,,ib ,union ,cal5d> ,no4 #ega #aaf?     
,,congress  #b;d ,session  ,h4 ,r4 #baac
 ,report ,no4 #aaf-fhh1 ,"p ,i ,,9 ,,!  
,,h\se ,,( ,,repres5tatives  ,april #h1 
#bjai,mr4 ,neal 7= himself & ,mr4       
,brady7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,ways &       
,means1 & 9 addition to ! ,committee on 
,en]gy & ,comm]ce1 = 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$  ,decemb] #bd1 #bjbj;,additional
 sponsors3 ,mr4 ,van ,drew1 ,ms4        
,f9k5au]1 ,ms4 ,h\lahan1 ,mr4 ,rask91   
,mr4 ,mc,adams1 ,ms4 ,und]wood1 ,ms4    
,slotk91 ,mr4 ,lip9ski1 ,ms4 ,l(gr51 &  
,mr4 ,amodei  ,decemb] #bd1             
#bjbj,report$ f ! ,committee on ,ways & 
,means ) an amendment,strike out all    
aft] ! enact+ clause & ins]t ! "p pr9t$ 
9 italic  ,decemb] #bd1 #bjbj;,committee
 on ,en]gy & ,comm]ce dis*>g$2 committ$ 
to ! ,committee ( ! ,:ole ,h\se on !    
,/ate ( ! ,union & ord]$ to be          

printed,for text ( introduc$ bill1 see  
copy ( bill z introduc$ on ,april #h1   
#bjai  ,a ,,bill  ,to am5d titles ,,xi &
 ,,xviii ( ! ,social ,security ,act to  
provide = drug manufactur] price        
transp>5cy1 to require c]ta9            
manufactur]s to report on product       
samples provid$ to c]ta9 heal? c>e      
provid]s1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z !         
,prescription ,drug ,sun%9e1            
,transp>5cy1 ,acc\ntability & ,report+  
,act or ! ,prescription ,drug ,,/> ,act4
  #b4 ,drug manufactur] price transp>5cy
  7a7 ,9 g5]al ,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#d71 = ea* su* trigg]$   
,,spike increase 9 accordance ) ! tim+  
describ$ 9 subsection 7d774  7b7        
,trigg]$ ,,spike increase  7#a7 ,9 g5]al
 ,a trigg]$ ,,spike increase occurs1 )  
respect an applicable drug & ye> 7beg9n+
 ) #bjba & ref]r$ to 9 ?is p>agraph z ! 
applicable ye>71 9 any ( ! foll[+ cases3
 7,a7 ,if !re is at lea/ a #aj p]c5t 7or
 #aj1jjj7 cumulative increase ) respect 
to ! :olesale acquisition co/ 7or       
alt]native co/ measure specifi$ by !    
,secret>y "u p>agraph 7#c77 ( su* drug  
dur+ a cal5d>-ye> p]iod beg9n+ & end+ )9
 ! lookback p]iod t is ! #e-ye> p]iod   
prec$+ su* applicable ye>4  7,b7 ,if !re
 is at lea/ a #be p]c5t 7or #be1jjj7    
cumulative increase ) respect to !      
:olesale acquisition co/ 7or su*        

alt]native co/ measure7 ( su* drug dur+ 
any ?ree-cal5d>-ye> p]iod beg9n+ & end+ 
)9 su* lookback p]iod4  7,c7 ,9 ! case (
 su* a drug t is fir/ cov]$ "u title    
,,xviii ) respect to su* applicable 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* applicable
 ye> 7or p] c\rse ( treatm5t 9 su*      
applicable ye>1 z def9$ by ! ,secret>y7 
is at lea/ #bf1jjj4  7#b7 ,index+ doll> 
am\nts ,! doll> am\nts appli$ "u        
p>agraph 7#a7 = #bjbb & ea* subsequ5t   
ye> %all be ! doll> am\nts specifi$ 9   
su* p>agraph = ! previ\s ye> increas$ by
 ! annual p]c5tage increase 9 ! consum] 
price index 7all items2 ,u4,s4 city     
av]age7 z ( ,septemb] ( su* previ\s ye>4
 ,if any am\nt e/abli%$ "u p>agraph     
7#a71 aft] application ( ?is p>agraph1 =
 a ye> is n a multiple ( #aj1 x %all be 
r\nd$ to ! ne>e/ multiple ( #aj4  7#c7  
,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*
 drug1 or use su* alt]native co/ measure
 if ! :olesale acquisition co/ is n     
available4  7#d7 ,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-- 7,a7 !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]2 or  7,b7 su* increase is   
less ?an ! :olesale acquisition co/ 7or 
alt]native co/ measure specifi$ by !    
,secret>y "u p>agraph 7#c77 ( su* drug  
dur+ ! cal5d>-ye> p]iod describ$ 9      
p>agraph 7#a77;,a7 or ! ?ree-cal5d>-ye> 
p]iod describ$ 9 p>agraph 7#a77;,b71 z  
applicable1 = su* increase1 increas$ by 
! p]c5tage increase 9 ! consum] price   

index = all urban consum]s 7all items2  
,unit$ ,/ates city av]age7 = ! #ab-mon? 
p]iod end+ six mon?s prior to !         
cal5d>-ye> p]iod s describ$ & = !       
#cf-mon? p]iod end+ six mon?s prior to !
 ?ree-cal5d>-ye> p]iod s describ$1      
respectively4  7#e7 ,unit det]m9ation ,=
 purposes ( det]m9+ ! :olesale          
acquisition co/ 9 c>ry+ out ?is section1
 ! ,secret>y %all det]m9e a unit 7su* z 
a unit size7 to apply4  7#f7 ,public    
po/+ ,beg9n+ ) respect to #bjba1 !      
,secret>y %all publicly po/ on !        
,int]net website ( ! ,dep>tm5t ( ,heal? 
& ,human ,s]vices-- 7,a7 alt]native     
p]c5tages1 doll> am\nts1 & lookback     
p]iods t1 if appli$ "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> if 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[+1 z applicable to ! increase ( 
! drug3 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#d71 ! 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 subp>agraph 7,b71 ! t]m     
applicable drug means1 ) respect to a   
lookback p]iod describ$ 9 subsection    
7b77#a71 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,a71 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  
subsection 7b77#a7 ) 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  7b7 ,report+  
to ! ,secret>y ( ! ,treasury  7#a7 ,9   
g5]al ,subp>t ,a ( "p ,,iii ( sub*apt]  
,a ( *apt] #fa ( ! ,int]nal ,rev5ue     
,code ( #aihf is am5d$ by ins]t+ aft]   
section #fjci;,j ! foll[+ new section3  
#fjci,k4 ,drug price ,,spike increase   
report+ ,ea* manufactur] 7)9 ! mean+ (  
section #aabh,l ( ! ,social ,security   
,act7 %all file a return 7at su* "t & 9 
su* =m & mann] z ! ,secret>y may        
provide7 %[+ = su* ye> ) respect to :i* 
su* section applies all in=mation &     
support+ docum5tation & ! c]tification  
includ$ )9 a ju/ification report$ by !  
manufactur] "u subsection 7c77#a7 ( su* 
section4  4  7#b7 ,cl]ical am5dm5t ,!   
table ( sections = subp>t ,a ( "p ,,iii 
( sub*apt] ,a ( *apt] #fa ( su* ,code is
 am5d$ by ins]t+ aft] ! item relat+ to  
section #fjci;,j ! foll[+ new item3     
,sec4 #fjci,k4 ,drug price ,,spike      
increase report+4  4  #c4 ,requirem5t = 
manufactur]s ( c]ta9 drugs1 devices1    

biologicals1 & m$ical supplies to report
 on product samples provid$ to c]ta9    
heal? c>e provid]s  7a7 ,9 g5]al        
,section #aabh;,g7a7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;h7a77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#c7 ,c]ta9 
product samples  7,a7 ,9 g5]al ,9       
addition to ! requirem5ts "u p>agraphs  
7#a77;,a7 & 7#b71 on ! #ij? day ( ea*   
cal5d> ye> 7beg9n+ ) #bjbc71 any        
applicable manufactur] t provides a     
paym5t or o!r transf] ( value t is a    
product sample describ$ 9 subp>agraph   
7,b7 to any cov]$ recipi5t 7or to an    
entity or individual at ! reque/ (1 or  
designat$ on behalf (1 su* a cov]$      
recipi5t7 %all submit to ! ,secret>y1 9 
su* electronic =m z ! ,secret>y %all    
require1 ! foll[+ in=mation 7aggregat$  
p] ea* drug1 device1 biological1 or     
m$ical supply1 z applicable7 ) respect  
to ! prec$+ cal5d> ye>3 7i7 ,! total    
quantity ( all su* paym5ts or o!r       
transf]s ( value provid$ to all cov]$   

recipi5ts4  7ii7 ,! total value ( all   
su* paym5ts or o!r transf]s ( value     
provid$ to all cov]$ recipi5ts4  7iii7  
,if applicable1 in=mation describ$ 9    
clauses 7vii7 & 7viii7 ( p>agraph       
7#a77;,a7 ) respect to su* a paym5t or  
o!r transf] ( value4  7,b7 ,product     
sample describ$ ,= purposes (           
subp>agraph 7,a71 a product sample      
describ$ 9 ?is subp>agraph is a product 
sample t is n int5d$ to be sold & is    
int5d$ = pati5t use4  4  7b7 ,public    
availability ( in=mation ,section       
#aabh;,g7c77#a77;,c77ii7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;h7c77#a77;,c77ii77 is am5d$--
 7#a7 by /rik+ 7ii7 conta9s & ins]t+    
7ii77,i7 ) respect to in=mation t is n  
in=mation submitt$ "u p>agraph 7#c7 (   
subsection 7a71 conta9s2  7#b7 by /rik+ 
1 z applicable2 & ins]t+ 1 z applicable2
 &2 &  7#c7 by add+ at ! end ! foll[+   
new subclause3  7,,ii7 ) respect to     
in=mation submitt$ "u p>agraph 7#c7 (   
subsection 7a71 conta9s in=mation t is  

pres5t$ by ! "n ( ! applicable          
manufactur]1 ! total am\nt ( all paym5ts
 or o!r transf]s ( value describ$ 9 su* 
p>agraph provid$ to all cov]$ recipi5ts1
 ! total value ( all su* paym5ts or o!r 
transf]s ( value provid$ to all cov]$   
recipi5ts1 & ! "n ( ! cov]$ drug1       
device1 biological1 or m$ical supply1 z 
applicable2  4  7c7 ,con=m+ am5dm5t     
,section #aabh;,g7e77#aj77;,b77ii7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;a-#g;h7e77#aj77;,b77ii77 is am5d$ 
by /rik+ ,product samples & ins]t+      
,except = purposes ( p>agraph 7#c7 (    
subsection 7a71 product samples4  7d7   
,report+ to ! ,secret>y ( ! ,treasury   
7#a7 ,9 g5]al ,subp>t ,a ( "p ,,iii (   
sub*apt] ,a ( *apt] #fa ( ! ,int]nal    
,rev5ue ,code ( #aihf1 z am5d$ by       
section #b1 is fur!r am5d$ by ins]t+    
aft] section #fjci,k ! foll[+ new       
section3  #fjci,l4 ,product samples (   
applicable manufactur]s ,ea* applicable 
manufactur] 7)9 ! mean+ ( section       
#aabh;,g7a77#c7 ( ! ,social ,security   

,act7 %all file a return 7at su* "t & 9 
su* =m & mann] z ! ,secret>y may        
provide7 %[+ = su* ye> to :i* su*       
section applies-- 7#a7 ! am\nt describ$ 
9 section #aabh;,g7a77#c77;,a77ii7 ( su*
 ,act ) respect to su* ye>1 &  7#b7 !   
portion ( su* am\nt = :i* a d$uction 0  
claim$ "u section #afb4  4  7#b7        
,cl]ical am5dm5t ,! table ( sections =  
subp>t ,a ( "p ,,iii ( sub*apt] ,a (    
*apt] #fa ( su* ,code1 z am5d$ by       
section #b1 is fur!r am5d$ by ins]t+    
aft] ! item relat+ to section #fjci,k ! 
foll[+ new item3  ,sec4 #fjci,l4        
,product samples ( applicable           
manufactur]s4  4  #d4 ,analysis & report
 on inpati5t hospital drug co/s  7a7    
,analysis ,! ,secret>y ( ,heal? & ,human
 ,s]vices %all conduct an analysis t1 to
 ! ext5t practicable-- 7#a7 focuses on  
drugs t are furni%$ 9 ! inpati5t sett+2 
7#b7 includes data on inpati5t hospital 
drug co/s1 ,m$ic>e sp5d+1 volume1 &     
sp5d+ p] admission2  7#c7 consid]s tr5ds
 9 inpati5t hospital drug co/s1 su* z   

tr5ds by hospital size1 classification (
 urban or rural1 :e!r ! hospital is a   
tea*+ hospital1 or o!r categorization2 &
  7#d7 exam9es ! impact ( drug %ortages 
on s]vices t are furni%$ 9 an inpati5t  
hospital sett+4  ,9 conduct+ su*        
analysis1 ! ,secret>y may conduct       
hospital surveys1 use data f hospital   
co/ reports1 or use o!r data z det]m9$  
by ! ,secret>y4  7b7 ,report ,n lat] ?an
 ,janu>y #a1 #bjba1 ! ,secret>y %all    
submit to ! ,committee on ,ways & ,means
 ( ! ,h\se ( ,repres5tatives & ! ,f9ance
 ,committee ( ! ,s5ate a report on drug 
co/s 9 ! inpati5t hospital sett+1       
includ+ ! analyses describ$ 9 p>agraphs 
7#a7 ?r\gh 7#d7 ( subsection 7a74  7c7  
,fund+ ,= purposes ( c>ry+ out ?is      
section1 !re %all be transf]r$ to !     
,secret>y #c1jjj1jjj f ! ,f$]al         
,hospital ,insurance ,tru/ ,fund "u     
section #ahag ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie;i74  #e4 ,public  
disclosure ( drug disc\nts ,section     
#aaej;,a ( ! ,social ,security ,act 7#db

 ,u4,s4,c4 #acbj;b-#bc7 is am5d$-- 7#a7 
9 subsection 7c71 9 ! matt] prec$+      
p>agraph 7#a71 by ins]t+ 7o!r ?an z     
p]mitt$ "u subsection 7e77 aft] disclos$
 by ! ,secret>y2 &  7#b7 by add+ at !   
end ! foll[+ new subsection3  7e7       
,public availability ( c]ta9 in=mation  
7#a7 ,9 g5]al ,9 ord] to all[ !         
comp>ison ( ,p,b,ms' ability to         
negotiate rebates1 disc\nts1 & price    
concessions & ! am\nt ( su* rebates1    
disc\nts1 & price concessions t are     
pass$ ?r\gh to plan sponsors1 beg9n+    
,janu>y #a1 #bjbj1 ! ,secret>y %all make
 available on ! ,int]net website ( !    
,dep>tm5t ( ,heal? & ,human ,s]vices !  
in=mation ) respect to ! second prec$+  
cal5d> ye> provid$ to ! ,secret>y on    
g5]ic disp5s+ rates 7z describ$ 9       
p>agraph 7#a7 ( subsection 7b7 &        
in=mation provid$ to ! ,secret>y "u     
p>agraphs 7#b7 & 7#c7 ( su* subsection  
t1 z det]m9$ by ! ,secret>y1 is )       
respect to ea* ,,pbm4  7#b7             
,availability ( data ,9 c>ry+ out       

p>agraph 7#a71 ! ,secret>y %all ensure !
 foll[+3 7,a7 ,confid5tiality ,!        
in=mation describ$ 9 su* p>agraph is    
display$ 9 a mann] t prev5ts !          
disclosure ( in=mation on rebates1      
disc\nts1 & price concessions1 ) respect
 to an individual drug or an individual 
plan4  7,b7 ,class ( drug ,! in=mation  
describ$ 9 su* p>agraph is made         
available by class ( drug1 us+ an exi/+ 
classification sy/em1 b only if ! class 
conta9s su* numb] ( drugs1 z specifi$ by
 ! ,secret>y1 to ensure confid5tiality (
 propriet>y in=mation or o!r in=mation t
 is prev5t$ to be disclos$ "u           
subp>agraph 7,a74  4  #f4 ,requir+ c]ta9
 manufactur]s to report drug pric+      
in=mation ) respect to drugs "u !       
,m$ic>e program  7a7 ,9 g5]al ,section  
#ahdg;,a ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7#a7 
9 subsection 7b7-- 7,a7 9 p>agraph      
7#b77;,a71 by ins]t+ or subsection      
7f77#b71 z applicable be=e ! p]iod at ! 
end2  7,b7 9 p>agraph 7#c71 9 ! matt]   

prec$+ subp>agraph 7,a71 by ins]t+ or   
subsection 7f77#b71 z applicable1 be=e  
det]m9$ by2 &  7,c7 9 p>agraph          
7#f77;,a71 9 ! matt] prec$+ clause 7i71 
by ins]t+ or subsection 7f77#b71 z      
applicable1 be=e det]m9$ by2 &  7#b7 9  
subsection 7f7-- 7,a7 by /rik+ ,=       
requirem5ts & ins]t+ ! foll[+3  7#a7 ,9 
g5]al ,= requirem5ts  2 &  7,b7 by add+ 
at ! end ! foll[+ new p>agraph3  7#b7   
,manufactur]s )\t a rebate agreem5t "u  
title ,,xix  7,a7 ,9 g5]al ,9 ! case ( a
 manufactur] ( a drug or biological     
describ$ 9 subp>agraph 7,c71 7,e71 or   
7,g7 ( section #ahdb7o77#a7 or 9 clause 
7ii7 or 7iii7 ( section                 
#ahha7;b77#ad77;,b7 t does n h a rebate 
agreem5t 9 effect "u section #aibg1 =   
cal5d> qu>t]s beg9n+ on or aft] ,janu>y 
#a1 #bjbj1 su* manufactur] %all report  
to ! ,secret>y ! in=mation describ$ 9   
subsection 7b77#c77;,a77iii7 ( su*      
section #aibg ) respect to su* drug or  
biological 9 a "t & mann] specifi$ by ! 
,secret>y4  7,b7 ,audit ,in=mation      

report$ "u subp>agraph 7,a7 is subject  
to audit by ! ,inspector ,g5]al ( !     
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7,c7 ,v]ification ,! ,secret>y may      
survey :olesal]s & manufactur]s t       
directly di/ribute drugs describ$ 9     
subp>agraph 7,a71 :5 necess>y1 to v]ify 
manufactur] prices & manufactur]'s      
av]age sales prices 7includ+ :olesale   
acquisition co/7 if requir$ to make     
paym5t report$ "u subp>agraph 7,a74 ,!  
,secret>y may impose a civil monet>y    
p5alty 9 an am\nt n to exce$ #ajj1jjj on
 a :olesal]1 manufactur]1 or direct     
sell]1 if ! :olesal]1 manufactur]1 or   
direct sell] ( su* a drug refuses a     
reque/ = in=mation ab\t *>ges or prices 
by ! ,secret>y 9 connection ) a survey  
"u ?is subp>agraph or kn[+ly provides   
false in=mation4 ,! 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         
subp>agraph 9 ! same mann] z su*        

provisions apply to a p5alty or proce$+ 
"u section #aabh;,a7a74  7,d7           
,confid5tiality ,not)/&+ any o!r        
provision ( law1 in=mation disclos$ by  
manufactur]s or :olesal]s "u ?is        
p>agraph 7o!r ?an ! :olesale acquisition
 co/ = purposes ( c>ry+ out ?is section7
 is confid5tial & %all n be disclos$ by 
! ,secret>y 9 a =m :i* discloses !      
id5tity ( a specific manufactur] or     
:olesal] or prices *>g$ = drugs by su*  
manufactur] or :olesal]1 except-- 7i7 z 
! ,secret>y det]m9es to be necess>y to  
c>ry out ?is section 7includ+ !         
det]m9ation & implem5tation ( ! paym5t  
am\nt71 or to c>ry out section #ahdg;,b2
  7ii7 to p]mit ! ,comptroll] ,g5]al to 
review ! in=mation provid$2 &  7iii7 to 
p]mit ! ,director ( ! ,congressional    
,budget ,(fice to review ! in=mation    
provid$4  4  7b7 ,en=cem5t ,section     
#ahdg;,a su* ,act 7#db ,u4,s4,c4        
#aciew-#c;a7 is fur!r am5d$-- 7#a7 9    
subsection 7d77#d7-- 7,a7 9 subp>agraph 
7,a71 by /rik+ ,9 g5]al & ins]t+        

,misrepres5tation2  7,b7 9 subp>agraph  
7,b71 by /rik+ subp>agraph 7,b7 & ins]t+
 subp>agraph 7,a71 7,b71 or 7,c72  7,c7 
by r$esignat+ subp>agraph 7,b7 z        
subp>agraph 7,d72 &  7,d7 by ins]t+ aft]
 subp>agraph 7,a7 ! foll[+ new          
subp>agraphs3  7,b7 ,failure to provide 
timely in=mation ,if ! ,secret>y        
det]m9es t a manufactur] describ$ 9     
subsection 7f77#b7 has fail$ to report  
on in=mation describ$ 9 section         
#aibg7;b77#c77;,a77iii7 ) respect to a  
drug or biological 9 accordance ) su*   
subsection1 ! ,secret>y %all apply a    
civil money p5alty 9 an am\nt ( #aj1jjj 
= ea* day ! manufactur] has fail$ to    
report su* in=mation & su* am\nt %all be
 paid to ! ,treasury4  7,c7 ,false      
in=mation ,any manufactur] requir$ to   
submit in=mation "u subsection 7f77#b7 t
 kn[+ly provides false in=mation is     
subject to a civil money p5alty 9 an    
am\nt n to exce$ #ajj1jjj = ea* item (  
false in=mation4 ,su* civil money       
p5alties are 9 addition to o!r p5alties 

z may be prescrib$ by law4  2 &  7#b7 9 
subsection 7c77#f77;,a71 by /rik+ !     
p]iod at ! end & ins]t+ 1 except t1 =   
purposes ( subsection 7f77#b71 !        
,secret>y may1 if ! ,secret>y det]m9es  
appropriate1 exclude repackag]s ( a drug
 or biological f su* t]m44  7c7 ,report 
,n lat] ?an ,janu>y #a1 #bjba1 !        
,inspector ,g5]al ( ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices %all assess & submit 
to ,congress a report on ! accuracy (   
av]age sales price in=mation submitt$ by
 manufactur]s "u section #ahdg;,a ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#c;a74 ,su* report %all include  
any recomm5dations on h[ to improve !   
accuracy ( su* in=mation4  ,decemb] #bd1
 #bjbj,report$ f ! ,committee on ,ways &
 ,means ) an amendment,december #bd1    
#bjbj;,committee on ,en]gy & ,comm]ce   
dis*>g$2 committ$ to ! ,committee ( !   
,:ole ,h\se on ! ,/ate ( ! ,union &     
ord]$ to be pr9t$