,i  #aag? ,,congress  #a/ ,session  ,h4 
,r4 #cbeh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ad1 #bjba ,ms4  
,sewell 7= h]self & ,mr4 ,bilirakis7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d title ,,xxvii ( !      
,public ,heal? ,s]vice ,act to improve  
pati5t access to anti-canc] oral        
m$ications1 & = o!r purposes4  #a4 ,%ort
 title ,?is ,act may be cit$ z ! ,timely
 ,access to ,canc] ,treatm5t ,act (     
#bjba or ! ,,tact ,act ( #bjba4  #b4    
,pati5t access to anti-,canc] oral      
m$ications  7a7 ,9 g5]al ,section       
#bgai;,a ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #cjj;gg-#ai;,a7 is am5d$
 by add+ at ! end ! foll[+ new          
subsection3  7f7 ,access to anti-,canc] 
oral m$ications  7#a7 ,requirem5ts =    
contracts betwe5 gr\p heal? plans or    
heal? insurance issu]s & ph>macies ,if a
 gr\p heal? plan or a heal? insurance   
issu] (f]+ gr\p or individual heal?     
insurance cov]age cov]s or provides any 

b5efits = anti-canc] oral m$ications 7z 
def9$ 9 p>agraph 7#d77 & ent]s into a   
contract ) a ph>macy1 :e!r directly or  
?r\gh an ag5t ( su* plan or issu]       
7includ+ a ph>macy b5efit manag]71 to   
disp5se su* m$ications to p>ticipants1  
b5efici>ies1 or enrollees ( ! plan or   
cov]age1 su* plan or issu] %all require1
 z conditions ( su* contract1 su*       
ph>macy to c>ry out ! proc$ures describ$
 9 p>agraph 7#b74  7#b7 ,proc$ures      
describ$ ,= purposes ( p>agraph 7#a71 ! 
proc$ures describ$ 9 ?is p>agraph )     
respect to a p>ticipant1 b5efici>y1 or  
enrollee ( ! plan or cov]age & a heal?  
c>e provid] :o submits to su* ph>macy a 
prescription = an anti-canc] oral       
m$ication = su* p>ticipant1 b5efici>y1  
or enrollee are ! foll[+ 7z applicable73
  7,a7 ,ph>macy confirmation ( ability  
to disp5se ,n lat] ?an #bd h\rs aft]    
receiv+ su* prescription-- 7i7 confirm  
to su* heal? c>e provid] t su* ph>macy  
receiv$ su* prescription2 &  7ii7 in=m  
su* heal? c>e provid]1 z well z su* plan

 or issu]1 :e!r su* ph>macy w disp5se   
su* anti-canc] oral m$ication to su*    
p>ticipant1 b5efici>y1 or enrollee by n 
lat] ?an #gb h\rs aft] receiv+ su*      
prescription1 includ+ any "t = b5efits  
v]ification1 prior au?orization1 or any 
o!r adm9i/rative proc$ure requir$ by !  
ag5t ( su* plan or issu] 7includ+ a     
ph>macy b5efit manag]7 prior to au?oriz+
 ! ph>macy to disp5se ! m$ication4  7,b7
 ,ph>macy able to fill prescription ,9 !
 case t su* ph>macy in=ms su* heal? c>e 
provid] 9 writ+ "u subp>agraph 7,a77ii7 
t su* ph>macy is able to disp5se su*    
anti-canc] oral m$ication to su*        
p>ticipant1 b5efici>y1 or enrollee by ! 
#gb-;h\r deadl9e describ$ 9 su*         
subp>agraph1 disp5se su* anti-canc] oral
 m$ication to su* p>ticipant1 b5efici>y1
 or enrollee by su* deadl9e4  7,c7      
,ph>macy unable to fill prescription ,9 
! case t su* ph>macy in=ms su* heal? c>e
 provid] "u subp>agraph 7,a77ii7 t su*  
ph>macy is n able to disp5se su*        
anti-canc] oral m$ication to su*        

p>ticipant1 b5efici>y1 or enrollee by ! 
#gb-;h\r deadl9e describ$ 9 su*         
subp>agraph1 imm$iately provide a writt5
 notice to-- 7i7 ! prescrib+ physician  
or o!r heal? c>e provid]2  7ii7 ! gr\p  
heal? plan or a heal? insurance issu]   
(f]+ gr\p or individual heal? insurance 
cov]age2 &  7iii7 su* p>ticipant1       
b5efici>y1 or enrollee2  ) a cle> &     
und]/&able explanation ( su* inability &
 ( ! option ( su* p>ticipant1 b5efici>y1
 or enrollee to be disp5s$ su*          
anti-canc] oral m$ication f any provid] 
or ph>macy describ$ 9 p>agraph          
7#c77;,c71 9 accordance ) ! co/-%>+     
requirem5ts describ$ 9 subp>agraphs 7,a7
 & 7,b7 ( su* p>agraph4  7,d7 ,ph>macy  
,failure to ,communicate ,if ! ph>macy  
does n communicate its ability to       
disp5se z requir$ by subp>agraph 7,a71  
or1 aft] confirm+ t x w disp5se an      
anti-canc] oral m$ication "u su*        
subp>agraph1 does n actually disp5se su*
 m$ication by ! #gb-;h\r deadl9e        
describ$ 9 su* p>agraph1 su* ph>macy    

%all be deem$ to h confirm$ t x is n    
able to disp5se su* m$ication "u        
subp>agraph 7,c74  7#c7 ,requirem5ts =  
gr\p heal? plans & heal? insurance      
issu]s  7,a7 ,pati5t selection (        
alt]nate provid] or ph>macy ,if a gr\p  
heal? plan or a heal? insurance issu]   
(f]+ gr\p or individual heal? insurance 
cov]age 7or its ag5t1 includ+ a ph>macy 
b5efits manag]7 describ$ 9 p>agraph 7#a7
 ent]s into a contract describ$ 9 su*   
p>agraph1 ) a ph>macy & su* ph>macy1 )  
respect to a p>ticipant1 b5efici>y1 or  
enrollee ( ! plan or cov]age & heal? c>e
 provid] :o submits to su* ph>macy a    
prescription = an anti-canc] oral       
m$ication = su* p>ticipant1 b5efici>y1  
or enrollee1 in=ms su* heal? c>e provid]
 "u subp>agraph 7,a77ii7 ( su* p>agraph 
t su* ph>macy w n disp5se su* anti-canc]
 oral m$ication to su* p>ticipant1      
b5efici>y1 or enrollee by ! #gb-;h\r    
deadl9e describ$ 9 su* subp>agraph 7or 9
 ! case t ! p>ticipant1 b5efici>y1 or   
enrollee has n receiv$ ! anti-canc] oral

 m$ication by ! #gb-;h\r deadl9e71 !    
plan or issu]--  7i7 %all au?orize su*  
p>ticipant1 b5efici>y1 or enrollee to   
select any provid] or ph>macy describ$ 9
 subp>agraph 7,c7 to disp5se su*        
anti-canc] oral m$ication to su*        
p>ticipant1 b5efici>y1 or enrollee bas$ 
on ! writt5 notic$ describ$ 9 p>agraph  
7#b77;,c7 or a c]tification by !        
prescrib+ physician or o!r heal?        
pr(essional t ! p>ticipant1 b5efici>y1  
or enrollee has n receiv$ ! anti-canc]  
oral m$ication by ! #gb-;h\r deadl9e2 & 
7ii7 9 ! case ! provid] or ph>macy      
select$ "u clause 7i7 does n h a        
contract ) su* plan or issu] to disp5se 
su* anti-canc] oral m$ication to su*    
p>ticipant1 gr\p heal? plan or heal?    
insurance issu] (f]+ gr\p or individual 
heal? insurance cov]age describ$ 9      
p>agraph 7#a7 %all cov] ! m$ication &   
pay ! provid] or ph>macy 9 accordance ) 
! provisions ( subp>agraph 7,b74  7,b7  
,cov]age requirem5ts = prescriptions    
disp5s$ by alt]nate provid] or ph>macy  

,= prescriptions disp5s$ by an alt]nate 
provid] or ph>macy 9 accordance )       
subp>agraph 7,a7 t does n h a contract )
 a gr\p heal? plan or a heal? insurance 
issu] (f]+ gr\p or individual heal?     
insurance cov]age 7or its ag5t1 includ+ 
a ph>macy b5efits manag]7 describ$ 9    
p>agraph 7#a7 to disp5se su* anti-canc] 
oral m$ication to su* p>ticipant1 su*   
gr\p heal? plan or a heal? insurance    
issu] 7or its ag5t1 includ+ a ph>macy   
b5efits manag]7 %all cov] ! m$ication & 
pay ! provid] or ph>macy subject !      
foll[+ requirem5ts-- 7i7 su* m$ication w
 be provid] )\t impos+ any requirem5t "u
 ! plan = prior au?orization ( !        
m$ication or any limitation on cov]age t
 is m re/rictive ?an ! requirem5ts or   
limitations t apply to anti-canc] oral  
m$ications receiv$ f p>ticipat+ provid]s
 & ph>macies ) respect to su* plan2     
7ii7 ! co/-%>+ requirem5t 7express$ z a 
copaym5t am\nt or co9surance rate7 is n 
great] ?an ! requirem5t t w\ld apply if 
su* s]vices 7 provid$ by a p>ticipat+   

provid] or a p>ticipat+ ph>macy2  7iii7 
su* co/-%>+ requirem5t is calculat$ z if
 ! total am\nt t w\ld h be5 *>g$ = su*  
s]vices by su* p>ticipat+ provid] or    
p>ticipat+ ph>macy 7 equal to !         
recogniz$ am\nt 7z det]m9$ by !         
,secret>y7 = su* anti-canc] oral        
m$ications1 plan1 & ye>2  7iv7 ! gr\p   
heal? plan pays to su* provid] or       
ph>macy1 respectively1 ! am\nt by :i* ! 
recogniz$ am\nt = su* s]vices & ye>     
involv$ exce$s ! co/-%>+ am\nt = su*    
s]vices 7z det]m9$ 9 accordance )       
clauses 7ii7 & 7iii77 & ye>2  7v7 any   
co/-%>+ paym5ts made by ! p>ticipant or 
b5efici>y ) respect to su* anti-canc]   
oral m$ication s furni%$ %all be c\nt$  
t[>d any 9-network d$uctible or         
out-(-pocket maximums appli$ "u ! plan  
7& su* 9-network d$uctible &            
out-(-pocket maximums %all be appli$7 9 
! same mann] z if su* co/-%>+ paym5ts 7 
made ) respect to anti-canc] oral       
m$ication furni%$ by a p>ticipat+       
provid] or a p>ticipat+ ph>macy2 &  7vi7

 su* m$ication w be provid$ )\t reg>d to
 any o!r t]m or condition ( su* cov]age 
7o!r ?an exclusion or coord9ation (     
b5efits1 or an affiliation or wait+     
p]iod1 p]mitt$ "u section #bgjd ( ?is   
,act1 includ+ z incorporat$ pursuant to 
section #gae ( ! ,employee ,retirem5t   
,income ,security ,act ( #aigd & section
 #ihae ( ?is ,act1 & o!r ?an applicable 
co/-%>+74  7,c7 ,provid] or ph>macy     
describ$ ,a provid] or ph>macy describ$ 
9 ?is subp>agraph1 ) respect to a       
p>ticipant1 b5efici>y1 or enrollee ( a  
gr\p heal? plan or gr\p or individual   
heal? insurance cov]age describ$ 9      
p>agraph 7#a7 & a prescription = an     
anticanc] oral m$ication = su*          
p>ticipant1 b5efici>y or enrollee1 is a 
provid] or ph>macy t--  7i7 is lic5s$ by
 ! ,/ate 9 :i* su* provid] or ph>macy is
 locat$ to disp5se su* anti-canc] oral  
m$ication1 if su* a lic5se is requir$ by
 ! ,/ate2  7ii7 is ei!r locat$ )9 a     
reasonable di/ance 7z det]m9$ by !      
,secret>y7 ( ! resid5ce ( su*           

p>ticipant1 b5efici>y1 or enrollee1 or  
is able to deliv] su* anti-canc] oral   
m$ication to su* p>ticipant1 b5efici>y1 
or enrollee at su* resid5ce2 &  7iii7 is
 able to disp5se 7& if applicable1      
deliv]71 su* anti-canc] oral m$ication  
to su* p>ticipant1 b5efici>y1 or        
enrollee )9 #dh h\rs ( ! date on :i* x  
receives ! prescription4  ,= purposes ( 
?is section1 a provid] or ph>macy       
describ$ 9 ?is subp>agraph includes a   
physician or o!r heal? c>e practition]  
au?oriz$ to disp5se anti-canc] oral     
m$ication to su* p>ticipant1 b5efici>y1 
or enrollee pursuant to ! law ( ! ,/ate 
9 :i* ! physician or o!r heal? c>e      
practition] is locat$4  7,d7 ,prior     
au?orization requirem5ts ,9 ! case ( a  
gr\p heal? plan or a heal? insurance    
issu] (f]+ gr\p or individual heal?     
insurance cov]age t requires prior      
au?orization = an anti-canc] oral       
m$ication to be disp5s$ to a p>ticipant1
 b5efici>y1 or enrollee ( ! plan or     
cov]age1 su* plan or issu] 7or its ag5t 

1 includ+ a ph>macy b5efits manag]7 %all
 make a decision ) respect to a reque/ =
 su* a prior au?orization by n lat] ?an 
#gb h\rs aft] receiv+ su* reque/4 ,9 !  
case t su* plan or issu] 7or its ag5t1  
includ+ a ph>macy b5efits manag]7 does n
 make a decision ) respect to a reque/ =
 prior au?orization = an anticanc] oral 
m$ication to be disp5s$ to a p>ticipant1
 b5efici>y1 or enrollee ( ! plan or     
cov]age by ! #gb-;h\r deadl9e describ$ 9
 ! previ\s s5t5ce1 su* p>ticipant1      
b5efici>y or enrollee may select any    
ph>macy describ$ 9 subp>agraph 7,c7 to  
disp5se su* anticanc] oral m$ication to 
su* p>ticipant1 b5efici>y1 or enrollee1 
9 accordance ) ! co/-%>+ requirem5ts    
describ$ 9 subp>agraph 7,b7 b only if ! 
prescription = su* anti-canc] oral      
m$ication meets ! cl9ical guidel9es set 
=? by ! ,national ,compreh5sive ,canc]  
,network4  7#d7 ,anti-canc] oral        
m$ication def9$ ,9 ?is subsection1 ! t]m
 anti-canc] oral m$ication means a drug 
or biological 7z def9$ 9 section        

#ahfa7t7 ( ! ,social ,security ,act7 t  
is us$ 9 an anti-canc] *emo!rapeutic    
regim5 = a m$ically accept$ indication1 
includ+ any relat$ supportive c>e drugs 
& biologicals t are disp5s$ z an        
outpati5t & tak5 by ! m\?4  4  7b7      
,effective date ,! am5dm5ts made by ?is 
section %all apply ) respect to plan    
ye>s beg9n+ on or aft] ,janu>y #a1      
#bjbb4  7c7 ,,gao report &              
recomm5dations  7#a7 ,9 g5]al ,n lat]   
?an #b ye>s aft] ! date ( enactm5t ( ?is
 ,act1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all submit to ! ,*air & ,rank+  
,memb] ( ! ,committee on ,heal?1        
,education1 ,labor & ,p5sions ( ! ,s5ate
 & ! ,*air & ,rank+ ,memb] ( !          
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report on !   
effects ( ! implem5tation ( subsection  
7f7 ( section #bgai;,a ( ! ,public      
,heal? ,s]vice ,act 7z add$ by          
subsection 7a77 on ! timely access (    
pati5ts to anti-canc] oral m$ications 7z
 def9$ 9 subsection 7f77#d7 ( su*       

section71 toge!r ) su* recomm5dations z 
! ,comptroll] ,g5]al det]m9es are       
appropriate4  7#b7 ,items includ$ ,!    
report submitt$ "u p>agraph 7#a7 %all   
include--  7,a7 a comp>ison ( ! am\nt ( 
"t betwe5 ! date on :i* a prescription  
is writt5 & ! date on :i* a pati5t      
receives an anti-canc] oral m$ication   
be=e & aft] ! implem5tation ( subsection
 7f7 ( section #bgai;,a ( ! ,public     
,heal? ,s]vice ,act2  7,b7 an assessm5t 
( ! effects on pati5t heal? outcomes1   
includ+ morbidity & mortality2  7,c7 an 
evaluation ( co/s to pati5ts1 heal?     
insurance issu]s1 physicians1 & o!r     
heal?c>e provid]s2 &  7,d7 a risk       
assessm5t ) mitigation recomm5dations on
 any actual or pot5tial fraud1 wa/e &   
abuse relat+ to ! implem5tation ( su*   
subsection4