,,ii  #aah? ,,congress  #a/ ,session    
,s4 #abfi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #be1 #bjbc,mrs4 
,%ahe5 7= h]self & ,ms4 ,coll9s7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to r$uce ! price ( insul9 & 
provide = pati5t protections ) respect  
to ! co/ ( insul94  #a4 ,%ort title2    
table ( cont5ts  7a7 ,%ort title ,?is   
,act may be cit$ z ! ,improv+ ,ne$$     
,safegu>ds = ,us]s ( ,lifesav+ ,insul9  
,n[ ,act ( #bjbc or ! ,,insul9 ,act (   
#bjbc4  7b7 ,table ( cont5ts ,! table ( 
cont5ts = ?is ,act is z foll[s3 ,sec4   
#a4 ,%ort title2 table ( cont5ts4,,title
 ,i--,comm]cial m>ket pati5t            
protections,sec4 #aja4 ,requirem5ts )   
respect to co/-%>+ = c]ta9 insul9       
products4,sec4 #ajb4 ,application to    
retiree & c]ta9 small gr\p plans4,sec4  
#ajc4 ,adm9i/ration4,,title             
,,ii--,ph>macy b5efit manag] transp>5cy 
& rebate reform,sec4 #bja4 ,full rebate 

on insul9 pass-?r\gh to plan4,,title    
,,iii--,biosimil> biological product &  
g5]ic drug competition &                
affordability,sec4 #cja4 ,ensur+ timely 
access to g5]ics4,sec4 #cjb4 ,p]mitt$   
mid-ye> *anges 9 ,m$ic>e "p ,d plan     
=mul>ies = c]ta9 biosimil> biological   
products & ! ref]5ce product ( su*      
biosimil>s4,sec4 #cjc4 ,exp$it+         
competitive biosimil> competition4,sec4 
#cjd4 ,insul9 competition report4  ,i   
,comm]cial m>ket pati5t protections     
#aja4 ,requirem5ts ) respect to co/-%>+ 
= c]ta9 insul9 products  7a7 ,9 g5]al   
,"p ,d ( title ,,xxvii ( ! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#cjj;gg-#aaa et seq47 is am5d$ by add+  
at ! end ! foll[+3  #bgii;,a-#aa4       
,requirem5ts ) respect to co/-%>+ =     
c]ta9 insul9 products  7a7 ,9 g5]al ,=  
plan ye>s beg9n+ on or aft] ,janu>y #a1 
#bjbd1 a gr\p heal? plan or heal?       
insurance issu] (f]+ gr\p or individual 
heal? insurance cov]age %all provide    
cov]age ( select$ insul9 products1 & )  

respect to su* products1 %all n-- 7#a7  
apply any d$uctible2 or  7#b7 impose any
 co/-%>+ requirem5ts 9 excess (1 p]     
#cj-;day supply-- 7,a7 = any applicable 
plan ye> beg9n+ be=e ,janu>y #a1 #bjbe1 
#ce2 or  7,b7 = any plan ye> beg9n+ on  
or aft] ,janu>y #a1 #bjbe1 ! less] (--  
7i7 #ce2 or  7ii7 ! am\nt equal to #be  
p]c5t ( ! negotiat$ price ( ! select$   
insul9 product net ( all price          
concessions receiv$ by or on behalf ( ! 
plan or issu]1 includ+ price concessions
 receiv$ by or on behalf ( ?ird-p>ty    
entities provid+ s]vices to ! plan or   
issu]1 su* z ph>macy b5efit managem5t   
s]vices or ?ird p>ty adm9i/rators4  7b7 
,def9itions ,9 ?is section3 7#a7        
,select$ insul9 products ,! t]m select$ 
insul9 products means1 = any plan ye>   
beg9n+ on or aft] ,janu>y #a1 #bjbd1 at 
lea/ "o ( ea* dosage =m 7su* z vial1 p51
 or inhal] dosage =ms7 ( ea* diff]5t    
type 7su* z rapid-act+1 %ort-act+1      
int]m$iate-act+1 long-act+1 & pre-mix$7 
( insul91 :5 su* =m is lic5s$ & m>ket$1 

z select$ by ! gr\p heal? plan or heal? 
insurance issu]4  7#b7 ,insul9 ,! t]m   
insul9 means insul9 t is lic5s$ "u      
subsection 7a7 or 7k7 ( section #cea &  
cont9ues to be m>ket$ pursuant to su*   
lic5sure4  7c7 ,out-(-,network provid]s 
,no?+ 9 ?is section requires a plan or  
issu] t has a network ( provid]s to     
provide b5efits = select$ insul9        
products describ$ 9 ?is section t are   
deliv]$ by an out-(-network provid]1 or 
precludes a plan or issu] t has a       
network ( provid]s f impos+ high]       
co/-%>+ ?an ! levels specifi$ 9         
subsection 7a7 = select$ insul9 products
 describ$ 9 ?is section t are deliv]$ by
 an out-(-network provid]4  7d7 ,rule ( 
con/ruction ,subsection 7a7 %all n be   
con/ru$ to require cov]age (1 or prev5t 
a gr\p heal? plan or heal? insurance    
cov]age f impos+ co/-%>+ o!r ?an !      
levels specifi$ 9 subsection 7a7 on1    
insul9 products t are n select$ insul9  
products1 to ! ext5t t su* cov]age is n 
o!rwise requir$ & su* co/-%>+ is o!rwise

 p]mitt$ "u ,f$]al & applicable ,/ate   
law4  7e7 ,application ( co/-,%>+ t[>ds 
d$uctibles & out-(-,pocket maximums ,any
 co/-%>+ paym5ts made pursuant to       
subsection 7a77#b7 %all be c\nt$ t[>d   
any d$uctible or out-(-pocket maximum t 
applies "u ! plan or cov]age4  7f7 ,o!r 
requirem5ts ,a gr\p heal? plan or heal? 
insurance issu] (f]+ gr\p or individual 
heal? insurance cov]age %all n impose1  
directly or ?r\gh an entity provid+     
ph>macy b5efit managem5t s]vices1 any   
prior au?orization or o!r m$ical        
managem5t requirem5t1 or o!r simil>     
conditions1 on select$ insul9 products1 
except z cl9ically ju/ifi$ = safety     
reasons1 to ensure reasonable quantity  
limits & z specifi$ by ! ,secret>y4  4  
7b7 ,no effect on o!r co/-,%>+ ,section 
#acjb7;d77#b7 ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act 7#db ,u4,s4,c4      
#ahjbb7;d77#b77 is am5d$ by add+ at !   
end ! foll[+ new subp>agraph3  7,d7     
,special rule relat+ to insul9 cov]age  
,= plans ye>s beg9n+ on or aft] ,janu>y 

#a1 #bjbe1 ! exemption ( cov]age (      
select$ insul9 products 7z def9$ 9      
section #bgii;,a-#aa7;b7 ( ! ,public    
,heal? ,s]vice ,act7 f ! application (  
any d$uctible pursuant to section       
#bgii;,a-#aa7;a77#a7 ( su* ,act1 section
 #gbf7;a77#a7 ( ! ,employee ,retirem5t  
,income ,security ,act ( #aigd1 or      
section #ihbf7;a77#a7 ( ! ,int]nal      
,rev5ue ,code ( #aihf %all n be consid]$
 :5 det]m9+ ! actu>ial value ( a        
qualifi$ heal? plan "u ?is subsection4  
4  7c7 ,cov]age ( c]ta9 insul9 products 
"u cata/rophic plans ,section #acjb7;e7 
( ! ,pati5t ,protection & ,af=dable ,c>e
 ,act 7#db ,u4,s4,c4 #ahjbb7;e77 is     
am5d$ by add+ at ! end ! foll[+3  7#d7  
,cov]age ( c]ta9 insul9 products  7,a7  
,9 g5]al ,not)/&+ p>agraph 7#a77;,b77i71
 a heal? plan describ$ 9 p>agraph 7#a7  
%all provide cov]age ( select$ insul9   
products1 9 accordance ) section        
#bgii;,a-#aa ( ! ,public ,heal? ,s]vice 
,act1 be=e an enroll$ individual has    
incurr$1 dur+ ! plan ye>1 co/-%>+       

exp5ses 9 an am\nt equal to ! annual    
limitation 9 effect "u subsection       
7c77#a7 = ! plan ye>4  7,b7 ,t]m9ology  
,= purposes ( subp>agraph 7,a7-- 7i7 !  
t]m select$ insul9 products has ! mean+ 
giv5 su* t]m 9 section #bgii;,a-#aa7;b7 
( ! ,public ,heal? ,s]vice ,act2 &  7ii7
 ! requirem5ts ( section #bgii;,a-#aa ( 
su* ,act %all be appli$ by deem+ ea*    
ref]5ce 9 su* section to individual     
heal? insurance cov]age to be a ref]5ce 
to a plan describ$ 9 p>agraph 7#a74  4  
7d7 ,,erisa  7#a7 ,9 g5]al ,subp>t ,b ( 
"p #g ( subtitle ,b ( title ,i ( !      
,employee ,retirem5t ,income ,security  
,act ( #aigd 7#bi ,u4,s4,c4 #aahe et    
seq47 is am5d$ by add+ at ! end !       
foll[+3  #gbf4 ,requirem5ts ) respect to
 co/-%>+ = c]ta9 insul9 products  7a7 ,9
 g5]al ,= plan ye>s beg9n+ on or aft]   
,janu>y #a1 #bjbd1 a gr\p heal? plan or 
heal? insurance issu] (f]+ gr\p heal?   
insurance cov]age %all provide cov]age (
 select$ insul9 products1 & ) respect to
 su* products1 %all n-- 7#a7 apply any  

d$uctible2 or  7#b7 impose any co/-%>+  
requirem5ts 9 excess (1 p] #cj-;day     
supply-- 7,a7 = any applicable plan ye> 
beg9n+ be=e ,janu>y #a1 #bjbe1 #ce2 or  
7,b7 = any plan ye> beg9n+ on or aft]   
,janu>y #a1 #bjbe1 ! less] (-- 7i7 #ce2 
or  7ii7 ! am\nt equal to #be p]c5t ( ! 
negotiat$ price ( ! select$ insul9      
product net ( all price concessions     
receiv$ by or on behalf ( ! plan or     
issu]1 includ+ price concessions receiv$
 by or on behalf ( ?ird-p>ty entities   
provid+ s]vices to ! plan or issu]1 su* 
z ph>macy b5efit managem5t s]vices or   
?ird p>ty adm9i/rators4  7b7 ,def9itions
 ,9 ?is section3 7#a7 ,select$ insul9   
products ,! t]m select$ insul9 products 
means1 = any plan ye> beg9n+ on or aft] 
,janu>y #a1 #bjbd1 at lea/ "o ( ea*     
dosage =m 7su* z vial1 p51 or inhal]    
dosage =ms7 ( ea* diff]5t type 7su* z   
rapid-act+1 %ort-act+1 int]m$iate-act+1 
long-act+1 & pre-mix$7 ( insul91 :5 su* 
=m is lic5s$ & m>ket$1 z select$ by !   
gr\p heal? plan or heal? insurance      

issu]4  7#b7 ,insul9 ,! t]m insul9 means
 insul9 t is lic5s$ "u subsection 7a7 or
 7k7 ( section #cea ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 &     
cont9ues to be m>ket$ pursuant to su*   
lic5sure4  7c7 ,out-(-,network provid]s 
,no?+ 9 ?is section requires a plan or  
issu] t has a network ( provid]s to     
provide b5efits = select$ insul9        
products describ$ 9 ?is section t are   
deliv]$ by an out-(-network provid]1 or 
precludes a plan or issu] t has a       
network ( provid]s f impos+ high]       
co/-%>+ ?an ! levels specifi$ 9         
subsection 7a7 = select$ insul9 products
 describ$ 9 ?is section t are deliv]$ by
 an out-(-network provid]4  7d7 ,rule ( 
con/ruction ,subsection 7a7 %all n be   
con/ru$ to require cov]age (1 or prev5t 
a gr\p heal? plan or heal? insurance    
cov]age f impos+ co/-%>+ o!r ?an !      
levels specifi$ 9 subsection 7a7 on1    
insul9 products t are n select$ insul9  
products1 to ! ext5t t su* cov]age is n 
o!rwise requir$ & su* co/-%>+ is o!rwise

 p]mitt$ "u ,f$]al & applicable ,/ate   
law4  7e7 ,application ( co/-,%>+ t[>ds 
d$uctibles & out-(-,pocket maximums ,any
 co/-%>+ paym5ts made pursuant to       
subsection 7a77#b7 %all be c\nt$ t[>d   
any d$uctible or out-(-pocket maximum t 
applies "u ! plan or cov]age4  7f7 ,o!r 
requirem5ts ,a gr\p heal? plan or heal? 
insurance issu] (f]+ gr\p heal?         
insurance cov]age %all n impose1        
directly or ?r\gh an entity provid+     
ph>macy b5efit managem5t s]vices1 any   
prior au?orization or o!r m$ical        
managem5t requirem5t1 or o!r simil>     
conditions1 on select$ insul9 products1 
except z cl9ically ju/ifi$ = safety     
reasons1 to ensure reasonable quantity  
limits & z specifi$ by ! ,secret>y4  4  
7#b7 ,cl]ical am5dm5t ,! table ( cont5ts
 9 section #a ( ! ,employee ,retirem5t  
,income ,security ,act ( #aigd 7#bi     
,u4,s4,c4 #ajja et seq47 is am5d$ by    
ins]t+ aft] ! item relat+ to section    
#gbe ! foll[+3  ,sec4 #gbf4 ,requirem5ts
 ) respect to co/-%>+ = c]ta9 insul9    

products4  4  7e7 ,int]nal ,rev5ue ,code
  7#a7 ,9 g5]al ,sub*apt] ,b ( *apt]    
#ajj ( ! ,int]nal ,rev5ue ,code ( #aihf 
is am5d$ by add+ at ! end ! foll[+ new  
section3  #ihbf4 ,requirem5ts ) respect 
to co/-%>+ = c]ta9 insul9 products  7a7 
,9 g5]al ,= plan ye>s beg9n+ on or aft] 
,janu>y #a1 #bjbd1 a gr\p heal? plan    
%all provide cov]age ( select$ insul9   
products1 & ) respect to su* products1  
%all n-- 7#a7 apply any d$uctible2 or   
7#b7 impose any co/-%>+ requirem5ts 9   
excess (1 p] #cj-;day supply-- 7,a7 =   
any applicable plan ye> beg9n+ be=e     
,janu>y #a1 #bjbe1 #ce2 or  7,b7 = any  
plan ye> beg9n+ on or aft] ,janu>y #a1  
#bjbe1 ! less] (-- 7i7 #ce2 or  7ii7 !  
am\nt equal to #be p]c5t ( ! negotiat$  
price ( ! select$ insul9 product net (  
all price concessions receiv$ by or on  
behalf ( ! plan1 includ+ price          
concessions receiv$ by or on behalf (   
?ird-p>ty entities provid+ s]vices to ! 
plan1 su* z ph>macy b5efit managem5t    
s]vices or ?ird p>ty adm9i/rators4  7b7 

,def9itions ,9 ?is section3 7#a7        
,select$ insul9 products ,! t]m select$ 
insul9 products means1 = any plan ye>   
beg9n+ on or aft] ,janu>y #a1 #bjbd1 at 
lea/ "o ( ea* dosage =m 7su* z vial1 p51
 or inhal] dosage =ms7 ( ea* diff]5t    
type 7su* z rapid-act+1 %ort-act+1      
int]m$iate-act+1 long-act+1 & pre-mix$7 
( insul91 :5 su* =m is lic5s$ & m>ket$1 
z select$ by ! gr\p heal? plan4  7#b7   
,insul9 ,! t]m insul9 means insul9 t is 
lic5s$ "u subsection 7a7 or 7k7 (       
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7 & cont9ues to 
be m>ket$ pursuant to su* lic5sure4  7c7
 ,out-(-,network provid]s ,no?+ 9 ?is   
section requires a plan t has a network 
( provid]s to provide b5efits = select$ 
insul9 products describ$ 9 ?is section t
 are deliv]$ by an out-(-network        
provid]1 or precludes a plan t has a    
network ( provid]s f impos+ high]       
co/-%>+ ?an ! levels specifi$ 9         
subsection 7a7 = select$ insul9 products
 describ$ 9 ?is section t are deliv]$ by

 an out-(-network provid]4  7d7 ,rule ( 
con/ruction ,subsection 7a7 %all n be   
con/ru$ to require cov]age (1 or prev5t 
a gr\p heal? plan f impos+ co/-%>+ o!r  
?an ! levels specifi$ 9 subsection 7a7  
on1 insul9 products t are n select$     
insul9 products1 to ! ext5t t su*       
cov]age is n o!rwise requir$ & su*      
co/-%>+ is o!rwise p]mitt$ "u ,f$]al &  
applicable ,/ate law4  7e7 ,application 
( co/-,%>+ t[>ds d$uctibles &           
out-(-,pocket maximums ,any co/-%>+     
paym5ts made pursuant to subsection     
7a77#b7 %all be c\nt$ t[>d any d$uctible
 or out-(-pocket maximum t applies "u ! 
plan4  7f7 ,o!r requirem5ts ,a gr\p     
heal? plan %all n impose1 directly or   
?r\gh an entity provid+ ph>macy b5efit  
managem5t s]vices1 any prior            
au?orization or o!r m$ical managem5t    
requirem5t1 or o!r simil> conditions1 on
 select$ insul9 products1 except z      
cl9ically ju/ifi$ = safety reasons1 to  
ensure reasonable quantity limits & z   
specifi$ by ! ,secret>y  4  7#b7        

,cl]ical am5dm5t ,! table ( sections =  
sub*apt] ,b ( *apt] #ajj ( su* ,code1 z 
am5d$ by section #ajb7;c77#b71 is fur!r 
am5d$ by add+ at ! end ! foll[+ new     
item3  ,sec4 #ihbg4 ,requirem5ts )      
respect to co/-%>+ = c]ta9 insul9       
products4  4  #ajb4 ,application to     
retiree & c]ta9 small gr\p plans  7a7   
,,erisa ,section #gcb7;a7 ( ! ,employee 
,retirem5t ,income ,security ,act (     
#aigd 7#bi ,u4,s4,c4 #aaia;a7a77 is     
am5d$ by /rik+ section #gaa & ins]t+    
sections #gaa & #gbf4  7b7 ,,irc ,!     
,int]nal ,rev5ue ,code ( #aihf is       
am5d$-- 7#a7 9 section #ihca7;a71 by    
add+ at ! end ! foll[+ flu% text3       
,p>agraph 7#b7 %all n apply to !        
requirem5ts "u sections #ihaa & #ihbf4 2
 &  7#b7 9 section #dihj;,d7d77#a71 by  
/rik+ section #ihaa & ins]t+ sections   
#ihaa & #ihbf4  #ajc4 ,adm9i/ration  7a7
 ,implem5tation ,not)/&+ any o!r        
provision ( law1 ! ,secret>y ( ,heal? & 
,human ,s]vices1 ! ,secret>y ( ,labor1 &
 ! ,secret>y ( ! ,treasury may implem5t 

! provisions (1 includ+ ! am5dm5ts made 
by1 ?is title = plan ye>s t beg9 on or  
aft] ,janu>y #a1 #bjbd1 & end n lat] ?an
 ,janu>y #a1 #bjbg1 by subregulatory    
guidance1 program in/ruction1 or        
o!rwise4  7b7 ,non-,application ( !     
,pap]work ,r$uction ,act ,*apt] #ce (   
title #dd1 ,unit$ ,/ates ,code 7commonly
 ref]r$ to z ! ,pap]work ,r$uction ,act 
( #aiie71 %all n apply to ! provisions  
(1 includ+ ! am5dm5ts made by1 ?is      
title4  ,,ii ,ph>macy b5efit manag]     
transp>5cy & rebate re=m  #bja4 ,full   
rebate on insul9 pass-?r\gh to plan ,"p 
,a ( title ,,xxvii ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et  
seq47 is fur!r am5d$ by add+ at ! end ! 
foll[+3  #bgbi;,a4 ,full rebate on      
insul9 pass-?r\gh to plan  7a7 ,9 g5]al 
,a ph>macy b5efits manag]1 a ?ird-p>ty  
adm9i/rator ( a gr\p heal? plan1 a heal?
 insurance issu] (f]+ gr\p heal?        
insurance cov]age1 or an entity provid+ 
ph>macy b5efits managem5t s]vices "u su*
 heal? plan or heal? insurance cov]age  

%all remit #ajj p]c5t ( rebates1 fees1  
alt]native disc\nts1 & all o!r          
remun]ation receiv$ f a ph>maceutical   
manufactur]1 di/ributor or any o!r ?ird 
p>ty1 t are relat$ to utilization (     
insul9 "u su* heal? plan or heal?       
insurance cov]age1 to ! gr\p heal? plan4
  7b7 ,=m & mann] ( remittance ,su*     
rebates1 fees1 alt]native disc\nts1 &   
o!r remun]ation %all be-- 7#a7 remitt$  
to ! gr\p heal? plan 9 a timely fa%ion  
aft] ! p]iod = :i* su* rebates1 fees1 or
 o!r remun]ation is calculat$1 & 9 no   
case lat] ?an #ij days aft] ! end ( su* 
p]iod2  7#b7 fully disclos$ & enum]at$  
to ! gr\p heal? plan sponsor2 &  7#c7   
available = audit by ! plan sponsor1 or 
a ?ird-p>ty designat$ by a plan sponsor 
no less ?an once p] plan ye>4  4  ,,iii 
,biosimil> biological product & g5]ic   
drug competition & af=dability  #cja4   
,ensur+ timely access to g5]ics ,section
 #eje7q7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77  
is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9

 subp>agraph 7,a77i71 by ins]t+ 1       
#aj4ca1 aft] #aj4cj2  7,b7 9 subp>agraph
 7,e7-- 7i7 by /rik+ application & &    
ins]t+ application or2  7ii7 by /rik+   
,if ! ,secret>y & ins]t+ ! foll[+3  7i7 
,9 g5]al ,if ! ,secret>y  2 &  7iii7 by 
/rik+ ! second s5t5ce & ins]t+ ! foll[+3
  7ii7 ,prim>y purpose ( delay+  7,i7 ,9
 g5]al ,9 det]m9+ :e!r a petition 0     
submitt$ ) ! prim>y purpose ( delay+ an 
application1 ! ,secret>y may consid] !  
foll[+ factors3 7aa7 ,:e!r ! petition 0 
submitt$ 9 accordance ) p>agraph        
7#b77;,b71 bas$ on :5 ! petition] knew  
or reasonably %\ld h kn[n ! relevant    
in=mation reli$ ^u to =m ! basis ( su*  
petition4  7bb7 ,:e!r ! petition] has   
submitt$ multiple or s]ial petitions or 
supplem5ts to petitions rais+ issues t  
reasonably c\ld h be5 kn[n to !         
petition] at ! "t ( submission ( ! e>li]
 petition or petitions4  7cc7 ,:e!r !   
petition 0 submitt$ close 9 "t to a     
kn[n1 fir/ date ^u :i* an application "u
 subsection 7b77#b7 or 7j7 ( ?is section

 or section #cea7k7 ( ! ,public ,heal?  
,s]vice ,act c\ld be approv$4  7dd7     
,:e!r ! petition 0 submitt$ )\t relevant
 data or in=mation 9 support ( !        
sci5tific positions =m+ ! basis ( su*   
petition4  7ee7 ,:e!r ! petition raises 
! same or sub/antially simil> issues z a
 prior petition to :i* ! ,secret>y has  
respond$ sub/antively already1 includ+  
if ! subsequ5t submission foll[s su*    
response f ! ,secret>y closely 9 "t4    
7ff7 ,:e!r ! petition reque/s *ang+ !   
applicable /&>ds t o!r applicants are   
requir$ to meet1 includ+ reque/+ te/+1  
data1 or label+ /&>ds t are m on]\s or  
rigor\s ?an ! /&>ds ! ,secret>y has     
det]m9$ to be applicable to ! li/$ drug1
 ref]5ce product1 or petition]'s v]sion 
( ! same drug4  7gg7 ,! petition]'s     
record ( submitt+ petitions to ! ,food &
 ,drug ,adm9i/ration t h be5 det]m9$ by 
! ,secret>y to h be5 submitt$ ) ! prim>y
 purpose ( delay4  7hh7 ,o!r relevant & 
appropriate factors1 :i* ! ,secret>y    
%all describe 9 guidance4  7,,ii7       

,guidance ,! ,secret>y may issue or     
update guidance1 z appropriate1 to      
describe factors ! ,secret>y consid]s 9 
accordance ) subclause 7,i74  2  7,c7 by
 add+ at ! end ! foll[+3  7iii7 ,ref]ral
 to ! ,f$]al ,trade ,commission ,!      
,secret>y %all e/abli% proc$ures =      
ref]r+ to ! ,f$]al ,trade ,commission   
any petition or supplem5t to a petition 
t ! ,secret>y det]m9es 0 submitt$ ) !   
prim>y purpose ( delay+ approval ( an   
application4 ,su* proc$ures %all include
 notification to ! petition] by !       
,secret>y4  2  7,d7 by /rik+ subp>agraph
 7,f72  7,e7 by r$esignat+ subp>agraphs 
7,g7 ?r\gh 7,i7 z subp>agraphs 7,f7     
?r\gh 7,h71 respectively2 &  7,f7 9     
subp>agraph 7,h71 z s r$esignat$1 by    
/rik+ submission ( ?is petition & ins]t+
 submission ( ?is docum5t2  7#b7 9      
p>agraph 7#b7-- 7,a7 by r$esignat+      
subp>agraphs 7,a7 ?r\gh 7,c7 z          
subp>agraphs 7,c7 ?r\gh 7,e71           
respectively2  7,b7 by ins]t+ be=e      
subp>agraph 7,c71 z s r$esignat$1 !     

foll[+3  7,a7 ,9 g5]al ,a p]son %all    
submit a petition to ! ,secret>y "u     
p>agraph 7#a7 be=e fil+ a civil action 9
 :i* ! p]son seeks to set aside1 delay1 
resc9d1 )draw1 or prev5t submission1    
review1 or approval ( an application    
submitt$ "u subsection 7b77#b7 or 7j7 ( 
?is section or section #cea7k7 ( !      
,public ,heal? ,s]vice ,act4 ,su*       
petition & any supplem5t to su* a       
petition %all describe all in=mation &  
argum5ts t =m ! basis ( ! relief reque/$
 9 any civil action describ$ 9 ! previ\s
 s5t5ce4  7,b7 ,timely submission (     
citiz5 petition ,a petition & any       
supplem5t to a petition %all be submitt$
 )9 #fj days aft] ! p]son knew1 or      
reasonably %\ld h kn[n1 ! in=mation t   
=ms ! basis ( ! reque/ made 9 ! petition
 or supplem5t4  2  7,c7 9 subp>agraph   
7,c71 z s r$esignat$-- 7i7 9 ! head+1 by
 /rik+ )9 #aej days2  7ii7 9 clause 7i71
 by /rik+ dur+ ! #aej-;day p]iod ref]r$ 
to 9 p>agraph 7#a77;,f712 &  7iii7 by   
am5d+ clause 7ii7 to read z foll[s3     

7ii7 on or aft] ! date t is #aea days   
aft] ! date ( submission ( ! petition1 !
 ,secret>y approves or has approv$ !    
application t is ! subject ( ! petition 
)\t hav+ made su* a f9al decision4  2   
7,d7 by am5d+ subp>agraph 7,d71 z s     
r$esignat$1 to read z foll[s3  7,d7     
,dismissal ( c]ta9 civil actions  7i7   
,petition ,if a p]son files a civil     
action aga9/ ! ,secret>y 9 :i* a p]son  
seeks to set aside1 delay1 resc9d1      
)draw1 or prev5t submission1 review1 or 
approval ( an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( ?is section 
or section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act )\t comply+ ) ! requirem5ts
 ( subp>agraph 7,a71 ! c\rt %all dismiss
 )\t prejudice ! action = failure to    
exhau/ adm9i/rative rem$ies4  7ii7      
,timel9ess ,if a p]son files a civil    
action aga9/ ! ,secret>y 9 :i* a p]son  
seeks to set aside1 delay1 resc9d1      
)draw1 or prev5t submission1 review1 or 
approval ( an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( ?is section 

or section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act )\t comply+ ) ! requirem5ts
 ( subp>agraph 7,b71 ! c\rt %all dismiss
 ) prejudice ! action = failure to      
timely file a petition4  7iii7 ,f9al    
response ,if a civil action is fil$     
aga9/ ! ,secret>y ) respect to any issue
 rais$ 9 a petition timely fil$ "u      
p>agraph 7#a7 9 :i* ! petition] reque/s 
t ! ,secret>y take any =m ( action t    
c\ld1 if tak51 set aside1 delay1 resc9d1
 )draw1 or prev5t submission1 review1 or
 approval ( an application submitt$ "u  
subsection 7b77#b7 or 7j7 ( ?is section 
or section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act be=e ! ,secret>y has tak5  
f9al ag5cy action on ! petition )9 !    
mean+ ( subp>agraph 7,c71 ! c\rt %all   
dismiss )\t prejudice ! action = failure
 to exhau/ adm9i/rative rem$ies4  2 &   
7,e7 9 clause 7iii7 ( subp>agraph 7,e71 
z s r$esignat$1 by /rik+ z def9$ "u     
subp>agraph 7#b77;,a7 & ins]t+ )9 !     
mean+ ( subp>agraph 7,c72 &  7#c7 9     
p>agraph 7#d7-- 7,a7 by /rik+           

,exceptions & all t foll[s ?r\gh ,?is   
subsection does & ins]t+                
,exceptions4--,?is subsection does2     
7,b7 by /rik+ subp>agraph 7,b72 &  7,c7 
by r$esignat+ clauses 7i7 & 7ii7 z      
subp>agraphs 7,a7 & 7,b71 respectively1 
& adju/+ ! m>g9s accord+ly4  #cjb4      
,p]mitt$ mid-ye> *anges 9 ,m$ic>e "p ,d 
plan =mul>ies = c]ta9 biosimil>         
biological products & ! ref]5ce product 
( su* biosimil>s  7a7 ,9 g5]al ,section 
#ahfj;,d-#d7;b7 ( ! ,social ,security   
,act 7#db #e ,u4,s4,c4 #aciew-#ajd7;b77 
is am5d$ by add+ at ! end ! foll[+ new  
p>agraph3  7#e7 ,mid-ye> *anges 9       
=mul>ies p]mitt$ = c]ta9 biosimil>      
biological products & ! ref]5ce product 
( su* biosimil>s ,if a ,,pdp sponsor ( a
 prescription drug plan uses a =mul>y   
7includ+ ! use ( ti]$ co/-%>+71 ! foll[+
 %all apply3 7,a7 ,9 g5]al ,= plan ye>  
#bjbd1 & subsequ5t plan ye>s1 9 ! case (
 a cov]$ "p ,d drug t is ! ref]5ce      
biological product 7z def9$ 9 section   
#ahdg;,a7c77#f77;,i77 ) respect to a    

biosimil> biological product 7z def9$ 9 
section #ahdg;,a7c77#f77;,h771 ! ,,pdp  
sponsor may1 ) respect to a =mul>y1 at  
any "t aft] ! fir/ #fj days ( ! plan    
ye>1 subject to p>agraph 7#c77;,e71     
*ange ! pref]r$ or ti]$ co/-%>+ /atus ( 
su* ref]5ce biological product if su*   
,,pdp sponsor adds1 at ! same "t1 to su*
 =mul>y su* biosimil> biological product
 at ! same or a high] pref]r$ /atus1 or 
to ! same or l[] co/-%>+ ti]1 z t ( su* 
ref]5ce biological product imm$iately   
prior to su* *ange4  7,b7 ,reque/ =     
approval ( *ange ,prior to mak+ a *ange 
describ$ 9 clause 7i71 ! ,,pdp sponsor  
%all submit to ! ,secret>y a reque/ to  
make su* *ange4 ,if ! ,secret>y approves
 ! reque/ or has n provid$ a decision to
 ! ,,pdp sponsor reg>d+ su* reque/ )9   
#cj days ( receiv+ su* reque/1 su* ,,pdp
 sponsor may make su* *ange4  4  7b7    
,adm9i/ration  7#a7 ,implem5tation      
,not)/&+ any o!r provision ( law1 !     
,secret>y ( ,heal? & ,human ,s]vices may
 implem5t ! am5dm5t made by subsection  

7a7 by subregulatory guidance1 program  
in/ruction1 or o!rwise4  7#b7           
,non-application ( ! ,pap]work ,r$uction
 ,act ,*apt] #ce ( title #dd1 ,unit$    
,/ates ,code 7commonly ref]r$ to z !    
,pap]work ,r$uction ,act ( #aiie71 %all 
n apply to ! implem5tation ( ! am5dm5t  
made by subsection 7a74  #cjc4 ,exp$it+ 
competitive biosimil> competition  7a7  
,9 g5]al ,section #cea7k7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77 is am5d$ by add+ at ! end !    
foll[+3  7#aj7 ,exp$it+ competitive     
biosimil> competition  7,a7 ,9 g5]al ,! 
,secret>y may1 at ! reque/ ( ! sponsor (
 an application "u ?is subsection = a   
biosimil> biological product t is       
designat$ z a competitive biosimil>     
!rapy pursuant to subsection 7b71       
exp$ite ! developm5t & review ( su*     
application "u ?is subsection4  7,b7    
,designation process  7i7 ,reque/ ,!    
sponsor ( an application "u ?is         
subsection may reque/ ! ,secret>y to    
designate ! drug z a competitive        

biosimil> !rapy4 ,a reque/ = su*        
designation may be made concurr5tly )1  
or at any "t prior to1 ! submission ( a 
biosimil> biological product lic5se     
application "u ?is subsection4  7ii7    
,crit]ia ,a biological product is       
eligible = designation z a competitive  
biosimil> !rapy "u ?is p>agraph if !    
,secret>y det]m9es t !re is inadequate  
biosimil> competition4  7iii7           
,designation ,n lat] ?an #fj cal5d> days
 aft] ! receipt ( a reque/ "u clause    
7i71 ! ,secret>y may-- 7,i7 det]m9e :e!r
 ! biosimil> biological product t is !  
subject ( ! reque/ meets ! crit]ia      
describ$ 9 clause 7ii72 &  7,,ii7 if !  
,secret>y f9ds t su* product meets su*  
crit]ia1 designate ! biosimil>          
biological product z a competitive      
biosimil> !rapy4  7,c7 ,actions ,9      
exp$it+ ! developm5t & review ( an      
application "u subp>agraph 7,a71 !      
,secret>y may1 z reque/$ by ! applicant1
 take actions includ+ ! foll[+3 7i7     
,hold meet+s ) ! sponsor & ! review team

 ?r\gh\t ! developm5t ( ! biosimil>     
biological product prior to submission (
 ! application "u ?is subsection4  7ii7 
,provide timely advice to1 & int]active 
communication )1 ! sponsor reg>d+ !     
developm5t ( ! drug to ensure t !       
developm5t program to ga!r ! data       
necess>y = approval is z effici5t z     
practicable4  7iii7 ,involve s5ior      
manag]s & exp]i5c$ review /aff1 z       
appropriate1 9 a collaborative1         
coord9at$ review ( su* application1     
includ+ ) respect to biological         
product-device comb9ation products & o!r
 complex products4  7iv7 ,assign a      
cross-discipl9>y project lead-- 7,i7 to 
facilitate an effici5t review ( !       
developm5t program & application1       
includ+ manufactur+ inspections2 &      
7,,ii7 to s]ve z a sci5tific liaison    
betwe5 ! review team & ! applicant4     
7,d7 ,inspections ,) respect to an      
application describ$ 9 subp>agraph 7,a71
 9 ! case ( an inspection report t f9ds 
approval ( su* biological product is    

dep5d5t ^u rem$iation ( a facility1 if !
 applicant atte/s t necess>y *anges h   
be5 made to ! facility1 ! ,secret>y %all
 exp$ite re9spection ( su* facility1    
includ+ e/abli%+ a set timel9e to       
re9spect ! facility or make a           
det]m9ation ab\t ! response ( !         
applicant & :e!r to approve !           
application4  7,e7 ,report+ requirem5t  
,n lat] ?an #a ye> aft] ! date (        
lic5sure "u ?is subsection ) respect to 
a biosimil> biological product = :i* !  
developm5t & review is exp$it$ "u ?is   
p>agraph1 ! hold] ( ! lic5se ( su*      
biosimil> biological product %all report
 to ! ,secret>y on :e!r ! biosimil>     
biological product has be5 m>ket$ 9     
int]/ate comm]ce s9ce ! date ( su*      
lic5sure4  7,f7 ,inadequate biosimil>   
competition ,9 ?is p>agraph1 ! t]m      
inadequate biosimil> competition means1 
) respect to a biological product1 !re  
are few] ?an #c lic5s$ biological       
products on ! li/ publi%$ "u p>agraph   
7#i77;,a7 7n includ+ biological products

 on ! discont9u$ section ( su* li/7 t   
are biosimil> biological products ) !   
same ref]5ce product4  4  #cjd4 ,insul9 
competition report ,n lat] ?an #a ye>   
aft] ! date ( ! enactm5t ( ?is ,act1 !  
,secret>y ( ,heal? & ,human ,s]vices1 9 
collaboration ) ! ,adm9i/rator = !      
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices & ! 
,commission] ( ,food & ,drugs1 %all--   
7#a7 complete a /udy to det]m9e ! ext5t 
(1 & causes (1 delays 9 gett+ insul9    
products to m>ket1 & ! m>ket dynamics & 
ext5t biosimil> biological product      
developm5t & competition c\ld increase1 
or is increas+1 ! numb] ( biological    
products approv$ & available to pati5ts1
 includ+ by exam9+ b>ri]s to-- 7,a7     
placem5t ( biosimil> biological products
 on heal? insurance =mul>ies2  7,b7     
m>ket entry ( insul9 product 9 ! ,unit$ 
,/ates1 z comp>$ to o!r highly develop$ 
nations2 &  7,c7 pati5t & provid]       
education ar\nd biosimil> biological    
products2 &  7#b7 submit a report to    
,congress t describes ! results ( ! /udy

 conduct$ pursuant to p>agraph 7#a7 &   
recomm5d$ policy solutions4