,,ii  #aai? ,,congress  #a/ ,session    
,s4 #hhb  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #f1 #bjbe,mrs4    
,blackburn 7= h]self1 ,ms4 ,hassan1 ,mr4
 ,lank=d1 ,mr4 ,w>n]1 ,mr4 ,m>%all1 &   
,mr4 ,wel*7 introduc$ ! foll[+ bill2 :i*
 0 read twice & ref]r$ to ! ,committee  
on ,f9ance  ,a ,,bill  ,to am5d title   
,,xviii ( ! ,social ,security ,act to   
assure ph>macy access & *oice =         
b5efici>ies "u prescription drug plans &
 ,,ma-,,pd plans & to e/abli%           
requirem5ts ( ph>macy b5efit manag]s "u 
,m$ic>e "p ,d4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,pati5ts ,be=e     
,middlem5 ,act4  #b4 ,assur+ ph>macy    
access & *oice = ,m$ic>e b5efici>ies    
7a7 ,9 g5]al ,section                   
#ahfj;,d-#d7;b77#a7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;b77#a77 is am5d$ by /rik+  
subp>agraph 7,a7 & ins]t+ ! foll[+3     
7,a7 ,9 g5]al  7i7 ,p>ticipation ( any  
will+ ph>macy ,a ,,pdp sponsor (f]+ a   
prescription drug plan %all p]mit any   

ph>macy t meets ! /&>d contract t]ms &  
conditions "u su* plan to p>ticipate z a
 network ph>macy ( su* plan4  7ii7      
,contract t]ms & conditions  7,i7 ,9    
g5]al ,not)/&+ any o!r provision ( law1 
= plan ye>s beg9n+ on or aft] ,janu>y   
#a1 #bjbh1 9 accordance ) clause 7i71   
contract t]ms & conditions (f]$ by su*  
,,pdp sponsor %all be reasonable &      
relevant accord+ to /&>ds e/abli%$ by ! 
,secret>y "u subclause 7,,ii74  7,,ii7  
,/&>ds ,n lat] ?an ! fir/ ,monday 9     
,april ( #bjbg1 ! ,secret>y %all e/abli%
 /&>ds = reasonable & relevant contract 
t]ms & conditions = purposes ( ?is      
clause4  7,,iii7 ,reque/ = in=mation ,n 
lat] ?an ,april #a1 #bjbf1 = purposes ( 
e/abli%+ ! /&>ds "u subclause 7,,ii71 ! 
,secret>y %all issue a reque/ =         
in=mation to seek input on tr5ds 9      
prescription drug plan & network ph>macy
 contract t]ms & conditions1 curr5t     
prescription drug plan & network ph>macy
 contract+ practices1 :e!r ph>macy      
reimbursem5t & disp5s+ fees paid by     

,,pdp sponsors to network ph>macies     
suffici5tly cov] ! +r$i5t & op]ational  
co/s ( su* ph>macies1 ! use &           
application ( ph>macy quality measures  
by ,,pdp sponsors = network ph>macies1  
,,pdp sponsor re/rictions or limitations
 on ! disp5s+ ( cov]$ "p ,d drugs by    
network ph>macies 7or any subsets ( su* 
ph>macies71 ,,pdp sponsor audit+        
practices = network ph>macies1 areas 9  
curr5t regulations or program guidance  
relat$ to contract+ betwe5 prescription 
drug plans & network ph>macies requir+  
cl>ification or additional specificity1 
factors = consid]ation 9 det]m9+ !      
reasonabl5ess & relevance ( contract    
t]ms & conditions betwe5 prescription   
drug plans & network ph>macies1 & o!r   
issues z det]m9$ appropriate by !       
,secret>y4  4  7b7 ,ess5tial retail     
ph>macies ,section #ahfj;,d-#db ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aeb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7e7 ,ess5tial  
retail ph>macies  7#a7 ,9 g5]al ,)      

respect to plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbh1 ! ,secret>y %all     
publi% reports1 at lea/ once e #b ye>s  
until #bjcd1 & p]iodically !reaft]1 t   
provide in=mation1 to ! ext5t feasible1 
on-- 7,a7 tr5ds 9 +r$i5t co/            
reimbursem5t1 disp5s+ fees1 inc5tive    
paym5ts & o!r fees paid by ,,pdp        
sponsors (f]+ prescription drug plans & 
,,ma organizations (f]+ ,,ma-,,pd plans 
"u ?is "p to ess5tial retail ph>macies  
7z def9$ 9 p>agraph 7#b77 ) respect to !
 disp5s+ ( cov]$ "p ,d drugs1 includ+ a 
comp>ison ( su* tr5ds betwe5 ess5tial   
retail ph>macies & ph>macies t are n    
ess5tial retail ph>macies2  7,b7 tr5ds 9
 am\nts paid to ,,pdp sponsors (f]+     
prescription drug plans & ,,ma          
organizations (f]+ ,,ma-,,pd plans "u   
?is "p by ess5tial retail ph>macies )   
respect to ! disp5s+ ( cov]$ "p ,d      
drugs1 includ+ a comp>ison ( su* tr5ds  
betwe5 ess5tial retail ph>macies &      
ph>macies t are n ess5tial retail       
ph>macies2  7,c7 tr5ds 9 ess5tial retail

 ph>macy p>ticipation 9 ph>macy networks
 & pref]r$ ph>macy networks =           
prescription drug plans (f]$ by ,,pdp   
sponsors & ,,ma-,,pd plans (f]$ by ,,ma 
organizations "u ?is "p1 includ+ a      
comp>ison ( su* tr5ds betwe5 ess5tial   
retail ph>macies & ph>macies t are n    
ess5tial retail ph>macies2  7,d7 tr5ds 9
 ! numb] ( ess5tial retail ph>macies1   
includ+ v>iation 9 su* tr5ds by         
geographic region or o!r factors2  7,e7 
a comp>ison ( co/-%>+ = cov]$ "p ,d     
drugs disp5s$ by ess5tial retail        
ph>macies t are network ph>macies =     
prescription drug plans (f]$ by ,,pdp   
sponsors & ,,ma-,,pd plans (f]$ by ,,ma 
organizations "u ?is "p & co/-%>+ =     
cov]$ "p ,d drugs disp5s$ by o!r network
 ph>macies = su* plans locat$ 9 simil>  
geographic areas t are n ess5tial retail
 ph>macies2  7,f7 a comp>ison ( ! volume
 ( cov]$ "p ,d drugs disp5s$ by ess5tial
 retail ph>macies t are network         
ph>macies = prescription drug plans (f]$
 by ,,pdp sponsors & ,,ma-,,pd plans    

(f]$ by ,,ma organizations "u ?is "p &  
su* volume ( disp5s+ by network         
ph>macies = su* plans locat$ 9 simil>   
geographic areas t are n ess5tial retail
 ph>macies1 includ+ in=mation on any    
patt]ns or tr5ds 9 su* comp>ison        
specific to c]ta9 types ( cov]$ "p ,d   
drugs1 su* z g5]ic drugs or drugs       
specifi$ z specialty drugs by a ,,pdp   
sponsor "u a prescription drug plan or  
an ,,ma organization "u an ,,ma-,,pd    
plan2 &  7,g7 a comp>ison ( ! in=mation 
describ$ 9 subp>agraphs 7,a7 ?r\gh 7,f7 
betwe5 ess5tial retail ph>macies t are  
network ph>macies = prescription drug   
plans (f]$ by ,,pdp sponsors "u ?is "p &
 ess5tial retail ph>macies t are network
 ph>macies = ,,ma-,,pd plans (f]$ by    
,,ma organizations "u ?is "p4  7#b7     
,def9ition ( ess5tial retail ph>macy ,9 
?is subsection1 ! t]m ess5tial retail   
ph>macy means1 ) respect to a plan ye>1 
a retail ph>macy t-- 7,a7 is n a ph>macy
 t is an affiliate z def9$ 9 p>agraph   
7#d72 &  7,b7 is locat$ 9-- 7i7 a       

m$ically und]s]v$ area 7z designat$     
pursuant to section #ccj7;b77#c77;,a7 ( 
! ,public ,heal? ,s]vice ,act72  7ii7 a 
rural area 9 :i* !re is no o!r retail   
ph>macy )9 #aj miles1 z det]m9$ by !    
,secret>y2  7iii7 a suburban area 9 :i* 
!re is no o!r retail ph>macy )9 #b      
miles1 z det]m9$ by ! ,secret>y2 or     
7iv7 an urban area 9 :i* !re is no o!r  
retail ph>macy )9 #a mile1 z det]m9$ by 
! ,secret>y4  7#c7 ,li/ ( ess5tial      
retail ph>macies  7,a7 ,publication (   
li/ ( ess5tial retail ph>macies ,= ea*  
plan ye> 7beg9n+ ) plan ye> #bjbh71 !   
,secret>y %all publi%1 on a publicly    
available int]net website ( ! ,c5t]s =  
,m$ic>e  ,m$icaid ,s]vices1 a li/ (     
ph>macies t meet ! crit]ia describ$ 9   
subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#b7
 to be consid]$ an ess5tial retail      
ph>macy4  7,b7 ,requir$ submissions f   
pdp sponsors ,= ea* plan ye> 7beg9n+ )  
plan ye> #bjbh71 ea* ,,pdp sponsor (f]+ 
a prescription drug plan & ea* ,,ma     
organization (f]+ an ,,ma-,,pd plan %all

 submit to ! ,secret>y1 = ! purposes (  
det]m9+ retail ph>macies t meet !       
crit]ion specifi$ 9 subp>agraph 7,a7 (  
p>agraph 7#b71 a li/ ( retail ph>macies 
t are affiliates ( su* sponsor or       
organization1 or are affiliates ( a     
ph>macy b5efit manag] act+ on behalf (  
su* sponsor or organization1 at a "t1 & 
9 a =m & mann]1 specifi$ by ! ,secret>y4
  7,c7 ,report+ by pdp sponsors & ma    
organizations ,= ea* plan ye> beg9n+ )  
plan ye> #bjbg1 ea* ,,pdp sponsor (f]+ a
 prescription drug plan & ea* ,,ma      
organization (f]+ an ,,ma-,,pd plan "u  
?is "p %all submit to ! ,secret>y       
in=mation on inc5tive paym5ts & o!r fees
 paid by su* sponsor or organization to 
ph>macies1 ins(> z any su* paym5ts or   
fees are n o!rwise report$1 at a "t1 & 9
 a =m & mann]1 specifi$ by ! ,secret>y4 
7,d7 ,implem5tation ,not)/&+ any o!r    
provision ( law1 ! ,secret>y may        
implem5t ?is p>agraph by program        
in/ruction or o!rwise4  7,e7            
,nonapplication ( pap]work r$uction act 

,*apt] #ce ( title #dd1 ,unit$ ,/ates   
,code1 %all n apply to ! implem5tation (
 ?is p>agraph4  7#d7 ,def9ition (       
affiliate ,9 ?is subsection1 ! t]m      
affiliate means any entity t is own$ by1
 controll$ by1 or relat$ "u a common    
own]%ip /ructure ) a ph>macy b5efit     
manag] or a manag$ c>e entity or o!r    
specifi$ entity 7z su* t]ms are def9$ 9 
section #aijc7m77#i77;,d774  4  7c7     
,en=cem5t  7#a7 ,9 g5]al ,section       
#ahfj;,d-#d7;b77#a7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;b77#a77 is am5d$ by add+ at
 ! end ! foll[+ new subp>agraph3  7,f7  
,en=cem5t ( /&>ds = reasonable &        
relevant contract t]ms & conditions  7i7
 ,allegation submission process  7,i7 ,9
 g5]al ,n lat] ?an ,janu>y #a1 #bjbh1 ! 
,secret>y %all e/abli% a process ?r\gh  
:i* a ph>macy may submit to ! ,secret>y 
an allegation ( a violation by a ,,pdp  
sponsor (f]+ a prescription drug plan ( 
! /&>ds = reasonable & relevant contract
 t]ms & conditions "u subp>agraph       

7,a77ii71 or ( subclause 7,,viii7 ( ?is 
clause4  7,,ii7 ,frequ5cy ( submission  
7aa7 ,9 g5]al ,except z provid$ 9 item  
7bb71 ! allegation submission process "u
 ?is clause %all all[ ph>macies to      
submit any allegations ( violations     
describ$ 9 subclause 7,i7 n m frequ5tly 
?an once p] plan ye> p] contract betwe5 
a ph>macy & a ,,pdp sponsor4  7bb7      
,allegations relat+ to contract         
modifications ,9 ! case :]e a contract  
betwe5 a ph>macy & a ,,pdp sponsor is   
modifi$ foll[+ ! submission (           
allegations by a ph>macy ) respect to   
su* contract & plan ye>1 ! allegation   
submission process "u ?is clause %all   
all[ su* ph>macy to submit an additional
 allegation relat$ to ^? modifications )
 respect to su* contract & plan ye>4    
7,,iii7 ,access to relevant docum5ts &  
mat]ials ,a ,,pdp sponsor subject to an 
allegation "u ?is clause-- 7aa7 %all    
provide docum5ts or mat]ials1 z specifi$
 by ! ,secret>y1 includ+ contract (f]s  
made by su* sponsor to su* ph>macy or   

correspond5ce relat$ to su* (f]s1 to !  
,secret>y at a "t1 & 9 a =m & mann]1    
specifi$ by ! ,secret>y2 &  7bb7 %all n 
prohibit or o!rwise limit ! ability ( a 
ph>macy to submit su* docum5ts or       
mat]ials to ! ,secret>y = ! purpose (   
submitt+ an allegation or provid+       
evid5ce = su* an allegation "u ?is      
clause4  7,,iv7 ,/&>diz$ template ,!    
,secret>y %all e/abli% a /&>diz$        
template = ph>macies to use = !         
submission ( allegations describ$ 9     
subclause 7,i74 ,su* template %all      
require t ! submission include a        
c]tification by ! ph>macy t ! in=mation 
includ$ is accurate1 complete1 & true to
 ! be/ ( ! k1 in=mation1 & belief ( su* 
ph>macy4  7,v7 ,prev5t+ frivol\s        
allegations ,9 ! case :]e ! ,secret>y   
det]m9es t a ph>macy has submitt$       
frivol\s allegations "u ?is clause on a 
r\t9e basis1 ! ,secret>y may tempor>ily 
prohibit su* ph>macy f us+ ! allegation 
submission process "u ?is clause1 z     
det]m9$ appropriate by ! ,secret>y4     

7,,vi7 ,exemption f fre$om ( in=mation  
act ,allegations submitt$ "u ?is clause 
%all be exempt f disclosure "u section  
#eeb ( title #e1 ,unit$ ,/ates ,code4   
7,,vii7 ,rule ( con/ruction ,no?+ 9 ?is 
clause %all be con/ru$ z limit+ !       
ability ( a ph>macy to pursue o!r legal 
actions or rem$ies1 consi/5t )          
applicable ,f$]al or ,/ate law1 )       
respect to a pot5tial violation ( a     
requirem5t describ$ 9 ?is subp>agraph4  
7,,viii7 ,anti-retaliation &            
anti-co]cion ,consi/5t ) applicable     
,f$]al or ,/ate law1 a ,,pdp sponsor    
%all n-- 7aa7 retaliate aga9/ a ph>macy 
= submitt+ any allegations "u ?is       
clause2 or  7bb7 co]ce1 intimidate1     
?reat51 or int]f]e ) ! ability ( a      
ph>macy to submit any su* allegations4  
7ii7 ,inve/igation ,! ,secret>y %all    
inve/igate1 z det]m9$ appropriate by !  
,secret>y1 allegations submitt$ pursuant
 to clause 7i74  7iii7 ,en=cem5t  7,i7  
,9 g5]al ,9 ! case :]e ! ,secret>y      
det]m9es t a ,,pdp sponsor (f]+ a       

prescription drug plan has violat$ !    
/&>ds = reasonable & relevant contract  
t]ms & conditions "u subp>agraph        
7,a77ii71 ! ,secret>y may use au?orities
 "u sections #aheg7;g7 &                
#ahfj;,d-#ab7;b77#c77;,e7 to impose     
civil monet>y p5alties or o!r int]m$iate
 sanctions4  7,,ii7 ,application ( civil
 monet>y p5alties ,! provisions (       
section #aabh;,a 7o!r ?an subsections   
7a7 & 7b77 %all apply to a civil monet>y
 p5alty "u ?is clause 9 ! same mann] z  
su* provisions apply to a p5alty or     
proce$+ "u section #aabh;,a7a74  4  7#b7
 ,con=m+ am5dm5t ,section #aheg7;g77#a7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#bg7;g77#a77 is am5d$--
 7,a7 9 subp>agraph 7,j71 by /rik+ or   
aft] ! semicolon2  7,b7 by r$esignat+   
subp>agraph 7,k7 z subp>agraph 7,l72    
7,c7 by ins]t+ aft] subp>agraph 7,j71 ! 
foll[+ new subp>agraph3  7,k7 fails to  
comply ) ! /&>ds = reasonable & relevant
 contract t]ms & conditions "u          
subp>agraph 7,a77ii7 ( section          

#ahfj;,d-#d7;b77#a72 or  2  7,d7 9      
subp>agraph 7,l71 z r$esignat$ by       
subp>agraph 7,b71 by /rik+ ?r\gh 7,j7 & 
ins]t+ ?r\gh 7,k72 &  7,e7 9 ! flu%     
matt] foll[+ subp>agraph 7,l71 z s      
r$esignat$1 by /rik+ subp>agraphs 7,a7  
?r\gh 7,k7 & ins]t+ subp>agraphs 7,a7   
?r\gh 7,l74  7d7 ,acc\ntability (       
ph>macy b5efit manag]s = violations (   
reasonable & relevant contract t]ms &   
conditions  7#a7 ,9 g5]al ,section      
#ahfj;,d-#ab7;b7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #aciew-#aab7 is     
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#i7 ,acc\ntability ( ph>macy
 b5efit manag]s = violations (          
reasonable & relevant contract t]ms &   
conditions ,= plan ye>s beg9n+ on or    
aft] ,janu>y #a1 #bjbh1 ea* contract    
ent]$ into ) a ,,pdp sponsor "u ?is "p )
 respect to a prescription drug plan    
(f]$ by su* sponsor %all provide t any  
ph>macy b5efit manag] act+ on behalf (  
su* sponsor has a writt5 agreem5t ) !   
,,pdp sponsor "u :i* ! ph>macy b5efit   

manag] agrees to reimburse ! ,,pdp      
sponsor = any am\nts paid by su* sponsor
 "u section                             
#ahfj;,d-#d7;b77#a77;,f77iii77,i7 to !  
,secret>y z a result ( a violation      
describ$ 9 su* section if su* violation 
is relat$ to a responsibility delegat$  
to ! ph>macy b5efit manag] by su* ,,pdp 
sponsor4  4  7#b7 ,,ma-,,pd plans       
,section #aheg7;f77#c7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#bg7;f77#c77 is am5d$ by add+ at 
! end ! foll[+ new subp>agraph3  7,f7   
,acc\ntability ( ph>macy b5efit manag]s 
= violations ( reasonable & relevant    
contract t]ms ,= plan ye>s beg9n+ on or 
aft] ,janu>y #a1 #bjbh1 section         
#ahfj;,d-#ab7;b77#i74  4  7e7 ,bi5nial  
report on en=cem5t & ov]sight ( ph>macy 
access requirem5ts ,section #ahfj;,d-#db
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciew-#aeb71 z am5d$ by      
subsection 7b71 is am5d$ by add+ at !   
end ! foll[+ new subsection3  7f7       
,bi5nial report on en=cem5t & ov]sight (

 ph>macy access requirem5ts  7#a7 ,9    
g5]al ,n lat] ?an #b ye>s aft] ! date ( 
enactm5t ( ?is subsection1 & at lea/    
once e #b ye>s !reaft]1 ! ,secret>y %all
 publi% a report on en=cem5t & ov]sight 
actions & activities und]tak5 by !      
,secret>y ) respect to ! requirem5ts "u 
section #ahfj;,d-#d7;b77#a74  7#b7      
,limitation ,a report "u p>agraph 7#a7  
%all n disclose-- 7,a7 id5tifiable      
in=mation ab\t individuals or entities  
unless su* in=mation is o!rwise publicly
 available2 or  7,b7 trade secrets )    
respect to any entities4  4  #c4        
,requirem5ts ( ph>macy b5efit manag]s "u
 ,m$ic>e "p ,d  7a7 ,prescription drug  
plans ,section #ahfj;,d-#ab ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#aciew-#aab7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7h7            
,requirem5ts relat+ to ph>macy b5efit   
manag]s ,= plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbh3 7#a7 ,agreem5ts )    
ph>macy b5efit manag]s ,ea* contract    
ent]$ into ) a ,,pdp sponsor "u ?is "p )

 respect to a prescription drug plan    
(f]$ by su* sponsor %all provide t any  
ph>macy b5efit manag] act+ on behalf (  
su* sponsor has a writt5 agreem5t ) !   
,,pdp sponsor "u :i* ! ph>macy b5efit   
manag]1 & any affiliates ( su* ph>macy  
b5efit manag]1 z applicable1 agree to   
meet ! foll[+ requirem5ts3 7,a7 ,no     
income o!r ?an bona fide s]vice fees    
7i7 ,9 g5]al ,! ph>macy b5efit manag] & 
any affiliate ( su* ph>macy b5efit      
manag] %all n d]ive any remun]ation )   
respect to any s]vices provid$ on behalf
 ( any entity or individual1 9          
connection ) ! utilization ( cov]$ "p ,d
 drugs1 f any su* entity or individual  
o!r ?an bona fide s]vice fees1 subject  
to clauses 7ii7 & 7iii74  7ii7 ,inc5tive
 paym5ts ,= ! purposes ( ?is subsection1
 an inc5tive paym5t 7z det]m9$ by !     
,secret>y7 paid by a ,,pdp sponsor to a 
ph>macy b5efit manag] t is p]=m+ s]vices
 on behalf ( su* sponsor %all be deem$ a
 bona fide s]vice fee 7ev5 if su* paym5t
 does n o!rwise meet ! def9ition ( su*  

t]m "u p>agraph 7#g77;,b77 if su* paym5t
 is a flat doll> am\nt1 is consi/5t )   
fair m>ket value 7z specifi$ by !       
,secret>y71 is relat$ to s]vices        
actually p]=m$ by ! ph>macy b5efit      
manag] or affiliate ( su* ph>macy b5efit
 manag]1 on behalf ( ! ,,pdp sponsor    
mak+ su* paym5t1 9 connection ) !       
utilization ( cov]$ "p ,d drugs1 & meets
 additional requirem5ts1 if any1 z      
det]m9$ appropriate by ! ,secret>y4     
7iii7 ,cl>ification on rebates &        
disc\nts us$ to l[] co/s = cov]$ "p d   
drugs ,rebates1 disc\nts1 & o!r price   
concessions receiv$ by a ph>macy b5efit 
manag] or an affiliate ( a ph>macy      
b5efit manag] f manufactur]s1 ev5 if su*
 price concessions are calculat$ z a    
p]c5tage ( a drug's price1 %all n be    
consid]$ a violation ( ! requirem5ts (  
clause 7i7 if !y are fully pass$ ?r\gh  
to a ,,pdp sponsor & are compliant ) all
 regulatory & subregulatory requirem5ts 
relat$ to direct & indirect remun]ation 
= manufactur] rebates "u ?is "p1 includ+

 9 cases :]e a ,,pdp sponsor is act+ z a
 ph>macy b5efit manag] on behalf ( a    
prescription drug plan (f]$ by su* ,,pdp
 sponsor4  7iv7 ,evaluation (           
remun]ation arrangem5ts ,compon5ts (    
subsets ( remun]ation arrangem5ts 7su* z
 fees or o!r =ms ( comp5sation paid to  
or reta9$ by ! ph>macy b5efit manag] or 
affiliate ( su* ph>macy b5efit manag]71 
z det]m9$ appropriate by ! ,secret>y1   
betwe5 ph>macy b5efit manag]s or        
affiliates ( su* ph>macy b5efit manag]s1
 z applicable1 & o!r entities involv$ 9 
! disp5s+ or utilization ( cov]$ "p ,d  
drugs 7includ+ ,,pdp sponsors1          
manufactur]s1 ph>macies1 & o!r entities 
z det]m9$ appropriate by ! ,secret>y7   
%all be subject to review by !          
,secret>y1 9 consultation ) ! ,(fice ( !
 ,inspector ,g5]al ( ! ,dep>tm5t (      
,heal? & ,human ,s]vices1 z det]m9$     
appropriate by ! ,secret>y4 ,!          
,secret>y1 9 consultation ) ! ,(fice ( !
 ,inspector ,g5]al1 %all review :e!r    
remun]ation "u su* arrangem5ts is       

consi/5t ) fair m>ket value 7z specifi$ 
by ! ,secret>y7 ?r\gh reviews &         
assessm5ts ( su* remun]ation1 z det]m9$ 
appropriate4  7v7 ,disgorgem5t ,!       
ph>macy b5efit manag] %all disgorge any 
remun]ation paid to su* ph>macy b5efit  
manag] or an affiliate ( su* ph>macy    
b5efit manag] 9 violation ( ?is         
subp>agraph to ! ,,pdp sponsor4  7vi7   
,additional requirem5ts ,! ph>macy      
b5efit manag] %all-- 7,i7 ent] into a   
writt5 agreem5t ) any affiliate ( su*   
ph>macy b5efit manag]1 "u :i* !         
affiliate %all id5tify & disgorge any   
remun]ation describ$ 9 clause 7v7 to !  
ph>macy b5efit manag]2 &  7,,ii7 atte/1 
subject to any requirem5ts det]m9$      
appropriate by ! ,secret>y1 t ! ph>macy 
b5efit manag] has ent]$ into a writt5   
agreem5t describ$ 9 subclause 7,i7 ) any
 relevant affiliate ( ! ph>macy b5efit  
manag]4  7,b7 ,transp>5cy reg>d+        
gu>antees & co/ p]=mance evaluations ,! 
ph>macy b5efit manag] %all-- 7i7 def9e1 
int]pret1 & apply1 9 a fully transp>5t &

 consi/5t mann] = purposes ( calculat+  
or o!rwise evaluat+ ph>macy b5efit      
manag] p]=mance aga9/ pric+ gu>antees or
 simil> co/ p]=mance measurem5ts relat$ 
to rebates1 disc\nts1 price concessions1
 or net co/s1 t]ms su* z-- 7,i7 g5]ic   
drug1 9 a mann] consi/5t ) ! def9ition (
 ! t]m "u section #dbc4d ( title #db1   
,code ( ,f$]al ,regulations1 or a       
successor regulation2  7,,ii7 br& "n    
drug1 9 a mann] consi/5t ) ! def9ition (
 ! t]m "u section #dbc4d ( title #db1   
,code ( ,f$]al ,regulations1 or a       
successor regulation2  7,,iii7 specialty
 drug2  7,,iv7 rebate2 &  7,v7 disc\nt2 
7ii7 id5tify any drugs1 claims1 or price
 concessions exclud$ f any pric+        
gu>antee or o!r co/ p]=mance measure 9 a
 cle> & consi/5t mann]2 &  7iii7 :]e a  
pric+ gu>antee or o!r co/ p]=mance      
measure is bas$ on a pric+ b5*m>k o!r   
?an ! :olesale acquisition co/ 7z def9$ 
9 section #ahdg;,a7c77#f77;,b77 ( a     
drug1 calculate & provide a :olesale    
acquisition co/-bas$ equival5t to !     

pric+ gu>antee or o!r co/ p]=mance      
measure4  7,c7 ,provision ( in=mation   
7i7 ,9 g5]al ,n lat] ?an ,july #a ( ea* 
ye>1 beg9n+ 9 #bjbh1 ! ph>macy b5efit   
manag] %all submit to ! ,,pdp sponsor1 &
 to ! ,secret>y1 a report1 9 accordance 
) ?is subp>agraph1 & %all make su*      
report available to su* sponsor at no   
co/ to su* sponsor 9 a =mat specifi$ by 
! ,secret>y "u p>agraph 7#e74 ,ea* su*  
report %all include1 ) respect to su*   
,,pdp sponsor & ea* plan (f]$ by su*    
sponsor1 ! foll[+ in=mation ) respect to
 ! previ\s plan ye>3 7,i7 ,a li/ ( all  
drugs cov]$ by ! plan t 7 disp5s$       
includ+1 ) respect to ea* su* drug--    
7aa7 ! br& "n1 g5]ic or non-propriet>y  
"n1 & ,national ,drug ,code2  7bb7 !    
numb] ( plan enrollees = :om ! drug 0   
disp5s$1 ! total numb] ( prescription   
claims = ! drug 7includ+ orig9al        
prescriptions & refills1 c\nt$ z sep>ate
 claims71 & ! total numb] ( dosage units
 ( ! drug disp5s$2  7cc7 ! numb] (      
prescription claims describ$ 9 item 7bb7

 by ea* type ( disp5s+ *annel ?r\gh :i* 
! drug 0 disp5s$1 includ+ retail1 mail  
ord]1 specialty ph>macy1 long t]m c>e   
ph>macy1 home infusion ph>macy1 or o!r  
types ( ph>macies or provid]s2  7dd7 !  
av]age :olesale acquisition co/1 li/$ z 
co/ p] day's supply1 co/ p] dosage unit1
 & co/ p] typical c\rse ( treatm5t 7z   
applicable72  7ee7 ! av]age :olesale    
price = ! drug1 li/$ z price p] day's   
supply1 price p] dosage unit1 & price p]
 typical c\rse ( treatm5t 7z            
applicable72  7ff7 ! total out-(-pocket 
sp5d+ by plan enrollees on su* drug aft]
 application ( any b5efits "u ! plan1   
includ+ plan enrollee sp5d+ ?r\gh       
copaym5ts1 co9surance1 & d$uctibles2    
7gg7 total rebates paid by ! manufactur]
 on ! drug z report$ "u ! ,detail$ ,,dir
 ,report 7or any successor report7      
submitt$ by su* sponsor to ! ,c5t]s =   
,m$ic>e  ,m$icaid ,s]vices2  7hh7 all   
o!r direct or indirect remun]ation on ! 
drug z report$ "u ! ,detail$ ,,dir      
,report 7or any successor report7       

submitt$ by su* sponsor to ! ,c5t]s =   
,m$ic>e  ,m$icaid ,s]vices2  7ii7 !     
av]age ph>macy reimbursem5t am\nt paid  
by ! plan = ! drug 9 ! aggregate &      
disaggregat$ by disp5s+ *annel id5tifi$ 
9 item 7cc72  7jj7 ! av]age ,national   
,av]age ,drug ,acquisition ,co/         
7,,nadac72 &  7kk7 total                
manufactur]-d]iv$ rev5ue1 inclusive (   
bona fide s]vice fees1 attributable to !
 drug & reta9$ by ! ph>macy b5efit      
manag] & any affiliate ( su* ph>macy    
b5efit manag]4  7,,ii7 ,9 ! case ( a    
ph>macy b5efit manag] t has an affiliate
 t is a retail1 mail ord]1 or specialty 
ph>macy1 ) respect to drugs cov]$ by su*
 plan t 7 disp5s$1 ! foll[+ in=mation3  
7aa7 ,! p]c5tage ( total prescriptions t
 7 disp5s$ by ph>macies t are an        
affiliate ( ! ph>macy b5efit manag] =   
ea* drug4  7bb7 ,! int]qu>tile range ( !
 total comb9$ co/s paid by ! plan & plan
 enrollees1 p] dosage unit1 p] c\rse (  
treatm5t1 p] #cj-;day supply1 & p]      
#ij-;day supply = ea* drug disp5s$ by   

ph>macies t are n an affiliate ( !      
ph>macy b5efit manag] & t are includ$ 9 
! ph>macy network ( su* plan4  7cc7 ,!  
int]qu>tile range ( ! total comb9$ co/s 
paid by ! plan & plan enrollees1 p]     
dosage unit1 p] c\rse ( treatm5t1 p]    
#cj-;day supply1 & p] #ij-;day supply = 
ea* drug disp5s$ by ph>macies t are an  
affiliate ( ! ph>macy b5efit manag] & t 
are includ$ 9 ! ph>macy network ( su*   
plan4  7dd7 ,! l[e/ total comb9$ co/    
paid by ! plan & plan enrollees1 p]     
dosage unit1 p] c\rse ( treatm5t1 p]    
#cj-;day supply1 & p] #ij-;day supply1 =
 ea* drug t is available f any ph>macy  
includ$ 9 ! ph>macy network ( su* plan4 
7ee7 ,! diff]5ce betwe5 ! av]age        
acquisition co/ ( ! affiliate1 su* z a  
ph>macy or o!r entity t acquires        
prescription drugs1 t initially acquires
 ! drug & ! am\nt report$ "u subclause  
7,i77jj7 = ea* drug4  7ff7 ,a li/       
inclusive ( ! br& "n1 g5]ic or          
non-propriet>y "n1 & ,national ,drug    
,code ( cov]$ "p ,d drugs subject to an 

agreem5t ) a cov]$ entity "u section    
#cdj;,b ( ! ,public ,heal? ,s]vice ,act 
= :i* ! ph>macy b5efit manag] or an     
affiliate ( ! ph>macy b5efit manag] _h a
 contract or o!r arrangem5t ) su* a     
cov]$ entity 9 ! s]vice area ( su* plan4
  7,,iii7 ,:]e a drug approv$ "u section
 #eje7;c7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7ref]r$ to 9 ?is         
subclause z ! li/$ drug7 is cov]$ by !  
plan1 ! foll[+ in=mation3 7aa7 ,a li/ ( 
curr5tly m>ket$ g5]ic drugs approv$ "u  
section #eje7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act pursuant to an  
application t ref]5ces su* li/$ drug t  
are n cov]$ by ! plan1 are cov]$ on !   
same =mul>y ti] or a =mul>y ti]         
typically associat$ ) high] co/-%>+ ?an 
! li/$ drug1 or are subject to          
utilization managem5t t ! li/$ drug is n
 subject to4  7bb7 ,! e/imat$ av]age    
b5efici>y co/-%>+ "u ! plan = a #cj-;day
 supply ( ! li/$ drug4  7cc7 ,:]e a     
g5]ic drug li/$ "u item 7aa7 is on a    
=mul>y ti] typically associat$ ) high]  

co/-%>+ ?an ! li/$ drug1 ! e/imat$      
av]age co/-%>+ t a b5efici>y w\ld h paid
 = a #cj-;day supply ( ea* ( ! g5]ic    
drugs describ$ 9 item 7aa71 _h ! plan   
provid$ cov]age = su* drugs on ! same   
=mul>y ti] z ! li/$ drug4  7dd7 ,a      
writt5 ju/ification = provid+ m         
favorable cov]age ( ! li/$ drug ?an !   
g5]ic drugs describ$ 9 item 7aa74  7ee7 
,! numb] ( curr5tly m>ket$ g5]ic drugs  
approv$ "u section #eje7;j7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act pursuant 
to an application t ref]5ces su* li/$   
drug4  7,,iv7 ,:]e a ref]5ce product 7z 
def9$ 9 section #cea7;i7 ( ! ,public    
,heal? ,s]vice ,act7 is cov]$ by ! plan1
 ! foll[+ in=mation3 7aa7 ,a li/ (      
curr5tly m>ket$ biosimil> biological    
products lic5s$ "u section #cea7k7 ( !  
,public ,heal? ,s]vice ,act pursuant to 
an application t ref]s to su* ref]5ce   
product t are n cov]$ by ! plan1 are    
cov]$ on ! same =mul>y ti] or a =mul>y  
ti] typically associat$ ) high] co/-%>+ 
?an ! ref]5ce product1 or are subject to

 utilization managem5t t ! ref]5ce      
product is n subject to4  7bb7 ,!       
e/imat$ av]age b5efici>y co/-%>+ "u !   
plan = a #cj-;day supply ( ! ref]5ce    
product4  7cc7 ,:]e a biosimil>         
biological product li/$ "u item 7aa7 is 
on a =mul>y ti] typically associat$ )   
high] co/-%>+ ?an ! ref]5ce product1 !  
e/imat$ av]age co/-%>+ t a b5efici>y    
w\ld h paid = a #cj-;day supply ( ea* ( 
! biosimil> biological products describ$
 9 item 7aa71 _h ! plan provid$ cov]age 
= su* products on ! same =mul>y ti] z ! 
ref]5ce product4  7dd7 ,a writt5        
ju/ification = provid+ m favorable      
cov]age ( ! ref]5ce product ?an !       
biosimil> biological product describ$ 9 
item 7aa74  7ee7 ,! numb] ( curr5tly    
m>ket$ biosimil> biological products    
lic5s$ "u section #cea7k7 ( ! ,public   
,heal? ,s]vice ,act1 pursuant to an     
application t ref]s to su* ref]5ce      
product4  7,v7 ,total gross sp5d+ on    
cov]$ "p ,d drugs by ! plan1 n net (    
rebates1 fees1 disc\nts1 or o!r direct  

or indirect remun]ation4  7,,vi7 ,!     
total am\nt reta9$ by ! ph>macy b5efit  
manag] or an affiliate ( su* ph>macy    
b5efit manag] 9 rev5ue relat$ to        
utilization ( cov]$ "p ,d drugs "u t    
plan1 inclusive ( bona fide s]vice fees4
  7,,vii7 ,! total sp5d+ on cov]$ "p ,d 
drugs net ( rebates1 fees1 disc\nts1 or 
o!r direct & indirect remun]ation by !  
plan4  7,,viii7 ,an explanation ( any   
b5efit design p>amet]s "u su* plan t    
enc\rage plan enrollees to fill         
prescriptions at ph>macies t are an     
affiliate ( su* ph>macy b5efit manag]1  
su* z mail & specialty home deliv]y     
programs1 & retail & mail auto-refill   
programs4  7,,ix7 ,! foll[+ in=mation3  
7aa7 ,a li/ ( all brok]s1 consultants1  
advisors1 & auditors t receive          
comp5sation f ! ph>macy b5efit manag] or
 an affiliate ( su* ph>macy b5efit      
manag] = ref]rals1 consult+1 audit+1 or 
o!r s]vices (f]$ to ,,pdp sponsors      
relat$ to ph>macy b5efit managem5t      
s]vices4  7bb7 ,! am\nt ( comp5sation   

provid$ by su* ph>macy b5efit manag] or 
affiliate to ea* su* brok]1 consultant1 
advisor1 & auditor4  7cc7 ,! me?odology 
= calculat+ ! am\nt ( comp5sation       
provid$ by su* ph>macy b5efit manag] or 
affiliate1 = ea* su* brok]1 consultant1 
advisor1 & auditor4  7,x7 ,a li/ ( all  
affiliates ( ! ph>macy b5efit manag]4   
7,,xi7 ,a summ>y docum5t submitt$ 9 a   
/&>diz$ template develop$ by ! ,secret>y
 t includes su* in=mation describ$ 9    
subclauses 7,i7 ?r\gh 7,x74  7ii7       
,writt5 explanation ( contracts or      
agreem5ts ) drug manufactur]s  7,i7 ,9  
g5]al ,! ph>macy b5efit manag] %all1 n  
lat] ?an #cj days aft] ! f9alization (  
any contract or agreem5t betwe5 su*     
ph>macy b5efit manag] or an affiliate ( 
su* ph>macy b5efit manag] & a drug      
manufactur] 7or subsidi>y1 ag5t1 or     
entity affiliat$ ) su* drug manufactur]7
 t makes rebates1 disc\nts1 paym5ts1 or 
o!r f9ancial inc5tives relat$ to "o or m
 cov]$ "p ,d drugs or o!r prescription  
drugs1 z applicable1 ( ! manufactur]    

directly or indirectly cont+5t ^u       
cov]age1 =mul>y placem5t1 or utilization
 managem5t conditions on any o!r cov]$  
"p ,d drugs or o!r prescription drugs1 z
 applicable1 submit to ! ,,pdp sponsor a
 writt5 explanation ( su* contract or   
agreem5t4  7,,ii7 ,requirem5ts ,a writt5
 explanation "u subclause 7,i7 %all--   
7aa7 include ! manufactur] subject to ! 
contract or agreem5t1 all cov]$ "p ,d   
drugs & o!r prescription drugs1 z       
applicable1 subject to ! contract or    
agreem5t & ! manufactur]s ( su* drugs1 &
 a high-level description ( ! t]ms ( su*
 contract or agreem5t & h[ su* t]ms     
apply to su* drugs2 &  7bb7 be c]tifi$  
by ! ,*ief ,executive ,(fic]1 ,*ief     
,f9ancial ,(fic]1 or ,g5]al ,c\nsel (   
su* ph>macy b5efit manag]1 or affiliate 
( su* ph>macy b5efit manag]1 z          
applicable1 or an individual delegat$ ) 
! au?ority to sign on behalf ( "o ( ^!  
(fic]s1 :o reports directly to ! (fic]4 
7,,iii7 ,def9ition ( o!r prescription   
drugs ,= purposes ( ?is clause1 ! t]m   

o!r prescription drugs means            
prescription drugs cov]$ z supplem5tal  
b5efits "u ?is "p or prescription drugs 
paid outside ( ?is "p4  7,d7 ,audit     
rights  7i7 ,9 g5]al ,n less ?an once a 
ye>1 at ! reque/ ( ! ,,pdp sponsor1 !   
ph>macy b5efit manag] %all all[ = an    
audit ( ! ph>macy b5efit manag] to      
ensure compliance ) all t]ms &          
conditions "u ! writt5 agreem5t describ$
 9 ?is p>agraph & ! accuracy ( in=mation
 report$ "u subp>agraph 7,c74  7ii7     
,auditor ,! ,,pdp sponsor %all h ! "r to
 select an auditor4 ,! ph>macy b5efit   
manag] %all n impose any limitations on 
! selection ( su* auditor4  7iii7       
,provision ( in=mation ,! ph>macy b5efit
 manag] %all make available to su*      
auditor all records1 data1 contracts1 & 
o!r in=mation necess>y to confirm !     
accuracy ( in=mation provid$ "u         
subp>agraph 7,c71 subject to reasonable 
re/rictions on h[ su* in=mation mu/ be  
report$ to prev5t r$isclosure ( su*     
in=mation4  7iv7 ,tim+ ,! ph>macy b5efit

 manag] mu/ provide in=mation "u clause 
7iii7 & o!r in=mation1 data1 & records  
relevant to ! audit to su* auditor )9 #f
 mon?s ( ! initiation ( ! audit &       
respond to reque/s = additional         
in=mation f su* auditor )9 #cj days aft]
 ! reque/ = additional in=mation4  7v7  
,in=mation f affiliates ,! ph>macy      
b5efit manag] %all be responsible =     
provid+ to su* auditor in=mation requir$
 to be report$ "u subp>agraph 7,c7 or "u
 clause 7iii7 ( ?is subp>agraph t is    
own$ or held by an affiliate ( su*      
ph>macy b5efit manag]4  7#b7 ,en=cem5t  
7,a7 ,9 g5]al ,ea* ,,pdp sponsor %all-- 
7i7 disgorge to ! ,secret>y any am\nts  
disgorg$ to ! ,,pdp sponsor by a ph>macy
 b5efit manag] "u p>agraph 7#a77;,a77v72
  7ii7 require1 9 a writt5 agreem5t )   
any ph>macy b5efit manag] act+ on behalf
 ( su* sponsor or affiliate ( su*       
ph>macy b5efit manag]1 t su* ph>macy    
b5efit manag] or affiliate reimburse !  
,,pdp sponsor = any civil money p5alty  
impos$ on ! ,,pdp sponsor z a result ( !

 failure ( ! ph>macy b5efit manag] or   
affiliate to meet ! requirem5ts (       
p>agraph 7#a7 t are applicable to !     
ph>macy b5efit manag] or affiliate "u ! 
agreem5t2 &  7iii7 require1 9 a writt5  
agreem5t ) any su* ph>macy b5efit manag]
 act+ on behalf ( su* sponsor or        
affiliate ( su* ph>macy b5efit manag]1 t
 su* ph>macy b5efit manag] or affiliate 
be subject to punitive rem$ies = brea* (
 contract = failure to comply ) !       
requirem5ts applicable "u p>agraph 7#a74
  7,b7 ,report+ ( alleg$ violations ,!  
,secret>y %all make available & ma9ta9 a
 me*anism = manufactur]s1 ,,pdp         
sponsors1 ph>macies1 & o!r entities t h 
contractual relation%ips ) ph>macy      
b5efit manag]s or affiliates ( su*      
ph>macy b5efit manag]s to report1 on a  
confid5tial basis1 alleg$ violations (  
p>agraph 7#a77;,a7 or subp>agraph 7,c74 
7,c7 ,anti-retaliation & anti-co]cion   
,consi/5t ) applicable ,f$]al or ,/ate  
law1 a ,,pdp sponsor %all n-- 7i7       
retaliate aga9/ an individual or entity 

= report+ an alleg$ violation "u        
subp>agraph 7,b72 or  7ii7 co]ce1       
intimidate1 ?reat51 or int]f]e ) !      
ability ( an individual or entity to    
report any su* alleg$ violations4  7#c7 
,c]tification ( compliance  7,a7 ,9     
g5]al ,ea* ,,pdp sponsor %all furni% to 
! ,secret>y 7at a "t & 9 a mann]        
specifi$ by ! ,secret>y7 an annual      
c]tification ( compliance ) ?is         
subsection1 z well z su* in=mation z !  
,secret>y det]m9es necess>y to c>ry out 
?is subsection4  7,b7 ,implem5tation    
,not)/&+ any o!r provision ( law1 !     
,secret>y may implem5t ?is p>agraph by  
program in/ruction or o!rwise4  7#d7    
,rule ( con/ruction ,no?+ 9 ?is         
subsection %all be con/ru$ z-- 7,a7     
prohibit+ flat disp5s+ fees or          
reimbursem5t or paym5t = +r$i5t co/s    
7includ+ cu/om>y1 indu/ry-/&>d disc\nts 
directly relat$ to drug acquisition t   
are reta9$ by ph>macies or :olesal]s7 to
 entities t acquire or disp5se          
prescription drugs2 or  7,b7 modify+    

regulatory requirem5ts or sub-regulatory
 program in/ruction or guidance relat$  
to ph>macy paym5t1 reimbursem5t1 or     
disp5s+ fees4  7#e7 ,/&>d =mats  7,a7 ,9
 g5]al ,n lat] ?an ,june #a1 #bjbg1 !   
,secret>y %all specify /&>d1            
ma*9e-readable =mats = ph>macy b5efit   
manag]s to submit annual reports requir$
 "u p>agraph 7#a77;,c77i74  7,b7        
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y may        
implem5t ?is p>agraph by program        
in/ruction or o!rwise4  7#f7            
,confid5tiality  7,a7 ,9 g5]al          
,in=mation disclos$ by a ph>macy b5efit 
manag]1 an affiliate ( a ph>macy b5efit 
manag]1 a ,,pdp sponsor1 or a ph>macy "u
 ?is subsection t is n o!rwise publicly 
available or available = pur*ase %all n 
be disclos$ by ! ,secret>y or a ,,pdp   
sponsor receiv+ ! in=mation1 except t ! 
,secret>y may disclose ! in=mation = !  
foll[+ purposes3 7i7 ,z ! ,secret>y     
det]m9es necess>y to c>ry out ?is "p4   
7ii7 ,to p]mit ! ,comptroll] ,g5]al to  

review ! in=mation provid$4  7iii7 ,to  
p]mit ! ,director ( ! ,congressional    
,budget ,(fice to review ! in=mation    
provid$4  7iv7 ,to p]mit ! ,executive   
,director ( ! ,m$ic>e ,paym5t ,advisory 
,commission to review ! in=mation       
provid$4  7v7 ,to ! ,attorney ,g5]al = !
 purposes ( conduct+ ov]sight & en=cem5t
 "u ?is title4  7vi7 ,to ! ,inspector   
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices 9 accordance ) its au?orities  
"u ! ,inspector ,g5]al ,act ( #aigh     
7section #djf ( title #e1 ,unit$ ,/ates 
,code71 & o!r applicable /atutes4  7,b7 
,re/riction on use ( in=mation ,!       
,secret>y1 ! ,comptroll] ,g5]al1 !      
,director ( ! ,congressional ,budget    
,(fice1 & ! ,executive ,director ( !    
,m$ic>e ,paym5t ,advisory ,commission   
%all n report on or disclose in=mation  
disclos$ pursuant to subp>agraph 7,a7 to
 ! public 9 a mann] t w\ld id5tify-- 7i7
 a specific ph>macy b5efit manag]1      
affiliate1 ph>macy1 manufactur]1        
:olesal]1 ,,pdp sponsor1 or plan2 or    

7ii7 contract prices1 rebates1 disc\nts1
 or o!r remun]ation = specific drugs 9 a
 mann] t may all[ ! id5tification (     
specific contract+ p>ties or ( su*      
specific drugs4  7#g7 ,def9itions ,=    
purposes ( ?is subsection3 7,a7         
,affiliate ,! t]m affiliate means1 )    
respect to any ph>macy b5efit manag] or 
,,pdp sponsor1 any entity t1 directly or
 indirectly-- 7i7 owns or is own$ by1   
controls or is controll$ by1 or is      
o!rwise relat$ 9 any own]%ip /ructure to
 su* ph>macy b5efit manag] or ,,pdp     
sponsor2 or  7ii7 acts z a contractor1  
pr9cipal1 or ag5t to su* ph>macy b5efit 
manag] or ,,pdp sponsor1 ins(> z su*    
contractor1 pr9cipal1 or ag5t p]=ms any 
( ! functions describ$ "u subp>agraph   
7,c74  7,b7 ,bona fide s]vice fee ,! t]m
 bona fide s]vice fee means a fee t is  
reflective ( ! fair m>ket value 7z      
specifi$ by ! ,secret>y1 ?r\gh notice & 
comm5t rulemak+7 = a bona fide1 itemiz$ 
s]vice actually p]=m$ on behalf ( an    
entity1 t ! entity w\ld o!rwise p]=m 7or

 contract =7 9 ! abs5ce ( ! s]vice      
arrangem5t & t is n pass$ on 9 :ole or 9
 "p to a cli5t or cu/om]1 :e!r or n !   
entity takes title to ! drug4 ,su* fee  
mu/ be a flat doll> am\nt & %all n be   
directly or indirectly bas$ on1 or      
cont+5t ^u-- 7i7 drug price1 su* z      
:olesale acquisition co/ or drug b5*m>k 
price 7su* z av]age :olesale price72    
7ii7 ! am\nt ( disc\nts1 rebates1 fees1 
or o!r direct or indirect remun]ation ) 
respect to cov]$ "p ,d drugs disp5s$ to 
enrollees 9 a prescription drug plan1   
except z p]mitt$ pursuant to p>agraph   
7#a77;,a77ii72  7iii7 cov]age or =mul>y 
placem5t decisions or ! volume or value 
( any ref]rals or bus9ess g5]at$ betwe5 
! p>ties to ! arrangem5t2 or  7iv7 any  
o!r am\nts or me?odologies prohibit$ by 
! ,secret>y4  7,c7 ,ph>macy b5efit      
manag] ,! t]m ph>macy b5efit manag]     
means any p]son or entity t1 ei!r       
directly or ?r\gh an int]m$i>y1 acts z a
 price negotiator or gr\p pur*as] on    
behalf ( a ,,pdp sponsor or prescription

 drug plan1 or manages ! prescription   
drug b5efits provid$ by su* sponsor or  
plan1 includ+ ! process+ & paym5t (     
claims = prescription drugs1 ! p]=mance 
( drug utilization review1 ! process+ ( 
drug prior au?orization reque/s1 !      
adjudication ( appeals or grievances    
relat$ to ! prescription drug b5efit1   
contract+ ) network ph>macies1 controll+
 ! co/ ( cov]$ "p ,d drugs1 or !        
provision ( relat$ s]vices4 ,su* t]m    
includes any p]son or entity t c>ries   
out "o or m ( ! activities describ$ 9 ! 
prec$+ s5t5ce1 irrespective ( :e!r su*  
p]son or entity calls itself a ph>macy  
b5efit manag]4  4  7b7 ,,ma-,,pd plans  
,section #aheg7;f77#c7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#bg7;f77#c771 z am5d$ by section 
#b7;d77#b71 is am5d$ by add+ at ! end ! 
foll[+ new subp>agraph3  7,g7           
,requirem5ts relat+ to ph>macy b5efit   
manag]s ,= plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbh1 section              
#ahfj;,d-#ab7;h74  4  7c7               

,nonapplication ( ,pap]work ,r$uction   
,act ,*apt] #ce ( title #dd1 ,unit$     
,/ates ,code1 %all n apply to !         
implem5tation ( ?is subsection4