,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #dacd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #a1 #bjbj,mr4    
,cornyn 7= himself & ,mr4 ,b5net7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to e/abli% a       
demon/ration project to increase access 
to biosimil> biological products "u !   
,m$ic>e program4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,increas+ ,access  
to ,biosimil>s ,act ( #bjbj4  #b4       
,demon/ration project to increase access
 to biosimil> biological products "u !  
,m$ic>e program  7a7 ,e/abli%m5t ,beg9n+
 n lat] ?an #a ye> aft] ! date (        
enactm5t ( ?is ,act1 ! ,secret>y %all   
e/abli% & implem5t a #e-ye> nationwide  
demon/ration project "u "p ,b ( title   
,,xviii ( ! ,social ,security ,act 7#db 
,u4,s4,c4 #acie;j et seq47 to evaluate !
 b5efits ( provid+ a %>$ sav+s paym5t = 
biosimil> biological products furni%$ "u
 su* "p4 ,at ! discretion ( ! ,secret>y1
 ! demon/ration project may be ext5d$ = 

an additional #b ye>s pa/ ! initial     
#e-ye> p]iod4  7b7 ,p>ticipation  7#a7  
,9 g5]al ,p>ticipation 9 ! demon/ration 
project %all be volunt>y & a p>ticipat+ 
provid] may t]m9ate p>ticipation at any 
"t & ! ,secret>y may t]m9ate !          
p>ticipation ( su* a provid] at any "t =
 failure to comply ) ! requirem5ts ( !  
demon/ration project4  7#b7 ,application
 & selection ,to p>ticipate 9 !         
demon/ration project1 an eligible       
provid] %all submit to ! ,secret>y an   
application 9 su* =m & mann] & conta9+  
su* in=mation z specifi$ by ! ,secret>y4
 ,ea* eligible provid] :o submits su* an
 application %all be select$ by !       
,secret>y = p>ticipation "u !           
demon/ration project4  7#c7             
,p>ticipation 9 innovation c5t] models  
,p>ticipation 9 ! demon/ration project  
%all n preclude an eligible provid] f   
also p>ticipat+ 9 any model au?oriz$ "u 
section #aaae;,a ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #acae;a71 includ+ ! 
,oncology ,c>e ,model & ! ,oncology ,c>e

 ,fir/ ,model1 or impact metrics or     
exp5ditures ) respect to an eligible    
provid] "u any model au?oriz$ "u su*    
section4  7c7 ,cov]age ,except z o!rwise
 provid$ 9 ?is section1 paym5t may be   
made "u ! demon/ration project = a      
biosimil> biological product only if su*
 product is cov]$ "u "p ,b ( title      
,,xviii ( ! ,social ,security ,act 7#db 
,u4,s4,c4 #acie;j et seq47 & su* paym5t 
%all be made 9 ! same mann] z paym5t is 
provid$ = su* a product "u su* "p4  7d7 
,additional paym5t  7#a7 ,9 g5]al       
,subject to p>agraphs 7#b7 & 7#c71 9    
addition to ! am\nt ( paym5t t w\ld     
o!rwise be made "u "p ,b ( title ,,xviii
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #acie;j et seq47 = a biosimil>
 biological product furni%$ or disp5s$  
by a p>ticipat+ provid] to a ,m$ic>e    
b5efici>y "u ! demon/ration project1 !re
 %all be made an additional paym5t1 9 an
 am\nt det]m9$ by ! ,secret>y1 t        
reflects a portion ( any diff]5ce betwe5
 su* am\nt ( paym5t "u su* "p1 z comp>$ 

to ! am\nt ( paym5t t w\ld h be5 made "u
 su* "p if ! ref]5ce biological product 
_h be5 furni%$ or disp5s$ to !          
b5efici>y4  7#b7 ,m$ic>e ,b5efici>y     
,co9surance ,liability ,! additional    
paym5t provid$ "u p>agraph 7#a7 %all n  
be tak5 into acc\nt :5 det]m9+ ! am\nt (
 co9surance "u section #ahcc7;a77#a77,s7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciel7a77#a77,s77 = a        
biosimil> biological product furni%$ or 
disp5s$ to a ,m$ic>e b5efici>y by a     
p>ticipat+ provid] "u ! demon/ration    
project4 ,! ,secret>y may use a portion 
( ! diff]5ce describ$ 9 su* p>agraph to 
waive or r$uce ! am\nt ( co9surance     
o!rwise applicable "u su* section = su* 
a biosimil> biological4  7#c7 ,exception
 to ,additional ,paym5t ,a p>ticipat+   
provid] may only receive ! additional   
paym5t describ$ 9 p>agraph 7#a7 )       
respect to a biosimil> biological       
product furni%$ or disp5s$ by !         
p>ticipat+ provid] to a ,m$ic>e         
b5efici>y "u ! demon/ration project1 if 

! am\nt ( paym5t det]m9$ "u section     
#ahdg;,a ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #aciew-#c;a7 = ! biosimil>   
biologic product is less ?an ! am\nt (  
paym5t det]m9$ "u su* section = !       
ref]5ce biological product4  7e7 ,waiv] 
au?ority ,! ,secret>y may waive su*     
requirem5ts ( titles ,,xi & ,,xviii ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acja et seq41 #acie et seq47 z may be  
necess>y to c>ry out ! demon/ration     
project4  7f7 ,data collection  7#a7 ,9 
g5]al ,! ,secret>y %all collect data on 
! sex1 race1 e?nicity1 & geographic &   
socioeconomic *>act]i/ics ( ,m$ic>e     
b5efici>ies to :om a biosimil>          
biological product is furni%$ or disp5s$
 by a p>ticipat+ provid] "u !           
demon/ration project4  7#b7             
,consid]ation ,! ,secret>y %all take    
into acc\nt data collect$ "u p>agraph   
7#a7 9 evaluat+ ! demon/ration project 9
 ea* ( ! reports submitt$ "u subsection 
7g74  7g7 ,reports  7#a7 ,int]im        
evaluation & report ,n lat] ?an #c ye>s 

aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y %all submit to ,congress a    
report t conta9s an analysis ( !        
appropriat5ess ( exp&+ or ext5d+ !      
demon/ration project &1 to ! ext5t su*  
analysis det]m9es su* an expansion or   
ext5sion appropriate1 recomm5dations =  
su* expansion or ext5sion1 respectively4
  7#b7 ,evaluation & report ,n lat] ?an 
#a ye> aft] ! date ( completion ( !     
demon/ration project1 ! ,secret>y %all  
submit to ,congress a report t conta9s a
 f9al analysis ( ! project &            
recomm5dations describ$ 9 p>agraph 7#a74
  7h7 ,def9itions ,9 ?is section3 7#a7  
,biosimil> biological product ,! t]m    
biosimil> biological product has ! mean+
 giv5 t t]m 9 section                   
#ahdg;,a7c77#f77;,h7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,h774  7#b7         
,demon/ration project ,! t]m            
demon/ration project means !            
demon/ration project conduct$ "u ?is    
section4  7#c7 ,eligible provid] ,! t]m 

eligible provid] means a provid] (      
s]vices or suppli] t is eligible to     
receive paym5t "u "p ,b ( title ,,xviii 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #acie;j et seq47 = furni%+ or 
disp5s+ a biosimil> biological product4 
7#d7 ,m$ic>e b5efici>y ,! t]m ,m$ic>e   
b5efici>y means an individual :o is     
enroll$ = b5efits "u su* "p4  7#e7      
,p>ticipat+ provid] ,! t]m p>ticipat+   
provid] means an eligible provid] t has 
be5 select$ = p>ticipation "u ! project 
"u subsection 7b77#b7 & ) respect to :om
 su* p>ticipation has n be5 t]m9at$4    
7#f7 ,ref]5ce biological product ,! t]m 
ref]5ce biological product has ! mean+  
giv5 t t]m 9 section                    
#ahdg;,a7c77#f77;,i7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,i774  7#g7         
,secret>y ,! t]m ,secret>y means !      
,secret>y ( ,heal? & ,human ,s]vices4