,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #cefa  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #bb1 #bjbc ,mrs4 
,rodg]s ( ,wa%+ton 7= h]self & ,mr4     
,pallone7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce1 & 9 addition to ! ,committees 
on ,ways & ,means1 & ,education & !     
,work=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 promote hospital & insur]  
price transp>5cy1 & = o!r purposes4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,promot+ ,access to ,treatm5ts &        
,increas+ ,extremely ,ne$$ ,transp>5cy  
,act ( #bjbc or ! ,,pati5t ,act ( #bjbc4
  ,i ,increas+ price transp>5cy to l[]  
co/s  #aja4 ,price transp>5cy           
requirem5ts  7a7 ,9 g5]al ,section      
#bgah7;e7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #cjj;gg-#ah7;e77 is 
am5d$--  7#a7 by /rik+ ,ea* hospital &  
ins]t+ ! foll[+3  7#a7 ,9 g5]al ,ea*    

hospital  2  7#b7 by ins]t+ 1 )\t       
subscription & free ( *>ge1 9 a s+le    
ma*9e-readable file1 aft] a li/2  7#c7  
by ins]t+ & a li/1 9 pla9 language & )\t
 subscription & free ( *>ge1 9 a        
consum]-fri5dly =mat1 ( ! hospital's    
/&>d *>ges = z _m ( ! #gj ,c5t]s =      
,m$ic>e  ,m$icaid ,s]vices-specifi$     
%oppable s]vices t are provid$ by !     
hospital1 & z _m additional             
hospital-select$ %oppable s]vices 7or   
all su* additional s]vices1 if su*      
hospital provides few] ?an #cjj %oppable
 s]vices7 z may be necess>y = a comb9$  
total ( at lea/ #cjj %oppable s]vices   
aft] ,social ,security ,act2 &  7#d7 by 
add+ at ! end ! foll[+3 ,su* li/s %all  
be updat$ n less frequ5tly ?an annually4
 ,beg9n+ ,janu>y #a1 #bjbd1 ea* hospital
 %all include 9 its li/s ( /&>d *>ges1  
along ) su* additional in=mation z !    
,secret>y may require ) respect to su*  
*>ges = purposes ( promot+ public       
aw>5ess ( hospital pric+ 9 advance (    
receiv+ a hospital item or s]vice1 !    

foll[+3  7,a7 ,a pla9 language          
description ( ea* item or s]vice includ$
 on su* li/1 includ+1 z applicable1 !   
,heal?c>e ,common ,proc$ure ,cod+ ,sy/em
 7,,hcpcs7 code1 ! ,diagnosis ,relat$   
,gr\p 7,,drg71 ! ,national ,drug ,code  
7,,ndc71 or o!r pay] id5tifi] us$ or    
approv$ by ! ,c5t]s = ,m$ic>e  ,m$icaid 
,s]vices = su* item or s]vice4  7,b7 ,! 
gross *>ge1 express$ z a doll> am\nt1 = 
ea* su* item or s]vice1 :5 provid$ 91 z 
applicable1 ! hospital inpati5t sett+ & 
outpati5t dep>tm5t sett+4  7,c7 ,any    
curr5t pay]-specific negotiat$ *>ges1   
cle>ly associat$ ) ! "n ( ! ?ird p>ty   
pay] & plan & express$ z a doll> am\nt1 
t applies to ea* su* item or s]vice :5  
provid$ 91 z applicable1 ! hospital     
inpati5t sett+ & outpati5t dep>tm5t     
sett+4  7,d7 ,! de-id5tifi$ maximum &   
m9imum negotiat$ *>ges = ea* su* item or
 s]vice4  7,e7 ,! disc\nt$ ca% price1   
express$ z a doll> am\nt1 = ea* su* item
 or s]vice :5 provid$ 91 z applicable1 !
 hospital inpati5t sett+ & outpati5t    

dep>tm5t sett+4 ,if ! disc\nt$ ca% price
 is a p]c5tage ( ano!r value provid$1 ! 
calculat$ value mu/ be ent]$ z a doll>  
am\nt4 ,if ! disc\nt$ ca% price equates 
to ! gross *>ge1 ! gross *>ge %all be   
re-ent]$ to indicate t no ca% disc\nt is
 available4  7#b7 ,deem$ compliance )   
%oppable s]vices requirem5t = c]ta9 ye>s
 ,) respect to a ye> be=e #bjbe1 a      
hospital %all be deem$ to meet !        
requirem5t ( p>agraph 7#a7 t su*        
hospital make available a li/ ( /&>d    
*>ges = %oppable s]vices if ! hospital  
ma9ta9s an int]net-bas$ price e/imator  
tool t meets ! foll[+ requirem5ts3  7,a7
 ,! tool provides e/imates = z _m ( !   
#gj ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices 
specifi$ %oppable s]vices t are provid$ 
by ! hospital1 & z _m additional        
hospital-select$ %oppable s]vices 7or   
all su* additional s]vices1 if su*      
hospital provides few] ?an #cjj %oppable
 s]vices7 z may be necess>y = a comb9$  
total ( at lea/ #cjj %oppable s]vices4  
7,b7 ,! tool all[s heal? c>e consum]s   

to1 at ! "t !y use ! tool1 obta9 an     
e/imate ( ! am\nt !y w be obligat$ to   
pay ! hospital = ! %oppable s]vice4     
7,c7 ,! tool is prom95tly display$ on ! 
hospital's website & easily accessible  
to ! public1 )\t subscription1 fee1 or  
hav+ to submit p]sonal id5tify+         
in=mation1 & se>*able by s]vice         
description1 bill+ code1 & pay]4  ,!    
,secret>y may n deem ! e/abli%m5t ( an  
int]net-bas$ price e/imator tool t meets
 ! requirem5ts ( ?is p>agraph to        
con/itute compliance ) ! requirem5t (   
p>agraph 7#a7 t su* hospital make       
available a li/ ( /&>d *>ges = %oppable 
s]vices = #bjbe or a subsequ5t ye>4     
7#c7 ,uni=m me?od & =mat ,n lat] ?an    
,janu>y #a1 #bjbe1 ! ,secret>y %all     
implem5t a /&>d1 uni=m me?od & =mat =   
hospitals to use 9 ord] to satisfy !    
requirem5ts ( ?is subsection = disclos+ 
directly to ! public *>ge & price       
in=mation4 ,su* me?od & =mat may be     
simil> to any template e/abli%$ by !    
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices z ( 

! date ( ! enactm5t ( ?is p>agraph =    
report+ su* in=mation "u ?is subsection 
& %all meet su* /&>ds z det]m9$         
appropriate by ! ,secret>y4  7#d7       
,monitor+ ( pric+ in=mation ,!          
,secret>y1 9 consultation ) ! ,inspector
 ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices1 %all1 ?r\gh notice & comm5t   
rulemak+1 e/abli% a process to regul>ly 
monitor ! accuracy & validity ( pric+   
in=mation display$ by ea* hospital      
pursuant to p>agraph 7#a74  7#e7        
,def9itions ,not)/&+ any o!r provision (
 law1 = ! purpose ( p>agraphs 7#a7 &    
7#b73  7,a7 ,de-id5tifi$ maximum        
negotiat$ *>ge ,! t]m de-id5tifi$       
maximum negotiat$ *>ge means ! highe/   
*>ge t a hospital has negotiat$ ) all   
?ird p>ty pay]s = an item or s]vice4    
7,b7 ,de-id5tifi$ m9imum negotiat$ *>ge 
,! t]m de-id5tifi$ m9imum negotiat$ *>ge
 means ! l[e/ *>ge t a hospital has     
negotiat$ ) all ?ird p>ty pay]s = an    
item or s]vice4  7,c7 ,disc\nt$ ca%     
price ,! t]m disc\nt$ ca% price means ! 

*>ge t applies to an individual :o pays 
ca%1 or ca% equival5t1 = a hospital item
 or s]vice4 ,hospitals t d n (f]        
self-pay disc\nts may display !         
hospital's undisc\nt$ gross *>ges z f\nd
 9 ! hospital *>gema/]4  7,d7 ,gross    
*>ge ,! t]m gross *>ge means ! *>ge = an
 individual item or s]vice t is reflect$
 on a hospital's *>gema/]1 abs5t any    
disc\nts4  7,e7 ,pay]-specific negotiat$
 *>ge ,! t]m pay]-specific negotiat$    
*>ge means ! *>ge t a hospital has      
negotiat$ ) a ?ird p>ty pay] = an item  
or s]vice4  7,f7 ,%oppable s]vice ,! t]m
 %oppable s]vice means a s]vice t c be  
s*$ul$ by a heal? c>e consum] 9 advance4
  7,g7 ,?ird p>ty pay] ,! t]m ?ird p>ty 
pay] means an entity t is1 by /atute1   
contract1 or agreem5t1 legally          
responsible = paym5t ( a claim = a heal?
 c>e item or s]vice4  7#f7 ,en=cem5t    
7,a7 ,9 g5]al ,9 ! case ( a hospital t  
fails to comply ) ?is subsection--  7i7 
! ,secret>y %all notify su* hospital (  
su* failure n lat] ?an #cj days aft] !  

date on :i* ! ,secret>y det]m9es su*    
failure exi/s2 &  7ii7 n lat] ?an #de   
days aft] ! date ( su* notification1 !  
hospital %all complete a corrective     
action plan to comply ) su* requirem5ts4
  7,b7 ,civil monet>y p5alty  7i7 ,9    
g5]al ,9 addition to any o!r en=cem5t   
actions or p5alties t may apply "u      
subsection 7b77#c7 or ano!r provision ( 
law1 a hospital t has receiv$ a         
notification "u subp>agraph 7,a77i7 &   
fails to satisfy ! requirem5t "u        
subp>agraph 7,a77ii7 or o!rwise comply )
 ! requirem5ts ( ?is subsection by !    
date t is #ij days aft] su* notification
 %all be subject to a civil monet>y     
p5alty ( an am\nt-- 7,i7 9 ! case !     
hospital provides n m ?an #cj b$s 7z    
det]m9$ "u section                      
#ahj4ij7;c77#b77;ii77,d7 ( title #de1   
,code ( ,f$]al ,regulations1 z 9 effect 
on ! date ( ! enactm5t ( ?is p>agraph71 
n to exce$ #cjj p] day t ! violation is 
ongo+ z det]m9$ by ! ,secret>y2 &       
7,,ii7 9 ! case ! hospital provides m   

?an #cj b$s 7z s det]m9$71 equal to--   
7aa7 subject to item 7bb71 #aj p] b$ p] 
day t ! violation is ongo+ z det]m9$ by 
! ,secret>y1 b = violations occurr+ be=e
 ,janu>y #a1 #bjbd1 n to exce$ #e1ejj p]
 ea* su* day2 or  7bb7 9 ! case su*     
hospital has fail$ to satisfy !         
requirem5t "u subp>agraph 7,a77ii7 or   
o!rwise comply ) ! requirem5ts ( ?is    
subsection = any cont9u\s #a-ye> p]iod  
beg9n+ on or aft] ,janu>y #a1 #bjbd1 & !
 am\nt o!rwise impos$ "u item 7aa7 = su*
 failure = su* p]iod w\ld be less ?an   
#e1jjj1jjj1 an am\nt n less ?an         
#e1jjj1jjj4  7ii7 ,increase au?ority ,9 
apply+ ?is subp>agraph ) respect to     
violations occurr+ 9 #bjbe or a         
subsequ5t ye>1 ! ,secret>y may ?r\gh    
notice & comm5t rulemak+ increase any   
doll> am\nt appli$ "u ?is subp>agraph by
 an am\nt specifi$ by ! ,secret>y4      
7iii7 ,application ( c]ta9 provisions ,!
 provisions ( section #aabh;,a ( !      
,social ,security ,act 7o!r ?an         
subsections 7a7 & 7b7 ( su* section7    

%all apply to a civil monet>y p5alty    
impos$ "u clause 7i7 9 ! same mann] z   
su* provisions apply to a civil monet>y 
p5alty impos$ "u subsection 7a7 ( su*   
section4  4  7b7 ,publication ( li/ (   
hospitals  7#a7 ,li/ ( hospitals ,beg9n+
 n lat] ?an #ij days aft] ! date (      
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices 7ref]r$ to 9   
?is section z ! ,secret>y7 %all e/abli% 
& ma9ta9 a publicly available li/ on !  
website ( ! ,c5t]s = ,m$ic>e  ,m$icaid  
,s]vices ( ea* hospital ) respect to :i*
 ! ,secret>y has conduct$ a review ( su*
 hospital's compliance ) ! provisions ( 
section #bgah7;e7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;gg-#ah7;e774 ,su* li/ %all include1
 ) respect to ea* su* hospital t 0      
noncompliant ) su* provisions1 a        
specification z to :e!r su* hospital--  
7,a7 has be5 issu$ a civil monet>y      
p5alty2  7,b7 has receiv$ a w>n+ notice2
 or  7,c7 has submitt$ a corrective     
action plan4  7#b7 ,additions & updates 

,9 ! case ( a hospital n includ$ on !   
li/ describ$ 9 p>agraph 7#a7 z ( ! date 
( ! e/abli%m5t ( su* li/ & t is subject 
to a review ( su* hospital's compliance 
) ! provisions describ$ 9 su* p>agraph  
aft] su* date1 ! ,secret>y %all add su* 
hospital to su* li/1 along ) !          
specifications describ$ 9 su* p>agraph1 
n lat] ?an #a bus9ess day aft] su*      
review occurs4 ,! ,secret>y %all update 
su* specifications ) respect to any     
hospital includ$ on su* li/--  7,a7 n   
lat] ?an #a bus9ess day aft] any        
subsequ5t review ( su* hospital's       
compliance ) su* provisions2 &  7,b7 n  
lat] ?an #a bus9ess day aft] any p5alty1
 notice1 or reque/ describ$ 9 p>agraph  
7#a7 is made ) respect to su* hospital4 
7#c7 ,,foia reque/s ,any p5alty1 notice1
 or reque/ describ$ 9 p>agraph 7#a7 %all
 be subject to public disclosure1 9 full
 & )\t r$action1 "u section #eeb ( title
 #ba1 ,unit$ ,/ates ,code1 not)/&+ any  
exemptions or exclusions o!rwise        
available "u su* section #eeb4  7#d7    

,reports to ,congress ,n lat] ?an #a ye>
 aft] ! date ( enactm5t ( ?is ,act & ea*
 ye> !reaft]1 ! ,secret>y ( ,heal? &    
,human ,s]vices %all submit to          
,congress1 & make publicly available1 a 
report t conta9s in=mation reg>d+       
compla9ts ( alleg$ violations ( law &   
en=cem5t activities by ! ,secret>y "u ! 
hospital price transp>5cy rule implem5t+
 section #bgah7;e7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;gg-#ah7;e774 ,su* report %all be   
made available to ! public on ! website 
( ! ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices4
 ,ea* su* report %all include1 ) respect
 to ! ye> involv$--  7,a7 ! numb] (     
compliance & en=cem5t inquiries op5$ by 
! ,secret>y pursuant to su* section2    
7,b7 ! numb] ( notices ( noncompliance  
issu$ by ! ,secret>y bas$ on su*        
inquiries2  7,c7 ! id5tity ( ea*        
hospital entity t receiv$ a notice (    
noncompliance & ! nature ( ! failure    
giv+ rise to ! ,secret>y's det]m9ation (
 noncompliance2  7,d7 ! am\nt ( civil   

monet>y p5alty assess$ aga9/ ! hospital 
entity2  7,e7 :e!r ! hospital entity    
subsequ5tly correct$ ! noncompliance2 & 
7,f7 an analysis ( factors contribut+ to
 increas+ heal? c>e co/s4  7#e7 ,,gao   
report ,n lat] ?an #a ye> aft] ! date ( 
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all submit to 
! ,committee on ,en]gy & ,comm]ce ( !   
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report on !       
compliance & en=cem5t ) ! hospital price
 transp>5cy rule implem5t+ section      
#bgah7;e7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #cjj;gg-#ah7;e774 ,!
 report %all include recomm5dations     
relat$ to-- 7,a7 improv+ price          
transp>5cy to pati5ts1 employ]s1 & !    
public2 &  7,b7 increas$ civil monet>y  
p5alty am\nts to ensure compliance4     
7#f7 ,reque/ = in=mation ,n lat] ?an    
,janu>y #a1 #bjbe1 ! ,secret>y ( ,heal? 
& ,human ,s]vices %all issue a public   
reque/ = in=mation z to ! be/ me?od     

?r\gh :i* hospitals may be requir$ to   
publi% quality data 7su* z data requir$ 
to be report$ "u ! ,m$ic>e ,hospital    
,comp>e program7 alongside data requir$ 
to be report$ "u section #bgah7;e7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;gg-#ah7;e774  7c7 ,ensur+
 accessibility ?r\gh implem5tation ,9   
implem5t+ ! am5dm5ts made by ?is        
section1 ! ,secret>y ( ,heal? & ,human  
,s]vices %all ?r\gh rulemak+ ensure t a 
hospital submitt+ *>ges & in=mation     
pursuant to su* am5dm5ts takes          
reasonable /eps 7z specifi$ by !        
,secret>y7 to ensure ! accessibility (  
su* *>ges & in=mation to individuals )  
limit$ ,engli% pr(ici5cy4 ,su* /eps may 
include ! hospital's provision (        
int]pretation s]vices or ! hospital's   
provision ( translations ( *>ges &      
in=mation4  #ajb4 ,/r5g!n+ heal? insur] 
transp>5cy requirem5ts  7a7 ,transp>5cy 
9 cov]age ,section #acaa7;e77#c77;,c7 ( 
! ,pati5t ,protection & ,af=dable ,c>e  
,act 7#db ,u4,s4,c4 #ahjca7;e77#c77;,c77

 is am5d$--  7#a7 by /rik+ ,! ,ex*ange &
 ins]t+ ! foll[+3  7i7 ,9 g5]al ,!      
,ex*ange  2  7#b7 9 clause 7i71 z ins]t$
 by p>agraph 7#a7-- 7,a7 by /rik+       
p>ticipat+ provid] & ins]t+ provid]2    
7,b7 by ins]t+ %all include ! in=mation 
specifi$ 9 clause 7ii7 & aft] su*       
in=mation2  7,c7 by /rik+ an ,int]net   
website & ins]t+ a self-s]vice tool t   
meets ! requirem5ts ( clause 7iii72 &   
7,d7 by /rik+ & su* o!r & all t foll[s  
?r\gh ! p]iod & ins]t+ or1 at ! option  
su* individual1 ?r\gh a pap] or phone   
disclosure 7z select$ by su* individual 
& provid$ at no co/ to su* individual7 t
 meets su* requirem5ts z ! ,secret>y may
 specify42 &  7#c7 by add+ at ! end !   
foll[+ new clauses3  7ii7 ,specifi$     
in=mation ,= purposes ( clause 7i71 !   
in=mation specifi$ 9 ?is clause is1 )   
respect to an item or s]vice = :i*      
b5efits are available "u a heal? plan   
furni%$ by a heal? c>e provid]1 !       
foll[+3 7,i7 ,if su* provid] is a       
p>ticipat+ provid] ) respect to su* item

 or s]vice1 ! 9-network rate 7z def9$ 9 
subp>agraph 7,f77 = su* item or s]vice4 
7,,ii7 ,if su* provid] is n describ$ 9  
subclause 7,i71 ! maximum all[$ am\nt = 
su* item or s]vice4  7,,iii7 ,! am\nt ( 
co/ %>+ 7includ+ d$uctibles1 copaym5ts1 
& co9surance7 t ! individual w incur =  
su* item or s]vice 7:i*1 9 ! case su*   
item or s]vice is to be furni%$ by a    
provid] describ$ 9 subclause 7,,ii71    
%all be calculat$ us+ ! maximum am\nt   
describ$ 9 su* subclause74  7,,iv7 ,!   
am\nt ! individual has already          
accumulat$ ) respect to any d$uctible or
 out ( pocket maximum "u ! plan 7brok5  
d[n1 9 ! case sep>ate d$uctibles or     
maximums apply to sep>ate individuals   
enroll$ 9 ! plan1 by su* sep>ate        
d$uctibles or maximums1 9 addition to   
any cumulative d$uctible or maximum74   
7,v7 ,9 ! case su* plan imposes any     
frequ5cy or volume limitations ) respect
 to su* item or s]vice 7exclud+ m$ical  
necessity det]m9ations71 ! am\nt t su*  
individual has accru$ t[>ds su*         

limitation ) respect to su* item or     
s]vice4  7,,vi7 ,any prior au?orization1
 concurr5t review1 /ep !rapy1 fail fir/1
 or simil> requirem5ts applicable to    
cov]age ( su* item or s]vice "u su*     
plan4  7iii7 ,self-s]vice tool ,=       
purposes ( clause 7i71 a self-s]vice    
tool e/abli%$ by a heal? plan meets !   
requirem5ts ( ?is clause if su* tool--  
7,i7 is bas$ on an int]net website2     
7,,ii7 provides = real-"t responses to  
reque/s describ$ 9 su* clause2  7,,iii7 
is updat$ 9 a mann] su* t in=mation     
provid$ ?r\gh su* tool is timely &      
accurate2  7,,iv7 all[s su* a reque/ to 
be made ) respect to an item or s]vice  
furni%$ by--  7aa7 a specific provid] t 
is a p>ticipat+ provid] ) respect to su*
 item or s]vice2  7bb7 all provid]s t   
are p>ticipat+ provid]s ) respect to su*
 plan & su* item or s]vice2 or  7cc7 a  
provid] t is n describ$ 9 item 7bb72 &  
7,v7 provides t su* a reque/ may be made
 ) respect to an item or s]vice ?r\gh   
use ( ! bill+ code = su* item or s]vice 

or ?r\gh use ( a descriptive t]m = su*  
item or s]vice4  ,! ,secret>y may       
require su* tool1 z a condition (       
comply+ ) subclause 7,v71 to l9k        
multiple bill+ codes to a s+le          
descriptive t]m if ! ,secret>y det]m9es 
t ! bill+ codes to be s l9k$ correspond 
to items & s]vices4  4  7b7 ,disclosure 
( additional in=mation ,section         
#acaa7;e77#c7 ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act 7#db ,u4,s4,c4      
#ahjca7;e77#c77 is am5d$ by add+ at !   
end ! foll[+ new subp>agraphs3  7,e7    
,rate & paym5t in=mation  7i7 ,9 g5]al  
,n lat] ?an ,janu>y #a1 #bjbe1 & e #c   
mon?s !reaft]1 ea* heal? plan %all      
submit to ! ,ex*ange1 ! ,secret>y1 !    
,/ate insurance commission]1 & make     
available to ! public1 ! rate & paym5t  
in=mation describ$ 9 clause 7ii7 9      
accordance ) clause 7iii74  7ii7 ,rate &
 paym5t in=mation describ$ ,= purposes (
 clause 7i71 ! rate & paym5t in=mation  
describ$ 9 ?is clause is1 ) respect to a
 heal? plan1 ! foll[+3 7,i7 ,) respect  

to ea* item or s]vice = :i* b5efits are 
available "u su* plan1 ! 9-network rate 
9 effect z ( ! date ( ! submission ( su*
 in=mation ) ea* provid] 7id5tifi$ by   
national provid] id5tifi]7 t is a       
p>ticipat+ provid] ) respect to su* item
 or s]vice1 o!r ?an su* a rate 9 effect 
) a provid] t1 dur+ ! #a-ye> p]iod end+ 
on su* date1 submitt$ few] ?an #aj      
claims = su* item or s]vice to su* plan4
  7,,ii7 ,) respect to ea* drug         
7id5tifi$ by national drug code7 = :i*  
b5efits are available "u su* plan1 !    
av]age am\nt paid by su* plan 7net (    
rebates1 disc\nts1 & price concessions7 
= su* drug disp5s$ or adm9i/]$ dur+ !   
#ij-;day p]iod beg9n+ #ahj days be=e su*
 date ( submission to ea* provid] t 0 a 
p>ticipat+ provid] ) respect to su*     
drug1 brok5 d[n by ea* su* provid]      
7id5tifi$ by national provid] id5tifi]71
 o!r ?an su* an am\nt paid to a provid] 
t1 dur+ su* p]iod1 submitt$ few] ?an #bj
 claims = su* drug to su* plan4  7,,iii7
 ,) respect to ea* item or s]vice = :i* 

b5efits are available "u su* plan1 !    
am\nt bill$1 & ! am\nt all[$ by ! plan1 
= ea* su* item or s]vice furni%$ dur+ ! 
#ij-;day p]iod specifi$ 9 subclause     
7,,ii7 by a provid] t 0 n a p>ticipat+  
provid] ) respect to su* item or s]vice1
 brok5 d[n by ea* su* provid] 7id5tifi$ 
by national provid] id5tifi]71 o!r ?an  
items & s]vices ) respect to :i* few]   
?an #bj claims = su* item or s]vice 7   
submitt$ to su* plan dur+ su* p]iod4    
7iii7 ,mann] ( submission ,rate & paym5t
 in=mation requir$ to be submitt$ & made
 available "u ?is subp>agraph %all be s 
submitt$ & s made available 9 #c sep>ate
 ma*9e-readable files correspond+ to !  
in=mation describ$ 9 ea* ( subclauses   
7,i7 ?r\gh 7,,iii7 ( clause 7ii7 t meet 
su* requirem5ts z specifi$ by !         
,secret>y ?r\gh rulemak+4 ,su*          
requirem5ts %all ensure t su* files are 
limit$ to an appropriate size1 are made 
available 9 a widely-available =mat t   
all[s = in=mation conta9$ 9 su* files to
 be comp>$ across heal? plans1 & are    

accessible to individuals at no co/ &   
)\t ! ne$ to e/abli% a us] acc\nt or    
provid] o!r cr$5tials4  7iv7 ,us] guide 
,ea* heal? plan %all make available to !
 public in/ructions writt5 9 pla9       
language expla9+ h[ individuals may se>*
 = in=mation describ$ 9 clause 7ii7 9   
files submitt$ 9 accordance ) clause    
7iii74  7,f7 ,def9itions ,9 ?is         
p>agraph3 7i7 ,p>ticipat+ provid] ,! t]m
 p>ticipat+ provid] has ! mean+ giv5 su*
 t]m 9 section #bgii;,a-#a ( ! ,public  
,heal? ,s]vice ,act4  7ii7 ,9-network   
rate ,! t]m 9-network rate means1 )     
respect to a heal? plan & an item or    
s]vice furni%$ by a provid] t is a      
p>ticipat+ provid] ) respect to su* plan
 & item or s]vice1 ! contract$ rate 9   
effect betwe5 su* plan & su* provid] =  
su* item or s]vice4  4  7c7 ,reports    
7#a7 ,compliance ,n lat] ?an ,janu>y #a1
 #bjbe1 ! ,comptroll] ,g5]al ( ! ,unit$ 
,/ates %all submit to ,congress a report
 conta9+--  7,a7 an analysis ( heal?    
plan compliance ) ! am5dm5ts made by ?is

 section2  7,b7 an analysis ( en=cem5t (
 su* am5dm5ts by ! ,secret>ies ( ,heal? 
& ,human ,s]vices1 ,labor1 & !          
,treasury2  7,c7 recomm5dations relat+  
to improv+ su* en=cem5t2 &  7,d7        
recomm5dations relat+ to improv+ public 
disclosure1 & public aw>5ess1 (         
in=mation requir$ to be made available  
by su* plans pursuant to su* am5dm5ts4  
7#b7 ,prices ,n lat] ?an ,janu>y #a1    
#bjbh1 ! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all submit to ,congress a report
 conta9+ an assessm5t ( diff]5ces 9     
negotiat$ prices 7& any tr5ds 9 su*     
prices7 9 ! private m>ket betwe5-- 7,a7 
rural & urban areas2  7,b7 ! individual1
 small gr\p1 & l>ge gr\p m>kets2  7,c7  
consolidat$ & nonconsolidat$ heal? c>e  
provid] areas 7z specifi$ by !          
,secret>y72  7,d7 nonpr(it & =-pr(it    
hospitals2  7,e7 nonpr(it & =-pr(it     
insur]s2 &  7,f7 insur]s s]v+ local or  
regional areas & insur]s s]v+ multi/ate 
or national areas4  7d7 ,ensur+         
accessibility ?r\gh implem5tation ,9    

implem5t+ ! am5dm5ts made by ?is        
section1 ! ,secret>y %all ?r\gh rulemak+
 ensure t any entity mak+ available     
in=mation pursuant to su* am5dm5ts takes
 reasonable /eps 7z specifi$ by !       
,secret>y7 to ensure ! accessibility (  
su* to individuals ) limit$ ,engli%     
pr(ici5cy4 ,su* /eps may include !      
entity's provision ( int]pretation      
s]vices or ( translations ( su*         
in=mation4  7e7 ,effective date  7#a7 ,9
 g5]al ,! am5dm5ts made by subsection   
7a7 %all apply beg9n+ ,janu>y #a1 #bjbe4
  7#b7 ,cont9u$ applicability ( rules = 
previ\s ye>s ,no?+ 9 ! am5dm5ts made by 
?is section may be con/ru$ z affect+ !  
applicability ( ! rule entitl$          
,transp>5cy 9 ,cov]age publi%$ by !     
,dep>tm5t ( ! ,treasury1 ! ,dep>tm5t (  
,labor1 & ! ,dep>tm5t ( ,heal? & ,human 
,s]vices on ,novemb] #ab1 #bjbj 7#he    
,f$4 ,reg4 #gbaeh7 be=e ,janu>y #a1     
#bjbe4  #ajc4 ,requir+ a sep>ate        
id5tification numb] & an atte/ation =   
ea* (f-campus outpati5t dep>tm5t ( a    

provid] ,section #ahcc7t7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4 #aciel7t77
 is am5d$ by add+ at ! end ! foll[+ new 
p>agraph3  7#bc7 ,use ( unique heal?    
id5tifi]s2 atte/ation  7,a7 ,9 g5]al ,no
 paym5t may be made "u ?is subsection   
7or "u an applicable paym5t sy/em       
pursuant to p>agraph 7#ba77 = items &   
s]vices furni%$ on or aft] ,janu>y #a1  
#bjbf1 by an (f-campus outpati5t        
dep>tm5t ( a provid] 7z def9$ 9         
subp>agraph 7,c77 unless--  7i7 su*     
dep>tm5t has obta9$1 & su* items &      
s]vices are bill$ "u1 a /&>d unique     
heal? id5tifi] = heal? c>e provid]s 7z  
describ$ 9 section #aagc7;b77 t is      
sep>ate f su* id5tifi] = su* provid]2 & 
7ii7 su* provid] has submitt$ to !      
,secret>y1 dur+ ! #b-ye> p]iod end+ on !
 date su* items & s]vices are s furni%$1
 an atte/ation t su* dep>tm5t is        
compliant ) ! requirem5ts describ$ 9    
section #dac4fe ( title #db1 ,code (    
,f$]al ,regulations 7or a successor     
regulation74  7,b7 ,process = submission

 & review ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is p>agraph1 ! ,secret>y 
%all1 ?r\gh notice & comm5t rulemak+1   
e/abli% a process = ea* provid] ) an    
(f-campus outpati5t dep>tm5t ( a provid]
 to submit an atte/ation pursuant to    
subp>agraph 7,a77ii71 & = ! ,secret>y to
 review ea* su* atte/ation & det]m9e1   
?r\gh site visits or ?r\gh remote audits
 7z det]m9$ appropriate by ! ,secret>y71
 :e!r su* dep>tm5t is compliant ) !     
requirem5ts describ$ 9 su* subp>agraph4 
7,c7 ,(f-campus outpati5t dep>tm5t ( a  
provid] def9$ ,= purposes ( ?is         
p>agraph1 ! t]m (f-campus outpati5t     
dep>tm5t ( a provid] means a dep>tm5t ( 
a provid] 7z def9$ 9 section #dac4fe (  
title #db1 ,code ( ,f$]al ,regulations1 
or any successor regulation7 t is n     
locat$--  7i7 on ! campus 7z def9$ 9 su*
 section7 ( su* provid]2 or  7ii7 )9 !  
di/ance 7describ$ 9 su* def9ition (     
campus7 f a remote location ( a hospital
 facility 7z def9$ 9 su* section74  4   
#ajd4 ,m&atory report+ ) respect to     

c]ta9 heal?-relat$ own]%ip in=mation ,"p
 ,a ( title ,,xi ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #acja et seq47 is   
am5d$ by add+ at ! end ! foll[+ new     
section3  #aaej;,d4 ,m&atory report+ )  
respect to c]ta9 heal?-relat$ own]%ip   
in=mation  7a7 ,m&atory report+ )       
respect c]ta9 heal?-,relat$ own]%ip     
in=mation  7#a7 ,initial report ,n lat] 
?an ,janu>y #a1 #bjbe 7or 9 ! case ( a  
specifi$ entity =m$ aft] ,janu>y #a1    
#bjbe1 )9 #fj days ( becom+ a specifi$  
entity71 ea* specifi$ entity 7z def9$ 9 
subsection 7f77#e77 %all submit to !    
,secret>y1 9 a =m & mann] specifi$ by ! 
,secret>y1 a report conta9+ ! foll[+    
in=mation3  7,a7 ,data on m]g]s1        
acquisitions1 & *anges 9 own]%ip )      
respect to su* specifi$ entity = !      
previ\s #a-ye> p]iod4  7,b7 ,9 ! case t 
a specifi$ entity is1 or includes1 a    
hospital1 ! additional in=mation        
describ$ 9 subsection 7b74  7,c7 ,z     
applicable1 ! "n1 address1 & bus9ess    
/ructure ( ! p>5t company ( su* specifi$

 entity 7includ+ ! tax /atus ( su* p>5t 
company71 z ( ! date ( ! submission (   
?is report4  7,d7 ,any o!r in=mation )  
respect to own]%ip ( a specifi$ entity1 
z det]m9$ by ! ,secret>y4  7#b7         
,subsequ5t reports ,n lat] ?an #a ye>   
aft] submitt+ ! report "u p>agraph 7#a71
 & annually !reaft]1 ea* specifi$ entity
 %all submit to ! ,secret>y an updat$   
report1 includ+-- 7,a7 7i7 data on      
m]g]s1 acquisitions1 & *anges 9 own]%ip 
) respect to su* entities = ! previ\s   
#a-ye> p]iod2 &  7ii7 any o!r in=mation 
) respect to own]%ip ( a specifi$       
entity1 z det]m9$ by ! ,secret>y2 &     
7,b7 9 ! case t a specifi$ entity is1 or
 includes1 a hospital1 ! additional     
in=mation describ$ 9 subsection 7b74    
7b7 ,additional in=mation submitt$ by   
c]ta9 specifi$ entities ,= purposes (   
p>agraphs 7#a77;,b7 & 7#b77;,b7 (       
subsection 7a71 ) respect to a specifi$ 
entity t is1 or includes1 a hospital1 ! 
in=mation describ$ 9 ?is subsection is !
 foll[+ in=mation ) respect to ! previ\s

 #a-ye> p]iod3 7#a7 ,! bus9ess /ructure 
( ! specifi$ entity1 includ+ ! bus9ess  
type & ! tax /atus ( su* entity4  7#b7  
,! av]age debt-to-e>n+s ratio ( !       
specifi$ entity4  7#c7 ,! av]age am\nt (
 debt incurr$--  7,a7 by ! hospital2 &  
7,b7 by ! entire specifi$ entity4  7#d7 
,in=mation ) respect to real e/ate      
leases & pur*ases = prop]ty us$1 or     
int5d$ to be us$1 to furni% or o!rwise  
support ! provision ( heal? c>e s]vices4
  7#e7 ,9 ! case ( a non-pr(it hospital1
 a subsidi>y ( a non-pr(it hospital1 or 
a #eja7;c77#c7 entity t %>es common     
own]%ip ) a non-pr(it hospital1 capital 
ga9s inve/m5ts 7disaggregat$ by ! type (
 inve/m5t7 & any taxes paid on su* ga9s 
f su* inve/m5ts4  7#f7 ,z applicable1   
in=mation ) respect to ! p>5t company ( 
su* specifi$ entity4  7c7 ,public       
report+ ,n lat] ?an ,janu>y #a1 #bjbg1 &
 annually !reaft]1 ! ,secret>y %all po/ 
on a publicly available website ( !     
,dep>tm5t ( ,heal? & ,human ,s]vices a  
report ) respect to ! previ\s #a-ye>    

p]iod1 includ+--  7#a7 ! numb] (        
specifi$ entities report+ = su* ye>1    
disaggregat$ by ! bus9ess /ructure ( ea*
 specifi$ entity2  7#b7 ! numb] ( own]s 
( ea* specifi$ entity2  7#c7 any *ange 9
 own]%ip = ea* specifi$ entity2  7#d7   
any *ange 9 ! tax /atus ( a specifi$    
entity2  7#e7 an analysis ( tr5ds 9     
horizontal & v]tical consolidation1     
disaggregat$ by bus9ess /ructure &      
provid] type2 &  7#f7 z applicable1 !   
"n1 address1 & bus9ess /ructure ( ! p>5t
 company ( su* specifi$ entity 7includ+ 
! bus9ess type & ! tax /atus ( su* p>5t 
company74  7d7 ,audits ,! ,secret>y %all
 conduct an annual audit consi/+ ( a    
r&om sample ( specifi$ entities to v]ify
 compliance ) ! requirem5ts ( ?is       
section & ! accuracy ( in=mation        
submitt$ pursuant to ?is section4  7e7  
,p5alty = failure ,to report ,if a      
specifi$ entity fails to provide a      
complete report "u subsection 7a71 or   
submits a report conta9+ false          
in=mation1 su* entity %all be subject to

 a civil monet>y p5alty ( n m ?an       
#e1jjj1jjj = ea* su* report n provid$ or
 conta9+ false in=mation4 ,su* p5alty   
%all be impos$ & collect$ 9 ! same mann]
 z civil money p5alties "u subsection   
7a7 ( section #aabh;,a are impos$ &     
collect$ "u t section4  7f7             
,inapplicability ( ,pap]work ,r$uction  
,act ,*apt] #ce ( title #dd1 ,unit$     
,/ates ,code1 %all n apply to           
collections ( in=mation made "u ?is     
section4  7g7 ,def9itions ,9 ?is        
section3  7#a7 ,heal? plan ,! t]m heal? 
plan has ! mean+ giv5 su* t]m 9 section 
#aabh;,c7c74  7#b7 ,hospital ,! t]m     
hospital has ! mean+ giv5 su* t]m 9     
section #ahfa7;e74  7#c7 ,indep5d5t     
free/&+ em]g5cy dep>tm5t ,! t]m         
indep5d5t free/&+ em]g5cy dep>tm5t has !
 mean+ giv5 su* t]m 9 section           
#bgii;,a-#a7;a77#c77;,d7 ( ! ,public    
,heal? ,s]vice ,act4  7#d7 ,private     
equity company ,! t]m private equity    
company means a publicly-trad$ or       
non-publicly trad$ company t collects   

capital inve/m5ts f individuals or      
entities & pur*ases an own]%ip %>e ( a  
provid] ( s]vices 7z def9$ 9 section    
#ahfa7u774  7#e7 ,specifi$ entity ,! t]m
 specifi$ entity means-- 7,a7 a         
hospital2  7,b7 a physician-own$        
physician practice ) m ?an #be          
physicians = a ye>2  7,c7 a physician   
practice own$ by a hospital1 a heal?    
plan1 a private equity company1 or a    
v5ture capital firm2  7,d7 an ambulatory
 surgical c5t] meet+ ! /&>ds specifi$ "u
 section #ahcb7;a77#b77;,f77i72 or  7,e7
 an indep5d5t free/&+ em]g5cy dep>tm5t4 
7#f7 ,v5ture capital fund ,! t]m v5ture 
capital fund has ! mean+ giv5 su* t]m 9 
section #bge4bjc7l7-#a ( title #ag1     
,code ( ,f$]al ,regulations4  4  #aje4  
,increas+ price transp>5cy ( cl9ical    
diagno/ic laboratory te/s "u ! ,m$ic>e  
program ,section #ahdf ( ! ,social      
,security ,act 7#db ,u4,s4,c4 #aciew-#b7
 is am5d$--  7#a7 9 ! head]1 by ins]t+ &
 additional requirem5ts aft] sanctions2 
&  7#b7 by add+ at ! end ! foll[+ new   

subsection3  7c7 ,price transp>5cy      
requirem5t  7#a7 ,9 g5]al ,beg9n+       
,janu>y #a1 #bjbe1 ea* provid] ( s]vices
 or suppli] t is available to furni% any
 specifi$ cl9ical diagno/ic laboratory  
te/ "u ?is title %all-- 7,a7 make       
publicly available on an int]net website
 ! in=mation describ$ 9 p>agraph 7#b7 ) 
respect to ea* su* specifi$ cl9ical     
diagno/ic laboratory te/ t su* provid]  
or suppli] is s available to furni%2 &  
7,b7 ensure t su* in=mation is updat$ n 
less frequ5tly ?an annually4  7#b7      
,in=mation describ$ ,= purposes (       
p>agraph 7#a71 ! in=mation describ$ 9   
?is p>agraph is1 ) respect to a provid] 
( s]vices or suppli] & a specifi$       
cl9ical diagno/ic laboratory te/1 !     
foll[+3  7,a7 ,! disc\nt$ ca% price =   
su* te/ 7or1 if no su* price exi/s1 !   
gross *>ge = su* te/74  7,b7 ,!         
deid5tifi$ m9imum negotiat$ rate 9      
effect betwe5 su* provid] or suppli] &  
any gr\p heal? plan or gr\p or          
individual heal? insurance cov]age = su*

 te/4  7,c7 ,! deid5tifi$ maximum       
negotiat$ rate 9 effect betwe5 su*      
provid] or suppli] & any su* plan or    
cov]age = su* te/4  7#c7 ,inclusion (   
ancill>y s]vices ,any price or rate = a 
specifi$ cl9ical diagno/ic laboratory   
te/ available to be furni%$ by a provid]
 ( s]vices or suppli] made publicly     
available 9 accordance ) p>agraph 7#a7  
%all include ! price or rate 7z         
applicable7 = any ancill>y item or      
s]vice 7su* z specim5 collection        
s]vices7 t w\ld normally be furni%$ by  
su* provid] or suppli] z "p ( su* te/1 z
 specifi$ by ! ,secret>y4  7#d7         
,en=cem5t  7,a7 ,9 g5]al ,9 ! case t !  
,secret>y det]m9es t a provid] ( s]vices
 or suppli] is n 9 compliance ) p>agraph
 7#a7-- 7i7 n lat] ?an #cj days aft] su*
 det]m9ation1 ! ,secret>y %all notify   
su* provid] or suppli] ( su*            
det]m9ation2  7ii7 n lat] ?an #ij days  
aft] su* notification is s5t1 su*       
provid] or suppli] %all complete a      
corrective action plan to comply ) su*  

p>agraph & submit su* plan to !         
,secret>y2 &  7iii7 if su* provid] or   
suppli] cont9ues to fail to comply ) su*
 p>agraph aft] ! date t is #ij days aft]
 su* notification is s5t1 ! ,secret>y   
may impose a civil monet>y p5alty 9 an  
am\nt n to exce$ #cjj = ea* day 7beg9n+ 
) ! date t is #ia days aft] su*         
notification 0 s5t7 dur+ :i* su* failure
 is ongo+4  7,b7 ,application ( c]ta9   
provisions ,! provisions ( section      
#aabh;,a 7o!r ?an subsections 7a7 & 7b7 
( su* section7 %all apply to a civil    
monet>y p5alty impos$ "u ?is p>agraph 9 
! same mann] z su* provisions apply to a
 civil monet>y p5alty impos$ "u         
subsection 7a7 ( su* section4  7#e7     
,def9itions ,9 ?is subsection3  7,a7    
,gr\p heal? plan2 gr\p heal? insurance  
cov]age2 individual heal? insurance     
cov]age ,! t]ms gr\p heal? plan1 gr\p   
heal? insurance cov]age1 & individual   
heal? insurance cov]age h ! mean+ giv5  
su* t]ms 9 section #bgia ( ! ,public    
,heal? ,s]vice ,act4  7,b7 ,specifi$    

cl9ical diagno/ic laboratory te/ ! t]m  
specifi$ cl9ical diagno/ic laboratory   
te/ means a cl9ical diagno/ic laboratory
 te/ t is includ$ on ! li/ ( %oppable   
s]vices specifi$ by ! ,c5t]s = ,m$ic>e  
,m$icaid ,s]vices 7z describ$ 9 section 
#ahj4fj ( title #db1 ,code ( ,f$]al     
,regulations 7or a successor            
regulation774  4  #ajf4 ,promot+        
transp>5cy ( common own]%ip int]e/s "u  
p>ts ,c & ,d ( ! ,m$ic>e program  7a7   
,m$ic>e ,advantage ,section #aheg7;e7 ( 
! ,social ,security ,act 7#db ,u4,s4,c4 
#aciew-#bg7;e77 is am5d$ by add+ at !   
end ! foll[+ new p>agraph3  7#f7        
,requir$ disclosure ( c]ta9 in=mation   
relat+ to heal? c>e provid] own]%ip     
7,a7 ,9 g5]al ,= plan ye>s beg9n+ on or 
aft] ,janu>y #a1 #bjbe1 a contract "u   
?is section ) an ,,ma organization %all 
require ! organization to report to !   
,secret>y1 n lat] ?an #a ye> aft] ! la/ 
day ( su* plan ye>1 ! in=mation describ$
 9 subp>agraph 7,b7 ) respect to su*    
plan ye>4  7,b7 ,in=mation describ$ ,=  

purposes ( subp>agraph 7,a71 ! in=mation
 describ$ 9 ?is subp>agraph is1 )       
respect to an ,,ma organization & a plan
 ye>1 ! foll[+3 7i7 ,! numb] ( items &  
s]vices furni%$ dur+ su* plan ye> by ea*
 specifi$ provid] 7z def9$ 9 subp>agraph
 7,c77 = :i* paym5t 0 made by su*       
organization4  7ii7 ,! numb] ( items &  
s]vices furni%$ dur+ su* plan ye> by    
provid]s ( s]vices or suppli]s n        
describ$ 9 clause 7i7 = :i* paym5t 0    
made by su* organization4  7iii7 ,!     
av]age p]-enrollee numb] ( qualify+     
diagnoses 7z def9$ 9 subp>agraph 7,c77  
made dur+ su* plan ye> by specifi$      
provid]s 7includ+ ?r\gh *>t reviews &   
heal? risk assessm5ts7 ) respect to     
individuals enroll$ "u an ,,ma plan (f]$
 by su* organization1 brok5 d[n by site 
( s]vice ( su* provid]s1 z specifi$ by !
 ,secret>y4  7iv7 ,! av]age p]-enrollee 
numb] ( qualify+ diagnoses made dur+ su*
 plan ye> by provid]s ( s]vices &       
suppli]s n describ$ 9 clause 7iii7      
7includ+ ?r\gh su* reviews & assessm5ts7

 ) respect to su* individuals1 brok5 d[n
 by site ( s]vice ( su* provid]s4  7v7  
,! av]age risk score 7z calculat$ "u !  
me?odology describ$ 9 subp>agraph       
7,c77i77 = su* an individual = su* plan 
ye> :o receiv$ items & s]vices f a      
specifi$ provid] dur+ su* plan ye>4     
7vi7 ,! av]age risk score = su* an      
individual = su* plan ye> :o did n      
receive items & s]vices f a specifi$    
provid] dur+ su* plan ye>4  7vii7 ,!    
av]age risk score = su* an individual = 
su* plan ye> :o receiv$ a heal? risk    
assessm5t f an assessm5t entity t 0 a   
specifi$ assessm5t entity dur+ su* plan 
ye>4  7viii7 ,! av]age risk score = su* 
an individual = su* plan ye> :o receiv$ 
a heal? risk assessm5t f an assessm5t   
entity t 0 n a specifi$ assessm5t entity
 dur+ su* plan ye>4  7ix7 ,! numb] (    
prior au?orization reque/s = an item or 
s]vice submitt$ to su* organization dur+
 su* plan ye>1 ! numb] ( su* reque/s t 7
 approv$1 ! numb] ( su* reque/s t 7     
d5i$1 & ! numb] ( su* d5i$ reque/s t 7  

subsequ5tly appeal$ & !n approv$1 brok5 
d[n by :e!r ! entity propos+ to furni%  
su* item or s]vice 0 a specifi$ provid] 
or n a specifi$ provid]4  7x7 ,! total  
am\nt ( inc5tive-bas$ paym5ts made to1 &
 ! total am\nt ( %>$ losses rec\pm5ts   
collect$ f1 specifi$ provid]s dur+ su*  
plan ye>4  7xi7 ,! total am\nt (        
inc5tive-bas$ paym5ts made to1 & ! total
 am\nt ( %>$ losses rec\pm5ts collect$  
f1 provid]s ( s]vices & suppli]s n      
describ$ 9 clause 7x7 dur+ su* plan ye>4
  7xii7 ,! all[$ am\nt1 & ! am\nt ( co/ 
%>+ impos$1 ) respect to ea* item &     
s]vice furni%$ dur+ su* plan ye> by     
specifi$ provid]s paid by su*           
organization4  7xiii7 ,! all[$ am\nt1 & 
! am\nt ( co/ %>+ impos$1 ) respect to  
ea* item & s]vice furni%$ dur+ su* plan 
ye> by provid]s ( s]vices & suppli]s n  
describ$ 9 clause 7xii7 paid by su*     
organization4  7xiv7 ,= ea* ,,ma plan   
(f]$ by su* organization dur+ su* plan  
ye>-- 7,i7 ! total am\nt ( paym5ts made 
"u section #ahec7;a77#a7 to su*         

organization = cov]age ( individuals "u 
su* plan1 & ! total am\nt ( paym5ts made
 by su* individuals to su* organization 
= cov]age "u su* plan2  7,,ii7 ! total  
am\nt exp5d$ "u su* plan z paym5t =     
items & s]vices furni%$ by ea* specifi$ 
provid] dur+ su* ye>2  7,,iii7 ! total  
am\nt exp5d$ "u su* plan z paym5t =     
items & s]vices furni%$ by provid]s (   
s]vices or suppli]s n describ$ 9        
subclause 7,,ii7 dur+ su* ye>2  7,,iv7 !
 m$ical loss ratio "u su* plan ) respect
 to individuals furni%$ an item or      
s]vice f a specifi$ provid] dur+ su*    
ye>2 &  7,v7 ! m$ical loss ratio "u su* 
plan ) respect to individuals n describ$
 9 subclause 7,,iv74  7,c7 ,def9itions  
,9 ?is p>agraph3 7i7 ,assessm5t entity  
,! t]m assessm5t entity means an entity 
) a focus on furni%+ 9-home m$ical      
assessm5ts1 z specifi$ by ! ,secret>y4  
7ii7 ,qualify+ diagnosis ,! t]m qualify+
 diagnosis means1 ) respect to an       
individual1 a diagnosis t is tak5 into  
acc\nt 9 calculat+ a risk score = su*   

individual "u ! risk adju/m5t me?odology
 e/abli%$ by ! ,secret>y pursuant to    
section #ahec7;a77#c74  7iii7 ,specifi$ 
assessm5t entity ,! t]m specifi$        
assessm5t entity means1 ) respect to an 
,,ma organization & a plan ye>1 an      
assessm5t entity ) respect to :i* su*   
organization 7or any p]son ) an own]%ip 
or control int]e/ 7z def9$ 9 section    
#aabd7;a77#c77 9 su* organization7 is a 
p]son ) an own]%ip or control int]e/ 7z 
s def9$74  7iv7 ,specifi$ provid] ,! t]m
 specifi$ provid] means1 ) respect to an
 ,,ma organization & a plan ye>1 a      
provid] ( s]vices or suppli] ) respect  
to :i* su* organization 7or any p]son ) 
an own]%ip or control int]e/ 7z def9$ 9 
section #aabd7;a77#c77 9 su*            
organization7 is a p]son ) an own]%ip or
 control int]e/ 7z s def9$74  7,d7      
,nonapplication ( ,pap]work ,r$uction   
,act ,*apt] #ce ( title #dd1 ,unit$     
,/ates ,code1 %all n apply to in=mation 
collect$ "u ?is p>agraph4  4  7b7       
,ph>macy b5efit manag] & ph>macy        

in=mation ,section #ahfj;,d-#ab7;b7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aab7;b77 is am5d$ by add+ at !  
end ! foll[+ new p>agraphs3  7#i7       
,provision ( in=mation relat+ to ph>macy
 own]%ip  7,a7 ,9 g5]al ,= plan ye>s    
beg9n+ on or aft] ,janu>y #a1 #bjbe1 a  
contract ent]$ into "u ?is "p ) a ,,pdp 
sponsor %all require ! sponsor to report
 to ! ,secret>y1 n lat] ?an #a ye> aft] 
! la/ day ( su* plan ye>1 ! in=mation   
describ$ 9 subp>agraph 7,b7 ) respect to
 su* plan ye>4  7,b7 ,in=mation describ$
 ,= purposes ( subp>agraph 7,a71 !      
in=mation describ$ 9 ?is subp>agraph is1
 = ea* prescription drug plan (f]$ by a 
,,pdp sponsor = a plan ye>1 ! foll[+3   
7i7 ,! negotiat$ price = ea* cov]$ "p ,d
 drug = :i* b5efits are available "u su*
 plan = ea* network ph>macy 7includ+ an 
id5tification ( :e!r ea* su* ph>macy is 
a specifi$ ph>macy74  7ii7 ,! av]age    
p]-drug am\nt ( direct & indirect       
remun]ation paid by specifi$ ph>macies =
 su* cov]$ "p ,d drugs disp5s$ dur+ su* 

plan ye> "u su* plan4  7iii7 ,! av]age  
p]-drug am\nt ( direct & indirect       
remun]ation paid by ph>macies n describ$
 9 clause 7ii7 = su* cov]$ "p ,d drugs  
disp5s$ dur+ su* plan ye> "u su* plan4  
7,c7 ,def9itions ,9 ?is p>agraph3 7i7   
,direct & indirect remun]ation ,! t]m   
direct & indirect remun]ation has !     
mean+ giv5 su* t]m 9 section #dbc4cjh ( 
title #db1 ,code ( ,f$]al ,regulations  
7or any successor regulation74  7ii7    
,network ph>macy ,! t]m network ph>macy 
has ! mean+ giv5 su* t]m 9 section      
#dbc4ajj ( title #db1 ,code ( ,f$]al    
,regulations 7or any successor          
regulation74  7iii7 ,negotiat$ price ,! 
negotiat$ price = a cov]$ "p ,d drug    
%all take into acc\nt all negotiat$     
price concessions1 su* z disc\nts1      
direct or indirect subsidies1 rebates1 &
 direct or indirect remun]ations1 = su* 
drug1 & include any disp5s+ fee = su*   
drug4  7iv7 ,specifi$ ph>macy ,! t]m    
specifi$ ph>macy means1 ) respect to an 
,,pdp sponsor & a plan ye>1 a ph>macy ) 

respect to :i* su* sponsor 7or any p]son
 ) an own]%ip or control int]e/ 7z def9$
 9 section #aabd7;a77#c77 9 su* sponsor7
 is a p]son ) an own]%ip or control     
int]e/ 7z s def9$74  7,d7               
,nonapplication ( ,pap]work ,r$uction   
,act ,*apt] #ce ( title #dd1 ,unit$     
,/ates ,code1 %all n apply to in=mation 
collect$ "u ?is p>agraph4  7#aj7        
,provision ( in=mation by ph>macy b5efit
 manag]s  7,a7 ,9 g5]al ,= plan ye>s    
beg9n+ on or aft] ,janu>y #a1 #bjbe1 a  
contract ent]$ into "u ?is "p ) a ,,pdp 
sponsor %all prohibit su* sponsor f     
ent]+ into a contract ) a specifi$      
ph>macy b5efit manag] = purposes ( p]=m+
 any s]vice ) respect to cov]$ "p ,d    
drugs disp5s$ "u any prescription drug  
plan (f]$ by su* sponsor = su* plan ye> 
unless su* manag] agrees to report to ! 
,secret>y1 n lat] ?an #a ye> aft] ! la/ 
day ( su* plan ye>1 ! in=mation describ$
 9 subp>agraph 7,b7 ) respect to ea*    
prescription drug plan = :i* su* manag] 
is provid+ any su* s]vice dur+ su* plan 

ye>1 reg>dless ( ! sponsor ( su* plan4  
7,b7 ,in=mation describ$ ,= purposes (  
subp>agraph 7,a71 ! in=mation describ$ 9
 ?is subp>agraph is1 ) respect to a     
ph>macy b5efit manag] p]=m+ s]vices "u a
 prescription drug plan = a plan ye>1 ! 
foll[+3  7i7 ,) respect to ! total am\nt
 ( ph>macy & manufactur] rebates        
collect$ by su* manag] 7or collect$ on  
behalf ( su* plan by any o!r entity ) a 
contract 9 effect ) su* manag] = su*    
collection7 = all cov]$ "p ,d drugs     
disp5s$ "u su* plan dur+ su* plan ye>-- 
7,i7 ! total am\nt ( su* rebates pass$  
?r\gh to ! ,,pdp sponsor ( su* plan2 &  
7,,ii7 ! total am\nt ( su* rebates      
reta9$ by su* manag] or su* o!r         
entities4  7ii7 ,! total am\nt paid by  
su* manag] to ph>macies = drugs furni%$ 
"u su* plan dur+ su* plan ye>4  7iii7 ,!
 total am\nt ( paym5ts made by su*      
sponsor to su* manag] z reimbursem5t =  
su* manag]'s paym5ts describ$ 9 clause  
7ii74  7iv7 ,! total am\nt ( paym5ts    
made by su* sponsor to su* manag] z fees

 = s]vices furni%$ by su* manag] )      
respect to su* plan = su* plan ye> 7n   
includ+ paym5ts describ$ 9 clause       
7iii774  7v7 ,! total am\nt (           
adm9i/rative co/s incurr$ by su* manag] 
= furni%+ su* s]vices "u su* plan = su* 
plan ye>4  7vi7 ,a specification z to   
:e!r su* manag] is a specifi$ ph>macy   
b5efit manag] ) respect to ! ,,pdp      
sponsor ( su* plan4  7,c7 ,def9ition ,9 
?is p>agraph1 ! t]m specifi$ ph>macy    
b5efit manag] means1 ) respect to an    
,,pdp sponsor & a plan ye>1 a ph>macy   
b5efit manag] ) respect to :i* su*      
sponsor 7or any p]son ) an own]%ip or   
control int]e/ 7z def9$ 9 section       
#aabd7;a77#c77 9 su* sponsor7 is a p]son
 ) an own]%ip or control int]e/ 7z s    
def9$74  4  7c7 ,enc\nt] data ,section  
#ahei ( ! ,social ,security ,act 7#db   
,u4,s4,c4 #aciew-#bh7 is am5d$ by add+  
at ! end ! foll[+ new subsection3  7j7  
,inclusion ( c]ta9 in=mation 9 enc\nt]  
data  7#a7 ,9 g5]al ,9 ! case ( any     
enc\nt] data submitt$ by a ,m$ic>e      

,advantage plan ) respect to an item or 
s]vice furni%$ to an individual "u su*  
plan dur+ a plan ye> beg9n+ on or aft]  
,janu>y #a1 #bjbe1 ! ,secret>y %all     
require t su* data include-- 7,a7 !     
all[$ am\nt = su* item or s]vice2  7,b7 
! am\nt ( co/ %>+ 7includ+ d$uctibles1  
copaym5ts1 & co9surance7 impos$ = su*   
item or s]vice2  7,c7 9 ! case su*      
individual 0 furni%$1 dur+ su* plan ye> 
be=e su* item or s]vice 0 s furni%$1 an 
at-home heal? risk assessm5t f a        
specifi$ assessm5t entity1 an indicator 
t su* individual 0 s furni%$ su* an     
assessm5t by su* an entity2 &  7,d7 9 ! 
case su* individual 0 furni%$1 dur+ su* 
plan ye> be=e su* item or s]vice 0 s    
furni%$1 an at-home heal? risk assessm5t
 f an assessm5t entity n describ$ 9     
subp>agraph 7,c71 an indicator 7di/9ct f
 ! indicator describ$ 9 su* subp>agraph7
 t su* individual 0 s furni%$ su* an    
assessm5t by su* an entity4  7#b7       
,def9itions ,= purposes ( ?is           
subsection1 ! t]ms assessm5t entity &   

specifi$ assessm5t entity h ! mean+ giv5
 su* t]ms 9 section #aheg7;e77#f74  4   
7d7 ,med,p,a,c report ,n lat] ?an       
,decemb] #ca1 #bjbg1 & e #b ye>s        
!reaft]1 ! ,m$ic>e ,paym5t ,advisory    
,commission %all submit to ,congress a  
report on ! effects ( v]tical           
integration 9 ! heal? c>e sector on !   
,m$ic>e program4 ,su* report %all       
include an analysis ( ! effects (       
entities su* z heal? c>e provid]s1      
ph>macies1 ,,pdp sponsors1 ,m$ic>e      
,advantage organizations1 & ph>macy     
b5efit manag]s t 7 previ\sly "u sep>ate 
own]%ip f "o ano!r com+ "u common       
own]%ip4  7e7 ,publication ,n lat] ?an  
,janu>y #a1 #bjbg1 ! ,secret>y ( ,heal? 
& ,human ,s]vices %all e/abli% a process
 "u :i* in=mation submitt$ to !         
,secret>y pursuant to ! am5dm5ts made by
 subsections 7a7 & 7b7 is publicly      
disclos$4 ,su* process %all ensure t any
 in=mation s disclos$ does n id5tify a  
specific drug manufactur]1 provid] (    
s]vices or suppli]1 ph>macy1 ph>macy    

b5efit manag]1 or any price *>g$ )      
respect to a p>ticul> drug4  #ajg4      
,ov]sight ( ph>macy b5efits manag]      
s]vices  7a7 ,,phsa ,title ,,xxvii ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;gg et seq47 is am5d$--   
7#a7 9 "p ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa
 et seq471 by add+ at ! end ! foll[+ new
 section3  #bgii;,a-#aa4 ,ov]sight (    
ph>macy b5efits manag] s]vices  7a7 ,9  
g5]al ,= plan ye>s beg9n+ on or aft]    
,janu>y #a1 #bjbe1 a gr\p heal? plan or 
heal? insurance issu] (f]+ gr\p heal?   
insurance cov]age or an entity or       
subsidi>y provid+ ph>macy b5efits       
managem5t s]vices on behalf ( su* a plan
 or issu] %all n ent] into a contract ) 
a drug manufactur]1 di/ributor1         
:olesal]1 subcontractor1 rebate         
aggregator1 or any associat$ ?ird p>ty t
 limits ! disclosure ( in=mation to plan
 sponsors 9 su* a mann] t prev5ts ! plan
 or issu]1 or an entity or subsidi>y    
provid+ ph>macy b5efits managem5t       
s]vices on behalf ( a plan or issu]1 f  

mak+ ! reports describ$ 9 subsection    
7b74  7b7 ,reports  7#a7 ,9 g5]al ,=    
plan ye>s beg9n+ on or aft] ,janu>y #a1 
#bjbe1 n less frequ5tly ?an annually1 a 
heal? insurance issu] (f]+ gr\p heal?   
insurance cov]age or an entity provid+  
ph>macy b5efits managem5t s]vices on    
behalf ( a gr\p heal? plan or an issu]  
provid+ gr\p heal? insurance cov]age    
%all submit to ! plan sponsor 7z def9$ 9
 section #c7af77;,b7 ( ! ,employee      
,retirem5t ,income ,security ,act (     
#aigd7 ( su* gr\p heal? plan or heal?   
insurance cov]age a report 9 accordance 
) ?is subsection & make su* report      
available to ! plan sponsor 9 a         
ma*9e-readable =mat4 ,ea* su* report    
%all include1 ) respect to ! applicable 
gr\p heal? plan or heal? insurance      
cov]age--  7,a7 z applicable1 in=mation 
collect$ f drug manufactur]s by su*     
issu] or entity on ! total am\nt (      
copaym5t assi/ance doll>s paid1 or      
copaym5t c>ds appli$1 t 7 fund$ by !    
drug manufactur] ) respect to !         

p>ticipants & b5efici>ies 9 su* plan or 
cov]age2  7,b7 a li/ ( ea* drug cov]$ by
 su* plan1 issu]1 or entity provid+     
ph>macy b5efits managem5t s]vices t 0   
disp5s$ dur+ ! report+ p]iod1 includ+1 )
 respect to ea* su* drug dur+ ! report+ 
p]iod--  7i7 ! br& "n1 *emical entity1 &
 ,national ,drug ,code2  7ii7 ! numb] ( 
p>ticipants & b5efici>ies = :om ! drug 0
 fill$ dur+ ! plan ye>1 ! total numb] ( 
prescription fills = ! drug 7includ+    
orig9al prescriptions & refills71 & !   
total numb] ( dosage units ( ! drug     
disp5s$ across ! plan ye>1 includ+ :e!r 
! disp5s+ *annel 0 by retail1 mail ord]1
 or specialty ph>macy2  7iii7 ! :olesale
 acquisition co/1 li/$ z co/ p] days    
supply & co/ p] pill1 or 9 ! case ( a   
drug 9 ano!r =m1 p] dose2  7iv7 ! total 
out-(-pocket sp5d+ by p>ticipants &     
b5efici>ies on su* drug1 includ+        
p>ticipant & b5efici>y sp5d+ ?r\gh      
copaym5ts1 co9surance1 & d$uctibles2 &  
7v7 = any drug = :i* gross sp5d+ ( !    
gr\p heal? plan or heal? insurance      

cov]age exce$$ #aj1jjj dur+ ! report+   
p]iod-- 7,i7 a li/ ( all o!r drugs 9 !  
same !rapeutic category or class1       
includ+ br& "n drugs & biological       
products & g5]ic drugs or biosimil>     
biological products t are 9 ! same      
!rapeutic category or class z su* drug2 
&  7,,ii7 ! rationale = pref]r$ =mul>y  
placem5t ( su* drug 9 t !rapeutic       
category or class1 if applicable2  7,c7 
a li/ ( ea* !rapeutic category or class 
( drugs t 7 disp5s$ "u ! heal? plan or  
heal? insurance cov]age dur+ ! report+  
p]iod1 &1 ) respect to ea* su* !rapeutic
 category or class ( drugs1 dur+ !      
report+ p]iod--  7i7 total gross sp5d+  
by ! plan1 be=e manufactur] rebates1    
fees1 or o!r manufactur] remun]ation2   
7ii7 ! numb] ( p>ticipants & b5efici>ies
 :o fill$ a prescription = a drug 9 t   
category or class2  7iii7 if applicable 
to t category or class1 a description ( 
! =mul>y ti]s & utilization me*anisms   
7su* z prior au?orization or /ep !rapy7 
employ$ = drugs 9 t category or class2  

7iv7 ! total out-(-pocket sp5d+ by      
p>ticipants & b5efici>ies1 includ+      
p>ticipant & b5efici>y sp5d+ ?r\gh      
copaym5ts1 co9surance1 & d$uctibles2 &  
7v7 = ea* !rapeutic category or class "u
 :i* #c or m drugs are includ$ on !     
=mul>y ( su* plan or cov]age-- 7,i7 !   
am\nt receiv$1 or expect$ to be receiv$1
 f drug manufactur]s 9 rebates1 fees1   
alt]native disc\nts1 or o!r             
remun]ation--  7aa7 t has be5 paid1 or  
is to be paid1 by drug manufactur]s =   
claims incurr$ dur+ ! report+ p]iod2 or 
7bb7 t is relat$ to utilization ( drugs1
 9 su* !rapeutic category or class2     
7,,ii7 ! total net sp5d+1 aft] d$uct+   
rebates1 price concessions1 alt]native  
disc\nts or o!r remun]ation f drug      
manufactur]s1 by ! heal? plan or heal?  
insurance cov]age on t category or class
 ( drugs2 &  7,,iii7 ! net price p]     
c\rse ( treatm5t or s+le fill1 su* z a  
#cj-;day supply or #ij-;day supply1     
incurr$ by ! heal? plan or heal?        
insurance cov]age & its p>ticipants &   

b5efici>ies1 aft] manufactur] rebates1  
fees1 & o!r remun]ation = drugs disp5s$ 
)9 su* !rapeutic category or class dur+ 
! report+ p]iod2  7,d7 total gross sp5d+
 on prescription drugs by ! plan or     
cov]age dur+ ! report+ p]iod1 be=e      
rebates & o!r manufactur] fees or       
remun]ation2  7,e7 total am\nt receiv$1 
or expect$ to be receiv$1 by ! heal?    
plan or heal? insurance cov]age 9 drug  
manufactur] rebates1 fees1 alt]native   
disc\nts1 & all o!r remun]ation receiv$ 
f ! manufactur] or any ?ird p>ty1 o!r   
?an ! plan sponsor1 relat$ to           
utilization ( drug or drug sp5d+ "u t   
heal? plan or heal? insurance cov]age   
dur+ ! report+ p]iod2  7,f7 ! total net 
sp5d+ on prescription drugs by ! heal?  
plan or heal? insurance cov]age dur+ !  
report+ p]iod2 &  7,g7 am\nts paid      
directly or indirectly 9 rebates1 fees1 
or any o!r type ( remun]ation to brok]s1
 consultants1 advisors1 or any o!r      
individual or firm :o ref]r$ ! gr\p     
heal? plan's or heal? insurance issu]'s 

bus9ess to ! ph>macy b5efits manag]4    
7#b7 ,privacy requirem5ts ,heal?        
insurance issu]s (f]+ gr\p heal?        
insurance cov]age & entities provid+    
ph>macy b5efits managem5t s]vices on    
behalf ( a gr\p heal? plan %all provide 
in=mation "u p>agraph 7#a7 9 a mann]    
consi/5t ) ! privacy1 security1 & brea* 
notification regulations promulgat$ "u  
section #bfd7;c7 ( ! ,heal? ,insurance  
,portability & ,acc\ntability ,act (    
#aiif1 & %all re/rict ! use & disclosure
 ( su* in=mation accord+ to su* privacy 
regulations4  7#c7 ,disclosure &        
r$isclosure  7,a7 ,limitation to bus9ess
 associates ,a gr\p heal? plan receiv+ a
 report "u p>agraph 7#a7 may disclose   
su* in=mation only to bus9ess associates
 ( su* plan z def9$ 9 section #afj4ajc (
 title #de1 ,code ( ,f$]al ,regulations 
7or successor regulations74  7,b7       
,cl>ification reg>d+ public disclosure (
 in=mation ,no?+ 9 ?is section prev5ts a
 heal? insurance issu] (f]+ gr\p heal?  
insurance cov]age or an entity provid+  

ph>macy b5efits managem5t s]vices on    
behalf ( a gr\p heal? plan f plac+      
reasonable re/rictions on ! public      
disclosure ( ! in=mation conta9$ 9 a    
report describ$ 9 p>agraph 7#a71 except 
t su* issu] or entity may n re/rict     
disclosure ( su* report to ! ,dep>tm5t (
 ,heal? & ,human ,s]vices1 ! ,dep>tm5t (
 ,labor1 ! ,dep>tm5t ( ! ,treasury1 !   
,comptroll] ,g5]al ( ! ,unit$ ,/ates1 or
 applicable ,/ate ag5cies4  7,c7 ,limit$
 =m ( report ,! ,secret>y %all def9e    
?r\gh rulemak+ a limit$ =m ( ! report "u
 p>agraph 7#a7 requir$ ( plan sponsors  
:o are drug manufactur]s1 drug          
:olesal]s1 or o!r direct p>ticipants 9 !
 drug supply *a91 9 ord] to prev5t      
anti-competitive behavior4  7#d7 ,report
 to ,,gao ,a heal? insurance issu] (f]+ 
gr\p heal? insurance cov]age or an      
entity provid+ ph>macy b5efits managem5t
 s]vices on behalf ( a gr\p heal? plan  
%all submit to ! ,comptroll] ,g5]al ( ! 
,unit$ ,/ates ea* ( ! fir/ #d reports   
submitt$ to a plan sponsor "u p>agraph  

7#a7 ) respect to su* cov]age or plan1 &
 o!r su* reports z reque/$1 9 accordance
 ) ! privacy requirem5ts "u p>agraph    
7#b71 ! disclosure & r$isclosure /&>ds  
"u p>agraph 7#c71 ! /&>ds specifi$      
pursuant to p>agraph 7#e71 & su* o!r    
in=mation t ! ,comptroll] ,g5]al        
det]m9es necess>y to c>ry out ! /udy "u 
section #b7;d7 ( ! ,ph>macy ,b5efits    
,manag] ,acc\ntability ,act4  7#e7 ,/&>d
 =mat ,n lat] ?an ,june #a1 #bjbc1 !    
,secret>y %all specify ?r\gh rulemak+   
/&>ds = heal? insurance issu]s &        
entities requir$ to submit reports "u   
p>agraph 7#d7 to submit su* reports 9 a 
/&>d =mat4  7c7 ,en=cem5t  7#a7 ,9 g5]al
 ,! ,secret>y1 9 consultation ) !       
,secret>y ( ,labor & ! ,secret>y ( !    
,treasury1 %all en=ce ?is section4  7#b7
 ,failure to provide timely in=mation ,a
 heal? insurance issu] or an entity     
provid+ ph>macy b5efits managem5t       
s]vices t violates subsection 7a7 or    
fails to provide in=mation requir$ "u   
subsection 7b7 %all be subject to a     

civil monet>y p5alty 9 ! am\nt ( #aj1jjj
 = ea* day dur+ :i* su* violation       
cont9ues or su* in=mation is n disclos$ 
or report$4  7#c7 ,false in=mation ,a   
heal? insurance issu] or entity provid+ 
ph>macy b5efits managem5t s]vices t     
kn[+ly provides false in=mation "u ?is  
section %all be subject to a civil money
 p5alty 9 an am\nt n to exce$ #ajj1jjj =
 ea* item ( false in=mation4 ,su* civil 
money p5alty %all be 9 addition to o!r  
p5alties z may be prescrib$ by law4     
7#d7 ,proc$ure ,! provisions ( section  
#aabh;,a ( ! ,social ,security ,act1 o!r
 ?an subsection 7a7 & 7b7 & ! fir/      
s5t5ce ( subsection 7c77#a7 ( su*       
section %all apply to civil monet>y     
p5alties "u ?is subsection 9 ! same     
mann] z su* provisions apply to a p5alty
 or proce$+ "u section #aabh;,a ( !     
,social ,security ,act4  7#e7 ,waiv]s ,!
 ,secret>y may waive p5alties "u        
p>agraph 7#b71 or ext5d ! p]iod ( "t =  
compliance ) a requirem5t ( ?is section1
 = an entity 9 violation ( ?is section t

 has made a good-fai? ef=t to comply )  
?is section4  7d7 ,rule ( con/ruction   
,no?+ 9 ?is section %all be con/ru$ to  
p]mit a heal? insurance issu]1 gr\p     
heal? plan1 or o!r entity to re/rict    
disclosure to1 or o!rwise limit ! access
 (1 ! ,dep>tm5t ( ,heal? & ,human       
,s]vices to a report describ$ 9         
subsection 7b77#a7 or in=mation relat$  
to compliance ) subsection 7a7 by su*   
issu]1 plan1 or entity4  7e7 ,def9ition 
,9 ?is section1 ! t]m :olesale          
acquisition co/ has ! mean+ giv5 su* t]m
 9 section #ahdg;,a7c77#f77;,b7 ( !     
,social ,security ,act4  2 &  7#b7 9    
section #bgbc 7#db ,u4,s4,c4            
#cjj;gg-#bb7--  7,a7 9 subsection 7a7-- 
7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an 
subsections 7a7 & 7b7 ( section         
#bgii;,a-#aa7 aft] "p ,d2 &  7ii7 9     
p>agraph 7#b71 by ins]t+ 7o!r ?an       
subsections 7a7 & 7b7 ( section         
#bgii;,a-#aa7 aft] "p ,d2 &  7,b7 9     
subsection 7b7--  7i7 9 p>agraph 7#a71  
by ins]t+ 7o!r ?an subsections 7a7 & 7b7

 ( section #bgii;,a-#aa7 aft] "p ,d2    
7ii7 9 p>agraph 7#b77;,a71 by ins]t+    
7o!r ?an subsections 7a7 & 7b7 ( section
 #bgii;,a-#aa7 aft] "p ,d2 &  7iii7 9   
p>agraph 7#b77;,c77ii71 by ins]t+ 7o!r  
?an subsections 7a7 & 7b7 ( section     
#bgii;,a-#aa7 aft] "p ,d4  7b7 ,,erisa  
7#a7 ,9 g5]al ,subtitle ,b ( title ,i ( 
! ,employee ,retirem5t ,income ,security
 ,act ( #aigd 7#bi ,u4,s4,c4 #ajba et   
seq47 is am5d$--  7,a7 9 subp>t ,b ( "p 
#g 7#bi ,u4,s4,c4 #aahe et seq471 by    
add+ at ! end ! foll[+3  #gbf4 ,ov]sight
 ( ph>macy b5efits manag] s]vices  7a7  
,9 g5]al ,= plan ye>s beg9n+ on or aft] 
,janu>y #a1 #bjbe1 a gr\p heal? plan 7or
 heal? insurance issu] (f]+ gr\p heal?  
insurance cov]age 9 connection ) su* a  
plan7 or an entity or subsidi>y provid+ 
ph>macy b5efits managem5t s]vices on    
behalf ( su* a plan or issu] %all n ent]
 into a contract ) a drug manufactur]1  
di/ributor1 :olesal]1 subcontractor1    
rebate aggregator1 or any associat$ ?ird
 p>ty t limits ! disclosure ( in=mation 

to plan sponsors 9 su* a mann] t prev5ts
 ! plan or issu]1 or an entity or       
subsidi>y provid+ ph>macy b5efits       
managem5t s]vices on behalf ( a plan or 
issu]1 f mak+ ! reports describ$ 9      
subsection 7b74  7b7 ,reports  7#a7 ,9  
g5]al ,= plan ye>s beg9n+ on or aft]    
,janu>y #a1 #bjbe1 n less frequ5tly ?an 
annually1 a heal? insurance issu] (f]+  
gr\p heal? insurance cov]age or an      
entity provid+ ph>macy b5efits managem5t
 s]vices on behalf ( a gr\p heal? plan  
or an issu] provid+ gr\p heal? insurance
 cov]age %all submit to ! plan sponsor  
7z def9$ 9 section #c7af77;,b77 ( su*   
gr\p heal? plan or gr\p heal? insurance 
cov]age a report 9 accordance ) ?is     
subsection & make su* report available  
to ! plan sponsor 9 a ma*9e-readable    
=mat4 ,ea* su* report %all include1 )   
respect to ! applicable gr\p heal? plan 
or heal? insurance cov]age-- 7,a7 z     
applicable1 in=mation collect$ f drug   
manufactur]s by su* issu] or entity on !
 total am\nt ( copaym5t assi/ance doll>s

 paid1 or copaym5t c>ds appli$1 t 7     
fund$ by ! drug manufactur] ) respect to
 ! p>ticipants & b5efici>ies 9 su* plan 
or cov]age2  7,b7 a li/ ( ea* drug cov]$
 by su* plan1 issu]1 or entity provid+  
ph>macy b5efits managem5t s]vices t 0   
disp5s$ dur+ ! report+ p]iod1 includ+1 )
 respect to ea* su* drug dur+ ! report+ 
p]iod-- 7i7 ! br& "n1 *emical entity1 & 
,national ,drug ,code2  7ii7 ! numb] (  
p>ticipants & b5efici>ies = :om ! drug 0
 fill$ dur+ ! plan ye>1 ! total numb] ( 
prescription fills = ! drug 7includ+    
orig9al prescriptions & refills71 & !   
total numb] ( dosage units ( ! drug     
disp5s$ across ! plan ye>1 includ+ :e!r 
! disp5s+ *annel 0 by retail1 mail ord]1
 or specialty ph>macy2  7iii7 ! :olesale
 acquisition co/1 li/$ z co/ p] days    
supply & co/ p] pill1 or 9 ! case ( a   
drug 9 ano!r =m1 p] dose2  7iv7 ! total 
out-(-pocket sp5d+ by p>ticipants &     
b5efici>ies on su* drug1 includ+        
p>ticipant & b5efici>y sp5d+ ?r\gh      
copaym5ts1 co9surance1 & d$uctibles2 &  

7v7 = any drug = :i* gross sp5d+ ( !    
gr\p heal? plan or heal? insurance      
cov]age exce$$ #aj1jjj dur+ ! report+   
p]iod--  7,i7 a li/ ( all o!r drugs 9 ! 
same !rapeutic category or class1       
includ+ br& "n drugs & biological       
products & g5]ic drugs or biosimil>     
biological products t are 9 ! same      
!rapeutic category or class z su* drug2 
&  7,,ii7 ! rationale = pref]r$ =mul>y  
placem5t ( su* drug 9 t !rapeutic       
category or class1 if applicable2  7,c7 
a li/ ( ea* !rapeutic category or class 
( drugs t 7 disp5s$ "u ! heal? plan or  
heal? insurance cov]age dur+ ! report+  
p]iod1 &1 ) respect to ea* su* !rapeutic
 category or class ( drugs1 dur+ !      
report+ p]iod-- 7i7 total gross sp5d+ by
 ! plan1 be=e manufactur] rebates1 fees1
 or o!r manufactur] remun]ation2  7ii7 !
 numb] ( p>ticipants & b5efici>ies :o   
fill$ a prescription = a drug 9 t       
category or class2  7iii7 if applicable 
to t category or class1 a description ( 
! =mul>y ti]s & utilization me*anisms   

7su* z prior au?orization or /ep !rapy7 
employ$ = drugs 9 t category or class2  
7iv7 ! total out-(-pocket sp5d+ by      
p>ticipants & b5efici>ies1 includ+      
p>ticipant & b5efici>y sp5d+ ?r\gh      
copaym5ts1 co9surance1 & d$uctibles2 &  
7v7 = ea* !rapeutic category or class "u
 :i* #c or m drugs are includ$ on !     
=mul>y ( su* plan or cov]age--  7,i7 !  
am\nt receiv$1 or expect$ to be receiv$1
 f drug manufactur]s 9 rebates1 fees1   
alt]native disc\nts1 or o!r             
remun]ation-- 7aa7 t has be5 paid1 or is
 to be paid1 by drug manufactur]s =     
claims incurr$ dur+ ! report+ p]iod2 or 
7bb7 t is relat$ to utilization ( drugs1
 9 su* !rapeutic category or class2     
7,,ii7 ! total net sp5d+1 aft] d$uct+   
rebates1 price concessions1 alt]native  
disc\nts or o!r remun]ation f drug      
manufactur]s1 by ! heal? plan or heal?  
insurance cov]age on t category or class
 ( drugs2 &  7,,iii7 ! net price p]     
c\rse ( treatm5t or s+le fill1 su* z a  
#cj-;day supply or #ij-;day supply1     

incurr$ by ! heal? plan or heal?        
insurance cov]age & its p>ticipants &   
b5efici>ies1 aft] manufactur] rebates1  
fees1 & o!r remun]ation = drugs disp5s$ 
)9 su* !rapeutic category or class dur+ 
! report+ p]iod2  7,d7 total gross sp5d+
 on prescription drugs by ! plan or     
cov]age dur+ ! report+ p]iod1 be=e      
rebates & o!r manufactur] fees or       
remun]ation2  7,e7 total am\nt receiv$1 
or expect$ to be receiv$1 by ! heal?    
plan or heal? insurance cov]age 9 drug  
manufactur] rebates1 fees1 alt]native   
disc\nts1 & all o!r remun]ation receiv$ 
f ! manufactur] or any ?ird p>ty1 o!r   
?an ! plan sponsor1 relat$ to           
utilization ( drug or drug sp5d+ "u t   
heal? plan or heal? insurance cov]age   
dur+ ! report+ p]iod2  7,f7 ! total net 
sp5d+ on prescription drugs by ! heal?  
plan or heal? insurance cov]age dur+ !  
report+ p]iod2 &  7,g7 am\nts paid      
directly or indirectly 9 rebates1 fees1 
or any o!r type ( remun]ation to brok]s1
 consultants1 advisors1 or any o!r      

individual or firm :o ref]r$ ! gr\p     
heal? plan's or heal? insurance issu]'s 
bus9ess to ! ph>macy b5efits manag]4    
7#b7 ,privacy requirem5ts ,heal?        
insurance issu]s (f]+ gr\p heal?        
insurance cov]age & entities provid+    
ph>macy b5efits managem5t s]vices on    
behalf ( a gr\p heal? plan %all provide 
in=mation "u p>agraph 7#a7 9 a mann]    
consi/5t ) ! privacy1 security1 & brea* 
notification regulations promulgat$ "u  
section #bfd7;c7 ( ! ,heal? ,insurance  
,portability & ,acc\ntability ,act (    
#aiif1 & %all re/rict ! use & disclosure
 ( su* in=mation accord+ to su* privacy 
regulations4  7#c7 ,disclosure &        
r$isclosure  7,a7 ,limitation to bus9ess
 associates ,a gr\p heal? plan receiv+ a
 report "u p>agraph 7#a7 may disclose   
su* in=mation only to bus9ess associates
 ( su* plan z def9$ 9 section #afj4ajc (
 title #de1 ,code ( ,f$]al ,regulations 
7or successor regulations74  7,b7       
,cl>ification reg>d+ public disclosure (
 in=mation ,no?+ 9 ?is section prev5ts a

 heal? insurance issu] (f]+ gr\p heal?  
insurance cov]age or an entity provid+  
ph>macy b5efits managem5t s]vices on    
behalf ( a gr\p heal? plan f plac+      
reasonable re/rictions on ! public      
disclosure ( ! in=mation conta9$ 9 a    
report describ$ 9 p>agraph 7#a71 except 
t su* issu] or entity may n re/rict     
disclosure ( su* report to ! ,dep>tm5t (
 ,heal? & ,human ,s]vices1 ! ,dep>tm5t (
 ,labor1 ! ,dep>tm5t ( ! ,treasury1 !   
,comptroll] ,g5]al ( ! ,unit$ ,/ates1 or
 applicable ,/ate ag5cies4  7,c7 ,limit$
 =m ( report ,! ,secret>y %all def9e    
?r\gh rulemak+ a limit$ =m ( ! report "u
 p>agraph 7#a7 requir$ ( plan sponsors  
:o are drug manufactur]s1 drug          
:olesal]s1 or o!r direct p>ticipants 9 !
 drug supply *a91 9 ord] to prev5t      
anti-competitive behavior4  7#d7 ,report
 to ,,gao ,a heal? insurance issu] (f]+ 
gr\p heal? insurance cov]age or an      
entity provid+ ph>macy b5efits managem5t
 s]vices on behalf ( a gr\p heal? plan  
%all submit to ! ,comptroll] ,g5]al ( ! 

,unit$ ,/ates ea* ( ! fir/ #d reports   
submitt$ to a plan sponsor "u p>agraph  
7#a7 ) respect to su* cov]age or plan1 &
 o!r su* reports z reque/$1 9 accordance
 ) ! privacy requirem5ts "u p>agraph    
7#b71 ! disclosure & r$isclosure /&>ds  
"u p>agraph 7#c71 ! /&>ds specifi$      
pursuant to p>agraph 7#e71 & su* o!r    
in=mation t ! ,comptroll] ,g5]al        
det]m9es necess>y to c>ry out ! /udy "u 
section #b7;d7 ( ! ,ph>macy ,b5efits    
,manag] ,acc\ntability ,act4  7#e7 ,/&>d
 =mat ,n lat] ?an ,june #a1 #bjbc1 !    
,secret>y %all specify ?r\gh rulemak+   
/&>ds = heal? insurance issu]s &        
entities requir$ to submit reports "u   
p>agraph 7#d7 to submit su* reports 9 a 
/&>d =mat4  7c7 ,rule ( con/ruction     
,no?+ 9 ?is section %all be con/ru$ to  
p]mit a heal? insurance issu]1 gr\p     
heal? plan1 or o!r entity to re/rict    
disclosure to1 or o!rwise limit ! access
 (1 ! ,dep>tm5t ( ,labor to a report    
describ$ 9 subsection 7b77#a7 or        
in=mation relat$ to compliance )        

subsection 7a7 by su* issu]1 plan1 or   
entity4  7d7 ,def9ition ,9 ?is section1 
! t]m :olesale acquisition co/ has !    
mean+ giv5 su* t]m 9 section            
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act4  2 &  7,b7 9 section    
#ejb 7#bi ,u4,s4,c4 #aacb7--  7i7 9     
subsection 7a7-- 7,i7 9 p>agraph 7#f71  
by /rik+ or 7#i7 & ins]t+ 7#i71 or      
7#ac72  7,,ii7 9 p>agraph 7#aj71 by     
/rik+ at ! end or2  7,,iii7 9 p>agraph  
7#aa71 at ! end by /rik+ ! p]iod &      
ins]t+ 2 or2 &  7,,iv7 by add+ at ! end 
! foll[+ new p>agraph3  7#ab7 by !      
,secret>y1 9 consultation ) ! ,secret>y 
( ,heal? & ,human ,s]vices1 & !         
,secret>y ( ! ,treasury1 to en=ce       
section #gbf4  2  7ii7 9 subsection     
7b77#c71 by ins]t+ & subsections        
7a77#ab7 & 7c77#ac7 be=e 1 ! ,secret>y  
is n2 &  7iii7 9 subsection 7c71 by add+
 at ! end ! foll[+ new p>agraph3  7#ac7 
,secret>ial en=cem5t au?ority relat+ to 
ov]sight ( ph>macy b5efits manag]       
s]vices  7,a7 ,failure to provide timely

 in=mation ,! ,secret>y1 9 consultation 
) ! ,secret>y ( ,heal? & ,human ,s]vices
 & ! ,secret>y ( ! ,treasury1 may impose
 a p5alty aga9/ any heal? insurance     
issu] or entity provid+ ph>macy b5efits 
managem5t s]vices t violates section    
#gbf7;a7 or fails to provide in=mation  
requir$ "u section #gbf7;b7 9 ! am\nt ( 
#aj1jjj = ea* day dur+ :i* su* violation
 cont9ues or su* in=mation is n disclos$
 or report$4  7,b7 ,false in=mation ,!  
,secret>y1 9 consultation ) ! ,secret>y 
( ,heal? & ,human ,s]vices & ! ,secret>y
 ( ! ,treasury1 may impose a p5alty     
aga9/ a heal? insurance issu] or entity 
provid+ ph>macy b5efits managem5t       
s]vices t kn[+ly provides false         
in=mation "u section #gbf 9 an am\nt n  
to exce$ #ajj1jjj = ea* item ( false    
in=mation4 ,su* p5alty %all be 9        
addition to o!r p5alties z may be       
prescrib$ by law4  7,c7 ,waiv]s ,!      
,secret>y may waive p5alties "u         
subp>agraph 7,a71 or ext5d ! p]iod ( "t 
= compliance ) a requirem5t ( section   

#gbf1 = an entity 9 violation ( su*     
section t has made a good-fai? ef=t to  
comply ) su* section4  4  7#b7 ,cl]ical 
am5dm5t ,! table ( cont5ts 9 section #a 
( ! ,employee ,retirem5t ,income        
,security ,act ( #aigd 7#bi ,u4,s4,c4   
#ajja et seq47 is am5d$ by ins]t+ aft] !
 item relat+ to section #gbe ! foll[+   
new item3  ,sec4 #gbf4 ,ov]sight (      
ph>macy b5efits manag] s]vices4  4  7c7 
,,irc  7#a7 ,9 g5]al ,sub*apt] ,b (     
*apt] #ajj ( ! ,int]nal ,rev5ue ,code ( 
#aihf is am5d$ by add+ at ! end !       
foll[+3  #ihbf4 ,ov]sight ( ph>macy     
b5efits manag] s]vices  7a7 ,9 g5]al ,= 
plan ye>s beg9n+ on or aft] ,janu>y #a1 
#bjbe1 a gr\p heal? plan or an entity or
 subsidi>y provid+ ph>macy b5efits      
managem5t s]vices on behalf ( su* a plan
 %all n ent] into a contract ) a drug   
manufactur]1 di/ributor1 :olesal]1      
subcontractor1 rebate aggregator1 or any
 associat$ ?ird p>ty t limits !         
disclosure ( in=mation to plan sponsors 
9 su* a mann] t prev5ts ! plan1 or an   

entity or subsidi>y provid+ ph>macy     
b5efits managem5t s]vices on behalf ( a 
plan1 f mak+ ! reports describ$ 9       
subsection 7b74  7b7 ,reports  7#a7 ,9  
g5]al ,= plan ye>s beg9n+ on or aft]    
,janu>y #a1 #bjbe1 n less frequ5tly ?an 
annually1 an entity provid+ ph>macy     
b5efits managem5t s]vices on behalf ( a 
gr\p heal? plan %all submit to ! plan   
sponsor 7z def9$ 9 section #c7af77;,b7 (
 ! ,employee ,retirem5t ,income         
,security ,act ( #aigd7 ( su* gr\p heal?
 plan a report 9 accordance ) ?is       
subsection & make su* report available  
to ! plan sponsor 9 a ma*9e-readable    
=mat4 ,ea* su* report %all include1 )   
respect to ! applicable gr\p heal?      
plan-- 7,a7 z applicable1 in=mation     
collect$ f drug manufactur]s by su*     
entity on ! total am\nt ( copaym5t      
assi/ance doll>s paid1 or copaym5t c>ds 
appli$1 t 7 fund$ by ! drug manufactur] 
) respect to ! p>ticipants & b5efici>ies
 9 su* plan2  7,b7 a li/ ( ea* drug     
cov]$ by su* plan or entity provid+     

ph>macy b5efits managem5t s]vices t 0   
disp5s$ dur+ ! report+ p]iod1 includ+1 )
 respect to ea* su* drug dur+ ! report+ 
p]iod-- 7i7 ! br& "n1 *emical entity1 & 
,national ,drug ,code2  7ii7 ! numb] (  
p>ticipants & b5efici>ies = :om ! drug 0
 fill$ dur+ ! plan ye>1 ! total numb] ( 
prescription fills = ! drug 7includ+    
orig9al prescriptions & refills71 & !   
total numb] ( dosage units ( ! drug     
disp5s$ across ! plan ye>1 includ+ :e!r 
! disp5s+ *annel 0 by retail1 mail ord]1
 or specialty ph>macy2  7iii7 ! :olesale
 acquisition co/1 li/$ z co/ p] days    
supply & co/ p] pill1 or 9 ! case ( a   
drug 9 ano!r =m1 p] dose2  7iv7 ! total 
out-(-pocket sp5d+ by p>ticipants &     
b5efici>ies on su* drug1 includ+        
p>ticipant & b5efici>y sp5d+ ?r\gh      
copaym5ts1 co9surance1 & d$uctibles2 &  
7v7 = any drug = :i* gross sp5d+ ( !    
gr\p heal? plan exce$$ #aj1jjj dur+ !   
report+ p]iod--  7,i7 a li/ ( all o!r   
drugs 9 ! same !rapeutic category or    
class1 includ+ br& "n drugs & biological

 products & g5]ic drugs or biosimil>    
biological products t are 9 ! same      
!rapeutic category or class z su* drug2 
&  7,,ii7 ! rationale = pref]r$ =mul>y  
placem5t ( su* drug 9 t !rapeutic       
category or class1 if applicable2  7,c7 
a li/ ( ea* !rapeutic category or class 
( drugs t 7 disp5s$ "u ! heal? plan dur+
 ! report+ p]iod1 &1 ) respect to ea*   
su* !rapeutic category or class ( drugs1
 dur+ ! report+ p]iod-- 7i7 total gross 
sp5d+ by ! plan1 be=e manufactur]       
rebates1 fees1 or o!r manufactur]       
remun]ation2  7ii7 ! numb] ( p>ticipants
 & b5efici>ies :o fill$ a prescription =
 a drug 9 t category or class2  7iii7 if
 applicable to t category or class1 a   
description ( ! =mul>y ti]s &           
utilization me*anisms 7su* z prior      
au?orization or /ep !rapy7 employ$ =    
drugs 9 t category or class2  7iv7 !    
total out-(-pocket sp5d+ by p>ticipants 
& b5efici>ies1 includ+ p>ticipant &     
b5efici>y sp5d+ ?r\gh copaym5ts1        
co9surance1 & d$uctibles2 &  7v7 = ea*  

!rapeutic category or class "u :i* #c or
 m drugs are includ$ on ! =mul>y ( su*  
plan--  7,i7 ! am\nt receiv$1 or expect$
 to be receiv$1 f drug manufactur]s 9   
rebates1 fees1 alt]native disc\nts1 or  
o!r remun]ation-- 7aa7 t has be5 paid1  
or is to be paid1 by drug manufactur]s =
 claims incurr$ dur+ ! report+ p]iod2 or
  7bb7 t is relat$ to utilization (     
drugs1 9 su* !rapeutic category or      
class2  7,,ii7 ! total net sp5d+1 aft]  
d$uct+ rebates1 price concessions1      
alt]native disc\nts or o!r remun]ation f
 drug manufactur]s1 by ! heal? plan on t
 category or class ( drugs2 &  7,,iii7 !
 net price p] c\rse ( treatm5t or s+le  
fill1 su* z a #cj-;day supply or        
#ij-;day supply1 incurr$ by ! heal? plan
 & its p>ticipants & b5efici>ies1 aft]  
manufactur] rebates1 fees1 & o!r        
remun]ation = drugs disp5s$ )9 su*      
!rapeutic category or class dur+ !      
report+ p]iod2  7,d7 total gross sp5d+  
on prescription drugs by ! plan dur+ !  
report+ p]iod1 be=e rebates & o!r       

manufactur] fees or remun]ation2  7,e7  
total am\nt receiv$1 or expect$ to be   
receiv$1 by ! heal? plan 9 drug         
manufactur] rebates1 fees1 alt]native   
disc\nts1 & all o!r remun]ation receiv$ 
f ! manufactur] or any ?ird p>ty1 o!r   
?an ! plan sponsor1 relat$ to           
utilization ( drug or drug sp5d+ "u t   
heal? plan dur+ ! report+ p]iod2  7,f7 !
 total net sp5d+ on prescription drugs  
by ! heal? plan dur+ ! report+ p]iod2 & 
7,g7 am\nts paid directly or indirectly 
9 rebates1 fees1 or any o!r type (      
remun]ation to brok]s1 consultants1     
advisors1 or any o!r individual or firm 
:o ref]r$ ! gr\p heal? plan's bus9ess to
 ! ph>macy b5efits manag]4  7#b7        
,privacy requirem5ts ,entities provid+  
ph>macy b5efits managem5t s]vices on    
behalf ( a gr\p heal? plan %all provide 
in=mation "u p>agraph 7#a7 9 a mann]    
consi/5t ) ! privacy1 security1 & brea* 
notification regulations promulgat$ "u  
section #bfd7;c7 ( ! ,heal? ,insurance  
,portability & ,acc\ntability ,act (    

#aiif1 & %all re/rict ! use & disclosure
 ( su* in=mation accord+ to su* privacy 
regulations4  7#c7 ,disclosure &        
r$isclosure  7,a7 ,limitation to bus9ess
 associates ,a gr\p heal? plan receiv+ a
 report "u p>agraph 7#a7 may disclose   
su* in=mation only to bus9ess associates
 ( su* plan z def9$ 9 section #afj4ajc (
 title #de1 ,code ( ,f$]al ,regulations 
7or successor regulations74  7,b7       
,cl>ification reg>d+ public disclosure (
 in=mation ,no?+ 9 ?is section prev5ts  
an entity provid+ ph>macy b5efits       
managem5t s]vices on behalf ( a gr\p    
heal? plan f plac+ reasonable           
re/rictions on ! public disclosure ( !  
in=mation conta9$ 9 a report describ$ 9 
p>agraph 7#a71 except t su* entity may n
 re/rict disclosure ( su* report to !   
,dep>tm5t ( ,heal? & ,human ,s]vices1 ! 
,dep>tm5t ( ,labor1 ! ,dep>tm5t ( !     
,treasury1 ! ,comptroll] ,g5]al ( !     
,unit$ ,/ates1 or applicable ,/ate      
ag5cies4  7,c7 ,limit$ =m ( report ,!   
,secret>y %all def9e ?r\gh rulemak+ a   

limit$ =m ( ! report "u p>agraph 7#a7   
requir$ ( plan sponsors :o are drug     
manufactur]s1 drug :olesal]s1 or o!r    
direct p>ticipants 9 ! drug supply *a91 
9 ord] to prev5t anti-competitive       
behavior4  7#d7 ,report to ,,gao ,an    
entity provid+ ph>macy b5efits managem5t
 s]vices on behalf ( a gr\p heal? plan  
%all submit to ! ,comptroll] ,g5]al ( ! 
,unit$ ,/ates ea* ( ! fir/ #d reports   
submitt$ to a plan sponsor "u p>agraph  
7#a7 ) respect to su* plan1 & o!r su*   
reports z reque/$1 9 accordance ) !     
privacy requirem5ts "u p>agraph 7#b71 ! 
disclosure & r$isclosure /&>ds "u       
p>agraph 7#c71 ! /&>ds specifi$ pursuant
 to p>agraph 7#e71 & su* o!r in=mation t
 ! ,comptroll] ,g5]al det]m9es necess>y 
to c>ry out ! /udy "u section #b7;d7 ( !
 ,ph>macy ,b5efits ,manag]              
,acc\ntability ,act4  7#e7 ,/&>d =mat ,n
 lat] ?an ,june #a1 #bjbc1 ! ,secret>y  
%all specify ?r\gh rulemak+ /&>ds =     
entities requir$ to submit reports "u   
p>agraph 7#d7 to submit su* reports 9 a 

/&>d =mat4  7c7 ,en=cem5t  7#a7 ,9 g5]al
 ,! ,secret>y1 9 consultation ) !       
,secret>y ( ,labor & ! ,secret>y (      
,heal? & ,human ,s]vices1 %all en=ce ?is
 section4  7#b7 ,failure to provide     
timely in=mation ,an entity provid+     
ph>macy b5efits managem5t s]vices t     
violates subsection 7a7 or fails to     
provide in=mation requir$ "u subsection 
7b7 %all be subject to a civil monet>y  
p5alty 9 ! am\nt ( #aj1jjj = ea* day    
dur+ :i* su* violation cont9ues or su*  
in=mation is n disclos$ or report$4     
7#c7 ,false in=mation ,an entity provid+
 ph>macy b5efits managem5t s]vices t    
kn[+ly provides false in=mation "u ?is  
section %all be subject to a civil money
 p5alty 9 an am\nt n to exce$ #ajj1jjj =
 ea* item ( false in=mation4 ,su* civil 
money p5alty %all be 9 addition to o!r  
p5alties z may be prescrib$ by law4     
7#d7 ,proc$ure ,! provisions ( section  
#aabh;,a ( ! ,social ,security ,act1 o!r
 ?an subsection 7a7 & 7b7 & ! fir/      
s5t5ce ( subsection 7c77#a7 ( su*       

section %all apply to civil monet>y     
p5alties "u ?is subsection 9 ! same     
mann] z su* provisions apply to a p5alty
 or proce$+ "u section #aabh;,a ( !     
,social ,security ,act4  7#e7 ,waiv]s ,!
 ,secret>y may waive p5alties "u        
p>agraph 7#b71 or ext5d ! p]iod ( "t =  
compliance ) a requirem5t ( ?is section1
 = an entity 9 violation ( ?is section t
 has made a good-fai? ef=t to comply )  
?is section4  7d7 ,rule ( con/ruction   
,no?+ 9 ?is section %all be con/ru$ to  
p]mit a gr\p heal? plan or o!r entity to
 re/rict disclosure to1 or o!rwise limit
 ! access (1 ! ,dep>tm5t ( ! ,treasury  
to a report describ$ 9 subsection       
7b77#a7 or in=mation relat$ to          
compliance ) subsection 7a7 by su* plan 
or entity4  7e7 ,def9ition ,9 ?is       
section1 ! t]m :olesale acquisition co/ 
has ! mean+ giv5 su* t]m 9 section      
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act4  4  7#b7 ,cl]ical       
am5dm5t ,! table ( sections = sub*apt]  
,b ( *apt] #ajj ( ! ,int]nal ,rev5ue    

,code ( #aihf is am5d$ by add+ at ! end 
! foll[+ new item3  ,sec4 #ihbf4        
,ov]sight ( ph>macy b5efits manag]      
s]vices4  4  7d7 ,,gao /udy  7#a7 ,9    
g5]al ,n lat] ?an #c ye>s aft] ! date ( 
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all submit to 
,congress a report on--  7,a7 ph>macy   
networks ( gr\p heal? plans1 heal?      
insurance issu]s1 & entities provid+    
ph>macy b5efits managem5t s]vices "u su*
 gr\p heal? plan or gr\p or individual  
heal? insurance cov]age1 includ+        
networks t h ph>macies t are "u common  
own]%ip 79 :ole or "p7 ) gr\p heal?     
plans1 heal? insurance issu]s1 or       
entities provid+ ph>macy b5efits        
managem5t s]vices or ph>macy b5efits    
adm9i/rative s]vices "u gr\p heal? plan 
or gr\p or individual heal? insurance   
cov]age2  7,b7 z x relates to ph>macy   
networks t include ph>macies "u common  
own]%ip describ$ 9 subp>agraph 7,a7--   
7i7 :e!r su* networks are design$ to    
enc\rage enrollees ( a plan or cov]age  

to use su* ph>macies ov] o!r network    
ph>macies = specific s]vices or drugs1 &
 if s1 ! reasons ! networks give =      
enc\rag+ use ( su* ph>macies2 &  7ii7   
:e!r su* ph>macies are us$ by enrollees 
disproportionately m 9 ! aggregate or = 
specific s]vices or drugs comp>$ to o!r 
network ph>macies2  7,c7 :e!r gr\p heal?
 plans & heal? insurance issu]s (f]+    
gr\p or individual heal? insurance      
cov]age h options to elect diff]5t      
network pric+ arrangem5ts 9 ! m>ketplace
 ) entities t provide ph>macy b5efits   
managem5t s]vices1 ! preval5ce ( elect+ 
su* diff]5t network pric+ arrangem5ts2  
7,d7 ph>macy network design p>amet]s t  
enc\rage enrollees 9 ! plan or cov]age  
to fill prescriptions at mail ord]1     
specialty1 or retail ph>macies t are    
:olly or p>tially-own$ by t issu] or    
entity2 &  7,e7 ! degree to :i* mail    
ord]1 specialty1 or retail ph>macies t  
disp5se prescription drugs to an        
enrollee 9 a gr\p heal? plan or heal?   
insurance cov]age t are "u common       

own]%ip 79 :ole or "p7 ) gr\p heal?     
plans1 heal? insurance issu]s1 or       
entities provid+ ph>macy b5efits        
managem5t s]vices or ph>macy b5efits    
adm9i/rative s]vices "u gr\p heal? plan 
or gr\p or individual heal? insurance   
cov]age receive reimbursem5t t is great]
 ?an ! m$ian price *>g$ to ! gr\p heal? 
plan or heal? insurance issu] :5 ! same 
drug is disp5s$ to enrollees 9 ! plan or
 cov]age by o!r ph>macies includ$ 9 !   
ph>macy network ( t plan1 issu]1 or     
entity t are n :olly or p>tially own$ by
 ! heal? insurance issu] or entity      
provid+ ph>macy b5efits managem5t       
s]vices4  7#b7 ,requirem5t ,!           
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all ensure t ! report "u p>agraph 7#a7 
does n conta9 in=mation t w\ld all[ a   
read] to id5tify a specific plan or     
entity provid+ ph>macy b5efits managem5t
 s]vices or o!rwise conta9 comm]cial or 
f9ancial in=mation t is privileg$ or    
confid5tial4  7#c7 ,def9itions ,9 ?is   
subsection1 ! t]ms gr\p heal? plan1     

heal? insurance cov]age1 & heal?        
insurance issu] h ! mean+s giv5 su* t]ms
 9 section #bgia ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;gg-#ia74  ,,ii ,support+ pati5ts1  
heal? c>e work]s1 community heal? c5t]s1
 & hospitals  #bja4 ,ext5sion =         
community heal? c5t]s1 ! national heal? 
s]vice corps1 & tea*+ heal? c5t]s t     
op]ate ,,gme programs  7a7 ,tea*+ heal? 
c5t]s t op]ate graduate m$ical education
 programs ,section #cdj;,h7g7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bef;h7g77 is am5d$--  7#a7 by
 am5d+ p>agraph 7#a7 to read z foll[s3  
7#a7 ,9 g5]al ,to c>ry out ?is section1 
!re are appropriat$ su* sums z may be   
necess>y1 n to exce$--  7,a7            
#bcj1jjj1jjj1 = ! p]iod ( fiscal ye>s   
#bjaa ?r\gh #bjae2  7,b7 #fj1jjj1jjj =  
ea* ( fiscal ye>s #bjaf & #bjag2  7,c7  
#abf1ejj1jjj = ea* ( fiscal ye>s #bjah  
?r\gh #bjbc2  7,d7 #age1jjj1jjj = ea* ( 
fiscal ye>s #bjbd & #bjbe2  7,e7        
#bbe1jjj1jjj = ea* ( fiscal ye>s #bjbf &

 #bjbg2 &  7,f7 #bge1jjj1jjj = ea* (    
fiscal ye>s #bjbh & #bjbi4  2 &  7#b7 by
 add+ at ! end ! foll[+3  7#c7          
,availability ,! am\nts made available  
"u p>agraph 7#a7 %all rema9 available   
until exp5d$4  4  7b7 ,ext5sion =       
community heal? c5t]s ,section          
#ajejc7;b77#a77;,f7 ( ! ,pati5t         
,protection & ,af=dable ,c>e ,act 7#db  
,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is    
am5d$-- 7#a7 by /rik+ & be=e            
#d1jjj1jjj1jjj & ins]t+ a comma2 &  7#b7
 by ins]t+ 1 & #d1bjj1jjj1jjj = ea* (   
fiscal ye>s #bjbd & #bjbe be=e !        
semicolon4  7c7 ,ext5sion = ! ,national 
,heal? ,s]vice ,corps ,section          
#ajejc7;b77#b7 ( ! ,pati5t ,protection &
 ,af=dable ,c>e ,act 7#db ,u4,s4,c4     
#bed;b-#b7;b77#b77 is am5d$--  7#a7 9   
subp>agraph 7,g71 by /rik+ & at ! end2  
7#b7 9 subp>agraph 7,h71 by /rik+ !     
p]iod at ! end & ins]t+ 2 &2 &  7#c7 by 
add+ at ! end ! foll[+3  7,i7           
#cej1jjj1jjj = ea* ( fiscal ye>s #bjbd &
 #bjbe4  4  7d7 ,application (          

provisions ,am\nts appropriat$ pursuant 
to ! am5dm5ts made by ?is section %all  
be subject to ! requirem5ts conta9$ 9   
,public ,law #aag-cbh = funds = programs
 au?oriz$ "u sections #ccj ?r\gh #cdj ( 
! ,public ,heal? ,s]vice ,act4  7e7     
,con=m+ am5dm5t ,p>agraph 7#d7 ( section
 #cjad7;h7 ( title #ah1 ,unit$ ,/ates   
,code1 is am5d$ by /rik+ & section      
#cja7;d7 ( division ,,bb ( !            
,consolidat$ ,appropriations ,act1      
#bjba4 & ins]t+ section #cja7;d7 (      
division ,,bb ( ! ,consolidat$          
,appropriations ,act1 #bjba1 & section  
#bja7;d7 ( ! ,,pati5t ,act ( #bjbc4     
#bjb4 ,ext5sion ( special diabetes      
programs  7a7 ,ext5sion ( special       
diabetes programs = type i diabetes     
,section #ccj;,b7b77#b7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bed;c-#b7;b77#b77 is am5d$-- 7#a7 9    
subp>agraph 7,c71 by /rik+ & at ! end2  
7#b7 9 subp>agraph 7,d71 by /rik+ !     
p]iod & ins]t+ 2 &2 &  7#c7 by add+ at !
 end ! foll[+ new subp>agraph3  7,e7    

#agj1jjj1jjj = ea* ( fiscal ye>s #bjbd &
 #bjbe4  4  7b7 ,ext5d+ fund+ = special 
diabetes programs = indians ,section    
#ccj;,c7c77#b7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bed;c-#c7;c77#b77 is am5d$--  7#a7 9   
subp>agraph 7,c71 by /rik+ & at ! end2  
7#b7 9 subp>agraph 7,d71 by /rik+ !     
p]iod & ins]t+ 2 &2 &  7#c7 by add+ at !
 end ! foll[+ new subp>agraph3  7,e7    
#agj1jjj1jjj = ea* ( fiscal ye>s #bjbd &
 #bjbe4  4  #bjc4 ,delay+ c]ta9         
disproportionate %>e hospital paym5t    
r$uctions "u ! ,m$icaid program ,section
 #aibc7;f77#g77;,a7 ( ! ,social         
,security ,act 7#db                     
,u4,s4,c4#acifr-#d7;f77#g77;,a77 is     
am5d$-- 7#a7 9 clause 7i71 9 ! matt]    
prec$+ subclause 7,i71 by /rik+ #bjbd & 
ins]t+ #bjbf2 &  7#b7 9 clause 7ii71 by 
/rik+ #bjbd & ins]t+ #bjbf4  #bjd4      
,m$icaid improvem5t fund ,section       
#aida7;b77#c77;,a7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4                    
#acifw-#a7;b77#c77;,a77 is am5d$ by     

/rik+ #g1jjj1jjj1jjj & ins]t+ #j4  ,,iii
 ,r$uc+ heal? c>e co/s  #cja4 ,increas+ 
transp>5cy 9 g5]ic drug applications    
7a7 ,9 g5]al ,section #eje7;j77#c7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77#c77 is am5d$ by
 add+ at ! end ! foll[+3  7,h7 7i7 ,^u  
reque/ 79 controll$ correspond5ce or an 
analog\s process7 by a p]son t has      
submitt$ or int5ds to submit an         
abbreviat$ application "u ?is subsection
 = a drug t is requir$ by regulation to 
conta9 "o or m ( ! same inactive +r$i5ts
 9 ! same conc5trations z ! li/$ drug   
ref]r$ to1 or = :i* ! ,secret>y det]m9es
 !re is a sci5tific ju/ification = an   
approa* t is 9 vitro 9 :ole or 9 "p to  
be us$ to demon/rate bioequival5ce = a  
drug if su* a drug conta9s "o or m ( !  
same inactive +r$i5ts 9 ! same          
conc5trations z ! li/$ drug1 ! ,secret>y
 %all in=m ! p]son :e!r su* drug is     
qualitatively & quantitatively ! same z 
! li/$ drug4 ,! ,secret>y may also      
provide su* in=mation to su* a p]son on 

! ,secret>y's own initiative dur+ !     
review ( an abbreviat$ application "u   
?is subsection = su* drug4  7ii7        
,not)/&+ section #cja7;j71 if !         
,secret>y det]m9es t su* drug is n      
qualitatively or quantitatively ! same z
 ! li/$ drug1 ! ,secret>y %all id5tify &
 disclose to ! p]son-- 7,i7 ! +r$i5t or 
+r$i5ts t cause su* drug n to be        
qualitatively or quantitatively ! same z
 ! li/$ drug2 &  7,,ii7 = any +r$i5t =  
:i* !re is an id5tifi$ quantitative     
deviation1 :e!r ! quantity or proportion
 ( any +r$i5t 9 su* drug is great] ?an  
or less ?an ! quantity or proportion (  
su* +r$i5t 9 ! li/$ drug4  7iii7 ,if !  
,secret>y det]m9es t su* drug is        
qualitatively & quantitatively ! same z 
! li/$ drug1 ! ,secret>y %all n *ange or
 resc9d su* det]m9ation aft] !          
submission ( an abbreviat$ application =
 su* drug "u ?is subsection unless--    
7,i7 ! =mulation ( ! li/$ drug has be5  
*ang$ & ! ,secret>y has det]m9$ t !     
prior li/$ drug =mulation 0 )drawn =    

reasons ( safety or effectiv5ess2 or    
7,,ii7 ! ,secret>y makes a writt5       
det]m9ation t ! prior det]m9ation mu/ be
 *ang$ because an error has be5         
id5tifi$4  7iv7 ,if ! ,secret>y makes a 
writt5 det]m9ation describ$ 9 clause    
7iii77,,ii71 ! ,secret>y %all provide   
notice & a copy ( ! writt5 det]m9ation  
to ! p]son mak+ ! reque/ "u clause 7i74 
7v7 ,! disclosures requir$ by ?is       
subp>agraph are disclosures au?oriz$ by 
law1 includ+ = purposes ( section #aije 
( title #ah1 ,unit$ ,/ates ,code4  4    
7b7 ,guidance  7#a7 ,9 g5]al ,n lat] ?an
 "o ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices %all issue draft guidance1 or  
update guidance1 describ+ h[ ! ,secret>y
 w det]m9e :e!r a drug is qualitatively 
& quantitatively ! same z ! li/$ drug 7z
 su* t]ms are us$ 9 section             
#eje7;j77#c77;,h7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a771 includ+ ) respect to   
assess+ p,h adju/]s4  7#b7 ,process ,9  

issu+ guidance "u ?is subsection1 !     
,secret>y ( ,heal? & ,human ,s]vices    
%all--  7,a7 publi% draft guidance2     
7,b7 provide a p]iod ( at lea/ #fj days 
= comm5t on ! draft guidance2 &  7,c7   
aft] consid]+ any comm5ts receiv$ & n   
lat] ?an "o ye> aft] ! close ( ! comm5t 
p]iod on ! draft guidance1 publi% f9al  
guidance4  7c7 ,applicability ,section  
#eje7;j77#c77;,h7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a71 applies beg9n+ on ! date
 ( enactm5t ( ?is ,act1 irrespective ( !
 date on :i* ! guidance requir$ by      
subsection 7b7 is f9aliz$4  #cjb4 ,p>ity
 9 ,m$ic>e paym5ts = hospital outpati5t 
dep>tm5t s]vices furni%$ (f-campus  7a7 
,9 g5]al ,section #ahcc7t77#af7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7t77#af77 is am5d$ by add+ at !   
end ! foll[+ new subp>agraph3  7,h7     
,p>ity 9 fee s*$ule am\nt = c]ta9       
s]vices furni%$ by an (f-campus         
outpati5t dep>tm5t ( a provid]  7i7 ,9  
g5]al ,subject to clause 7iii71 9 ! case

 ( specifi$ ,,opd s]vices 7z def9$ 9    
clause 7iv77 t are furni%$ dur+ #bjbe or
 a subsequ5t ye> by an (f-campus        
outpati5t dep>tm5t ( a provid] 7z def9$ 
9 clause 7iv771 !re %all be sub/itut$ = 
! am\nt o!rwise det]m9$ "u ?is          
subsection = su* s]vice & ye> an am\nt  
equal to ! paym5t am\nt t w\ld h be5    
payable "u ! applicable paym5t sy/em "u 
?is "p 7o!r ?an "u ?is subsection7 _h   
su* s]vices be5 furni%$ by su* a        
dep>tm5t subject to su* paym5t sy/em    
pursuant to p>agraph 7#ba77;,c74  7ii7  
,n budget neutral implem5tation ,9 mak+ 
any budget neutrality adju/m5ts "u ?is  
subsection = #bjbe or a subsequ5t ye>1 !
 ,secret>y %all n take into acc\nt !    
r$uc$ exp5ditures t result f !          
application ( ?is subp>agraph4  7iii7   
,transition ,! ,secret>y %all provide = 
a #d-ye> phase-9 ( ! application (      
clause 7i71 ) clause 7i7 be+ fully      
applicable = specifi$ ,,opd s]vices     
beg9n+ ) #bjbh4  7iv7 ,def9itions ,=    
purposes ( ?is subp>agraph3 7,i7        

,designat$ ambulatory paym5t            
classification gr\p ,! t]m designat$    
ambulatory paym5t classification gr\p   
means an ambulatory paym5t              
classification gr\p = drug adm9i/ration 
s]vices4  7,,ii7 ,specifi$ ,,opd s]vices
 def9$ ,! t]m specifi$ ,,opd s]vices    
means cov]$ ,,opd s]vices includ$ 9 a   
designat$ ambulatory paym5t             
classification gr\p4  7,,iii7 ,(f-campus
 outpati5t dep>tm5t ( a provid] def9$ ,!
 t]m (f-campus outpati5t dep>tm5t ( a   
provid] means a dep>tm5t ( a provid] 7z 
def9$ 9 section #dac4fe7;a77#b7 ( title 
#db1 ,code ( ,f$]al ,regulations7 t is n
 locat$--  7aa7 on ! campus 7z su* t]m  
is def9$ 9 su* section #dac4fe7;a77#b77 
( su* provid]2 or  7bb7 )9 ! di/ance    
7describ$ 9 su* def9ition ( campus7 f a 
remote location ( a hospital facility 7z
 def9$ 9 su* section #dac4fe7;a77#b774  
4  7b7 ,implem5tation ,section          
#ahcc7t77#ab7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #aciel7t77#ab77 is      
am5d$-- 7#a7 9 subp>agraph 7,d71 by     

/rik+ & at ! end2  7#b7 9 subp>agraph   
7,e71 by /rik+ ! p]iod at ! end & ins]t+
 2 &2 &  7#c7 by add+ at ! end ! foll[+ 
new subp>agraph3  7,f7 ! det]m9ation (  
any paym5t am\nt "u p>agraph 7#af77;,h71
 includ+ ! transition "u clause 7iii7 ( 
su* p>agraph4  4  #cjc4 ,improv+        
transp>5cy & prev5t+ ! use ( abusive    
spread pric+ & relat$ practices 9       
,m$icaid  7a7 ,ph>macy price            
reimbursem5t requirem5ts  7#a7 ,9 g5]al 
,section #aibg7;e7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is  
am5d$ by add+ at ! end ! foll[+3  7#f7  
,ph>macy price reimbursem5t requir$ ,a  
contract betwe5 ! ,/ate & a manag$ c>e  
entity 7or subcontractor ( a manag$ c>e 
entity t manages ! ph>macy b5efit = su* 
entity 79 ?is section ref]r$ to z a     
,,pbm71 or o!r specifi$ entity 7z su*   
t]ms are def9$ 9 section                
#aijc7m77#i77;,d77 t includes provisions
 mak+ ! manag$ c>e 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
 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 ! drug2 &  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 ! ,,pbm2  7,b7 paym5t to ! entity or 
! ,,pbm 7z applicable7 = adm9i/rative   
s]vices p]=m$ by ! entity or ,,pbm is   
limit$ to an adm9i/rative fee t cov]s ! 
reasonable co/ ( provid+ 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 is 9
 excess ( ! am\nt paid to ! ph>macies on
 behalf ( ! 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[+ = a reasonable adm9i/rative fee z 
describ$ 9 subp>agraph 7,b77 is n       
all[able = purposes ( claim+ ,f$]al     
mat*+ paym5ts "u ?is title4  4  7#b7    
,con=m+ am5dm5ts ,section               
#aijc7m77#b77;,a77xiii7 ( su* ,act 7#db 

,u4,s4,c4 #acif;b7m77#b77;,a77xiii77 is 
am5d$-- 7,a7 by /rik+ & 7,,iii7 & ins]t+
 7,,iii72  7,b7 by ins]t+ be=e ! p]iod  
at ! end ! foll[+3 1 & 7,,iv7 ! ph>macy 
b5efit provid$ by ! entity 7or ph>macy  
b5efit manag] on behalf ( ! entity "u a 
contract71 ! o!r specifi$ entity 7z     
def9$ 9 p>agraph 7#i77;,d771 or by ano!r
 arrangem5t betwe5 ! entity & ! ph>macy 
b5efit manag]1 %all comply ) !          
requirem5ts ( section #aibg7;e77#f72 &  
7,c7 by mov+ ! left m>g9 #b ems to !    
left4  7#c7 ,effective date ,! am5dm5ts 
made by ?is subsection apply to         
contracts betwe5 ,/ates & manag$ c>e    
entities1 or o!r specifi$ entities1 t h 
an initial effective date or are r5ew$  
on or aft] ! date t is #ah mon?s aft] ! 
date ( enactm5t ( ?is ,act4  7b7 ,ensur+
 accurate paym5ts to ph>macies "u       
,m$icaid  7#a7 ,9 g5]al ,section        
#aibg7;f7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$--
  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 
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+ ,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 directly or f a       
ph>macy b5efit manag] or o!r specifi$   

entity 7z def9$ 9 section               
#aijc7m77#i77;,d77 t has a contract ) ! 
,/ate or a manag$ c>e entity1 %all      
respond to surveys ( retail prices      
conduct$ "u ?is subsection4  7,g7       
,survey in=mation ,in=mation on national
 drug acquisition prices obta9$ "u ?is  
p>agraph %all be made publicly available
 9 a timely mann] foll[+ ! collection ( 
su* in=mation & %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 
is available dur+ ! survey p]iod4  7,h7 
,report on specialty ph>macies ,n lat]  
?an #a ye> aft] ! date t ?is subp>agraph
 takes effect1 ! ,secret>y %all submit  
to ,congress a report exam9+ specialty  
drug cov]age & reimbursem5t "u ?is      
title1 includ+-- 7i7 a description ( h[ 

,/ate ,m$icaid programs def9e specialty 
drugs & specialty ph>macies2  7ii7 !    
am\nt ,/ate ,m$icaid programs pay =     
specialty drugs2  7iii7 h[ ,/ates &     
manag$ c>e entities det]m9e paym5t =    
specialty drugs2  7iv7 ! sett+s 9 :i*   
specialty drugs are disp5s$ to          
individuals receiv+ b5efits "u ?is title
 7su* z retail community ph>macies or   
specialty ph>macies72  7v7 ! ext5t to   
:i* speciality drugs 7z def9$ by !      
respective ,/ates7 are captur$ 9 !      
national av]age drug acquisition co/    
survey 7or ?r\gh ano!r process72  7vi7  
examples ( specialty drug disp5s+ fees  
to support ! s]vices associat$ ) disp5s+
 su* specialty drugs2 &  7vii7          
recomm5dations z to :e!r specialty      
ph>macies %\ld be includ$ 9 ! survey (  
retail prices to ensure national av]age 
drug acquisition co/s capture drugs sold
 at specialty ph>macies1 & h[ su*       
specialty ph>macies %\ld be def9$4  7,i7
 ,en=cem5t ,at ! discretion ( !         
,secret>y1 ! ,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$4  2 &  7,c7 9 
p>agraph 7#b7--  7i7 9 subp>agraph 7,a71
 by ins]t+ 7includ+ paym5t rates "u     
,m$icaid manag$ c>e plans7 aft] "u ?is  
title2 &  7ii7 9 subp>agraph 7,b71 by   
ins]t+ 1 & ! basis = su* disp5s+ fees   
be=e ! semicolon at ! end4  7#b7        
,effective date ,! am5dm5ts made by ?is 
subsection take effect on ! fir/ day ( !
 fir/ qu>t] t beg9s on or aft] ! date t 
is #ah mon?s aft] ! date ( enactm5t (   
?is ,act4