,,ib ,union ,cal5d> ,no4 #bfd #aaf? ,,congress #a/ ,session ,h4 ,r4 #c ,report ,no4 #aaf-cbd1 ,p>ts ,i1 ,,ii & ,,iii ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #ai1 #bjai ,mr4 ,pallone 7= himself1 ,mr4 ,neal1 & ,mr4 ,scott ( ,virg9ia7 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$ ,decemb] #f1 #bjai ,report$ f ! ,committee on ,en]gy & ,comm]ce ) an am5dm5t ,/rike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,decemb] #f1 #bjai ,report$ f ! ,committee on ,ways & ,means ) an am5dm5t ,/rike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 boldface roman ,decemb] #f1 #bjai ,ref]ral to ! ,committee on ,education & ,labor ext5d$ = a p]iod end+ n lat] ?an ,decemb] #i1 #bjai ,decemb] #i1 #bjai ,additional sponsors3 ,mr4 ,l>son ( ,connecticut1 ,ms4 ,ku/] ( ,new ,hamp%ire1 ,ms4 ,de,gette1 ,mr4 ,ru%1 ,ms4 ,%alala1 ,mr4 ,ryan1 ,mr4 ,morelle1 ,mr4 ,sablan1 ,mr4 ,case1 ,mr4 ,engel1 ,ms4 ,ca/or ( ,florida1 ,ms4 ,frankel1 ,mr4 ,evans1 ,mr4 ,c\rtney1 ,mr4 ,norcross1 ,ms4 ,moore1 ,mr4 ,kildee1 ,ms4 ,norton1 ,mr4 ,mc,govern1 ,mr4 ,visclosky1 ,mr4 ,c>bajal1 ,mr4 ,pappas1 ,ms4 ,bonamici1 ,ms4 ,hill ( ,cali=nia1 ,mrs4 ,hayes1 ,mr4 ,c>twright1 ,mr4 ,mc,nerney1 ,ms4 ,blunt ,ro*e/]1 ,mr4 ,kim1 ,mr4 ,trone1 ,mr4 ,allr$1 ,mr4 ,rose ( ,new ,york1 ,mr4 ,?ompson ( ,cali=nia1 ,ms4 ,m5g1 ,mr4 ,coh51 ,mr4 ,suozzi1 ,ms4 ,wild1 ,ms4 ,e%oo1 ,mr4 ,soto1 ,mr4 ,hors=d1 ,mr4 ,vela1 ,mrs4 ,beatty1 ,ms4 ,wass]man ,s*ultz1 ,mr4 ,keat+1 ,mr4 ,gold51 ,mr4 ,s*iff1 ,ms4 ,craig1 ,mr4 ,wel*1 ,mr4 ,mi*ael ,f4 ,doyle ( ,p5nsylvania1 ,ms4 ,g>cia ( ,texas1 ,mr4 ,danny ,k4 ,davis ( ,ill9ois1 ,mr4 ,ruiz1 ,ms4 ,matsui1 ,ms4 ,slotk91 ,ms4 ,wilson ( ,florida1 ,mr4 ,loebsack1 ,mr4 ,cri/1 ,mrs4 ,bu/os1 ,ms4 ,muc>sel-,p[ell1 ,mr4 ,ca/5 ( ,ill9ois1 ,ms4 ,s*ri]1 ,mr4 ,cuell>1 ,ms4 ,wexton1 ,mr4 ,cleav]1 ,ms4 ,s*ak[sky1 ,mr4 ,s>banes1 ,mr4 ,sean ,patrick ,maloney ( ,new ,york1 ,mr4 ,lawson ( ,florida1 ,mr4 ,phillips1 ,mr4 ,s*neid]1 ,mr4 ,meeks1 ,mr4 ,espaillat1 ,mr4 ,lyn*1 ,mr4 ,higg9s ( ,new ,york1 ,mr4 ,langev91 ,ms4 ,judy ,*u ( ,cali=nia1 ,ms4 ,/ev5s1 ,mr4 ,p]lmutt]1 ,ms4 ,davids ( ,kansas1 ,mrs4 ,axne1 ,mr4 ,ha/+s1 ,mr4 ,bey]1 ,mrs4 ,l[ey1 ,mr4 ,mc,eachin1 ,mrs4 ,torres ( ,cali=nia1 ,mr4 ,payne1 ,ms4 ,scanlon1 ,mr4 ,deut*1 ,mr4 ,y>mu?1 ,ms4 ,spanb]g]1 ,mr4 ,jeffries1 ,mrs4 ,mc,bath1 ,mrs4 ,d+ell1 ,ms4 ,f9k5au]1 ,mr4 ,g>am5di1 ,ms4 ,mc,collum1 ,mr4 ,veasey1 ,mr4 ,ca/ro ( ,texas1 ,mr4 ,gonzalez ( ,texas1 ,ms4 ,bass1 ,mr4 ,bi%op ( ,georgia1 ,mr4 ,smi? ( ,wa%+ton1 ,mr4 ,l[5?al1 & ,mrs4 ,flet*] ,decemb] #i1 #bjai ,report$ f ! ,committee on ,education & ,labor ) an am5dm5t2 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union & ord]$ to be pr9t$ ,/rike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 boldface italic ,= text ( introduc$ bill1 see copy ( bill z introduc$ on ,septemb] #ai1 #bjai ,a ,,bill ,to e/abli% a fair price negotiation program1 protect ! ,m$ic>e program f excessive price increases1 & e/abli% an out-(-pocket maximum = ,m$ic>e "p ,d enrollees1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,9 g5]al ,?is ,act may be cit$ z ! ,l[] ,drug ,co/s ,n[ ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,l[]+ ,prices ,?r\gh ,fair ,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 ,title ,,ii--,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates ,sec4 #bja4 ,m$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 ,b5efici>ies ,sec4 #cja4 ,m$ic>e "p ,d b5efit r$esign4 ,sec4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4 ,sec4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4 ,title ,,iv--,prescription ,drug ,policies = ,l[-,income ,individuals ,sec4 #dja4 ,adju/m5ts to ,m$ic>e "p ,d co/-%>+ r$uctions = l[-income individuals4 ,sec4 #djb4 ,dissem9ation to ,m$ic>e "p ,d subsidy eligible individuals ( in=mation comp>+ premiums ( c]ta9 prescription drug plans4 ,sec4 #djc4 ,provid+ = intellig5t assignm5t ( c]ta9 subsidy eligible individuals auto-enroll$ "u ,m$ic>e prescription drug plans & ,,ma-,,pd plans4 ,sec4 #djd4 ,exp&+ eligibility = l[-income subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #dje4 ,automatic eligibility ( c]ta9 l[-income t]ritorial resid5ts = premium & co/-%>+ subsidies "u ! ,m$ic>e program2 ,sunset ( enhanc$ allotm5t program4 ,sec4 #djf4 ,automatic qualification ( c]ta9 ,m$icaid b5efici>ies = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #djg4 ,elim9at+ ! res\rce requirem5t ) respect to subsidy eligible individuals "u "p ,d ( ! ,m$ic>e program4 ,title ,v--,drug ,price ,transp>5cy ,sec4 #eja4 ,drug price transp>5cy4 ,title ,,vi--,miscellane\s ,sec4 #fja4 ,tempor>y increase 9 ,m$ic>e "p ,b paym5t = c]ta9 biosimil> biological products4 ,i ,l[]+ ,prices ,?r\gh ,fair ,drug ,price ,negotiation #aja4 ,provid+ = l[] prices = c]ta9 high-pricesectiond s+le s\rce drugs 7a7 ,program ,to l[] prices = c]ta9 high-,pric$ s+le s\rce drugs ,title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by add+ at ! end ! foll[+ new "p3 ,e ,fair ,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 ,fair ,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/ ( 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 plan ye> 7beg9n+ ) plan ye> #bjbc7 or1 if agre$ to 9 an agreem5t "u section #aaic by ! ,secret>y & manufactur] involv$1 a p]iod ( m ?an "o plan ye> 7beg9n+ on or aft] ,janu>y #a1 #bjbc74 7#b7 ,price applicability p]iod ,! t]m price applicability p]iod means1 ) respect to a drug1 ! p]iod beg9n+ ) ! initial price applicability ye> ) respect to :i* su* drug is a select$ drug & end+ ) ! la/ plan 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 ,april #ae ( ! plan ye> t beg9s #b ye>s prior to su* ye>4 7#d7 ,volunt>y negotiation p]iod ,! t]m volunt>y 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 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug2 & 7,b7 end+ on ,m>* #ca ( ! ye> t beg9s "o ye> prior to ! initial price applicability ye>4 7c7 ,o!r def9itions ,= purposes ( ?is "p3 7#a7 ,fair price eligible individual ,! t]m fair price eligible individual means1 ) respect to a select$ drug-- 7,a7 9 ! case su* drug is furni%$ or disp5s$ to ! individual at a ph>macy or by a mail ord] s]vice-- 7i7 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 "u :i* cov]age is provid$ = su* drug2 & 7ii7 an individual :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or disp5s$2 & 7,b7 9 ! case su* drug is furni%$ or adm9i/]$ to ! individual by a hospital1 physician1 or o!r provid] ( s]vices or suppli]-- 7i7 an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title if su* select$ drug is cov]$ "u ! respective "p2 & 7ii7 an individual :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,maximum fair price ,! t]m maximum fair price means1 ) respect to a plan ye> dur+ a price applicability p]iod & ) respect to a select$ drug 7z def9$ 9 section #aaib7;c77 ) respect to su* p]iod1 ! price publi%$ pursuant to section #aaie 9 ! ,f$]al ,regi/] = su* drug & ye>4 7#c7 ,av]age int]national m>ket price def9$ 7,a7 ,9 g5]al ,! t]ms av]age int]national m>ket price & ,,aim price mean1 ) respect to a drug1 ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit 7z def9$ 9 p>agraph 7#d77 ( ! drug = sales ( su* drug 7calculat$ across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type71 z comput$ 7z ( ! date ( publication ( su* drug z a select$ drug "u section #aaib7;a77 9 all c\ntries describ$ 9 clause 7ii7 ( subp>agraph 7,b7 t are applicable c\ntries 7z describ$ 9 clause 7i7 ( su* subp>agraph7 ) respect to su* drug4 7,b7 ,applicable c\ntries 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 a c\ntry describ$ 9 clause 7ii7 is an applicable c\ntry describ$ 9 ?is clause ) respect to a drug if !re is available an av]age price = any unit = ! drug = sales ( su* drug 9 su* c\ntry4 7ii7 ,c\ntries describ$ ,= purposes ( ?is p>agraph1 ! foll[+ are c\ntries describ$ 9 ?is clause3 7,i7 ,au/ralia4 7,,ii7 ,canada4 7,,iii7 ,france4 7,,iv7 ,g]many4 7,v7 ,japan4 7,,vi7 ,! ,unit$ ,k+dom4 7#d7 ,unit ,! t]m unit means1 ) respect to a drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! drug t is disp5s$4 #aaib4 ,selection ( negotiation-eligible drugs z select$ drugs 7a7 ,9 g5]al ,n lat] ?an ! select$ drug publication date ) respect to an initial price applicability ye>1 ! ,secret>y %all select & publi% 9 ! ,f$]al ,regi/] a li/ (-- 7#a7 7,a7 ) respect to an initial price applicability ye> dur+ ! p]iod beg9n+ ) #bjbc & end+ ) #bjbg1 at lea/ #be negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod beg9n+ aft] #bjbc1 ! maximum numb] 7if su* numb] is less ?an #be7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7,b7 ) respect to an initial price applicability ye> dur+ ! p]iod beg9n+ ) #bjbh & end+ ) #bjcb1 at lea/ #cj negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #cj7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 & 7,c7 ) respect to an initial price applicability ye> beg9n+ aft] #bjcb1 at lea/ #ce negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #ce7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7#b7 all negotiation-eligible drugs describ$ 9 subp>agraph 7,c7 ( su* subsection ) respect to su* ye>2 & 7#c7 all new-entrant negotiation-eligible drugs 7z def9$ 9 subsection 7g77#a77 ) respect to su* ye>4 ,ea* drug publi%$ on ! li/ pursuant to ! previ\s s5t5ce %all be subject to ! negotiation process "u section #aaid = ! volunt>y 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 ,9 apply+ ?is subsection1 any negotiation-eligible drug t is select$ "u ?is subsection = an initial price applicability ye> %all n c\nt t[>d ! requir$ m9imum am\nt ( drugs to be select$ "u p>agraph 7#a7 = any subsequ5t ye>1 includ+ su* a drug s select$ t is subject to r5egotiation "u section #aaid4 7b7 ,selection ( drugs ,9 c>ry+ out subsection 7a77#a7 ! ,secret>y %all select = inclusion on ! publi%$ li/ describ$ 9 subsection 7a7 ) respect to a price applicability p]iod1 ! negotiation-eligible drugs t ! ,secret>y projects w result 9 ! greate/ sav+s to ! ,f$]al ,gov]nm5t or fair price eligible individuals dur+ ! price applicability p]iod4 ,9 mak+ ?is projection ( sav+s = drugs = :i* !re is an ,,aim price = a price applicability p]iod1 ! sav+s %all be project$ across diff]5t dosage =ms & /r5g?s ( ! drugs & n bas$ on ! specific =mulation or package size or package type ( ! drugs1 tak+ into consid]ation bo? ! volume ( drugs = :i* paym5t is made1 to ! ext5t su* data is available1 & ! am\nt by :i* ! net price = ! drugs exce$s ! ,,aim price = ! drugs4 7c7 ,select$ drug ,= purposes ( ?is "p1 ea* 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 plan ye> beg9n+ be=e ! fir/ plan ye> beg9n+ aft] ! date on :i* ! ,secret>y det]m9es two or m drug products-- 7#a7 are approv$ or lic5s$ 7z applicable7-- 7,a7 "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act us+ su* drug z ! li/$ drug2 or 7,b7 "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act us+ su* drug z ! ref]5ce product2 & 7#b7 cont9ue to be m>ket$4 7d7 ,negotiation-,eligible drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug1 z def9$ 9 subsection 7e71 t meets any ( ! foll[+ crit]ia3 7,a7 ,cov]$ "p ,d drugs ,! drug is among ! #abe cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e77 = :i* !re 0 an e/imat$ greate/ net sp5d+ "u p>ts ,c & ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,b7 ,o!r drugs ,! drug is among ! #abe drugs = :i* !re 0 an e/imat$ greate/ net sp5d+ 9 ! ,unit$ ,/ates 7includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates71 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,c7 ,insul9 ,! drug is a qualify+ s+le s\rce drug describ$ 9 subsection 7e77#c74 7#b7 ,cl>ification ,9 det]m9+ :e!r a qualify+ s+le s\rce drug satisfies any ( ! crit]ia describ$ 9 p>agraph 7#a71 ! ,secret>y %all1 to ! ext5t practicable1 use data t is aggregat$ across dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7#c7 ,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 ,= purposes ( ?is "p1 ! t]m qualify+ s+le s\rce drug means any ( ! foll[+3 7#a7 ,drug products ,a drug t-- 7,a7 is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & cont9ues to be m>ket$ pursuant to su* approval2 & 7,b7 is n ! li/$ drug = any drug t is approv$ & cont9ues to be m>ket$ "u section #eje7;j7 ( su* ,act4 7#b7 ,biological products ,a biological product t-- 7,a7 is lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 includ+ any product t has be5 deem$ to be lic5s$ "u section #cea ( su* ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji1 & cont9ues to be m>ket$ "u section #cea ( su* ,act2 & 7,b7 is n ! ref]5ce product = any biological product t is lic5s$ & cont9ues to be m>ket$ "u section #cea7k7 ( su* ,act4 7#c7 ,insul9 product ,not)/&+ p>agraphs 7#a7 & 7#b71 any insul9 product t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act & cont9ues to be m>ket$ "u su* section #eje or #cea1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & cont9ues to be m>ket$ pursuant to su* lic5sure4 ,= purposes ( apply+ p>agraphs 7#a7 & 7#b71 a drug or biological product t is m>ket$ by ! same sponsor or manufactur] 7or an affiliate !re( or a cross-lic5s$ produc] or di/ributor7 z ! li/$ drug or ref]5ce product describ$ 9 su* respective p>agraph %all n be tak5 into consid]ation4 7f7 ,in=mation on int]national drug prices ,= purposes ( det]m9+ :i* negotiation-eligible drugs to select "u subsection 7a7 &1 9 ! case ( su* drugs t are select$ drugs1 to det]m9e ! maximum fair price = su* a drug & :e!r su* maximum fair price %\ld be r5egotiat$ "u section #aaid1 ! ,secret>y %all use data relat+ to ! ,,aim price ) respect to su* drug z available or provid$ to ! ,secret>y & %all on an ongo+ basis reque/ f manufactur]s ( select$ drugs in=mation on ! ,,aim price ( su* a drug4 7g7 ,new-entrant negotiation-eligible drugs 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m new-entrant negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug-- 7,a7 t is fir/ approv$ or lic5s$1 z describ$ 9 p>agraph 7#a71 7#b71 or 7#c7 ( subsection 7e71 z applicable1 dur+ ! ye> prec$+ su* select$ drug publication date2 & 7,b7 t ! ,secret>y det]m9es "u p>agraph 7#b7 is likely to be a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date4 7#b7 ,det]m9ation ,9 ! case ( a qualify+ s+le s\rce drug t meets ! crit]ia describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a71 ) respect to an initial price applicability ye>1 if ! :olesale acquisition co/ at :i* su* drug is fir/ m>ket$ 9 ! ,unit$ ,/ates is equal to or great] ?an ! m$ian h\sehold income 7z det]m9$ accord+ to ! mo/ rec5t data collect$ by ! ,unit$ ,/ates ,c5sus ,bureau71 ! ,secret>y %all det]m9e be=e ! select$ drug publication date ) respect to ! initial price applicability ye>1 if ! drug is likely to be includ$ z a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date1 bas$ on ! project$ sp5d+ "u title ,,xviii or 9 ! ,unit$ ,/ates on su* drug4 ,= purposes ( ?is p>agraph ! t]m ,unit$ ,/ates includes ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates4 #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 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug1 "u :i*-- 7#a7 dur+ ! volunt>y 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]iod & 9 accordance ) subsection 7c71 agree to7 a maximum fair price = su* select$ drug ( ! manufactur] 9 ord] to provide access to su* price-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug 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 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 ) a process & dur+ a p]iod specifi$ by ! ,secret>y pursuant to rulemak+1 r5egotiate 7&1 by n lat] ?an ! la/ date ( su* p]iod & 9 accordance ) subsection 7c71 agree to7 ! maximum fair price = su* drug if ! ,secret>y det]m9es t !re is a mat]ial *ange 9 any ( ! factors describ$ 9 section #aaid7;d7 relat+ to ! drug1 includ+ *anges 9 ! ,,aim price = su* drug1 9 ord] to provide access to su* maximum fair price 7z s r5egotiat$7-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug 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 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 ! maximum fair price 7includ+ z r5egotiat$ pursuant to p>agraph 7#b771 ) respect to su* a select$ drug1 %all be provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ! ph>macy or by a mail ord] s]vice at ! po9t-(-sale ( su* drug2 7#d7 ! manufactur]1 subject to subsection 7d71 submits to ! ,secret>y1 9 a =m & mann] specifi$ by ! ,secret>y-- 7,a7 = ! volunt>y negotiation p]iod = ! price applicability p]iod 7&1 if applicable1 be=e any p]iod ( r5egotiation specifi$ pursuant to p>agraph 7#b77 ) respect to su* drug all in=mation t ! ,secret>y requires to c>ry out ! negotiation 7or r5egotiation process7 "u ?is "p1 includ+ in=mation describ$ 9 section #aaib7;f7 & section #aaid7;d77#a72 & 7,b7 on an ongo+ basis1 in=mation on *anges 9 prices = su* drug t w\ld affect ! ,,aim price = su* drug or o!rwise provide a basis = r5egotiation ( ! maximum fair price = su* drug pursuant to p>agraph 7#b72 7#e7 ! manufactur] agrees t 9 ! case ! select$ drug ( a manufactur] is a drug describ$ 9 subsection 7c71 ! manufactur] w1 9 accordance ) su* subsection1 make any paym5t requir$ "u su* subsection ) respect to su* drug2 & 7#f7 ! 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 drug1 until su* drug is no long] consid]$ a select$ drug "u section #aaib7;c74 7c7 ,special rule = c]ta9 select$ drugs )\t ,,aim price 7#a7 ,9 g5]al ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug & = :i* an ,,aim price becomes available beg9n+ ) respect to a subsequ5t plan ye> dur+ ! price applicability p]iod = su* drug1 if ! ,secret>y det]m9es t ! am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug is great] ?an ! am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug1 !n by n lat] ?an "o ye> aft] ! date ( su* det]m9ation1 ! manufactur] ( su* select$ drug %all pay to ! ,treasury an am\nt equal to ! product (-- 7,a7 ! diff]5ce betwe5 su* am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug & su* am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug2 & 7,b7 ! numb] ( units ( su* drug sold 9 ! ,unit$ ,/ates1 includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates1 dur+ ! p]iod describ$ 9 p>agraph 7#b77;,b74 7#b7 ,am\nts describ$ 7,a7 ,weight$ av]age price be=e ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to ! weight$ av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* dosage /r5g? & =m = ! drug dur+ ! p]iod beg9n+ ) ! fir/ plan ye> = :i* ! drug is includ$ on ! li/ ( negotiation-eligible drugs publi%$ "u section #aaib7;d7 & end+ ) ! la/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is no ,,aim price available = su* drug4 7,b7 ,am\nt multipli] aft] ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to #bjj p]c5t ( ! ,,aim price = su* drug ) respect to ! fir/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is an ,,aim price available = su* drug4 7d7 ,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 may be us$ only by ! ,secret>y or disclos$ to & us$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates or ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( c>ry+ out ?is "p4 7e7 ,regulations 7#a7 ,9 g5]al ,! ,secret>y %all1 pursuant to rulemak+1 specify1 9 accordance ) p>agraph 7#b71 ! in=mation t mu/ be submitt$ "u subsection 7a77#d74 7#b7 ,in=mation specifi$ ,in=mation describ$ 9 p>agraph 7#a71 ) respect to a select$ drug1 %all include in=mation on sales ( ! drug 7by ! manufactur] ( ! drug or by ano!r entity "u lic5se or o!r agreem5t ) ! manufactur]1 ) respect to ! sales ( su* drug1 reg>dless ( ! "n "u :i* ! drug is sold7 9 any =eign c\ntry t is "p ( ! ,,aim price4 ,! ,secret>y %all v]ify1 to ! ext5t practicable1 su* sales f appropriate (ficials ( ! gov]nm5t ( ! =eign c\ntry involv$4 7f7 ,compliance ) requirem5ts = adm9i/ration ( program ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all comply ) requirem5ts impos$ by ! ,secret>y or a ?ird p>ty ) a contract "u section #aaif7;c77#a71 z applicable1 = purposes ( adm9i/]+ ! program4 #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 7b7 & 7c71 ! ,secret>y & ! manufactur]-- 7#a7 %all dur+ ! volunt>y negotiation p]iod ) respect to ! initial price applicability ye> = su* drug1 9 accordance ) ?is section1 negotiate a maximum fair price = su* drug = ! purpose describ$ 9 section #aaic7;a77#a72 & 7#b7 z applicable pursuant to section #aaic7;a77#b7 & 9 accordance ) ! process specifi$ pursuant to su* section1 r5egotiate su* maximum fair price = su* drug = ! purpose describ$ 9 su* section4 7b7 ,negotiat+ me?odology & objective 7#a7 ,9 g5]al ,! ,secret>y %all develop & use a consi/5t me?odology = negotiations "u subsection 7a7 t1 9 accordance ) p>agraph 7#b7 & subject to p>agraph 7#c71 a*ieves ! l[e/ maximum fair price = ea* select$ drug :ile appropriately rew>d+ innovation4 7#b7 ,prioritiz+ factors ,9 consid]+ ! factors describ$ 9 subsection 7d7 9 negotiat+ 7&1 z applicable1 r5egotiat+7 ! maximum fair price = a select$ drug1 ! ,secret>y %all1 to ! ext5t practicable1 consid] all ( ! available factors li/$ b %all prioritize ! foll[+ factors3 7,a7 ,rese>* & developm5t co/s ,! factor describ$ 9 p>agraph 7#a77;,a7 ( subsection 7d74 7,b7 ,m>ket data ,! factor describ$ 9 p>agraph 7#a77;,b7 ( su* subsection4 7,c7 ,unit co/s ( production & di/ribution ,! factor describ$ 9 p>agraph 7#a77;,c7 ( su* subsection4 7,d7 ,comp>ison to exi/+ !rapeutic alt]natives ,! factor describ$ 9 p>agraph 7#b77;,a7 ( su* subsection4 7#c7 ,requirem5t 7,a7 ,9 g5]al ,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 9 ! case t ! manufactur] ( ! select$ drug (f]s "u ! negotiation or r5egotiation1 z applicable1 a price = su* drug t is n m ?an ! t>get price describ$ 9 subp>agraph 7,b7 = su* drug = ! respective ye>1 ! ,secret>y %all agree "u su* negotiation or r5egotiation1 respectively1 to su* (f]$ price z ! maximum fair price4 7,b7 ,t>get price 7i7 ,9 g5]al ,subject to clause 7ii71 ! t>get price describ$ 9 ?is subp>agraph = a select$ drug ) respect to a ye>1 is ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit ( su* drug = sales ( su* drug1 z comput$ 7across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug7 9 ! applicable c\ntry describ$ 9 section #aaia7;c77#c77;,b7 ) respect to su* drug t1 ) respect to su* ye>1 has ! l[e/ av]age price = su* drug z comp>$ to ! av]age prices 7z s comput$7 ( su* drug ) respect to su* ye> 9 ! o!r applicable c\ntries describ$ 9 su* section ) respect to su* drug4 7ii7 ,select$ drugs )\t ,,aim price ,9 apply+ ?is p>agraph 9 ! case ( negotiat+ ! maximum fair price ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 or1 z applicable1 r5egotiat+ ! maximum fair price = su* drug ) respect to a subsequ5t ye> dur+ ! price applicability p]iod = su* drug be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! t>get price describ$ 9 ?is subp>agraph = su* drug & respective ye> is ! am\nt t is #hj p]c5t ( ! av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* drug & ye>4 7#d7 ,annual report ,aft] ! completion ( ea* volunt>y negotiation p]iod1 ! ,secret>y %all submit to ,congress a report on ! maximum fair prices negotiat$ 7or1 z applicable1 r5egotiat$7 = su* p]iod4 ,su* report %all include in=mation on h[ su* prices s negotiat$ 7or r5egotiat$7 meet ! requirem5ts ( ?is "p1 includ+ ! requirem5ts ( ?is subsection4 7c7 ,limitation 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = a select$ drug1 ) respect to ea* plan ye> dur+ a price applicability p]iod = su* drug1 %all n exce$ #abj p]c5t ( ! ,,aim price applicable to su* drug ) respect to su* ye>4 7#b7 ,select$ drugs )\t ,,aim price ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 = ea* plan ye> dur+ ! price applicability p]iod be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = ! select$ drug %all n exce$ ! am\nt equal to #he p]c5t ( ! av]age manufactur] price = ! drug ) respect to su* ye>4 7d7 ,consid]ations ,= 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 ! ,secret>y %all1 consi/5t ) subsection 7b77#b71 take into consid]ation ! foll[+ factors3 7#a7 ,manufactur]-specific in=mation ,! foll[+ in=mation1 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$]al f9ancial support = novel !rapeutic discov]y & developm5t ) respect to ! drug4 7,e7 ,data on pat5ts & on exi/+ & p5d+ exclusivity = ! drug4 7,f7 ,national sales data = ! drug4 7,g7 ,in=mation on cl9ical trials = ! drug 9 ! ,unit$ ,/ates or 9 applicable c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#b7 ,in=mation on alt]native products ,! foll[+ in=mation3 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 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 ,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$1 or n t]m9ally ill4 ,no?+ 9 ! previ\s s5t5ce %all affect ! application or consid]ation ( an ,,aim price = a select$ drug4 7#c7 ,=eign sales in=mation ,to ! ext5t available on a timely basis1 includ+ z provid$ by a manufactur] ( ! select$ drug or o!rwise1 in=mation on sales ( ! select$ drug 9 ea* ( ! c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#d7 ,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 7e7 ,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 7d77#a72 & 7#b7 by n lat] ?an ,octob] #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 may require4 ,! ,secret>y %all reque/1 f ! manufactur] or o!rs1 su* additional in=mation z may be ne$$ to c>ry out ! negotiation & r5egotiation process "u ?is section4 #aaie4 ,publication ( maximum fair prices 7a7 ,9 g5]al ,) respect to an initial price applicability ye> & select$ drug ) respect to su* ye>1 n lat] ?an ,april #a ( ! plan ye> prior to su* initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! maximum fair price = su* drug negotiat$ "u ?is "p ) ! manufactur] ( su* drug4 7b7 ,updates 7#a7 ,subsequ5t ye> maximum fair prices ,= a select$ drug1 = ea* plan ye> subsequ5t to ! initial price applicability ye> = su* drug ) respect to :i* an agreem5t = su* drug is 9 effect "u section #aaic1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/]-- 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 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p1 contracts ) prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title1 & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i* ! maximum fair price = a select$ drug is provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( ! drug = ! applicable price p]iod = su* drug & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u su* plans or cov]age = ! select$ drug4 7,b7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p & contracts ) hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i*1 9 ! case ( a select$ drug furni%$ or adm9i/]$ by su* a hospital1 physician1 or o!r provid] ( s]vices or suppli] to fair price eligible individuals 7:o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( section #aaia7;c77#a771 ! maximum fair price = ! select$ drug is provid$ to su* hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s 7z applicable7 ) respect to su* individuals & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u ! respective "p1 plan1 or cov]age = ! select$ drug4 7,c7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts & contracts describ$ 9 subp>agraphs 7,a7 & 7,b77 to ensure t1 n lat] ?an #ij days aft] ! disp5s+ ( a select$ drug to a fair price eligible individual 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 ! less] (-- 7,i7 ! :olesale acquisition co/ ( ! drug2 7,,ii7 ! national av]age drug acquisition co/ ( ! drug2 & 7,,iii7 any o!r simil> det]m9ation ( ph>macy acquisition co/s ( ! drug1 z det]m9$ by ! ,secret>y2 & 7ii7 ! maximum fair price = ! drug4 7,d7 ,! 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 ( fair price eligible individuals z ! ,secret>y may specify2 & 7ii7 any o!r disc\nts4 7,e7 ,! e/abli%m5t ( proc$ures to ent] into appropriate agreem5ts & protocols = ! ongo+ computation ( ,,aim prices = select$ drugs1 includ+1 to ! ext5t possible1 to compute ! ,,aim price = select$ drugs & includ+ by provid+ t ! manufactur] ( su* a select$ drug %\ld provide in=mation = su* computation n lat] ?an #c mon?s aft] ! fir/ date ( ! volunt>y negotiation p]iod = su* select$ drug4 7,f7 ,! 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,g7 ,! e/abli%m5t ( proc$ures to negotiate & apply ! maximum fair price 9 a mann] t does n include any disp5s+ or simil> fee4 7,h7 ,! e/abli%m5t ( proc$ures to c>ry out ! provisions ( ?is "p1 z applicable1 ) respect to-- 7i7 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 fair price eligible individuals :o are enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ by a heal? insurance issu] 9 ! individual or gr\p m>ket ) respect to :i* !re is an agreem5t 9 effect "u section #aaig2 & 7iii7 fair price eligible individuals :o are entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title4 7,i7 ,! e/abli%m5t ( a negotiation process & r5egotiation process 9 accordance ) section #aaid1 includ+ a process = acquir+ in=mation describ$ 9 subsection 7d7 ( su* section & det]m9+ am\nts describ$ 9 subsection 7b7 ( su* section4 7,j7 ,! provision ( a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 fair price eligible individuals1 & ! ?ird p>ty ) a contract "u subsection 7c77#a74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,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 may be report$4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7c77#a7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf or section #aaih1 z applicable4 7b7 ,collection ( data 7#a7 ,f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7#b7 ,f heal? plans ,! ,secret>y may collect appropriate data f gr\p heal? plans or heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7c7 ,contract ) ?ird p>ties 7#a7 ,9 g5]al ,! ,secret>y may 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 "p4 ,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 "p2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is "p1 z necess>y = ! manufactur] to fulfill its obligations "u ?is "p2 & 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#b7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#a7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is "p4 #aaig4 ,volunt>y p>ticipation by o!r heal? plans 7a7 ,agreem5t to p>ticipate "u program 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 "u ! program "u ?is "p ! ,secret>y %all be treat$ z hav+ 9 effect an agreem5t ) a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod-- 7,a7 ) respect to su* select$ drug furni%$ or disp5s$ at a ph>macy or by mail ord] s]vice if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or disp5s$2 & 7,b7 ) respect to su* select$ drug furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli] if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,opt+ out ( agreem5t ,! ,secret>y %all n be treat$ z hav+ 9 effect an agreem5t "u ! program "u ?is "p ) a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod if su* a plan or issu] affirmatively elects1 ?r\gh a process specifi$ by ! ,secret>y1 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 7b7 ,publication ( election ,) respect to ea* price applicability p]iod & ea* select$ drug ) respect to su* p]iod1 ! ,secret>y & ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 z applicable1 %all make public a li/ ( ea* gr\p heal? plan & ea* issu] ( heal? insurance cov]age1 ) respect to :i* cov]age is provid$ "u su* plan or cov]age = su* drug1 t has elect$ "u subsection 7a7 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 #aaih4 ,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 plan ye> dur+ ! price applicability p]iod = 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 fair price eligible individual :o ) respect to su* drug is describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & :o is furni%$ or disp5s$ su* drug dur+ su* ye>2 or 7#b7 to a hospital1 physician1 or o!r provid] ( s]vices or suppli] ) respect to 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>2 %all be subject to a civil monet>y p5alty equal to t5 times ! am\nt equal to ! diff]5ce betwe5 ! price = su* drug made available = su* ye> by su* manufactur] ) respect to su* individual or hospital1 physician1 provid]1 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 plan ye> dur+ ! price applicability p]iod = su* drug1 t is 9 violation ( a requirem5t impos$ pursuant to section #aaic7;a77#f7 %all be subject to a civil monet>y p5alty ( n m ?an #a1jjj1jjj = ea* su* violation4 7c7 ,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 #aaii4 ,miscellane\s provisions 7a7 ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to data collect$ "u ?is "p4 7b7 ,national ,academy ( ,m$ic9e /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,national ,academy ( ,m$ic9e %all conduct a /udy1 & submit to ,congress a report1 on recomm5dations = improvem5ts to ! program "u ?is "p1 includ+ ! det]m9ation ( ! limits appli$ "u section #aaid7;c74 7c7 ,med,p,a,c /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy1 & submit to ,congress a report1 on ! program "u ?is "p ) respect to ! ,m$ic>e program "u title ,,xviii1 includ+ ) respect to ! effect ( ! program on individuals entitl$ to b5efits or enroll$ "u su* title4 7d7 ,limitation on judicial review ,! foll[+ %all n be subject to judicial review3 7#a7 ,! selection ( drugs = publication "u section #aaib7;a74 7#b7 ,! det]m9ation ( :e!r a drug is a negotiation-eligible drug "u section #aaib7;d74 7#c7 ,! det]m9ation ( ! maximum fair price ( a select$ drug "u section #aaid4 7#d7 ,! det]m9ation ( units ( a drug = purposes ( section #aaia7;c77#c74 7e7 ,coord9ation ,9 c>ry+ out ?is "p ) respect to gr\p heal? plans or heal? insurance cov]age (f]$ 9 ! gr\p m>ket t are subject to ov]sight by ! ,secret>y ( ,labor or ! ,secret>y ( ! ,treasury1 ! ,secret>y ( ,heal? & ,human ,s]vices %all coord9ate ) su* respective ,secret>y4 7f7 ,data %>+ ,! ,secret>y %all %>e ) ! ,secret>y ( ! ,treasury su* in=mation z is necess>y to det]m9e ! tax impos$ by section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 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 def9$ 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#b7 applicable = su* drug & a plan ye> dur+ su* p]iod aft] p>agraph 7#d74 7,b7 ,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$ by ins]t+ 1 except z provid$ "u "p ,e ( title ,,xi aft] ! ,secret>y4 7,c7 ,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 def9$ 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 ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug & = ea* plan ye> dur+ su* p]iod4 4 7,d7 ,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 #aaif7;b74 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 ,"u gr\p heal? plans & heal? insurance cov]age 7,a7 ,,phsa ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgbi ! foll[+ new section3 #bgbi;,a4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan or cov]age if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 if cov]age ( su* select$ drug is provid$ "u su* plan or cov]age if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plans or cov]age (f]$ by su* plan or issu]s1 to ! individuals enroll$ "u su* plans or cov]age1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y1 to individuals entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 su* individuals s enroll$ 9 su* plans & cov]age1 & su* hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ 9 su* plans & cov]age4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,,erisa 7i7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaha et4 seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ ! maximum fair price negotiat$ "u su* "p = su* drug 9 lieu ( ! contract$ rate "u su* plan or cov]age = su* select$ drug2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p to su* plan1 issu]1 & cov]age1 & su* individuals s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7ii7 ,cl]ical am5dm5t ,! table ( sections = subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by add+ at ! end ! foll[+3 ,sec4 #gaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices4 4 7,c7 ,,irc 7i7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan-- 7#a7 ! provisions ( su* "p %all apply to ! plans (f]$ by su* plan1 & to ! individuals enroll$ "u su* plans1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans2 7#b7 ! plan %all apply any co/-%>+ responsibilities "u su* plan1 ) respect to su* select$ drug1 by sub/itut+ ! maximum fair price negotiat$ "u su* "p = su* drug 9 lieu ( ! contract$ rate "u su* plan = su* select$ drug2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p to su* plan & su* individuals s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7ii7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices4 4 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #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 ! ,june #af? 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 ! ,april #a/ imm$iately foll[+ ! ,june #af? describ$ 9 p>agraph 7#a7 & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has 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 7#e7 ,9 ! case ( a select$ drug ) respect to :i* a paym5t is due "u subsection 7c7 ( su* section #aaic1 ! p]iod beg9n+ on ! date on :i* ! ,secret>y ( ,heal? & ,human ,s]vices c]tifies t su* paym5t is ov]due & end+ on ! date t su* paym5t is made 9 full4 7c7 ,applicable p]c5tage ,! 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 ,def9itions ,! t]ms select$ drug publication date & maximum fair price h ! mean+ giv5 su* t]ms 9 section #aaia ( ! ,social ,security ,act & ! t]m select$ drug has ! mean+ giv5 su* t]m 9 section #aaib ( su* ,act4 7e7 ,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 #bge ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ or by section #daib be=e ! p]iod at ! end ( subsection 7a77#f74 7c7 ,con=m+ am5dm5ts 7#a7 ,section #dbba7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or #daib aft] section #daia4 7#b7 ,section #fdaf7;b77#b7 ( su* ,code is am5d$ by ins]t+ or #daib aft] section #daia4 7d7 ,cl]ical am5dm5ts 7#a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,o!r m$ical products4 7#b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,o!r m$ical products 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,select$ drugs dur+ noncompliance p]iods4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 ,,ii ,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates #bja4 ,m$ic>e "p ,b rebate by manufactur]s 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,rebate by manufactur]s = s+le s\rce drugs ) 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 #bjba1 ! ,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] ( 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 #bjba1 ! 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 ( section #ahdg;,a7c77#f771 includ+ a biosimil> biological product 7z def9$ 9 subp>agraph 7,h7 ( su* section71 paid = "u ?is "p1 except su* t]m %all n include su* a drug or biological-- 7i7 if ! av]age total all[$ *>ges = a ye> p] individual t uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 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 = #bjbb1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjba1 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>1 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 ,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#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 p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraph 7,b71 ! total numb] ( units ( ! bill+ & paym5t code = su* "p ,b rebatable drug furni%$ "u ?is "p dur+ ! cal5d> qu>t]2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! paym5t am\nt "u subp>agraph 7,b7 or 7,c7 ( section #ahdg;,a7b77#a71 z applicable1 = su* "p ,b rebatable 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 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( units ( ! bill+ & paym5t code = ea* "p ,b rebatable drug furni%$ dur+ a cal5d> qu>t] %all n include-- 7i7 units packag$ into ! paym5t = a proc$ure or s]vice "u section #ahcc7t7 or "u section #ahcc7;i7 7in/ead ( sep>ately payable "u su* respective section72 7ii7 units includ$ "u ! s+le paym5t sy/em = r5al dialysis s]vices "u section #ahha7;b77#ad72 or 7iii7 units ( a "p ,b rebatable drug ( a manufactur] furni%$ to an individual1 if su* manufactur]1 ) respect to ! furni%+ ( su* units ( su* drug1 provides = disc\nts "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or = rebates "u section #aibg4 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] beg9n+ ,janu>y #a1 #bjaf4 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 = ,july #bjae4 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#d7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,subject to subp>agraph 7,b71 9 ! case ( a "p ,b rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjae1 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 ,july #bjae "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] ,july #a1 #bjae1 p>agraph 7#a77;,b7 %all be appli$ z if ! ref]5ce to ,july #a1 #bjba "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 #bjba4 7,c7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate am\nt "u p>agraph 7#a77;,b7 ) 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 ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,d7 ,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#b77 & 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 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 ,july #bjae "u su* p>agraph 7 a ref]5ce to ! ,july ( ! ye> prec$+ su* la/ ye>4 7#e7 ,application to b5efici>y co9surance ,9 ! case ( a "p ,b rebatable drug1 if ! paym5t am\nt = a qu>t] exce$s ! inflation adju/$ paym5t = su* qu>t]-- 7,a7 9 comput+ ! am\nt ( any co9surance applicable "u ?is title to an individual ) respect to su* drug1 ! computation ( su* co9surance %all be bas$ on ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c77;,c7 = su* "p ,b rebatable drug2 & 7,b7 ! am\nt ( su* co9surance is equal to #bj p]c5t ( su* inflation-adju/$ paym5t am\nt s det]m9$4 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 7#h7 ,/udy & report 7,a7 ,/udy ,! ,secret>y %all conduct a /udy ( ! feasibility ( & op]ational issues involv$ ) ! foll[+3 7i7 ,includ+ multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c77 9 ! rebate sy/em "u ?is subsection4 7ii7 ,includ+ drugs & biologicals paid = "u ,,ma plans "u "p ,c 9 ! rebate sy/em "u ?is subsection4 7iii7 ,includ+ drugs exclud$ "u p>agraph 7#b77;,a7 & units ( ! bill+ & paym5t code ( ! drugs exclud$ "u p>agraph 7#c77;,b7 9 ! rebate sy/em "u ?is subsection4 7,b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a74 7#i7 ,application to multiple s\rce drugs ,! ,secret>y may1 bas$ on ! report submitt$ "u p>agraph 7#h7 & pursuant to rulemak+1 apply ! provisions ( ?is subsection to multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c771 includ+1 = purposes ( det]m9+ ! rebate am\nt "u p>agraph 7#c71 by calculat+ manufactur]-specific av]age sales prices = ! b5*m>k p]iod & ! rebate p]iod4 4 7b7 ,am\nts payable2 co/-,%>+ ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,s71 by /rik+ ) respect to & ins]t+ subject to subp>agraph 7,,dd71 ) respect to2 7ii7 by /rik+ & 7,,cc7 & ins]t+ 7,,cc72 & 7iii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,dd7 ) respect to a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* ! paym5t am\nt = a cal5d> qu>t] "u p>agraph 7#c77;,a77ii77,i7 ( su* section = 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 ! diff]5ce betwe5 7i7 ! paym5t am\nt "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* drug1 & 7ii7 #bj p]c5t ( ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* drug2 7,b7 9 p>agraph 7#d71 by ins]t+ subject to p>agraph 7#a77;,,dd71 be=e ! applicable am\nt2 & 7,c7 by add+ at ! end ( ! flu% left matt] foll[+ p>agraph 7#i71 ! foll[+3 ,= purposes ( apply+ p>agraph 7#a77;,,dd71 subsection 7t77#bc71 & section #ahcd7x77#e71 ! ,secret>y %all make su* e/imates & use su* data z ! ,secret>y det]m9es appropriate1 & not)/&+ any o!r provision ( law1 may d s by program in/ruction or o!rwise4 2 7#b7 9 subsection 7t71 by add+ at ! end ! foll[+ new p>agraph3 7#bc7 ,"p ,b rebatable drugs ,! am\nt ( paym5t "u ?is subsection = a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* ! paym5t am\nt = a cal5d> qu>t] "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* qu>t] exce$s ! inflation adju/$ paym5t "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* qu>t] & t is furni%$ z "p ( a cov]$ ,,opd s]vice 7or gr\p ( s]vices71 %all be ! diff]5ce betwe5-- 7,a7 ! paym5t "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* drug2 & 7,b7 #bj p]c5t ( ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* drug4 4 7c7 ,con=m+ am5dm5t 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+ or section #ahcd7x7 aft] section #aibg4 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s ,"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 ,9 g5]al 7#a7 ,9 g5]al ,subject to ! provisions ( ?is section1 9 ord] = cov]age to be available "u ?is "p = a "p ,d rebatable drug 7z def9$ 9 subsection 7h77#a77 ( a manufactur] 7z def9$ 9 section #aibg7k77#e77 disp5s$ dur+ an applicable ye>1 ! manufactur] mu/ h ent]$ into & h 9 effect an agreem5t describ$ 9 subsection 7b74 7#b7 ,au?oriz+ ,cov]age = ,drugs ,n ,cov]$ ,"u ,agreem5ts ,p>agraph 7#a7 %all n apply to ! disp5s+ ( a cov]$ "p ,d drug if-- 7,a7 ! ,secret>y has made a det]m9ation t ! availability ( ! drug is ess5tial to ! heal? ( b5efici>ies "u ?is "p2 or 7,b7 ! ,secret>y det]m9es t 9 a specifi$ p]iod 7z specifi$ by ! ,secret>y71 !re 7 ext5uat+ circum/ances4 7#c7 ,applicable ye> ,= purposes ( ?is section ! t]m applicable ye> means a ye> beg9n+ ) #bjbb4 7b7 ,agreem5ts 7#a7 ,t]ms ( agreem5t ,an agreem5t describ$ 9 ?is subsection1 ) respect to a manufactur] ( a "p ,d rebatable drug1 is an agreem5t "u :i* ! foll[+ %all apply3 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #i mon?s aft] ! end ( ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! ,secret>y1 = ea* "p ,d rebatable drug ( ! manufactur]1 %all report to ! manufactur] ! foll[+ = su* ye>3 7i7 ,in=mation on ! total numb] ( units 7z def9$ 9 subsection 7h77#b77 = ea* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age manufactur] price increase describ$ 9 subsection 7c77#a77;,b7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7iii7 ,! rebate am\nt specifi$ "u subsection 7c7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7,b7 ,manufactur] requirem5ts ,= ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! manufactur] ( ! "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 subp>agraph 7,a7 = su* ye>1 %all provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 subsection 7c7 = su* dosage =m & /r5g? ) respect to su* drug = su* ye>4 7#b7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section1 ) respect to a "p ,d rebatable drug1 %all be effective = an initial p]iod ( n less ?an "o ye> & %all be automatically r5ew$ = a p]iod ( n less ?an "o ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 b su* he>+ %all n delay ! effective date ( ! t]m9ation4 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 #cj ( ! plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( ! plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7,c7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is p>agraph %all n affect rebates due "u ! agreem5t "u ?is section be=e ! effective date ( its t]m9ation4 7,d7 ,delay be=e re5try ,9 ! case ( any agreem5t "u ?is section ) a manufactur] t is t]m9at$ 9 a plan ye>1 ! ,secret>y may n ent] into ano!r su* agreem5t ) ! manufactur] 7or a successor manufactur]7 be=e ! subsequ5t plan ye>1 unless ! ,secret>y f9ds good cause = an e>li] re9/atem5t ( su* an agreem5t4 7c7 ,rebate am\nt 7#a7 ,9 g5]al ,= 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>agraphs 7,b7 & 7,c7 ( p>agraph 7#e71 ! am\nt equal to ! product (-- 7,a7 ! total numb] ( units ( su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>2 & 7,b7 ! am\nt 7if any7 by :i*-- 7i7 ! 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 7ii7 ! 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 ,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 7h77#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? disp5s$ dur+ ea* su* cal5d> qu>t] ( su* ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* ye>4 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 subp>agraphs 7,a7 & 7,d7 ( 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 & an applicable ye>2 increas$ by 7,b7 ! p]c5tage by :i* ! applicable ye> ,,cpi-,u 7z def9$ 9 subsection 7h77#e77 = ! applicable ye> exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subsection 7h77#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 7h77#f77 ( su* dosage =m & /r5g?1 z calculat$ = a unit ( su* drug1 ) respect to ea* cal5d> qu>t] ( ! paym5t am\nt b5*m>k ye> 7z def9$ 9 subsection 7h77#c772 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* cal5d> qu>t] ( ! paym5t am\nt b5*m>k ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ ! 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] ,janu>y #a1 #bjaf1 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 7h77#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 7h77#d7 z if ! ref]5ce to ,janu>y #bjaf "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 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u p>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 ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,c7 ,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+ ! am\nt specifi$ 9 ?is subsection ) respect to su* "p ,d rebatable drug & an applicable ye> ) consid]ation ( ! orig9al "p ,d rebatable drug4 7ii7 ,l9e ext5sion def9$ ,9 ?is subp>agraph1 ! t]m l9e ext5sion means1 ) respect to a "p ,d rebatable drug1 a new =mulation ( ! drug 7z det]m9$ by ! ,secret>y71 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,d7 ,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#b77 & 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 7h77#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 7h77#d7 z if ! ref]5ce to ,janu>y #bjaf "u su* subsection 7 a ref]5ce to ,janu>y ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* drug4 7d7 ,rebate deposits ,am\nts paid z rebates "u subsection 7c7 %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 7e7 ,in=mation ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all use in=mation submitt$ by manufactur]s "u section #aibg7;b77#c74 7f7 ,civil money p5alty ,9 ! case ( a manufactur] ( a "p ,d rebatable drug ) an agreem5t 9 effect "u ?is section :o has fail$ to comply ) ! t]ms ( ! agreem5t "u subsection 7b77#a77;,b7 ) respect to su* drug = an applicable ye>1 ! ,secret>y may impose a civil money p5alty on su* manufactur] 9 an am\nt equal to #abe p]c5t ( ! am\nt specifi$ 9 subsection 7c7 = 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 7g7 ,judicial review ,!re %all be no 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 7h7 ,def9itions ,9 ?is section3 7#a7 ,"p ,d rebatable drug def9$ 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 = #bjbc1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbb1 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 ( #bjbb2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is subp>agraph 7or subp>agraph 7,a77 = ! 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 def9$ ,! t]m unit means1 ) respect to a "p ,d rebatable drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! "p ,d rebatable drug t is disp5s$ to individuals "u ?is "p4 7#c7 ,paym5t am\nt b5*m>k ye> ,! t]m paym5t am\nt b5*m>k ye> means ! ye> beg9n+ ,janu>y #a1 #bjaf4 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 = ,janu>y #bjaf4 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 4 ,,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$+ #bjbb & = 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 = #bjbb & 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$+ #bjbb1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ & #bjba2 & 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$+ #bjbb1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjba2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjba2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjba2 & 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$+ #bjbb1 ! 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 = #bjbb & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 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+ = #bjba2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbb1 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$+ #bjbb1 = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( ye>s #bjaa ?r\gh #bjba1 9 apply+4 7b7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is am5d$ by ins]t+ aft] #hj p]c5t ! foll[+3 7or1 ) respect to a cov]age ye> aft] #bjba1 #bj p]c5t74 7c7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq471 z am5d$ by section #bjb1 is fur!r am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,b ! foll[+ new section3 #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 #bjba1 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 provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbb4 7,b7 ,provision ( disc\nt$ prices at ! po9t-(-sale ,! disc\nt$ prices describ$ 9 subp>agraph 7,a7 %all be provid$ to ! applicable b5efici>y at ! ph>macy or by ! mail ord] s]vice at ! po9t-(-sale ( an applicable drug4 7,c7 ,tim+ ( agreem5t 7i7 ,special rule = #bjbb ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ on ,decemb] #ca1 #bjbb1 ! manufactur] %all ent] into su* agreem5t n lat] ?an #cj days aft] ! date ( ! e/abli%m5t ( a model agreem5t "u subsection 7a74 7ii7 #bjbc & subsequ5t ye>s ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to plan ye> #bjbc or a subsequ5t plan ye>1 ! manufactur] %all ent] into su* agreem5t 7or su* agreem5t %all be r5ew$ "u p>agraph 7#d77;,a77 n lat] ?an ,janu>y #cj ( ! prec$+ ye>4 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 may 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 #cj ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( 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 "u :i* disc\nt$ prices are provid$ to applicable b5efici>ies at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( an applicable drug2 7,c7 ! 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,d7 ! 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 ! ,secret>y may specify2 & 7,e7 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 ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ! program "u ?is section by program in/ruction or o!rwise4 7#f7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 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 ,! ,secret>y may impose a civil money p5alty on a manufactur] t fails to provide applicable b5efici>ies disc\nts = applicable drugs ( ! manufactur] 9 accordance ) su* agreem5t = 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/s = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = su* ye>4 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 def9$ 9 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 ) respect to an applicable drug ( a manufactur] furni%$ dur+ a ye> to an applicable b5efici>y-- 7i7 :o has n incurr$ co/s = 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/s 9 ! ye> t are equal to or exce$ su* ?re%old = ! ye>1 #gj p]c5t ( ! negotiat$ price ( su* drug4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+ ! responsibility ( an applicable b5efici>y = paym5t ( a disp5s+ fee = an applicable drug4 7,c7 ,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 at or 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 at or 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 regulation71 except t su* negotiat$ price %all n include any disp5s+ 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 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 #bjbb1 &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 aft] ,janu>y #a1 #bjbb1 ) 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 = #bjbb & 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 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c2 4 7d7 ,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$+ #bjbb1 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$+ #bjbb or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbb & 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$+ #bjbb1 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$+ #bjbb1 ! 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$+ #bjbb1 ! 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$+ #bjbb1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! 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 #bjbb1 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 = #bjbb & 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 #bjbb 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 #bjba1 ! ,m$ic>e cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbb & 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 #bjba1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,a ) ! ,secret>y2 & 7,b7 = #bjbb & 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 #bjba1 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 = #bjbb & 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 #bjbb1 & 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 #bjbb4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye> #bjbb & subsequ5t plan ye>s4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances ,section #ahfj;,d-#b7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 z am5d$ by section #cja1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,subject to subp>agraphs 7,c7 & 7,d7 & ins]t+ ,subject to subp>agraphs 7,c71 7,d71 & 7,e72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,enrollee option reg>d+ spread+ co/-%>+ ,! ,secret>y %all e/abli% by regulation a process "u :i*1 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 a prescription drug plan or an ,,ma-,,pd plan %all1 9 ! case ( a "p ,d eligible individual enroll$ ) su* plan = su* plan ye> :o is n a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77 & ) respect to :om ! plan projects t ! disp5s+ ( ! fir/ fill ( a cov]$ "p ,d drug to su* individual w result 9 ! individual incurr+ co/s t are equal to or above ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = su* plan ye>1 provide su* individual ) ! option to make ! co9surance paym5t requir$ "u subp>agraph 7,a7 7= ! portion ( su* co/s t are n above su* annual out-(-pocket ?re%old7 9 ! =m ( p]iodic in/allm5ts ov] ! rema9d] ( su* plan ye>4 4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$-- 7#a7 by r$esignat+ ! p>agraph 7#f71 z add$ by section #ejced ( division ,e ( ! ,bip>tisan ,budget ,act ( #bjah 7,public ,law #aae-abc71 z p>agraph 7#g72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ( ph>macy quality measures 7,a7 ,9 g5]al ,a ,,pdp sponsor t implem5ts inc5tive paym5ts to a ph>macy or price concessions paid by a ph>macy bas$ on quality measures %all use measures e/abli%$ or approv$ by ! ,secret>y "u subp>agraph 7,b7 ) respect to paym5t = cov]$ "p ,d drugs disp5s$ by su* ph>macy4 7,b7 ,/&>d ph>macy quality measures ,! ,secret>y %all e/abli% or approve /&>d quality measures f a cons5sus & evid5ce-bas$ organization = paym5ts describ$ 9 subp>agraph 7,a74 ,su* measures %all focus on pati5t heal? outcomes & be bas$ on prov5 crit]ia measur+ ph>macy p]=mance4 7,c7 ,effective date ,! requirem5t "u subp>agraph 7,a7 %all take effect = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 or su* e>li] date specifi$ by ! ,secret>y if ! ,secret>y det]m9es !re are suffici5t measures e/abli%$ or approv$ "u subp>agraph 7,b7 to meet ! requirem5t "u subp>agraph 7,a74 4 ,,iv ,prescription ,drug ,policies = ,l[-,income ,individuals #dja4 ,adju/m5ts to ,m$ic>e "p ,d co/-%>+ r$uctions = l[-income individuals ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 z am5d$ by section #cja7;d71 is fur!r am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,d7-- 7i7 9 clause 7ii7-- 7,i7 by /rik+ t does n exce$ #a = & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ t does n exce$-- 7,i7 = plan ye>s be=e plan ye> #bjba-- 7aa7 = a g5]ic drug or a pref]r$ drug t is a multiple s\rce drug 7z def9$ 9 section #aibg7k77#g77;,a77i771 #a or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 7bb7 = any o!r drug1 #c or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 2 & 7,,ii7 by add+ at ! end ! foll[+ new subclauses3 7,,ii7 = plan ye> #bjba-- 7aa7 = a g5]ic drug1 #j2 & 7bb7 = any o!r drug1 ! doll> am\nt appli$ "u ?is clause 7aft] application ( p>agraph 7#d77;,a77 = plan ye> #bjbj = a drug describ$ 9 subclause 7,i77bb72 & 7,,iii7 = a subsequ5t ye>1 ! doll> am\nt appli$ "u ?is clause = ! previ\s ye> = ! drug1 increas$ by ! annual p]c5tage increase 9 ! consum] price index 7all items2 ,u4,s4 city av]age7 z ( ,septemb] ( su* previ\s ye>4 2 & 7ii7 9 clause 7iii7-- 7,i7 by /rik+ does n exce$ ! copaym5t am\nt specifi$ "u & ins]t+ does n exce$-- 7,i7 = plan ye>s beg9n+ be=e plan ye> #bjba1 ! copaym5t am\nt specifi$ "u 2 7,,ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+ new subclause3 7,,ii7 = plan ye> #bjba & ea* subsequ5t plan ye>1 ! copaym5t am\nt appli$ "u clause 7ii7 = ! drug & ye> involv$4 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,r\nd+ ,any am\nt e/abli%$ "u clause 7ii7 ( subp>agraph 7,d71 includ+ z appli$ "u clause 7iii7 ( su* subp>agraph or p>agraph 7#b77;,d71 t is bas$ on an increase ( #c1 t is n a multiple ( #e c5ts or #aj c5ts1 respectively1 %all be r\nd$ to ! ne>e/ multiple ( #e c5ts or #aj c5ts1 respectively4 2 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,d7-- 7i7 by /rik+ ( co9surance ( & ins]t+ (-- 7i7 = plan ye>s be=e plan ye> #bjba1 co9surance ( 2 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7ii7 = plan ye> #bjba & ea* subsequ5t plan ye>1 a copaym5t am\nt t does n exce$ ! copaym5t am\nt appli$ "u p>agraph 7#a77;,d77ii7 = ! drug & ye> involv$4 2 & 7,b7 9 subp>agraph 7,e7-- 7i7 by /rik+ subsection 7c71 ! sub/itution = & ins]t+ subsection 7c7-- 7i7 = plan ye>s be=e plan ye> #bjba1 ! sub/itution = 2 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7ii7 = plan ye> #bjba1 ! elim9ation ( any co/-%>+ impos$ "u section #ahfj;,d-#b7;b77#d77;,a74 2 & 7#c7 9 p>agraph 7#d77;,a77ii71 by ins]t+ 7be=e #bjba7 aft] subsequ5t ye>4 #djb4 ,dissem9ation to ,m$ic>e "p ,d subsidy eligible individuals ( in=mation comp>+ premiums ( c]ta9 prescription drug plans ,section #ahfj;,d-#a7;c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;c77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,in=mation on premiums = subsidy eligible individuals 7i7 ,9 g5]al ,= plan ye> #bjbb & ea* subsequ5t plan ye>1 ! ,secret>y %all dissem9ate to ea* subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77 in=mation "u ?is p>agraph comp>+ premiums t w\ld apply to su* individual = prescription drug cov]age "u ,,lis b5*m>k plans1 includ+1 9 ! case ( an individual enroll$ 9 a prescription drug plan "u ?is "p1 in=mation t comp>es ! premium t w\ld apply if su* individual 7 to rema9 enroll$ 9 su* plan to premiums t w\ld apply if ! individual 7 to enroll 9 o!r ,,lis b5*m>k plans4 7ii7 ,,lis b5*m>k plan ,= purposes ( clause 7i71 ! t]m ,,lis b5*m>k plan means1 ) respect to an individual1 a prescription drug plan "u ?is "p t is (f]$ 9 ! region 9 :i* ! individual resides &-- 7,i7 t provides = a premium t is n m ?an ! l[-income b5*m>k premium am\nt 7z def9$ 9 section #ahfj;,d-#ad7;b77#b77 = su* region2 or 7,,ii7 ) respect to :i* ! premium w\ld be waiv$ z de m9imis pursuant to section #ahfj;,d-#ad7;a77#e7 = su* individual4 4 #djc4 ,provid+ = intellig5t assignm5t ( c]ta9 subsidy eligible individuals auto-enroll$ "u ,m$ic>e prescription drug plans & ,,ma-,,pd plans 7a7 ,9 g5]al ,section #ahfj;,d-#a7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;b77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c7-- 7,a7 by ins]t+ aft] ,,pdp region ! foll[+3 or ?r\gh use ( an intellig5t assignm5t process t is design$ to maximize ! access ( su* individual to necess>y prescription drugs :ile m9imiz+ co/s to su* individual & to ! program "u ?is "p to ! greate/ ext5t possible4 ,9 ! case ! ,secret>y enrolls su* individuals ?r\gh use ( an intellig5t assignm5t process1 su* process %all take into acc\nt ! ext5t to :i* prescription drugs necess>y = ! individual are cov]$ 9 ! case ( a ,,pdp sponsor ( a prescription drug plan t uses a =mul>y1 ! use ( prior au?orization or o!r re/rictions on access to cov]age ( su* prescription drugs by su* a sponsor1 & ! ov]all quality ( a prescription drug plan z measur$ by quality rat+s e/abli%$ by ! ,secret>y2 & 7,b7 by /rik+ ,no?+ 9 ! previ\s s5t5ce & ins]t+ ,no?+ 9 ?is subp>agraph2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 by ins]t+ aft] ,,pdp region ! foll[+3 or ?r\gh use ( an intellig5t assignm5t process t is design$ to maximize ! access ( su* individual to necess>y prescription drugs :ile m9imiz+ co/s to su* individual & to ! program "u ?is "p to ! greate/ ext5t possible4 ,9 ! case ! ,secret>y enrolls su* individuals ?r\gh use ( an intellig5t assignm5t process1 su* process %all take into acc\nt ! ext5t to :i* prescription drugs necess>y = ! individual are cov]$ 9 ! case ( a ,,pdp sponsor ( a prescription drug plan t uses a =mul>y1 ! use ( prior au?orization or o!r re/rictions on access to cov]age ( su* prescription drugs by su* a sponsor1 & ! ov]all quality ( a prescription drug plan z measur$ by quality rat+s e/abli%$ by ! ,secret>y2 & 7,b7 by /rik+ ,no?+ 9 ! previ\s s5t5ce & ins]t+ ,no?+ 9 ?is subp>agraph4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply ) respect to plan ye>s beg9n+ ) plan ye> #bjbb4 #djd4 ,exp&+ eligibility = l[-income subsidies "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 z am5d$ by sections #cja7;d7 & #dja1 is fur!r am5d$-- 7#a7 9 ! subsection head+1 by /rik+ individuals & all t foll[s ?r\gh l9e & ins]t+ c]ta9 individuals2 7#b7 9 p>agraph 7#a7-- 7,a7 by /rik+ ! p>agraph head+ & ins]t+ ,individuals ) c]ta9 l[ incomes2 & 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #aej p]c5t7 aft] #ace p]c5t2 7#c7 9 p>agraph 7#b7-- 7,a7 by /rik+ ! p>agraph head+ & ins]t+ ,o!r l[-income individuals2 & 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #aej p]c5t7 aft] #ace p]c5t2 & 7ii7 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #bjj p]c5t7 aft] #aej p]c5t2 & 7#d7 9 p>agraph 7#c77;,a77ii71 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #bjj p]c5t7 aft] #aej p]c5t4 #dje4 ,automatic eligibility ( c]ta9 l[-income t]ritorial resid5ts = premium & co/-%>+ subsidies "u ! ,m$ic>e program2 ,sunset ( enhanc$ allotm5t program 7a7 ,automatic eligibility ( c]ta9 l[-,income t]ritorial resid5ts = premium & co/-,%>+ subsidies "u ! ,m$ic>e program 7#a7 ,9 g5]al ,section #ahfj;,d-#ad7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77 is am5d$-- 7,a7 9 subp>agraph 7,b77v7-- 7i7 9 subclause 7,i71 by /rik+ & at ! end2 7ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by ins]t+ aft] subclause 7,,ii7 ! foll[+ new subclause3 7,,iii7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 %all provide t any "p ,d eligible individual :o is enroll$ = m$ical assi/ance "u ! ,/ate ,m$icaid plan ( a t]ritory 7z def9$ 9 section #aice7;f77 "u title ,,xix 7or a waiv] ( su* a plan7 %all be treat$ z a subsidy eligible individual describ$ 9 p>agraph 7#a74 2 & 7,b7 9 subp>agraph 7,f71 by add+ at ! end ! foll[+ new s5t5ce3 ,! previ\s s5t5ce %all n apply ) respect to eligibility det]m9ations = premium & co/-%>+ subsidies "u ?is section made on or aft] ,janu>y #a1 #bjba44 7#b7 ,con=m+ am5dm5t ,section #ahfj;,d-#ca7;j77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ada7;j77#b77;,d77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,! previ\s s5t5ce %all n apply ) respect to am\nts made available to a ,/ate "u ?is p>agraph on or aft] ,janu>y #a1 #bjba44 7b7 ,sunset ( enhanc$ allotm5t program 7#a7 ,9 g5]al ,section #aice7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7;e77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a71 by ins]t+ aft] su* ,/ate ! foll[+3 be=e ,janu>y #a1 #bjba2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ aft] a ye> ! foll[+3 7be=e #bjba72 & 7ii7 9 subp>agraph 7,b77iii71 by /rik+ a subsequ5t ye> & ins]t+ ea* ( fiscal ye>s #bjjh ?r\gh #bjbj4 7#b7 ,t]ritory def9$ ,section #aice ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,t]ritory def9$ ,9 ?is section1 ! t]m t]ritory means ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa4 4 #djf4 ,automatic qualification ( c]ta9 ,m$icaid b5efici>ies = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program ,clause 7v7 ( section #ahfj;,d-#ad7;a77#c77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,b771 z am5d$ by section #dje1 is fur!r am5d$-- 7#a7 9 subclause 7,,ii71 by /rik+ & at ! end2 7#b7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] subclause 7,,iii7 ! foll[+ new subclause3 7,,iv7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb1 %all1 not)/&+ ! prec$+ clauses ( ?is subp>agraph1 provide t any "p ,d eligible individual n describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 :o is enroll$1 z ( ! day be=e ! date on :i* su* individual atta9s ! age ( #fe1 = m$ical assi/ance "u a ,/ate plan "u title ,,xix 7or a waiv] ( su* plan7 pursuant to clause 7i77,,viii7 or 7ii77,,xx7 ( section #aijb7;a77#aj77;,a71 & :o has income bel[ #bjj p]c5t ( ! pov]ty l9e applicable to a family ( ! size involv$1 %all be treat$ z a subsidy eligible individual describ$ 9 p>agraph 7#a7 = a limit$ p]iod ( "t1 z specifi$ by ! ,secret>y4 4 #djg4 ,elim9at+ ! res\rce requirem5t ) respect to subsidy eligible individuals "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a77#c77;,a77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,a77iii77 is am5d$ by ins]t+ 9 ! case ( a plan ye> beg9n+ be=e ,janu>y #a1 #bjbb1 be=e meets4 ,v ,drug ,price ,transp>5cy #eja4 ,drug price transp>5cy ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new sections3 #aaej;,c4 ,report+ on drug prices 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 :o is responsible = sett+ ! :olesale acquisition co/ = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m1 adju/$ = inflation occurr+ aft] ! date ( enactm5t ( ?is section1 = a mon?'s supply or a typical c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7ii7 n a prev5tative vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii or "u a ,/ate ,m$icaid plan "u title ,,xix or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b74 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y if1 ) respect to ! qualify+ drug-- 7,a7 !re is an increase 9 ! price ( ! qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a #ab-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7,b7 ! e/imat$ price ( ! qualify+ drug or sp5d+ p] individual or p] us] ( su* drug 7z e/imat$ by ! ,secret>y7 = ! applicable ye> 7or p] c\rse ( treatm5t 9 su* applicable ye> z det]m9$ by ! ,secret>y7 is at lea/ #bf1jjj beg9n+ on or aft] ,janu>y #a1 #bjba4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y-- 7,a7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjai1 & end+ on ! day t is #fj days aft] ! date ( ! enactm5t ( ?is section1 n lat] ?an #ij days aft] su* date ( enactm5t2 7,b7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs aft] ! p]iod describ$ 9 subp>agraph 7,a71 n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase = su* qualify+ drug2 & 7,c7 9 ! case ( a report ) respect to a qualify+ drug t meets ! crit]ia "u p>agraph 7#a77;,b71 n lat] ?an #cj days aft] su* drug meets su* crit]ia4 7c7 ,cont5ts ,a report "u subsection 7b71 consi/5t ) ! /&>d = disclosures describ$ 9 section #bac4c7;d7 ( title #ab1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is section71 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug )9 ! #ab-mon? p]iod or #cf-mon? p]iod z describ$ 9 subsection 7b77#a77;,a77i7 or 7b77#a77;,a77ii71 & ! effective date ( su* price increase or ! co/ associat$ ) a qualify+ drug if su* drug meets ! crit]ia "u subsection 7b77#a77;,b7 & ! effective date at :i* su* drug meets su* crit]ia2 7,b7 an explanation =1 & description (1 ea* price increase = su* drug t w occur dur+ ! #ab-mon? p]iod or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77i7 or 7b77#a77;,a77ii71 z applicable2 7,c7 an explanation =1 & description (1 ! co/ associat$ ) a qualify+ drug if su* drug meets ! crit]ia "u subsection 7b77#a77;,b71 z applicable2 7,d7 if kn[n & diff]5t f ! manufactur] ( ! qualify+ drug1 ! id5tity (-- 7i7 ! sponsor or sponsors ( any inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = cl9ical inve/igations ) respect to su* drug1 = :i* ! full reports are submitt$ z "p ( ! application-- 7,i7 = approval ( ! drug "u section #eje ( su* ,act2 or 7,,ii7 = lic5sure ( ! drug "u section #cea ( ! ,pubic ,heal? ,s]vice ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7,e7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 if applicable2 7,f7 ! curr5t :olesale acquisition co/ ( ! drug2 7,g7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 & 7iii7 pur*as+ or acquir+ su* drug f ano!r manufactur]1 if applicable2 7,h7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,i7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is necess>y to demon/rate t x meets applicable /atutory /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable2 7,j7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7,k7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,l7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,m7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #ab-mon? p]iod describ$ 9 subsection 7b77#a77;,a77i7 or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77ii71 z applicable2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #ab-mon? p]iods describ$ 9 subsection 7b77#a77;,a77i7 or ! #cf-mon? p]iods describ$ 9 subsection 7b77#a77;,a77ii71 z applicable2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials1 includ+ on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate & z specifi$ by ! ,secret>y4 7d7 ,in=mation provid$ ,! manufactur] ( a qualify+ drug t is requir$ to submit a report "u subsection 7b71 %all ensure t su* report & any explanation =1 & description (1 ea* price increase describ$ 9 subsection 7c77#a7 %all be tru?ful1 n mislead+1 & accurate4 7e7 ,civil monet>y p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 foll[+ notification by ! ,secret>y to ! manufactur] t ! manufactur] is n 9 compliance ) ?is section1 %all be subject to a civil monet>y p5alty ( #ge1jjj = ea* day on :i* ! violation cont9ues4 7f7 ,false in=mation ,any manufactur] t submits a report = a drug z requir$ by ?is section t kn[+ly provides false in=mation 9 su* report is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7g7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#d71 ! ,secret>y %all po/ ea* report submitt$ "u subsection 7b7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! day ! price increase ( a qualify+ drug is s*$ul$ to g into effect4 7#b7 ,=mat ,9 develop+ ! =mat 9 :i* reports w be publicly po/$ "u p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back f consum] advocates & readability exp]ts on ! =mat & pres5tation ( ! cont5t ( su* reports to ensure t su* reports are-- 7,a7 us]-fri5dly to ! public2 & 7,b7 writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,li/ ,9 addition to ! reports submitt$ "u subsection 7b71 ! ,secret>y %all also po/ a li/ ( ea* qualify+ drug ) respect to :i* ! manufactur] 0 requir$ to submit su* a report 9 ! prec$+ ye> & :e!r su* manufactur] 0 requir$ to submit su* report bas$ on a qualify+ price increase or :e!r su* drug meets ! crit]ia "u subsection 7b77#a77;,b74 7#d7 ,protect$ in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 #aaej;,d4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ! ,committees on ,en]gy & ,comm]ce & ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committees on ,heal?1 ,education1 ,labor1 & ,p5sions & ,f9ance ( ! ,s5ate1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is us]-fri5dly to ! public & writt5 9 pla9 language t consum]s c readily und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #aaej;,c2 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section2 7#c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out section #aaej;,c2 & 7#d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7b7 ,protect$ in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 4 ,,vi ,miscellane\s #fja4 ,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 biosimil> biological product is-- 7,i7 9 ! case ( su* a product = :i* paym5t 0 made "u ?is p>agraph z ( ,decemb] #ca1 #bjai1 ! #e-ye> p]iod beg9n+ on ,janu>y #a1 #bjbj2 & 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+ ,janu>y #a1 #bjbj1 & end+ ,decemb] #ca1 #bjbd1 ! #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 is n m ?an ! av]age sales price = ! ref]5ce biological product2 & 7,,ii7 9 ! case ( a product describ$ 9 clause 7ii77,,ii71 ! :olesale acquisition co/ is n m ?an ! :olesale acquisition co/ = ! ref]5ce biological product4 4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,l[]+ ,prices ,?r\gh ,fair ,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 ,title ,,ii--,m$ic>e ,p>ts ,b & ,d ,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 ,b5efici>ies ,sec4 #cja4 ,m$ic>e "p ,d b5efit r$esign4 ,sec4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4 ,sec4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4 ,title ,,iv--,prescription ,drug ,policies = ,l[-,income ,individuals ,sec4 #dja4 ,adju/m5ts to ,m$ic>e "p ,d co/-%>+ r$uctions = l[-income individuals4 ,sec4 #djb4 ,dissem9ation to ,m$ic>e "p ,d subsidy eligible individuals ( in=mation comp>+ premiums ( c]ta9 prescription drug plans4 ,sec4 #djc4 ,provid+ = intellig5t assignm5t ( c]ta9 subsidy eligible individuals auto-enroll$ "u ,m$ic>e prescription drug plans & ,,ma-,,pd plans4 ,sec4 #djd4 ,exp&+ eligibility = l[-income subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #dje4 ,automatic eligibility ( c]ta9 l[-income t]ritorial resid5ts = premium & co/-%>+ subsidies "u ! ,m$ic>e program2 ,sunset ( enhanc$ allotm5t program4 ,sec4 #djf4 ,automatic qualification ( c]ta9 ,m$icaid b5efici>ies = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program4 ,sec4 #djg4 ,elim9at+ ! res\rce requirem5t ) respect to subsidy eligible individuals "u "p ,d ( ! ,m$ic>e program4 ,sec4 #djh4 ,provid+ = c]ta9 rules reg>d+ ! treatm5t ( eligible retirem5t plans 9 det]m9+ ! eligibility ( individuals = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program4 ,title ,v--,drug ,price ,transp>5cy ,sec4 #eja4 ,drug price transp>5cy4 ,i ,l[]+ ,prices ,?r\gh ,fair ,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 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by add+ at ! end ! foll[+ new "p3 ,e ,fair ,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 ,fair ,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/ ( 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 plan ye> 7beg9n+ ) plan ye> #bjbc7 or1 if agre$ to 9 an agreem5t "u section #aaic by ! ,secret>y & manufactur] involv$1 a p]iod ( m ?an "o plan ye> 7beg9n+ on or aft] ,janu>y #a1 #bjbc74 7#b7 ,price applicability p]iod ,! t]m price applicability p]iod means1 ) respect to a drug1 ! p]iod beg9n+ ) ! initial price applicability ye> ) respect to :i* su* drug is a select$ drug & end+ ) ! la/ plan 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 ,april #ae ( ! plan ye> t beg9s #b ye>s prior to su* ye>4 7#d7 ,volunt>y negotiation p]iod ,! t]m volunt>y 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 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug2 & 7,b7 end+ on ,m>* #ca ( ! ye> t beg9s "o ye> prior to ! initial price applicability ye>4 7c7 ,o!r def9itions ,= purposes ( ?is "p3 7#a7 ,fair price eligible individual ,! t]m fair price eligible individual means1 ) respect to a select$ drug-- 7,a7 9 ! case su* drug is furni%$ or disp5s$ to ! individual at a ph>macy or by a mail ord] s]vice-- 7i7 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 "u :i* cov]age is provid$ = su* drug2 & 7ii7 an individual :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or disp5s$2 & 7,b7 9 ! case su* drug is furni%$ or adm9i/]$ to ! individual by a hospital1 physician1 or o!r provid] ( s]vices or suppli]-- 7i7 an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title if su* select$ drug is cov]$ "u ! respective "p2 & 7ii7 an individual :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,maximum fair price ,! t]m maximum fair price means1 ) respect to a plan 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 ,av]age int]national m>ket price def9$ 7,a7 ,9 g5]al ,! t]ms av]age int]national m>ket price & ,,aim price mean1 ) respect to a drug1 ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit 7z def9$ 9 p>agraph 7#d77 ( ! drug = sales ( su* drug 7calculat$ across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type71 z comput$ 7z ( ! date ( publication ( su* drug z a select$ drug "u section #aaib7;a77 9 all c\ntries describ$ 9 clause 7ii7 ( subp>agraph 7,b7 t are applicable c\ntries 7z describ$ 9 clause 7i7 ( su* subp>agraph7 ) respect to su* drug4 7,b7 ,applicable c\ntries 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 a c\ntry describ$ 9 clause 7ii7 is an applicable c\ntry describ$ 9 ?is clause ) respect to a drug if !re is available an av]age price = any unit = ! drug = sales ( su* drug 9 su* c\ntry4 7ii7 ,c\ntries describ$ ,= purposes ( ?is p>agraph1 ! foll[+ are c\ntries describ$ 9 ?is clause3 7,i7 ,au/ralia4 7,,ii7 ,canada4 7,,iii7 ,france4 7,,iv7 ,g]many4 7,v7 ,japan4 7,,vi7 ,! ,unit$ ,k+dom4 7#d7 ,unit ,! t]m unit means1 ) respect to a drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! drug t is disp5s$4 #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 ! ,secret>y %all select & publi% 9 ! ,f$]al ,regi/] a li/ (-- 7#a7 7,a7 ) respect to an initial price applicability ye> dur+ ! p]iod beg9n+ ) #bjbc & end+ ) #bjbg1 at lea/ #be negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod beg9n+ aft] #bjbc1 ! maximum numb] 7if su* numb] is less ?an #be7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7,b7 ) respect to an initial price applicability ye> dur+ ! p]iod beg9n+ ) #bjbh & end+ ) #bjcb1 at lea/ #cj negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #cj7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 & 7,c7 ) respect to an initial price applicability ye> beg9n+ aft] #bjcb1 at lea/ #ce negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #ce7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7#b7 all negotiation-eligible drugs describ$ 9 subp>agraph 7,c7 ( su* subsection ) respect to su* ye>2 & 7#c7 all new-entrant negotiation-eligible drugs 7z def9$ 9 subsection 7g77#a77 ) respect to su* ye>4 ,ea* drug publi%$ on ! li/ pursuant to ! previ\s s5t5ce %all be subject to ! negotiation process "u section #aaid = ! volunt>y 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 ,9 apply+ ?is subsection1 any negotiation-eligible drug t is select$ "u ?is subsection = an initial price applicability ye> %all n c\nt t[>d ! requir$ m9imum am\nt ( drugs to be select$ "u p>agraph 7#a7 = any subsequ5t ye>1 includ+ su* a drug s select$ t is subject to r5egotiation "u section #aaid4 7b7 ,selection ( drugs ,9 c>ry+ out subsection 7a77#a7 ! ,secret>y %all select = inclusion on ! publi%$ li/ describ$ 9 subsection 7a7 ) respect to a price applicability p]iod1 ! negotiation-eligible drugs t ! ,secret>y projects w result 9 ! greate/ sav+s to ! ,f$]al ,gov]nm5t or fair price eligible individuals dur+ ! price applicability p]iod4 ,9 mak+ ?is projection ( sav+s = drugs = :i* !re is an ,,aim price = a price applicability p]iod1 ! sav+s %all be project$ across diff]5t dosage =ms & /r5g?s ( ! drugs & n bas$ on ! specific =mulation or package size or package type ( ! drugs1 tak+ into consid]ation bo? ! volume ( drugs = :i* paym5t is made1 to ! ext5t su* data is available1 & ! am\nt by :i* ! net price = ! drugs exce$s ! ,,aim price = ! drugs4 7c7 ,select$ drug ,= purposes ( ?is "p1 ea* 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 plan ye> beg9n+ be=e ! fir/ plan ye> beg9n+ aft] ! date on :i* ! ,secret>y det]m9es two or m drug products-- 7#a7 are approv$ or lic5s$ 7z applicable7-- 7,a7 "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act us+ su* drug z ! li/$ drug2 or 7,b7 "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act us+ su* drug z ! ref]5ce product2 & 7#b7 cont9ue to be m>ket$4 7d7 ,negotiation-,eligible drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! 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 meets any ( ! foll[+ crit]ia3 7,a7 ,cov]$ "p ,d drugs ,! drug is among ! #abe cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e77 = :i* !re 0 an e/imat$ greate/ net sp5d+ "u p>ts ,c & ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,b7 ,o!r drugs ,! drug is among ! #abe drugs = :i* !re 0 an e/imat$ greate/ net sp5d+ 9 ! ,unit$ ,/ates 7includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates71 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,c7 ,insul9 ,! drug is a qualify+ s+le s\rce drug describ$ 9 subsection 7e77#c74 7#b7 ,cl>ification ,9 det]m9+ :e!r a qualify+ s+le s\rce drug satisfies any ( ! crit]ia describ$ 9 p>agraph 7#a71 ! ,secret>y %all1 to ! ext5t practicable1 use data t is aggregat$ across dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7#c7 ,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 ,= purposes ( ?is "p1 ! t]m qualify+ s+le s\rce drug means any ( ! foll[+3 7#a7 ,drug products ,a drug t-- 7,a7 is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & cont9ues to be m>ket$ pursuant to su* approval2 & 7,b7 is n ! li/$ drug = any drug t is approv$ & cont9ues to be m>ket$ "u section #eje7;j7 ( su* ,act4 7#b7 ,biological products ,a biological product t-- 7,a7 is lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 includ+ any product t has be5 deem$ to be lic5s$ "u section #cea ( su* ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji1 & cont9ues to be m>ket$ "u section #cea ( su* ,act2 & 7,b7 is n ! ref]5ce product = any biological product t is lic5s$ & cont9ues to be m>ket$ "u section #cea7k7 ( su* ,act4 7#c7 ,insul9 product ,not)/&+ p>agraphs 7#a7 & 7#b71 any insul9 product t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act & cont9ues to be m>ket$ "u su* section #eje or #cea1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & cont9ues to be m>ket$ pursuant to su* lic5sure4 ,= purposes ( apply+ p>agraphs 7#a7 & 7#b71 a drug or biological product t is m>ket$ by ! same sponsor or manufactur] 7or an affiliate !re( or a cross-lic5s$ produc] or di/ributor7 z ! li/$ drug or ref]5ce product describ$ 9 su* respective p>agraph %all n be tak5 into consid]ation4 7f7 ,in=mation on int]national drug prices ,= purposes ( det]m9+ :i* negotiation-eligible drugs to select "u subsection 7a7 &1 9 ! case ( su* drugs t are select$ drugs1 to det]m9e ! maximum fair price = su* a drug & :e!r su* maximum fair price %\ld be r5egotiat$ "u section #aaid1 ! ,secret>y %all use data relat+ to ! ,,aim price ) respect to su* drug z available or provid$ to ! ,secret>y & %all on an ongo+ basis reque/ f manufactur]s ( select$ drugs in=mation on ! ,,aim price ( su* a drug4 7g7 ,new-entrant negotiation-eligible drugs 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m new-entrant negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug-- 7,a7 t is fir/ approv$ or lic5s$1 z describ$ 9 p>agraph 7#a71 7#b71 or 7#c7 ( subsection 7e71 z applicable1 dur+ ! ye> prec$+ su* select$ drug publication date2 & 7,b7 t ! ,secret>y det]m9es "u p>agraph 7#b7 is likely to be includ$ z a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date4 7#b7 ,det]m9ation ,9 ! case ( a qualify+ s+le s\rce drug t meets ! crit]ia describ$ 9 subp>agraph 7,a7 ( p>agraph 7#a71 ) respect to an initial price applicability ye>1 if ! :olesale acquisition co/ at :i* su* drug is fir/ m>ket$ 9 ! ,unit$ ,/ates is equal to or great] ?an ! m$ian h\sehold income 7z det]m9$ accord+ to ! mo/ rec5t data collect$ by ! ,unit$ ,/ates ,c5sus ,bureau71 ! ,secret>y %all det]m9e be=e ! select$ drug publication date ) respect to ! initial price applicability ye>1 if ! drug is likely to be includ$ z a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date1 bas$ on ! project$ sp5d+ "u title ,,xviii or 9 ! ,unit$ ,/ates on su* drug4 ,= purposes ( ?is p>agraph ! t]m ,unit$ ,/ates includes ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates4 #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 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug1 "u :i*-- 7#a7 dur+ ! volunt>y 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]iod & 9 accordance ) subsection 7c71 agree to7 a maximum fair price = su* select$ drug ( ! manufactur] 9 ord] to provide access to su* price-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug 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 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 ) a process & dur+ a p]iod specifi$ by ! ,secret>y pursuant to rulemak+1 r5egotiate 7&1 by n lat] ?an ! la/ date ( su* p]iod & 9 accordance ) subsection 7c71 agree to7 ! maximum fair price = su* drug if ! ,secret>y det]m9es t !re is a mat]ial *ange 9 any ( ! factors describ$ 9 section #aaid7;d7 relat+ to ! drug1 includ+ *anges 9 ! ,,aim price = su* drug1 9 ord] to provide access to su* maximum fair price 7z s r5egotiat$7-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug 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 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 ! maximum fair price 7includ+ z r5egotiat$ pursuant to p>agraph 7#b771 ) respect to su* a select$ drug1 %all be provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ! ph>macy or by a mail ord] s]vice at ! po9t-(-sale ( su* drug2 7#d7 ! manufactur]1 subject to subsection 7d71 submits to ! ,secret>y1 9 a =m & mann] specifi$ by ! ,secret>y-- 7,a7 = ! volunt>y negotiation p]iod = ! price applicability p]iod 7&1 if applicable1 be=e any p]iod ( r5egotiation specifi$ pursuant to p>agraph 7#b77 ) respect to su* drug all in=mation t ! ,secret>y requires to c>ry out ! negotiation 7or r5egotiation process7 "u ?is "p1 includ+ in=mation describ$ 9 section #aaib7;f7 & section #aaid7;d77#a72 & 7,b7 on an ongo+ basis1 in=mation on *anges 9 prices = su* drug t w\ld affect ! ,,aim price = su* drug or o!rwise provide a basis = r5egotiation ( ! maximum fair price = su* drug pursuant to p>agraph 7#b72 7#e7 ! manufactur] agrees t 9 ! case ! select$ drug ( a manufactur] is a drug describ$ 9 subsection 7c71 ! manufactur] w1 9 accordance ) su* subsection1 make any paym5t requir$ "u su* subsection ) respect to su* drug2 & 7#f7 ! 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 drug1 until su* drug is no long] consid]$ a select$ drug "u section #aaib7;c74 7c7 ,special rule = c]ta9 select$ drugs )\t ,,aim price 7#a7 ,9 g5]al ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug & = :i* an ,,aim price becomes available beg9n+ ) respect to a subsequ5t plan ye> dur+ ! price applicability p]iod = su* drug1 if ! ,secret>y det]m9es t ! am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug is great] ?an ! am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug1 !n by n lat] ?an "o ye> aft] ! date ( su* det]m9ation1 ! manufactur] ( su* select$ drug %all pay to ! ,treasury an am\nt equal to ! product (-- 7,a7 ! diff]5ce betwe5 su* am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug & su* am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug2 & 7,b7 ! numb] ( units ( su* drug sold 9 ! ,unit$ ,/ates1 includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates1 dur+ ! p]iod describ$ 9 p>agraph 7#b77;,b74 7#b7 ,am\nts describ$ 7,a7 ,weight$ av]age price be=e ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to ! weight$ av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* dosage /r5g? & =m = ! drug dur+ ! p]iod beg9n+ ) ! fir/ plan ye> = :i* ! drug is includ$ on ! li/ ( negotiation-eligible drugs publi%$ "u section #aaib7;d7 & end+ ) ! la/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is no ,,aim price available = su* drug4 7,b7 ,am\nt multipli] aft] ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to #bjj p]c5t ( ! ,,aim price = su* drug ) respect to ! fir/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is an ,,aim price available = su* drug4 7d7 ,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 may 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 7e7 ,regulations 7#a7 ,9 g5]al ,! ,secret>y %all1 pursuant to rulemak+1 specify1 9 accordance ) p>agraph 7#b71 ! in=mation t mu/ be submitt$ "u subsection 7a77#d74 7#b7 ,in=mation specifi$ ,in=mation describ$ 9 p>agraph 7#a71 ) respect to a select$ drug1 %all include in=mation on sales ( ! drug 7by ! manufactur] ( ! drug or by ano!r entity "u lic5se or o!r agreem5t ) ! manufactur]1 ) respect to ! sales ( su* drug1 reg>dless ( ! "n "u :i* ! drug is sold7 9 any =eign c\ntry t is "p ( ! ,,aim price4 ,! ,secret>y %all v]ify1 to ! ext5t practicable1 su* sales f appropriate (ficials ( ! gov]nm5t ( ! =eign c\ntry involv$4 7f7 ,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 section #aaif7;c77#a71 z applicable1 = purposes ( adm9i/]+ ! program4 #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 7b7 & 7c71 ! ,secret>y & ! manufactur]-- 7#a7 %all dur+ ! volunt>y negotiation p]iod ) respect to ! initial price applicability ye> = su* drug1 9 accordance ) ?is section1 negotiate a maximum fair price = su* drug = ! purpose describ$ 9 section #aaic7;a77#a72 & 7#b7 z applicable pursuant to section #aaic7;a77#b7 & 9 accordance ) ! process specifi$ pursuant to su* section1 r5egotiate su* maximum fair price = su* drug = ! purpose describ$ 9 su* section4 7b7 ,negotiat+ me?odology & objective 7#a7 ,9 g5]al ,! ,secret>y %all develop & use a consi/5t me?odology = negotiations "u subsection 7a7 t1 9 accordance ) p>agraph 7#b7 & subject to p>agraph 7#c71 a*ieves ! l[e/ maximum fair price = ea* select$ drug :ile appropriately rew>d+ innovation4 7#b7 ,prioritiz+ factors ,9 consid]+ ! factors describ$ 9 subsection 7d7 9 negotiat+ 7&1 z applicable1 r5egotiat+7 ! maximum fair price = a select$ drug1 ! ,secret>y %all1 to ! ext5t practicable1 consid] all ( ! available factors li/$ b %all prioritize ! foll[+ factors3 7,a7 ,rese>* & developm5t co/s ,! factor describ$ 9 p>agraph 7#a77;,a7 ( subsection 7d74 7,b7 ,m>ket data ,! factor describ$ 9 p>agraph 7#a77;,b7 ( su* subsection4 7,c7 ,unit co/s ( production & di/ribution ,! factor describ$ 9 p>agraph 7#a77;,c7 ( su* subsection4 7,d7 ,comp>ison to exi/+ !rapeutic alt]natives ,! factor describ$ 9 p>agraph 7#b77;,a7 ( su* subsection4 7#c7 ,requirem5t 7,a7 ,9 g5]al ,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 9 ! case t ! manufactur] ( ! select$ drug (f]s "u ! negotiation or r5egotiation1 z applicable1 a price = su* drug t is n m ?an ! t>get price describ$ 9 subp>agraph 7,b7 = su* drug = ! respective ye>1 ! ,secret>y %all agree "u su* negotiation or r5egotiation1 respectively1 to su* (f]$ price z ! maximum fair price4 7,b7 ,t>get price 7i7 ,9 g5]al ,subject to clause 7ii71 ! t>get price describ$ 9 ?is subp>agraph = a select$ drug ) respect to a ye>1 is ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit ( su* drug = sales ( su* drug1 z comput$ 7across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug7 9 ! applicable c\ntry describ$ 9 section #aaia7;c77#c77;,b7 ) respect to su* drug t1 ) respect to su* ye>1 has ! l[e/ av]age price = su* drug z comp>$ to ! av]age prices 7z s comput$7 ( su* drug ) respect to su* ye> 9 ! o!r applicable c\ntries describ$ 9 su* section ) respect to su* drug4 7ii7 ,select$ drugs )\t ,,aim price ,9 apply+ ?is p>agraph 9 ! case ( negotiat+ ! maximum fair price ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 or1 z applicable1 r5egotiat+ ! maximum fair price = su* drug ) respect to a subsequ5t ye> dur+ ! price applicability p]iod = su* drug be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! t>get price describ$ 9 ?is subp>agraph = su* drug & respective ye> is ! am\nt t is #hj p]c5t ( ! av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* drug & ye>4 7#d7 ,annual report ,aft] ! completion ( ea* volunt>y negotiation p]iod1 ! ,secret>y %all submit to ,congress a report on ! maximum fair prices negotiat$ 7or1 z applicable1 r5egotiat$7 = su* p]iod4 ,su* report %all include in=mation on h[ su* prices s negotiat$ 7or r5egotiat$7 meet ! requirem5ts ( ?is "p1 includ+ ! requirem5ts ( ?is subsection4 7c7 ,limitation 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = a select$ drug1 ) respect to ea* plan ye> dur+ a price applicability p]iod = su* drug1 %all n exce$ #abj p]c5t ( ! ,,aim price applicable to su* drug ) respect to su* ye>4 7#b7 ,select$ drugs )\t ,,aim price ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 = ea* plan ye> dur+ ! price applicability p]iod be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = ! select$ drug %all n exce$ ! am\nt equal to #he p]c5t ( ! av]age manufactur] price = ! drug ) respect to su* ye>4 7d7 ,consid]ations ,= 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 ! ,secret>y %all1 consi/5t ) subsection 7b77#b71 take into consid]ation ! foll[+ factors3 7#a7 ,manufactur]-specific in=mation ,! foll[+ in=mation1 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 = ! drug 9 ! ,unit$ ,/ates or 9 applicable c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#b7 ,in=mation on alt]native products ,! foll[+ in=mation3 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 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 ,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 ,no?+ 9 ! previ\s s5t5ce %all affect ! application or consid]ation ( an ,,aim price = a select$ drug4 7#c7 ,=eign sales in=mation ,to ! ext5t available on a timely basis1 includ+ z provid$ by a manufactur] ( ! select$ drug or o!rwise1 in=mation on sales ( ! select$ drug 9 ea* ( ! c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#d7 ,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 7e7 ,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 7d77#a72 & 7#b7 by n lat] ?an ,octob] #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 may require4 ,! ,secret>y %all reque/1 f ! manufactur] or o!rs1 su* additional in=mation z may be ne$$ to c>ry out ! negotiation & r5egotiation process "u ?is section4 #aaie4 ,publication ( maximum fair prices 7a7 ,9 g5]al ,) respect to an initial price applicability ye> & select$ drug ) respect to su* ye>1 n lat] ?an ,april #a ( ! plan ye> prior to su* initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! maximum fair price = su* drug negotiat$ "u ?is "p ) ! manufactur] ( su* drug4 7b7 ,updates 7#a7 ,subsequ5t ye> maximum fair prices ,= a select$ drug1 = ea* plan ye> subsequ5t to ! initial price applicability ye> = su* drug ) respect to :i* an agreem5t = su* drug is 9 effect "u section #aaic1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/]-- 7,a7 subject to subp>agraph 7,b71 ! am\nt equal to ! maximum fair price publi%$ = 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$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p1 contracts ) prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title1 & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i* ! maximum fair price = a select$ drug is provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( ! drug = ! applicable price p]iod = su* drug & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u su* plans or cov]age = ! select$ drug4 7,b7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p & contracts ) hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i*1 9 ! case ( a select$ drug furni%$ or adm9i/]$ by su* a hospital1 physician1 or o!r provid] ( s]vices or suppli] to fair price eligible individuals 7:o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( section #aaia7;c77#a771 ! maximum fair price = ! select$ drug is provid$ to su* hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s 7z applicable7 ) respect to su* individuals & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u ! respective "p1 plan1 or cov]age = ! select$ drug4 7,c7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts & contracts describ$ 9 subp>agraphs 7,a7 & 7,b77 to ensure t1 n lat] ?an #ij days aft] ! disp5s+ ( a select$ drug to a fair price eligible individual 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 ! less] (-- 7,i7 ! :olesale acquisition co/ ( ! drug2 7,,ii7 ! national av]age drug acquisition co/ ( ! drug2 & 7,,iii7 any o!r simil> det]m9ation ( ph>macy acquisition co/s ( ! drug1 z det]m9$ by ! ,secret>y2 & 7ii7 ! maximum fair price = ! drug4 7,d7 ,! 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 ( fair price eligible individuals z ! ,secret>y may specify2 & 7ii7 any o!r disc\nts4 7,e7 ,! e/abli%m5t ( proc$ures to ent] into appropriate agreem5ts & protocols = ! ongo+ computation ( ,,aim prices = select$ drugs1 includ+1 to ! ext5t possible1 to compute ! ,,aim price = select$ drugs & includ+ by provid+ t ! manufactur] ( su* a select$ drug %\ld provide in=mation = su* computation n lat] ?an #c mon?s aft] ! fir/ date ( ! volunt>y negotiation p]iod = su* select$ drug4 7,f7 ,! 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,g7 ,! e/abli%m5t ( proc$ures to negotiate & apply ! maximum fair price 9 a mann] t does n include any disp5s+ or simil> fee4 7,h7 ,! e/abli%m5t ( proc$ures to c>ry out ! provisions ( ?is "p1 z applicable1 ) respect to-- 7i7 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 fair price eligible individuals :o are enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ by a heal? insurance issu] 9 ! individual or gr\p m>ket ) respect to :i* !re is an agreem5t 9 effect "u section #aaig2 & 7iii7 fair price eligible individuals :o are entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title4 7,i7 ,! e/abli%m5t ( a negotiation process & r5egotiation process 9 accordance ) section #aaid1 includ+ a process = acquir+ in=mation describ$ 9 subsection 7d7 ( su* section & det]m9+ am\nts describ$ 9 subsection 7b7 ( su* section4 7,j7 ,! provision ( a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 fair price eligible individuals1 & ! ?ird p>ty ) a contract "u subsection 7c77#a74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,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 may be report$4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7c77#a7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf or section #aaih1 z applicable4 7b7 ,collection ( data 7#a7 ,f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7#b7 ,f heal? plans ,! ,secret>y may collect appropriate data f gr\p heal? plans or heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7c7 ,contract ) ?ird p>ties 7#a7 ,9 g5]al ,! ,secret>y may 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 "p4 ,at a m9imum1 ! contract ) a ?ird p>ty "u ! prec$+ s5t5ce %all require t ! ?ird p>ty-- 7,a7 receive & transmit in=mation betwe5 ! ,secret>y1 manufactur]s1 & o!r individuals or entities ! ,secret>y det]m9es appropriate2 7,b7 receive1 di/ribute1 or facilitate ! di/ribution ( funds ( manufactur]s to appropriate individuals or entities 9 ord] to meet ! obligations ( manufactur]s "u agreem5ts "u ?is "p2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is "p1 z necess>y = ! manufactur] to fulfill its obligations "u ?is "p2 & 7,d7 p]mit manufactur]s to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ by ! ?ird p>ty to det]m9e disc\nts = applicable drugs ( ! manufactur] "u ! program4 7#b7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#a7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is "p4 #aaig4 ,volunt>y p>ticipation by o!r heal? plans 7a7 ,agreem5t to p>ticipate "u program 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 "u ! program "u ?is "p ! ,secret>y %all be treat$ z hav+ 9 effect an agreem5t ) a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod-- 7,a7 ) respect to su* select$ drug furni%$ or disp5s$ at a ph>macy or by mail ord] s]vice if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or disp5s$2 & 7,b7 ) respect to su* select$ drug furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli] if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,opt+ out ( agreem5t ,! ,secret>y %all n be treat$ z hav+ 9 effect an agreem5t "u ! program "u ?is "p ) a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod if su* a plan or issu] affirmatively elects1 ?r\gh a process specifi$ by ! ,secret>y1 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 7b7 ,publication ( election ,) respect to ea* price applicability p]iod & ea* select$ drug ) respect to su* p]iod1 ! ,secret>y & ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 z applicable1 %all make public a li/ ( ea* gr\p heal? plan & ea* issu] ( heal? insurance cov]age1 ) respect to :i* cov]age is provid$ "u su* plan or cov]age = su* drug1 t has elect$ "u subsection 7a7 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 #aaih4 ,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 plan ye> dur+ ! price applicability p]iod = 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 fair price eligible individual :o ) respect to su* drug is describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & :o is furni%$ or disp5s$ su* drug dur+ su* ye>2 or 7#b7 to a hospital1 physician1 or o!r provid] ( s]vices or suppli] ) respect to 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>2 %all be subject to a civil monet>y p5alty equal to t5 times ! am\nt equal to ! diff]5ce betwe5 ! price = su* drug made available = su* ye> by su* manufactur] ) respect to su* individual or hospital1 physician1 provid]1 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 plan ye> dur+ ! price applicability p]iod = su* drug1 t is 9 violation ( a requirem5t impos$ pursuant to section #aaic7;a77#f7 %all be subject to a civil monet>y p5alty ( n m ?an #a1jjj1jjj = ea* su* violation4 7c7 ,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$+ "u section #aabh;,a7a74 #aaii4 ,miscellane\s provisions 7a7 ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to data collect$ "u ?is "p4 7b7 ,national ,academy ( ,m$ic9e /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,national ,academy ( ,m$ic9e %all conduct a /udy1 & submit to ,congress a report1 on recomm5dations = improvem5ts to ! program "u ?is "p1 includ+ ! det]m9ation ( ! limits appli$ "u section #aaid7;c74 7c7 ,med,p,a,c /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy1 & submit to ,congress a report1 on ! program "u ?is "p ) respect to ! ,m$ic>e program "u title ,,xviii1 includ+ ) respect to ! effect ( ! program on individuals entitl$ to b5efits or enroll$ "u su* title4 7d7 ,limitation on judicial review ,! foll[+ %all n be subject to judicial review3 7#a7 ,! selection ( drugs = publication "u section #aaib7;a74 7#b7 ,! det]m9ation ( :e!r a drug is a negotiation-eligible drug "u section #aaib7;d74 7#c7 ,! det]m9ation ( ! maximum fair price ( a select$ drug "u section #aaid4 7#d7 ,! det]m9ation ( units ( a drug = purposes ( section #aaia7;c77#c74 7e7 ,coord9ation ,9 c>ry+ out ?is "p ) respect to gr\p heal? plans or heal? insurance cov]age (f]$ 9 ! gr\p m>ket t are subject to ov]sight by ! ,secret>y ( ,labor or ! ,secret>y ( ! ,treasury1 ! ,secret>y ( ,heal? & ,human ,s]vices %all coord9ate ) su* respective ,secret>y4 7f7 ,data %>+ ,! ,secret>y %all %>e ) ! ,secret>y ( ! ,treasury su* in=mation z is necess>y to det]m9e ! tax impos$ by section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 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 def9$ 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#b7 applicable = su* drug & a plan ye> dur+ su* p]iod aft] p>agraph 7#d74 7,b7 ,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$ by ins]t+ 1 except z provid$ "u "p ,e ( title ,,xi aft] ! ,secret>y4 7,c7 ,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 def9$ 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 ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug & = ea* plan ye> dur+ su* p]iod4 4 7,d7 ,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 #aaif7;b74 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 ,"u gr\p heal? plans & heal? insurance cov]age 7,a7 ,,phsa ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgbi ! foll[+ new section3 #bgbi;,a4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ ! maximum fair price negotiat$ "u su* "p = su* drug 9 lieu ( ! contract$ rate "u su* plan or cov]age = su* select$ drug2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p to su* plan1 issu]1 & cov]age1 & su* individuals s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,,erisa 7i7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaha et4 seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ ! maximum fair price negotiat$ "u su* "p = su* drug 9 lieu ( ! contract$ rate "u su* plan or cov]age = su* select$ drug2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p to su* plan1 issu]1 & cov]age1 & su* individuals s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7ii7 ,cl]ical am5dm5t ,! table ( sections = "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by add+ at ! end ! foll[+3 ,sec4 #gaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices4 4 7,c7 ,,irc 7i7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plan1 & to ! individuals enroll$ "u su* plan dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 if cov]age ( su* select$ drug is provid$ "u su* plan if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plan1 to ! individuals enroll$ "u su* plan1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y1 to individuals entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan %all apply any co/-%>+ responsibilities "u su* plan1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan & su* individuals s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7ii7 ,application to retiree & c]ta9 small gr\p heal? plans ,section #ihca7;a77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ o!r ?an ) respect to section #ihaf1 be=e any gr\p heal? plan4 7iii7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices4 4 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #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 ! ,june #af? 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 ! ,april #a/ imm$iately foll[+ ! ,june #af? describ$ 9 p>agraph 7#a7 & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has 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$4 7#e7 ,9 ! case ( a select$ drug ) respect to :i* a paym5t is due "u subsection 7c7 ( su* section #aaic1 ! p]iod beg9n+ on ! date on :i* ! ,secret>y ( ,heal? & ,human ,s]vices c]tifies t su* paym5t is ov]due & end+ on ! date t su* paym5t is made 9 full4 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$uction = excise tax paym5ts ,section #bge ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ or by section #daib be=e ! p]iod at ! end ( subsection 7a77#f74 7c7 ,con=m+ am5dm5ts 7#a7 ,section #dbba7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or #daib aft] section #daia4 7#b7 ,section #fdaf7;b77#b7 ( su* ,code is am5d$ by ins]t+ or #daib aft] section #daia4 7d7 ,cl]ical am5dm5ts 7#a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,o!r m$ical products4 7#b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,o!r m$ical products 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,select$ drugs dur+ noncompliance p]iods4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 ,,ii ,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates #bja4 ,m$ic>e "p ,b rebate by manufactur]s 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,rebate by manufactur]s = s+le s\rce drugs ) 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 #bjba1 ! ,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] ( 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 #bjba1 ! 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 ( section #ahdg;,a7c77#f771 includ+ a biosimil> biological product 7z def9$ 9 subp>agraph 7,h7 ( su* section71 paid = "u ?is "p1 except su* t]m %all n include su* a drug or biological-- 7i7 if ! av]age total all[$ *>ges = a ye> p] individual t uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 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 = #bjbb1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjba1 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>1 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 ,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#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 p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraphs 7,b7 & 7,g71 ! total numb] ( units ( ! bill+ & paym5t code = su* "p ,b rebatable drug furni%$ "u ?is "p dur+ ! cal5d> qu>t]2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! paym5t am\nt "u subp>agraph 7,b7 or 7,c7 ( section #ahdg;,a7b77#a71 z applicable1 = su* "p ,b rebatable 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 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( units ( ! bill+ & paym5t code = ea* "p ,b rebatable drug furni%$ dur+ a cal5d> qu>t] %all n include-- 7i7 units packag$ into ! paym5t = a proc$ure or s]vice "u section #ahcc7t7 or "u section #ahcc7;i7 7in/ead ( sep>ately payable "u su* respective section72 7ii7 units includ$ "u ! s+le paym5t sy/em = r5al dialysis s]vices "u section #ahha7;b77#ad72 or 7iii7 units ( a "p ,b rebatable drug ( a manufactur] furni%$ to an individual1 if su* manufactur]1 ) respect to ! furni%+ ( su* units ( su* drug1 provides = disc\nts "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or = rebates "u section #aibg4 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] beg9n+ ,janu>y #a1 #bjaf4 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 = ,july #bjae4 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 ,c\nt+ units 7i7 ,cut-(f p]iod to c\nt units ,= purposes ( subp>agraph 7,a77i71 subject to clause 7ii71 to c\nt ! total numb] ( bill+ units = a "p ,b rebatable drug = a qu>t]1 ! ,secret>y may use a cut-(f p]iod 9 ord] to exclude f su* total numb] ( bill+ units = su* qu>t] claims = s]vices furni%$ dur+ su* qu>t] t 7 n process$ at an appropriate "t prior to ! end ( ! cut-(f p]iod4 7ii7 ,c\nt+ units = claims process$ aft] cut-(f p]iod ,if ! ,secret>y uses a cut-(f p]iod pursuant to clause 7i71 9 ! case ( units ( a "p ,b rebatable drug furni%$ dur+ a qu>t] b pursuant to application ( su* cut-(f p]iod exclud$ = purposes ( subp>agraph 7,a77i7 f ! total numb] ( bill+ units = ! drug = su* qu>t]1 ! ,secret>y %all c\nt su* units ( su* drug s furni%$ 9 ! total numb] ( bill+ units = su* drug = a subsequ5t qu>t]1 z ! ,secret>y det]m9es appropriate4 7#d7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,subject to subp>agraph 7,b71 9 ! case ( a "p ,b rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjae1 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 ,july #bjae "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] ,july #a1 #bjae1 p>agraph 7#a77;,b7 %all be appli$ z if ! ref]5ce to ,july #a1 #bjba "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 #bjba4 7,c7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate am\nt "u p>agraph 7#a77;,b7 ) respect to a "p ,b rebatable drug t is describ$ z curr5tly 9 %ortage on ! %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,d7 ,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#b77 & 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 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 ,july #bjae "u su* p>agraph 7 a ref]5ce to ! ,july ( ! ye> prec$+ su* la/ ye>4 7#e7 ,application to b5efici>y co9surance ,9 ! case ( a "p ,b rebatable drug1 if ! paym5t am\nt = a qu>t] exce$s ! inflation adju/$ paym5t = su* qu>t]-- 7,a7 9 comput+ ! am\nt ( any co9surance applicable "u ?is title to an individual ) respect to su* drug1 ! computation ( su* co9surance %all be bas$ on ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c77;,c7 = su* "p ,b rebatable drug2 & 7,b7 ! am\nt ( su* co9surance is equal to #bj p]c5t ( su* inflation-adju/$ paym5t am\nt s det]m9$4 7#f7 ,rebate deposits ,am\nts paid z rebates "u p>agraph 7#a77;,b7 %all be deposit$ 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$+ "u section #aabh;,a7a74 7#h7 ,/udy & report 7,a7 ,/udy ,! ,secret>y %all conduct a /udy ( ! feasibility ( & op]ational issues involv$ ) ! foll[+3 7i7 ,includ+ multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c77 9 ! rebate sy/em "u ?is subsection4 7ii7 ,includ+ drugs & biologicals paid = "u ,,ma plans "u "p ,c 9 ! rebate sy/em "u ?is subsection4 7iii7 ,includ+ drugs exclud$ "u p>agraph 7#b77;,a7 & units ( ! bill+ & paym5t code ( ! drugs exclud$ "u p>agraph 7#c77;,b7 9 ! rebate sy/em "u ?is subsection4 7,b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a74 7#i7 ,application to multiple s\rce drugs ,! ,secret>y may1 bas$ on ! report submitt$ "u p>agraph 7#h7 & pursuant to rulemak+1 apply ! provisions ( ?is subsection to multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c771 includ+1 = purposes ( det]m9+ ! rebate am\nt "u p>agraph 7#c71 by calculat+ manufactur]-specific av]age sales prices = ! b5*m>k p]iod & ! rebate p]iod4 4 7b7 ,am\nts payable2 co/-,%>+ ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,s71 by /rik+ ) respect to & ins]t+ subject to subp>agraph 7,,dd71 ) respect to2 7ii7 by /rik+ & 7,,cc7 & ins]t+ 7,,cc72 & 7iii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,dd7 ) respect to a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* ! paym5t am\nt = a cal5d> qu>t] "u p>agraph 7#c77;,a77ii77,i7 ( su* section = 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 ! diff]5ce betwe5 7i7 ! paym5t am\nt "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* drug1 & 7ii7 #bj p]c5t ( ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* drug2 7,b7 by add+ at ! end ( ! flu% left matt] foll[+ p>agraph 7#i71 ! foll[+3 ,= purposes ( apply+ p>agraph 7#a77;,,dd71 subsections 7i77#i7 & 7t77#c77;,h71 & section #ahcd7x77#e71 ! ,secret>y %all make su* e/imates & use su* data z ! ,secret>y det]m9es appropriate1 & not)/&+ any o!r provision ( law1 may d s by program in/ruction or o!rwise4 2 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 #ahcd7x77 furni%$ on or aft] ,july #a1 #bjba1 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahcd7x77#e71 p>agraph 7#a77;,,dd7 ( subsection 7a71 & ! flu% left matt] foll[+ p>agraph 7#i7 ( subsection 7a71 %all1 z det]m9$ appropriate by ! ,secret>y1 apply "u ?is subsection 9 ! same mann] z su* provisions ( section #ahcd7x77#e7 & subsection 7a7 apply "u su* section & subsection4 2 & 7#c7 9 subsection 7t77#c71 by add+ at ! end ! foll[+ new subp>agraph3 7,h7 ,"p ,b rebatable drugs ,9 ! case ( a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 furni%$ on or aft] ,july #a1 #bjba1 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahcd7x77#e71 p>agraph 7#a77;,,dd7 ( subsection 7a71 & ! flu% left matt] foll[+ p>agraph 7#i7 ( subsection 7a71 %all1 z det]m9$ appropriate by ! ,secret>y1 apply "u ?is subsection 9 ! same mann] z su* provisions ( section #ahcd7x77#e7 & subsection 7a7 apply "u su* section & subsection4 4 7c7 ,con=m+ am5dm5t 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+ or section #ahcd7x7 aft] section #aibg4 #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 ,9 g5]al 7#a7 ,9 g5]al ,subject to ! provisions ( ?is section1 9 ord] = cov]age to be available "u ?is "p = a "p ,d rebatable drug 7z def9$ 9 subsection 7h77#a77 ( a manufactur] 7z def9$ 9 section #aibg7k77#e77 disp5s$ dur+ an applicable ye>1 ! manufactur] mu/ h ent]$ into & h 9 effect an agreem5t describ$ 9 subsection 7b74 7#b7 ,au?oriz+ ,cov]age = ,drugs ,n ,cov]$ ,"u ,agreem5ts ,p>agraph 7#a7 %all n apply to ! disp5s+ ( a cov]$ "p ,d drug if-- 7,a7 ! ,secret>y has made a det]m9ation t ! availability ( ! drug is ess5tial to ! heal? ( b5efici>ies "u ?is "p2 or 7,b7 ! ,secret>y det]m9es t 9 ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ on ,decemb] #ca1 #bjbb1 !re 7 ext5uat+ circum/ances4 7#c7 ,applicable ye> ,= purposes ( ?is section ! t]m applicable ye> means a ye> beg9n+ ) #bjbb4 7b7 ,agreem5ts 7#a7 ,t]ms ( agreem5t ,an agreem5t describ$ 9 ?is subsection1 ) respect to a manufactur] ( a "p ,d rebatable drug1 is an agreem5t "u :i* ! foll[+ %all apply3 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #i mon?s aft] ! end ( ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! ,secret>y1 = ea* "p ,d rebatable drug ( ! manufactur]1 %all report to ! manufactur] ! foll[+ = su* ye>3 7i7 ,in=mation on ! total numb] ( units 7z def9$ 9 subsection 7h77#b77 = ea* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age manufactur] price increase describ$ 9 subsection 7c77#a77;,b7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7iii7 ,! rebate am\nt specifi$ "u subsection 7c7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7,b7 ,manufactur] requirem5ts ,= ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! manufactur] ( ! "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 subp>agraph 7,a7 = su* ye>1 %all provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 subsection 7c7 = su* dosage =m & /r5g? ) respect to su* drug = su* ye>4 7#b7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section1 ) respect to a "p ,d rebatable drug1 %all be effective = an initial p]iod ( n less ?an "o ye> & %all be automatically r5ew$ = a p]iod ( n less ?an "o ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #cj days aft] ! date ( notice ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 b su* he>+ %all n delay ! effective date ( ! t]m9ation4 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 #cj ( ! plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( ! plan ye>1 z ( ! day aft] ! end ( ! succe$+ plan ye>4 7,c7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is p>agraph %all n affect rebates due "u ! agreem5t "u ?is section be=e ! effective date ( its t]m9ation4 7,d7 ,delay be=e re5try ,9 ! case ( any agreem5t "u ?is section ) a manufactur] t is t]m9at$ 9 a plan ye>1 ! ,secret>y may n ent] into ano!r su* agreem5t ) ! manufactur] 7or a successor manufactur]7 be=e ! subsequ5t plan ye>1 unless ! ,secret>y f9ds good cause = an e>li] re9/atem5t ( su* an agreem5t4 7c7 ,rebate am\nt 7#a7 ,9 g5]al ,= 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>agraphs 7,b7 & 7,c7 ( p>agraph 7#e71 ! am\nt equal to ! product (-- 7,a7 ! total numb] ( units ( su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>2 & 7,b7 ! am\nt 7if any7 by :i*-- 7i7 ! 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$s 7ii7 ! inflation-adju/$ 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 ,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 7h77#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? disp5s$ dur+ ea* su* cal5d> qu>t] ( su* ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* ye>4 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 subp>agraphs 7,a7 & 7,d7 ( 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 & an applicable ye>2 increas$ by 7,b7 ! p]c5tage by :i* ! applicable ye> ,,cpi-,u 7z def9$ 9 subsection 7h77#e77 = ! applicable ye> exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subsection 7h77#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 7h77#f77 ( su* dosage =m & /r5g?1 z calculat$ = a unit ( su* drug1 ) respect to ea* cal5d> qu>t] ( ! paym5t am\nt b5*m>k ye> 7z def9$ 9 subsection 7h77#c772 & 7,b7 ! ratio (-- 7i7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* cal5d> qu>t] ( ! paym5t am\nt b5*m>k ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ ! 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] ,janu>y #a1 #bjaf1 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 7h77#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 7h77#d7 z if ! ref]5ce to ,janu>y #bjaf "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 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u p>agraph 7#a7 ) respect to a "p ,d rebatable drug t is describ$ z curr5tly 9 %ortage on ! %ortage li/ 9 effect "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,c7 ,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+ ! am\nt specifi$ 9 ?is subsection ) respect to su* "p ,d rebatable drug & an applicable ye> ) consid]ation ( ! orig9al "p ,d rebatable drug4 7ii7 ,l9e ext5sion def9$ ,9 ?is subp>agraph1 ! t]m l9e ext5sion means1 ) respect to a "p ,d rebatable drug1 a new =mulation ( ! drug 7z det]m9$ by ! ,secret>y71 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,d7 ,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#b77 & 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 7h77#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 7h77#d7 z if ! ref]5ce to ,janu>y #bjaf "u su* subsection 7 a ref]5ce to ,janu>y ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* drug4 7d7 ,rebate deposits ,am\nts paid z rebates "u subsection 7c7 %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 7e7 ,in=mation ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all use in=mation submitt$ by manufactur]s "u section #aibg7;b77#c74 7f7 ,civil money p5alty ,9 ! case ( a manufactur] ( a "p ,d rebatable drug ) an agreem5t 9 effect "u ?is section :o has fail$ to comply ) ! t]ms ( ! agreem5t "u subsection 7b77#a77;,b7 ) respect to su* drug = an applicable ye>1 ! ,secret>y may impose a civil money p5alty on su* manufactur] 9 an am\nt equal to #abe p]c5t ( ! am\nt specifi$ 9 subsection 7c7 = 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$+ "u section #aabh;,a7a74 7g7 ,judicial review ,!re %all be no judicial review ( ! foll[+3 7#a7 ,! det]m9ation ( units "u ?is section4 7#b7 ,! det]m9ation ( :e!r a drug is a "p ,d rebatable drug "u ?is section4 7#c7 ,! calculation ( ! rebate am\nt "u ?is section4 7h7 ,def9itions ,9 ?is section3 7#a7 ,"p ,d rebatable drug def9$ 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 = #bjbc1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbb1 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 ( #bjbb2 & 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 def9$ ,! t]m unit means1 ) respect to a "p ,d rebatable drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! "p ,d rebatable drug t is disp5s$ to individuals "u ?is "p4 7#c7 ,paym5t am\nt b5*m>k ye> ,! t]m paym5t am\nt b5*m>k ye> means ! ye> beg9n+ ,janu>y #a1 #bjaf4 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 = ,janu>y #bjaf4 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 4 7b7 ,con=m+ am5dm5t 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;c71 is fur!r am5d$ by /rik+ section #aibg or section #ahcd7x7 & ins]t+ section #aibg1 section #ahcd7x71 or section #ahfj;,d-#ad;,b4 ,,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$+ #bjbb & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbb & ea* subsequ5t ye> aft] p>agraph 7#c72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ & #bjba2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjba2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjba2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjba2 & 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$+ #bjbb1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 9 subclause 7,v71 by /rik+ or at ! end2 7,,ii7 9 subclause 7,,vi7-- 7aa7 by /rik+ = a subsequ5t ye> & ins]t+ = #bjba2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbb1 is equal to #b1jjj2 or 7,,viii7 = a subsequ5t ye>1 is equal to ! am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = ! ye> involv$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ &1 = a ye> prec$+ #bjbb1 = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( ye>s #bjaa ?r\gh #bjba1 9 apply+4 7b7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is am5d$ by ins]t+ aft] #hj p]c5t ! foll[+3 7or1 ) respect to a cov]age ye> aft] #bjba1 #bj p]c5t74 7c7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq471 z am5d$ by section #bjb1 is fur!r am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,b ! foll[+ new section3 #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 #bjba1 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 provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbb4 7,b7 ,provision ( disc\nt$ prices at ! po9t-(-sale ,! disc\nt$ prices describ$ 9 subp>agraph 7,a7 %all be provid$ to ! applicable b5efici>y at ! ph>macy or by ! mail ord] s]vice at ! po9t-(-sale ( an applicable drug4 7,c7 ,tim+ ( agreem5t 7i7 ,special rule = #bjbb ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ on ,decemb] #ca1 #bjbb1 ! manufactur] %all ent] into su* agreem5t n lat] ?an #cj days aft] ! date ( ! e/abli%m5t ( a model agreem5t "u subsection 7a74 7ii7 #bjbc & subsequ5t ye>s ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to plan ye> #bjbc or a subsequ5t plan ye>1 ! manufactur] %all ent] into su* agreem5t 7or su* agreem5t %all be r5ew$ "u p>agraph 7#d77;,a77 n lat] ?an ,janu>y #cj ( ! prec$+ ye>4 7#b7 ,provision ( appropriate data ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all collect & h available appropriate data1 z det]m9$ 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 may 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 #cj ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( 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$ures "u :i* disc\nt$ prices are provid$ to applicable b5efici>ies at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( an applicable drug2 7,c7 ! 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,d7 ! 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 ! ,secret>y may specify2 & 7,e7 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 ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ! program "u ?is section by program in/ruction or o!rwise4 7#f7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 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 ,! ,secret>y may impose a civil money p5alty on a manufactur] t fails to provide applicable b5efici>ies disc\nts = applicable drugs ( ! manufactur] 9 accordance ) su* agreem5t = 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/s = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = su* ye>4 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 def9$ 9 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 ) respect to an applicable drug ( a manufactur] furni%$ dur+ a ye> to an applicable b5efici>y-- 7i7 :o has n incurr$ co/s = 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/s 9 ! ye> t are equal to or exce$ su* ?re%old = ! ye>1 #gj p]c5t ( ! negotiat$ price ( su* drug4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+ ! responsibility ( an applicable b5efici>y = paym5t ( a disp5s+ fee = an applicable drug4 7,c7 ,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 at or 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 at or 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$]al ,regulations 7or any successor regulation71 except t1 ) respect to an applicable drug1 su* negotiat$ price %all n include any disp5s+ 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 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 #bjbb1 &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 aft] ,janu>y #a1 #bjbb1 ) 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$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ 8assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "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 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c2 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or1 = a ye> prec$+ #bjbb1 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$+ #bjbb or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbb & 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$+ #bjbb1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbb1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbb1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is am5d$ 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$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbb1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ 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 = #bjbb & 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$-- 7,a7 by ins]t+ = a ye> be=e #bjbb aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7#g7 ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is am5d$-- 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 #bjba1 ! ,m$ic>e cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 2 7ii7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 h ent]$ into & h 9 effect-- 7,a7 = #bjaa ?r\gh #bjba1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,a ) ! ,secret>y2 & 7,b7 = #bjbb & 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 #bjba1 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 = #bjbb & 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 #bjbb1 & 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 #bjbb4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye> #bjbb & subsequ5t plan ye>s4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drugs plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances ,section #ahfj;,d-#b7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 z am5d$ by section #cja1 is fur!r am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,subject to subp>agraphs 7,c7 & 7,d7 & ins]t+ ,subject to subp>agraphs 7,c71 7,d71 & 7,e72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,enrollee option reg>d+ spread+ co/-%>+ ,! ,secret>y %all e/abli% by regulation a process "u :i*1 ) respect to plan ye> #bjbb & subsequ5t plan ye>s1 a prescription drug plan or an ,,ma-,,pd plan %all1 9 ! case ( a "p ,d eligible individual enroll$ ) su* plan = su* plan ye> :o is n a subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77 & ) respect to :om ! plan projects t ! disp5s+ ( ! fir/ fill ( a cov]$ "p ,d drug to su* individual w result 9 ! individual incurr+ co/s t are equal to or above ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = su* plan ye>1 provide su* individual ) ! option to make ! co9surance paym5t requir$ "u subp>agraph 7,a7 7= ! portion ( su* co/s t are n above su* annual out-(-pocket ?re%old7 9 ! =m ( p]iodic in/allm5ts ov] ! rema9d] ( su* plan ye>4 4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$-- 7#a7 by r$esignat+ ! p>agraph 7#f71 z add$ by section #ejced ( division ,e ( ! ,bip>tisan ,budget ,act ( #bjah 7,public ,law #aae-abc71 z p>agraph 7#g72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,application ( ph>macy quality measures 7,a7 ,9 g5]al ,a ,,pdp sponsor t implem5ts inc5tive paym5ts to a ph>macy or price concessions paid by a ph>macy bas$ on quality measures %all use measures e/abli%$ or approv$ by ! ,secret>y "u subp>agraph 7,b7 ) respect to paym5t = cov]$ "p ,d drugs disp5s$ by su* ph>macy4 7,b7 ,/&>d ph>macy quality measures ,! ,secret>y %all e/abli% or approve /&>d quality measures f a cons5sus & evid5ce-bas$ organization = paym5ts describ$ 9 subp>agraph 7,a74 ,su* measures %all focus on pati5t heal? outcomes & be bas$ on prov5 crit]ia measur+ ph>macy p]=mance4 7,c7 ,effective date ,! requirem5t "u subp>agraph 7,a7 %all take effect = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 or su* e>li] date specifi$ by ! ,secret>y if ! ,secret>y det]m9es !re are suffici5t measures e/abli%$ or approv$ "u subp>agraph 7,b7 to meet ! requirem5t "u subp>agraph 7,a74 4 ,,iv ,prescription ,drug ,policies = ,l[-,income ,individuals #dja4 ,adju/m5ts to ,m$ic>e "p ,d co/-%>+ r$uctions = l[-income individuals ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 z am5d$ by section #cja7;d71 is fur!r am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,d7-- 7i7 9 clause 7ii7-- 7,i7 by /rik+ t does n exce$ #a = & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ t does n exce$-- 7,i7 = plan ye>s be=e plan ye> #bjba-- 7aa7 = a g5]ic drug or a pref]r$ drug t is a multiple s\rce drug 7z def9$ 9 section #aibg7k77#g77;,a77i771 #a or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 7bb7 = any o!r drug1 #c or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 2 & 7,,ii7 by add+ at ! end ! foll[+ new subclauses3 7,,ii7 = plan ye> #bjba-- 7aa7 = a g5]ic drug1 #j2 & 7bb7 = any o!r drug1 ! doll> am\nt appli$ "u ?is clause 7aft] application ( p>agraph 7#d77;,a77 = plan ye> #bjbj = a drug describ$ 9 subclause 7,i77bb72 & 7,,iii7 = a subsequ5t ye>1 ! doll> am\nt appli$ "u ?is clause = ! previ\s ye> = ! drug1 increas$ by ! annual p]c5tage increase 9 ! consum] price index 7all items2 ,u4,s4 city av]age7 z ( ,septemb] ( su* previ\s ye>4 2 & 7ii7 9 clause 7iii7-- 7,i7 by /rik+ does n exce$ ! copaym5t am\nt specifi$ "u & ins]t+ does n exce$-- 7,i7 = plan ye>s beg9n+ be=e plan ye> #bjba1 ! copaym5t am\nt specifi$ "u 2 7,,ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+ new subclause3 7,,ii7 = plan ye> #bjba & ea* subsequ5t plan ye>1 ! copaym5t am\nt appli$ "u clause 7ii7 = ! drug & ye> involv$4 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,r\nd+ ,any am\nt e/abli%$ "u clause 7ii7 ( subp>agraph 7,d71 includ+ z appli$ "u clause 7iii7 ( su* subp>agraph or p>agraph 7#b77;,d71 t is bas$ on an increase ( #c1 t is n a multiple ( #e c5ts or #aj c5ts1 respectively1 %all be r\nd$ to ! ne>e/ multiple ( #e c5ts or #aj c5ts1 respectively4 2 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,d7-- 7i7 by /rik+ ( co9surance ( & ins]t+ (-- 7i7 = plan ye>s be=e plan ye> #bjba1 co9surance ( 2 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7ii7 = plan ye> #bjba & ea* subsequ5t plan ye>1 a copaym5t am\nt t does n exce$ ! copaym5t am\nt appli$ "u p>agraph 7#a77;,d77ii7 = ! drug & ye> involv$4 2 & 7,b7 9 subp>agraph 7,e7-- 7i7 by /rik+ subsection 7c71 ! sub/itution = & ins]t+ subsection 7c7-- 7i7 = plan ye>s be=e plan ye> #bjba1 ! sub/itution = 2 7ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7ii7 = plan ye> #bjba1 ! elim9ation ( any co/-%>+ impos$ "u section #ahfj;,d-#b7;b77#d77;,a74 2 & 7#c7 9 p>agraph 7#d77;,a77ii71 by ins]t+ 7be=e #bjba7 aft] subsequ5t ye>4 #djb4 ,dissem9ation to ,m$ic>e "p ,d subsidy eligible individuals ( in=mation comp>+ premiums ( c]ta9 prescription drug plans ,section #ahfj;,d-#a7;c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;c77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,in=mation on premiums = subsidy eligible individuals 7i7 ,9 g5]al ,= plan ye> #bjbb & ea* subsequ5t plan ye>1 ! ,secret>y %all dissem9ate to ea* subsidy eligible individual 7z def9$ 9 section #ahfj;,d-#ad7;a77#c77 in=mation "u ?is p>agraph comp>+ premiums t w\ld apply to su* individual = prescription drug cov]age "u ,,lis b5*m>k plans1 includ+1 9 ! case ( an individual enroll$ 9 a prescription drug plan "u ?is "p1 in=mation t comp>es ! premium t w\ld apply if su* individual 7 to rema9 enroll$ 9 su* plan to premiums t w\ld apply if ! individual 7 to enroll 9 o!r ,,lis b5*m>k plans4 7ii7 ,,lis b5*m>k plan ,= purposes ( clause 7i71 ! t]m ,,lis b5*m>k plan means1 ) respect to an individual1 a prescription drug plan "u ?is "p t is (f]$ 9 ! region 9 :i* ! individual resides &-- 7,i7 t provides = a premium t is n m ?an ! l[-income b5*m>k premium am\nt 7z def9$ 9 section #ahfj;,d-#ad7;b77#b77 = su* region2 or 7,,ii7 ) respect to :i* ! premium w\ld be waiv$ z de m9imis pursuant to section #ahfj;,d-#ad7;a77#e7 = su* individual4 4 #djc4 ,provid+ = intellig5t assignm5t ( c]ta9 subsidy eligible individuals auto-enroll$ "u ,m$ic>e prescription drug plans & ,,ma-,,pd plans 7a7 ,9 g5]al ,section #ahfj;,d-#a7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja7;b77#a77 is am5d$-- 7#a7 9 subp>agraph 7,c7-- 7,a7 by ins]t+ aft] ,,pdp region ! foll[+3 or ?r\gh use ( an intellig5t assignm5t process t is design$ to maximize ! access ( su* individual to necess>y prescription drugs :ile m9imiz+ co/s to su* individual & to ! program "u ?is "p to ! greate/ ext5t possible4 ,9 ! case ! ,secret>y enrolls su* individuals ?r\gh use ( an intellig5t assignm5t process1 su* process %all take into acc\nt ! ext5t to :i* prescription drugs necess>y = ! individual are cov]$ 9 ! case ( a ,,pdp sponsor ( a prescription drug plan t uses a =mul>y1 ! use ( prior au?orization or o!r re/rictions on access to cov]age ( su* prescription drugs by su* a sponsor1 & ! ov]all quality ( a prescription drug plan z measur$ by quality rat+s e/abli%$ by ! ,secret>y2 & 7,b7 by /rik+ ,no?+ 9 ! previ\s s5t5ce & ins]t+ ,no?+ 9 ?is subp>agraph2 & 7#b7 9 subp>agraph 7,d7-- 7,a7 by ins]t+ aft] ,,pdp region ! foll[+3 or ?r\gh use ( an intellig5t assignm5t process t is design$ to maximize ! access ( su* individual to necess>y prescription drugs :ile m9imiz+ co/s to su* individual & to ! program "u ?is "p to ! greate/ ext5t possible4 ,9 ! case ! ,secret>y enrolls su* individuals ?r\gh use ( an intellig5t assignm5t process1 su* process %all take into acc\nt ! ext5t to :i* prescription drugs necess>y = ! individual are cov]$ 9 ! case ( a ,,pdp sponsor ( a prescription drug plan t uses a =mul>y1 ! use ( prior au?orization or o!r re/rictions on access to cov]age ( su* prescription drugs by su* a sponsor1 & ! ov]all quality ( a prescription drug plan z measur$ by quality rat+s e/abli%$ by ! ,secret>y2 & 7,b7 by /rik+ ,no?+ 9 ! previ\s s5t5ce & ins]t+ ,no?+ 9 ?is subp>agraph4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply ) respect to plan ye>s beg9n+ ) plan ye> #bjbb4 #djd4 ,exp&+ eligibility = l[-income subsidies "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a771 z am5d$ by sections #cja7;d7 & #dja1 is fur!r am5d$-- 7#a7 9 ! subsection head+1 by /rik+ individuals & all t foll[s ?r\gh l9e & ins]t+ c]ta9 individuals2 7#b7 9 p>agraph 7#a7-- 7,a7 by /rik+ ! p>agraph head+ & ins]t+ ,individuals ) c]ta9 l[ incomes2 & 7,b7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #aej p]c5t7 aft] #ace p]c5t2 7#c7 9 p>agraph 7#b7-- 7,a7 by /rik+ ! p>agraph head+ & ins]t+ ,o!r l[-income individuals2 & 7,b7 9 subp>agraph 7,a7-- 7i7 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #aej p]c5t7 aft] #ace p]c5t2 & 7ii7 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #bjj p]c5t7 aft] #aej p]c5t2 & 7#d7 9 p>agraph 7#c77;,a77ii71 by ins]t+ 7or1 ) respect to a plan ye> beg9n+ on or aft] ,janu>y #a1 #bjbb1 #bjj p]c5t7 aft] #aej p]c5t4 #dje4 ,automatic eligibility ( c]ta9 l[-income t]ritorial resid5ts = premium & co/-%>+ subsidies "u ! ,m$ic>e program2 ,sunset ( enhanc$ allotm5t program 7a7 ,automatic eligibility ( c]ta9 l[-,income t]ritorial resid5ts = premium & co/-,%>+ subsidies "u ! ,m$ic>e program 7#a7 ,9 g5]al ,section #ahfj;,d-#ad7;a77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77 is am5d$-- 7,a7 9 subp>agraph 7,b77v7-- 7i7 9 subclause 7,i71 by /rik+ & at ! end2 7ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iii7 by ins]t+ aft] subclause 7,,ii7 ! foll[+ new subclause3 7,,iii7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 %all provide t any "p ,d eligible individual :o is enroll$ = m$ical assi/ance "u ! ,/ate ,m$icaid plan ( a t]ritory 7z def9$ 9 section #aice7;f77 "u title ,,xix 7or a waiv] ( su* a plan7 %all be treat$ z a subsidy eligible individual describ$ 9 p>agraph 7#a74 2 & 7,b7 9 subp>agraph 7,f71 by add+ at ! end ! foll[+ new s5t5ce3 ,! previ\s s5t5ce %all n apply ) respect to eligibility det]m9ations = premium & co/-%>+ subsidies "u ?is section made on or aft] ,janu>y #a1 #bjba44 7#b7 ,con=m+ am5dm5t ,section #ahfj;,d-#ca7;j77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ada7;j77#b77;,d77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,! previ\s s5t5ce %all n apply ) respect to am\nts made available to a ,/ate "u ?is p>agraph on or aft] ,janu>y #a1 #bjba44 7b7 ,sunset ( enhanc$ allotm5t program 7#a7 ,9 g5]al ,section #aice7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7;e77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a71 by ins]t+ aft] su* ,/ate ! foll[+3 be=e ,janu>y #a1 #bjba2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ aft] a ye> ! foll[+3 7be=e #bjba72 & 7ii7 9 subp>agraph 7,b77iii71 by /rik+ a subsequ5t ye> & ins]t+ ea* ( fiscal ye>s #bjjh ?r\gh #bjbj4 7#b7 ,t]ritory def9$ ,section #aice ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#e7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,t]ritory def9$ ,9 ?is section1 ! t]m t]ritory means ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ! ,nor!rn ,m>iana ,isl&s1 & ,am]ican ,samoa4 4 #djf4 ,automatic qualification ( c]ta9 ,m$icaid b5efici>ies = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program ,clause 7v7 ( section #ahfj;,d-#ad7;a77#c77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,b771 z am5d$ by section #dje1 is fur!r am5d$-- 7#a7 9 subclause 7,,ii71 by /rik+ & at ! end2 7#b7 9 subclause 7,,iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] subclause 7,,iii7 ! foll[+ new subclause3 7,,iv7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb1 %all1 not)/&+ ! prec$+ clauses ( ?is subp>agraph1 provide t any "p ,d eligible individual n describ$ 9 subclause 7,i71 7,,ii71 or 7,,iii7 :o is enroll$1 z ( ! day be=e ! date on :i* su* individual atta9s ! age ( #fe1 = m$ical assi/ance "u a ,/ate plan "u title ,,xix 7or a waiv] ( su* plan7 pursuant to clause 7i77,,viii7 or 7ii77,,xx7 ( section #aijb7;a77#aj77;,a71 & :o has income bel[ #bjj p]c5t ( ! pov]ty l9e applicable to a family ( ! size involv$1 %all be treat$ z a subsidy eligible individual describ$ 9 p>agraph 7#a7 = a limit$ p]iod ( "t1 z specifi$ by ! ,secret>y4 4 #djg4 ,elim9at+ ! res\rce requirem5t ) respect to subsidy eligible individuals "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a77#c77;,a77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,a77iii77 is am5d$ by ins]t+ 9 ! case ( a plan ye> beg9n+ be=e ,janu>y #a1 #bjbb1 be=e meets4 #djh4 ,provid+ = c]ta9 rules reg>d+ ! treatm5t ( eligible retirem5t plans 9 det]m9+ ! eligibility ( individuals = premium & co/-%>+ subsidies "u "p ,d ( ! ,m$ic>e program ,section #ahfj;,d-#ad7;a77#c77;,c77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,c77i77 is am5d$1 by /rik+ except t support & ma9t5ance furni%$ 9 k9d %all n be c\nt$ z income2 & & ins]t+ except t-- 7,i7 support & ma9t5ance furni%$ 9 k9d %all n be c\nt$ z income2 & 7,,ii7 = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbb1 any di/ribution or )drawal f an eligible retirem5t plan 7z def9$ 9 subp>agraph 7,b7 ( section #djb7;c77#h7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 b exclud+ any def9$ b5efit plan describ$ 9 clause 7iv7 or 7v7 ( su* subp>agraph & any qualifi$ tru/ 7z def9$ 9 subp>agraph 7,a7 ( su* section7 :i* is "p ( su* a def9$ b5efit plan7 %all be c\nt$ z income2 & 4 ,v ,drug ,price ,transp>5cy #eja4 ,drug price transp>5cy ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new sections3 #aaej;,c4 ,report+ on drug prices 7a7 ,def9itions ,9 ?is section3 7#a7 ,manufactur] ,! t]m manufactur] means ! p]son-- 7,a7 t holds ! application = a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,b7 :o is responsible = sett+ ! :olesale acquisition co/ = ! drug4 7#b7 ,qualify+ drug ,! t]m qualify+ drug means any drug t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act-- 7,a7 t has a :olesale acquisition co/ ( #ajj or m1 adju/$ = inflation occurr+ aft] ! date ( enactm5t ( ?is section1 = a mon?'s supply or a typical c\rse ( treatm5t t la/s less ?an a mon?1 & is-- 7i7 subject to section #ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 & 7ii7 n a prev5tative vacc9e2 & 7,b7 = :i*1 dur+ ! previ\s cal5d> ye>1 at lea/ #a doll> ( ! total am\nt ( sales 7 = individuals enroll$ "u ! ,m$ic>e program "u title ,,xviii or "u a ,/ate ,m$icaid plan "u title ,,xix or "u a waiv] ( su* plan4 7#c7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 t t]m 9 section #ahdg;,a7c77#f77;,b74 7b7 ,report 7#a7 ,report requir$ ,! manufactur] ( a qualify+ drug %all submit a report to ! ,secret>y if1 ) respect to ! qualify+ drug-- 7,a7 !re is an increase 9 ! price ( ! qualify+ drug t results 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a #ab-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjai2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjai2 7,b7 ! e/imat$ price ( ! qualify+ drug or sp5d+ p] individual or p] us] ( su* drug 7z e/imat$ by ! ,secret>y7 = ! applicable ye> 7or p] c\rse ( treatm5t 9 su* applicable ye> z det]m9$ by ! ,secret>y7 is at lea/ #bf1jjj beg9n+ on or aft] ,janu>y #a1 #bjba2 or 7,c7 !re 0 an increase 9 ! price ( ! qualify+ drug t result$ 9 an increase 9 ! :olesale acquisition co/ ( t drug t is equal to-- 7i7 #aj p]c5t or m )9 a #ab-mon? p]iod t beg9s & ends dur+ ! #e-ye> p]iod prec$+ ,janu>y #a1 #bjba2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod t beg9s & ends dur+ ! #e-ye> p]iod prec$+ ,janu>y #a1 #bjba4 7#b7 ,report deadl9e ,ea* report describ$ 9 p>agraph 7#a7 %all be submitt$ to ! ,secret>y-- 7,a7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ ! p]iod beg9n+ on ,janu>y #a1 #bjai1 & end+ on ! day t is #fj days aft] ! date ( ! enactm5t ( ?is section1 n lat] ?an #ij days aft] su* date ( enactm5t2 7,b7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs aft] ! p]iod describ$ 9 subp>agraph 7,a71 n lat] ?an #cj days prior to ! plann$ effective date ( su* price increase = su* qualify+ drug2 7,c7 9 ! case ( a report ) respect to a qualify+ drug t meets ! crit]ia "u p>agraph 7#a77;,b71 n lat] ?an #cj days aft] su* drug meets su* crit]ia2 & 7,d7 9 ! case ( a report ) respect to an increase 9 ! price ( a qualify+ drug t occurs dur+ a #ab-mon? or #cf-mon? p]iod describ$ 9 p>agraph 7#a77;,c71 n lat] ?an ,april #a1 #bjba4 7c7 ,cont5ts ,a report "u subsection 7b71 consi/5t ) ! /&>d = disclosures describ$ 9 section #bac4c7;d7 ( title #ab1 ,code ( ,f$]al ,regulations 7z 9 effect on ! date ( enactm5t ( ?is section71 %all1 at a m9imum1 include-- 7#a7 ) respect to ! qualify+ drug-- 7,a7 ! p]c5tage by :i* ! manufactur] w raise ! :olesale acquisition co/ ( ! drug )9 ! #ab-mon? p]iod or #cf-mon? p]iod z describ$ 9 subsection 7b77#a77;,a77i71 7b77#a77;,a77ii71 7b77#a77;,c77i71 or 7b77#a77;,c77ii71 z applicable1 & ! effective date ( su* price increase or ! co/ associat$ ) a qualify+ drug if su* drug meets ! crit]ia "u subsection 7b77#a77;,b7 & ! effective date at :i* su* drug meets su* crit]ia2 7,b7 an explanation =1 & description (1 ea* price increase = su* drug t w occur dur+ ! #ab-mon? p]iod or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77i71 7b77#a77;,a77ii71 7b77#a77;,c77i71 or 7b77#a77;,c77ii71 z applicable2 7,c7 an explanation =1 & description (1 ! co/ associat$ ) a qualify+ drug if su* drug meets ! crit]ia "u subsection 7b77#a77;,b71 z applicable2 7,d7 if kn[n & diff]5t f ! manufactur] ( ! qualify+ drug1 ! id5tity (-- 7i7 ! sponsor or sponsors ( any inve/igational new drug applications "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = cl9ical inve/igations ) respect to su* drug1 = :i* ! full reports are submitt$ z "p ( ! application-- 7,i7 = approval ( ! drug "u section #eje ( su* ,act2 or 7,,ii7 = lic5sure ( ! drug "u section #cea ( ! ,pubic ,heal? ,s]vice ,act2 & 7ii7 ! sponsor ( an application = ! drug approv$ "u su* section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7,e7 a description ( ! hi/ory ( ! manufactur]'s price increases = ! drug s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se1 if applicable2 7,f7 ! curr5t :olesale acquisition co/ ( ! drug2 7,g7 ! total exp5ditures ( ! manufactur] on-- 7i7 mat]ials & manufactur+ = su* drug2 7ii7 acquir+ pat5ts & lic5s+ = su* drug2 & 7iii7 pur*as+ or acquir+ su* drug f ano!r manufactur]1 if applicable2 7,h7 ! p]c5tage ( total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t 0 d]iv$ f ,f$]al funds2 7,i7 ! total exp5ditures ( ! manufactur] on rese>* & developm5t = su* drug t is necess>y to demon/rate t x meets applicable /atutory /&>ds = approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act1 z applicable2 7,j7 ! total exp5ditures ( ! manufactur] on pursu+ new or exp&$ indications or dosage *anges = su* drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea ( ! ,public ,heal? ,s]vice ,act2 7,k7 ! total exp5ditures ( ! manufactur] on c>ry+ out po/m>ket requirem5ts relat$ to su* drug1 includ+ "u section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,l7 ! total rev5ue & ! net pr(it g5]at$ f ! qualify+ drug = ea* cal5d> ye> s9ce ! approval ( ! application = ! drug "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or ! issuance ( ! lic5se = ! drug "u section #cea ( ! ,public ,heal? ,s]vice ,act1 or s9ce ! manufactur] acquir$ su* approv$ application or lic5se2 & 7,m7 ! total co/s associat$ ) m>ket+ & adv]tis+ = ! qualify+ drug2 7#b7 ) respect to ! manufactur]-- 7,a7 ! total rev5ue & ! net pr(it ( ! manufactur] = ea* ( ! #ab-mon? p]iod describ$ 9 subsection 7b77#a77;,a77i7 or 7b77#a77;,c77i7 or ! #cf-mon? p]iod describ$ 9 subsection 7b77#a77;,a77ii7 or 7b77#a77;,c77ii71 z applicable2 7,b7 all /ock-bas$ p]=mance metrics us$ by ! manufactur] to det]m9e executive comp5sation = ea* ( ! #ab-mon? p]iods describ$ 9 subsection 7b77#a77;,a77i7 or 7b77#a77;,c77i7 or ! #cf-mon? p]iods describ$ 9 subsection 7b77#a77;,a77ii7 or 7b77#a77;,c77ii71 z applicable2 & 7,c7 any additional in=mation ! manufactur] *ooses to provide relat$ to drug pric+ decisions1 su* z total exp5ditures on-- 7i7 drug rese>* & developm5t2 or 7ii7 cl9ical trials1 includ+ on drugs t fail$ to receive approval by ! ,food & ,drug ,adm9i/ration2 & 7#c7 su* o!r relat$ in=mation z ! ,secret>y consid]s appropriate & z specifi$ by ! ,secret>y4 7d7 ,in=mation provid$ ,! manufactur] ( a qualify+ drug t is requir$ to submit a report "u subsection 7b71 %all ensure t su* report & any explanation =1 & description (1 ea* price increase describ$ 9 subsection 7c77#a7 %all be tru?ful1 n mislead+1 & accurate4 7e7 ,civil monet>y p5alty ,any manufactur] ( a qualify+ drug t fails to submit a report = ! drug z requir$ by ?is section1 foll[+ notification by ! ,secret>y to ! manufactur] t ! manufactur] is n 9 compliance ) ?is section1 %all be subject to a civil monet>y p5alty ( #ge1jjj = ea* day on :i* ! violation cont9ues4 7f7 ,false in=mation ,any manufactur] t submits a report = a drug z requir$ by ?is section t kn[+ly provides false in=mation 9 su* report is subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 7g7 ,public po/+ 7#a7 ,9 g5]al ,subject to p>agraph 7#d71 ! ,secret>y %all po/ ea* report submitt$ "u subsection 7b7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices ! day ! price increase ( a qualify+ drug is s*$ul$ to g into effect4 7#b7 ,=mat ,9 develop+ ! =mat 9 :i* reports w be publicly po/$ "u p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ b5efici>y gr\ps1 & %all seek fe$back f consum] advocates & readability exp]ts on ! =mat & pres5tation ( ! cont5t ( su* reports to ensure t su* reports are-- 7,a7 us]-fri5dly to ! public2 & 7,b7 writt5 9 pla9 language t consum]s c readily und]/&4 7#c7 ,li/ ,9 addition to ! reports submitt$ "u subsection 7b71 ! ,secret>y %all also po/ a li/ ( ea* qualify+ drug ) respect to :i* ! manufactur] 0 requir$ to submit su* a report 9 ! prec$+ ye> & :e!r su* manufactur] 0 requir$ to submit su* report bas$ on a qualify+ price increase or :e!r su* drug meets ! crit]ia "u subsection 7b77#a77;,b74 7#d7 ,protect$ in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 #aaej;,d4 ,annual report to ,congress 7a7 ,9 ,g5]al ,subject to subsection 7b71 ! ,secret>y %all submit to ! ,committees on ,en]gy & ,comm]ce & ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committees on ,heal?1 ,education1 ,labor1 & ,p5sions & ,f9ance ( ! ,s5ate1 & po/ on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 a way t is us]-fri5dly to ! public & writt5 9 pla9 language t consum]s c readily und]/&1 an annual report-- 7#a7 summ>iz+ ! in=mation report$ pursuant to section #aaej;,c2 7#b7 includ+ copies ( ! reports & support+ detail$ economic analyses submitt$ pursuant to su* section2 7#c7 detail+ ! co/s & exp5ditures incurr$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 c>ry+ out section #aaej;,c2 & 7#d7 expla9+ h[ ! ,dep>tm5t ( ,heal? & ,human ,s]vices is improv+ consum] & provid] in=mation ab\t drug value & drug price transp>5cy4 7b7 ,protect$ in=mation ,9 c>ry+ out ?is section1 ! ,secret>y %all en=ce applicable law conc]n+ ! protection ( confid5tial comm]cial in=mation & trade secrets4 4 #a4 ,%ort title2 table ( cont5ts 7a7 ,9 g5]al ,?is ,act may be cit$ z ! ,l[] ,drug ,co/s ,n[ ,act ( #bjai4 7b7 ,table ( cont5ts ,! table ( cont5ts is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,l[]+ ,prices ,?r\gh ,fair ,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 ,title ,,ii--,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates ,sec4 #bja4 ,m$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 ,b5efici>ies ,sec4 #cja4 ,m$ic>e "p ,d b5efit r$esign4 ,i ,l[]+ ,prices ,?r\gh ,fair ,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 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by add+ at ! end ! foll[+ new "p3 ,e ,fair ,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 ,fair ,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/ ( 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 plan ye> 7beg9n+ ) plan ye> #bjbc7 or1 if agre$ to 9 an agreem5t "u section #aaic by ! ,secret>y & manufactur] involv$1 a p]iod ( m ?an "o plan ye> 7beg9n+ on or aft] ,janu>y #a1 #bjbc74 7#b7 ,price applicability p]iod ,! t]m price applicability p]iod means1 ) respect to a drug1 ! p]iod beg9n+ ) ! initial price applicability ye> ) respect to :i* su* drug is a select$ drug & end+ ) ! la/ plan 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 ,april #ae ( ! plan ye> t beg9s #b ye>s prior to su* ye>4 7#d7 ,volunt>y negotiation p]iod ,! t]m volunt>y 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 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug2 & 7,b7 end+ on ,m>* #ca ( ! ye> t beg9s "o ye> prior to ! initial price applicability ye>4 7c7 ,o!r def9itions ,= purposes ( ?is "p3 7#a7 ,fair price eligible individual ,! t]m fair price eligible individual means1 ) respect to a select$ drug-- 7,a7 9 ! case su* drug is furni%$ or disp5s$ to ! individual at a ph>macy or by a mail ord] s]vice-- 7i7 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 "u :i* cov]age is provid$ = su* drug2 & 7ii7 an individual :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or disp5s$2 & 7,b7 9 ! case su* drug is furni%$ or adm9i/]$ to ! individual by a hospital1 physician1 or o!r provid] ( s]vices or suppli]-- 7i7 an individual :o is entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title if su* select$ drug is cov]$ "u ! respective "p2 & 7ii7 an individual :o is enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ 9 ! gr\p or individual m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 ) respect to :i* !re is 9 effect an agreem5t ) ! ,secret>y "u section #aaig ) respect to su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,maximum fair price ,! t]m maximum fair price means1 ) respect to a plan ye> dur+ a price applicability p]iod & ) respect to a select$ drug 7z def9$ 9 section #aaib7;c77 ) respect to su* p]iod1 ! price publi%$ pursuant to section #aaie 9 ! ,f$]al ,regi/] = su* drug & ye>4 7#c7 ,av]age int]national m>ket price def9$ 7,a7 ,9 g5]al ,! t]ms av]age int]national m>ket price & ,,aim price mean1 ) respect to a drug1 ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit 7z def9$ 9 p>agraph 7#d77 ( ! drug = sales ( su* drug 7calculat$ across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type71 z comput$ 7z ( ! date ( publication ( su* drug z a select$ drug "u section #aaib7;a77 9 all c\ntries describ$ 9 clause 7ii7 ( subp>agraph 7,b7 t are applicable c\ntries 7z describ$ 9 clause 7i7 ( su* subp>agraph7 ) respect to su* drug4 7,b7 ,applicable c\ntries 7i7 ,9 g5]al ,= purposes ( subp>agraph 7,a71 a c\ntry describ$ 9 clause 7ii7 is an applicable c\ntry describ$ 9 ?is clause ) respect to a drug if !re is available an av]age price = any unit = ! drug = sales ( su* drug 9 su* c\ntry4 7ii7 ,c\ntries describ$ ,= purposes ( ?is p>agraph1 ! foll[+ are c\ntries describ$ 9 ?is clause3 7,i7 ,au/ralia4 7,,ii7 ,canada4 7,,iii7 ,france4 7,,iv7 ,g]many4 7,v7 ,japan4 7,,vi7 ,! ,unit$ ,k+dom4 7#d7 ,unit ,! t]m unit means1 ) respect to a drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! drug t is disp5s$4 #aaib4 ,selection ( negotiation-eligible drugs z select$ drugs 7a7 ,9 g5]al ,n lat] ?an ! select$ drug publication date ) respect to an initial price applicability ye>1 ! ,secret>y %all select & publi% 9 ! ,f$]al ,regi/] a li/ (-- 7#a7 7,a7 ) respect to an initial price applicability ye> dur+ ! p]iod beg9n+ ) #bjbc & end+ ) #bjbg1 at lea/ #be negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod beg9n+ aft] #bjbc1 ! maximum numb] 7if su* numb] is less ?an #be7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7,b7 ) respect to an initial price applicability ye> dur+ ! p]iod beg9n+ ) #bjbh & end+ ) #bjcb1 at lea/ #cj negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #cj7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 & 7,c7 ) respect to an initial price applicability ye> beg9n+ aft] #bjcb1 at lea/ #ce negotiation-eligible drugs describ$ 9 subp>agraphs 7,a7 & 7,b71 b n subp>agraph 7,c71 ( subsection 7d77#a7 7or1 ) respect to an initial price applicability ye> dur+ su* p]iod1 ! maximum numb] 7if su* numb] is less ?an #ce7 ( su* negotiation-eligible drugs = ! ye>7 ) respect to su* ye>2 7#b7 all negotiation-eligible drugs describ$ 9 subp>agraph 7,c7 ( su* subsection ) respect to su* ye>2 & 7#c7 all new-entrant negotiation-eligible drugs 7z def9$ 9 subsection 7g77#a77 ) respect to su* ye>4 ,ea* drug publi%$ on ! li/ pursuant to ! previ\s s5t5ce %all be subject to ! negotiation process "u section #aaid = ! volunt>y 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 ,9 apply+ ?is subsection1 any negotiation-eligible drug t is select$ "u ?is subsection = an initial price applicability ye> %all n c\nt t[>d ! requir$ m9imum am\nt ( drugs to be select$ "u p>agraph 7#a7 = any subsequ5t ye>1 includ+ su* a drug s select$ t is subject to r5egotiation "u section #aaid4 7b7 ,selection ( drugs ,9 c>ry+ out subsection 7a77#a7 ! ,secret>y %all select = inclusion on ! publi%$ li/ describ$ 9 subsection 7a7 ) respect to a price applicability p]iod1 ! negotiation-eligible drugs t ! ,secret>y projects w result 9 ! greate/ sav+s to ! ,f$]al ,gov]nm5t or fair price eligible individuals dur+ ! price applicability p]iod4 ,9 mak+ ?is projection ( sav+s = drugs = :i* !re is an ,,aim price = a price applicability p]iod1 ! sav+s %all be project$ across diff]5t dosage =ms & /r5g?s ( ! drugs & n bas$ on ! specific =mulation or package size or package type ( ! drugs1 tak+ into consid]ation bo? ! volume ( drugs = :i* paym5t is made1 to ! ext5t su* data is available1 & ! am\nt by :i* ! net price = ! drugs exce$s ! ,,aim price = ! drugs4 7c7 ,select$ drug ,= purposes ( ?is "p1 ea* 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 plan ye> beg9n+ be=e ! fir/ plan ye> beg9n+ aft] ! date on :i* ! ,secret>y det]m9es two or m drug products-- 7#a7 are approv$ or lic5s$ 7z applicable7-- 7,a7 "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act us+ su* drug z ! li/$ drug2 or 7,b7 "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act us+ su* drug z ! ref]5ce product2 & 7#b7 cont9ue to be m>ket$4 7d7 ,negotiation-,eligible drug 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug1 z def9$ 9 subsection 7e71 t meets any ( ! foll[+ crit]ia3 7,a7 ,cov]$ "p ,d drugs ,! drug is among ! #abe cov]$ "p ,d drugs 7z def9$ 9 section #ahfj;,d-#b7;e77 = :i* !re 0 an e/imat$ greate/ net sp5d+ "u p>ts ,c & ,d ( title ,,xviii1 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,b7 ,o!r drugs ,! drug is among ! #abe drugs = :i* !re 0 an e/imat$ greate/ net sp5d+ 9 ! ,unit$ ,/ates 7includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates71 z det]m9$ by ! ,secret>y1 dur+ ! mo/ rec5t plan ye> prior to su* drug publication date = :i* data are available4 7,c7 ,insul9 ,! drug is a qualify+ s+le s\rce drug describ$ 9 subsection 7e77#c74 7#b7 ,cl>ification ,9 det]m9+ :e!r a qualify+ s+le s\rce drug satisfies any ( ! crit]ia describ$ 9 p>agraph 7#a71 ! ,secret>y %all1 to ! ext5t practicable1 use data t is aggregat$ across dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug4 7#c7 ,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 ,= purposes ( ?is "p1 ! t]m qualify+ s+le s\rce drug means any ( ! foll[+3 7#a7 ,drug products ,a drug t-- 7,a7 is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & cont9ues to be m>ket$ pursuant to su* approval2 & 7,b7 is n ! li/$ drug = any drug t is approv$ & cont9ues to be m>ket$ "u section #eje7;j7 ( su* ,act4 7#b7 ,biological products ,a biological product t-- 7,a7 is lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 includ+ any product t has be5 deem$ to be lic5s$ "u section #cea ( su* ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji1 & cont9ues to be m>ket$ "u section #cea ( su* ,act2 & 7,b7 is n ! ref]5ce product = any biological product t is lic5s$ & cont9ues to be m>ket$ "u section #cea7k7 ( su* ,act4 7#c7 ,insul9 product ,not)/&+ p>agraphs 7#a7 & 7#b71 any insul9 product t is approv$ "u subsection 7c7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or lic5s$ "u subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act & cont9ues to be m>ket$ "u su* section #eje or #cea1 includ+ any insul9 product t has be5 deem$ to be lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act pursuant to section #gjjb7;e77#d7 ( ! ,biologics ,price ,competition & ,innovation ,act ( #bjji & cont9ues to be m>ket$ pursuant to su* lic5sure4 ,= purposes ( apply+ p>agraphs 7#a7 & 7#b71 a drug or biological product t is m>ket$ by ! same sponsor or manufactur] 7or an affiliate !re( or a cross-lic5s$ produc] or di/ributor7 z ! li/$ drug or ref]5ce product describ$ 9 su* respective p>agraph %all n be tak5 into consid]ation4 7f7 ,in=mation on int]national drug prices ,= purposes ( det]m9+ :i* negotiation-eligible drugs to select "u subsection 7a7 &1 9 ! case ( su* drugs t are select$ drugs1 to det]m9e ! maximum fair price = su* a drug & :e!r su* maximum fair price %\ld be r5egotiat$ "u section #aaid1 ! ,secret>y %all use data relat+ to ! ,,aim price ) respect to su* drug z available or provid$ to ! ,secret>y & %all on an ongo+ basis reque/ f manufactur]s ( select$ drugs in=mation on ! ,,aim price ( su* a drug4 7g7 ,new-entrant negotiation-eligible drugs 7#a7 ,9 g5]al ,= purposes ( ?is "p1 ! t]m new-entrant negotiation-eligible drug means1 ) respect to ! select$ drug publication date ) respect to an initial price applicability ye>1 a qualify+ s+le s\rce drug-- 7,a7 t is fir/ approv$ or lic5s$1 z describ$ 9 p>agraph 7#a71 7#b71 or 7#c7 ( subsection 7e71 z applicable1 dur+ ! ye> prec$+ su* select$ drug publication date2 & 7,b7 t ! ,secret>y det]m9es "u p>agraph 7#b7 is likely to be a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date4 7#b7 ,det]m9ation ,9 ! case ( a qualify+ s+le s\rce drug t meets ! crit]ia describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#a71 ) respect to an initial price applicability ye>1 if ! :olesale acquisition co/ at :i* su* drug is fir/ m>ket$ 9 ! ,unit$ ,/ates is equal to or great] ?an ! m$ian h\sehold income 7z det]m9$ accord+ to ! mo/ rec5t data collect$ by ! ,unit$ ,/ates ,c5sus ,bureau71 ! ,secret>y %all det]m9e be=e ! select$ drug publication date ) respect to ! initial price applicability ye>1 if ! drug is likely to be includ$ z a negotiation-eligible drug ) respect to ! subsequ5t select$ drug publication date1 bas$ on ! project$ sp5d+ "u title ,,xviii or 9 ! ,unit$ ,/ates on su* drug4 ,= purposes ( ?is p>agraph ! t]m ,unit$ ,/ates includes ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates4 #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 ,june #ae foll[+ ! select$ drug publication date ) respect to su* select$ drug1 "u :i*-- 7#a7 dur+ ! volunt>y 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]iod & 9 accordance ) subsection 7c71 agree to7 a maximum fair price = su* select$ drug ( ! manufactur] 9 ord] to provide access to su* price-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug 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 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 ) a process & dur+ a p]iod specifi$ by ! ,secret>y pursuant to rulemak+1 r5egotiate 7&1 by n lat] ?an ! la/ date ( su* p]iod & 9 accordance ) subsection 7c71 agree to7 ! maximum fair price = su* drug if ! ,secret>y det]m9es t !re is a mat]ial *ange 9 any ( ! factors describ$ 9 section #aaid7;d7 relat+ to ! drug1 includ+ *anges 9 ! ,,aim price = su* drug1 9 ord] to provide access to su* maximum fair price 7z s r5egotiat$7-- 7,a7 to fair price eligible individuals :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & are furni%$ or disp5s$ su* drug 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 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 ! maximum fair price 7includ+ z r5egotiat$ pursuant to p>agraph 7#b771 ) respect to su* a select$ drug1 %all be provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ! ph>macy or by a mail ord] s]vice at ! po9t-(-sale ( su* drug2 7#d7 ! manufactur]1 subject to subsection 7c71 submits to ! ,secret>y1 9 a =m & mann] specifi$ by ! ,secret>y-- 7,a7 = ! volunt>y negotiation p]iod = ! price applicability p]iod 7&1 if applicable1 be=e any p]iod ( r5egotiation specifi$ pursuant to p>agraph 7#b77 ) respect to su* drug all in=mation t ! ,secret>y requires to c>ry out ! negotiation 7or r5egotiation process7 "u ?is "p1 includ+ in=mation describ$ 9 section #aaib7;f7 & section #aaid7;d77#a72 & 7,b7 on an ongo+ basis1 in=mation on *anges 9 prices = su* drug t w\ld affect ! ,,aim price = su* drug or o!rwise provide a basis = r5egotiation ( ! maximum fair price = su* drug pursuant to p>agraph 7#b72 7#e7 ! manufactur] agrees t 9 ! case ! select$ drug ( a manufactur] is a drug describ$ 9 subsection 7c71 ! manufactur] w1 9 accordance ) su* subsection1 make any paym5t requir$ "u su* subsection ) respect to su* drug2 & 7#f7 ! 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 drug1 until su* drug is no long] consid]$ a select$ drug "u section #aaib7;c74 7c7 ,special rule = c]ta9 select$ drugs )\t ,,aim price 7#a7 ,9 g5]al ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug & = :i* an ,,aim price becomes available beg9n+ ) respect to a subsequ5t plan ye> dur+ ! price applicability p]iod = su* drug1 if ! ,secret>y det]m9es t ! am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug is great] ?an ! am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug1 !n by n lat] ?an "o ye> aft] ! date ( su* det]m9ation1 ! manufactur] ( su* select$ drug %all pay to ! ,treasury an am\nt equal to ! product (-- 7,a7 ! diff]5ce betwe5 su* am\nt describ$ 9 p>agraph 7#b77;,a7 = a unit ( su* drug & su* am\nt describ$ 9 p>agraph 7#b77;,b7 = a unit ( su* drug2 & 7,b7 ! numb] ( units ( su* drug sold 9 ! ,unit$ ,/ates1 includ+ ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & ! t]ritories ( ! ,unit$ ,/ates1 dur+ ! p]iod describ$ 9 p>agraph 7#b77;,b74 7#b7 ,am\nts describ$ 7,a7 ,weight$ av]age price be=e ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to ! weight$ av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* dosage /r5g? & =m = ! drug dur+ ! p]iod beg9n+ ) ! fir/ plan ye> = :i* ! drug is includ$ on ! li/ ( negotiation-eligible drugs publi%$ "u section #aaib7;d7 & end+ ) ! la/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is no ,,aim price available = su* drug4 7,b7 ,am\nt multipli] aft] ,,aim price available ,= purposes ( p>agraph 7#a71 ! am\nt describ$ 9 ?is subp>agraph = a select$ drug describ$ 9 su* p>agraph1 is ! am\nt equal to #bjj p]c5t ( ! ,,aim price = su* drug ) respect to ! fir/ plan ye> dur+ ! price applicability p]iod = su* drug ) respect to :i* !re is an ,,aim price available = su* drug4 7d7 ,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 may be us$ only by ! ,secret>y or disclos$ to & us$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates or ! ,m$ic>e ,paym5t ,advisory ,commission = purposes ( c>ry+ out ?is "p4 7e7 ,regulations 7#a7 ,9 g5]al ,! ,secret>y %all1 pursuant to rulemak+1 specify1 9 accordance ) p>agraph 7#b71 ! in=mation t mu/ be submitt$ "u subsection 7a77#d74 7#b7 ,in=mation specifi$ ,in=mation describ$ 9 p>agraph 7#a71 ) respect to a select$ drug1 %all include in=mation on sales ( ! drug 7by ! manufactur] ( ! drug or by ano!r entity "u lic5se or o!r agreem5t ) ! manufactur]1 ) respect to ! sales ( su* drug1 reg>dless ( ! "n "u :i* ! drug is sold7 9 any =eign c\ntry t is "p ( ! ,,aim price4 ,! ,secret>y %all v]ify1 to ! ext5t practicable1 su* sales f appropriate (ficials ( ! gov]nm5t ( ! =eign c\ntry involv$4 7f7 ,compliance ) requirem5ts = adm9i/ration ( program ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all comply ) requirem5ts impos$ by ! ,secret>y or a ?ird p>ty ) a contract "u section #aaif7;c77#a71 z applicable1 = purposes ( adm9i/]+ ! program4 #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 7b7 & 7c71 ! ,secret>y & ! manufactur]-- 7#a7 %all dur+ ! volunt>y negotiation p]iod ) respect to ! initial price applicability ye> = su* drug1 9 accordance ) ?is section1 negotiate a maximum fair price = su* drug = ! purpose describ$ 9 section #aaic7;a77#a72 & 7#b7 z applicable pursuant to section #aaic7;a77#b7 & 9 accordance ) ! process specifi$ pursuant to su* section1 r5egotiate su* maximum fair price = su* drug = ! purpose describ$ 9 su* section4 7b7 ,negotiat+ me?odology & objective 7#a7 ,9 g5]al ,! ,secret>y %all develop & use a consi/5t me?odology = negotiations "u subsection 7a7 t1 9 accordance ) p>agraph 7#b7 & subject to p>agraph 7#c71 a*ieves ! l[e/ maximum fair price = ea* select$ drug :ile appropriately rew>d+ innovation4 7#b7 ,prioritiz+ factors ,9 consid]+ ! factors describ$ 9 subsection 7d7 9 negotiat+ 7&1 z applicable1 r5egotiat+7 ! maximum fair price = a select$ drug1 ! ,secret>y %all1 to ! ext5t practicable1 consid] all ( ! available factors li/$ b %all prioritize ! foll[+ factors3 7,a7 ,rese>* & developm5t co/s ,! factor describ$ 9 p>agraph 7#a77;,a7 ( subsection 7d74 7,b7 ,m>ket data ,! factor describ$ 9 p>agraph 7#a77;,b7 ( su* subsection4 7,c7 ,unit co/s ( production & di/ribution ,! factor describ$ 9 p>agraph 7#a77;,c7 ( su* subsection4 7,d7 ,comp>ison to exi/+ !rapeutic alt]natives ,! factor describ$ 9 p>agraph 7#b77;,a7 ( su* subsection4 7#c7 ,requirem5t 7,a7 ,9 g5]al ,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 9 ! case t ! manufactur] ( ! select$ drug (f]s "u ! negotiation or r5egotiation1 z applicable1 a price = su* drug t is n m ?an ! t>get price describ$ 9 subp>agraph 7,b7 = su* drug = ! respective ye>1 ! ,secret>y %all agree "u su* negotiation or r5egotiation1 respectively1 to su* (f]$ price z ! maximum fair price4 7,b7 ,t>get price 7i7 ,9 g5]al ,subject to clause 7ii71 ! t>get price describ$ 9 ?is subp>agraph = a select$ drug ) respect to a ye>1 is ! av]age price 7:i* %all be ! net av]age price1 if practicable1 & volume-weight$1 if practicable7 = a unit ( su* drug = sales ( su* drug1 z comput$ 7across diff]5t dosage =ms & /r5g?s ( ! drug & n bas$ on ! specific =mulation or package size or package type ( ! drug7 9 ! applicable c\ntry describ$ 9 section #aaia7;c77#c77;,b7 ) respect to su* drug t1 ) respect to su* ye>1 has ! l[e/ av]age price = su* drug z comp>$ to ! av]age prices 7z s comput$7 ( su* drug ) respect to su* ye> 9 ! o!r applicable c\ntries describ$ 9 su* section ) respect to su* drug4 7ii7 ,select$ drugs )\t ,,aim price ,9 apply+ ?is p>agraph 9 ! case ( negotiat+ ! maximum fair price ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 or1 z applicable1 r5egotiat+ ! maximum fair price = su* drug ) respect to a subsequ5t ye> dur+ ! price applicability p]iod = su* drug be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! t>get price describ$ 9 ?is subp>agraph = su* drug & respective ye> is ! am\nt t is #hj p]c5t ( ! av]age manufactur] price 7z def9$ 9 section #aibg7k77#a77 = su* drug & ye>4 7#d7 ,annual report ,aft] ! completion ( ea* volunt>y negotiation p]iod1 ! ,secret>y %all submit to ,congress a report on ! maximum fair prices negotiat$ 7or1 z applicable1 r5egotiat$7 = su* p]iod4 ,su* report %all include in=mation on h[ su* prices s negotiat$ 7or r5egotiat$7 meet ! requirem5ts ( ?is "p1 includ+ ! requirem5ts ( ?is subsection4 7c7 ,limitation 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = a select$ drug1 ) respect to ea* plan ye> dur+ a price applicability p]iod = su* drug1 %all n exce$ #abj p]c5t ( ! ,,aim price applicable to su* drug ) respect to su* ye>4 7#b7 ,select$ drugs )\t ,,aim price ,9 ! case ( a select$ drug = :i* !re is no ,,aim price available ) respect to ! initial price applicability ye> = su* drug1 = ea* plan ye> dur+ ! price applicability p]iod be=e ! fir/ plan ye> = :i* !re is an ,,aim price available = su* drug1 ! maximum fair price negotiat$ 7includ+ z r5egotiat$7 "u ?is section = ! select$ drug %all n exce$ ! am\nt equal to #he p]c5t ( ! av]age manufactur] price = ! drug ) respect to su* ye>4 7d7 ,consid]ations ,= 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 ! ,secret>y %all1 consi/5t ) subsection 7b77#b71 take into consid]ation ! foll[+ factors3 7#a7 ,manufactur]-specific in=mation ,! foll[+ in=mation1 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$]al f9ancial support = novel !rapeutic discov]y & developm5t ) respect to ! drug4 7,e7 ,data on pat5ts & on exi/+ & p5d+ exclusivity = ! drug4 7,f7 ,national sales data = ! drug4 7,g7 ,in=mation on cl9ical trials = ! drug 9 ! ,unit$ ,/ates or 9 applicable c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#b7 ,in=mation on alt]native products ,! foll[+ in=mation3 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 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 ,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$1 or n t]m9ally ill4 ,no?+ 9 ! previ\s s5t5ce %all affect ! application or consid]ation ( an ,,aim price = a select$ drug4 7#c7 ,=eign sales in=mation ,to ! ext5t available on a timely basis1 includ+ z provid$ by a manufactur] ( ! select$ drug or o!rwise1 in=mation on sales ( ! select$ drug 9 ea* ( ! c\ntries describ$ 9 section #aaia7;c77#c77;,b74 7#d7 ,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 7e7 ,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 7d77#a72 & 7#b7 by n lat] ?an ,octob] #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 may require4 ,! ,secret>y %all reque/1 f ! manufactur] or o!rs1 su* additional in=mation z may be ne$$ to c>ry out ! negotiation & r5egotiation process "u ?is section4 #aaie4 ,publication ( maximum fair prices 7a7 ,9 g5]al ,) respect to an initial price applicability ye> & select$ drug ) respect to su* ye>1 n lat] ?an ,april #a ( ! plan ye> prior to su* initial price applicability ye>1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/] ! maximum fair price = su* drug negotiat$ "u ?is "p ) ! manufactur] ( su* drug4 7b7 ,updates 7#a7 ,subsequ5t ye> maximum fair prices ,= a select$ drug1 = ea* plan ye> subsequ5t to ! initial price applicability ye> = su* drug ) respect to :i* an agreem5t = su* drug is 9 effect "u section #aaic1 ! ,secret>y %all publi% 9 ! ,f$]al ,regi/]-- 7,a7 subject to subp>agraph 7,b71 ! am\nt equal to ! maximum fair price publi%$ = 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$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p1 contracts ) prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title1 & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i* ! maximum fair price = a select$ drug is provid$ to fair price eligible individuals1 :o ) respect to su* drug are describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a71 at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( ! drug = ! applicable price p]iod = su* drug & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u su* plans or cov]age = ! select$ drug4 7,b7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts ) manufactur]s "u ?is "p & contracts ) hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s & agreem5ts "u section #aaig ) gr\p heal? plans & heal? insurance issu]s ( heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket7 "u :i*1 9 ! case ( a select$ drug furni%$ or adm9i/]$ by su* a hospital1 physician1 or o!r provid] ( s]vices or suppli] to fair price eligible individuals 7:o ) respect to su* drug are describ$ 9 subp>agraph 7,b7 ( section #aaia7;c77#a771 ! maximum fair price = ! select$ drug is provid$ to su* hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s 7z applicable7 ) respect to su* individuals & provid+ t su* maximum fair price is us$ = det]m9+ co/-%>+ "u ! respective "p1 plan1 or cov]age = ! select$ drug4 7,c7 ,! e/abli%m5t ( proc$ures 7includ+ ?r\gh agreem5ts & contracts describ$ 9 subp>agraphs 7,a7 & 7,b77 to ensure t1 n lat] ?an #ij days aft] ! disp5s+ ( a select$ drug to a fair price eligible individual 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 ! less] (-- 7,i7 ! :olesale acquisition co/ ( ! drug2 7,,ii7 ! national av]age drug acquisition co/ ( ! drug2 & 7,,iii7 any o!r simil> det]m9ation ( ph>macy acquisition co/s ( ! drug1 z det]m9$ by ! ,secret>y2 & 7ii7 ! maximum fair price = ! drug4 7,d7 ,! 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 ( fair price eligible individuals z ! ,secret>y may specify2 & 7ii7 any o!r disc\nts4 7,e7 ,! e/abli%m5t ( proc$ures to ent] into appropriate agreem5ts & protocols = ! ongo+ computation ( ,,aim prices = select$ drugs1 includ+1 to ! ext5t possible1 to compute ! ,,aim price = select$ drugs & includ+ by provid+ t ! manufactur] ( su* a select$ drug %\ld provide in=mation = su* computation n lat] ?an #c mon?s aft] ! fir/ date ( ! volunt>y negotiation p]iod = su* select$ drug4 7,f7 ,! 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,g7 ,! e/abli%m5t ( proc$ures to negotiate & apply ! maximum fair price 9 a mann] t does n include any disp5s+ or simil> fee4 7,h7 ,! e/abli%m5t ( proc$ures to c>ry out ! provisions ( ?is "p1 z applicable1 ) respect to-- 7i7 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 fair price eligible individuals :o are enroll$ "u a gr\p heal? plan or heal? insurance cov]age (f]$ by a heal? insurance issu] 9 ! individual or gr\p m>ket ) respect to :i* !re is an agreem5t 9 effect "u section #aaig4 7,i7 ,! e/abli%m5t ( a negotiation process & r5egotiation process 9 accordance ) section #aaid1 includ+ a process = acquir+ in=mation describ$ 9 subsection 7d7 ( su* section & det]m9+ am\nts describ$ 9 subsection 7b7 ( su* section4 7,j7 ,! provision ( a reasonable dispute resolution me*anism to resolve disagreem5ts betwe5 manufactur]s1 fair price eligible individuals1 & ! ?ird p>ty ) a contract "u subsection 7c77#a74 7#b7 ,monitor+ compliance 7,a7 ,9 g5]al ,! ,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 may be report$4 7,b7 ,notification ,if a ?ird p>ty ) a contract "u subsection 7c77#a7 det]m9es t ! manufactur] is n 9 compliance ) su* agreem5t1 ! ?ird p>ty %all notify ! ,secret>y ( su* noncompliance = appropriate en=cem5t "u section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf or section #aaih1 z applicable4 7b7 ,collection ( data 7#a7 ,f prescription drug plans & ,,ma-,,pd plans ,! ,secret>y may collect appropriate data f prescription drug plans "u "p ,d ( title ,,xviii & ,,ma-,,pd plans "u "p ,c ( su* title 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7#b7 ,f heal? plans ,! ,secret>y may collect appropriate data f gr\p heal? plans or heal? insurance issu]s (f]+ gr\p or individual heal? insurance cov]age 9 a timeframe t all[s = maximum fair prices to be provid$ "u ?is "p = select$ drugs4 7#c7 ,coord9ation ( data collection ,to ! ext5t feasible1 z det]m9$ by ! ,secret>y1 ! ,secret>y %all ensure t data collect$ pursuant to ?is subsection is coord9at$ )1 & n duplicative (1 o!r data collection ef=ts4 7c7 ,contract ) ?ird p>ties 7#a7 ,9 g5]al ,! ,secret>y may 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 "p4 ,at a m9imum1 ! contract ) a ?ird p>ty "u ! prec$+ s5t5ce %all require t ! ?ird p>ty-- 7,a7 receive & transmit in=mation betwe5 ! ,secret>y1 manufactur]s1 & o!r individuals or entities ! ,secret>y det]m9es appropriate2 7,b7 receive1 di/ribute1 or facilitate ! di/ribution ( funds ( manufactur]s to appropriate individuals or entities 9 ord] to meet ! obligations ( manufactur]s "u agreem5ts "u ?is "p2 7,c7 provide adequate & timely in=mation to manufactur]s1 consi/5t ) ! agreem5t ) ! manufactur] "u ?is "p1 z necess>y = ! manufactur] to fulfill its obligations "u ?is "p2 & 7,d7 p]mit manufactur]s to conduct p]iodic audits1 directly or ?r\gh contracts1 ( ! data & in=mation us$ by ! ?ird p>ty to det]m9e disc\nts = applicable drugs ( ! manufactur] "u ! program4 7#b7 ,p]=mance requirem5ts ,! ,secret>y %all e/abli% p]=mance requirem5ts = a ?ird p>ty ) a contract "u p>agraph 7#a7 & safegu>ds to protect ! indep5d5ce & integrity ( ! activities c>ri$ out by ! ?ird p>ty "u ! program "u ?is "p4 7d7 ,coord9ation ,) #cdj;,b ,program ,9 ! case ( a manufactur] ( a select$ drug1 ) respect to an initial price applicability ye>1 = ea* ye> ) respect to :i* a maximum fair price is appli$ "u ?is "p = su* drug1 su* drug %all n be consid]$ a cov]$ outpati5t drug subject to an agreem5t "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act4 #aaig4 ,volunt>y p>ticipation by o!r heal? plans 7a7 ,agreem5t to p>ticipate "u program 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 "u ! program "u ?is "p ! ,secret>y %all be treat$ z hav+ 9 effect an agreem5t ) a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod-- 7,a7 ) respect to su* select$ drug furni%$ or disp5s$ at a ph>macy or by mail ord] s]vice if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or disp5s$2 & 7,b7 ) respect to su* select$ drug furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli] if cov]age is provid$ "u su* plan or cov]age dur+ su* p]iod = su* select$ drug z s furni%$ or adm9i/]$4 7#b7 ,opt+ out ( agreem5t ,! ,secret>y %all n be treat$ z hav+ 9 effect an agreem5t "u ! program "u ?is "p ) a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod if su* a plan or issu] affirmatively elects1 ?r\gh a process specifi$ by ! ,secret>y1 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 7b7 ,publication ( election ,) respect to ea* price applicability p]iod & ea* select$ drug ) respect to su* p]iod1 ! ,secret>y & ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 z applicable1 %all make public a li/ ( ea* gr\p heal? plan & ea* issu] ( heal? insurance cov]age1 ) respect to :i* cov]age is provid$ "u su* plan or cov]age = su* drug1 t has elect$ "u subsection 7a7 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 #aaih4 ,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 plan ye> dur+ ! price applicability p]iod = 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 fair price eligible individual :o ) respect to su* drug is describ$ 9 subp>agraph 7,a7 ( section #aaia7;c77#a7 & :o is furni%$ or disp5s$ su* drug dur+ su* ye>2 or 7#b7 to a hospital1 physician1 or o!r provid] ( s]vices or suppli] ) respect to 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>2 %all be subject to a civil monet>y p5alty equal to t5 times ! am\nt equal to ! diff]5ce betwe5 ! price = su* drug made available = su* ye> by su* manufactur] ) respect to su* individual or hospital1 physician1 provid]1 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 plan ye> dur+ ! price applicability p]iod = su* drug1 t is 9 violation ( a requirem5t impos$ pursuant to section #aaic7;a77#f7 %all be subject to a civil monet>y p5alty ( n m ?an #a1jjj1jjj = ea* su* violation4 7c7 ,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$+ "u section #aabh;,a7a74 #aaii4 ,miscellane\s provisions 7a7 ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to data collect$ "u ?is "p4 7b7 ,national ,academy ( ,m$ic9e /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,national ,academy ( ,m$ic9e %all conduct a /udy1 & submit to ,congress a report1 on recomm5dations = improvem5ts to ! program "u ?is "p1 includ+ ! det]m9ation ( ! limits appli$ "u section #aaid7;c74 7c7 ,med,p,a,c /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,m$ic>e ,paym5t ,advisory ,commission %all conduct a /udy1 & submit to ,congress a report1 on ! program "u ?is "p ) respect to ! ,m$ic>e program "u title ,,xviii1 includ+ ) respect to ! effect ( ! program on individuals entitl$ to b5efits or enroll$ "u su* title4 7d7 ,limitation on judicial review ,! foll[+ %all n be subject to judicial review3 7#a7 ,! selection ( drugs = publication "u section #aaib7;a74 7#b7 ,! det]m9ation ( :e!r a drug is a negotiation-eligible drug "u section #aaib7;d74 7#c7 ,! det]m9ation ( ! maximum fair price ( a select$ drug "u section #aaid4 7#d7 ,! det]m9ation ( units ( a drug = purposes ( section #aaia7;c77#c74 7e7 ,coord9ation ,9 c>ry+ out ?is "p ) respect to gr\p heal? plans or heal? insurance cov]age (f]$ 9 ! gr\p m>ket t are subject to ov]sight by ! ,secret>y ( ,labor or ! ,secret>y ( ! ,treasury1 ! ,secret>y ( ,heal? & ,human ,s]vices %all coord9ate ) su* respective ,secret>y4 7f7 ,data %>+ ,! ,secret>y %all %>e ) ! ,secret>y ( ! ,treasury su* in=mation z is necess>y to det]m9e ! tax impos$ by section #daib ( ! ,int]nal ,rev5ue ,code ( #aihf4 7g7 ,,gao /udy ,n lat] ?an ,decemb] #ca1 #bjbe1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy (1 & submit to ,congress a report on1 ! implem5tation ( ! ,fair ,price ,negotiation ,program "u ?is "p4 7h7 ,inflation rebate = gr\p heal? plans 7#a7 ,9 g5]al ,n lat] ?an ,decemb] #ca1 #bjba1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 submit to ,congress a report on ! feasibility ( ! ,secret>y ( ,labor-- 7,a7 e/abli%+ an agreem5t process ) manufactur]s ( prescription drugs "u :i* manufactur]s provide = inflation rebates 79 a mann] simil> to rebates "u section #ahcd7x7 & #ahfj;,d-#ad;,b ) respect to "p ,b & "p ,d drugs1 respectively7 ) respect to drugs t are furni%$ or disp5s$ to p>ticipants1 enrollees1 & b5efici>ies ( heal? insurance cov]age 9 connection ) a gr\p heal? plan2 & 7,b7 e/abli%+ an en=cem5t me*anism ) respect to su* agreem5t process t ensures t su* inflation rebates are1 proportionally di/ribut$1 ) respect to co/s1 to-- 7i7 p>ticipants1 enrollees1 & b5efici>ies ( heal? insurance cov]age (f]$ 9 ! gr\p m>ket2 & 7ii7 a heal? insurance issu] (f]+ heal? insurance cov]age 9 ! gr\p m>ket4 7#b7 ,regulations ,n lat] ?an ,decemb] #ca1 #bjbb1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 promulgate regulations consi/5t ) ! in=mation conta9$ 9 ! report submitt$ pursuant to p>agraph 7#a7 if-- 7,a7 ! ,secret>y ( ,labor det]m9es ! prices ( a suffici5t numb] 7z det]m9$ by ! ,secret>y ( ,labor7 ( drugs describ$ 9 p>agraph 7#a77;,a7 h increas$ at a p]c5tage t exce$s ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = a p]iod ( "t 7z det]m9$ by ! ,secret>y ( ,labor72 & 7,b7 ! ,secret>y ( ,labor f9ds t ! agreem5t process id5tifi$ pursuant to subp>agraph 7,a7 ( p>agraph 7#a7 & ! en=cem5t me*anism id5tifi$ pursuant to subp>agraph 7,b7 ( su* p>agraph are feasible4 4 7b7 ,application ( maximum fair prices & con=m+ am5dm5ts 7#a7 ,"u ,m$ic>e prescription drug program 7,a7 ,exception to non-int]f]5ce ,section #ahfj;,d-#aa7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;i77 is am5d$ by ins]t+ 1 except z provid$ "u "p ,e ( title ,,xi1 aft] ! ,secret>y4 7,b7 ,application z negotiat$ price ,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 def9$ 9 section #aaib7;c771 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b77#b771 ! negotiat$ price describ$ 9 ?is subsection %all be ! maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug & = ea* plan ye> dur+ su* p]iod4 4 7,c7 ,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 #aaif7;b74 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 ,"u gr\p heal? plans & heal? insurance cov]age 7,a7 ,,phsa ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #bgbi ! foll[+ new section3 #bgbi;,a4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ ! maximum fair price negotiat$ "u su* "p = su* drug 9 lieu ( ! contract$ rate "u su* plan or cov]age = su* select$ drug2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p to su* plan1 issu]1 & cov]age1 & su* individuals s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7,b7 ,,erisa 7i7 ,9 g5]al ,subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaha et4 seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan or cov]age-- 7#a7 ! provisions ( su* "p %all apply1 z applicable-- 7,a7 if cov]age ( su* select$ drug is provid$ "u su* plan or cov]age if ! drug is furni%$ or disp5s$ at a ph>macy or by a mail ord] s]vice1 to ! plans or cov]age (f]$ by su* plan or issu]1 & to ! individuals enroll$ "u su* plans or cov]age1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans dur+ su* p]iod2 & 7,b7 if cov]age ( su* select$ drug is provid$ "u su* plan or cov]age if ! drug is furni%$ or adm9i/]$ by a hospital1 physician1 or o!r provid] ( s]vices or suppli]1 to ! plans or cov]age (f]$ by su* plan or issu]s1 to ! individuals enroll$ "u su* plans or cov]age1 & to hospitals1 physicians1 & o!r provid]s ( s]vices & suppli]s dur+ su* p]iod1 ) respect to su* drug 9 ! same mann] z su* provisions apply to ! ,secret>y1 to individuals entitl$ to b5efits "u "p ,a ( title ,,xviii or enroll$ "u "p ,b ( su* title1 & to hospitals1 physicians1 & o!r provid]s & suppli]s p>ticipat+ "u title ,,xviii dur+ su* p]iod2 7#b7 ! plan or issu] %all apply any co/-%>+ responsibilities "u su* plan or cov]age1 ) respect to su* select$ drug1 by sub/itut+ an am\nt n m ?an ! maximum fair price negotiat$ "u su* "p ,e ( title ,,xi = su* drug 9 lieu ( ! drug price ^u :i* ! co/-%>+ w\ld h o!rwise appli$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* am\nt2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 & su* individuals s enroll$ 9 su* plans4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan or issu] to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan or cov]age be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7ii7 ,application to retiree & c]ta9 small gr\p heal? plans ,section #gcb7;a7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aaia;a7a77 is am5d$ by /rik+ section #gaa & ins]t+ sections #gaa & #gaf4 7iii7 ,cl]ical am5dm5t ,! table ( sections = subp>t ,b ( "p #g ( subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd is am5d$ by add+ at ! end ! foll[+3 ,sec4 #gaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices4 4 7,c7 ,,irc 7i7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #ihaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,drug ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) respect to :i* cov]age is provid$ "u su* plan-- 7#a7 ! provisions ( su* "p %all apply to ! plans (f]$ by su* plan1 & to ! individuals enroll$ "u su* plans1 dur+ su* p]iod1 ) respect to su* select$ drug1 9 ! same mann] z su* provisions apply to prescription drug plans & ,,ma-,,pd plans1 & to individuals enroll$ "u su* prescription drug plans & ,,ma-,,pd plans2 7#b7 ! plan %all apply any co/-%>+ responsibilities "u su* plan1 ) respect to su* select$ drug1 by sub/itut+ ! maximum fair price negotiat$ "u su* "p = su* drug 9 lieu ( ! contract$ rate "u su* plan = su* select$ drug2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p to su* plan & su* individuals s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,drug ,price ,negotiation ,program ,a gr\p heal? plan %all publicly disclose 9 a mann] & 9 accordance ) a process specifi$ by ! ,secret>y any election made "u section #aaig ( ! ,social ,security ,act by ! plan to n p>ticipate 9 ! ,fair ,drug ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act ) respect to a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 = :i* cov]age is provid$ "u su* plan be=e ! beg9n+ ( ! plan ye> = :i* su* election 0 made4 4 7ii7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihaf4 ,fair ,price ,drug ,negotiation ,program & application ( maximum fair prices4 4 #ajb4 ,select$ drug manufactur] excise tax impos$ dur+ noncompliance p]iods 7a7 ,9 g5]al ,sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #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 ! ,june #af? 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 ! ,april #a/ imm$iately foll[+ ! ,june #af? describ$ 9 p>agraph 7#a7 & end+ on ! fir/ date dur+ :i* ! manufactur] ( ! drug has 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$4 7#e7 ,9 ! case ( a select$ drug ) respect to :i* a paym5t is due "u subsection 7c7 ( su* section #aaic1 ! p]iod beg9n+ on ! date on :i* ! ,secret>y ( ,heal? & ,human ,s]vices c]tifies t su* paym5t is ov]due & end+ on ! date t su* paym5t is made 9 full4 7c7 ,applicable p]c5tage ,! 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 ,def9itions ,! t]ms select$ drug publication date & maximum fair price h ! mean+ giv5 su* t]ms 9 section #aaia ( ! ,social ,security ,act & ! t]m select$ drug has ! mean+ giv5 su* t]m 9 section #aaib ( su* ,act4 7e7 ,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$uction = excise tax paym5ts ,section #bge ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ or by section #daib be=e ! p]iod at ! end ( subsection 7a77#f74 7c7 ,con=m+ am5dm5ts 7#a7 ,section #dbba7;a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ or #daib aft] section #daia4 7#b7 ,section #fdaf7;b77#b7 ( su* ,code is am5d$ by ins]t+ or #daib aft] section #daia4 7d7 ,cl]ical am5dm5ts 7#a7 ,! head+ ( sub*apt] ,e ( *apt] #cb ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ,m$ical devices & ins]t+ ,o!r m$ical products4 7#b7 ,! table ( sub*apt]s = *apt] #cb ( su* ,code is am5d$ by /rik+ ! item relat+ to sub*apt] ,e & ins]t+ ! foll[+ new item3 ,sub*apt] ,e4 ,o!r m$ical products 4 7#c7 ,! table ( sections = sub*apt] ,e ( *apt] #cb ( su* ,code is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #daib4 ,select$ drugs dur+ noncompliance p]iods4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to sales aft] ! date ( ! enactm5t ( ?is ,act4 ,,ii ,m$ic>e ,p>ts ,b & ,d ,prescription ,drug ,inflation ,rebates #bja4 ,m$ic>e "p ,b rebate by manufactur]s 7a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7x7 ,rebate by manufactur]s = s+le s\rce drugs ) 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 #bjba1 ! ,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 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 #bjba1 ! 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 ( section #ahdg;,a7c77#f771 includ+ a biosimil> biological product 7z def9$ 9 subp>agraph 7,h7 ( su* section71 paid = "u ?is "p1 except su* t]m %all n include su* a drug or biological-- 7i7 if ! av]age total all[$ *>ges = a ye> p] individual t uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 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 = #bjbb1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjba1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 z ( ! fir/ qu>t] ( ! previ\s ye>2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is clause 7or clause 7i77 = ! previ\s ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 z ( ! fir/ qu>t] ( ! 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#c7 ,rebate am\nt 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! 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 p>agraph 7#d71 ! am\nt equal to ! product (-- 7i7 subject to subp>agraph 7,b71 ! total numb] ( bill+ units1 z describ$ 9 section #ahdg;,a7b77#f77;,b71 = su* "p ,b rebatable drug furni%$ "u ?is "p dur+ ! cal5d> qu>t]2 & 7ii7 ! am\nt 7if any7 by :i*-- 7,i7 ! paym5t am\nt "u subp>agraph 7,b7 or 7,c7 ( section #ahdg;,a7b77#a71 z applicable1 = su* "p ,b rebatable 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 ,exclud$ units ,= purposes ( subp>agraph 7,a77i71 ! total numb] ( bill+ units = "p ,b rebatable drugs furni%$ dur+ a cal5d> qu>t] %all n include-- 7i7 units packag$ into ! paym5t = a relat$ proc$ure or s]vice "u section #ahcc7t7 or "u section #ahcc7;i7 7in/ead ( sep>ately payable "u su* respective section72 7ii7 units includ$ "u ! s+le paym5t sy/em = r5al dialysis s]vices "u section #ahha7;b77#ad72 or 7iii7 units ( a "p ,b rebatable drug ( a manufactur] t is furni%$ to an individual1 if su* manufactur]1 ) respect to ! furni%+ ( su* units ( su* drug1 provides = disc\nts "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or = rebates "u section #aibg4 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] beg9n+ ,janu>y #a1 #bjaf4 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 = ,july #bjae4 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#d7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,subject to subp>agraph 7,b71 9 ! case ( a "p ,b rebatable drug fir/ approv$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjae1 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 ,july #bjae "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$4 7,b7 ,timel9e = provision ( rebates = new drugs ,9 ! case ( a "p ,b rebatable drug fir/ approv$ by ! ,food & ,drug ,adm9i/ration aft] ,july #a1 #bjae1 clause 7i7 ( p>agraph 7#a77;,b7 %all be appli$ z if ! ref]5ce to ,july #a1 #bjba "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 #bjba4 7,c7 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u p>agraph 7#a77;,b7 ) respect to a "p ,b rebatable drug t appe>s on ! drug %ortage li/ 9 effect "u section #ejf7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or 9 ! case ( o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,d7 ,select$ drugs ,9 ! case ( a "p ,b rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c771 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod 7z def9$ 9 section #aaia7;b77#b7 ) 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 ,july #bjae "u su* p>agraph 7 a ref]5ce to ! ,july ( ! ye> prec$+ su* la/ ye>4 7#e7 ,application to b5efici>y co9surance ,9 ! case ( a "p ,b rebatable drug = :i* a rebate is payable "u ?is subsection-- 7,a7 9 comput+ ! am\nt ( any co9surance applicable "u ?is title to an individual ) respect to su* drug1 ! computation ( su* co9surance %all be bas$ on ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#c77;,c7 = su* "p ,b rebatable drug2 & 7,b7 ! am\nt ( su* co9surance is equal to #bj p]c5t ( su* inflation-adju/$ paym5t am\nt s det]m9$4 7#f7 ,rebate deposits ,am\nts paid z rebates "u p>agraph 7#a77;,b7 %all be deposit$ 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$+ "u section #aabh;,a7a74 7#h7 ,/udy & report 7,a7 ,/udy ,! ,secret>y %all conduct a /udy ( ! feasibility ( & op]ational issues involv$ ) ! foll[+3 7i7 ,includ+ multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c77 9 ! rebate sy/em "u ?is subsection4 7ii7 ,includ+ drugs & biologicals paid = "u ,,ma plans "u "p ,c 9 ! rebate sy/em "u ?is subsection4 7iii7 ,includ+ drugs exclud$ "u p>agraph 7#b77;,a7 & bill+ units ( drugs exclud$ "u p>agraph 7#c77;,b7 9 ! rebate sy/em "u ?is subsection4 7,b7 ,report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all submit to ,congress a report on ! /udy conduct$ "u subp>agraph 7,a74 7#i7 ,application to multiple s\rce drugs ,! ,secret>y may1 bas$ on ! report submitt$ "u p>agraph 7#h7 & pursuant to rulemak+1 apply ! provisions ( ?is subsection to multiple s\rce drugs 7z def9$ 9 section #ahdg;,a7c77#f77;,c771 includ+1 = purposes ( det]m9+ ! rebate am\nt "u p>agraph 7#c71 by calculat+ manufactur]-specific av]age sales prices = ! b5*m>k p]iod & ! rebate p]iod4 4 7b7 ,am\nts payable2 co/-,%>+ ,section #ahcc7;a7 ( ! ,social ,security ,act is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,s71 by /rik+ ) respect to & ins]t+ subject to subp>agraph 7,,dd71 ) respect to2 7,b7 by /rik+ & 7,,cc7 & ins]t+ 7,,cc72 & 7,c7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,dd7 ) respect to a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7x77 = :i* a rebate is payable "u su* section1 ! am\nts paid %all be ! diff]5ce betwe5 7i7 ! paym5t am\nt "u p>agraph 7#c77;,a77ii77,i7 ( su* section = su* drug1 & 7ii7 #bj p]c5t ( ! inflation-adju/$ paym5t am\nt "u p>agraph 7#c77;,a77ii77,,ii7 ( su* section = su* drug2 & 7#b7 by add+ at ! end ( ! flu% left matt] foll[+ p>agraph 7#i71 ! foll[+3 ,= purposes ( apply+ p>agraph 7#a77;,,dd7 & section #ahcd7x77#e71 ! ,secret>y %all make su* e/imates & use su* data z ! ,secret>y det]m9es appropriate4 4 7c7 ,con=m+ am5dm5t 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+ or section #ahcd7x7 aft] section #aibg4 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s ,"p ,d ( title ,,xviii ( ! ,social ,security ,act is am5d$ 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 ,9 g5]al ,subject to ! provisions ( ?is section1 9 ord] = cov]age to be available "u ?is "p = a "p ,d rebatable drug ( a manufactur] disp5s$ dur+ an applicable ye>1 ! manufactur] mu/ h ent]$ into & h 9 effect an agreem5t describ$ 9 subsection 7b74 ,= purposes ( ?is section ! t]m applicable ye> means a ye> beg9n+ ) #bjbb4 7b7 ,agreem5ts 7#a7 ,t]ms ( agreem5t ,an agreem5t describ$ 9 ?is subsection1 ) respect to a manufactur] ( a "p ,d rebatable drug1 is an agreem5t "u :i* ! foll[+ applies3 7,a7 ,secret>ial provision ( in=mation ,n lat] ?an #i mon?s aft] ! end ( ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! ,secret>y1 = ! "p ,d rebatable drug ( ! manufactur]1 reports to ! manufactur] ! foll[+ = su* ye>3 7i7 ,in=mation on ! total units 7z def9$ 9 subsection 7g77#b77 disp5s$ = ea* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age manufactur] price increase describ$ 9 subsection 7c77#a77;,b7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7iii7 ,! rebate am\nt specifi$ "u subsection 7c7 = ea* dosage =m & /r5g? ) respect to su* drug & ye>4 7,b7 ,manufactur] requirem5ts ,= ea* applicable ye> ) respect to :i* ! agreem5t is 9 effect1 ! manufactur] ( ! "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 subp>agraph 7,a7 = su* ye>1 provides to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 subsection 7c7 = su* dosage =m & /r5g? ) respect to su* drug = su* ye>4 7#b7 ,l5g? ( agreem5t 7,a7 ,9 g5]al ,an agreem5t "u ?is section1 ) respect to a "p ,d rebatable drug1 %all be effective = an initial p]iod ( n less ?an "o ye> & %all be automatically r5ew$ = a p]iod ( n less ?an "o ye> unless t]m9at$ "u subp>agraph 7,b74 7,b7 ,t]m9ation 7i7 ,by ,secret>y ,! ,secret>y may provide = t]m9ation ( an agreem5t "u ?is section = violation ( ! requirem5ts ( ! agreem5t or o!r good cause %[n4 ,su* t]m9ation %all n be effective e>li] ?an #fj days aft] ! date ( notice ( su* t]m9ation4 ,! ,secret>y %all provide1 ^u reque/1 a manufactur] ) a he>+ conc]n+ su* a t]m9ation1 b su* he>+ %all n delay ! effective date ( ! t]m9ation4 7ii7 ,by a manufactur] ,a manufactur] may t]m9ate an agreem5t "u ?is section = any reason4 ,any su* t]m9ation %all n be effective until ! ye> beg9n+ at lea/ #fj days aft] ! date ! manufactur] provides notice to ! ,secret>y4 7,c7 ,effectiv5ess ( t]m9ation ,any t]m9ation "u ?is p>agraph %all n affect rebates due "u ! agreem5t "u ?is section be=e ! effective date ( its t]m9ation4 7,d7 ,delay be=e re5try ,9 ! case ( any agreem5t "u ?is section ) a manufactur] :i* is t]m9at$ 9 a plan ye>1 ano!r su* agreem5t ) ! manufactur] 7or a successor manufactur]7 may n be ent]$ into be=e ! subsequ5t plan ye>1 unless ! ,secret>y f9ds good cause = an e>li] re9/atem5t ( su* an agreem5t4 7#c7 ,in=mation ,= purposes ( c>ry+ out ?is section1 ! ,secret>y %all use in=mation submitt$ by manufactur]s "u section #aibg7;b77#c74 7c7 ,rebate am\nt 7#a7 ,9 g5]al ,= 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>agraphs 7,b7 & 7,c7 ( p>agraph 7#c71 ! am\nt equal to ! product (-- 7,a7 ! total av]age numb] ( units weight$ by1 & disp5s$ =1 su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug & ye>2 & 7,b7 ! am\nt 7if any7 by :i*-- 7i7 ! av]age manufactur] price 7z def9$ 9 subsection 7g77 paid = su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug dur+ ! ye>2 exce$s 7ii7 ! inflation-adju/$ paym5t am\nt det]m9$ "u p>agraph 7#b7 = su* dosage =m & /r5g? ) respect to su* "p ,d rebatable drug dur+ ! ye>4 7#b7 ,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 subp>agraphs 7,a7 & 7,d7 ( p>agraph 7#c71 is-- 7,a7 ! av]age manufactur] price paid = su* dosage =m & /r5g? ) respect to su* drug 9 ! paym5t am\nt b5*m>k ye> 7z def9$ 9 subsection 7g77#c772 increas$ by 7,b7 ! p]c5tage by :i* ! rebate p]iod ,,cpi-,u 7z def9$ 9 subsection 7g77#e77 = ! applicable ye> exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 9 subsection 7g77#d774 7#c7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,9 ! case ( a "p ,d rebatable drug fir/ approv$ by ! ,food & ,drug ,adm9i/ration aft] ,janu>y #a1 #bjaf1 subp>agraph 7,a7 ( p>agraph 7#b7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k ye> 7 def9$ "u subsection 7g77#c7 z ! fir/ ye> beg9n+ aft] ! day on :i* ! drug 0 fir/ m>ket$ & subp>agraph 7,b7 ( p>agraph 7#b7 %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 ,janu>y #bjaf "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 ,exemption = %ortages ,! ,secret>y may r$uce or waive ! rebate "u p>agraph 7#a7 ) respect to a "p ,d rebatable drug 9 ! case ( a %ortage ( su* drug or o!r exig5t circum/ances1 z det]m9$ by ! ,secret>y4 7,c7 ,treatm5t ( new =mulations 7i7 ,9 g5]al ,9 ! case ( a "p ,d rebatable drug t is a l9e ext5sion ( a s+le s\rce drug or an innovator multiple s\rce drug t is an oral solid dosage =m1 ! ,secret>y %all e/abli% a =mula = det]m9+ ! am\nt specifi$ 9 ?is subsection ) respect to su* "p ,d rebatable drug & an applicable ye> ) consid]ation ( ! s+le s\rce drug or an innovator multiple s\rce drug4 7ii7 ,l9e ext5sion def9$ ,9 ?is subp>agraph1 ! t]m l9e ext5sion means1 ) respect to a "p ,d rebatable drug1 a new =mulation ( ! drug 7z det]m9$ by ! ,secret>y71 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,d7 ,select$ drugs ,9 ! case ( a "p ,d rebatable drug t is a select$ drug 7z def9$ 9 section #aaib7;c771 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod 7z def9$ 9 section #aaia7;b77#b7 ) respect to su* drug1 subp>agraph 7,a7 ( p>agraph 7#b7 %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#b7 %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 ,janu>y #bjaf "u su* subsection 7 a ref]5ce to ,janu>y ( ! la/ ye> beg9n+ dur+ su* price applicability p]iod ) respect to su* drug4 7d7 ,rebate deposits ,am\nts paid z rebates "u subsection 7c7 %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 7e7 ,civil money p5alty ,9 ! case ( a manufactur] ( a "p ,d rebatable drug ) an agreem5t 9 effect "u ?is section :o has fail$ to comply ) ! t]ms ( ! agreem5t "u subsection 7b77#a77;,b7 ) respect to su* drug = an applicable ye>1 ! ,secret>y may impose a civil money p5alty on su* manufactur] 9 an am\nt equal to #abe p]c5t ( ! am\nt specifi$ 9 subsection 7c7 = 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$+ "u section #aabh;,a7a74 7f7 ,judicial review ,!re %all be no judicial review ( ! foll[+3 7#a7 ,! det]m9ation ( units "u ?is section4 7#b7 ,! det]m9ation ( :e!r a drug is a "p ,d rebatable drug "u ?is section4 7#c7 ,! calculation ( ! rebate am\nt "u ?is section4 7g7 ,def9itions ,9 ?is section3 7#a7 ,"p ,d rebatable drug def9$ 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 total co/ "u a prescription drug plan "u ?is "p or ,,ma-,,pd plan "u "p ,c = su* ye> p] individual :o uses su* a drug or biological1 z det]m9$ by ! ,secret>y1 are 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 = #bjbc1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbb1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 z ( ,janu>y ( #bjbb2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is subp>agraph 7or subp>agraph 7,a77 = ! previ\s ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 z ( ,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 def9$ ,! t]m unit means1 ) respect to a "p ,d rebatable drug1 ! l[e/ id5tifiable quantity 7su* z a capsule or tablet1 milligram ( molecules1 or grams7 ( ! "p ,d rebatable drug t is disp5s$ to individuals enroll$ "u a prescription drug plan "u ?is "p or an ,,ma-,,pd plan "u "p ,c4 7#c7 ,paym5t am\nt b5*m>k ye> ,! t]m paym5t am\nt b5*m>k ye> means ! ye> beg9n+ ,janu>y #a1 #bjaf4 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 = ,janu>y #bjaf4 7#e7 ,rebate p]iod ,,cpi-,u ,! t]m rebate p]iod ,,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] = an applicable ye>1 giv5 su* t]m 9 section #aibg7k77#a71 ) respect to a cov]$ outpati5t drug ( a manufactur] = a rebate p]iod "u section #aibg4 ,= purposes ( apply+ ! previ\s s5t5ce1 ) respect to a "p ,d rebatable drug ( a manufactur] & an applicable ye>1 ! ,secret>y %all use ! in=mation ) respect to ! av]age manufactur] price = su* drug report$ by ! manufactur] "u section #aibg7;b77#c7 ) respect to ea* ( ! qu>t]s 9 ! applicable ye> & calculate an annual av]age manufactur] price = su* applicable ye> z ! av]age ( su* av]age manufactur] prices = ea* su* qu>t]1 weight$ by units ( su* drug sold or disp5s$ ) respect to su* applicable ye>4 4 ,,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$+ #bjbb & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbb & ea* subsequ5t ye> aft] p>agraph 7#c72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ & #bjba2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjba2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjba2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbb1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjba2 & 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$+ #bjbb1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & 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] #bjba = 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+ = #bjba2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbb1 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$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ &1 = a ye> prec$+ #bjbb1 = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( ye>s #bjaa ?r\gh #bjba1 9 apply+4 7b7 ,decreas+ re9surance paym5t am\nt ,section #ahfj;,d-#ae7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is am5d$ by ins]t+ aft] #hj p]c5t ! foll[+3 7or1 ) respect to a cov]age ye> aft] #bjba1 #bj p]c5t74 7c7 ,manufactur] disc\nt program 7#a7 ,9 g5]al ,"p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq471 z am5d$ by section #bjb1 is fur!r am5d$ by ins]t+ aft] section #ahfj;,d-#ad;,b ! foll[+ new section3 #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 #bjba1 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 provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbb4 7,b7 ,provision ( disc\nt$ prices at ! po9t-(-sale ,! disc\nt$ prices describ$ 9 subp>agraph 7,a7 %all be provid$ to ! applicable b5efici>y at ! ph>macy or by ! mail ord] s]vice at ! po9t-(-sale ( an applicable drug4 7,c7 ,tim+ ( agreem5t 7i7 ,special rule = #bjbb ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to ! p]iod beg9n+ on ,janu>y #a1 #bjbb1 & end+ on ,decemb] #ca1 #bjbb1 ! manufactur] %all ent] into su* agreem5t n lat] ?an #cj days aft] ! date ( ! e/abli%m5t ( a model agreem5t "u subsection 7a74 7ii7 #bjbc & subsequ5t ye>s ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to plan ye> #bjbc or a subsequ5t plan ye>1 ! manufactur] %all ent] into su* agreem5t 7or su* agreem5t %all be r5ew$ "u p>agraph 7#d77;,a77 n lat] ?an ,janu>y #cj ( ! prec$+ ye>4 7#b7 ,provision ( appropriate data ,ea* manufactur] ) an agreem5t 9 effect "u ?is section %all collect & h available appropriate data1 z det]m9$ 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 may 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 #cj ( a plan ye>1 z ( ! day aft] ! end ( ! plan ye>2 & 7,,ii7 if ! t]m9ation occurs on or aft] ,janu>y #cj ( 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$ures "u :i* disc\nt$ prices are provid$ to applicable b5efici>ies at ph>macies or by mail ord] s]vice at ! po9t-(-sale ( an applicable drug2 7,c7 ! 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,d7 ! 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 ! ,secret>y may specify2 & 7,e7 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 may implem5t ! program "u ?is section by program in/ruction or o!rwise4 7#f7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! program "u ?is section4 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 ,! ,secret>y may impose a civil money p5alty on a manufactur] t fails to provide applicable b5efici>ies disc\nts = applicable drugs ( ! manufactur] 9 accordance ) su* agreem5t = ea* su* failure 9 an am\nt ! ,secret>y det]m9es is comm5surate ) ! 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/s = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = su* ye>4 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;b7 ( ! ,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 def9$ 9 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 ) respect to an applicable drug ( a manufactur] furni%$ dur+ a ye> to an applicable b5efici>y-- 7i7 :o has n incurr$ co/s = 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/s 9 ! ye> t are equal to or exce$ su* ?re%old = ! ye>1 #gj p]c5t ( ! negotiat$ price ( su* drug4 7,b7 ,cl>ification ,no?+ 9 ?is section %all be con/ru$ z affect+ ! responsibility ( an applicable b5efici>y = paym5t ( a disp5s+ fee = an applicable drug4 7,c7 ,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 at or 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 at or 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$]al ,regulations 7z 9 effect on ! date ( enactm5t ( section #ahfj;,d-#ad;,a71 except t su* negotiat$ price %all n include any disp5s+ 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 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 #bjbb1 &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 aft] ,janu>y #a1 #bjbb1 ) 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$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance an ins]t+ 8assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "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 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c2 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or1 = a ye> prec$+ #bjbb1 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$+ #bjbb or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbb & 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$+ #bjbb1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbb1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbb1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbb1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e7-- 7,i7 by ins]t+ = a ye> prec$+ #bjbb1 aft] subsection 7c72 & 7,,ii7 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$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbb1 any disc\nt 4 7,b7 9 clause 7i71 z ins]t$ 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 = #bjbb & 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$-- 7,a7 by ins]t+ = a ye> be=e #bjbb aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7#g7 ,p>agraph 7#a7 ( section #ahfj;,d-#dc7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7;a77 is am5d$ to read z foll[s3 7#a7 p>ticipate 9-- 7,a7 = #bjaa ?r\gh #bjba1 ! ,m$ic>e cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbb & ea* subsequ5t ye>1 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye> #bjbb & subsequ5t plan ye>s4 ,decemb] #i1 #bjai ,report$ f ! ,committee on ,education & ,labor ) an am5dm5t2 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union & ord]$ to be pr9t$