,,ii  #aah? ,,congress  #a/ ,session    
,s4 #babi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #bb1 #bjbc ,mr4  
,lank=d 7= himself & ,mr4 ,m55dez7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
require ,,pdp sponsors ( a prescription 
drug plan & ,m$ic>e ,advantage          
organizations (f]+ an ,,ma-,,pd plan "u 
"p ,d ( ! ,m$ic>e program t use a =mul>y
 to include c]ta9 g5]ic drugs &         
biosimil> biological products on su*    
=mul>y1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z ! ,ensur+ 
,access to ,l[]-,co/ ,m$ic9es = ,s5iors 
,act4  #b4 ,requirem5ts = ,,pdp sponsors
 ( prescription drug plans & ,m$ic>e    
advantage organizations (f]+ ,,ma-,,pd  
plans "u "p ,d ( ! ,m$ic>e program t use
 =mul>ies  7a7 ,9 g5]al ,section        
#ahfj;,d-#d7;b77#c7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;b77#c77 is am5d$ by add+ at

 ! end ! foll[+ new subp>agraphs3  7,j7 
,requir$ inclusion ( c]ta9 g5]ic drugs &
 biosimil> biological products  7i7 ,9  
g5]al ,subject to ! succe$+ provisions (
 ?is subp>agraph1 ) respect to a plan   
ye> beg9n+ on or aft] ,janu>y #a1 #bjbe1
 ! foll[+ rules %all apply3 7,i7 ,if !  
=mul>y includes a "p ,d ref]5ce drug1 ! 
=mul>y %all include ea* "p ,d g5]ic drug
 ( su* "p ,d ref]5ce drug = :i* !       
:olesale acquisition co/ is less ?an !  
:olesale acquisition co/ ( su* "p ,d    
ref]5ce drug4  7,,ii7 ,if ! =mul>y      
includes a "p ,d ref]5ce biological     
product1 ! =mul>y %all include at lea/  
"o "p ,d biosimil> biological ( su* "p  
,d ref]5ce biological product = :i* !   
:olesale acquisition co/ is less ?an !  
:olesale acquisition co/ ( su* "p ,d    
ref]5ce biological product 7if "o or m  
su* "p ,d biosimil> biologicals is      
available74  7ii7 ,det]m9ations &       
implem5tation ,det]m9ations ( "p ,d     
g5]ic drugs & "p ,d biosimil> biological
 products describ$ 9 subclauses 7,i7 &  

7,,ii7 ( clause 7i7 & implem5tation (   
=mul>y requirem5ts "u clause 7i7 %all be
 made by ,,pdp sponsors (f]+            
prescription drug plans 9 accordance )  
uni=m requirem5ts e/abli%$ by !         
,secret>y 7by program in/ruction or     
o!rwise71 :i* %all provide = su*        
det]m9ations to be made z ( specifi$    
dates 79 ! case ( det]m9ations dur+ a   
plan ye>1 on a qu>t]ly basis71 & = any  
associat$ =mul>y *anges to be implem5t$ 
promptly !reaft] 79 accordance )        
timeframes specifi$ by ! ,secret>y74    
,su* uni=m requirem5ts %all also specify
 circum/ances "u :i* a "p ,d g5]ic drug 
or "p ,d biosimil> biological product   
%all be deem$ = purposes ( subclauses   
7,i7 & 7,,ii7 ( clause 7i7 to h a l[]   
:olesale acquisition co/ ?an its "p ,d  
ref]5ce drug or "p ,d ref]5ce biological
 product 7s z to require its inclusion  
on =mul>ies71 includ+ :]e no :olesale   
acquisition co/ is publi%$ = su* "p ,d  
ref]5ce drug or "p ,d ref]5ce biological
 product or ! "p ,d ref]5ce drug or "p  

,d ref]5ce biological product is n      
available = pur*ase by ! ,,pdp sponsor  
7or its network ph>macies7 f its        
manufactur] at ! publi%$ :olesale       
acquisition co/4  7iii7 ,prohibition on 
c]ta9 limits on access ,! ,,pdp sponsor 
(f]+ ! prescription drug plan may n     
impose limits on access to a "p ,d g5]ic
 drug requir$ to be includ$ on ! =mul>y 
"u clause 7i77,i7 or a "p ,d biosimil>  
biological product requir$ to be includ$
 on ! =mul>y "u clause 7i77,,ii71       
includ+ ?r\gh prior au?orization1       
utilization managem5t1 or /ep !rapy1 t  
are m re/rictive ?an any su* limits     
impos$ on access to ! "p ,d ref]5ce drug
 ( su* "p ,d g5]ic drug or "p ,d ref]5ce
 biological product ( su* "p ,d         
biosimil> biological product1           
respectively1 or t o!rwise h ! effect ( 
giv+ pref]r$ /atus to su* "p ,d ref]5ce 
drug or "p ,d ref]5ce biological product
 ov] su* "p ,d g5]ic drug or "p ,d      
biosimil> biological product1           
respectively4  7iv7 ,def9itions ,9 ?is  

subp>agraph & subp>agraph 7,k73  7,i7   
,"p ,d biosimil> biological product ,!  
t]m "p ,d biosimil> biological product  
means a cov]$ "p ,d drug t is a         
biosimil> biological product 7z def9$ 9 
section #ahdg;,a7c77#f77;,h774  7,,ii7  
,"p ,d g5]ic drug ,! t]m "p ,d g5]ic    
drug means a cov]$ "p ,d drug t is      
approv$ "u section #eje7;j7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act4  7,,iii7
 ,"p ,d ref]5ce biological product ,!   
t]m "p ,d ref]5ce biological product    
means a cov]$ "p ,d drug t is a ref]5ce 
biological product 7z def9$ 9 section   
#ahdg;,a7c77#f77;,i774  7,,iv7 ,"p ,d   
ref]5ce drug ,! t]m "p ,d ref]5ce drug  
means1 ) respect to a "p ,d g5]ic drug1 
a cov]$ "p ,d drug t is ! li/$ drug 7z  
describ$ 9 clause 7i7 ( section         
#eje7;j77#b77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act7 t is ref]r$ to 
9 ! abbreviat$ application = su* "p ,d  
g5]ic drug "u su* section4  7,v7        
,:olesale acquisition co/ ,! t]m        
:olesale acquisition co/ has ! mean+    

giv5 su* t]m 9 section                  
#ahdg;,a7c77#f77;,b74  7,k7 ,co/-,%>+   
ti]+ requirem5ts ) respect to "p ,d     
g5]ic drugs & "p ,d biosimil> biological
 products  7i7 ,g5]ic drug & biosimil>  
biological product co/-%>+ ti] ,)       
respect to a plan ye> beg9n+ on or aft] 
,janu>y #a1 #bjbe1 if ! ,,pdp sponsor   
(f]+ ! prescription drug plan applies   
ti]$ co/-%>+ 7?r\gh copaym5t or         
co9surance ti]s7 to cov]$ "p ,d drugs on
 a =mul>y1 ! ,,pdp sponsor %all--  7,i7 
h at lea/ "o co/-%>+ ti] on ! =mul>y t  
only includes "p ,d g5]ic drugs & "p ,d 
biosimil> biological products2 &  7,,ii7
 ) respect to ea* co/-%>+ ti] describ$ 9
 subclause 7,i7 on ! =mul>y1 ei!r apply 
no co/-%>+ requirem5t or a copaym5t t   
is--  7aa7 9 ! case :]e ! l[e/ br&$ drug
 ti] ( su* =mul>y bases co/-%>+ on a    
copaym5t am\nt1 an am\nt at lea/ #bj l[]
 ?an ! copaym5t = su* l[e/ br&$ drug ti]
 7b 9 no case may su* copaym5t am\nt be 
less ?an z]o72 or  7bb7 9 ! case :]e !  
l[e/ br&$ drug ti] ( su* =mul>y bases   

co/-%>+ on a co9surance p]c5tage1 an    
am\nt at lea/ #bj l[] ?an ! actu>ially  
expect$ av]age co/-%>+ am\nt payable = !
 cov]$ "p ,d drugs includ$ on su* l[e/  
br&$ drug ti]1 det]m9$ us+ processes &  
me?ods e/abli%$ "u section              
#ahfj;,d-#aa7;c7 7b 9 no case may su*   
copaym5t am\nt be less ?an z]o74  7ii7  
,specialty g5]ic drug & biosimil>       
biological product co/-%>+ ti] ,)       
respect to a plan ye> beg9n+ on or aft] 
,janu>y #a1 #bjbe1 if ! ,,pdp sponsor   
(f]+ ! prescription drug plan has a     
specialty ti]1 ! ,,pdp sponsor %all--   
7,i7 h a second specialty ti] on su*    
=mul>y t only includes "p ,d g5]ic drugs
 & "p ,d biosimil> biological products--
  7aa7 = :i* ! co/ 7z def9$ by !        
,secret>y7 is great] ?an a co/ ?re%old  
specifi$ by ! ,secret>y2 &  7bb7 )      
respect to :i* ! "p ,d ref]5ce drug =   
su* a "p ,d g5]ic drug or ! "p ,d       
ref]5ce biological product = su* a "p ,d
 biosimil> biological product is ei!r   
includ$ on a co/-%>+ ti] on su* =mul>y )

 a co/-%>+ requirem5t t is great] ?an ! 
co/-%>+ requirem5t appli$ "u subclause  
7,,ii71 or exclud$ f su* =mul>y2 &      
7,,ii7 apply a co9surance co/-%>+       
requirem5t ) respect to ! co/-%>+ ti]   
requir$ = ! =mul>y "u subclause 7,i7 t  
is at lea/ #e p]c5tage po9ts l[] ?an !  
co9surance p]c5tage applicable to any   
o!r specialty ti] ( ! =mul>y4  7iii7    
,placem5t ( c]ta9 g5]ic drugs &         
biosimil> biological products ,ea* "p ,d
 g5]ic drug & ea* "p ,d biosimil>       
biological product requir$ to be includ$
 on ! =mul>y "u subp>agraph 7,j77i7 %all
 be includ$ ei!r on a co/-%>+ ti]       
describ$ 9 clause 7i77,i7 or1 if        
applicable1 ! co/-%>+ ti] requir$ = !   
=mul>y "u clause 7ii77,i74  7iv7        
,application  7,i7 ,9 g5]al ,!          
requirem5ts "u clauses 7i7 ?r\gh 7iii7  
%all1 subject to ! requirem5ts "u       
section #ahfj;,d-#ad1 apply aft] !      
individual has satisfi$ any d$uctible "u
 subsections 7a77#b77;,a77i7 or 7b77#a7 
( section #ahfj;,d-#b4  7,,ii7          

,limitation ,! ,secret>y %all n approve 
any b5efit design = a prescription drug 
plan or an ,,ma-,,pd plan to :i* !      
requirem5ts ( ?is subp>agraph apply if  
su* b5efit design has any d$uctible     
applicable to any "p ,d g5]ic drug or "p
 ,d biosimil> biological product unless 
su* d$uctible1 or a great] d$uctible1   
also applies to all o!r cov]$ "p ,d     
drugs on ! =mul>y ( su* plan 7subject to
 ! requirem5ts "u section #ahfj;,d-#ad71
 except = less] or z]o d$uctibles       
applicable only to p>ticul> types (     
cov]$ "p ,d drugs :i* ! ,secret>y       
det]m9es w>rant favorable co/-%>+ :5 su*
 less] or z]o d$uctibles are also       
applicable to "p ,d g5]ic drugs & "p ,d 
biosimil> biological products ( ! giv5  
type4  7v7 ,def9itions ,9 ?is           
subp>agraph3 7,i7 ,br& drug ,! t]m br&  
drug means a cov]$ "p ,d drug t is      
approv$ "u section #eje7;c7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act or lic5s$
 "u section #cea7;a7 ( ! ,public ,heal? 
,s]vice ,act4  7,,ii7 ,l[e/ br&$ drug   

ti] ,! t]m l[e/ br&$ drug ti] means !   
co/-%>+ ti] ( a =mul>y :i* includes at  
lea/ #a br& drug & provides = ! l[e/    
level ( co/ %>+ applicable to any su*   
ti]1 z det]m9$ by ! ,secret>y4  7,,iii7 
,specialty ti] ,! t]m specialty ti]     
means a co/-%>+ ti] consi/+ only ( cov]$
 "p ,d drugs t h a co/ 7z def9$ by !    
,secret>y7 :i* equals or exce$s an      
applicable co/ ?re%old e/abli%$ by !    
,secret>y = high-co/ cov]$ "p ,d drugs  
to be eligible = inclusion on su*       
co/-%>+ ti]4  4  7b7 ,con=m+ am5dm5ts   
,section #ahfj;,d-#b ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajb7 is am5d$-- 7#a7 9          
subsection 7b77#b7--  7,a7 9 subp>agraph
 7,a71 by /rik+ & p>agraphs 7#h7 & 7#i7 
& ins]t+ 1 p>agraphs 7#h7 & 7#i71 &     
section #ahfj;,d-#d7;b77#c77,k72 &  7,b7
 9 subp>agraph 7,b71 by ins]t+ be=e !   
p]iod ! foll[+3 & section               
#ahfj;,d-#d7;b77#c77,k72 &  7#b7 9      
subsection 7c71 by add+ at ! end !      
foll[+ new p>agraph3  7#g7 ,treatm5t (  

co/-%>+ = "p ,d g5]ic drugs & "p ,d     
biosimil> biological products ,! cov]age
 is provid$ 9 accordance ) section      
#ahfj;,d-#d7;b77#c77,k74  4