,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #bedf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #be1         
#bjai,ms4 ,murk[ski 7= h]self1 ,mr4     
,jones1 ,mr4 ,cassidy1 ,ms4 ,hassan1    
,mrs4 ,hyde-,smi?1 ,ms4 ,ros51 ,mr4     
,cram]1 & ,mr4 ,k+7 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$ication /ep !rapy
 protocols  7a7 ,9 g5]al ,! ,employee   
,retirem5t ,income ,security ,act (     
#aigd is am5d$ by ins]t+ aft] section   
#gae ( su* ,act 7#bi ,u4,s4,c4 #aahe;d7 
! foll[+ new section3  #gaf4 ,requir$   
exceptions process = m$ication /ep !rapy

 protocols  7a7 ,9 g5]al ,9 ! case ( a  
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 m$ication /ep !rapy       
protocol1 ! plan or cov]age %all--  7#a7
 implem5t a cle> & transp>5t process = a
 p>ticipant or b5efici>y 7or ! prescrib+
 heal? c>e provid] on behalf ( !        
p>ticipant or b5efici>y7 to reque/ an   
exception to su* m$ication /ep !rapy    
protocol1 pursuant to subsection 7b72 & 
7#b7 :]e ! p>ticipant or b5efici>y or   
prescrib+ heal? c>e provid]'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 ! heal? plan or cov]age =   
pati5t co/-%>+ rates or am\nts at ! "t (
 ! p>ticipant's or b5efici>y's enrollm5t
 9 ! heal? plan or heal? insurance      
cov]age4  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 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$ evid5ce4  
7#b7 ,delay ( effective treatm5t w\ld   
lead to sev]e or irrev]sible            
consequ5ces1 & ! treatm5t o!rwise       
requir$ "u ! protocol is reasonably     
expect$ 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 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+ heal? c>e provid] & has       
previ\sly receiv$ approval = cov]age ( !
 relevant drug or drugs = ! disease or  
condition by any gr\p heal? plan or     
heal? insurance issu]4  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--  7,a7 %all provide !   
prescrib+ heal? c>e provid] or b5efici>y
 or designat$ ?ird-p>ty advocate an     
opportunity to pres5t su* provid]'s     
cl9ical rationale & relevant m$ical     

in=mation = ! gr\p heal? plan or heal?  
insurance issu] to evaluate su* reque/ =
 exception2  7,b7 %all 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,c7 may n require ! submission
 ( any in=mation or support+            
docum5tation beyond :at is /rictly      
necess>y to det]m9e :e!r any ( !        
circum/ances li/$ 9 subsection 7b7      
exi/s2 &  7,d7 %all 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#b74  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 on ! int]net 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 ! 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 ! reque/+ provid] ) 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$ication /ep !rapy protocol
 may s]i\sly jeop>dize ! life or heal? (
 ! p>ticipant or b5efici>y1 ! plan or   
issu] %all conduct a review ( ! reque/ &
 respond to ! reque/+ prescrib] ) ei!r a
 det]m9ation ( exception eligibility or 
a reque/ = additional requir$ in=mation 
/rictly necess>y to make a det]m9ation (
 :e!r ! conditions specifi$ 9 subsection
 7b7 are 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 ! reque/+
 provid] ) 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 ,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$1 prescription 
drug or drugs be=e ! plan or heal?      
insurance issu] approves cov]age = !    
non-pref]r$ drug !rapy prescrib$4  7f7  
,cl>ification ,?is section %all apply ) 
respect to any gr\p heal? plan or heal? 
insurance cov]age (f]$ 9 connection )   
su* a plan t provides cov]age ( a       
prescription drug pursuant to a policy t

 meets ! def9ition ( ! t]m m$ication /ep
 !rapy protocol 9 subsection 7e71       
reg>dless ( :e!r su* policy is describ$ 
by su* gr\p heal? plan or heal?         
insurance cov]age z a /ep !rapy         
protocol4  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 #gad ! foll[+ new     
items3  ,sec4 #gae4 ,additional m>ket   
re=ms4,sec4 #gaf4 ,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 #gaf ( ! ,employee ,retirem5t   

,income ,security ,act ( #aigd1 z add$  
by subsection 7a74