,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bgcj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #h1          
#bjbe,mrs4 ,blackburn 7= h]self & ,mr4  
,book]7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,f9ance  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
improve access to innovative treatm5t   
options = end-/age r5al disease "u !    
,m$ic>e program1 & = o!r purposes4  #a4 
,%ort title  7a7 ,9 g5]al ,?is ,act may 
be cit$ z ! ,kidney ,c>e ,access        
,protection ,act4  7b7 ,table ( cont5ts 
,! table ( cont5ts ( ?is ,act is z      
foll[s3 ,sec4 #a4 ,%ort title4,,title   
,i--,protect+ pati5t access to kidney   
c>e innovation,sec4 #aja4 ,ref9+ !      
end-/age r5al disease paym5t sy/em to   
improve access to innovative treatm5t   
options4,sec4 #ajb4 ,ensur+ ,m$ic>e     
,advantage supports kidney c>e          
innovative !rapies4,,title              
,,ii--,address+ /aff+ b>ri]s ) ,,esrd   
m>ket basket labor adjustments,sec4     

#bja4 ,ensur+ accuracy & /ability 9     
kidney c>e paym5t4  ,i ,protect+ pati5t 
access to kidney c>e innovation  #aja4  
,ref9+ ! end-/age r5al disease paym5t   
sy/em to improve access to innovative   
treatm5t options  7a7 ,ext5sion (       
,transitional ,drug ,add-,on ,paym5t    
,adju/m5t 7,,tdapa7 p]iod ,! ,secret>y (
 ,heal? & ,human ,s]vices 79 ?is section
 ref]r$ to z ! ,secret>y7 %all pay !    
transitional drug add-on paym5t adju/m5t
 "u section #dac4bcd7;c7 ( title #db1   
,code ( ,f$]al ,regulations 7or a       
successor regulation71 = n less ?an #c  
ye>s = any new r5al dialysis drug or    
biological product-- 7#a7 approv$ by !  
,food & ,drug ,adm9i/ration on or aft]  
,janu>y #a1 #bjbj1 "u section #eje ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb72  7#b7 t qualifies = su*
 adju/m5t "u su* section2 &  7#c7 t is  
furni%$ on or aft] ,janu>y #a1 #bjbf4   
7b7 ,p]man5t po/-,,tdapa adju/m5t       

,section #ahha7;b77#ad7 ( ! ,social     
,security ,act 7#db ,u4,s4,c4           
#acierr7b77#ad77 is am5d$ by add+ at !  
end ! foll[+ new subp>agraph3  7,j7     
,paym5t = new & innovative drugs1       
biologicals1 & devices t are r5al       
dialysis s]vices  7i7 ,9 g5]al ,= any   
new r5al dialysis drug or biological    
product t is us$ to treat or manage a   
condition z def9$ 9 section #dac4bcd7;a7
 ( title #db1 ,code ( ,f$]al            
,regulations t receiv$ a transitional   
drug add-on paym5t adju/m5t 7ref]r$ to 9
 ?is subp>agraph z ,,tdapa7 "u section  
#dac4bcd7;c7 ( su* title1 & 0 furni%$ on
 or aft] ,janu>y #a1 #bjbd1 ! ,secret>y 
%all e/abli% a p]man5t add-on adju/m5t  
to ! base rate = claims submitt$ on or  
aft] ,janu>y #a1 #bjbf1 t includes !    
adm9i/ration ( su* drugs or biologicals4
  7ii7 ,calculation ( ! po/-,,tdapa     
add-on adju/m5t ,9 calculat+ ! add-on   
adju/m5t describ$ 9 clause 7i71 !       
,secret>y %all-- 7,i7 base ! calculation
 on-- 7aa7 except z provid$ 9 items 7bb7

 & 7cc71 ! mo/ rec5t #ab-mon? p]iod (   
utilization = ! new r5al dialysis drug  
or biological product & ! mo/ rec5t     
available full cal5d> qu>t] ( av]age    
sales price data = su* drug or product2 
7bb7 if ! mo/ rec5t available full      
cal5d> qu>t] ( av]age sales price data  
reflects #j or negative sales1 #ajj     
p]c5t ( ! :olesale acquisition co/ 7z   
def9$ 9 section #ahdg;,a7c77#f77 ( su*  
drug or product2 or  7cc7 if ! :olesale 
acquisition co/ is n available1 ! drug  
manufactur]'s invoice2  7,,ii7 calculate
 ! po/-,,tdapa add-on paym5t adju/m5t z 
! exp5ditures = ! new r5al dialysis drug
 or biological product divid$ by ! total
 numb] ( r5al dialysis s]vices dur+ :i* 
su* drug or biological 0 adm9i/]$ dur+ !
 same p]iod2  7,,iii7 set ! am\nt ( !   
add-on adju/m5t z an am\nt equal to #fe 
p]c5t ( ! am\nt calculat$ "u subclause  
7,,ii72  7,,iv7 update ! add-on adju/m5t
 annually to acc\nt = inflation>y       
*anges2 &  7,v7 apply ! add-on adju/m5t 
am\nt imm$iately ^u ! expiration ( !    

,,tdapa p]iod & availability ( !        
po/-,,tdapa add-on adju/m5t4  7iii7     
,implem5tation ,?is subp>agraph %all n  
be implem5t$ 9 a budget neutral mann] & 
%all n be adju/$ by any applicable      
pati5t-level case-mix adju/m5ts describ$
 9 section #dac4bce ( title #db1 ,code (
 ,f$]al ,regulations 7or any successor  
regulation74  4  7c7 ,cl>ification to   
def9ition ( r5al dialysis s]vices       
,section #ahha7;b77#ad77;,b7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#acierr7b77#ad77;,b77 is am5d$-- 7#a7 by
 r$esignat+ clauses 7i7 ?r\gh 7iv7 z    
subclauses 7,i7 ?r\gh 7,,iv71           
respectively2  7#b7 by ins]t+ 7i7 aft]  
7,b72  7#c7 9 clause 7i77,,iv71 z add$  
by p>agraph 7#b71 by /rik+ clause 7i7 & 
ins]t+ subclause 7,i72  7#d7 9 ! flu%   
text at ! end1 by /rik+ ,su* t]m does n 
& ins]t+ ! foll[+3  7ii7 ,su* t]m-- 7,i7
 does n  2  7#e7 9 clause 7ii71 z add$  
by p>agraph 7#b7-- 7,a7 9 subclause     
7,i71 by /rik+ ! p]iod at ! end & ins]t+
 2 &2 &  7,b7 by add+ at ! end ! foll[+3

  7,,ii7 does n include drugs or        
biological products us$ to treat a      
comorbid disease or condition 7includ+  
c>diovascul> disease1 an inflammatory   
condition1 canc]1 diabetes1 & obesity7 t
 may occur 9 an individual :o has be5   
det]m9$ to h end-/age r5al diseases & is
 receiv+ dialysis &-- 7aa7 t h be5      
approv$ by ! ,food & ,drug ,adm9i/ration
 aft] ,decemb] #ca1 #bjbe2 &  7bb7 d n  
sub/itute = a drug or biological includ$
 9 ! ,,esrd prospective paym5t sy/em    
base rate4  2 &  7#f7 by add+ at ! end !
 foll[+ new clause3  7iii7              
,implem5tation ,beg9n+ on ! date (      
enactm5t ( ?is clause1 = purposes (     
implem5t+ clause 7ii77,,ii71 ! ,secret>y
 %all require t a claim = a drug or     
biological product describ$ 9 su*       
clause1 t is payable "u ?is "p & is     
furni%$ by a provid] ( s]vices or r5al  
dialysis facility1 conta9 ! ,,ay modifi]
 7or a successor modifi]74  4  7d7      
,revisions to ,transitional ,add-,on    
,paym5t ,adju/m5t = ,new & ,innovative  

,equipm5t & ,supplies 7,,tpnies7  7#a7  
,ext5sion ( p]iod ,! ,secret>y %all pay 
! transitional add-on paym5t adju/m5t = 
new & innovative equipm5t & supplies "u 
section #dac4bcf ( title #db1 ,code (   
,f$]al ,regulations 7or a successor     
regulation71 = n less ?an #c ye>s = any 
new r5al dialysis device t-- 7,a7       
qualifies = su* adju/m5t2 &  7,b7 is    
furni%$ on or aft] ,janu>y #a1 #bjbf4   
7#b7 ,eligibility ( break?r\gh devices  
,beg9n+ ,janu>y #a1 #bjbf1 a device     
designat$ = exp$it$ developm5t &        
priority review "u section #eae;,b ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;e-#c7 %all be       
eligible = a transitional add-on paym5t 
adju/m5t = new & innovative equipm5t &  
supplies "u section #dac4bcf ( title    
#db1 ,code ( ,f$]al ,regulations 7or a  
successor regulation74  7#c7 ,inclusion 
( capital-relat$ assets 9 ! transitional
 add-on paym5t adju/m5t = new &         
innovative equipm5t & supplies &        
po/-,transitional ,add-,on ,paym5t      

,adju/m5t = ,new & ,innovative ,equipm5t
 & ,supplies ,beg9n+ ,janu>y #a1 #bjbf1 
! ,secret>y %all n apply ! crit]ion     
describ$ 9 section #dac4bcf7;b77#f7 (   
title #db1 ,code ( ,f$]al ,regulations  
7or a successor regulation71 t excludes 
capital-relat$ assets f ! transitional  
add-on paym5t adju/m5t = new &          
innovative equipm5t & supplies & %all   
calculate su* adju/m5t = capital-relat$ 
assets t are devices t o!rwise meet !   
requirem5ts = ! transitional add-on     
paym5t adju/m5t = new & innovative      
equipm5t4  7e7 ,effective date ,!       
am5dm5ts made by ?is section %all take  
effect on ,janu>y #a1 #bjbf1 & apply to 
items & s]vices furni%$ on or aft] su*  
date4  #ajb4 ,ensur+ ,m$ic>e ,advantage 
supports kidney c>e innovative !rapies  
7a7 ,9 g5]al ,section #ahec7;c7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#bc7;c77 is am5d$ by add+ at !   
end ! foll[+ new p>agraph3  7#h7        
,treatm5t ( innovative products =       
enrollees ) end-/age r5al disease  7,a7 

,9 g5]al ,beg9n+ ,janu>y #a1 #bjbf1 !   
,secret>y %all make direct paym5t       
adju/m5ts to provid]s ( s]vices or r5al 
dialysis facilities =-- 7i7 any new r5al
 dialysis drug or biological product t  
receives a transitional drug add-on     
paym5t adju/m5t "u section #dac4bcd7;c7 
( title #db1 ,code ( ,f$]al             
,regulations2 or  7ii7 an item or s]vice
 t receives a transitional add-on paym5t
 adju/m5t = new & innovative equipm5t & 
supplies "u section #dac4bcf ( su*      
title4  7,b7 ,am\nt ( direct paym5t ,!  
am\nt ( ! adju/m5t %all equal ! am\nt   
det]m9$ "u ! end-/age r5al disease      
prospective paym5t sy/em describ$ 9     
section #ahha7;b77#ad74  7,c7 ,duration 
( direct paym5t ,! ,secret>y %all make  
paym5ts "u subp>agraph 7,a7 = ! duration
 ( ! transitional paym5t "u ! end-/age  
r5al disease prospective paym5t sy/em   
describ$ 9 su* section4  4  7b7 ,con=m+ 
am5dm5ts ,section #ahea7;i7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#aciew-#ba7 is am5d$-- 7#a7 9 p>agraph  

7#a71 by ins]t+ #ahec7;c77#h71 aft]     
#ahhf7;h77#c77;,d712 &  7#b7 9 p>agraph 
7#b71 by ins]t+ #ahec7;c77#h71 aft]     
#ahec7;h714  ,,ii ,address+ /aff+ b>ri]s
 ) ,,esrd m>ket basket labor adju/m5ts  
#bja4 ,ensur+ accuracy & /ability 9     
kidney c>e paym5t ,section              
#ahha7;b77#ad77;,f77i7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#acierr7b77#ad77;,f77i77 is am5d$-- 7#a7
 9 subclause 7,i71 by /rik+ subclauses  
7,,ii7 & 7,,iii7 & ins]t+ subclauses    
7,,ii71 7,,iii71 & 7,,iv72  7#b7 9      
subclause 7,,ii71 by ins]t+ & aft]      
application ( subclause 7,,iv7 aft]     
subclause 7,i72 &  7#c7 by add+ at ! end
 ! foll[+ new subclause3  7,,iv7 ,beg9n+
 ) #bjbf1 ! ,secret>y %all compute an   
adju/m5t to ! increase factor describ$ 9
 subclause 7,i7 = ! annual update ( !   
paym5t am\nts e/abli%$ "u ?is p>agraph =
 ! previ\s ye> to acc\nt = =eca/ error  
7ref]r$ to 9 ?is subclause z ! =eca/    
error adju/m5t74 ,! initial adju/m5t 79 
#bjbf7 to ! increase factor %all take   

into acc\nt ! cumulative =eca/ error =  
#bjba & #bjbb4 ,subsequ5t adju/m5ts 9   
succe$+ ye>s %all take into acc\nt !    
=eca/ error f ! mo/ rec5tly available   
ye> = :i* !re is f9al data4 ,! =eca/    
error adju/m5t "u ?is subclause %all    
apply :5ev] ! diff]5ce betwe5 ! =eca/$ &
 actual p]c5tage *ange 9 ! prices ( an  
appropriate mix ( goods & s]vices       
includ$ 9 r5al dialysis s]vices exce$s  
#j4e p]c5tage po9ts4  4