,,ii  #aahth ,,congress  #b;d ,session  
,s4 #ecdi  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,november #bj1 
#bjbd,mr4 ,young 7for himself and ,mr4  
,padilla7 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 ensure prompt coverage
 of breakthrough devices under the      
,medicare program1 and for other        
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,ensuring ,patient  
,access to ,critical ,breakthrough      
,products ,act of #bjbd4  #b4 ,ensuring 
prompt coverage of breakthrough devices 
under the ,medicare program  7a7        
,ensuring coverage through a            
transitional coverage period  7#a7 ,in  
general ,section #ahfb7;a77#a7 of the   
,social ,security ,act 7#db ,u4,s4,c4   
#aciey7a77#a77 is amended-- 7,a7 in     
subparagraph 7,o71 by striking and at   
the end2  7,b7 in subparagraph 7,p71 by 
adding and at the end2 and  7,c7 by     

inserting after subparagraph 7,p7 the   
following new subparagraph3  7,q7 in the
 case of a breakthrough device 7as      
defined in section #ahfa7nnn77 furnished
 during the transitional coverage period
 7as so defined7 with respect to such   
device1 which is not furnished in       
accordance with the ,food and ,drug     
,administration-approved labeling for   
such device or that the ,secretary      
determines1 based on a review of        
clinical data1 presents an undue risk of
 harm that outweighs the potential      
clinical benefits for individuals       
entitled to benefits under part ,a or   
enrolled under part ,b2  4  7#b7        
,definitions ,section #ahfa of the      
,social ,security ,act 7#db ,u4,s4,c4   
#aciex7 is amended by adding at the end 
the following new subsection3  7nnn7    
,breakthrough device  7#a7 ,in general  
,the term breakthrough device means a   
device so designated by the ,secretary  
under section #ahii;,c4  7#b7           
,transitional coverage period ,the term 

transitional coverage period means1 with
 respect to a breakthrough device1 the  
#d-year period that begins on the date  
that such device is so designated by the
 ,secretary under section #ahii;,c4  4  
7#c7 ,breakthrough device determinations
 ,part ,e of title ,,xviii of the       
,social ,security ,act 7#db ,u4,s4,c4   
#aciex et seq47 is amended by adding at 
the end the following new section3      
#ahii;,c4 ,designation of breakthrough  
devices  7a7 ,in general ,beginning #ah 
months after the date of the enactment  
of this section1 upon application of a  
manufacturer of a device 7as defined in 
section #bja of the ,federal ,food1     
,drug1 and ,cosmetic ,act7 that is      
cleared1 classified1 or approved under  
section #eaj7k71 #eac7;f77#b71 or #eae  
of such ,act on or after the date of the
 enactment of this section1 the         
,secretary shall designate such device  
as a breakthrough device if the         
,secretary determines that such device  
meets the criteria specified in         

subsection 7b74  7b7 ,criteria ,for     
purposes of subsection 7a71 the criteria
 specified in this subsection is1 with  
respect to a device1 that the device is 
provided with priority review pursuant  
to section #eae;,b of the ,federal      
,food1 ,drug1 and ,cosmetic ,act4  7c7  
,determination process  7#a7 ,in general
 ,the ,secretary shall make a           
determination with respect to a device  
that is the subject of an application   
described in subsection 7a7 not later   
than #f months after such application is
 submitted to the ,secretary4  7#b7     
,explanation required in case of        
determination that device does not meet 
criteria for designation ,in the case   
that the ,secretary determines that a   
device that is the subject of an        
application described in subsection 7a7 
does not meet the criteria specified in 
subsection 7b71 the ,secretary shall    
notify the manufacturer of such device  
of such determination and include in    
such notification an explanation        

identifying the specific criterion or   
criteria that such device failed to     
meet4  7d7 ,reports ,the ,secretary     
shall submit to ,congress on an annual  
basis a report specifying-- 7#a7 the    
number of applications received under   
this section during such year2  7#b7 the
 number of devices designated as        
breakthrough devices under this section 
during such year2 and  7#c7 the number  
of applications for a designation for a 
device under this section with respect  
to which the ,secretary determined that 
such device did not meet the criteria   
specified in subsection 7b7 during such 
year4  4  7b7 ,ensuring issuance of     
national coverage determination during  
transition period ,section #ahfb7l77#b7 
of the ,social ,security ,act 7#db      
,u4,s4,c4 #aciey7l77#b77 is amended by  
adding at the end the following new     
flush sentence3 ,in the case of a       
request for a national coverage         
determination with respect to a         
breakthrough device 7as defined in      

section #ahfa7nnn771 the ,secretary     
shall ensure that a final decision is   
made on such request prior to the end of
 the transitional coverage period 7as so
 defined7 for such device if such       
request was submitted to the ,secretary 
before the date that is #i months 7or   
#ab months1 in the case such request is 
a request to which subparagraph 7,b7    
applies7 before the last day of such    
period4 4  7c7 ,funding ,in addition to 
amounts otherwise available1 there are  
appropriated to the ,centers for        
,medicare  ,medicaid ,services ,program 
,management ,account1 out of any monies 
in the ,treasury not otherwise          
appropriated1 #aj1jjj1jjj for each of   
fiscal years #bjbe through #bjcj1 to    
remain available until expended1 to     
carry out the amendments made by this   
section4