,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #djaa  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #ab1 #bjbc,mr4  
,bilirakis 7= himself & ,ms4 ,sewell7   
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 oral m$ications1 & =   
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,timely ,access to     
,cl9ical ,treatm5t ,act ( #bjbc or !    
,,tact ,act ( #bjbc 4  #b4 ,pati5t      
access to 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 oral m$ications  7#a7 ,requirem5ts = 
contracts betwe5 gr\p heal? plans or    
heal? insurance issu]s & ph>macies ,if a
 gr\p heal? plan or a heal? insurance   
issu] (f]+ gr\p or individual heal?     
insurance cov]age cov]s or provides any 
b5efits = oral m$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 b5efits manag]7 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 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] z well z su* plan 
or issu] :e!r su* ph>macy w disp5se su* 
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  
b5efits manag]7 prior to au?oriz+ !     
ph>macy to disp5se ! m$ication4  7,b7   
,ph>macy able to fill prescription ,9 ! 
case t su* ph>macy in=ms su* heal? c>e  
provid] "u subp>agraph 7,a77ii7 t su*   
ph>macy is able to disp5se su* oral     
m$ication to su* p>ticipant1 b5efici>y1 
or enrollee by ! #gb-;h\r deadl9e       
describ$ 9 su* subp>agraph1 disp5se su* 
oral m$ication to su* p>ticipant1       
b5efici>y1 or enrollee by su* deadl9e4  
7,c7 ,ph>macy unable to fill            
prescription ,9 ! case t su* ph>macy    
in=ms su* heal? c>e provid] "u          
subp>agraph 7,a77ii7 t su* ph>macy is n 
able to disp5se su* oral m$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 enrollee1  ) a cle> &     
und]/&able explanation ( su* inability &
 ( ! option ( su* p>ticipant1 b5efici>y1
 or enrollee to be disp5s$ su* oral     
m$ication f any provid] or ph>macy      
describ$ 9 subp>agraph 7,c7 ( p>agraph  
7#c71 9 accordance ) ! 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 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 & a heal?  
c>e provid] :o submits to su* ph>macy a 
prescription = an oral m$ication = su*  
p>ticipant1 b5efici>y1 or enrollee1     
in=ms su* heal? c>e provid] "u          
subp>agraph 7,a77ii7 ( su* p>agraph t   
su* ph>macy w n disp5se su* oral        
m$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$ ! 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* oral    
m$ication to su* p>ticipant1 b5efici>y1 
or enrollee bas$ on ! writt5 notice     
describ$ 9 p>agraph 7#b77;,c7 or a      
c]tification by a ! prescrib+ physician 
or o!r heal? pr(essional t ! p>ticipant1
 b5efici>y1 or enrollee has n receiv$ ! 
oral m$ication by ! #gb-;h\r deadl9e2 & 
7ii7 9 ! case t ! provid] or ph>macy    
select$ "u clause 7i7 does n h a        
contract ) su* plan or issu] to disp5se 
su* oral m$ication to su* p>ticipant1   
gr\p heal? plan or a heal? insurance    
issu] (f]+ gr\p or individual heal?     
insurance cov]age describ$ 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* 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 to ! foll[+  
requirem5ts-- 7i7 su* m$ication w be    
provid$ )\t impos+ any requirem5t "u !  
plan = prior au?orization ( ! m$ication 
or any limitation on cov]age t is m     
re/rictive ?an ! requirem5ts or         
limitations t apply to oral m$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* 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*
 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$7 9 
! same mann] z if su* co/-%>+ paym5ts 7 
made ) respect to oral m$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 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* 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* oral
 m$ication to su* p>ticipant1 b5efici>y1
 or enrollee at su* resid5ce2 &  7iii7  
is able to disp5se 7& if applicable1    
deliv]71 su* oral m$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 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$4  7,d7 ,prior au?orization    
requirem5ts ,9 ! case ( a gr\p heal?    
plan or a heal? insurance issu] (f]+    
gr\p or individual heal? insurance      
cov]age t requires prior au?orization = 
an oral m$ication to be disp5s$ to a    
p>ticipant1 b5efici>y1 or enrollee ( !  
plan or cov]age1 su* plan or issu] 7or  
its ag5t1 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  
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* oral    
m$ication to su* p>ticipant1 b5efici>y1 
or enrollee1 9 accordance ) ! co/-%>+   
requirem5ts describ$ 9 subp>agraph 7,b74
  7,e7 ,use ( relevant quality measures 
"u inc5tive paym5t & adju/m5t sy/ems ,if
 a gr\p heal? plan or a heal? insurance 
issu] (f]+ gr\p or individual heal?     
insurance cov]age uses an inc5tive      
paym5t & adju/m5t sy/em 7z def9$ by !   
,secret>y7 9 det]m9+ ph>macy            
reimbursem5t paym5ts = oral m$ications1 
su* sy/em %all only use quality measures
 t are relevant to ! p]=mance ( su*     
ph>macy ) respect to areas t ! ph>macy c
 impact bas$ on ! oral m$ications       
disp5s$ & manag$ by ! ph>macy4  7#d7    
,oral m$ication def9$ ,9 ?is subsection1
 ! t]m oral m$ication means a drug or   
biological 7z def9$ 9 section #ahfa7t7 (

 ! ,social ,security ,act7 t is us$ = a 
m$ically accept$ indication t is disp5s$
 z an outpati5t & tak5 by m\?4  4  7b7  
,con=m+ am5dm5t ,section #bgai;,a7e7 ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #cjj;gg-#ai;a7e77 is am5d$ by 
ins]t+ 7o!r ?an subsection 7f77 aft] ,! 
provisions ( ?is section4  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 ,labor1 &        
,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 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 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  7d7 ,effective date ,!     
am5dm5ts made by ?is section %all apply 
) respect to plan ye>s beg9n+ on or aft]
 ,janu>y #a1 #bjbd4