,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #fafj  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #g1 #bjba    
,ms4 ,matsui 7= h]self1 ,mr4 ,?ompson ( 
,cali=nia1 ,mr4 ,mull91 & ,mr4 ,kelly ( 
,p5nsylvania7 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 titles     
,,xviii & ,,xix ( ! ,social ,security   
,act & title ,,xxvii ( ! ,public ,heal? 
,s]vice ,act to provide = cov]age (     
c]ta9 drugs us$ 9 ! treatm5t or         
managem5t ( a r>e disease or condition1 
& = o!r purposes4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,access to ,r>e    
,indications ,act ( #bjba4  #b4 ,cov]age
 ( c]ta9 drugs us$ 9 treatm5t or        
managem5t ( r>e disease or condition    
7a7 ,m$ic>e  7#a7 ,9 g5]al ,section     
#ahfa7t77#b7 ( ! ,social ,security ,act 

7#db ,u4,s4,c4 #aciex7t77#b77 is am5d$--
  7,a7 9 subp>agraph 7,a71 by ins]t+    
aft] regim5 ! foll[+3 1 or 9 ! treatm5t 
or managem5t ( a disease or condition   
affect+ #bjj1jjj or few] individuals 9 !
 ,unit$ ,/ates12 &  7,b7 9 subp>agraph  
7,b77ii7--  7i7 9 subclause 7,i71 by    
/rik+ 1 or at ! end & ins]t+ a          
semicolon2  7ii7 9 subclause 7,,ii71 by 
/rik+ ! p]iod at ! end & ins]t+ 2 or2 & 
7iii7 by add+ at ! end ! foll[+ new     
subclause3  7,,iii7 9 ! case ( a drug t 
is us$ 9 ! treatm5t or managem5t ( a    
disease or condition affect+ #bjj1jjj or
 few] individuals 9 ! ,unit$ ,/ates1 su*
 use is support$ by pe]-review$ m$ical  
lit]ature1 cl9ical guidel9es1 or an     
exp]t 9 su* disease or condition z      
id5tifi$ by a m$ical society involv$ 9 !
 treatm5t or managem5t ( su* disease or 
condition1 & is n review$ unfavorably 9 
! comp5dia describ$ 9 section           
#aibg7;g77#a77;,b77i71 or li/$ z a      
contra9dication 9 ! ,,fda-approv$       
label+4  4  7#b7 ,m$ically accept$ uses 

( cov]$ "p d drugs 9 treat+ r>e         
conditions ,section                     
#ahfj;,d-#b7;e77#d77;,a7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;e77#d77;,a77 is am5d$--    
7,a7 9 clause 7i77,,ii71 by /rik+ &2    
7,b7 by r$esignat+ clause 7ii7 z clause 
7iii72 &  7,c7 by ins]t+ aft] clause    
7i77,,ii7 ! foll[+ new clause3  7ii7 9 !
 case ( a cov]$ "p ,d drug us$ 9 !      
treatm5t or managem5t ( a disease or    
condition affect+ #bjj1jjj or few]      
individuals 9 ! ,unit$ ,/ates1 9 section
 #ahfa7t77#b77;,b72 &  4  7#c7          
,effective date ,! am5dm5ts made by ?is 
subsection apply ) respect to items &   
s]vices furni%$ on or aft] ! date t is  
#cj days aft] ! date ( ! enactm5t ( ?is 
,act4  7b7 ,m$icaid  7#a7 ,9 g5]al      
,section #aibg7k77#f7 ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7k77#f77 is am5d$ to read z    
foll[s3  7#f7 ,m$ically accept$         
indication ,! t]m m$ically accept$      
indication means any use = a cov]$      

drug--  7,a7 :i* is approv$ "u ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act2  7,b7   
:i* is support$ by "o or m citations    
includ$ or approv$ = inclusion 9 any ( !
 comp5dia describ$ 9 subsection         
7g77#a77;,b77i72 or  7,c7 9 ! case ( a  
drug us$ to treat or manage a disease or
 condition affect+ #bjj1jjj or few]     
individuals 9 ! ,unit$ ,/ates-- 7i7 !   
use ( su* drug is support$ by           
pe]-review$ m$ical lit]ature1 cl9ical   
guidel9es1 or an exp]t 9 su* disease or 
condition z id5tifi$ by a m$ical society
 involv$ 9 ! treatm5t or managem5t ( su*
 disease or condition2 &  7ii7 is n     
review$ unfavorably 9 ! comp5dia        
describ$ 9 subsection 7g77#a77;,b77i71  
or li/$ z a contra9dication 9 !         
,,fda-approv$ label+4  4  7#b7 ,con=m+  
am5dm5t ,section #aibg7;d77#d77;,c7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acifr-#h7;d77#d77;,c77 is am5d$ by     
/rik+ comp5dia & ins]t+ s\rces4  7#c7   
,effective date ,! am5dm5ts made by ?is 
subsection apply ) respect to cov]$     

outpati5t drugs furni%$ on or aft] !    
date t is #cj days aft] ! date ( !      
enactm5t ( ?is ,act4  7c7 ,private heal?
 insurance  7#a7 ,9 g5]al ,subp>t ,,ii (
 "p ,a ( title ,,xxvii ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#cjj;gg-#aa et seq47 is am5d$ by add+ at
 ! end ! foll[+ new section3  #bgcj4 ,9 
g5]al ,cov]age ( c]ta9 drugs us$ 9      
treatm5t or managem5t ( a r>e disease or
 condition ,a gr\p heal? plan or a heal?
 insurance issu] (f]+ gr\p or individual
 heal? insurance cov]age %all provide a 
me*anism = exp$it$ =mul>y exception1    
reconsid]ation1 & appeal ( any d5ial (  
cov]age = a drug or biological-- 7#a7   
approv$ by ! ,food & ,drug              
,adm9i/ration2  7#b7 = :i* ! use is     
relat$ to treatm5t or managem5t ( a     
disease or condition affect+ #bjj1jjj or
 few] individuals 9 ! ,unit$ ,/ates2 &  
7#c7 ! use ( :i* is support$ by !       
,,fda-approv$ label1 pe]-review$        
lit]ature1 cl9ical guidel9es1 or an     
exp]t 9 su* disease or condition z      

id5tifi$ by a m$ical society involv$ 9 !
 treatm5t or managem5t ( su* disease or 
condition1 & t is n review$ unfavorably 
9 ! comp5dia describ$ 9 section         
#aibg7;g77#a77;,b77i7 ( ! ,social       
,security ,act or li/$ z a              
contra9dication 9 ! ,,fda-approv$       
label+4  4  7#b7 ,effective date ,!     
am5dm5t made by ?is subsection applies )
 respect to plan ye>s beg9n+ on or aft] 
! date t is #cj days aft] ! date ( !    
enactm5t ( ?is ,act4