,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #aeei  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #f1 #bjai,mr4    
,coll9s ( ,new ,york introduc$ ! foll[+ 
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,public ,heal? ,s]vice ,act to /r5g!n  
program integrity & enhance l[-income   
pati5t b5efits = safety net provid]s4   
#a4 ,%ort title ,?is ,act may be cit$ z 
! #cdj;,b ,protection & ,acc\ntability  
,act ( #bjai4  #b4 ,/r5g!n+ #cdj;,b     
program integrity & enhanc+ l[-income   
pati5t b5efits = safety net provid]s    
7a7 ,def9ition ( pati5t ,section        
#cdj;,b7b7 ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bef;b7b77 is am5d$ 
by add+ at ! end ! foll[+ new p>agraph3 
7#c7 ,pati5t  7,a7 ,9 g5]al ,9 ?is      
section1 ! t]m pati5t means1 ) respect  
to a cov]$ entity describ$ 9 subp>agraph
 7,l7 or 7,m7 ( subsection 7a77#d71 an  
individual :o1 on a                     
prescription-by-prescription or         
ord]-by-ord] basis--  7i7 receives a    

heal? c>e s]vice at a cov]$ entity or an
 outpati5t hospital facility describ$ 9 
subsection 7c77#c7 :i* is regi/]$ = !   
drug disc\nt program "u ?is section &   
li/$ on ! public int]net website ( !    
,dep>tm5t ( ,heal? & ,human ,s]vices    
relat+ to ?is section2  7ii7 receives an
 outpati5t 9-p]son heal? c>e s]vice f a 
heal? c>e provid] employ$ by ! cov]$    
entity or :o is an indep5d5t contractor 
( ! cov]$ entity1 su* t ! cov]$ entity  
bills = s]vices on behalf ( ! provid]2  
7iii7 receives a drug t is ord]$ or     
prescrib$ by ! cov]$ entity provid]1    
includ+ any r5ewals ( exi/+             
prescriptions1 z a result ( ! s]vice    
describ$ 9 clause 7ii72  7iv7 9 ! case (
 a cov]$ entity t has a contract ) a    
,/ate or local gov]nm5t describ$ 9      
subclause 7,,iii7 ( subsection          
7a77#d77,l77i71 receives a heal? c>e    
s]vice or range ( su* s]vices1 to       
include ! ord]+ or prescrib+ ( a cov]$  
outpati5t drug1 f ! cov]$ entity        
pursuant to su* contract2  7v7 is       

classifi$ z an outpati5t :5 ! drug is   
ord]$ or prescrib$1 z demon/rat$ by h[ !
 s]vice 0 reimburs$ by ! applicable     
pay]1 or1 :]e ! cov]$ entity does n seek
 su* reimbursem5t1 h[ ! s]vice w\ld h   
be5 reimburs$ "u title ,,xviii ( !      
,social ,security ,act2 &  7vi7 has a   
relation%ip ) ! cov]$ entity su* t !    
cov]$ entity creates & ma9ta9s auditable
 heal? c>e records :i* demon/rate t--   
7,i7 ! cov]$ entity has a               
provid]-to-pati5t relation%ip ) !       
individual2 &  7,,ii7 responsibility = !
 individual's heal? c>e s]vice t result$
 9 ! prescription or ord] = ! drug      
describ$ 9 clause 7iii7 is ) ! cov]$    
entity4  7,b7 ,exclusions ,= purposes ( 
?is section1 an individual %all n be    
consid]$ a pati5t ( a cov]$ entity      
describ$ 9 subp>agraph 7,l7 or 7,m7 (   
subsection 7a77#d7 if--  7i7 !          
individual is an inmate ( a correctional
 facility2  7ii7 ! heal? c>e s]vice     
describ$ 9 clause 7ii7 ( subp>agraph    
7,a7 receiv$ by ! individual f ! cov]$  

entity consi/s only ( ! adm9i/ration or 
infusion ( a drug or drugs1 or ! disp5s+
 ( a drug or drugs = subsequ5t          
self-adm9i/ration or adm9i/ration 9 !   
home sett+1 )\t a cov]$ entity          
provid]-to-pati5t enc\nt]2  7iii7 !     
heal? c>e s]vice describ$ 9 clause 7ii7 
( subp>agraph 7,a7 receiv$ by !         
individual f ! cov]$ entity is provid$  
by a heal? c>e organization t has only  
an affiliation arrangem5t ) ! cov]$     
entity1 ev5 if ! cov]$ entity has access
 to ! affiliat$ organization's records2 
or  7iv7 ! prim>y relation%ip betwe5 !  
individual & ! cov]$ entity is "o (     
employm5t4  7,c7 ,regulations ,n lat]   
?an #ahj days aft] ! date ( enactm5t ( !
 #cdj;,b ,protection & ,acc\ntability   
,act ( #bjai1 ! ,secret>y %all          
promulgate f9al regulations ?r\gh       
notice-&-comm5t rulemak+ to def9e ! t]m 
pati5t ) respect to cov]$ entities      
describ$ 9 subp>agraph 7,l7 or 7,m7 (   
subsection 7a77#d7 to reflect !         
requirem5ts describ$ 9 subp>agraphs 7,a7

 & 7,b7 ( ?is p>agraph4  7,d7 ,def9ition
 relat+ to o!r cov]$ entities ,9 ?is    
section1 ! t]m pati5t1 ) respect to a   
cov]$ entity describ$ 9 subp>agraphs    
7,a7 ?r\gh 7,k7 ( subsection 7a77#d71   
has ! mean+ giv5 su* t]m 9 ! ,octob]    
#bd1 #aiif1 ,,hrsa ,f9al ,notice ,reg>d+
 ,section #fjb ( ! ,vet]ans ,heal? ,c>e 
,act ( #aiib ,pati5t & ,entity          
,eligibility 7#fa ,f$ ,reg4 #eeaef74    
7,e7 ,record ret5tion ,a cov]$ entity   
describ$ 9 subp>agraph 7,l7 or 7,m7 (   
subsection 7a77#d7 %all reta9 auditable 
heal? c>e records :i* demon/rate !      
exi/5ce ( a pati5t relation%ip 9        
accordance ) ?is p>agraph = ea*         
prescription or ord] = a roll+ p]iod ( n
 less ?an five ye>s1 or long] to ! ext5t
 requir$ by ,/ate or ,f$]al law4  4  7b7
 ,treatm5t ( contract$ s]vices          
,subsection 7a7 ( section #cdj;,b ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! 
end ! foll[+ new p>agraphs3  7#aa7      
,contract$ s]vices ,9 ! case ( a cov]$  

entity describ$ 9 subp>agraph 7,l7 or   
7,m7 ( subsection 7a77#d7 t elects to   
ent] into a contractual arrangem5t ) a  
?ird p>ty = s]vices relat$ to ! drug    
disc\nt program "u ?is section1 su* z to
 disp5se cov]$ outpati5t drugs subject  
to an agreem5t "u ?is section to pati5ts
 ( ! cov]$ entity1 to adm9i/] contract$ 
ph>macy s]vices1 or to provide any o!r  
s]vice relat$ to ! drug disc\nt program 
"u ?is section1 ! remun]ation = :i* is  
bas$ 9 :ole or 9 "p on ! volume (       
disp5s$ cov]$ outpati5t drugs subject to
 an agreem5t "u ?is section1 su* cov]$  
entity %all--  7,a7 h a contractual     
agreem5t 9 place betwe5 ! cov]$ entity &
 ea* contract$ entity1 includ+ ) ea*    
location ( a ph>macy contract$ to       
disp5se cov]$ outpati5t drugs subject to
 an agreem5t "u ?is section to pati5ts  
7z s def9$7 ( ! cov]$ entity1 :i* %all  
specify t ! contract$ entity %all adh]e 
to all requirem5ts ( ! drug disc\nt     
program "u ?is section1 b t ultimate    
responsibility = program compliance &   

ov]sight ( compliance by ea* contract$  
entity %all rema9 ) ! cov]$ entity & t  
all cov]$ outpati5t drugs subject to an 
agreem5t "u ?is section %all be pur*as$ 
by ! cov]$ entity2  7,b7 regi/] ea* su* 
agreem5t ) ! ,secret>y1 include 9 su*   
regi/ration su* in=mation z %all be     
specifi$ by ! ,secret>y1 & make         
available su* agreem5t ^u reque/ by !   
,secret>y2  7,c7 ensure ! compliance (  
ea* su* agreem5t ) ! requirem5ts ( ?is  
section to prev5t drug div]sion 9       
violation ( subp>agraph 7,b7 ( p>agraph 
7#e7 & to prev5t duplicate disc\nts 9   
violation ( subp>agraph 7,a7 ( su*      
p>agraph be=e utiliz+ ! s]vices ( !     
contract$ entity1 includ+ by--  7i7     
develop+ & implem5t+1 ) ea* contract$   
entity subject to su* an agreem5t1 a    
sy/em to v]ify eligibility ( pati5ts 7z 
s def9$7 ( ! entity2  7ii7 develop+ &   
implem5t+1 ) ea* su* contract$ entity1 a
 me*anism = track+ ! inv5tory ( cov]$   
outpati5t drugs t are subject to an     
agreem5t "u ?is section t is suitable to

 prev5t div]sion 9 violation (          
subp>agraph 7,b7 ( p>agraph 7#e7 & to   
prev5t duplicate disc\nts 9 violation ( 
subp>agraph 7,a7 ( su* p>agraph1 su* z a
 sep>ate inv5tory = su* drugs2 &  7iii7 
e/abli%+ a me*anism ) ea* su* contract$ 
entity & ea* applicable ,/ate ,m$icaid  
ag5cy t is suitable to prev5t duplicate 
disc\nts = cov]$ outpati5t drugs t are  
subject to an agreem5t "u ?is section1  
includ+ su* drugs disp5s$ to enrollees (
 ,m$icaid manag$ c>e organizations1 &   
complies ) regulations on me?odologies  
to prev5t duplicate disc\nts issu$ by ! 
,secret>y2  7,d7 make available1 to !   
ext5t ! cov]$ entity (f]s a *>ity c>e   
policy or has an obligation "u          
subsection 7a77#e77;,e7 to h a slid+ fee
 scale1 pati5t access to a cov]$        
entity's prescription drug *>ity c>e    
b5efit & its slid+ fee scale1 & develop+
 & implem5t+1 ) ea* su* contract$       
entity1 a me*anism = docum5t+ ! income &
 insurance /atus ( ea* pati5t 7z s      
def9$7 ( ! cov]$ entity & ! am\nt ea*   

su* pati5t pays to receive cov]$        
outpati5t drugs t are subject to an     
agreem5t "u ?is section2  7,e7 ma9ta91 &
 ensure t ea* su* contract$ entity      
ma9ta9s1 auditable records t p]ta9 to ! 
compliance ( ! cov]$ entity & !         
contract$ entity ) ! requirem5ts        
describ$ 9 ?is p>agraph1 = a roll+ p]iod
 ( n less ?an #e ye>s2  7,f7 e/abli% a  
process =1 & conduct1 p]iodic comp>isons
 ( ! cov]$ entity's prescrib+ records ) 
! disp5s+ records ( ea* su* contract$   
entity1 z applicable1 to detect pot5tial
 irregul>ities & to ensure t all drugs  
disp5s$ by ! contract$ entity are =     
pati5ts 7z s def9$7 ( ! cov]$ entity2   
7,g7 provide = annual on-site audits (  
ea* su* contract$ entity to be conduct$ 
by an indep5d5t outside auditor2  7,h7  
ma9ta9 arrangem5ts to disp5se cov]$     
outpati5t drugs t are subject to an     
agreem5t "u ?is section to pati5ts 7z s 
def9$7 ( ! cov]$ entity ) no m ?an #e   
contract ph>macy locations at any giv5  
"t1 all ( :i* mu/ be locat$ )9 7or1 =   

mail-ord] ph>macies1 s]ve pati5ts resid+
 97 l[]-income 7us+ ,am]ican ,community 
,survey data z det]m9$ by ! ,secret>y7  
c5sus tracts s]v$ by ! cov]$ entity1    
except 9 ! case t ! cov]$ entity files a
 publicly available exception reque/ ) !
 ,secret>y t seeks au?orization to      
e/abli% a p>ticul> contract ph>macy     
arrangem5t 9 a high]-income c5sus tract 
& expla9s ! reason 9 t p>ticul> case su*
 a contract ph>macy w\ld be/ meet ! ne$s
 ( l[-income pati5ts ( ! cov]$ entity1 &
 ! ,secret>y decides to grant ! reque/  
to e/abli% "o ( ! #e contract ph>macies 
9 ! c5sus tract reque/$2  7,i7 ensure1 z
 applicable1 t pati5ts 7z s def9$7 ( !  
cov]$ entity h access to ! cov]$        
entity's prescription drug *>ity c>e    
b5efit ?r\gh ea* contract ph>macy       
location at ! "t ( pur*ase ( ea* cov]$  
outpati5t drug subject to an agreem5t "u
 ?is section to ! same ext5t su* pati5ts
 h access to ! b5efit ) respect to su*  
drugs pur*as$ directly ?r\gh ! cov]$    
entity2 &  7,j7 limit any am\nt paid by 

! cov]$ entity1 or any ag5t ( ! cov]$   
entity1 to ! contract$ entity = disp5s+ 
cov]$ outpati5t drugs subject to an     
agreem5t "u ?is section or = any o!r    
s]vice relat$ to ! drug disc\nt program 
"u ?is section to a reasonable am\nt1   
:i* %all n exce$ ! fair m>ket value (   
su* drug disp5s+ or o!r s]vice4  ,9 !   
case ! ,secret>y grants a reque/ "u     
subp>agraph 7,h7 to e/abli% a p>ticul>  
contract ph>macy arrangem5t 9 a         
high]-income c5sus tract1 ! ,secret>y   
%all make su* decision available on a   
public website4  7#ab7 ,audit+ ,a cov]$ 
entity describ$ 9 subp>agraph 7,l7 or   
7,m7 ( subsection 7a77#d7 & a contract$ 
entity t ent] into a contractual        
arrangem5t describ$ 9 p>agraph 7#aa7    
%all p]mit--  7,a7 ! ,secret>y to audit 
! records ( ! cov]$ entity & ( !        
contract$ entity t p]ta9 to ! cov]$     
entity's & ! contract$ entity's         
compliance ) ! requirem5ts describ$ 9   
su* p>agraph2 &  7,b7 ! manufactur] ( a 
cov]$ outpati5t drug t is subject to an 

agreem5t "u ?is section 7or its         
designee7 to audit su* records ( ! cov]$
 entity & ( ! contract$ entity solely ) 
respect to su* drugs ( ! manufactur]4   
7#ac7 ,regulations  7,a7 ,n lat] ?an    
#ahj days aft] ! date ( enactm5t ( ?is  
p>agraph1 ! ,secret>y %all promulgate   
f9al regulations ?r\gh notice-&-comm5t  
rulemak+ to implem5t ! requirem5ts (    
p>agraph 7#aa7 & p>agraph 7#ab74 ,su*   
regulations %all include model t]ms = ! 
contractual agreem5t describ$ 9         
subp>agraph 7,a7 ( p>agraph 7#aa74  7,b7
 ,n lat] ?an #ahj days aft] ! date (    
enactm5t ( ?is p>agraph1 ! ,secret>y    
%all promulgate f9al regulations ?r\gh  
notice-&-comm5t rulemak+ to e/abli%     
proc$ures1 9 ! case 9 :i* ! ,secret>y   
det]m9es t a violation ( ! annual       
contract ph>macy indep5d5t on-site audit
 requirem5t 9 subp>agraph 7,f7 (        
p>agraph 7#aa71 ) respect to a contract 
ph>macy arrangem5t1 0 kn[+ &            
int5tional--  7i7 = remov+ ! contract   
ph>macy arrangem5t f a cov]$ entity's   

contract ph>macy network & disqualify+ !
 entity f add+ any additional contract  
ph>macies = a reasonable p]iod1 to be   
det]m9$ by ! ,secret>y1 ( n less ?an two
 ye>s2 &  7ii7 = requir+ t ! entity pay 
a monet>y p5alty to a manufactur] or    
manufactur]s 9 ! =m ( int]e/ on sums t  
are ow$ to ! manufactur] due to         
violations ( subp>agraph 7,a7 or 7,b7 ( 
subsection 7a77#e7 t occurr$ at "o or m 
contract ph>macies & t 7 discov]$ lat]  
?an su* violations w\ld h be5 if !      
entity _h compli$ ) its obligation to h 
annual indep5d5t audits ( contract      
ph>macies conduct$4  7#ad7 ,mail ord]   
/udy & regulations  7,a7 ,report ,n lat]
 ?an #ahj days aft] ! date ( ! enactm5t 
( ?is p>agraph1 ! ,secret>y %all conduct
 a /udy 7& submit to ,congress a report 
conta9+ ! results ( su* /udy7 reg>d+    
compliance conc]ns associat$ ) cov]$    
entities describ$ 9 subp>agraph 7,l7 or 
7,m7 ( subsection 7a77#d7 contract+ )   
mail ord] ph>macies to disp5se cov]$    
outpati5t drugs subject to an agreem5t  

"u ?is section1 & any additional        
safegu>ds or limitations necess>y &     
appropriate to r$uce ^? compliance      
conc]ns4  7,b7 ,regulations ,n lat] ?an 
#ahj days aft] ! submission ( ! report  
"u subp>agraph 7,a71 ! ,secret>y %all   
promulgate f9al regulations applicable  
to cov]$ entities describ$ 9 su*        
subp>agraph1 ?r\gh notice-&-comm5t      
rulemak+1 to implem5t any additional    
safegu>ds or limitations recomm5d$ by ! 
/udy4  7#ae7 ,contract ph>macy          
moratorium ,no cov]$ entity describ$ 9  
subp>agraphs 7,l7 or 7,m7 ( subsection  
7a77#d7 %all ent] into a new or exp&$   
contractual arrangem5t pursuant to :i* a
 ?ird p>ty disp5ses cov]$ outpati5t     
drugs subject to an agreem5t "u ?is     
section to pati5ts 7z s def9$7 ( ! cov]$
 entity dur+ ! p]iod beg9n+ on ! date ( 
! enactm5t ( ?is p>agraph & end+ on !   
latt] (--  7,a7 ! effective date ( f9al 
regulations describ$ 9 p>agraph 7#ac72  
7,b7 ! effective date ( f9al regulations
 describ$ 9 p>agraph 7#ad72  7,c7 !     

effective date ( f9al regulations issu$ 
?r\gh ,secret>ial notice-&-comm5t       
rulemak+ t take into consid]ation !     
f9d+s & recomm5dations 9 ! report f !   
,inspector ,g5]al ( ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices requir$ "u subsection
 7g77#c74  4  7c7 ,regulations ,to r$uce
 duplicate disc\nt risks ,subsection    
7a77#e77;,a7 ( section #cdj;,b ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! 
end ! foll[+ new clause3  7iii7 ,n lat] 
?an "o ye> aft] ! date ( ! enactm5t (   
?is clause1 ! ,secret>y %all promulgate 
f9al regulations ?r\gh notice-&-comm5t  
rulemak+1 describ+ me?odologies = ,/ate 
,m$icaid programs & all cov]$ entities  
"u subsection 7a77#d7 to id5tify & bill 
drugs subject to an agreem5t "u ?is     
section 9 a mann] t ensures compliance )
 #cdj;,b ,program prohibitions reg>d+   
duplicate disc\nts1 includ+ ! duplicate 
disc\nt prohibition "u section          
#aibg7;j77#a7 ( ! ,social ,security     
,act1 to include ! application ( su*    

prohibitions to ,m$icaid manag$ c>e     
enrollees4 ,su* me?odologies %all       
include ! use ( #cdj;,b-specific claims 
id5tifi]s1 & ! provision ( claims-level 
data by cov]$ entities to ,/ates z well 
z manufactur]s ( cov]$ outpati5t drugs  
suffici5t to id5tify claims t include   
drugs subject to an agreem5t "u ?is     
section & to prev5t duplicate disc\nts4 
4  7d7 ,am\nt *>g$ to l[-,income pati5ts
  7#a7 ,9 g5]al ,subsection 7a77#e7 (   
section #cdj;,b ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is  
am5d$ by add+ at ! end ! foll[+ new     
subp>agraphs3  7,e7 ,am\nt *>g$ to      
l[-income pati5ts ,z a condition (      
c]tification or rec]tification "u       
subp>agraph 7,e7 ( p>agraph 7#g71 ea*   
cov]$ entity describ$ 9 subp>agraph 7,l7
 or 7,m7 ( subsection 7a77#d7 mu/       
e/abli% a slid+ scale fee s*$ule =      
provid+ cov]$ outpati5t drugs t are     
subject to an agreem5t "u ?is section1  
directly or "u a contractual arrangem5t 
pursuant to :i* a ?ird p>ty disp5ses su*

 drugs1 to pati5ts ( ! cov]$ entity :o  
are--  7i7 l[-income individuals2 &     
7ii7 n cov]$ "u m9imum ess5tial cov]age1
 z def9$ 9 section #ejjj;,a7f7 ( !      
,int]nal ,rev5ue ,code4  7,f7           
,regulations ,n lat] ?an #ahj days aft] 
! date ( enactm5t ( ?is subp>agraph1 !  
,secret>y %all promulgate f9al          
regulations ?r\gh notice-&-comm5t       
rulemak+1 to implem5t ! requirem5ts "u  
subp>agraph 7,e74 ,su* regulations      
%all--  7i7 def9e ! t]m l[-income       
individual2  7ii7 provide a me?odology =
 e/abli%+ ! slid+ scale fee s*$ule1 :i* 
%all apply1 :]e o!rwise applicable to a 
cov]$ entity1 reg>dless ( :e!r ! cov]$  
outpati5t drug is disp5s$ by ! cov]$    
entity directly or a *ild site ( ! cov]$
 entity or by a contract$ entity        
describ$ 9 p>agraph 7#aa72 &  7iii7     
ensure ! security & protection (        
privileg$ or o!rwise confid5tial data f 
unau?oriz$ disclosure or re-disclosure4 
4  7e7 ,private non-,pr(it ,,d%         
hospitals & outpati5t hospital          

facilities  7#a7 ,def9ition ,subp>agraph
 7,l7 ( section #cdj;,b7a77#d7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bef;b7a77#d77 is am5d$ to    
read z foll[s3  7,l7 ,a subsection 7d7  
hospital 7z def9$ 9 section             
#ahhf7;d77#a77;,b7 ( ! ,social ,security
 ,act7 t-- 7i7 is--  7,i7 own$ or op]at$
 by a unit ( ,/ate or local gov]nm5t2   
7,,ii7 a public or private non-pr(it    
corporation :i* is =mally grant$        
gov]nm5tal p[]s by a unit ( ,/ate or    
local gov]nm5t2 or  7,,iii7 a private   
non-pr(it hospital :i* has a contract ) 
a ,/ate or local gov]nm5t to provide    
heal? c>e s]vices1 :i* include ! ord]+  
or prescrib+ ( cov]$ outpati5t drugs t  
are subject to an agreem5t "u ?is       
section1 to l[-income individuals :o are
 n entitl$ to b5efits "u title ,,xviii (
 ! ,social ,security ,act or eligible = 
assi/ance "u ! ,/ate plan = m$ical      
assi/ance "u title ,,xix ( su* ,act2    
7ii7 = ! mo/ rec5t co/ report+ p]iod t  
end$ be=e ! cal5d> qu>t] involv$1 _h a  

disproportionate %>e adju/m5t p]c5tage  
7z det]m9$ "u section #ahhf7;d77#e77;,f7
 ( ! ,social ,security ,act7 great] ?an 
#aa4ge p]c5t or 0 describ$ 9 section    
#ahhf7;d77#e77;,f77i77,,ii7 ( su* ,act2 
&  7iii7 does n obta9 cov]$ outpati5t   
drugs ?r\gh a gr\p pur*as+ organization 
or o!r gr\p pur*as+ arrangem5t4  ,if !  
,secret>y det]m9es t a hospital t is    
eligible = p>ticipation 9 ! #cdj;,b     
program "u ?is subp>agraph obta9$ cov]$ 
outpati5t drugs ?r\gh a gr\p pur*as+    
organization or ano!r gr\p pur*as+      
arrangem5t :ile t hospital 0 p>ticipat+ 
9 ! drug disc\nt program "u ?is section1
 !n ! ,secret>y %all remove su* hospital
 f su* program & ! hospital %all n be   
p]mitt$ to seek re-enrollm5t = a p]iod (
 at lea/ #ab mon?s aft] its removal f ! 
program4  4  7#b7 ,/udy & report2       
moratorium2 outpati5t hospital          
facilities2 audits ,subsection 7c7 (    
section #cdj;,b ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is  
am5d$ to read z foll[s3  7c7 ,cov]$     

entities t are private1 non-,pr(it ,,d% 
hospitals  7#a7 ,/udy & report  7,a7    
,/udy ,! ,comptroll] ,g5]al ( ! ,unit$  
,/ates %all conduct a /udy on !         
relation%ip betwe5 ! disproportionate   
%>e adju/m5t p]c5tages ( private cov]$  
entities describ$ 9 subclauses 7,,ii7 & 
7,,iii7 ( subsection 7a77#d77,l77i7 & ! 
levels ( *>ity c>e provid$ by su*       
entities to outpati5ts4  7,b7 ,report ,n
 lat] ?an #ahj days aft] ! date (       
enactm5t ( ! #cdj;,b ,protection &      
,acc\ntability ,act ( #bjai1 !          
,comptroll] ,g5]al %all submit to !     
appropriate committees ( ,congress a    
report on ! results ( ! /udy conduct$ "u
 subp>agraph 7,a71 includ+              
recomm5dations on a metric t1 z appli$  
to a private cov]$ entity describ$ 9 su*
 subp>agraph1 reflects a high level (   
*>ity c>e provid$ to outpati5ts z a     
p]c5tage ( ! cov]$ entity's ov]all      
exp5ses = outpati5t c>e1 & c\ld replace 
! metric describ$ 9 subclause 7ii7 (    
subsection 7a77#d77,l74 ,! ,comptroll]  

,g5]al %all recomm5d ! metric t be/     
aligns ) ! level ( *>ity c>e provid$ to 
outpati5ts z a p]c5tage ( ov]all        
hospital op]at+ exp5ses on outpati5t c>e
 if no metric is id5tifi$ t provides a  
precise measure ( su* p]c5tage4  7#b7   
,moratorium  7,a7 ,9 g5]al ,= ! p]iod   
describ$ 9 subp>agraph 7,b7-- 7i7 a     
private cov]$ entity describ$ 9         
subclauses 7,,ii7 or 7,,iii7 (          
subsection 7a77#d77,l77i7 may p>ticipate
 9 ! drug disc\nt program "u ?is section
 z a cov]$ entity only if x 0 prop]ly   
enroll$ z a cov]$ entity 9 ! drug       
disc\nt program "u ?is section z ( !    
date ( ! enactm5t ( ! #cdj;,b           
,protection & ,acc\ntability ,act (     
#bjai & cont9u\sly enroll$ !reaft]2 &   
7ii7 ) respect to a facility or         
organization describ$ 9 p>agraph 7#c7 ( 
?is subsection t is :olly own$ by a     
private cov]$ entity describ$ 9         
subclause 7,,ii7 or 7,,iii7 ( subsection
 7a77#d77,l77i71 only a facility or     
organization t 0 prop]ly enroll$ z a    

*ild site 9 ! drug disc\nt program "u   
?is section z ( ! date ( ! enactm5t ( ! 
#cdj;,b ,protection & ,acc\ntability    
,act ( #bjai & cont9u\sly enroll$       
!reaft] may p>ticipate 9 ! drug disc\nt 
program "u ?is section4  7,b7 ,p]iod    
describ$ ,= purposes ( subp>agraph 7,a71
 ! p]iod describ$ 9 ?is subp>agraph is !
 p]iod beg9n+ on ! date ( enactm5t ( !  
#cdj;,b ,protection & ,acc\ntability    
,act ( #bjai & end+ on ! effective date 
describ$ 9 subp>agraph 7,c74  7,c7      
,effective date ( replacem5t metric  7i7
 ,9 g5]al ,= purposes ( subp>agraph     
7,b71 subject to clause 7ii71 !         
effective date describ$ 9 ?is           
subp>agraph is ! effective date specifi$
 9 legislation t1 ) respect to private  
cov]$ entities describ$ 9 subclauses    
7,,ii7 & 7,,iii7 ( subsection           
7a77#d77,l77i7--  7,i7 replaces ! metric
 describ$ 9 clause 7ii7 ( subsection    
7a77#d77,l7 ) a metric t m accurately   
reflects ! levels ( outpati5t *>ity c>e 
z a p]c5tage ( ov]all exp5ses =         

outpati5t c>e provid$ by su* entities2 &
  7,,ii7 takes into acc\nt ! report     
submitt$ "u p>agraph 7#a71 includ+ by   
address+ ! ,comptroll] ,g5]al's         
recomm5dations includ$ 9 su* report4    
7ii7 ,exception ,if legislation describ$
 9 clause 7i7 is n enact$ by ! date t is
 "o ye> aft] ! date ( submission ( !    
report "u p>agraph 7#a7--  7,i7 !       
,secret>y %all promulgate f9al          
regulations t implem5t1 to ! ext5t      
practicable1 ! ,comptroll] ,g5]al's     
recomm5dations includ$ )9 su* report n  
lat] ?an ! date t is #ahj days aft] su* 
"o-ye> date2 &  7,,ii7 = purposes (     
subp>agraph 7,b71 ! effective date      
describ$ 9 ?is subp>agraph is !         
effective date ( su* f9al regulations4  
7#c7 ,outpati5t hospital facilities ,a  
facility or organization may p>ticipate 
9 ! drug disc\nt program "u ?is section 
z a *ild site ( a cov]$ entity describ$ 
9 subp>agraph 7,l7 or 7,m7 ( subsection 
7a77#d7 only if su* facility or         
organization--  7,a7 is :olly own$ by a 

cov]$ entity describ$ 9 subp>agraph 7,l7
 or 7,m7 ( subsection 7a77#d72  7,b7    
except 9 ! case 9 :i* ! p>5t cov]$      
entity is a *ildr5's hospital describ$ 9
 subp>agraph 7,m7 ( subsection 7a77#d7  
:i* does n file a ,m$ic>e co/ report1 is
 li/$ on ! ,m$ic>e co/ report mo/       
rec5tly fil$ by ! p>5t cov]$ entity on a
 l9e t is reimbursable "u ?is title1 if 
su* co/ report demon/rates t ! s]vices  
provid$ at ! facility or organization h 
associat$ outpati5t co/s & *>ges "u ?is 
title1 & if ! p>5t cov]$ entity has     
provid$ a copy ( su* co/ report to !    
,(fice ( ,ph>macy ,affairs ( ! ,heal?   
,res\rces & ,s]vices ,adm9i/ration2     
7,c7 9 ! case t ! p>5t cov]$ entity is a
 *ildr5's hospital describ$ 9           
subp>agraph 7,m7 ( subsection 7a77#d7   
:i* does n file a ,m$ic>e co/ report1   
w\ld be correctly includ$ on a          
reimbursable l9e ) associat$ outpati5t  
co/s & *>ges "u title ,,xviii on a      
,m$ic>e co/ report ( ! p>5t cov]$       
entity1 if fil$1 & ! p>5t cov]$ entity  

au?oriz+ (ficial has submitt$ a sign$   
/atem5t to ! ,secret>y :i* c]tifies !   
=ego+ & t ! reque/$ outpati5t facility  
is an integral "p ( ! *ildr5's hospital 
& is provid+ heal? c>e s]vices to       
pati5ts ( su* hospital2  7,d7 meets !   
provid]-bas$ /atus requirem5ts "u       
section #dac4fe ( title #db1 ,code (    
,f$]al ,regulations or "u any successor 
to su* section2  7,e7 provides outpati5t
 heal? c>e s]vices & is n limit$ to     
provid+ only drugs or drug adm9i/ration2
  7,f7 provides a level ( free or       
disc\nt$ heal? c>e s]vices to           
individuals :o meet ! p>5t cov]$        
entity's crit]ia = f9ancial assi/ance & 
are unable to pay = all or a portion ( !
 s]vices1 z report$ at co/ to ! ,int]nal
 ,rev5ue ,s]vice "u section #eja7r77#d7 
( ! ,int]nal ,rev5ue ,code = ! cal5d>   
ye>1 t is simil> to t ( ! p>5t cov]$    
entity2 &  7,g7 adh]es to ! p>5t cov]$  
entity's slid+ scale fee s*$ule =       
provid+ cov]$ outpati5t drugs t are     
subject to an agreem5t "u ?is section to

 pati5ts :o are 7i7 l[-income           
individuals2 & 7ii7 n cov]$ "u m9imum   
ess5tial cov]age1 z def9$ 9 section     
#ejjj;,a7f7 ( ! ,int]nal ,rev5ue ,code4 
,su* slid+ fee s*$ules mu/ be made      
publicly available 9 a simil> mann] to a
 #eja7;c77#c7 hospital's f9ancial       
assi/ance policy z requir$ "u section   
#eja7r7 ( ! ,int]nal ,rev5ue ,code (    
#aihf4  7#d7 ,c]tification & audit+     
7,a7 ,a cov]$ entity describ$ 9         
subclause 7,,iii7 ( subsection          
7a77#d77,l77i7 %all-- 7i7 n less ?an    
annually1 provide to ! ,secret>y a      
c]tification execut$ by ! hospital's    
#cdj;,b ,program au?oriz+ (ficial & an  
appropriate gov]nm5t (ficial 7su* z !   
gov]nor1 c\nty executive1 mayor1 or an  
individual au?oriz$ to repres5t & b9d ! 
gov]nm5tal entity71 c]tify+ t--  7,i7 a 
contract is curr5tly 9 =ce betwe5 su*   
cov]$ entity & ! ,/ate or local gov]nm5t
 to provide heal? c>e s]vices1 to       
include direct m$ical c>e & ! ord]+ or  
prescrib+ ( cov]$ outpati5t drugs t are 

subject to an agreem5t "u ?is section1  
to l[-income individuals :o are n       
entitl$ to b5efits "u title ,,xviii ( ! 
,social ,security ,act or eligible =    
assi/ance "u ! ,/ate plan "u title ,,xix
 ( su* ,act2  7,,ii7 su* contract       
creates en=ceable expectations = su*    
cov]$ entity = ! provision ( ! heal? c>e
 s]vices describ$ 9 subclause 7,i7 to ! 
individuals describ$ 9 su* subclause2 & 
7,,iii7 ! heal? c>e s]vices describ$ 9  
subclause 7,i7 repres5t a significant   
portion ( ! hospital's op]at+ rev5ues1 &
 are n = s]vices ! cov]$ entity is      
o!rwise obligat$ to provide "u ,/ate or 
,f$]al law2  7ii7 make available !      
contract describ$ 9 subclause 7,,iii7 ( 
subsection 7a77#d77,l77i7 to ! ,secret>y
 = publication on ! public int]net      
website ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices relat+ to ?is section2 &  7iii7
 p]mit ! ,secret>y to audit ! records ( 
! cov]$ entity t p]ta9 to its compliance
 ) ! requirem5ts describ$ 9 subclause   
7,,iii7 ( subsection 7a77#d77,l77i7 &   

?is subp>agraph4  7,b7 ,a facility or   
organization t p>ticipates 9 ! drug     
disc\nt program "u ?is section pursuant 
to p>agraph 7#c7 %all p]mit ! ,secret>y 
to audit ! records ( su* facility or    
organization t p]ta9 to its compliance )
 ! requirem5ts describ$ 9 su* p>agraph4 
7,c7 ,! ,secret>y %all issue guidel9es  
to implem5t ! requirem5ts describ$ 9 ?is
 p>agraph1 :i* %all1 at a m9imum1 def9e 
! t]m l[-income individuals = purposes (
 subclause 7,i7 ( subp>agraph 7,a77i71 &
 id5tify ! applicable me?odology &      
?re%old = det]m9+ t ! heal? c>e s]vices 
describ$ 9 su* subclause repres5t a     
significant portion ( ! hospital's      
op]at+ rev5ues4  4  7f7 ,report+        
requirem5ts ,section #cdj;,b ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bef;b7 is am5d$ by add+ at ! end !     
foll[+ new subsections3  7f7 ,report+   
requirem5ts = cov]$ entities  7#a7 ,9   
g5]al ,a cov]$ entity describ$ 9        
subp>agraph 7,l7 or 7,m7 ( subsection   
7a77#d7 %all annually submit to !       

,secret>y an electronic & se>*able data 
report 9 a ma*9e-readable =mat4 ,su*    
report %all conta91 ) respect to ! ye>  
cov]$ by ! report1 in=mation on--  7,a7 
! numb] & p]c5tage ( pati5ts ( ! cov]$  
entity1 disaggregat$ by insurance /atus 
7includ+ at lea/ ! ,m$ic>e program "u   
title ,,xviii ( ! ,social ,security     
,act1 ! ,m$icaid program "u title ,,xix 
( su* ,act1 ! ,*ildr5's ,heal?          
,insurance ,program "u title ,,xxi ( su*
 ,act1 ! ,,tric>e program "u *apt] #ee (
 title #aj1 ,unit$ ,/ates ,code1 heal?  
insurance cov]age or a gr\p heal? plan1 
& un9sur$71 & by ! type ( site ( !      
disp5s+ ( ! cov]$ outpati5t drug subject
 to an agreem5t "u ?is section 7p>5t    
cov]$ entity1 facility or organization  
describ$ 9 subsection 7c77#c71 contract$
 entity describ$ 9 subsection 7a77#aa772
  7,b7 ! aggregate am\nt ( gross        
reimbursem5t receiv$ by ! cov]$ entity  
7calculat$ be=e subtract+ any           
adm9i/rative or o!r fees us+ a          
me?odology provid$ by ! ,secret>y7 =    

cov]$ outpati5t drugs subject to an     
agreem5t "u ?is section1 includ+        
reimbursem5t receiv$ ?r\gh facilities or
 organizations describ$ 9 subsection    
7c77#c7 or pursuant to contractual      
arrangem5ts describ$ 9 subsection       
7a77#aa72  7,c7 ! aggregate acquisition 
co/ = cov]$ outpati5t drugs subject to  
an agreem5t "u ?is section disp5s$ dur+ 
! ye>2  7,d7 ! aggregate am\nt paid by !
 cov]$ entity1 or any ag5t ( ! cov]$    
entity1 to contract$ entities describ$ 9
 subsection 7a77#aa7 = disp5s+ cov]$    
outpati5t drugs subject to an agreem5t  
"u ?is section or = any o!r s]vice      
relat$ to ! drug disc\nt program "u ?is 
section2  7,e7 h[ ! entity prev5ts      
duplicate disc\nts "u subp>agraph 7,a7 (
 subsection 7a77#e7 & drug div]sion "u  
subp>agraph 7,b7 ( su* subsection2  7,f7
 ! volume ( cov]$ outpati5t drugs       
subject to an agreem5t "u ?is section   
disp5s$ by ! cov]$ entity &1 9 ! case ( 
a cov]$ entity t has ent]$ into a       
contractual arrangem5t pursuant to :i* a

 ?ird p>ty disp5ses cov]$ outpati5t     
drugs subject to an agreem5t "u ?is     
section to pati5ts ( ! cov]$ entity1 by 
ea* su* contract$ entity2  7,g7         
quantitative data 9 t]ms ( ! am\nt &    
p]c5tage ( *>itable c>e1 z su* t]m is   
def9$ = purposes ( ,m$ic>e co/ report+  
or o!r report+ requirem5ts id5tifi$ by !
 ,secret>y1 provid$ to pati5ts ( ! cov]$
 entity by ! cov]$ entity 9 ! =m ( cov]$
 outpati5t drugs subject to an agreem5t 
"u ?is section2  7,h7 ! "n ( any        
?ird-p>ty v5dor or o!r simil> entity 7if
 any7 t ! cov]$ entity reta9s to adm9i/]
 ! cov]$ entity's inv5tory managem5t    
sy/em or contract ph>macy arrangem5t2 & 
7,i7 o!r report+ requirem5ts z !        
,secret>y det]m9es is necess>y or       
appropriate = effective managem5t &     
ov]sight ( ! drug disc\nt program "u ?is
 section4  7#b7 ,tim+ ( fir/ report ,!  
fir/ report submitt$ "u p>agraph 7#a7   
%all be submitt$ n lat] ?an #ah mon?s   
aft] ! date ( enactm5t ( ?is subsection4
  7#c7 ,atte/ation ,ea* report submitt$ 

"u p>agraph 7#a7 %all be accompani$ by  
an atte/ation1 9 a =m & mann] specifi$  
by ! ,secret>y1 t ! in=mation submitt$ 9
 su* report is complete & accurate4 ,su*
 atte/ation %all be subject to section  
#ajja ( title #ah1 ,unit$ ,/ates ,code4 
7#d7 ,sanctions ,if ! ,secret>y f9ds t a
 cov]$ entity is 9 violation ( !        
requirem5t "u p>agraph 7#a7 & !         
,secret>y det]m9es t su* violation 0    
kn[+ & int5tional1 ! ,secret>y %all     
remove ! entity f ! drug disc\nt program
 "u ?is section & disqualify ! entity f 
re-entry into su* program = a reasonable
 p]iod ( "t to be det]m9$ by !          
,secret>y4  7#e7 ,regulations ,n lat]   
?an #ahj days aft] ! date ( enactm5t (  
?is subsection1 ! ,secret>y %all        
promulgate f9al regulations ?r\gh       
notice-&-comm5t rulemak+ to implem5t !  
requirem5ts "u p>agraphs 7#a7 ?r\gh     
7#d74  7#f7 ,public database ,!         
,secret>y %all make ! data report$ by   
cov]$ entities "u ?is subsection        
available to ! public on ! website ( !  

,dep>tm5t ( ,heal? & ,human ,s]vices 9  
an electronic & se>*able =mat1 :i* %all 
make ea* category ( data report$        
available bo? 9 ! aggregate & brok5 d[n 
by p>5t cov]$ entities1 *ild sites1 &   
contract ph>macies1 b %all n id5tify    
specific p>5t cov]$ entities1 *ild      
sites1 or contract ph>macies4  7g7      
,reports to ,congress  7#a7 ,report by !
 ,secret>y ,n lat] ?an two ye>s aft] !  
date ( ! enactm5t ( ?is subsection1 !   
,secret>y %all submit to ! ,committee on
 ,en]gy & ,comm]ce ( ! ,h\se (          
,repres5tatives & ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate a report1 :i* %all conta9--   
7,a7 ) respect to cov]$ entities        
describ$ 9 subp>agraph 7,l7 or 7,m7 (   
subsection 7a77#d71 ! in=mation conta9$ 
9 ! fir/ report submitt$ by su* entities
 to ! ,secret>y "u subsection 7f72 &    
7,b7 a description ( ! audits conduct$  
by ! ,secret>y pursuant to subp>agraph  
7,c7 ( subsection 7a77#e71 includ+ !    
me?odology us$ = conduct+ su* audits1 ! 

results ( su* audits1 & actions tak5 by 
! ,secret>y 9 response to su* audits1 z 
well z actions tak5 by ! ,secret>y 9    
response to audits conduct$ by          
manufactur]s pursuant to su*            
subp>agraph4  7#b7 ,report by !         
,comptroll] ,g5]al ,n lat] ?an "o ye>   
aft] ! date ( ! enactm5t ( ?is          
subsection1 ! ,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 ! use by
 cov]$ entities ( contractual           
arrangem5ts pursuant to :i* a ?ird p>ty 
disp5ses cov]$ outpati5t drugs subject  
to an agreem5t "u ?is section to pati5ts
 ( ! cov]$ entity1 disaggregat$ by cov]$
 entity types & ! physical di/ance ( !  
contract$ entity's location f !         
respective p>5t cov]$ entity location4  
7#c7 ,annual reports by ! ,inspector    
,g5]al ,n lat] ?an ,july #a ( ea* ye>   
7beg9n+ ) #bjah71 ! ,inspector ,g5]al ( 

! ,dep>tm5t ( ,heal? & ,human ,s]vices  
%all submit to appropriate committees ( 
,congress a report on ! contractual     
arrangem5ts betwe5 cov]$ entities & ?ird
 p>ties describ$ 9 p>agraph 7#aa7 (     
subsection 7a71 includ+ ! me?ods &      
am\nts ( remun]ation ex*ang$ betwe5 su* 
cov]$ entities & su* contract$ entities1
 & ! ext5t to :i* contract ph>macies are
 improv+ access to m$ic9es by pati5ts ( 
su* cov]$ entities4 ,! fir/ su* annual  
report %all include recomm5dations1 z ! 
,inspector ,g5]al det]m9es appropriate1 
t address safegu>ds to r$uce duplicate  
disc\nt+ & div]sion )9 contract ph>macy 
arrangem5ts & re=ms to ensure ^!        
arrangem5ts are t>get$ exclusively at   
improv+ access to m$ic9es = l[-income or
 vuln]able pati5ts ( cov]$ entities4    
,subsequ5t reports "u ?is p>agraph %\ld 
cont9ue to monitor su* issues & be      
updat$ z *anges are made to ! drug      
disc\nt program "u ?is section4  4  7g7 
,us] fees "u ! #cdj;,b drug disc\nt     
program ,section #cdj;,b ( ! ,public    

,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bef;b71 z previ\sly am5d$1 is fur!r    
am5d$ by add+ at ! end ! foll[+ new     
subsection3  7h7 ,us] fees  7#a7 ,9     
g5]al ,subject to p>agraph 7#f71 !      
,secret>y %all assess & collect a us]   
fee f cov]$ entities describ$ 9         
subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( 
subsection 7a77#d74 ,9 c>ry+ out ?is    
subsection1 ! ,secret>y %all n require  
manufactur]s to collect any us] fee or  
to adm9i/] ! us] fee program e/abli%$ "u
 ?is subsection4  7#b7 ,paym5t ,a cov]$ 
entity describ$ 9 subp>agraph 7,l71     
7,m71 7,n71 or 7,o7 ( subsection 7a77#d7
 %all pay to ! ,secret>y a fee assess$  
"u p>agraph 7#a7 by su* date t is ! lat]
 (--  7,a7 ! date ( ! c]tification or   
rec]tification ( ! cov]$ entity1 z      
applicable2 or  7,b7 ! date t is #cj    
days aft] ! date ( ! enactm5t ( an      
appropriations ,act provid+ = !         
collection & obligation ( fees "u ?is   
subsection = a fiscal ye>4  7#c7 ,am\nt 
( fee ,! am\nt ( a fee "u p>agraph 7#a7 

%all be equal to ! am\nt det]m9$ by !   
,secret>y "u p>agraph 7#d74  7#d7       
,det]m9ation ( am\nt ( fee  7,a7 ,9     
g5]al ,! ,secret>y %all1 n lat] ?an #ahj
 days be=e ! />t ( ea* fiscal ye> t     
beg9s aft] ,septemb] #cj1 #bjai1        
e/abli%1 = ! next fiscal ye>1 ! am\nt ( 
! fee payable "u ?is subsection by a    
cov]$ entity us+ pur*ase data submitt$  
by cov]$ entities describ$ 9 p>agraph   
7#a71 & us+ data submitt$ by            
manufactur]s on sales to cov]$ entities 
( cov]$ outpati5t drugs subject to an   
agreem5t "u ?is section1 pursuant to    
regulations to be issu$ by ! ,secret>y4 
,su* am\nt1 ) respect to a cov]$ entity 
& ye>1 %all n exce$ #j4a p]c5t ( ! total
 paid dur+ ! previ\s ye> by su* cov]$   
entity to manufactur]s = pur*ases (     
cov]$ outpati5t drugs subject to an     
agreem5t "u ?is section4  7#e7 ,use (   
fees  7,a7 ,9 g5]al ,any fee collect$ "u
 p>agraph 7#a7 %all be us$ = purposes ( 
adm9i/]+ ?is section1 enhanc+ program   
integrity & ov]sight activities "u ?is  

section 7includ+ ?r\gh audits "u ?is    
section ( cov]$ entities &              
manufactur]s71 & promot+ access to      
cl9ical & co/-effective ph>macy s]vices 
among safety net cl9ics & hospitals t   
p>ticipate "u ?is section1 su* z ?r\gh--
  7i7 ! developm5t ( a multi-functional 
web-bas$ sy/em to collect fees "u       
p>agraph 7#a72  7ii7 ! improvem5t ( !   
integrity1 transp>5cy1 security1 &      
reliability ( ! ,(fice ( ,ph>macy       
,affairs ,in=mation ,sy/em1 includ+ to  
ensure t ! database cont9ues to meet !  
ne$s ( ext]nal /akehold]s2 &  7iii7     
improvem5ts to ! compliance tool ( !    
,(fice ( ,ph>macy ,affairs1 us$ to      
integrate all in=mation relat$ to cov]$ 
entities & manufactur]s ) agreem5ts "u  
?is section4  7,b7 ,supplem5t n supplant
 ,any fee collect$ "u p>agraph 7#a7 %all
 be us$ to supplem5t & n supplant !     
am\nt o!rwise provid$ 9 appropriations  
,acts to c>ry out ?is section4  7#f7    
,availability ( fees ,fees au?oriz$ "u  
p>agraph 7#a7 %all be collect$ &        

available = obligation only to ! ext5t &
 9 ! am\nt provid$ 9 advance 9          
appropriations ,acts4 ,su* fees are     
au?oriz$ to rema9 available until       
exp5d$4  7#g7 ,regulations ,n lat] ?an  
#ahj days aft] ! date ( enactm5t ( ?is  
subsection1 ! ,secret>y %all promulgate 
f9al regulations ?r\gh notice-&-comm5t  
rulemak+ to implem5t ! us] fee          
collection pursuant to ?is subsection4  
7#h7 ,ov]sight ( us] fee program  7,a7  
,/udy ,! ,inspector ,g5]al ( ! ,dep>tm5t
 ( ,heal? & ,human ,s]vices %all conduct
 an annual review ( ! us] fee program   
e/abli%$ by ?is subsection4  7,b7       
,report ,n lat] ?an ,july #a ( ea* ye>  
7beg9n+ ) #bjai71 ! ,inspector ,g5]al ( 
! ,dep>tm5t ( ,heal? & ,human ,s]vices  
%all submit to ! appropriate committees 
( ,congress a report on ! /udy conduct$ 
"u subp>agraph 7,a71 toge!r ) su*       
recomm5dations z ! ,inspector ,g5]al    
det]m9es appropriate4  4  7h7           
,direct-,hire au?ority ,section         
#cdj;,b7d7 ( ! ,public ,heal? ,s]vice   

,act 7#db ,u4,s4,c4 #bef;b7d77 is am5d$ 
by add+ at ! end ! foll[+ new p>agraph3 
7#e7 ,direct-hire au?ority ,not)/&+     
section #ccjd7;a77#c7 ( title #e1 ,unit$
 ,/ates ,code1 & sections #ccji ?r\gh   
#ccah ( su* title1 & section #ccg (     
title #e ( ! ,code ( ,f$]al ,regulations
 7or any successor regulations71 !      
,secret>y may1 beg9n+ on ! date ( !     
enactm5t ( ?is p>agraph1 ex]cise        
direct-hire au?ority to appo9t a m9imum 
( t5 qualifi$ c&idates to p]man5t       
positions )9 ! competitive s]vice 9 ord]
 to c>ry out managem5t & ov]sight       
activities "u ?is section4  4  7i7      
,applicability ,except z o!rwise        
indicat$1 ! provisions (1 includ+       
am5dm5ts made by1 ?is ,act %all n apply 
to cov]$ entities def9$ "u subp>agraphs 
7,a7 ?r\gh 7,k71 7,n71 or 7,o7 (        
subsection 7a77#d74