,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dfai  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #h1 #bjai,ms4 
,s*ak[sky 7= h]self1 ,mr4 ,higg9s ( ,new
 ,york1 & ,ms4 ,wild7 introduc$ ! foll[+
 bill2 :i* 0 ref]r$ to ! ,committee on  
,en]gy & ,comm]ce1 & 9 addition to !    
,committee on ,ways & ,means1 = 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 am5d  
title ,,xviii ( ! ,social ,security ,act
 to require drug manufactur]s to pay a  
,m$ic>e "p ,d rebate = c]ta9 drugs if ! 
price ( su* drugs increases fa/] ?an    
inflation4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,ph>maceutical ,rebates 
= ,excessive ,pric+ ,above ,inflation   
,act or ! ,ph>maceutical ,,repai ,act4  
#b4 ,m$ic>e "p ,d prescription drug     
inflation rebate by manufactur]s ,"p ,d 
( title ,,xviii ( ! ,social ,security   
,act is am5d$ by ins]t+ aft] section    
#ahfj;,d-#ad;,a 7#db ,u4,s4,c4          

#aciew-#aad;a7 ! foll[+ new section3    
#ahfj;,d-#ad;,b4 ,manufactur] rebate =  
c]ta9 drugs ) prices increas+ fa/] ?an  
inflation  7a7 ,9 g5]al ,subject to !   
provisions ( ?is section1 9 ord] =      
cov]age to be available "u ?is "p = a "p
 ,d rebatable drug ( a manufactur]      
disp5s$ dur+ an applicable ye>1 !       
manufactur] mu/ h ent]$ into & h 9      
effect an agreem5t describ$ 9 subsection
 7b74 ,= purposes ( ?is section ! t]m   
applicable ye> means a ye> beg9n+ )     
#bjbb4  7b7 ,agreem5ts  7#a7 ,t]ms (    
agreem5t ,an agreem5t describ$ 9 ?is    
subsection1 ) respect to a manufactur] (
 a "p ,d rebatable drug1 is an agreem5t 
"u :i* ! foll[+ applies3  7,a7          
,secret>ial provision ( in=mation ,n    
lat] ?an #i mon?s aft] ! end ( ea*      
applicable ye> ) respect to :i* !       
agreem5t is 9 effect1 ! ,secret>y1 = !  
"p ,d rebatable drug ( ! manufactur]1   
reports to ! manufactur] ! foll[+ = su* 
ye>3  7i7 ,in=mation on ! total units 7z
 def9$ 9 subsection 7g77#b77 disp5s$ =  

ea* dosage =m & /r5g? ) respect to su*  
"p ,d rebatable drug & ye>4  7ii7       
,in=mation on ! am\nt 7if any7 ( !      
excess av]age manufactur] price increase
 describ$ 9 subsection 7c77#a77;,b7 =   
ea* dosage =m & /r5g? ) respect to su*  
drug & ye>4  7iii7 ,! rebate am\nt      
specifi$ "u subsection 7c7 = ea* dosage 
=m & /r5g? ) respect to su* drug & ye>4 
7,b7 ,manufactur] requirem5ts ,= ea*    
applicable ye> ) respect to :i* !       
agreem5t is 9 effect1 ! manufactur] ( ! 
"p ,d rebatable drug1 = ea* dosage =m & 
/r5g? ) respect to su* drug1 n lat] ?an 
#cj days aft] ! date ( receipt f !      
,secret>y ( ! in=mation describ$ 9      
subp>agraph 7,a7 = su* ye>1 provides to 
! ,secret>y a rebate t is equal to !    
am\nt specifi$ 9 subsection 7c7 = su*   
dosage =m & /r5g? ) respect to su* drug 
= su* ye>4  7#b7 ,l5g? ( agreem5t  7,a7 
,9 g5]al ,an agreem5t "u ?is section1 ) 
respect to a "p ,d rebatable drug1 %all 
be effective = an initial p]iod ( n less
 ?an "o ye> & %all be automatically     

r5ew$ = a p]iod ( n less ?an "o ye>     
unless t]m9at$ "u subp>agraph 7,b74     
7,b7 ,t]m9ation  7i7 ,by ,secret>y ,!   
,secret>y may provide = t]m9ation ( an  
agreem5t "u ?is section = violation ( ! 
requirem5ts ( ! agreem5t or o!r good    
cause %[n4 ,su* t]m9ation %all n be     
effective e>li] ?an #fj days aft] ! date
 ( notice ( su* t]m9ation4 ,! ,secret>y 
%all provide1 ^u reque/1 a manufactur] )
 a he>+ conc]n+ su* a t]m9ation1 b su*  
he>+ %all n delay ! effective date ( !  
t]m9ation4  7ii7 ,by a manufactur] ,a   
manufactur] may t]m9ate an agreem5t "u  
?is section = any reason4 ,any su*      
t]m9ation %all n be effective until !   
ye> beg9n+ at lea/ #fj days aft] ! date 
! manufactur] provides notice to !      
,secret>y4  7,c7 ,effectiv5ess (        
t]m9ation ,any t]m9ation "u ?is p>agraph
 %all n affect rebates due "u ! agreem5t
 "u ?is section be=e ! effective date ( 
its t]m9ation4  7,d7 ,delay be=e re5try 
,9 ! case ( any agreem5t "u ?is section 
) a manufactur] :i* is t]m9at$ 9 a plan 

ye>1 ano!r su* agreem5t ) ! manufactur] 
7or a successor manufactur]7 may n be   
ent]$ into be=e ! subsequ5t plan ye>1   
unless ! ,secret>y f9ds good cause = an 
e>li] re9/atem5t ( su* an agreem5t4     
7#c7 ,in=mation ,= purposes ( c>ry+ out 
?is section1 ! ,secret>y %all use       
in=mation submitt$ by manufactur]s "u   
section #aibg7;b77#c74  7c7 ,rebate     
am\nt  7#a7 ,9 g5]al ,= purposes ( ?is  
section1 ! am\nt specifi$ 9 ?is         
subsection = a dosage =m & /r5g? )      
respect to a "p ,d rebatable drug &     
applicable ye> is1 subject to           
subp>agraphs 7,b7 & 7,c7 ( p>agraph     
7#c71 ! am\nt equal to ! product (--    
7,a7 ! total av]age numb] ( units       
weight$ by1 & disp5s$ =1 su* dosage =m &
 /r5g? ) respect to su* "p ,d rebatable 
drug & ye>2 &  7,b7 ! am\nt 7if any7 by 
:i*-- 7i7 ! av]age manufactur] price 7z 
def9$ 9 subsection 7g77 paid = su*      
dosage =m & /r5g? ) respect to su* "p ,d
 rebatable drug dur+ ! ye>2 exce$s  7ii7
 ! inflation-adju/$ paym5t am\nt det]m9$

 "u p>agraph 7#b7 = su* dosage =m &     
/r5g? ) respect to su* "p ,d rebatable  
drug dur+ ! ye>4  7#b7 ,det]m9ation (   
inflation-adju/$ paym5t am\nt ,!        
inflation-adju/$ paym5t am\nt det]m9$ "u
 ?is p>agraph = a dosage =m & /r5g? )   
respect to a "p ,d rebatable drug = an  
applicable ye>1 subject to subp>agraphs 
7,a7 & 7,d7 ( p>agraph 7#c71 is--  7,a7 
! av]age manufactur] price paid = su*   
dosage =m & /r5g? ) respect to su* drug 
9 ! paym5t am\nt b5*m>k ye> 7z def9$ 9  
subsection 7g77#c772 increas$ by  7,b7 !
 p]c5tage by :i* ! rebate p]iod ,,cpi-,u
 7z def9$ 9 subsection 7g77#e77 = !     
applicable ye> exce$s ! b5*m>k p]iod    
,,cpi-,u 7z def9$ 9 subsection 7g77#d774
  7#c7 ,special treatm5t ( c]ta9 drugs &
 exemption  7,a7 ,subsequ5tly approv$   
drugs ,9 ! case ( a "p ,d rebatable drug
 fir/ approv$ by ! ,food & ,drug        
,adm9i/ration aft] ,janu>y #a1 #bjaf1   
subp>agraph 7,a7 ( p>agraph 7#b7 %all be
 appli$ z if ! t]m paym5t am\nt b5*m>k  
ye> 7 def9$ "u subsection 7g77#c7 z !   

fir/ ye> beg9n+ aft] ! day on :i* ! drug
 0 fir/ m>ket$ & subp>agraph 7,b7 (     
p>agraph 7#b7 %all be appli$ z if ! t]m 
b5*m>k p]iod ,,cpi-,u 7 def9$ "u        
subsection 7g77#d7 z if ! ref]5ce to    
,janu>y #bjaf "u su* subsection 7 a     
ref]5ce to ,janu>y ( ! fir/ ye> beg9n+  
aft] ! date on :i* ! drug 0 fir/ m>ket$ 
by any manufactur]4  7,b7 ,exemption =  
%ortages ,! ,secret>y may r$uce or waive
 ! rebate "u p>agraph 7#a7 ) respect to 
a "p ,d rebatable drug 9 ! case ( a     
%ortage ( su* drug or o!r exig5t        
circum/ances1 z det]m9$ by ! ,secret>y4 
7,c7 ,treatm5t ( new =mulations  7i7 ,9 
g5]al ,9 ! case ( a "p ,d rebatable drug
 t is a l9e ext5sion ( a s+le s\rce drug
 or an innovator multiple s\rce drug t  
is an oral solid dosage =m1 ! ,secret>y 
%all e/abli% a =mula = det]m9+ ! am\nt  
specifi$ 9 ?is subsection ) respect to  
su* "p ,d rebatable drug & an applicable
 ye> ) consid]ation ( ! s+le s\rce drug 
or an innovator multiple s\rce drug4    
7ii7 ,l9e ext5sion def9$ ,9 ?is         

subp>agraph1 ! t]m l9e ext5sion means1 )
 respect to a "p ,d rebatable drug1 a   
new =mulation ( ! drug 7z det]m9$ by !  
,secret>y71 su* z an ext5d$ release     
=mulation1 b does n include an          
abuse-det]r5t =mulation ( ! drug 7z     
det]m9$ by ! ,secret>y71 reg>dless (    
:e!r su* abuse-det]r5t =mulation is an  
ext5d$ release =mulation4  7d7 ,rebate  
deposits ,am\nts paid z rebates "u      
subsection 7c7 %all be deposit$ into !  
,m$ic>e ,prescription ,drug ,acc\nt 9 ! 
,f$]al ,supplem5t>y ,m$ical ,insurance  
,tru/ ,fund e/abli%$ "u section #ahda4  
7e7 ,civil money p5alty ,9 ! case ( a   
manufactur] ( a "p ,d rebatable drug )  
an agreem5t 9 effect "u ?is section :o  
has fail$ to comply ) ! t]ms ( !        
agreem5t "u subsection 7b77#a77;,b7 )   
respect to su* drug = an applicable ye>1
 ! ,secret>y may impose a civil money   
p5alty on su* manufactur] 9 an am\nt    
equal to #abe p]c5t ( ! am\nt specifi$ 9
 subsection 7c7 = su* drug = su* ye>4 ,!
 provisions ( section #aabh;,a 7o!r ?an 

subsections 7a7 7) respect to am\nts (  
p5alties or additional assessm5ts7 &    
7b77 %all apply to a civil money p5alty 
"u ?is subsection 9 ! same mann] z su*  
provisions apply to a p5alty or proce$+ 
"u section #aabh;,a7a74  7f7 ,judicial  
review ,!re %all be no judicial review (
 ! foll[+3 7#a7 ,! det]m9ation ( units  
"u ?is section4  7#b7 ,! det]m9ation (  
:e!r a drug is a "p ,d rebatable drug "u
 ?is section4  7#c7 ,! calculation ( !  
rebate am\nt "u ?is section4  7g7       
,def9itions ,9 ?is section3 7#a7 ,"p ,d 
rebatable drug def9$  7,a7 ,9 g5]al ,!  
t]m "p ,d rebatable drug means a drug or
 biological t w\ld 7)\t application (   
?is section7 be a cov]$ "p ,d drug1     
except su* t]m %all1 ) respect to an    
applicable ye>1 n include su* a drug or 
biological if ! av]age total co/ "u a   
prescription drug plan "u ?is "p or     
,,ma-,,pd plan "u "p ,c = su* ye> p]    
individual :o uses su* a drug or        
biological1 z det]m9$ by ! ,secret>y1   
are less ?an1 subject to subp>agraph    

7,b71 #ajj1 z det]m9$ by ! ,secret>y us+
 ! mo/ rec5t data available or1 if data 
is n available1 z e/imat$ by !          
,secret>y4  7,b7 ,increase ,! doll>     
am\nt appli$ "u subp>agraph 7,a7-- 7i7 =
 #bjbc1 %all be ! doll> am\nt specifi$  
"u su* subp>agraph = #bjbb1 increas$ by 
! p]c5tage increase 9 ! consum] price   
index = all urban consum]s 7,unit$      
,/ates city av]age7 z ( ,janu>y ( #bjbb2
 &  7ii7 = a subsequ5t ye>1 %all be !   
doll> am\nt specifi$ 9 ?is subp>agraph  
7or subp>agraph 7,a77 = ! previ\s ye>1  
increas$ by ! p]c5tage increase 9 !     
consum] price index = all urban consum]s
 7,unit$ ,/ates city av]age7 z ( ,janu>y
 ( ! previ\s ye>4  ,any doll> am\nt     
specifi$ "u ?is subp>agraph t is n a    
multiple ( #aj %all be r\nd$ to ! ne>e/ 
multiple ( #aj4  7#b7 ,unit def9$ ,! t]m
 unit means1 ) respect to a "p ,d       
rebatable drug1 ! l[e/ id5tifiable      
quantity 7su* z a capsule or tablet1    
milligram ( molecules1 or grams7 ( ! "p 
,d rebatable drug t is disp5s$ to       

individuals enroll$ "u a prescription   
drug plan "u ?is "p or an ,,ma-,,pd plan
 "u "p ,c4  7#c7 ,paym5t am\nt b5*m>k   
ye> ,! t]m paym5t am\nt b5*m>k ye> means
 ! ye> beg9n+ ,janu>y #a1 #bjaf4  7#d7  
,b5*m>k p]iod ,,cpi-,u ,! t]m b5*m>k    
p]iod ,,cpi-,u means ! consum] price    
index = all urban consum]s 7,unit$      
,/ates city av]age7 = ,janu>y #bjaf4    
7#e7 ,rebate p]iod ,,cpi-,u ,! t]m      
rebate p]iod ,,cpi-,u means1 ) respect  
to an applicable ye>1 ! consum] price   
index = all urban consum]s 7,unit$      
,/ates city av]age7 = ,janu>y ( su* ye>4
  7#f7 ,av]age manufactur] price ,! t]m 
av]age manufactur] price has ! mean+1 ) 
respect to a "p ,d rebatable drug ( a   
manufactur] = an applicable ye>1 giv5   
su* t]m 9 section #aibg7k77#a71 )       
respect to a cov]$ outpati5t drug ( a   
manufactur] = a rebate p]iod "u section 
#aibg4 ,= purposes ( apply+ ! previ\s   
s5t5ce1 ) respect to a "p ,d rebatable  
drug ( a manufactur] & an applicable    
ye>1 ! ,secret>y %all use ! in=mation ) 

respect to ! av]age manufactur] price = 
su* drug report$ by ! manufactur] "u    
section #aibg7;b77#c7 ) respect to ea* (
 ! qu>t]s 9 ! applicable ye> & calculate
 an annual av]age manufactur] price =   
su* applicable ye> z ! av]age ( su*     
av]age manufactur] prices = ea* su*     
qu>t]1 weight$ by units ( su* drug sold 
or disp5s$ ) respect to su* applicable  
ye>4  4