,,ii ,cal5d> ,no4 #bff #aah? ,,congress 
#a/ ,session  ,s4 #bigc ,report ,no4    
#aah-abb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$
 ,,/ates  ,septemb] #bh 7legislative    
day1 ,septemb] #bb71 #bjbc,mr4 ,wyd5    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,decemb] #g1 #bjbc,report$ by  
,mr4 ,wyd51 ) an amendment,strike out   
all aft] ! enact+ clause & ins]t ! "p   
pr9t$ 9 italic  ,a ,,bill  ,to am5d     
titles ,,xviii & ,,xix ( ! ,social      
,security ,act to e/abli% requirem5ts   
relat+ to ph>macy b5efit manag]s "u !   
,m$ic>e & ,m$icaid programs1 & = o!r    
purposes4  #a4 ,%ort title2 table (     
cont5ts  7a7 ,%ort title ,?is ,act may  
be cit$ z ! ,mod]niz+ & ,ensur+ ,,pbm   
,acc\ntability ,act4  7b7 ,table (      
cont5ts ,! table ( cont5ts ( ?is ,act is
 z foll[s3 ,sec4 #a4 ,%ort title2 table 
( cont5ts4,sec4 #b4 ,arrangem5ts )      
ph>macy b5efit manag]s ) respect to     
prescription drug plans & ,,ma-,,pd     
plans4,sec4 #c4 ,ensur+ fair assessm5t (

 ph>macy p]=mance & quality "u ,m$ic>e  
"p ,d4,sec4 #d4 ,promot+ transp>5cy =   
ph>macies "u ,m$ic>e "p ,d4,sec4 #e4    
,prev5t+ ! use ( abusive spread pric+ 9 
,m$icaid4,sec4 #f4 ,ensur+ accurate     
paym5ts to ph>macies "u ,m$icaid4,sec4  
#g4 ,,oig /udy & report on drug price   
m>k-ups 9 ,m$ic>e "p ,d4,sec4 #h4       
,resolv+ ,p,t committee conflicts (     
int]e/4,sec4 #i4 ,enhanc+ ,,pbm         
transp>5cy requirem5ts4,sec4 #aj4       
,facilitat+ midye> =mul>y *anges =      
biosimil>s4,sec4 #aa4 ,/r5g!n+ ph>macy  
access = s5iors4,sec4 #ab4              
,b5efici>y-focus$ li/5+ sessions to     
improve prescription drug plan          
transp>5cy1 access1 & *oice4,sec4 #ac4  
,report+ on en=cem5t & ov]sight (       
ph>macy access requirem5ts4,sec4 #ad4   
,,gao /udy on price-relat$ comp5sation  
across ! supply *a94,sec4 #ae4 ,reports 
on inappropriate ph>macy                
rejections4,sec4 #af4 ,,gao /udy on drug
 %ortages4,sec4 #ag4 ,report on         
biosimil> & g5]ic access "u ,m$ic>e "p  

,d4,sec4 #ah4 ,m$ic>e ,improvem5t ,fund4
  #b4 ,arrangem5ts ) ph>macy b5efit     
manag]s ) respect to prescription drug  
plans & ,,ma-,,pd plans  7a7 ,9 g5]al   
7#a7 ,prescription drug plans ,section  
#ahfj;,d-#ab ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ 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 #bjbf3 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] agrees 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$ 9 connection ) ! utilization ( 

cov]$ "p ,d drugs f any 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 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 if su* paym5t is a flat doll>
 am\nt1 is consi/5t ) fair m>ket value1 
& is relat$ to s]vices actually p]=m$ by
 ! ph>macy b5efit manag] or affiliate ( 
su* ph>macy b5efit manag] 9 connection )
 ! utilization ( cov]$ "p ,d drugs4     
7iii7 ,cl>ification on rebates &        
disc\nts us$ to l[] co/s = cov]$ "p d   
drugs ,rebates1 disc\nts1 & o!r price   
concessions receiv$ 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 & exclusively us$ to 
l[] co/s = prescription drugs "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 ,remun]ation    
arrangem5ts betwe5 ph>macy b5efit       
manag]s or affiliates ( su* ph>macy     
b5efit manag]s1 z applicable1 & o!r     
entities involv$ 9 ! disp5s+ or         
utilization ( cov]$ "p ,d drugs 7includ+
 ,,pdp sponsors1 manufactur]s1          
ph>macies1 & o!r entities z det]m9$     
appropriate by ! ,secret>y7 %all be     
subject to review by ! ,secret>y & !    
,(fice ( ! ,inspector ,g5]al ( !        
,dep>tm5t ( ,heal? & ,human ,s]vices4 ,!
 ,secret>y1 9 consultation ) ! ,(fice ( 
! ,inspector ,g5]al1 %all evaluate :e!r 
remun]ation "u su* arrangem5ts is       
consi/5t ) fair m>ket value ?r\gh       
reviews & assessm5ts ( su* remun]ation1 
z det]m9$ appropriate4  7,b7 ,transp>5cy
 reg>d+ gu>antees & co/ p]=mance        
evaluations ,! ph>macy b5efit manag]    
%all-- 7i7 def9e1 int]pret1 & apply1 9 a
 fully transp>5t & consi/5t mann] =     

purposes ( calculat+ or o!rwise evaluat+
 ph>macy b5efit manag] p]=mance aga9/   
pric+ gu>antees or simil> co/ p]=mance  
measurem5ts relat$ to rebates1 disc\nts1
 price concessions1 or net co/s1 t]ms   
su* z-- 7,i7 g5]ic drug1 9 a mann]      
consi/5t ) ! def9ition ( ! t]m "u       
section #dbc4d ( title #db1 ,code (     
,f$]al ,regulations1 or a successor     
regulation2  7,,ii7 br& "n drug1 9 a    
mann] consi/5t ) ! def9ition ( ! t]m "u 
section #dbc4d ( title #db1 ,code (     
,f$]al ,regulations1 or a successor     
regulation2  7,,iii7 specialty drug2    
7,,iv7 rebate2 &  7,v7 disc\nt2  7ii7   
id5tify any drugs1 claims1 or price     
concessions exclud$ f any pric+ gu>antee
 or o!r co/ p]=mance calculation or     
evaluation 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      
measure 9 ! writt5 agreem5t4  7,c7      
,provision ( in=mation  7i7 ,9 g5]al ,n 
lat] ?an ,july #a ( ea* ye>1 beg9n+ 9   
#bjbf1 ! 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#d74 ,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 co/ p] day's     
supply1 co/ p] dosage unit1 & co/ 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,,nadac7 = retail community ph>macies2 
&  7kk7 total manufactur]-d]iv$ rev5ue1 
inclusive ( bona fide s]vice fees1      
reta9$ by ! ph>macy b5efit manag] & any 
affiliate ( su* ph>macy b5efit manag]   
attributable to ! drug4  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/ (     
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 ! li/$ drug1 ! 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 ( prescription 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 ,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  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
 prescription drugs ( ! manufactur]     
directly or indirectly cont+5t ^u       
cov]age1 =mul>y placem5t1 or utilization
 managem5t conditions on any o!r        
prescription drugs1 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 prescription drugs 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 affiliate ( su* ph>macy  
b5efit manag]1 or an individual delegat$
 ) ! au?ority to sign on behalf ( "o (  
^! (fic]s1 :o reports directly to !     
(fic]4  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 & !    
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 t is own$ or held by an
 affiliate ( su* ph>macy b5efit manag]4 
7,e7 ,en=cem5t ,! ph>macy b5efit manag] 
%all-- 7i7 disgorge to a ,,pdp sponsor  
7or1 9 a case :]e ! ,,pdp sponsor is an 
affiliate ( su* ph>macy b5efit manag]1  
to ! ,secret>y7 any paym5t1 remun]ation1
 or o!r am\nt receiv$ by ! ph>macy      

b5efit manag] or an affiliate ( su*     
ph>macy b5efit manag] 9 violation (     
subp>agraph 7,a7 or ! writt5 agreem5t   
ent]$ into ) su* sponsor "u ?is "p )    
respect to a prescription drug plan2    
7ii7 reimburse ! ,,pdp sponsor = any    
civil money p5alty impos$ on ! ,,pdp    
sponsor z a result ( ! failure ( !      
ph>macy b5efit manag] to meet !         
requirem5ts ( ?is p>agraph t are        
applicable to ! ph>macy b5efit manag] "u
 ! agreem5t2 &  7iii7 be subject to     
punitive rem$ies = brea* ( contract =   
failure to comply ) ! requirem5ts       
applicable "u ?is p>agraph4  7#b7       
,c]tification ( compliance ,ea* ,,pdp   
sponsor %all furni% to ! ,secret>y 79 a 
"t & mann] specifi$ 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#c7 ,rule (           
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ z prohibit+ paym5ts relat$ to
 reimbursem5t = +r$i5t co/s to any      

entity t acquires prescription drugs1   
su* z a ph>macy or :olesal]4  7#d7 ,/&>d
 =mats ,n lat] ?an ,june #a1 #bjbe1 !   
,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#e7        
,confid5tiality  7,a7 ,9 g5]al          
,in=mation disclos$ by a ph>macy b5efit 
manag] or ,,pdp sponsor "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 a    
specific ph>macy b5efit manag]1         
affiliate1 manufactur] or :olesal]1     
,,pdp sponsor1 or plan1 or contract     
prices1 rebates1 disc\nts1 or o!r       
remun]ation = specific drugs 9 a mann] t
 may all[ ! id5tification ( specific    
contract+ p>ties4  7#f7 ,def9itions ,=  
purposes ( ?is subsection3 7,a7         
,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 ,,pdp sponsor1 
or t acts z a contractor or ag5t to su* 
ph>macy b5efit manag] or ,,pdp sponsor1 
ins(> z su* contractor 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 = 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 are 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 disc\nts1 rebates1 fees1  
or o!r direct or indirect remun]ation   
am\nts ) 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 #bjbf1 section              
#ahfj;,d-#ab7;h74  4  7#c7 ,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 #bj1jjj1jjj = fiscal ye>   
#bjbf1 to rema9 available until exp5d$1 
to c>ry out ! am5dm5ts made by ?is      
subsection4  7,b7 ,,oig ,9 addition to  
am\nts o!rwise available1 !re is        
appropriat$ to ! ,inspector ,g5]al ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices1   
out ( any money 9 ! ,treasury n o!rwise 
appropriat$1 #e1jjj1jjj = fiscal ye>    
#bjbf1 to rema9 available until exp5d$1 

to c>ry out ! am5dm5ts made by ?is      
subsection4  7b7 ,,gao /udy & report on 
c]ta9 report+ requirem5ts  7#a7 ,/udy ,!
 ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79
 ?is subsection ref]r$ to z !           
,comptroll] ,g5]al7 %all conduct a /udy 
on ,f$]al & ,/ate report+ requirem5ts = 
heal? plans & ph>macy b5efit manag]s    
relat$ to ! transp>5cy ( prescription   
drug co/s & prices4 ,su* /udy %all      
include an analysis ( ! foll[+3 7,a7    
,f$]al /atutory & regulatory report+    
requirem5ts = heal? plans & ph>macy     
b5efit manag]s relat$ to prescription   
drug co/s & prices4  7,b7 ,select$      
,/ates' /atutory & regulatory report+   
requirem5ts = heal? plans & ph>macy     
b5efit manag]s relat$ to prescription   
drug co/s & prices4  7,c7 ,! ext5t to   
:i* ! /atutory & regulatory report+     
requirem5ts id5tifi$ 9 subp>agraphs 7,a7
 & 7,b7 ov]lap & conflict4  7,d7 ,!     
res\rces requir$ by heal? plans &       
ph>macy b5efit manag]s to comply ) !    
report+ requirem5ts describ$ 9          

subp>agraphs 7,a7 & 7,b74  7,e7 ,o!r    
items det]m9$ appropriate by !          
,comptroll] ,g5]al4  7#b7 ,report ,n    
lat] ?an #b ye>s aft] ! date on :i*     
in=mation is fir/ requir$ to be report$ 
"u section #ahfj;,d-#ab7;h77#a77;,c7 ( !
 ,social ,security ,act1 z add$ by      
subsection 7a77#a71 ! ,comptroll] ,g5]al
 %all submit to ,congress a report      
conta9+ ! results ( ! /udy conduct$ "u  
p>agraph 7#a71 toge!r ) recomm5dations =
 legislation & adm9i/rative actions t   
w\ld /reaml9e & r$uce ! burd5 associat$ 
) ! report+ requirem5ts = heal? plans & 
ph>macy b5efit manag]s describ$ 9       
p>agraph 7#a74  7c7 ,med,p,a,c reports  
on agreem5ts ) ph>macy b5efit manag]s ) 
respect to prescription drug plans &    
,,ma-,,pd plans ,! ,m$ic>e ,paym5t      
,advisory ,commission %all submit to    
,congress ! foll[+ reports3 7#a7 ,n lat]
 ?an ,m>* #ca1 #bjbg1 a report reg>d+   
agreem5ts ) ph>macy b5efit manag]s )    
respect to prescription drug plans &    
,,ma-,,pd plans4 ,su* report %all       

include-- 7,a7 a description ( tr5ds &  
patt]ns1 includ+ relevant av]ages1      
totals1 & o!r figures = ea* ( ! types ( 
in=mation submitt$2  7,b7 an analysis ( 
any diff]5ces 9 agreem5ts & _! effects  
on plan enrollee out-(-pocket sp5d+ &   
av]age ph>macy reimbursem5t1 & any o!r  
impacts2 &  7,c7 any recomm5dations !   
,commission det]m9es appropriate4  7#b7 
,n lat] ?an ,m>* #ca1 #bjbi1 a report   
describ+ any *anges ) respect to !      
in=mation describ$ 9 p>agraph 7#a7 ov]  
"t1 toge!r ) any recomm5dations !       
,commission det]m9es appropriate4  #c4  
,ensur+ fair assessm5t ( ph>macy        
p]=mance & quality "u ,m$ic>e "p ,d  7a7
 ,/&>diz$ ph>macy p]=mance measures     
,section #ahfj;,d-#b ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7f7            
,application ( /&>diz$ ph>macy p]=mance 
measures  7#a7 ,measures ,= plan ye>s   
beg9n+ on or aft] ,janu>y #a1 #bjbe1 a  
,,pdp sponsor (f]+ a prescription drug  

plan & an ,,ma organization (f]+ an     
,,ma-,,pd plan %all1 = purposes (       
inc5tive paym5ts1 price concessions1 or 
any fees or o!r remun]ation paid or *>g$
 to a ph>macy bas$ on p]=mance measures1
 only use measures t are-- 7,a7 e/abli%$
 or adopt$ by ! ,secret>y "u p>agraph   
7#b7 & includ$ on ! li/ describ$ 9      
subp>agraph 7,b7 ( su* p>agraph2 &  7,b7
 relevant to ! p]=mance ( su* ph>macy   
bas$ on ! type ( ph>macy 7includ+       
retail1 mail ord]1 specialty1 long t]m  
c>e1 & home infusion or o!r types (     
ph>macies71 drugs disp5s$ by su*        
ph>macy1 & ph>macy s]vices us$ to       
disp5se & manage drugs by su* ph>macy4  
7#b7 ,/&>diz$ ph>macy p]=mance measures 
7,a7 ,measures  7i7 ,9 g5]al ,not)/&+   
any o!r provision ( law1 ! ,secret>y    
%all e/abli% 7or adopt pursuant to      
clause 7iii77 /&>diz$ ph>macy p]=mance  
measures t may be us$ by a ,,pdp sponsor
 (f]+ a prescription drug plan & an ,,ma
 organization (f]+ an ,,ma-,,pd plan = !
 purpose ( det]m9+ inc5tive paym5ts1    

price concessions1 or fees or o!r       
remun]ation describ$ 9 p>agraph 7#a74   
7ii7 ,requirem5ts ,! measures "u clause 
7i7 %all focus on ph>macy p]=mance &    
quality ( c>e bas$ on ! type ( ph>macy1 
z det]m9$ by ! ,secret>y4 ,su* measures 
%all be evid5ce-bas$1 feasible1         
appropriate & reasonable4  7iii7        
,adoption ( measure ,9 lieu ( e/abli%+  
"s or all ( ! measures "u ?is p>agraph1 
! ,secret>y may adopt measures t are    
endors$ by "o or m multi-/akehold]      
cons5sus organizations 7su* z ! ,ph>macy
 ,quality ,alliance71 t has p>ticipation
 f ph>macies 7includ+ retail & specialty
 ph>macies n own$ or affiliat$ ) a plan1
 ph>macy b5efit manag]1 or o!r ph>macy71
 heal? plans1 ph>macy b5efit manag]s1 & 
! ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices4  
,any measure adopt$ "u ?is clause %all  
be deem$ to meet ! requirem5ts "u clause
 7ii74  7,b7 ,ma9t5ance ( li/  7i7 ,9   
g5]al ,! ,secret>y %all ma9ta91 & publi%
 on a publicly available int]net        
website1 a li/ ( measures e/abli%$ or   

adopt$ "u ?is p>agraph4 ,su* li/ %all   
initially be publi%$ no lat] ?an ,june  
#a1 #bjbd4  7ii7 ,update ,! ,secret>y   
%all p]iodically evaluate measures1 & h[
 measures are appli$ by type ( ph>macy &
 update ! measures on ! li/ "u clause   
7i7 s t su* measures meet ! requirem5ts 
"u subp>agraph 7,a77ii74  7#c7          
,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 "u   
?is subsection4  4  7b7 ,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 #d1jjj1jjj =      
fiscal ye> #bjbe1 to rema9 available    
until exp5d$1 to c>ry out ! am5dm5t made
 by subsection 7a74  #d4 ,promot+       
transp>5cy = ph>macies "u ,m$ic>e "p ,d 
7a7 ,transp>5cy = ph>macies ,section    
#ahfj;,d-#b7;f7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#ajb7;f771 z 

add$ by section #c1 is am5d$ by add+ at 
! end ! foll[+ new p>agraph3  7#d7      
,transp>5cy = ph>macies  7,a7 ,9 g5]al  
,= plan ye>s beg9n+ on or aft] ,janu>y  
#a1 #bjbe1 a ,,pdp sponsor (f]+ a       
prescription drug plan & an ,,ma        
organization (f]+ an ,,ma-,,pd plan1 )  
respect to paym5t made by su* ,,pdp     
sponsor or su* ,,ma organization to a   
ph>macy = a cov]$ "p ,d drug disp5s$ by 
su* ph>macy dur+ a plan ye>1 %all       
promptly furni%1 ^u pay+ a claim = a    
cov]$ "p ,d drug f a ph>macy1 to su*    
ph>macy in=mation relat$ to su* claim1  
su* z ! ,network ,reimbursem5t ,,id1    
fees1 ph>macy price concessions1        
disc\nts1 inc5tives1 or any o!r =ms (   
remun]ation t affect paym5t & pric+ ( ! 
claim4  7,b7 ,/&>diz$ =mat ,! ,,pdp     
sponsor & ! ,,ma organization %all      
furni% ! in=mation describ$ 9           
subp>agraph 7,a7 9 a /&>diz$ =mat 7z    
specifi$ by ! ,secret>y7 t includes all 
fields ne$$ to price ! claim = a cov]$  
"p ,d drug disp5s$ by su* ph>macy4  7,c7

 ,availability ( in=mation to ! secret>y
 ,a ,,pdp sponsor (f]+ a prescription   
drug plan or an ,,ma organization (f]+  
an ,,ma-,,pd plan %all make ! in=mation 
describ$ 9 subp>agraph 7,a7 available to
 ! ,secret>y ^u reque/4  7,d7           
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y %all       
implem5t ?is p>agraph by program        
in/ruction or o!rwise4  4  7b7 ,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 #b1jjj1jjj =      
fiscal ye> #bjbe1 to rema9 available    
until exp5d$1 to c>ry out ! am5dm5t made
 by subsection 7a74  #e4 ,prev5t+ ! use 
( abusive spread pric+ 9 ,m$icaid  7a7  
,9 g5]al ,section #aibg7;e7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;e77 is am5d$ by add+ at ! end
 ! foll[+3  7#f7 ,transp>5t prescription
 drug pass-?r\gh pric+ requir$ ,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*-- 7,a7 any paym5t    
made by ! entity or ! ,,pbm 7z          
applicable7 = su* a drug-- 7i7 is limit$
 to-- 7,i7 +r$i5t co/2 &  7,,ii7 a      
pr(essional disp5s+ fee t is n less ?an 
! pr(essional disp5s+ fee t ! ,/ate plan
 or waiv] w\ld pay if ! plan or waiv] 0 
mak+ ! paym5t directly2  7ii7 is pass$  
?r\gh 9 its entirety by ! entity or     
,,pbm to ! ph>macy or provid] t disp5ses
 ! drug 7& %all n be r$uc$ or d5i$      

retroactively "u po/-adjudication       
processes72 &  7iii7 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$]al    
,regulations1 or any successor          
regulation7 = su* drug if-- 7,i7 su*    
drug 0 subject to an agreem5t "u section
 #cdj;,b ( ! ,public ,heal? ,s]vice     
,act2  7,,ii7 su* paym5t = ! +r$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 &  7,,iii7 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  7,b7     
paym5t to ! entity or ! ,,pbm 7z        
applicable7 = adm9i/rative s]vices p]=m$
 by ! entity or ,,pbm is limit$ to !    
fair m>ket value ( su* s]vices2  7,c7 ! 
entity or ! ,,pbm 7z applicable7 %all   
make available to ! ,/ate1 & ! ,secret>y
 ^u reque/1 all co/s & paym5ts relat$ to
 cov]$ outpati5t drugs & accompany+     
adm9i/rative s]vices incurr$1 receiv$1  
or made by ! entity or ! ,,pbm1 includ+ 
+r$i5t co/s1 pr(essional disp5s+ fees1  
adm9i/rative fees1 po/-sale &           
po/-invoice fees1 disc\nts1 or relat$   
adju/m5ts su* z direct & indirect       
remun]ation fees1 & any & all o!r       
remun]ation2 &  7,d7 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 
assessm5ts 7aft] all[+ = an adm9i/rative
 fee z describ$ 9 subp>agraph 7,b77 is n
 all[able = purposes ( claim+ ,f$]al    
mat*+ paym5ts "u ?is title4  4  7b7     
,def9ition ( ph>macy b5efit manag]      
,section #aibg7k7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acifr-#h7k77 is    
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#ab7 ,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 or o!r        
specifi$ entity 7z su* t]ms are def9$ 9 
section #aijc7m77#i77;,d771 or manages !
 prescription drug b5efits provid$ by   
su* ,/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 
c>ries out #a or m ( ! activities       
describ$ 9 ! prec$+ s5t5ce1 irrespective
 ( :e!r su* p]son or entity calls itself
 a ph>macy b5efit manag]4  4  7c7       
,con=m+ am5dm5ts ,section #aijc7m7 ( su*
 ,act 7#db ,u4,s4,c4 #acif;b7m77 is     
am5d$-- 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 ! entity1 or a ph>macy     
b5efit manag] act+ on behalf ( ! entity 
"u a contract or o!r arrangem5t betwe5 !
 entity & ! ph>macy b5efit manag]1 p]=ms
 any ( ! activities describ$ 9 section  
#aibg7k77#ab71 su* activities %all      
comply ) ! requirem5ts ( section        
#aibg7;e77#f72 &  7,c7 by mov+ ! left   
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  7d7 ,effective date
 ,! am5dm5ts made by ?is section 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
  #f4 ,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 by /rik+ & aft] ! semicolon
 at ! end ( p>agraph 7#a77;,a77i7 & 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 to det]m9e !        
national av]age drug acquisition co/ 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\nts &
 rebates 7to ! ext5t any in=mation )    
respect to su* disc\nts & rebates is    
available7 bas$ on a mon?ly survey ( su*
 ph>macies2 &  2  7#b7 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 9
 ! ,/ate t receives any paym5t1         
reimbursem5t1 adm9i/rative fee1 disc\nt1
 or rebate 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 or rebate 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$71 %all respond to surveys ( retail
 prices conduct$ "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
 & %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+    
frame & numb] ( ph>macies sampl$ mon?ly4
  7iii7 ,in=mation on price concessions 
to ! ph>macy1 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 ,! ,secret>y   
may en=ce non-compliance ) ?is p>agraph 
by a ph>macy ?r\gh ! e/abli%m5t (       

p5alties or ! susp5sion ( paym5ts "u ?is
 title1 9 full or 9 "p1 until compliance
 ) ?is p>agraph has be5 complet$4  2    
7#c7 9 p>agraph 7#b7-- 7,a7 9           
subp>agraph 7,a71 by ins]t+ 1 includ+   
paym5t rates "u ,m$icaid 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#d7 9 p>agraph 7#d71 by  
ins]t+ 1 & #e1jjj1jjj = fiscal ye> #bjbd
 & ea* fiscal ye> !reaft]1 aft] #bjaj4  
7b7 ,effective date ,! am5dm5ts made by 
?is section take effect on ! fir/ day ( 
! fir/ qu>t] t beg9s on or aft] ! date t
 is #ah mon?s aft] ! date ( enactm5t (  
?is ,act4  #g4 ,,oig /udy & report on   
drug price m>k-ups 9 ,m$ic>e "p ,d      
,section #ahfj;,d-#db ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7e7 ,,oig /udy 
& report on drug price m>k-,ups "u ?is  

"p  7#a7 ,/udy ,! ,inspector ,g5]al ( ! 
,dep>tm5t ( ,heal? & ,human ,s]vices 79 
?is subsection ref]r$ to z ! ,inspector 
,g5]al7 %all conduct a /udy on ! impact 
( relat$ p>ty transactions )9 select    
v]tically integrat$ entities on !       
negotiat$ price 7z def9$ 9 section      
#ahfj;,d-#b7;d77#a77;,b77 paid by "p ,d 
plan sponsors = cov]$ "p ,d drugs4 ,su* 
/udy may include an analysis ( ! foll[+3
 7,a7 ,acquisition co/s by ! affiliate  
)9 su* v]tically integrat$ entities t   
initially acquires ! prescription drug =
 a sample ( cov]$ "p ,d drugs1 includ+  
at lea/ #e g5]ic drugs1 br& drugs1      
specialty br& drugs1 & specialty g5]ic  
drugs4  7,b7 ,! me?odologies &          
negotiation processes us$ to calculate  
transf] prices or o!r transactions      
betwe5 relat$ p>ties ) respect to su*   
cov]$ "p ,d drugs4  7,c7 ,! impact ( !  
transactions describ$ 9 subp>agraph 7,b7
 on ! negotiat$ price1 net ( direct &   
indirect remun]ation1 = su* cov]$ "p ,d 
drugs4  7,d7 ,! m>g9 captur$ by diff]5t 

affiliates )9 su* v]tically integrat$   
entities ?r\gh ! transactions describ$ 9
 subp>agraph 7,b74  7,e7 ,an assessm5t (
 ! impact ( ! transactions describ$ 9   
subp>agraph 7,b7 on co/s to individuals 
enroll$ 9 a prescription drug plan or an
 ,,ma-,,pd plan & program sp5d+ on      
prescription drugs "u ?is "p4  7,f7 ,o!r
 issues det]m9$ to be relevant &        
appropriate by ! ,inspector ,g5]al4     
7#b7 ,report ,n lat] ?an #c ye>s aft] ! 
date ( enactm5t ( ?is subsection1 !     
,inspector ,g5]al %all submit to !      
,committee on ,f9ance ( ! ,s5ate & !    
,committee on ,en]gy & ,comm]ce & !     
,committee on ,ways & ,means ( ! ,h\se (
 ,repres5tatives a report conta9+ !     
results ( ! /udy conduct$ "u p>agraph   
7#a71 toge!r ) recomm5dations = su*     
legislation & adm9i/rative action z !   
,inspector ,g5]al det]m9es appropriate4 
7#c7 ,fund+ ,9 addition to am\nts       
o!rwise available1 !re is appropriat$ to
 ! ,inspector ,g5]al1 out ( any money 9 
! ,treasury n o!rwise appropriat$1      

#e1bjj1jjj = fiscal ye> #bjbd1 to rema9 
available until exp5d$1 to c>ry out ?is 
subsection4  4  #h4 ,resolv+ ,p,t       
committee conflicts ( int]e/ ,section   
#ahfj;,d-#d7;b77#c77;,a77ii77,i7 ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajd7;b77#c77;,a77ii77,i77 is    
am5d$ by ins]t+ ! foll[+ be=e !         
semicolon3 7&1 = #bjbe & ea* subsequ5t  
ye>1 any ph>macy b5efit manag] act+ "u  
contract ) su* sponsor (f]+ su* plan74  
#i4 ,enhanc+ ,,pbm transp>5cy           
requirem5ts  7a7 ,9 g5]al ,section      
#aaej;,a ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #acbj;b-#bc7 is am5d$-- 7#a7 
by /rik+ subsection 7a7 & ins]t+ !      
foll[+3  7a7 ,provision ( in=mation     
7#a7 ,9 g5]al ,! foll[+ entities %all   
provide ! in=mation describ$ 9          
subsection 7b7 to ! ,secret>y &1 9 !    
case ( an entity describ$ 9 subp>agraph 
7,b7 or an affiliate ( su* entity       
describ$ 9 subp>agraph 7,c71 to ! heal? 
b5efits plan ) :i* ! entity is "u       
contract1 at su* times1 & 9 su* =m &    

mann]1 z ! ,secret>y %all specify3 7,a7 
,a heal? b5efits plan4  7,b7 ,any entity
 t provides ph>macy b5efits managem5t   
s]vices on behalf ( a heal? b5efits plan
 79 ?is section ref]r$ to z a ,,pbm7 t  
manages prescription drug cov]age "u a  
contract )-- 7i7 a ,,pdp sponsor ( a    
prescription drug plan or an ,,ma       
organization (f]+ an ,,ma-,,pd plan "u  
"p ,d ( title ,,xviii2 or  7ii7 a       
qualifi$ heal? b5efits plan (f]$ ?r\gh  
an ex*ange e/abli%$ by a ,/ate "u       
section #acaa ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act4  7,c7 ,any         
affiliate ( an entity describ$ 9        
subp>agraph 7,b7 t acts z a price       
negotiator or gr\p pur*as] on behalf (  
su* ,,pbm1 ,,pdp sponsor1 ,,ma          
organization1 or qualifi$ heal? b5efits 
plan4  7#b7 ,affiliate def9$ ,9 ?is     
section1 ! t]m affiliate means any      
entity t is own$ by1 controll$ by1 or   
relat$ "u a common own]%ip /ructure ) a 
,,pbm 7includ+ an entity own$ or        
controll$ by ! ,,pdp sponsor ( a        

prescription drug plan1 ,,ma            
organization (f]+ an ,,ma-,,pd plan1 or 
qualifi$ heal? b5efits plan = :i* su*   
entity is act+ z a price negotiator or  
gr\p pur*as]74  2  7#b7 9 subsection    
7b7-- 7,a7 9 p>agraph 7#b71 by ins]t+ & 
p]c5tage aft] & ! aggregate am\nt2 &    
7,b7 by add+ at ! end ! foll[+ new      
p>agraph3  7#d7 ,! am\nt 79 ! aggregate 
& disaggregat$ by type7 ( all fees !    
,,pbm or an affiliate ( ! ,,pbm receives
 f all ph>maceutical manufactur]s 9     
connection ) pati5t utilization "u !    
plan1 & ! am\nt & p]c5tage 79 !         
aggregate & disaggregat$ by type7 ( su* 
fees t are pass$ ?r\gh to ! plan sponsor
 or issu]4  2 &  7#c7 by add+ at ! end !
 foll[+ new subsection3  7e7 ,annual    
report ,! ,secret>y %all make publicly  
available on ! int]net website ( !      
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices an  
annual report t summ>izes ! tr5ds obs]v$
 ) respect to data report$ "u subsection
 7b74  4  7b7 ,effective date ,!        
am5dm5ts made by ?is section %all apply 

to plan or contract ye>s beg9n+ on or   
aft] ,janu>y #a1 #bjbg4  7c7            
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y may        
implem5t ! am5dm5ts made by ?is section 
by program in/ruction or o!rwise4  7d7  
,non-,application ( ! pap]work r$uction 
act ,*apt] #ce ( title #dd1 ,unit$      
,/ates ,code 7commonly ref]r$ to z !    
,pap]work ,r$uction ,act ( #aiie71 %all 
n apply to ! implem5tation ( ! am5dm5ts 
made by ?is section4  #aj4 ,facilitat+  
midye> =mul>y *anges = biosimil>s  7a7  
,9 g5]al ,section #ahfj;,d-#d7;b7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajd7;b77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#e7        
,mid-ye> *anges 9 =mul>ies p]mitt$ =    
c]ta9 biosimil> biological products & ! 
ref]5ce product ( su* biosimil>s ,if a  
,,pdp sponsor ( a prescription drug plan
 uses a =mul>y 7includ+ ! use ( ti]$    
co/-%>+71 ! foll[+ %all apply3 7,a7 ,9  
g5]al ,= plan ye> #bjbe1 & subsequ5t    
plan ye>s1 9 ! case ( a cov]$ "p ,d drug

 t is ! ref]5ce biological product 7z   
def9$ 9 section #cea7;i7 ( ! ,public    
,heal? ,s]vice ,act7 ) respect to a     
biosimil> biological product 7def9$ z a 
biological product lic5s$ "u section    
#cea7k7 ( su* ,act71 ! ,,pdp sponsor    
may1 ) respect to a =mul>y1 at any "t   
aft] ! fir/ #fj days ( ! plan ye>1      
subject to p>agraph 7#c77;,e71 *ange !  
pref]r$ or ti]$ co/-%>+ /atus ( su*     
ref]5ce biological product if su* ,,pdp 
sponsor adds1 be=e or at ! same "t1 to  
su* =mul>y su* biosimil> biological     
product at ! same or a high] pref]r$    
/atus1 or to ! same or l[] co/-%>+ ti]1 
z t ( su* ref]5ce biological product    
imm$iately prior to su* *ange4  7,b7    
,reque/ = approval ( *ange ,prior to    
mak+ a *ange describ$ 9 subp>agraph     
7,a71 ! ,,pdp sponsor %all submit to !  
,secret>y a reque/ to make su* *ange4   
,if ! ,secret>y approves ! reque/ or has
 n provid$ a decision to ! ,,pdp sponsor
 reg>d+ su* reque/ )9 #cj days ( receiv+
 su* reque/1 su* ,,pdp sponsor may make 

su* *ange4  4  7b7 ,adm9i/ration  7#a7  
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y ( ,heal? & 
,human ,s]vices may implem5t ! am5dm5t  
made by subsection 7a7 by program       
in/ruction or o!rwise4  7#b7            
,non-application ( ! ,pap]work ,r$uction
 ,act ,*apt] #ce ( title #dd1 ,unit$    
,/ates ,code 7commonly ref]r$ to z !    
,pap]work ,r$uction ,act ( #aiie71 %all 
n apply to ! implem5tation ( ! am5dm5t  
made by subsection 7a74  #aa4 ,/r5g!n+  
ph>macy access = s5iors ,section        
#ahfj;,d-#d7;b77#a7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;b77#a77 is am5d$ by add+ at
 ! end ! foll[+ new subp>agraph3  7,f7  
,limit$ access drugs  7i7 ,limitation on
 re/rictions or limits on access ,= ea* 
plan ye> 7beg9n+ ) plan ye> #bjbf71 a   
,,pdp sponsor (f]+ a prescription drug  
plan-- 7,i7 may n re/rict or limit      
access to any cov]$ "p ,d drug to a     
subset ( _! network ph>macies1 o!r ?an )
 respect to a limit$ access drug1 z     

def9$ 9 clause 7v72 &  7,,ii7 %all      
docum5t ! rationale = :y a cov]$ "p ,d  
drug meets ! def9ition ( a limit$ access
 drug "u clause 7v71 if su* plan        
re/ricts or limits access to a limit$   
access drug to a subset ( network       
ph>macies4  7ii7 ,annual submission (   
in=mation to ! secret>y on limit$ access
 drugs ,= ea* plan ye> 7beg9n+ ) plan   
ye> #bjbf71 ea* ,,pdp sponsor (f]+ a    
prescription drug plan %all submit to ! 
,secret>y1 at a "t & 9 a mann] specifi$ 
by ! ,secret>y1 ) respect to ea*        
prescription drug plan (f]$ by ! sponsor
 dur+ su* plan ye>-- 7,i7 a li/ ( all   
cov]$ "p ,d drugs t ! ,,pdp sponsor     
designat$ z a limit$ access drug2       
7,,ii7 = ea* cov]$ "p ,d drug includ$ 9 
! li/ describ$ 9 subclause 7,i71 a      
writt5 rationale = :y su* drug meets !  
def9ition ( a limit$ access drug2       
7,,iii7 a summ>y ( ! requirem5ts impos$ 
on network ph>macies 7includ+ all       
accr$itation requirem5ts1 if any7 to    
ensure appropriate h&l+ & disp5s+ ( ea* 

cov]$ "p ,d drug includ$ 9 ! li/        
describ$ 9 subclause 7,i72  7,,iv7 !    
p]c5tages ( ea* cov]$ "p ,d drug includ$
 9 ! li/ describ$ 9 subclause 7,i7 t is 
disp5s$ ?r\gh retail ph>macies1         
specialty ph>macies1 mail ord]          
ph>macies1 or o!r disp5s+ *annels z     
def9$ by ! ,,pdp sponsor1 respectively2 
7,v7 ! annual p]c5tage ( ea* cov]$ "p ,d
 drug includ$ 9 ! li/ describ$ 9        
subclause 7,i7 t is disp5s$ ?r\gh a     
ph>macy t is affiliat$ ) ! plan or is an
 affiliate 7z def9$ 9 section           
#ahfj;,d-#ab7;h77#d77;,a77 ( a ph>macy  
b5efit manag] act+ on behalf ( su*      
sponsor or su* plan2 &  7,,vi7 any o!r  
in=mation det]m9$ appropriate by !      
,secret>y4  7iii7 ,ph>macy access to    
limit$ access drug in=mation ,= plan    
ye>s beg9n+ ) plan ye> #bjbf1 ^u !      
reque/ ( a network ph>macy1 a ,,pdp     
sponsor ( a prescription drug plan %all 
provide su* ph>macy1 n lat] ?an #ad days
 aft] receiv+ su* reque/1 ) ! in=mation 
describ$ 9 subclauses 7,i71 7,,ii71 &   

7,,iii7 ( clause 7ii74  7iv7 ,,hhs      
annual report on limit$ access drugs ,n 
lat] ?an ,decemb] #ca1 #bjbh1 & annually
 !reaft]1 ! ,secret>y %all submit to !  
,committee on ,f9ance ( ! ,s5ate1 & !   
,committee on ,ways & ,means & !        
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report on     
compliance by ,,pdp sponsors ) !        
requirem5ts "u ?is subp>agraph4 ,ea* su*
 report %all include-- 7,i7 a           
description ( ! patt]ns1 tr5ds1         
v>iations1 & rationales = ! designation 
by ,,pdp sponsors ( c]ta9 cov]$ "p ,d   
drugs z limit$ access drugs1 & !        
implications ( su* designations on      
b5efici>y access to su* cov]$ "p ,d     
drugs2  7,,ii7 a description ( !        
in=mation submitt$ to ! ,secret>y "u    
clause 7ii7 79 a mann] t does n disclose
 ! id5tity ( a ph>macy1 a ,,pdp sponsor1
 a prescription drug plan1 or ph>macy   
b5efit manag]1 or any propriet>y pric+  
in=mation72 &  7,,iii7 any o!r in=mation
 det]m9$ appropriate by ! ,secret>y4    

7v7 ,limit$ access drug def9$ ,9 ?is    
subp>agraph1 ! t]m limit$ access drug   
means a cov]$ "p ,d drug t meets at lea/
 "o ( ! foll[+3 7,i7 ,! ,food & ,drug   
,adm9i/ration has re/rict$ di/ribution (
 su* cov]$ "p ,d drug to c]ta9          
facilities or physicians4  7,,ii7 ,!    
disp5s+ ( su* cov]$ "p ,d drug requires 
extraord9>y special h&l+1 provid]       
coord9ation1 or pati5t education t _c be
 met by a network ph>macy4  4  7vii7    
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y %all       
implem5t ?is subp>agraph by program     
in/ruction or o!rwise4  7viii7          
,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 "u   
?is subp>agraph4  4  #ab4               
,b5efici>y-focus$ li/5+ sessions to     
improve prescription drug plan          
transp>5cy1 access1 & *oice ,section    
#ahfj;,d-#db ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aeb71 z am5d$ by 

section #g1 is am5d$ by add+ at ! end ! 
foll[+ new subsection3  7f7             
,b5efici>y-,focus$ li/5+ sessions ,to   
improve prescription drug plan          
transp>5cy1 access1 & *oice  7#a7 ,9    
g5]al ,n lat] ?an ,decemb] #ca1 #bjbd1 !
 ,secret>y %all hold at lea/ "o         
b5efici>y-focus$ li/5+ session to       
receive input on pot5tial improvem5ts to
 ! exp]i5ce )1 & transp>5cy (1          
prescription drug plans "u ?is "p1 z    
describ$ 9 p>agraph 7#b74  7#b7         
,b5efici>y-focus$ li/5+ sessions ,any   
b5efici>y-focus$ li/5+ session held "u  
p>agraph 7#a7 %all be op5 to ! public1  
includ+ b5efici>ies1 c>egiv]s (         
b5efici>ies1 consum] & pati5t advocacy  
organizations1 heal? c>e provid]s1 & o!r
 int]e/$ p>ties4 ,any su* li/5+ sessions
 may include an opportunity = ! public  
to provide input to ! ,secret>y on      
pot5tial improvem5ts to-- 7,a7 !        
in=mation made available by prescription
 drug plans to individuals2  7,b7 tools 
& me*anisms to assi/ enrollees (        

prescription drug plans 9 navigat+ plan 
compla9t sy/ems1 z well z ! effici5cy & 
effectiv5ess ( su* sy/ems2  7,c7 tools &
 me*anisms to assi/ b5efici>ies 9       
select+ a prescription drug plan2  7,d7 
tools & me*anisms to assi/ enrollees (  
prescription drug plans 9 navigat+      
utilization managem5t requirem5ts ( su* 
plans1 su* z /ep !rapy & prior          
au?orization2  7,e7 access to1 &        
effectiv5ess & utilization (1 electronic
 real-"t b5efit tools 7z describ$ 9     
section #dbc4afj7;b77#g7 ( title #db1   
,code ( ,f$]al ,regulations1 or any     
successor regulation7 & b5efici>y       
real-"t b5efit tools 7z describ$ 9      
section #dbc4abh7;d77#d7 ( title #db1   
,code ( ,f$]al ,regulations1 or any     
successor regulation72  7,f7 =mul>y     
managem5t & ov]sight by prescription    
drug plans2 &  7,g7 o!r subjects1 z     
det]m9$ appropriate by ! ,secret>y4  4  
#ac4 ,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 
section #ab1 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7g7 ,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  #ad4 ,,gao /udy on       
price-relat$ comp5sation across ! supply
 *a9 ,section #ahfj;,d-#db ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb71 z am5d$ by section #ac1 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7h7 ,,gao /udy & report on 
price-,relat$ comp5sation & paym5t      

/ructures 9 ! prescription drug 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 ?is "p4  
,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 "p ,d plan sponsors2     
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 advise "p ,d plan sponsors   

ab\t ph>macy b5efits or review "p ,d    
plan sponsor 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
 ?is "p & ! ,m$icaid program "u title   
,,xix4  7,f7 ,! effects ( drug          
price-relat$ 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 subsection1 ! ,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  4  #ae4 ,reports on       
inappropriate ph>macy rejections        
,section #ahfj;,d-#db ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb71 z am5d$ by section #ad1 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7i7 ,bi5nial report on     
ef=ts ,to address inappropriate ph>macy 
rejections & inappropriate cov]age      
d5ials "u ,m$ic>e "p ,d  7#a7 ,9 g5]al  
,n lat] ?an ,janu>y #a1 #bjbf1 & at lea/
 once e #d ye>s !reaft]1 ! ,secret>y1 9 
consultation ) ! ,(fice ( ! ,inspector  
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices1 %all po/1 on a publicly       
available website1 a report relat$ to   
prev5t+1 id5tify+1 or address+          
inappropriate ph>macy rejections 7z     
def9$ 9 p>agraph 7#b77;,b77 &           
inappropriate cov]age d5ials 7z def9$ 9 
p>agraph 7#b77;,a77 "u ?is "p4 ,su*     
reports %all include-- 7,a7 a           
description ( programs1 reviews1 or     

initiatives und]way to prev5t1 id5tify1 
or address su* rejections & d5ials1 9   
accordance ) exi/+ au?orities2  7,b7 a  
summ>y ( data collect$ or o!r in=mation 
available ) respect to su* rejections & 
d5ials1 includ+-- 7i7 /&>ds 7if any su* 
/&>ds h be5 adopt$7 us$ by ! ,secret>y =
 id5tify+ ,,pdp sponsors & ,,ma         
organizations ) relatively high rates ( 
su* rejections or d5ials2 &  7ii7       
notable longitud9al tr5ds or o!r        
patt]ns1 z det]m9$ appropriate by !     
,secret>y2  7,c7 an ov]view ( corrective
 actions tak5 & te*nical assi/ance      
provid$ by ! ,secret>y 9 response to    
violations ( exi/+ requirem5ts ) respect
 to su* rejections & d5ials2 &  7,d7 a  
description ( b>ri]s1 if any1 prev5t+ ! 
,secret>y f tak+ adm9i/rative actions   
suffici5t to id5tify & address su*      
rejections & d5ials4  7#b7 ,def9itions  
,= purposes ( ?is subsection3 7,a7      
,inappropriate cov]age d5ial ,! t]m     
inappropriate cov]age d5ial means a     
d5ial ( cov]age ( a cov]$ "p ,d drug    

claim t violates ! requirem5ts ( ?is "p4
  7,b7 ,inappropriate ph>macy rejections
 ,! t]m inappropriate ph>macy rejection 
means a rejection ( a cov]$ "p ,d drug  
claim t violates ! requirem5ts ( ?is "p1
 su* z ?r\gh ! application ( utilization
 managem5t requirem5ts t ! ,secret>y has
 n approv$4  4  #af4 ,,gao /udy on drug 
%ortages ,section #ahfj;,d-#db ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aeb71 z am5d$ by section #ae1 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7j7 ,,gao /udy & report on 
drug %ortages  7#a7 ,/udy ,! ,comptroll]
 ,g5]al ( ! ,unit$ ,/ates 79 ?is        
subsection ref]r$ to z ! ,comptroll]    
,g5]al7 %all conduct a /udy on factors  
contribut+ to %ortages ( cov]$ "p ,d    
drugs across ! outpati5t prescription   
drug supply *a94 ,su* /udy %all include 
analysis (-- 7,a7 common features ( &   
tr5ds 9 cov]$ "p ,d drugs t h exp]i5c$  
at lea/ #a %ortage 7z def9$ "u section  
#ejf;,c ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act72  7,b7 patt]ns1 tr5ds1 &

 v>iations 9 ! duration ( %ortages      
exp]i5c$ by cov]$ "p ,d drugs2  7,c7    
patt]ns1 tr5ds1 & v>iations 9 !         
proximate causes & o!r pot5tial causes (
 %ortages exp]i5c$ by cov]$ "p ,d drugs2
  7,d7 effects ( su* %ortages on        
b5efici>ies enroll$ 9 prescription drug 
plans "u ?is "p1 includ+ ) respect to   
access to cov]$ "p ,d drugs &           
out-(-pocket co/s2 &  7,e7 o!r issues   
det]m9$ appropriate by ! ,comptroll]    
,g5]al4  7#b7 ,report ,n lat] ?an #b    
ye>s aft] ! date ( enactm5t ( ?is       
subsection1 ! ,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
  4  #ag4 ,report on biosimil> & g5]ic  
access "u ,m$ic>e "p ,d ,section        
#ahfj;,d-#db ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aeb71 z am5d$ by 
section #af1 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7k7 ,,oig      

report on biosimil> & g5]ic access "u "p
 d  7#a7 ,/udy ,! ,(fice ( ! ,inspector 
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices 7ref]r$ to 9 ?is subsection z !
 ,(fice ( ! ,inspector ,g5]al7 %all     
conduct a /udy on biosimil> & g5]ic drug
 access & adoption "u prescription drug 
plans (f]$ "u ?is "p1 includ+ ) respect 
to b>ri]s to increas$ adoption &        
utilization ( l[]-pric$ biosimil> &     
g5]ic utilization1 plan features t      
disc\rage or enc\rage ! utilization ( ^!
 products1 & ! gross & net sp5d+ effects
 ( policies t increas$ adoption ( ^!    
products "u ?is "p4  7#b7 ,report ,n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is subsection1 ! ,(fice ( ! ,inspector
 ,g5]al %all publi% a report on ! /udy  
conduct$ "u p>agraph 7#a74  4  #ah4     
,m$ic>e ,improvem5t ,fund ,section      
#ahih7;b77#a7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie;iii7b77#a77 is    
am5d$ by /rik+ dur+ & aft] fiscal ye>   
#bjbb1 #ahj1jjj1jjj & ins]t+ ! foll[+3  
8dur+ & aft]--  7,a7 fiscal ye> #bjbb1  

#ahj1jjj1jjj2 &  7,b7 fiscal ye> #bjbh1 
#a1idg1jjj1jjj  4  #a4 ,%ort title2     
table ( cont5ts  7a7 ,%ort title ,?is   
,act may be cit$ z ! ,mod]niz+ & ,ensur+
 ,,pbm ,acc\ntability ,act4  7b7 ,table 
( cont5ts ,! table ( cont5ts ( ?is ,act 
is z foll[s3 ,sec4 #a4 ,%ort title2     
table ( cont5ts4,sec4 #b4 ,arrangem5ts )
 ph>macy b5efit manag]s ) respect to    
prescription drug plans & ,,ma-,,pd     
plans4,sec4 #c4 ,ensur+ fair assessm5t (
 ph>macy p]=mance & quality "u ,m$ic>e  
"p ,d4,sec4 #d4 ,promot+ transp>5cy =   
ph>macies "u ,m$ic>e "p ,d4,sec4 #e4    
,prev5t+ ! use ( abusive spread pric+ 9 
,m$icaid4,sec4 #f4 ,ensur+ accurate     
paym5ts to ph>macies "u ,m$icaid4,sec4  
#g4 ,,oig /udy & report on drug price   
m>k-ups 9 ,m$ic>e "p ,d4,sec4 #h4       
,resolv+ ,p,t committee conflicts (     
int]e/4,sec4 #i4 ,enhanc+ ,,pbm         
transp>5cy requirem5ts4,sec4 #aj4       
,facilitat+ midye> =mul>y *anges =      
biosimil>s4,sec4 #aa4 ,/r5g!n+ ph>macy  
access = s5iors4,sec4 #ab4              

,b5efici>y-focus$ li/5+ sessions to     
improve prescription drug plan          
transp>5cy1 access1 & *oice4,sec4 #ac4  
,report+ on en=cem5t & ov]sight (       
ph>macy access requirem5ts4,sec4 #ad4   
,,gao /udy on price-relat$ comp5sation  
across ! supply *a94,sec4 #ae4 ,reports 
on inappropriate ph>macy                
rejections4,sec4 #af4 ,,gao /udy on drug
 %ortages4,sec4 #ag4 ,report on         
biosimil> & g5]ic access "u ,m$ic>e "p  
,d4,sec4 #ah4 ,m$ic>e ,improvem5t ,fund4
  #b4 ,arrangem5ts ) ph>macy b5efit     
manag]s ) respect to prescription drug  
plans & ,,ma-,,pd plans  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 #bjbf3 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] agrees 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$ 9 connection ) ! utilization ( 
cov]$ "p ,d drugs f any 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 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 if su* paym5t is a flat doll>
 am\nt1 is consi/5t ) fair m>ket value1 
& is relat$ to s]vices actually p]=m$ by
 ! ph>macy b5efit manag] or affiliate ( 
su* ph>macy b5efit manag] 9 connection )
 ! utilization ( cov]$ "p ,d drugs4     

7iii7 ,cl>ification on rebates &        
disc\nts us$ to l[] co/s = cov]$ "p d   
drugs ,rebates1 disc\nts1 & o!r price   
concessions receiv$ 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 & exclusively us$ to 
l[] co/s = prescription drugs "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 ,remun]ation    
arrangem5ts betwe5 ph>macy b5efit       
manag]s or affiliates ( su* ph>macy     
b5efit manag]s1 z applicable1 & o!r     
entities involv$ 9 ! disp5s+ or         
utilization ( cov]$ "p ,d drugs 7includ+
 ,,pdp sponsors1 manufactur]s1          
ph>macies1 & o!r entities z det]m9$     
appropriate by ! ,secret>y7 %all be     
subject to review by ! ,secret>y & !    
,(fice ( ! ,inspector ,g5]al ( !        

,dep>tm5t ( ,heal? & ,human ,s]vices4 ,!
 ,secret>y1 9 consultation ) ! ,(fice ( 
! ,inspector ,g5]al1 %all evaluate :e!r 
remun]ation "u su* arrangem5ts is       
consi/5t ) fair m>ket value ?r\gh       
reviews & assessm5ts ( su* remun]ation1 
z det]m9$ appropriate4  7,b7 ,transp>5cy
 reg>d+ gu>antees & co/ p]=mance        
evaluations ,! ph>macy b5efit manag]    
%all-- 7i7 def9e1 int]pret1 & apply1 9 a
 fully transp>5t & consi/5t mann] =     
purposes ( calculat+ or o!rwise evaluat+
 ph>macy b5efit manag] p]=mance aga9/   
pric+ gu>antees or simil> co/ p]=mance  
measurem5ts relat$ to rebates1 disc\nts1
 price concessions1 or net co/s1 t]ms   
su* z-- 7,i7 g5]ic drug1 9 a mann]      
consi/5t ) ! def9ition ( ! t]m "u       
section #dbc4d ( title #db1 ,code (     
,f$]al ,regulations1 or a successor     
regulation2  7,,ii7 br& "n drug1 9 a    
mann] consi/5t ) ! def9ition ( ! t]m "u 
section #dbc4d ( title #db1 ,code (     
,f$]al ,regulations1 or a successor     
regulation2  7,,iii7 specialty drug2    

7,,iv7 rebate2 &  7,v7 disc\nt2  7ii7   
id5tify any drugs1 claims1 or price     
concessions exclud$ f any pric+ gu>antee
 or o!r co/ p]=mance calculation or     
evaluation 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      
measure 9 ! writt5 agreem5t4  7,c7      
,provision ( in=mation  7i7 ,9 g5]al ,n 
lat] ?an ,july #a ( ea* ye>1 beg9n+ 9   
#bjbf1 ! 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#d74 ,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 co/ p] day's     
supply1 co/ p] dosage unit1 & co/ 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,,nadac7 = retail community ph>macies2 
&  7kk7 total manufactur]-d]iv$ rev5ue1 
inclusive ( bona fide s]vice fees1      
reta9$ by ! ph>macy b5efit manag] & any 
affiliate ( su* ph>macy b5efit manag]   

attributable to ! drug4  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/ (     
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 ! li/$ drug1 ! 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 ( prescription 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 ,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  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

 prescription drugs ( ! manufactur]     
directly or indirectly cont+5t ^u       
cov]age1 =mul>y placem5t1 or utilization
 managem5t conditions on any o!r        
prescription drugs1 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 prescription drugs 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 affiliate ( su* ph>macy  
b5efit manag]1 or an individual delegat$
 ) ! au?ority to sign on behalf ( "o (  
^! (fic]s1 :o reports directly to !     
(fic]4  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 & !    
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 t is own$ or held by an
 affiliate ( su* ph>macy b5efit manag]4 
7,e7 ,en=cem5t ,! ph>macy b5efit manag] 
%all-- 7i7 disgorge to a ,,pdp sponsor  
7or1 9 a case :]e ! ,,pdp sponsor is an 
affiliate ( su* ph>macy b5efit manag]1  
to ! ,secret>y7 any paym5t1 remun]ation1
 or o!r am\nt receiv$ by ! ph>macy      
b5efit manag] or an affiliate ( su*     
ph>macy b5efit manag] 9 violation (     
subp>agraph 7,a7 or ! writt5 agreem5t   
ent]$ into ) su* sponsor "u ?is "p )    
respect to a prescription drug plan2    
7ii7 reimburse ! ,,pdp sponsor = any    
civil money p5alty impos$ on ! ,,pdp    
sponsor z a result ( ! failure ( !      
ph>macy b5efit manag] to meet !         
requirem5ts ( ?is p>agraph t are        
applicable to ! ph>macy b5efit manag] "u
 ! agreem5t2 &  7iii7 be subject to     
punitive rem$ies = brea* ( contract =   
failure to comply ) ! requirem5ts       

applicable "u ?is p>agraph4  7#b7       
,c]tification ( compliance ,ea* ,,pdp   
sponsor %all furni% to ! ,secret>y 79 a 
"t & 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#c7 ,rule (           
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ z prohibit+ paym5ts relat$ to
 reimbursem5t = +r$i5t co/s to any      
entity t acquires prescription drugs1   
su* z a ph>macy or :olesal]4  7#d7 ,/&>d
 =mats ,n lat] ?an ,june #a1 #bjbe1 !   
,secret>y %all specify /&>d1            
ma*9e-readable =mats = ph>macy b5efit   
manag]s to submit annual reports requir$
 "u p>agraph 7#a77;,c77i74  7#e7        
,confid5tiality  7,a7 ,9 g5]al          
,in=mation disclos$ by a ph>macy b5efit 
manag] or ,,pdp sponsor "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 a    
specific ph>macy b5efit manag]1         
affiliate1 manufactur] or :olesal]1     
,,pdp sponsor1 or plan1 or contract     
prices1 rebates1 disc\nts1 or o!r       
remun]ation = specific drugs 9 a mann] t
 may all[ ! id5tification ( specific    
contract+ p>ties4  7#f7 ,def9itions ,=  
purposes ( ?is subsection3 7,a7         
,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 ,,pdp sponsor1 
or t acts z a contractor or ag5t to su* 
ph>macy b5efit manag] or ,,pdp sponsor1 
ins(> z su* contractor 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 = 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 are 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 disc\nts1 rebates1 fees1  
or o!r direct or indirect remun]ation   
am\nts ) 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 #bjbf1 section              
#ahfj;,d-#ab7;h74  4  7#c7 ,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 #bj1jjj1jjj = fiscal ye>   
#bjbf1 to rema9 available until exp5d$1 
to c>ry out ! am5dm5ts made by ?is      
subsection4  7,b7 ,,oig ,9 addition to  
am\nts o!rwise available1 !re is        
appropriat$ to ! ,inspector ,g5]al ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices1   
out ( any money 9 ! ,treasury n o!rwise 
appropriat$1 #e1jjj1jjj = fiscal ye>    
#bjbf1 to rema9 available until exp5d$1 
to c>ry out ! am5dm5ts made by ?is      
subsection4  7b7 ,,gao /udy & report on 
c]ta9 report+ requirem5ts  7#a7 ,/udy ,!
 ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79
 ?is subsection ref]r$ to z !           
,comptroll] ,g5]al7 %all conduct a /udy 
on ,f$]al & ,/ate report+ requirem5ts = 
heal? plans & ph>macy b5efit manag]s    
relat$ to ! transp>5cy ( prescription   
drug co/s & prices4 ,su* /udy %all      
include an analysis ( ! foll[+3 7,a7    
,f$]al /atutory & regulatory report+    
requirem5ts = heal? plans & ph>macy     
b5efit manag]s relat$ to prescription   

drug co/s & prices4  7,b7 ,select$      
,/ates' /atutory & regulatory report+   
requirem5ts = heal? plans & ph>macy     
b5efit manag]s relat$ to prescription   
drug co/s & prices4  7,c7 ,! ext5t to   
:i* ! /atutory & regulatory report+     
requirem5ts id5tifi$ 9 subp>agraphs 7,a7
 & 7,b7 ov]lap & conflict4  7,d7 ,!     
res\rces requir$ by heal? plans &       
ph>macy b5efit manag]s to comply ) !    
report+ requirem5ts describ$ 9          
subp>agraphs 7,a7 & 7,b74  7,e7 ,o!r    
items det]m9$ appropriate by !          
,comptroll] ,g5]al4  7#b7 ,report ,n    
lat] ?an #b ye>s aft] ! date on :i*     
in=mation is fir/ requir$ to be report$ 
"u section #ahfj;,d-#ab7;h77#a77;,c7 ( !
 ,social ,security ,act1 z add$ by      
subsection 7a77#a71 ! ,comptroll] ,g5]al
 %all submit to ,congress a report      
conta9+ ! results ( ! /udy conduct$ "u  
p>agraph 7#a71 toge!r ) recomm5dations =
 legislation & adm9i/rative actions t   
w\ld /reaml9e & r$uce ! burd5 associat$ 
) ! report+ requirem5ts = heal? plans & 

ph>macy b5efit manag]s describ$ 9       
p>agraph 7#a74  7c7 ,med,p,a,c reports  
on agreem5ts ) ph>macy b5efit manag]s ) 
respect to prescription drug plans &    
,,ma-,,pd plans ,! ,m$ic>e ,paym5t      
,advisory ,commission %all submit to    
,congress ! foll[+ reports3 7#a7 ,n lat]
 ?an ,m>* #ca1 #bjbg1 a report reg>d+   
agreem5ts ) ph>macy b5efit manag]s )    
respect to prescription drug plans &    
,,ma-,,pd plans4 ,su* report %all       
include-- 7,a7 a description ( tr5ds &  
patt]ns1 includ+ relevant av]ages1      
totals1 & o!r figures = ea* ( ! types ( 
in=mation submitt$2  7,b7 an analysis ( 
any diff]5ces 9 agreem5ts & _! effects  
on plan enrollee out-(-pocket sp5d+ &   
av]age ph>macy reimbursem5t1 & any o!r  
impacts2 &  7,c7 any recomm5dations !   
,commission det]m9es appropriate4  7#b7 
,n lat] ?an ,m>* #ca1 #bjbi1 a report   
describ+ any *anges ) respect to !      
in=mation describ$ 9 p>agraph 7#a7 ov]  
"t1 toge!r ) any recomm5dations !       
,commission det]m9es appropriate4  #c4  

,ensur+ fair assessm5t ( ph>macy        
p]=mance & quality "u ,m$ic>e "p ,d  7a7
 ,/&>diz$ ph>macy p]=mance measures     
,section #ahfj;,d-#b ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7f7            
,application ( /&>diz$ ph>macy p]=mance 
measures  7#a7 ,measures ,= plan ye>s   
beg9n+ on or aft] ,janu>y #a1 #bjbe1 a  
,,pdp sponsor (f]+ a prescription drug  
plan & an ,,ma organization (f]+ an     
,,ma-,,pd plan %all1 = purposes (       
inc5tive paym5ts1 price concessions1 or 
any fees or o!r remun]ation paid or *>g$
 to a ph>macy bas$ on p]=mance measures1
 only use measures t are-- 7,a7 e/abli%$
 or adopt$ by ! ,secret>y "u p>agraph   
7#b7 & includ$ on ! li/ describ$ 9      
subp>agraph 7,b7 ( su* p>agraph2 &  7,b7
 relevant to ! p]=mance ( su* ph>macy   
bas$ on ! type ( ph>macy 7includ+       
retail1 mail ord]1 specialty1 long t]m  
c>e1 & home infusion or o!r types (     
ph>macies71 drugs disp5s$ by su*        

ph>macy1 & ph>macy s]vices us$ to       
disp5se & manage drugs by su* ph>macy4  
7#b7 ,/&>diz$ ph>macy p]=mance measures 
7,a7 ,measures  7i7 ,9 g5]al ,not)/&+   
any o!r provision ( law1 ! ,secret>y    
%all e/abli% 7or adopt pursuant to      
clause 7iii77 /&>diz$ ph>macy p]=mance  
measures t may be us$ by a ,,pdp sponsor
 (f]+ a prescription drug plan & an ,,ma
 organization (f]+ an ,,ma-,,pd plan = !
 purpose ( det]m9+ inc5tive paym5ts1    
price concessions1 or fees or o!r       
remun]ation describ$ 9 p>agraph 7#a74   
7ii7 ,requirem5ts ,! measures "u clause 
7i7 %all focus on ph>macy p]=mance &    
quality ( c>e bas$ on ! type ( ph>macy1 
z det]m9$ by ! ,secret>y4 ,su* measures 
%all be evid5ce-bas$1 feasible1         
appropriate & reasonable4  7iii7        
,adoption ( measure ,9 lieu ( e/abli%+  
"s or all ( ! measures "u ?is p>agraph1 
! ,secret>y may adopt measures t are    
endors$ by "o or m multi-/akehold]      
cons5sus organizations 7su* z ! ,ph>macy
 ,quality ,alliance71 t has p>ticipation

 f ph>macies 7includ+ retail & specialty
 ph>macies n own$ or affiliat$ ) a plan1
 ph>macy b5efit manag]1 or o!r ph>macy71
 heal? plans1 ph>macy b5efit manag]s1 & 
! ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices4  
,any measure adopt$ "u ?is clause %all  
be deem$ to meet ! requirem5ts "u clause
 7ii74  7,b7 ,ma9t5ance ( li/  7i7 ,9   
g5]al ,! ,secret>y %all ma9ta91 & publi%
 on a publicly available int]net        
website1 a li/ ( measures e/abli%$ or   
adopt$ "u ?is p>agraph4 ,su* li/ %all   
initially be publi%$ no lat] ?an ,june  
#a1 #bjbd4  7ii7 ,update ,! ,secret>y   
%all p]iodically evaluate measures1 & h[
 measures are appli$ by type ( ph>macy &
 update ! measures on ! li/ "u clause   
7i7 s t su* measures meet ! requirem5ts 
"u subp>agraph 7,a77ii74  7#c7          
,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 "u   
?is subsection4  4  7b7 ,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 #d1jjj1jjj =      
fiscal ye> #bjbe1 to rema9 available    
until exp5d$1 to c>ry out ! am5dm5t made
 by subsection 7a74  #d4 ,promot+       
transp>5cy = ph>macies "u ,m$ic>e "p ,d 
7a7 ,transp>5cy = ph>macies ,section    
#ahfj;,d-#b7;f7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#ajb7;f771 z 
add$ by section #c1 is am5d$ by add+ at 
! end ! foll[+ new p>agraph3  7#d7      
,transp>5cy = ph>macies  7,a7 ,9 g5]al  
,= plan ye>s beg9n+ on or aft] ,janu>y  
#a1 #bjbe1 a ,,pdp sponsor (f]+ a       
prescription drug plan & an ,,ma        
organization (f]+ an ,,ma-,,pd plan1 )  
respect to paym5t made by su* ,,pdp     
sponsor or su* ,,ma organization to a   
ph>macy = a cov]$ "p ,d drug disp5s$ by 
su* ph>macy dur+ a plan ye>1 %all       
promptly furni%1 ^u pay+ a claim = a    
cov]$ "p ,d drug f a ph>macy1 to su*    
ph>macy in=mation relat$ to su* claim1  

su* z ! ,network ,reimbursem5t ,,id1    
fees1 ph>macy price concessions1        
disc\nts1 inc5tives1 or any o!r =ms (   
remun]ation t affect paym5t & pric+ ( ! 
claim4  7,b7 ,/&>diz$ =mat ,! ,,pdp     
sponsor & ! ,,ma organization %all      
furni% ! in=mation describ$ 9           
subp>agraph 7,a7 9 a /&>diz$ =mat 7z    
specifi$ by ! ,secret>y7 t includes all 
fields ne$$ to price ! claim = a cov]$  
"p ,d drug disp5s$ by su* ph>macy4  7,c7
 ,availability ( in=mation to ! secret>y
 ,a ,,pdp sponsor (f]+ a prescription   
drug plan or an ,,ma organization (f]+  
an ,,ma-,,pd plan %all make ! in=mation 
describ$ 9 subp>agraph 7,a7 available to
 ! ,secret>y ^u reque/4  7,d7           
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y %all       
implem5t ?is p>agraph by program        
in/ruction or o!rwise4  4  7b7 ,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 #b1jjj1jjj =      
fiscal ye> #bjbe1 to rema9 available    
until exp5d$1 to c>ry out ! am5dm5t made
 by subsection 7a74  #e4 ,prev5t+ ! use 
( abusive spread pric+ 9 ,m$icaid  7a7  
,9 g5]al ,section #aibg7;e7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;e77 is am5d$ by add+ at ! end
 ! foll[+3  7#f7 ,transp>5t prescription
 drug pass-?r\gh pric+ requir$ ,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*-- 7,a7 any paym5t    
made by ! entity or ! ,,pbm 7z          
applicable7 = su* a drug-- 7i7 is limit$
 to-- 7,i7 +r$i5t co/2 &  7,,ii7 a      
pr(essional disp5s+ fee t is n less ?an 
! pr(essional disp5s+ fee t ! ,/ate plan
 or waiv] w\ld pay if ! plan or waiv] 0 
mak+ ! paym5t directly2  7ii7 is pass$  
?r\gh 9 its entirety by ! entity or     
,,pbm to ! ph>macy or provid] t disp5ses
 ! drug 7& %all n be r$uc$ or d5i$      
retroactively "u po/-adjudication       
processes72 &  7iii7 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-- 7,i7 su*    
drug 0 subject to an agreem5t "u section
 #cdj;,b ( ! ,public ,heal? ,s]vice     
,act2  7,,ii7 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 &  7,,iii7 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  7,b7     
paym5t to ! entity or ! ,,pbm 7z        
applicable7 = adm9i/rative s]vices p]=m$
 by ! entity or ,,pbm is limit$ to !    
fair m>ket value ( su* s]vices2  7,c7 ! 
entity or ! ,,pbm 7z applicable7 %all   
make available to ! ,/ate1 & ! ,secret>y
 ^u reque/1 all co/s & paym5ts relat$ to
 cov]$ outpati5t drugs & accompany+     
adm9i/rative s]vices incurr$1 receiv$1  

or made by ! entity or ! ,,pbm1 includ+ 
+r$i5t co/s1 pr(essional disp5s+ fees1  
adm9i/rative fees1 po/-sale &           
po/-invoice fees1 disc\nts1 or relat$   
adju/m5ts su* z direct & indirect       
remun]ation fees1 & any & all o!r       
remun]ation2 &  7,d7 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 
assessm5ts 7aft] all[+ = an adm9i/rative
 fee z describ$ 9 subp>agraph 7,b77 is n
 all[able = purposes ( claim+ ,f$]al    
mat*+ paym5ts "u ?is title4  4  7b7     
,def9ition ( ph>macy b5efit manag]      
,section #aibg7k7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acifr-#h7k77 is    
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#ab7 ,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 or o!r        
specifi$ entity 7z su* t]ms are def9$ 9 
section #aijc7m77#i77;,d771 or manages !
 prescription drug b5efits provid$ by   
su* ,/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 
c>ries out #a or m ( ! activities       
describ$ 9 ! prec$+ s5t5ce1 irrespective
 ( :e!r su* p]son or entity calls itself
 a ph>macy b5efit manag]4  4  7c7       
,con=m+ am5dm5ts ,section #aijc7m7 ( su*
 ,act 7#db ,u4,s4,c4 #acif;b7m77 is     
am5d$-- 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 ! entity1 or a ph>macy     
b5efit manag] act+ on behalf ( ! entity 
"u a contract or o!r arrangem5t betwe5 !
 entity & ! ph>macy b5efit manag]1 p]=ms
 any ( ! activities describ$ 9 section  
#aibg7k77#ab71 su* activities %all      
comply ) ! requirem5ts ( section        
#aibg7;e77#f72 &  7,c7 by mov+ ! left   
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  7d7 ,effective date
 ,! am5dm5ts made by ?is section 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
  #f4 ,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 by /rik+ & aft] ! semicolon
 at ! end ( p>agraph 7#a77;,a77i7 & all 
t prec$es x ?r\gh 7#a7 & ins]t+ !       
foll[+3  7#a7 ,det]m9+ ph>macy actual   
acquisition co/s ,! ,secret>y %all      
conduct a survey ( retail community     
ph>macy drug prices to det]m9e !        
national av]age drug acquisition co/ z  
foll[s3 7,a7 ,use ( v5dor ,! ,secret>y  
may contract s]vices =-- 7i7 ) respect  
to retail community ph>macies1 !        
det]m9ation ( retail survey prices ( !  
national av]age drug acquisition co/ =  
cov]$ outpati5t drugs t repres5t a      
nationwide av]age ( consum] pur*ase     
prices = su* drugs1 net ( all disc\nts &
 rebates 7to ! ext5t any in=mation )    
respect to su* disc\nts & rebates is    
available7 bas$ on a mon?ly survey ( su*

 ph>macies2 &  2  7#b7 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 9
 ! ,/ate t receives any paym5t1         
reimbursem5t1 adm9i/rative fee1 disc\nt1
 or rebate 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 or rebate 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$71 %all respond to surveys ( retail
 prices conduct$ "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
 & %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+    
frame & numb] ( ph>macies sampl$ mon?ly4
  7iii7 ,in=mation on price concessions 
to ! ph>macy1 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 ,! ,secret>y   
may en=ce non-compliance ) ?is p>agraph 
by a ph>macy ?r\gh ! e/abli%m5t (       
p5alties or ! susp5sion ( paym5ts "u ?is
 title1 9 full or 9 "p1 until compliance
 ) ?is p>agraph has be5 complet$4  2    
7#c7 9 p>agraph 7#b7-- 7,a7 9           
subp>agraph 7,a71 by ins]t+ 1 includ+   
paym5t rates "u ,m$icaid 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#d7 9 p>agraph 7#d71 by  
ins]t+ 1 & #e1jjj1jjj = fiscal ye> #bjbd
 & ea* fiscal ye> !reaft]1 aft] #bjaj4  

7b7 ,effective date ,! am5dm5ts made by 
?is section take effect on ! fir/ day ( 
! fir/ qu>t] t beg9s on or aft] ! date t
 is #ah mon?s aft] ! date ( enactm5t (  
?is ,act4  #g4 ,,oig /udy & report on   
drug price m>k-ups 9 ,m$ic>e "p ,d      
,section #ahfj;,d-#db ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7e7 ,,oig /udy 
& report on drug price m>k-ups "u ?is "p
  7#a7 ,/udy ,! ,inspector ,g5]al ( !   
,dep>tm5t ( ,heal? & ,human ,s]vices 79 
?is subsection ref]r$ to z ! ,inspector 
,g5]al7 %all conduct a /udy on ! impact 
( relat$ p>ty transactions )9 select    
v]tically integrat$ entities on !       
negotiat$ price 7z def9$ 9 section      
#ahfj;,d-#b7;d77#a77;,b77 paid by "p ,d 
plan sponsors = cov]$ "p ,d drugs4 ,su* 
/udy may include an analysis ( ! foll[+3
 7,a7 ,acquisition co/s by ! affiliate  
)9 su* v]tically integrat$ entities t   
initially acquires ! prescription drug =
 a sample ( cov]$ "p ,d drugs1 includ+  

at lea/ #e g5]ic drugs1 br& drugs1      
specialty br& drugs1 & specialty g5]ic  
drugs4  7,b7 ,! me?odologies &          
negotiation processes us$ to calculate  
transf] prices or o!r transactions      
betwe5 relat$ p>ties ) respect to su*   
cov]$ "p ,d drugs4  7,c7 ,! impact ( !  
transactions describ$ 9 subp>agraph 7,b7
 on ! negotiat$ price1 net ( direct &   
indirect remun]ation1 = su* cov]$ "p ,d 
drugs4  7,d7 ,! m>g9 captur$ by diff]5t 
affiliates )9 su* v]tically integrat$   
entities ?r\gh ! transactions describ$ 9
 subp>agraph 7,b74  7,e7 ,an assessm5t (
 ! impact ( ! transactions describ$ 9   
subp>agraph 7,b7 on co/s to individuals 
enroll$ 9 a prescription drug plan or an
 ,,ma-,,pd plan & program sp5d+ on      
prescription drugs "u ?is "p4  7,f7 ,o!r
 issues det]m9$ to be relevant &        
appropriate by ! ,inspector ,g5]al4     
7#b7 ,report ,n lat] ?an #c ye>s aft] ! 
date ( enactm5t ( ?is subsection1 !     
,inspector ,g5]al %all submit to !      
,committee on ,f9ance ( ! ,s5ate & !    

,committee on ,en]gy & ,comm]ce & !     
,committee on ,ways & ,means ( ! ,h\se (
 ,repres5tatives a report conta9+ !     
results ( ! /udy conduct$ "u p>agraph   
7#a71 toge!r ) recomm5dations = su*     
legislation & adm9i/rative action z !   
,inspector ,g5]al det]m9es appropriate4 
7#c7 ,fund+ ,9 addition to am\nts       
o!rwise available1 !re is appropriat$ to
 ! ,inspector ,g5]al1 out ( any money 9 
! ,treasury n o!rwise appropriat$1      
#e1bjj1jjj = fiscal ye> #bjbd1 to rema9 
available until exp5d$1 to c>ry out ?is 
subsection4  4  #h4 ,resolv+ ,p,t       
committee conflicts ( int]e/ ,section   
#ahfj;,d-#d7;b77#c77;,a77ii77,i7 ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajd7;b77#c77;,a77ii77,i77 is    
am5d$ by ins]t+ ! foll[+ be=e !         
semicolon3 7&1 = #bjbe & ea* subsequ5t  
ye>1 any ph>macy b5efit manag] act+ "u  
contract ) su* sponsor (f]+ su* plan74  
#i4 ,enhanc+ ,,pbm transp>5cy           
requirem5ts  7a7 ,9 g5]al ,section      
#aaej;,a ( ! ,social ,security ,act 7#db

 ,u4,s4,c4 #acbj;b-#bc7 is am5d$-- 7#a7 
by /rik+ subsection 7a7 & ins]t+ !      
foll[+3  7a7 ,provision ( in=mation     
7#a7 ,9 g5]al ,! foll[+ entities %all   
provide ! in=mation describ$ 9          
subsection 7b7 to ! ,secret>y &1 9 !    
case ( an entity describ$ 9 subp>agraph 
7,b7 or an affiliate ( su* entity       
describ$ 9 subp>agraph 7,c71 to ! heal? 
b5efits plan ) :i* ! entity is "u       
contract1 at su* times1 & 9 su* =m &    
mann]1 z ! ,secret>y %all specify3 7,a7 
,a heal? b5efits plan4  7,b7 ,any entity
 t provides ph>macy b5efits managem5t   
s]vices on behalf ( a heal? b5efits plan
 79 ?is section ref]r$ to z a ,,pbm7 t  
manages prescription drug cov]age "u a  
contract )-- 7i7 a ,,pdp sponsor ( a    
prescription drug plan or an ,,ma       
organization (f]+ an ,,ma-,,pd plan "u  
"p ,d ( title ,,xviii2 or  7ii7 a       
qualifi$ heal? b5efits plan (f]$ ?r\gh  
an ex*ange e/abli%$ by a ,/ate "u       
section #acaa ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act4  7,c7 ,any         

affiliate ( an entity describ$ 9        
subp>agraph 7,b7 t acts z a price       
negotiator or gr\p pur*as] on behalf (  
su* ,,pbm1 ,,pdp sponsor1 ,,ma          
organization1 or qualifi$ heal? b5efits 
plan4  7#b7 ,affiliate def9$ ,9 ?is     
section1 ! t]m affiliate means any      
entity t is own$ by1 controll$ by1 or   
relat$ "u a common own]%ip /ructure ) a 
,,pbm 7includ+ an entity own$ or        
controll$ by ! ,,pdp sponsor ( a        
prescription drug plan1 ,,ma            
organization (f]+ an ,,ma-,,pd plan1 or 
qualifi$ heal? b5efits plan = :i* su*   
entity is act+ z a price negotiator or  
gr\p pur*as]74  2  7#b7 9 subsection    
7b7-- 7,a7 9 p>agraph 7#b71 by ins]t+ & 
p]c5tage aft] & ! aggregate am\nt2 &    
7,b7 by add+ at ! end ! foll[+ new      
p>agraph3  7#d7 ,! am\nt 79 ! aggregate 
& disaggregat$ by type7 ( all fees !    
,,pbm or an affiliate ( ! ,,pbm receives
 f all ph>maceutical manufactur]s 9     
connection ) pati5t utilization "u !    
plan1 & ! am\nt & p]c5tage 79 !         

aggregate & disaggregat$ by type7 ( su* 
fees t are pass$ ?r\gh to ! plan sponsor
 or issu]4  2 &  7#c7 by add+ at ! end !
 foll[+ new subsection3  7e7 ,annual    
report ,! ,secret>y %all make publicly  
available on ! ,int]net website ( !     
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices an  
annual report t summ>izes ! tr5ds obs]v$
 ) respect to data report$ "u subsection
 7b74  4  7b7 ,effective date ,!        
am5dm5ts made by ?is section %all apply 
to plan or contract ye>s beg9n+ on or   
aft] ,janu>y #a1 #bjbg4  7c7            
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y may        
implem5t ! am5dm5ts made by ?is section 
by program in/ruction or o!rwise4  7d7  
,non-application ( ! pap]work r$uction  
act ,*apt] #ce ( title #dd1 ,unit$      
,/ates ,code 7commonly ref]r$ to z !    
,pap]work ,r$uction ,act ( #aiie71 %all 
n apply to ! implem5tation ( ! am5dm5ts 
made by ?is section4  #aj4 ,facilitat+  
midye> =mul>y *anges = biosimil>s  7a7  
,9 g5]al ,section #ahfj;,d-#d7;b7 ( !   

,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajd7;b77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#e7        
,mid-ye> *anges 9 =mul>ies p]mitt$ =    
c]ta9 biosimil> biological products & ! 
ref]5ce product ( su* biosimil>s ,if a  
,,pdp sponsor ( a prescription drug plan
 uses a =mul>y 7includ+ ! use ( ti]$    
co/-%>+71 ! foll[+ %all apply3 7,a7 ,9  
g5]al ,= plan ye> #bjbe1 & subsequ5t    
plan ye>s1 9 ! case ( a cov]$ "p ,d drug
 t is ! ref]5ce biological product 7z   
def9$ 9 section #cea7;i7 ( ! ,public    
,heal? ,s]vice ,act7 ) respect to a     
biosimil> biological product 7def9$ z a 
biological product lic5s$ "u section    
#cea7k7 ( su* ,act71 ! ,,pdp sponsor    
may1 ) respect to a =mul>y1 at any "t   
aft] ! fir/ #fj days ( ! plan ye>1      
subject to p>agraph 7#c77;,e71 *ange !  
pref]r$ or ti]$ co/-%>+ /atus ( su*     
ref]5ce biological product if su* ,,pdp 
sponsor adds1 be=e or at ! same "t1 to  
su* =mul>y su* biosimil> biological     
product at ! same or a high] pref]r$    

/atus1 or to ! same or l[] co/-%>+ ti]1 
z t ( su* ref]5ce biological product    
imm$iately prior to su* *ange4  7,b7    
,reque/ = approval ( *ange ,prior to    
mak+ a *ange describ$ 9 subp>agraph     
7,a71 ! ,,pdp sponsor %all submit to !  
,secret>y a reque/ to make su* *ange4   
,if ! ,secret>y approves ! reque/ or has
 n provid$ a decision to ! ,,pdp sponsor
 reg>d+ su* reque/ )9 #cj days ( receiv+
 su* reque/1 su* ,,pdp sponsor may make 
su* *ange4  4  7b7 ,adm9i/ration  7#a7  
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y ( ,heal? & 
,human ,s]vices may implem5t ! am5dm5t  
made by subsection 7a7 by program       
in/ruction or o!rwise4  7#b7            
,non-application ( ! ,pap]work ,r$uction
 ,act ,*apt] #ce ( title #dd1 ,unit$    
,/ates ,code 7commonly ref]r$ to z !    
,pap]work ,r$uction ,act ( #aiie71 %all 
n apply to ! implem5tation ( ! am5dm5t  
made by subsection 7a74  #aa4 ,/r5g!n+  
ph>macy access = s5iors ,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  
,limit$ access drugs  7i7 ,limitation on
 re/rictions or limits on access ,= ea* 
plan ye> 7beg9n+ ) plan ye> #bjbf71 a   
,,pdp sponsor (f]+ a prescription drug  
plan-- 7,i7 may n re/rict or limit      
access to any cov]$ "p ,d drug to a     
subset ( _! network ph>macies1 o!r ?an )
 respect to a limit$ access drug1 z     
def9$ 9 clause 7v72 &  7,,ii7 %all      
docum5t ! rationale = :y a cov]$ "p ,d  
drug meets ! def9ition ( a limit$ access
 drug "u clause 7v71 if su* plan        
re/ricts or limits access to a limit$   
access drug to a subset ( network       
ph>macies4  7ii7 ,annual submission (   
in=mation to ! secret>y on limit$ access
 drugs ,= ea* plan ye> 7beg9n+ ) plan   
ye> #bjbf71 ea* ,,pdp sponsor (f]+ a    
prescription drug plan %all submit to ! 
,secret>y1 at a "t & 9 a mann] specifi$ 
by ! ,secret>y1 ) respect to ea*        
prescription drug plan (f]$ by ! sponsor

 dur+ su* plan ye>-- 7,i7 a li/ ( all   
cov]$ "p ,d drugs t ! ,,pdp sponsor     
designat$ z a limit$ access drug2       
7,,ii7 = ea* cov]$ "p ,d drug includ$ 9 
! li/ describ$ 9 subclause 7,i71 a      
writt5 rationale = :y su* drug meets !  
def9ition ( a limit$ access drug2       
7,,iii7 a summ>y ( ! requirem5ts impos$ 
on network ph>macies 7includ+ all       
accr$itation requirem5ts1 if any7 to    
ensure appropriate h&l+ & disp5s+ ( ea* 
cov]$ "p ,d drug includ$ 9 ! li/        
describ$ 9 subclause 7,i72  7,,iv7 !    
p]c5tages ( ea* cov]$ "p ,d drug includ$
 9 ! li/ describ$ 9 subclause 7,i7 t is 
disp5s$ ?r\gh retail ph>macies1         
specialty ph>macies1 mail ord]          
ph>macies1 or o!r disp5s+ *annels z     
def9$ by ! ,,pdp sponsor1 respectively2 
7,v7 ! annual p]c5tage ( ea* cov]$ "p ,d
 drug includ$ 9 ! li/ describ$ 9        
subclause 7,i7 t is disp5s$ ?r\gh a     
ph>macy t is affiliat$ ) ! plan or is an
 affiliate 7z def9$ 9 section           
#ahfj;,d-#ab7;h77#d77;,a77 ( a ph>macy  

b5efit manag] act+ on behalf ( su*      
sponsor or su* plan2 &  7,,vi7 any o!r  
in=mation det]m9$ appropriate by !      
,secret>y4  7iii7 ,ph>macy access to    
limit$ access drug in=mation ,= plan    
ye>s beg9n+ ) plan ye> #bjbf1 ^u !      
reque/ ( a network ph>macy1 a ,,pdp     
sponsor ( a prescription drug plan %all 
provide su* ph>macy1 n lat] ?an #ad days
 aft] receiv+ su* reque/1 ) ! in=mation 
describ$ 9 subclauses 7,i71 7,,ii71 &   
7,,iii7 ( clause 7ii74  7iv7 ,,hhs      
annual report on limit$ access drugs ,n 
lat] ?an ,decemb] #ca1 #bjbh1 & annually
 !reaft]1 ! ,secret>y %all submit to !  
,committee on ,f9ance ( ! ,s5ate1 & !   
,committee on ,ways & ,means & !        
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives a report on     
compliance by ,,pdp sponsors ) !        
requirem5ts "u ?is subp>agraph4 ,ea* su*
 report %all include-- 7,i7 a           
description ( ! patt]ns1 tr5ds1         
v>iations1 & rationales = ! designation 
by ,,pdp sponsors ( c]ta9 cov]$ "p ,d   

drugs z limit$ access drugs1 & !        
implications ( su* designations on      
b5efici>y access to su* cov]$ "p ,d     
drugs2  7,,ii7 a description ( !        
in=mation submitt$ to ! ,secret>y "u    
clause 7ii7 79 a mann] t does n disclose
 ! id5tity ( a ph>macy1 a ,,pdp sponsor1
 a prescription drug plan1 or ph>macy   
b5efit manag]1 or any propriet>y pric+  
in=mation72 &  7,,iii7 any o!r in=mation
 det]m9$ appropriate by ! ,secret>y4    
7v7 ,limit$ access drug def9$ ,9 ?is    
subp>agraph1 ! t]m limit$ access drug   
means a cov]$ "p ,d drug t meets at lea/
 "o ( ! foll[+3 7,i7 ,! ,food & ,drug   
,adm9i/ration has re/rict$ di/ribution (
 su* cov]$ "p ,d drug to c]ta9          
facilities or physicians4  7,,ii7 ,!    
disp5s+ ( su* cov]$ "p ,d drug requires 
extraord9>y special h&l+1 provid]       
coord9ation1 or pati5t education t _c be
 met by a network ph>macy4  4  7vii7    
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y %all       
implem5t ?is subp>agraph by program     

in/ruction or o!rwise4  7viii7          
,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 "u   
?is subp>agraph4  4  #ab4               
,b5efici>y-focus$ li/5+ sessions to     
improve prescription drug plan          
transp>5cy1 access1 & *oice ,section    
#ahfj;,d-#db ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aeb71 z am5d$ by 
section #g1 is am5d$ by add+ at ! end ! 
foll[+ new subsection3  7f7             
,b5efici>y-focus$ li/5+ sessions to     
improve prescription drug plan          
transp>5cy1 access1 & *oice  7#a7 ,9    
g5]al ,n lat] ?an ,decemb] #ca1 #bjbd1 !
 ,secret>y %all hold at lea/ "o         
b5efici>y-focus$ li/5+ session to       
receive input on pot5tial improvem5ts to
 ! exp]i5ce )1 & transp>5cy (1          
prescription drug plans "u ?is "p1 z    
describ$ 9 p>agraph 7#b74  7#b7         
,b5efici>y-focus$ li/5+ sessions ,any   
b5efici>y-focus$ li/5+ session held "u  

p>agraph 7#a7 %all be op5 to ! public1  
includ+ b5efici>ies1 c>egiv]s (         
b5efici>ies1 consum] & pati5t advocacy  
organizations1 heal? c>e provid]s1 & o!r
 int]e/$ p>ties4 ,any su* li/5+ sessions
 may include an opportunity = ! public  
to provide input to ! ,secret>y on      
pot5tial improvem5ts to-- 7,a7 !        
in=mation made available by prescription
 drug plans to individuals2  7,b7 tools 
& me*anisms to assi/ enrollees (        
prescription drug plans 9 navigat+ plan 
compla9t sy/ems1 z well z ! effici5cy & 
effectiv5ess ( su* sy/ems2  7,c7 tools &
 me*anisms to assi/ b5efici>ies 9       
select+ a prescription drug plan2  7,d7 
tools & me*anisms to assi/ enrollees (  
prescription drug plans 9 navigat+      
utilization managem5t requirem5ts ( su* 
plans1 su* z /ep !rapy & prior          
au?orization2  7,e7 access to1 &        
effectiv5ess & utilization (1 electronic
 real-"t b5efit tools 7z describ$ 9     
section #dbc4afj7;b77#g7 ( title #db1   
,code ( ,f$]al ,regulations1 or any     

successor regulation7 & b5efici>y       
real-"t b5efit tools 7z describ$ 9      
section #dbc4abh7;d77#d7 ( title #db1   
,code ( ,f$]al ,regulations1 or any     
successor regulation72  7,f7 =mul>y     
managem5t & ov]sight by prescription    
drug plans2 &  7,g7 o!r subjects1 z     
det]m9$ appropriate by ! ,secret>y4  4  
#ac4 ,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 
section #ab1 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7g7 ,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  #ad4 ,,gao /udy on       
price-relat$ comp5sation across ! supply
 *a9 ,section #ahfj;,d-#db ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb71 z am5d$ by section #ac1 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7h7 ,,gao /udy & report on 
price-relat$ comp5sation & paym5t       
/ructures 9 ! prescription drug 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 ?is "p4  
,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$i>ies 9 ! prescription drug supply
 *a91 includ+-- 7i7 ph>macy b5efit      
manag]s2  7ii7 "p ,d plan sponsors2     
7iii7 drug :olesal]s2  7iv7 ph>macies2  
7v7 manufactur]s2  7vi7 ph>macy s]vices 
adm9i/rative organizations2  7vii7      
brok]s1 auditors1 consultants1 & o!r    
entities t advise "p ,d plan sponsors   
ab\t ph>macy b5efits or review "p ,d    
plan sponsor contracts ) ph>macy b5efit 
manag]s2 &  7viii7 o!r s]vice provid]s t
 contract ) any ( ! entities describ$ 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
 ?is "p & ! ,m$icaid program "u title   
,,xix4  7,f7 ,! effects ( drug          
price-relat$ 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 subsection1 ! ,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  4  #ae4 ,reports on       
inappropriate ph>macy rejections        
,section #ahfj;,d-#db ( ! ,social       
,security ,act 7#db ,u4,s4,c4           
#aciew-#aeb71 z am5d$ by section #ad1 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7i7 ,bi5nial report on     
ef=ts to address inappropriate ph>macy  
rejections & inappropriate cov]age      
d5ials "u ,m$ic>e "p ,d  7#a7 ,9 g5]al  
,n lat] ?an ,janu>y #a1 #bjbf1 & at lea/
 once e #d ye>s !reaft]1 ! ,secret>y1 9 

consultation ) ! ,(fice ( ! ,inspector  
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices1 %all po/1 on a publicly       
available website1 a report relat$ to   
prev5t+1 id5tify+1 or address+          
inappropriate ph>macy rejections 7z     
def9$ 9 p>agraph 7#b77;,b77 &           
inappropriate cov]age d5ials 7z def9$ 9 
p>agraph 7#b77;,a77 "u ?is "p4 ,su*     
reports %all include-- 7,a7 a           
description ( programs1 reviews1 or     
initiatives und]way to prev5t1 id5tify1 
or address su* rejections & d5ials1 9   
accordance ) exi/+ au?orities2  7,b7 a  
summ>y ( data collect$ or o!r in=mation 
available ) respect to su* rejections & 
d5ials1 includ+-- 7i7 /&>ds 7if any su* 
/&>ds h be5 adopt$7 us$ by ! ,secret>y =
 id5tify+ ,,pdp sponsors & ,,ma         
organizations ) relatively high rates ( 
su* rejections or d5ials2 &  7ii7       
notable longitud9al tr5ds or o!r        
patt]ns1 z det]m9$ appropriate by !     
,secret>y2  7,c7 an ov]view ( corrective
 actions tak5 & te*nical assi/ance      

provid$ by ! ,secret>y 9 response to    
violations ( exi/+ requirem5ts ) respect
 to su* rejections & d5ials2 &  7,d7 a  
description ( b>ri]s1 if any1 prev5t+ ! 
,secret>y f tak+ adm9i/rative actions   
suffici5t to id5tify & address su*      
rejections & d5ials4  7#b7 ,def9itions  
,= purposes ( ?is subsection3 7,a7      
,inappropriate cov]age d5ial ,! t]m     
inappropriate cov]age d5ial means a     
d5ial ( cov]age ( a cov]$ "p ,d drug    
claim t violates ! requirem5ts ( ?is "p4
  7,b7 ,inappropriate ph>macy rejections
 ,! t]m inappropriate ph>macy rejection 
means a rejection ( a cov]$ "p ,d drug  
claim t violates ! requirem5ts ( ?is "p1
 su* z ?r\gh ! application ( utilization
 managem5t requirem5ts t ! ,secret>y has
 n approv$4  4  #af4 ,,gao /udy on drug 
%ortages ,section #ahfj;,d-#db ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aeb71 z am5d$ by section #ae1 is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7j7 ,,gao /udy & report on 
drug %ortages  7#a7 ,/udy ,! ,comptroll]

 ,g5]al ( ! ,unit$ ,/ates 79 ?is        
subsection ref]r$ to z ! ,comptroll]    
,g5]al7 %all conduct a /udy on factors  
contribut+ to %ortages ( cov]$ "p ,d    
drugs across ! outpati5t prescription   
drug supply *a94 ,su* /udy %all include 
analysis (-- 7,a7 common features ( &   
tr5ds 9 cov]$ "p ,d drugs t h exp]i5c$  
at lea/ #a %ortage 7z def9$ "u section  
#ejf;,c ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act72  7,b7 patt]ns1 tr5ds1 &
 v>iations 9 ! duration ( %ortages      
exp]i5c$ by cov]$ "p ,d drugs2  7,c7    
patt]ns1 tr5ds1 & v>iations 9 !         
proximate causes & o!r pot5tial causes (
 %ortages exp]i5c$ by cov]$ "p ,d drugs2
  7,d7 effects ( su* %ortages on        
b5efici>ies enroll$ 9 prescription drug 
plans "u ?is "p1 includ+ ) respect to   
access to cov]$ "p ,d drugs &           
out-(-pocket co/s2 &  7,e7 o!r issues   
det]m9$ appropriate by ! ,comptroll]    
,g5]al4  7#b7 ,report ,n lat] ?an #b    
ye>s aft] ! date ( enactm5t ( ?is       
subsection1 ! ,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
  4  #ag4 ,report on biosimil> & g5]ic  
access "u ,m$ic>e "p ,d ,section        
#ahfj;,d-#db ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aeb71 z am5d$ by 
section #af1 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7k7 ,,oig      
report on biosimil> & g5]ic access "u "p
 d  7#a7 ,/udy ,! ,(fice ( ! ,inspector 
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices 7ref]r$ to 9 ?is subsection z !
 ,(fice ( ! ,inspector ,g5]al7 %all     
conduct a /udy on biosimil> & g5]ic drug
 access & adoption "u prescription drug 
plans (f]$ "u ?is "p1 includ+ ) respect 
to b>ri]s to increas$ adoption &        
utilization ( l[]-pric$ biosimil> &     
g5]ic utilization1 plan features t      
disc\rage or enc\rage ! utilization ( ^!
 products1 & ! gross & net sp5d+ effects
 ( policies t increas$ adoption ( ^!    

products "u ?is "p4  7#b7 ,report ,n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is subsection1 ! ,(fice ( ! ,inspector
 ,g5]al %all publi% a report on ! /udy  
conduct$ "u p>agraph 7#a74  4  #ah4     
,m$ic>e ,improvem5t ,fund ,section      
#ahih7;b77#a7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie;iii7b77#a77 is    
am5d$ by /rik+ dur+ & aft] fiscal ye>   
#bjbb1 #ahj1jjj1jjj & ins]t+ ! foll[+3  
8dur+ & aft]--  7,a7 fiscal ye> #bjbb1  
#ahj1jjj1jjj2 &  7,b7 fiscal ye> #bjbh1 
#a1idg1jjj1jjj  4  ,decemb] #g1         
#bjbc,report$ ) an am5dm5t