,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #dgd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #ac1 #bjai,mr4
 ,wyd5 7= himself1 ,mr4 ,c>d91 ,mr4     
,c>p]1 ,mr4 ,coons1 ,ms4 ,duckwor?1 ,ms4
 ,klobu*>1 ,mr4 ,m55dez1 ,ms4 ,/ab5[1 & 
,mr4 ,te/]7 introduc$ ! foll[+ bill2 :i*
 0 read twice & ref]r$ to ! ,committee  
on ,f9ance  ,a ,,bill  ,to am5d title   
,,xi ( ! ,social ,security ,act to      
require drug manufactur]s to publicly   
ju/ify unnecess>y price increases4  #a4 
,%ort title ,?is ,act may be cit$ z !   
,/opp+ ! ,ph>maceutical ,indu/ry f      
,keep+ drugs ,exp5sive 7,,spike7 ,act ( 
#bjai4  #b4 ,drug manufactur] price     
transp>5cy ,title ,,xi ( ! ,social      
,security ,act 7#db ,u4,s4,c4 #acja et  
seq47 is am5d$ by ins]t+ aft] section   
#aabh,k ! foll[+ new section3  #aabh,l4 
,drug manufactur] price transp>ency  7a7
 ,9 g5]al ,effective beg9n+ on ,july #a1
 #bjai1 subject to subsection 7e71 !    
,secret>y %all require a manufactur] (  
an applicable drug to submit to !       

,secret>y ! ju/ification describ$ 9     
subsection 7c7 9 accordance ) ! tim+    
describ$ 9 subsection 7d74  7b7         
,def9itions ,9 ?is section3 7#a7        
,applicable drug ,subject to p>agraph   
7#b71 ! t]m applicable drug means a     
drug1 z def9$ 9 section #bja7;g7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba7;g771 t is subject  
to section #ejc7;b77#a7 ( su* ,act 7#ba 
,u4,s4,c4 #cec7;b77#a771 & t ! ,secret>y
 det]m9es is describ$ 9 ei!r ( ! foll[+ 
subp>agraphs3  7,a7 ,! drug 7p] dose7-- 
7i7 has a :olesale acquisition co/ ( at 
lea/ #aj doll>s2 &  7ii7 _h an increase 
9 ! :olesale acquisition co/ ( ! drug1 )
 respect to det]m9ations made-- 7,i7    
dur+ #bjbj1 ( at lea/ #ajj p]c5t s9ce ! 
date ( ! enactm5t ( ?is section2  7,,ii7
 dur+ #bjba1 ( at lea/ #ajj p]c5t 9 !   
prec$+ #ab mon?s or ( at lea/ #aej p]c5t
 9 ! prec$+ #b ye>s2  7,,iii7 dur+      
#bjbb1 ( at lea/ #ajj p]c5t 9 ! prec$+  
#ab mon?s or ( at lea/ #bjj p]c5t 9 !   
prec$+ #c ye>s2  7,,iv7 dur+ #bjbc1 ( at

 lea/ #ajj p]c5t 9 ! prec$+ #ab mon?s or
 ( at lea/ #bej p]c5t 9 ! prec$+ #d     
ye>s2 or  7,v7 on or aft] ,janu>y #a1   
#bjbd1 ( at lea/ #ajj p]c5t 9 ! prec$+  
#ab mon?s or ( at lea/ #cjj p]c5t 9 !   
prec$+ #e ye>s4  7,b7 ,! drug 7p]       
dose7-- 7i7 is 9 ! top #ej? p]c5tile (  
net sp5d+ "u title ,,xviii or ,,xix 9 at
 lea/ "o ( ! prec$+ #e ye>s2 &  7ii7 _h 
an increase 9 ! :olesale acquisition co/
 ( ! drug1 ) respect to det]m9ations    
made-- 7,i7 dur+ #bjbj1 ( at lea/ #ae   
p]c5t s9ce ! date ( ! enactm5t ( ?is    
section2  7,,ii7 dur+ #bjba1 ( at lea/  
#ae p]c5t 9 ! prec$+ #ab mon?s or ( at  
lea/ #bj p]c5t 9 ! prec$+ #b ye>s2      
7,,iii7 dur+ #bjbb1 ( at lea/ #ae p]c5t 
9 ! prec$+ #ab mon?s or ( at lea/ #cj   
p]c5t 9 ! prec$+ #c ye>s2  7,,iv7 dur+  
#bjbc1 ( at lea/ #ae p]c5t 9 ! prec$+   
#ab mon?s or ( at lea/ #dj p]c5t 9 !    
prec$+ #d ye>s2 or  7,v7 on or aft]     
,janu>y #a1 #bjbd1 ( at lea/ #ae p]c5t 9
 ! prec$+ #ab mon?s or ( at lea/ #ej    
p]c5t 9 ! prec$+ #e ye>s4  7#b7 ,special

 rule ,= purposes ( apply+ p>agraph     
7#a71 ! ,secret>y may sub/itute = ea*   
p]c5tage describ$ 9 subp>agraph 7,a7 or 
7,b7 ( su* p>agraph 7o!r ?an ! p]c5tile 
describ$ subp>agraph 7,b77i7 ( su*      
p>agraph7 a p]c5tage )9 a de m9imis     
range specifi$ by ! ,secret>y bel[ !    
p]c5tage s describ$4  7#c7 ,manufactur] 
,! t]m manufactur] has ! mean+ giv5 t   
t]m 9 section #eha7aj7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cfj;eee7#aj774  7#d7 ,:olesale         
acquisition co/ ,! t]m :olesale         
acquisition co/ has ! mean+ giv5 t t]m 9
 section #ahdg;,a7c77#f77;,b74  7c7     
,ju/ification describ$ ,! ju/ification  
describ$ 9 ?is subsection is all        
relevant in=mation & support+           
docum5tation necess>y to ju/ify !       
increase 9 ! :olesale acquisition co/ ( 
! applicable drug ( ! manufactur]1 :i*  
may include ! foll[+3  7#a7 ,!          
individual factors t h contribut$ to !  
increase 9 ! :olesale acquisition co/4  
7#b7 ,an explanation ( ! role ( ea*     

factor 9 contribut+ to su* increase4    
7#c7 ,total exp5ditures ( ! manufactur] 
on-- 7,a7 mat]ials & manufactur+ = su*  
drug2  7,b7 acquir+ pat5ts & lic5s+ =   
ea* drug ( ! manufactur]2 &  7,c7 co/s  
to pur*ase or acquire ! drug f ano!r    
company1 if applicable4  7#d7 ,!        
p]c5tage ( total exp5ditures ( !        
manufactur] on rese>* & developm5t = su*
 drug t 0 d]iv$ f ,f$]al funds4  7#e7 ,!
 total exp5ditures ( ! manufactur] on   
rese>* & developm5t = su* drug4  7#f7 ,!
 total rev5ue & net pr(it g5]at$ f !    
applicable drug = ea* cal5d> ye> s9ce   
drug approval4  7#g7 ,! total co/s      
associat$ ) m>ket+ & adv]tis+ = !       
applicable drug4  7#h7 ,additional      
in=mation specific to ! manufactur] ( ! 
applicable drug1 su* z--  7,a7 ! total  
rev5ue & net pr(it ( ! manufactur] = !  
p]iod ( su* increase1 z det]m9$ by !    
,secret>y2  7,b7 metrics us$ to det]m9e 
executive comp5sation2  7,c7 any        
additional in=mation relat$ to drug     
pric+ decisions ( ! manufactur]1 su* z  

total exp5ditures on--  7i7 drug rese>* 
& developm5t2 or  7ii7 cl9ical trials on
 drugs t fail$ to receive approval by ! 
,food & ,drug ,adm9i/ration4  7d7 ,tim+ 
7#a7 ,notification ,n lat] ?an #fj days 
aft] ! date on :i* ! ,secret>y makes !  
det]m9ation t a drug is an applicable   
drug "u subsection 7b71 ! ,secret>y %all
 notify ! manufactur] ( ! applicable    
drug ( su* det]m9ation4  7#b7           
,submission ( ju/ification ,n lat] ?an  
#ahj days aft] ! date on :i* a          
manufactur] receives a notification "u  
p>agraph 7#a71 ! manufactur] %all submit
 to ! ,secret>y ! ju/ification requir$  
"u subsection 7a74  7#c7 ,po/+ on       
int]net website  7,a7 ,9 g5]al ,subject 
to subp>agraph 7,b71 n lat] ?an #cj days
 aft] receiv+ ! ju/ification "u p>agraph
 7#b71 ! ,secret>y %all po/ on ! int]net
 website ( ! ,c5t]s = ,m$ic>e  ,m$icaid 
,s]vices ! ju/ification1 toge!r ) a     
summ>y ( su* ju/ification t is writt5 & 
=matt$ us+ language t is easily         
und]/&able by b5efici>ies "u titles     

,,xviii & ,,xix4  7,b7 ,exception ,!    
,secret>y %all e/abli% a process "u :i* 
a manufactur] ( an applicable drug may  
submit a reque/ to ! ,secret>y t c]ta9  
propriet>y in=mation disclos$ z "p (    
ju/ification 9 subsection 7c7 be exclud$
 f ! po/+ describ$ 9 subp>agraph 7,a7   
if1 z det]m9$ by ! ,secret>y 79         
consultation ) ! ,inspector ,g5]al ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices71 !
 public disclosure ( su* in=mation w\ld 
directly lead to increas$ prices (      
prescription drugs4 ,if propriet>y      
in=mation is exclud$ f ! po/+ pursuant  
to ! prec$+ s5t5ce1 to ! ext5t feasible1
 ! summ>y ( ! in=mation describ$ 9      
subp>agraph 7,a7 %all include a summ>y (
 su* propriet>y in=mation4  7e7         
,exception to requirem5t = submission ,!
 requirem5t to submit a ju/ification "u 
subsection 7a7 %all n apply 9 ! case :]e
 ! manufactur]1 aft] receiv+ !          
notification "u subsection 7d77#a7 )    
respect to an applicable drug ( !       
manufactur]1 r$uces ! :olesale          

acquisition co/ ( a drug s t x no long] 
meets ! def9ition ( an applicable drug  
"u subsection 7b7 = at lea/ a #f-mon?   
p]iod1 z det]m9$ by ! ,secret>y4  7f7   
,p5alties ,! provisions ( subsection    
7b77#c77;,c7 ( section #aibg %all apply 
to a manufactur] t fails to submit !    
ju/ification requir$ "u subsection 7a7  
on a timely basis or t kn[+ly provides  
false in=mation 9 ! same mann] z su*    
provisions apply to a manufactur] ) an  
agreem5t "u t section4  4