,,ii  #aai? ,,congress  #b;d ,session   
,s4 #dahi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #be1 #bjbf,mrs4   
,%ahe5 7= h]self1 ,ms4 ,coll9s1 ,mr4    
,w>nock1 ,mr4 ,k5n$y1 ,ms4 ,ros51 ,mr4  
,tub]ville1 ,mr4 ,k+1 ,ms4 ,murk[ski1   
,mr4 ,kelly1 ,mr4 ,grassley1 ,ms4       
,baldw91 & ,mrs4 ,britt7 introduc$ !    
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 ( #bjbf or ! 
,,insul9 ,act ( #bjbf4  7b7 ,table (    
cont5ts ,! table ( cont5ts = ?is ,act is
 z foll[s3 ,sec4 #a4 ,%ort title2 table 
( cont5ts4,sec4 #b4 ,s5se (             
,congress4,,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 ,exp$it+   
competitive biosimil> competition4,sec4 
#cjc4 ,insul9 competition report4,,title
 ,,iv--,programs = provid+ af=dable     
insul9 to un9sur$ individuals,sec4 #dja4
 ,pilot program = provid+ af=dable      
insul9 to un9sur$ individuals4,sec4     
#djb4 ,,gao /udy on un9sur$ individuals 
:o use insul94,sec4 #djc4 ,insul9       
res\rce c5t] & hotl9e = un9sur$         
individuals4  #b4 ,s5se ( ,congress ,x  
is ! s5se ( ,congress t ,congress %\ld  
enact subsequ5t legislation t provides =
 an (fset = any co/s to ! ,f$]al        
,gov]nm5t result+ f ! enactm5t ( ?is    
,act4  ,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-#ab4 ,requirem5ts ) respect to 
co/-%>+ = c]ta9 insul9 products  7a7 ,9 
g5]al ,= plan ye>s beg9n+ on or aft]    
,janu>y #a1 #bjbg1 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$uctible2 or   
7#b7 impose any co/-%>+ requirem5ts 9   
excess (1 p] #cj-;day supply-- 7,a7 =   
any applicable plan ye> beg9n+ be=e     
,janu>y #a1 #bjbh1 #ce2 or  7,b7 = any  
plan ye> beg9n+ on or aft] ,janu>y #a1  
#bjbh1 ! less] (-- 7i7 #ce2 or  7ii7 !  
am\nt equal to #be p]c5t ( ! negotiat$  
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 #bjbg1 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 issu] 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 #bjbh1 ! exemption ( cov]age (      
select$ insul9 products 7z def9$ 9      
section #bgii;,a-#ab7;b7 ( ! ,public    
,heal? ,s]vice ,act7 f ! application (  
any d$uctible pursuant to section       
#bgii;,a-#ab7;a77#a7 ( su* ,act1 section
 #gbg7;a77#a7 ( ! ,employee ,retirem5t  
,income ,security ,act ( #aigd1 or      
section #ihbg7;a77#a7 ( ! ,int]nal      
,rev5ue ,code ( #aihf %all n be consid]$
 :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
 = plan ye>s beg9n+ on or aft] ,janu>y  
#a1 #bjbg1 a heal? plan describ$ 9      
p>agraph 7#a7 %all provide cov]age (    
select$ insul9 products1 9 accordance ) 
section #bgii;,a-#ab ( ! ,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-#ab7;b7 
( ! ,public ,heal? ,s]vice ,act2 &  7ii7
 ! requirem5ts ( section #bgii;,a-#ab ( 
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  #gbg4 ,requirem5ts ) respect to
 co/-%>+ = c]ta9 insul9 products  7a7 ,9
 g5]al ,= plan ye>s beg9n+ on or aft]   
,janu>y #a1 #bjbg1 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$uctible2 or  7#b7 impose any co/-%>+  
requirem5ts 9 excess (1 p] #cj-;day     
supply-- 7,a7 = any applicable plan ye> 
beg9n+ be=e ,janu>y #a1 #bjbh1 #ce2 or  
7,b7 = any plan ye> beg9n+ on or aft]   
,janu>y #a1 #bjbh1 ! less] (-- 7i7 #ce2 
or  7ii7 ! am\nt equal to #be p]c5t ( ! 
negotiat$ 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 #bjbg1 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    
issu] 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    
#gbf ! foll[+3  ,sec4 #gbg4 ,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[+3     
#ihbg4 ,requirem5ts ) respect to co/-%>+
 = c]ta9 insul9 products  7a7 ,9 g5]al  
,= plan ye>s beg9n+ on or aft] ,janu>y  
#a1 #bjbg1 a gr\p heal? plan %all       
provide cov]age ( select$ insul9        
products1 & ) respect to su* products1  

%all n-- 7#a7 apply any d$uctible2 or   
7#b7 impose any co/-%>+ requirem5ts 9   
excess (1 p] #cj-;day supply-- 7,a7 =   
any applicable plan ye> beg9n+ be=e     
,janu>y #a1 #bjbh1 #ce2 or  7,b7 = any  
plan ye> beg9n+ on or aft] ,janu>y #a1  
#bjbh1 ! less] (-- 7i7 #ce2 or  7ii7 !  
am\nt equal to #be p]c5t ( ! negotiat$  
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 #bjbg1 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>y4  4  7#b7       
,cl]ical am5dm5t ,! table ( sections =  
sub*apt] ,b ( *apt] #ajj ( su* ,code is 
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 & #gbg4  7b7 ,,irc ,!     
,int]nal ,rev5ue ,code ( #aihf is       
am5d$-- 7#a7 9 section #ihca7;a71 by    
add+ at ! end ! foll[+ flu% text3       
,p>agraph 7#b7 %all n apply to !        
requirem5ts "u sections #ihaa & #ihbg4 2
 &  7#b7 9 section #dihj;,d7d77#a71 by  
/rik+ section #ihaa & ins]t+ section    
#ihaa or #ihbg4  #ajc4 ,adm9i/ration    
7a7 ,implem5tation ,not)/&+ any o!r     
provision ( law1 ! ,secret>y ( ,heal? & 
,human ,s]vices1 ! ,secret>y ( ,labor1 &
 ! ,secret>y ( ! ,treasury may implem5t 
! provisions (1 includ+ ! am5dm5ts made 
by1 ?is title = plan ye>s t beg9 on or  
aft] ,janu>y #a1 #bjbg1 & end n lat] ?an
 ,janu>y #a1 #bjcj1 by subregulatory    
guidance1 program in/ruction1 or        
o!rwise4  7b7 ,non-,application ( !     
,pap]work ,r$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  7a7
 ,,phsa ,"p ,d ( title ,,xxvii ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;gg-#aaa et seq471 z am5d$
 by section #aja1 is fur!r am5d$ by add+
 at ! end ! foll[+3  #bgii;,a-#ac4 ,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  7b7   
,,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    
seq471 z am5d$ by section #aja1 is fur!r
 am5d$ by add+ at ! end ! foll[+3  #gbh4
 ,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  7#b7  
,cl]ical am5dm5t ,! table ( cont5ts 9   
section #a ( ! ,employee ,retirem5t     
,income ,security ,act ( #aigd 7#bi     
,u4,s4,c4 #ajja et seq471 z am5d$ by    
section #aja1 is fur!r am5d$ by ins]t+  
aft] ! item relat+ to section #gbg !    
foll[+3  ,sec4 #gbh4 ,full rebate on    

insul9 pass-?r\gh to plan4  4  7c7      
,int]nal ,rev5ue ,code  7#a7 ,9 g5]al   
,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal  
,rev5ue ,code ( #aihf1 z am5d$ by       
section #aja1 is fur!r am5d$ by add+ at 
! end ! foll[+ new section3  #ihbh4     
,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 or an entity provid+       
ph>macy b5efits managem5t s]vices "u su*
 heal? plan %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? plan1 
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  7#b7  
,cl]ical am5dm5t ,! table ( sections =  
sub*apt] ,b ( *apt] #ajj ( su* ,code1 z 
am5d$ by section #aja1 is fur!r am5d$ by
 add+ at ! end ! foll[+ new item3  ,sec4
 #ihbh4 ,full rebate on insul9          
pass-?r\gh to plan4  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$esignat+ clauses 7i7 & 7ii7 z      
subp>agraphs 7,a7 & 7,b71 respectively1 
& adju/+ ! m>g9s accord+ly4  #cjb4      
,exp$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  #cjc4 ,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  ,,iv       
,programs = provid+ af=dable insul9 to  
un9sur$ individuals  #dja4 ,pilot       
program = provid+ af=dable insul9 to    
un9sur$ individuals ,"p ,p ( title ,,iii
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bhj;g et seq47 is am5d$ by   
add+ at ! end ! foll[+3  #cii,v-#h4     

,pilot program = provid+ af=dable insul9
 to un9sur$ individuals  7a7 ,9 g5]al ,!
 ,secret>y %all conduct a #e-ye> pilot  
program "u :i* ! ,secret>y aw>ds grants 
to #aj ,/ates = purposes ( provid+      
af=dable insul9 to un9sur$ individuals4 
7b7 ,aw>ds ,! ,secret>y %all aw>d grants
 "u ?is section to #aj ,/ates t-- 7#a7  
submit an application to ! ,secret>y1 at
 su* "t1 9 su* mann]1 & conta9+ su*     
in=mation z ! ,secret>y may require2 &  
7#b7 h high rates ( un9sur$ individuals 
& individuals diagnos$ ) diabetes1 :i*  
may include high rates ( newly diagnos$ 
diabetes4  7c7 ,use ( funds ,a ,/ate    
%all use ! grant funds receiv$ "u ?is   
section = any ( ! foll[+ purposes3 7#a7 
,to assi/ 9 ! pur*ase or disp5s+ (      
insul91 ?r\gh ,f$]ally qualifi$ heal?   
c5t]s & retail community ph>macies1 =   
un9sur$ individuals4  7#b7 ,to enroll   
individuals 9 programs "u :i* drug      
manufactur]s provide f9ancial or        
m$ication assi/ance to l[-income        
individuals1 9 ord] to assi/ su*        

individuals 9 obta9+ insul94  7#c7 ,to  
all[ ,f$]ally qualifi$ heal? c5t]s to   
e/abli% new1 or ma9ta9 or exp& exi/+1   
on-site ph>macies own$ & op]at$ by !    
heal? c5t] t provide l[-co/ insul9 to   
pati5ts1 & to all[ retail community     
ph>macies to provide l[-co/ insul9 to   
pati5ts4  7#d7 ,to engage 9 o!r         
activities to assi/ un9sur$ individuals 
9 obta9+ insul91 z ! ,secret>y det]m9es 
appropriate4  7d7 ,=mula ,! ,secret>y   
%all e/abli% a =mula = purposes (       
det]m9+ ! grant am\nt "u ?is section =  
ea* ,/ate4 ,su* =mula %all-- 7#a7       
provide = a m9imum am\nt t w be provid$ 
to ea* ,/ate2 &  7#b7 take into acc\nt !
 rates ( individuals ) type #a or type  
#b1 insul9-dep5d5t diabetes & ( un9sur$ 
individuals 9 ea* ,/ate = purposes (    
det]m9+ any additional am\nts provid$ to
 a ,/ate4  7e7 ,acc\ntability &         
,ov]sight ,a ,/ate receiv+ a grant "u   
?is section %all1 n lat] ?an #a ye> aft]
 receiv+ ! grant1 submit a report to !  
,secret>y t includes-- 7#a7 a           

description ( ! purposes = :i* ! grant  
funds receiv$ by ! ,/ate 7 exp5d$ 9 !   
prec$+ fiscal ye>1 & ! activities ( !   
,/ate "u ! grant dur+ su* ye>2 &  7#b7 !
 numb] ( individuals s]v$ ?r\gh ! grant4
  7f7 ,def9itions ,9 ?is section3 7#a7  
,af=dable ,! t]m af=dable1 ) respect to 
insul91 means t ! out-(-pocket co/ to ! 
individual = ! insul9 is n m ?an #ce p] 
#a-mon? supply4  7#b7 ,f$]ally-qualifi$ 
heal? c5t] ,! t]m ,f$]ally-qualifi$     
heal? c5t] has ! mean+ giv5 su* t]m 9   
section #aije7l77#b7 ( ! ,social        
,security ,act4  7#c7 ,insul9 ,! t]m    
insul9 means insul9 t is lic5s$ "u      
subsection 7a7 or 7k7 ( section #cea &  
cont9ues to be m>ket$ "u su* section4   
7#d7 ,retail community ph>macy ,! t]m   
retail community ph>macy has ! mean+    
giv5 su* t]m 9 section #aibg7k77#aj7 ( !
 ,social ,security ,act4  7#e7 ,un9sur$ 
individual ,! t]m un9sur$ individual    
means an individual :o-- 7,a7 is a      
citiz5 ( ! ,unit$ ,/ates or a qualifi$  
ali5 7z def9$ 9 section #dca7;b7 ( !    

,p]sonal ,responsibility & ,"w          
,opportunity ,reconciliation ,act (     
#aiif72  7,b7 does n qualify = cov]age  
"u a ,f$]al heal? c>e program 7z def9$ 9
 section #aabh;,b7f7 ( ! ,social        
,security ,act71 ! heal? program        
e/abli%$ "u *apt] #hi ( title #e1 ,unit$
 ,/ates ,code1 or a gr\p heal? plan or  
gr\p heal? insurance cov]age 7z def9$ 9 
section #bgia72 &  7,c7 is n entitl$ to 
a premium assi/ance tax cr$it "u section
 #cf;,b ( ! ,int]nal ,rev5ue ,code (    
#aihf4  7g7 ,au?orization (             
appropriations ,to c>ry out ?is section1
 !re is au?oriz$ to be appropriat$      
#ajj1jjj1jjj = fiscal ye> #bjbg1 to     
rema9 available until exp5d$4  4  #djb4 
,,gao /udy on un9sur$ individuals :o use
 insul9  7a7 ,9 g5]al ,! ,comptroll]    
,g5]al ( ! ,unit$ ,/ates %all conduct a 
/udy1 9 consultation ) pati5t1 cl9ical1 
& provid] gr\ps & o!r exp]ts1 & n lat]  
?an #b ye>s aft] ! date ( enactm5t ( ?is
 ,act1 issue a report1 on ! *>act]i/ics 
( un9sur$ individuals :o use insul94    

,su* /udy & report %all1 to ! ext5t data
 is available1 include consid]ation (-- 
7#a7 any ,/ates or regions 9 :i* !re is 
a high] preval5ce ( su* individuals2    
7#b7 any id5tifiable pot5tial reasons = 
un9sur$ /atus2  7#c7 demographic        
*>act]i/ics ( su* individuals1 su* z    
race & e?nicity2 &  7#d7 income level ( 
su* individuals4  7b7 ,def9itions ,9 ?is
 section1 ! t]ms insul9 & un9sur$       
individual h ! mean+s giv5 su* t]ms 9   
section #cii,v-#h ( ! ,public ,heal?    
,s]vice ,act1 z add$ by section #dja4   
#djc4 ,insul9 res\rce c5t] & hotl9e =   
un9sur$ individuals  7a7 ,9 g5]al ,!    
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
%all aw>d a grant to an eligible entity 
= purposes (-- 7#a7 e/abli%+ & ma9ta9+ a
 res\rce c5t] ( assi/ance programs (f]$ 
by manufactures or o!r entities t are   
available to un9sur$ individuals seek+  
af=dable insul92 &  7#b7 conduct+ !     
public education activities describ$ 9  
subsection 7c77#g74  7b7 ,eligible      

entities ,to be eligible to receive !   
grant "u subsection 7a71 an entity      
%all-- 7#a7 be a trade1 indu/ry1 or     
pr(essional association1 community- &   
consum]-focus$ nonpr(it entity1 or o!r  
entity1 z det]m9$ by ! ,secret>y t--    
7,a7 is capable ( c>ry+ out ! duties    
describ$ 9 subsection 7c72  7,b7 meets !
 /&>ds describ$ 9 subsection 7e72 &     
7,c7 provides in=mation consi/5t ) !    
/&>ds develop$ "u subsection 7f72 &     
7#b7 submit an application to !         
,secret>y1 at su* "t1 9 su* mann]1 &    
conta9+ su* in=mation z ! ,secret>y may 
require1 includ+ in=mation demon/rat+ t 
! entity-- 7,a7 has exi/+ relation%ips1 
or c\ld readily e/abli% relation%ips1 ) 
consum]s 7includ+ un9sur$ individuals71 
heal? c>e provid]s1 manufactur]s (      
insul91 social s]vice provid]s1         
ph>macies1 & o!r exp]ts t ! ,secret>y   
det]m9es appropriate1 to meet ! goals ( 
?is section2 &  7,b7 has1 or w e/abli%1 
p>tn]%ips )1 & solicit fe$back f1 o!r   
entities 9 o!r indu/ries1 pr(essional   

associations1 & community- &            
consum]-focus$ nonpr(it organizations1  
to meet ! goals ( ?is section4  7c7     
,duties ,an entity t receives a grant "u
 ?is section %all-- 7#a7 di/ribute fair 
& imp>tial in=mation conc]n+ eligibility
 = manufactur]1 f\ndational1 & o!r      
assi/ance programs available to pati5ts 
seek+ af=dable insul92  7#b7 facilitate 
enrollm5t 9 manufactur] assi/ance       
programs or o!r assi/ance programs =    
un9sur$ individuals2  7#c7 make         
available to ! public1 ?r\gh a /&>diz$  
website1 a cle>+h\se ( support available
 to pati5ts1 includ+-- 7,a7 a l9k to    
,f$]ally qualifi$ heal? c5t]s & o!r     
provid]s1 by ,,zip ,code2  7,b7 a l9k to
 retail community ph>macies1 by ,,zip   
,code2 &  7,c7 in=mation ab\t h[ to     
enroll 9 heal? insurance2  7#d7 provide 
in=mation 9 a mann] t is culturally &   
l+ui/ically appropriate2  7#e7 e/abli% a
 hotl9e ?r\gh :i* individuals may rea*  
exp]ts ) que/ions ab\t access to insul91
 & t-- 7,a7 is a #bd_/g real-"t hotl9e2 

7,b7 provides voice & text support2 &   
7,c7 is /aff$ by navigators or lic5s$   
heal? c>e pr(essionals2  7#f7 provide   
guidance to hospitals on h[ to %>e !    
website & hotl9e ) pati5ts2 &  7#g7     
conduct public education activities1 9  
collaboration ) ! ,dep>tm5t ( ,heal? &  
,human ,s]vices1 to raise aw>5ess ( !   
availability ( all manufactur]1         
f\ndational1 & o!r assi/ance programs   
available to pati5ts seek+ af=dable     
insul91 ) a focus on un9sur$            
individuals2 includ+ by-- 7,a7 p>tn]+ ) 
community heal? c5t]s1 hospitals1 retail
 community ph>macies1 & community-bas$  
organizations ) a focus on access to    
af=dable m$ic9e2 &  7,b7 work+ ) ,/ate &
 local heal? dep>tm5ts to t>get !       
programs c>ri$ out us+ ! grant to       
und]s]v$ communities4  7d7 ,duties ( !  
,secret>y ,! ,secret>y %all-- 7#a7      
ensure adequate ma9t5ance ( ! res\rce   
c5t] e/abli%$ by ! entity receiv+ a     
grant "u subsection 7a72  7#b7 publicize
 su* res\rce c5t] on ! website ( !      

,dep>tm5t ( ,heal? & ,human ,s]vices &  
across ,f$]al ag5cies1 z ! ,secret>y    
det]m9es appropriate2 &  7#c7 ensure t  
su* res\rce c5t] meets ! /&>ds "u       
subsection 7e71 & )draw ! grant & make  
an aw>d to a diff]5t eligible entity 9 !
 case t an eligible entity fails to meet
 su* /&>ds4  7e7 ,/&>ds ,! ,secret>y    
%all e/abli% /&>ds = ! res\rce c5t] "u  
?is section1 includ+ provisions to      
ensure t ! entity receiv+ a grant "u ?is
 section is qualifi$ to engage 9 !      
activities describ$ 9 ?is section & to  
avoid conflicts ( int]e/4 ,"u su* /&>ds1
 su* entity-- 7#a7 %all n-- 7,a7 be a   
manufactur] ( insul9 products2 or  7,b7 
receive any consid]ation directly or    
indirectly f any manufactur] ( insul9   
products 9 connection ) ! enrollm5t (   
any individuals 9 an assi/ance program2 
&  7#b7 %all provide in=mation t is     
fair1 accurate1 & imp>tial4  7f7 ,data  
collection & evaluations ,! ,secret>y   
may collect data & conduct evaluations )
 respect to ! s]vices provid$ by !      

res\rce c5t] describ$ 9 ?is section =   
purposes ( assess+ ! ext5t to :i* !     
provision ( ! s]vices-- 7#a7 r$uces out 
( pocket insul9 co/s = un9sur$          
individuals2  7#b7 increases aw>5ess (  
assi/ance programs or f\ndational       
support available = un9sur$ individuals2
 &  7#c7 improves utilization ( !       
res\rces describ$ 9 p>agraph 7#b7 by    
un9sur$ individuals4  7g7 ,reports to   
,congress ,! ,secret>y %all submit to ! 
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions & ! ,committee on    
,appropriations ( ! ,s5ate & !          
,committee on ,en]gy & ,comm]ce & !     
,committee on ,appropriations ( ! ,h\se 
( ,repres5tatives1 & make publicly      
available1 annual reports on !          
activities c>ri$ out "u ?is section1    
includ+ any *anges 9 ! availability or  
scope ( assi/ance programs (f]$ by      
insul9 manufactur]s & in=mation ab\t !  
numb] ( individuals :o use ! res\rce    
c5t]1 includ+ ! website or hotl9e4  7h7 
,def9itions ,9 ?is section-- 7#a7 ! t]m 

assi/ance program means a program to    
assi/ pati5ts 9 obta9+ a drug at a r$uc$
 co/1 & includes ?ird-p>ty paym5ts1     
f9ancial assi/ance1 disc\nts1 product   
v\*]s1 & o!r r$uctions 9 out-(-pocket   
exp5ses2  7#b7 ! t]m ,f$]ally-qualifi$  
heal? c5t] has ! mean+ giv5 su* t]m 9   
section #aije7l77#b7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#acif;d7l77#b772  7#c7 ! 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*
 lic5sure2  7#d7 ! t]m retail community 
ph>macy has ! mean+ giv5 su* t]m 9      
section #aibg7k77#aj7 ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7k77#aj772 &  7#e7 ! t]m       
un9sur$ individual means an individual  
:o-- 7,a7 does n qualify = cov]age "u a 
,f$]al heal? c>e program 7z def9$ 9     
section #aabh;,b7f7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#acbj;a-#g;b7f7771 ! heal? program      

e/abli%$ "u *apt] #hi ( title #e1 ,unit$
 ,/ates ,code1 or a gr\p heal? plan or  
gr\p heal? insurance cov]age 7z def9$ 9 
section #bgia ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #cjj;gg-#ia772 &   
7,b7 is n entitl$ to a premium assi/ance
 tax cr$it "u section #cf;,b ( !        
,int]nal ,rev5ue ,code ( #aihf4  7i7    
,fund+ ,to c>ry out ?is section1 !re are
 au?oriz$ to be appropriat$ #b1jjj1jjj =
 ea* ( fiscal ye>s #bjbg ?r\gh #bjcb4