,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bijc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ah          
7legislative day1 ,septemb] #af71       
#bjbe,ms4 ,murk[ski 7= h]self1 ,ms4     
,hassan1 ,mr4 ,m>%all1 ,ms4 ,ros51 ,mr4 
,padilla1 ,mr4 ,hick5loop]1 ,mr4        
,m]kley1 ,mr4 ,sullivan1 ,mr4 ,w>nock1  
,mrs4 ,hyde-,smi?1 ,ms4 ,cortez ,ma/o1  
,mr4 ,moran1 ,mr4 ,cram]1 ,mr4 ,ka9e1   
,mr4 ,budd1 ,mrs4 ,%ahe51 ,mr4 ,book]1  
,mr4 ,wyd51 & ,mr4 ,coons7 introduc$ !  
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,employee ,retirem5t ,income ,security
 ,act ( #aigd to require a gr\p heal?   
plan or heal? insurance cov]age (f]$ 9  
connection ) su* a plan to provide an   
exceptions process = any m$ication /ep  
!rapy protocol1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,safe ,/ep ,act4  #b4 ,requir$          
exceptions process = m$ication /ep !rapy
 protocols  7a7 ,requir$ exceptions     

process = m$ication /ep !rapy protocols 
,! ,employee ,retirem5t ,income         
,security ,act ( #aigd is am5d$ by      
ins]t+ aft] section #gac ( su* ,act 7#bi
 ,u4,s4,c4 #aahe;b7 ! foll[+ new        
section3  #gac;,a4 ,requir$ exceptions  
process = m$ication /ep !rapy protocols 
7a7 ,9 g5]al ,9 ! case ( a gr\p heal?   
plan or heal? insurance issu] (f]+      
cov]age (f]$ 9 connection ) su* a plan t
 provides cov]age ( a prescription drug 
pursuant to a m$ication /ep !rapy       
protocol1 ! plan or issu] %all-- 7#a7   
implem5t a cle>1 prompt1 & transp>5t    
process = a p>ticipant or b5efici>y 7or 
! prescrib+ heal? c>e provid] 7ref]r$ to
 9 ?is section z ! prescrib]7 on behalf 
( ! p>ticipant or b5efici>y7 to reque/  
an exception to su* m$ication /ep !rapy 
protocol1 pursuant to subsection 7b72 & 
7#b7 :]e ! p>ticipant or b5efici>y or   
prescrib]'s reque/ = an exception to !  
m$ication /ep !rapy protocols satisfies 
! crit]ia & requirem5ts ( subsection    
7b71 cov] ! reque/$ drug 9 accordance ) 

! t]ms e/abli%$ by ! plan or cov]age =  
pati5t co/-%>+ rates or am\nts at !     
beg9n+ ( ! plan ye>4  7b7 ,circum/ances 
= exception approval ,! circum/ances    
requir+ an exception to a m$ication /ep 
!rapy protocol1 pursuant to a reque/ "u 
subsection 7a71 are any ( ! foll[+3 7#a7
 ,any treatm5ts o!rwise requir$ "u !    
protocol1 or treatm5ts 9 ! same         
ph>macological class or hav+ ! same     
me*anism ( action1 includ+ treatm5ts    
provid$ prior to ! effective date ( !   
p>ticipant's or b5efici>y's cov]age "u !
 plan or cov]age1 h be5 ineffective 9 ! 
treatm5t ( ! disease or condition ( !   
p>ticipant or b5efici>y1 :5 prescrib$   
consi/5t ) cl9ical indications1 cl9ical 
guidel9es1 or o!r pe]-review$ evid5ce1  
bas$ on ! prescrib+ heal? c>e           
pr(essional's judgem5t or relevant      
in=mation provid$ by ! p>ticipant or    
b5efici>y 7includ+ ! m$ical records ( ! 
p>ticipant or b5efici>y74  7#b7 ,delay (
 effective treatm5t w\ld lead to sev]e  
or irrev]sible consequ5ces1 or wors5    

disease progression or a comorbidity & !
 treatm5t o!rwise requir$ "u ! protocol 
is reasonably expect$ by ! prescrib] to 
be ineffective bas$ ^u ! docum5t$       
physical or m5tal *>act]i/ics ( !       
p>ticipant or b5efici>y & ! kn[n        
*>act]i/ics ( su* treatm5t4  7#c7 ,any  
treatm5ts o!rwise requir$ "u ! protocol 
are contra9dicat$ = ! p>ticipant or     
b5efici>y or h caus$1 or are likely to  
cause1 bas$ on cl9ical1 pe]-review$     
evid5ce1 an adv]se reaction or o!r      
physical or m5tal h>m to ! p>ticipant or
 b5efici>y4  7#d7 ,any treatm5t o!rwise 
requir$ "u ! protocol has prev5t$1 w    
prev5t1 or is likely to prev5t a        
p>ticipant or b5efici>y f a*iev+ or     
ma9ta9+ reasonable & safe functional    
ability 9 p]=m+ occupational            
responsibilities or activities ( daily  
liv+ 7z def9$ 9 section #dda4eje ( title
 #db1 ,code ( ,f$]al ,regulations 7or   
successor regulations774  7#e7 ,!       
p>ticipant or b5efici>y is /able = 8 or 
h] disease or condition on !            

prescription drug or drugs select$ by ! 
prescrib] & has previ\sly receiv$       
approval = cov]age ( ! relevant drug or 
drugs = ! disease or condition by any   
public or private heal? plan4  7#f7 ,o!r
 circum/ances1 z det]m9$ by ! ,secret>y4
  7c7 ,requirem5t ( a cle> process  7#a7
 ,9 g5]al ,! process requir$ by         
subsection 7a7 %all-- 7,a7 provide !    
prescrib] or p>ticipant or b5efici>y an 
opportunity to pres5t su* prescrib]'s   
cl9ical rationale & relevant m$ical     
in=mation = ! gr\p heal? plan or heal?  
insurance issu] to evaluate su* reque/ =
 exception2  7,b7 develop & use a /&>d  
=m & in/ructions = ! reque/ ( an        
exception "u subsection 7b71 available 9
 pap] & electronic =ms1 & all[ =        
submission ( su* =m by pap] & electronic
 means2  7,c7 provide bo? pap] &        
electronic means = ! submission (       
reque/s = additional in=mation2  7,d7   
cle>ly set =? all requir$ in=mation & ! 
specific crit]ia t w be us$ to det]m9e  
:e!r an exception is w>rant$1 :i* may   

require disclosure (-- 7i7 ! m$ical     
hi/ory or o!r heal? records ( !         
p>ticipant or b5efici>y demon/rat+ t !  
p>ticipant or b5efici>y seek+ an        
exception-- 7,i7 has tri$ o!r drugs     
includ$ 9 ! drug !rapy class )\t        
success2 or  7,,ii7 has tak5 ! reque/$  
drug = a cl9ically appropriate am\nt (  
"t to e/abli% /ability1 9 relation to ! 
condition be+ treat$ & prescription     
guidel9es giv5 by ! prescrib+ physician2
 or  7ii7 o!r cl9ical in=mation t may be
 relevant to conduct+ ! exception       
review2  7,e7 n require ! submission (  
any in=mation or support+ docum5tation  
beyond :at is /rictly necess>y 7z       
det]m9$ by ! ,secret>y7 to det]m9e :e!r 
a circum/ance li/$ 9 subsection 7b7     
exi/s2  7,f7 cle>ly outl9e conditions "u
 :i* an exception reque/ w>rants exp$it$
 resolution f ! gr\p heal? plan or heal?
 insurance issu]1 pursuant to subsection
 7d77#b72 &  7,g7 all[ a repres5tative (
 a p>ticipant or b5efici>y1 :i* may     
include a designat$ ?ird-p>ty advocate1 

to act on behalf ( ! p>ticipant or      
b5efici>y4  7#b7 ,availability ( process
 in=mation ,! gr\p heal? plan or heal?  
insurance issu] %all make in=mation     
reg>d+ ! process requir$ "u subsection  
7a7 readily available 9 ! relevant plan 
mat]ials1 includ+ ! summ>y ( b5efits &1 
if available1 on ! website ( ! gr\p     
heal? plan or heal? insurance issu]4    
,su* in=mation %all include-- 7,a7 !    
requirem5ts = reque/+ an exception to a 
m$ication /ep !rapy protocol pursuant to
 ?is section2 &  7,b7 any =ms1 support+ 
in=mation1 & contact in=mation1 z       
appropriate4  7d7 ,tim+ = det]m9ation ( 
exception ,! process requir$ "u         
subsection 7a77#a7 %all provide = !     
disposition ( reque/s receiv$ "u su*    
p>agraph 9 accordance ) ! foll[+3 7#a7  
,subject to p>agraph 7#b71 n lat] ?an   
#gb h\rs aft] receiv+ an initial        
exception reque/1 ! plan or issu] %all  
respond to ! p>ticipant or b5efici>y &1 
if applicable1 ! reque/+ prescrib] )    
ei!r a det]m9ation ( exception          

eligibility or a reque/ = additional    
requir$ in=mation /rictly necess>y to   
make a det]m9ation ( :e!r ! conditions  
specifi$ 9 subsection 7b7 are met4 ,!   
plan or issu] %all respond to !         
p>ticipant or b5efici>y &1 if           
applicable1 ! reque/+ prescrib]1 ) a    
det]m9ation ( exception eligibility no  
lat] ?an #gb h\rs aft] receipt ( !      
additional requir$ in=mation4  7#b7 ,9 !
 case ( a reque/ "u circum/ances 9 :i* !
 applicable m$ication /ep !rapy protocol
 may s]i\sly jeop>dize ! life or heal? (
 ! p>ticipant or b5efici>y1 may         
jeop>dize ! ability ( ! p>ticipant or   
b5efici>y to rega9 maximum function1 or 
may subject ! p>ticipant or b5efici>y to
 sev]e pa9 t _c be adequately manag$ )\t
 ! treatm5t t is ! subject ( ! reque/1 !
 plan or issu] %all conduct a review ( !
 reque/ & respond to ! p>ticipant or    
b5efici>y &1 if applicable1 ! reque/+   
prescrib]1 ) ei!r a det]m9ation (       
exception eligibility or a reque/ =     
additional requir$ in=mation /rictly    

necess>y to make a det]m9ation ( :e!r ! 
conditions specifi$ 9 subsection 7b7 are
 met1 9 accordance ) ! foll[+3 7,a7 ,if 
! plan or issu] c make a det]m9ation (  
exception eligibility )\t additional    
in=mation1 su* det]m9ation %all be made 
on an exp$it$ basis1 & no lat] ?an #bd  
h\rs aft] receipt ( su* reque/4  7,b7   
,if ! plan or issu] requires additional 
in=mation be=e mak+ a det]m9ation (     
exception eligibility1 ! plan or issu]  
%all respond to ! p>ticipant or         
b5efici>y &1 if applicable1 ! reque/+   
prescrib]1 ) a reque/ = su* in=mation )9
 #bd h\rs ( ! reque/ = a det]m9ation1 & 
%all respond ) a det]m9ation ( exception
 eligibility z quickly z ! condition or 
disease requires1 & no lat] ?an #bd h\rs
 aft] receipt ( ! additional requir$    
in=mation4  7e7 ,duration ( a grant ,if 
an exception to a m$ication /ep !rapy   
protocol is grant$ "u ?is section to a  
p>ticipant or b5efici>y1 cov]age = !    
reque/$ drug %all rema9 9 effect )      
respect to su* p>ticipant or b5efici>y =

 n less ?an "o ye>4  7f7 ,m$ication /ep 
!rapy protocol ,9 ?is section1 ! t]m    
m$ication /ep !rapy protocol means a    
drug !rapy utilization managem5t        
protocol or program "u :i* a gr\p heal? 
plan or heal? insurance issu] (f]+ gr\p 
heal? insurance cov]age ( prescription  
drugs requires a p>ticipant or b5efici>y
 to try an alt]native pref]r$           
prescription drug or drugs be=e ! plan  
or heal? insurance issu] approves       
cov]age = ! non-pref]r$ drug !rapy      
prescrib$4  7g7 ,cl>ification ,?is      
section %all apply ) respect to any gr\p
 heal? plan or heal? insurance cov]age  
(f]$ 9 connection ) su* a plan t        
provides cov]age ( a prescription drug  
pursuant to a policy t meets ! def9ition
 ( ! t]m m$ication /ep !rapy protocol 9 
subsection 7f71 reg>dless ( :e!r su*    
policy is describ$ by su* gr\p heal?    
plan or heal? insurance cov]age z a /ep 
!rapy protocol4  7h7 ,report+  7#a7     
,report+ to ! ,secret>y ,n lat] ?an #c  
ye>s aft] ! date ( enactm5t ( ! ,safe   

,/ep ,act & n lat] ?an ,octob] #a ( ea* 
ye> !reaft]1 ea* gr\p heal? plan & heal?
 insurance issu] (f]+ gr\p heal?        
insurance cov]age %all report to !      
,secret>y1 9 su* mann] z ! ,secret>y    
%all require1 ! foll[+3 7,a7 ,! numb] ( 
/ep !rapy exception reque/s receiv$ =   
ea* exception circum/ance describ$ 9    
p>agraphs 7#a7 ?r\gh 7#f7 ( subsection  
7b71 & ! numb]s ( su* reque/s = ea* su* 
circum/ance t 7-- 7i7 approv$2  7ii7    
d5i$1 & ! reasons = ! d5ials2  7iii7    
initially d5i$ & appeal$2 &  7iv7       
initially d5i$ & !n subsequ5tly rev]s$  
by int]nal appeals or ext]nal reviews4  
7,b7 ,! numb] ( times a plan or issu]   
reque/$ additional in=mation 9 response 
to a /ep !rapy exception reque/1 by     
exception circum/ance describ$ 9        
p>agraphs 7#a7 ?r\gh 7#f7 ( subsection  
7b74  7,c7 ,! numb] ( exception reque/s 
submitt$ by p>ticipants or b5efici>ies1 
& ! numb] ( exception reque/s submitt$  
by prescrib]s1 by m$ical specialty4     
7,d7 ,! m$ical conditions = :i*         

p>ticipants & b5efici>ies 7 grant$      
exceptions due to ! likelihood t swit*+ 
f a prescription drug w likely cause an 
adv]se reaction by1 or physical or m5tal
 h>m to1 ! p>ticipant or b5efici>y1 z   
describ$ 9 subsection 7b77#c74  7,e7 ,! 
entities responsible = provid+ ph>macy  
b5efit managem5t s]vices = ! gr\p heal? 
plan or heal? insurance cov]age4  7#b7  
,in=mation ,a gr\p heal? plan or heal?  
insurance issu] (f]+ gr\p heal?         
insurance cov]age %all n ent] into a    
contract ) a ?ird-p>ty adm9i/rator or an
 entity provid+ ph>macy b5efit managem5t
 s]vices on behalf ( ! plan or cov]age t
 prev5ts ! plan or issu] f obta9+ f !   
?ird-p>ty adm9i/rator or ! entity       
provid+ ph>macy b5efit managem5t s]vices
 any in=mation ne$$ = ! plan or issu] to
 comply ) ! report+ requirem5ts "u      
p>agraph 7#a74  7#c7 ,reports to        
,congress ,n lat] ?an #c ye>s aft] !    
date ( enactm5t ( ! ,safe ,/ep ,act1 & n
 lat] ?an ,octob] #a ( ea* ye> !reaft]1 
! ,secret>y %all submit to ,congress1 & 

make publicly available1 a report t     
conta9s a summ>y & analysis ( !         
in=mation report$ "u p>agraph 7#a71     
includ+ an analysis (1 ) respect to     
reque/s = exceptions "u ?is section1    
approvals1 & d5ials1 includ+ ! reasons =
 d5ials2 appeals & ext]nal reviews2 &   
tr5ds1 if any1 9 exception reque/s by   
m$ical specialty or m$ical condition4  4
  7b7 ,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 #gac ! foll[+ new item3  ,sec4  
#gac;,a4 ,requir$ exceptions process =  
m$ication /ep !rapy protocols4  4  7c7  
,effective date  7#a7 ,9 g5]al ,!       
am5dm5t made by subsection 7a7 applies )
 respect to plan ye>s beg9n+ ) ! fir/   
plan ye> t beg9s at lea/ #f mon?s aft] !
 date ( ! enactm5t ( ?is ,act4  7#b7    
,regulations ,n lat] ?an #f mon?s aft] !
 date ( ! enactm5t ( ?is ,act1 !        
,secret>y ( ,labor %all issue f9al      

regulations1 ?r\gh notice & comm5t      
rulemak+1 to implem5t ! provisions (    
section #gac;,a ( ! ,employee ,retirem5t
 ,income ,security ,act ( #aigd1 z add$ 
by subsection 7a74