,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bdi  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,janu>y #bd1 #bjbe,mrs4
 ,blackburn 7= h]self & ,mr4 ,lank=d7   
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
facilitate pati5t access to c]ta9       
p$iatric te*nologies4  #a4 ,%ort title  
,?is ,act may be cit$ z ! ,access to    
,p$iatric ,te*nologies ,act ( #bjbe4    
#b4 ,facilitat+ access to p$iatric      
te*nologies  7a7 ,9 g5]al ,section #ahdh
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciew-#d7 is am5d$ by add+ at
 ! end ! foll[+ new subsection3  7u7    
,facilitat+ access to p$iatric          
te*nologies  7#a7 ,9 g5]al ,= ea*       
qualify+ p$iatric te*nology 7z def9$ 9  
p>agraph 7#d77 furni%$ on or aft]       
,janu>y #a1 #bjbf1 ! ,secret>y %all1 ^u 
receipt ( a manufactur] reque/ "u       
p>agraph 7#c71 e/abli% national relative
 value units "u ! physician fee s*$ule  

e/abli%$ "u ?is section1 to ! ext5t no  
su* national relative value units h be5 
e/abli%$ = su* qualify+ p$iatric        
te*nology "u su* fee s*$ule4  7#b7      
,paym5t me?odology ,! ,secret>y %all    
e/abli% national relative value units = 
a qualify+ p$iatric te*nology "u ?is    
subsection-- 7,a7 9 accordance ) !      
paym5t me?odology e/abli%$ "u ?is       
section & applicable regulations2 &     
7,b7 us+ available data relat$ to !     
qualify+ p$iatric te*nology1 :i* may    
include applicable contractor pric+     
in=mation1 claims data1 "t & motion     
/udies1 invoice in=mation1 or o!r       
in=mation us$ by ! ,secret>y 9 e/abli%+ 
paym5t rates4  7#c7 ,implem5tation  7,a7
 ,9 g5]al ,^u writt5 reque/ to !        
,secret>y f ! manufactur] ( a qualify+  
p$iatric te*nology1 ! ,secret>y %all    
e/abli% national relative value units "u
 p>agraph 7#a7 ?r\gh ! annual rulemak+  
process = ! physician fee s*$ule        
e/abli%$ "u ?is section1 9 accordance ) 
! timel9e describ$ 9 subp>agraph 7,b74  

7,b7 ,timel9e  7i7 ,9 ! case :]e !      
,secret>y receives a reque/ "u ?is      
p>agraph on or be=e ,may #a ( a giv5 ye>
 f a manufactur] ) respect to a qualify+
 p$iatric te*nology ( ! manufactur]1 !  
,secret>y %all e/abli% national relative
 value units = ! qualify+ p$iatric      
te*nology 9 ! rulemak+ process dur+ t   
ye> = ! physician fee s*$ule e/abli%$ "u
 ?is section4  7ii7 ,9 ! case :]e !     
,secret>y receives a reque/ "u ?is      
p>agraph aft] ,may #a ( a giv5 ye> f a  
manufactur] ) respect to a qualify+     
p$iatric te*nology ( ! manufactur]1 !   
,secret>y %all e/abli% national relative
 value units = ! qualify+ p$iatric      
te*nology 9 ! rulemak+ process dur+ !   
foll[+ ye> = ! physician fee s*$ule     
e/abli%$ "u ?is section4  7,c7 ,cont5t (
 manufactur] reque/s ,a manufactur]     
submitt+ a reque/ "u ?is p>agraph )     
respect to a qualify+ p$iatric te*nology
 ( ! manufactur] %all include 9 su*     
reque/ in=mation to v]ify t ! te*nology 
is a qualify+ p$iatric te*nology & to   

all[ ! ,secret>y to e/abli% national    
relative value units = su* te*nology1   
includ+ 7to ! ext5t available7          
contractor pric+ in=mation1 claims data1
 "t & motion /udies1 invoice in=mation1 
or o!r relevant in=mation4  7#d7        
,qualify+ p$iatric te*nology def9$ ,9   
?is subsection1 ! t]m qualify+ p$iatric 
te*nology means a m$ical device t is--  
7,a7 cov]$ "u ?is title2  7,b7 approv$1 
cle>$1 or au?oriz$ "u section #eaj7k71  
#eac7;f77#b71 or #eae ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7k71 #cfj;c7f77#b71 #cfj;e72  7,c7  
describ$ by a tempor>y ,level ,i ,,hcpcs
 ,code int5d$ = em]g+ te*nologies1      
s]vices1 or proc$ures2 &  7,d7 7i7 us$ z
 "p ( a proc$ure pr$om9antly p]=m$ on   
p$iatric pati5ts2 or  7ii7 has o!rwise  
be5 specifically design$ = safe &       
effective use 9 p$iatric populations4   
7#e7 ,rule ( con/ruction ,no?+ 9 ?is    
subsection %all be con/ru$ to require   
cov]age ( a qualify+ p$iatric te*nology 
"u ?is title or alt] ! requirem5ts (    

section #ahfb7;a77#a77;,a74  4