,,ib  ,union ,cal5d> ,no4 #hja  #aah?   
,,congress  #b;d ,session  ,h4 ,r4 #afia
  ,report ,no4 #aah-ieb1 ,"p ,i  ,,9 ,,!
 ,,h\se ,,( ,,repres5tatives  ,m>* #bb1 
#bjbc ,mr4 ,w5/rup 7= himself1 ,ms4     
,del,bene1 ,mr4 ,bilirakis1 ,mr4        
,crd5as1 ,mr4 ,moore ( ,utah1 ,ms4      
,sewell1 ,mr4 ,gu?rie1 & ,ms4 ,e%oo7    
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$    
,decemb] #bd1 #bjbd ,additional         
sponsors3 ,mr4 ,joyce ( ,p5nsylvania1   
,ms4 ,ku/]1 ,mr4 ,cr5%aw1 ,mr4 ,kilm]1  
,mrs4 ,mill] ( ,we/ ,virg9ia1 ,ms4      
,craig1 ,mrs4 ,/eel1 ,ms4 ,dean (       
,p5nsylvania1 ,mr4 ,bacon1 ,mr4 ,pet]s1 
,mr4 ,bald]son1 ,mr4 ,au*9closs1 ,mr4   
,curtis1 ,ms4 ,h\lahan1 ,mr4 ,buc%on1   
,mr4 ,fitzpatrick1 ,mr4 ,yakym1 ,ms4    
,l(gr51 ,ms4 ,s*ri]1 ,mrs4 ,trahan1 ,mr4

 ,lieu1 ,mr4 ,mc,govern1 ,mr4 ,boyle (  
,p5nsylvania1 ,ms4 ,wild1 ,mr4 ,b]a1    
,mr4 ,correa1 ,ms4 ,port]1 ,mr4         
,swalwell1 ,mr4 ,ciscomani1 ,mr4        
,f]guson1 ,mr4 ,c>ey1 ,mr4 ,simpson1    
,mrs4 ,kim ( ,cali=nia1 ,mr4 ,pappas1   
,mr4 ,burgess1 ,mrs4 ,mill]-,meeks1 ,ms4
 ,scanlon1 ,mr4 ,panetta1 ,mr4 ,dunn (  
,florida1 ,mr4 ,mull91 ,ms4 ,ross1 ,mr4 
,kelly ( ,p5nsylvania1 ,ms4 ,de,gette1  
,ms4 ,lee ( ,florida1 ,mr4 ,got!im]1    
,mr4 ,phillips1 ,ms4 ,t5ney1 ,mr4 ,b>r1 
,mr4 ,kean ( ,new ,j]sey1 ,mr4 ,neguse1 
,mr4 ,p5ce1 ,mrs4 ,fis*ba*1 ,mr4 ,ma/1  
,mr4 ,johnson ( ,ohio1 ,mr4 ,langwor?y1 
,ms4 ,van ,duyne1 ,ms4 ,pett]s51 ,mr4   
,f9/ad1 ,mr4 ,la,hood1 ,mr4 ,s*neid]1   
,mr4 ,ow5s1 ,mr4 ,smuck]1 ,mr4 ,?ompson 
( ,p5nsylvania1 ,ms4 ,c>aveo1 ,mr4      
,ru!r=d1 ,mr4 ,cr[1 ,mr4 ,we/]man1 ,mr4 
,arm/rong1 ,mr4 ,coh51 ,mr4 ,soto1 ,mr4 
,c>t] ( ,georgia1 ,mr4 ,nickel1 ,mr4    
,ob]nolte1 ,mr4 ,smi? ( ,nebraska1 ,mr4 
,james1 ,ms4 ,maloy1 ,ms4 ,b>ragn1 ,mr4 
,davis ( ,nor? ,c>ol9a1 ,ms4 ,slotk91   

,mr4 ,davis ( ,ill9ois1 ,ms4 ,/rickl&1 &
 ,ms4 ,/ev5s  ,decemb] #bd1 #bjbd       
,report$ f ! ,committee on ,ways &      
,means ) an am5dm5t ,/rike out all aft] 
! enact+ clause & ins]t ! "p pr9t$ 9    
italic  ,decemb] #bd1 #bjbd ,committee  
on ,en]gy & ,comm]ce dis*>g$2 committ$  
to ! ,committee ( ! ,:ole ,h\se on !    
,/ate ( ! ,union & ord]$ to be pr9t$ ,= 
text ( introduc$ bill1 see copy ( bill z
 introduc$ on ,m>* #bb1 #bjbc  ,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 ( #bjbd4  #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$7 )
 respect to su* device1 :i* is n furni%$
 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 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 trial in=mation f an         
applicable device cl9ical trial 7z su*  
t]ms are def9$ 9 section #djb7;j7 ( su* 
,act7 t enroll$ individuals entitl$ to  
b5efits "u "p ,a or enroll$ "u "p ,b4   
7#c7 ,! device is n a cl9ical diagno/ic 
laboratory te/4  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 #bjbe ?r\gh #bjcj1 to rema9        
available until exp5d$1 to c>ry out !   
am5dm5ts made by ?is section4  ,decemb] 
#bd1 #bjbd ,report$ f ! ,committee on   
,ways & ,means ) an am5dm5t ,decemb]    
#bd1 #bjbd ,committee on ,en]gy &       
,comm]ce dis*>g$2 committ$ to !         
,committee ( ! ,:ole ,h\se on ! ,/ate ( 
! ,union & ord]$ to be pr9t$