,i71 by /rik+ 2 & & ins]t+ 1 or2 & 7,,iv7 by add+ at ! end ! foll[+ new subp>agraph3 7,j7 vacc9es describ$ 9 section #aije7;a77#ac77;,b7 & ! adm9i/ration ( su* vacc9es2 & 4 7,b7 ,application to alt]native co/-%>+ ,section #aiaf;,a7b77#c77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifo-#a7;b77#c77;,b77 is am5d$ by add+ at ! end ! foll[+ new clause3 7xiv7 ,vacc9es describ$ 9 section #aije7;a77#ac77;,b7 & ! adm9i/ration ( su* vacc9es4 4 7#c7 ,increas$ ,,fmap = adult vacc9es ,section #aije7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7b77 is am5d$-- 7,a7 by /rik+ & 7#e7 & ins]t+ 7#e72 7,b7 by /rik+ s]vices & vacc9es describ$ 9 subp>agraphs 7,a7 & 7,b7 ( subsection 7a77#ac71 & prohibits co/-%>+ = su* s]vices & vacc9es & ins]t+ s]vices describ$ 9 subsection 7a77#ac77;,a71 & prohibits co/-%>+ = su* s]vices2 7,c7 by /rik+ m$ical assi/ance = su* s]vices & vacc9es & ins]t+ m$ical assi/ance = su* s]vices2 & 7,d7 by ins]t+ 1 & 7#f7 dur+ ! fir/ #h fiscal qu>t]s beg9n+ on or aft] ! effective date ( ?is clause1 9 ! case ( a ,/ate :i*1 z ( ! date ( enactm5t ( ! ,act titl$ ,an ,act to provide = reconciliation pursuant to title ,,ii ( ,s4 ,con4 ,res4 #ad1 provides m$ical assi/ance = vacc9es describ$ 9 subsection 7a77#ac77;,b7 & _! adm9i/ration & prohibits co/-%>+ = su* vacc9es1 ! ,f$]al m$ical assi/ance p]c5tage1 z det]m9$ "u ?is subsection & subsection 7y71 %all be increas$ by #a p]c5tage po9t ) respect to m$ical assi/ance = su* vacc9es be=e ! fir/ p]iod4 7b7 ,,*ip 7#a7 ,requir+ cov]age ( adult vacc9ations ,section #bajc7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77 is am5d$ by add+ at ! end ! foll[+ p>agraph3 7#ab7 ,requir$ cov]age ( approv$1 recomm5d$ adult vacc9es & _! adm9i/ration ,reg>dless ( ! type ( cov]age elect$ by a ,/ate "u subsection 7a71 if ! ,/ate *ild heal? plan or a waiv] ( su* plan provides *ild heal? assi/ance or pregnancy-relat$ assi/ance 7z def9$ 9 section #baab7 to an individual :o is #ai ye>s ( age or old]1 su* assi/ance %all include cov]age ( vacc9es describ$ 9 section #aije7;a77#ac77;,b7 & _! adm9i/ration4 4 7#b7 ,no co/-%>+ = vacc9ations ,section #bajc7;e77#b7 ( su* ,act 7#db ,u4,s4,c4 #acig;cc7e77#b77 is am5d$ by ins]t+ vacc9es describ$ 9 subsection 7c77#ab7 7& ! adm9i/ration ( su* vacc9es71 aft] 9 vitro diagno/ic products describ$ 9 subsection 7c77#aj7 7& adm9i/ration ( su* products714 7c7 ,effective date ,! am5dm5ts made by ?is section take effect on ! #a/ day ( ! #a/ fiscal qu>t] t beg9s on or aft] ! date t is #a ye> aft] ! date ( enactm5t ( ?is ,act & %all apply to exp5ditures made "u a ,/ate plan or waiv] ( su* plan "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif ?r\gh #acifw-#f7 or "u a ,/ate *ild heal? plan or waiv] ( su* plan "u title ,,xxi ( su* ,act 7#db ,u4,s4,c4 #acig;aa ?r\gh #acigmm7 on or aft] su* effective date4 ,,vi ,additional ,insul9 ,policies #fja4 ,,erisa requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,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[+3 #gbf4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 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* section1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 ( su* ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh7 & cont9ues to be m>ket$ pursuant to su* lic5sure4 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$uctible or out-(-pocket maximum t applies "u ! plan or cov]age4 4 7b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is am5d$ by ins]t+ aft] ! item relat+ to section #gbe ! foll[+3 ,sec4 #gbf4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products4 4 #fjb4 ,public ,heal? ,s]vice ,act requirem5ts ) respect to co/-%>+ = insul9 products 7a7 ,9 g5]al ,"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[+3 #bgii;,a-#aa4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 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* section1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & cont9ues to be m>ket$ pursuant to su* lic5sure4 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$uctible or out-(-pocket maximum t applies "u ! plan or cov]age4 4 7b7 ,no effect on o!r co/-,%>+ ,section #acjb7;d77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahjbb7;d77#b77 is am5d$ 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-#aa7;b7 ( ! ,public ,heal? ,s]vice ,act7 f ! application ( any d$uctible pursuant to section #bgii;,a-#aa7;a77#a7 ( su* ,act1 section #gbf7;a77#a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd1 or section #ihbf7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf %all n be consid]$ :5 det]m9+ ! actu>ial value ( a qualifi$ heal? plan "u ?is subsection4 4 7c7 ,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[+3 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-#aa ( ! ,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-#aa7;b7 ( ! ,public ,heal? ,s]vice ,act2 & 7ii7 ! requirem5ts ( section #bgii;,a-#aa ( 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 #fjc4 ,,irc requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj is am5d$ by add+ at ! end ! foll[+ new section3 #ihbf4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbc1 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* section1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 ( su* ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji 7,public ,law #aaa-adh7 & cont9ues to be m>ket$ pursuant to su* lic5sure4 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$uctible or out-(-pocket maximum t applies "u ! plan4 4 7b7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbf4 ,requirem5ts ) respect to co/-%>+ = c]ta9 insul9 products4 4