,,ii ,cal5d> ,no4 #ahd #aad? ,,congress 
#a/ ,session  ,s4 #abec ,report ,no4    
#aad-aje ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$
 ,,/ates  ,may #g1 #bjae,mr4 ,burr 7=   
himself1 ,mr4 ,b5net1 & ,mr4 ,alex&]7   
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,july #cj1 #bjae,report$ by    
,mr4 ,hat*1 ) an am5dm5t & an am5dm5t to
 ! title,strike out all aft] ! enact+   
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to am5d title ,,xviii ( !      
,social ,security ,act to provide       
cov]age ( c]ta9 disposable m$ical       
te*nologies "u ! ,m$ic>e program1 & =   
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,pati5t ,access to     
,disposable ,m$ical ,te*nology ,act (   
#bjae4  #b4 ,cov]age ( c]ta9 disposable 
m$ical te*nologies "u ! ,m$ic>e program 
7a7 ,cov]age ,section #ahfa ( ! ,social 
,security ,act 7#db ,u4,s4,c4 #aciex7 is
 am5d$--  7#a7 9 subsection 7n7-- 7,a7  
by ins]t+ sub/itute disposable m$ical   
te*nologies 7z def9$ 9 subsection 7iii77

 & s]vices & supplies us$ 9 conjunction 
) su* te*nologies1 aft] hospital b$s12 &
  7,b7 by ins]t+ 7unless su* equipm5t is
 a sub/itute disposable m$ical te*nology
 or a s]vice or supply us$ 9 conjunction
 ) su* a te*nology7 aft] r5tal basis2 & 
7#b7 by add+ at ! end ! foll[+ new      
subsection3  7iii7 ,sub/itute disposable
 m$ical te*nology ,! t]m sub/itute      
disposable m$ical te*nology means m$ical
 equipm5t t-- 7#a7 is prim>ily &        
cu/om>ily us$ to s]ve a m$ical purpose2 
7#b7 w\ld o!rwise be cov]$ z durable    
m$ical equipm5t "u ?is title b = ! fact 
t su* equipm5t is n durable 7z def9$ by 
! ,secret>y = purposes ( cov]age (      
durable m$ical equipm5t "u ?is title72 &
  7#c7 ! ,secret>y det]m9es sub/itutes =
 durable m$ical equipm5t4  ,9 mak+ !    
det]m9ation "u p>agraph 7#c71 !         
,secret>y %all consult ) m$ical         
specialty societies1 m$ical device      
manufactur]s1 pati5t gr\ps1 & o!r       
/akehold]s z "p ( ! annual rulemak+     
process = durable m$ical equipm5t "u ?is

 title4  4  7b7 ,paym5t provisions      
,section #ahcd7;a7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #aciem7a77 is am5d$
 by add+ at ! end ! foll[+ new p>agraph3
  7#bc7 ,special paym5t rule = sub/itute
 disposable m$ical te*nologies ,not)/&+ 
! prec$+ provisions ( ?is subsection1 ! 
,secret>y %all det]m9e ! paym5t am\nt "u
 ?is subsection = a sub/itute disposable
 m$ical te*nology 7z def9$ 9 section    
#ahfa7;iii771 & = any relat$ supplies & 
s]vice fees incurr$ 9 conjunction ) !   
use & ma9t5ance ( su* te*nology1 9      
accordance ) ! foll[+3  7,a7 ,s+le      
paym5t am\nt ,! ,secret>y %all det]m9e a
 s+le paym5t am\nt t %all be paid = a   
sub/itute disposable m$ical te*nology & 
= any relat$ supplies & s]vice fees     
incurr$ 9 conjunction ) ! use &         
ma9t5ance ( su* te*nology4 ,a paym5t =  
su* a te*nology & = any su* relat$      
supplies & s]vice fees made 9 ! am\nt ( 
su* s+le paym5t am\nt %all con/itute    
full paym5t "u ?is title = su* te*nology
 & su* relat$ supplies & s]vice fees4   

7,b7 ,calculation ( paym5t am\nt ,! s+le
 paym5t am\nt describ$ 9 subp>agraph    
7,a7 = a sub/itute disposable m$ical    
te*nology & = any relat$ supplies &     
s]vice fees incurr$ 9 conjunction ) !   
use & ma9t5ance ( su* te*nology %all be 
calculat$ by--  7i7 calculat+ ! sum ( ! 
am\nts ( paym5t t o!rwise w\ld be made  
"u ?is section =-- 7,i7 ! item ( durable
 m$ical equipm5t = :i* ! ,secret>y      
det]m9es1 pursuant to section           
#ahfa7;iii77#c71 t su* sub/itute        
disposable m$ical te*nology sub/itutes2 
&  7,,ii7 all relat$ supplies & s]vice  
fees incurr$ 9 conjunction ) ! use &    
ma9t5ance ( su* item ( durable m$ical   
equipm5t2  7ii7 calculat+ ! am\nt t is  
#ie p]c5t ( ! sum calculat$ "u clause   
7i72 &  7iii7 calculat+ ! s+le paym5t   
am\nt = ! sub/itute disposable m$ical   
te*nology & = any relat$ supplies &     
s]vice fees incurr$ 9 conjunction ) !   
use & ma9t5ance ( su* te*nology su* t ! 
sum ( ! paym5ts "u ?is subsection =--   
7,i7 all sub/itute disposable m$ical    

te*nologies t ! ,secret>y det]m9es1     
pursuant to section #ahfa7;iii77#c71 w  
be necess>y to provide a sub/itute = !  
item ( durable m$ical equipm5t describ$ 
9 clause 7i77,i72 &  7,,ii7 any relat$  
supplies & s]vice fees incurr$ 9        
conjunction ) ! use & ma9t5ance ( su*   
te*nologies1  & is equal to ! am\nt     
calculat$ "u clause 7ii74 ,9 mak+ su*   
calculation1 ! ,secret>y %all consult ) 
m$ical specialty societies1 m$ical      
device manufactur]s1 pati5t gr\ps1 & o!r
 /akehold]s to ensure t an appropriate  
comp>ison is made t captures use ( !    
v>i\s te*nologies 7includ+ relat$       
supplies1 if any7 ov] an av]age c\rse ( 
!rapy = a typical pati5t4  7,c7         
,lump-sum paym5t ,! s+le paym5t am\nt   
describ$ 9 subp>agraph 7,a7 = a         
sub/itute disposable m$ical te*nology & 
= any relat$ supplies & s]vice fees     
incurr$ 9 conjunction ) ! use &         
ma9t5ance ( su* te*nology %all be made 9
 a lump-sum am\nt4  7,d7 ,paym5t =      
physicians' & hospital outpati5t        

dep>tm5t s]vices ,no?+ 9 ?is p>agraph   
%\ld be con/ru$ z limit+ or *ang+ paym5t
 = items or s]vices = :i* paym5t is made
 "u section #ahdh or section #ahcc7t74  
4  7c7 ,con=m+ am5dm5t ,section         
#ahdg7;a77#g77;,b7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4                    
#aciew-#c7;a77#g77;,b77 is am5d$-- 7#a7 
9 clause 7i71 by /rik+ & at ! end2  7#b7
 9 clause 7ii71 by /rik+ ! p]iod at !   
end & ins]t+ 2 &2 &  7#c7 by add+ at !  
end ! foll[+ new clause3  7iii7 t are   
sub/itute disposable m$ical te*nologies 
7z def9$ 9 section #ahfa7;iii774  4  7d7
 ,effective date ,! provisions (1 &     
am5dm5ts made by1 ?is section %all apply
 ) respect to items & s]vices furni%$ on
 or aft] ,janu>y #a1 #bjaf4  7e7 ,rule (
 con/ruction2 implem5tation  7#a7 ,rule 
( con/ruction ,no?+ 9 ?is section or !  
am5dm5ts made by ?is section %all be    
con/ru$ z-- 7,a7 affect+ ! ability ( a  
physician 7or any o!r prescrib+         
practition]7 to ex]cise _! judgm5t 9    
prescrib+ or ord]+ = a ,m$ic>e b5efici>y

 appropriate durable m$ical equipm5t or 
o!r m$ical device or te*nology = !      
treatm5t ( an illness1 injury1 or       
condition ( ! ,m$ic>e b5efici>y2 or     
7,b7 affect+ ! ability ( ! ,m$ic>e      
b5efici>y to access appropriate durable 
m$ical equipm5t or o!r appropriate      
m$ical device or te*nology = su*        
treatm5t4  7#b7 ,implem5tation ,!       
,secret>y %all implem5t ! provisions (1 
& am5dm5ts made by1 ?is section 9 a     
mann] su* t ! me?odologies = det]m9+    
cov]age ( an item ( durable m$ical      
equipm5t 7z def9$ 9 section #ahfa7n7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciex7n777 7o!r ?an su* an item t is a 
sub/itute disposable m$ical te*nology 7z
 def9$ 9 section #ahfa7;iii777 & !      
paym5t am\nt = ! item ( durable m$ical  
equipm5t 7o!r ?an su* an item t is a    
sub/itute disposable m$ical te*nology 7z
 s def9$77 "u section #ahcd or #ahdg (  
su* ,act 7#db ,u4,s4,c4 #aciem1         
#aciew-#c71 z ! case may be1 is n       
affect$ by ! cov]age ( & paym5t am\nt = 

a sub/itute disposable m$ical te*nology 
"u sections #ahfa7;iii7 & #ahcd7;a77#bc7
 ( su* ,act1 respectively1 z add$ by    
subsections 7a7 & 7b71 respectively4    
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,pati5t ,access to ,disposable ,m$ical
 ,te*nology ,act ( #bjae4  #b4 ,treatm5t
 ( disposable devices  7a7 ,9 g5]al     
,section #ahcd ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by 
add+ at ! end ! foll[+ new subsection3  
7s7 ,paym5t = applicable disposable     
devices  7#a7 ,sep>ate paym5t ,!        
,secret>y %all make a paym5t 7sep>ate f 
! paym5ts o!rwise made "u section #ahie7
 9 ! am\nt e/abli%$ "u p>agraph 7#c7 to 
a home heal? ag5cy = an applicable      
disposable device 7z def9$ 9 p>agraph   
7#b77 :5 furni%$ on or aft] ,janu>y #a1 
#bjag1 to an individual :o receives home
 heal? s]vices = :i* paym5t is made "u  
section #ahie7;b74  7#b7 ,applicable    
disposable device ,9 ?is subsection1 !  
t]m applicable disposable device means a
 disposable device t1 z det]m9$ by !    

,secret>y1 is-- 7,a7 a disposable       
negative pressure w\nd !rapy device t is
 an integrat$ sy/em compris$ ( a        
non-manual vacuum pump1 a receptacle =  
collect+ exudate1 & dress+s = ! purposes
 ( w\nd !rapy2 &  7,b7 a sub/itute =1 & 
us$ 9 lieu (1 a negative pressure w\nd  
!rapy durable m$ical equipm5t item t is 
an integrat$ sy/em ( a negative pressure
 vacuum pump1 a sep>ate exudate         
collection cani/]1 & dress+s t w\ld     
o!rwise be cov]$ = individuals = su*    
w\nd !rapy4  7#c7 ,paym5t am\nt ,!      
,secret>y %all e/abli% ! sep>ate paym5t 
am\nt = an applicable disposable device 
su* t su* am\nt is equal to--  7,a7 =   
#bjag1 #bjah1 & #bjai1 ! great] (-- 7i7 
! paym5t t w\ld be made "u section      
#ahcc7t7 7relat+ to paym5t = cov]$ ,,opd
 s]vices7 = ! ye> = ! ,level ,i         
,heal?c>e ,common ,proc$ure ,cod+ ,sy/em
 7,,hcpcs7 code = :i* ! description = a 
pr(essional s]vice includes ! furni%+ ( 
su* device2 or  7ii7 an am\nt equal to  
#aej p]c5t ( ! paym5t t appli$ "u su*   

section #ahcc7t7 = #bjae = su* ,,hcpcs  
code2 &  7,b7 = #bjbj & ea* subsequ5t   
ye>1 ! paym5t t w\ld be made "u su*     
section #ahcc7t7 = ! ye> = su* ,,hcpcs  
code4  4  7b7 ,con=m+ am5dm5ts  7#a7    
,co9surance ,section #ahcc7;a77#a7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7a77#a77 is am5d$-- 7,a7 by /rik+ 
& be=e 7,z72 &  7,b7 by ins]t+ be=e !   
semicolon at ! end ! foll[+3 1 & 7,,aa7 
) respect to an applicable disposable   
device 7z def9$ 9 p>agraph 7#b7 (       
section #ahcd7s77 furni%$ to an         
individual pursuant to p>agraph 7#a7 (  
su* section1 ! am\nt paid %all be equal 
to #hj p]c5t ( ! less] ( ! actual *>ge  
or ! am\nt det]m9$ "u p>agraph 7#c7 (   
su* section4  7#b7 ,home heal? ,section 
#ahfa7m77#e7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciex7m77#e77 is am5d$  
by ins]t+ & applicable disposable       
devices 7z def9$ 9 section #ahcd7s77#b77
 aft] durable m$ical equipm5t4  7c7     
,reports  7#a7 ,,gao /udy & report on   
disposable devices  7,a7 ,/udy ,!       

,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct a /udy on ! value (        
disposable devices to ! ,m$ic>e program 
& ,m$ic>e b5efici>ies & ! role (        
disposable devices z sub/itutes =       
durable m$ical equipm5t4 ,su* /udy %all 
address ! foll[+3  7i7 ,! types (       
disposable devices t c\ld pot5tially    
qualify z be+ sub/itutes = durable      
m$ical equipm5t "u ! ,m$ic>e program1 ! 
simil>ities & diff]5ces betwe5 su*      
disposable devices & ! durable m$ical   
equipm5t = :i* !y w\ld be a sub/itute1 &
 ! ext5t to :i* o!r pay]s1 includ+ !    
,m$icaid program & private pay]s1 cov]  
su* disposable devices4  7ii7 ,views (1 
& in=mation f1 m$ical device            
manufactur]s1 provid]s ( s]vices1 &     
suppli]s on ! inc5tives & dis9c5tives "u
 curr5t ,m$ic>e cov]age & paym5t        
policies = disposable devices t are     
sub/itutes = durable m$ical equipm5t &  
h[ su* policies affect manufactur]s'    
decisions to develop innovative products
 & provid]s' & suppli]s' decisions to   

use su* products4  7iii7 ,implications (
 exp&+ cov]age "u ! ,m$ic>e program to  
include additional disposable devices t 
are sub/itutes = durable m$ical         
equipm5t4  7iv7 ,paym5t me?odologies t  
c\ld be us$ to pay = disposable devices 
t are sub/itutes = durable m$ical       
equipm5t o!r ?an applicable disposable  
devices pursuant to ! am5dm5ts made by  
subsections 7a7 & 7b74  7v7 ,o!r        
applicable areas det]m9$ appropriate by 
! ,comptroll] ,g5]al4  7,b7 ,report ,n  
lat] ?an #ah mon?s aft] ! date ( !      
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all submit to 
,congress & ! ,secret>y ( ,heal? &      
,human ,s]vices a report on ! /udy      
conduct$ "u subp>agraph 7,a71 toge!r )  
recomm5dations = su* legislation &      
adm9i/rative action z ! ,comptroll]     
,g5]al det]m9es to be appropriate4  7#b7
 ,,gao /udy & report on ! impact ( !    
paym5t ( applicable disposable devices  
7,a7 ,/udy ,! ,comptroll] ,g5]al ( !    
,unit$ ,/ates %all conduct a /udy on !  

impact ( ! paym5t = applicable          
disposable devices 7z def9$ 9 section   
#ahcd7s77#b7 ( ! ,social ,security ,act7
 "u ! provisions (1 & am5dm5ts made by1 
subsections 7a7 & 7b74 ,su* /udy %all   
address ! foll[+3  7i7 ,! impact on     
utilization & ,m$ic>e program &         
b5efici>y sp5d+ z a result ( su*        
provisions & am5dm5ts4  7ii7 ,! type (  
,m$ic>e b5efici>ies :o1 "u ! home heal? 
b5efit1 use ! applicable disposable     
device & ! p]iod ( use ( ! applicable   
disposable devices comp>$ to !          
b5efici>ies :o use ! sub/itute durable  
m$ical equipm5t & _! p]iod ( use4  7iii7
 ,h[ paym5t rates ( o!r pay]s1 includ+ !
 ,m$icaid program & private pay]s1 =    
applicable disposable devices comp>e to 
! paym5t rates = su* devices "u su*     
provisions & am5dm5ts4  7iv7 ,o!r       
applicable areas det]m9$ appropriate by 
! ,comptroll] ,g5]al4  7,b7 ,report ,n  
lat] ?an #d ye>s aft] ! date ( !        
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all submit to 

,congress & ! ,secret>y ( ,heal? &      
,human ,s]vices a report on ! /udy      
conduct$ "u subp>agraph 7,a71 toge!r )  
recomm5dations = su* legislation &      
adm9i/rative action z ! ,comptroll]     
,g5]al det]m9es to be appropriate4  7d7 
,effective date ,! am5dm5ts made by ?is 
section %all apply to items furni%$ on  
or aft] ,janu>y #a1 #bjag4  ,am5d !     
title s z to read3 ,a bill to am5d title
 ,,xviii ( ! ,social ,security ,act to  
provide = ! treatm5t ( c]ta9 disposable 
m$ical te*nologies "u ! ,m$ic>e         
program44 ,july #cj1 #bjae,report$ ) an 
am5dm5t & an am5dm5t to ! title