,i  #aahth ,,congress  #b;d ,session    
,h4 ,r4 #gici  ,,in ,,the ,,house ,,of  
,,representatives  ,april #aa1 #bjbd,mr4
 ,carey 7for himself and ,mr4 ,davis of 
,illinois7 introduced the following     
bill2 which was referred to the         
,committee on ,ways and ,means1 and in  
addition to the ,committee on ,energy   
and ,commerce1 for a period to be       
subsequently determined by the ,speaker1
 in each case for consideration of such 
provisions as fall within the           
jurisdiction of the committee concerned 
,a ,,bill  ,to amend title ,,xviii of   
the ,social ,security ,act to improve   
,medicare beneficiary access to new     
medical technologies that improve health
 care quality and outcomes by ensuring  
that breakthrough devices are eligible  
for conditional approval under the      
,medicare ,new ,technology ,add-,on     
,payment 7,,ntap7 ,program1 enabling    
these medical breakthroughs to be       
provided to ,medicare beneficiaries     
without unnecessary delay4  #a4 ,short  

title ,this ,act may be cited as the    
,patient ,access to ,innovative ,new    
,technologies ,act of #bjbd4  #b4       
,increasing adoption of and access to   
breakthrough devices  7a7 ,in general   
,section #ahhf7;d77#e77,k7 of the       
,social ,security ,act 7#db ,u4,s4,c4   
#acieww7d77#e77,k77 is amended by adding
 at the end the following new clause3   
7x7  7,i7 ,a breakthrough device that is
 not approved1 cleared1 or authorized   
under section #eaj7k71 #eac7;f77#b71 or 
#eae of the ,federal ,food1 ,drug1 and  
,cosmetic ,act by the deadline specified
 in section #dab4hg7;f77#b7 of title    
#db1 ,code of ,federal ,regulations 7or 
a successor regulation7 may be          
conditionally approved for the new      
technology add-on payment under this    
subparagraph for a particular fiscal    
year1 effective for discharges beginning
 in the first quarter after receiving   
such approval1 clearance1 or            
authorization1 provided that the        
approval1 clearance1 or authorization is

 granted before ,july #a of the fiscal  
year for which the applicant applied for
 new technology add-on payments4  7,,ii7
 ,for purposes of this clause1 the term 
breakthrough device means a medical     
device that--  7aa7 is designated for   
expedited development and priority      
review under section #eae;,b of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act2 and  7bb7 has been approved1      
cleared1 or authorized under section    
#eaj7k71 #eac7;f77#b71 or #eae of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act for the indication for which the   
designation described in item 7aa7 was  
made4  7,,iii7 ,this clause shall not be
 considered an adjustment and shall be  
implemented in a budget neutral manner4 
4  7b7 ,effective date ,this section1   
and the amendments made by this section1
 shall take effect on the enactment of  
this ,act and shall apply to a          
breakthrough device 7as defined in      
section #ahhf7;d77#e77,k77x77,,ii7 of   
the ,social ,security ,act1 as added by 

subsection 7a77 that is 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;e7 on or after ,july
 #a1 #bjbc4