,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #fegd  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #bf1 #bjah,ms4  
,s*ak[sky 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 "p ,d (    
title ,,xviii ( ! ,social ,security ,act
 to require ! ,secret>y ( ,heal? &      
,human ,s]vices to det]m9e1 on behalf ( 
,m$ic>e b5efici>ies1 cov]$ "p ,d drug   
prices = c]ta9 cov]$ "p ,d drugs1 & =   
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,m$ic>e ,fair ,drug    
,pric+ ,act ( #bjah4  #b4 ,requirem5t to
 det]m9e l[] cov]$ "p ,d drug prices =  
c]ta9 cov]$ "p ,d drugs  7a7 ,9 g5]al   
,section #ahfj;,d-#aa7;i7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciew-#aaa7;i77 is am5d$--  7#a7 by    
/rik+ 7i7 ,non9t]f]5ce4--,9 & ins]t+ !  

foll[+3  7i7 ,non9t]f]5ce  7#a7 ,9 g5]al
 ,9  2  7#b7 by ins]t+ subject to       
p>agraph 7#b71 aft] "p12 &  7#c7 by add+
 at ! end ! foll[+ new p>agraph3  7#b7  
,exception = specifi$ drugs  7,a7       
,requirem5t  7i7 ,9 g5]al ,not)/&+      
p>agraph 7#a71 ! "p ,d price = specifi$ 
drugs %all be det]m9$ 9 accordance ) !  
process describ$ 9 subp>agraph 7,b74    
7ii7 ,specifi$ drugs ,= purposes ( ?is  
p>agraph1 ! t]m specifi$ drug means a   
cov]$ "p ,d drug-- 7,i7 t is--  7aa7 a  
s+le s\rce drug or biological2  7bb7 n a
 biological product lic5s$ pursuant to  
an application "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act2 &  7cc7 n  
bo? manufactur$ by m ?an two drug       
manufactur]s & manufactur$ by at lea/ "o
 su* manufactur] z a g5]ic drug2 or     
7,,ii7 t-- 7aa7 is select$ by !         
,secret>y = purposes ( ?is p>agraph2 &  
7bb7 ! ,secret>y det]m9es is a cov]$ "p 
,d drug ) respect to :i* !re is limit$  
ability = ,,pdp sponsors & ,,ma         
organizations to negotiate manufactur]  

rebates1 su* t ! ,secret>y det]m9es t ! 
failure to apply ?is p>agraph w h a     
significant fiscal impact on ! program  
"u ?is title4  7iii7 ,"p ,d price def9$ 
,= purposes ( ?is p>agraph1 ! t]m "p ,d 
price means1 ) respect to a cov]$ "p ,d 
drug1 ! price 7includ+ disc\nts1        
rebates1 & o!r price concessions7 t may 
be *>g$ to ,,pdp sponsors & ,,ma        
organizations = su* drug = "p ,d        
eligible individuals :o are enroll$ "u a
 prescription drug plan or "u an        
,,ma-,,pd plan4  7iv7 ,regulations =    
id5tification ( specifi$ drugs ,!       
,secret>y1 n lat] ?an "o ye> aft] ! date
 ( ! enactm5t ( ?is p>agraph1 %all      
promulgate regulations reg>d+ !         
id5tification ( s+le s\rce drugs &      
biologicals z specifi$ drugs4  7v7      
,process to petition t drug is no long] 
a specifi$ drug ,! ,secret>y %all       
e/abli% a process "u :i* a manufactur] =
 a specifi$ drug may petition !         
,secret>y = ! resc9d+ ( a previ\s       
id5tification ( a drug z a specifi$ drug

 "u clause 7ii7 bas$ ^u ! drug involv$  
no long] be+ a specifi$ drug4  7,b7     
,price det]m9ation process ,= purposes (
 subp>agraph 7,a71 ! process describ$ 9 
?is subp>agraph1 ) respect to ! "p ,d   
price = a specifi$ drug = a plan ye>1 is
 ! foll[+3  7i7 ,limit$ p]iod =         
negotiation = fir/ plan ye>  7,i7 ,9    
g5]al ,! ,secret>y %all negotiate su*   
price ) ! drug manufactur] involv$ = a  
p]iod ( n m ?an #ij days beg9n+ on !    
date ( id5tification ( ! drug z a       
specifi$ drug = su* plan ye> by !       
,secret>y4  7,,ii7 ,successful          
negotiations ,9 ! case t su* negotiation
 ) respect to su* #ij-;day p]iod results
 9 a price t is agre$ to by bo? !       
,secret>y & manufactur]1 su* price %all 
be ! maximum "p ,d price = su* specifi$ 
drug ?r\gh ! end ( ! plan ye> beg9n+    
aft] su* p]iod4  7ii7 ,secret>y sets    
price = fir/ plan ye> 9 case ( failure  
to negotiate price ,9 ! case t          
negotiations "u clause 7i71 ) respect to
 a specifi$ drug1 d n result 9 a price =

 su* specifi$ drug t is s agre$ to by ! 
,secret>y & drug manufactur]1 !         
,secret>y %all det]m9e a price = su*    
drug bas$ on--  7,i7 ! in=mation provid$
 to ! ,secret>y by ! drug manufactur]   
dur+ ! #ij-;day p]iod describ$ 9 clause 
7i77,i7 reg>d+ co/s associat$ ) su* drug
 t are applicable ) respect to su* drug 
manufactur]2  7,,ii7 9 ! case t paym5t  
is made = su* drug by ! ,dep>tm5t (     
,vet]ans ,affairs or "u title ,,xix1 !  
net pric$ paid = su* drug by su*        
,dep>tm5t or "u su* title1 z applicable2
  7,,iii7 ensur+ af=dability ( su* drug1
 & accessibility to su* drug1 =         
individuals entitl$ to b5efits "u "p ,a 
or enroll$ "u "p ,b2 &  7,,iv7 su* o!r  
factors z ! ,secret>y det]m9es          
appropriate4  ,! price det]m9$ "u ?is   
clause %all be ! maximum "p ,d price =  
su* specifi$ drug ?r\gh ! end ( ! plan  
ye> beg9n+ aft] su* det]m9ation ( su*   
price4  7iii7 ,price 9 subsequ5t plan   
ye>s ,= ea* plan ye> t is subsequ5t to !
 plan ye> = :i* a price is det]m9$ = a  

specifi$ drug "u clause 7i7 or 7ii7 & 9 
:i*1 on ! fir/ day ( su* subsequ5t plan 
ye>1 ! id5tification ( su* drug z a     
specifi$ drug /ill applies1 ! maximum   
price = su* drug %all be ! maximum "p ,d
 price = ! previ\s ye> det]m9$ "u clause
 7i7 or 7ii71 z applicable1 increas$ by 
! p]c5tage increase 9 ! consum] price   
index = all urban consum]s 7all items2  
,u4,s4 city av]age7 = ! #ab-mon? p]iod  
end+ ) ,june ( ! ye> be=e su* subsequ5t 
plan ye>4  7iv7 ,consultation ,9 det]m9+
 a price = a specifi$ drug "u clause    
7ii71 ! ,secret>y may consult ) !       
,comptroll] ,g5]al1 ! ,m$ic>e ,paym5t   
,advisory ,commission1 ! ,m$icaid &     
,,*ip ,paym5t & ,access ,commission1 or 
o!r outside1 indep5d5t exp]ts4  7,c7 ,no
 *ange 9 rules = =mul>ies  7i7 ,9 g5]al 
,no?+ 9 subp>agraph 7,a7 or 7,b7 %all be
 con/ru$ to au?orize ! ,secret>y to     
e/abli% or require a p>ticul> =mul>y4   
7ii7 ,con/ruction ,clause 7i7 %all n be 
con/ru$ z affect+ ! ,secret>y's au?ority
 to ensure appropriate & adequate access

 to cov]$ "p ,d drugs "u prescription   
drug plans & "u ,,ma-,,pd plans1 includ+
 compliance ( su* plans ) =mul>y        
requirem5ts "u section                  
#ahfj;,d-#d7;b77#c74  7,d7 ,con/ruction 
,no?+ 9 ?is p>agraph %all be con/ru$ z--
 7i7 prev5t+ ! sponsor ( a prescription 
drug plan1 or an organization (f]+ an   
,,ma-,,pd plan1 f obta9+ a disc\nt or   
r$uction ( ! price = a cov]$ "p ,d drug 
describ$ 9 subp>agraph 7,a7 bel[ ! price
 negotiat$ "u su* subp>agraph or det]m9$
 "u subp>agraph 7,b72 or  7ii7 p]mitt+ !
 ,secret>y to make propriet>y data      
available to ! public4  7,e7 ,def9itions
 ,9 ?is p>agraph3  7i7 ,drug manufactur]
 ,! t]m drug manufactur] has ! mean+    
giv5 ! t]m manufactur] 9 section        
#ahfj;,d-#ad;,a7g77#e74  7ii7 ,s+le     
s\rce drug or biological ,! t]m s+le    
s\rce drug or biological has ! mean+    
giv5 su* t]m 9 section                  
#ahdg;,a7c77#f77;,d74  4  7b7 ,requir+  
p>ticipation 9 negotiation process z    
condition ( "p ,d drug cov]age ,section 

#ahfj;,d-#ad;,a7b7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#aad;a7b77  
is am5d$ by add+ at ! end ! foll[+ new  
p>agraph3  7#e7 ,p>ticipation 9         
negotiation process ,ea* agreem5t "u ?is
 subsection %all include1 ) respect to  
plans ye>s beg9n+ ) plan ye> #bjai1 an  
agreem5t by ! manufactur]1 ) respect to 
ea* specifi$ drug ( su* manufactur] "u  
section #ahfj;d-#aa7;i77#b71 to         
p>ticipate 9 ! negotiation process "u   
su* section = su* drug1 includ+ accept+ 
! price result+ f ! negotiation 7or1 9 !
 case t su* negotiation does n result 9 
a price = su* drug t is agre$ to by !   
,secret>y & ! manufactur]1 ! price      
result+ f ! application ( subp>agraph   
7,b77ii7 ( su* section7 z ! maximum     
price = su* drug = ! p]iod provid$ "u   
su* section4  4  #c4 ,/udy & report  7a7
 ,/udy ,! ,secret>y ( ,heal? & ,human   
,s]vices %all conduct a /udy exam9+--   
7#a7 ! impact ( ! am5dm5ts made by      
section #b on--  7,a7 ! co/ ( s+le s\rce
 drugs & biologicals 7z def9$ 9 section 

#ahdg;,a7c77#f77;,d7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,d777 = :i* paym5t  
is made "u "p ,b ( title ,,xviii ( su*  
,act2 &  7,b7 ! accessibility ( su*     
drugs & biologicals = individuals       
entitl$ to b5efits "u "p ,a ( su* title 
or enroll$ "u "p ,b ( su* title2 &  7#b7
 options t w\ld p]mit or require !      
,secret>y to create & implem5t1 n lat]  
?an "o ye> aft] ! date ( ! report       
describ$ 9 subsection 7b7--  7,a7 a     
me?od to apply to su* s+le s\rce drugs &
 biologicals = :i* ! ,secret>y det]m9es 
appropriate--  7i7 an au?ority simil> to
 ! au?ority grant$ to ! ,secret>y "u    
subp>agraph 7,a7 ( section              
#ahfj;,d-#aa7;i77#b7 ( su* ,act 7relat+ 
to negotiat+ ) drug manufactur]s ! "p ,d
 prices = c]ta9 specifi$ drugs72 &  7ii7
 a negotiation process simil> to !      
process "u subp>agraph 7,b7 ( su*       
section2 &  7,b7 a me?od1 su* z a rebate
 program1 to incorporate ! rate         
negotiat$ = su* drugs & biologicals     

pursuant to ! au?ority describ$ 9       
subp>agraph 7,a7 into paym5ts = su*     
drugs & biologicals "u "p ,b ( su* ,act4
  7b7 ,report ,n lat] ?an "o ye> aft] ! 
date ( ! enactm5t ( ?is ,act1 !         
,secret>y ( ,heal? & ,human ,s]vices    
%all submit a report to ,congress on !  
results ( ! /udy conduct$ "u subsection 
7a74 ,su* report %all include           
recomm5dations reg>d+ ! options exam9$  
pursuant to p>agraph 7#b7 ( su*         
subsection4