,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #hhaf  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #be1 #bjbd,mr4  
,bu*anan introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committee  
on ,ways & ,means1 = 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   
provide = a cognitive impairm5t         
detection b5efit "u ! ,m$ic>e program1 &
 = o!r purposes4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,am]ican ,m$ical   
,innovation & ,inve/m5t ,act ( #bjbd4   
#b4 ,cognitive impairm5t detection      
b5efit 9 ! ,m$ic>e annual wellness visit
 & initial prev5tive physical exam9ation
  7a7 ,annual wellness visit  7#a7 ,9   
g5]al ,section #ahfa7;hhh77#b7 ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#aciex7hhh77#b77 is am5d$ by /rik+      
subp>agraph 7,d7 & ins]t+ ! foll[+3     

7,d7 ,detection ( any cognitive         
impairm5t t %all-- 7i7 be p]=m$ us+ "o (
 ! cognitive impairm5t detection tools  
id5tifi$ by ! ,national ,in/itute on    
,ag+ z meet+ its crit]ia = select+      
in/rum5ts to detect cognitive impairm5t 
9 ! prim>y c>e sett+2 &  7ii7 include   
docum5tation ( ! tool us$ = detect+     
cognitive impairm5t & results ( !       
assessm5t 9 ! pati5t's m$ical record4  4
  7#b7 ,effective date ,! am5dm5t made  
by p>agraph 7#a7 %all apply to annual   
wellness visits furni%$ on or aft]      
,janu>y #a1 #bjbe4  7b7 ,initial        
prev5tive physical exam9ation  7#a7 ,9  
g5]al ,section #ahfa7ww77#a7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciex7ww77#a77 is am5d$ by /rik+       
agreem5t ) ! individual1 & & ins]t+     
agreem5t ) ! individual1 detection ( any
 cognitive impairm5t z describ$ 9       
subsection 7hhh77#b77;,d71 &4  7#b7     
,effective date ,! am5dm5t made by      
p>agraph 7#a7 %all apply to initial     
prev5tive physical exam9ations furni%$  

on or aft] ,janu>y #a1 #bjbe4  #c4      
,improv+ ! national & local cov]age     
det]m9ation processes "u ! ,m$ic>e      
program  7a7 ,9 g5]al ,section #ahfb7l7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciey7l77 is am5d$ by add+ at
 ! end ! foll[+ new p>agraph3  7#g7     
,limitation on duration ( cov]age )     
evid5ce developm5t det]m9ations  7,a7 ,9
 g5]al ,subject to subp>agraph 7,b71 9 !
 case ( a f9al decision "u p>agraph     
7#c77;,c77i7 7includ+ any su* decision  
made on a class-wide basis7 made on or  
aft] ! date ( ! enactm5t ( ?is p>agraph 
t results 9 cov]age ( an item or s]vice 
pursuant to subsection 7a77#a77;,e71 !  
,secret>y %all1 n lat] ?an #aj ye>s aft]
 ! date on :i* su* cov]age becomes      
effective pursuant to su* subsection1   
initiate a r$et]m9ation ) respect to su*
 item or s]vice4  7,b7 ,exception ,!    
,secret>y may delay a r$et]m9ation      
describ$ 9 subp>agraph 7,a7 ) respect to
 an item or s]vice = a p]iod ( "t       
det]m9$ appropriate by ! ,secret>y if-- 

7i7 ! ,secret>y f9ds t su* item or      
s]vice is reasonable & necess>y to c>ry 
out ! purposes describ$ 9 section #aadb2
 or  7ii7 ! entity responsible = su*    
item or s]vice reque/s su* ext5sion4    
7,c7 ,po/+ ( in=mation ,n lat] ?an #a   
ye> aft] ! date ( ! enactm5t ( ?is      
p>agraph1 & annually !reaft]1 !         
,secret>y po/ on ! public website ( !   
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices !   
foll[+ in=mation3 7i7 ,! numb] ( items &
 s]vices cov]$ "u ?is title pursuant to 
subsection 7a77#a77;,e74  7ii7 ,a       
description ( ea* su* item or s]vice4   
7iii7 ,! ye> 9 :i* cov]age ( ea* su*    
item or s]vice became effective pursuant
 to su* subsection4  4  7b7 ,provision (
 explanation 9 case ( c]ta9 reject$     
reque/s ,section #ahfb7l7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciey7l771 z am5d$ by subsection 7a71  
is fur!r am5d$ by add+ at ! end ! foll[+
 new p>agraph3  7#h7 ,requirem5t to     
provide explanation 9 case ( c]ta9      
reject$ reque/s ,) respect to ea*       

docum5t receiv$ by ! ,secret>y on or    
aft] ! date t is #a ye> aft] ! date ( ! 
enactm5t ( ?is p>agraph t id5tifies     
itself z a complete1 =mal reque/ = a    
national cov]age det]m9ation 7z describ$
 9 ! notice entitl$ ,m$ic>e ,program2   
,revis$ ,process = ,mak+ ,national      
,cov]age ,det]m9ations 7#gh ,f$4 ,reg4  
#dhafd7 or a successor regulation71 !   
,secret>y %all1 n lat] ?an #ij days aft]
 receipt ( su* docum5t-- 7,a7 det]m9e   
:e!r su* docum5t is a complete1 =mal    
reque/ = a national cov]age det]m9ation2
 &  7,b7 9 ! case t ! ,secret>y f9ds t  
su* docum5t is n a complete1 =mal reque/
 = a national cov]age det]m9ation1      
transmit to ! entity submitt+ su*       
docum5t in=mation on su* f9d+ t includes
 a specification ( additional in=mation 
ne$$ to make su* docum5t a complete1    
=mal reque/ = a national cov]age        
det]m9ation4  4  7c7 ,improv+ access to 
items & s]vices "u local cov]age        
det]m9ations ,section #ahfb7l77#e7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   

#aciey7l77#e77 is am5d$ by add+ at ! end
 ! foll[+ new subp>agraph3  7,e7 ,ensur+
 consi/5cy ) applicable rules ,!        
,secret>y %all require ea* ,m$ic>e      
adm9i/rative contractor t develops a    
local cov]age det]m9ation to ensure t   
any su* local cov]age det]m9ation does n
 conflict ) any law1 rul+1 regulation1  
national cov]age det]m9ation1 paym5t    
policy1 or cod+ policy4  4  7d7 ,fund+  
,!re are au?oriz$ to be appropriat$     
#a1jjj1jjj = fiscal ye> #bjbd = purposes
 ( c>ry+ out ! am5dm5ts made by ?is     
section4  #d4 ,m$ic>e cov]age ( ext]nal 
infusion pumps & non-self-adm9i/rable   
home infusion drugs ,section #ahfa7n7 ( 
! ,social ,security ,act 7#db ,u4,s4,c4 
#aciex7n77 is am5d$ by add+ at ! end !  
foll[+ new s5t5ce3 ,beg9n+ ) ! fir/     
cal5d> qu>t] beg9n+ on or aft] ! date t 
is #a ye> aft] ! date ( ! enactm5t ( ?is
 s5t5ce1 an ext]nal infusion pump &     
associat$ home infusion drug 7z def9$ 9 
subsection 7iii77#c77;,c77 or o!r       
associat$ supplies t d n meet !         

appropriate = use 9 ! home requirem5t   
appli$ to ! def9ition ( durable m$ical  
equipm5t "u section #dad4bjb ( title    
#db1 ,code ( ,f$]al ,regulations 7or any
 successor to su* regulation7 %all be   
treat$ z meet+ su* requirem5t if ea* ( !
 foll[+ crit]ia is satisfi$3 7#a7 ,!    
prescrib+ in=mation approv$ by ! ,food &
 ,drug ,adm9i/ration = ! home infusion  
drug associat$ ) ! pump in/ructs t !    
drug %\ld be adm9i/]$ by or "u !        
sup]vision ( a heal? c>e pr(essional4   
7#b7 ,a qualifi$ home infusion !rapy    
suppli] 7z def9$ 9 subsection           
7iii77#c77;,d77 adm9i/]s or sup]vises ! 
adm9i/ration ( ! drug or biological 9 a 
safe & effective mann] 9 ! pati5t's home
 7z def9$ 9 subsection 7iii77#c77;,b774 
7#c7 ,! prescrib+ in=mation describ$ 9  
p>agraph 7#a7 in/ructs t ! drug %\ld be 
infus$ at lea/ #ab times p] ye>-- 7,a7  
intrav5\sly or subcutane\sly2 or  7,b7  
at infusion rates t ! ,secret>y det]m9es
 w\ld require ! use ( an ext]nal        
infusion pump4  4  #e4 ,guidance on     

,m$ic>e paym5t = c]ta9 items involv+    
artificial intellig5ce ,n lat] ?an      
,janu>y #a1 #bjbf1 ! ,secret>y ( ,heal? 
& ,human ,s]vices %all use exi/+        
communications me*anisms to issue       
guidance on requirem5ts = paym5t "u "p  
,b ( title ,,xviii ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #acie;j et seq47 = 
remote monitor+ devices1 su* z cont9u\s 
glucose monitors1 t-- 7#a7 use an       
artificial intellig5ce compon5t 7su* z a
 cont9u\s adju/m5t compon5t72 &  7#b7   
transmit in=mation to a heal? c>e       
provid] = purposes ( managem5t &        
treatm5t ( an individual4  #f4 ,cl>ify+ 
paym5t = prescription digital !rapeutics
 "u ,m$ic>e  7a7 ,guidance to physicians
 ,n lat] ?an ,janu>y #a1 #bjbf1 !       
,secret>y ( ,heal? & ,human ,s]vices 79 
?is section ref]r$ to z ! ,secret>y7    
%all use exi/+ communication me*anisms  
to issue guidance on requirem5ts =      
paym5t "u "p ,b ( title ,,xviii ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#acie;j et seq47 = a prescription       

digital !rapeutic furni%$ by a physician
 or incid5t to a physician's pr(essional
 s]vice4  7b7 ,guidance to ,,ma         
organizations ,n lat] ?an #a ye> aft] ! 
date ( ! enactm5t ( ?is ,act1 !         
,secret>y %all issue to ,,ma            
organizations guidance to cl>ify !      
requirem5ts relat+ to :5 su*            
organizations may provide a prescription
 digital !rapeutic z a supplem5tal      
b5efit to an individual enroll$ "u a    
,,ma plan4  7c7 ,report to ,congress ,n 
lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y 
%all submit to ! ,committee on ,ways &  
,means & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 & 
! ,f9ance ,committee ( ! ,s5ate1 a      
report t includes-- 7#a7 an analysis (  
any exi/+ /atutory au?ority = !         
,secret>y to provide paym5t =           
prescription digital !rapeutics "u !    
,m$ic>e program2 &  7#b7 a description (
 any additional /atutory au?ority t is  
ne$$ by ! ,secret>y to exp& su* cov]age4
  7d7 ,def9itions ,9 ?is section3 7#a7  

,,ma t]ms ,! t]ms ,,ma plan1 ,,ma       
organization1 & supplem5tal b5efit h !  
mean+s giv5 ea* su* t]m 9 "p ,c ( title 
,,xviii ( ! ,social ,security ,act 7#db 
,u4,s4,c4 #aciew-#ba et seq474  7#b7    
,m$ic>e program ,! t]m ,m$ic>e program  
means ! ,m$ic>e program "u title ,,xviii
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #acie et seq474  7#c7         
,physician ,! t]m physician has ! mean+ 
giv5 su* t]m 9 section #ahfa7r7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciex7r774  7#d7 ,prescription digital 
!rapeutic ,! t]m prescription digital   
!rapeutic means an evid5ce-bas$ s(tw>e  
product1 includ+ any su* product t is a 
comb9ation product describ$ 9 section   
#ejc7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g771
 int5d$ = use 9 ! managem5t1 prev5tion1 
or treatm5t ( a disease or condition1 t 
acts directly z a m$ical int]v5tion or  
guides ! deliv]y ( a m$ical int]v5tion &
 t-- 7,a7 is regulat$ by ! ,food & ,drug
 ,adm9i/ration z a device 7z def9$ 9    

section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba771   
includ+ any su* device regulat$ z a     
comb9ation product 7z describ$ 9 section
 #ejc7;g7 ( su* ,act 7#ba ,u4,s4,c4     
#cec7;g772  7,b7 is cle>$ "u section    
#eaj7k71 classifi$ "u section           
#eac7;f77#b71 or approv$ "u section #eae
 ( su* ,act 7#ba ,u4,s4,c4 #cfj7k71     
#cfj;c7f77#b71 #cfj;e72 &  7,c7 may n be
 furni%$ to an individual )\t a         
prescription f a physician4