,,ii  #aad? ,,congress  #a/ ,session    
,s4 #aiac  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #cj1 #bjae ,mr4  
,toomey 7= himself1 ,mr4 ,br[n1 ,mr4    
,portman1 & ,mr4 ,ka9e7 introduc$ !     
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,f9ance  ,a ,,bill   
,to am5d title ,,xviii ( ! ,social      
,security ,act to e/abli% programs to   
prev5t prescription drug abuse "u !     
,m$ic>e program1 & = o!r purposes4  #a4 
,%ort title  ,?is ,act may be cit$ z !  
,/opp+ ,m$ication ,abuse & ,protect+    
,s5iors ,act ( #bjae4  #b4 ,programs to 
prev5t prescription drug abuse "u !     
,m$ic>e program  7a7 ,drug ,managem5t   
,program = ,at-,risk ,b5efici>ies  7#a7 
,9 g5]al ,section #ahfj;,d-#d7;c7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajd7;c77 is am5d$ by add+ at !  
end ! foll[+3  7#e7 ,drug managem5t     
program = at-risk b5efici>ies  7,a7     
,au?ority to e/abli% ,a ,,pdp sponsor   
may e/abli% a drug managem5t program =  
at-risk b5efici>ies "u :i*1 subject to  

subp>agraph 7,b71 ! ,,pdp sponsor may1 9
 ! case ( an at-risk b5efici>y =        
prescription drug abuse :o is an        
enrollee 9 a prescription drug plan (   
su* ,,pdp sponsor1 limit su* b5efici>y's
 access to cov]age = frequ5tly abus$    
drugs "u su* plan to frequ5tly abus$    
drugs t are prescrib$ = su* b5efici>y by
 a prescrib] 7or prescrib]s7 select$ "u 
subp>agraph 7,d71 & disp5s$ = su*       
b5efici>y by a ph>macy 7or ph>macies7   
select$ "u su* subp>agraph4  7,b7       
,requirem5t = notices  7i7 ,9 g5]al ,a  
,,pdp sponsor may n limit ! access ( an 
at-risk b5efici>y = prescription drug   
abuse to cov]age = frequ5tly abus$ drugs
 "u a prescription drug plan until su*  
sponsor--  7,i7 provides to ! b5efici>y 
an initial notice describ$ 9 clause 7ii7
 & a second notice describ$ 9 clause    
7iii72 &  7,,ii7 v]ifies ) ! provid]s ( 
! b5efici>y t ! b5efici>y is an at-risk 
b5efici>y = prescription drug abuse1 z  
describ$ 9 subp>agraph 7,c77iv74  7ii7  
,initial notice ,an initial writt5      

notice describ$ 9 ?is clause is a notice
 t provides to ! b5efici>y-- 7,i7 notice
 t ! ,,pdp sponsor has id5tifi$ !       
b5efici>y z pot5tially be+ an at-risk   
b5efici>y = prescription drug abuse2    
7,,ii7 in=mation1 :5 possible1 describ+ 
,/ate & ,f$]al public heal? res\rces t  
are design$ to address prescription drug
 abuse to :i* ! b5efici>y may h access1 
includ+ sub/ance use disord] treatm5t   
s]vices1 addiction treatm5t s]vices1    
m5tal heal? s]vices1 & o!r c\nsel+      
s]vices2  7,,iii7 a reque/ = ! b5efici>y
 to submit to ! ,,pdp sponsor pref]5ces 
= :i* prescrib]s & ph>macies ! b5efici>y
 w\ld pref] ! ,,pdp sponsor to select "u
 subp>agraph 7,d7 9 ! case t ! b5efici>y
 is id5tifi$ z an at-risk b5efici>y =   
prescription drug abuse z describ$ 9    
clause 7iii77,i72  7,,iv7 an explanation
 ( ! mean+ & consequ5ces ( !            
id5tification ( ! b5efici>y z pot5tially
 be+ an at-risk b5efici>y = prescription
 drug abuse1 includ+ an explanation ( ! 
drug managem5t program e/abli%$ by !    

,,pdp sponsor pursuant to subp>agraph   
7,a72  7,v7 cle> in/ructions t expla9 h[
 ! b5efici>y c contact ! ,,pdp sponsor 9
 ord] to submit to ! ,,pdp sponsor !    
pref]5ces describ$ 9 subclause 7,,iv7 & 
any o!r communications relat+ to ! drug 
managem5t program = at-risk b5efici>ies 
e/abli%$ by ! ,,pdp sponsor2  7,,vi7    
contact in=mation = o!r organizations t 
c provide ! b5efici>y ) in=mation reg>d+
 drug managem5t program = at-risk       
b5efici>ies 7simil> to ! in=mation      
provid$ by ! ,secret>y 9 o!r /&>diz$    
notices to "p ,d eligible individuals   
enroll$ 9 prescription drug plans "u ?is
 "p72 &  7,,vii7 notice t ! b5efici>y   
has a "r to an appeal pursuant to       
subp>agraph 7,e74  7iii7 ,second notice 
,a second writt5 notice describ$ 9 ?is  
clause is a notice t provides to !      
b5efici>y notice--  7,i7 t ! ,,pdp      
sponsor has id5tifi$ ! b5efici>y z an   
at-risk b5efici>y = prescription drug   
abuse2  7,,ii7 t su* b5efici>y has be5  
s5t1 or in=m$ (1 su* id5tification 9 !  

initial notice & is n[ subject to !     
requirem5ts ( ! drug managem5t program =
 at-risk b5efici>ies e/abli%$ by su*    
,,pdp sponsor = su* plan2  7,,iii7 ( !  
prescrib] & ph>macy select$ = su*       
individual "u subp>agraph 7,d72  7,,iv7 
(1 & in=mation ab\t1 ! "r ( ! b5efici>y 
to a reconsid]ation & an appeal "u      
subsection 7h7 ( su* id5tification & !  
prescrib]s & ph>macies select$2  7,v7 t 
! b5efici>y c1 9 ! case t ! b5efici>y   
has n previ\sly submitt$ to ! ,,pdp     
sponsor pref]5ces = :i* prescrib]s &    
ph>macies ! b5efici>y w\ld pref] ! ,,pdp
 sponsor select "u subp>agraph 7,d71    
submit su* pref]5ces to ! ,,pdp sponsor2
 &  7,,vi7 t includes cle> in/ructions t
 expla9 h[ ! b5efici>y c contact ! ,,pdp
 sponsor 9 ord] to submit to ! ,,pdp    
sponsor ! pref]5ces describ$ 9 subclause
 7,v74  7iv7 ,tim+ ( notices  7,i7 ,9   
g5]al ,subject to subclause 7,,ii71 a   
second writt5 notice describ$ 9 clause  
7iii7 %all be provid$ to ! b5efici>y on 
a date t is n less ?an #cj days aft] an 

initial notice describ$ 9 clause 7ii7 is
 provid$ to ! b5efici>y4  7,,ii7        
,exception ,9 ! case t ! ,,pdp sponsor1 
9 conjunction ) ! ,secret>y1 det]m9es t 
conc]ns id5tifi$ ?r\gh rulemak+ by !    
,secret>y reg>d+ ! heal? or safety ( !  
b5efici>y or reg>d+ significant drug    
div]sion activities require ! ,,pdp     
sponsor to provide a second notice      
describ$ 9 clause 7iii7 to ! b5efici>y  
on a date t is e>li] ?an ! date describ$
 9 subclause 7,,ii71 ! ,,pdp sponsor may
 provide su* second notice on su* e>li] 
date4  7,,iii7 ,=m ( notice ,! writt5   
notices "u clauses 7ii7 & 7iii7 %all be 
9 a =mat det]m9$ appropriate by !       
,secret>y1 tak+ into acc\nt b5efici>y   
pref]5ces4  7,c7 ,at-risk b5efici>y =   
prescription drug abuse  7i7 ,9 g5]al ,=
 purposes ( ?is p>agraph1 ! t]m at-risk 
b5efici>y = prescription drug abuse     
means a "p ,d eligible individual :o is 
n an exempt$ individual describ$ 9      
clause 7ii7 &-- 7,i7 :o is id5tifi$     
?r\gh crit]ia develop$ by ! ,secret>y 9 

consultation ) ,,pdp sponsors & o!r     
/akehold]s describ$ 9 subsection section
 #b7;g77#b77;,a7 ( ! ,/opp+ ,m$ication  
,abuse & ,protect+ ,s5iors ,act ( #bjae 
bas$ on cl9ical factors indicat+ misuse 
or abuse ( prescription drugs describ$ 9
 subp>agraph 7,g71 includ+ dosage1      
quantity1 duration ( use1 numb] (       
prescrib]s1 & numb] ( ph>macies us$ to  
obta9 su* drug2 or  7,,ii7 ) respect to 
:om ! ,,pdp sponsor ( a prescription    
drug plan1 ^u enroll+ su* individual 9  
su* plan1 receiv$ notice f ! ,secret>y t
 su* individual 0 id5tifi$ "u ?is       
p>agraph to be an at-risk b5efici>y =   
prescription drug abuse "u a            
prescription drug plan 9 :i* su*        
individual 0 previ\sly enroll$ & su*    
id5tification has n be5 t]m9at$ "u      
subp>agraph 7,f74  7ii7 ,exempt$        
individual describ$ ,an exempt$         
individual describ$ 9 ?is clause is an  
individual :o-- 7,i7 receives hospice   
c>e "u ?is title2  7,,ii7 resides 9 a   
long-t]m c>e facility1 a facility       

describ$ 9 section #aije7;d71 or o!r    
facility "u contract ) a s+le ph>macy2  
or  7,,iii7 ! ,secret>y elects to treat 
z an exempt$ individual = purposes (    
clause 7i74  7iii7 ,program size ,!     
,secret>y %all e/abli% policies1 includ+
 ! crit]ia develop$ "u clause 7i77,i7 & 
! exemptions "u clause 7ii77,,iii71 to  
ensure t ! population ( enrollees 9 a   
drug managem5t program = at-risk        
b5efici>ies op]at$ by a prescription    
drug plan c be effectively manag$ by su*
 plans4  7iv7 ,cl9ical contact ,)       
respect to ea* at-risk b5efici>y =      
prescription drug abuse enroll$ 9 a     
prescription drug plan (f]$ by a ,,pdp  
sponsor1 ! ,,pdp sponsor %all contact ! 
b5efici>y's physicians reg>d+ :e!r      
prescrib$ m$ications are appropriate =  
su* b5efici>y's m$ical conditions4  7,d7
 ,selection ( prescrib]s  7i7 ,9 g5]al  
,) respect to ea* at-risk b5efici>y =   
prescription drug abuse enroll$ 9 a     
prescription drug plan (f]$ by su*      
sponsor1 a ,,pdp sponsor %all1 bas$ on !

 pref]5ces submitt$ to ! ,,pdp sponsor  
by ! b5efici>y pursuant to clauses      
7ii77,,iii7 & 7iii77,v7 ( subp>agraph   
7,b7 if applicable1 select--  7,i7 "o1  
or1 if ! ,,pdp sponsor reasonably       
det]m9es x necess>y to provide !        
b5efici>y ) reasonable access "u clause 
7ii71 m ?an "o1 individual :o is        
au?oriz$ to prescribe frequ5tly abus$   
drugs 7ref]r$ to 9 ?is p>agraph z a     
prescrib]7 :o may write prescriptions = 
su* drugs = su* b5efici>y2 &  7,,ii7 "o1
 or1 if ! ,,pdp sponsor reasonably      
det]m9es x necess>y to provide !        
b5efici>y ) reasonable access "u clause 
7ii71 m ?an "o1 ph>macy t may disp5se   
su* drugs to su* b5efici>y4  7ii7       
,reasonable access ,9 mak+ ! selection  
"u ?is subp>agraph1 a ,,pdp sponsor %all
 ensure1 tak+ into acc\nt geographic    
location1 b5efici>y pref]5ce1 impact on 
co/-%>+1 & reasonable travel "t1 t !    
b5efici>y cont9ues to h reasonable      
access to drugs describ$ 9 subp>agraph  
7,g71 includ+--  7,i7 = individuals )   

multiple resid5ces2 &  7,,ii7 9 ! case (
 natural disa/]s & simil> em]g5cy       
situations4  7iii7 ,b5efici>y pref]5ces 
7,i7 ,9 g5]al ,if an at-risk b5efici>y =
 prescription drug abuse submits        
pref]5ces = :i* 9-network prescrib]s &  
ph>macies ! b5efici>y w\ld pref] ! ,,pdp
 sponsor select 9 response to a notice  
"u subp>agraph 7,b71 ! ,,pdp sponsor    
%all--  7aa7 review su* pref]5ces2  7bb7
 select or *ange ! selection ( a        
prescrib] or ph>macy = ! b5efici>y bas$ 
on su* pref]5ces2 &  7cc7 in=m !        
b5efici>y ( su* selection or *ange (    
selection4  7,,ii7 ,exception ,9 ! case 
t ! ,,pdp sponsor det]m9es t a *ange to 
! selection ( a prescrib] or ph>macy "u 
item 7bb7 by ! ,,pdp sponsor is         
contribut+ or w\ld contribute to        
prescription drug abuse or drug div]sion
 by ! b5efici>y1 ! ,,pdp sponsor may    
*ange ! selection ( a prescrib] or      
ph>macy = ! b5efici>y4 ,if ! ,,pdp      
sponsor *anges ! selection pursuant to !
 prec$+ s5t5ce1 ! ,,pdp sponsor %all    

provide ! b5efici>y )--  7aa7 at lea/   
#cj days writt5 notice ( ! *ange (      
selection2 &  7bb7 a rationale = !      
*ange4  7,,iii7 ,tim+ ,an at-risk       
b5efici>y = prescription drug abuse may 
*oose to express _! prescrib] & ph>macy 
pref]5ce at any date :ile enroll$ 9 !   
program1 includ+ aft] a second notice "u
 subp>agraph 7,b77iii7 has be5 provid$4 
7iv7 ,confirmation ,be=e select+ a      
prescrib] or ph>macy "u ?is subp>agraph1
 a ,,pdp sponsor mu/ notify ! prescrib] 
& ph>macy t ! b5efici>y involv$ has be5 
id5tifi$ = inclusion 9 ! drug managem5t 
program = at-risk b5efici>ies & t !     
prescrib] & ph>macy has be5 select$ z ! 
b5efici>y's designat$ prescrib] &       
ph>macy4  7,e7 ,appeals ,! id5tification
 ( an individual z an at-risk b5efici>y 
= prescription drug abuse "u ?is        
p>agraph1 a cov]age det]m9ation made "u 
a drug managem5t program = at-risk      
b5efici>ies1 & ! selection ( a prescrib]
 or ph>macy "u subp>agraph 7,d7 )       
respect to su* individual %all be       

subject to an exp$it$ reconsid]ation &  
appeal pursuant to subsection 7h74  7,f7
 ,t]m9ation ( id5tification  7i7 ,9     
g5]al ,! ,secret>y %all develop /&>ds = 
! t]m9ation ( id5tification ( an        
individual z an at-risk b5efici>y =     
prescription drug abuse "u ?is p>agraph4
 ,"u su* /&>ds su* id5tification %all   
t]m9ate z ( ! e>li] (--  7,i7 ! date !  
individual demon/rates t ! individual is
 no long] likely1 9 ! abs5ce ( !        
re/rictions "u ?is p>agraph1 to be an   
at-risk b5efici>y = prescription drug   
abuse describ$ 9 subp>agraph 7,c77i72 or
  7,,ii7 ! end ( su* maximum p]iod (    
id5tification z ! ,secret>y may specify4
  7ii7 ,rule ( con/ruction ,no?+ 9      
clause 7i7 %all be con/ru$ z prev5t+ a  
plan f id5tify+ an individual z an      
at-risk b5efici>y = prescription drug   
abuse "u subp>agraph 7,c77i7 aft] su*   
t]m9ation on ! basis ( additional       
in=mation on drug use occurr+ aft] !    
date ( notice ( su* t]m9ation4  7,g7    
,frequ5tly abus$ drug ,= purposes ( ?is 

subsection1 ! t]m frequ5tly abus$ drug  
means a drug t is det]m9$ by ! ,secret>y
 to be frequ5tly abus$ or div]t$ & t    
is--  7i7 a ,controll$ ,drug ,sub/ance 9
 ,s*$ule ,,cii2 or  7ii7 )9 ! same class
 or category ( drugs z a ,controll$     
,drug ,sub/ance 9 ,s*$ule ,,cii1 z      
det]m9$ ?r\gh notice & comm5t rulemak+4 
7,h7 ,data disclosure  7i7 ,data on     
decision to impose limitation ,9 ! case 
( an at-risk b5efici>y = prescription   
drug abuse 7or an individual :o is a    
pot5tially at-risk b5efici>y =          
prescription drug abuse7 ^: access to   
cov]age = frequ5tly abus$ drugs "u a    
prescription drug plan has be5 limit$ by
 a ,,pdp sponsor "u ?is p>agraph1 !     
,secret>y %all e/abli% rules & proc$ures
 to require su* ,,pdp sponsor to        
disclose data1 includ+ necess>y         
individually id5tifiable heal?          
in=mation1 ab\t ! decision to impose su*
 limitations & ! limitations impos$ by !
 ,,pdp sponsor "u ?is "p4  7ii7 ,data to
 r$uce fraud1 abuse1 & wa/e ,! ,secret>y

 %all e/abli% rules & proc$ures to      
require ,,pdp sponsors op]at+ a drug    
managem5t program = at-risk b5efici>ies 
"u ?is p>agraph to provide ! ,secret>y )
 su* data z ! ,secret>y det]m9es        
appropriate = purposes ( id5tify+       
patt]ns ( prescription drug utilization 
= plan enrollees t are outside normal   
patt]ns & t may indicate fraudul5t1     
m$ically unnecess>y1 or unsafe use4     
7,i7 ,%>+ ( in=mation = subsequ5t plan  
enrollm5ts ,! ,secret>y %all e/abli%    
proc$ures "u :i* ,,pdp sponsors :o (f]  
prescription drug plans %all %>e        
in=mation ) respect to individuals :o   
are at-risk b5efici>ies = prescription  
drug abuse 7or individuals :o are       
pot5tially at-risk b5efici>ies =        
prescription drug abuse7 & enroll$ 9 a  
prescription drug plan & :o subsequ5tly 
dis5roll f su* plan & enroll 9 ano!r    
prescription drug plan (f]$ by ano!r    
,,pdp sponsor4  7,j7 ,privacy issues    
,prior to ! implem5tation ( ! rules &   
proc$ures "u ?is p>agraph1 ! ,secret>y  

%all cl>ify privacy requirem5ts1 includ+
 requirem5ts "u ! regulations promulgat$
 pursuant to section #bfd7;c7 ( ! ,heal?
 ,insurance ,portability &              
,acc\ntability ,act ( #aiif 7#db        
,u4,s4,c4 #acbj;d-#b note71 relat$ to ! 
%>+ ( data "u subp>agraphs 7,h7 & 7,i7  
by ,,pdp sponsors4 ,su* cl>ification    
%all provide t ! %>+ ( su* data %all be 
consid]$ to be protect$ heal? in=mation 
9 accordance ) ! requirem5ts ( !        
regulations promulgat$ pursuant to su*  
section #bfd7;c74  7,k7 ,education ,!   
,secret>y %all provide education to     
enrollees 9 prescription drug plans (   
,,pdp sponsors & provid]s reg>d+ ! drug 
managem5t program = at-risk b5efici>ies 
describ$ 9 ?is p>agraph1 includ+        
education--  7i7 provid$ ?r\gh ! improp]
 paym5t outrea* & education program     
describ$ 9 section #ahgd;,a7h72 &  7ii7 
?r\gh curr5t education ef=ts 7su* z     
,/ate heal? insurance assi/ance programs
 describ$ 9 subsection 7a77#a77;,a7 (   
section #aai ( ! ,m$ic>e ,improvem5ts = 

,pati5ts & ,provid]s ,act ( #bjjh 7#db  
,u4,s4,c4 #acie;b-#c note77 & mat]ials  
direct$ t[>d su* enrollees4  7,l7 ,,cms 
compliance review ,! ,secret>y %all     
ensure t exi/+ plan sponsor compliance  
reviews & audit processes include ! drug
 managem5t programs = at-risk           
b5efici>ies "u ?is p>agraph1 includ+    
appeals processes "u su* programs4  4   
7#b7 ,in=mation = consum]s ,section     
#ahfj;,d-#d7;a77#a77;,b7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;a77#a77;,b77 is am5d$ by   
add+ at ! end ! foll[+3  7v7 ,! drug    
managem5t program = at-risk b5efici>ies 
"u subsection 7c77#e74  4  7#c7 ,dual   
eligibles ,section                      
#ahfj;,d-#a7;b77#c77;,d7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#aja7;b77#c77;,d77 is am5d$ by   
ins]t+ 1 subject to su* limits z !      
,secret>y may e/abli% = individuals     
id5tifi$ pursuant to section            
#ahfj;,d-#d7;c77#e7 aft] ! ,secret>y4   
7b7 ,utilization managem5t programs     

,section #ahfj;,d-#d7;c7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;c771 z am5d$ by subsection 
7a77#a71 is am5d$--  7#a7 9 p>agraph    
7#a71 by ins]t+ aft] subp>agraph 7,d7 ! 
foll[+ new subp>agraph3  7,e7 ,a        
utilization managem5t tool to prev5t    
drug abuse 7z describ$ 9 p>agraph       
7#e77;,a774  2 &  7#b7 by add+ at ! end 
! foll[+ new p>agraph3  7#f7            
,utilization managem5t tool to prev5t   
drug abuse  7,a7 ,9 g5]al ,a tool       
describ$ 9 ?is p>agraph is any ( !      
foll[+3  7i7 ,a utilization tool design$
 to prev5t ! abuse ( frequ5tly abus$    
drugs by individuals & to prev5t !      
div]sion ( su* drugs at ph>macies4  7ii7
 ,retrospective utilization review to   
id5tify-- 7,i7 individuals t receive    
frequ5tly abus$ drugs at a frequ5cy or 9
 am\nts t are n cl9ically appropriate2 &
  7,,ii7 provid]s ( s]vices or suppli]s 
t may facilitate ! abuse or div]sion (  
frequ5tly abus$ drugs by b5efici>ies4   
7iii7 ,consultation ) ! contractor      

describ$ 9 subp>agraph 7,b7 to v]ify if 
an individual enroll+ 9 a prescription  
drug plan (f]$ by a ,,pdp sponsor has   
be5 previ\sly id5tifi$ by ano!r ,,pdp   
sponsor z an individual describ$ 9      
clause 7ii77,i74  7,b7 ,report+ ,a ,,pdp
 sponsor (f]+ a prescription drug plan 9
 a ,/ate %all submit to ! ,secret>y & ! 
,m$ic>e drug integrity contractor ) :i* 
! ,secret>y has ent]$ into a contract "u
 section #ahic ) respect to su* ,/ate a 
report1 on a mon?ly basis1 conta9+      
in=mation on--  7i7 any provid] (       
s]vices or suppli] describ$ 9           
subp>agraph 7,a77ii77,,ii7 t is id5tifi$
 by su* plan sponsor dur+ ! #cj-;day    
p]iod be=e su* report is submitt$2 &    
7ii7 ! "n & prescription records (      
individuals describ$ 9 p>agraph         
7#e77;,c74  7,c7 ,,cms compliance review
 ,! ,secret>y %all ensure t plan sponsor
 annual compliance reviews & program    
audits include a c]tification t         
utilization managem5t tools "u ?is      
p>agraph are 9 compliance ) !           

requirem5ts = su* tools4  4  7c7        
,treatm5t ( c]ta9 compla9ts = purposes (
 quality or p]=mance assessm5t ,section 
#ahfj;,d-#db ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aeb7 is am5d$ by 
add+ at ! end ! foll[+ new subsection3  
7d7 ,treatm5t ( c]ta9 compla9ts =       
purposes ( quality or p]=mance assessm5t
 ,9 conduct+ a quality or p]=mance      
assessm5t ( a ,,pdp sponsor1 ! ,secret>y
 %all develop or utilize exi/+ scre5+   
me?ods = review+ & consid]+ compla9ts t 
are receiv$ f enrollees 9 a prescription
 drug plan (f]$ by su* ,,pdp sponsor & t
 are compla9ts reg>d+ ! lack ( access by
 ! individual to prescription drugs due 
to a drug managem5t program = at-risk   
b5efici>ies4  4  7d7 ,s5se ( ,congress  
reg>d+ use ( te*nology tools ,to combat 
fraud ,x is ! s5se ( ,congress t ,,ma   
organizations & ,,pdp sponsors %\ld     
consid] us+ e-prescrib+ & o!r heal?     
in=mation te*nology tools to support    
combat+ fraud "u ,,ma-,,pd plans &      
prescription drug plans "u p>ts ,c & ,d 

( ! ,m$ic>e ,program4  7e7 ,,gao /udy & 
report  7#a7 ,/udy ,! ,comptroll] ,g5]al
 ( ! ,unit$ ,/ates %all conduct a /udy  
on ! implem5tation ( ! am5dm5ts made by 
?is section1 includ+ ! effectiv5ess ( ! 
at-risk b5efici>ies = prescription drug 
abuse drug managem5t programs au?oriz$  
by section #ahfj;,d-#d7;c77#e7 ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aj7;c77#e771 z add$ by          
subsection 7a77#a74 ,su* /udy %all      
include an analysis (--  7,a7 !         
imp$im5ts1 if any1 t impair ! ability ( 
individuals describ$ 9 subp>agraph 7,c7 
( su* section #ahfj;,d-#d7;c77#e7 to    
access cl9ically appropriate levels (   
prescription drugs2  7,b7 ! types (--   
7i7 individuals :o1 9 ! implem5tation ( 
su* section1 are det]m9$ to be          
individuals describ$ 9 su* subp>agraph2 
&  7ii7 prescrib]s & ph>macies t are    
select$ "u subp>agraph 7,d7 ( su*       
section2  7,c7 ! ext5t ( prescription   
drug abuse beyond ,controll$ ,drug      
,sub/ances 9 ,s*$ule ,,cii 9 p>ts ,c &  

,d ( ! ,m$ic>e program2 &  7,d7 o!r     
areas det]m9$ appropriate by !          
,comptroll] ,g5]al4  7#b7 ,report ,n    
lat] ?an ,july #a1 #bjai1 ! ,comptroll] 
,g5]al ( ! ,unit$ ,/ates %all submit to 
! appropriate committees ( jurisdiction 
( ,congress a report on ! /udy conduct$ 
"u p>agraph 7#a71 toge!r )              
recomm5dations = su* legislation &      
adm9i/rative action z ! ,comptroll]     
,g5]al det]m9es to be appropriate4  7f7 
,report by ,secret>y  7#a7 ,9 g5]al ,n  
lat] ?an #ab mon?s aft] ! date ( !      
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all submit to 
! appropriate committees ( jurisdiction 
( ,congress a report on ways to improve 
^u ! appeals process = ,m$ic>e          
b5efici>ies ) respect to prescription   
drug cov]age "u "p ,d ( title ,,xviii ( 
! ,social ,security ,act4 ,su* report   
%all include an analysis comp>+ appeals 
processes "u p>ts ,c & ,d ( su* title   
,,xviii4  7#b7 ,fe$back ,9 developm5t ( 
! report describ$ 9 p>agraph 7#a71 !    

,secret>y ( ,heal? & ,human ,s]vices    
%all solicit fe$back on ! curr5t appeals
 process f /akehold]s1 su* z            
b5efici>ies1 consum] advocates1 plan    
sponsors1 ph>macy b5efit manag]s1       
ph>maci/s1 provid]s1 indep5d5t review   
entity evaluators1 & ph>maceutical      
manufactur]s4  7g7 ,effective date  7#a7
 ,9 g5]al ,except z provid$ 9 subsection
 7d77#b71 ! am5dm5ts made by ?is section
 %all apply to prescription drug plans =
 plan ye>s beg9n+ on or aft] ,janu>y #a1
 #bjah4  7#b7 ,/akehold] meet+s prior to
 effective date  7,a7 ,9 g5]al ,n lat]  
?an ,janu>y #a1 #bjag1 ! ,secret>y (    
,heal? & ,human ,s]vices %all conv5e    
/akehold]s1 includ+ individuals entitl$ 
to b5efits "u "p ,a ( title ,,xviii ( ! 
,social ,security ,act or enroll$ "u "p 
,b ( su* title ( su* ,act1 advocacy     
gr\ps repres5t+ su* individuals1        
cl9icians1 plan sponsors1 ph>maci/s1    
retail ph>macies1 entities delegat$ by  
plan sponsors1 & bioph>maceutical       
manufactur]s = input reg>d+ ! topics    

describ$ 9 subp>agraph 7,b74  7,b7      
,topics describ$ ,! topics describ$ 9   
?is subp>agraph are ! topics (-- 7i7 !  
impact on co/-%>+ & ensur+ accessibility
 to prescription drugs = enrollees 9    
prescription drug plans ( ,,pdp sponsors
 :o are at-risk b5efici>ies =           
prescription drug abuse 7z def9$ 9      
p>agraph 7#e77;,c7 ( section            
#ahfj;,d-#d7;c7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#aj7;c7772   
7ii7 ! use ( an exp$it$ appeals process 
"u :i* su* an enrollee may appeal an    
id5tification ( su* enrollee z an       
at-risk b5efici>y = prescription drug   
abuse "u su* p>agraph 7simil> to !      
processes e/abli%$ "u ! ,m$ic>e         
,advantage program "u "p ,c ( title     
,,xviii ( ! ,social ,security ,act72    
7iii7 ! types ( enrollees t %\ld be     
treat$ z exempt$ individuals1 z describ$
 9 clause 7ii7 ( su* p>agraph2  7iv7 !  
mann] 9 :i* t]ms & def9itions 9 p>agraph
 7#e7 ( su* section #ahfj;,d-#d7;c7 %\ld
 be appli$1 su* z ! use ( cl9ical       

appropriat5ess 9 det]m9+ :e!r an        
enrollee is an at-risk b5efici>y =      
prescription drug abuse z def9$ 9       
subp>agraph 7,c7 ( su* p>agraph 7#e72   
7v7 ! in=mation to be includ$ 9 !       
notices describ$ 9 subp>agraph 7,b7 (   
su* section & ! /&>dization ( su*       
notices2  7vi7 ) respect to a ,,pdp     
sponsor t e/abli%es a drug managem5t    
program = at-risk b5efici>ies "u su*    
p>agraph 7#e71 ! responsibilities ( su* 
,,pdp sponsor ) respect to !            
implem5tation ( su* program2  7vii7     
notices = plan enrollees at ! po9t (    
sale t w\ld expla9 :y an at-risk        
b5efici>y has be5 prohibit$ f receiv+ a 
prescription at a location outside ( !  
designat$ ph>macy2 &  7viii7            
evid5ce-bas$ prescrib+ guidel9es =      
opiates4  7,c7 ,rulemak+ ,! ,secret>y ( 
,heal? & ,human ,s]vices %all1 tak+ into
 acc\nt ! input ga!r$ pursuant to       
subp>agraph 7,a7 & aft] provid+ notice &
 an opportunity to comm5t1 promulgate   
regulations to c>ry out ! provisions (1 

& am5dm5ts made by subsections 7a7 &    
7b74