#aae? ,,congress  #b;d ,session  ,s4    
#beed  ,,an ,,act  ,to ensure t heal?   
insurance issu]s & gr\p heal? plans d n 
prohibit ph>macy provid]s f provid+     
c]ta9 in=mation to enrollees4  #a4 ,%ort
 title ,?is ,act may be cit$ z ! ,pati5t
 ,"r to ,"k ,drug ,prices ,act4  #b4    
,prohibition on limit+ c]ta9 in=mation  
on drug prices ,subp>t ,,ii ( "p ,a (   
title ,,xxvii ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et     
seq47 is am5d$ by add+ at ! end !       
foll[+3  #bgbi4 ,in=mation on           
prescription drugs  7a7 ,9 g5]al ,a gr\p
 heal? plan or a heal? insurance issu]  
(f]+ gr\p or individual heal? insurance 
cov]age %all--  7#a7 n re/rict1 directly
 or indirectly1 any ph>macy t disp5ses a
 prescription drug to an enrollee 9 !   
plan or cov]age f in=m+ 7or p5alize su* 
ph>macy = in=m+7 an enrollee ( any      
diff]5tial betwe5 ! enrollee's          
out-(-pocket co/ "u ! plan or cov]age ) 
respect to acquisition ( ! drug & !     
am\nt an individual w\ld pay =          

acquisition ( ! drug )\t us+ any heal?  
plan or heal? insurance cov]age2 &  7#b7
 ensure t any entity t provides ph>macy 
b5efits managem5t s]vices "u a contract 
) any su* heal? plan or heal? insurance 
cov]age does n1 ) respect to su* plan or
 cov]age1 re/rict1 directly or          
indirectly1 a ph>macy t disp5ses a      
prescription drug f in=m+ 7or p5alize   
su* ph>macy = in=m+7 an enrollee ( any  
diff]5tial betwe5 ! enrollee's          
out-(-pocket co/ "u ! plan or cov]age ) 
respect to acquisition ( ! drug & !     
am\nt an individual w\ld pay =          
acquisition ( ! drug )\t us+ any heal?  
plan or heal? insurance cov]age4  7b7   
,def9ition ,= purposes ( ?is section1 ! 
t]m out-(-pocket co/1 ) respect to      
acquisition ( a drug1 means ! am\nt to  
be paid by ! enrollee "u ! plan or      
cov]age1 includ+ any co/-%>+ 7includ+   
any d$uctible1 copaym5t1 or co9surance7 
&1 z det]m9$ by ! ,secret>y1 any o!r    
exp5diture4  4  #c4 ,mod]niz+ ! report+ 
( biological & biosimil> products       

,subtitle ,b ( title ,,xi ( ! ,m$ic>e   
,prescription ,drug1 ,improvem5t1 &     
,mod]nization ,act ( #bjjc 7,public ,law
 #ajh-agc7 is am5d$--  7#a7 9 section   
#aaaa-- 7,a7 by r$esignat+ p>agraphs    
7#c7 ?r\gh 7#h7 z p>agraphs 7#f7 ?r\gh  
7#aa71 respectively2  7,b7 by ins]t+    
aft] p>agraph 7#b7 ! foll[+3  7#c7      
,biosimil> biological product ,! t]m    
biosimil> biological product means a    
biological product = :i* an application 
"u section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act is approv$4  7#d7          
,biosimil> biological product applicant 
,! t]m biosimil> biological product     
applicant means a p]son :o has fil$ or  
receiv$ approval = a biosimil>          
biological product "u section #cea7k7 ( 
! ,public ,heal? ,s]vice ,act4  7#e7    
,biosimil> biological product           
application ,! t]m biosimil> biological 
product application means an application
 = lic5sure ( a biological product "u   
section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act4  2  7,c7 9 p>agraph 7#f71 

z s r$esignat$1 by ins]t+ 1 or a        
biological product = :i* an application 
is approv$ "u section #cea7;a7 ( !      
,public ,heal? ,s]vice ,act be=e !      
p]iod2  7,d7 9 p>agraph 7#g71 z s       
r$esignat$-- 7i7 by /rik+ p>agraph 7#c7 
& ins]t+ p>agraph 7#f72  7ii7 by ins]t+ 
or a ref]5ce product 9 a biosimil>      
biological product application aft]     
,,&a2 &  7iii7 by ins]t+ or "u section  
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 be=e ! p]iod2 &  7,e7 by add+ at ! end 
! foll[+3  7#ab7 ,ref]5ce product ,! t]m
 ref]5ce product means a br& "n drug =  
:i* a lic5se is 9 effect "u section     
#cea7;a7 ( ! ,public ,heal? ,s]vice     
,act4  2  7#b7 9 section #aaab-- 7,a7 9 
subsection 7a7--  7i7 9 p>agraph 7#a7-- 
7,i7 by ins]t+ or a biosimil> biological
 product applicant :o has submitt$ a    
biosimil> biological product application
 = :i* a /atem5t "u section             
#cea7l77#c77;,b77ii77,i7 ( ! ,public    
,heal? ,s]vice ,act has be5 provid$ aft]
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 

&  7,,ii7 by ins]t+ or ! biosimil>      
biological product t is ! subject ( !   
biosimil> biological product            
application1 z applicable aft] ! ,,&a2 &
  7ii7 9 p>agraph 7#b7-- 7,i7 9 ! matt] 
prec$+ subp>agraph 7,a71 by ins]t+ or a 
biosimil> biological product applicant  
aft] g5]ic drug applicant2  7,,ii7 9    
subp>agraph 7,a7-- 7aa7 by /rik+ m>ket+ 
& ins]t+ m>ket+12 &  7bb7 by ins]t+ or !
 ref]5ce product 9 ! biosimil>          
biological product application be=e     
involv$2  7,,iii7 9 subp>agraph 7,b71 by
 ins]t+ or ( ! biosimil> biological     
product = :i* ! biosimil> biological    
product application 0 submitt$ aft]     
submitt$2 &  7,,iv7 by am5d+ subp>agraph
 7,c7 to read z foll[s3  7,c7 z         
applicable--  7i7 ! #ahj-;day p]iod     
ref]r$ to 9 section                     
#eje7;j77#e77;,b77iv7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act z x applies to  
su* ,,&a or to any o!r ,,&a bas$ on !   
same br& "n drug2 or  7ii7 ! #a-ye>     
p]iod ref]r$ to 9 section               

#cea7k77#f77;,a7 ( ! ,public ,heal?     
,s]vice ,act z x applies to su*         
biosimil> biological product application
 or to any o!r biosimil> biological     
product application bas$ on ! same br&  
"n drug4  2 &  7,b7 9 subsection 7b7--  
7i7 by am5d+ p>agraph 7#a7 to read z    
foll[s3  7#a7 ,requirem5t  7,a7 ,g5]ic  
drugs ,a g5]ic drug applicant t has     
submitt$ an ,,&a conta9+ a c]tification 
"u section #eje7;j77#b77;,a77vii77,,iv7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act ) respect to a li/$ drug & ano!r   
g5]ic drug applicant t has submitt$ an  
,,&a conta9+ su* a c]tification = ! same
 li/$ drug %all ea* file ! agreem5t 9   
accordance ) subsection 7c74 ,! agreem5t
 %all be fil$ prior to ! date ( ! fir/  
comm]cial m>ket+ ( ei!r ( ! g5]ic drugs 
= :i* su* ,a,n,d,as 7 submitt$4  7,b7   
,biosimil> biological products ,a       
biosimil> biological product applicant t
 has submitt$ a biosimil> biological    
product application = :i* a /atem5t "u  
section #cea7l77#c77;,b77ii77,i7 ( !    

,public ,heal? ,s]vice ,act has be5     
provid$ ) respect to a ref]5ce product &
 ano!r biosimil> biological product     
applicant t has submitt$ a biosimil>    
biological product application = :i* su*
 a /atem5t = ! same ref]5ce product has 
be5 provid$ %all ea* file ! agreem5t 9  
accordance ) subsection 7c74 ,! agreem5t
 %all be fil$ prior to ! date ( ! fir/  
comm]cial m>ket+ ( ei!r ( ! biosimil>   
biological products = :i* su* biosimil> 
biological product applications 7       
submitt$4  2 &  7ii7 9 p>agraph 7#b7--  
7,i7 by /rik+ betwe5 two g5]ic drug     
applicants is an agreem5t & ins]t+ is1 z
 applicable1 an agreem5t betwe5 #b g5]ic
 drug applicants2 &  7,,ii7 by ins]t+ 1 
or an agreem5t betwe5 #b biosimil>      
biological product applicants reg>d+ !  
#a-ye> p]iod ref]r$ to 9 section        
#cea7k77#f77;,a7 ( ! ,public ,heal?     
,s]vice ,act z x applies to ! biosimil> 
biological product applications ) :i* ! 
agreem5t is conc]n$ be=e ! p]iod2  7#c7 
9 section #aaae1 by /rik+ or g5]ic drug 

applicant ea* place su* t]m appe>s &    
ins]t+ 1 g5]ic drug applicant1 or       
biosimil> biological product applicant2 
&  7#d7 9 section #aaag1 by /rik+ 1 or  
any agreem5t betwe5 g5]ic drug          
applicants & ins]t+ or a biosimil>      
biological product applicant1 any       
agreem5t betwe5 g5]ic drug applicants1  
or any agreem5t betwe5 biosimil>        
biological product applicants4  ,pass$ !
 ,s5ate ,septemb] #ag1 #bjah4,secret>y