,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #ceac  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #af1 #bjae  
,mr4 ,cumm+s 7= himself1 ,mr4 ,ellison1 
,ms4 ,norton1 & ,mr4 ,s>banes7 introduc$
 ! foll[+ bill2 :i* 0 ref]r$ to !       
,committee on ,en]gy & ,comm]ce1 & 9    
addition to ! ,committees on ,ways &    
,means & ! ,judici>y1 = 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 ensure great]   
af=dability ( prescription drugs4  #a4  
,%ort title2 table ( cont5ts  7a7 ,%ort 
title ,?is ,act may be cit$ z !         
,prescription ,drug ,af=dability ,act ( 
#bjae4  7b7 ,table ( cont5ts ,! table ( 
cont5ts = ?is ,act is z foll[s3  ,sec4  
#a4 ,%ort title2 table ( cont5ts4 ,title
 ,i--,drugs "u ! ,m$ic>e program ,sec4  
#aja4 ,negotiation ( l[] cov]$ "p ,d    
drug prices on behalf ( ,m$ic>e         
b5efici>ies4 ,sec4 #ajb4 ,accel]ation ( 
! clos+ ( ! ,m$ic>e ,"p ,d donut hole4  

,title ,,ii--,prescription drug         
importation ,sec4 #bja4 ,prescription   
drug importation4 ,sec4 #bjb4 ,s5se ( ! 
,h\se ( ,repres5tatives reg>d+ trade    
agreem5ts4 ,title ,,iii--,m$ic>e &      
,m$icaid rebates ,sec4 #cja4 ,requir+   
drug manufactur]s to provide drug       
rebates = drugs disp5s$ to l[-income    
individuals4 ,sec4 #cjb4 ,apply+ !      
,m$icaid additional rebate requirem5t to
 g5]ic drugs4 ,title ,,iv--,pay-=-delay 
block+ ,sec4 #dja4 ,pres]v+ access to   
af=dable g5]ics4 ,title ,v--,fraud ,sec4
 #eja4 ,conditions on aw>d ( drug       
exclusivity4 ,title ,,vi--,transp>5cy   
,sec4 #fja4 ,drug manufactur] report+4  
,i ,drugs "u ! ,m$ic>e program  #aja4   
,negotiation ( l[] cov]$ "p ,d drug     
prices on behalf ( ,m$ic>e b5efici>ies  
7a7 ,negotiation by ,secret>y ,section  
#ahfj;,d-#aa ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by 
/rik+ subsection 7i7 7relat+ to         
non9t]f]5ce7 & ins]t+ ! foll[+3  7i7    
,negotiation ( ,l[] ,drug ,prices  7#a7 

,9 g5]al ,not)/&+ any o!r provision (   
law1 ! ,secret>y %all negotiate )       
ph>maceutical manufactur]s ! prices     
7includ+ disc\nts1 rebates1 & o!r price 
concessions7 t may be *>g$ to ,,pdp     
sponsors & ,,ma organizations = cov]$ "p
 ,d drugs = "p ,d eligible individuals  
:o are enroll$ "u a prescription drug   
plan or "u an ,,ma-,,pd plan4  7#b7 ,no 
*ange 9 rules = =mul>ies  7,a7 ,9 g5]al 
,no?+ 9 p>agraph 7#a7 %all be con/ru$ to
 au?orize ! ,secret>y to e/abli% or     
require a p>ticul> =mul>y4  7,b7        
,con/ruction ,subp>agraph 7,a7 %all n be
 con/ru$ z affect+ ! ,secret>y's        
au?ority to ensure appropriate &        
adequate access to cov]$ "p ,d drugs "u 
prescription drug plans & "u ,,ma-,,pd  
plans1 includ+ compliance ( su* plans ) 
=mul>y requirem5ts "u section           
#ahfj;,d-#d7;b77#c74  7#c7 ,con/ruction 
,no?+ 9 ?is subsection %all be con/ru$ z
 prev5t+ ! sponsor ( a prescription drug
 plan1 or an organization (f]+ an       
,,ma-,,pd plan1 f obta9+ a disc\nt or   

r$uction ( ! price = a cov]$ "p ,d drug 
bel[ ! price negotiat$ "u p>agraph 7#a74
  4  7b7 ,effective date ,! am5dm5t made
 by subsection 7a7 %all take effect on !
 date ( ! enactm5t ( ?is ,act & %all    
fir/ apply to negotiations & prices =   
plan ye>s beg9n+ on ,janu>y #a1 #bjaf4  
#ajb4 ,accel]ation ( ! clos+ ( ! ,m$ic>e
 ,"p ,d donut hole  7a7 ,r$uction 9     
co9surance ,section #ahfj;,d-#b7;b77#b7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#ajb7;b77#b77 is       
am5d$-- 7#a7 9 ea* ( subclauses 7,,ii7 &
 7,,iii7 ( subp>agraph 7,c77ii71 by     
/rik+ #bjbj & ins]t+ #bjag2 &  7#b7 9   
subp>agraph 7,d77ii7-- 7,a7 9 subclause 
7,,ii71 by ins]t+ & at ! end2 &  7,b7 by
 /rik+ clauses 7,,iii7 ?r\gh 7,,vi7 &   
ins]t+ ! foll[+3  7,,iii7 #bjag is #ajj 
p]c5t4  4  7b7 ,increase 9 manufactur]  
rebate ,section                         
#ahfj;,d-#ad;,a7g77#d77;,a7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#aciew-#aad;a7g77#d77;,a77 is am5d$ by  
ins]t+ 7or1 = #bjag & subsequ5t ye>s1   

#ge p]c5t7 aft] #ej p]c5t4  ,,ii        
,prescription drug importation  #bja4   
,prescription drug importation  7a7     
,importation by ph>maci/s & :olesal]s   
,section #hjd7;b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#chd7;b77 is am5d$ by /rik+ ,!          
,secret>y1 & ins]t+ ,! ,secret>y1 n lat]
 ?an ,janu>y #a1 #bjaf14  7b7           
,importation by individuals  7#a7 ,9    
g5]al ,section #hjd ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#chd7 is am5d$-- 7,a7 9 subsection 7f71 
by /rik+ )9 ,canada2  7,b7 9 subsection 
7j7-- 7i7 9 p>agraph 7#a71 9 ! matt]    
prec$+ subp>agraph 7,a71 by ins]t+ f    
c\ntries o!r ?an ,canada aft] devices2 &
  7ii7 9 p>agraph 7#c7-- 7,i7 9 ! head+1
 by /rik+ f ,canada & ins]t+ f c\ntries 
o!r ?an ,canada2 &  7,,ii7 9 subp>agraph
 7,c71 by /rik+ f ,canada12 &  7,c7 by  
/rik+ subsection 7l7 & ins]t+ ! foll[+3 
7l7 ,importation ( prescription drugs f 
,canada ,individuals may import f       
,canada any prescription drug t meets ! 

requirem5ts ( subp>agraphs 7,a7 ?r\gh   
7,f7 ( subsection 7j77#c74  4  7#b7     
,regulations ,n lat] ?an ,janu>y #a1    
#bjaf1 ! ,secret>y ( ,heal? & ,human    
,s]vices %all promulgate regulations )  
respect to subsection 7l7 ( section #hjd
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #chd7 7z am5d$ by   
p>agraph 7#a77;,b774  7#c7 ,effective   
date ,! am5dm5ts made by p>agraph 7#a7  
%all take effect on ! effective date ( !
 f9al regulations promulgat$ 9          
accordance ) p>agraph 7#b74  7c7        
,,fdasia am5dm5t ,subsection 7c7 (      
section #gjh ( ! ,food & ,drug          
,adm9i/ration ,safety & ,innovation ,act
 7,public ,law #aab-add2 #abf ,/at4     
#ajfh7 is am5d$ by /rik+ ,! am5dm5t made
 by & all t foll[s ?r\gh ! p]iod at !   
end & ins]t+ ,! am5dm5t made by         
subsection 7a7 & ! regulations          
promulgat$ "u subsection 7b7 %all apply 
beg9n+ on ! effective date ( !          
regulations promulgat$ "u section       
#hjd7;b7 ( ! ,f$]al ,food1 ,drug1 &     

,cosmetic ,act 7#ba ,u4,s4,c4 #chd7;b77 
& ! am5dm5ts made by section #bja7;b7 ( 
! ,prescription ,drug ,af=dability ,act 
( #bjae44  #bjb4 ,s5se ( ! ,h\se (      
,repres5tatives reg>d+ trade agreem5ts  
,x is ! s5se ( ! ,h\se ( ,repres5tatives
 t ! ,unit$ ,/ates ,trade ,repres5tative
 %\ld n negotiate trade agreem5ts t w\ld
 raise ! prices ( prescription drugs 9 !
 ,unit$ ,/ates1 ext5d ! p]iods ( m>ket  
exclusivity o!rwise available =         
prescription drugs1 or remove           
flexibility 9 ,f$]al or ,/ate law reg>d+
 pric+ ( prescription drugs4  ,,iii     
,m$ic>e & ,m$icaid rebates  #cja4       
,requir+ drug manufactur]s to provide   
drug rebates = drugs disp5s$ to         
l[-income individuals  7a7 ,9 g5]al     
,section #ahfj;,d-#b ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajb7 is am5d$-- 7#a7 9          
subsection 7e77#a71 9 ! matt] prec$+    
subp>agraph 7,a71 by ins]t+ & subsection
 7f7 aft] ?is subsection2 &  7#b7 by    
add+ at ! end ! foll[+ new subsection3  

7f7 ,prescription drug rebate agreem5t =
 rebate eligible individuals  7#a7      
,requirem5t  7,a7 ,9 g5]al ,= plan ye>s 
beg9n+ on or aft] ,janu>y #a1 #bjag1 9  
?is "p1 ! t]m cov]$ "p ,d drug does n   
include any drug or biological product t
 is manufactur$ by a manufactur] t has n
 ent]$ into & h 9 effect a rebate       
agreem5t describ$ 9 p>agraph 7#b74  7,b7
 #bjaf plan ye> requirem5t ,any drug or 
biological product manufactur$ by a     
manufactur] t decl9es to ent] into a    
rebate agreem5t describ$ 9 p>agraph 7#b7
 = ! p]iod beg9n+ on ,janu>y #a1 #bjaf1 
& end+ on ,decemb] #ca1 #bjaf1 %all n be
 includ$ z a cov]$ "p ,d drug = !       
subsequ5t plan ye>4  7#b7 ,rebate       
agreem5t ,a rebate agreem5t "u ?is      
subsection %all require ! manufactur] to
 provide to ! ,secret>y a rebate = ea*  
rebate p]iod 7z def9$ 9 p>agraph        
7#f77;,b77 end+ aft] ,decemb] #ca1      
#bjae1 9 ! am\nt specifi$ 9 p>agraph    
7#c7 = any cov]$ "p ,d drug ( !         
manufactur] disp5s$ aft] ,decemb] #ca1  

#bjae1 to any rebate eligible individual
 7z def9$ 9 p>agraph 7#f77;,a77 = :i*   
paym5t 0 made by a ,,pdp sponsor or ,,ma
 organization "u ?is "p = su* p]iod1    
includ+ paym5ts pass$ ?r\gh ! l[-income 
& re9surance subsidies "u sections      
#ahfj;,d-#ad & #ahfj;,d-#ae7;b71        
respectively4 ,su* rebate %all be paid  
by ! manufactur] to ! ,secret>y n lat]  
?an #cj days aft] ! date ( receipt ( !  
in=mation describ$ 9 section            
#ahfj;,d-#ab7;b77#g71 includ+ z su*     
section is appli$ "u section            
#aheg7;f77#c71 or #cj days aft] !       
receipt ( in=mation "u subp>agraph 7,d7 
( p>agraph 7#c71 z det]m9$ by !         
,secret>y4 ,ins(> z n inconsi/5t ) ?is  
subsection1 ! ,secret>y %all e/abli%    
t]ms & conditions ( su* agreem5t relat+ 
to compliance1 p5alties1 & program      
evaluations1 inve/igations1 & audits t  
are simil> to ! t]ms & conditions =     
rebate agreem5ts "u p>agraphs 7#c7 &    
7#d7 ( section #aibg7;b74  7#c7 ,rebate 
= rebate eligible ,m$ic>e drug plan     

enrollees  7,a7 ,9 g5]al ,! am\nt ( !   
rebate specifi$ "u ?is p>agraph = a     
manufactur] = a rebate p]iod1 ) respect 
to ea* dosage =m & /r5g? ( any cov]$ "p 
,d drug provid$ by su* manufactur] &    
disp5s$ to a rebate eligible individual1
 %all be equal to ! product (--  7i7 !  
total numb] ( units ( su* dosage =m &   
/r5g? ( ! drug s provid$ & disp5s$ = :i*
 paym5t 0 made by a ,,pdp sponsor or an 
,,ma organization "u ?is "p = ! rebate  
p]iod1 includ+ paym5ts pass$ ?r\gh !    
l[-income & re9surance subsidies "u     
sections #ahfj;,d-#ad &                 
#ahfj;,d-#ae7;b71 respectively2 &  7ii7 
! am\nt 7if any7 by :i*-- 7,i7 !        
,m$icaid rebate am\nt 7z def9$ 9        
subp>agraph 7,b77 = su* =m1 /r5g?1 &    
p]iod1 exce$s  7,,ii7 ! av]age ,m$ic>e  
drug program rebate eligible rebate     
am\nt 7z def9$ 9 subp>agraph 7,c77 = su*
 =m1 /r5g?1 & p]iod4  7,b7 ,m$icaid     
rebate am\nt ,= purposes ( ?is p>agraph1
 ! t]m ,m$icaid rebate am\nt means1 )   
respect to ea* dosage =m & /r5g? ( a    

cov]$ "p ,d drug provid$ by !           
manufactur] = a rebate p]iod--  7i7 9 ! 
case ( a s+le s\rce drug or an innovator
 multiple s\rce drug1 ! am\nt specifi$ 9
 p>agraph 7#a77;,a77ii77,,ii7 or        
7#b77;,c7 ( section #aibg7;c7 plus !    
am\nt1 if any1 specifi$ 9 subp>agraph   
7,a77ii7 ( p>agraph 7#b7 ( su* section1 
= su* =m1 /r5g?1 & p]iod2 or  7ii7 9 !  
case ( any o!r cov]$ outpati5t drug1 !  
am\nt specifi$ 9 p>agraph 7#c77;,a77i7 (
 su* section = su* =m1 /r5g?1 & p]iod4  
7,c7 ,av]age ,m$ic>e drug program rebate
 eligible rebate am\nt ,= purposes ( ?is
 subsection1 ! t]m av]age ,m$ic>e drug  
program rebate eligible rebate am\nt    
means1 ) respect to ea* dosage =m &     
/r5g? ( a cov]$ "p ,d drug provid$ by a 
manufactur] = a rebate p]iod1 ! sum1 =  
all ,,pdp sponsors "u "p ,d & ,,ma      
organizations adm9i/]+ an ,,ma-,,pd plan
 "u "p ,c1 (--  7i7 ! product1 = ea* su*
 sponsor or organization1 (-- 7,i7 ! sum
 ( all rebates1 disc\nts1 or o!r price  
concessions 7n tak+ into acc\nt any     

rebate provid$ "u p>agraph 7#b7 or any  
disc\nts "u ! program "u section        
#ahfj;,d-#ad;,a7 = su* dosage =m & /r5g?
 ( ! drug disp5s$1 calculat$ on a       
p]-unit basis1 b only to ! ext5t t any  
su* rebate1 disc\nt1 or o!r price       
concession applies equally to drugs     
disp5s$ to rebate eligible ,m$ic>e drug 
plan enrollees & drugs disp5s$ to ,,pdp 
& ,,ma-,,pd enrollees :o are n rebate   
eligible individuals2 &  7,,ii7 ! numb] 
( ! units ( su* dosage & /r5g? ( ! drug 
disp5s$ dur+ ! rebate p]iod to rebate   
eligible individuals enroll$ 9 !        
prescription drug plans adm9i/]$ by !   
,,pdp sponsor or ! ,,ma-,,pd plans      
adm9i/]$ by ! ,,ma organization2 divid$ 
by  7ii7 ! total numb] ( units ( su*    
dosage & /r5g? ( ! drug disp5s$ dur+ !  
rebate p]iod to rebate eligible         
individuals enroll$ 9 all prescription  
drug plans adm9i/]$ by ,,pdp sponsors & 
all ,,ma-,,pd plans adm9i/]$ by ,,ma    
organizations4  7,d7 ,use ( e/imates ,! 
,secret>y may e/abli% a me?odology =    

e/imat+ ! av]age ,m$ic>e drug program   
rebate eligible rebate am\nts = ea*     
rebate p]iod bas$ on bid & utilization  
in=mation "u ?is "p & may use ^!        
e/imates z ! basis = det]m9+ ! rebates  
"u ?is section4 ,if ! ,secret>y elects  
to e/imate ! av]age ,m$ic>e drug program
 rebate eligible rebate am\nts1 !       
,secret>y %all e/abli% a reconciliation 
process = adju/+ manufactur] rebate     
paym5ts n lat] ?an #c mon?s aft] ! date 
t manufactur]s receive ! in=mation      
collect$ "u section                     
#ahfj;,d-#ab7;b77#g77;,b74  7#d7 ,l5g? (
 agreem5t ,! provisions ( p>agraph 7#d7 
( section #aibg7;b7 7o!r ?an clauses    
7iv7 & 7v7 ( subp>agraph 7,b77 %all     
apply to rebate agreem5ts "u ?is        
subsection 9 ! same mann] z su* p>agraph
 applies to a rebate agreem5t "u su*    
section4  7#e7 ,o!r t]ms & conditions ,!
 ,secret>y %all e/abli% o!r t]ms &      
conditions ( ! rebate agreem5t "u ?is   
subsection1 includ+ t]ms & conditions   
relat$ to compliance1 t are consi/5t )  

?is subsection4  7#f7 ,def9itions ,9 ?is
 subsection & section                   
#ahfj;,d-#ab7;b77#g73 7,a7 ,rebate      
eligible individual ,! t]m rebate       
eligible individual means--  7i7 a      
subsidy eligible individual 7z def9$ 9  
section #ahfj;,d-#ad7;a77#c77;,a772     
7ii7 a ,m$icaid b5efici>y treat$ z a    
subsidy eligible individual "u clause   
7v7 ( section #ahfj;,d-#ad7;a77#c77;,b72
 &  7iii7 any "p ,d eligible individual 
n describ$ 9 clause 7i7 or 7ii7 :o is   
det]m9$ = purposes ( ! ,/ate plan "u    
title ,,xix to be eligible = m$ical     
assi/ance "u clause 7i71 7iii71 or 7iv7 
( section #aijb7;a77#aj77;,e74  7,b7    
,rebate p]iod ,! t]m rebate p]iod has ! 
mean+ giv5 su* t]m 9 section            
#aibg7k77#h74  4  7b7 ,report+          
requirem5t = ! det]m9ation & paym5t (   
rebates by manufactur]s relat$ to rebate
 = rebate eligible ,m$ic>e drug plan    
enrollees  7#a7 ,requirem5ts = ,,pdp    
sponsors ,section #ahfj;,d-#ab7;b7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   

#aciew-#aab7;b77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#g7        
,report+ requirem5t = ! det]m9ation &   
paym5t ( rebates by manufactur]s relat$ 
to rebate = rebate eligible ,m$ic>e drug
 plan enrollees  7,a7 ,9 g5]al ,=       
purposes ( ! rebate "u section          
#ahfj;,d-#b7;f7 = contract ye>s beg9n+  
on or aft] ,janu>y #a1 #bjag1 ea*       
contract ent]$ into ) a ,,pdp sponsor "u
 ?is "p ) respect to a prescription drug
 plan %all require t ! sponsor comply ) 
subp>agraphs 7,b7 & 7,c74  7,b7 ,report 
=m & cont5ts ,n lat] ?an a date specifi$
 by ! ,secret>y1 a ,,pdp sponsor ( a    
prescription drug plan "u ?is "p %all   
report to ea* manufactur]--  7i7        
in=mation 7by ,national ,drug ,code     
numb]7 on ! total numb] ( units ( ea*   
dosage1 =m1 & /r5g? ( ea* drug ( su*    
manufactur] disp5s$ to rebate eligible  
,m$ic>e drug plan enrollees "u any      
prescription drug plan op]at$ by ! ,,pdp
 sponsor dur+ ! rebate p]iod2  7ii7     
in=mation on ! price disc\nts1 price    

concessions1 & rebates = su* drugs = su*
 =m1 /r5g?1 & p]iod2  7iii7 in=mation on
 ! ext5t to :i* su* price disc\nts1     
price concessions1 & rebates apply      
equally to rebate eligible ,m$ic>e drug 
plan enrollees & ,,pdp enrollees :o are 
n rebate eligible ,m$ic>e drug plan     
enrollees2 &  7iv7 any additional       
in=mation t ! ,secret>y det]m9es is     
necess>y to enable ! ,secret>y to       
calculate ! av]age ,m$ic>e drug program 
rebate eligible rebate am\nt 7z def9$ 9 
p>agraph 7#c77;,c7 ( su* section71 & to 
det]m9e ! am\nt ( ! rebate requir$ "u   
?is section1 = su* =m1 /r5g?1 & p]iod4  
,su* report %all be 9 a =m consi/5t ) a 
/&>d report+ =mat e/abli%$ by !         
,secret>y4  7,c7 ,submission to         
,secret>y ,ea* ,,pdp sponsor %all       
promptly transmit a copy ( ! in=mation  
report$ "u subp>agraph 7,b7 to !        
,secret>y = ! purpose ( audit ov]sight &
 evaluation4  7,d7 ,confid5tiality (    
in=mation ,! provisions ( subp>agraph   
7,d7 ( section #aibg7;b77#c71 relat+ to 

confid5tiality ( in=mation1 %all apply  
to in=mation report$ by ,,pdp sponsors  
"u ?is p>agraph 9 ! same mann] t su*    
provisions apply to in=mation disclos$  
by manufactur]s or :olesal]s "u su*     
section1 except--  7i7 t any ref]5ce to 
?is section 9 clause 7i7 ( su*          
subp>agraph %all be treat$ z be+ a      
ref]5ce to ?is section2  7ii7 ! ref]5ce 
to ! ,director ( ! ,congressional       
,budget ,(fice 9 clause 7iii7 ( su*     
subp>agraph %all be treat$ z includ+ a  
ref]5ce to ! ,m$ic>e ,paym5t ,advisory  
,commission2 &  7iii7 clause 7iv7 ( su* 
subp>agraph %all n apply4  7,e7         
,ov]sight ,in=mation report$ "u ?is     
p>agraph may be us$ by ! ,inspector     
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices = ! /atutorily au?oriz$        
purposes ( audit1 inve/igation1 &       
evaluations4  7,f7 ,p5alties = failure  
to provide timely in=mation & provision 
( false in=mation ,9 ! case ( a ,,pdp   
sponsor-- 7i7 t fails to provide        
in=mation requir$ "u subp>agraph 7,b7 on

 a timely basis1 ! sponsor is subject to
 a civil money p5alty 9 ! am\nt (       
#aj1jjj = ea* day 9 :i* su* in=mation   
has n be5 provid$2 or  7ii7 t kn[+ly 7z 
def9$ 9 section #aabh;,a7i77 provides   
false in=mation "u su* subp>agraph1 !   
sponsor is subject to a civil money     
p5alty 9 an am\nt n to exce$ #ajj1jjj = 
ea* item ( false in=mation4  ,su* civil 
money p5alties are 9 addition to o!r    
p5alties z may be prescrib$ by law4 ,!  
provisions ( section #aabh;,a 7o!r ?an  
subsections 7a7 & 7b77 %all apply to a  
civil money p5alty "u ?is subp>agraph 9 
! same mann] z su* provisions apply to a
 p5alty or proce$+ "u section           
#aabh;,a7a74  4  7#b7 ,application to   
,,ma organizations ,section             
#aheg7;f77#c7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is  
am5d$ by add+ at ! end ! foll[+3  7,d7  
,report+ requirem5t relat$ to rebate =  
rebate eligible ,m$ic>e drug plan       
enrollees ,section #ahfj;,d-#ab7;b77#g74
  4  7c7 ,deposit ( rebates into ,m$ic>e

 ,prescription ,drug ,acc\nt ,section   
#ahfj;,d-#af7;c7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #aciew-#aaf7;c77 is 
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#f7 ,rebate = rebate        
eligible ,m$ic>e drug plan enrollees    
,am\nts paid "u a rebate agreem5t "u    
section #ahfj;,d-#b7;f7 %all be deposit$
 into ! ,acc\nt4  4  7d7 ,exclusion f   
det]m9ation ( be/ price & av]age        
manufactur] price "u ,m$icaid  7#a7     
,exclusion f be/ price det]m9ation      
,section #aibg7;c77#a77;,c77ii77,i7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acifr-#h7;c77#a77;,c77ii77,i77 is am5d$
 by ins]t+ & am\nts paid "u a rebate    
agreem5t "u section #ahfj;,d-#b7;f7 aft]
 ?is section4  7#b7 ,exclusion f av]age 
manufactur] price det]m9ation ,section  
#aibg7k77#a77;,b77i7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7k77#a77;,b77i77 is am5d$--    
7,a7 9 subclause 7,,iv71 by /rik+ & aft]
 ! semicolon2  7,b7 9 subclause 7,v71 by
 /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 

7,c7 by add+ at ! end ! foll[+3  7,,vi7 
am\nts paid "u a rebate agreem5t "u     
section #ahfj;,d-#b7;f74  4  #cjb4      
,apply+ ! ,m$icaid additional rebate    
requirem5t to g5]ic drugs  7a7 ,9 g5]al 
,section #aibg7;c77#c7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;c77#c77 is am5d$--  7#a7 9   
subp>agraph 7,a71 by /rik+ ,! am\nt &   
ins]t+ ,except z provid$ 9 subp>agraph  
7,c71 ! am\nt2 &  7#b7 by add+ at ! end 
! foll[+ new subp>agraph3  7,c7         
,additional rebate  7i7 ,9 g5]al ,!     
am\nt ( ! rebate specifi$ 9 ?is p>agraph
 = a rebate p]iod1 ) respect to ea*     
dosage =m & /r5g? ( a cov]$ outpati5t   
drug o!r ?an a s+le s\rce drug or an    
innovator multiple s\rce drug1 %all be  
increas$ 9 ! mann] t ! rebate = a dosage
 =m & /r5g? ( a s+le s\rce drug or an   
innovator multiple s\rce drug is        
increas$ "u subp>agraphs 7,a7 & 7,d7 (  
p>agraph 7#b71 except z provid$ 9 clause
 7ii74  7ii7 ,special rules =           
application ( provision ,9 apply+       

subp>agraphs 7,a7 & 7,d7 ( p>agraph 7#b7
 "u clause 7i7-- 7,i7 ! ref]5ce 9       
subp>agraph 7,a77i7 ( su* p>agraph to   
#aiij %all be deem$ a ref]5ce to #bjad2 
7,,ii7 subject to clause 7iii71 !       
ref]5ce 9 subp>agraph 7,a77ii7 ( su*    
p>agraph to cal5d> qu>t] beg9n+ ,july   
#a1 #aiij %all be deem$ a ref]5ce to !  
cal5d> qu>t] 9 :i* ! av]age manufactur] 
price = ! drug is ! l[e/ dur+ !         
#ab-;cal5d> qu>t] p]iod end+ on         
,septemb] #cj1 #bjad2  7,,iii7 subject  
to clause 7iii71 ! ref]5ce 9 subp>agraph
 7,a77ii7 ( su* p>agraph to ,septemb]   
#aiij %all be deem$ a ref]5ce to ! la/  
mon? ( su* cal5d> qu>t]2  7,,iv7 !      
ref]5ces 9 subp>agraph 7,d7 ( su*       
p>agraph to p>agraph 7#a77;,a77ii71 ?is 
p>agraph1 & ,decemb] #ca1 #bjji %all be 
deem$ ref]5ces to subp>agraph 7,a71 ?is 
subp>agraph1 & ,decemb] #ca1 #bjad1     
respectively2 &  7,v7 any ref]5ce 9 su* 
p>agraph to a s+le s\rce drug or an     
innovator multiple s\rce drug %all be   
deem$ to be a ref]5ce to a drug to :i*  

clause 7i7 applies4  7iii7 ,special rule
 = c]ta9 non9novator multiple s\rce     
drugs ,9 apply+ p>agraph                
7#b77;,a77ii77,,ii7 "u clause 7i7 )     
respect to a cov]$ outpati5t drug t is  
fir/ sold z a drug o!r ?an a s+le s\rce 
drug or an innovator multiple s\rce drug
 aft] ! date t is #c ye>s be=e ! date ( 
! enactm5t ( ?is subp>agraph1 su*       
p>agraph %all be appli$--  7,i7 by      
sub/itut+ ! applicable qu>t] = ! cal5d> 
qu>t] beg9n+ ,july #a1 #aiij2 &  7,,ii7 
by sub/itut+ ! la/ mon? 9 su* applicable
 qu>t] = ,septemb] #aiij4  7iv7         
,applicable qu>t] def9$ ,9 ?is          
subsection1 ! t]m applicable qu>t]      
means1 ) respect to a drug describ$ 9   
clause 7iii71 ! fif? full cal5d> qu>t] 9
 :i* ! drug is sold z a drug o!r ?an a  
s+le s\rce drug or an innovator multiple
 s\rce drug4  4  7b7 ,effective date ,! 
am5dm5ts made by subsection 7a7 %all    
apply to rebate p]iods beg9n+ aft]      
,decemb] #ca1 #bjad4  ,,iv ,pay-=-delay 
block+  #dja4 ,pres]v+ access to        

af=dable g5]ics ,! ,f$]al ,trade        
,commission ,act 7#ae ,u4,s4,c4 #dd et  
seq47 is am5d$ 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 
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 product4  7#b7            
,presumption & violation ,9 su* a       
proce$+1 an agreem5t %all be presum$ to 
h anticompetitive effects & be a        
violation ( ?is section if--  7,a7 an   
,,&a fil] receives any?+ ( value1       
includ+ an exclusive lic5se2 &  7,b7 !  
,,&a fil] agrees to limit or =ego       
rese>*1 developm5t1 manufactur+1 m>ket+1
 or sales ( ! ,,&a product = any p]iod (
 "t4  7b7 ,exclusions ,no?+ 9 ?is       
section %all prohibit a resolution or   
settlem5t ( a pat5t infr+em5t claim 9   
:i* ! consid]ation grant$ by ! ,,nda    

hold] to ! ,,&a fil] z "p ( ! resolution
 or settlem5t includes only "o or m ( ! 
foll[+3  7#a7 ,! "r to m>ket ! ,,&a     
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*
 drug4  7#b7 ,a paym5t = reasonable     
litigation exp5ses n to exce$           
#g1ejj1jjj4  7#c7 ,a cov5ant n to sue on
 any claim t ! ,,&a product infr+es a   
,unit$ ,/ates pat5t4  7c7 ,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$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#b774  7#d7 ,,&a fil] ,! t]m   
,,&a fil] means a p>ty t owns or        
controls an ,,&a fil$ ) ! ,commission ( 
,food & ,drugs 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 ,drug     
product ,! t]m drug product has ! mean+ 
giv5 su* t]m 9 section #cad4c7;b7 (     
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulation74  7#g7    
,,nda ,! t]m ,,nda means a new drug     
application fil$ "u section #eje7;b7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7;b774  7#h7 ,,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#i7 ,p>ty ,! t]m p>ty means 
any p]son1 p>tn]%ip1 corporation1 or o!r
 legal entity4  7#aj7 ,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#aa7 ,pat5t infr+em5t claim ,! t]m     
pat5t infr+em5t claim means any         
allegation made to an ,,&a fil]1 :e!r or
 n includ$ 9 a compla9t fil$ ) a c\rt ( 
law1 t its ,,&a or ,,&a product may     
infr+e any pat5t held by1 or exclusively
 lic5s$ to1 ! ,,nda hold] ( ! drug      
product4  7#ab7 ,/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;a74  4  ,v ,fraud  #eja4  
,conditions on aw>d ( drug exclusivity  
,sub*apt] ,e ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by 
add+ at ! end ! foll[+3  #efi;,d4       
,conditions on aw>d ( drug exclusivity  
7a7 ,t]m9ation ( exclusivity ,not)/&+   

any o!r provision ( ?is ,act1 any p]iod 
( exclusivity describ$ 9 subsection 7b7 
grant$ to a p]son or assign$ to a p]son 
on or aft] ! date ( enactm5t ( ?is      
section ) respect to a drug %all be     
t]m9at$ if ! p]son to :i* su*           
exclusivity 0 grant$ or any p]son to :i*
 su* exclusivity is assign$--  7#a7     
commits a violation describ$ 9          
subsection 7c77#a7 ) respect to su*     
drug2 or  7#b7 fails to report su* a    
violation z requir$ by subsection 7e74  
7b7 ,exclusivities affect$ ,! p]iods (  
exclusivity describ$ 9 ?is subsection   
are ^? p]iods ( exclusivity grant$ "u   
any ( ! foll[+ sections3  7#a7 ,clause  
7ii71 7iii71 or 7iv7 ( section          
#eje7;c77#c77;,e74  7#b7 ,clause 7iv7 ( 
section #eje7;j77#e77;,b74  7#c7 ,clause
 7ii71 7iii71 or 7iv7 ( section         
#eje7;j77#e77;,f74  7#d7 ,section       
#eje;,a4  7#e7 ,section #eje;,e4  7#f7  
,section #ebg4  7#g7 ,section           
#cea7k77#g7 ( ! ,public ,heal? ,s]vice  
,act4  7#h7 ,any o!r provision ( ?is    

,act t provides = m>ket exclusivity 7or 
ext5sion ( m>ket exclusivity7 ) respect 
to a drug4  7c7 ,violations  7#a7 ,9    
g5]al ,a violation describ$ 9 ?is       
subsection is a violation ( a law       
describ$ 9 p>agraph 7#b7 t results 9--  
7,a7 a crim9al conviction ( a p]son     
describ$ 9 subsection 7a72  7,b7 a civil
 judgm5t aga9/ a p]son describ$ 9       
subsection 7a72 or  7,c7 a settlem5t    
agreem5t 9 :i* a p]son describ$ 9       
subsection 7a7 admits to fault4  7#b7   
,laws describ$ ,! laws describ$ 9 ?is   
p>agraph are ! foll[+3  7,a7 ,!         
provisions ( ?is ,act t prohibit-- 7i7 !
 adult]ation or misbr&+ ( a drug2  7ii7 
! mak+ ( false /atem5ts to ! ,secret>y  
or committ+ fraud2 or  7iii7 ! illegal  
m>ket+ ( a drug4  7,b7 ,! provisions (  
sub*apt] ,,iii ( *apt] #cg ( title #ca1 
,unit$ ,/ates ,code 7commonly kn[n z !  
,false ,claims ,act74  7,c7 ,section    
#bhg ( title #ah1 ,unit$ ,/ates ,code4  
7,d7 ,! ,m$ic>e & ,m$icaid ,pati5t      
,protection & ,program ,act ( #aihg     

7commonly kn[n z ! ,antikickback        
,/atute74  7,e7 ,section #aibg ( !      
,social ,security ,act4  7,f7 ,a ,/ate  
law aga9/ fraud comp>able to a law      
describ$ 9 subp>agraphs 7,a7 ?r\gh 7,e74
  7d7 ,date ( exclusivity t]m9ation ,!  
date on :i* ! exclusivity %all be       
t]m9at$ z describ$ 9 subsection 7a7 is !
 date on :i*1 z applicable--  7#a7 a    
f9al judgm5t is ent]$ relat+ to a       
violation describ$ 9 subp>agraph 7,a7 or
 7,b7 ( subsection 7c77#a72 or  7#b7    
7,a7 a settlem5t agreem5t describ$ 9    
subsection 7c77#a77;,c7 is approv$ by a 
c\rt ord] t is or becomes f9al &        
nonappealable2 or  7,b7 if !re is no    
c\rt ord] approv+ a settlem5t agreem5t  
describ$ 9 subsection 7c77#a77;,c71 a   
c\rt ord] dismiss+ ! applicable case1   
issu$ aft] ! settlem5t agreem5t1 is or  
becomes f9al & nonappealable4  7e7      
,report+ ( in=mation ,a p]son describ$ 9
 subsection 7a7 t commits a violation   
describ$ 9 subsection 7c77#a7 %all      
report su* violation to ! ,secret>y no  

lat] ?an #cj days aft] ! date t--  7#a7 
a f9al judgm5t is ent]$ relat+ to a     
violation describ$ 9 subp>agraph 7,a7 or
 7,b7 ( subsection 7c77#a72 or  7#b7    
7,a7 a settlem5t agreem5t describ$ 9    
subsection 7c77#a77;,c7 is approv$ by a 
c\rt ord] t is or becomes f9al &        
nonappealable2 or  7,b7 if !re is no    
c\rt ord] approv+ a settlem5t agreem5t  
describ$ 9 subsection 7c77#a77;,c71 a   
c\rt ord] dismiss+ ! applicable case1   
issu$ aft] ! settlem5t agreem5t1 is or  
becomes f9al & nonappealable4  4  ,,vi  
,transp>5cy  #fja4 ,drug manufactur]    
report+  7a7 ,report+ on dome/ic sales  
,! manufactur] ( a drug approv$ "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 #bfb7 %all submit to
 ! ,secret>y ( ,heal? & ,human ,s]vices 
& to ,congress an annual report1 :i*    
%all be made publicly available1 outl9+ 
) respect to ea* su* drug1 dur+ !       
previ\s cal5d> ye>--  7#a7 ! total      

exp5ditures ( ! manufactur] on-- 7,a7   
drug rese>* & developm5t2  7,b7 cl9ical 
trials2  7,c7 mat]ials & manufactur+2   
7,d7 acquisition co/s1 includ+ co/s = ! 
pur*ase ( pat5ts & lic5s+2 &  7,e7      
m>ket+ & adv]tis+ = ! promotion ( ! drug
 to consum]s & prescrib]s2  7#b7 ! total
 pr(it to ! manufactur] attributable to 
su* drug2  7#c7 ! total am\nt ( f9ancial
 assi/ance ! manufactur] has provid$    
?r\gh pati5t prescription assi/ance     
programs ) respect to su* drug1 if any2 
7#d7 any ,f$]al b5efits receiv$ by !    
manufactur]1 includ+ tax cr$its1 grants 
f ! ,national ,in/itutes ( ,heal?1 & o!r
 ,f$]al b5efits ) respect to su* drug2 &
  7#e7 any additional in=mation !       
manufactur] *ooses to provide relat$ to 
drug pric+ decisions1 su* z total       
exp5ditures on drug rese>* & developm5t 
or cl9ical trials on drugs t fail$ to   
receive approval by ! ,food & ,drug     
,adm9i/ration4  7b7 ,report+ on =eign   
sales ,9 ! case ( a manufactur] ( a drug
 t sells su* drug to ! ,f$]al ,gov]nm5t1

 includ+ ?r\gh ! heal? programs ( !     
,dep>tm5t ( ,vet]ans ,affairs1 !        
,dep>tm5t ( ,def5se1 & ! ,indian ,heal? 
,s]vice & ?r\gh ! ,m$ic>e program "u    
title ,,xviii ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie et seq471 or t has
 ent]$ into an agreem5t "u section      
#cdj;,b ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bef;b71 ! manufactur]   
%all include 9 ! report submitt$ "u     
subsection 7a7 in=mation ab\t ! price ( 
! drug1 & pr(its f & volume ( sales ( ! 
drug1 9 ea* =eign c\ntry 9 :i* ! drug is
 sold1 z applicable4