,,ii  #aah? ,,congress  #a/ ,session    
,s4 #bgfd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ab1         
#bjbc,mr4 ,b>rasso introduc$ ! foll[+   
bill2 :i* 0 read twice & ref]r$ to !    
,committee on ,f9ance  ,a ,,bill  ,to   
am5d title ,,xviii ( ! ,social ,security
 ,act to provide = a rebate by          
manufactur]s = select$ drugs &          
biological products subject to maximum  
fair price negotiation4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,protect+    
,pati5t ,access to ,canc] & ,complex    
,!rapies ,act ( #bjbc4  #b4 ,rebate by  
manufactur]s = select$ drugs &          
biological products subject to maximum  
fair price negotiation  7a7 ,ma9ta9+    
paym5ts "u "p ,b bas$ on ,,asp#f        
,section #ahdg;,a7b77#a77;,b7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#c;a7b77#a77;,b77 is am5d$ by    
/rik+ or 9 ! case ( su* a drug or       
biological product t is a select$ drug &
 all t foll[s ?r\gh ! semicolon & ins]t+
 a semicolon4  7b7 ,rebate by           

manufactur]s = select$ drugs &          
biological products subject to maximum  
fair price negotiation  7#a7 ,9 g5]al   
,section #ahdg;,a ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #aciew-#c;a7 is     
am5d$-- 7,a7 by r$esignat+ subsection   
7j7 z subsection 7k72 &  7,b7 by ins]t+ 
aft] subsection 7i7 ! foll[+ new        
subsection3  7j7 ,rebate by manufactur]s
 = select$ drugs & biological products  
subject to maximum fair price           
negotiation  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] ! fir/   
day ( ! initial price applicability     
p]iod 7z def9$ 9 section #aaia7;b77#b771
 ! ,secret>y %all1 = ea* select$ drug 7z
 def9$ 9 section #aaib7;c77 ( ea*       
manufactur] ) an agreem5t "u section    
#aaic = :i* a maximum fair price is 9   
effect & = :i* paym5t may be made "u ?is
 "p1 report to ea* manufactur] ( su*    
select$ drug ! foll[+ = su* cal5d> qu>t]
 dur+ su* price applicability p]iod3 7i7

 ,in=mation on ! total numb] ( units ( !
 bill+ & paym5t code = su* select$ drug 
furni%$ "u ?is "p dur+ su* cal5d> qu>t]4
  7ii7 ,in=mation on ! sum (-- 7,i7 !   
am\nt 7if any7 by :i*-- 7aa7 ! ,,asp#f  
paym5t am\nt 7z def9$ 9 p>agraph 7#e77 =
 su* drug & cal5d> qu>t]1 less ! ,,asp#f
 co9surance am\nt = su* drug & cal5d>   
qu>t]2 exce$s  7bb7 ! ,,mfp#f paym5t    
am\nt 7z s def9$7 = su* drug & cal5d>   
qu>t]1 less ! ,,mfp#f co9surance am\nt =
 su* drug & cal5d> qu>t]2 &  7,,ii7 !   
am\nt 7if any7 by :i*-- 7aa7 ! ,,asp#f  
co9surance am\nt 7z def9$ 9 p>agraph    
7#e77 = su* drug & cal5d> qu>t]2 exce$s 
7bb7 ! ,,mfp#f co9surance am\nt 7z s    
def9$7 = su* drug & cal5d> qu>t]4  7iii7
 ,! rebate am\nt specifi$ "u subp>agraph
 7,b7 = su* drug & cal5d> qu>t]4  7,b7  
,manufactur] requirem5t ,= ea* cal5d>   
qu>t] beg9n+ on or aft] ! fir/ day ( !  
initial price applicability p]iod 7z    
def9$ 9 section #aaia7;b77#b771 !       
manufactur] ( a select$ 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        
subp>agraph 7,a77ii7 multipli$ by !     
numb] ( units specifi$ 9 subp>agraph    
7,a77i7 = su* drug = su* cal5d> qu>t]4  
,! rebate requir$ "u ?is subp>agraph    
%all be 9 addition to any o!r rebates   
requir$ "u ?is title or title ,,xix1    
includ+ ! paym5ts requir$ "u subsections
 7h7 & 7i74  7#b7 ,calculation (        
b5efici>y co9surance bas$ on mfp#f  7,a7
 ,9 g5]al ,subject to subp>agraph 7,b71 
9 ! case ( a select$ drug ) respect to  
:i* a rebate is paid "u ?is subsection--
 7i7 ! am\nt ( any co9surance applicable
 "u ?is "p to an individual to :om su*  
drug is furni%$ dur+ a cal5d> qu>t] %all
 be equal to ! ,,mfp#f co9surance am\nt2
 &  7ii7 ! am\nt ( su* co9surance = su* 
cal5d> qu>t] %all be appli$ z a p]c5t1 z
 det]m9$ by ! ,secret>y1 to ! paym5t    
am\nt t w\ld o!rwise apply "u subsection
 7b77#a77;,b74  7,b7 ,cl>ification      

reg>d+ application ( inflation rebate   
,if a rebate is requir$ "u subsection   
7i7 ) respect to a select$ drug = a     
cal5d> qu>t]1 ! less] ( ! am\nt (       
co9surance comput$ "u subp>agraph 7,a7  
or ! co9surance comput$ "u subsection   
7i77#e7 %all apply = su* drug & cal5d>  
qu>t]4  7#c7 ,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#d7  
,civil money p5alty ,! civil money      
p5alty e/abli%$ "u p>agraph 7#g7 (      
subsection 7i7 %all apply to ! failure  
to comply ) ?is subsection 9 ! same     
mann] z su* p5alty applies to failures  
to comply ) ! requirem5ts "u p>agraph   
7#a77;,b7 ( subsection 7i74  7#e7       
,def9itions ,9 ?is subsection1 ) respect
 to a select$ drug = a cal5d> qu>t] dur+
 a price applicability p]iod3 7,a7      
,,asp#f co9surance am\nt ,! ,,asp#f     
co9surance am\nt is equal to #bj p]c5t (
 ! ,,asp#f paym5t am\nt4  7,b7 ,,asp#f  

paym5t am\nt ,! ,,asp#f paym5t am\nt is 
equal to #ajf p]c5t ( ! am\nt det]m9$ "u
 p>agraph 7#d7 ( subsection 7b7 = su*   
drug dur+ su* cal5d> qu>t]4  7,c7       
,,mfp#f co9surance am\nt ,! ,,mfp#f     
co9surance am\nt is equal to #bj p]c5t (
 ! ,,mfp#f paym5t am\nt4  7,d7 ,,mfp#f  
paym5t am\nt ,! ,,mfp#f paym5t am\nt is 
equal to #ajf p]c5t ( ! maximum fair    
price 7z def9$ 9 section #aaia7;c77#b77 
applicable = su* drug dur+ su* cal5d>   
qu>t]4  7#f7 ,cl>ification ,no?+ 9 "p ,e
 ( title ,,xi or ?is subsection %all be 
con/ru$ to require a manufactur] to     
provide select$ drugs at maximum fair   
prices o!r ?an ?r\gh ! rebate requir$ "u
 ?is subsection4  4  7#b7 ,am\nts       
payable2 co/-%>+ ,section #ahcc7;a77#a7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7
 9 subp>agraph 7,g71 by /rik+ subsection
 7i77#i7 & ins]t+ p>agraphs 7#i7 & 7#aa7
 ( subsection 7i72  7,b7 9 subp>agraph  
7,s71 by /rik+ subp>agraph 7,,ee7 &     
ins]t+ subp>agraphs 7,,ee7 & 7,,ii72    

7,c7 by /rik+ & 7,,hh7 & ins]t+ 7,,hh72 
&  7,d7 by ins]t+ be=e ! semicolon at ! 
end ! foll[+3 1 & 7,,ii7 ) respect to a 
select$ drug 7z def9$ 9 section         
#aaib7;c77 t is subject to a rebate "u  
section #ahdg;,a7j71 ! am\nts paid %all 
be equal to ! p]c5t ( ! paym5t am\nt    
o!rwise det]m9$ "u section              
#ahdg;,a7b77#a77;,b7 t equals ! diff]5ce
 betwe5 7i7 #ajj p]c5t1 & 7ii7 ! p]c5t  
appli$ "u section                       
#ahdg;,a7j77#b77;,a77ii74  7#c7 ,,asc   
con=m+ am5dm5ts ,section #ahcc7;i7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7i77 is am5d$ by add+ at ! end !  
foll[+ new p>agraph3  7#aa7 ,9 ! case ( 
a select$ drug 7z def9$ 9 section       
#aaib7;c771 subject to a rebate "u      
section #ahdg;,a7j7 = :i* paym5t "u ?is 
subsection is n packag$ into a paym5t = 
a s]vice furni%$ on or aft] ! initial   
price applicability ye> = ! select$ drug
 "u ! revis$ paym5t sy/em "u ?is        
subsection1 9 lieu ( calculation (      
co9surance & ! am\nt ( paym5t o!rwise   

applicable "u ?is subsection1 !         
provisions ( section #ahdg7;j77#b7 &    
p>agraph 7#a77;,,ii7 ( subsection 7a71  
%all1 z det]m9$ appropriate by !        
,secret>y1 apply "u ?is subsection 9 !  
same mann] z su* provisions ( section   
#ahdg;,a7j77#b7 & subsection 7a7 apply  
"u su* section & subsection4  4  7#d7   
,,opps con=m+ am5dm5t ,section          
#ahcc7t77#h7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciel7t77#h77 is am5d$  
by add+ at ! end ! foll[+ new           
subp>agraph3  7,g7 ,select$ drugs       
subject to rebate ,9 ! case ( a select$ 
drug 7z def9$ 9 section #aaib7;c771     
subject to a rebate "u section          
#ahdg;,a7j7 = :i* paym5t "u ?is         
subsection is n packag$ into a paym5t = 
a cov]$ ,,opd s]vice 7or gr\p ( s]vices7
 furni%$ on or aft] ! initial price     
applicability ye> = ! select$ drug1 & ! 
paym5t = su* drug is ! same z ! am\nt = 
a cal5d> qu>t] "u section               
#ahdg;,a7b77#a77;,b71 "u ! sy/em "u ?is 
subsection1 9 lieu ( ! calculation ( !  

copaym5t am\nt & ! am\nt o!rwise        
applicable "u ?is subsection 7o!r ?an ! 
application ( ! limitation describ$ 9   
subp>agraph 7,c771 ! provisions (       
section #ahdg;,a7j77#b7 & p>agraph      
7#a77;,,ii7 ( subsection 7a71 %all1 z   
det]m9$ by ! ,secret>y apply "u ?is     
section 9 ! same mann] z su* provisions 
( section #ahdg;,a7j77#b7 & subsection  
7a7 apply "u su* section & subsection4  
4  7#e7 ,exclusion ( select$ drug mfp   
rebates f asp calculation ,section      
#ahdg;,a7c77#c7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 
is am5d$ by /rik+ subsection 7i7 &      
ins]t+ subsection 7i71 subsection 7j74  
7#f7 ,coord9ation ) m$icaid rebate      
in=mation disclosures ,section          
#aibg7;b77#c77;,d77i7 ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;b77#c77;,d77i77 is am5d$ by  
/rik+ & ! rebate & ins]t+ & ! rebates4  
7#g7 ,provision ( rebates ,section      
#aaic7;a7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acbj;f-#b7;a77 is       

am5d$-- 7,a7 9 p>agraph 7#a71 by /rik+  
subp>agraph 7,b7 & ins]t+ ! foll[+3     
7,b7 by pay+ rebates 9 accordance )     
section #ahdg;,a7j72  2  7,b7 9 p>agraph
 7#b71 by /rik+ subp>agraph 7,b7 &      
ins]t+ ! foll[+3  7,b7 by pay+ rebates 9
 accordance ) section #ahdg;,a7j72  2 & 
7,c7 9 p>agraph 7#c71 by /rik+          
subp>agraph 7,b7 & ins]t+ ! foll[+3     
7,b7 by pay+ rebates 9 accordance )     
section #ahdg;,a7j72  4  7c7 ,con=m+    
am5dm5ts  7#a7 ,section #ahdg;,a7i77#e7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#c;a7i77#e77 is am5d$1 
9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7
 by /rik+ ,9 ! case & ins]t+ ,subsection
 to subsection 7j77#b77;,b71 9 ! case2 &
  7,b7 by /rik+ 7or1 9 ! case ( a "p ,b 
rebatable drug t is a select$ drug 7z   
def9$ 9 section #aaib7;c771 ! paym5t    
am\nt describ$ 9 subsection 7b77#a77;,b7
 = su* drug74  7#b7 ,section            
#ahcc7;a77#a77;,,ee7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciel7a77#a77;,,ee77 is am5d$-- 7,a7 by

 /rik+ 7or1 9 ! case ( a "p ,b rebatable
 drug t is a select$ drug 7z def9$ 9    
section #aaib7;c7 = :i*1 ! paym5t am\nt 
describ$ 9 section #ahdg;,a7b77#a77;,b77
 = su* drug = su* qu>t]2 &  7,b7 by     
/rik+ or section #ahdg;,a7b77#a77;,b71 z
 applicable14