,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cchd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #c1 #bjbj,ms4     
,mc,sally introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,f9ance  ,a ,,bill  ,to all[ =          
negotiation ( prices = c]ta9 cov]$      
,m$ic>e "p ,d drugs1 to all[ =          
importation by individuals (            
prescription drugs f ,canada1 to pres]ve
 access to af=dable g5]ics & biosimil>s1
 to increase ! use ( real-"t b5efit     
tools to l[] b5efici>y co/s1 to e/abli% 
a manufactur] disc\nt program1 & = o!r  
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,l[]+ ,prescription ,drug  
,prices = ,am]ica's ,s5iors & ,families 
,act ( #bjbj4  #b4 ,negotiation ( prices
 = c]ta9 cov]$ "p ,d drugs foll[+ p]iod 
( exclusivity  7a7 ,9 g5]al ,section    
#ahfj;,d-#aa ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$--  
7#a7 9 subsection 7i71 by /rik+ ,9 ord] 
& ins]t+ ,except z provid$ 9 subsection 
7k71 9 ord]2 &  7#b7 by add+ at ! end ! 

foll[+ new subsection3  7k7 ,negotiation
 ( prices = c]ta9 cov]$ "p ,d drugs     
foll[+ p]iod ( exclusivity  7#a7 ,9     
g5]al ,not)/&+ any o!r provision ( law1 
subject to p>agraph 7#b71 ! ,secret>y   
%all1 = plan ye>s beg9n+ on or aft] !   
date on :i* ! applicable p]iod ) respect
 to an applicable cov]$ "p ,d drug 7z ^?
 t]ms are def9$ 9 p>agraph 7#c77        
expires-- 7,a7 negotiate directly )     
ph>maceutical manufactur]s ! prices t   
may be *>g$ to ,,pdp sponsors & ,,ma    
organizations = su* applicable cov]$ "p 
,d drug2 &  7,b7 complete su*           
negotiations n lat] ?an #c mon?s prior  
to ! beg9n+ ( ea* su* plan ye>4  7#b7   
,use ( ,m$icaid be/ price if            
negotiations fail ,9 ! case :]e !       
,secret>y is n able to rea* an agreem5t 
"u p>agraph 7#a7 ) respect to an        
applicable cov]$ "p ,d drug = a plan ye>
 by ! date specifi$ 9 p>agraph          
7#a77;,b71 ! price t a ph>maceutical    
manufactur] may *>ge to ,,pdp sponsors &
 ,,ma organizations = su* applicable    

cov]$ "p ,d drug = ! plan ye> %all be   
det]m9$ us+ ! me?odology us$ to det]m9e 
! be/ price ( a cov]$ outpati5t drug "u 
section #aibg7;c77#a77;,c74  7#c7       
,def9itions ,9 ?is subsection3 7,a7     
,applicable cov]$ "p ,d drug ,! t]m     
applicable cov]$ "p ,d drug means a     
cov]$ "p ,d drug = :i* !re is 9 effect--
 7i7 9 ! case ( a drug approv$ "u       
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act1 a pat5t on an active    
+r$i5t ( ! drug2 or  7ii7 9 ! case ( a  
biological product1 a pat5t on !        
/ructure ( ! biological product4  ,a    
pat5t %all be consid]$ to be 9 effect = 
purposes ( ?is subp>agraph dur+ any     
ext5sion ( ! pat5t t]m "u section #aef (
 title #ce1 ,unit$ ,/ates ,code4  7,b7  
,applicable p]iod ,! t]m applicable     
p]iod means1 ) respect to an applicable 
cov]$ "p ,d drug1 any applicable pat5t  
describ$ 9 subp>agraph 7,a74  7#d7      
,condition ( cov]age  7,a7 ,9 g5]al     
,subject to subp>agraph 7,b71 9 ord] =  
cov]age to be available "u ?is "p = an  

applicable cov]$ "p ,d drug 7z def9$ 9  
section #ahfj;,d-#b7;e77 ( a manufactur]
 ) respect to a plan ye> beg9n+ on or   
aft] ! date on :i* ! applicable p]iod ) 
respect to su* cov]$ "p ,d drug expires1
 ! manufactur] mu/ provide su*          
applicable cov]$ "p ,d drug to ,,pdp    
sponsors & ,,ma organizations at ! price
 negotiat$ "u p>agraph 7#a7 or ! price  
det]m9$ "u p>agraph 7#b71 if applicable1
 = ! plan ye>4  7,b7 ,au?oriz+ cov]age 9
 c]ta9 circum/ances ,subp>agraph 7,a7   
%all n apply to ! disp5s+ ( a cov]$ "p  
,d drug if ! ,secret>y has made a       
det]m9ation t ! availability ( ! drug is
 ess5tial to ! heal? ( b5efici>ies "u   
?is "p4  4  7b7 ,effective date ,!      
am5dm5ts made by ?is section %all apply 
to cov]$ "p ,d drugs disp5s$ on or aft] 
,janu>y #a1 #bjba4  #c4 ,drug           
importation ,*apt] ,,viii ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cha et seq47 is am5d$ by add+
 at ! end ! foll[+3  #haj4 ,importation 
by individuals ( prescription drugs f   

,canada  7a7 ,9 g5]al ,not)/&+ any o!r  
provision ( ?is ,act1 n lat] ?an #ahj   
days aft] ! date ( enactm5t ( ?is       
section1 ! ,secret>y %all promulgate    
regulations p]mitt+ individuals to      
safely import into ! ,unit$ ,/ates a    
prescription drug describ$ 9 subsection 
7b74  7b7 ,prescription drug ,a         
prescription drug describ$ 9 ?is        
subsection-- 7#a7 is a prescription drug
 t-- 7,a7 is pur*as$ f an approv$       
,canadian ph>macy2  7,b7 is disp5s$ by a
 ph>maci/ lic5s$ to practice ph>macy &  
disp5se prescription drugs 9 ,canada2   
7,c7 is pur*as$ = p]sonal use by !      
individual1 n = resale1 9 quantities t d
 n exce$ a #ij-;day supply2  7,d7 is    
fill$ us+ a valid prescription issu$ by 
a physician lic5s$ to practice 9 a ,/ate
 9 ! ,unit$ ,/ates2 &  7,e7 has ! same  
active +r$i5t or +r$i5ts1 r\te (        
adm9i/ration1 dosage =m1 & /r5g? z a    
prescription drug approv$ by ! ,secret>y
 "u *apt] ,v2 &  7#b7 does n include--  
7,a7 a controll$ sub/ance 7z def9$ 9    

section #ajb ( ! ,controll$ ,sub/ances  
,act72  7,b7 a biological product 7z    
def9$ 9 section #cea ( ! ,public ,heal? 
,s]vice ,act72  7,c7 an infus$ drug     
7includ+ a p]itoneal dialysis solution72
  7,d7 an intrav5\sly inject$ drug2     
7,e7 a drug t is inhal$ dur+ surg]y2    
7,f7 a p>5t]al drug2  7,g7 a drug       
manufactur$ ?r\gh "o or m biote*nology  
processes1 includ+-- 7i7 a !rapeutic    
,,dna plasmid product2  7ii7 a !rapeutic
 syn!tic peptide product ( n m ?an #dj  
am9o acids2  7iii7 a monoclonal antibody
 product = 9 vivo use2 &  7iv7 a        
!rapeutic recomb9ant ,,dna-d]iv$        
product2  7,h7 a drug requir$ to be     
refrig]at$ at any "t dur+ manufactur+1  
pack+1 process+1 or hold+2 or  7,i7 a   
photoreactive drug4  7c7 ,approv$       
,canadian ph>macy  7#a7 ,9 g5]al ,9 ?is 
section1 an approv$ ,canadian ph>macy is
 a ph>macy t-- 7,a7 is locat$ 9 ,canada2
 &  7,b7 ! ,secret>y c]tifies-- 7i7 is  
lic5s$ to op]ate & disp5se prescription 
drugs to individuals 9 ,canada2 &  7ii7 

meets ! crit]ia "u p>agraph 7#c74  7#b7 
,publication ( approv$ ,canadian        
ph>macies ,! ,secret>y %all publi% on ! 
int]net website ( ! ,food & ,drug       
,adm9i/ration a li/ ( approv$ ,canadian 
ph>macies1 includ+ ! int]net website    
address ( ea* su* approv$ ,canadian     
ph>macy1 f :i* individuals may pur*ase  
prescription drugs 9 accordance )       
subsection 7a74  7#c7 ,additional       
crit]ia ,to be an approv$ ,canadian     
ph>macy1 ! ,secret>y %all c]tify t !    
ph>macy-- 7,a7 has be5 9 exi/5ce = a    
p]iod ( at lea/ #e ye>s prec$+ ! date ( 
su* c]tification & has a purpose o!r ?an
 to p>ticipate 9 ! program e/abli%$ "u  
?is section2  7,b7 op]ates 9 accordance 
) ph>macy /&>ds set =? by ! prov9cial   
ph>macy rules & regulations enact$ 9    
,canada2  7,c7 has processes e/abli%$ by
 ! ph>macy1 or p>ticipates 9 ano!r      
e/abli%$ process1 to c]tify t ! physical
 premises & data report+ proc$ures &    
lic5ses are 9 compliance ) all          
applicable laws & regulations1 & has    

implem5t$ policies design$ to monitor   
ongo+ compliance ) su* laws &           
regulations2  7,d7 conducts or commits  
to p>ticipate 9 ongo+ & compreh5sive    
quality assurance programs & implem5ts  
su* quality assurance measures1 includ+ 
bl9d te/+1 to ensure ! v]acity &        
reliability ( ! f9d+s ( ! quality       
assurance program2  7,e7 agrees t       
laboratories approv$ by ! ,secret>y %all
 be us$ to conduct product te/+ to      
det]m9e ! safety & efficacy ( sample    
ph>maceutical products2  7,f7 has       
e/abli%$1 or w e/abli% or p>ticipate 91 
a process = resolv+ grievances & w be   
held acc\ntable = violations ( e/abli%$ 
guidel9es & rules2  7,g7 does n resell  
products f onl9e ph>macies locat$       
outside ,canada to cu/om]s 9 ! ,unit$   
,/ates2 &  7,h7 meets any o!r crit]ia   
e/abli%$ by ! ,secret>y4  4  #d4        
,pres]v+ access ?r\gh ,,ftc actions  7a7
 ,pres]ve ,access to ,af=dable ,g5]ics &
 ,biosimil>s  7#a7 ,unlawful comp5sation
 = delay  7,a7 ,9 g5]al ,! ,f$]al ,trade

 ,commission ,act 7#ae ,u4,s4,c4 #da et 
seq47 is am5d$ by ins]t+ aft] section   
#bf 7#ae ,u4,s4,c4 #eg;c-#b7 ! foll[+3  
#bg4 ,pres]v+ access to af=dable g5]ics 
& biosimil>s  7a7 ,9 g5]al  7#a7        
,en=cem5t proce$+ ,! ,commission may    
initiate a proce$+ to en=ce ! provisions
 ( ?is section aga9/ ! p>ties to any    
agreem5t resolv+ or settl+1 on a f9al or
 int]im basis1 a pat5t infr+em5t claim1 
9 connection ) ! sale ( a drug product  
or biological product4  7#b7            
,presumption & violation  7,a7 ,9 g5]al 
,subject to subp>agraph 7,b71 9 su* a   
proce$+1 an agreem5t %all be presum$ to 
h anticompetitive effects & %all be a   
violation ( ?is section if-- 7i7 an ,,&a
 fil] or a biosimil> biological product 
application fil] receives any?+ ( value1
 includ+ an exclusive lic5se2 &  7ii7 ! 
,,&a fil] or biosimil> biological       
product application fil] agrees to limit
 or =ego rese>*1 developm5t1            
manufactur+1 m>ket+1 or sales ( ! ,,&a  
product or biosimil> biological product1

 z applicable1 = any p]iod ( "t4  7,b7  
,exception ,subp>agraph 7,a7 %all n     
apply if ! p>ties to su* agreem5t       
demon/rate by cle> & conv9c+ evid5ce t--
 7i7 ! value describ$ 9 subp>agraph     
7,a77i7 is comp5sation solely = o!r     
goods or s]vices t ! ,,&a fil] or       
biosimil> biological product application
 fil] has promis$ to provide2 or  7ii7 !
 procompetitive b5efits ( ! agreem5t    
outweigh ! anticompetitive effects ( !  
agreem5t4  7b7 ,limitations ,9 det]m9+  
:e!r ! settl+ p>ties h met _! burd5 "u  
subsection 7a77#b77;,b71 ! fact f9d]    
%all n presume-- 7#a7 t entry w\ld n h  
occurr$ until ! expiration ( ! relevant 
pat5t or /atutory exclusivity2 or  7#b7 
t ! agreem5t's provision = entry ( !    
,,&a product or biosimil> biological    
product prior to ! expiration ( !       
relevant pat5t or /atutory exclusivity  
means t ! agreem5t is procompetitive4   
7c7 ,exclusions ,no?+ 9 ?is section %all
 prohibit a resolution or settlem5t ( a 
pat5t infr+em5t claim 9 :i* !           

consid]ation grant$ by ! ,,nda hold] or 
biological product lic5se hold] to !    
,,&a fil] or biosimil> biological       
product application fil]1 respectively1 
z "p ( ! resolution or settlem5t        
includes only "o or m ( ! foll[+3 7#a7  
,! "r to m>ket ! ,,&a product or        
biosimil> biological product 9 ! ,unit$ 
,/ates prior to ! expiration (-- 7,a7   
any pat5t t is ! basis = ! pat5t        
infr+em5t claim2 or  7,b7 any pat5t "r  
or o!r /atutory exclusivity t w\ld      
prev5t ! m>ket+ ( su* ,,&a product or   
biosimil> biological product4  7#b7 ,a  
paym5t = reasonable litigation exp5ses n
 to exce$ #g1ejj1jjj4  7#c7 ,a cov5ant n
 to sue on any claim t ! ,,&a product or
 biosimil> biological product infr+es a 
,unit$ ,/ates pat5t4  7d7 ,en=cem5t     
7#a7 ,en=cem5t ,a violation ( ?is       
section %all be treat$ z a violation (  
section #e4  7#b7 ,judicial review  7,a7
 ,9 g5]al ,any p>ty t is subject to a   
f9al ord] ( ! ,commission1 issu$ 9 an   
adm9i/rative adjudicative proce$+ "u !  

au?ority ( subsection 7a77#a71 may1 )9  
#cj days ( ! issuance ( su* ord]1       
petition = review ( su* ord] 9-- 7i7 !  
,unit$ ,/ates ,c\rt ( ,appeals = !      
,di/rict ( ,columbia ,circuit2  7ii7 !  
,unit$ ,/ates ,c\rt ( ,appeals = !      
circuit 9 :i* ! ultimate p>5t entity1 z 
def9$ 9 section #hja4a7;a77#c7 ( title  
#af1 ,code ( ,f$]al ,regulations1 or any
 successor !reto1 ( ! ,,nda hold] or    
biological product lic5se hold] is      
incorporat$ z ( ! date t ! ,,nda or     
biological product lic5se application1 z
 applicable1 is fil$ ) ! ,commission] ( 
,food & ,drugs2 or  7iii7 ! ,unit$      
,/ates ,c\rt ( ,appeals = ! circuit 9   
:i* ! ultimate p>5t entity ( ! ,,&a fil]
 or biosimil> biological product        
application fil] is incorporat$ z ( !   
date t ! ,,&a or biosimil> biological   
product application is fil$ ) !         
,commission] ( ,food & ,drugs4  7,b7    
,treatm5t ( f9d+s ,9 a proce$+ =        
judicial review ( a f9al ord] ( !       
,commission1 ! f9d+s ( ! ,commission z  

to ! facts1 if support$ by evid5ce1 %all
 be conclusive4  7e7 ,antitru/ laws     
,no?+ 9 ?is section %all modify1 impair1
 limit1 or sup]s$e ! applicability ( !  
antitru/ laws z def9$ 9 subsection 7a7 (
 ! fir/ section ( ! ,clayton ,act 7#ae  
,u4,s4,c4 #ab7;a771 & ( section #e ( ?is
 ,act to ! ext5t t section #e applies to
 unfair me?ods ( competition4 ,no?+ 9   
?is section %all modify1 impair1 limit1 
or sup]s$e ! "r ( an ,,&a fil] or       
biosimil> biological product application
 fil] to ass]t claims or c\nt]claims    
aga9/ any p]son1 "u ! antitru/ laws or  
o!r laws relat+ to unfair competition4  
7f7 ,p5alties  7#a7 ,=feiture ,ea* p>ty 
t violates or assi/s 9 ! violation ( ?is
 section %all =feit & pay to ! ,unit$   
,/ates a civil p5alty suffici5t to det] 
violations ( ?is section1 b 9 no ev5t   
great] ?an #c times ! value receiv$ by !
 p>ty t is reasonably attributable to ! 
violation ( ?is section4 ,if no su*     
value has be5 receiv$ by ! ,,nda hold]  
or biological product lic5se hold]1 !   

p5alty to ! ,,nda hold] or biological   
product lic5se hold] %all be suffici5t  
to det] violations1 b 9 no ev5t great]  
?an #c times ! value giv5 to ! ,,&a fil]
 or biosimil> biological product        
application fil] reasonably attributable
 to ! violation ( ?is section4 ,su*     
p5alty %all accrue to ! ,unit$ ,/ates & 
may be recov]$ 9 a civil action br\ght  
by ! ,commission1 9 its own "n by any ( 
its attorneys designat$ by x = su*      
purpose1 9 a di/rict c\rt ( ! ,unit$    
,/ates aga9/ any p>ty t violates ?is    
section4 ,9 su* actions1 ! ,unit$ ,/ates
 di/rict c\rts are emp[]$ to grant      
m&atory injunctions & su* o!r & fur!r   
equitable relief z !y deem appropriate4 
7#b7 ,cease & desi/  7,a7 ,9 g5]al ,if !
 ,commission has issu$ a cease & desi/  
ord] ) respect to a p>ty 9 an           
adm9i/rative adjudicative proce$+ "u !  
au?ority ( subsection 7a77#a71 an action
 br\ght pursuant to p>agraph 7#a7 may be
 comm5c$ aga9/ su* p>ty at any "t be=e !
 expiration ( #a ye> aft] su* ord]      

becomes f9al pursuant to section #e7;g74
  7,b7 ,exception ,9 an action "u       
subp>agraph 7,a71 ! f9d+s ( !           
,commission z to ! mat]ial facts 9 !    
adm9i/rative adjudicative proce$+ )     
respect to ! violation ( ?is section by 
a p>ty %all be conclusive unless-- 7i7 !
 t]ms ( su* cease & desi/ ord] expressly
 provide t ! ,commission's f9d+s %all n 
be conclusive2 or  7ii7 ! ord] became   
f9al by reason ( section #e7;g77#a71 9  
:i* case su* f9d+ %all be conclusive if 
support$ by evid5ce4  7#c7 ,civil p5alty
 ,9 det]m9+ ! am\nt ( ! civil p5alty    
describ$ 9 ?is section1 ! c\rt %all take
 into acc\nt-- 7,a7 ! nature1           
circum/ances1 ext5t1 & gravity ( !      
violation2  7,b7 ) respect to !         
violator1 ! degree ( culpability1 any   
hi/ory ( violations1 ! ability to pay1  
any effect on ! ability to cont9ue do+  
bus9ess1 pr(its e>n$ by ! ,,nda hold] or
 biological product lic5se hold]1       
comp5sation receiv$ by ! ,,&a fil] or   
biosimil> biological product application

 fil]1 & ! am\nt ( comm]ce affect$2 &   
7,c7 o!r matt]s t ju/ice requires4  7#d7
 ,rem$ies 9 addition ,rem$ies provid$ 9 
?is subsection are 9 addition to1 & n 9 
lieu (1 any o!r rem$y provid$ by ,f$]al 
law4 ,no?+ 9 ?is p>agraph %all be       
con/ru$ to affect any au?ority ( !      
,commission "u any o!r provision ( law4 
7g7 ,def9itions ,9 ?is section3 7#a7    
,agreem5t ,! t]m agreem5t means any?+ t 
w\ld con/itute an agreem5t "u section #a
 ( ! ,%]man ,act 7#ae ,u4,s4,c4 #a7 or  
section #e ( ?is ,act4  7#b7 ,agreem5t  
resolv+ or settl+ a pat5t infr+em5t     
claim ,! t]m agreem5t resolv+ or settl+ 
a pat5t infr+em5t claim includes any    
agreem5t t is ent]$ into )9 #cj days ( !
 resolution or ! settlem5t ( ! claim1 or
 any o!r agreem5t t is cont+5t ^u1      
provides a cont+5t condition =1 or is   
o!rwise relat$ to ! resolution or       
settlem5t ( ! claim4  7#c7 ,,&a ,! t]m  
,,&a means an abbreviat$ new drug       
application fil$ "u section #eje7;j7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  

7#ba ,u4,s4,c4 #cee7;j77 or a new drug  
application fil$ "u section #eje7;b77#b7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;b77#b774  7#d7
 ,,&a fil] ,! t]m ,,&a fil] means a p>ty
 t owns or controls an ,,&a fil$ ) !    
,food & ,drug ,adm9i/ration or has !    
exclusive rights "u su* ,,&a to         
di/ribute ! ,,&a product4  7#e7 ,,&a    
product ,! t]m ,,&a product means !     
product to be manufactur$ "u ! ,,&a t is
 ! subject ( ! pat5t infr+em5t claim4   
7#f7 ,biological product ,! t]m         
biological product has ! mean+ giv5 su* 
t]m 9 section #cea7;i77#a7 ( ! ,public  
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7;i77#a774  7#g7 ,biological product
 lic5se application ,! t]m biological   
product lic5se application means an     
application "u section #cea7;a7 ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a774  7#h7 ,biological  
product lic5se hold] ,! t]m biological  
product lic5se hold] means-- 7,a7 !     
hold] ( an approv$ biological product   

lic5se application = a biological       
product2  7,b7 a p]son own+ or controll+
 en=cem5t ( any pat5ts t claim !        
biological product t is ! subject ( su* 
approv$ application2 or  7,c7 !         
pr$ecessors1 subsidi>ies1 divisions1    
gr\ps1 & affiliates controll$ by1       
controll+1 or "u common control ) any ( 
! entities describ$ 9 subp>agraphs 7,a7 
& 7,b7 7su* control to be presum$ by    
direct or indirect %>e own]%ip ( #ej    
p]c5t or great]71 z well z ! lic5sees1  
lic5sors1 successors1 & assigns ( ea* ( 
! entities4  7#i7 ,biosimil> biological 
product ,! t]m biosimil> biological     
product means ! product to be           
manufactur$ "u ! biosimil> biological   
product application t is ! subject ( !  
pat5t infr+em5t claim4  7#aj7 ,biosimil>
 biological product application ,! t]m  
biosimil> biological product application
 means an application "u section #cea7k7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb7k77 = lic5sure ( a       
biological product z biosimil> to1 or   

int]*angeable )1 a ref]5ce product4     
7#aa7 ,biosimil> biological product     
application fil] ,! t]m biosimil>       
biological product application fil]     
means a p>ty t owns or controls a       
biosimil> biological product application
 fil$ ) ! ,food & ,drug ,adm9i/ration or
 has ! exclusive rights "u su*          
application to di/ribute ! biosimil>    
biological product4  7#ab7 ,drug product
 ,! t]m drug product has ! mean+ giv5   
su* t]m 9 section #cad4c7;b7 ( title    
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulation74  7#ac7 ,,nda ,! 
t]m ,,nda means a new drug application  
fil$ "u section #eje7;b7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b774  7#ad7 ,,nda hold] 
,! t]m ,,nda hold] means-- 7,a7 ! hold] 
( an approv$ ,,nda application = a drug 
product2  7,b7 a p]son own+ or controll+
 en=cem5t ( ! pat5t li/$ 9 ! ,approv$   
,drug ,products ,) ,!rapeutic           
,equival5ce ,evaluations 7commonly kn[n 
z ! ,,fda ,orange ,book7 9 connection ) 

! ,,nda2 or  7,c7 ! pr$ecessors1        
subsidi>ies1 divisions1 gr\ps1 &        
affiliates controll$ by1 controll+1 or  
"u common control ) any ( ! entities    
describ$ 9 subp>agraphs 7,a7 & 7,b7 7su*
 control to be presum$ by direct or     
indirect %>e own]%ip ( #ej p]c5t or     
great]71 z well z ! lic5sees1 lic5sors1 
successors1 & assigns ( ea* ( !         
entities4  7#ae7 ,p>ty ,! t]m p>ty means
 any p]son1 p>tn]%ip1 corporation1 or   
o!r legal entity4  7#af7 ,pat5t         
infr+em5t ,! t]m pat5t infr+em5t means  
infr+em5t ( any pat5t or ( any fil$     
pat5t application1 ext5sion1 reissue1   
r5ewal1 division1 cont9uation1          
cont9uation 9 "p1 reexam9ation1 pat5t   
t]m re/oration1 pat5ts ( addition1 &    
ext5sions !re(4  7#ag7 ,pat5t infr+em5t 
claim ,! t]m pat5t infr+em5t claim means
 any allegation made to an ,,&a fil] or 
biosimil> biological product application
 fil]1 :e!r or n includ$ 9 a compla9t   
fil$ ) a c\rt ( law1 t its ,,&a or ,,&a 
product1 or biological product lic5se   

application or biological product1 may  
infr+e any pat5t held by1 or exclusively
 lic5s$ to1 ! ,,nda hold] or biological 
product lic5se hold] ( ! drug product or
 biological product1 z applicable4      
7#ah7 ,/atutory exclusivity ,! t]m      
/atutory exclusivity means ^?           
prohibitions on ! approval ( drug       
applications "u clauses 7ii7 ?r\gh 7iv7 
( section #eje7;c77#c77;,e7 7#e- &      
#c-ye> data exclusivity71 section #ebg  
7orphan drug exclusivity71 or section   
#eje;,a 7p$iatric exclusivity7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;c77#c77;,e71       
#cfj;cc1 #cee;a71 or on ! lic5s+ (      
biological product applications "u      
section #cea7k77#g7 7#ab-ye>            
exclusivity7 or p>agraph 7#b7 or 7#c7 ( 
section #cea7m7 7p$iatric exclusivity7 (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bfb7 or "u section #ebg ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7orphan drug exclusivity74  4  7,b7     
,effective date ,section #bg ( ! ,f$]al 

,trade ,commission ,act1 z add$ by ?is  
p>agraph1 %all apply to all agreem5ts   
describ$ 9 section #bg7;a77#a7 ( t ,act 
ent]$ into aft] ,june #ag1 #bjac4       
,section #bg7;f7 ( ! ,f$]al ,trade      
,commission ,act1 z add$ by ?is         
p>agraph1 %all apply to agreem5ts ent]$ 
into on or aft] ! date ( enactm5t ( ?is 
,act4  7#b7 ,c]tification ( agreem5ts   
,section #aaab ( ! ,m$ic>e ,prescription
 ,drug1 ,improvem5t1 & ,mod]nization    
,act ( #bjjc 7#ba ,u4,s4,c4 #cee note7  
is am5d$ by add+ at ! end ! foll[+3  7d7
 ,c]tification ,! ,*ief ,executive      
,(fic] or ! company (ficial responsible 
= negotiat+ any agreem5t "u subsection  
7a7 or 7b7 t is requir$ to be fil$ "u   
subsection 7c71 )9 #cj days aft] su*    
fil+1 %all execute & file ) ! ,assi/ant 
,attorney ,g5]al & ! ,commission a      
c]tification z foll[s3 ,i decl>e t !    
foll[+ is true1 correct1 & complete to !
 be/ ( my k3 ,! mat]ials fil$ ) ! ,f$]al
 ,trade ,commission & ! ,dep>tm5t (     
,ju/ice "u section #aaab ( subtitle ,b (

 title ,,xi ( ! ,m$ic>e ,prescription   
,drug1 ,improvem5t1 & ,mod]nization ,act
 ( #bjjc1 ) respect to ! agreem5t       
ref]5c$ 9 ?is c]tification-- 7#a7       
repres5t ! complete1 f9al1 & exclusive  
agreem5t betwe5 ! p>ties2  7#b7 include 
any ancill>y agreem5ts t are cont+5t ^u1
 provide a cont+5t condition =1 or are  
o!rwise relat$ to1 ! ref]5c$ agreem5t2 &
  7#c7 include writt5 descriptions ( any
 oral agreem5ts1 repres5tations1        
commitm5ts1 or promises betwe5 ! p>ties 
t are responsive to subsection 7a7 or   
7b7 ( su* section #aaab & h n be5 r$uc$ 
to writ+4  4  4  7#c7 ,=feiture (       
#ahj-;day exclusivity p]iod ,section    
#eje7;j77#e77;,d77i77,v7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is  
am5d$ by ins]t+ section #bg ( ! ,f$]al  
,trade ,commission ,act or aft] t !     
agreem5t has violat$4  7#d7 ,commission 
litigation au?ority ,section #af7;a77#b7
 ( ! ,f$]al ,trade ,commission ,act 7#ae
 ,u4,s4,c4 #ef7;a77#b77 is am5d$-- 7,a7 

9 subp>agraph 7,d71 by /rik+ or aft] !  
semicolon2  7,b7 9 subp>agraph 7,e71 by 
ins]t+ or aft] ! semicolon2 &  7,c7     
ins]t+ aft] subp>agraph 7,e7 ! foll[+3  
7,f7 "u section #bg2  4  7#e7 ,/atute ( 
limitations ,! ,f$]al ,trade ,commission
 %all comm5ce any en=cem5t proce$+      
describ$ 9 section #bg ( ! ,f$]al ,trade
 ,commission ,act1 z add$ by p>agraph   
7#a71 except = an action describ$ 9     
section #bg7;f77#b7 ( ! ,f$]al ,trade   
,commission ,act1 n lat] ?an #f ye>s    
aft] ! date on :i* ! p>ties to !        
agreem5t file ! c]tification "u section 
#aaab7;d7 ( ! ,m$ic>e ,prescription     
,drug ,improvem5t & ,mod]nization ,act (
 #bjjc 7#ba ,u4,s4,c4 #cee note74  7b7  
,citiz5 petitions ,section #eje7q77#a7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7q77#a77 is am5d$-- 
7#a7 9 subp>agraph 7,e7-- 7,a7 by /rik+ 
,if ! ,secret>y & ins]t+ ! foll[+3  7i7 
,9 g5]al ,if ! ,secret>y  2  7,b7 by    
/rik+ ! second s5t5ce & ins]t+ ! foll[+3
  7ii7 ,factors ,9 det]m9+ :e!r a       

petition 0 submitt$ ) ! prim>y purpose (
 delay+ ! approval ( an application1 !  
,secret>y %all consid]-- 7,i7 :e!r x    
appe>s1 bas$ on ! date t relevant       
in=mation reli$ ^u 9 ! petition became  
kn[n to ! petition] 7or reasonably %\ld 
h be5 kn[n to ! petition]71 z c]tifi$ by
 ! petition] 9 accordance ) subp>agraph 
7,h71 t ! petition] has tak5 an         
unreasonable l5g? ( "t to submit !      
petition2  7,,ii7 :e!r ! petition] has  
submitt$ multiple or s]ial petitions    
rais+ issues t reasonably c\ld h be5    
kn[n to ! petition] at ! "t ( submission
 ( ! e>li] petition or petitions2       
7,,iii7 :e!r ! petition 0 submitt$ close
 9 "t to a kn[n1 fir/ date ^u :i* an    
application "u subsection 7b77#b7 ( ?is 
section or section #cea7k7 ( ! ,public  
,heal? ,s]vice ,act c\ld be approv$2    
7,,iv7 :e!r ! petition 0 submitt$ )\t   
any data or in=mation 9 support ( !     
sci5tific positions set =? 9 ! petition2
  7,v7 :e!r ! petition raises ! same or 
sub/antially simil> issues z a prior    

petition to :i* ! ,secret>y has respond$
 sub/antively already1 p>ticul>ly if !  
subsequ5t submission foll[s ! e>li]     
response closely 9 "t2  7,,vi7 :e!r !   
petition conc]ns /&>ds = approval ( a   
drug = :i* ! ,secret>y has provid$ an   
opportunity = public input1 su* z draft 
or f9al product-specific guidance       
applicable to ! drug1 & ! petition] has 
n provid$ comm5t o!r ?an ?r\gh !        
petition2  7,,vii7 :e!r ! petition      
reque/s t o!r applicants meet /&>ds =   
te/+1 data1 or label+ = a drug t are m  
on]\s or rigor\s ?an ! /&>ds applicable 
to1 z applicable1 ! li/$ drug1 ref]5ce  
product1 or petition]'s v]sion ( ! same 
drug2  7,,viii7 ! hi/ory ( ! petition] )
 ! ,food & ,drug ,adm9i/ration1 su* z   
:e!r ! petition] has a hi/ory ( submitt+
 petitions t ! ,secret>y has det]m9$ 7  
submitt$ ) ! prim>y purpose ( delay2 &  
7,,ix7 o!r relevant consid]ations1 z !  
,secret>y may describe 9 guidance4  2 & 
7,c7 by add+ at ! end ! foll[+3  7iii7  
,public availability ,! ,secret>y %all  

publi% on ! int]net website ( ! ,food & 
,drug ,adm9i/ration a li/ ( any         
petitions t ! ,secret>y det]m9es 7      
submitt$ = ! prim>y purpose ( delay+ !  
approval ( an application4  7iv7        
,ref]ral to ! ,f$]al ,trade ,commission 
,! ,secret>y %all e/abli% proc$ures =   
ref]r+ to ! ,f$]al ,trade ,commission   
any petition or supplem5t to a petition 
t ! ,secret>y det]m9es 0 submitt$ ) !   
prim>y purpose ( delay+ approval ( an   
application4 ,su* proc$ures %all include
 notification to ! petition] & an       
opportunity = ! petition] to respond to 
! ,secret>y prior to ref]ral to ! ,f$]al
 ,trade ,commission4  2 &  7#b7 by add+ 
at ! end ! foll[+3  7,j7 ,timel9e =     
submitt+ petitions ,! ,secret>y may     
e/abli% a "t p]iod aft] ! relevant      
in=mation reli$ ^u 9 a petition became  
kn[n to ! petition] 7or reasonably %\ld 
h be5 kn[n to a petition]71 z c]tifi$ by
 ! petition] 9 accordance ) subp>agraph 
7,h71 & any petition t is submitt$ aft] 
su* "t p]iod has pass$ %all be summ>ily 

d5i$4  4  7c7 ,f$]al ,trade ,commission 
en=cem5t aga9/ %am petitions  7#a7      
,def9itions ,9 ?is subsection3 7,a7     
,commission ,! t]m ,commission means !  
,f$]al ,trade ,commission4  7,b7 ,cov]$ 
application ,! t]m cov]$ application    
means an application fil$ pursuant to   
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7 or section    
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k774  7,c7 ,cov]$   
petition ,! t]m cov]$ petition means a  
petition1 or a supplem5t to a petition1 
fil$ "u section #eje7q7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7q774  7,d7 ,p]son ,! t]m 
p]son-- 7i7 means an individual or      
entity2 &  7ii7 includes-- 7,i7 a       
successor & an assign ( an entity2 &    
7,,ii7 a jo9t v5ture1 subsidi>y1        
p>tn]%ip1 division1 gr\p1 & affiliate   
controll$ by an entity1 &  7,,iii7 a    
successor & an assign ( a jo9t v5ture1  
subsidi>y1 p>tn]%ip1 division1 gr\p1 &  

affiliate controll$ by an entity4  7,e7 
,s]ies ( cov]$ petitions ,! t]m s]ies ( 
cov]$ petitions means any gr\p ( m ?an  
#a cov]$ petition relat+ to ! same cov]$
 application4  7,f7 ,%am ,! t]m %am     
means a cov]$ petition t is objectively 
baseless & t attempts to use a          
gov]nm5tal process1 z oppos$ to !       
outcome ( t process1 to int]f]e ) !     
bus9ess ( a competitor1 or a s]ies (    
cov]$ petitions t attempts to use a     
gov]nm5tal process1 z oppos$ to !       
outcome ( t process1 to int]f]e ) !     
bus9ess ( a competitor4  7#b7 ,violation
 ,a p]son submitt+ or caus+ ! submission
 ( a cov]$ petition or a s]ies ( cov]$  
petitions t is a %am %all be liable =   
engag+ 9 an unfair me?od ( competition  
"u section #e7;a77#a7 ( ! ,f$]al ,trade 
,commission ,act 7#ae ,u4,s4,c4         
#de7;a77#a774  7#c7 ,civil action  7,a7 
,9 g5]al ,if ! ,commission has reason to
 believe t ! submission ( a cov]$       
petition or a s]ies ( cov]$ petitions   
con/itutes a violation ( section        

#e7;a77#a7 ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7;a77#a771 !    
,commission may comm5ce a civil action  
to recov] a civil p5alty & seek o!r     
appropriate relief 9 a di/rict c\rt ( ! 
,unit$ ,/ates aga9/ any p]son t submitt$
 or caus$ to be submitt$ su* cov]$      
petition or su* s]ies ( cov]$ petitions1
 includ+ successors or assigns4  7,b7   
,presumption ,9 a civil action "u       
subp>agraph 7,a71 a cov]$ petition %all 
be presum$ to be "p ( a s]ies ( cov]$   
petitions t is a %am "u p>agraph 7#b7 ( 
?is subsection if-- 7i7 ! ,secret>y (   
,heal? & ,human ,s]vices-- 7,i7 has     
det]m9$ t ! cov]$ petition 0 submitt$ ) 
! prim>y purpose ( delay+ ! approval ( a
 cov]$ application2 &  7,,ii7 has ref]r$
 su* det]m9ation to ! ,f$]al ,trade     
,commission 9 writ+1 includ+ a reason$  
basis = ! det]m9ation2 &  7ii7 ! cov]$  
petition 0 "p ( a s]ies ( cov]$         
petitions4  7,c7 ,exception ,!          
presumption 9 subp>agraph 7,b7 %all n   
apply if ! def5dant e/abli%es1 by a     

prepond]ance ( ! evid5ce1 t ! s]ies (   
cov]$ petitions t includes ! cov]$      
petition ref]r$ to ! ,commission by !   
,secret>y ( ,heal? & ,human ,s]vices is 
n a %am4  7,d7 ,civil p5alty ,9 an      
action "u subp>agraph 7,a71 any p]son t 
has be5 f\nd liable = a violation (     
section #e7;a77#a7 ( ! ,f$]al ,trade    
,commission ,act 7#ae ,u4,s4,c4         
#de7;a77#a77 %all be subject to a civil 
p5alty = ea* violation ( n m ?an !      
great] (-- 7i7 any rev5ue e>n$ f ! sale 
by su* p]son ( any drug product1 ref]5c$
 9 a cov]$ application t 0 ! subject ( a
 cov]$ petition or a s]ies ( cov]$      
petitions t is a %am1 dur+ ! p]iod 9 :i*
 ! cov]$ petition or s]ies ( cov]$      
petitions 0 "u review by ! ,secret>y (  
,heal? & ,human ,s]vices2 or  7ii7      
#ej1jjj = ea* cal5d> day t ea* cov]$    
petition t is a %am or t 0 "p ( a s]ies 
( cov]$ petitions t is a %am 0 "u review
 by ! ,secret>y ( ,heal? & ,human       
,s]vices4  7,e7 ,antitru/ laws ,no?+ 9  
?is subsection %all modify1 impair1     

limit1 or sup]s$e ! applicability ( !   
antitru/ laws z def9$ 9 subsection 7a7 (
 ! fir/ section ( ! ,clayton ,act 7#ae  
,u4,s4,c4 #ab7;a771 & ( section #e ( !  
,f$]al ,trade ,commission ,act 7#ae     
,u4,s4,c4 #de7 to ! ext5t t x applies to
 unfair me?ods ( competition4  7,f7     
,rule ( con/ruction ,! civil p5alty     
provid$ 9 ?is p>agraph is 9 addition to1
 & n 9 lieu (1 any o!r rem$ies provid$  
by ,f$]al law1 includ+ "u section #af ( 
! ,clayton ,act 7#ae ,u4,s4,c4 #bf7 or  
"u section #ac7;b7 ( ! ,f$]al ,trade    
,commission ,act 7#ae ,u4,s4,c4         
#ec7;b774 ,no?+ 9 ?is subp>agraph %all  
be con/ru$ to affect any au?ority ( !   
,commission "u any o!r provision ( law4 
7#d7 ,applicability ,?is subsection %all
 apply to any cov]$ petition submitt$ on
 or aft] ! date ( enactm5t ( ?is ,act4  
#e4 ,increas+ ! use ( real-"t b5efit    
tools to l[] b5efici>y co/s  7a7        
,requir+ prescription drug plan sponsors
 & ,m$ic>e ,advantage organizations ,to 
include real-,"t b5efit in=mation "u    

,m$ic>e "p ,d ,section #ahfj;,d-#d ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajd7 is am5d$-- 7#a7 by         
r$esignat+ subsection 7m7 7relat+ to    
program integrity transp>5cy measures71 
z add$ by section #fjfc7;c7 ( !         
,sub/ance ,use-,disord] ,prev5tion t    
,promotes ,opioid ,recov]y & ,treatm5t =
 ,pati5ts & ,communities ,act 7,public  
,law #aae-bga71 z subsection 7n72 &     
7#b7 by add+ at ! end ! foll[+ new      
subsection3  7o7 ,real-,"t b5efit       
in=mation  7#a7 ,9 g5]al ,aft] !        
,secret>y has adopt$ a /&>d "u p>agraph 
7#c7 = electronic real-"t b5efit tools1 
& at a "t det]m9$ appropriate by !      
,secret>y1 a ,,pdp sponsor ( a          
prescription drug plan %all implem5t "o 
or m ( su* tools t meet ! requirem5ts   
describ$ 9 p>agraph 7#b74  7#b7         
,requirem5ts ,= purposes ( p>agraph     
7#a71 ! requirem5ts describ$ 9 ?is      
p>agraph1 ) respect to an electronic    
real-"t b5efit tool1 are t ! tool is    
capable (-- 7,a7 integrat+ ) electronic 

prescrib+ & electronic heal? record     
sy/ems ( prescrib+ heal? c>e            
pr(essionals = ! transmission (         
eligibility & =mul>y & b5efit in=mation 
9 real "t to su* pr(essionals2 &  7,b7 )
 respect to a cov]$ "p ,d drug1         
transmitt+ su* in=mation specific to an 
individual enroll$ 9 a prescription drug
 plan1 includ+ ! foll[+3 7i7 ,a li/ (   
any cl9ically appropriate alt]natives to
 su* drug includ$ 9 ! =mul>y ( su* plan4
  7ii7 ,co/-%>+ in=mation & ! negotiat$ 
price = su* drug & su* alt]natives at-- 
7,i7 multiple ph>macy options1 includ+ !
 individual's pref]r$ ph>macy &1 z      
applicable1 o!r retail ph>macies & a    
mail ord] ph>macy2 &  7,,ii7 ! =mul>y   
/atus ( su* drug & su* alt]natives & any
 prior au?orization or o!r utilization  
managem5t requirem5ts applicable to su* 
drug & su* alt]natives includ$ 9 !      
=mul>y ( su* plan4  7#c7 ,/&>ds ,9 ord] 
to be treat$ 7= purposes ( ?is          
subsection7 z an electronic real-"t     
b5efit tool describ$ 9 p>agraph 7#a71   

su* tool %all comply ) te*nical /&>ds   
adopt$ by ! ,secret>y 9 consultation ) !
 ,national ,coord9ator = ,heal?         
,in=mation ,te*nology1 ! ,national      
,c\ncil = ,prescription ,drug ,programs1
 o!r /&>d sett+ organizations det]m9$   
appropriate by ! ,secret>y1 & /akehold]s
 includ+ ,,pdp sponsors1 ,m$ic>e        
,advantage organizations1 heal? c>e     
pr(essionals1 & heal? in=mation         
te*nology s(tw>e v5dors4  7#d7 ,rule (  
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ to prohibit ! application (  
p>agraph 7b77#g7 ( section #dbc4afj (   
title #db1 ,code ( ,f$]al ,regulations1 
z is to be add$ to su* section pursuant 
to ! f9al rule publi%$ 9 ! ,f$]al       
,regi/] on ,may #bc1 #bjai1 & titl$     
,mod]niz+ ,"p ,d & ,m$ic>e ,advantage   
,to ,l[] ,drug ,prices & ,r$uce         
,out-(-,pocket ,exp5ses 7#hd ,f$4 ,reg4 
#bchcb ?r\gh #bchhd74  4  7b7 ,requir+  
qualifi$ electronic heal? records ,to   
include real-,"t b5efit tools ,section  
#cjjj7ac7 ( ! ,public ,heal? ,s]vice    

,act 7#db ,u4,s4,c4 #cjj;jj7#ac77 is    
am5d$-- 7#a7 9 subp>agraph 7,a71 by     
/rik+ & at ! end2  7#b7 9 subp>agraph   
7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 &  
7#c7 by add+ at ! end ! foll[+3  7,c7   
includes1 or is capable ( includ+1 a    
real-"t b5efit tool t conveys           
pati5t-specific real-"t co/ & cov]age   
in=mation ) respect to prescription     
drugs t1 ) respect to any heal?         
in=mation te*nology c]tifi$ = electronic
 prescrib+1 ! te*nology %all be capable 
( incorporat+ ! in=mation describ$ 9    
clauses 7i7 & 7ii7 ( p>agraph 7#b77;,b7 
( section #ahfj;,d-#d7o7 ( ! ,social    
,security ,act at a "t specifi$ by !    
,secret>y b n be=e ! ,secret>y adopts a 
/&>d = su* tools z describ$ 9 p>agraph  
7#a7 ( su* section4  4  7c7 ,inclusion (
 use ( real-,"t electronic in=mation 9  
%>$ decision mak+ "u ,,mips ,section    
#ahdh7q77#b77;,b77iii77,,iv7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#d7q77#b77;,b77iii77,,iv77 is    
am5d$ by add+ at ! end ! foll[+ new     

s5t5ce3 ,?is subcategory %all include z 
an activity option1 beg9n+ ) ! p]=mance 
p]iod />t+ on ,janu>y #a1 #bjba1 use ( a
 real-"t b5efit tool z describ$ 9       
#ahfj;,d-#d7o744  #f4 ,m$ic>e "p ,d     
mod]nization r$esign  7a7 ,b5efit       
/ructure r$esign ,section               
#ahfj;,d-#b7;b7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is 
am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9   
subp>agraph 7,a71 9 ! matt] prec$+      
clause 7i71 by ins]t+ = a ye> prec$+    
#bjbb & = co/s above ! annual d$uctible 
specifi$ 9 p>agraph 7#a7 & up to !      
annual out-(-pocket ?re%old specifi$ 9  
p>agraph 7#d77;,b7 = #bjbb & ea*        
subsequ5t ye> aft] p>agraph 7#c72  7,b7 
9 subp>agraph 7,c7-- 7i7 9 clause 7i71 9
 ! matt] prec$+ subclause 7,i71 by      
ins]t+ = a ye> prec$+ #bjbb1 aft]       
p>agraph 7#d712 &  7ii7 9 clause        
7ii77,,iii71 by /rik+ & ea* subsequ5t   
ye> & ins]t+ & #bjba2 &  7,c7 9         
subp>agraph 7,d7-- 7i7 9 clause 7i7--   
7,i7 9 ! matt] prec$+ subclause 7,i71 by

 ins]t+ = a ye> prec$+ #bjbb1 aft]      
p>agraph 7#d712 &  7,,ii7 9 subclause   
7,i77bb71 by /rik+ a ye> aft] #bjah &   
ins]t+ ea* ( ye>s #bjah ?r\gh #bjba2 &  
7ii7 9 clause 7ii77,v71 by /rik+ #bjai &
 ea* subsequ5t ye> & ins]t+ ea* ( ye>s  
#bjai ?r\gh #bjba2  7#b7 9 p>agraph     
7#c77;,a7-- 7,a7 9 ! matt] prec$+ clause
 7i71 by ins]t+ = a ye> prec$+ #bjbb1   
aft] & 7#d712 &  7,b7 9 clause 7ii71 by 
/rik+ = a subsequ5t ye> & ins]t+ = ea* (
 ye>s #bjjg ?r\gh #bjba2  7#c7 9        
p>agraph 7#d7-- 7,a7 9 subp>agraph      
7,a7-- 7i7 9 clause 7i7-- 7,i7 by       
r$esignat+ subclauses 7,i7 & 7,,ii7 z   
items 7aa7 & 7bb71 respectively1 &      
ind5t+ appropriately2  7,,ii7 9 ! matt] 
prec$+ item 7aa71 z r$esignat$ by       
subclause 7,i71 by /rik+ is equal to !  
great] (-- & ins]t+ 8is equal to--  7,i7
 = a ye> prec$+ #bjbb1 ! great] (--  2  
7,,iii7 by /rik+ ! p]iod at ! end ( item
 7bb71 z r$esignat$ by subclause 7,i71 &
 ins]t+ 2 &2 &  7,,iv7 by add+ at ! end 
! foll[+3  7,,ii7 = #bjbb & ea* succe$+ 

ye>1 #j4  2 &  7ii7 9 clause 7ii7-- 7,i7
 by /rik+ clause 7i77,i7 & ins]t+ clause
 7i77,i77aa72 &  7,,ii7 by add+ at ! end
 ! foll[+ new s5t5ce3 ,! ,secret>y %all 
cont9ue to calculate ! doll> am\nts     
specifi$ 9 clause 7i77,i77aa71 includ+ )
 ! adju/m5t "u ?is clause1 aft] #bjba = 
purposes ( section                      
#ahfj;,d-#ad7;a77#a77;,d77iii742  7,b7 9
 subp>agraph 7,b7-- 7i7 9 clause 7i7--  
7,i7 9 subclause 7,v71 by /rik+ or at ! 
end2  7,,ii7 9 subclause 7,,vi7-- 7aa7  
by /rik+ = a subsequ5t ye> & ins]t+ =   
#bjba2 &  7bb7 by /rik+ ! p]iod at ! end
 & ins]t+ a semicolon2 &  7,,iii7 by    
add+ at ! end ! foll[+ new subclauses3  
7,,vii7 = #bjbb1 is equal to #c1ajj2 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+ & 

= a ye> prec$+ #bjbb = am\nts2 &  7,d7 9
 subp>agraph 7,e71 by /rik+ ,9 apply+ & 
ins]t+ ,= ea* ( #bjaa ?r\gh #bjba1 9    
apply+4  7b7 ,r$uction 9 b5efici>y      
co9surance  7#a7 ,9 g5]al ,section      
#ahfj;,d-#b7;b77#b77;,a7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajb7;b77#b77;,a771 z am5d$ by   
subsection 7a71 is am5d$-- 7,a7 by      
r$esignat+ clauses 7i7 & 7ii7 z         
subclauses 7,i7 & 7,,ii7 & mov+ su*     
subclauses #b ems to ! "r2  7,b7 by     
/rik+ #be p]c5t co9surance4--,subject to
 & ins]t+ 8,co9surance4--  7i7 ,9 g5]al 
,subject to  2  7,c7 9 ea* ( subclauses 
7,i7 & 7,,ii71 z r$esignat$ by          
subp>agraph 7,a71 by /rik+ #be p]c5t &  
ins]t+ ! applicable p]c5tage 7z def9$ 9 
clause 7ii772 &  7,d7 by add+ at ! end !
 foll[+ new clause3  7ii7 ,applicable   
p]c5tage def9$ ,= purposes ( clause 7i71
 ! t]m applicable p]c5tage means-- 7,i7 
= a ye> prec$+ #bjbb1 #be p]c5t2 &      
7,,ii7 = #bjbb & ea* subsequ5t ye>1 #bj 
p]c5t4  4  7#b7 ,con=m+ am5dm5t ,section

 #ahfj;,d-#ad7;a77#b77;,d7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#aciew-#aad7;a77#b77;,d77 is am5d$ by   
/rik+ #be p]c5t & ins]t+ ! applicable   
p]c5tage4  7c7 ,decreas+ re9surance     
paym5t am\nt ,section #ahfj;,d-#ae7;b7 (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #aciew-#aae7;b77 is am5d$-- 7#a7 9     
p>agraph 7#a7-- 7,a7 by /rik+ equal to  
#hj p]c5t & ins]t+ 8equal to--  7,a7 = a
 ye> prec$+ #bjbb1 #hj p]c5t  2  7,b7 9 
subp>agraph 7,a71 z add$ by p>agraph    
7#a71 by /rik+ ! p]iod at ! end & ins]t+
 2 &2 &  7,c7 by add+ at ! end ! foll[+ 
new subp>agraph3  7,b7 = a subsequ5t    
ye>1 ! sum (-- 7i7 an am\nt equal to !  
applicable p]c5tage specifi$ 9 p>agraph 
7#e77;,a7 ( su* all[able re9surance co/s
 attributable to t portion ( gross      
prescription drug co/s z specifi$ 9     
p>agraph 7#c7 incurr$ 9 ! cov]age ye>   
aft] su* individual has incurr$ co/s t  
exce$ ! annual out-(-pocket ?re%old     
specifi$ 9 section                      
#ahfj;,d-#b7;b77#d77;,b7 ) respect to   

applicable drugs 7z def9$ 9 section     
#ahfj;,d-#ad;,b7g77#b772 &  7ii7 an     
am\nt equal to ! applicable p]c5tage    
specifi$ 9 p>agraph 7#e77;,b7 ( all[able
 re9surance co/s attributable to t      
portion ( gross prescription drug co/s z
 specifi$ 9 p>agraph 7#c7 incurr$ 9 !   
cov]age ye> aft] su* individual has     
incurr$ co/s t exce$ ! annual           
out-(-pocket ?re%old specifi$ 9 section 
#ahfj;,d-#b7;b77#d77;,b7 ) respect to   
cov]$ "p ,d drugs t are n applicable    
drugs 7z s def9$74  2 &  7#b7 by add+ at
 ! end ! foll[+ new p>agraph3  7#e7     
,applicable p]c5tage specifi$ ,=        
purposes ( p>agraph 7#a77;,b71 !        
applicable p]c5tage specifi$ 9 ?is      
p>agraph is-- 7,a7 ) respect to         
applicable drugs 7z def9$ 9 section     
#ahfj;,d-#ad;,b7g77#b77-- 7i7 = #bjbb1  
#fj p]c5t2  7ii7 = #bjbc1 #dj p]c5t2 &  
7iii7 = #bjbd & ea* subsequ5t ye>1 #bj  
p]c5t2 &  7,b7 ) respect to cov]$ "p ,d 
drugs t are n applicable drugs 7z s     
def9$7-- 7i7 = #bjbb1 #hj p]c5t2  7ii7 =

 #bjbc1 #fj p]c5t2 &  7iii7 = #bjbd &   
ea* subsequ5t ye>1 #dj p]c5t4  4  7d7   
,manufactur] disc\nt program dur+       
initial & cata/rophic phases ( cov]age  
7#a7 ,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 #adiew-#aad7 ! foll[+ new    
section3  #ahfj;,d-#ad;,b4 ,manufactur] 
disc\nt program  7a7 ,e/abli%m5t ,!     
,secret>y %all e/abli% a manufactur]    
disc\nt program 79 ?is section ref]r$ to
 z ! program74 ,"u ! program1 !         
,secret>y %all ent] into agreem5ts      
describ$ 9 subsection 7b7 ) manufactur]s
 & provide = ! p]=mance ( ! duties      
describ$ 9 subsection 7c74 ,! ,secret>y 
%all e/abli% a model agreem5t = use "u !
 program by n lat] ?an ,janu>y #a1      
#bjba1 9 consultation ) manufactur]s1 & 
all[ = comm5t on su* model agreem5t4    
7b7 ,t]ms ( agreem5t  7#a7 ,9 g5]al     
7,a7 ,agreem5t ,an agreem5t "u ?is      
section %all require ! manufactur] to   
provide applicable b5efici>ies access to

 disc\nt$ prices = applicable drugs ( ! 
manufactur] t are disp5s$ on or aft]    
,janu>y #a1 #bjbb4  7,b7 ,provision (   
disc\nt$ prices at ! po9t-(-sale ,!     
disc\nt$ prices describ$ 9 subp>agraph  
7,a7 %all be provid$ to ! applicable    
b5efici>y at ! ph>macy or by ! mail ord]
 s]vice at ! po9t-(-sale ( an applicable
 drug4  7#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$+ plan ye>4    
7iii7 ,effectiv5ess ( t]m9ation ,any    
t]m9ation "u ?is subp>agraph %all n     
affect disc\nts = applicable drugs ( !  
manufactur] t are due "u ! agreem5t be=e
 ! effective date ( its t]m9ation4  7iv7
 ,notice to ?ird p>ty ,! ,secret>y %all 
provide notice ( su* t]m9ation to a ?ird
 p>ty ) a contract "u subsection 7d77#c7
 )9 n less ?an #cj days be=e ! effective
 date ( su* t]m9ation4  7#e7 ,effective 
date ( agreem5t ,an agreem5t "u ?is     
section %all take effect on a date      
det]m9$ appropriate by ! ,secret>y1 :i* 
may be at ! />t ( a cal5d> qu>t]4  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 ) "o
 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 ,adm9i/ration ,*apt]
 #ce ( title #dd1 ,unit$ ,/ates ,code1  
%all n apply to ! program "u ?is        
section4  7#f7 ,fund+ ,= purposes (     
c>ry+ out ?is section1 ! ,secret>y %all 
provide = ! transf]1 f ! ,f$]al         
,supplem5t>y ,m$ical ,insurance ,tru/   
,fund "u section #ahda to ! ,c5t]s =    
,m$ic>e  ,m$icaid ,s]vices ,program     
,managem5t ,acc\nt1 ( #d1jjj1jjj = ea* (
 fiscal ye>s #bjbj ?r\gh #bjbc1 to rema9
 available until exp5d$404  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 %all impose a
 civil money p5alty on a manufactur] t  
fails to provide applicable b5efici>ies 

disc\nts = applicable drugs ( !         
manufactur] 9 accordance ) su* agreem5t 
= ea* su* failure 9 an am\nt ! ,secret>y
 det]m9es is comm5surate ) ! sum (-- 7i7
 ! am\nt t ! manufactur] w\ld h paid )  
respect to su* disc\nts "u ! agreem5t1  
:i* w !n be us$ to pay ! disc\nts :i* ! 
manufactur] _h fail$ to provide2 &  7ii7
 #be p]c5t ( su* am\nt4  7,b7           
,application ,! provisions ( section    
#aabh;,a 7o!r ?an subsections 7a7 & 7b77
 %all apply to a civil money p5alty "u  
?is p>agraph 9 ! same mann] z su*       
provisions apply to a p5alty or proce$+ 
"u section #aabh;,a7a74  7f7            
,cl>ification reg>d+ availability ( o!r 
cov]$ "p d drugs ,no?+ 9 ?is section    
%all prev5t an applicable b5efici>y f   
pur*as+ a cov]$ "p ,d drug t is n an    
applicable drug 7includ+ a g5]ic drug or
 a drug t is n on ! =mul>y ( !          
prescription drug plan or ,,ma-,,pd plan
 t ! applicable b5efici>y is enroll$ 974
  7g7 ,def9itions ,9 ?is section3 7#a7  
,applicable b5efici>y ,! t]m applicable 

b5efici>y means an individual :o1 on !  
date ( disp5s+ a cov]$ "p ,d drug-- 7,a7
 is enroll$ 9 a prescription drug plan  
or an ,,ma-,,pd plan2  7,b7 is n enroll$
 9 a qualifi$ retiree prescription drug 
plan2 &  7,c7 has incurr$ co/s = cov]$  
"p ,d drugs 9 ! ye> t are above ! annual
 d$uctible specifi$ 9 section           
#ahfj;,d-#b7;b77#a74  7#b7 ,applicable  
drug ,! t]m applicable drug means1 )    
respect to an applicable b5efici>y1 a   
cov]$ "p ,d drug-- 7,a7 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 ,act 7includ+ a product  
lic5s$ "u subsection 7k7 ( su* section  
#cea72 &  7,b7 7i7 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 
7ii7 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  7iii7 is provid$ ?r\gh an exception 
or appeal4  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 means-- 7i7 ) respect to 
an applicable drug disp5s$ = an         
applicable b5efici>y :o has incurr$ co/s
 t are bel[ ! annual out-(-pocket       
?re%old specifi$ 9 section              
#ahfj;,d-#b7;b77#d77;,b71 #ic p]c5t ( ! 
negotiat$ price ( ! applicable drug ( a 
manufactur]2 &  7ii7 ) respect to an    
applicable drug disp5s$ = an applicable 
b5efici>y :o has incurr$ co/s = cov]$ "p
 ,d drugs 9 ! ye> t are equal to or     

exce$ ! annual out-(-pocket ?re%old     
specifi$ 9 section                      
#ahfj;,d-#b7;b77#d77;,b71 #hf p]c5t ( ! 
negotiat$ price ( ! applicable drug ( a 
manufactur]4  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 ,cl>ification =  
c]ta9 claims ,) respect to ! am\nt ( !  
negotiat$ price ( an individual claim = 
an applicable drug ) respect to an      
applicable b5efici>y1 ! manufactur] ( ! 
applicable drug %all provide-- 7i7 !    
disc\nt$ price "u clause 7i7 (          
subp>agraph 7,a7 only on ! portion ( !  
negotiat$ price ( ! applicable drug t   
falls above ! d$uctible specifi$ 9      
section #ahfj;,d-#b7;b77#a7 & bel[ !    
annual out-(-pocket ?re%old specifi$ 9  
section #ahfj;,d-#b7;b77#d77;,b72 &     
7ii7 ! disc\nt$ price "u clause 7ii7 (  
subp>agraph 7,a7 only on ! portion ( !  
negotiat$ price ( ! applicable drug t   
falls at or above su* annual            

out-(-pocket ?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
 #ahfj;,d-#b7;d77#a77;,b71 except t su* 
negotiat$ price %all n include any      
disp5s+ fee = ! applicable drug4  7#g7  
,qualifi$ retiree prescription drug plan
 ,! t]m qualifi$ retiree prescription   
drug plan has ! mean+ giv5 su* t]m 9    
section #ahfj;,d-#bb7;a77#b74  4  7#b7  
,sunset ( ,m$ic>e cov]age gap disc\nt   
program ,section #ahfj;,d-#ad;,a ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#acie-aad;a7 is am5d$-- 7,a7 9          

subsection 7a71 9 ! fir/ s5t5ce1 by     
/rik+ ,! ,secret>y & ins]t+ ,subject to 
subsection 7h71 ! ,secret>y2 &  7,b7 by 
add+ at ! end ! foll[+ new subsection3  
7h7 ,sunset ( program  7#a7 ,9 g5]al ,! 
program %all n apply to applicable drugs
 disp5s$ on or aft] ,janu>y #a1 #bjbb1  
&1 subject to p>agraph 7#b71 agreem5ts  
"u ?is section %all be t]m9at$ z ( su*  
date4  7#b7 ,cont9u$ application =      
applicable drugs disp5s$ prior to sunset
 ,! provisions ( ?is section 7includ+   
all responsibilities & duties7 %all     
cont9ue to apply aft] ,janu>y #a1 #bjbb1
 ) respect to applicable drugs disp5s$  
prior to su* date4  4  7#c7 ,inclusion (
 actu>ial value ( manufactur] disc\nts 9
 bids ,section #ahfj;,d-#aa ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#aciew-#aaa7 is am5d$-- 7,a7 9          
subsection 7b77#b77;,c77iii7-- 7i7 by   
/rik+ assumptions reg>d+ ! re9surance an
 ins]t+ 8assumptions reg>d+--  7,i7 !   
re9surance  2 &  7ii7 by add+ at ! end !
 foll[+3  7,,ii7 = #bjbb & ea* subsequ5t

 ye>1 ! manufactur] disc\nts provid$ "u 
section #ahfj;,d-#ad;,b 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 add$ by clause 7i7 (   
?is subp>agraph1 by add+ & at ! end2 &  
7iii7 by add+ at ! end ! foll[+3  7ii7 =
 #bjbb & ea* subsequ5t ye>1 !           
manufactur] disc\nts provid$ "u section 
#ahfj;,d-#ad;,b2  4  7#d7 ,cl>ification 
reg>d+ exclusion ( manufactur] disc\nts 
f ,tr,o,o,p ,section #ahfj;,d-#b7;b77#d7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciew-#ajb7;b77#d77 is       
am5d$-- 7,a7 9 subp>agraph 7,c71 by     
ins]t+ & subject to subp>agraph 7,f7    
aft] subp>agraph 7,e72 &  7,b7 by add+  
at ! end ! foll[+ new subp>agraph3  7,f7
 ,cl>ification reg>d+ exclusion (       
manufactur] disc\nts ,9 apply+          
subp>agraph 7,a71 incurr$ co/s %all n   
include any manufactur] disc\nts provid$

 "u section #ahfj;,d-#ad;,b4  4  7e7    
,det]m9ation ( all[able re9surance co/s 
,section #ahfj;,d-#ae7;b7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciew-#aae7;b77 is am5d$-- 7#a7 9      
p>agraph 7#b7-- 7,a7 by /rik+ co/s4--,= 
purposes & ins]t+ 8co/s4--  7,a7 ,9     
g5]al ,subject to subp>agraph 7,b71 =   
purposes  2 &  7,b7 by add+ at ! end !  
foll[+ new subp>agraph3  7,b7 ,inclusion
 ( manufactur] disc\nts on applicable   
drugs ,= purposes ( apply+ subp>agraph  
7,a71 ! t]m all[able re9surance co/s    
%all include ! portion ( ! negotiat$    
price 7z def9$ 9 section                
#ahfj;,d-#ad;,b7g77#f77 ( an applicable 
drug 7z def9$ 9 section                 
#ahfj;,d-#ad;,b7g77#b77 t 0 paid by a   
manufactur] "u ! manufactur] disc\nt    
program "u section #ahfj;,d-#ad;,b4  2 &
  7#b7 9 p>agraph 7#c7-- 7,a7 9 ! fir/  
s5t5ce1 by /rik+ ,= purposes & ins]t+   
,subject to p>agraph 7#b77;,b71 =       
purposes2 &  7,b7 9 ! second s5t5ce1 by 
ins]t+ or1 9 ! case ( an applicable     

drug1 by a manufactur] aft] by !        
individual or "u ! plan4  7f7 ,updat+   
risk adju/m5t me?odologies ,to acc\nt = 
"p ,d mod]nization r$esign ,section     
#ahfj;,d-#ae7;c7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #aciew-#aae7;c77 is 
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#c7 ,updat+ risk adju/m5t   
me?odologies to acc\nt = "p ,d          
mod]nization r$esign ,! ,secret>y %all  
update ! risk adju/m5t me?odologies us$ 
to adju/ bid am\nts pursuant to ?is     
subsection z appropriate to take into   
acc\nt *anges 9 b5efits "u ?is "p       
pursuant to ! am5dm5ts made by section  
#aba ( ! ,l[]+ ,prescription ,drug      
,prices = ,am]ica's ,s5iors & ,families 
,act ( #bjbj4  4  7g7 ,con=m+ am5dm5ts  
7#a7 ,section #ahfj;,d-#b ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajb7 is am5d$-- 7,a7 9          
subsection 7a77#b77;,a77i77,i71 by /rik+
 1 or an increase 9 ! initial & ins]t+  
or = a ye> prec$+ #bjbb an increase 9 ! 
initial2  7,b7 9 subsection             

7c77#a77;,c7-- 7i7 9 ! subp>agraph      
head+1 by /rik+ at initial cov]age      
limit2 &  7ii7 by ins]t+ = a ye> prec$+ 
#bjbb or ! annual out-(-pocket ?re%old  
specifi$ 9 subsection 7b77#d77;,b7 = !  
ye> = #bjbb & ea* subsequ5t ye> aft]    
subsection 7b77#c7 = ! ye> ea* place x  
appe>s2  7,c7 9 subsection 7d77#a77;,a71
 by /rik+ or an initial & ins]t+ or = a 
ye> prec$+ #bjbb an initial4  7#b7      
,section #ahfj;,d-#d7;a77#d77;,b77i7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciew-#ajd7;a77#d77;,b77 is am5d$ by   
/rik+ ! initial & ins]t+ = a ye> prec$+ 
#bjbb1 ! initial4  7#c7 ,section        
#ahfj;,d-#ad7;a7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is 
am5d$-- 7,a7 9 p>agraph 7#a7-- 7i7 9    
subp>agraph 7,c71 by /rik+ ,!           
cont9uation & ins]t+ ,= a ye> prec$+    
#bjbb1 ! cont9uation2  7ii7 9           
subp>agraph 7,e71 by /rik+ ,! elim9ation
 & ins]t+ ,= a ye> prec$+ #bjbb1 !      
elim9ation2 &  7iii7 9 subp>agraph      
7,d77iii71 by /rik+                     

#ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+
 #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 & 
7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph
 7,c71 by /rik+ ,! cont9uation & ins]t+ 
,= a ye> prec$+ #bjbb1 ! cont9uation2 & 
7ii7 9 subp>agraph 7,e7-- 7,i7 by ins]t+
 = a ye> prec$+ #bjbb1 aft] subsection  
7c72 &  7,,ii7 by /rik+                 
#ahfj;,d-#b7;b77#d77;,a77i77,i7 & ins]t+
 #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74   
7#d7 ,section #ahfj;,d-#ba7;d77#g7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aca7;d77#g77 is am5d$ by /rik+  
section #ahfj;,d-#b7;b77,b77#d77;,b77i7 
& ins]t+ section                        
#ahfj;,d-#b7;b77,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$--    
7,a7 by /rik+ ! value ( any disc\nt &   
ins]t+ ! foll[+3 8! value (--  7i7 =    
ye>s prior to #bjbb1 any disc\nt  2     
7,b7 9 clause 7i71 z ins]t$ by          
subp>agraph 7,a7 ( ?is p>agraph1 by     
/rik+ ! p]iod at ! end & ins]t+ 2 &2 &  

7,c7 by add+ at ! end ! foll[+ new      
clause3  7ii7 = #bjbb & ea* subsequ5t   
ye>1 any disc\nt provid$ pursuant to    
section #ahfj;,d-#ad;,b4  4  7#f7       
,section #ahfj;,d-#da7;a77#f7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aea7;a77#f77 is am5d$-- 7,a7 by 
ins]t+ = a ye> be=e #bjbb aft]          
#ahfj;,d-#b7;b77#c72 &  7,b7 by ins]t+ =
 su* ye> be=e ! p]iod4  7#g7 ,section   
#ahfj;,d-#dc7;a77#a7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#aec7;a77#a77 is am5d$ to read z 
foll[s3  7#a7 p>ticipate 9-- 7,a7 =     
#bjaa ?r\gh #bjba1 ! ,m$ic>e cov]age gap
 disc\nt program "u section             
#ahfj;,d-#ad;,a2 &  7,b7 = #bjbb & ea*  
subsequ5t ye>1 ! manufactur] disc\nt    
program "u section #ahfj;,d-#ad;,b2  4  
7h7 ,effective date ,! am5dm5ts made by 
?is section %all apply to plan ye> #bjbb
 & subsequ5t plan ye>s4  #g4            
,sev]ability ,if any provision ( ?is    
,act1 an am5dm5t made by ?is ,act1 or ! 
application ( su* provision or am5dm5t  

to any p]son or circum/ance is held to  
be uncon/itutional1 ! rema9d] ( ?is     
,act1 ! am5dm5ts made by ?is ,act1 & !  
application ( ! provisions ( su* ,act or
 am5dm5ts to any p]son or circum/ance   
%all n be affect$4