,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dffc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #aa1 #bjai,ms4
 ,port] 7= h]self1 ,ms4 ,und]wood1 ,mr4 
,cr[1 & ,mr4 ,blum5au]7 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$ic>e "p ,b     
rebate = c]ta9 drugs if ! price ( su*   
drugs increases fa/] ?an inflation4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,fre$om f ,price ,g\g+ ,act4  #b4       
,m$ic>e "p ,b prescription drug         
inflation rebate by manufactur]s  7a7 ,9
 g5]al ,section #ahcd ( ! ,social       
,security ,act 7#db ,u4,s4,c4 #aciem7 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7x7 ,rebate by manufactur]s

 = s+le s\rce drugs ) prices increas+   
fa/] ?an inflation  7#a7 ,requirem5ts   
7,a7 ,secret>ial provision ( in=mation  
,n lat] ?an #f mon?s aft] ! end ( ea*   
cal5d> qu>t] beg9n+ on or aft] ,july #a1
 #bjba1 ! ,secret>y %all1 = ea* "p ,b   
rebatable drug1 report to ea*           
manufactur] ( su* "p ,b rebatable drug !
 foll[+ = su* cal5d> qu>t]3  7i7        
,in=mation on ! total numb] ( bill+     
units describ$ 9 subp>agraph 7,a77i7 (  
p>agraph 7#c7 ) respect to su* drug &   
cal5d> qu>t]4  7ii7 ,in=mation on !     
am\nt 7if any7 ( ! excess av]age sales  
price increase describ$ 9 subp>agraph   
7,a77ii7 ( su* p>agraph = su* drug &    
cal5d> qu>t]4  7iii7 ,! rebate am\nt    
specifi$ "u su* p>agraph = su* "p ,b    
rebatable drug & cal5d> qu>t]4  7,b7    
,manufactur] requirem5t ,= ea* cal5d>   
qu>t] beg9n+ on or aft] ,july #a1 #bjba1
 ! manufactur] ( a "p ,b rebatable drug 
%all1 = su* drug1 n lat] ?an #cj days   
aft] ! date ( receipt f ! ,secret>y ( ! 
in=mation describ$ 9 subp>agraph 7,a7 = 

su* cal5d> qu>t]1 provide to ! ,secret>y
 a rebate t is equal to ! am\nt specifi$
 9 p>agraph 7#c7 = su* drug = su* cal5d>
 qu>t]4  7#b7 ,"p ,b rebatable drug     
def9$  7,a7 ,9 g5]al ,9 ?is subsection1 
! t]m "p ,b rebatable drug means a s+le 
s\rce drug or biological 7z def9$ 9     
subp>agraph 7,d7 ( section              
#ahdg;,a7c77#f771 includ+ a biosimil>   
biological product 7z def9$ 9           
subp>agraph 7,h7 ( su* section71 paid = 
"u ?is "p1 except su* t]m %all n include
 su* a drug or biological--  7i7 if !   
av]age total all[$ *>ges = a ye> p]     
individual t uses su* a drug or         
biological1 z det]m9$ by ! ,secret>y1   
are less ?an1 subject to subp>agraph    
7,b71 #ajj2 or  7ii7 t is a vacc9e      
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
section #ahfa7s77#aj74  7,b7 ,increase  
,! doll> am\nt appli$ "u subp>agraph    
7,a77i7--  7i7 = #bjbb1 %all be ! doll> 
am\nt specifi$ "u su* subp>agraph =     
#bjba1 increas$ by ! p]c5tage increase 9
 ! consum] price index = all urban      

consum]s 7,unit$ ,/ates city av]age7 z (
 ! fir/ qu>t] ( ! previ\s ye>2 &  7ii7 =
 a subsequ5t ye>1 %all be ! doll> am\nt 
specifi$ 9 ?is clause 7or clause 7i77 = 
! previ\s ye>1 increas$ by ! p]c5tage   
increase 9 ! consum] price index = all  
urban consum]s 7,unit$ ,/ates city      
av]age7 z ( ! fir/ qu>t] ( ! previ\s    
ye>4  ,any doll> am\nt specifi$ "u ?is  
subp>agraph t is n a multiple ( #aj %all
 be r\nd$ to ! ne>e/ multiple ( #aj4    
7#c7 ,rebate am\nt  7,a7 ,9 g5]al ,=    
purposes ( p>agraph 7#a77;,b71 ! am\nt  
specifi$ 9 ?is p>agraph = a "p ,b       
rebatable drug assign$ to a bill+ &     
paym5t code = a cal5d> qu>t] is1 subject
 to p>agraph 7#d71 ! am\nt equal to !   
product (--  7i7 subject to subp>agraph 
7,b71 ! total numb] ( bill+ units1 z    
describ$ 9 section #ahdg;,a7b77#f77;,b71
 = su* "p ,b rebatable drug furni%$ "u  
?is "p dur+ ! cal5d> qu>t]2 &  7ii7 !   
am\nt 7if any7 by :i*-- 7,i7 ! paym5t   
am\nt "u subp>agraph 7,b7 or 7,c7 (     
section #ahdg;,a7b77#a71 z applicable1 =

 su* "p ,b rebatable drug dur+ ! cal5d> 
qu>t]2 exce$s  7,,ii7 ! inflation-adju/$
 paym5t am\nt det]m9$ "u subp>agraph    
7,c7 = su* "p ,b rebatable drug dur+ !  
cal5d> qu>t]4  7,b7 ,exclud$ units ,=   
purposes ( subp>agraph 7,a77i71 ! total 
numb] ( bill+ units = "p ,b rebatable   
drugs furni%$ dur+ a cal5d> qu>t] %all n
 include--  7i7 units packag$ into !    
paym5t = a relat$ proc$ure or s]vice "u 
section #ahcc7t7 or "u section #ahcc7;i7
 7in/ead ( sep>ately payable "u su*     
respective section72  7ii7 units includ$
 "u ! s+le paym5t sy/em = r5al dialysis 
s]vices "u section #ahha7;b77#ad72 or   
7iii7 units ( a "p ,b rebatable drug ( a
 manufactur] t is furni%$ to an         
individual1 if su* manufactur]1 )       
respect to ! furni%+ ( su* units ( su*  
drug1 provides = disc\nts "u section    
#cdj;,b ( ! ,public ,heal? ,s]vice ,act 
or = rebates "u section #aibg4  7,c7    
,det]m9ation ( inflation-adju/$ paym5t  
am\nt ,! inflation-adju/$ paym5t am\nt  
det]m9$ "u ?is subp>agraph = a "p ,b    

rebatable drug = a cal5d> qu>t] is--    
7i7 ! paym5t am\nt = ! bill+ & paym5t   
code = su* drug 9 ! paym5t am\nt b5*m>k 
qu>t] 7z def9$ 9 subp>agraph 7,d772     
increas$ by  7ii7 ! p]c5tage by :i* !   
rebate p]iod ,,cpi-,u 7z def9$ 9        
subp>agraph 7,f77 = ! cal5d> qu>t]      
exce$s ! b5*m>k p]iod ,,cpi-,u 7z def9$ 
9 subp>agraph 7,e774  7,d7 ,paym5t am\nt
 b5*m>k qu>t] ,! t]m paym5t am\nt b5*m>k
 qu>t] means ! cal5d> qu>t] beg9n+      
,janu>y #a1 #bjaf4  7,e7 ,b5*m>k p]iod  
,,cpi-,u ,! t]m b5*m>k p]iod ,,cpi-,u   
means ! consum] price index = all urban 
consum]s 7,unit$ ,/ates city av]age7 =  
,july #bjae4  7,f7 ,rebate p]iod        
,,cpi-,u ,! t]m rebate p]iod ,,cpi-,u   
means1 ) respect to a cal5d> qu>t]      
describ$ 9 subp>agraph 7,c71 ! great] ( 
! b5*m>k p]iod ,,cpi-,u & ! consum]     
price index = all urban consum]s 7,unit$
 ,/ates city av]age7 = ! fir/ mon? ( !  
cal5d> qu>t] t is two cal5d> qu>t]s     
prior to su* describ$ cal5d> qu>t]4     
7#d7 ,special treatm5t ( c]ta9 drugs &  

exemption  7,a7 ,subsequ5tly approv$    
drugs ,subject to subp>agraph 7,b71 9 ! 
case ( a "p ,b rebatable drug fir/      
approv$ by ! ,food & ,drug ,adm9i/ration
 aft] ,july #a1 #bjae1 clause 7i7 (     
p>agraph 7#c77;,c7 %all be appli$ z if !
 t]m paym5t am\nt b5*m>k qu>t] 7 def9$  
"u p>agraph 7#c77;,d7 z ! ?ird full     
cal5d> qu>t] aft] ! day on :i* ! drug 0 
fir/ m>ket$ & clause 7ii7 ( p>agraph    
7#c77;,c7 %all be appli$ z if ! t]m     
b5*m>k p]iod ,,cpi-,u 7 def9$ "u        
p>agraph 7#c77;,e7 z if ! ref]5ce to    
,july #bjae "u su* p>agraph 7 a ref]5ce 
to ! fir/ mon? ( ! fir/ full cal5d>     
qu>t] aft] ! day on :i* ! drug 0 fir/   
m>ket$4  7,b7 ,timel9e = provision (    
rebates = new drugs ,9 ! case ( a "p ,b 
rebatable drug fir/ approv$ by ! ,food &
 ,drug ,adm9i/ration aft] ,july #a1     
#bjae1 clause 7i7 ( p>agraph 7#a77;,b7  
%all be appli$ z if ! ref]5ce to ,july  
#a1 #bjba "u su* p>agraph 7 a ref]5ce to
 ! lat] ( ! #f? full cal5d> qu>t] aft] !
 day on :i* ! drug 0 fir/ m>ket$ or     

,july #a1 #bjba4  7,c7 ,exemption =     
%ortages ,! ,secret>y may r$uce or waive
 ! rebate "u p>agraph 7#a77;,b7 )       
respect to a "p ,b rebatable drug t     
appe>s on ! drug %ortage li/ 9 effect "u
 section #ejf7;e7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act or 9 ! case (   
o!r exig5t circum/ances1 z det]m9$ by ! 
,secret>y4  7#e7 ,application to        
b5efici>y co9surance ,9 ! case ( a "p ,b
 rebatable drug = :i* a rebate is       
payable "u ?is subsection-- 7,a7 9      
comput+ ! am\nt ( any co9surance        
applicable "u ?is title to an individual
 ) respect to su* drug1 ! computation ( 
su* co9surance %all be bas$ on !        
inflation-adju/$ paym5t am\nt det]m9$ "u
 p>agraph 7#c77;,c7 = su* "p ,b         
rebatable drug2 &  7,b7 ! am\nt ( su*   
co9surance is equal to #bj p]c5t ( su*  
inflation-adju/$ paym5t am\nt s det]m9$4
  7#f7 ,rebate deposits ,am\nts paid z  
rebates "u p>agraph 7#a77;,b7 %all be   
deposit$ into ! ,f$]al ,supplem5t>y     
,m$ical ,insurance ,tru/ ,fund e/abli%$ 

"u section #ahda4  7#g7 ,civil money    
p5alty ,if a manufactur] ( a "p ,b      
rebatable drug has fail$ to comply ) !  
requirem5ts "u p>agraph 7#a77;,b7 = su* 
drug = a cal5d> qu>t]1 ! manufactur]    
%all be subject to1 9 accordance ) a    
process e/abli%$ by ! ,secret>y pursuant
 to regulations1 a civil money p5alty 9 
an am\nt equal to at lea/ #abe p]c5t ( !
 am\nt specifi$ 9 p>agraph 7#c7 = su*   
drug = su* cal5d> qu>t]4 ,! provisions (
 section #aabh;,a 7o!r ?an subsections  
7a7 7) respect to am\nts ( p5alties or  
additional assessm5ts7 & 7b77 %all apply
 to a civil money p5alty "u ?is p>agraph
 9 ! same mann] z su* provisions apply  
to a p5alty or proce$+ "u section       
#aabh;,a7a74  7#h7 ,/udy & report  7,a7 
,/udy ,! ,secret>y %all conduct a /udy (
 ! feasibility ( & op]ational issues    
involv$ ) ! foll[+3  7i7 ,includ+       
multiple s\rce drugs 7z def9$ 9 section 
#ahdg;,a7c77#f77;,c77 9 ! rebate sy/em  
"u ?is subsection4  7ii7 ,includ+ drugs 
& biologicals paid = "u ,,ma plans "u "p

 ,c 9 ! rebate sy/em "u ?is subsection4 
7iii7 ,includ+ drugs exclud$ "u p>agraph
 7#b77;,a7 & bill+ units ( drugs exclud$
 "u p>agraph 7#c77;,b7 9 ! rebate sy/em 
"u ?is subsection4  7,b7 ,report ,n lat]
 ?an #c ye>s aft] ! date ( ! enactm5t ( 
?is subsection1 ! ,secret>y %all submit 
to ,congress a report on ! /udy conduct$
 "u subp>agraph 7,a74  7#i7 ,application
 to multiple s\rce drugs ,! ,secret>y   
may1 bas$ on ! report submitt$ "u       
p>agraph 7#h7 & pursuant to rulemak+1   
apply ! provisions ( ?is subsection to  
multiple s\rce drugs 7z def9$ 9 section 
#ahdg;,a7c77#f77;,c771 includ+1 =       
purposes ( det]m9+ ! rebate am\nt "u    
p>agraph 7#c71 by calculat+             
manufactur]-specific av]age sales prices
 = ! b5*m>k p]iod & ! rebate p]iod4  4  
7b7 ,am\nts payable2 co/-,%>+ ,section  
#ahcc7;a7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #aciel7a77 is am5d$--    
7#a7 9 p>agraph 7#a7--  7,a7 9          
subp>agraph 7,s71 by /rik+ ) respect to 
& ins]t+ subject to subp>agraph 7,,dd71 

) respect to2  7,b7 by /rik+ & 7,,cc7 & 
ins]t+ 7,,cc72 &  7,c7 by ins]t+ be=e ! 
semicolon at ! end ! foll[+3 1 & 7,,dd7 
) respect to a "p ,b rebatable drug 7z  
def9$ 9 p>agraph 7#b7 ( section         
#ahcd7x77 = :i* a rebate is payable "u  
su* section1 ! am\nts paid %all be !    
diff]5ce betwe5 7i7 ! paym5t am\nt "u   
p>agraph 7#c77;,a77ii77,i7 ( su* section
 = su* drug1 & 7ii7 #bj p]c5t ( !       
inflation-adju/$ paym5t am\nt "u        
p>agraph 7#c77;,a77ii77,,ii7 ( su*      
section = su* drug2 &  7#b7 by add+ at !
 end ( ! flu% left matt] foll[+ p>agraph
 7#i71 ! foll[+3 ,= purposes ( apply+   
p>agraph 7#a77;,,dd7 & section          
#ahcd7x77#e71 ! ,secret>y %all make su* 
e/imates & use su* data z ! ,secret>y   
det]m9es appropriate4 4  7c7 ,con=m+    
am5dm5t to "p ,b ,,asp calculation      
,section #ahdg;,a7c77#c7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#c77 is am5d$ by ins]t+  
or section #ahcd7x7 aft] section #aibg4