,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #dcag  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #aj1 #bjbe,mr4  
,c>t] ( ,georgia 7= himself1 ,mrs4      
,d+ell1 ,mr4 ,murphy1 ,ms4 ,ross1 ,mr4  
,arr+ton1 ,mrs4 ,h>%b>g]1 ,mr4 ,vic5te  
,gonzalez ( ,texas1 ,mr4 ,all51 ,mr4    
,kri%namoor?i1 ,mr4 ,rose1 ,mr4 ,tran1 &
 ,ms4 ,malliotakis7 introduc$ ! foll[+  
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce1 & 9 addition to !    
,committees on ,education & ,work=ce1 & 
,ways & ,means1 = a p]iod to be         
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to assure ph>macy  
access & *oice = ,m$ic>e b5efici>ies1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,ph>macy ,b5efit   
,manag] ,re=m ,act ( #bjbe or ! ,,pbm   
,re=m ,act ( #bjbe4  #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 #bjbi1 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 ( #bjbh1 ! ,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 #bjbg1 = 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 (       
affiliate2 ph>macy b5efit manag] ,9 ?is 
subsection1 ! t]ms affiliate & ph>macy  
b5efit manag] h ! mean+ giv5 ^? t]ms 9  
section #ahfj;,d-#ab7;h77#g74  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  7f7 ,fund+ 
,9 addition to am\nts o!rwise available1
 !re is appropriat$ to ! ,c5t]s =       
,m$ic>e  ,m$icaid ,s]vices ,program     
,managem5t ,acc\nt1 out ( any money 9 ! 
,treasury n o!rwise appropriat$1        
#ahh1jjj1jjj = fiscal ye> #bjbe1 to     
rema9 available until exp5d$1 to c>ry   
out ?is section4  #c4 ,mod]niz+ & ensur+

 pbm acc\ntability  7a7 ,9 g5]al  7#a7  
,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>macies7 %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          
#8disc\nt'2  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 ,! 
,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 ,! ,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  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   
,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  7#c7              
,nonapplication ( pap]work r$uction act 
,*apt] #ce ( title #dd1 ,unit$ ,/ates   
,code1 %all n apply to ! implem5tation (
 ?is subsection4  7#d7 ,fund+  7,a7     
,secret>y ,9 addition to am\nts o!rwise 
available1 !re is appropriat$ to !      
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices     
,program ,managem5t ,acc\nt1 out ( any  
money 9 ! ,treasury n o!rwise           
appropriat$1 #aac1jjj1jjj = fiscal ye>  
#bjbe1 to rema9 available until exp5d$1 
to c>ry out ?is subsection4  7,b7 ,,oig 
,9 addition to am\nts o!rwise available1
 !re is appropriat$ to ! ,inspector     
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices1 out ( any money 9 ! ,treasury 
n o!rwise appropriat$1 #bj1jjj1jjj =    
fiscal ye> #bjbe1 to rema9 available    
until exp5d$1 to c>ry out ?is           

subsection4  7b7 ,gao /udy & report on  
price-,relat$ comp5sation across !      
supply *a9  7#a7 ,/udy ,! ,comptroll]   
,g5]al ( ! ,unit$ ,/ates 79 ?is         
subsection ref]r$ to z ! ,comptroll]    
,g5]al7 %all conduct a /udy describ+ !  
use ( comp5sation & paym5t /ructures    
relat$ to a prescription drug's price )9
 ! retail prescription drug supply *a9 9
 "p ,d ( title ,,xviii ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#aja et seq474 ,su* /udy %all    
summ>ize in=mation f ,f$]al ag5cies &   
indu/ry exp]ts1 to ! ext5t available1 ) 
respect to ! foll[+3 7,a7 ,! type1      
magnitude1 o!r features 7su* z ! pric+  
b5*m>ks us$71 & preval5ce ( comp5sation 
& paym5t /ructures relat$ to a          
prescription drug's price1 su* z        
calculat+ fee am\nts z a p]c5tage ( a   
prescription drug's price1 betwe5       
int]m$i>ies 9 ! prescription drug supply
 *a91 includ+-- 7i7 ph>macy b5efit      
manag]s2  7ii7 ,,pdp sponsors (f]+      
prescription drug plans & ,m$ic>e       

,advantage organizations (f]+ ,,ma-,,pd 
plans2  7iii7 drug :olesal]s2  7iv7     
ph>macies2  7v7 manufactur]s2  7vi7     
ph>macy s]vices adm9i/rative            
organizations2  7vii7 brok]s1 auditors1 
consultants1 & o!r entities t-- 7,i7    
advise ,,pdp sponsors (f]+ prescription 
drug plans & ,m$ic>e ,advantage         
organizations (f]+ ,,ma-,,pd plans      
reg>d+ ph>macy b5efits2 or  7,,ii7      
review ,,pdp sponsor & ,m$ic>e          
,advantage organization contracts )     
ph>macy b5efit manag]s2 &  7viii7 o!r   
s]vice provid]s t contract ) any ( !    
entities describ$ 9 clauses 7i7 ?r\gh   
7vii7 t may use price-relat$ comp5sation
 & paym5t /ructures1 su* z rebate       
aggregators 7or o!r entities t negotiate
 or process price concessions on behalf 
( ph>macy b5efit manag]s1 plan sponsors1
 or ph>macies74  7,b7 ,! prim>y bus9ess 
models & comp5sation /ructures = ea*    
category ( int]m$i>y describ$ 9         
subp>agraph 7,a74  7,c7 ,v>iation 9     
price-relat$ comp5sation /ructures      

betwe5 affiliat$ entities 7su* z        
entities ) common own]%ip1 ei!r full or 
p>tial1 & subsidi>y relation%ips7 &     
unaffiliat$ entities4  7,d7 ,pot5tial   
conflicts ( int]e/ among contract+      
entities relat$ to ! use ( prescription 
drug price-relat$ comp5sation /ructures1
 su* z ! pot5tial = fees or o!r paym5ts 
set z a p]c5tage ( a prescription drug's
 price to advantage =mul>y selection1   
di/ribution1 or pur*as+ ( prescription  
drugs ) high] prices4  7,e7 ,notable    
diff]5ces1 if any1 9 ! use & level (    
price-bas$ comp5sation /ructures ov] "t 
& betwe5 diff]5t m>ket segm5ts1 su* z "u
 "p ,d ( title ,,xviii ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#aja et seq47 & ! ,m$icaid       
program "u title ,,xix ( su* ,act 7#db  
,u4,s4,c4 #acif et seq474  7,f7 ,!      
effects ( drug price-relat$ comp5sation 
/ructures & alt]native comp5sation      
/ructures on ,f$]al heal? c>e programs &
 program b5efici>ies1 includ+ ) respect 
to co/-%>+1 premiums1 ,f$]al outlays1   

biosimil> & g5]ic drug adoption &       
utilization1 drug %ortage risks1 & !    
pot5tial = fees set z a p]c5tage ( a    
drug's price to advantage ! =mul>y      
selection1 di/ribution1 or pur*as+ (    
drugs ) high] prices4  7,g7 ,o!r issues 
det]m9$ to be relevant & appropriate by 
! ,comptroll] ,g5]al4  7#b7 ,report ,n  
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is section1 ! ,comptroll] ,g5]al %all
 submit to ,congress a report conta9+ ! 
results ( ! /udy conduct$ "u p>agraph   
7#a71 toge!r ) recomm5dations = su*     
legislation & adm9i/rative action z !   
,comptroll] ,g5]al det]m9es appropriate4
  7c7 ,med,p,a,c reports on agreem5ts ) 
ph>macy b5efit manag]s ) respect to     
prescription drug plans & ,,ma-,,pd     
plans  7#a7 ,9 g5]al ,! ,m$ic>e ,paym5t 
,advisory ,commission %all submit to    
,congress ! foll[+ reports3 7,a7        
,initial report ,n lat] ?an ! fir/ ,m>* 
#ae occurr+ aft] ! date t is #b ye>s    
aft] ! date on :i* ! ,secret>y makes !  
data available to ! ,commission1 a      

report reg>d+ agreem5ts ) ph>macy b5efit
 manag]s ) respect to prescription drug 
plans & ,,ma-,,pd plans4 ,su* report    
%all include1 to ! ext5t practicable--  
7i7 a description ( tr5ds & patt]ns1    
includ+ relevant av]ages1 totals1 & o!r 
figures = ! types ( in=mation submitt$2 
7ii7 an analysis ( any diff]5ces 9      
agreem5ts & _! effects on plan enrollee 
out-(-pocket sp5d+ & av]age ph>macy     
reimbursem5t1 & o!r impacts2 &  7iii7   
any recomm5dations ! ,commission        
det]m9es appropriate4  7,b7 ,f9al report
 ,n lat] ?an #b ye>s aft] ! date on :i* 
! ,commission submits ! initial report  
"u subp>agraph 7,a71 a report describ+  
any *anges ) respect to ! in=mation     
describ$ 9 subp>agraph 7,a7 ov] "t1     
toge!r ) any recomm5dations !           
,commission det]m9es appropriate4  7#b7 
,fund+ ,9 addition to am\nts o!rwise    
available1 !re is appropriat$ to !      
,m$ic>e ,paym5t ,advisory ,commission1  
out ( any money 9 ! ,treasury n o!rwise 
appropriat$1 #a1jjj1jjj = fiscal ye>    

#bjbe1 to rema9 available until exp5d$1 
to c>ry out ?is subsection4  #d4        
,ov]sight ( ph>macy b5efit managem5t    
s]vices  7a7 ,public heal? s]vice act   
,title ,,xxvii ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et  
seq47 is am5d$-- 7#a7 9 "p ,d 7#db      
,u4,s4,c4 #cjj;gg-#aaa et seq471 by add+
 at ! end ! foll[+ new section3         
#bgii;,a-#aa4 ,ov]sight ( entities t    
provide ph>macy b5efit managem5t s]vices
  7a7 ,9 g5]al ,= plan ye>s beg9n+ on or
 aft] ! date t is #cj mon?s aft] ! date 
( enactm5t ( ?is section 7ref]r$ to 9   
?is subsection & subsection 7b7 z !     
effective date71 a gr\p heal? plan or a 
heal? insurance issu] (f]+ gr\p heal?   
insurance cov]age1 or an entity provid+ 
ph>macy b5efit managem5t s]vices on     
behalf ( su* a plan or issu]1 %all n    
ent] into a contract1 includ+ an        
ext5sion or r5ewal ( a contract1 ent]$  
into on or aft] ! effective date1 ) an  
applicable entity unless su* applicable 
entity agrees to-- 7#a7 n limit or delay

 ! disclosure ( in=mation to ! gr\p     
heal? plan 7includ+ su* a plan (f]$     
?r\gh a heal? insurance issu]7 9 su* a  
mann] t prev5ts an entity provid+       
ph>macy b5efit managem5t s]vices on     
behalf ( a gr\p heal? plan or heal?     
insurance issu] (f]+ gr\p heal?         
insurance cov]age f mak+ ! reports      
describ$ 9 subsection 7b72 &  7#b7      
provide ! entity provid+ ph>macy b5efit 
managem5t s]vices on behalf ( a gr\p    
heal? plan or heal? insurance issu]     
relevant in=mation necess>y to make !   
reports describ$ 9 subsection 7b74  7b7 
,reports  7#a7 ,9 g5]al ,= plan ye>s    
beg9n+ on or aft] ! effective date1 9 ! 
case ( any contract betwe5 a gr\p heal? 
plan or a heal? insurance issu] (f]+    
gr\p heal? insurance cov]age (f]$ 9     
connection ) su* a plan & an entity     
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( su* plan or issu]1 includ+ 
an ext5sion or r5ewal ( su* a contract1 
ent]$ into on or aft] ! effective date1 
! entity provid+ ph>macy b5efit         

managem5t s]vices on behalf ( su* a gr\p
 heal? plan or heal? insurance issu]1 n 
less frequ5tly ?an e #f mon?s 7or1 at ! 
reque/ ( a gr\p heal? plan1 n less      
frequ5tly ?an qu>t]ly1 & "u ! same      
conditions1 t]ms1 & co/ ( ! semiannual  
report "u ?is subsection71 %all submit  
to ! gr\p heal? plan a report 9         
accordance ) ?is section4 ,ea* su*      
report %all be made available to su*    
gr\p heal? plan 9 pla9 language1 9 a    
ma*9e-readable =mat1 & z ! ,secret>y may
 det]m9e1 o!r =mats4 ,ea* su* report    
%all include ! in=mation describ$ 9     
p>agraph 7#b74  7#b7 ,in=mation describ$
 ,= purposes ( p>agraph 7#a71 !         
in=mation describ$ 9 ?is p>agraph is1 ) 
respect to drugs cov]$ by a gr\p heal?  
plan or gr\p heal? insurance cov]age    
(f]$ by a heal? insurance issu] 9       
connection ) a gr\p heal? plan dur+ ea* 
report+ p]iod-- 7,a7 9 ! case ( a gr\p  
heal? plan t is (f]$ by a specifi$ l>ge 
employ] or t is a specifi$ l>ge plan1 & 
is n (f]$ z heal? insurance cov]age1 or 

9 ! case ( heal? insurance cov]age = :i*
 ! election "u p>agraph 7#c7 is made = !
 applicable report+ p]iod-- 7i7 a li/ ( 
drugs = :i* a claim 0 fil$ &1 ) respect 
to ea* su* drug on su* li/-- 7,i7 !     
contract$ comp5sation paid by ! gr\p    
heal? plan or heal? insurance issu] =   
ea* cov]$ drug 7id5tifi$ by ! ,national 
,drug ,code7 to ! entity provid+ ph>macy
 b5efit managem5t s]vices or o!r        
applicable entity on behalf ( ! gr\p    
heal? plan or heal? insurance issu]2    
7,,ii7 ! contract$ comp5sation paid to !
 ph>macy1 by any entity provid+ ph>macy 
b5efit managem5t s]vices or o!r         
applicable entity on behalf ( ! gr\p    
heal? plan or heal? insurance issu]1 =  
ea* cov]$ drug 7id5tifi$ by ! ,national 
,drug ,code72  7,,iii7 = ea* su* claim1 
! diff]5ce betwe5 ! am\nt paid "u       
subclause 7,i7 & ! am\nt paid "u        
subclause 7,,ii72  7,,iv7 ! propriet>y  
"n1 e/abli%$ "n or prop] "n1 & ,national
 ,drug ,code2  7,v7 = ea* claim = ! drug
 7includ+ orig9al prescriptions &       

refills7 & = ea* dosage unit ( ! drug = 
:i* a claim 0 fil$1 ! type ( disp5s+    
*annel us$ to furni% ! drug1 includ+    
retail1 mail ord]1 or specialty ph>macy2
  7,,vi7 ) respect to ea* drug disp5s$1 
= ea* type ( disp5s+ *annel 7includ+    
retail1 mail ord]1 or specialty         
ph>macy7-- 7aa7 :e!r su* drug is a br&  
"n drug or a g5]ic drug1 &-- 7,,aa7 9 ! 
case ( a br& "n drug1 ! :olesale        
acquisition co/1 li/$ z co/ p] days     
supply & co/ p] dosage unit1 on ! date  
su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( 
a g5]ic drug1 ! av]age :olesale price1  
li/$ z co/ p] days supply & co/ p]      
dosage unit1 on ! date su* drug 0       
disp5s$2 &  7bb7 ! total numb] (--      
7,,aa7 prescription claims 7includ+     
orig9al prescriptions & refills72 7,,bb7
 p>ticipants & b5efici>ies = :om a claim
 = su* drug 0 fil$ ?r\gh ! applicable   
disp5s+ *annel2 7,,cc7 dosage units &   
dosage units p] fill ( su* drug2 &      
7,,dd7 days supply ( su* drug p] fill2  
7,,vii7 ! net price p] c\rse ( treatm5t 

or s+le fill1 su* z a #cj-;day supply or
 #ij-;day supply to ! plan or cov]age   
aft] rebates1 fees1 alt]native disc\nts1
 or o!r remun]ation receiv$ f applicable
 entities2  7,,viii7 ! total am\nt (    
out-(-pocket sp5d+ by p>ticipants &     
b5efici>ies on su* drug1 includ+ sp5d+  
?r\gh copaym5ts1 co9surance1 &          
d$uctibles1 b n includ+ any am\nts sp5t 
by p>ticipants & b5efici>ies on drugs n 
cov]$ "u ! plan or cov]age1 or = :i* no 
claim is submitt$ "u ! plan or cov]age2 
7,,ix7 ! total net sp5d+ on ! drug2     
7,x7 ! total am\nt receiv$1 or expect$  
to be receiv$1 by ! plan or issu] f any 
applicable entity 9 rebates1 fees1      
alt]native disc\nts1 or o!r remun]ation2
  7,,xi7 ! total am\nt receiv$1 or      
expect$ to be receiv$1 by ! entity      
provid+ ph>macy b5efit managem5t        
s]vices1 f applicable entities1 9       
rebates1 fees1 alt]native disc\nts1 or  
o!r remun]ation f su* entities-- 7aa7 = 
claims incurr$ dur+ ! report+ p]iod2 &  
7bb7 t is relat$ to utilization ( su*   

drug or sp5d+ on su* drug2 &  7,,xii7 to
 ! ext5t feasible1 in=mation on ! total 
am\nt ( remun]ation = su* drug1 includ+ 
copaym5t assi/ance doll>s paid1 copaym5t
 c>ds appli$1 or o!r disc\nts provid$ by
 ea* drug manufactur] 7or entity        
adm9i/]+ copaym5t assi/ance on behalf ( 
su* drug manufactur]71 to ! p>ticipants 
& b5efici>ies enroll$ 9 su* plan or     
cov]age2  7ii7 a li/ ( ea* !rapeutic    
class 7z def9$ by ! ,secret>y7 = :i* a  
claim 0 fil$ "u ! gr\p heal? plan or    
heal? insurance cov]age dur+ ! report+  
p]iod1 &1 ) respect to ea* su* !rapeutic
 class-- 7,i7 ! total gross sp5d+ on    
drugs 9 su* class be=e rebates1 price   
concessions1 alt]native disc\nts1 or o!r
 remun]ation f applicable entities2     
7,,ii7 ! net sp5d+ 9 su* class aft] su* 
rebates1 price concessions1 alt]native  
disc\nts1 or o!r remun]ation f          
applicable entities2  7,,iii7 ! total   
am\nt receiv$1 or expect$ to be receiv$1
 by ! entity provid+ ph>macy b5efit     
managem5t s]vices1 f applicable         

entities1 9 rebates1 fees1 alt]native   
disc\nts1 or o!r remun]ation f su*      
entities-- 7aa7 = claims incurr$ dur+ ! 
report+ p]iod2 &  7bb7 t is relat$ to   
utilization ( drugs or drug sp5d+2      
7,,iv7 ! av]age net sp5d+ p] #cj-;day   
supply & p] #ij-;day supply by ! plan or
 by ! issu] ) respect to su* cov]age &  
its p>ticipants & b5efici>ies1 among all
 drugs )9 ! !rapeutic class = :i* a     
claim 0 fil$ dur+ ! report+ p]iod2  7,v7
 ! numb] ( p>ticipants & b5efici>ies :o 
fill$ a prescription = a drug 9 su*     
class1 includ+ ! ,national ,drug ,code =
 ea* su* drug2  7,,vi7 if applicable1 a 
description ( ! =mul>y ti]s &           
utilization me*anisms 7su* z prior      
au?orization or /ep !rapy7 employ$ =    
drugs 9 t class2 &  7,,vii7 ! total     
out-(-pocket sp5d+ "u ! plan or cov]age 
by p>ticipants & b5efici>ies1 includ+   
sp5d+ ?r\gh copaym5ts1 co9surance1 &    
d$uctibles1 b n includ+ any am\nts sp5t 
by p>ticipants & b5efici>ies on drugs n 
cov]$ "u ! plan or cov]age or = :i* no  

claim is submitt$ "u ! plan or cov]age2 
7iii7 ) respect to any drug = :i* gross 
sp5d+ "u ! gr\p heal? plan or heal?     
insurance cov]age exce$$ #aj1jjj dur+ ! 
report+ p]iod or1 9 ! case t gross sp5d+
 "u ! gr\p heal? plan or cov]age exce$$ 
#aj1jjj dur+ ! report+ p]iod ) respect  
to few] ?an #ej drugs1 ) respect to !   
#ej prescription drugs ) ! highe/ sp5d+ 
dur+ ! report+ p]iod-- 7,i7 a li/ ( all 
o!r drugs 9 ! same !rapeutic class z su*
 drug2  7,,ii7 if applicable1 !         
rationale = ! =mul>y placem5t ( su* drug
 9 t !rapeutic category or class1       
select$ f a li/ ( /&>d rationales       
e/abli%$ by ! ,secret>y1 9 consultation 
) /akehold]s2 &  7,,iii7 any *ange 9    
=mul>y placem5t comp>$ to ! prior plan  
ye>2 &  7iv7 9 ! case t su* plan or     
issu] 7or an entity provid+ ph>macy     
b5efit managem5t s]vices on behalf ( su*
 plan or issu]7 has an affiliat$ ph>macy
 or ph>macy "u common own]%ip1 includ+  
m&atory mail & specialty home deliv]y   
programs1 retail & mail auto-refill     

programs1 & co/-%>+ assi/ance inc5tives 
fund$ by an entity provid+ ph>macy      
b5efit s]vices-- 7,i7 an explanation (  
any b5efit design p>amet]s t enc\rage or
 require p>ticipants & b5efici>ies 9 !  
plan or cov]age to fill prescriptions at
 mail ord]1 specialty1 or retail        
ph>macies2  7,,ii7 ! p]c5tage ( total   
prescriptions disp5s$ by su* ph>macies  
to p>ticipants or b5efici>ies 9 su* plan
 or cov]age2 &  7,,iii7 a li/ ( all     
drugs disp5s$ by su* ph>macies to       
p>ticipants or b5efici>ies enroll$ 9 su*
 plan or cov]age1 &1 ) respect to ea*   
drug disp5s$-- 7aa7 ! am\nt *>g$1 p]    
dosage unit1 p] #cj-;day supply1 or p]  
#ij-;day supply 7z applicable7 to ! plan
 or issu]1 & to p>ticipants &           
b5efici>ies2  7bb7 ! m$ian am\nt *>g$ to
 su* plan or issu]1 & ! int]qu>tile     
range ( ! co/s1 p] dosage unit1 p]      
#cj-;day supply1 & p] #ij-;day supply1  
includ+ am\nts paid by ! p>ticipants &  
b5efici>ies1 :5 ! same drug is disp5s$  
by o!r ph>macies t are n affiliat$ ) or 

"u common own]%ip ) ! entity & t are    
includ$ 9 ! ph>macy network ( su* plan  
or cov]age2  7cc7 ! l[e/ co/ p] dosage  
unit1 p] #cj-;day supply & p] #ij-;day  
supply1 = ea* su* drug1 includ+ am\nts  
*>g$ to ! plan or cov]age & to          
p>ticipants & b5efici>ies1 t is         
available f any ph>macy includ$ 9 !     
network ( su* plan or cov]age2 &  7dd7 !
 net acquisition co/ p] dosage unit1 p] 
#cj-;day supply1 & p] #ij-;day supply1  
if su* drug is subject to a maximum     
price disc\nt2 &  7,b7 ) respect to any 
gr\p heal? plan1 includ+ gr\p heal?     
insurance cov]age (f]$ 9 connection )   
su* a plan1 reg>dless ( :e!r ! plan or  
cov]age is (f]$ by a specifi$ l>ge      
employ] or :e!r x is a specifi$ l>ge    
plan-- 7i7 a summ>y docum5t = ! gr\p    
heal? plan t includes su* in=mation     
describ$ 9 clauses 7i7 ?r\gh 7iv7 (     
subp>agraph 7,a71 z specifi$ by !       
,secret>y ?r\gh guidance1 program       
in/ruction1 or o!rwise 7) no requirem5t 
( notice & comm5t rulemak+71 t !        

,secret>y det]m9es useful to gr\p heal? 
plans = purposes ( select+ ph>macy      
b5efit managem5t s]vices1 su* z an      
e/imat$ net price to gr\p heal? plan &  
p>ticipant or b5efici>y1 a co/ p] claim1
 ! fee /ructure or reimbursem5t model1 &
 e/imat$ co/ p] p>ticipant or b5efici>y2
  7ii7 a summ>y docum5t = plans & issu]s
 to provide to p>ticipants &            
b5efici>ies1 :i* %all be made available 
to p>ticipants or b5efici>ies ^u reque/ 
to _! gr\p heal? plan 7includ+ 9 ! case 
( gr\p heal? insurance cov]age (f]$ 9   
connection ) su* a plan71 t-- 7,i7      
conta9s su* in=mation describ$ 9 clauses
 7iii71 7iv71 7v71 & 7vi71 z applicable1
 z specifi$ by ! ,secret>y ?r\gh        
guidance1 program in/ruction1 or o!rwise
 7) no requirem5t ( notice & comm5t     
rulemak+7 t ! ,secret>y det]m9es useful 
to p>ticipants or b5efici>ies 9 bett]   
und]/&+ ! plan or cov]age or b5efits "u 
su* plan or cov]age2  7,,ii7 conta9s    
only aggregate in=mation2 &  7,,iii7    
/ates t p>ticipants & b5efici>ies may   

reque/ specific1 claims-level in=mation 
requir$ to be furni%$ "u subsection 7c7 
f ! gr\p heal? plan or heal? insurance  
issu]2  7iii7 ) respect to drugs cov]$  
by su* plan or cov]age dur+ su* report+ 
p]iod-- 7,i7 ! total net sp5d+ by ! plan
 or cov]age = all su* drugs2  7,,ii7 !  
total am\nt receiv$1 or expect$ to be   
receiv$1 by ! plan or issu] f any       
applicable entity 9 rebates1 fees1      
alt]native disc\nts1 or o!r remun]ation2
 &  7,,iii7 to ! ext5t feasible1        
in=mation on ! total am\nt ( remun]ation
 = su* drugs1 includ+ copaym5t assi/ance
 doll>s paid1 copaym5t c>ds appli$1 or  
o!r disc\nts provid$ by ea* drug        
manufactur] 7or entity adm9i/]+ copaym5t
 assi/ance on behalf ( su* drug         
manufactur]7 to p>ticipants &           
b5efici>ies2  7iv7 am\nts paid directly 
or indirectly 9 rebates1 fees1 or any   
o!r type ( comp5sation 7z def9$ 9       
section #djh7;b77#b77;,b77ii77dd77,,aa7 
( ! ,employee ,retirem5t ,income        
,security ,act7 to brok]age firms1      

brok]s1 consultants1 advisors1 or any   
o!r individual or firm1 =-- 7,i7 !      
ref]ral ( ! gr\p heal? plan's or heal?  
insurance issu]'s bus9ess to an entity  
provid+ ph>macy b5efit managem5t        
s]vices1 includ+ ! id5tity ( ! recipi5t 
( su* am\nts2  7,,ii7 consid]ation ( !  
entity provid+ ph>macy b5efit managem5t 
s]vices by ! gr\p heal? plan or heal?   
insurance issu]2 or  7,,iii7 ! ret5tion 
( ! entity by ! gr\p heal? plan or heal?
 insurance issu]2  7v7 an explanation ( 
any b5efit design p>amet]s t enc\rage or
 require p>ticipants & b5efici>ies 9 su*
 plan or cov]age to fill prescriptions  
at mail ord]1 specialty1 or retail      
ph>macies t are affiliat$ ) or "u common
 own]%ip ) ! entity provid+ ph>macy     
b5efit managem5t s]vices "u su* plan or 
cov]age1 includ+ m&atory mail &         
specialty home deliv]y programs1 retail 
& mail auto-refill programs1 & co/-%>+  
assi/ance inc5tives directly or         
indirectly fund$ by su* entity2 &  7vi7 
total gross sp5d+ on all drugs "u ! plan

 or cov]age dur+ ! report+ p]iod4  7#c7 
,opt-9 = gr\p heal? insurance cov]age   
(f]$ by a specifi$ l>ge employ] or t is 
a specifi$ l>ge plan ,9 ! case ( gr\p   
heal? insurance cov]age (f]$ 9          
connection ) a gr\p heal? plan t is (f]$
 by a specifi$ l>ge employ] or is a     
specifi$ l>ge plan1 su* gr\p heal? plan 
may1 on an annual basis1 = plan ye>s    
beg9n+ on or aft] ! date t is #cj mon?s 
aft] ! date ( enactm5t ( ?is section1   
elect to require an entity provid+      
ph>macy b5efit managem5t s]vices on     
behalf ( ! heal? insurance issu] to     
submit to su* gr\p heal? plan a report t
 includes all ( ! in=mation describ$ 9  
p>agraph 7#b77;,a71 9 addition to !     
in=mation describ$ 9 p>agraph 7#b77;,b74
  7#d7 ,privacy requirem5ts  7,a7 ,9    
g5]al ,an entity provid+ ph>macy b5efit 
managem5t s]vices on behalf ( a gr\p    
heal? plan or a heal? insurance issu]   
(f]+ gr\p heal? insurance cov]age %all  
report in=mation "u p>agraph 7#a7 9 a   
mann] consi/5t ) ! privacy regulations  

promulgat$ "u section #acdjb7;a7 ( !    
,heal? ,in=mation ,te*nology = ,economic
 & ,cl9ical ,heal? ,act & consi/5t ) !  
privacy regulations promulgat$ "u !     
,heal? ,insurance ,portability &        
,acc\ntability ,act ( #aiif 9 "p #afj & 
subp>ts ,a & ,e ( "p #afd ( title #de1  
,code ( ,f$]al ,regulations 7or         
successor regulations7 7ref]r$ to 9 ?is 
p>agraph z ! ,,hipaa privacy            
regulations7 & %all re/rict ! use &     
disclosure ( su* in=mation accord+ to   
su* privacy regulations & su* ,,hipaa   
privacy regulations4  7,b7 ,additional  
requirem5ts  7i7 ,9 g5]al ,an entity    
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( a gr\p heal? plan or heal? 
insurance issu] (f]+ gr\p heal?         
insurance cov]age t submits a report "u 
p>agraph 7#a7 %all ensure t su* report  
conta9s only summ>y heal? in=mation1 z  
def9$ 9 section #afd4ejd7;a7 ( title    
#de1 ,code ( ,f$]al ,regulations 7or    
successor regulations74  7ii7           
,re/rictions ,9 c>ry+ out ?is           

subsection1 a gr\p heal? plan %all      
comply ) section #afd4ejd7;f7 ( title   
#de1 ,code ( ,f$]al ,regulations 7or a  
successor regulation71 & a plan sponsor 
%all act 9 accordance ) ! t]ms ( !      
agreem5t describ$ 9 su* section4  7,c7  
,rule ( con/ruction  7i7 ,no?+ 9 ?is    
section %all be con/ru$ to modify !     
requirem5ts = ! creation1 receipt1      
ma9t5ance1 or transmission ( protect$   
heal? in=mation "u ! ,,hipaa privacy    
regulations4  7ii7 ,no?+ 9 ?is section  
%all be con/ru$ to affect ! application 
( any ,f$]al or ,/ate privacy or civil  
rights law1 includ+ ! ,,hipaa privacy   
regulations1 ! ,g5etic ,in=mation       
,nondiscrim9ation ,act ( #bjjh 7,public 
,law #aaj-bcc7 7includ+ ! am5dm5ts made 
by su* ,act71 ! ,am]icans )             
,disabilities ,act ( #aiij 7#db         
,u4,s4,c4 #abaja et seq471 section #ejd 
( ! ,rehabilitation ,act ( #aigc 7#bi   
,u4,s4,c4 #gid71 section #aeeg ( !      
,pati5t ,protection & ,af=dable ,c>e    
,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi 

( ! ,civil ,rights ,act ( #aifd 7#db    
,u4,s4,c4 #bjjj;d71 & title ,,vii ( !   
,civil ,rights ,act ( #aifd 7#db        
,u4,s4,c4 #bjjj;e74  7,d7 ,writt5 notice
 ,ea* plan ye>1 gr\p heal? plans1       
includ+ ) respect to gr\p heal?         
insurance cov]age (f]$ 9 connection ) a 
gr\p heal? plan1 %all provide to ea*    
p>ticipant or b5efici>y writt5 notice   
in=m+ ! p>ticipant or b5efici>y ( !     
requirem5t = entities provid+ ph>macy   
b5efit managem5t s]vices on behalf ( !  
gr\p heal? plan or heal? insurance issu]
 (f]+ gr\p heal? insurance cov]age to   
submit reports to gr\p heal? plans "u   
p>agraph 7#a71 z applicable1 :i* may    
include incorporat+ su* notification 9  
plan docum5ts provid$ to ! p>ticipant or
 b5efici>y1 or provid+ individual       
notification4  7,e7 ,limitation to      
bus9ess associates ,a gr\p heal? plan   
receiv+ a report "u p>agraph 7#a7 may   
disclose su* in=mation only to ! entity 
f :i* ! report 0 receiv$ or to t        
entity's bus9ess associates z def9$ 9   

section #afj4ajc ( title #de1 ,code (   
,f$]al ,regulations 7or successor       
regulations7 or z p]mitt$ by ! ,,hipaa  
privacy regulations4  7,f7 ,cl>ification
 reg>d+ public disclosure ( in=mation   
,no?+ 9 ?is section %all prev5t an      
entity provid+ ph>macy b5efit managem5t 
s]vices on behalf ( a gr\p heal? plan or
 heal? insurance issu] (f]+ gr\p heal?  
insurance cov]age1 f plac+ reasonable   
re/rictions on ! public disclosure ( !  
in=mation conta9$ 9 a report describ$ 9 
p>agraph 7#a71 except t su* plan1 issu]1
 or entity may n-- 7i7 re/rict          
disclosure ( su* report to ! ,dep>tm5t (
 ,heal? & ,human ,s]vices1 ! ,dep>tm5t (
 ,labor1 or ! ,dep>tm5t ( ! ,treasury2  
or  7ii7 prev5t disclosure = ! purposes 
( subsection 7c71 or any o!r public     
disclosure requirem5t "u ?is section4   
7,g7 ,limit$ =m ( report ,! ,secret>y   
%all def9e ?r\gh rulemak+ a limit$ =m ( 
! report "u p>agraph 7#a7 requir$ )     
respect to any gr\p heal? plan e/abli%$ 
by a plan sponsor t is1 or is affiliat$ 

)1 a drug manufactur]1 drug :olesal]1 or
 o!r direct p>ticipant 9 ! drug supply  
*a91 9 ord] to prev5t anti-competitive  
behavior4  7#e7 ,/&>d =mat & regulations
  7,a7 ,9 g5]al ,n lat] ?an #ah mon?s   
aft] ! date ( enactm5t ( ?is section1 ! 
,secret>y %all specify ?r\gh rulemak+ a 
/&>d =mat = entities provid+ ph>macy    
b5efit managem5t s]vices on behalf (    
gr\p heal? plans & heal? insurance      
issu]s (f]+ gr\p heal? insurance        
cov]age1 to submit reports requir$ "u   
p>agraph 7#a74  7,b7 ,additional        
regulations ,n lat] ?an #ah mon?s aft] !
 date ( enactm5t ( ?is section1 !       
,secret>y %all1 ?r\gh rulemak+1         
promulgate any o!r f9al regulations     
necess>y to implem5t ! requirem5ts ( ?is
 section4 ,9 promulgat+ su* regulations1
 ! ,secret>y %all1 to ! ext5t           
practicable1 align ! report+ requirem5ts
 "u ?is section ) ! report+ requirem5ts 
"u section #bgii;,a-#aj4  7c7           
,requirem5t ,to provide in=mation to    
p>ticipants or b5efici>ies ,a gr\p heal?

 plan1 includ+ ) respect to gr\p heal?  
insurance cov]age (f]$ 9 connection ) a 
gr\p heal? plan1 ^u reque/ ( a          
p>ticipant or b5efici>y1 %all provide to
 su* p>ticipant or b5efici>y-- 7#a7 !   
summ>y docum5t describ$ 9 subsection    
7b77#b77;,b77ii72 &  7#b7 ! in=mation   
describ$ 9 subsection                   
7b77#b77;,a77i77,,iii7 ) respect to a   
claim made by or on behalf ( su*        
p>ticipant or b5efici>y4  7d7 ,en=cem5t 
7#a7 ,9 g5]al ,! ,secret>y %all en=ce   
?is section4 ,! en=cem5t au?ority "u ?is
 subsection %all apply only ) respect to
 gr\p heal? plans 7includ+ gr\p heal?   
insurance cov]age (f]$ 9 connection )   
su* a plan7 to :i* ! requirem5ts (      
subp>ts ,i & ,,ii ( "p ,a & "p ,d apply 
9 accordance ) section #bgbb1 & )       
respect to entities provid+ ph>macy     
b5efit managem5t s]vices on behalf ( su*
 plans & applicable entities provid+    
s]vices on behalf ( su* plans4  7#b7    
,failure to provide in=mation ,a gr\p   
heal? plan1 a heal? insurance issu] (f]+

 gr\p heal? insurance cov]age1 an entity
 provid+ ph>macy b5efit managem5t       
s]vices on behalf ( su* a plan or issu]1
 or an applicable entity provid+ s]vices
 on behalf ( su* a plan or issu] t      
violates subsection 7a72 an entity      
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( su* a plan or issu] t fails
 to provide ! in=mation requir$ "u      
subsection 7b72 or a gr\p heal? plan t  
fails to provide ! in=mation requir$ "u 
subsection 7c71 %all be subject to a    
civil monet>y p5alty 9 ! am\nt ( #aj1jjj
 = ea* day dur+ :i* su* violation       
cont9ues or su* in=mation is n disclos$ 
or report$4  7#c7 ,false in=mation ,a   
heal? insurance issu]1 an entity provid+
 ph>macy b5efit managem5t s]vices1 or a 
?ird p>ty adm9i/rator provid+ s]vices on
 behalf ( su* issu] (f]$ by a heal?     
insurance issu] t kn[+ly provides false 
in=mation "u ?is section %all be subject
 to a civil monet>y p5alty 9 an am\nt n 
to exce$ #ajj1jjj = ea* item ( false    
in=mation4 ,su* civil monet>y p5alty    

%all be 9 addition to o!r p5alties z may
 be prescrib$ by law4  7#d7 ,proc$ure ,!
 provisions ( section #aabh;,a ( !      
,social ,security ,act1 o!r ?an         
subsections 7a7 & 7b7 & ! fir/ s5t5ce ( 
subsection 7c77#a7 ( su* section %all   
apply to civil monet>y p5alties "u ?is  
subsection 9 ! same mann] z su*         
provisions apply to a p5alty or proce$+ 
"u su* section4  7#e7 ,waiv]s ,!        
,secret>y may waive p5alties "u p>agraph
 7#b71 or ext5d ! p]iod ( "t =          
compliance ) a requirem5t ( ?is section1
 = an entity 9 violation ( ?is section t
 has made a good-fai? ef=t to comply ) !
 requirem5ts 9 ?is section4  7e7 ,rule (
 con/ruction ,no?+ 9 ?is section %all be
 con/ru$ to p]mit a heal? insurance     
issu]1 gr\p heal? plan1 entity provid+  
ph>macy b5efit managem5t s]vices on     
behalf ( a gr\p heal? plan or heal?     
insurance issu]1 or o!r entity to       
re/rict disclosure to1 or o!rwise limit 
! access (1 ! ,secret>y to a report     
describ$ 9 subsection 7b77#a7 or        

in=mation relat$ to compliance )        
subsections 7a71 7b71 7c71 or 7d7 by su*
 issu]1 plan1 or entity4  7f7           
,def9itions ,9 ?is section3 7#a7        
,applicable entity ,! t]m applicable    
entity means-- 7,a7 an applicable gr\p  
pur*as+ organization1 drug manufactur]1 
di/ributor1 :olesal]1 rebate aggregator 
7or o!r pur*as+ entity design$ to       
aggregate rebates71 or associat$ ?ird   
p>ty2  7,b7 any subsidi>y1 p>5t1        
affiliate1 or subcontractor ( a gr\p    
heal? plan1 heal? insurance issu]1      
entity t provides ph>macy b5efit        
managem5t s]vices on behalf ( su* a plan
 or issu]1 or any entity describ$ 9     
subp>agraph 7,a72 or  7,c7 su* o!r      
entity z ! ,secret>y may specify ?r\gh  
rulemak+4  7#b7 ,applicable gr\p pur*as+
 organization ,! t]m applicable gr\p    
pur*as+ organization means a gr\p       
pur*as+ organization t is affiliat$ ) or
 "u common own]%ip ) an entity provid+  
ph>macy b5efit managem5t s]vices4  7#c7 
,contract$ comp5sation ,! t]m contract$ 

comp5sation means ! sum ( any +r$i5t co/
 & disp5s+ fee = a drug 7inclusive ( !  
out-(-pocket co/s to ! p>ticipant or    
b5efici>y71 or ano!r analog\s           
comp5sation /ructure t ! ,secret>y may  
specify ?r\gh regulations4  7#d7 ,gross 
sp5d+ ,! t]m gross sp5d+1 ) respect to  
prescription drug b5efits "u a gr\p     
heal? plan or heal? insurance cov]age1  
means ! am\nt sp5t by a gr\p heal? plan 
or heal? insurance issu] on prescription
 drug b5efits1 calculat$ be=e !         
application ( rebates1 fees1 alt]native 
disc\nts1 or o!r remun]ation4  7#e7 ,net
 sp5d+ ,! t]m net sp5d+1 ) respect to   
prescription drug b5efits "u a gr\p     
heal? plan or heal? insurance cov]age1  
means ! am\nt sp5t by a gr\p heal? plan 
or heal? insurance issu] on prescription
 drug b5efits1 calculat$ aft] !         
application ( rebates1 fees1 alt]native 
disc\nts1 or o!r remun]ation4  7#f7     
,plan sponsor ,! t]m plan sponsor has ! 
mean+ giv5 su* t]m 9 section #c7af77;,b7
 ( ! ,employee ,retirem5t ,income       

,security ,act ( #aigd4  7#g7           
,remun]ation ,! t]m remun]ation has !   
mean+ giv5 su* t]m by ! ,secret>y ?r\gh 
rulemak+1 :i* %all be reevaluat$ by !   
,secret>y e #e ye>s4  7#h7 ,specifi$    
l>ge employ] ,! t]m specifi$ l>ge       
employ] means1 9 connection ) a gr\p    
heal? plan 7includ+ gr\p heal? insurance
 cov]age (f]$ 9 connection ) su* a plan7
 e/abli%$ or ma9ta9$ by a s+le employ]1 
) respect to a cal5d> ye> or a plan ye>1
 z applicable1 an employ] :o employ$ an 
av]age ( at lea/ #ajj employees on      
bus9ess days dur+ ! prec$+ cal5d> ye> or
 plan ye> & :o employs at lea/ #a       
employee on ! fir/ day ( ! cal5d> ye> or
 plan ye>4  7#i7 ,specifi$ l>ge plan ,! 
t]m specifi$ l>ge plan means a gr\p     
heal? plan 7includ+ gr\p heal? insurance
 cov]age (f]$ 9 connection ) su* a plan7
 e/abli%$ or ma9ta9$ by a plan sponsor  
describ$ 9 clause 7ii7 or 7iii7 (       
section #c7af77;,b7 ( ! ,employee       
,retirem5t ,income ,security ,act (     
#aigd t _h an av]age ( at lea/ #ajj     

p>ticipants on bus9ess days dur+ !      
prec$+ cal5d> ye> or plan ye>1 z        
applicable4  7#aj7 ,:olesale acquisition
 co/ ,! t]m :olesale acquisition co/ has
 ! mean+ giv5 su* t]m 9 section         
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act4  2 &  7#b7 9 section    
#bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7
 9 subsection 7a7-- 7i7 9 p>agraph 7#a71
 by ins]t+ 7o!r ?an section             
#bgii;,a-#aa7 aft] "p ,d2 &  7ii7 9     
p>agraph 7#b71 by ins]t+ 7o!r ?an       
section #bgii;,a-#aa7 aft] "p ,d2 &     
7,b7 9 subsection 7b7-- 7i7 9 p>agraph  
7#a71 by ins]t+ 7o!r ?an section        
#bgii;,a-#aa7 aft] "p ,d2  7ii7 9       
p>agraph 7#b77;,a71 by ins]t+ 7o!r ?an  
section #bgii;,a-#aa7 aft] "p ,d2 &     
7iii7 9 p>agraph 7#b77;,c77ii71 by      
ins]t+ 7o!r ?an section #bgii;,a-#aa7   
aft] "p ,d4  7b7 ,employee retirem5t    
income security act ( #aigd  7#a7 ,9    
g5]al ,subtitle ,b ( title ,i ( !       
,employee ,retirem5t ,income ,security  
,act ( #aigd 7#bi ,u4,s4,c4 #ajba et    

seq47 is am5d$-- 7,a7 9 subp>t ,b ( "p  
#g 7#bi ,u4,s4,c4 #aahe et seq471 by    
add+ at ! end ! foll[+3  #gbf4 ,ov]sight
 ( entities t provide ph>macy b5efit    
managem5t s]vices  7a7 ,9 g5]al ,= plan 
ye>s beg9n+ on or aft] ! date t is #cj  
mon?s aft] ! date ( enactm5t ( ?is      
section 7ref]r$ to 9 ?is subsection &   
subsection 7b7 z ! effective date71 a   
gr\p heal? plan or a heal? insurance    
issu] (f]+ gr\p heal? insurance cov]age1
 or an entity provid+ ph>macy b5efit    
managem5t s]vices on behalf ( su* a plan
 or issu]1 %all n ent] into a contract1 
includ+ an ext5sion or r5ewal ( a       
contract1 ent]$ into on or aft] !       
effective date1 ) an applicable entity  
unless su* applicable entity agrees to--
 7#a7 n limit or delay ! disclosure (   
in=mation to ! gr\p heal? plan 7includ+ 
su* a plan (f]$ ?r\gh a heal? insurance 
issu]7 9 su* a mann] t prev5ts an entity
 provid+ ph>macy b5efit managem5t       
s]vices on behalf ( a gr\p heal? plan or
 heal? insurance issu] (f]+ gr\p heal?  

insurance cov]age f mak+ ! reports      
describ$ 9 subsection 7b72 &  7#b7      
provide ! entity provid+ ph>macy b5efit 
managem5t s]vices on behalf ( a gr\p    
heal? plan or heal? insurance issu]     
relevant in=mation necess>y to make !   
reports describ$ 9 subsection 7b74  7b7 
,reports  7#a7 ,9 g5]al ,= plan ye>s    
beg9n+ on or aft] ! effective date1 9 ! 
case ( any contract betwe5 a gr\p heal? 
plan or a heal? insurance issu] (f]+    
gr\p heal? insurance cov]age (f]$ 9     
connection ) su* a plan & an entity     
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( su* plan or issu]1 includ+ 
an ext5sion or r5ewal ( su* a contract1 
ent]$ into on or aft] ! effective date1 
! entity provid+ ph>macy b5efit         
managem5t s]vices on behalf ( su* a gr\p
 heal? plan or heal? insurance issu]1 n 
less frequ5tly ?an e #f mon?s 7or1 at ! 
reque/ ( a gr\p heal? plan1 n less      
frequ5tly ?an qu>t]ly1 & "u ! same      
conditions1 t]ms1 & co/ ( ! semiannual  
report "u ?is subsection71 %all submit  

to ! gr\p heal? plan a report 9         
accordance ) ?is section4 ,ea* su*      
report %all be made available to su*    
gr\p heal? plan 9 pla9 language1 9 a    
ma*9e-readable =mat1 & z ! ,secret>y may
 det]m9e1 o!r =mats4 ,ea* su* report    
%all include ! in=mation describ$ 9     
p>agraph 7#b74  7#b7 ,in=mation describ$
 ,= purposes ( p>agraph 7#a71 !         
in=mation describ$ 9 ?is p>agraph is1 ) 
respect to drugs cov]$ by a gr\p heal?  
plan or gr\p heal? insurance cov]age    
(f]$ by a heal? insurance issu] 9       
connection ) a gr\p heal? plan dur+ ea* 
report+ p]iod-- 7,a7 9 ! case ( a gr\p  
heal? plan t is (f]$ by a specifi$ l>ge 
employ] or t is a specifi$ l>ge plan1 & 
is n (f]$ z heal? insurance cov]age1 or 
9 ! case ( heal? insurance cov]age = :i*
 ! election "u p>agraph 7#c7 is made = !
 applicable report+ p]iod-- 7i7 a li/ ( 
drugs = :i* a claim 0 fil$ &1 ) respect 
to ea* su* drug on su* li/-- 7,i7 !     
contract$ comp5sation paid by ! gr\p    
heal? plan or heal? insurance issu] =   

ea* cov]$ drug 7id5tifi$ by ! ,national 
,drug ,code7 to ! entity provid+ ph>macy
 b5efit managem5t s]vices or o!r        
applicable entity on behalf ( ! gr\p    
heal? plan or heal? insurance issu]2    
7,,ii7 ! contract$ comp5sation paid to !
 ph>macy1 by any entity provid+ ph>macy 
b5efit managem5t s]vices or o!r         
applicable entity on behalf ( ! gr\p    
heal? plan or heal? insurance issu]1 =  
ea* cov]$ drug 7id5tifi$ by ! ,national 
,drug ,code72  7,,iii7 = ea* su* claim1 
! diff]5ce betwe5 ! am\nt paid "u       
subclause 7,i7 & ! am\nt paid "u        
subclause 7,,ii72  7,,iv7 ! propriet>y  
"n1 e/abli%$ "n or prop] "n1 & ,national
 ,drug ,code2  7,v7 = ea* claim = ! drug
 7includ+ orig9al prescriptions &       
refills7 & = ea* dosage unit ( ! drug = 
:i* a claim 0 fil$1 ! type ( disp5s+    
*annel us$ to furni% ! drug1 includ+    
retail1 mail ord]1 or specialty ph>macy2
  7,,vi7 ) respect to ea* drug disp5s$1 
= ea* type ( disp5s+ *annel 7includ+    
retail1 mail ord]1 or specialty         

ph>macy7-- 7aa7 :e!r su* drug is a br&  
"n drug or a g5]ic drug1 &-- 7,,aa7 9 ! 
case ( a br& "n drug1 ! :olesale        
acquisition co/1 li/$ z co/ p] days     
supply & co/ p] dosage unit1 on ! date  
su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( 
a g5]ic drug1 ! av]age :olesale price1  
li/$ z co/ p] days supply & co/ p]      
dosage unit1 on ! date su* drug 0       
disp5s$2 &  7bb7 ! total numb] (--      
7,,aa7 prescription claims 7includ+     
orig9al prescriptions & refills72 7,,bb7
 p>ticipants & b5efici>ies = :om a claim
 = su* drug 0 fil$ ?r\gh ! applicable   
disp5s+ *annel2 7,,cc7 dosage units &   
dosage units p] fill ( su* drug2 &      
7,,dd7 days supply ( su* drug p] fill2  
7,,vii7 ! net price p] c\rse ( treatm5t 
or s+le fill1 su* z a #cj-;day supply or
 #ij-;day supply to ! plan or cov]age   
aft] rebates1 fees1 alt]native disc\nts1
 or o!r remun]ation receiv$ f applicable
 entities2  7,,viii7 ! total am\nt (    
out-(-pocket sp5d+ by p>ticipants &     
b5efici>ies on su* drug1 includ+ sp5d+  

?r\gh copaym5ts1 co9surance1 &          
d$uctibles1 b n includ+ any am\nts sp5t 
by p>ticipants & b5efici>ies on drugs n 
cov]$ "u ! plan or cov]age1 or = :i* no 
claim is submitt$ "u ! plan or cov]age2 
7,,ix7 ! total net sp5d+ on ! drug2     
7,x7 ! total am\nt receiv$1 or expect$  
to be receiv$1 by ! plan or issu] f any 
applicable entity 9 rebates1 fees1      
alt]native disc\nts1 or o!r remun]ation2
  7,,xi7 ! total am\nt receiv$1 or      
expect$ to be receiv$1 by ! entity      
provid+ ph>macy b5efit managem5t        
s]vices1 f applicable entities1 9       
rebates1 fees1 alt]native disc\nts1 or  
o!r remun]ation f su* entities-- 7aa7 = 
claims incurr$ dur+ ! report+ p]iod2 &  
7bb7 t is relat$ to utilization ( su*   
drug or sp5d+ on su* drug2 &  7,,xii7 to
 ! ext5t feasible1 in=mation on ! total 
am\nt ( remun]ation = su* drug1 includ+ 
copaym5t assi/ance doll>s paid1 copaym5t
 c>ds appli$1 or o!r disc\nts provid$ by
 ea* drug manufactur] 7or entity        
adm9i/]+ copaym5t assi/ance on behalf ( 

su* drug manufactur]71 to ! p>ticipants 
& b5efici>ies enroll$ 9 su* plan or     
cov]age2  7ii7 a li/ ( ea* !rapeutic    
class 7z def9$ by ! ,secret>y7 = :i* a  
claim 0 fil$ "u ! gr\p heal? plan or    
heal? insurance cov]age dur+ ! report+  
p]iod1 &1 ) respect to ea* su* !rapeutic
 class-- 7,i7 ! total gross sp5d+ on    
drugs 9 su* class be=e rebates1 price   
concessions1 alt]native disc\nts1 or o!r
 remun]ation f applicable entities2     
7,,ii7 ! net sp5d+ 9 su* class aft] su* 
rebates1 price concessions1 alt]native  
disc\nts1 or o!r remun]ation f          
applicable entities2  7,,iii7 ! total   
am\nt receiv$1 or expect$ to be receiv$1
 by ! entity provid+ ph>macy b5efit     
managem5t s]vices1 f applicable         
entities1 9 rebates1 fees1 alt]native   
disc\nts1 or o!r remun]ation f su*      
entities-- 7aa7 = claims incurr$ dur+ ! 
report+ p]iod2 &  7bb7 t is relat$ to   
utilization ( drugs or drug sp5d+2      
7,,iv7 ! av]age net sp5d+ p] #cj-;day   
supply & p] #ij-;day supply by ! plan or

 by ! issu] ) respect to su* cov]age &  
its p>ticipants & b5efici>ies1 among all
 drugs )9 ! !rapeutic class = :i* a     
claim 0 fil$ dur+ ! report+ p]iod2  7,v7
 ! numb] ( p>ticipants & b5efici>ies :o 
fill$ a prescription = a drug 9 su*     
class1 includ+ ! ,national ,drug ,code =
 ea* su* drug2  7,,vi7 if applicable1 a 
description ( ! =mul>y ti]s &           
utilization me*anisms 7su* z prior      
au?orization or /ep !rapy7 employ$ =    
drugs 9 t class2 &  7,,vii7 ! total     
out-(-pocket sp5d+ "u ! plan or cov]age 
by p>ticipants & b5efici>ies1 includ+   
sp5d+ ?r\gh copaym5ts1 co9surance1 &    
d$uctibles1 b n includ+ any am\nts sp5t 
by p>ticipants & b5efici>ies on drugs n 
cov]$ "u ! plan or cov]age or = :i* no  
claim is submitt$ "u ! plan or cov]age2 
7iii7 ) respect to any drug = :i* gross 
sp5d+ "u ! gr\p heal? plan or heal?     
insurance cov]age exce$$ #aj1jjj dur+ ! 
report+ p]iod or1 9 ! case t gross sp5d+
 "u ! gr\p heal? plan or cov]age exce$$ 
#aj1jjj dur+ ! report+ p]iod ) respect  

to few] ?an #ej drugs1 ) respect to !   
#ej prescription drugs ) ! highe/ sp5d+ 
dur+ ! report+ p]iod-- 7,i7 a li/ ( all 
o!r drugs 9 ! same !rapeutic class z su*
 drug2  7,,ii7 if applicable1 !         
rationale = ! =mul>y placem5t ( su* drug
 9 t !rapeutic category or class1       
select$ f a li/ ( /&>d rationales       
e/abli%$ by ! ,secret>y1 9 consultation 
) /akehold]s2 &  7,,iii7 any *ange 9    
=mul>y placem5t comp>$ to ! prior plan  
ye>2 &  7iv7 9 ! case t su* plan or     
issu] 7or an entity provid+ ph>macy     
b5efit managem5t s]vices on behalf ( su*
 plan or issu]7 has an affiliat$ ph>macy
 or ph>macy "u common own]%ip1 includ+  
m&atory mail & specialty home deliv]y   
programs1 retail & mail auto-refill     
programs1 & co/ %>+ assi/ance inc5tives 
fund$ by an entity provid+ ph>macy      
b5efit s]vices-- 7,i7 an explanation (  
any b5efit design p>amet]s t enc\rage or
 require p>ticipants & b5efici>ies 9 !  
plan or cov]age to fill prescriptions at
 mail ord]1 specialty1 or retail        

ph>macies2  7,,ii7 ! p]c5tage ( total   
prescriptions disp5s$ by su* ph>macies  
to p>ticipants or b5efici>ies 9 su* plan
 or cov]age2 &  7,,iii7 a li/ ( all     
drugs disp5s$ by su* ph>macies to       
p>ticipants or b5efici>ies enroll$ 9 su*
 plan or cov]age1 &1 ) respect to ea*   
drug disp5s$-- 7aa7 ! am\nt *>g$1 p]    
dosage unit1 p] #cj-;day supply1 or p]  
#ij-;day supply 7z applicable7 to ! plan
 or issu]1 & to p>ticipants &           
b5efici>ies2  7bb7 ! m$ian am\nt *>g$ to
 su* plan or issu]1 & ! int]qu>tile     
range ( ! co/s1 p] dosage unit1 p]      
#cj-;day supply1 & p] #ij-;day supply1  
includ+ am\nts paid by ! p>ticipants &  
b5efici>ies1 :5 ! same drug is disp5s$  
by o!r ph>macies t are n affiliat$ ) or 
"u common own]%ip ) ! entity & t are    
includ$ 9 ! ph>macy network ( su* plan  
or cov]age2  7cc7 ! l[e/ co/ p] dosage  
unit1 p] #cj-;day supply & p] #ij-;day  
supply1 = ea* su* drug1 includ+ am\nts  
*>g$ to ! plan or cov]age & to          
p>ticipants & b5efici>ies1 t is         

available f any ph>macy includ$ 9 !     
network ( su* plan or cov]age2 &  7dd7 !
 net acquisition co/ p] dosage unit1 p] 
#cj-;day supply1 & p] #ij-;day supply1  
if su* drug is subject to a maximum     
price disc\nt2 &  7,b7 ) respect to any 
gr\p heal? plan1 includ+ gr\p heal?     
insurance cov]age (f]$ 9 connection )   
su* a plan1 reg>dless ( :e!r ! plan or  
cov]age is (f]$ by a specifi$ l>ge      
employ] or :e!r x is a specifi$ l>ge    
plan-- 7i7 a summ>y docum5t = ! gr\p    
heal? plan t includes su* in=mation     
describ$ 9 clauses 7i7 ?r\gh 7iv7 (     
subp>agraph 7,a71 z specifi$ by !       
,secret>y ?r\gh guidance1 program       
in/ruction1 or o!rwise 7) no requirem5t 
( notice & comm5t rulemak+71 t !        
,secret>y det]m9es useful to gr\p heal? 
plans = purposes ( select+ ph>macy      
b5efit managem5t s]vices1 su* z an      
e/imat$ net price to gr\p heal? plan &  
p>ticipant or b5efici>y1 a co/ p] claim1
 ! fee /ructure or reimbursem5t model1 &
 e/imat$ co/ p] p>ticipant or b5efici>y2

  7ii7 a summ>y docum5t = plans & issu]s
 to provide to p>ticipants &            
b5efici>ies1 :i* %all be made available 
to p>ticipants or b5efici>ies ^u reque/ 
to _! gr\p heal? plan 7includ+ 9 ! case 
( gr\p heal? insurance cov]age (f]$ 9   
connection ) su* a plan71 t-- 7,i7      
conta9s su* in=mation describ$ 9 clauses
 7iii71 7iv71 7v71 & 7vi71 z applicable1
 z specifi$ by ! ,secret>y ?r\gh        
guidance1 program in/ruction1 or o!rwise
 7) no requirem5t ( notice & comm5t     
rulemak+7 t ! ,secret>y det]m9es useful 
to p>ticipants or b5efici>ies 9 bett]   
und]/&+ ! plan or cov]age or b5efits "u 
su* plan or cov]age2  7,,ii7 conta9s    
only aggregate in=mation2 &  7,,iii7    
/ates t p>ticipants & b5efici>ies may   
reque/ specific1 claims-level in=mation 
requir$ to be furni%$ "u subsection 7c7 
f ! gr\p heal? plan or heal? insurance  
issu]2  7iii7 ) respect to drugs cov]$  
by su* plan or cov]age dur+ su* report+ 
p]iod-- 7,i7 ! total net sp5d+ by ! plan
 or cov]age = all su* drugs2  7,,ii7 !  

total am\nt receiv$1 or expect$ to be   
receiv$1 by ! plan or issu] f any       
applicable entity 9 rebates1 fees1      
alt]native disc\nts1 or o!r remun]ation2
 &  7,,iii7 to ! ext5t feasible1        
in=mation on ! total am\nt ( remun]ation
 = su* drugs1 includ+ copaym5t assi/ance
 doll>s paid1 copaym5t c>ds appli$1 or  
o!r disc\nts provid$ by ea* drug        
manufactur] 7or entity adm9i/]+ copaym5t
 assi/ance on behalf ( su* drug         
manufactur]7 to p>ticipants &           
b5efici>ies2  7iv7 am\nts paid directly 
or indirectly 9 rebates1 fees1 or any   
o!r type ( comp5sation 7z def9$ 9       
section #djh7;b77#b77;,b77ii77dd77,,aa77
 to brok]age firms1 brok]s1 consultants1
 advisors1 or any o!r individual or     
firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? 
plan's or heal? insurance issu]'s       
bus9ess to an entity provid+ ph>macy    
b5efit managem5t s]vices1 includ+ !     
id5tity ( ! recipi5t ( su* am\nts2      
7,,ii7 consid]ation ( ! entity provid+  
ph>macy b5efit managem5t s]vices by !   

gr\p heal? plan or heal? insurance      
issu]2 or  7,,iii7 ! ret5tion ( ! entity
 by ! gr\p heal? plan or heal? insurance
 issu]2  7v7 an explanation ( any b5efit
 design p>amet]s t enc\rage or require  
p>ticipants & b5efici>ies 9 su* plan or 
cov]age to fill prescriptions at mail   
ord]1 specialty1 or retail ph>macies t  
are affiliat$ ) or "u common own]%ip ) !
 entity provid+ ph>macy b5efit managem5t
 s]vices "u su* plan or cov]age1 includ+
 m&atory mail & specialty home deliv]y  
programs1 retail & mail auto-refill     
programs1 & co/-%>+ assi/ance inc5tives 
directly or indirectly fund$ by su*     
entity2 &  7vi7 total gross sp5d+ on all
 drugs "u ! plan or cov]age dur+ !      
report+ p]iod4  7#c7 ,opt-9 = gr\p heal?
 insurance cov]age (f]$ by a specifi$   
l>ge employ] or t is a specifi$ l>ge    
plan ,9 ! case ( gr\p heal? insurance   
cov]age (f]$ 9 connection ) a gr\p heal?
 plan t is (f]$ by a specifi$ l>ge      
employ] or is a specifi$ l>ge plan1 su* 
gr\p heal? plan may1 on an annual basis1

 = plan ye>s beg9n+ on or aft] ! date t 
is #cj mon?s aft] ! date ( enactm5t (   
?is section1 elect to require an entity 
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( ! heal? insurance issu] to 
submit to su* gr\p heal? plan a report t
 includes all ( ! in=mation describ$ 9  
p>agraph 7#b77;,a71 9 addition to !     
in=mation describ$ 9 p>agraph 7#b77;,b74
  7#d7 ,privacy requirem5ts  7,a7 ,9    
g5]al ,an entity provid+ ph>macy b5efit 
managem5t s]vices on behalf ( a gr\p    
heal? plan or a heal? insurance issu]   
(f]+ gr\p heal? insurance cov]age %all  
report in=mation "u p>agraph 7#a7 9 a   
mann] consi/5t ) ! privacy regulations  
promulgat$ "u section #acdjb7;a7 ( !    
,heal? ,in=mation ,te*nology = ,economic
 & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4  
#agicb7;a77 & consi/5t ) ! privacy      
regulations promulgat$ "u ! ,heal?      
,insurance ,portability & ,acc\ntability
 ,act ( #aiif 9 "p #afj & subp>ts ,a &  
,e ( "p #afd ( title #de1 ,code ( ,f$]al
 ,regulations 7or successor regulations7

 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa  
privacy regulations7 & %all re/rict !   
use & disclosure ( su* in=mation accord+
 to su* privacy regulations & su*       
,,hipaa privacy regulations4  7,b7      
,additional requirem5ts  7i7 ,9 g5]al   
,an entity provid+ ph>macy b5efit       
managem5t s]vices on behalf ( a gr\p    
heal? plan or heal? insurance issu] (f]+
 gr\p heal? insurance cov]age t submits 
a report "u p>agraph 7#a7 %all ensure t 
su* report conta9s only summ>y heal?    
in=mation1 z def9$ 9 section            
#afd4ejd7;a7 ( title #de1 ,code ( ,f$]al
 ,regulations 7or successor             
regulations74  7ii7 ,re/rictions ,9     
c>ry+ out ?is subsection1 a gr\p heal?  
plan %all comply ) section #afd4ejd7;f7 
( title #de1 ,code ( ,f$]al ,regulations
 7or a successor regulation71 & a plan  
sponsor %all act 9 accordance ) ! t]ms (
 ! agreem5t describ$ 9 su* section4     
7,c7 ,rule ( con/ruction  7i7 ,no?+ 9   
?is section %all be con/ru$ to modify ! 
requirem5ts = ! creation1 receipt1      

ma9t5ance1 or transmission ( protect$   
heal? in=mation "u ! ,,hipaa privacy    
regulations4  7ii7 ,no?+ 9 ?is section  
%all be con/ru$ to affect ! application 
( any ,f$]al or ,/ate privacy or civil  
rights law1 includ+ ! ,,hipaa privacy   
regulations1 ! ,g5etic ,in=mation       
,nondiscrim9ation ,act ( #bjjh 7,public 
,law #aaj-bcc7 7includ+ ! am5dm5ts made 
by su* ,act71 ! ,am]icans )             
,disabilities ,act ( #aiij 7#db         
,u4,s4,c4 #abaja et seq471 section #ejd 
( ! ,rehabilitation ,act ( #aigc 7#bi   
,u4,s4,c4 #gid71 section #aeeg ( !      
,pati5t ,protection & ,af=dable ,c>e    
,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi 
( ! ,civil ,rights ,act ( #aifd 7#db    
,u4,s4,c4 #bjjj;d71 & title ,,vii ( !   
,civil ,rights ,act ( #aifd 7#db        
,u4,s4,c4 #bjjj;e74  7,d7 ,writt5 notice
 ,ea* plan ye>1 gr\p heal? plans1       
includ+ ) respect to gr\p heal?         
insurance cov]age (f]$ 9 connection ) a 
gr\p heal? plan1 %all provide to ea*    
p>ticipant or b5efici>y writt5 notice   

in=m+ ! p>ticipant or b5efici>y ( !     
requirem5t = entities provid+ ph>macy   
b5efit managem5t s]vices on behalf ( !  
gr\p heal? plan or heal? insurance issu]
 (f]+ gr\p heal? insurance cov]age to   
submit reports to gr\p heal? plans "u   
p>agraph 7#a71 z applicable1 :i* may    
include incorporat+ su* notification 9  
plan docum5ts provid$ to ! p>ticipant or
 b5efici>y1 or provid+ individual       
notification4  7,e7 ,limitation to      
bus9ess associates ,a gr\p heal? plan   
receiv+ a report "u p>agraph 7#a7 may   
disclose su* in=mation only to ! entity 
f :i* ! report 0 receiv$ or to t        
entity's bus9ess associates z def9$ 9   
section #afj4ajc ( title #de1 ,code (   
,f$]al ,regulations 7or successor       
regulations7 or z p]mitt$ by ! ,,hipaa  
privacy regulations4  7,f7 ,cl>ification
 reg>d+ public disclosure ( in=mation   
,no?+ 9 ?is section %all prev5t an      
entity provid+ ph>macy b5efit managem5t 
s]vices on behalf ( a gr\p heal? plan or
 heal? insurance issu] (f]+ gr\p heal?  

insurance cov]age1 f plac+ reasonable   
re/rictions on ! public disclosure ( !  
in=mation conta9$ 9 a report describ$ 9 
p>agraph 7#a71 except t su* plan1 issu]1
 or entity may n-- 7i7 re/rict          
disclosure ( su* report to ! ,dep>tm5t (
 ,heal? & ,human ,s]vices1 ! ,dep>tm5t (
 ,labor1 or ! ,dep>tm5t ( ! ,treasury2  
or  7ii7 prev5t disclosure = ! purposes 
( subsection 7c71 or any o!r public     
disclosure requirem5t "u ?is section4   
7,g7 ,limit$ =m ( report ,! ,secret>y   
%all def9e ?r\gh rulemak+ a limit$ =m ( 
! report "u p>agraph 7#a7 requir$ )     
respect to any gr\p heal? plan e/abli%$ 
by a plan sponsor t is1 or is affiliat$ 
)1 a drug manufactur]1 drug :olesal]1 or
 o!r direct p>ticipant 9 ! drug supply  
*a91 9 ord] to prev5t anti-competitive  
behavior4  7#e7 ,/&>d =mat & regulations
  7,a7 ,9 g5]al ,n lat] ?an #ah mon?s   
aft] ! date ( enactm5t ( ?is section1 ! 
,secret>y %all specify ?r\gh rulemak+ a 
/&>d =mat = entities provid+ ph>macy    
b5efit managem5t s]vices on behalf (    

gr\p heal? plans & heal? insurance      
issu]s (f]+ gr\p heal? insurance        
cov]age1 to submit reports requir$ "u   
p>agraph 7#a74  7,b7 ,additional        
regulations ,n lat] ?an #ah mon?s aft] !
 date ( enactm5t ( ?is section1 !       
,secret>y %all1 ?r\gh rulemak+1         
promulgate any o!r f9al regulations     
necess>y to implem5t ! requirem5ts ( ?is
 section4 ,9 promulgat+ su* regulations1
 ! ,secret>y %all1 to ! ext5t           
practicable1 align ! report+ requirem5ts
 "u ?is section ) ! report+ requirem5ts 
"u section #gbe4  7c7 ,requirem5t ,to   
provide in=mation to p>ticipants or     
b5efici>ies ,a gr\p heal? plan1 includ+ 
) respect to gr\p heal? insurance       
cov]age (f]$ 9 connection ) a gr\p heal?
 plan1 ^u reque/ ( a p>ticipant or      
b5efici>y1 %all provide to su*          
p>ticipant or b5efici>y-- 7#a7 ! summ>y 
docum5t describ$ 9 subsection           
7b77#b77;,b77ii72 &  7#b7 ! in=mation   
describ$ 9 subsection                   
7b77#b77;,a77i77,,iii7 ) respect to a   

claim made by or on behalf ( su*        
p>ticipant or b5efici>y4  7d7 ,rule (   
con/ruction ,no?+ 9 ?is section %all be 
con/ru$ to p]mit a heal? insurance      
issu]1 gr\p heal? plan1 entity provid+  
ph>macy b5efit managem5t s]vices on     
behalf ( a gr\p heal? plan or heal?     
insurance issu]1 or o!r entity to       
re/rict disclosure to1 or o!rwise limit 
! access (1 ! ,secret>y to a report     
describ$ 9 subsection 7b77#a7 or        
in=mation relat$ to compliance )        
subsections 7a71 7b71 or 7c7 ( ?is      
section or section #ejb7;c77#ac7 by su* 
issu]1 plan1 or entity4  7e7 ,def9itions
 ,9 ?is section3 7#a7 ,applicable entity
 ,! t]m applicable entity means-- 7,a7  
an applicable gr\p pur*as+ organization1
 drug manufactur]1 di/ributor1 :olesal]1
 rebate aggregator 7or o!r pur*as+      
entity design$ to aggregate rebates71 or
 associat$ ?ird p>ty2  7,b7 any         
subsidi>y1 p>5t1 affiliate1 or          
subcontractor ( a gr\p heal? plan1 heal?
 insurance issu]1 entity t provides     

ph>macy b5efit managem5t s]vices on     
behalf ( su* a plan or issu]1 or any    
entity describ$ 9 subp>agraph 7,a72 or  
7,c7 su* o!r entity z ! ,secret>y may   
specify ?r\gh rulemak+4  7#b7           
,applicable gr\p pur*as+ organization ,!
 t]m applicable gr\p pur*as+            
organization means a gr\p pur*as+       
organization t is affiliat$ ) or "u     
common own]%ip ) an entity provid+      
ph>macy b5efit managem5t s]vices4  7#c7 
,contract$ comp5sation ,! t]m contract$ 
comp5sation means ! sum ( any +r$i5t co/
 & disp5s+ fee = a drug 7inclusive ( !  
out-(-pocket co/s to ! p>ticipant or    
b5efici>y71 or ano!r analog\s           
comp5sation /ructure t ! ,secret>y may  
specify ?r\gh regulations4  7#d7 ,gross 
sp5d+ ,! t]m gross sp5d+1 ) respect to  
prescription drug b5efits "u a gr\p     
heal? plan or heal? insurance cov]age1  
means ! am\nt sp5t by a gr\p heal? plan 
or heal? insurance issu] on prescription
 drug b5efits1 calculat$ be=e !         
application ( rebates1 fees1 alt]native 

disc\nts1 or o!r remun]ation4  7#e7 ,net
 sp5d+ ,! t]m net sp5d+1 ) respect to   
prescription drug b5efits "u a gr\p     
heal? plan or heal? insurance cov]age1  
means ! am\nt sp5t by a gr\p heal? plan 
or heal? insurance issu] on prescription
 drug b5efits1 calculat$ aft] !         
application ( rebates1 fees1 alt]native 
disc\nts1 or o!r remun]ation4  7#f7     
,plan sponsor ,! t]m plan sponsor has ! 
mean+ giv5 su* t]m 9 section            
#c7af77;,b74  7#g7 ,remun]ation ,! t]m  
remun]ation has ! mean+ giv5 su* t]m by 
! ,secret>y ?r\gh rulemak+1 :i* %all be 
reevaluat$ by ! ,secret>y e #e ye>s4    
7#h7 ,specifi$ l>ge employ] ,! t]m      
#8specifi$ l>ge employ]' means1 9       
connection ) a gr\p heal? plan 7includ+ 
gr\p heal? insurance cov]age (f]$ 9     
connection ) su* a plan7 e/abli%$ or    
ma9ta9$ by a s+le employ]1 ) respect to 
a cal5d> ye> or a plan ye>1 z           
applicable1 an employ] :o employ$ an    
av]age ( at lea/ #ajj employees on      
bus9ess days dur+ ! prec$+ cal5d> ye> or

 plan ye> & :o employs at lea/ #a       
employee on ! fir/ day ( ! cal5d> ye> or
 plan ye>4  7#i7 ,specifi$ l>ge plan ,! 
t]m specifi$ l>ge plan means a gr\p     
heal? plan 7includ+ gr\p heal? insurance
 cov]age (f]$ 9 connection ) su* a plan7
 e/abli%$ or ma9ta9$ by a plan sponsor  
describ$ 9 clause 7ii7 or 7iii7 (       
section #c7af77;,b7 t _h an av]age ( at 
lea/ #ajj p>ticipants on bus9ess days   
dur+ ! prec$+ cal5d> ye> or plan ye>1 z 
applicable4  7#aj7 ,:olesale acquisition
 co/ ,! t]m :olesale acquisition co/ has
 ! mean+ giv5 su* t]m 9 section         
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,b774  2  7,b7 9    
section #ejb 7#bi ,u4,s4,c4 #aacb7-- 7i7
 9 subsection 7a77#f71 by /rik+ or 7#i7 
& ins]t+ 7#i71 or 7#ac72  7ii7 9        
subsection 7b77#c71 by /rik+ "u         
subsection 7c77#i7 & ins]t+ "u p>agraphs
 7#i7 & 7#ac7 ( subsection 7c72 &  7iii7
 9 subsection 7c71 by add+ at ! end !   
foll[+3  7#ac7 ,secret>ial en=cem5t     

au?ority relat+ to ov]sight ( ph>macy   
b5efit managem5t s]vices  7,a7 ,failure 
to provide in=mation ,! ,secret>y may   
impose a p5alty aga9/ a plan adm9i/rator
 ( a gr\p heal? plan1 a heal? insurance 
issu] (f]+ gr\p heal? insurance cov]age1
 or an entity provid+ ph>macy b5efit    
managem5t s]vices on behalf ( su* a plan
 or issu]1 or an applicable entity 7z   
def9$ 9 section #gbf7;f77 t violates    
section #gbf7;a72 an entity provid+     
ph>macy b5efit managem5t s]vices on     
behalf ( su* a plan or issu] t fails to 
provide ! in=mation requir$ "u section  
#gbf7;b72 or any p]son :o causes a gr\p 
heal? plan to fail to provide !         
in=mation requir$ "u section #gbf7;c71 9
 ! am\nt ( #aj1jjj = ea* day dur+ :i*   
su* violation cont9ues or su* in=mation 
is n disclos$ or report$4  7,b7 ,false  
in=mation ,! ,secret>y may impose a     
p5alty aga9/ a plan adm9i/rator ( a gr\p
 heal? plan1 a heal? insurance issu]    
(f]+ gr\p heal? insurance cov]age1 an   
entity provid+ ph>macy b5efit managem5t 

s]vices1 or an applicable entity 7z     
def9$ 9 section #gbf7;f77 t kn[+ly      
provides false in=mation "u section     
#gbf1 9 an am\nt n to exce$ #ajj1jjj =  
ea* item ( false in=mation4 ,su* p5alty 
%all be 9 addition to o!r p5alties z may
 be prescrib$ by law4  7,c7 ,waiv]s ,!  
,secret>y may waive p5alties "u         
subp>agraph 7,a71 or ext5d ! p]iod ( "t 
= compliance ) a requirem5t ( ?is       
section1 = an entity 9 violation (      
section #gbf t has made a good-fai? ef=t
 to comply ) ! requirem5ts ( section    
#gbf4  2 &  7,c7 9 section #gcb7;a7 7#bi
 ,u4,s4,c4 #aaia;a7a771 by /rik+ section
 #gaa & ins]t+ sections #gaa & #gbf4    
7#b7 ,cl]ical am5dm5t ,! table ( cont5ts
 9 section #a ( ! ,employee ,retirem5t  
,income ,security ,act ( #aigd 7#bi     
,u4,s4,c4 #ajja et seq47 is am5d$ by    
ins]t+ aft] ! item relat+ to section    
#gbe ! foll[+ new item3  ,sec4 #gbf4    
,ov]sight ( entities t provide ph>macy  
b5efit managem5t s]vices4  4  7c7       
,int]nal rev5ue code ( #aihf  7#a7 ,9   

g5]al ,*apt] #ajj ( ! ,int]nal ,rev5ue  
,code ( #aihf is am5d$-- 7,a7 by add+ at
 ! end ( sub*apt] ,b ! foll[+3  #ihbf4  
,ov]sight ( entities t provide ph>macy  
b5efit managem5t s]vices  7a7 ,9 g5]al  
,= plan ye>s beg9n+ on or aft] ! date t 
is #cj mon?s aft] ! date ( enactm5t (   
?is section 7ref]r$ to 9 ?is subsection 
& subsection 7b7 z ! effective date71 a 
gr\p heal? plan1 or an entity provid+   
ph>macy b5efit managem5t s]vices on     
behalf ( su* a plan1 %all n ent] into a 
contract1 includ+ an ext5sion or r5ewal 
( a contract1 ent]$ into on or aft] !   
effective date1 ) an applicable entity  
unless su* applicable entity agrees to--
 7#a7 n limit or delay ! disclosure (   
in=mation to ! gr\p heal? plan 9 su* a  
mann] t prev5ts an entity provid+       
ph>macy b5efit managem5t s]vices on     
behalf ( a gr\p heal? plan f mak+ !     
reports describ$ 9 subsection 7b72 &    
7#b7 provide ! entity provid+ ph>macy   
b5efit managem5t s]vices on behalf ( a  
gr\p heal? plan relevant in=mation      

necess>y to make ! reports describ$ 9   
subsection 7b74  7b7 ,reports  7#a7 ,9  
g5]al ,= plan ye>s beg9n+ on or aft] !  
effective date1 9 ! case ( any contract 
betwe5 a gr\p heal? plan & an entity    
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( su* plan1 includ+ an       
ext5sion or r5ewal ( su* a contract1    
ent]$ into on or aft] ! effective date1 
! entity provid+ ph>macy b5efit         
managem5t s]vices on behalf ( su* a gr\p
 heal? plan1 n less frequ5tly ?an e #f  
mon?s 7or1 at ! reque/ ( a gr\p heal?   
plan1 n less frequ5tly ?an qu>t]ly1 & "u
 ! same conditions1 t]ms1 & co/ ( !     
semiannual report "u ?is subsection71   
%all submit to ! gr\p heal? plan a      
report 9 accordance ) ?is section4 ,ea* 
su* report %all be made available to su*
 gr\p heal? plan 9 pla9 language1 9 a   
ma*9e-readable =mat1 & z ! ,secret>y may
 det]m9e1 o!r =mats4 ,ea* su* report    
%all include ! in=mation describ$ 9     
p>agraph 7#b74  7#b7 ,in=mation describ$
 ,= purposes ( p>agraph 7#a71 !         

in=mation describ$ 9 ?is p>agraph is1 ) 
respect to drugs cov]$ by a gr\p heal?  
plan dur+ ea* report+ p]iod-- 7,a7 9 !  
case ( a gr\p heal? plan t is (f]$ by a 
specifi$ l>ge employ] or t is a specifi$
 l>ge plan1 & is n (f]$ z heal?         
insurance cov]age1 or 9 ! case ( heal?  
insurance cov]age = :i* ! election "u   
p>agraph 7#c7 is made = ! applicable    
report+ p]iod-- 7i7 a li/ ( drugs = :i* 
a claim 0 fil$ &1 ) respect to ea* su*  
drug on su* li/-- 7,i7 ! contract$      
comp5sation paid by ! gr\p heal? plan = 
ea* cov]$ drug 7id5tifi$ by ! ,national 
,drug ,code7 to ! entity provid+ ph>macy
 b5efit managem5t s]vices or o!r        
applicable entity on behalf ( ! gr\p    
heal? plan2  7,,ii7 ! contract$         
comp5sation paid to ! ph>macy1 by any   
entity provid+ ph>macy b5efit managem5t 
s]vices or o!r applicable entity on     
behalf ( ! gr\p heal? plan1 = ea* cov]$ 
drug 7id5tifi$ by ! ,national ,drug     
,code72  7,,iii7 = ea* su* claim1 !     
diff]5ce betwe5 ! am\nt paid "u         

subclause 7,i7 & ! am\nt paid "u        
subclause 7,,ii72  7,,iv7 ! propriet>y  
"n1 e/abli%$ "n or prop] "n1 & ,national
 ,drug ,code2  7,v7 = ea* claim = ! drug
 7includ+ orig9al prescriptions &       
refills7 & = ea* dosage unit ( ! drug = 
:i* a claim 0 fil$1 ! type ( disp5s+    
*annel us$ to furni% ! drug1 includ+    
retail1 mail ord]1 or specialty ph>macy2
  7,,vi7 ) respect to ea* drug disp5s$1 
= ea* type ( disp5s+ *annel 7includ+    
retail1 mail ord]1 or specialty         
ph>macy7-- 7aa7 :e!r su* drug is a br&  
"n drug or a g5]ic drug1 &-- 7,,aa7 9 ! 
case ( a br& "n drug1 ! :olesale        
acquisition co/1 li/$ z co/ p] days     
supply & co/ p] dosage unit1 on ! date  
su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( 
a g5]ic drug1 ! av]age :olesale price1  
li/$ z co/ p] days supply & co/ p]      
dosage unit1 on ! date su* drug 0       
disp5s$2 &  7bb7 ! total numb] (--      
7,,aa7 prescription claims 7includ+     
orig9al prescriptions & refills72 7,,bb7
 p>ticipants & b5efici>ies = :om a claim

 = su* drug 0 fil$ ?r\gh ! applicable   
disp5s+ *annel2 7,,cc7 dosage units &   
dosage units p] fill ( su* drug2 &      
7,,dd7 days supply ( su* drug p] fill2  
7,,vii7 ! net price p] c\rse ( treatm5t 
or s+le fill1 su* z a #cj-;day supply or
 #ij-;day supply to ! plan aft] rebates1
 fees1 alt]native disc\nts1 or o!r      
remun]ation receiv$ f applicable        
entities2  7,,viii7 ! total am\nt (     
out-(-pocket sp5d+ by p>ticipants &     
b5efici>ies on su* drug1 includ+ sp5d+  
?r\gh copaym5ts1 co9surance1 &          
d$uctibles1 b n includ+ any am\nts sp5t 
by p>ticipants & b5efici>ies on drugs n 
cov]$ "u ! plan1 or = :i* no claim is   
submitt$ "u ! plan2  7,,ix7 ! total net 
sp5d+ on ! drug2  7,x7 ! total am\nt    
receiv$1 or expect$ to be receiv$1 by ! 
plan f any applicable entity 9 rebates1 
fees1 alt]native disc\nts1 or o!r       
remun]ation2  7,,xi7 ! total am\nt      
receiv$1 or expect$ to be receiv$1 by ! 
entity provid+ ph>macy b5efit managem5t 
s]vices1 f applicable entities1 9       

rebates1 fees1 alt]native disc\nts1 or  
o!r remun]ation f su* entities-- 7aa7 = 
claims incurr$ dur+ ! report+ p]iod2 &  
7bb7 t is relat$ to utilization ( su*   
drug or sp5d+ on su* drug2 &  7,,xii7 to
 ! ext5t feasible1 in=mation on ! total 
am\nt ( remun]ation = su* drug1 includ+ 
copaym5t assi/ance doll>s paid1 copaym5t
 c>ds appli$1 or o!r disc\nts provid$ by
 ea* drug manufactur] 7or entity        
adm9i/]+ copaym5t assi/ance on behalf ( 
su* drug manufactur]71 to ! p>ticipants 
& b5efici>ies enroll$ 9 su* plan2  7ii7 
a li/ ( ea* !rapeutic class 7z def9$ by 
! ,secret>y7 = :i* a claim 0 fil$ "u !  
gr\p heal? plan dur+ ! report+ p]iod1 &1
 ) respect to ea* su* !rapeutic class-- 
7,i7 ! total gross sp5d+ on drugs 9 su* 
class be=e rebates1 price concessions1  
alt]native disc\nts1 or o!r remun]ation 
f applicable entities2  7,,ii7 ! net    
sp5d+ 9 su* class aft] su* rebates1     
price concessions1 alt]native disc\nts1 
or o!r remun]ation f applicable         
entities2  7,,iii7 ! total am\nt        

receiv$1 or expect$ to be receiv$1 by ! 
entity provid+ ph>macy b5efit managem5t 
s]vices1 f applicable entities1 9       
rebates1 fees1 alt]native disc\nts1 or  
o!r remun]ation f su* entities-- 7aa7 = 
claims incurr$ dur+ ! report+ p]iod2 &  
7bb7 t is relat$ to utilization ( drugs 
or drug sp5d+2  7,,iv7 ! av]age net     
sp5d+ p] #cj-;day supply & p] #ij-;day  
supply by ! plan & its p>ticipants &    
b5efici>ies1 among all drugs )9 !       
!rapeutic class = :i* a claim 0 fil$    
dur+ ! report+ p]iod2  7,v7 ! numb] (   
p>ticipants & b5efici>ies :o fill$ a    
prescription = a drug 9 su* class1      
includ+ ! ,national ,drug ,code = ea*   
su* drug2  7,,vi7 if applicable1 a      
description ( ! =mul>y ti]s &           
utilization me*anisms 7su* z prior      
au?orization or /ep !rapy7 employ$ =    
drugs 9 t class2 &  7,,vii7 ! total     
out-(-pocket sp5d+ "u ! plan by         
p>ticipants & b5efici>ies1 includ+ sp5d+
 ?r\gh copaym5ts1 co9surance1 &         
d$uctibles1 b n includ+ any am\nts sp5t 

by p>ticipants & b5efici>ies on drugs n 
cov]$ "u ! plan or = :i* no claim is    
submitt$ "u ! plan2  7iii7 ) respect to 
any drug = :i* gross sp5d+ "u ! gr\p    
heal? plan exce$$ #aj1jjj dur+ ! report+
 p]iod or1 9 ! case t gross sp5d+ "u !  
gr\p heal? plan exce$$ #aj1jjj dur+ !   
report+ p]iod ) respect to few] ?an #ej 
drugs1 ) respect to ! #ej prescription  
drugs ) ! highe/ sp5d+ dur+ ! report+   
p]iod-- 7,i7 a li/ ( all o!r drugs 9 !  
same !rapeutic class z su* drug2  7,,ii7
 if applicable1 ! rationale = ! =mul>y  
placem5t ( su* drug 9 t !rapeutic       
category or class1 select$ f a li/ (    
/&>d rationales e/abli%$ by ! ,secret>y1
 9 consultation ) /akehold]s2 &  7,,iii7
 any *ange 9 =mul>y placem5t comp>$ to !
 prior plan ye>2 &  7iv7 9 ! case t su* 
plan 7or an entity provid+ ph>macy      
b5efit managem5t s]vices on behalf ( su*
 plan7 has an affiliat$ ph>macy or      
ph>macy "u common own]%ip1 includ+      
m&atory mail & specialty home deliv]y   
programs1 retail & mail auto-refill     

programs1 & co/ %>+ assi/ance inc5tives 
fund$ by an entity provid+ ph>macy      
b5efit s]vices-- 7,i7 an explanation (  
any b5efit design p>amet]s t enc\rage or
 require p>ticipants & b5efici>ies 9 !  
plan to fill prescriptions at mail ord]1
 specialty1 or retail ph>macies2  7,,ii7
 ! p]c5tage ( total prescriptions       
disp5s$ by su* ph>macies to p>ticipants 
or b5efici>ies 9 su* plan2 &  7,,iii7 a 
li/ ( all drugs disp5s$ by su* ph>macies
 to p>ticipants or b5efici>ies enroll$ 9
 su* plan1 &1 ) respect to ea* drug     
disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage  
unit1 p] #cj-;day supply1 or p] #ij-;day
 supply 7z applicable7 to ! plan1 & to  
p>ticipants & b5efici>ies2  7bb7 ! m$ian
 am\nt *>g$ to su* plan1 & ! int]qu>tile
 range ( ! co/s1 p] dosage unit1 p]     
#cj-;day supply1 & p] #ij- day supply1  
includ+ am\nts paid by ! p>ticipants &  
b5efici>ies1 :5 ! same drug is disp5s$  
by o!r ph>macies t are n affiliat$ ) or 
"u common own]%ip ) ! entity & t are    
includ$ 9 ! ph>macy network ( su* plan2 

7cc7 ! l[e/ co/ p] dosage unit1 p]      
#cj-;day supply & p] #ij-;day supply1 = 
ea* su* drug1 includ+ am\nts *>g$ to !  
plan & to p>ticipants & b5efici>ies1 t  
is available f any ph>macy includ$ 9 !  
network ( su* plan2 &  7dd7 ! net       
acquisition co/ p] dosage unit1 p]      
#cj-;day supply1 & p] #ij-;day supply1  
if su* drug is subject to a maximum     
price disc\nt2 &  7,b7 ) respect to any 
gr\p heal? plan1 reg>dless ( :e!r ! plan
 is (f]$ by a specifi$ l>ge employ] or  
:e!r x is a specifi$ l>ge plan-- 7i7 a  
summ>y docum5t = ! gr\p heal? plan t    
includes su* in=mation describ$ 9       
clauses 7i7 ?r\gh 7iv7 ( subp>agraph    
7,a71 z specifi$ by ! ,secret>y ?r\gh   
guidance1 program in/ruction1 or o!rwise
 7) no requirem5t ( notice & comm5t     
rulemak+71 t ! ,secret>y det]m9es useful
 to gr\p heal? plans = purposes (       
select+ ph>macy b5efit managem5t        
s]vices1 su* z an e/imat$ net price to  
gr\p heal? plan & p>ticipant or         
b5efici>y1 a co/ p] claim1 ! fee        

/ructure or reimbursem5t model1 &       
e/imat$ co/ p] p>ticipant or b5efici>y2 
7ii7 a summ>y docum5t = plans to provide
 to p>ticipants & b5efici>ies1 :i* %all 
be made available to p>ticipants or     
b5efici>ies ^u reque/ to _! gr\p heal?  
plan1 t-- 7,i7 conta9s su* in=mation    
describ$ 9 clauses 7iii71 7iv71 7v71 &  
7vi71 z applicable1 z specifi$ by !     
,secret>y ?r\gh guidance1 program       
in/ruction1 or o!rwise 7) no requirem5t 
( notice & comm5t rulemak+7 t !         
,secret>y det]m9es useful to p>ticipants
 or b5efici>ies 9 bett] und]/&+ ! plan  
or b5efits "u su* plan2  7,,ii7 conta9s 
only aggregate in=mation2 &  7,,iii7    
/ates t p>ticipants & b5efici>ies may   
reque/ specific1 claims-level in=mation 
requir$ to be furni%$ "u subsection 7c7 
f ! gr\p heal? plan2  7iii7 ) respect to
 drugs cov]$ by su* plan dur+ su*       
report+ p]iod-- 7,i7 ! total net sp5d+  
by ! plan = all su* drugs2  7,,ii7 !    
total am\nt receiv$1 or expect$ to be   
receiv$1 by ! plan f any applicable     

entity 9 rebates1 fees1 alt]native      
disc\nts1 or o!r remun]ation2 &  7,,iii7
 to ! ext5t feasible1 in=mation on !    
total am\nt ( remun]ation = su* drugs1  
includ+ copaym5t assi/ance doll>s paid1 
copaym5t c>ds appli$1 or o!r disc\nts   
provid$ by ea* drug manufactur] 7or     
entity adm9i/]+ copaym5t assi/ance on   
behalf ( su* drug manufactur]7 to       
p>ticipants & b5efici>ies2  7iv7 am\nts 
paid directly or indirectly 9 rebates1  
fees1 or any o!r type ( comp5sation 7z  
def9$ 9 section                         
#djh7;b77#b77;,b77ii77dd77,,aa7 ( !     
,employee ,retirem5t ,income ,security  
,act 7#bi ,u4,s4,c4                     
#aajh7;b77#b77;,b77ii77dd77,,aa777 to   
brok]age firms1 brok]s1 consultants1    
advisors1 or any o!r individual or firm1
 =-- 7,i7 ! ref]ral ( ! gr\p heal?      
plan's bus9ess to an entity provid+     
ph>macy b5efit managem5t s]vices1       
includ+ ! id5tity ( ! recipi5t ( su*    
am\nts2  7,,ii7 consid]ation ( ! entity 
provid+ ph>macy b5efit managem5t s]vices

 by ! gr\p heal? plan2 or  7,,iii7 !    
ret5tion ( ! entity by ! gr\p heal?     
plan2  7v7 an explanation ( any b5efit  
design p>amet]s t enc\rage or require   
p>ticipants & b5efici>ies 9 su* plan to 
fill prescriptions at mail ord]1        
specialty1 or retail ph>macies t are    
affiliat$ ) or "u common own]%ip ) !    
entity provid+ ph>macy b5efit managem5t 
s]vices "u su* plan1 includ+ m&atory    
mail & specialty home deliv]y programs1 
retail & mail auto-refill programs1 &   
co/-%>+ assi/ance inc5tives directly or 
indirectly fund$ by su* entity2 &  7vi7 
total gross sp5d+ on all drugs "u ! plan
 dur+ ! report+ p]iod4  7#c7 ,opt-9 =   
gr\p heal? insurance cov]age (f]$ by a  
specifi$ l>ge employ] or t is a specifi$
 l>ge plan ,9 ! case ( gr\p heal?       
insurance cov]age (f]$ 9 connection ) a 
gr\p heal? plan t is (f]$ by a specifi$ 
l>ge employ] or is a specifi$ l>ge plan1
 su* gr\p heal? plan may1 on an annual  
basis1 = plan ye>s beg9n+ on or aft] !  
date t is #cj mon?s aft] ! date (       

enactm5t ( ?is section1 elect to require
 an entity provid+ ph>macy b5efit       
managem5t s]vices on behalf ( ! heal?   
insurance issu] to submit to su* gr\p   
heal? plan a report t includes all ( !  
in=mation describ$ 9 p>agraph 7#b77;,a71
 9 addition to ! in=mation describ$ 9   
p>agraph 7#b77;,b74  7#d7 ,privacy      
requirem5ts  7,a7 ,9 g5]al ,an entity   
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( a gr\p heal? plan %all     
report in=mation "u p>agraph 7#a7 9 a   
mann] consi/5t ) ! privacy regulations  
promulgat$ "u section #acdjb7;a7 ( !    
,heal? ,in=mation ,te*nology = ,economic
 & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4  
#agicb7;a77 & consi/5t ) ! privacy      
regulations promulgat$ "u ! ,heal?      
,insurance ,portability & ,acc\ntability
 ,act ( #aiif 9 "p #afj & subp>ts ,a &  
,e ( "p #afd ( title #de1 ,code ( ,f$]al
 ,regulations 7or successor regulations7
 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa  
privacy regulations7 & %all re/rict !   
use & disclosure ( su* in=mation accord+

 to su* privacy regulations & su*       
,,hipaa privacy regulations4  7,b7      
,additional requirem5ts  7i7 ,9 g5]al   
,an entity provid+ ph>macy b5efit       
managem5t s]vices on behalf ( a gr\p    
heal? plan t submits a report "u        
p>agraph 7#a7 %all ensure t su* report  
conta9s only summ>y heal? in=mation1 z  
def9$ 9 section #afd4ejd7;a7 ( title    
#de1 ,code ( ,f$]al ,regulations 7or    
successor regulations74  7ii7           
,re/rictions ,9 c>ry+ out ?is           
subsection1 a gr\p heal? plan %all      
comply ) section #afd4ejd7;f7 ( title   
#de1 ,code ( ,f$]al ,regulations 7or a  
successor regulation71 & a plan sponsor 
%all act 9 accordance ) ! t]ms ( !      
agreem5t describ$ 9 su* section4  7,c7  
,rule ( con/ruction  7i7 ,no?+ 9 ?is    
section %all be con/ru$ to modify !     
requirem5ts = ! creation1 receipt1      
ma9t5ance1 or transmission ( protect$   
heal? in=mation "u ! ,,hipaa privacy    
regulations4  7ii7 ,no?+ 9 ?is section  
%all be con/ru$ to affect ! application 

( any ,f$]al or ,/ate privacy or civil  
rights law1 includ+ ! ,,hipaa privacy   
regulations1 ! ,g5etic ,in=mation       
,nondiscrim9ation ,act ( #bjjh 7,public 
,law #aaj-bcc7 7includ+ ! am5dm5ts made 
by su* ,act71 ! ,am]icans )             
,disabilities ,act ( #aiij 7#db         
,u4,s4,c4 #abaja et seq471 section #ejd 
( ! ,rehabilitation ,act ( #aigc 7#bi   
,u4,s4,c4 #gid71 section #aeeg ( !      
,pati5t ,protection & ,af=dable ,c>e    
,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi 
( ! ,civil ,rights ,act ( #aifd 7#db    
,u4,s4,c4 #bjjj;d71 & title ,,vii ( !   
,civil ,rights ,act ( #aifd 7#db        
,u4,s4,c4 #bjjj;e74  7,d7 ,writt5 notice
 ,ea* plan ye>1 gr\p heal? plans %all   
provide to ea* p>ticipant or b5efici>y  
writt5 notice in=m+ ! p>ticipant or     
b5efici>y ( ! requirem5t = entities     
provid+ ph>macy b5efit managem5t s]vices
 on behalf ( ! gr\p heal? plan to submit
 reports to gr\p heal? plans "u p>agraph
 7#a71 z applicable1 :i* may include    
incorporat+ su* notification 9 plan     

docum5ts provid$ to ! p>ticipant or     
b5efici>y1 or provid+ individual        
notification4  7,e7 ,limitation to      
bus9ess associates ,a gr\p heal? plan   
receiv+ a report "u p>agraph 7#a7 may   
disclose su* in=mation only to ! entity 
f :i* ! report 0 receiv$ or to t        
entity's bus9ess associates z def9$ 9   
section #afj4ajc ( title #de1 ,code (   
,f$]al ,regulations 7or successor       
regulations7 or z p]mitt$ by ! ,,hipaa  
privacy regulations4  7,f7 ,cl>ification
 reg>d+ public disclosure ( in=mation   
,no?+ 9 ?is section %all prev5t an      
entity provid+ ph>macy b5efit managem5t 
s]vices on behalf ( a gr\p heal? plan1 f
 plac+ reasonable re/rictions on !      
public disclosure ( ! in=mation conta9$ 
9 a report describ$ 9 p>agraph 7#a71    
except t su* plan or entity may n-- 7i7 
re/rict disclosure ( su* report to !    
,dep>tm5t ( ,heal? & ,human ,s]vices1 ! 
,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( !  
,treasury2 or  7ii7 prev5t disclosure = 
! purposes ( subsection 7c71 or any o!r 

public disclosure requirem5t "u ?is     
section4  7,g7 ,limit$ =m ( report ,!   
,secret>y %all def9e ?r\gh rulemak+ a   
limit$ =m ( ! report "u p>agraph 7#a7   
requir$ ) respect to any gr\p heal? plan
 e/abli%$ by a plan sponsor t is1 or is 
affiliat$ )1 a drug manufactur]1 drug   
:olesal]1 or o!r direct p>ticipant 9 !  
drug supply *a91 9 ord] to prev5t       
anti-competitive behavior4  7#e7 ,/&>d  
=mat & regulations  7,a7 ,9 g5]al ,n    
lat] ?an #ah mon?s aft] ! date (        
enactm5t ( ?is section1 ! ,secret>y %all
 specify ?r\gh rulemak+ a /&>d =mat =   
entities provid+ ph>macy b5efit         
managem5t s]vices on behalf ( gr\p heal?
 plans1 to submit reports requir$ "u    
p>agraph 7#a74  7,b7 ,additional        
regulations ,n lat] ?an #ah mon?s aft] !
 date ( enactm5t ( ?is section1 !       
,secret>y %all1 ?r\gh rulemak+1         
promulgate any o!r f9al regulations     
necess>y to implem5t ! requirem5ts ( ?is
 section4 ,9 promulgat+ su* regulations1
 ! ,secret>y %all1 to ! ext5t           

practicable1 align ! report+ requirem5ts
 "u ?is section ) ! report+ requirem5ts 
"u section #ihbe4  7c7 ,requirem5t ,to  
provide in=mation to p>ticipants or     
b5efici>ies ,a gr\p heal? plan1 ^u      
reque/ ( a p>ticipant or b5efici>y1 %all
 provide to su* p>ticipant or           
b5efici>y-- 7#a7 ! summ>y docum5t       
describ$ 9 subsection 7b77#b77;,b77ii72 
&  7#b7 ! in=mation describ$ 9          
subsection 7b77#b77;,a77i77,,iii7 )     
respect to a claim made by or on behalf 
( su* p>ticipant or b5efici>y4  7d7     
,rule ( con/ruction ,no?+ 9 ?is section 
%all be con/ru$ to p]mit a heal?        
insurance issu]1 gr\p heal? plan1 entity
 provid+ ph>macy b5efit managem5t       
s]vices on behalf ( a gr\p heal? plan or
 heal? insurance issu]1 or o!r entity to
 re/rict disclosure to1 or o!rwise limit
 ! access (1 ! ,secret>y to a report    
describ$ 9 subsection 7b77#a7 or        
in=mation relat$ to compliance )        
subsections 7a71 7b71 or 7c7 ( ?is      
section or section #dihj;,d7g7 by su*   

issu]1 plan1 or entity4  7e7 ,def9itions
 ,9 ?is section3 7#a7 ,applicable entity
 ,! t]m applicable entity means-- 7,a7  
an applicable gr\p pur*as+ organization1
 drug manufactur]1 di/ributor1 :olesal]1
 rebate aggregator 7or o!r pur*as+      
entity design$ to aggregate rebates71 or
 associat$ ?ird p>ty2  7,b7 any         
subsidi>y1 p>5t1 affiliate1 or          
subcontractor ( a gr\p heal? plan1 heal?
 insurance issu]1 entity t provides     
ph>macy b5efit managem5t s]vices on     
behalf ( su* a plan or issu]1 or any    
entity describ$ 9 subp>agraph 7,a72 or  
7,c7 su* o!r entity z ! ,secret>y may   
specify ?r\gh rulemak+4  7#b7           
,applicable gr\p pur*as+ organization ,!
 t]m applicable gr\p pur*as+            
organization means a gr\p pur*as+       
organization t is affiliat$ ) or "u     
common own]%ip ) an entity provid+      
ph>macy b5efit managem5t s]vices4  7#c7 
,contract$ comp5sation ,! t]m contract$ 
comp5sation means ! sum ( any +r$i5t co/
 & disp5s+ fee = a drug 7inclusive ( !  

out-(-pocket co/s to ! p>ticipant or    
b5efici>y71 or ano!r analog\s           
comp5sation /ructure t ! ,secret>y may  
specify ?r\gh regulations4  7#d7 ,gross 
sp5d+ ,! t]m gross sp5d+1 ) respect to  
prescription drug b5efits "u a gr\p     
heal? plan1 means ! am\nt sp5t by a gr\p
 heal? plan on prescription drug        
b5efits1 calculat$ be=e ! application ( 
rebates1 fees1 alt]native disc\nts1 or  
o!r remun]ation4  7#e7 ,net sp5d+ ,! t]m
 net sp5d+1 ) respect to prescription   
drug b5efits "u a gr\p heal? plan1 means
 ! am\nt sp5t by a gr\p heal? plan on   
prescription drug b5efits1 calculat$    
aft] ! application ( rebates1 fees1     
alt]native disc\nts1 or o!r remun]ation4
  7#f7 ,plan sponsor ,! t]m plan sponsor
 has ! mean+ giv5 su* t]m 9 section     
#c7af77;,b7 ( ! ,employee ,retirem5t    
,income ,security ,act ( #aigd 7#bi     
,u4,s4,c4 #ajjb7af77;,b774  7#g7        
,remun]ation ,! t]m remun]ation has !   
mean+ giv5 su* t]m by ! ,secret>y1 ?r\gh
 rulemak+1 :i* %all be reevaluat$ by !  

,secret>y e #e ye>s4  7#h7 ,specifi$    
l>ge employ] ,! t]m specifi$ l>ge       
employ] means1 9 connection ) a gr\p    
heal? plan e/abli%$ or ma9ta9$ by a s+le
 employ]1 ) respect to a cal5d> ye> or a
 plan ye>1 z applicable1 an employ] :o  
employ$ an av]age ( at lea/ #ajj        
employees on bus9ess days dur+ ! prec$+ 
cal5d> ye> or plan ye> & :o employs at  
lea/ #a employee on ! fir/ day ( !      
cal5d> ye> or plan ye>4  7#i7 ,specifi$ 
l>ge plan ,! t]m specifi$ l>ge plan     
means a gr\p heal? plan e/abli%$ or     
ma9ta9$ by a plan sponsor describ$ 9    
clause 7ii7 or 7iii7 ( section          
#c7af77;,b7 ( ! ,employee ,retirem5t    
,income ,security ,act ( #aigd 7#bi     
,u4,s4,c4 #ajjb7af77;,b77 t _h an av]age
 ( at lea/ #ajj p>ticipants on bus9ess  
days dur+ ! prec$+ cal5d> ye> or plan   
ye>1 z applicable4  7#aj7 ,:olesale     
acquisition co/ ,! t]m :olesale         
acquisition co/ has ! mean+ giv5 su* t]m
 9 section #ahdg;,a7c77#f77;,b7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   

#aciew-#c;a7c77#f77;,b774  4  7#b7      
,exception = c]ta9 gr\p heal? plans     
,section #ihca7;a77#b7 ( ! ,int]nal     
,rev5ue ,code ( #aihf is am5d$ by ins]t+
 o!r ?an ) respect to section #ihbf1    
be=e any gr\p heal? plan4  7#c7         
,en=cem5t ,section #dihj;,d ( ! ,int]nal
 ,rev5ue ,code ( #aihf is am5d$ by add+ 
at ! end ! foll[+ new subsection3  7g7  
,application to requirem5ts impos$ on   
c]ta9 entities provid+ ph>macy b5efit   
managem5t s]vices ,9 ! case ( any       
requirem5t "u section #ihbf t applies ) 
respect to an entity provid+ ph>macy    
b5efit managem5t s]vices on behalf ( a  
gr\p heal? plan1 any ref]5ce 9 ?is      
section to su* gr\p heal? plan 7& !     
ref]5ce 9 subsection 7e77#a7 to !       
employ]7 %all be treat$ z includ+ a     
ref]5ce to su* entity4  4  7#d7 ,cl]ical
 am5dm5t ,! table ( sections = sub*apt] 
,b ( *apt] #ajj ( ! ,int]nal ,rev5ue    
,code ( #aihf is am5d$ by add+ at ! end 
! foll[+ new item3  ,sec4 #ihbf4        
,ov]sight ( entities t provide ph>macy  

b5efit managem5t s]vices4  4  #e4       
,ensur+ accurate paym5ts to ph>macies "u
 m$icaid  7a7 ,9 g5]al ,section         
#aibg7;f7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$--
 7#a7 9 p>agraph 7#a77;,a7-- 7,a7 by    
r$esignat+ clause 7ii7 z clause 7iii72 &
  7,b7 by /rik+ & aft] ! semicolon at ! 
end ( clause 7i7 & all t prec$es x ?r\gh
 7#a7 & ins]t+ ! foll[+3  7#a7 ,det]m9+ 
ph>macy actual acquisition co/s ,!      
,secret>y %all conduct a survey ( retail
 community ph>macy drug prices &        
applicable non-retail ph>macy drug      
prices to det]m9e national av]age drug  
acquisition co/ b5*m>ks 7z su* t]m is   
def9$ by ! ,secret>y7 z foll[s3 7,a7    
,use ( v5dor ,! ,secret>y may contract  
s]vices =-- 7i7 ) respect to retail     
community ph>macies1 ! det]m9ation (    
retail survey prices ( ! national av]age
 drug acquisition co/ = cov]$ outpati5t 
drugs t repres5t a nationwide av]age (  
consum] pur*ase prices = su* drugs1 net 
( all disc\nts1 rebates1 & o!r price    

concessions 7to ! ext5t any in=mation ) 
respect to su* disc\nts1 rebates1 & o!r 
price concessions is available7 bas$ on 
a mon?ly survey ( su* ph>macies2  7ii7 )
 respect to applicable non-retail       
ph>macies-- 7,i7 ! det]m9ation ( survey 
prices1 sep>ate f ! survey prices       
describ$ 9 clause 7i71 ( ! non-retail   
national av]age drug acquisition co/ =  
cov]$ outpati5t drugs t repres5t a      
nationwide av]age ( consum] pur*ase     
prices = su* drugs1 net ( all disc\nts1 
rebates1 & o!r price concessions 7to !  
ext5t any in=mation ) respect to su*    
disc\nts1 rebates1 & o!r price          
concessions is available7 bas$ on a     
mon?ly survey ( su* ph>macies2 &  7,,ii7
 at ! discretion ( ! ,secret>y1 = ea*   
type ( applicable non-retail ph>macy1 ! 
det]m9ation ( survey prices1 sep>ate f !
 survey prices describ$ 9 clause 7i7 or 
subclause 7,i7 ( ?is clause1 ( !        
national av]age drug acquisition co/ =  
su* type ( ph>macy = cov]$ outpati5t    
drugs t repres5t a nationwide av]age (  

consum] pur*ase prices = su* drugs1 net 
( all disc\nts1 rebates1 & o!r price    
concessions 7to ! ext5t any in=mation ) 
respect to su* disc\nts1 rebates1 & o!r 
price concessions is available7 bas$ on 
a mon?ly survey ( su* ph>macies2 &  2   
7#b7 9 subp>agraph 7,b7 ( p>agraph 7#a71
 by /rik+ subp>agraph 7,a77ii7 & ins]t+ 
subp>agraph 7,a77iii72  7#c7 9          
subp>agraph 7,d7 ( p>agraph 7#a71 by    
/rik+ clauses 7ii7 & 7iii7 & ins]t+ !   
foll[+3  7ii7 ,! v5dor mu/ update !     
,secret>y no less (t5 ?an mon?ly on !   
survey prices = cov]$ outpati5t drugs4  
7iii7 ,! v5dor mu/ diff]5tiate1 9       
collect+ & report+ survey data1 = all   
co/ in=mation collect$1 :e!r a ph>macy  
is a retail community ph>macy or an     
applicable non-retail ph>macy1 includ+  
:e!r su* ph>macy is an affiliate 7z     
def9$ 9 subsection 7k77#ad771 &1 9 !    
case ( an applicable non-retail ph>macy1
 :i* type ( applicable non-retail       
ph>macy x is us+ ! relevant ph>macy type
 indicators includ$ 9 ! guidance requir$

 by subsection 7d77#b7 ( section #ddabc 
( ! ,act titl$ #8,an ,act to provide =  
reconciliation pursuant to title ,,ii ( 
,h4 ,con4 ,res4 #ad4'  2  7#d7 by add+  
at ! end ( p>agraph 7#a7 ! foll[+3  7,f7
 ,survey report+ ,9 ord] to meet !      
requirem5t ( section #aijb7;a77#ed71 a  
,/ate %all require t any retail         
community ph>macy or applicable         
non-retail ph>macy 9 ! ,/ate t receives 
any paym5t1 reimbursem5t1 adm9i/rative  
fee1 disc\nt1 rebate1 or o!r price      
concession relat$ to ! disp5s+ ( cov]$  
outpati5t drugs to individuals receiv+  
b5efits "u ?is title1 reg>dless ( :e!r  
su* paym5t1 reimbursem5t1 adm9i/rative  
fee1 disc\nt1 rebate1 or o!r price      
concession is receiv$ f ! ,/ate or a    
manag$ c>e entity or o!r specifi$ entity
 7z su* t]ms are def9$ 9 section        
#aijc7m77#i77;,d77 directly or f a      
ph>macy b5efit manag] or ano!r entity t 
has a contract ) ! ,/ate or a manag$ c>e
 entity or o!r specifi$ entity 7z s     
def9$71 %all respond to surveys conduct$

 "u ?is p>agraph4  7,g7 ,survey         
in=mation ,in=mation on national drug   
acquisition prices obta9$ "u ?is        
p>agraph %all be made publicly available
 9 a =m & mann] to be det]m9$ by !      
,secret>y & %all include at lea/ !      
foll[+3 7i7 ,! mon?ly response rate to !
 survey includ+ a li/ ( ph>macies n 9   
compliance ) subp>agraph 7,f74  7ii7 ,! 
sampl+ me?odology & numb] ( ph>macies   
sampl$ mon?ly4  7iii7 ,in=mation on     
price concessions to ph>macies1 includ+ 
disc\nts1 rebates1 & o!r price          
concessions1 to ! ext5t t su* in=mation 
may be publicly releas$ & has be5       
collect$ by ! ,secret>y z "p ( ! survey4
  7,h7 ,p5alties  7i7 ,9 g5]al ,subject 
to clauses 7ii71 7iii71 & 7iv71 !       
,secret>y %all en=ce ! provisions ( ?is 
p>agraph ) respect to a ph>macy ?r\gh ! 
e/abli%m5t ( civil money p5alties       
applicable to a retail community ph>macy
 or an applicable non-retail ph>macy4   
7ii7 ,basis = p5alties ,! ,secret>y %all
 impose a civil money p5alty e/abli%$ "u

 ?is subp>agraph on a retail community  
ph>macy or applicable non-retail ph>macy
 if-- 7,i7 ! retail ph>macy or          
applicable non-retail ph>macy refuses or
 o!rwise fails to respond to a reque/ = 
in=mation ab\t prices 9 connection ) a  
survey "u ?is subsection2  7,,ii7 kn[+ly
 provides false in=mation 9 response to 
su* a survey2 or  7,,iii7 o!rwise fails 
to comply ) ! requirem5ts e/abli%$ "u   
?is p>agraph4  7iii7 ,p>amet]s =        
p5alties  7,i7 ,9 g5]al ,a civil money  
p5alty e/abli%$ "u ?is subp>agraph may  
be assess$ ) respect to ea* violation1 &
 ) respect to ea* non-compliant retail  
community ph>macy 7includ+ a ph>macy t  
is "p ( a *a97 or non-compliant         
applicable non-retail ph>macy 7includ+ a
 ph>macy t is "p ( a *a971 9 an am\nt n 
to exce$ #ajj1jjj = ea* su* violation4  
7,,ii7 ,consid]ations ,9 det]m9+ ! am\nt
 ( a civil money p5alty impos$ "u ?is   
subp>agraph1 ! ,secret>y may consid] !  
size1 bus9ess /ructure1 & type ( ph>macy
 involv$1 z well z ! type ( violation & 

o!r relevant factors1 z det]m9$         
appropriate by ! ,secret>y4  7iv7 ,rule 
( application ,! provisions ( section   
#aabh;,a 7o!r ?an subsections 7a7 & 7b77
 %all apply to a civil money p5alty "u  
?is subp>agraph 9 ! same mann] z su*    
provisions apply to a civil money p5alty
 or proce$+ "u section #aabh;,a7a74 7,i7
 ,limitation on use ( applicable        
non-retail ph>macy pric+ in=mation ,no  
,/ate %all use pric+ in=mation report$  
by applicable non-retail ph>macies "u   
subp>agraph 7,a77ii7 to develop or in=m 
paym5t me?odologies = retail community  
ph>macies4  2  7#e7 9 p>agraph 7#b7--   
7,a7 9 subp>agraph 7,a71 by ins]t+ 1    
includ+ paym5t rates & me?odologies =   
det]m9+ +r$i5t co/ reimbursem5t "u      
manag$ c>e entities or o!r specifi$     
entities 7z su* t]ms are def9$ 9 section
 #aijc7m77#i77;,d771 aft] "u ?is title2 
&  7,b7 9 subp>agraph 7,b71 by ins]t+ & 
! basis = su* disp5s+ fees be=e !       
semicolon2  7#f7 by r$esignat+ p>agraph 
7#d7 z p>agraph 7#e72  7#g7 by ins]t+   

aft] p>agraph 7#c7 ! foll[+ new         
p>agraph3  7#d7 ,ov]sight  7,a7 ,9 g5]al
 ,! ,inspector ,g5]al ( ! ,dep>tm5t (   
,heal? & ,human ,s]vices %all conduct   
p]iodic /udies ( ! survey data report$  
"u ?is subsection1 z appropriate1       
includ+ ) respect to sub/antial         
v>iations 9 acquisition co/s or o!r     
applicable co/s1 z well z ) respect to  
h[ int]nal transf] prices & relat$ p>ty 
transactions may influ5ce ! co/s report$
 by ph>macies t are affiliates 7z def9$ 
9 subsection 7k77#ad77 or are own$ by1  
controll$ by1 or relat$ "u a common     
own]%ip /ructure ) a :olesal]1          
di/ributor1 or o!r entity t acquires    
cov]$ outpati5t drugs relative to co/s  
report$ by ph>macies n affiliat$ ) su*  
entities4 ,! ,inspector ,g5]al %all     
provide p]iodic updates to ,congress on 
! results ( su* /udies1 z appropriate1 9
 a mann] t does n disclose trade secrets
 or o!r propriet>y in=mation4  7,b7     
,appropriation ,!re is appropriat$ to ! 
,inspector ,g5]al ( ! ,dep>tm5t ( ,heal?

 & ,human ,s]vices1 out ( any money 9 ! 
,treasury n o!rwise appropriat$1        
#e1jjj1jjj = fiscal ye> #bjbe1 to rema9 
available until exp5d$1 to c>ry out ?is 
p>agraph4  2 &  7#h7 9 p>agraph 7#e71 z 
s r$esignat$-- 7,a7 by ins]t+ 1 &       
#i1jjj1jjj = fiscal ye> #bjbe & ea*     
fiscal ye> !reaft]1 aft] #bjaj2 &  7,b7 
by ins]t+ ,funds appropriat$ "u ?is     
p>agraph = fiscal ye> #bjbe & any       
subsequ5t fiscal ye> %all rema9         
available until exp5d$4 aft] ! p]iod4   
7b7 ,def9itions ,section #aibg7k7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#acifr-#h7k77 is am5d$-- 7#a7 9 ! matt] 
prec$+ p>agraph 7#a71 by /rik+ ,9 !     
section & ins]t+ ,9 ?is section2 &  7#b7
 by add+ at ! end ! foll[+ new          
p>agraphs3  7#ab7 ,applicable non-retail
 ph>macy ,! t]m applicable non-retail   
ph>macy means a ph>macy t is lic5s$ z a 
ph>macy by ! ,/ate & t is n a retail    
community ph>macy1 includ+ a ph>macy t  
disp5ses prescription m$ications to     
pati5ts prim>ily ?r\gh mail & specialty 

ph>macies4 ,su* t]m does n include nurs+
 home ph>macies1 long-t]m c>e facility  
ph>macies1 hospital ph>macies1 cl9ics1  
*>itable or n-=-pr(it ph>macies1        
gov]nm5t ph>macies1 or l[ disp5s+       
ph>macies 7z def9$ by ! ,secret>y74     
7#ac7 ,affiliate ,! 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 ,effective  
date  7#a7 ,9 g5]al ,subject to p>agraph
 7#b71 ! am5dm5ts made by ?is section   
%all take effect on ! fir/ day ( ! fir/ 
qu>t] t beg9s on or aft] ! date t is #f 
mon?s aft] ! date ( enactm5t ( ?is ,act4
  7#b7 ,delay$ application to applicable
 non-retail ph>macies ,! ph>macy survey 
requirem5ts e/abli%$ by ! am5dm5ts to   
section #aibg7;f7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acifr-#h7;f77 made 
by ?is section %all apply to retail     
community ph>macies beg9n+ on !         

effective date describ$ 9 p>agraph 7#a71
 b %all n apply to applicable non-retail
 ph>macies until ! fir/ day ( ! fir/    
qu>t] t beg9s on or aft] ! date t is #ah
 mon?s aft] ! date ( enactm5t ( ?is     
,act4  7d7 ,id5tification ( applicable  
non-,retail ph>macies  7#a7 ,9 g5]al ,n 
lat] ?an ,janu>y #a1 #bjbg1 ! ,secret>y 
( ,heal? & ,human ,s]vices %all publi%  
guidance specify+ ph>macies t meet !    
def9ition ( applicable non-retail       
ph>macies 7z su* t]m is def9$ 9         
subsection 7k77#ab7 ( section #aibg ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acifr-#h71 z add$ by subsection 7b771 &
 t w be subject to ! survey requirem5ts 
"u subsection 7f77#a7 ( su* section1 z  
am5d$ by subsection 7a74  7#b7          
,inclusion ( ph>macy type indicators ,! 
guidance publi%$ "u p>agraph 7#a7 %all  
include ph>macy type indicators to      
di/+ui% betwe5 diff]5t types (          
applicable non-retail ph>macies1 su* z  
ph>macies t disp5se prescriptions       
prim>ily ?r\gh ! mail & ph>macies t     

disp5se prescriptions t require special 
h&l+ or di/ribution4 ,an applicable     
non-retail ph>macy may be id5tifi$ ?r\gh
 multiple ph>macy type indicators4  7e7 
,implem5tation  7#a7 ,implem5tation ( ! 
am5dm5ts made by ?is section %all be    
exempt f ! requirem5ts ( section #eec ( 
title #e1 ,unit$ ,/ates ,code4  7f7     
,nonapplication ( pap]work r$uction act 
,*apt] #ce ( title #dd1 ,unit$ ,/ates   
,code1 %all n apply to any data         
collection und]tak5 by ! ,secret>y (    
,heal? & ,human ,s]vices "u section     
#aibg7;f7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acifr-#h7;f771 z am5d$  
by ?is section4  #f4 ,prev5t+ ! use (   
abusive spread pric+ 9 m$icaid  7a7 ,9  
g5]al ,section #aibg ( ! ,social        
,security ,act 7#db ,u4,s4,c4 #acifr-#h7
 is am5d$-- 7#a7 9 subsection 7e71 by   
add+ at ! end ! foll[+ new p>agraph3    
7#f7 ,transp>5t prescription drug pass- 
?r\gh pric+ requir$  7,a7 ,9 g5]al ,a   
contract betwe5 ! ,/ate & a ph>macy     
b5efit manag] 7ref]r$ to 9 ?is p>agraph 

z a ,,pbm71 or a contract betwe5 ! ,/ate
 & a manag$ c>e entity or o!r specifi$  
entity 7z su* t]ms are def9$ 9 section  
#aijc7m77#i77;,d7 & collectively ref]r$ 
to 9 ?is p>agraph z ! entity7 t includes
 provisions mak+ ! entity responsible = 
cov]age ( cov]$ outpati5t drugs disp5s$ 
to individuals enroll$ ) ! entity1 %all 
require t paym5t = su* drugs & relat$   
adm9i/rative s]vices 7z applicable71    
includ+ paym5ts made by a ,,pbm on      
behalf ( ! ,/ate or entity1 is bas$ on a
 transp>5t prescription drug pass-?r\gh 
pric+ model "u :i*-- 7i7 any paym5t made
 by ! entity or ! ,,pbm 7z applicable7 =
 su* a drug-- 7,i7 is limit$ to-- 7aa7  
+r$i5t co/2 &  7bb7 a pr(essional       
disp5s+ fee t is n less ?an !           
pr(essional disp5s+ fee t ! ,/ate w\ld  
pay if ! ,/ate 7 mak+ ! paym5t directly 
9 accordance ) ! ,/ate plan2  7,,ii7 is 
pass$ ?r\gh 9 its entirety 7except z    
r$uc$ "u ,f$]al or ,/ate laws &         
regulations 9 response to in/ances (    
wa/e1 fraud1 or abuse7 by ! entity or   

,,pbm to ! ph>macy or provid] t disp5ses
 ! drug2 &  7,,iii7 is made 9 a mann] t 
is consi/5t ) sections #ddg4ejb1        
#ddg4eab1 #ddg4ead1 & #ddg4eah ( title  
#db1 ,code ( ,f$]al ,regulations 7or any
 successor regulation7 z if su*         
requirem5ts appli$ directly to ! entity 
or ! ,,pbm1 except t any paym5t by !    
entity or ! ,,pbm = ! +r$i5t co/ ( su*  
drug pur*as$ by a cov]$ entity 7z def9$ 
9 subsection 7a77#e77;,b77 may exce$ !  
actual acquisition co/ 7z def9$ 9       
#ddg4ejb ( title #db1 ,code ( ,f$]al    
,regulations1 or any successor          
regulation7 = su* drug if-- 7aa7 su*    
drug 0 subject to an agreem5t "u section
 #cdj;,b ( ! ,public ,heal? ,s]vice     
,act2  7bb7 su* paym5t = ! +r$i5t co/ ( 
su* drug does n exce$ ! maximum paym5t t
 w\ld h be5 made by ! entity or ! ,,pbm 
= ! +r$i5t co/ ( su* drug if su* drug _h
 n be5 pur*as$ by su* cov]$ entity2 &   
7cc7 su* cov]$ entity reports to !      
,secret>y 79 a =m & mann] specifi$ by ! 
,secret>y71 on an annual basis & )      

respect to paym5ts = ! +r$i5t co/s ( su*
 drugs s pur*as$ by su* cov]$ entity t  
are 9 excess ( ! actual acquisition co/s
 = su* drugs1 ! aggregate am\nt ( su*   
excess2  7ii7 paym5t to ! entity or !   
,,pbm 7z applicable7 = adm9i/rative     
s]vices p]=m$ by ! entity or ,,pbm is   
limit$ to an adm9i/rative fee t reflects
 ! fair m>ket value 7z def9$ by !       
,secret>y7 ( su* s]vices2  7iii7 !      
entity or ! ,,pbm 7z applicable7 makes  
available to ! ,/ate1 & ! ,secret>y ^u  
reque/ 9 a =m & mann] specifi$ by !     
,secret>y1 all co/s & paym5ts relat$ to 
cov]$ outpati5t drugs & accompany+      
adm9i/rative s]vices 7z describ$ 9      
clause 7ii77 incurr$1 receiv$1 or made  
by ! entity or ! ,,pbm1 brok5 d[n 7z    
specifi$ by ! ,secret>y71 to ! ext5t su*
 co/s & paym5ts are attributable to an  
individual cov]$ outpati5t drug1 by ea* 
su* drug1 includ+ any +r$i5t co/s1      
pr(essional disp5s+ fees1 adm9i/rative  
fees 7z describ$ 9 clause 7ii771        
po/-sale & po/-invoice fees1 disc\nts1  

or relat$ adju/m5ts su* z direct &      
indirect remun]ation fees1 & any & all  
o!r remun]ation1 z def9$ by ! ,secret>y2
 &  7iv7 any =m ( spread pric+ :]eby any
 am\nt *>g$ or claim$ by ! entity or !  
,,pbm 7z applicable7 t exce$s ! am\nt   
paid to ! ph>macies or provid]s on      
behalf ( ! ,/ate or entity1 includ+ any 
po/-sale or po/-invoice fees1 disc\nts1 
or relat$ adju/m5ts su* z direct &      
indirect remun]ation fees or assessm5ts1
 z def9$ by ! ,secret>y1 7aft] all[+ =  
an adm9i/rative fee z describ$ 9 clause 
7ii77 is n all[able = purposes ( claim+ 
,f$]al mat*+ paym5ts "u ?is title4  7,b7
 ,publication ( in=mation ,! ,secret>y  
%all publi%1 n less frequ5tly ?an on an 
annual basis & 9 a mann] t does n       
disclose ! id5tity ( a p>ticul> cov]$   
entity or organization1 in=mation       
receiv$ by ! ,secret>y pursuant to      
subp>agraph 7,a77iii77,,iii7 t is brok5 
out by ,/ate & by ea* ( ! foll[+        
categories ( cov]$ entity )9 ea* su*    
,/ate3 7i7 ,cov]$ entities describ$ 9   

subp>agraph 7,a7 ( section              
#cdj;,b7a77#d7 ( ! ,public ,heal?       
,s]vice ,act4  7ii7 ,cov]$ entities     
describ$ 9 subp>agraphs 7,b7 ?r\gh 7,k7 
( su* section4  7iii7 ,cov]$ entities   
describ$ 9 subp>agraph 7,l7 ( su*       
section4  7iv7 ,cov]$ entities describ$ 
9 subp>agraph 7,m7 ( su* section4  7v7  
,cov]$ entities describ$ 9 subp>agraph  
7,n7 ( su* section4  7vi7 ,cov]$        
entities describ$ 9 subp>agraph 7,o7 (  
su* section4  2 &  7#b7 9 subsection    
7k71 z previ\sly am5d$ by ?is title1 by 
add+ at ! end ! foll[+ new p>agraph3    
7#ad7 ,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$i>y1 acts z a price negotiator or 
gr\p pur*as] on behalf ( a ,/ate1 manag$
 c>e entity 7z def9$ 9 section          
#aijc7m77#i77;,d771 or o!r specifi$     
entity 7z s def9$71 or manages !        
prescription drug b5efits provid$ by a  
,/ate1 manag$ c>e entity1 or o!r        
specifi$ entity1 includ+ ! process+ &   

paym5t ( claims = prescription drugs1 ! 
p]=mance ( drug utilization review1 !   
process+ ( drug prior au?orization      
reque/s1 ! manag+ ( appeals or          
grievances relat$ to ! prescription drug
 b5efits1 contract+ ) ph>macies1        
controll+ ! co/ ( cov]$ outpati5t drugs1
 or ! provision ( s]vices relat$ !reto4 
,su* t]m includes any p]son or entity t 
acts z a price negotiator 7) reg>d to   
paym5t am\nts to ph>macies & provid]s = 
a cov]$ outpati5t drug or ! net co/ ( ! 
drug7 or gr\p pur*as] on behalf ( a     
,/ate1 manag$ c>e entity1 or o!r        
specifi$ entity or t c>ries out #a or m 
( ! o!r activities describ$ 9 ! prec$+  
s5t5ce1 irrespective ( :e!r su* p]son or
 entity calls itself a ph>macy b5efit   
manag]4  4  7b7 ,con=m+ am5dm5ts        
,section #aijc7m7 ( su* ,act 7#db       
,u4,s4,c4 #acif;b7m77 is am5d$-- 7#a7 9 
p>agraph 7#b77;,a77xiii7-- 7,a7 by /rik+
 & 7,,iii7 & ins]t+ 7,,iii72  7,b7 by   
ins]t+ be=e ! p]iod at ! end ! foll[+3 1
 & 7,,iv7 if ! contract includes        

provisions mak+ ! entity responsible =  
cov]age ( cov]$ outpati5t drugs1 !      
entity %all comply ) ! requirem5ts (    
section #aibg7;e77#f72 &  7,c7 by mov+ !
 m>g9 #b ems to ! left2 &  7#b7 by add+ 
at ! end ! foll[+ new p>agraph3  7#aj7  
,no paym5t %all be made "u ?is title to 
a ,/ate ) respect to exp5ditures incurr$
 by ! ,/ate = paym5t = s]vices provid$  
by an o!r specifi$ entity 7z def9$ 9    
p>agraph 7#i77;,d77iii77 unless su*     
s]vices are provid$ 9 accordance ) a    
contract betwe5 ! ,/ate & su* entity :i*
 satisfies ! requirem5ts ( p>agraph     
7#b77;,a77xiii74  4  7c7 ,effective date
 ,! am5dm5ts made by ?is section %all   
apply to contracts betwe5 ,/ates &      
manag$ c>e entities1 o!r specifi$       
entities1 or ph>macy b5efit manag]s t h 
an effective date beg9n+ on or aft] !   
date t is #ah mon?s aft] ! date (       
enactm5t ( ?is ,act4  7d7 ,implem5tation
  7#a7 ,implem5tation ( ! am5dm5ts made 
by ?is section %all be exempt f !       
requirem5ts ( section #eec ( title #e1  

,unit$ ,/ates ,code4  7e7               
,nonapplication ( pap]work r$uction act 
,*apt] #ce ( title #dd1 ,unit$ ,/ates   
,code1 %all n apply to any data         
collection und]tak5 by ! ,secret>y (    
,heal? & ,human ,s]vices "u section     
#aibg7;e7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acifr-#h7;e771 z am5d$  
by ?is section4