,,ii  #aai? ,,congress  #a/ ,session    
,s4 #ceea  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #ag1 #bjbe,mr4
 ,tillis 7= himself & ,mr4 ,he9ri*7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,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 ! ,provid+ ,reali/ic 
,opportunity ,to ,equal & ,comp>able    
,treatm5t = ,r>e ,act or ! ,,protect =  
,r>e ,act4  #b4 ,cov]age ( c]ta9 drugs  
us$ 9 treatm5t or managem5t ( a r>e     
disease or condition  7a7 ,m$ic>e  7#a7 
,def9ition  7,a7 ,9 g5]al ,section      
#ahfa7t77#b7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciex7t77#b77 is am5d$--
 7i7 9 subp>agraph 7,a71 by ins]t+ aft] 
regim5 ! foll[+3 1 or us$ 9 ! treatm5t  
or managem5t ( a disease or condition   

affect+ #bjj1jjj or few] individuals 9 !
 ,unit$ ,/ates12 &  7ii7 9 subp>agraph  
7,b77ii7-- 7,i7 9 subclause 7,i71 by    
/rik+ 1 or at ! end & ins]t+ a          
semicolon2  7,,ii7 9 subclause 7,,ii71  
by /rik+ ! p]iod at ! end & ins]t+ 2 or2
 &  7,,iii7 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$ical lit]ature1 includ+   
cl9ical guidel9es1 & is n specifically  
li/$ z n indicat$ 9 "o or m ( ! comp5dia
 describ$ 9 section                     
#aibg7;g77#a77;,b77i71 or li/$ z        
contra9dicat$ 9 ! label+ approv$ by !   
,food & ,drug ,adm9i/ration4  4  7,b7   
,effective date ,! am5dm5ts made by     
subp>agraph 7,a7 %all apply to items &  
s]vices furni%$ on or aft] ,janu>y #a1  
#bjbg44  7#b7 ,m$ically accept$ uses (  
cov]$ "p ,d drugs 9 treat+ r>e          
conditions  7,a7 ,9 g5]al ,section      

#ahfj;,d-#b7;e77#d77;,a77i7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;e77#d77;,a77i77 is am5d$1 9
 ! matt] prec$+ subclause 7,i71 by      
ins]t+ or 9 ! case ( a cov]$ "p ,d drug 
us$ 9 ! treatm5t or managem5t ( a       
disease or condition affect+ #bjj1jjj or
 few] individuals 9 ! ,unit$ ,/ates1    
aft] regim51  7,b7 ,effective date ,!   
am5dm5t made by subp>agraph 7,a7 %all   
apply to plan ye>s beg9n+ on or aft]    
,janu>y #a1 #bjbg4  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]$      
outpati5t 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    
:i*1 9 ! case ( a drug us$ to treat or  

manage a disease or condition affect+   
#bjj1jjj or few] individuals 9 ! ,unit$ 
,/ates-- 7i7 is a use ( su* drug t is   
support$ by pe]-review$ m$ical          
lit]ature1 cl9ical guidel9es1 or an     
exp]t 9 su* disease or condition1 z     
id5tifi$ by a m$ical society involv$ 9 !
 treatm5t or managem5t ( su* disease or 
condition2 &  7ii7 is a use ( su* drug t
 is n li/$ z n indicat$ 9 ! comp5dia    
describ$ 9 subsection 7g77#a77;,b77i71  
or li/$ z contra9dicat$ 9 ! label+      
approv$ by ! ,food & ,drug              
,adm9i/ration4  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 %all apply ) respect to cov]$
 outpati5t drugs furni%$ on or aft]     
,janu>y #a1 #bjbg4  7c7 ,private heal?  
insurance  7#a7 ,9 g5]al  7,a7 ,,phsa   
,"p ,d ( title ,,xxvii ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      

#cjj;gg-#aaa et seq47 is am5d$ by add+  
at ! end ! foll[+ new section3          
#bgii;,a-#aa4 ,exp$it$ process = review 
associat$ ) 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 an 
exp$it$ process pursuant to section     
#bgai by :i* a p>ticipant1 b5efici>y1 or
 enrollee1 or a designee or prescrib+   
physician 7or o!r prescrib]1 z          
appropriate7 ( ! p>ticipant1 b5efici>y1 
or enrollee1 may appeal any d5ial (     
cov]age = a drug or biological product--
 7#a7 approv$ "u section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act or      
lic5s$ "u section #cea2  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--    
7,a7 ! label+ = ! drug or biological    
product approv$ pursuant to su* section 
#eje or #cea2 or  7,b7 pe]-review$      

lit]ature1 includ+ cl9ical guidel9es1 & 
t is n review$ unfavorably 9 ! comp5dia 
describ$ 9 section #aibg7;g77#a77;,b77i7
 ( ! ,social ,security ,act & is n li/$ 
z a contra9dication 9 su* approv$       
label+4  4  7,b7 ,,erisa  7i7 ,9 g5]al  
,subp>t ,b ( "p #g ( subtitle ,b ( title
 ,i ( ! ,employee ,retirem5t ,income    
,security ,act ( #aigd 7#bi ,u4,s4,c4   
#aahe et seq47 is am5d$ by add+ at ! end
 ! foll[+ new section3  #gcf4 ,exp$it$  
process = review associat$ ) 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    
heal? insurance cov]age %all provide an 
exp$it$ process pursuant to section     
#bgai ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #cjj;gg-#ai7 by :i* a    
p>ticipant or b5efici>y1 or a designee  
or prescrib+ physician 7or o!r          
prescrib]1 z appropriate7 ( ! p>ticipant
 or b5efici>y1 may appeal any d5ial (   
cov]age = a drug or biological product--
 7#a7 approv$ "u section #eje ( ! ,f$]al

 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb72  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-- 7,a7 !
 label+ = ! drug or biological product  
approv$ pursuant to su* section #eje or 
#cea2 or  7,b7 pe]-review$ lit]ature1   
includ+ cl9ical guidel9es1 & t is n     
review$ unfavorably 9 ! comp5dia        
describ$ 9 section #aibg7;g77#a77;,b77i7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #acifr-#h7;g77#a77;,b77i77 &  
is n li/$ z a contra9dication 9 su*     
approv$ label+4  4  7ii7 ,cl]ical       
am5dm5t ,! table ( cont5ts 9 section #a 
( ! ,employee ,retirem5t ,income        
,security ,act ( #aigd 7#bi ,u4,s4,c4   
#ajja et seq47 is am5d$ by ins]t+ aft] !
 item relat+ to section #gbe ! foll[+   
new item3  ,sec4 #gbf4 ,exp$it$ process 
= review associat$ ) c]ta9 drugs us$ 9  

treatm5t or managem5t ( a r>e disease or
 condition4  4  7,c7 ,,irc  7i7 ,9 g5]al
 ,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal 
,rev5ue ,code ( #aihf is am5d$ by add+  
at ! end ! foll[+ new section3  #ihbf4  
,exp$it$ process = review associat$ )   
c]ta9 drugs us$ 9 treatm5t or managem5t 
( a r>e disease or condition ,a gr\p    
heal? plan %all provide an exp$it$      
process pursuant to section #bgai ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;gg-#ai7 by :i* a         
p>ticipant or b5efici>y1 or a designee  
or prescrib+ physician 7or o!r          
prescrib]1 z appropriate7 ( ! p>ticipant
 or b5efici>y1 may appeal any d5ial (   
cov]age = a drug or biological product--
 7#a7 approv$ "u section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb72  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-- 7,a7 !
 label+ = ! drug or biological product  
approv$ pursuant to su* section #eje or 
#cea2 or  7,b7 pe]-review$ lit]ature1   
includ+ cl9ical guidel9es1 & t is n     
review$ unfavorably 9 ! comp5dia        
describ$ 9 section #aibg7;g77#a77;,b77i7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #acifr-#h7;g77#a77;,b77i77 &  
is n li/$ z a contra9dication 9 su*     
approv$ label+4  4  7ii7 ,cl]ical       
am5dm5t ,! table ( sections = sub*apt]  
,b ( *apt] #ajj ( ! ,int]nal ,rev5ue    
,code ( #aihf is am5d$ by add+ at ! end 
! foll[+ new item3 ,sec4 #ihbf4 ,exp$it$
 process = review associat$ ) c]ta9     
drugs us$ 9 treatm5t or managem5t ( a   
r>e disease or condition44  7#b7        
,effective date ,! am5dm5ts made by ?is 
subsection %all apply ) respect to plan 
ye>s beg9n+ on or aft] ,janu>y #a1      
#bjbg4