,,ii  #aai? ,,congress  #b;d ,session   
,s4 #djcg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #aj1 #bjbf,mrs4   
,%ahe5 7= h]self & ,ms4 ,coll9s7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to ensure cont9u$  
access to diabetes te*nology ^u ,m$ic>e 
enrollm5t1 & = o!r purposes4  #a4 ,%ort 
title ,?is ,act may be cit$ z !         
,diabetes ,int]v5tions ,address+ ,b>ri]s
 to ,enrollm5t1 ,te*nology1 & ,education
 ,s]vices 7,,diabetes7 ,act or !        
,diabetes ,act4  #b4 ,f9d+s2 ,s5se (    
,congress  7a7 ,f9d+s ,congress f9ds !  
foll[+3 7#a7 ,accord+ to ! ,c5t]s =     
,disease ,control & ,prev5tion1 9 #bjba1
 an e/imat$ #ch1djj1jjj ,am]icans1 or   
#aa4f p]c5t ( ! entire ,unit$ ,/ates    
population1 h diabetes4  7#b7 ,! total  
numb] ( individuals ) diabetes is       
project$ to increase to an e/imat$      
#ed1ijj1jjj individuals by #bjcj4  7#c7 
,diabetes disproportionately impacts !  
,m$ic>e population1 z ! ,c5t]s = ,m$ic>e

  ,m$icaid ,s]vices f\nd 9 #bjbb1 & #bf 
p]c5t ( ,m$ic>e b5efici>ies h diabetes4 
7#d7 ,bo? type #a & #b diabetes c       
significantly h>m long-t]m heal? & is   
associat$ ) num]\s comorbidities su* z  
canc]1 he>t disease1 *ronic kidney      
disease1 bl9dness1 & amputations4  7#e7 
,! direct & indirect co/ ( diabetes is  
significant z ! ,am]ican ,diabetes      
,association f\nd t ! total annual co/ (
 diabetes 9 #bjbb 0 #dab1ijj1jjj1jjj1   
#cjf1fjj1jjj1jjj ( :i* is attributable  
to direct m$ical co/s4  7#f7 ,! ,am]ican
 ,diabetes ,association & ! ,am]ican    
,association ( ,cl9ical ,endocr9ology h 
set =? cl9ical guidel9es t include ! use
 ( cont9u\s glucose monitors1 insul9    
pumps1 automat$ insul9 deliv]y sy/ems1 &
 diabetes self-managem5t tra9+ =        
individuals ) diabetes4  7#g7 ,an       
automat$ insul9 deliv]y sy/em consi/s ( 
a cont9u\s glucose monitor1 an insul9   
pump1 & an algori?m or s(tw>e4  7#h7 ,! 
algori?m or s(tw>e is a critical        
compon5t ( an automat$ insul9 deliv]y   

sy/em z x cont9u\sly le>ns ! us]'s      
behavior & physiological responses &    
automatically adm9i/]s ! appropriate    
am\nt ( insul94  7#i7 ,m$ic>e curr5tly  
fails to sep>ately reimburse = !        
ess5tial algori?ms & s(tw>e t drive     
automat$ insul9 deliv]y 7,,aid7 sy/ems1 
:i* may /ifle future innovation &       
ma9t5ance1 & imp$e b5efici>y access4    
7#aj7 ,m$ic>e has an exi/+ pa?way to    
sep>ately reimburse = ! algori?m or     
s(tw>e 9 an automat$ insul9 deliv]y     
sy/em1 ! ,m$ic>e durable m$ical equipm5t
 b5efit4  7#aa7 ,includ+ cont9u\s       
glucose monitors1 durable insul9 pumps1 
& relat$ supplies into ! competitive    
bidd+ program fur!r limits innovation & 
access to diabetes te*nologies4  7#ab7  
,! ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices' 
f9al rule entitl$ ,m$ic>e & ,m$icaid    
,programs2 ,cal5d> ,ye> #bjbf ,home     
,heal? ,prospective ,paym5t ,sy/em 7,,hh
 ,,pps7 ,rate ,update2 ,requirem5ts = ! 
,,hh ,quality ,report+ ,program & ! ,,hh
 ,value-,bas$ ,pur*as+ ,exp&$ ,model2   

,durable ,m$ical ,equipm5t1 ,pro/hetics1
 ,or?otics1 & ,supplies 7,,dmepos7      
,competitive ,bidd+ ,program ,updates2  
,,dmepos ,accr$itation ,requirem5ts2    
,provid] ,enrollm5t2 & ,o!r ,m$ic>e &   
,m$icaid ,policies 7#ij ,f$4 ,reg4      
#eecdb 7,decemb] #b1 #bjbe771 :i*       
reclassifies cont9u\s glucose monitors &
 durable insul9 pumps z items requir+   
frequ5t & sub/antial s]vic+ :5 !y are   
phas$ into ! competitive bidd+ program1 
w h num]\s un9t5d$ consequ5ces t may    
prev5t ,m$ic>e b5efici>ies f access+ !  
cont9u\s glucose monitor or durable     
insul9 pump !y ne$ to survive4  7b7     
,s5se ( ,congress reg>d+ automat$ insul9
 deliv]y sy/ems ,x is ! s5se ( ,congress
 t ! ,secret>y ( ,heal? & ,human        
,s]vices %\ld commit to take            
adm9i/rative action to-- 7#a7 recognize 
t ! algori?m or s(tw>e 9 an automat$    
insul9 deliv]y sy/em is a reasonable &  
necess>y item = ! diagnosis or treatm5t 
( illness or injury or to improve !     
function+ ( a mal=m$ body memb] consi/5t

 ) ,m$ic>e cov]age requirem5ts "u       
section #ahfb7;a77#a77;,a7 ( ! ,social  
,security ,act2  7#b7 ensure ! algori?m 
or s(tw>e 9 an automat$ insul9 deliv]y  
sy/em is treat$ z a sep>ately payable   
supply to durable m$ical equipm5t2 &    
7#c7 :5 applicable1 recognize ! algori?m
 or s(tw>e 9 an automat$ insul9 deliv]y 
sy/em z m$ical supplies associat$ ) !   
injection ( insul9 consi/5t ) section   
#ahfj;,d-#b7;e77#a7 ( ! ,social         
,security ,act4  #c4 ,cont9u$ access to 
diabetes relat$ te*nologies  7a7 ,9     
g5]al ,section #ahfa7ww7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciex7ww77 is am5d$-- 7#a7 9 p>agraph  
7#a7-- 7,a7 by /rik+ & aft] ^u !        
agreem5t ) ! individual12 &  7,b7 by    
ins]t+ & ensur+ c>e cont9uity =         
individuals us+ diabetes te*nology cov]$
 "u "p ,b z describ$ 9 p>agraph 7#e71   
aft] 7z def9$ 9 p>agraph 7#d7712 &  7#b7
 by add+ at ! end ! foll[+ new p>agraph3
  7#e7 7,a7 ,subject to subp>agraphs    
7,b7 & 7,c7 ( ?is p>agraph1 dur+ ! fir/ 

#ab mon?s ( an individual's enrollm5t = 
b5efits "u "p ,b1 a provid] 7z def9$ 9  
subp>agraph 7,e77 may c]tify to !       
,secret>y t an individual is us+ #a or  
multiple diabetes te*nologies cov]$ "u  
"p ,b 7z def9$ 9 subp>agraph 7,d774     
7,b7 ,dur+ ! initial prev5tive physical 
exam9ation or o!r cov]$ s]vice z det]m9$
 appropriate by ! ,secret>y dur+ ! p]iod
 describ$ 9 subp>agraph 7,a71 ! provid] 
may make a det]m9ation ( ! individual's 
use ( diabetes te*nology cov]$ "u "p ,b4
 ,9 ! case :]e ! provid] makes su*      
det]m9ation1 ! provid] %all submit a    
c]tification to ! ,secret>y z requir$ "u
 subp>agraph 7,c74  7,c7 ,n lat] ?an    
,janu>y #a1 #bjbg1 ! ,secret>y %all--   
7i7 issue a f9aliz$ c]tification =m1    
develop$ pursuant to public notice &    
opportunity = comm5t1 = use "u ?is      
p>agraph2  7ii7 issue guidance &        
in/ructions to m$ic>e adm9i/rative      
contractors 7z def9$ 9 section          
#ahgd;,a7a77#c771 t require ! relevant  
m$ic>e adm9i/rative contractors to only 

assess :e!r ! c]tification =m is includ$
 9 ! individual's m$ical records :5 mak+
 a det]m9ation ( :e!r cov]age ( !       
diabetes te*nology cov]$ "u "p ,b is    
reasonable & necess>y z describ$ 9      
section #ahfb7;a77#a77;,a72  7iii7      
develop a process ?r\gh notice & comm5t 
rulemak+ = consid]+ :e!r an individual's
 diabetes te*nology t is n cov]$ "u "p  
,b at ! "t ( ! c]tification describ$ 9  
subp>agraph 7,a7 %\ld be a cov]$ b5efit 
"u exi/+ /atutory au?ority2 &  7iv7     
issue appropriate guidance to relevant  
audit & ov]sight entities to ensure ^?  
entities d n inappropriately cause      
disruptions 9 access to diabetes        
te*nology cov]$ "u "p ,b4  7,d7 ,=      
purposes ( ?is p>agraph1 ! t]m diabetes 
te*nology cov]$ "u "p ,b means1 )       
respect to an individual1 any device1   
relat$ supplies1 & s(tw>e or algori?m t1
 at ! "t ! c]tification describ$ 9      
subp>agraph 7,c7 is made ) respect to ! 
individual1 is cov]$ "u "p ,b = an      
individual t has diabetes "u !          

applicable ,,icd-#aj code li/1 z det]m9$
 by ! ,secret>y4  7,e7 ,= purposes ( ?is
 p>agraph1 ! t]m provid] means a        
physician 7z def9$ 9 section #ahfa7r771 
nurse practition]1 cl9ical nurse        
speciali/1 physician assi/ant1 7z ^?    
t]ms are def9$ 9 section                
#ahfa7;aa77#e771 or c]tifi$             
nurse-midwife 7z def9$ 9 section        
#ahfa7;gg77#b771 or o!r provid] (       
s]vices or suppli] z det]m9$ appropriate
 by ! ,secret>y4  4  7b7 ,effective date
 ,! am5dm5ts made by ?is section %all   
apply to items & s]vices furni%$ on or  
aft] ,janu>y #a1 #bjbg4  #d4 ,improv+   
access to diabetes outpati5t            
self-managem5t tra9+ s]vices  7a7 ,9    
g5]al ,section #ahfa7qq7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciex7qq77 is am5d$-- 7#a7 9 p>agraph  
7#a7-- 7,a7 by /rik+ ! ,secret>y        
det]m9es appropriate & ins]t+ specifi$ 9
 p>agraph 7#c72 &  7,b7 by /rik+ !      
physician :o is manag+ ! individual's   
diabetic condition & ins]t+ a physician 

or qualifi$ nonphysician practition]2   
7#b7 9 p>agraph 7#b77;,b71 by /rik+     
p>agraph & ins]t+ subp>agraph2 &  7#c7  
by add+ at ! end ! foll[+ new p>agraph3 
7#c7 ,= purposes ( p>agraph 7#a7 &      
subject to subp>agraph 7,b71 ! times    
specifi$ 9 ?is p>agraph are ! foll[+3   
7,a7 ,an initial #aj h\rs ( individual  
or gr\p educational & tra9+ s]vices to  
rema9 available until us$4  7,b7 ,an    
additional #b h\rs ( individual or gr\p 
educational & tra9+ s]vices ea* ye>1    
beg9n+ ) ! ye> 9 :i* ! initial #aj h\rs 
describ$ 9 subp>agraph 7,a7 are         
complet$4  7#d7 ,! ,secret>y %all n     
limit ! quantity or duration (          
educational & tra9+ s]vices furni%$ by a
 c]tifi$ provid] to an individual )     
diabetes if su* s]vices are deem$       
m$ically necess>y by a physician or     
qualifi$ non-physician practition]4  4  
7b7 ,m$ical nutrition !rapy s]vices     
,section #ahfa7s77#b77,v7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciex7s77#b77,v77 is am5d$-- 7#a7 by   

/rik+ clause 7i72  7#b7 by r$esignat+   
clauses 7ii7 & 7iii7 z clauses 7i7 &    
7ii71 respectively2 &  7#c7 9 clause    
7ii71 z s r$esignat$1 by /rik+ aft]     
consid]ation ( & ins]t+ consi/5t )4  7c7
 ,co/-,%>+ ,section #ahcc ( ! ,social   
,security ,act 7#db ,u4,s4,c4 #aciel7 is
 am5d$-- 7#a7 9 subsection 7a77#a7--    
7,a7 by /rik+ & 7,,hh7 & ins]t+ 7,,hh72 
&  7,b7 by ins]t+ ! foll[+ be=e !       
semicolon at ! end3 & 7,,ii7 ) respect  
to diabetes outpati5t self-managem5t    
tra9+ s]vices 7z def9$ 9 section        
#ahfa7qq771 ! am\nt paid %all be #ajj   
p]c5t ( ! less] ( ! actual *>ge = !     
s]vices or ! am\nt det]m9$ "u ! fee     
s*$ule t applies to su* s]vices "u ?is  
"p22 &  7#b7 9 subsection 7b71 9 ! fir/ 
s5t5ce-- 7,a7 by /rik+ 1 & 7#ac7 &      
ins]t+ 7#ac72 &  7,b7 by /rik+          
#ahfa7n744 & ins]t+ #ahfa7n71 & 7#ad7   
su* d$uctible %all n apply ) respect to 
diabetes outpati5t self-managem5t tra9+ 
s]vices 7z def9$ 9 section #ahfa7qq774  
7d7 ,application ,! am5dm5ts made by ?is

 section %all apply ) respect to items &
 s]vices furni%$ on or aft] ,janu>y #a1 
#bjbg4  #e4 ,,cmi te/+ ( provid+ virtual
 diabetes outpati5t self-managem5t tra9+
 s]vices ,section #aaae;,a ( ! ,social  
,security ,act 7#db ,u4,s4,c4 #acae;a7  
is am5d$-- 7#a7 9 subsection            
7b77#b77;,a71 by add+ at ! end ! foll[+ 
new s5t5ce3 ,! models select$ "u ?is    
subp>agraph %all include ! te/+ ( !     
model describ$ 9 subsection 7h742 &     
7#b7 by add+ at ! end ! foll[+ new      
subsection3  7h7 ,te/+ ( provid+ virtual
 diabetes outpati5t self-,managem5t     
tra9+ s]vices  7#a7 ,e/abli%m5t ,n lat] 
?an ,janu>y #a1 #bjbg1 ! ,secret>y %all 
implem5t a model to te/ ! impact (      
provid+ cov]age "u title ,,xviii =      
virtual diabetes outpati5t              
self-managem5t tra9+ s]vices furni%$ to 
applicable b5efici>ies ) respect to     
improv$ heal? outcomes = su* applicable 
b5efici>ies & r$uc$ exp5ditures "u su*  
title ,,xviii4  7#b7 ,model design  7,a7
 ,9 g5]al ,! ,secret>y %all design !    

model "u ?is subsection 9 su* a mann] to
 all[ = ! evaluation ( demographic      
*>act]i/ics ( applicable b5efici>ies    
p>ticipat+ 9 su* model & ! ext5t to :i* 
su* model accompli%es ! foll[+ purposes3
 7i7 ,improvem5t 9 heal? outcomes )     
respect to ! diabetic conditions1       
includ+ by r$uc+ ,a#a;c levels4  7ii7   
,r$uc$ hospitalizations due to          
diabetic-relat$ complications4  7iii7   
,increas$ utilization ( diabetes        
outpati5t self-managem5t tra9+ s]vices z
 evid5c$ by1 = example1 ,m$ic>e         
b5efici>y p>ticipation & utilization (  
cov]$ h\rs dur+ ! fir/ ye> & subsequ5t  
ye>s or use ( diabetes outpati5t        
self-managem5t tra9+ s]vices 9 rural &  
und]s]v$ communities4  7iv7 ,improv$    
m$ication adh]5ce4  7v7 ,r$uc$          
exp5ditures "u ?is title attributable to
 ! model4  7,b7 ,consultation ,9 design+
 ! model "u ?is subsection1 ! ,secret>y 
%all1 n lat] ?an #c mon?s aft] ! date ( 
! enactm5t ( ?is subsection1 consult )  
/akehold]s 9 ! field ( diabetes c>e &   

education1 cl9icians 9 ! prim>y c>e     
community1 exp]ts 9 digital heal?1 &    
b5efici>y gr\ps4  7#c7 ,def9itions ,9   
?is subsection3 7,a7 ,applicable        
b5efici>y ,! t]m applicable b5efici>y   
means an individual ) diabetes z        
describ$ 9 section #ahfa7qq74  7,b7     
,qualifi$ web-bas$ program ,! t]m       
qualifi$ web-bas$ program means a       
web-bas$ program-- 7i7 design$ to furni%
 educational & tra9+ s]vices to an      
individual ) diabetes to ensure !rapy   
compliance ) respect to ! individual's  
diabetic condition or to provide !      
individual ) necess>y skills & k        
7includ+ skills relat$ to !             
self-adm9i/ration ( injectable drugs7 to
 p>ticipate 9 ! individual's managem5t (
 su* condition2 &  7ii7 t meets !       
quality /&>ds describ$ 9 section        
#ahfa7qq77#b77;,b74  7,c7 ,virtual      
diabetes outpati5t self-managem5t tra9+ 
s]vices ,! t]m virtual diabetes         
outpati5t self-managem5t tra9+ s]vices  
means any diabetes outpati5t            

self-managem5t tra9+ s]vices 7z def9$ 9 
section #ahfa7qq77 furni%$ by a qualifi$
 web-bas$ program = syn*ron\s or        
asyn*ron\s diabetes outpati5t           
self-managem5t tra9+ s]vices4  4  #f4   
,provid+ insul9 pump tra9+ & education  
7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1    
#bjbg1 ! ,secret>y ( ,heal? & ,human    
,s]vices 79 ?is section ref]r$ to z !   
,secret>y7 %all e/abli% new ,heal?c>e   
,common ,proc$ure ,cod+ ,sy/em codes "u 
! fee s*$ule e/abli%$ "u section        
#ahdh7;b7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #aciew-#d7;b77 t describe
 hook-up1 calibration1 & pati5t tra9+ ) 
respect to an insul9 pump simil> to     
,curr5t ,proc$ural ,t]m9ology codes     
#iebdi & #iebej 7& any succe$+ codes74  
,! ,secret>y %all ensure ! newly        
e/abli%$ codes suffici5tly describe     
pati5t education & tra9+ z well z insul9
 pump placem5t s]vices = te*nologies    
cov]$ "u section #ahcd ( ! ,social      
,security ,act 7#db ,u4,s4,c4 #aciem7 & 
"p ,d ( title ,,xviii ( ! ,social       

,security ,act 7#db ,u4,s4,c4           
#aciew-#aja et seq474  7b7 ,education & 
outrea* ,! ,secret>y %all use exi/+     
communications & me*anisms to provide   
education & outrea* to /akehold]s )     
respect to ! ability ( heal?            
pr(essionals to bill ! newly e/abli%$   
codes describ$ 9 subsection 7a74  #g4   
,national cov]age det]m9ation on insul9 
pumps ,n lat] ?an #ahj days aft] ! date 
( enactm5t ( ?is ,act1 ! ,secret>y (    
,heal? & ,human ,s]vices %all issue a   
propos$ national cov]age det]m9ation 7z 
def9$ 9 section #ahfi7;f77#a77;,b7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#acie;ff7f77#a77;,b777 = infusion pumps1
 cont9u\s subcutane\s insul9 infusion   
7,,csii71 numb] #bhj4ad pursuant to     
section #ahfb7l7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #aciey7l774  #h4    
,report on enrollee access to           
diabetes-relat$ s]vices & te*nologies 9 
,f$]al heal? c>e programs  7a7 ,9 g5]al 
,n lat] ?an #a ye> aft] ! date (        
enactm5t ( ?is ,act1 ! ,comptroll]      

,g5]al ( ! ,unit$ ,/ates1 9             
collaboration ) ! ,secret>y ( ,heal? &  
,human ,s]vices1 %all submit to !       
,committee on ,f9ance & ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce & ! ,committee on ,ways &      
,means ( ! ,h\se ( ,repres5tatives1 a   
report t assesses ! b>ri]s individuals  
face 9 access+ diabetes te*nologies &   
diabetes self-managem5t education &     
support s]vices across ,f$]al heal? c>e 
programs4 ,! report %all specifically   
review b>ri]s1 :i* include prior        
au?orization practices1 ! use ( pref]r$ 
=mul>ies1 cov]age int5sity limitations1 
& o!r utilization managem5t te*niques1  
to access+ diabetes te*nologies &       
diabetes self-managem5t education &     
support s]vices fac$ by individuals     
enroll$ 9 a ,f$]al heal? c>e program1 & 
:e!r any ,f$]al law1 regulation1 or     
policy adv]sely affects access to ^?    
cov]$ s]vices or limits ! ability (     
individuals ) diabetes to receive       

s]vices t align ) /&>ds ( c>e4  7b7     
,def9itions ,9 ?is section3 7#a7        
,diabetes te*nologies ,! t]m diabetes   
te*nologies means items describ$ 9      
section #ahfa7ww77#e77;,d7 ( ! ,social  
,security ,act1 z add$ by section #c1 & 
any device1 relat$ supplies1 & s(tw>e or
 algori?m t monitors or manages an      
individual's diabetes t is m$ically     
necess>y = ! individual's diagnosis (   
diabetes1 reg>dless ( :e!r ! device1    
relat$ supplies1 & s(tw>e or algori?m is
 cov]$ "u "p ,b ( title ,,xviii ( !     
,social ,security ,act4 ,su* t]m        
includes glucose monitors1 insul9       
deliv]y te*nologies1 relat$ supplies1 & 
s(tw>e or algori?ms4  7#b7 ,diabetes    
self-managem5t education & support      
s]vices ,! t]m diabetes self-managem5t  
education & support s]vices means       
s]vices describ$ 9 section #ahfa7qq7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciex7qq774  7#c7 ,f$]al heal? c>e     
program ,! t]m ,f$]al heal? c>e program 
means any plan or program t provides    

heal? b5efits1 :e!r ?r\gh insurance or  
o!rwise1 t is directly fund$ 9 :ole or 9
 "p1 by ! ,unit$ ,/ates ,gov]nm5t1      
includ+ a ,f$]al heal? c>e program 7z   
def9$ 9 section #aabh;,b7f7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;b7f777 & a heal? b5efits plan
 "u *apt] #hi ( title #e1 ,unit$ ,/ates 
,code4  #i4 ,ensur+ access to           
diabetes-relat$ te*nologies ,section    
#ahdg7;a77#b7 ( ! ,social ,security ,act
 7#db #aciew-#c7;a77#b77 is am5d$ by    
add+ at ! end ! foll[+ new subp>agraph3 
7,e7 ,c]ta9 diabetic-relat$ items       
,cont9u\s glucose monitors & insul9     
pumps t are cov]$ z durable m$ical      
equipm5t "u section #ahfa7n7 furni%$ on 
or aft] ,janu>y #a1 #bjca4  4