,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #hbfa  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #g1 #bjbd,mr4    
,s*weik]t 7= himself & ,mr4 ,?ompson (  
,cali=nia7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,ways &     
,means1 & 9 addition to ! ,committee on 
,en]gy & ,comm]ce1 = a p]iod to be      
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
ext5d c]ta9 flexibilities & paym5t      
adju/m5ts "u ! ,m$ic>e program1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,pres]v+ ,teleheal?1       
,hospital1 & ,ambulance ,access ,act4   
,i ,pres]v+ ,pati5ts' ,access to ,c>e 9 
! ,home  #aja4 ,ext5sion ( c]ta9        
teleheal? flexibilities  7a7 ,remov+    
geographic requirem5ts & exp&+ orig9at+ 
sites = teleheal? s]vices ,section      
#ahcd7m7 ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #aciem7 is am5d$-- 7#a7 9    

p>agraph 7#b77;,b77iii71 by /rik+ end+  
,decemb] #ca1 #bjbd & ins]t+ end+       
,decemb] #ca1 #bjbf2 &  7#b7 9 p>agraph 
7#d77;,c77iii71 by /rik+ end+ on        
,decemb] #ca1 #bjbd & ins]t+ end+ on    
,decemb] #ca1 #bjbf4  7b7 ,exp&+        
practition]s eligible to furni%         
teleheal? s]vices ,section              
#ahcd7m77#d77;,e7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #aciem7m77#d77;,e77 
is am5d$ by /rik+ end+ on ,decemb] #ca1 
#bjbd & ins]t+ end+ on ,decemb] #ca1    
#bjbf4  7c7 ,ext5d+ teleheal? s]vices = 
f$]ally qualifi$ heal? c5t]s & rural    
heal? cl9ics ,section #ahcd7m77#h77;,a7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciem7m77#h77;,a77 is am5d$  
by /rik+ end+ on ,decemb] #ca1 #bjbd &  
ins]t+ end+ on ,decemb] #ca1 #bjbf4  7d7
 ,delay+ ! 9-,p]son requirem5ts "u      
m$ic>e = m5tal heal? s]vices furni%$    
?r\gh teleheal? & telecommunications    
te*nology  7#a7 ,delay 9 requirem5ts =  
m5tal heal? s]vices furni%$ ?r\gh       
teleheal? ,section #ahcd7m77#g77;,b77i7 

( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciem7m77#g77;,b77i77 is     
am5d$1 9 ! matt] prec$+ subclause 7,i71 
by /rik+ on or aft] & all t foll[s ?r\gh
 describ$ 9 section #aace7;g77#a77;,b77 
& ins]t+ on or aft] ,janu>y #a1 #bjbg4  
7#b7 ,m5tal heal? visits furni%$ by     
rural heal? cl9ics ,section #ahcd7y77#b7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciem7y77#b77 is am5d$ by    
/rik+ ,janu>y #a1 #bjbe & all t foll[s  
?r\gh ! p]iod at ! end & ins]t+ ,janu>y 
#a1 #bjbg44  7#c7 ,m5tal heal? visits   
furni%$ by ,f$]ally qualifi$ heal? c5t]s
 ,section #ahcd7o77#d77;,b7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#aciem7o77#d77;,b77 is am5d$ by /rik+   
,janu>y #a1 #bjbe & all t foll[s ?r\gh !
 p]iod at ! end & ins]t+ ,janu>y #a1    
#bjbg44  7e7 ,all[+ = ! furni%+ (       
audio-,only teleheal? s]vices ,section  
#ahcd7m77#i7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciem7m77#i77 is am5d$  
by /rik+ end+ on ,decemb] #ca1 #bjbd &  
ins]t+ end+ on ,decemb] #ca1 #bjbf4  7f7

 ,ext5d+ use ( teleheal? ,to conduct    
face-to-,face enc\nt] prior to          
rec]tification ( eligibility = hospice  
c>e ,section #ahad7;a77#g77;,d77i77,,ii7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii77 
is am5d$-- 7#a7 by /rik+ end+ on        
,decemb] #ca1 #bjbd & ins]t+ end+ on    
,decemb] #ca1 #bjbf2 &  7#b7 by ins]t+ 1
 except t ?is subclause %all n apply 9 !
 case ( su* an enc\nt] ) an individual  
occurr+ on or aft] ,janu>y #a1 #bjbe1 if
 su* individual is locat$ 9 an area t is
 subject to a moratorium on ! enrollm5t 
( hospice programs "u ?is title pursuant
 to section #ahff7;j77#g71 if su*       
individual is receiv+ hospice c>e f a   
provid] t is subject to enhanc$ ov]sight
 "u ?is title pursuant to section       
#ahff7;j77#c71 or if su* enc\nt] is     
p]=m$ by a hospice physician or nurse   
practition] :o is n enroll$ "u section  
#ahff7;j7 & is n an opt-out physician or
 practition] 7z def9$ 9 section         
#ahjb7;b77#f77;,d77 be=e ! semicolon4   

7g7 ,program in/ruction au?ority ,!     
,secret>y ( ,heal? & ,human ,s]vices may
 implem5t ! am5dm5ts made by ?is section
 ?r\gh program in/ruction or o!rwise4   
#ajb4 ,guidance on furni%+ s]vices via  
teleheal? to individuals ) limit$       
,engli% pr(ici5cy  7a7 ,9 g5]al ,n lat] 
?an #a ye> aft] ! date ( ! enactm5t (   
?is section1 ! ,secret>y ( ,heal? &     
,human ,s]vices1 9 consultation ) #a or 
m entities f ea* ( ! categories describ$
 9 p>agraphs 7#a7 ?r\gh 7#g7 (          
subsection 7b71 %all issue & dissem9ate1
 or update & revise z applicable1       
guidance = ! entities describ$ 9 su*    
subsection on ! foll[+3 7#a7 ,be/       
practices on facilitat+ & integrat+ use 
( int]pret]s dur+ a telem$ic9e          
appo9tm5t4  7#b7 ,be/ practices on      
provid+ accessible in/ructions on h[ to 
access telecommunications sy/ems 7z su* 
t]m is us$ = purposes ( section #ahcd7m7
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciem7m77 = individuals )    
limit$ ,engli% pr(ici5cy4  7#c7 ,be/    

practices on improv+ access to digital  
pati5t portals = individuals ) limit$   
,engli% pr(ici5cy4  7#d7 ,be/ practices 
on integrat+ ! use ( video plat=ms t    
enable multi-p]son video calls furni%$  
via a telecommunications sy/em =        
purposes ( provid+ int]pretation dur+ a 
telem$ic9e appo9tm5t = an individual )  
limit$ ,engli% pr(ici5cy4  7#e7 ,be/    
practices = provid+ pati5t mat]ials1    
communications1 & in/ructions 9 multiple
 languages1 includ+ text message        
appo9tm5t rem9d]s & prescription        
in=mation4  7b7 ,entities describ$ ,=   
purposes ( subsection 7a71 an entity    
describ$ 9 ?is subsection is an entity 9
 #a or m ( ! foll[+ categories3 7#a7    
,heal? in=mation te*nology s]vice       
provid]s1 includ+-- 7,a7 electronic     
m$ical record companies2  7,b7 remote   
pati5t monitor+ companies2 &  7,c7      
teleheal? or mobile heal? v5dors &      
companies4  7#b7 ,heal? c>e provid]s1   
includ+-- 7,a7 physicians2 &  7,b7      
hospitals4  7#c7 ,heal? insur]s4  7#d7  

,language s]vice companies4  7#e7       
,int]pret] or translator pr(essional    
associations4  7#f7 ,heal? & language   
s]vices quality c]tification            
organizations4  7#g7 ,pati5t & consum]  
advocates1 includ+ su* advocates t "w ) 
individuals ) limit$ ,engli% pr(ici5cy4 
#ajc4 ,e/abli%m5t ( modifi] =           
rec]tifications ( hospice c>e           
eligibility conduct$ ?r\gh teleheal?    
,section #ahad7;a77#g77;,d77i77,,ii7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#acie;f7a77#g77;,d77i77,,ii771 z am5d$  
by section #aja7;f71 is fur!r am5d$ by  
ins]t+ 1 provid$ t1 9 ! case ( su* an   
enc\nt] occurr+ on or aft] ! date t is  
#b ye>s aft] ! date ( ! enactm5t ( !    
,pres]v+ ,teleheal?1 ,hospital1 &       
,ambulance ,access ,act1 su* physician  
or nurse practition] includes 9 any     
claim = su* enc\nt] "o or m modifi]s or 
codes specifi$ by ! ,secret>y to        
indicate t su* enc\nt] 0 furni%$ ?r\gh  
teleheal? aft] z det]m9$ appropriate by 
! ,secret>y4  #ajd4 ,ext5d+ acute       

hospital c>e at home waiv] flexibilities
 ,section #ahff;,g ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #acie;cc-#g7 is    
am5d$-- 7#a7 9 subsection 7a77#a71 by   
/rik+ #bjbd & ins]t+ #bjbi2 &  7#b7 9   
subsection 7b7-- 7,a7 9 ! head]1 by     
/rik+ ,/udy & report & ins]t+ ,/udies & 
reports2  7,b7 9 p>agraph 7#a7-- 7i7 9 !
 matt] prec$+ subp>agraph 7,a71 by /rik+
 ,! ,secret>y & ins]t+ ,n lat] ?an      
,septemb] #cj1 #bjbd1 & aga9 n lat] ?an 
,septemb] #cj1 #bjbh1 ! ,secret>y2  7ii7
 9 clause 7vi71 by /rik+ & at ! end2    
7iii7 9 clause 7vii71 by /rik+ ! p]iod &
 ins]t+ 2 &2 &  7iv7 by add+ at ! end ! 
foll[+ new clause3  7viii7 9 ! case ( ! 
second /udy conduct$ "u ?is p>agraph1 ! 
quality ( c>e1 outcomes1 co/s1 quantity 
& int5sity ( s]vices1 & o!r relevant    
metrics betwe5 individuals :o ent]$ into
 ! ,acute ,hospital ,c>e at ,home       
initiative directly f an em]g5cy        
dep>tm5t comp>$ ) individuals :o ent]$  
into ! ,acute ,hospital ,c>e at ,home   
initiative directly f an exi/+ inpati5t 

/ay 9 a hospital4  2 &  7,c7 9 p>agraph 
7#b7-- 7i7 9 ! head]1 by /rik+ ,report &
 ins]t+ ,reports2 &  7ii7 by ins]t+ &   
aga9 n lat] ?an ,septemb] #cj1 #bjbh1   
aft] #bjbd12 &  7iii7 by /rik+ on ! /udy
 conduct$ "u p>agraph 7#a74 & ins]t+ !  
foll[+3 on-- 7,a7 ) respect to ! fir/   
report submitt$ "u ?is p>agraph1 ! fir/ 
/udy conduct$ "u p>agraph 7#a72 &  7,b7 
) respect to ! second report submitt$ "u
 ?is p>agraph1 ! second /udy conduct$ "u
 p>agraph 7#a74  4  #aje4 ,report on    
we>able m$ical devices ,n lat] ?an #ah  
mon?s aft] ! date ( ! enactm5t ( ?is    
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all conduct a te*nology         
assessm5t (1 & submit to ,congress a    
report on1 ! capabilities & limitations 
( we>able m$ical devices us$ to support 
cl9ical decision-mak+4 ,su* report %all 
include a description (-- 7#a7 !        
pot5tial = su* devices to accurately    
prescribe treatm5ts2  7#b7 an exam9ation
 ( ! b5efits & *all5ges ( artificial    
intellig5ce to augm5t su* capabilities2 

&  7#c7 policy options to enhance !     
b5efits & mitigate pot5tial *all5ges (  
develop+ or us+ su* devices4  #ajf4     
,enhanc+ c]ta9 program integrity        
requirem5ts = ,,dme "u ,m$ic>e  7a7     
,durable m$ical equipm5t ,section       
#ahcd7;a7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #aciem7a77 is am5d$ by   
add+ at ! end ! foll[+ new p>agraph3    
7#bc7 ,ma/] ,li/ inclusion & claim      
review = c]ta9 items  7,a7 ,ma/] ,li/   
inclusion ,beg9n+ ,janu>y #a1 #bjbf1 =  
purposes ( ! ,ma/] ,li/ describ$ 9      
section #dad4bcd7;b7 ( title #db1 ,code 
( ,f$]al ,regulations 7or any successor 
regulation71 an item = :i* paym5t may be
 made "u ?is subsection %all be treat$ z
 hav+ ab]rant bill+ patt]ns 7z su* t]m  
is us$ = purposes ( su* section7 if !   
,secret>y det]m9es t1 )\t explanatory   
contribut+ factors 7su* z furni%+ em]g5t
 c>e s]vices71 a sub/antial numb] (     
writt5 ord]s = su* items "u ?is         
subsection are f an ord]+ physician or  
applicable practition] ) :om !          

individual involv$ does n h a prior     
relation%ip1 z det]m9$ on ! basis (     
prior paym5t exp]i5ce4  7,b7 ,claim     
review ,) respect to items furni%$ on or
 aft] ,janu>y #a1 #bjbf t are includ$ on
 ! ,ma/] ,li/ pursuant to subp>agraph   
7,a71 if su* an item is n subject to a  
det]m9ation ( cov]age 9 advance pursuant
 to p>agraph 7#ae77;,c71 ! ,secret>y may
 conduct prepaym5t review ( claims =    
paym5t = su* item4  4  7b7 ,report on   
id5tify+ cl9ical diagno/ic laboratory   
te/s at high risk = fraud & effective   
mitigation measures ,n lat] ?an ,janu>y 
#a1 #bjbf1 ! ,inspector ,g5]al ( !      
,dep>tm5t ( ,heal? & ,human ,s]vices    
%all submit to ,congress a report       
assess+ fraudul5t claims = cl9ical      
diagno/ic laboratory te/s = :i* paym5t  
may be made "u section #ahcd;,a ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciem-#a7 & effective tools = r$uc+ su*
 fraudul5t claims4 ,! report %all       
include-- 7#a7 :i*1 if any1 cl9ical     
diagno/ic laboratory te/s are id5tifi$ z

 be+ at high risk ( fraudul5t claims1 & 
an analysis ( ! factors t contribute to 
su* risk2  7#b7 ) respect to a cl9ical  
diagno/ic laboratory te/ id5tifi$ "u    
subp>agraph 7,a7 z be+ at high risk (   
fraudul5t claims-- 7,a7 ! am\nt payable 
"u su* section #ahcd;,a ) respect to su*
 te/2  7,b7 ! numb] ( su* te/s furni%$  
to individuals enroll$ "u "p ,b ( title 
,,xviii ( ! ,social ,security ,act 7#db 
,u4,s4,c4 #acie;j et seq472  7,c7 :e!r  
an ord] = su* a te/ 0 m likely to come f
 a provid] ) :om ! individual involv$   
did n h a prior relation%ip1 z det]m9$  
on ! basis ( prior paym5t exp]i5ce2 &   
7,d7 ! frequ5cy ) :i* a claim = paym5t  
"u su* section #ahcd;,a includ$ ! paym5t
 modifi] id5tifi$ by code #ei or #ia2 & 
7#c7 sugge/$ /rategies = r$uc+ ! numb] (
 fraudul5t claims made ) respect to te/s
 s id5tifi$ z be+ at high risk1         
includ+-- 7,a7 an analysis ( :e!r !     
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices c   
detect ab]rant bill+ patt]ns ) respect  
to su* te/s 9 a timely mann]2  7,b7 any 

/rategies = id5tify+ & monitor+ !       
provid]s :o are outli]s ) respect to !  
numb] ( su* te/s t su* provid]s ord]2 & 
7,c7 t>get$ education ef=ts to mitigate 
improp] bill+ = su* te/s4  ,,ii ,su/a9+ 
,access to ,hospital & ,em]g5cy ,s]vices
  #bja4 ,ext5sion ( increas$ inpati5t   
hospital paym5t adju/m5t = c]ta9        
l[-volume hospitals  7a7 ,9 g5]al       
,section #ahhf7;d77#ab7 ( ! ,social     
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#ab77 is am5d$-- 7#a7 9      
subp>agraph 7,b71 by /rik+ dur+ !       
portion ( fiscal ye> #bjbe beg9n+ on    
,janu>y #a1 #bjbe1 & end+ on ,septemb]  
#cj1 #bjbe1 &2  7#b7 9 subp>agraph      
7,c77i7-- 7,a7 9 ! matt] prec$+         
subclause 7,i7-- 7i7 by /rik+ or portion
 ( a fiscal ye>2 &  7ii7 by /rik+ #bjbd 
& ! portion ( fiscal ye> #bjbe beg9n+ on
 ,octob] #a1 #bjbd1 & end+ on ,decemb]  
#ca1 #bjbd & ins]t+ #bjbe2  7,b7 9      
subclause 7,,iii71 by /rik+ #bjbd & !   
portion ( fiscal ye> #bjbe beg9n+ on    
,octob] #a1 #bjbd1 & end+ on ,decemb]   

#ca1 #bjbd & ins]t+ #bjbe2 &  7,c7 9    
subclause 7,,iv71 by /rik+ ! portion (  
fiscal ye> #bjbe beg9n+ on ,janu>y #a1  
#bjbe1 & end+ on ,septemb] #cj1 #bjbe1  
&2 &  7#c7 9 subp>agraph 7,d7-- 7,a7 9 !
 matt] prec$+ clause 7i71 by /rik+ #bjbd
 or dur+ ! portion ( fiscal ye> #bjbe   
beg9n+ on ,octob] #a1 #bjbd1 & end+ on  
,decemb] #ca1 #bjbd & ins]t+ #bjbe2 &   
7,b7 9 clause 7ii71 by /rik+ #bjbd & !  
portion ( fiscal ye> #bjbe beg9n+ on    
,octob] #a1 #bjbd1 & end+ on ,decemb]   
#ca1 #bjbd & ins]t+ #bjbe4  7b7         
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y ( ,heal? & 
,human ,s]vices may implem5t !          
provisions (1 includ+ ! am5dm5ts made   
by1 ?is section by program in/ruction or
 o!rwise4  #bjb4 ,ext5sion ( !          
,m$ic>e-dep5d5t hospital program  7a7 ,9
 g5]al ,section #ahhf7;d77#e77;,g7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#acieww7d77#e77;,g77 is am5d$-- 7#a7 9  
clause 7i71 by /rik+ ,janu>y #a1 #bjbe &
 ins]t+ ,octob] #a1 #bjbe2 &  7#b7 9    

clause 7ii77,,ii71 by /rik+ ,janu>y #a1 
#bjbe & ins]t+ ,octob] #a1 #bjbe4  7b7  
,con=m+ am5dm5ts  7#a7 ,ext5sion ( t>get
 am\nt ,section #ahhf7;b77#c77;,d7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#acieww7b77#c77;,d77 is am5d$-- 7,a7 9 !
 matt] prec$+ clause 7i71 by /rik+      
,janu>y #a1 #bjbe & ins]t+ ,octob] #a1  
#bjbe2 &  7,b7 9 clause 7iv71 by /rik+  
#bjbd & ! portion ( fiscal ye> #bjbe    
beg9n+ on ,octob] #a1 #bjbd1 & end+ on  
,decemb] #ca1 #bjbd & ins]t+ #bjbe4     
7#b7 ,p]mitt+ hospitals to decl9e       
reclassification ,section #aceja7;e77#b7
 ( ! ,omnibus ,budget ,reconciliation   
,act ( #aiic 7#db ,u4,s4,c4 #acieww     
note7 is am5d$ by /rik+ #bjbd1 or !     
portion ( fiscal ye> #bjbe beg9n+ on    
,octob] #a1 #bjbd1 & end+ on ,decemb]   
#ca1 #bjbd & ins]t+ #bjbe4  #bjc4       
,ext5sion ( add-on paym5ts = ambulance  
s]vices  7a7 ,9 g5]al ,section #ahcd7l7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciem7l77 is am5d$-- 7#a7 9  
p>agraph 7#ab77;,a71 by /rik+ ,janu>y   

#a1 #bjbe & ins]t+ ,octob] #a1 #bjbe2 & 
7#b7 9 p>agraph 7#ac71 by /rik+ ,janu>y 
#a1 #bjbe 9 ea* place x appe>s & ins]t+ 
,octob] #a1 #bjbe 9 ea* su* place4  7b7 
,program in/ruction au?ority ,not)/&+   
any o!r provision ( law1 ! ,secret>y (  
,heal? & ,human ,s]vices may implem5t ! 
provisions (1 includ+ am5dm5ts made by1 
?is section ?r\gh program in/ruction or 
o!rwise4  ,,iii ,(fsets  #cja4 ,revis+  
phase-9 ( ,m$ic>e cl9ical laboratory te/
 paym5t *anges  7a7 ,revis$ phase-,9 (  
r$uctions f private payor rate          
implem5tation ,section #ahcd;,a7b77#c7 (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #aciem-#a7;b77#c77 is am5d$-- 7#a7 9   
subp>agraph 7,a71 by /rik+ #bjbg &      
ins]t+ #bjbh2 &  7#b7 9 subp>agraph     
7,b7-- 7,a7 9 clause 7ii71 by /rik+     
#bjbd & ins]t+ #bjbe2 &  7,b7 9 clause  
7iii71 by /rik+ #bjbe ?r\gh #bjbg &     
ins]t+ #bjbf ?r\gh #bjbh4  7b7 ,revis$  
report+ p]iod = report+ ( private sector
 paym5t rates = e/abli%m5t ( ,m$ic>e    
paym5t rates ,section                   

#ahcd;,a7a77#a77;,b7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciem-#a7;a77#a77;,b77 is am5d$-- 7#a7 
9 clause 7i71 by /rik+ #bjbd & ins]t+   
#bjbe2 &  7#b7 9 clause 7ii71 by /rik+  
#bjbe ea* place x appe>s & ins]t+ #bjbf4
  7c7 ,implem5tation ,! ,secret>y (     
,heal? & ,human ,s]vices may implem5t ! 
am5dm5ts made by ?is section by program 
in/ruction or o!rwise4  #cjb4           
,arrangem5ts ) ph>macy b5efit manag]s ) 
respect to prescription drug plans &    
,,ma-,,pd plans  7a7 ,9 g5]al  7#a7     
,prescription drug plans ,section       
#ahfj;,d-#ab ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ 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 #bjbg3 7#a7 ,agreem5ts
 ) ph>macy b5efit manag]s ,ea* contract 
ent]$ into ) a ,,pdp sponsor "u ?is "p )
 respect to a prescription drug plan    
(f]$ by su* sponsor %all provide t any  
ph>macy b5efit manag] act+ on behalf (  

su* sponsor has a writt5 agreem5t ) !   
,,pdp sponsor "u :i* ! ph>macy b5efit   
manag]1 & any affiliates ( su* ph>macy  
b5efit manag]1 z applicable1 agree to   
meet ! foll[+ requirem5ts3 7,a7 ,no     
income o!r ?an bona fide s]vice fees    
7i7 ,9 g5]al ,! ph>macy b5efit manag] & 
any affiliate ( su* ph>macy b5efit      
manag] %all n d]ive any remun]ation )   
respect to any s]vices provid$ on behalf
 ( any entity or individual1 9          
connection ) ! utilization ( cov]$ "p ,d
 drugs1 f any su* entity or individual  
o!r ?an bona fide s]vice fees1 subject  
to clauses 7ii7 & 7iii74  7ii7 ,inc5tive
 paym5ts ,= ! purposes ( ?is subsection1
 an inc5tive paym5t 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 fee7ev5
 if su* paym5t does n o!rwise meet !    
def9ition ( su* t]m "u p>agraph         
7#g77;,b77 if su* paym5t is a flat doll>
 am\nt1 is consi/5t ) fair m>ket value  
7z specifi$ by ! ,secret>y71 is relat$  

to s]vices actually p]=m$ by ! ph>macy  
b5efit manag] or affiliate ( su* ph>macy
 b5efit manag]1 on behalf ( ! entity    
mak+ su* paym5t1 9 connection ) !       
utilization ( cov]$ "p ,d drugs1 & meets
 additional requirem5ts1 if any1 z      
det]m9$ appropriate by ! ,secret>y4     
7iii7 ,cl>ification on rebates &        
disc\nts us$ to l[] co/s = cov]$ "p d   
drugs ,rebates1 disc\nts1 & o!r price   
concessions receiv$ by a ph>macy b5efit 
manag] or an affiliate ( a ph>macy      
b5efit manag] f manufactur]s1 ev5 if su*
 price concessions are calculat$ z a    
p]c5tage ( a drug's price1 %all n be    
consid]$ a violation ( ! requirem5ts (  
clause 7i7 if !y are fully pass$ ?r\gh  
to a ,,pdp sponsor & are compliant ) all
 regulatory & subregulatory requirem5ts 
relat$ to direct & indirect remun]ation 
= manufactur] rebates "u ?is "p1 includ+
 9 cases :]e a ,,pdp sponsor is act+ z a
 ph>macy b5efit manag] on behalf ( a    
prescription drug plan (f]$ by su* ,,pdp
 sponsor4  7iv7 ,evaluation (           

remun]ation arrangem5ts ,compon5ts (    
subsets ( remun]ation arrangem5ts 7su* z
 fees or o!r =ms ( comp5sation paid to  
or reta9$ by ! ph>macy b5efit manag] or 
affiliate ( su* ph>macy b5efit manag]71 
z det]m9$ appropriate by ! ,secret>y1   
betwe5 ph>macy b5efit manag]s or        
affiliates ( su* ph>macy b5efit manag]s1
 z applicable1 & o!r entities involv$ 9 
! disp5s+ or utilization ( cov]$ "p ,d  
drugs 7includ+ ,,pdp sponsors1          
manufactur]s1 ph>macies1 & o!r entities 
z det]m9$ appropriate by ! ,secret>y7   
%all be subject to review by !          
,secret>y1 9 consultation ) ! ,(fice ( !
 ,inspector ,g5]al ( ! ,dep>tm5t (      
,heal? & ,human ,s]vices1 z det]m9$     
appropriate by ! ,secret>y4 ,!          
,secret>y1 9 consultation ) ! ,(fice ( !
 ,inspector ,g5]al1 %all review :e!r    
remun]ation "u su* arrangem5ts is       
consi/5t ) fair m>ket value 7z specifi$ 
by ! ,secret>y7 ?r\gh reviews &         
assessm5ts ( su* remun]ation1 z det]m9$ 
appropriate4  7v7 ,disgorgem5t ,!       

ph>macy b5efit manag] %all disgorge any 
remun]ation paid to su* ph>macy b5efit  
manag] or an affiliate ( su* ph>macy    
b5efit manag] 9 violation ( ?is         
subp>agraph to ! ,,pdp sponsor4  7vi7   
,additional requirem5ts ,! ph>macy      
b5efit manag] %all-- 7,i7 ent] into a   
writt5 agreem5t ) any affiliate ( su*   
ph>macy b5efit manag]1 "u :i* !         
affiliate %all id5tify & disgorge any   
remun]ation describ$ 9 clause 7v7 to !  
ph>macy b5efit manag]2 &  7,,ii7 atte/1 
subject to any requirem5ts det]m9$      
appropriate by ! ,secret>y1 t ! ph>macy 
b5efit manag] has ent]$ into a writt5   
agreem5t describ$ 9 subclause 7,i7 ) any
 relevant affiliate ( ! ph>macy b5efit  
manag]4  7,b7 ,transp>5cy reg>d+        
gu>antees & co/ p]=mance evaluations ,! 
ph>macy b5efit manag] %all-- 7i7 def9e1 
int]pret1 & apply1 9 a fully transp>5t &
 consi/5t mann] = purposes ( calculat+  
or o!rwise evaluat+ ph>macy b5efit      
manag] p]=mance aga9/ pric+ gu>antees or
 simil> co/ p]=mance measurem5ts relat$ 

to rebates1 disc\nts1 price concessions1
 or net co/s1 t]ms su* z-- 7,i7 g5]ic   
drug1 9 a mann] consi/5t ) ! def9ition (
 ! t]m "u section #dbc4d ( title #db1   
,code ( ,f$]al ,regulations1 or a       
successor regulation2  7,,ii7 br& "n    
drug1 9 a mann] consi/5t ) ! def9ition (
 ! t]m "u section #dbc4d ( title #db1   
,code ( ,f$]al ,regulations1 or a       
successor regulation2  7,,iii7 specialty
 drug2  7,,iv7 rebate2 &  7,v7 disc\nt2 
7ii7 id5tify any drugs1 claims1 or price
 concessions exclud$ f any pric+        
gu>antee or o!r co/ p]=mance 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   
#bjbg1 ! ph>macy b5efit manag] %all     
submit to ! ,,pdp sponsor1 & to !       
,secret>y1 a report1 9 accordance ) ?is 
subp>agraph1 & %all make su* report     
available to su* sponsor at no co/ to   
su* sponsor 9 a =mat specifi$ by !      
,secret>y "u p>agraph 7#e74 ,ea* su*    
report %all include1 ) respect to su*   
,,pdp sponsor & ea* plan (f]$ by su*    
sponsor1 ! foll[+ in=mation ) respect to
 ! previ\s plan ye>3 7,i7 ,a li/ ( all  
drugs cov]$ by ! plan t 7 disp5s$       
includ+1 ) respect to ea* su* drug--    
7aa7 ! br& "n1 g5]ic or non-propriet>y  
"n1 & ,national ,drug ,code2  7bb7 !    
numb] ( plan enrollees = :om ! drug 0   
disp5s$1 ! total numb] ( prescription   
claims = ! drug 7includ+ orig9al        
prescriptions & refills1 c\nt$ z sep>ate
 claims71 & ! total numb] ( dosage units
 ( ! drug disp5s$2  7cc7 ! numb] (      
prescription claims describ$ 9 item 7bb7
 by ea* type ( disp5s+ *annel ?r\gh :i* 
! drug 0 disp5s$1 includ+ retail1 mail  

ord]1 specialty ph>macy1 long t]m c>e   
ph>macy1 home infusion ph>macy1 or o!r  
types ( ph>macies or provid]s2  7dd7 !  
av]age :olesale acquisition co/1 li/$ z 
co/ p] day's supply1 co/ p] dosage unit1
 & co/ p] typical c\rse ( treatm5t 7z   
applicable72  7ee7 ! av]age :olesale    
price = ! drug1 li/$ z 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,,nadac72 &  7kk7 total                
manufactur]-d]iv$ rev5ue1 inclusive (   
bona fide s]vice fees1 attributable to !
 drug & reta9$ by ! ph>macy b5efit      
manag] & any affiliate ( su* ph>macy    
b5efit manag]4  7,,ii7 ,9 ! case ( a    
ph>macy b5efit manag] t has an affiliate
 t is a retail1 mail ord]1 or specialty 
ph>macy1 ) respect to drugs cov]$ by su*
 plan t 7 disp5s$1 ! foll[+ in=mation3  
7aa7 ,! p]c5tage ( total prescriptions t
 7 disp5s$ by ph>macies t are an        
affiliate ( ! ph>macy b5efit manag] =   
ea* drug4  7bb7 ,! int]qu>tile range ( !
 total comb9$ co/s paid by ! plan & plan
 enrollees1 p] dosage unit1 p] c\rse (  
treatm5t1 p] #cj-;day supply1 & p]      
#ij-;day supply = ea* drug disp5s$ by   
ph>macies t are n an affiliate ( !      
ph>macy b5efit manag] & t are includ$ 9 

! ph>macy network ( su* plan4  7cc7 ,!  
int]qu>tile range ( ! total comb9$ co/s 
paid by ! plan & plan enrollees1 p]     
dosage unit1 p] c\rse ( treatm5t1 p]    
#cj-;day supply1 & p] #ij-;day supply = 
ea* drug disp5s$ by ph>macies t are an  
affiliate ( ! ph>macy b5efit manag] & t 
are includ$ 9 ! ph>macy network ( su*   
plan4  7dd7 ,! l[e/ total comb9$ co/    
paid by ! plan & plan enrollees1 p]     
dosage unit1 p] c\rse ( treatm5t1 p]    
#cj-;day supply1 & p] #ij-;day supply1 =
 ea* drug t is available f any ph>macy  
includ$ 9 ! ph>macy network ( su* plan4 
7ee7 ,! diff]5ce betwe5 ! av]age        
acquisition co/ ( ! affiliate1 su* z a  
ph>macy or o!r entity t acquires        
prescription drugs1 t initially acquires
 ! drug & ! am\nt report$ "u subclause  
7,i77jj7 = ea* drug4  7ff7 ,a li/       
inclusive ( ! br& "n1 g5]ic or          
non-propriet>y "n1 & ,national ,drug    
,code ( cov]$ "p ,d drugs subject to an 
agreem5t ) a cov]$ entity "u section    
#cdj;,b ( ! ,public ,heal? ,s]vice ,act 

= :i* ! ph>macy b5efit manag] or an     
affiliate ( ! ph>macy b5efit manag] _h a
 contract or o!r arrangem5t ) su* a     
cov]$ entity 9 ! s]vice area ( su* plan4
  7,,iii7 ,:]e a drug approv$ "u section
 #eje7;c7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7ref]r$ to 9 ?is         
subclause z ! li/$ drug7 is cov]$ by !  
plan1 ! foll[+ in=mation3 7aa7 ,a li/ ( 
curr5tly m>ket$ g5]ic drugs approv$ "u  
section #eje7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act pursuant to an  
application t ref]5ces su* li/$ drug t  
are n cov]$ by ! plan1 are cov]$ on !   
same =mul>y ti] or a =mul>y ti]         
typically associat$ ) high] co/-%>+ ?an 
! li/$ drug1 or are subject to          
utilization managem5t t ! li/$ drug is n
 subject to4  7bb7 ,! e/imat$ av]age    
b5efici>y co/-%>+ "u ! plan = a #cj-;day
 supply ( ! li/$ drug4  7cc7 ,:]e a     
g5]ic drug li/$ "u item 7aa7 is on a    
=mul>y ti] typically associat$ ) high]  
co/-%>+ ?an ! li/$ drug1 ! e/imat$      
av]age co/-%>+ t a b5efici>y w\ld h paid

 = a #cj-;day supply ( ea* ( ! g5]ic    
drugs describ$ 9 item 7aa71 _h ! plan   
provid$ cov]age = su* drugs on ! same   
=mul>y ti] z ! li/$ drug4  7dd7 ,a      
writt5 ju/ification = provid+ m         
favorable cov]age ( ! li/$ drug ?an !   
g5]ic drugs describ$ 9 item 7aa74  7ee7 
,! numb] ( curr5tly m>ket$ g5]ic drugs  
approv$ "u section #eje7;j7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act pursuant 
to an application t ref]5ces su* li/$   
drug4  7,,iv7 ,:]e a ref]5ce product 7z 
def9$ 9 section #cea7;i7 ( ! ,public    
,heal? ,s]vice ,act7 is cov]$ by ! plan1
 ! foll[+ in=mation3 7aa7 ,a li/ (      
curr5tly m>ket$ biosimil> biological    
products lic5s$ "u section #cea7k7 ( !  
,public ,heal? ,s]vice ,act pursuant to 
an application t ref]s to su* ref]5ce   
product t are n cov]$ by ! plan1 are    
cov]$ on ! same =mul>y ti] or a =mul>y  
ti] typically associat$ ) high] co/-%>+ 
?an ! ref]5ce product1 or are subject to
 utilization managem5t t ! ref]5ce      
product is n subject to4  7bb7 ,!       

e/imat$ av]age b5efici>y co/-%>+ "u !   
plan = a #cj-;day supply ( ! ref]5ce    
product4  7cc7 ,:]e a biosimil>         
biological product li/$ "u item 7aa7 is 
on a =mul>y ti] typically associat$ )   
high] co/-%>+ ?an ! 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 ( cov]$ "p ,d drugs "u t    
plan1 inclusive ( bona fide s]vice fees4
  7,,vii7 ,! total sp5d+ on cov]$ "p ,d 
drugs net ( rebates1 fees1 disc\nts1 or 
o!r direct & indirect remun]ation by !  
plan4  7,,viii7 ,an explanation ( any   
b5efit design p>amet]s "u su* plan t    
enc\rage plan enrollees to fill         
prescriptions at ph>macies t are an     
affiliate ( su* ph>macy b5efit manag]1  
su* z mail & specialty home deliv]y     
programs1 & retail & mail auto-refill   
programs4  7,,ix7 ,! foll[+ in=mation3  
7aa7 ,a li/ ( all brok]s1 consultants1  
advisors1 & auditors t receive          
comp5sation f ! ph>macy b5efit manag] or
 an affiliate ( su* ph>macy b5efit      
manag] = ref]rals1 consult+1 audit+1 or 
o!r s]vices (f]$ to ,,pdp sponsors      
relat$ to ph>macy b5efit managem5t      
s]vices4  7bb7 ,! am\nt ( comp5sation   
provid$ by su* ph>macy b5efit manag] or 
affiliate to ea* su* brok]1 consultant1 

advisor1 & auditor4  7cc7 ,! me?odology 
= calculat+ ! am\nt ( comp5sation       
provid$ by su* ph>macy b5efit manag] or 
affiliate1 = ea* su* brok]1 consultant1 
advisor1 & auditor4  7,x7 ,a li/ ( all  
affiliates ( ! ph>macy b5efit manag]4   
7,,xi7 ,a summ>y docum5t submitt$ 9 a   
/&>diz$ template develop$ by ! ,secret>y
 t includes su* in=mation describ$ 9    
subclauses 7,i7 ?r\gh 7,x74  7ii7       
,writt5 explanation ( contracts or      
agreem5ts ) drug manufactur]s  7,i7 ,9  
g5]al ,! ph>macy b5efit manag] %all1 n  
lat] ?an #cj days aft] ! f9alization (  
any contract or agreem5t betwe5 su*     
ph>macy b5efit manag] or an affiliate ( 
su* ph>macy b5efit manag] & a drug      
manufactur] 7or subsidi>y1 ag5t1 or     
entity affiliat$ ) su* drug manufactur]7
 t makes rebates1 disc\nts1 paym5ts1 or 
o!r f9ancial inc5tives relat$ to "o or m
 cov]$ "p ,d drugs or o!r prescription  
drugs1 z applicable1 ( ! manufactur]    
directly or indirectly cont+5t ^u       
cov]age1 =mul>y placem5t1 or utilization

 managem5t conditions on any o!r cov]$  
"p ,d drugs or o!r prescription drugs1 z
 applicable1 submit to ! ,,pdp sponsor a
 writt5 explanation ( su* contract or   
agreem5t4  7,,ii7 ,requirem5ts ,a writt5
 explanation "u subclause 7,i7 %all--   
7aa7 include ! manufactur] subject to ! 
contract or agreem5t1 all cov]$ "p ,d   
drugs & o!r prescription drugs1 z       
applicable1 subject to ! contract or    
agreem5t & ! manufactur]s ( su* drugs1 &
 a high-level description ( ! t]ms ( su*
 contract or agreem5t & h[ su* t]ms     
apply to su* drugs2 &  7bb7 be c]tifi$  
by ! ,*ief ,executive ,(fic]1 ,*ief     
,f9ancial ,(fic]1 or ,g5]al ,c\nsel (   
su* ph>macy b5efit manag]1 or affiliate 
( su* ph>macy b5efit manag]1 z          
applicable1 or an individual delegat$ ) 
! au?ority to sign on behalf ( "o ( ^!  
(fic]s1 :o reports directly to ! (fic]4 
7,,iii7 ,def9ition ( o!r prescription   
drugs ,= purposes ( ?is clause1 ! t]m   
o!r prescription drugs means            
prescription drugs cov]$ z supplem5tal  

b5efits "u ?is "p or prescription drugs 
paid outside ( ?is "p4  7,d7 ,audit     
rights  7i7 ,9 g5]al ,n less ?an once a 
ye>1 at ! reque/ ( ! ,,pdp sponsor1 !   
ph>macy b5efit manag] %all all[ = an    
audit ( ! ph>macy b5efit manag] to      
ensure compliance ) all t]ms &          
conditions "u ! writt5 agreem5t & !     
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#b7 ,en=cem5t  7,a7 ,9 g5]al ,ea* ,,pdp
 sponsor %all-- 7i7 disgorge to !       
,secret>y any am\nts disgorg$ to ! ,,pdp
 sponsor by a ph>macy b5efit manag] "u  
p>agraph 7#a77;,a77v72  7ii7 require1 9 
a writt5 agreem5t ) any ph>macy b5efit  
manag] act+ on behalf ( su* sponsor or  
affiliate ( su* ph>macy b5efit manag]1 t
 su* ph>macy b5efit manag] or affiliate 
reimburse ! ,,pdp sponsor = any civil   
money p5alty impos$ on ! ,,pdp sponsor z
 a result ( ! failure ( ! ph>macy b5efit
 manag] or affiliate to meet !          
requirem5ts ( p>agraph 7#a7 t are       
applicable to ! ph>macy b5efit manag] or

 affiliate "u ! agreem5t2 &  7iii7      
require1 9 a writt5 agreem5t ) any su*  
ph>macy b5efit manag] act+ on behalf (  
su* sponsor or affiliate ( su* ph>macy  
b5efit manag]1 t su* ph>macy b5efit     
manag] or affiliate be subject to       
punitive rem$ies = brea* ( contract =   
failure to comply ) ! requirem5ts       
applicable "u p>agraph 7#a74  7,b7      
,report+ ( alleg$ violations ,!         
,secret>y %all make available & ma9ta9 a
 me*anism = manufactur]s1 ,,pdp         
sponsors1 ph>macies1 & o!r entities t h 
contractual relation%ips ) ph>macy      
b5efit manag]s or affiliates ( su*      
ph>macy b5efit manag]s to report1 on a  
confid5tial basis1 alleg$ violations (  
p>agraph 7#a77;,a7 or subp>agraph 7,c74 
7,c7 ,anti-retaliation & anti-co]cion   
,consi/5t ) applicable ,f$]al or ,/ate  
law1 a ,,pdp sponsor %all n-- 7i7       
retaliate aga9/ an individual or entity 
= report+ an alleg$ violation "u        
subp>agraph 7,b72 or  7ii7 co]ce1       
intimidate1 ?reat51 or int]f]e ) !      

ability ( an individual or entity to    
report any su* alleg$ violations4  7#c7 
,c]tification ( compliance  7,a7 ,9     
g5]al ,ea* ,,pdp sponsor %all furni% to 
! ,secret>y 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,b7 ,implem5tation ,not)/&+ any o!r    
provision ( law1 ! ,secret>y may        
implem5t ?is p>agraph by program        
in/ruction or o!rwise4  7#d7 ,rule (    
con/ruction ,no?+ 9 ?is subsection %all 
be con/ru$ z prohibit+ paym5ts relat$ to
 reimbursem5t = +r$i5t co/s to any      
entity t acquires prescription drugs1   
su* z a ph>macy or :olesal]4  7#e7 ,/&>d
 =mats  7,a7 ,9 g5]al ,n lat] ?an ,june 
#a1 #bjbf1 ! ,secret>y %all specify     
/&>d1 ma*9e-readable =mats = ph>macy    
b5efit manag]s to submit annual reports 
requir$ "u p>agraph 7#a77;,c77i74  7,b7 
,implem5tation ,not)/&+ any o!r         
provision ( law1 ! ,secret>y may        

implem5t ?is p>agraph by program        
in/ruction or o!rwise4  7#f7            
,confid5tiality  7,a7 ,9 g5]al          
,in=mation disclos$ by a ph>macy b5efit 
manag]1 an affiliate ( a ph>macy b5efit 
manag]1 a ,,pdp sponsor1 or a ph>macy "u
 ?is subsection t is n o!rwise publicly 
available or available = pur*ase %all n 
be disclos$ by ! ,secret>y or a ,,pdp   
sponsor receiv+ ! in=mation1 except t ! 
,secret>y may disclose ! in=mation = !  
foll[+ purposes3 7i7 ,z ! ,secret>y     
det]m9es necess>y to c>ry out ?is "p4   
7ii7 ,to p]mit ! ,comptroll] ,g5]al to  
review ! in=mation provid$4  7iii7 ,to  
p]mit ! ,director ( ! ,congressional    
,budget ,(fice to review ! in=mation    
provid$4  7iv7 ,to p]mit ! ,executive   
,director ( ! ,m$ic>e ,paym5t ,advisory 
,commission to review ! in=mation       
provid$4  7v7 ,to ! ,attorney ,g5]al = !
 purposes ( conduct+ ov]sight & en=cem5t
 "u ?is title4  7vi7 ,to ! ,inspector   
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices 9 accordance ) its au?orities  

"u ! ,inspector ,g5]al ,act ( #aigh     
7section #djf ( title #e1 ,unit$ ,/ates 
,code71 & o!r applicable /atutes4  7,b7 
,re/riction on use ( in=mation ,!       
,secret>y1 ! ,comptroll] ,g5]al1 !      
,director ( ! ,congressional ,budget    
,(fice1 & ! ,executive ,director ( !    
,m$ic>e ,paym5t ,advisory ,commission   
%all n report on or disclose in=mation  
disclos$ pursuant to subp>agraph 7,a7 to
 ! public 9 a mann] t w\ld id5tify-- 7i7
 a specific ph>macy b5efit manag]1      
affiliate1 ph>macy1 manufactur]1        
:olesal]1 ,,pdp sponsor1 or plan2 or    
7ii7 contract prices1 rebates1 disc\nts1
 or o!r remun]ation = specific drugs 9 a
 mann] t may all[ ! id5tification (     
specific contract+ p>ties or ( su*      
specific drugs4  7#g7 ,def9itions ,=    
purposes ( ?is subsection3 7,a7         
,affiliate ,! t]m affiliate 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 7z      
specifi$ by ! ,secret>y7 = a bona fide1 
itemiz$ s]vice actually p]=m$ on behalf 
( an entity1 t ! entity w\ld o!rwise    
p]=m 7or contract =7 9 ! abs5ce ( !     
s]vice arrangem5t & t is n pass$ on 9   
:ole or 9 "p to a cli5t or cu/om]1 :e!r 
or n ! entity takes title to ! drug4    
,su* fee mu/ be a flat doll> am\nt &    
%all n be directly or indirectly bas$   
on1 or cont+5t ^u-- 7i7 drug price1 su* 
z :olesale acquisition co/ or drug      
b5*m>k price 7su* z av]age :olesale     
price72  7ii7 ! am\nt ( disc\nts1       
rebates1 fees1 or o!r direct or indirect
 remun]ation ) respect to cov]$ "p ,d   
drugs disp5s$ to enrollees 9 a          
prescription drug plan1 except z p]mitt$
 pursuant to p>agraph 7#a77;,a77ii72    
7iii7 cov]age or =mul>y placem5t        

decisions or ! volume or value ( any    
ref]rals or bus9ess g5]at$ betwe5 !     
p>ties to ! arrangem5t2 or  7iv7 any o!r
 am\nts or me?odologies prohibit$ by !  
,secret>y4  7,c7 ,ph>macy b5efit manag] 
,! t]m ph>macy b5efit manag] means any  
p]son or entity t1 ei!r directly or     
?r\gh an int]m$i>y1 acts z a price      
negotiator or gr\p pur*as] on behalf ( a
 ,,pdp sponsor or prescription drug     
plan1 or manages ! prescription drug    
b5efits provid$ by su* sponsor or plan1 
includ+ ! process+ & paym5t ( claims =  
prescription drugs1 ! p]=mance ( drug   
utilization review1 ! process+ ( drug   
prior au?orization reque/s1 !           
adjudication ( appeals or grievances    
relat$ to ! prescription drug b5efit1   
contract+ ) network ph>macies1 controll+
 ! co/ ( cov]$ "p ,d drugs1 or !        
provision ( relat$ s]vices4 ,su* t]m    
includes any p]son or entity t c>ries   
out "o or m ( ! activities describ$ 9 ! 
prec$+ s5t5ce1 irrespective ( :e!r su*  
p]son or entity calls itself a ph>macy  

b5efit manag]4  4  7#b7 ,,ma-,,pd plans 
,section #aheg7;f77#c7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#bg7;f77#c77 is am5d$ by add+ at 
! end ! foll[+ new subp>agraph3  7,f7   
,requirem5ts relat+ to ph>macy b5efit   
manag]s ,= plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbg1 section              
#ahfj;,d-#ab7;h74  4  7#c7              
,nonapplication ( pap]work r$uction act 
,*apt] #ce ( title #dd1 ,unit$ ,/ates   
,code1 %all n apply to ! implem5tation (
 ?is subsection4  7#d7 ,fund+  7,a7     
,secret>y ,9 addition to am\nts o!rwise 
available1 !re is appropriat$ to !      
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices     
,program ,managem5t ,acc\nt1 out ( any  
money 9 ! ,treasury n o!rwise           
appropriat$1 #aac1jjj1jjj = fiscal ye>  
#bjbe1 to rema9 available until exp5d$1 
to c>ry out ?is subsection4  7,b7 ,,oig 
,9 addition to am\nts o!rwise available1
 !re is appropriat$ to ! ,inspector     
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices1 out ( any money 9 ! ,treasury 

n o!rwise appropriat$1 #bj1jjj1jjj =    
fiscal ye> #bjbe1 to rema9 available    
until exp5d$1 to c>ry out ?is           
subsection4  7b7 ,,gao /udy & report on 
c]ta9 report+ requirem5ts  7#a7 ,/udy ,!
 ,comptroll] ,g5]al ( ! ,unit$ ,/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 #bjbh1 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$2  7,b7 an analysis ( 
any diff]5ces 9 agreem5ts & _! effects  
on plan enrollee out-(-pocket sp5d+ &   
av]age ph>macy reimbursem5t1 & any o!r  
impacts2 &  7,c7 any recomm5dations !   
,commission det]m9es appropriate4  7#b7 
,n lat] ?an ,m>* #ca1 #bjcj1 a report   
describ+ any *anges ) respect to !      
in=mation describ$ 9 p>agraph 7#a7 ov]  
"t1 toge!r ) any recomm5dations !       
,commission det]m9es appropriate4  #cjc4
 ,ext5d+ ! adju/m5t to ! calculation (  
hospice cap am\nts "u ! ,m$ic>e program 
,section #ahad7;i77#b77;,b7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#acie;f7i77#b77;,b77 is am5d$-- 7#a7 9  
clause 7ii71 by /rik+ #bjcc & ins]t+    
#bjcd2 &  7#b7 9 clause 7iii71 by /rik+ 
#bjcc & ins]t+ #bjcd4