,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #ecdc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ae1        
#bjbe,mr4 ,moore ( ,utah 7= himself1    
,ms4 ,del,bene1 ,mr4 ,yakym1 ,ms4       
,sewell1 ,mr4 ,bilirakis1 & ,mrs4       
,trahan7 introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,ways &       
,means1 & 9 addition to ! ,committee on 
,en]gy & ,comm]ce1 = a p]iod to be      
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
ensure prompt cov]age ( break?r\gh      
devices "u ! ,m$ic>e program4  #a4 ,%ort
 title  ,?is ,act may be cit$ z !       
,ensur+ ,pati5t ,access to ,critical    
,break?r\gh ,products ,act4  #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$-- 7,a7 9        
subp>agraph 7,o71 by /rik+ & at ! end2  
7,b7 9 subp>agraph 7,p71 by add+ & at ! 
end2 &  7,c7 by ins]t+ aft] subp>agraph 
7,p7 ! foll[+ new subp>agraph3  7,q7 9 !
 case ( a break?r\gh device 7z def9$ 9  
section #ahfa7nnn77 furni%$ dur+ !      
transitional cov]age p]iod 7z s def9$7 )
 respect to su* device1 :i* is n furni%$
 = ! diagnosis or treatm5t ( illness or 
injury or to improve ! function+ ( a    
mal=m$ body memb] 9 accordance ) ! ,food
 & ,drug ,adm9i/ration-approv$ label+ = 
su* device & = ! indication = :i* su*   
device 0 provid$ priority review "u     
section #eae;,b ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act1 or t ! ,secret>y     
f9ds1 bas$ 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 t--   
7,a7 is s designat$ by ! ,secret>y "u   
section #ahii;,d2 &  7,b7 is furni%$ at 
su* frequ5cy z specifi$ 9 ! ,food &     
,drug ,adm9i/ration-approv$ label+ = su*
 device 7or1 9 ! case su* device has no 
frequ5cy s specifi$1 at su* frequ5cy z  
det]m9$ appropriate by ! ,secret>y74    
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;,d4  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;,d4    
,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 are1 
) respect to a device1 ! foll[+3 7#a7 ,!
 device is provid$ ) priority review    
pursuant to section #eae;,b ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act4  7#b7 ,9
 ! case su* device is cle>$ "u section  
#eaj7k7 ( su* ,act1 su* device is s     
cle>$ bas$ on cl9ical data1 :i* may     
include cl9ical trial in=mation f an    
applicable device cl9ical trial 7z su*  
t]ms are def9$ 9 section #djb7;j7 ( su* 
,act71 t includ$ individuals entitl$ to 
b5efits "u "p ,a or enroll$ "u "p ,b4   
7#c7 ,! device w\ld1 )\t application (  
section #ahfb7;a71 o!rwise be cov]$ "u  
"p ,a or ,b4  7#d7 ,! device does n1    
bas$ on a review ( cl9ical data1 pres5t 

an undue risk ( h>m t outweighs !       
pot5tial cl9ical b5efits = individuals  
entitl$ to b5efits "u "p ,a or enroll$  
"u "p ,b1 z det]m9$ by ! ,secret>y4  7c7
 ,det]m9ation process  7#a7 ,9 g5]al ,! 
,secret>y %all make a det]m9ation )     
respect to ! designation ( 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 ( nondesignation ,) respect to a   
device t is ! subject ( an application  
describ$ 9 subsection 7a71 9 ! case t ! 
,secret>y det]m9es t su* device does n  
meet ! crit]ia specifi$ 9 subsection    
7b71 ! ,secret>y %all notify !          
manufactur] ( su* device ( su*          
det]m9ation & include 9 su* notification
 an id5tification ( ! specific crit]ion 
or crit]ia t su* device fail$ to meet & 
an explanation ( :y su* device fail$ to 
meet su* crit]ion or crit]ia4  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  7e7 ,review ( ab]rant bill+ ,!
 ,secret>y may conduct a review ( !     
m$ical necessity & reasonabl5ess ( a    
break?r\gh device furni%$ by a provid] (
 s]vice or suppli] t ! ,secret>y        
det]m9es has an ab]rant bill+ patt]n )  
respect to su* a device or o!rwise is an
 outli] ) respect to ! furni%+ ( su*    
device comp>$ to simil>ly situat$       
provid]s ( s]vices & suppli]s4  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/ 7or det]m9e t su* device  
is o!rwise cov]$ "u ?is title7 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 #bjbe ?r\gh #bjcj1 to    
rema9 available until exp5d$1 to c>ry   
out ! am5dm5ts made by ?is section4