,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #ciad  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #h1 #bjbj,ms4    
,mc,sally 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 (  
#bjbj4  #b4 ,cov]age & paym5t =         
break?r\gh devices "u ! ,m$ic>e program 
7a7 ,9 g5]al ,"p ,e ( title ,,xviii ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#aciex et seq47 is am5d$ by add+ at !   
end ! foll[+ new section3  #ahii;,c4    
,cov]age ( break?r\gh devices  7a7      
,break?r\gh devices  7#a7 ,9 g5]al ,=   
purposes ( ?is section1 ! t]m break?r\gh
 device means a m$ical device t is a    
device 7z def9$ 9 section #bja ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act7 &
 t is-- 7,a7 provid$ ) review priority  

by ! ,secret>y "u subsection 7d77#e7 (  
section #eae ( su* ,act2 &  7,b7 approv$
 or cle>$ pursuant to section #eaj7k71  
#eac7;f71 or #eae ( su* ,act = use 9    
treat+ an indication on or aft] ,july   
#a1 #bjai4  ,su* t]m also includes a    
break?r\gh device t is a specifi$       
break?r\gh device 7z def9$ 9 subsection 
7e77#a77;,b77 approv$ or cle>$ pursuant 
to section #eaj7k71 #eac7;f71 or #eae ( 
su* ,act = use 9 treat+ an indication on
 or aft] ,decemb] #a1 #bjah4  7#b7      
,limitation on numb] ( #eaj7k7 devices  
,) respect to a #e-ye> p]iod1 9 no case 
may m ?an five m$ical devices describ$ 9
 p>agraph 7#a7 t are classifi$ "u       
section #eaj7k7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act be cov]$ & paid = "u  
?is title by reason ( ?is section dur+  
ea* su* #e-ye> p]iod4  7b7 ,cov]age     
7#a7 ,transitional cov]age  7,a7 ,9     
g5]al ,dur+ ! transitional cov]age p]iod
 7z def9$ 9 subp>agraph 7,b77 a         
break?r\gh device %all be-- 7i7 deem$ to
 be reasonable & necess>y = purposes (  

section #ahfb7;a77#a77;,a72  7ii7 deem$ 
to be a m$ical or o!r heal? s]vice =    
purposes ( section #ahfa7s72  7iii7     
deem$ to be approv$ = an additional     
paym5t "u section #ahhf7;d77#e77,k7 7o!r
 ?an ) respect to ! co/ crit]ion "u     
clause 7ii77,i7 ( su* section72  7iv7   
deem$ to be approv$ = pass-?r\gh paym5t 
"u section #ahcc7t77#f7 & section       
#ahcc7;i7 7o!r ?an ) respect to ! co/   
crit]ion "u section                     
#ahcc7t77#f77;,a77iv772 &  7v7 ins(> z  
su* break?r\gh device may be furni%$ 9 a
 sett+ = :i* paym5t is made "u an       
applicable paym5t sy/em describ$ 9      
subp>agraphs 7,d7 ?r\gh 7,l7 (          
subsection 7c77#d71 deem$ eligible = an 
additional paym5t or paym5t adju/m5t1 z 
! case may be1 pursuant to subsection   
7d77#c7 :5 furni%$ 9 a sett+ = :i*      
paym5t is made "u su* an applicable     
paym5t sy/em dur+ su* transitional      
cov]age p]iod4  7,b7 ,transitional      
cov]age p]iod def9$ ,z us$ 9 ?is        
section1 ! t]m transitional cov]age     

p]iod means1 ) respect to a break?r\gh  
device1 ! p]iod t-- 7i7 beg9s on ! date 
( ! approval "u section #eae ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act or ( !   
cle>ance "u section #eaj7k7 ( su* ,act1 
z applicable1 ( su* device by !         
,secret>y = ! indication describ$ 9     
subsection 7a77#a72 &  7ii7 ends on !   
la/ day ( ! #c-ye> p]iod t beg9s on !   
date t ! ,secret>y1 pursuant to         
subsection 7c77#b71 updates ! relevant  
applicable paym5t sy/em 7z def9$ 9      
subsection 7c77#d77 to recognize !      
unique tempor>y or p]man5t code or codes
 assign$ "u subsection 7c77#a7 to su*   
break?r\gh device1 except z provid$ 9   
subsections 7d77#a77;,b7 & 7d77#b77;,b74
  7,c7 ,data us$ to meet ! ,,ntap &     
pass-?r\gh co/ crit]ia ,9 det]m9+ :e!r a
 break?r\gh device qualifies = an       
additional paym5t "u section            
#ahhf7;d77#e77,k7 or = pass-?r\gh paym5t
 "u section #ahcc7t77#f7 or section     
#ahcc7;i71 ! ,secret>y %all use ! mo/   
rec5tly available data & in=mation on ! 

co/s ( su* break?r\gh device1 :i* may   
include li/ prices & invoice prices *>g$
 = su* break?r\gh device4  7#b7 ,process
 = regul> cov]age ,= purposes ( !       
application ( section #ahfb7;a77#a77;,a7
 to a break?r\gh device furni%$ aft] !  
transitional cov]age p]iod 7z def9$ 9   
p>agraph 7#a77;,b77 = su* device1 !     
,secret>y %all e/abli% a process = !    
cov]age ( su* break?r\gh devices "u ?is 
title aft] su* p]iod z foll[s3 7,a7     
,id5tification ( additional evid5ce  7i7
 ,9 g5]al ,) respect to a break?r\gh    
device1 n lat] ?an #a ye> aft] ! date ( 
! approval ( su* device "u section #eae 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act or ( ! cle>ance ( su* device "u    
section #eaj7k7 ( su* ,act1 z           
applicable1 ! ,secret>y %all id5tify    
:e!r any additional data or evid5ce is  
requir$ ) respect to any indications =  
su* device = purposes ( ! application ( 
su* section #ahfb7;a77#a77;,a7 to su*   
device = su* indications4  7ii7         
,non-duplication ( data reque/s ,9 c>ry+

 out clause 7i7 ) respect to a          
break?r\gh device1 ! ,secret>y %all     
ensure t data or evid5ce id5tifi$-- 7,i7
 does n duplicate data requir$ to be    
collect$ by ! ,food & ,drug             
,adm9i/ration ) respect to su*          
break?r\gh device2  7,,ii7 m9imizes !   
adm9i/rative burd5s ( data collection & 
report+ on provid]s ( s]vices1 suppli]s1
 & manufactur]s ( break?r\gh devices2 & 
7,,iii7 is n o!rwise unnecess>y or      
r$undant4  7,b7 ,proposal = cov]age aft]
 ! transitional cov]age p]iod ,n lat]   
?an #b ye>s aft] ! date ( ! approval or 
cle>ance ( a break?r\gh device by !     
,food & ,drug ,adm9i/ration1 ! ,secret>y
 %all develop a proposal = cov]age "u   
?is title ( su* break?r\gh device = su* 
indications z ! ,secret>y det]m9es to be
 appropriate1 bas$ on ! data & evid5ce  
collect$ "u subp>agraph 7,a71 = su*     
devices furni%$ aft] ! transitional     
cov]age p]iod "u p>agraph 7#a7 = su*    
device4 ,if ! ,secret>y does n1 on a    
date t is be=e ! end ( su* #b-ye> p]iod1

 take action to modify ! indications =  
:i* cov]age ( a break?r\gh device may be
 provid$ "u ?is title aft] su* p]iod1 = 
purposes ( section #ahfb7;a77#a77;,a7   
cov]age "u ?is title ( su* break?r\gh   
device %all be made = all indications = 
:i* su* device is approv$ "u section    
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or cle>$ "u section      
#eaj7k7 ( su* ,act4  7#c7 ,rules (      
con/ruction ,no?+ 9 ?is section %all be 
con/ru$ to-- 7,a7 affect ! ability ( !  
manufactur] ( a break?r\gh device to    
seek approval = pass-?r\gh paym5t /atus 
"u section #ahcc7t77#f7 or to seek      
approval = an additional paym5t "u      
section #ahhf7;d77#e77,k7 ins(> z su*   
break?r\gh device does n qualify =      
transitional cov]age "u p>agraph 7#a72  
or  7,b7 affect ! application & approval
 process = pass-?r\gh paym5t /atus "u   
section #ahcc7t77#f7 or = an additional 
paym5t "u section #ahhf7;d77#e77,k7 9 ! 
case ( a m$ical device t is n approv$ by
 ! ,food & ,drug ,adm9i/ration z a      

break?r\gh device4  7c7 ,cod+  7#a7     
,prompt assignm5t ,n lat] ?an ?ree mon?s
 aft] ! date ( approval or cle>ance ( a 
break?r\gh device by ! ,food & ,drug    
,adm9i/ration1 subject to subsection    
7b77#a77;,b71 ! ,secret>y %all assign a 
unique tempor>y or p]man5t code or codes
 = purposes ( cov]age & paym5t = su*    
break?r\gh device "u ! applicable paym5t
 sy/ems 7describ$ 9 p>agraph 7#d774     
7#b7 ,updates  7,a7 ,,ipps ,! ,secret>y 
%all provide = semiannual updates "u !  
applicable paym5t sy/em describ$ 9      
p>agraph 7#d77;,a7 7relat+ to ! inpati5t
 hospital prospective paym5t sy/em7 to  
recognize ! code or codes assign$ "u    
p>agraph 7#a74  7,b7 ,,opps ,! ,secret>y
 %all provide = qu>t]ly updates "u !    
applicable paym5t sy/em describ$ 9      
p>agraph 7#d77;,b7 7relat+ to !         
outpati5t hospital prospective paym5t   
sy/em7 to recognize ! code or codes     
assign$ "u p>agraph 7#a74  7,c7 ,o!r    
paym5t sy/ems ,! ,secret>y %all provide 
= semiannual or qu>t]ly updates1 z !    

case may be1 "u ! applicable paym5t     
sy/ems describ$ 9 subp>agraphs 7,c7     
?r\gh 7,l7 ( p>agraph 7#d7 to recognize 
! code or codes assign$ "u p>agraph     
7#a74  7#c7 ,transp>5cy ,! process = !  
assignm5t ( a code or codes "u ?is      
subsection %all provide = public notice 
& a mean+ful opportunity = public comm5t
 f affect$ p>ties4  7#d7 ,applicable    
paym5t sy/ems describ$ ,= purposes ( ?is
 subsection1 ! t]m applicable paym5t    
sy/ems means-- 7,a7 ) respect to        
inpati5t hospital s]vices1 ! prospective
 paym5t sy/em = inpati5t hospital       
s]vices e/abli%$ "u section #ahhf7;d72  
7,b7 ) respect to outpati5t hospital    
s]vices1 ! prospective paym5t sy/em =   
cov]$ ,,opd s]vices e/abli%$ "u section 
#ahcc7t72  7,c7 ) respect to ambulatory 
surgical c5t] s]vices1 ! fee s*$ule =   
su* s]vices e/abli%$ "u section         
#ahcc7;i72  7,d7 ) respect to           
physicians' s]vices1 ! physician fee    
s*$ules e/abli%$ "u section #ahdh2  7,e7
 ) respect to cov]$ items ( durable     

m$ical equipm5t1 ! applicable fee       
s*$ules e/abli%$ "u section #ahcd2  7,f7
 ) respect to diagno/ic laboratory te/s1
 ! paym5t am\nts "u section #ahcd;,a & !
 fee s*$ules e/abli% "u section #ahdh1 z
 ! case may be2  7,g7 ) respect to r5al 
dialysis s]vices furni%$ by a provid] ( 
s]vices or a r5al dialysis facility1 !  
s+le paym5t sy/em e/abli%$ "u section   
#ahha7;b77#ad72  7,h7 ) respect to      
inpati5t hospital s]vices furni%$ by    
rehabilitation facilities1 ! prospective
 paym5t sy/em e/abli%$ "u section       
#ahhf7;j72  7,i7 ) respect to inpati5t  
hospital s]vices furni%$ by long-t]m c>e
 hospitals1 ! prospective paym5t sy/em  
"u section #ahhf7m72  7,j7 ) respect to 
inpati5t hospital s]vices furni%$ by    
psy*iatric hospitals & psy*iatric units1
 ! prospective paym5t sy/em "u section  
#ahhf7s72  7,k7 ) respect to home heal? 
s]vices1 ! prospective paym5t sy/em "u  
section #ahie2 &  7,l7 ) respect to     
items & s]vices1 or a provid] ( s]vices 
or suppli]1 n describ$ 9 subp>agraphs   

7,a7 ?r\gh 7,k71 ! paym5t sy/em e/abli%$
 "u ?is title = su* items & s]vices :5  
furni%$ by su* provid] ( s]vices or     
suppli]4  7d7 ,paym5t  7#a7 ,inpati5t   
,hospital ,prospective ,paym5t ,sy/em3  
,deem$ eligibility = break?r\gh paym5t  
,! ,secret>y %all deem ea* break?r\gh   
device z approv$ = an additional paym5t 
"u section #ahhf7;d77#e77,k7 = ! #c-ye> 
p]iod t beg9s-- 7,a7 except z provid$ 9 
subp>agraph 7,b71 on ! date t !         
,secret>y1 pursuant to subsection       
7c77#b77;,a71 updates ! paym5t sy/em "u 
section #ahhf7;d7 to recognize ! unique 
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
break?r\gh device2 or  7,b7 9 ! case ( a
 device t has n receiv$ approval or     
cle>ance z a break?r\gh device by !     
,food & ,drug ,adm9i/ration be=e su*    
paym5t sy/em is updat$ "u subsection    
7c77#b77;,a7 to recognize ! unique      
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
device1 on ! date ( su* approval or     

cle>ance4  ,no?+ 9 ?is p>agraph %all be 
con/ru$ to affect ! au?ority ( !        
,secret>y to use claims data to e/abli% 
new diagnosis or proc$ure codes =       
break?r\gh devices or to id5tify        
appropriate diagnosis-relat$ gr\ps = !  
assignm5t ( break?r\gh devices "u annual
 rulemak+ to c>ry out section           
#ahhf7;d77#e77,k74  7#b7 ,outpati5t     
,prospective ,paym5t ,sy/em3 ,deem$     
eligibility = pass-?r\gh paym5t ,!      
,secret>y %all deem ea* break?r\gh      
device z approv$ = pass-?r\gh paym5t "u 
section #ahcc7t77#f7 7includ+ = purposes
 ( section #ahcc7;i77#b77;,d77 dur+ !   
#c-ye> p]iod t beg9s-- 7,a7 except z    
provid$ 9 subp>agraph 7,b71 on ! date t 
! ,secret>y1 pursuant to subsection     
7c77#b77;,b71 updates ! paym5t sy/em "u 
section #ahcc7t7 to recognize ! unique  
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
break?r\gh device2 or  7,b7 9 ! case ( a
 device t has n receiv$ approval or     
cle>ance z a break?r\gh device by !     

,food & ,drug ,adm9i/ration be=e su*    
paym5t sy/em is updat$ "u subsection    
7c77#b77;,b7 to recognize ! unique      
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
device1 on ! date ( su* approval or     
cle>ance4  ,no?+ 9 ?is p>agraph %all be 
con/ru$ to affect ! au?ority ( !        
,secret>y to use claims data to e/abli% 
new ambulatory paym5t classification    
gr\ps = break?r\gh devices or to revise 
su* gr\ps to take into acc\nt break?r\gh
 devices "u annual rulemak+ to c>ry out 
section #ahcc7t74  7#c7 ,o!r paym5t     
sy/ems  7,a7 ,9 g5]al ,9 ! case ( a     
break?r\gh device t is furni%$ & = :i*  
paym5t may be made "u ! paym5t sy/em    
e/abli%$ "u section #ahcd1 #ahcd;,a1    
#ahdh1 #ahha7;b77#ad71 #ahhf7;j71       
#ahhf7m71 #ahhf7s71 or #ahie1 or any o!r
 provision ( ?is title 7o!r ?an sections
 #ahcc7;i71 #ahcc7t71 & #ahhf7;d771 !   
,secret>y %all provide = an additional  
paym5t = su* break?r\gh device "u su*   
applicable paym5t sy/em or an adju/m5t  

to su* applicable paym5t sy/em1 z ! case
 may be4 ,! paym5t basis = su*          
additional paym5t or adju/m5t1 z ! case 
may be1 %all equal an am\nt t !         
,secret>y det]m9es cov]s ! co/s ( su*   
break?r\gh device4  7,b7 ,co/ in=mation 
,9 det]m9+ ! co/s ( a break?r\gh device 
= purposes ( det]m9+ an additional      
paym5t or paym5t adju/m5t "u subp>agraph
 7,a71 ! ,secret>y %all use ! mo/       
rec5tly available data & in=mation on ! 
co/s ( su* break?r\gh device1 :i* may   
include li/ prices & invoice prices *>g$
 = su* break?r\gh device4  7,c7 ,rule ( 
con/ruction ,no?+ 9 ?is p>agraph %all be
 con/ru$ to affect ! au?ority ( !       
,secret>y to use claims data to e/abli% 
new or modify exi/+ ambulatory paym5t   
classification gr\ps1 diagnosis-relat$  
gr\ps1 level ,,ii ,,hcpcs codes1 or su* 
o!r gr\ps or codes z ! ,secret>y may    
e/abli% "u ! annual rulemak+ au?ority "u
 ! provisions ref]r$ to 9 subp>agraph   
7,a74  7,d7 ,cl9ical diagno/ic          
laboratory te/s ,an additional paym5t or

 paym5t adju/m5t "u subp>agraph 7,a7 = a
 break?r\gh device "u ! applicable      
paym5t sy/em e/abli%$ 9 section #ahcd;,a
 may be 9 ! =m ( an increase to ! am\nt 
det]m9$ = ! break?r\gh device us+       
cross-walk+ "u section                  
#ahcd;,a7c77#a77;,a71 an ext5sion ( !   
initial p]iod ( paym5t applicable to    
advance diagno/ic laboratory te/s "u    
section #ahcd;,a7d77#a77;,a71 & 9 su*   
o!r =m or mann] z ! ,secret>y det]m9es  
reflects ! co/s = su* break?r\gh device 
"u ! relevant provisions ( section      
#ahcd;,a4  7#d7 ,paym5t = break?r\gh    
devices aft] ! transitional cov]age     
p]iod ,paym5t = a break?r\gh device t is
 furni%$ aft] ! conclusion ( !          
transitional cov]age p]iod "u subsection
 7b77#a7 = su* device %all be made      
pursuant to ! applicable paym5t sy/em   
involv$1 tak+ into acc\nt ! additional  
evid5ce & data collect$ "u subsection   
7b77#b74  7e7 ,special rules = c]ta9    
break?r\gh devices  7#a7 ,cov]age (     
specifi$ break?r\gh devices  7,a7 ,9    

g5]al ,subject to ! succe$+ provisions (
 ?is subsection & not)/&+ any o!r       
provision ( law1 ! ,secret>y %all       
provide = cov]age & paym5t pursuant to  
?is section ( a specifi$ break?r\gh     
device 7z def9$ 9 subp>agraph 7,b774    
7,b7 ,specifi$ break?r\gh device def9$  
,9 ?is section1 ! t]m specifi$          
break?r\gh device means a break?r\gh    
device ) respect to :i* no ,m$ic>e      
b5efit category exi/s4  7#b7 ,p]iod (   
transitional cov]age  7,a7 ,9 g5]al     
,subject to subp>agraph 7,c71 !         
provisions ( subsection 7b77#a7 7relat+ 
to ! transitional cov]age p]iod & paym5t
 = break?r\gh devices1 includ+ ! use ( !
 mo/ rec5tly available data & in=mation 
on co/s7 %all apply to a specifi$       
break?r\gh device 9 ! same mann] z su*  
provisions apply to a break?r\gh device4
 ,! ,secret>y may use me?odologies "u   
exi/+ paym5t sy/ems e/abli%$ "u ?is     
title1 may provide = appropriate        
adju/m5ts to su* me?odologies1 or may   
e/abli% a new paym5t me?odology "u ?is  

title1 to provide = paym5t = a specifi$ 
break?r\gh device to ensure ! paym5t    
basis = su* paym5t cov]s co/s ( !       
specifi$ break?r\gh device4  7,b7       
,report  7i7 ,9 g5]al ,) respect to ea* 
specifi$ break?r\gh device1 ! ,secret>y 
%all submit to ,congress a report on !  
cov]age ( & paym5t = su* specifi$       
break?r\gh device "u ?is section t      
includes ! foll[+ in=mation3 7,i7 ,!    
mann] 9 :i* cov]age is provid$ & paym5t 
is made = ! specifi$ break?r\gh device1 
includ+ h[ su* device 0 classifi$ 7su* z
 an item ( durable m$ical equipm5t or   
o!rwise7 & ! paym5t me?odology !        
,secret>y appli$ ) respect to su*       
device4  7,,ii7 ,! impact ( !           
availability ( ! specifi$ break?r\gh    
device to ,m$ic>e b5efici>ies1 includ+  
impacts on ! quality ( pati5t c>e1      
pati5t outcomes1 & pati5t exp]i5ce4     
7,,iii7 ,! impact ( ! availability ( !  
specifi$ break?r\gh device to ,m$ic>e   
b5efici>ies on program exp5ditures "u   
?is title4  7,,iv7 ,su* o!r in=mation z 

! ,secret>y det]m9es to be appropriate4 
7ii7 ,deadl9e  7,i7 ,9 g5]al ,except z  
provid$ 9 subclause 7,,ii71 ! ,secret>y 
%all submit a report requir$ "u ?is     
subp>agraph no lat] ?an ! end ( !       
transitional p]iod ( cov]age & paym5t   
applicable to su* specifi$ break?r\gh   
device4  7,,ii7 ,ext5sion to g5]ate     
additional data ,if ! ,secret>y det]m9es
 t additional data or evid5ce is requir$
 to complete a report requir$ "u ?is    
subp>agraph ) respect to a specifi$     
break?r\gh device1 ! deadl9e "u ?is     
clause may be ext5d$ = an additional two
 ye>s4  7,c7 ,additional p]iod (        
transitional cov]age to develop         
additional data ,ins(> z ! ,secret>y    
det]m9es t additional data or evid5ce is
 requir$ to complete a report requir$ "u
 subp>agraph 7,b7 ) respect to a        
specifi$ break?r\gh device1 !           
transitional cov]age p]iod ( cov]age &  
paym5t = su* device %all be ext5d$ by ! 
less] (-- 7i7 two ye>s2 or  7ii7 ! am\nt
 ( additional "t requir$ = ! submission 

( ! report ) respect to su* device4     
7#c7 ,cov]age & paym5t aft] !           
transitional p]iod ,! ,secret>y may     
cont9ue to provide = cov]age ( & paym5t 
= a specifi$ break?r\gh device aft] !   
end ( ! transitional p]iod ( cov]age &  
paym5t = break?r\gh devices ?r\gh !     
national cov]age det]m9ation process if 
! ,secret>y det]m9es t ! specifi$       
break?r\gh device-- 7,a7 improves !     
quality ( c>e & pati5t outcomes2  7,b7  
improves ! deliv]y ( c>e2 or  7,c7      
r$uces sp5d+ "u ?is title )\t r$uc+ !   
quality ( c>e4  4  7b7 ,/udy ( limit on 
#eaj7k7 break?r\gh devices  7#a7 ,/udy  
,! ,secret>y ( ,heal? & ,human ,s]vices 
%all conduct a /udy on ! effect ( !     
limit "u section #ahii;,c7a77#b7 ( !    
,social ,security ,act1 z add$ by       
subsection 7a71 on ! numb] ( devices    
cle>$ "u section #eaj7k7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7k77 t are break?r\gh     
devices = purposes ( su* section        
#ahii;,c4  7#b7 ,matt]s exam9$ ,9       

conduct+ ! /udy describ$ 9 p>agraph     
7#a71 ! ,secret>y %all-- 7,a7 det]m9e ! 
numb] ( m$ical devices cle>$ "u su*     
section #eaj7k7 dur+ ! #e-ye> p]iod     
beg9n+ on ! date ( ! enactm5t ( ?is     
,act2  7,b7 det]m9e ! numb] ( su*       
devices t 7 n includ$ z break?r\gh      
devices = purposes ( su* section        
#ahii;,c by reason ( ! limitation "u    
subsection 7a77#b7 ( su* section2 &     
7,c7 exam9e ! impact ( su* limitation on
 access to su* devices = individuals    
entitl$ to b5efits "u "p ,a or enroll$ 9
 "p ,b ( title ,,xviii ( ! ,social      
,security ,act 7#db ,u4,s4,c4 #acie et  
seq47 or bo?4  7#c7 ,report ,n lat] ?an 
#f ye>s aft] ! date ( ! enactm5t ( ?is  
,act1 ! ,secret>y %all submit to        
,congress a report on ! /udy conduct$ "u
 ?is subsection & %all include su*      
recomm5dations = legislative or         
adm9i/rative *anges z ! ,secret>y       
det]m9es to be appropriate4  7c7        
,cl>ification reg>d+ c]ta9 paym5ts  7#a7
 ,,ipps new te*nology paym5t ,section   

#ahhf7;d77#e77,k7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77 
is am5d$ by add+ at ! end ! foll[+ new  
clause3  7x7 ,dur+ ! p]iod ) respect to 
:i* a new m$ical s]vice or te*nology is 
eligible = an additional paym5t "u ?is  
subsection by reason ( ?is subp>agraph1 
any local cov]age det]m9ation 7z def9$ 9
 section #ahfi7;f77#b77;,b77 t w\ld     
affect ! cov]age (1 or ! additional     
paym5t "u ?is subsection =1 su* new     
m$ical s]vice or te*nology %all h no =ce
 or effect 9 law or regulation4  4  7#b7
 ,,opps pass-?r\gh paym5t ,section      
#ahcc7t77#f7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciel7t77#f77 is am5d$  
by add+ at ! end ! foll[+ new           
subp>agraph3  7,k7 ,prohibition on use (
 local cov]age det]m9ations to affect   
cov]age ( & paym5t = pass-?r\gh products
 ,dur+ ! p]iod ) respect to :i* a drug1 
biological1 or m$ical device is eligible
 = an additional paym5t "u ?is p>agraph1
 any local cov]age det]m9ation 7z def9$ 
9 section #ahfi7;f77#b77;,b77 t w\ld    

affect ! cov]age (1 or ! additional     
paym5t "u ?is p>agraph =1 su* drug1     
biological1 or m$ical device %all h no  
=ce or effect 9 law or regulation4  4   
7#c7 ,effective date ,?is subsection1 & 
! am5dm5ts made by ?is subsection1 %all 
apply ) respect to items & s]vices      
furni%$ on or aft] ! date ( ! enactm5t (
 ?is ,act1 includ+ any su* item or      
s]vice t is eligible on su* date = an   
additional paym5t "u section #ahhf7;d7 (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #acieww7d77 by reason ( p>agraph       
7#e77,k7 ( su* section or "u section    
#ahcc7t77#f7 ( su* ,act 7#db ,u4,s4,c4  
#acieww7t77#f771 or t w\ld h be5 s      
eligible on su* date b = a local cov]age
 det]m9ation t limits or d5ies cov]age (
 & su* additional paym5t = ! item or    
s]vice4  7d7 ,con=m+ am5dm5ts  7#a7     
,inpati5t ,prospective ,paym5t ,sy/em   
,section #ahhf7;d77#e77,k7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77,k771 z am5d$ by         
subsection 7c77#a71 is am5d$ by add+ at 

! end ! foll[+ new clause3  7xi7        
,effective = dis*>ges occurr+ on or aft]
 ,octob] #a1 #bjbj1 9 ! case ( a new    
m$ical s]vice or te*nology t is a       
break?r\gh device 7z def9$ 9 section    
#ahii;,c7a771 ! additional paym5t       
e/abli%$ = su* break?r\gh device "u ?is 
subp>agraph %all be made = ! #c-ye>     
p]iod applicable to su* break?r\gh      
device "u section #ahii;,c7d77#a74 ,9   
det]m9+ ! am\nt ( ! additional paym5t = 
a break?r\gh device "u ?is subp>agraph  
dur+ su* #c-ye> p]iod1 ! ,secret>y %all 
apply section #dab4hh7;b7 ( title #db1  
,code ( ,f$]al ,regulations 7or any     
successor regulation71 z if ! ref]5ce to
 #ej p]c5t 9 su* section 7 a ref]5ce to 
#hj p]c5t4  4  7#b7 ,outpati5t          
,prospective ,paym5t ,sy/em ,section    
#ahcc7t77#f77;,c7 ( su* ,act 7#db       
,u4,s4,c4 #aciel7t77#f77;,c77 is am5d$  
by add+ at ! end ! foll[+ new clause3   
7iii7 ,special rule = break?r\gh devices
 ,not)/&+ clause 7i7 or 7ii71 or any o!r
 provision ( ?is p>agraph to ! contr>y1 

9 ! case ( a break?r\gh device 7z def9$ 
9 section #ahii;,c7a77 t is furni%$ on  
or aft] ,janu>y #a1 #bjba1 paym5t "u ?is
 p>agraph = su* break?r\gh device %all  
be made = ! #c-ye> p]iod applicable to  
su* break?r\gh device "u section        
#ahii;,c7d77#b74 ,! provisions ( ?is    
clause %all also apply = purposes (     
transitional pass-?r\gh paym5t "u       
section #ahcc7;i77#b77;,d74  4  7#c7    
,competitive bidd+ program ,section     
#ahdg7;a7 ( su* ,act 7#db ,u4,s4,c4     
#aciew-#c7;a77 is am5d$-- 7,a7 9        
p>agraph 7#b77;,a7-- 7i7 by /rik+ &     
exclud+ drugs & ins]t+ exclud+ drugs2 & 
7ii7 by ins]t+ be=e ! p]iod at ! end !  
foll[+3 1 & exclud+ break?r\gh devices  
7z def9$ 9 section #ahii;,c7a772 &  7,b7
 9 p>agraph 7#g71 by add+ at ! end !    
foll[+ new subp>agraph3  7,c7           
,break?r\gh devices ,a break?r\gh device
 describ$ 9 p>agraph 7#b77;,a7 t is     
furni%$ dur+ ! transitional cov]age     
p]iod 7z def9$ 9 section                
#ahii;,c7b77#a77;,b77 applicable to su* 

device "u section #ahii;,c4  4  7e7     
,effective date ,?is section1 & !       
am5dm5ts made by ?is section1 %all take 
effect on ! date ( ! enactm5t ( ?is ,act
 &1 unless o!rwise specifi$ 9 ?is       
section 7or 9 an am5dm5t made by ?is    
section71 %all apply to break?r\gh      
devices 7z def9$ 9 section #ahii;,c7a7 (
 ! ,social ,security ,act1 z add$ by    
subsection 7a771 approv$ or cle>$ on or 
aft] ,july #a1 #bjai1 or1 9 ! case ( a  
specifi$ break?r\gh device 7z def9$ 9   
su* section z s add$71 approv$ or cle>$ 
on or aft] ,decemb] #a1 #bjah4