,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #diac  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #cj1 #bjai,mr4
 ,mc,kinley 7= himself & ,ms4 ,ku/] (   
,new ,hamp%ire7 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   
require ,,pdp sponsors ( a prescription 
drug plan "u "p ,d ( ! ,m$ic>e program t
 use a =mul>y to include c]ta9 g5]ic    
drugs & biosimil> biological products on
 su* =mul>y1 & = o!r purposes4  #a4     
,requirem5ts = ,,pdp sponsors (         
prescription drug plans "u "p ,d ( !    
,m$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,i7 

,requir$ inclusion ( c]ta9 g5]ic drugs &
 biosimil> biological products  7i7 ,9  
g5]al ,) respect to a plan ye> beg9n+ on
 or aft] ,janu>y #a1 #bjba1 ! =mul>y    
%all include--  7,i7 ea* cov]$ g5]ic    
drug = :i* ! :olesale acquisition co/ is
 less ?an ! :olesale acquisition co/ ( !
 ref]5ce drug ( su* cov]$ g5]ic drug2 & 
7,,ii7 ea* cov]$ biosimil> biological   
product = :i* ! :olesale acquisition co/
 is less ?an ! :olesale acquisition co/ 
( ! ref]5ce biological product ( su*    
cov]$ biosimil> biological product4     
7ii7 ,prohibition on c]ta9 limits on    
access ,! ,,pdp sponsor (f]+ !          
prescription drug plan may n impose     
limits on access to a cov]$ g5]ic drug  
requir$ to be includ$ on ! =mul>y "u    
clause 7i77,i7 or a cov]$ 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 ! ref]5ce drug ( su*

 cov]$ g5]ic drug or ref]5ce biological 
product ( su* cov]$ biosimil> biological
 product1 respectively1 or t o!rwise h !
 effect ( giv+ pref]r$ /atus to su*     
ref]5ce drug or ref]5ce biological      
product ov] su* cov]$ g5]ic drug or     
cov]$ biosimil> biological product1     
respectively4  7iii7 ,def9itions ,9 ?is 
subp>agraph & subp>agraph 7,j73  7,i7   
,cov]$ biosimil> biological product ,!  
t]m cov]$ 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  
,cov]$ g5]ic drug ,! t]m cov]$ g5]ic    
drug means a cov]$ "p ,d drug t is a    
drug describ$ 9 section                 
#ahfj;,d-#b7;e77#a77;,a7 & approv$ "u   
section #eje7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act4  7,,iii7       
,ref]5ce biological product ,! t]m      
ref]5ce biological product has ! mean+  
giv5 su* t]m 9 section                  
#ahdg;,a7c77#f77;,i74  7,,iv7 ,ref]5ce  
drug ,! t]m ref]5ce drug means1 )       

respect to a cov]$ g5]ic drug1 ! 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* cov]$  
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,j7 ,co/-,%>+   
ti]+ requirem5ts ) respect to cov]$     
g5]ic drugs & cov]$ biosimil> biological
 products  7i7 ,g5]ic drug co/-,%>+ ti] 
,) respect to a plan ye> beg9n+ on or   
aft] ,janu>y #a1 #bjba1 ! ,,pdp sponsor 
(f]+ ! prescription drug plan %all--    
7,i7 h at lea/ "o co/-%>+ ti] on !      
=mul>y t only includes cov]$ g5]ic drugs
 & cov]$ biosimil> biological products2 
&  7,,ii7 apply a co/-%>+ requirem5t )  
respect to ea* co/-%>+ ti] describ$ 9   
subclause 7,i7 on ! =mul>y t is         
mean+fully less] ?an ! l[e/ co/-%>+     
requirem5t applicable ) respect to any  
co/-%>+ ti] on su* =mul>y t includes a  

br& drug 7ref]r$ to 9 ?is subp>agraph z 
! l[e/ br& drug co/-%>+ ti]74  7ii7     
,specialty g5]ic drug co/-,%>+ ti] ,)   
respect to a plan ye> beg9n+ on or aft] 
,janu>y #a1 #bjba1 if ! ,,pdp sponsor   
(f]+ ! prescription drug plan has a     
co/-%>+ ti] = specialty br& drugs on !  
=mul>y1 ! ,,pdp sponsor %all-- 7,i7 h a 
co/-%>+ ti] on su* =mul>y t only        
includes cov]$ g5]ic drugs & cov]$      
biosimil> biological products--  7aa7 = 
:i* ! :olesale acquisition co/ is great]
 ?an a ?re%old specifi$ by ! ,secret>y2 
&  7bb7 ) respect to :i* ! ref]5ce drug 
= su* a cov]$ g5]ic drug or ! ref]5ce   
biological product = su* a cov]$        
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 co/-%>+ requirem5t )     
respect to ! co/-%>+ ti] requir$ = !    
=mul>y "u subclause 7,i7 t is mean+fully
 less] ?an ! co/-%>+ requirem5t         

applicable ) respect to ! co/-%>+ ti] = 
specialty br& drugs on su* =mul>y4      
7iii7 ,placem5t ( c]ta9 g5]ic drugs &   
biosimil> biological products ,ea* cov]$
 g5]ic drug & ea* cov]$ biosimil>       
biological product requir$ to be includ$
 on ! =mul>y "u subp>agraph 7,i77i7 %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        
,def9itions ,9 ?is subp>agraph3 7,i7    
,br& drug ,! t]m br& drug means a cov]$ 
"p ,d drug t is a drug describ$ 9       
section #ahfj;,d-#b7;e77#a77;,a7 &      
approv$ "u section #eje7;c7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act4  7,,ii7 
,mean+fully less] ,! t]m mean+fully     
less] means-- 7aa7 = purposes (         
subclause 7,,ii7 ( clause 7i71 su* a    
less] co/-%>+ requirem5t t ! ,secret>y  
det]m9es w likely significantly         
inc5tivize ! utilization ( cov]$ g5]ic  
drugs & cov]$ biosimil> biological      
products on a co/-%>+ ti] describ$ 9    

subclause 7,i7 ( su* clause on a =mul>y 
ov] cov]$ "p ,d drugs on ! l[e/ br& drug
 co/-%>+ ti] on su* =mul>y2 &  7bb7 =   
purposes ( subclause 7,,ii7 ( clause    
7ii71 su* a less] co/-%>+ requirem5t t !
 ,secret>y det]m9es w likely            
significantly inc5tivize ! utilization (
 cov]$ g5]ic drugs & cov]$ biosimil>    
biological products on ! co/-%>+ ti]    
requir$ = ! =mul>y "u subclause 7,i7 (  
su* clause ov] cov]$ "p ,d drugs on !   
co/-%>+ ti] = specialty br& drugs on su*
 =mul>y4  7,,iii7 ,specialty br& drug ,!
 t]m specialty br& drug means a br& drug
 = :i* ! :olesale acquisition co/ is    
great] ?an a ?re%old specifi$ by !      
,secret>y4  4  7b7 ,con=m+ am5dm5t      
,section #ahfj;,d-#b7;b77#b77;,b7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajb7;b77#b77;,b77 is am5d$ by   
ins]t+ be=e ! p]iod ! foll[+3 & section 
#ahfj;,d-#d7;b77#c77;,j74