,i #aag? ,,congress #a/ ,session ,h4 ,r4 #c ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #bb1 #bjba ,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 ,ov]sight & ,re=m1 & ,vet]ans' ,affairs1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to 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 ,%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 ,sec4 #ajc4 ,fair ,price ,negotiation ,implem5tation ,fund4 ,title ,,ii--,prescription ,drug ,inflation ,rebates ,sec4 #bja4 ,m$ic>e "p ,b rebate by manufactur]s4 ,sec4 #bjb4 ,m$ic>e "p ,d rebate by manufactur]s4 ,sec4 #bjc4 ,provision reg>d+ inflation rebates = gr\p heal? plans & gr\p heal? insurance cov]age4 ,sec4 #bjd4 ,annual report on drug co/s 9 gr\p heal? plans & gr\p heal? insurance cov]age4 ,sec4 #bje4 ,collection ( data4 ,title ,,iii--,"p ,d ,improvem5ts & ,maximum ,out-(-,pocket ,cap = ,m$ic>e ,b5efici>ies ,sec4 #cja4 ,m$ic>e "p ,d b5efit r$esign4 ,sec4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drug plans & ,,ma-,,pd plans "u ,m$ic>e program to spread out co/-%>+ "u c]ta9 circum/ances4 ,sec4 #cjc4 ,e/abli%m5t ( ph>macy quality measures "u ,m$ic>e "p ,d4 ,title ,,iv--,drug ,price ,transp>5cy ,sec4 #dja4 ,drug price transp>5cy4 ,title ,v--,,nih1 ,,fda1 & ,ov]dose ,epidemic ,fund+ ,subtitle ,a--,biom$ical ,innovation ,expansion ,sec4 #eja4 ,,nih ,innovation ,initiatives4 ,sec4 #ejb4 ,,nih cl9ical trial4 ,sec4 #ejc4 ,innovation ,network4 ,subtitle ,b--,inve/+ 9 ,safety & ,innovation ,sec4 #eaa4 ,food & ,drug ,adm9i/ration4 ,sec4 #eab4 ,/udy on high-risk1 high-rew>d drugs4 ,subtitle ,c--,ov]dose ,epidemic ,response ,sec4 #eba4 ,ov]dose ,epidemic ,response ,fund4 ,sec4 #ebb4 ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration4 ,sec4 #ebc4 ,c5t]s = ,disease ,control & ,prev5tion4 ,sec4 #ebd4 ,food & ,drug ,adm9i/ration4 ,sec4 #ebe4 ,national ,in/itutes ( ,heal?4 ,sec4 #ebf4 ,heal? ,res\rces & ,s]vices ,adm9i/ration4 ,sec4 #ebg4 ,adm9i/ration = ,*ildr5 & ,families4 ,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> #bjbd7 or1 if agre$ to 9 an agreem5t "u section #aaic by ! ,secret>y & manufactur] involv$1 a p]iod ( m ?an "o plan ye> 7beg9n+ on or aft] ,janu>y #a1 #bjbd74 7#b7 ,price applicability p]iod ,! t]m price applicability p]iod means1 ) respect to a drug1 ! p]iod beg9n+ ) ! initial price applicability ye> ) respect to :i* su* drug is a select$ 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 if cov]age is provid$ "u su* plan = su* select$ 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 subject to subsection 7h71 ! ,secret>y %all select & publi% 9 ! ,f$]al ,regi/] a li/ (-- 7#a7 7,a7 ) respect to an initial price applicability ye> dur+ #bjbd1 at lea/ #be negotiation-eligible drugs describ$ 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] #bjbd1 ! 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+ #bjbe or a subsequ5t ye>1 at lea/ #ej 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 #ej7 ( 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 7h7 ,conflict ( int]e/ 7#a7 ,9 g5]al ,9 ! case ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices det]m9es ! ,secret>y has a conflict1 ) respect to a matt] describ$ 9 p>agraph 7#b71 ! individual describ$ 9 p>agraph 7#c7 %all c>ry out ! duties ( ! ,secret>y "u ?is "p1 ) respect to a negotiation-eligible drug1 t w\ld o!rwise be su* a conflict4 7#b7 ,matt] describ$ ,a matt] describ$ 9 ?is p>agraph is-- 7,a7 a f9ancial int]e/ 7z describ$ 9 section #bfce4djb ( title #e1 ,code ( ,f$]al ,regulations1 z 9 effect on ! date ( ! enactm5t ( ?is section1 7except = an int]e/ describ$ 9 subsection 7b77#b77;iv7 ( su* section77 on ! date ( ! select$ drug publication date1 ) respect ! price applicability ye> 7z applicable72 7,b7 a p]sonal or bus9ess relation%ip 7z describ$ 9 section #bfce4ejb ( su* title7 on ! date ( ! select$ drug publication date1 ) respect ! price applicability ye>2 7,c7 employm5t by a manufactur] ( a negotiation-eligible drug dur+ ! prec$+ #aj-ye> p]iod beg9n+ on ! date ( ! select$ drug publication date1 ) respect to ea* price applicability ye>2 & 7,d7 any o!r matt] ! ,g5]al ,c\nsel det]m9es appropriate4 7#c7 ,individual describ$ ,an individual describ$ 9 ?is p>agraph is-- 7,a7 ! highe/-rank+ (fic] or employee ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7z det]m9$ by ! organizational *>t ( ! ,dep>tm5t7 t does n h a conflict "u ?is subsection2 & 7,b7 is nom9at$ by ! ,presid5t & confirm$ by ! ,s5ate ) respect to ! position4 #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>y1 consi/5t ) subsection 7b77#b71 %all take into consid]ation ! factors describ$ 9 p>agraphs 7#a71 7#b71 7#c71 & 7#e71 & may take into consid]ation ! factor describ$ 9 p>agraph 7#d73 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 ,,va drug pric+ in=mation ,in=mation disclos$ to ! ,secret>y pursuant to subsection 7f74 7#e7 ,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 7f7 ,disclosure ( in=mation ,= purposes ( ?is "p1 ! ,secret>y ( ,vet]ans ,affairs may disclose to ! ,secret>y ( ,heal? & ,human ,s]vices ! price ( any negotiation-eligible drug t is pur*as$ pursuant to section #habf ( title #ch1 ,unit$ ,/ates ,code4 #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 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 ,f$]al 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 #aaig4 ,volunt>y p>ticipation by o!r heal? plans 7a7 ,agreem5t ,to p>ticipate "u program 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 "u ! program "u ?is "p ! ,secret>y %all be treat$ z hav+ 9 effect an agreem5t ) a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act71 ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod-- 7,a7 ) 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]+ gr\p or individual heal? insurance cov]age ) respect to a price applicability p]iod & a select$ drug ) respect to su* p]iod if su* a plan or issu] affirmatively elects1 ?r\gh a process specifi$ by ! ,secret>y1 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 7b7 ,publication ( election ,) respect to ea* price applicability p]iod & ea* select$ drug ) respect to su* p]iod1 ! ,secret>y & ! ,secret>y ( ,labor & ! ,secret>y ( ! ,treasury1 z applicable1 %all make public a li/ ( ea* gr\p heal? plan & ea* heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 ) respect to :i* cov]age is provid$ "u su* plan or cov]age = su* drug1 t has elect$ "u subsection 7a7 n to p>ticipate "u ! program ) respect to su* p]iod & drug4 #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 #bjbg1 ! ,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 #bjbg1 ! ,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 #bjbg1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy (1 & submit to ,congress a report on1 ! implem5tation ( ! ,fair ,price ,negotiation ,program "u ?is "p4 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#b77 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 ,d ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,fair ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) 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$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan1 issu]1 & cov]age1 su* 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 ,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 ,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 et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #gbf4 ,fair ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) 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* maximum fair price2 & 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 ,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 ,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 & #gbf4 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 #gbf4 ,fair ,price ,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 #ihbf4 ,fair ,price ,negotiation ,program & application ( maximum fair prices 7a7 ,9 g5]al ,9 ! case ( a gr\p heal? plan t is treat$ "u section #aaig ( ! ,social ,security ,act z hav+ 9 effect an agreem5t ) ! ,secret>y "u ! ,fair ,price ,negotiation ,program "u "p ,e ( title ,,xi ( su* ,act1 ) respect to a price applicability p]iod 7z def9$ 9 section #aaia7;b7 ( su* ,act7 & a select$ drug 7z def9$ 9 section #aaib7;c7 ( su* ,act7 ) respect to su* p]iod ) 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$1 & su* co/-%>+ responsibilities ) respect to su* select$ drug may n exce$ su* maximum fair price2 & 7#c7 ! ,secret>y %all apply ! provisions ( su* "p ,e to su* plan & su* individuals s enroll$ 9 su* plan4 7b7 ,notification reg>d+ nonp>ticipation 9 ,fair ,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 ,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 #ihbf1 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 #ihbf4 ,fair ,price ,negotiation ,program & application ( maximum fair prices4 4 7#c7 ,fair price negotiation program prices includ$ 9 be/ price & ,,amp ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7,a7 9 subsection 7c77#a77;,c77ii7-- 7i7 9 subclause 7,,iii71 by /rik+ at ! end 2 &2 7ii7 9 subclause 7,,iv71 by /rik+ at ! end ! p]iod & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subclause3 7,v7 9 ! case ( a rebate p]iod & a cov]$ outpati5t drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 dur+ su* rebate p]iod1 %all be inclusive ( ! price = su* drug made available f ! manufactur] dur+ ! rebate p]iod by reason ( application ( "p ,e ( title ,,xi to any :olesal]1 retail]1 provid]1 heal? ma9t5ance organization1 nonpr(it entity1 or gov]nm5tal entity )9 ! ,unit$ ,/ates4 2 & 7,b7 9 subsection 7k77#a77;,b71 by add+ at ! end ! foll[+ new clause3 7iii7 ,cl>ification ,not)/&+ clause 7i71 9 ! case ( a rebate p]iod & a cov]$ outpati5t drug t is a select$ drug 7z def9$ 9 section #aaib7;c77 dur+ su* rebate p]iod1 any r$uction 9 price paid dur+ ! rebate p]iod to ! manufactur] = ! drug by a :olesal] or retail community ph>macy describ$ 9 subp>agraph 7,a7 by reason ( application ( "p ,e ( title ,,xi %all be includ$ 9 ! av]age manufactur] price = ! cov]$ outpati5t drug4 4 7#d7 ,,fehbp ,section #hijb ( title #e1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+3 7p7 ,a contract may n be made or a plan approv$ "u ?is *apt] ) any c>ri] t has affirmatively elect$1 pursuant to section #aaig ( ! ,social ,security ,act1 n to p>ticipate 9 ! ,fair ,price ,negotiation ,program e/abli%$ "u section #aaia ( su* ,act = any select$ drug 7z t t]m is def9$ 9 section #aaib7;c7 ( su* ,act74 4 7#e7 ,option ( ,secret>y ( ,vet]ans ,affairs to pur*ase cov]$ drugs at maximum fair prices ,section #habf ( title #ch1 ,unit$ ,/ates ,code1 is am5d$-- 7,a7 9 subsection 7a77#b71 by ins]t+ 1 subject to subsection 7j71 aft] may n exce$2 7,b7 9 subsection 7d71 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ 1 subject to subsection 7j7 aft] = ! procurem5t ( ! drug2 & 7,c7 by add+ at ! end ! foll[+ new subsection3 7j7 7#a7 ,9 ! case ( a cov]$ drug t is a select$ drug1 = any ye> dur+ ! price applicability p]iod = su* drug1 if ! ,secret>y det]m9es t ! maximum fair price ( su* drug = su* ye> is less ?an ! price = su* drug o!rwise 9 effect pursuant to ?is section 7includ+ aft] application ( any r$uction "u subsection 7a77#b7 & any disc\nt "u subsection 7c771 at ! option ( ! ,secret>y1 9 lieu ( ! maximum price 7det]m9$ aft] application ( ! r$uction "u subsection 7a77#b7 & any disc\nt "u subsection 7c71 z applicable7 t w\ld be p]mitt$ to be *>g$ dur+ su* ye> = su* drug pursuant to ?is section )\t application ( ?is subsection1 ! maximum price p]mitt$ to be *>g$ dur+ su* ye> = su* drug pursuant to ?is section %all be su* maximum fair price = su* drug & ye>4 7#b7 ,= purposes ( ?is subsection3 7,a7 ,! t]m maximum fair price means1 ) respect to a select$ drug & ye> dur+ ! price applicability p]iod = su* drug1 ! maximum fair price 7z def9$ 9 section #aaia7;c77#b7 ( ! ,social ,security ,act7 = su* drug & ye>4 7,b7 ,! t]m negotiation eligible drug has ! mean+ giv5 su* t]m 9 section #aaib7;d77#a7 ( ! ,social ,security ,act4 7,c7 ,! t]m price applicability p]iod has1 ) respect to a select$ drug1 ! mean+ giv5 su* t]m 9 section #aaia7;b77#b7 ( su* ,act4 7,d7 ,! t]m select$ drug means1 ) respect to a ye>1 a drug t is a select$ drug "u section #aaib7;c7 ( su* ,act = su* ye>4 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 #ajc4 ,fair ,price ,negotiation ,implem5tation ,fund 7a7 ,9 g5]al ,!re is h]eby e/abli%$ a ,fair ,price ,negotiation ,implem5tation ,fund 7ref]r$ to 9 ?is section z ! ,fund74 ,! ,secret>y ( ,heal? & ,human ,s]vices may obligate & exp5d am\nts 9 ! ,fund to c>ry out ?is title & titles ,,ii & ,,iii 7& ! am5dm5ts made by su* titles74 7b7 ,fund+ ,!re is au?oriz$ to be appropriat$1 & !re is h]eby appropriat$1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to ! ,fund #c1jjj1jjj1jjj1 to rema9 available until exp5d$1 ( :i*-- 7#a7 #fjj1jjj1jjj %all become available on ! date ( ! enactm5t ( ?is ,act2 7#b7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbb2 7#c7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbc2 7#d7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbd2 & 7#e7 #fjj1jjj1jjj %all become available on ,octob] #a1 #bjbe4 7c7 ,supplem5t n supplant ,any am\nts appropriat$ pursuant to ?is section %all be 9 addition to any o!r am\nts o!rwise appropriat$ pursuant to any o!r provision ( law4 ,,ii ,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 7z7 ,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 #bjbc1 ! ,secret>y %all1 = ea* "p ,b rebatable drug1 report to ea* manufactur] ( su* "p ,b rebatable drug ! foll[+ = su* cal5d> qu>t]3 7i7 ,in=mation on ! total numb] ( units ( ! bill+ & paym5t code describ$ 9 subp>agraph 7,a77i7 ( p>agraph 7#c7 ) respect to su* drug & cal5d> qu>t]4 7ii7 ,in=mation on ! am\nt 7if any7 ( ! excess av]age sales price increase describ$ 9 subp>agraph 7,a77ii7 ( su* p>agraph = su* drug & cal5d> qu>t]4 7iii7 ,! rebate am\nt specifi$ "u su* p>agraph = su* "p ,b rebatable drug & cal5d> qu>t]4 7,b7 ,manufactur] requirem5t ,= ea* cal5d> qu>t] beg9n+ on or aft] ,july #a1 #bjbc1 ! manufactur] ( a "p ,b rebatable drug %all1 = su* drug1 n lat] ?an #cj days aft] ! date ( receipt f ! ,secret>y ( ! in=mation describ$ 9 subp>agraph 7,a7 = su* cal5d> qu>t]1 provide to ! ,secret>y a rebate t is equal to ! am\nt specifi$ 9 p>agraph 7#c7 = su* drug = su* cal5d> qu>t]4 7#b7 ,"p ,b rebatable drug def9$ 7,a7 ,9 g5]al ,9 ?is subsection1 ! t]m "p ,b rebatable drug means a s+le s\rce drug or biological 7z def9$ 9 subp>agraph 7,d7 ( 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 = #bjbd1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbc1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod end+ ) ,june ( ! previ\s ye>2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is clause 7or clause 7i77 = ! previ\s ye>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 #bjbc "u su* p>agraph 7 a ref]5ce to ! lat] ( ! #f? full cal5d> qu>t] aft] ! day on :i* ! drug 0 fir/ m>ket$ or ,july #a1 #bjbc4 7,c7 ,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-- 7i7 = cal5d> qu>t]s dur+ su* p]iod = :i* a maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug has be5 det]m9$ & is appli$ "u "p ,e ( title ,,xi1 ! rebate am\nt "u p>agraph 7#a77;,b7 %all be waiv$2 & 7ii7 9 ! case su* drug is det]m9$ 7pursuant to su* section #aaib7;c77 to no long] be a select$ drug1 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod ) respect to su* drug1 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,,dd7 & ins]t+ 7,,ee72 & 7iii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,ee7 ) respect to a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7z77 = :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;,,ee71 subsections 7i77#i7 & 7t77#h77;,f71 & section #ahcd7z77#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 #ahcd7z77 = :i* paym5t "u ?is subsection is n packag$ into a paym5t = a cov]$ ,,opd s]vice 7z def9$ 9 subsection 7t77#a77;,b77 7or gr\p ( s]vices7 furni%$ on or aft] ,july #a1 #bjbc1 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahcd7z77#e71 p>agraph 7#a77;,,ee7 ( 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 #ahcd7z77#e7 & subsection 7a7 apply "u su* section & subsection4 2 & 7#c7 9 subsection 7t77#h71 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,"p ,b rebatable drugs ,9 ! case ( a "p ,b rebatable drug 7z def9$ 9 p>agraph 7#b7 ( section #ahcd7z77 = :i* paym5t "u ?is "p is n packag$ into a paym5t = a s]vice furni%$ on or aft] ,july #a1 #bjbc1 "u ! sy/em "u ?is subsection1 9 lieu ( calculation ( co9surance & ! am\nt ( paym5t o!rwise applicable "u ?is subsection1 ! provisions ( section #ahcd7z77#e71 p>agraph 7#a77;,,ee7 ( 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 #ahcd7z77#e7 & subsection 7a7 apply "u su* section & subsection4 4 7c7 ,con=m+ am5dm5ts 7#a7 ,to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is am5d$ by ins]t+ or section #ahcd7z7 aft] section #aibg4 7#b7 ,exclud+ p>ts ,b drug inflation rebate f be/ price ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is am5d$ by ins]t+ or section #ahcd7z7 aft] ?is section4 7#c7 ,coord9ation ) ,m$icaid rebate in=mation disclosure ,section #aibg7;b77#c77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i77 is am5d$ by /rik+ or to c>ry out section #ahdg;,b & ins]t+ to c>ry out section #ahdg;,b or section #ahcd7z74 #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 #bjbc1 & end+ on ,decemb] #ca1 #bjbc1 !re 7 ext5uat+ circum/ances4 7#c7 ,applicable ye> ,= purposes ( ?is section ! t]m applicable ye> means a ye> beg9n+ ) #bjbc4 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]s ( ! 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+ ea* su* cal5d> qu>t] ( su* paym5t am\nt b5*m>k ye>2 to 7ii7 ! total numb] ( units ( su* dosage =m & /r5g? disp5s$ dur+ su* paym5t am\nt b5*m>k ye>4 7#e7 ,special treatm5t ( c]ta9 drugs & exemption 7,a7 ,subsequ5tly approv$ drugs ,9 ! case ( a "p ,d rebatable drug fir/ approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration aft] ,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-- 7i7 = plan ye>s dur+ su* p]iod = :i* a maximum fair price 7z def9$ 9 section #aaia7;c77#b77 = su* drug has be5 det]m9$ & is appli$ "u "p ,e ( title ,,xi1 ! rebate "u subsection 7b77#a77;,b7 %all be waiv$2 & 7ii7 9 ! case su* drug is det]m9$ 7pursuant to su* section #aaib7;c77 to no long] be a select$ drug1 = ea* applicable ye> beg9n+ aft] ! price applicability p]iod ) respect to su* drug1 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#d7 %all be appli$ z if ! t]m paym5t am\nt b5*m>k ye> 7 def9$ "u subsection 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 = #bjbd1 %all be ! doll> am\nt specifi$ "u su* subp>agraph = #bjbc1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod beg9n+ ) ,janu>y ( #bjbc2 & 7ii7 = a subsequ5t ye>1 %all be ! doll> am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! p]c5tage increase 9 ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 = ! #ab-mon? p]iod beg9n+ ) ,janu>y ( ! previ\s ye>4 ,any doll> am\nt specifi$ "u ?is subp>agraph t is n a multiple ( #aj %all be r\nd$ to ! ne>e/ multiple ( #aj4 7#b7 ,unit 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+ am5dm5ts 7#a7 ,to "p ,b ,,asp calculation ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c771 z am5d$ by section #bja7;c77#a71 is fur!r am5d$ by /rik+ section #aibg or section #ahcd7z7 & ins]t+ section #aibg1 section #ahcd7z71 or section #ahfj;,d-#ad;,b4 7#b7 ,exclud+ "p ,d drug inflation rebate f be/ price ,section #aibg7;c77#a77;,c77ii77,i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i771 z am5d$ by section #bja7;c77#b71 is fur!r am5d$ by /rik+ or section #ahcd7z7 & ins]t+ 1 section #ahcd7z71 or section #ahfj;,d-#ad;,b4 7#c7 ,coord9ation ) ,m$icaid rebate in=mation disclosure ,section #aibg7;b77#c77;,d77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77i771 z am5d$ by section #bja7;c77#c71 is fur!r am5d$ by /rik+ or section #ahcd7z7 & ins]t+ 1 section #ahcd7z71 or section #ahfj;,d-#ad;,b4 #bjc4 ,provision reg>d+ inflation rebates = gr\p heal? plans & gr\p heal? insurance cov]age 7a7 ,9 g5]al ,n lat] ?an ,decemb] #ca1 #bjbc1 ! ,secret>y ( ,labor1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 %all submit to ,congress a report on-- 7#a7 pot5tial models = an agreem5t process ) manufactur]s ( prescription drugs "u :i* su* manufactur]s provide = inflation rebates ) respect to su* drugs t are furni%$ or disp5s$ to p>ticipants & b5efici>ies ( gr\p heal? plans & heal? insurance cov]age (f]$ 9 ! gr\p m>ket 9 a mann] simil> to h[ manufactur]s provide = rebates "u section #ahcd7z7 ( ! ,social ,security ,act1 z add$ by section #bja1 & section #ahfj;,d-#ad;,b ( su* ,act1 z add$ by section #bjb1 ) respect to prescription drugs t are furni%$ or disp5s$ "u "p ,b ( title ,,xviii ( su* ,act & "p ,d ( su* title1 respectively2 & 7#b7 pot5tial models = en=cem5t me*anisms ) respect to su* an agreem5t process t ensure t su* inflation rebates are proportionally di/ribut$1 ) respect to co/s1 to gr\p heal? plans & heal? insurance issu]s (f]+ heal? insurance cov]age 9 ! gr\p m>ket1 to p>ticipants & b5efici>ies ( su* plans & cov]age1 or to bo?4 7b7 ,regulations ,n lat] ?an ,decemb] #ca1 #bjbd1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 promulgate regulations to implem5t a model describ$ 9 subsection 7a77#a7 & a model describ$ 9 subsection 7a77#b71 if ! ,secret>y det]m9es t-- 7#a7 ! prices ( a suffici5t numb] 7z det]m9$ by ! ,secret>y7 ( drugs describ$ 9 subsection 7a77#a7 h increas$ ov] a p]iod ( "t 7z det]m9$ by ! ,secret>y7 at a p]c5tage t exce$s ! p]c5tage by :i* ! consum] price index = all urban consum]s 7,unit$ ,/ates city av]age7 has increas$ ov] su* p]iod2 & 7#b7 su* model describ$ 9 subsection 7a77#a7 & su* model describ$ 9 subsection 7a77#b7 are feasible4 #bjd4 ,annual report on drug co/s 9 gr\p heal? plans & gr\p heal? insurance cov]age 7a7 ,initial report ,n lat] ?an ,decemb] #ca1 #bjbc1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 submit to ,congress a report1 ) respect to a p]iod 7z det]m9$ by ! ,secret>y ( ,labor71 on-- 7#a7 :e!r ! prices ( prescription drugs t are furni%$ or disp5s$ to p>ticipants & b5efici>ies ( gr\p heal? plans & heal? insurance cov]age (f]$ 9 ! gr\p m>ket dur+ su* p]iod 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 increas$ = su* p]iod2 & 7#b7 :e!r !re are me*anisms by :i* manufactur]s ( prescription drugs h attempt$ to recov] rebate paym5ts requir$ ( su* manufactur]s "u section #ahcd7z7 ( ! ,social ,security ,act1 z add$ by section #bja1 & section #ahfj;,d-#ad;,b ( su* ,act1 z add$ by section #bjb1 ) respect to prescription drugs t are furni%$ or disp5s$ "u "p ,b ( title ,,xviii ( su* ,act & "p ,d ( su* title1 respectively1 ?r\gh increas$ prices *>g$ ) respect to drugs t are furni%$ or disp5s$ to p>ticipants & b5efici>ies ( gr\p heal? plans & heal? insurance cov]age (f]$ 9 ! gr\p m>ket dur+ su* p]iod4 7b7 ,annual report ,n lat] ?an ,decemb] #ca ( ea* ye> foll[+ #bjbc1 ! ,secret>y ( ,labor %all1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ! ,treasury1 submit to ,congress a report updat+ ! in=mation & analysis includ$ 9 ! report requir$ "u subsection 7a71 reflect+1 9 "p1 new price & co/ in=mation & data = ! #ab-mon? p]iod aft] ! p]iod on :i* ! prior ye>'s report 0 bas$4 #bje4 ,collection ( data 7a7 ,manufactur]s ( prescription drugs ,manufactur]s ( prescription drugs %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury appropriate data z necess>y = ! ,secret>ies to obta9 in=mation ne$$ to provide ! reports "u sections #bjc & #bjd4 7b7 ,gr\p heal? plans & heal? insurance issu]s (f]+ heal? insurance cov]age 9 ! gr\p m>ket ,gr\p heal? plans & heal? insurance issu]s (f]+ heal? insurance cov]age 9 ! gr\p m>ket %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,labor1 & ! ,secret>y ( ! ,treasury appropriate data z necess>y = ! ,secret>ies to obta9 in=mation ne$$ to provide ! reports "u sections #bjc & #bjd4 ,,iii ,"p ,d ,improvem5ts & ,maximum ,out-(-,pocket ,cap = ,m$ic>e ,b5efici>ies #cja4 ,m$ic>e "p ,d b5efit r$esign 7a7 ,b5efit /ructure r$esign ,section #ahfj;,d-#b7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbd & = co/s above ! annual d$uctible specifi$ 9 p>agraph 7#a7 & up to ! annual out-(-pocket ?re%old specifi$ 9 p>agraph 7#d77;,b7 = #bjbd & ea* subsequ5t ye> aft] p>agraph 7#c72 7,b7 9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbd1 aft] p>agraph 7#d712 & 7ii7 9 clause 7ii77,,iii71 by /rik+ & ea* subsequ5t ye> & ins]t+ ?r\gh #bjbc2 & 7,c7 9 subp>agraph 7,d7-- 7i7 9 clause 7i7-- 7,i7 9 ! matt] prec$+ subclause 7,i71 by ins]t+ = a ye> prec$+ #bjbd1 aft] p>agraph 7#d712 & 7,,ii7 9 subclause 7,i77bb71 by /rik+ a ye> aft] #bjah & ins]t+ ea* ( ye>s #bjah ?r\gh #bjbc2 & 7ii7 9 clause 7ii77,v71 by /rik+ #bjai & ea* subsequ5t ye> & ins]t+ ea* ( ye>s #bjai ?r\gh #bjbc2 7#b7 9 p>agraph 7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause 7i71 by ins]t+ = a ye> prec$+ #bjbd1 aft] & 7#d712 & 7,b7 9 clause 7ii71 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjjg ?r\gh #bjbc2 & 7#c7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i7-- 7,i7 by r$esignat+ subclauses 7,i7 & 7,,ii7 z items 7aa7 & 7bb71 respectively1 & mov+ ! m>g9 ( ea* su* r$esignat$ item #b ems to ! "r2 7,,ii7 9 ! matt] prec$+ item 7aa71 z r$esignat$ by subclause 7,i71 by /rik+ is equal to ! great] (-- & ins]t+ 8is equal to-- 7,i7 = a ye> prec$+ #bjbd1 ! great] (-- 2 7,,iii7 by /rik+ ! p]iod at ! end ( item 7bb71 z r$esignat$ by subclause 7,i71 & ins]t+ 2 &2 & 7,,iv7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbd & ea* succe$+ ye>1 #j4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,i7 & ins]t+ clause 7i77,i77aa72 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 9 subclause 7,v71 by /rik+ or at ! end2 7,,ii7 9 subclause 7,,vi7-- 7aa7 by /rik+ = a subsequ5t ye> & ins]t+ = ea* ( ye>s #bjba ?r\gh #bjbc2 & 7bb7 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 & 7,,iii7 by add+ at ! end ! foll[+ new subclauses3 7,,vii7 = #bjbd1 is equal to #b1jjj2 or 7,,viii7 = a subsequ5t ye>1 is equal to ! am\nt specifi$ 9 ?is subp>agraph = ! previ\s ye>1 increas$ by ! annual p]c5tage increase describ$ 9 p>agraph 7#f7 = ! ye> involv$4 2 & 7ii7 9 clause 7ii71 by /rik+ clause 7i77,,ii7 & ins]t+ clause 7i72 7,c7 9 subp>agraph 7,c77i71 by /rik+ & = am\nts & ins]t+ &1 = a ye> prec$+ #bjbd1 = am\nts2 & 7,d7 9 subp>agraph 7,e71 by /rik+ ,9 apply+ & ins]t+ ,= ea* ( ye>s #bjaa ?r\gh #bjbc1 9 apply+4 7b7 ,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] #bjbc1 #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 #bjbc1 9 consultation ) manufactur]s1 & all[ = comm5t on su* model agreem5t4 7b7 ,t]ms ( agreem5t 7#a7 ,9 g5]al 7,a7 ,agreem5t ,an agreem5t "u ?is section %all require ! manufactur] to provide applicable b5efici>ies access to disc\nt$ prices = applicable drugs ( ! manufactur] t are disp5s$ on or aft] ,janu>y #a1 #bjbd4 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 = #bjbd ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to ! p]iod beg9n+ on ,janu>y #a1 #bjbd1 & end+ on ,decemb] #ca1 #bjbd1 ! manufactur] %all ent] into su* agreem5t n lat] ?an #cj days aft] ! date ( ! e/abli%m5t ( a model agreem5t "u subsection 7a74 7ii7 #bjbe & subsequ5t ye>s ,9 ord] = an agreem5t ) a manufactur] to be 9 effect "u ?is section ) respect to plan ye> #bjbe or a subsequ5t plan ye>1 ! manufactur] %all ent] into su* agreem5t 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/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t exce$ ! annual d$uctible ) respect to su* individual = su* ye>1 z specifi$ 9 section #ahfj;,d-#b7;b77#a71 section #ahfj;,d-#ad7;a77#a77;,b71 or section #ahfj;,d-#ad7;a77#b77;,b71 z applicable4 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] disp5s$ dur+ a ye> to an applicable b5efici>y-- 7i7 :o has n incurr$ co/s1 z det]m9$ 9 accordance ) section #ahfj;,d-#b7;b77#d77;,c71 = cov]$ "p ,d drugs 9 ! ye> t are equal to or exce$ ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>1 #ij p]c5t ( ! negotiat$ price ( su* drug2 & 7ii7 :o has incurr$ su* co/s1 z s det]m9$1 9 ! ye> t are equal to or exce$ su* ?re%old = ! ye>1 #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 above ! annual d$uctible specifi$ 9 section #ahfj;,d-#b7;b77#a7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price "u ?is section on only ! portion ( ! negotiat$ price ( ! applicable drug t falls above su* annual d$uctible4 7ii7 ,claims spann+ out-(-pocket ?re%old ,9 ! case :]e ! entire am\nt ( ! negotiat$ price ( an individual claim = an applicable drug ) respect to an applicable b5efici>y does n fall entirely bel[ or entirely above ! annual out-(-pocket ?re%old specifi$ 9 section #ahfj;,d-#b7;b77#d77;,b77i7 = ! ye>1 ! manufactur] ( ! applicable drug %all provide ! disc\nt$ price-- 7,i7 9 accordance ) subp>agraph 7,a77i7 on ! portion ( ! negotiat$ price ( ! applicable drug t falls bel[ su* ?re%old2 & 7,,ii7 9 accordance ) subp>agraph 7,a77ii7 on ! portion ( su* price ( su* drug t falls at or above su* ?re%old4 7#e7 ,manufactur] ,! t]m manufactur] means any entity :i* is engag$ 9 ! production1 prep>ation1 propagation1 comp\nd+1 conv]sion1 or process+ ( prescription drug products1 ei!r directly or indirectly by extraction f sub/ances ( natural orig91 or indep5d5tly by means ( *emical syn!sis1 or by a comb9ation ( extraction & *emical syn!sis4 ,su* t]m does n include a :olesale di/ributor ( drugs or a retail ph>macy lic5s$ "u ,/ate law4 7#f7 ,negotiat$ price ,! t]m negotiat$ price has ! mean+ giv5 su* t]m 9 section #dbc4ajj ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 except t1 ) respect to an applicable drug1 su* negotiat$ 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 #bjbd1 &1 subject to p>agraph 7#b71 agreem5ts "u ?is section %all be t]m9at$ z ( su* date4 7#b7 ,cont9u$ application = applicable drugs disp5s$ prior to sunset ,! provisions ( ?is section 7includ+ all responsibilities & duties7 %all cont9ue to apply aft] ,janu>y #a1 #bjbd1 ) respect to applicable drugs disp5s$ prior to su* date4 4 7#c7 ,inclusion ( actu>ial value ( manufactur] disc\nts 9 bids ,section #ahfj;,d-#aa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$-- 7,a7 9 subsection 7b77#b77;,c77iii7-- 7i7 by /rik+ assumptions reg>d+ ! re9surance & ins]t+ 8assumptions reg>d+-- 7,i7 ! re9surance 2 & 7ii7 by add+ at ! end ! foll[+3 7,,ii7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c subtract$ f ! actu>ial value to produce su* bid2 & 2 & 7,b7 9 subsection 7c77#a77;,c7-- 7i7 by /rik+ an actu>ial valuation ( ! re9surance & ins]t+ 8an actu>ial valuation (-- 7i7 ! re9surance 2 7ii7 9 clause 7i71 z ins]t$ by clause 7i7 ( ?is subp>agraph1 by add+ & at ! end2 & 7iii7 by add+ at ! end ! foll[+3 7ii7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nts provid$ "u section #ahfj;,d-#ad;,c2 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #ahfj;,d-#b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is am5d$-- 7,a7 9 subsection 7a77#b77;,a77i77,i71 by /rik+ 1 or an increase 9 ! initial & ins]t+ or1 = a ye> prec$+ #bjbd1 an increase 9 ! initial2 7,b7 9 subsection 7c77#a77;,c7-- 7i7 9 ! subp>agraph head+1 by /rik+ at initial cov]age limit2 & 7ii7 by ins]t+ = a ye> prec$+ #bjbd or ! annual out-(-pocket ?re%old specifi$ 9 subsection 7b77#d77;,b7 = ! ye> = #bjbd & ea* subsequ5t ye> aft] subsection 7b77#c7 = ! ye> ea* place x appe>s2 & 7,c7 9 subsection 7d77#a77;,a71 by /rik+ or an initial & ins]t+ or1 = a ye> prec$+ #bjbd1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is am5d$ by /rik+ ! initial & ins]t+ = a ye> prec$+ #bjbd1 ! initial4 7#c7 ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbd1 ! cont9uation2 7ii7 9 subp>agraph 7,d77iii71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 7iii7 9 subp>agraph 7,e71 by /rik+ ,! elim9ation & ins]t+ ,= a ye> prec$+ #bjbd1 ! elim9ation2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,c71 by /rik+ ,! cont9uation & ins]t+ ,= a ye> prec$+ #bjbd1 ! cont9uation2 & 7ii7 9 subp>agraph 7,e71 by /rik+ #ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+ #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is am5d$ by /rik+ section #ahfj;,d-#b7;b77#d77;,b77i7 & ins]t+ section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is am5d$-- 7,a7 by /rik+ ! value ( any disc\nt & ins]t+ ! foll[+3 ! value (-- 7i7 = ye>s prior to #bjbd1 any disc\nt 2 7,b7 9 clause 7i71 z ins]t$ by subp>agraph 7,a7 ( ?is p>agraph1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new clause3 7ii7 = #bjbd & ea* subsequ5t ye>1 any disc\nt provid$ pursuant to section #ahfj;,d-#ad;,c4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is am5d$-- 7,a7 by ins]t+ = a ye> be=e #bjbd aft] #ahfj;,d-#b7;b77#c72 & 7,b7 by ins]t+ = su* ye> be=e ! p]iod4 7#g7 ,section #ahfj;,d-#dc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is am5d$-- 7,a7 9 subsection 7a7-- 7i7 by /rik+ p>agraph 7#a7 & ins]t+ ! foll[+3 7#a7 p>ticipate 9-- 7,a7 = #bjaa ?r\gh #bjbc1 ! ,m$ic>e cov]age gap disc\nt program "u section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbd & ea* subsequ5t ye>1 ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 2 7ii7 by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 h ent]$ into & h 9 effect-- 7,a7 = #bjaa ?r\gh #bjbc1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,a ) ! ,secret>y2 & 7,b7 = #bjbd & ea* subsequ5t ye>1 an agreem5t describ$ 9 subsection 7b7 ( section #ahfj;,d-#ad;,c ) ! ,secret>y2 & 2 & 7iii7 by /rik+ p>agraph 7#c7 & ins]t+ ! foll[+3 7#c7 h ent]$ into & h 9 effect1 "u t]ms & conditions specifi$ by ! ,secret>y-- 7,a7 = #bjaa ?r\gh #bjbc1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( section #ahfj;,d-#ad;,a2 & 7,b7 = #bjbd & ea* subsequ5t ye>1 a contract ) a ?ird p>ty t ! ,secret>y has ent]$ into a contract ) "u subsection 7d77#c7 ( section #ahfj;,d-#ad;,c4 2 & 7,b7 by /rik+ subsection 7b7 & ins]t+ ! foll[+3 7b7 ,effective date ,p>agraphs 7#a77;,a71 7#b77;,a71 & 7#c77;,a7 ( subsection 7a7 %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjaa1 & be=e ,janu>y #a1 #bjbd1 & p>agraphs 7#a77;,b71 7#b77;,b71 & 7#c77;,b7 ( su* subsection %all apply to cov]$ "p ,d drugs disp5s$ "u ?is "p on or aft] ,janu>y #a1 #bjbd4 4 7#h7 ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7,a7 9 subsection 7c77#a77;,c77i77,,vi71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or "u ! manufactur] disc\nt program "u section #ahfj;,d-#ad;,c2 & 7,b7 9 subsection 7k77#a77;,b77i77,v71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or "u section #ahfj;,d-#ad;,c4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye> #bjbd & subsequ5t plan ye>s4 #cjb4 ,all[+ c]ta9 enrollees ( prescription drug plans & ,,ma-,,pd plans "u ,m$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$-- 7#a7 9 subp>agraph 7,a71 by /rik+ ,subject to subp>agraphs 7,c7 & 7,d7 & ins]t+ ,subject to subp>agraphs 7,c71 7,d71 & 7,e72 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,enrollee option reg>d+ spread+ co/-%>+ ,! ,secret>y %all e/abli% by regulation a process "u :i*1 ) respect to plan ye> #bjbd & subsequ5t plan ye>s1 a prescription drug plan or an ,,ma-,,pd plan %all1 9 ! case ( a "p ,d eligible individual enroll$ ) 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 #bjbd1 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 ,drug ,price ,transp>5cy #dja4 ,drug price transp>5cy ,"p ,a ( title ,,xi ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new sections3 #aaej;,d4 ,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 #bjba2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod beg9n+ on or aft] ,janu>y #a1 #bjba2 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 #bjbc2 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$+ ,janu>y #a1 #bjbc2 or 7ii7 #be p]c5t or m )9 a #cf-mon? p]iod t beg9s & ends dur+ ! #e-ye> p]iod prec$+ ,janu>y #a1 #bjbc4 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 #bjba1 & 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 #bjbc4 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 ( ! ,public ,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;,e4 ,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;,d2 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;,d2 & 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 ,v ,,nih1 ,,fda1 & ,ov]dose ,epidemic ,fund+ ,a ,biom$ical ,innovation ,expansion #eja4 ,,nih ,innovation ,initiatives 7a7 ,,nih ,innovation acc\nt 7#a7 ,9 g5]al ,section #ajja7;b7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,supplem5tal fund+ & additional activities 7,a7 ,9 g5]al ,9 addition to ! funds made available "u p>agraph 7#b71 !re are au?oriz$ to be appropriat$1 & are h]eby appropriat$1 to ! ,acc\nt1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to be available until exp5d$ )\t fur!r appropriation1 ! foll[+3 7i7 ,= fiscal ye> #bjbb1 #bee1djj1jjj4 7ii7 ,= fiscal ye> #bjbc1 #afj1djj1jjj4 7iii7 ,= fiscal ye> #bjbd1 #dad1fjj1jjj4 7iv7 ,= fiscal ye> #bjbe1 #edg1jjj1jjj4 7v7 ,= fiscal ye> #bjbf1 #idh1jjj1jjj4 7vi7 ,= fiscal ye> #bjbg1 #hdb1djj1jjj4 7vii7 ,= fiscal ye> #bjbh1 #a1jhi1fjj1jjj4 7viii7 ,= fiscal ye> #bjbi1 #a1aae1fjj1jjj4 7ix7 ,= fiscal ye> #bjcj1 #a1agj1fjj1jjj4 7x7 ,= fiscal ye> #bjca1 #ief1djj1jjj4 7,b7 ,supplem5tal fund+ = c]ta9 projects ,( ! total am\nts made available "u subp>agraph 7,a7 = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 a total am\nt n to exce$ ! foll[+ %all be made available = ! foll[+ categories ( ,,nih ,innovation ,projects3 7i7 ,= projects describ$ 9 p>agraph 7#d77;,a71 an am\nt n to exce$ a total ( #b1jgj1fjj1jjj z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjbb & #bjbd1 #ej1jjj1jjj4 7,,ii7 ,= fiscal ye> #bjbe1 #ajj1jjj1jjj4 7,,iii7 ,= ea* ( fiscal ye>s #bjbf & #bjbg1 #cjj1jjj1jjj4 7,,iv7 ,= ea* ( fiscal ye>s #bjbh ?r\gh #bjcj1 #cag1jjj1jjj4 7,v7 ,= fiscal ye> #bjca1 #cai1fjj1jjj4 7ii7 ,= projects describ$ 9 p>agraph 7#d77;,b71 an am\nt n to exce$ a total ( #b1jda1ijj1jjj z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjbb & #bjbd1 #ej1jjj1jjj4 7,,ii7 ,= fiscal ye> #bjbe1 #abh1jjj1jjj4 7,,iii7 ,= fiscal ye> #bjbf1 #bji1jjj1jjj4 7,,iv7 ,= fiscal ye> #bjbg1 #ajj1jjj1jjj4 7,v7 ,= fiscal ye> #bjbh1 #cbe1jjj1jjj4 7,,vi7 ,= fiscal ye> #bjbi1 #cej1jjj1jjj4 7,,vii7 ,= fiscal ye> #bjcj1 #djj1jjj1jjj4 7,,viii7 ,= fiscal ye> #bjca1 #dbi1ijj1jjj4 7iii7 ,= projects describ$ 9 p>agraph 7#d77;,c71 an am\nt n to exce$ a total ( #a1eeh1djj1jjj z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjbd & #bjbe1 #aea1bjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbf ?r\gh #bjcj1 #bea1bjj1jjj4 7iv7 ,= projects describ$ 9 p>agraph 7#d77;,d71 an am\nt n to exce$ #ae1djj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjca4 7,c7 ,additional ,,nih ,innovation ,projects ,9 addition to fund+ ,,nih ,innovation ,projects pursuant to subp>agraph 7,b71 ( ! total am\nts made available "u subp>agraph 7,a71 a total am\nt n to exce$ ! foll[+ %all be made available = ! foll[+ categories ( ,,nih ,innovation ,projects3 7i7 ,to support rese>* relat$ to combat+ antimicrobial resi/ance & antibiotic resi/ant bact]ia1 includ+ rese>* into new treatm5ts1 diagno/ics1 & vacc9es1 rese>*1 9 consultation ) ! ,c5t]s = ,disease ,control & ,prev5tion1 into /ew>d%ip1 & ! developm5t ( /rategies1 9 coord9ation ) ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority "u section #cai,l ( ! ,public ,heal? ,s]vice ,act1 to support comm]cialization ( new antibiotics1 n to exce$ a total ( #a1add1ejj1jjj1 z foll[s3 7,i7 ,= ea* ( fiscal ye>s #bjbb ?r\gh #bjbe1 #ajj1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbf & #bjbg1 #abj1jjj1jjj4 7,,iii7 ,= ea* ( fiscal ye>s #bjbh ?r\gh #bjcj1 #abe1jjj1jjj4 7,,iv7 ,= fiscal ye> #bjca1 #abi1ejj1jjj4 7ii7 ,to support rese>* & rese>* activities relat$ to r>e diseases or conditions1 includ+ /udies or analyses t help to bett] und]/& ! natural hi/ory ( a r>e disease or condition & translational /udies relat$ to r>e diseases or conditions1 n to exce$ a total ( #ecj1fjj1jjj1 z foll[s3 7,i7 ,= fiscal ye> #bjbb1 #dj1jjj1jjj4 7,,ii7 ,= fiscal ye> #bjbc1 #de1jjj1jjj4 7,,iii7 ,= fiscal ye> #bjbd1 #dh1jjj1jjj4 7,,iv7 ,= ea* ( fiscal ye>s #bjbe & #bjbf1 #eb1djj1jjj4 7,v7 ,= fiscal ye> #bjbg1 #ee1hjj1jjj4 7,,vi7 ,= fiscal ye> #bjbh1 #ef1jjj1jjj4 7,,vii7 ,= fiscal ye> #bjbi1 #eg1jjj1jjj4 7,,viii7 ,= ea* ( fiscal ye>s #bjcj & #bjca1 #fb1jjj1jjj4 4 7#b7 ,con=m+ am5dm5ts ,section #ajja ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7,a7 9 subsection 7a71 by /rik+ subsection 7b77#d7 & ins]t+ subsections 7b77#d7 & 7b77#e72 7,b7 9 subsection 7b77#a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraphs 7#d7 & 7#e72 7,c7 9 subsection 7c77#b77;,a77ii71 by ins]t+ or pursuant to subsection 7b77#e7 aft] subsection 7b77#c72 & 7,d7 9 subsection 7d71 by ins]t+ or pursuant to subsection 7b77#e7 aft] subsection 7b77#c74 7b7 ,workplan ,section #ajja7;c77#a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by add+ at ! end ! foll[+3 7,d7 ,updates ,! ,director ( ,,nih %all1 aft] seek+ recomm5dations 9 accordance ) ! process describ$ 9 subp>agraph 7,c71 update ! "w plan submitt$ "u ?is subsection = ea* ( fiscal ye>s #bjbb ?r\gh #bjca to reflect ! am5dm5ts made to ?is section by ! ,elijah ,e4 ,cumm+s ,l[] ,drug ,co/s ,n[ ,act4 4 7c7 ,annual reports ,section #ajja7;c77#b77;,a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by /rik+ #bjbg & ins]t+ #bjca4 7d7 ,sunset ,section #ajja7;e7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by /rik+ ,septemb] #cj1 #bjbf & ins]t+ ,septemb] #cj1 #bjca4 #ejb4 ,,nih cl9ical trial ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq47 is am5d$ by add+ at ! end ! foll[+3 #djd,o4 ,cl9ical ,trial ,accel]ation ,pilot ,initiative 7a7 ,e/abli%m5t ( pilot program ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,national ,in/itutes ( ,heal?1 %all1 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 e/abli% & implem5t a pilot program to aw>d multi-ye> contracts to eligible entities to support phase ,,ii cl9ical trials & phase ,,iii cl9ical trials-- 7#a7 to promote innovation 9 treatm5ts & te*nologies support+ ! advanc$ rese>* & developm5t & production ( high ne$ cures2 & 7#b7 to provide support = ! developm5t ( m$ical products & !rapies4 7b7 ,eligible entities ,to be eligible to receive assi/ance "u ! pilot program e/abli%$ "u subsection 7a71 an entity %all-- 7#a7 be seek+ to m>ket a m$ical product or !rapy t is ! subject ( cl9ical trial or trials to be support$ us+ su* assi/ance2 7#b7 be a public or private entity1 :i* may include a private or public rese>* in/itution1 a contract rese>* organization1 an in/itution ( high] education 7z def9$ 9 section #aja ( ! ,high] ,education ,act ( #aife 7#bj ,u4,s4,c4 #ajja771 a m$ical c5t]1 a biote*nology company1 or an academic rese>* in/itution2 & 7#c7 comply ) requirem5ts ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & section #cea ( ?is ,act1 z applicable1 at all /ages ( developm5t1 manufactur+1 review1 approval1 & safety surveillance ( a m$ical product4 7c7 ,duties ,! ,secret>y1 act+ ?r\gh ! ,director ( ,national ,in/itutes ( ,heal?1 %all-- 7#a7 9 e/abli%+ ! pilot program "u subsection 7a71 consult )-- 7,a7 ! ,director ( ! ,national ,c5t] = ,advanc+ ,translational ,sci5ces & ! o!r national rese>* in/itutes 9 consid]+ _! reque/s = new or exp&$ cl9ical trial support ef=ts2 & 7,b7 ! ,commission] ( ,food & ,drugs & any o!r head ( a ,f$]al ag5cy z ! ,secret>y det]m9es to be appropriate to ensure coord9ation & effici5tly advance cl9ical trial activities2 7#b7 9 implem5t+ ! pilot program "u subsection 7a71 consid] consult+ ) pati5ts & pati5t advocates2 & 7#c7 9 aw>d+ contracts "u ! pilot program "u subsection 7a71 consid]-- 7,a7 ! expect$ heal? impacts ( ! cl9ical trial or trials to be support$ "u ! contract2 & 7,b7 ! degree to :i* ! m$ical product or !rapy t is ! subject ( su* cl9ical trial or trials is a high ne$ cure4 7d7 ,exclusion ,a contract may n be aw>d$ "u ! pilot program "u subsection 7a7 if ! drug t is ! subject ( ! cl9ical trial or trials to be support$ "u ! contract is a drug designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act z a drug = a r>e disease or condition4 7e7 ,,nih ,cl9ical ,trial ,accel]ator ,acc\nt 7#a7 ,e/abli%m5t ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,,nih ,cl9ical ,trial ,accel]ator ,acc\nt 7ref]r$ to 9 ?is section z ! ,acc\nt71 = purposes ( c>ry+ out ?is section4 7#b7 ,transf] ( direct sp5d+ sav+s ,!re %all be transf]r$ to ! ,acc\nt f ! g5]al fund ( ! ,treasury1 #djj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf1 to be available until exp5d$ )\t fur!r appropriation4 7#c7 ,"w plan ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a "w plan t includes ! propos$ implem5tation ( ?is section & ! propos$ allocation ( funds 9 ! ,acc\nt4 7f7 ,reports to ,congress ,n lat] ?an ,octob] #a ( ea* fiscal ye>1 ! ,secret>y %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on-- 7#a7 ! implem5tation ( ?is section2 7#b7 any available results on phase ,,ii cl9ical trials & phase ,,iii cl9ical trials support$ "u ?is section dur+ su* fiscal ye>2 & 7#c7 ! ext5t to :i* ,f$]al funds are obligat$ to support su* cl9ical trials1 includ+ ! specific am\nt ( su* support & aw>ds pursuant to an allocation f ! ,acc\nt "u subsection 7e74 7g7 ,def9itions ,9 ?is section3 7#a7 ,phase ,,ii cl9ical trial ,! t]m phase ,,ii cl9ical trial means a phase ,,ii cl9ical inve/igation1 z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#b7 ,phase ,,iii cl9ical trials ,! t]m phase ,,iii cl9ical trial means a phase ,,iii cl9ical inve/igation1 z describ$ 9 section #cab4ba ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7#c7 ,high ne$ cure ,! t]m high ne$ cure has ! mean+ giv5 su* t]m 9 section #dhj7;a77#c74 4 #ejc4 ,innovation ,network ,"p ,a ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bha et seq471 z am5d$ by section #ejb1 is fur!r am5d$ by add+ at ! end ! foll[+3 #djd,p4 ,innovation ,network 7a7 ,funds ,! ,director ( ,,nih %all aw>d grants or contracts to eligible entities to develop1 exp&1 & enhance ! comm]cialization ( biom$ical products4 7b7 ,eligible entity ,9 ?is section1 ! t]m eligible entity means an entity receiv+ fund+ "u-- 7#a7 ! ,small ,bus9ess ,innovation ,rese>* program ( ! ,national ,in/itutes ( ,heal?2 or 7#b7 ! ,small ,bus9ess ,te*nology ,transf] program ( ! ,national ,in/itutes ( ,heal?4 7c7 ,use ( funds ,an eligible entity %all use ! funds receiv$ ?r\gh su* grant or contract to support-- 7#a7 ! ,comm]cialization ,read9ess ,pilot program ( ! ,national ,in/itutes ( ,heal?2 7#b7 ! ,innovation ,corps program ( ! ,national ,in/itutes ( ,heal?2 7#c7 ! ,comm]cialization ,accel]ator program ( ! ,national ,in/itutes ( ,heal?2 7#d7 ! ,comm]cialization ,assi/ance program ( ! ,national ,in/itutes ( ,heal?2 & 7#e7 su* o!r programs & activities z ! ,director ( ,,nih det]m9es to be appropriate1 to support ! comm]cialization /age ( rese>*1 lat] /age rese>* & developm5t1 te*nology transf]1 & comm]cialization te*nical assi/ance4 7d7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #ajj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf1 to be available until exp5d$4 4 ,b ,inve/+ 9 ,safety & ,innovation #eaa4 ,food & ,drug ,adm9i/ration 7a7 ,,fda ,innovation acc\nt 7#a7 ,9 g5]al ,section #ajjb7;b7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7,a7 9 p>agraph 7#a71 by /rik+ p>agraph 7#d7 & ins]t+ p>agraphs 7#d7 & 7#e72 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,supplem5tal fund+ & additional activities 7,a7 ,9 g5]al ,9 addition to ! funds made available "u p>agraph 7#b71 !re are au?oriz$ to be appropriat$1 & are h]eby appropriat$1 to ! ,acc\nt1 out ( any monies 9 ! ,treasury n o!rwise appropriat$1 to be available until exp5d$ )\t fur!r appropriation1 ! foll[+3 7i7 ,= fiscal ye> #bjbb1 #dag1ejj1jjj4 7ii7 ,= ea* ( fiscal ye>s #bjbc & #bjbd1 #aeg1ejj1jjj4 7iii7 ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjbg1 #aeb1ejj1jjj4 7iv7 ,= ea* ( fiscal ye>s #bjbh ?r\gh #bjca1 #bjb1ejj1jjj4 7,b7 ,supplem5tal fund+ = c]ta9 activities ,( ! total am\nts made available "u subp>agraph 7,a7 = ea* ( fiscal ye>s #bjbh ?r\gh #bjca1 a total am\nt n to exce$ #ej1jjj1jjj = ea* su* fiscal ye>1 %all be made available = ! activities "u subtitles ,a ?r\gh ,f 7includ+ ! am5dm5ts made by su* subtitles7 ( title ,,iii ( ?is ,act & section #ajad 7relat+ to ,int]c5t] ,in/itutes7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,c7 ,additional ,,fda activities ,9 addition to fund+ activities pursuant to subp>agraph 7,b71 ( ! total am\nts made available "u subp>agraph 7,a71 a total am\nt n to exce$ ! foll[+ %all be made available = ! foll[+ categories ( activities3 7i7 ,= mod]nization ( ! te*nical infra/ructure ( ! ,food & ,drug ,adm9i/ration1 includ+ enhancem5ts su* z int]op]ability across ! ag5cy1 & additional capabilities to develop an advanc$ in=mation te*nology infra/ructure to support ! ag5cy's regulatory mission3 7,i7 ,= fiscal ye> #bjbb1 #ahj1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjca1 #fj1jjj1jjj4 7ii7 ,= support = cont9u\s manufactur+ ( drugs & biological products1 includ+ complex biological products su* z reg5]ative m$ic9e !rapies1 ?r\gh grants to in/itutions ( high] education & nonpr(it organizations & o!r appropriate me*anisms1 = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 #bj1jjj1jjj4 7iii7 ,= support = ! ,commission] ( ,food & ,drugs to engage exp]ts1 su* z ?r\gh ! =mation & op]ation ( public-private p>tn]%ips or o!r appropriate collaborative ef=ts1 to advance ! developm5t & deliv]y ( individualiz$ human g5e !rapy products3 7,i7 ,= fiscal ye> #bjbb1 #ej1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjca1 #aj1jjj1jjj4 7iv7 ,= support = inspections1 en=cem5t1 & quality surveillance activities across ! ,food & ,drug ,adm9i/ration1 includ+ =eign & dome/ic inspections across products1 = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 #bj1jjj1jjj4 7v7 ,= support = activities ( ! ,food & ,drug ,adm9i/ration relat$ to cu/oms & bord] protection to provide improvem5ts to te*nologies1 inspection capacity1 & sites ( import 7includ+ int]national mail facilities7 9 :i* ! ,food & ,drug ,adm9i/ration op]ates1 = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 #aj1jjj1jjj4 7vi7 ,to fur!r advance ! developm5t ( a coord9at$ po/m>ket surveillance sy/em = all m$ical products1 includ+ drugs1 biological products1 & devices1 l9k$ to electronic heal? records 9 fur!rance ( ! ,food & ,drug ,adm9i/ration's po/m>ket surveillance capabilities3 7,i7 ,= fiscal ye> #bjbb1 #aab1ejj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbc ?r\gh #bjca1 #ab1ejj1jjj4 7vii7 ,= support = ,food & ,drug ,adm9i/ration activities to keep pace ) ! project$ product developm5t ( reg5]ative !rapies1 includ+ cellul> & somatic cell g5e !rapy products3 7,i7 ,= ea* ( fiscal ye>s #bjbb ?r\gh #bjbd1 #aj1jjj1jjj4 7,,ii7 ,= ea* ( fiscal ye>s #bjbe ?r\gh #bjca1 #e1jjj1jjj4 7viii7 ,= c>ry+ out section #gad;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a2 relat+ to hir+ au?ority = sci5tific1 te*nical1 & pr(essional p]sonnel71 = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 #b1ejj1jjj4 7ix7 ,= ! ,food & ,drug ,adm9i/ration to support improvem5ts to ! te*nological infra/ructure = report+ & analysis ( adv]se ev5ts associat$ ) ! use ( drugs & biological products1 = ea* ( fiscal ye>s #bjbb ?r\gh #bjca1 #ab1ejj1jjj4 4 7#b7 ,con=m+ am5dm5ts ,section #ajjb ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$-- 7,a7 9 subsection 7a71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 or pursuant to subp>agraph 7,a7 ( subsection 7b77#e7 to c>ry out ! activities describ$ 9 subp>agraphs 7,b7 & 7,c7 ( su* subsection2 & 7,b7 9 subsection 7d7-- 7i7 by ins]t+ or pursuant to subp>agraph 7,a7 ( subsection 7b77#e7 aft] subsection 7b77#c72 & 7ii7 by /rik+ subsection 7b77#d7 & ins]t+ subsections 7b77#d7 & 7b77#e74 7b7 ,annual ,report ,section #ajjb7;c77#b77;,a7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$1 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbf & ins]t+ #bjcb4 7c7 ,sunset ,section #ajjb7;e7 ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee7 is am5d$ by /rik+ ,septemb] #cj1 #bjbe & ins]t+ ,septemb] #cj1 #bjcj4 #eab4 ,/udy on high-risk1 high-rew>d drugs 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conduct a /udy to id5tify-- 7#a7 diseases or conditions t lack a treatm5t approv$ by ! ,food & ,drug ,adm9i/ration & in/ances 9 :i* developm5t ( a treatm5t = su* diseases or conditions c\ld fill an unmet m$ical ne$ = ! treatm5t ( a s]i\s or life-?reat5+ disease or condition or a r>e disease or condition2 & 7#b7 appropriate inc5tives t w\ld lead to ! developm5t1 approval1 & m>ket+ ( su* treatm5ts4 7b7 ,report to ,congress2 recomm5dations ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ! ,congress a report t includes-- 7#a7 f9d+s f ! /udy "u subsection 7a72 & 7#b7 recomm5dations reg>d+ legislation necess>y to create appropriate inc5tives id5tifi$ pursuant to subsection 7a77#b74 ,c ,ov]dose ,epidemic ,response #eba4 ,ov]dose ,epidemic ,response ,fund 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all use any funds made available pursuant to subsection 7b7 to c>ry out ! programs & activities describ$ 9 subsection 7c7 to address ! ov]dose & sub/ance use disord] epidemic4 ,su* funds %all be 9 addition to any funds :i* are o!rwise available to c>ry out su* programs & activities4 7b7 ,opioid ,epidemic ,response ,fund 7#a7 ,e/abli%m5t ( acc\nt ,!re is e/abli%$ 9 ! ,treasury an acc\nt1 to be kn[n z ! ,opioid ,epidemic ,response ,fund 7ref]r$ to 9 ?is section z ! ,fund71 = purposes ( fund+ ! programs & activities describ$ 9 subsection 7c74 7#b7 ,fund+ ,!re is au?oriz$ to be appropriat$1 & !re is appropriat$1 to ! ,fund1 out ( any monies 9 ! ,treasury n o!rwise appropriat$ #b1jjj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7#c7 ,availability ,am\nts made available by p>agraph 7#b7 %all be made available to ! ag5cies specifi$ 9 subsection 7c7 9 accordance ) su* subsection4 ,am\nts made available to an ag5cy pursuant to ! prec$+ s5t5ce = a fiscal ye> %all rema9 available until exp5d$4 7c7 ,programs & activities ,( ! total am\nt 9 ! ,fund = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf1 su* am\nt %all be allocat$ z foll[s3 7#a7 ,,samhsa ,= ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration to c>ry out programs & activities pursuant to section #ebb1 #a1ejj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7#b7 ,,cdc ,= ! ,c5t]s = ,disease ,control & ,prev5tion to c>ry out programs & activities pursuant to section #ebc1 #abj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7#c7 ,,fda ,= ! ,food & ,drug ,adm9i/ration to c>ry out programs & activities pursuant to section #ebd1 #aj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7#d7 ,,nih ,= ! ,national ,in/itutes ( ,heal? to c>ry out programs & activities pursuant to section #ebe1 #bdj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7#e7 ,,hrsa ,= ! ,heal? ,res\rces & ,s]vices ,adm9i/ration to c>ry out programs & activities pursuant to section #ebf1 #ij1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7#f7 ,,acf ,= ! ,adm9i/ration = ,*ildr5 & ,families to c>ry out programs & activities pursuant to section #ebg1 #dj1jjj1jjj = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf4 7d7 ,acc\ntability & ov]sight 7#a7 ,"w plan 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,appropriations1 & ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives1 a "w plan includ+ ! propos$ allocation ( funds made available pursuant to subsection 7b7 = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf & ! cont5ts describ$ 9 subp>agraph 7,b74 7,b7 ,cont5ts ,! "w plan submitt$ "u subp>agraph 7,a7 %all include-- 7i7 ! am\nt ( money to be obligat$ or exp5d$ out ( ! ,fund 9 ea* fiscal ye> = ea* program & activity describ$ 9 subsection 7c72 & 7ii7 a description & ju/ification ( ea* su* program & activity4 7#b7 ,annual reports ,n lat] ?an ,octob] #a ( ea* ( fiscal ye>s #bjbc ?r\gh #bjbg1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,appropriations1 & ! ,committee on ,education & ,labor ( ! ,h\se ( ,repres5tatives1 a report includ+-- 7,a7 ! am\nt ( money obligat$ or exp5d$ out ( ! ,fund 9 ! prior fiscal ye> = ea* program & activity describ$ 9 subsection 7c72 7,b7 a description ( all programs & activities us+ funds made available pursuant to subsection 7b72 & 7,c7 h[ ! programs & activities are respond+ to ! opioid & sub/ance use disord] epidemic4 7e7 ,limitations ,not)/&+ any au?ority 9 ?is subtitle or any appropriations ,act1 any funds made available pursuant to subsection 7b7 may n be us$ = any purpose o!r ?an ! programs & activities describ$ 9 subsection 7c74 #ebb4 ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration 7a7 ,9 g5]al ,! entirety ( ! funds made available pursuant to section #eba7;c77#a7 %all be = ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use to cont9ue to aw>d ! ,/ate ,opioid ,response ,grants fund$ by ! head+ ,sub/ance ,abuse ,& ,m5tal ,heal? ,s]vices ,adm9i/ration--,sub/ance ,abuse ,treatm5t 9 title ,,ii ( ! ,dep>tm5ts ( ,labor1 ,heal? & ,human ,s]vices1 & ,education1 & ,relat$ ,ag5cies ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 ,subject to subsections 7b7 & 7c71 su* grants %all be aw>d$ 9 ! same mann] & subject to ! same conditions z 7 applicable to su* grants = fiscal ye> #bjah4 7b7 ,requirem5t t treatm5t be evid5ce-,bas$ ,z a condition on receipt ( a grant pursuant to subsection 7a71 a grantee %all agree t-- 7#a7 treatm5ts1 practices1 or int]v5tions fund$ ?r\gh ! grant w be evid5ce-bas$2 & 7#b7 su* treatm5ts1 practices1 & int]v5tions w include m$ication-assi/$ treatm5t = individuals diagnos$ ) opioid use disord]1 us+ drugs only if ! drugs h be5 approv$ or lic5s$ by ! ,food & ,drug ,adm9i/ration "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7c7 ,res]vations ,( ! am\nt made available pursuant to section #eba7;c77#a7 = a fiscal ye>-- 7#a7 n less ?an #ge1jjj1jjj %all be res]v$ to make grants "u subsection 7a7 to ,indian ,tribes or ,tribal organizations2 & 7#b7 n less ?an #ej1jjj1jjj %all be res]v$ to make grants "u subsection 7a7 to political subdivisions ( ,/ates1 su* z c\nties1 cities1 or t[ns4 #ebc4 ,c5t]s = ,disease ,control & ,prev5tion 7a7 ,address+ opioid use disord] ,! entirety ( ! funds made available pursuant to section #eba7;c77#b7 %all be = ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 to cont9ue & exp& programs ( ! ,c5t]s = ,disease ,control & ,prev5tion to address opioid & sub/ance use disord]1 includ+ by-- 7#a7 improv+ ! timel9ess & quality ( data on ! opioid use disord] epidemic1 includ+ improvem5t (-- 7,a7 data on fatal & nonfatal ov]doses2 7,b7 syndromic surveillance2 7,c7 data on long-t]m sequelae 7includ+ neonatal ab/95ce syndrome72 & 7,d7 cause ( dea? report+ relat$ to sub/ance abuse or opioid ov]dose2 7#b7 exp&+ & /r5g!n+ evid5ce-bas$ prev5tion & education /rategies2 7#c7 support+ responsible prescrib+ practices1 includ+ ?r\gh developm5t & dissem9ation ( prescrib] guidel9es2 7#d7 improv+ access to & use ( effective prev5tion1 treatm5t1 & recov]y support1 includ+ ?r\gh grants & ! provision ( te*nical assi/ance to ,/ates & localities2 7#e7 /r5g!n+ p>tn]%ips ) fir/ respond]s1 includ+ to protect _! safety2 7#f7 consid]+ ! ne$s ( vuln]able populations2 7#g7 address+ infecti\s diseases l9k$ to ! opioid crisis2 7#h7 /r5g!n+ prescription drug monitor+ programs2 & 7#i7 provid+ f9ancial & te*nical assi/ance to ,/ate & local heal? dep>tm5t ef=ts to treat & prev5t sub/ance use disord]4 7b7 ,limitation ,( ! funds made available pursuant to section #eba7;c77#b7 = c>ry+ out ?is section1 n m ?an #bj p]c5t may be us$ = intramural purposes4 #ebd4 ,food & ,drug ,adm9i/ration ,! entirety ( ! funds made available pursuant to section #eba7;c77#c7 %all be = ! ,commission] ( ,food & ,drugs1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq47 or ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 & o!r applicable law1 to support widespread innovation 9 non-opioid & non-addictive m$ical products = pa9 treatm5t1 access to opioid addiction treatm5ts1 appropriate use ( approv$ opioids1 & ef=ts to r$uce illicit importation ( opioids4 ,su* support may include ! foll[+3 7#a7 ,facilitat+ ! developm5t ( non-opioid & non-addictive pa9 treatm5ts4 7#b7 ,advanc+ guidance docum5ts = sponsors ( non-opioid pa9 products4 7#c7 ,develop+ evid5ce to in=m ! pot5tial = nonprescription ov]dose !rapies4 7#d7 ,exam9+ exp&$ label+ indications = m$ication-assi/$ treatm5t4 7#e7 ,conduct+ public education & outrea*1 includ+ public work%ops or public meet+s1 reg>d+ ! b5efits ( m$ication-assi/$ treatm5t1 includ+ all drugs approv$ by ! ,food & ,drug ,adm9i/ration1 & device treatm5t options approv$ or cle>$ by ! ,food & ,drug ,adm9i/ration4 7#f7 ,explor+ ! expansion & possible m&atory nature ( prescrib] education reg>d+ pa9 managem5t & appropriate opioid prescrib+ ?r\gh au?orities "u section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74 7#g7 ,exam9+ options to limit ! duration ( opioid prescriptions = acute pa91 includ+ ?r\gh packag+ options4 7#h7 ,increas+ /aff & infra/ructure capacity to inspect & analyze packages at int]national mail facilities & pursue crim9al inve/igations4 #ebe4 ,national ,in/itutes ( ,heal? ,! entirety ( ! funds made available pursuant to section #eba7;c77#d7 %all be = ! ,director ( ! ,national ,in/itutes ( ,heal?1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq471 to c>ry out activities relat$ to-- 7#a7 accel]at+ rese>* = address+ ! opioid use disord] epidemic1 includ+ develop+ non-opioid m$ications & int]v5tions1 includ+ non-addictive m$ications1 to manage pa91 z well z develop+ m$ications & int]v5tions to treat & to prev5t sub/ance use disord]s2 7#b7 conduct+ & support+ rese>* on :i* treatm5ts 79 t]ms ( pa9 managem5t z well z treat+ & prev5t+ sub/ance use disord]s7 are optimal = :i* pati5ts2 & 7#c7 conduct+ & support+ rese>* on creat+ long]-la/+ or fa/]-act+ antidotes = opioid ov]dose1 p>ticul>ly 9 response to ! preval5ce ( f5tanyl & c>f5tanyl ov]doses4 #ebf4 ,heal? ,res\rces & ,s]vices ,adm9i/ration ,! entirety ( ! funds made available pursuant to section #eba7;c77#e7 %all be = ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 pursuant to applicable au?orities 9 titles ,,iii1 ,,vii1 & ,,viii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bda et seq471 to c>ry out activities t increase ! availability & capacity ( ! behavioral heal? work=ce4 ,su* activities %all include provid+ loan repaym5t assi/ance = sub/ance use disord] treatm5t provid]s4 #ebg4 ,adm9i/ration = ,*ildr5 & ,families ,( ! funds made available pursuant to section #eba7;c77#f7 = ea* ( fiscal ye>s #bjbb ?r\gh #bjbf1 #dj1jjj1jjj = ea* su* fiscal ye> %all be = ! ,secret>y ( ,heal? & ,human ,s]vices to c>ry out title ,i ( ! ,*ild ,abuse ,prev5tion & ,treatm5t ,act 7#db ,u4,s4,c4 #eaja et seq474