,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #bfgi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #ah1 #bjbc,ms4 
,ku/] 7= h]self1 ,mr4 ,c>t] ( ,georgia1 
,ms4 ,e%oo1 & ,mr4 ,gu?rie7 introduc$ ! 
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce1 & 9    
addition to ! ,committees on ,education 
& ! ,work=ce1 & ,ways & ,means1 = a     
p]iod to be subsequ5tly det]m9$ by !    
,speak]1 9 ea* case = consid]ation ( su*
 provisions z fall )9 ! jurisdiction ( !
 committee conc]n$  ,a ,,bill  ,to am5d 
! ,public ,heal? ,s]vice ,act1 !        
,employee ,retirem5t ,income ,security  
,act1 & ! ,int]nal ,rev5ue ,code ( #aihd
 to increase ov]sight ( ph>macy b5efits 
manag] s]vices1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,ph>macy ,b5efits ,manag] ,acc\ntability
 ,act4  #b4 ,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