,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #bjfi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #c1 #bjai,mr4  
,hors=d 7= himself & ,mr4 ,re$7         
introduc$ ! 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 ,,xi ( ! ,social
 ,security ,act to provide = drug       
manufactur] price transp>5cy4  #a4 ,%ort
 title ,?is ,act may be cit$ z ! ,/opp+ 
! ,ph>maceutical ,indu/ry f ,keep+ drugs
 ,exp5sive ,act or ! ,,spike ,act4  #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>5cy  7a7 ,9 g5]al ,)      
respect to ea* ye>1 beg9n+ ) #bjba1 !   
,secret>y %all1 at lea/ once dur+ su*   

ye>1 det]m9e if !re is a trigg]$ ,,spike
 increase 79 accordance ) subsection    
7b77 ) respect to an applicable drug 7z 
def9$ 9 subsection 7f77#a774 ,if !      
,secret>y det]m9es1 ) respect to a ye>1 
!re is su* an increase ) respect to an  
applicable drug1 ! manufactur] ( !      
applicable drug %all submit to !        
,secret>y ! ju/ification describ$ 9     
subsection 7c71 subject to subsection   
7b77#c71 = ea* su* trigg]$ ,,spike      
increase 9 accordance ) ! tim+ describ$ 
9 subsection 7d74  7b7 ,trigg]$ ,,spike 
increase  7#a7 ,9 g5]al ,a trigg]$      
,,spike increase occurs1 ) respect to an
 applicable drug & ye> 7beg9n+ ) #bjba71
 9 any ( ! foll[+ cases3  7,a7 ,if !re  
is a #aj p]c5t 7or #aj1jjj7 increase )  
respect to ! :olesale acquisition co/   
7or alt]native co/ measure specifi$ by !
 ,secret>y "u p>agraph 7#b77 ( su* drug 
dur+ any #ab-mon? p]iod beg9n+ & end+ )9
 ! lookback p]iod t is ! #e-ye> p]iod   
prec$+ #bjba or #bjbb1 respectively4    
7,b7 ,if !re is a #be p]c5t 7or #be1jjj7

 increase ) respect to ! :olesale       
acquisition co/ 7or su* alt]native co/  
measure7 ( su* drug dur+ any #cf-mon?   
p]iod beg9n+ & end+ )9 su* respective   
lookback p]iod4  7,c7 ,9 ! case ( su* a 
drug t is fir/ cov]$ "u title ,,xviii ) 
respect to su* ye>1 if ! e/imat$ co/ or 
sp5d+ "u su* title p] individual or p]  
us] ( su* drug 7z e/imat$ by !          
,secret>y7 = su* ye> 7or p] c\rse (     
treatm5t1 z def9$ by ! ,secret>y7 is at 
lea/ #bf1jjj4  7#b7 ,alt]native to ,,wac
 ,! ,secret>y may1 = purposes ( mak+    
det]m9ations "u p>agraph 7#a71 9        
addition to us+ ! :olesale acquisition  
co/ = an applicable drug1 use alt]native
 co/ measures ( su* drug4  7#c7         
,exception ,a ju/ification "u subsection
 7c7 %all n be requir$ = a trigg]$      
,,spike increase describ$ 9 p>agraph    
7#a7 ( an applicable drug ( a           
manufactur] if !re is any portion ( !   
lookback p]iod describ$ 9 ! respective  
subp>agraph ( su* p>agraph = su*        
increase t is includ$ )9 ! lookback     

p]iod = ano!r trigg]$ ,,spike increase  
7or comb9ation ( su* increases7 = :i* a 
ju/ification is made "u ?is section =   
su* drug by su* manufactur]4  7#d7 ,unit
 det]m9ation ,= purposes ( det]m9+ !    
:olesale acquisition co/ 9 c>ry+ out ?is
 section1 ! ,secret>y %all det]m9e a    
unit 7su* z a unit size7 to apply4  7#e7
 ,public po/+ ,beg9n+ ) respect to      
#bjba1 ! ,secret>y %all publicly po/ on 
! ,int]net website ( ! ,dep>tm5t (      
,heal? & ,human ,s]vices--  7,a7        
alt]native p]c5tages1 doll> am\nts1 &   
lookback p]iods t1 if appli$ "u p>agraph
 7#a71 w\ld be project$ to increase !   
numb] ( applicable drugs = :i* a trigg]$
 ,,spike increase w\ld occur = su* ye>2 
&  7,b7 ! numb] ( applicable drugs = :i*
 a trigg]$ ,,spike increase w\ld occur =
 su* ye> ( su* an alt]native p]c5tage1  
doll> am\nt1 or p]iod 7 appli$ = su*    
ye>4  7c7 ,ju/ification describ$  7#a7  
,9 g5]al ,! ju/ification describ$ 9 ?is 
subsection1 ) respect to a trigg]$      
,,spike increase describ$ 9 subsection  

7b77#a7 ( an applicable drug ( a        
manufactur]1 is--  7,a7 all ( !         
in=mation describ$ 9 p>agraph 7#b72     
7,b7 all ( ! in=mation & support+       
docum5tation describ$ 9 p>agraph 7#c71 z
 applicable to ! increase & drug2 &     
7,c7 a c]tification describ$ 9 p>agraph 
7#d74  7#b7 ,requir$ in=mation ,=       
purposes ( p>agraph 7#a71 ! in=mation   
describ$ 9 ?is p>agraph is ! 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 ,in=mation z applicable
 ,= purposes ( p>agraph 7#a71 !         
in=mation & support+ docum5tation       
describ$ 9 ?is p>agraph is ! foll[+3    
7,a7 ,total exp5ditures ( ! manufactur] 
on-- 7i7 mat]ials & manufactur+ = su*   
drug2  7ii7 acquir+ pat5ts & lic5s+ =   
ea* drug ( ! manufactur]2 &  7iii7 co/s 
to pur*ase or acquire ! drug f ano!r    
company1 if applicable4  7,b7 ,!        
p]c5tage ( total exp5ditures ( !        

manufactur] on rese>* & developm5t = su*
 drug t 0 d]iv$ f ,f$]al funds4  7,c7 ,!
 total exp5ditures ( ! manufactur] on   
rese>* & developm5t = su* drug4  7,d7 ,!
 total rev5ue & net pr(it g5]at$ f !    
applicable drug = ea* cal5d> ye> s9ce   
drug approval4  7,e7 ,! total co/s      
associat$ ) m>ket+ & adv]tis+ = !       
applicable drug4  7,f7 ,additional      
in=mation specific to ! manufactur] ( ! 
applicable drug1 su* z--  7i7 ! total   
rev5ue & net pr(it ( ! manufactur] = !  
p]iod ( su* increase1 z det]m9$ by !    
,secret>y2  7ii7 metrics us$ to det]m9e 
executive comp5sation2  7iii7 total     
exp5ditures on--  7,i7 drug rese>* &    
developm5t2 or  7,,ii7 cl9ical trials on
 drugs t fail$ to receive approval by ! 
,food & ,drug ,adm9i/ration2 &  7iv7 any
 additional in=mation relat$ to drug    
pric+ decisions ( ! manufactur]4  7,g7  
,any o!r relevant in=mation & support+  
docum5tation necess>y to ju/ify !       
trigg]+ ,,spike increase4  7,h7 ,any o!r
 relevant in=mation & support+          

docum5tation1 z specifi$ by ! ,secret>y4
  7#d7 ,c]tification ,= purposes (      
p>agraph 7#a71 ! c]tification describ$ 9
 ?is p>agraph is a c]tification1 t all  
su* in=mation & docum5tation is accurate
 & complete1 by "o ( ! foll[+3  7,a7 ,! 
*ief executive (fic] ( ! manufactur]4   
7,b7 ,! *ief f9ancial (fic] ( !         
manufactur]4  7,c7 ,an individual :o has
 delegat$ au?ority to sign =1 & :o      
reports directly to1 su* *ief executive 
(fic] or *ief f9ancial (fic]4  7d7 ,tim+
  7#a7 ,notification ,n lat] ?an #fj    
days aft] ! date on :i* ! ,secret>y     
makes ! det]m9ation t !re is a trigg]+  
,,spike increase ) respect to an        
applicable drug1 ! ,secret>y %all notify
 ! manufactur] ( ! applicable drug ( su*
 det]m9ation4  7#b7 ,submission (       
ju/ification ,n lat] ?an #ij days aft] !
 date on :i* a manufactur] receives a   
notification "u p>agraph 7#a71 subject  
to subsection 7b77#c71 ! manufactur]    
%all submit to ! ,secret>y !            
ju/ification requir$ "u subsection 7a71 

includ+ a summ>y ( su* ju/ification1 9 a
 =m & mann] specifi$ by ! ,secret>y4 ,9 
specify+ su* =m1 ) respect to ! summ>y  
requir$ "u ! previ\s s5t5ce1 ! ,secret>y
 %all provide t su* summ>y %all be 9 an 
easily und]/&able =mat1 z specifi$ by ! 
,secret>y1 & %all p]mit ! manufactur] to
 exclude propriet>y in=mation f su*     
summ>y4  7#c7 ,po/+ on ,int]net website 
,n lat] ?an #cj days aft] receiv+ !     
complete ju/ification "u p>agraph 7#b71 
! ,secret>y %all po/ on ! ,int]net      
website ( ! ,c5t]s = ,m$ic>e  ,m$icaid  
,s]vices ! summ>y includ$ = su*         
ju/ification4  7e7 ,p5alties  7#a7      
,failure to submit timely ju/ification  
,if ! ,secret>y det]m9es t a manufactur]
 has fail$ to submit a ju/ification z   
requir$ "u ?is section1 includ+ 9       
accordance ) ! tim+ & =m requir$1 )     
respect to an applicable drug1 !        
,secret>y %all apply a civil monet>y    
p5alty 9 an am\nt ( #aj1jjj = ea* day ! 
manufactur] has fail$ to submit su*     
ju/ification z s requir$4  7#b7 ,false  

in=mation ,any manufactur] t submits a  
ju/ification "u ?is section t kn[+ly    
provides false in=mation 9 su*          
ju/ification is subject to a civil      
monet>y p5alty 9 an am\nt n to exce$    
#ajj1jjj = ea* item ( false in=mation4  
7#c7 ,application ( proc$ures ,!        
provisions ( section #aabh;,a 7o!r ?an  
subsections 7a7 & 7b77 %all apply to a  
civil monet>y p5alty "u ?is subsection 9
 ! same mann] z su* provisions apply to 
a p5alty or proce$+ "u section          
#aabh;,a7a74 ,civil monet>y p5alties    
impos$ "u ?is subsection are 9 addition 
to o!r p5alties z may be prescrib$ by   
law4  7f7 ,def9itions ,9 ?is section3   
7#a7 ,applicable drug  7,a7 ,9 g5]al    
,subject to p>agraph 7#b71 ! t]m        
applicable drug means1 ) respect to a   
lookback p]iod describ$ 9 p>agraph 7#b71
 a cov]$ outpati5t drug 7z def9$ 9      
p>agraph 7#b7 ( section #aibg7k71 )\t   
application ( p>agraph 7#c7 ( su*       
section7 t is cov]$ "u title ,,xviii &  
is n a l[ co/ drug4  7,b7 ,exclusion (  

l[ co/ drugs ,= purposes ( subp>agraph  
7,a77iii71 n lat] ?an ,janu>y #a1 #bjba1
 ! ,secret>y %all specify a ?re%old 7su*
 z a co/ or sp5d+ ?re%old7 = id5tify+ 7&
 %all id5tify7 l[ co/ drugs to be       
exclud$ f ! def9ition ( ! t]m applicable
 drug1 su* z a drug t has a :olesale    
acquisition co/ ( less ?an #aj p] unit  
or less ?an #ajj 9 av]age e/imat$       
exp5ditures "u title ,,xviii p]         
individual p] ye> or p] us] ( su* drug  
p] ye>4 ,= purposes ( ?is section1 a    
drug %all n be consid]$ specifi$ z a l[ 
co/ drug = a lookback p]iod describ$ 9  
p>agraph 7#b7 ) respect to a ye> unless 
su* drug is id5tifi$ z be+ bel[ !       
specifi$ ?re%old = ! entirety ( !       
lookback p]iod4  7#b7 ,manufactur] ,!   
t]m manufactur] has ! mean+ giv5 t t]m 9
 section #ahdg;,a7c77#f77;,a74  7#c7    
,:olesale acquisition co/ ,! t]m        
:olesale acquisition co/ has ! mean+    
giv5 t t]m 9 section                    
#ahdg;,a7c77#f77;,b74  4