,,ii  #aai? ,,congress  #a/ ,session    
,s4 #agag  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #ab1 #bjbe ,mr4   
,"y 7= himself & ,mr4 ,padilla7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
ensure prompt cov]age ( break?r\gh      
devices "u ! ,m$ic>e program1 & = o!r   
purposes4  #a4  ,%ort title  ,?is ,act  
may be cit$ z ! ,ensur+ ,pati5t ,access 
to ,critical ,break?r\gh ,products ,act 
( #bjbe4  #b4  ,ensur+ prompt cov]age ( 
break?r\gh devices "u ! ,m$ic>e program 
7a7  ,ensur+ cov]age ?r\gh a            
transitional cov]age p]iod  7#a7  ,9    
g5]al  ,section #ahfb7;a77#a7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#aciey7a77#a77 is am5d$--  7,a7 9       
subp>agraph 7,o71 by /rik+ & at ! end2  
7,b7 9 subp>agraph 7,p71 by /rik+ !     
semicolon at ! end & ins]t+ 1 &2 &  7,c7
 by ins]t+ aft] subp>agraph 7,p7 !      
foll[+ new subp>agraph3  7,q7 9 ! case (

 a break?r\gh device 7z def9$ 9 section 
#ahfa7nnn77 furni%$ dur+ ! transitional 
cov]age p]iod 7z s def9$7 ) respect to  
su* device1 :i* is n furni%$ 9          
accordance ) ! ,food & ,drug            
,adm9i/ration-approv$ label+ = su*      
device or t ! ,secret>y det]m9es1 bas$  
on a review ( cl9ical data1 pres5ts an  
undue risk ( h>m t outweighs ! pot5tial 
cl9ical b5efits = individuals entitl$ to
 b5efits "u "p ,a or enroll$ "u "p ,b2  
4  7#b7  ,def9itions  ,section #ahfa ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciex7 is am5d$ by add+ at ! end !     
foll[+ new subsection3  7nnn7           
,break?r\gh device  7#a7  ,9 g5]al  ,!  
t]m break?r\gh device means a device s  
designat$ by ! ,secret>y "u section     
#ahii;,c4  7#b7  ,transitional cov]age  
p]iod  ,! t]m transitional cov]age p]iod
 means1 ) respect to a break?r\gh       
device1 ! #d-ye> p]iod t beg9s on ! date
 t su* device is s designat$ by !       
,secret>y "u section #ahii;,c4  4  7#c7 
,break?r\gh device det]m9ations  ,"p ,e 

( title ,,xviii ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciex et seq47 is  
am5d$ by add+ at ! end ! foll[+ new     
section3  #ahii;,c4  ,designation (     
break?r\gh devices  7a7  ,9 g5]al       
,beg9n+ #ah mon?s aft] ! date ( !       
enactm5t ( ?is section1 ^u application (
 a manufactur] ( a device 7z def9$ 9    
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act7 t is cle>$1 classifi$1  
or approv$ "u section #eaj7k71          
#eac7;f77#b71 or #eae ( su* ,act on or  
aft] ! date ( ! enactm5t ( ?is section1 
! ,secret>y %all designate su* device z 
a break?r\gh device if ! ,secret>y      
det]m9es t su* device meets ! crit]ia   
specifi$ 9 subsection 7b74  7b7         
,crit]ia  ,= purposes ( subsection 7a71 
! crit]ia specifi$ 9 ?is subsection is1 
) respect to a device1 t ! device is    
provid$ ) priority review pursuant to   
section #eae;,b ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act4  7c7  ,det]m9ation   
process  7#a7  ,9 g5]al  ,! ,secret>y   
%all make a det]m9ation ) respect to a  

device t is ! subject ( an application  
describ$ 9 subsection 7a7 n lat] ?an #f 
mon?s aft] su* application is submitt$  
to ! ,secret>y4  7#b7  ,explanation     
requir$ 9 case ( det]m9ation t device   
does n meet crit]ia = designation  ,9 ! 
case t ! ,secret>y det]m9es t a device t
 is ! subject ( an application describ$ 
9 subsection 7a7 does n meet ! crit]ia  
specifi$ 9 subsection 7b71 ! ,secret>y  
%all notify ! manufactur] ( su* device (
 su* det]m9ation & include 9 su*        
notification an explanation id5tify+ !  
specific crit]ion or crit]ia t su*      
device fail$ to meet4  7d7  ,reports  ,!
 ,secret>y %all submit to ,congress on  
an annual basis a report specify+--     
7#a7 ! numb] ( applications receiv$ "u  
?is section dur+ su* ye>2  7#b7 ! numb] 
( devices designat$ z break?r\gh devices
 "u ?is section dur+ su* ye>2 &  7#c7 ! 
numb] ( applications = a designation = a
 device "u ?is section ) respect to :i* 
! ,secret>y det]m9$ t su* device did n  
meet ! crit]ia specifi$ 9 subsection 7b7

 dur+ su* ye>4  4  7b7  ,ensur+ issuance
 ( national cov]age det]m9ation dur+    
transition p]iod  ,section #ahfb7l77#b7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciey7l77#b77 is am5d$ by    
add+ at ! end ! foll[+ new flu% s5t5ce3 
,9 ! case ( a reque/ = a national       
cov]age det]m9ation ) respect to a      
break?r\gh device 7z def9$ 9 section    
#ahfa7nnn771 ! ,secret>y %all ensure t a
 f9al decision is made on su* reque/    
prior to ! end ( ! transitional cov]age 
p]iod 7z s def9$7 = su* device if su*   
reque/ 0 submitt$ to ! ,secret>y be=e ! 
date t is #i mon?s 7or #ab mon?s1 9 !   
case su* reque/ is a reque/ to :i*      
subp>agraph 7,b7 applies7 be=e ! la/ day
 ( su* p]iod4  4  7c7  ,fund+  ,9       
addition to am\nts o!rwise available1   
!re are appropriat$ to ! ,c5t]s =       
,m$ic>e  ,m$icaid ,s]vices ,program     
,managem5t ,acc\nt1 out ( any monies 9 !
 ,treasury n o!rwise appropriat$1       
#aj1jjj1jjj = ea* ( fiscal ye>s #bjbf   
?r\gh #bjca1 to rema9 available until   

exp5d$1 to c>ry out ! am5dm5ts made by  
?is section4