,,ii  #aaith ,,congress  #ast ,session  
,s4 #bdi  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,january #bd1       
#bjbe,mrs4 ,blackburn 7for herself and  
,mr4 ,lankford7 introduced the following
 bill2 which was read twice and referred
 to the ,committee on ,finance  ,a      
,,bill  ,to amend title ,,xviii of the  
,social ,security ,act to facilitate    
patient access to certain pediatric     
technologies4  #a4 ,short title ,this   
,act may be cited as the ,access to     
,pediatric ,technologies ,act of #bjbe4 
#b4 ,facilitating access to pediatric   
technologies  7a7 ,in general ,section  
#ahdh of the ,social ,security ,act 7#db
 ,u4,s4,c4 #aciew-#d7 is amended by     
adding at the end the following new     
subsection3  7u7 ,facilitating access to
 pediatric technologies  7#a7 ,in       
general ,for each qualifying pediatric  
technology 7as defined in paragraph     
7#d77 furnished on or after ,january #a1
 #bjbf1 the ,secretary shall1 upon      
receipt of a manufacturer request under 

paragraph 7#c71 establish national      
relative value units under the physician
 fee schedule established under this    
section1 to the extent no such national 
relative value units have been          
established for such qualifying         
pediatric technology under such fee     
schedule4  7#b7 ,payment methodology    
,the ,secretary shall establish national
 relative value units for a qualifying  
pediatric technology under this         
subsection-- 7,a7 in accordance with the
 payment methodology established under  
this section and applicable regulations2
 and  7,b7 using available data related 
to the qualifying pediatric technology1 
which may include applicable contractor 
pricing information1 claims data1 time  
and motion studies1 invoice information1
 or other information used by the       
,secretary in establishing payment      
rates4  7#c7 ,implementation  7,a7 ,in  
general ,upon written request to the    
,secretary from the manufacturer of a   
qualifying pediatric technology1 the    

,secretary shall establish national     
relative value units under paragraph    
7#a7 through the annual rulemaking      
process for the physician fee schedule  
established under this section1 in      
accordance with the timeline described  
in subparagraph 7,b74  7,b7 ,timeline   
7i7 ,in the case where the ,secretary   
receives a request under this paragraph 
on or before ,may #a of a given year    
from a manufacturer with respect to a   
qualifying pediatric technology of the  
manufacturer1 the ,secretary shall      
establish national relative value units 
for the qualifying pediatric technology 
in the rulemaking process during that   
year for the physician fee schedule     
established under this section4  7ii7   
,in the case where the ,secretary       
receives a request under this paragraph 
after ,may #a of a given year from a    
manufacturer with respect to a          
qualifying pediatric technology of the  
manufacturer1 the ,secretary shall      
establish national relative value units 

for the qualifying pediatric technology 
in the rulemaking process during the    
following year for the physician fee    
schedule established under this section4
  7,c7 ,content of manufacturer requests
 ,a manufacturer submitting a request   
under this paragraph with respect to a  
qualifying pediatric technology of the  
manufacturer shall include in such      
request information to verify that the  
technology is a qualifying pediatric    
technology and to allow the ,secretary  
to establish national relative value    
units for such technology1 including 7to
 the extent available7 contractor       
pricing information1 claims data1 time  
and motion studies1 invoice information1
 or other relevant information4  7#d7   
,qualifying pediatric technology defined
 ,in this subsection1 the term          
qualifying pediatric technology means a 
medical device that is-- 7,a7 covered   
under this title2  7,b7 approved1       
cleared1 or authorized under section    
#eaj7k71 #eac7;f77#b71 or #eae of the   

,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj7k71            
#cfj;c7f77#b71 #cfj;e72  7,c7 described 
by a temporary ,level ,i ,,hcpcs ,code  
intended for emerging technologies1     
services1 or procedures2 and  7,d7 7i7  
used as part of a procedure             
predominantly performed on pediatric    
patients2 or  7ii7 has otherwise been   
specifically designed for safe and      
effective use in pediatric populations4 
7#e7 ,rule of construction ,nothing in  
this subsection shall be construed to   
require coverage of a qualifying        
pediatric technology under this title or
 alter the requirements of section      
#ahfb7;a77#a77;,a74  4