,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #faff  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,novemb] #bj1         
#bjbe,mr4 ,pallone 7= himself1 ,mr4     
,neal1 & ,mr4 ,scott ( ,virg9ia7        
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 exp& 
! drug price negotiation program "u     
title ,,xi ( ! ,social ,security ,act & 
repeal c]ta9 *anges to ! program made by
 ,public ,law #aai-ba1 to apply         
prescription drug inflation rebates "u !
 ,m$ic>e program to drugs furni%$ 9 !   
comm]cial m>ket1 & to e/abli%           
out-(-pocket limits on exp5ditures =    
prescription drugs "u private heal?     
insurance4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,l[]+ ,drug ,co/s =     
,am]ican ,families ,act4  ,i ,drug price

 negotiation program  #aja4 ,exp&+ !    
drug price negotiation program  7a7     
,increas+ ! numb] ( drugs subject to    
negotiation ,section #aaib7;a77#d7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;f-#a7;a77#d77 is am5d$ by /rik+   
#bj ea* place x appe>s & ins]t+ #ej 9   
ea* su* place4  7b7 ,expansion (        
def9ition ( maximum fair price eligible 
individual ,section #aaia7;c77#b7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;f7c77#b77 is am5d$-- 7#a7 9       
subp>agraph 7,a71 by ins]t+ 1 or a      
p>ticipant1 b5efici>y1 or enrollee :o is
 enroll$ "u a gr\p heal? plan or heal?  
insurance cov]age (f]$ 9 ! gr\p or      
individual m>ket 7z su* t]ms are def9$ 9
 section #bgia ( ! ,public ,heal?       
,s]vice ,act7 ) respect to :i* !re is 9 
effect an agreem5t ) ! ,secret>y "u     
section #aaig ) respect to su* select$  
drug z s furni%$ or disp5s$ aft] su*    
select$ drug2 &  7#b7 9 subp>agraph     
7,b71 by ins]t+ 1 or a p>ticipant1      
b5efici>y1 or enrollee :o is enroll$ "u 

a gr\p heal? plan or heal? insurance    
cov]age (f]$ 9 ! gr\p or individual     
m>ket 7z su* t]ms are def9$ 9 section   
#bgia ( ! ,public ,heal? ,s]vice ,act7 )
 respect to :i* !re is 9 effect an      
agreem5t ) ! ,secret>y "u section #aaig 
) respect to su* select$ drug z s       
furni%$ or adm9i/]$ aft] su* select$    
drug4  7c7 ,application ( adm9i/rative  
proc$ures to new maximum fair price     
eligible individuals ,section           
#aaif7;a77#c7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acbj;f-#e7;a77#c77 is  
am5d$-- 7#a7 9 subp>agraph 7,a71 by     
/rik+ & at ! end2  7#b7 9 subp>agraph   
7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 &  
7#c7 by add+ at ! end ! foll[+ new      
subp>agraph3  7,c7 maximum fair price   
eligible individuals n describ$ 9       
subp>agraph 7,a7 or 7,b74  4  7d7 ,heal?
 insur] agreem5ts ,"p ,e ( title ,,xi ( 
! ,social ,security ,act 7#db ,u4,s4,c4 
#acbj;f et seq47 is am5d$-- 7#a7 by     
r$esignat+ sections #aaig & #aaih z     
sections #aaih & #aaii1 respectively2 & 

7#b7 by ins]t+ aft] section #aaif !     
foll[+ new section3  #aaig4 ,volunt>y   
p>ticipation by o!r heal? plans  7a7    
,agreem5t ,to p>ticipate "u program     
7#a7 ,9 g5]al ,subject to p>agraph 7#b71
 "u ! program "u ?is "p ! ,secret>y %all
 be treat$ z hav+ 9 effect an agreem5t )
 a gr\p heal? plan or heal? insurance   
issu] (f]+ gr\p or individual heal?     
insurance cov]age 7z su* t]ms are def9$ 
9 section #bgia ( ! ,public ,heal?      
,s]vice ,act71 ) respect to a price     
applicability p]iod & a select$ drug )  
respect to su* p]iod-- 7,a7 9 ! case su*
 select$ drug furni%$ or disp5s$ at a   
ph>macy or by mail ord] s]vice if       
cov]age is provid$ "u su* plan or       
cov]age dur+ su* p]iod = su* select$    
drug z s furni%$ or disp5s$2 &  7,b7 9 !
 case su* select$ drug furni%$ or       
adm9i/]$ by a hospital1 physician1 or   
o!r provid] ( s]vices or suppli] if     
cov]age is provid$ "u su* plan or       
cov]age dur+ su* p]iod = su* select$    
drug z s furni%$ or adm9i/]$4  7#b7     

,opt+ out ( agreem5t ,! ,secret>y %all n
 be treat$ z hav+ 9 effect an agreem5t  
"u ! program "u ?is "p ) a gr\p heal?   
plan or heal? insurance issu] (f]+ gr\p 
or individual heal? insurance cov]age ) 
respect to a price applicability p]iod &
 a select$ drug ) respect to su* p]iod  
if su* a plan or issu] affirmatively    
elects1 ?r\gh a process specifi$ by !   
,secret>y1 n to p>ticipate "u ! program 
) respect to su* p]iod & drug4  7b7     
,publication ( election ,) respect to   
ea* price applicability p]iod & ea*     
select$ drug ) respect to su* p]iod1 !  
,secret>y & ! ,secret>y ( ,labor & !    
,secret>y ( ! ,treasury1 z applicable1  
%all make public a li/ ( ea* gr\p heal? 
plan & ea* heal? insurance issu] (f]+   
gr\p or individual heal? insurance      
cov]age1 ) respect to :i* cov]age is    
provid$ "u su* plan or cov]age = su*    
drug1 t has elect$ "u subsection 7a7 n  
to p>ticipate "u ! program ) respect to 
su* p]iod & drug4  4  7e7 ,application  
to gr\p heal? plans & heal? insurance   

cov]age  7#a7 ,,phsa ,"p ,d ( title     
,,xxvii ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #cjj;gg-#aaa et seq47 is 
am5d$ by add+ at ! end ! foll[+ new     
section3  #bgii;,a-#aa4 ,drug ,price    
,negotiation ,program & application (   
maximum fair prices  7a7 ,9 g5]al ,9 !  
case ( a gr\p heal? plan or heal?       
insurance issu] (f]+ gr\p or individual 
heal? insurance cov]age t is treat$ "u  
section #aaig ( ! ,social ,security ,act
 z hav+ 9 effect an agreem5t ) !        
,secret>y "u ! ,drug ,price ,negotiation
 ,program "u "p ,e ( title ,,xi ( su*   
,act1 ) respect to a price applicability
 p]iod 7z def9$ 9 section #aaia7;b7 (   
su* ,act7 & a select$ drug 7z def9$ 9   
section #aaib7;c7 ( su* ,act7 ) respect 
to su* p]iod = :i* cov]age is provid$ "u
 su* plan or cov]age-- 7#a7 ! provisions
 ( su* "p %all apply-- 7,a7 9 ! case !  
drug is furni%$ or disp5s$ at a ph>macy 
or by a mail ord] s]vice1 to su* plan or
 cov]age1 & to ! p>ticipants1           
b5efici>ies1 & enrollees enroll$ "u su* 

plan or cov]age1 dur+ su* p]iod1 )      
respect to su* select$ drug1 9 ! same   
mann] z su* provisions apply to         
prescription drug plans & ,,ma-,,pd     
plans1 & to p>ticipants1 b5efici>ies1 & 
enrollees enroll$ "u su* prescription   
drug plans & ,,ma-,,pd plans dur+ su*   
p]iod2 &  7,b7 9 ! case ! drug is       
furni%$ or adm9i/]$ by a hospital1      
physician1 or o!r provid] ( s]vices or  
suppli]1 to su* plan or cov]age1 & to ! 
p>ticipants1 b5efici>ies1 & enrollees   
enroll$ "u su* plan or cov]age1 & to    
hospitals1 physicians1 & o!r provid]s ( 
s]vices & suppli]s dur+ su* p]iod1 )    
respect to su* drug 9 ! same mann] z su*
 provisions apply to ! ,secret>y1 to    
p>ticipants1 b5efici>ies1 & enrollees   
entitl$ to b5efits "u "p ,a ( title     
,,xviii or enroll$ "u "p ,b ( su* title1
 & to hospitals1 physicians1 & o!r      
provid]s & suppli]s p>ticipat+ "u title 
,,xviii dur+ su* p]iod2  7#b7 ! plan or 
issu] %all apply any co/-%>+            
responsibilities "u su* plan or cov]age1

 ) respect to su* select$ drug1 by      
sub/itut+ an am\nt n m ?an ! maximum    
fair price negotiat$ "u su* "p ,e (     
title ,,xi = su* drug 9 lieu ( ! drug   
price ^u :i* ! co/-%>+ w\ld h o!rwise   
appli$1 & su* co/-%>+ responsibilities )
 respect to su* select$ drug may n exce$
 su* maximum fair price2 &  7#c7 !      
,secret>y %all apply ! provisions ( su* 
"p ,e to su* plan1 issu]1 & cov]age1 su*
 p>ticipants1 b5efici>ies1 & enrollees s
 enroll$ 9 su* plans & cov]age1 & su*   
hospitals1 physicians1 & o!r provid]s & 
suppli]s p>ticipat+ 9 su* plans &       
cov]age4  7b7 ,notification reg>d+      
nonp>ticipation 9 ,drug ,price          
,negotiation ,program ,a gr\p heal? plan
 or a heal? insurance issu] (f]+ gr\p or
 individual heal? insurance cov]age %all
 publicly disclose1 9 a mann] & 9       
accordance ) a process specifi$ by !    
,secret>y1 any election made "u section 
#aaig ( ! ,social ,security ,act by su* 
plan or issu] to n p>ticipate 9 ! ,drug 
,price ,negotiation ,program "u "p ,e ( 

title ,,xi ( su* ,act ) respect to a    
select$ drug 7z def9$ 9 section         
#aaib7;c7 ( su* ,act7 = :i* cov]age is  
provid$ "u su* plan or cov]age be=e !   
beg9n+ ( ! plan ye> = :i* su* election 0
 made4  4  7#b7 ,,erisa  7,a7 ,9 g5]al  
,subp>t ,b ( "p #g ( subtitle ,b ( title
 ,i ( ! ,employee ,retirem5t ,income    
,security ,act ( #aigd 7#bi ,u4,s4,c4   
#aahe et seq47 is am5d$ by add+ at ! end
 ! foll[+ new section3  #gbf4 ,drug     
,price ,negotiation ,program &          
application ( maximum fair prices  7a7  
,9 g5]al ,9 ! case ( a gr\p heal? plan  
or heal? insurance issu] (f]+ gr\p heal?
 insurance cov]age t is treat$ "u       
section #aaig ( ! ,social ,security ,act
 z hav+ 9 effect an agreem5t ) !        
,secret>y ( ,heal? & ,human ,s]vices "u 
! ,drug ,price ,negotiation ,program "u 
"p ,e ( title ,,xi ( su* ,act1 ) respect
 to a price applicability p]iod 7z def9$
 9 section #aaia7;b7 ( su* ,act7 & a    
select$ drug 7z def9$ 9 section         
#aaib7;c7 ( su* ,act7 ) respect to su*  

p]iod = :i* cov]age is provid$ "u su*   
plan or cov]age-- 7#a7 ! provisions (   
su* "p %all apply1 z applicable-- 7,a7 9
 ! case ! drug is furni%$ or disp5s$ at 
a ph>macy or by a mail ord] s]vice1 to  
su* plan or cov]age1 & to ! p>ticipants 
& b5efici>ies enroll$ "u su* plan or    
cov]age1 dur+ su* p]iod1 ) respect to   
su* select$ drug1 9 ! same mann] z su*  
provisions apply to prescription drug   
plans & ,,ma-,,pd plans1 & to           
p>ticipants & b5efici>ies enroll$ "u su*
 prescription drug plans & ,,ma-,,pd    
plans dur+ su* p]iod2 &  7,b7 9 ! case !
 drug is furni%$ or adm9i/]$ by a       
hospital1 physician1 or o!r provid] (   
s]vices or suppli]1 to ! gr\p heal? plan
 or cov]age (f]$ by an issu]1 to !      
p>ticipants & b5efici>ies enroll$ "u su*
 plans or cov]age1 & to hospitals1      
physicians1 & o!r provid]s ( s]vices &  
suppli]s dur+ su* p]iod1 ) respect to   
su* drug 9 ! same mann] z su* provisions
 apply to ! ,secret>y ( ,heal? & ,human 
,s]vices1 to p>ticipants & b5efici>ies  

entitl$ to b5efits "u "p ,a ( title     
,,xviii or enroll$ "u "p ,b ( su* title1
 & to hospitals1 physicians1 & o!r      
provid]s & suppli]s p>ticipat+ "u title 
,,xviii dur+ su* p]iod2  7#b7 ! plan or 
issu] %all apply any co/-%>+            
responsibilities "u su* plan or cov]age1
 ) respect to su* select$ drug1 by      
sub/itut+ an am\nt n m ?an ! maximum    
fair price negotiat$ "u su* "p ,e (     
title ,,xi = su* drug 9 lieu ( ! drug   
price ^u :i* ! co/-%>+ w\ld h o!rwise   
appli$1 & su* co/-%>+ responsibilities )
 respect to su* select$ drug may n exce$
 su* maximum fair price2 &  7#c7 !      
,secret>y %all apply ! provisions ( su* 
"p ,e to su* plan1 issu]1 & cov]age1 &  
su* p>ticipants & b5efici>ies s enroll$ 
9 su* plans4  7b7 ,notification reg>d+  
nonp>ticipation 9 ,drug ,price          
,negotiation ,program ,a gr\p heal? plan
 or a heal? insurance issu] (f]+ gr\p   
heal? insurance cov]age %all publicly   
disclose 9 a mann] & 9 accordance ) a   
process specifi$ by ! ,secret>y any     

election made "u section #aaig ( !      
,social ,security ,act by ! plan or     
issu] to n p>ticipate 9 ! ,drug ,price  
,negotiation ,program "u "p ,e ( title  
,,xi ( su* ,act ) respect to a select$  
drug 7z def9$ 9 section #aaib7;c7 ( su* 
,act7 = :i* cov]age is provid$ "u su*   
plan or cov]age be=e ! beg9n+ ( ! plan  
ye> = :i* su* election 0 made4  4  7,b7 
,application to retiree & c]ta9 small   
gr\p heal? plans ,section #gcb7;a7 ( !  
,employee ,retirem5t ,income ,security  
,act ( #aigd 7#bi ,u4,s4,c4 #aaia;a7a77 
is am5d$ by /rik+ section #gaa & ins]t+ 
sections #gaa & #gbf4  7,c7 ,cl]ical    
am5dm5t ,! table ( cont5ts 9 section #a 
( su* ,act is am5d$ by ins]t+ aft] !    
item relat+ to section #gbe ! foll[+ new
 item3  ,sec4 #gbf4 ,drug ,price        
,negotiation ,program & application (   
maximum fair prices4  4  7#c7 ,,irc     
7,a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj 
( ! ,int]nal ,rev5ue ,code ( #aihf is   
am5d$ by add+ at ! end ! foll[+ new     
section3  #ihbf4 ,drug ,price           

,negotiation ,program & application (   
maximum fair prices  7a7 ,9 g5]al ,9 !  
case ( a gr\p heal? plan t is treat$ "u 
section #aaig ( ! ,social ,security ,act
 z hav+ 9 effect an agreem5t ) !        
,secret>y ( ,heal? & ,human ,s]vices "u 
! ,drug ,price ,negotiation ,program "u 
"p ,e ( title ,,xi ( su* ,act1 ) respect
 to a price applicability p]iod 7z def9$
 9 section #aaia7;b7 ( su* ,act7 & a    
select$ drug 7z def9$ 9 section         
#aaib7;c7 ( su* ,act7 ) respect to su*  
p]iod = :i* cov]age is provid$ "u su*   
plan-- 7#a7 ! provisions ( su* "p %all  
apply1 z applicable-- 7,a7 if cov]age ( 
su* select$ drug is provid$ "u su* plan 
if ! drug is furni%$ or disp5s$ at a    
ph>macy or by a mail ord] s]vice1 to !  
plan1 & to ! p>ticipants & b5efici>ies  
enroll$ "u su* plan dur+ su* p]iod1 )   
respect to su* select$ drug1 9 ! same   
mann] z su* provisions apply to         
prescription drug plans & ,,ma-,,pd     
plans1 & to p>ticipants & b5efici>ies   
enroll$ "u su* prescription drug plans &

 ,,ma-,,pd plans dur+ su* p]iod2 &  7,b7
 if cov]age ( su* select$ drug is       
provid$ "u su* plan if ! drug is furni%$
 or adm9i/]$ by a hospital1 physician1  
or o!r provid] ( s]vices or suppli]1 to 
! plan1 to ! p>ticipants & b5efici>ies  
enroll$ "u su* plan1 & to hospitals1    
physicians1 & o!r provid]s ( s]vices &  
suppli]s dur+ su* p]iod1 ) respect to   
su* drug 9 ! same mann] z su* provisions
 apply to ! ,secret>y ( ,heal? & ,human 
,s]vices1 to p>ticipants & b5efici>ies  
entitl$ to b5efits "u "p ,a ( title     
,,xviii or enroll$ "u "p ,b ( su* title1
 & to hospitals1 physicians1 & o!r      
provid]s & suppli]s p>ticipat+ "u title 
,,xviii dur+ su* p]iod2  7#b7 ! plan    
%all apply any co/-%>+ responsibilities 
"u su* plan1 ) respect to su* select$   
drug1 by sub/itut+ an am\nt n m ?an !   
maximum fair price negotiat$ "u su* "p  
,e ( title ,,xi = su* drug 9 lieu ( !   
drug price ^u :i* ! co/-%>+ w\ld h      
o!rwise appli$1 & su* co/-%>+           
responsibilities ) respect to su*       

select$ drug may n exce$ su* maximum    
fair price2 &  7#c7 ! ,secret>y %all    
apply ! provisions ( su* "p ,e to su*   
plan & su* p>ticipants & b5efici>ies s  
enroll$ 9 su* plan4  7b7 ,notification  
reg>d+ nonp>ticipation 9 ,drug ,price   
,negotiation ,program ,a gr\p heal? plan
 %all publicly disclose 9 a mann] & 9   
accordance ) a process specifi$ by !    
,secret>y any election made "u section  
#aaig ( ! ,social ,security ,act by !   
plan to n p>ticipate 9 ! ,drug ,price   
,negotiation ,program "u "p ,e ( title  
,,xi ( su* ,act ) respect to a select$  
drug 7z def9$ 9 section #aaib7;c7 ( su* 
,act7 = :i* cov]age is provid$ "u su*   
plan be=e ! beg9n+ ( ! plan ye> = :i*   
su* election 0 made4  4  7,b7           
,application to retiree & c]ta9 small   
gr\p heal? plans ,section #ihca7;a77#b7 
( ! ,int]nal ,rev5ue ,code ( #aihf is   
am5d$ by ins]t+ o!r ?an ) respect to    
section #ihbf1 be=e any gr\p heal? plan4
  7,c7 ,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 ,drug ,price ,negotiation  
,program & application ( maximum fair   
prices4  4  #ajb4 ,requir+ consid]ation 
( av]age int]national m>ket price "u    
drug price negotiation program  7a7 ,9  
g5]al ,section #aaid7;e7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#acbj;f-#c7;e77 is am5d$ by add+ at !   
end ! foll[+ new p>agraph3  7#c7 ,av]age
 int]national m>ket price  7,a7 ,9 g5]al
 ,! av]age price 7:i* %all be ! net     
av]age price1 if practicable1 &         
volume-weight$1 if practicable7 = a unit
 7z def9$ 9 subp>agraph 7,c77 ( su* drug
 = sales ( su* drug 7calculat$ across   
diff]5t dosage =ms & /r5g?s ( ! drug & n
 bas$ on ! specific =mulation or package
 size or package type71 z comput$ 7z ( !
 date ( publication ( su* drug z a      
select$ drug "u section #aaib7;a77 9 all
 c\ntries describ$ 9 clause 7ii7 (      
subp>agraph 7,b7 t are applicable       
c\ntries 7z describ$ 9 clause 7i7 ( su* 

subp>agraph7 ) respect to su* drug4     
7,b7 ,applicable c\ntries  7i7 ,9 g5]al 
,= purposes ( subp>agraph 7,a71 a c\ntry
 describ$ 9 clause 7ii7 is an applicable
 c\ntry describ$ 9 ?is clause ) respect 
to a drug if !re is available an av]age 
price = any unit = ! drug = sales ( su* 
drug 9 su* c\ntry4  7ii7 ,c\ntries      
describ$ ,= purposes ( ?is p>agraph1 !  
foll[+ are c\ntries describ$ 9 ?is      
clause3 7,i7 ,au/ralia4  7,,ii7 ,canada4
  7,,iii7 ,france4  7,,iv7 ,g]many4     
7,v7 ,japan4  7,,vi7 ,! ,unit$ ,k+dom4  
7,c7 ,unit def9$ ,= purposes ( ?is      
p>agraph1 t]m unit means1 ) respect to a
 drug1 ! l[e/ id5tifiable quantity 7su* 
z a capsule or tablet1 milligram (      
molecules1 or grams7 ( ! drug t is      
disp5s$4  4  7b7 ,effective date ,!     
am5dm5t made by subsection 7a7 %all     
apply ) respect to negotiations "u !    
,drug ,price ,negotiation ,program "u "p
 ,e ( title ,,xi ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #acbj;f et seq47 =  
initial price applicability ye>s beg9n+ 

on or aft] ,janu>y #a1 #bjbh1 &         
r5egotiations "u su* program = ye>s     
beg9n+ on or aft] su* date4  #ajc4      
,repeal+ c]ta9 *anges to ! drug price   
negotiation program made by ,public ,law
 #aai-ba ,section #gabjc ( ! ,act titl$ 
,an ,act to provide = reconciliation    
pursuant to title ,,ii ( ,h4 ,con4 ,res4
 #ad 7,public ,law #aai-ba7 is repeal$1 
& ! provisions ( law am5d$ by su*       
section are h]eby re/or$ z if su*       
section _h n be5 enact$ into law4  ,,ii 
,prescription drug inflation rebates    
#bja4 ,application ( prescription drug  
inflation rebates to drugs furni%$ 9 !  
comm]cial m>ket  7a7 ,"p ,b drugs  7#a7 
,application ( prescription drug        
inflation rebates to drugs furni%$ 9 !  
comm]cial m>ket ,section #ahdg;,a7i7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciew-#c;a7i77 is am5d$-- 7,a7 9       
p>agraph 7#a77;,a77i71 by /rik+ units & 
ins]t+ bill+ units2  7,b7 9 p>agraph    
7#b77;,a71 by /rik+ = :i* paym5t is made
 "u ?is "p & ins]t+ t w\ld be payable "u

 ?is "p if su* drug 7 furni%$ to an     
individual enroll$ "u ?is "p2 &  7,c7 9 
p>agraph 7#c7-- 7i7 9 subp>agraph       
7,a77i71 by /rik+ units & ins]t+ bill+  
units2 &  7ii7 by /rik+ subp>agraph 7,b7
 & ins]t+ ! foll[+3  7,b7 ,total numb] (
 bill+ units ,= purposes ( subp>agraph  
7,a77i71 ! total numb] ( bill+ units )  
respect to a "p ,b rebatable drug is    
det]m9$ z foll[s3 7i7 ,det]m9e ! total  
numb] ( units equal to-- 7,i7 ! total   
numb] ( units1 z report$ "u subsection  
7c77#a77;,b7 = ea* ,national ,drug ,code
 ( su* drug dur+ ! cal5d> qu>t] t is two
 cal5d> qu>t]s prior to ! cal5d> qu>t] z
 describ$ 9 subp>agraph 7,a71 m9us      
7,,ii7 ! total numb] ( units ) respect  
to ea* ,national ,drug ,code ( su* drug 
= :i* paym5t 0 made "u a ,/ate plan "u  
title ,,xix 7or waiv] ( su* plan71 z    
report$ by ,/ates "u section            
#aibg7;b77#b77;,a7 = ! rebate p]iod t is
 ! same cal5d> qu>t] z describ$ 9       
subclause 7,i74  7ii7 ,conv]t ! units   
det]m9$ "u clause 7i7 to bill+ units = !

 bill+ & paym5t code ( su* drug1 us+ a  
me?odology simil> to ! me?odology us$ "u
 ?is section1 by divid+ ! units det]m9$ 
"u clause 7i7 = ea* ,national ,drug     
,code ( su* drug by ! bill+ unit = !    
bill+ & paym5t code ( su* drug4  7iii7  
,compute ! sum ( ! bill+ units = ea*    
,national ,drug ,code ( su* drug 9      
clause 7ii74  4  7#b7 ,effective date ,!
 am5dm5ts made by ?is subsection %all   
apply ) respect to cal5d> qu>t]s beg9n+ 
aft] ! date ( ! enactm5t ( ?is ,act4    
7b7 ,cov]$ "p ,d drugs  7#a7            
,application ( prescription drug        
inflation rebates to drugs furni%$ 9 !  
comm]cial m>ket ,section #ahfj;,d-#ad;,b
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciew-#aad;b7 is am5d$-- 7,a7
 9 subsection 7b7-- 7i7 9 p>agraph      
7#a7-- 7,i7 9 subp>agraph 7,a77i71 by   
/rik+ ! total numb] ( units & all t     
foll[s ?r\gh ! semicolon & ins]t+ !     
foll[+3 ! total numb] ( units t are us$ 
to calculate ! av]age manufactur] price 
( su* dosage =m & /r5g? ) respect to su*

 "p ,d rebatable drug1 z report$ by !   
manufactur] ( su* drug "u section #aibg 
= ea* mon?1 ) respect to su* p]iod22 &  
7,,ii7 by /rik+ subp>agraph 7,b7 &      
ins]t+ ! foll[+3  7,b7 ,exclud$ units ,=
 purposes ( subp>agraph 7,a77i71 !      
,secret>y %all exclude f ! total numb] (
 units = a dosage =m & /r5g? ) respect  
to a "p ,d rebatable drug1 ) respect to 
an applicable p]iod1 ! foll[+3 7i7      
,units ( ea* dosage =m & /r5g? ( su* "p 
,d rebatable drug = :i* paym5t 0 made "u
 a ,/ate plan "u title ,,xix 7or waiv] (
 su* plan71 z report$ by ,/ates "u      
section #aibg7;b77#b77;,a74  7ii7 ,units
 ( ea* dosage =m & /r5g? ( su* "p ,d    
rebatable drug = :i* a rebate is paid "u
 section #ahdg;,a7i74  7iii7 ,beg9n+ )  
plan ye> #bjbf1 units ( ea* dosage =m & 
/r5g? ( su* "p ,d rebatable drug = :i* !
 manufactur] provides a disc\nt "u !    
program "u section #cdj;,b ( ! ,public  
,heal? ,s]vice ,act4  2 &  7ii7 9       
p>agraph 7#f71 by /rik+ in=mation & all 
t foll[s ?r\gh rebatable cov]$ "p ,d    

drug disp5s$ & ins]t+ ! foll[+3 ,,amp   
reports4--,! ,secret>y %all provide = a 
me?od & process "u :i*1 9 ! case ( a    
manufactur] ( a "p ,d rebatable drug t  
submits revisions to in=mation submitt$ 
"u section #aibg by ! manufactur] )     
respect to su* drug2 &  7,b7 by /rik+   
subsection 7d7 & ins]t+ ! foll[+3  7d7  
,in=mation ,= purposes ( c>ry+ out ?is  
section1 ! ,secret>y %all use in=mation 
submitt$ by manufactur]s "u section     
#aibg7;b77#c7 & in=mation submitt$ by   
,/ates "u section #aibg7;b77#b77;,a74  4
  7#b7 ,effective date ,! am5dm5ts made 
by ?is subsection %all apply ) respect  
to applicable p]iods 7z def9$ 9 section 
#ahfj;,d-#ad;,b7g77#g7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciew-#aad;b7g77#g777 beg9n+ aft] !    
date ( ! enactm5t ( ?is ,act4  ,,iii    
,out-(-pocket limits = prescription     
drugs  #cja4 ,e/abli%+ an out-(-pocket  
limit on exp5ditures = prescription     
drugs "u gr\p heal? plans & gr\p &      
individual heal? insurance cov]age  7a7 

,,phsa ,title ,,xxvii ( ! ,public ,heal?
 ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et 
seq471 z am5d$ by section #aja1 is fur!r
 am5d$-- 7#a7 9 section #bgjg1 by add+  
at ! end ! foll[+ new subsection3  7e7  
,sunset ,! prec$+ provisions ( ?is      
section %all n apply ) respect to plan  
ye>s beg9n+ on or aft] ,janu>y #a1      
#bjbg4  2 &  7#b7 9 "p ,d1 by add+ at ! 
end ! foll[+ new section3  #bgii;,a-#ab4
 ,compreh5sive cov]age  7a7 ,cov]age =  
ess5tial heal? b5efits package ,a heal? 
insurance issu] t (f]s heal? insurance  
cov]age 9 ! individual or small gr\p    
m>ket %all ensure t su* cov]age includes
 ! ess5tial heal? b5efits package       
requir$ "u section #acjb7;a7 ( ! ,pati5t
 ,protection & ,af=dable ,c>e ,act4  7b7
 ,co/-,%>+ limitation  7#a7 ,9 g5]al ,a 
gr\p heal? plan & a heal? insurance     
issu] (f]+ gr\p or individual heal?     
insurance cov]age %all ensure t--  7,a7 
any annual co/-%>+ impos$ "u ! plan or  
cov]age 7includ+ any su* co/-%>+ s      
impos$ ) respect to prescription drugs7 

does n exce$ ! doll> am\nts specifi$ 9  
p>agraph 7#b72 &  7,b7 any annual       
co/-%>+ impos$ "u ! plan or cov]age )   
respect to prescription drugs does n    
exce$ ! doll> am\nts specifi$ 9 p>agraph
 7#c74  7#b7  ,limitation on ov]all     
out-(-pocket co/-%>+  ,= purposes (     
p>agraph 7#a77;,a71 ! doll> am\nts      
specifi$ 9 ?is p>agraph are ! foll[+3   
7,a7 ,) respect to self-only cov]age--  
7i7 = plan ye>s beg9n+ 9 #bjbg1 ! doll> 
am\nt 9 effect "u section #acjb7;c77#a7 
( ! ,pati5t ,protection & ,af=dable ,c>e
 ,act = su* cov]age = plan ye>s beg9n+ 9
 #bjad1 increas$ by an am\nt equal to ! 
product ( t am\nt & ! premium adju/m5t  
p]c5tage specifi$ 9 p>agraph 7#d7 ( su* 
section = ! cal5d> ye>2 &  7ii7 = plan  
ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 
! doll> am\nt 9 effect "u ?is           
subp>agraph = plan ye>s beg9n+ 9 #bjbg1 
increas$ by an am\nt equal to ! product 
( t am\nt ! premium adju/m5t p]c5tage   
specifi$ 9 p>agraph 7#d7 = ! cal5d> ye>4
  7,b7 ,) respect to cov]age o!r ?an    

self-only cov]age1 = plan ye>s beg9n+ 9 
#bjbg or a subsequ5t ye>1 twice ! am\nt 
9 effect "u subp>agraph 7,a7 = su* plan 
ye>4  ,if ! am\nt ( any increase "u     
subp>agraph 7,a7 is n a multiple ( #ej1 
su* increase %all be r\nd$ to ! next    
l[e/ multiple ( #ej4  7#c7  ,limitation 
on prescription drug out-(-pocket       
co/-%>+  ,= purposes ( p>agraph         
7#a77;,b71 ! doll> am\nts specifi$ 9 ?is
 p>agraph are ! foll[+3  7,a7 ,) respect
 to self-only cov]age-- 7i7 = plan ye>s 
beg9n+ 9 #bjbg1 #b1jjj2 &  7ii7 = plan  
ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 
! doll> am\nt 9 effect "u ?is           
subp>agraph = plan ye>s beg9n+ 9 #bjbg1 
increas$ by an am\nt equal to ! product 
( t am\nt & ! premium adju/m5t p]c5tage 
"u p>agraph 7#d7 = ! cal5d> ye>4  7,b7  
,) respect to cov]age o!r ?an self-only 
cov]age1 = plan ye>s beg9n+ 9 #bjbg or a
 subsequ5t ye>1 twice ! am\nt 9 effect  
"u subp>agraph 7,a7 = su* plan ye>4  ,if
 ! am\nt ( any increase "u subp>agraph  
7,a7 is n a multiple ( #ej1 su* increase

 %all be r\nd$ to ! next l[e/ multiple (
 #ej4  7#d7  ,premium adju/m5t p]c5tage 
,= purposes ( p>agraphs 7#b77;,a77ii7 & 
7#c77;,a77ii71 ! premium adju/m5t       
p]c5tage = any cal5d> ye> is ! p]c5tage 
7if any7 by :i* ! av]age p] capita      
premium = heal? insurance cov]age 9 !   
,unit$ ,/ates = ! prec$+ cal5d> ye> 7z  
e/imat$ by ! ,secret>y no lat] ?an      
,octob] #a ( su* prec$+ cal5d> ye>7     
exce$s su* av]age p] capita premium =   
#bjbf 7z det]m9$ by ! ,secret>y74  7#e7 
,co/-%>+  ,9 ?is section3 7,a7 ,9 g5]al 
,! t]m co/-%>+ includes--  7i7          
d$uctibles1 co9surance1 copaym5ts1 or   
simil> *>ges2 &  7ii7 any o!r exp5diture
 requir$ ( an insur$ individual :i* is a
 qualifi$ m$ical exp5se 7)9 ! mean+ (   
section #bbc7;d77#b7 ( ! ,int]nal       
,rev5ue ,code ( #aihf7 ) respect to     
ess5tial heal? b5efits cov]$ "u ! plan  
or cov]age4  7,b7  ,exceptions  ,su* t]m
 does n include premiums1 balance bill+ 
am\nts = non-network provid]s1 or sp5d+ 
= non-cov]$ s]vices4  7#f7              

,implem5tation  ,! ,secret>y may        
implem5t ! provisions ( ?is subsection  
by subregulatory guidance1 int]im f9al  
rule1 or o!rwise4  7c7  ,*ild-,only     
plans  ,if a heal? insurance issu] (f]s 
heal? insurance cov]age 9 any level (   
cov]age specifi$ "u section #acjb7;d7 ( 
! ,pati5t ,protection & ,af=dable ,c>e  
,act1 ! issu] %all also (f] su* cov]age 
9 t level z a plan 9 :i* ! only         
enrollees are individuals :o1 z ( !     
beg9n+ ( a plan ye>1 h n atta9$ ! age ( 
#ba4  7d7 ,d5tal only ,?is section %all 
n apply to a plan describ$ 9 section    
#acaa7;d77#b77;,b77ii7 ( ! ,pati5t      
,protection & ,af=dable ,c>e ,act4  4   
7b7 ,,erisa  7#a7 ,9 g5]al ,subp>t ,b ( 
"p #g ( subtitle ,b ( title ,i ( !      
,employee ,retirem5t ,income ,security  
,act ( #aigd 7#bi ,u4,s4,c4 #aahe et    
seq471 z am5d$ by section #aja1 is fur!r
 am5d$ by add+ at ! end ! foll[+ new    
section3  #gbg4 ,compreh5sive cov]age   
7a7 ,cov]age = ess5tial heal? b5efits   
package ,a heal? insurance issu] t (f]s 

heal? insurance cov]age 9 ! small gr\p  
m>ket %all ensure t su* cov]age includes
 ! ess5tial heal? b5efits package       
requir$ "u section #acjb7;a7 ( ! ,pati5t
 ,protection & ,af=dable ,c>e ,act4  7b7
 ,co/-,%>+ limitation  7#a7 ,9 g5]al ,a 
gr\p heal? plan & a heal? insurance     
issu] (f]+ gr\p heal? insurance cov]age 
%all ensure t--  7,a7 any annual co/-%>+
 impos$ "u ! plan or cov]age 7includ+   
any su* co/-%>+ s impos$ ) respect to   
prescription drugs7 does n exce$ ! doll>
 am\nts specifi$ 9 p>agraph 7#b72 &     
7,b7 any annual co/-%>+ impos$ "u ! plan
 or cov]age ) respect to prescription   
drugs does n exce$ ! doll> am\nts       
specifi$ 9 p>agraph 7#c74  7#b7         
,limitation on ov]all out-(-pocket      
co/-%>+  ,= purposes ( p>agraph         
7#a77;,a71 ! doll> am\nts specifi$ 9 ?is
 p>agraph are ! foll[+3  7,a7 ,) respect
 to self-only cov]age-- 7i7 = plan ye>s 
beg9n+ 9 #bjbg1 ! doll> am\nt 9 effect  
"u section #acjb7;c77#a7 ( ! ,pati5t    
,protection & ,af=dable ,c>e ,act = su* 

cov]age = plan ye>s beg9n+ 9 #bjad1     
increas$ by an am\nt equal to ! product 
( t am\nt & ! premium adju/m5t p]c5tage 
specifi$ 9 p>agraph 7#d7 ( su* section =
 ! cal5d> ye>2 &  7ii7 = plan ye>s      
beg9n+ 9 #bjbh or a subsequ5t ye>1 !    
doll> am\nt 9 effect "u ?is subp>agraph 
= plan ye>s beg9n+ 9 #bjbg1 increas$ by 
an am\nt equal to ! product ( t am\nt ! 
premium adju/m5t p]c5tage specifi$ 9    
p>agraph 7#d7 = ! cal5d> ye>4  7,b7 ,)  
respect to cov]age o!r ?an self-only    
cov]age1 = plan ye>s beg9n+ 9 #bjbg or a
 subsequ5t ye>1 twice ! am\nt 9 effect  
"u subp>agraph 7,a7 = su* plan ye>4  ,if
 ! am\nt ( any increase "u subp>agraph  
7,a7 is n a multiple ( #ej1 su* increase
 %all be r\nd$ to ! next l[e/ multiple (
 #ej4  7#c7  ,limitation on prescription
 drug out-(-pocket co/-%>+  ,= purposes 
( p>agraph 7#a77;,b71 ! doll> am\nts    
specifi$ 9 ?is p>agraph are ! foll[+3   
7,a7 ,) respect to self-only cov]age--  
7i7 = plan ye>s beg9n+ 9 #bjbg1 #b1jjj2 
&  7ii7 = plan ye>s beg9n+ 9 #bjbh or a 

subsequ5t ye>1 ! doll> am\nt 9 effect "u
 ?is subp>agraph = plan ye>s beg9n+ 9   
#bjbg1 increas$ by an am\nt equal to !  
product ( t am\nt & ! premium adju/m5t  
p]c5tage "u p>agraph 7#d7 = ! cal5d>    
ye>4  7,b7 ,) respect to cov]age o!r ?an
 self-only cov]age1 = plan ye>s beg9n+ 9
 #bjbg or a subsequ5t ye>1 twice ! am\nt
 9 effect "u subp>agraph 7,a7 = su* plan
 ye>4  ,if ! am\nt ( any increase "u    
subp>agraph 7,a7 is n a multiple ( #ej1 
su* increase %all be r\nd$ to ! next    
l[e/ multiple ( #ej4  7#d7  ,premium    
adju/m5t p]c5tage  ,= purposes (        
p>agraphs 7#b77;,a77ii7 & 7#c77;,a77ii71
 ! premium adju/m5t p]c5tage = any      
cal5d> ye> is ! p]c5tage 7if any7 by :i*
 ! av]age p] capita premium = heal?     
insurance cov]age 9 ! ,unit$ ,/ates = ! 
prec$+ cal5d> ye> 7z e/imat$ by !       
,secret>y no lat] ?an ,octob] #a ( su*  
prec$+ cal5d> ye>7 exce$s su* av]age p] 
capita premium = #bjbf 7z det]m9$ by !  
,secret>y74  7#e7  ,co/-%>+  ,9 ?is     
section3 7,a7 ,9 g5]al ,! t]m co/-%>+   

includes--  7i7 d$uctibles1 co9surance1 
copaym5ts1 or simil> *>ges2 &  7ii7 any 
o!r exp5diture requir$ ( an insur$      
individual :i* is a qualifi$ m$ical     
exp5se 7)9 ! mean+ ( section            
#bbc7;d77#b7 ( ! ,int]nal ,rev5ue ,code 
( #aihf7 ) respect to ess5tial heal?    
b5efits cov]$ "u ! plan or cov]age4     
7,b7  ,exceptions  ,su* t]m does n      
include premiums1 balance bill+ am\nts =
 non-network provid]s1 or sp5d+ =       
non-cov]$ s]vices4  7#f7  ,implem5tation
  ,! ,secret>y may implem5t ! provisions
 ( ?is subsection by subregulatory      
guidance1 int]im f9al rule1 or o!rwise4 
7c7  ,*ild-,only plans  ,if a heal?     
insurance issu] (f]s heal? insurance    
cov]age 9 any level ( cov]age specifi$  
"u section #acjb7;d7 ( ! ,pati5t        
,protection & ,af=dable ,c>e ,act1 !    
issu] %all also (f] su* cov]age 9 t     
level z a plan 9 :i* ! only enrollees   
are individuals :o1 z ( ! beg9n+ ( a    
plan ye>1 h n atta9$ ! age ( #ba4  7d7  
,d5tal only ,?is section %all n apply to

 a plan describ$ 9 section              
#acaa7;d77#b77;,b77ii7 ( ! ,pati5t      
,protection & ,af=dable ,c>e ,act4  4   
7#b7 ,cl]ical am5dm5t ,! table ( cont5ts
 9 section #a ( su* ,act is am5d$ by    
ins]t+ aft] ! item relat+ to section    
#gbf 7z ins]t$ by section #aja7 ! foll[+
 new item3  ,sec4 #gbg4 ,compreh5sive   
cov]age4  4  7c7 ,,irc  7#a7 ,9 g5]al   
,sub*apt] ,b ( *apt] #ajj ( ! ,int]nal  
,rev5ue ,code ( #aihf1 z am5d$ by       
section #aja1 is fur!r am5d$ by add+ at 
! end ! foll[+ new section3  #ihbg4     
,compreh5sive cov]age  7a7 ,co/-,%>+    
limitation  7#a7 ,9 g5]al ,a gr\p heal? 
plan %all ensure t--  7,a7 any annual   
co/-%>+ impos$ "u ! plan 7includ+ any   
su* co/-%>+ s impos$ ) respect to       
prescription drugs7 does n exce$ ! doll>
 am\nts specifi$ 9 p>agraph 7#b72 &     
7,b7 any annual co/-%>+ impos$ "u ! plan
 ) respect to prescription drugs does n 
exce$ ! doll> am\nts specifi$ 9 p>agraph
 7#c74  7#b7  ,limitation on ov]all     
out-(-pocket co/-%>+  ,= purposes (     

p>agraph 7#a77;,a71 ! doll> am\nts      
specifi$ 9 ?is p>agraph are ! foll[+3   
7,a7 ,) respect to self-only cov]age--  
7i7 = plan ye>s beg9n+ 9 #bjbg1 ! doll> 
am\nt 9 effect "u section #acjb7;c77#a7 
( ! ,pati5t ,protection & ,af=dable ,c>e
 ,act = su* cov]age = plan ye>s beg9n+ 9
 #bjad1 increas$ by an am\nt equal to ! 
product ( t am\nt & ! premium adju/m5t  
p]c5tage specifi$ 9 p>agraph 7#d7 ( su* 
section = ! cal5d> ye>2 &  7ii7 = plan  
ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 
! doll> am\nt 9 effect "u ?is           
subp>agraph = plan ye>s beg9n+ 9 #bjbg1 
increas$ by an am\nt equal to ! product 
( t am\nt ! premium adju/m5t p]c5tage   
specifi$ 9 p>agraph 7#d7 = ! cal5d> ye>4
  7,b7 ,) respect to cov]age o!r ?an    
self-only cov]age1 = plan ye>s beg9n+ 9 
#bjbg or a subsequ5t ye>1 twice ! am\nt 
9 effect "u subp>agraph 7,a7 = su* plan 
ye>4  ,if ! am\nt ( any increase "u     
subp>agraph 7,a7 is n a multiple ( #ej1 
su* increase %all be r\nd$ to ! next    
l[e/ multiple ( #ej4  7#c7  ,limitation 

on prescription drug out-(-pocket       
co/-%>+  ,= purposes ( p>agraph         
7#a77;,b71 ! doll> am\nts specifi$ 9 ?is
 p>agraph are ! foll[+3  7,a7 ,) respect
 to self-only cov]age-- 7i7 = plan ye>s 
beg9n+ 9 #bjbg1 #b1jjj2 &  7ii7 = plan  
ye>s beg9n+ 9 #bjbh or a subsequ5t ye>1 
! doll> am\nt 9 effect "u ?is           
subp>agraph = plan ye>s beg9n+ 9 #bjbg1 
increas$ by an am\nt equal to ! product 
( t am\nt & ! premium adju/m5t p]c5tage 
"u p>agraph 7#d7 = ! cal5d> ye>4  7,b7  
,) respect to cov]age o!r ?an self-only 
cov]age1 = plan ye>s beg9n+ 9 #bjbg or a
 subsequ5t ye>1 twice ! am\nt 9 effect  
"u subp>agraph 7,a7 = su* plan ye>4  ,if
 ! am\nt ( any increase "u subp>agraph  
7,a7 is n a multiple ( #ej1 su* increase
 %all be r\nd$ to ! next l[e/ multiple (
 #ej4  7#d7  ,premium adju/m5t p]c5tage 
,= purposes ( p>agraphs 7#b77;,a77ii7 & 
7#c77;,a77ii71 ! premium adju/m5t       
p]c5tage = any cal5d> ye> is ! p]c5tage 
7if any7 by :i* ! av]age p] capita      
premium = heal? insurance cov]age 9 !   

,unit$ ,/ates = ! prec$+ cal5d> ye> 7z  
e/imat$ by ! ,secret>y no lat] ?an      
,octob] #a ( su* prec$+ cal5d> ye>7     
exce$s su* av]age p] capita premium =   
#bjbf 7z det]m9$ by ! ,secret>y74  7#e7 
,co/-%>+  ,9 ?is section3 7,a7 ,9 g5]al 
,! t]m co/-%>+ includes--  7i7          
d$uctibles1 co9surance1 copaym5ts1 or   
simil> *>ges2 &  7ii7 any o!r exp5diture
 requir$ ( an insur$ individual :i* is a
 qualifi$ m$ical exp5se 7)9 ! mean+ (   
section #bbc7;d77#b7 ( ! ,int]nal       
,rev5ue ,code ( #aihf7 ) respect to     
ess5tial heal? b5efits cov]$ "u ! plan4 
7,b7  ,exceptions  ,su* t]m does n      
include premiums1 balance bill+ am\nts =
 non-network provid]s1 or sp5d+ =       
non-cov]$ s]vices4  7#f7  ,implem5tation
  ,! ,secret>y may implem5t ! provisions
 ( ?is subsection by subregulatory      
guidance1 int]im f9al rule1 or o!rwise4 
7b7 ,d5tal only ,?is section %all n     
apply to a plan describ$ 9 section      
#acaa7;d77#b77;,b77ii7 ( ! ,pati5t      
,protection & ,af=dable ,c>e ,act4  4   

7#b7 ,cl]ical am5dm5t ,! table (        
sections = sub*apt] ,b ( *apt] #ajj ( ! 
,int]nal ,rev5ue ,code ( #aihf1 z am5d$ 
by section #aja1 is fur!r am5d$ by add+ 
at ! end ! foll[+ new item3  ,sec4      
#ihbg4 ,compreh5sive cov]age4  4  7d7   
,con=m+ am5dm5ts ,! ,pati5t ,protection 
& ,af=dable ,c>e ,act 7,public ,law     
#aaa-adh7 is am5d$-- 7#a7 9 section     
#acjb-- 7,a7 9 subsection 7a77#b71 by   
ins]t+ ) respect to plan ye>s beg9n+    
be=e ,janu>y #a1 #bjbg1 be=e limits     
co/-%>+2 &  7,b7 9 subsection           
7e77#a77;,b77i7-- 7i7 by ins]t+ 7or1 )  
respect to plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbg1 9 effect "u section  
#bgii;,a-#ab7;b77#a77;,a77 ( ! ,public  
,heal? ,s]vice ,act7 aft] subsection    
7c77#a72 &  7ii7 by ins]t+ & except1 )  
respect to plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbg1 9 ! case ( an        
individual :o has incurr$ co/-%>+       
exp5ses ) respect to prescription drugs 
9 an am\nt equal to ! annual limitation 
9 effect "u section                     

#bgii;,a-#ab7;b77#a77;,b7 ( su* ,act1 = 
b5efits consi/+ ( prescription drugs    
aft] section #bgac2 &  7#b7 9 section   
#adjb7;c77#a77;,a71 by ins]t+ 7or1 )    
respect to plan ye>s beg9n+ on or aft]  
,janu>y #a1 #bjbg1 ! applicable         
out-(-pocket limit "u section           
#bgii;,a-#ab7;b77#a77;,a7 ( ! ,public   
,heal? ,s]vice ,act7 aft] section       
#acjb7;c77#a74  7e7 ,effective date ,!  
am5dm5ts made by ?is section %all apply 
) respect to plan ye>s beg9n+ on or aft]
 ,janu>y #a1 #bjbg4  #cjb4 ,requirem5ts 
) respect to co/-%>+ = insul9 products  
7a7 ,,phsa ,"p ,d ( title ,,xxvii ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;gg-#aaa et seq471 z am5d$
 by sections #aja & #cja1 is fur!r am5d$
 by add+ at ! end ! foll[+ new section3 
#bgii;,a-#ac4 ,requirem5ts ) respect to 
co/-%>+ = c]ta9 insul9 products  7a7 ,9 
g5]al ,= plan ye>s beg9n+ on or aft]    
,janu>y #a1 #bjbg1 a gr\p heal? plan or 
heal? insurance issu] (f]+ gr\p or      
individual heal? insurance cov]age %all 

provide cov]age ( select$ insul9        
products1 & ) respect to su* products1  
%all n-- 7#a7 apply any d$uctible2 or   
7#b7 impose any co/-%>+ 9 excess ( !    
less] (1 p] #cj-;day supply-- 7,a7 #ce2 
or  7,b7 ! am\nt equal to #be p]c5t ( ! 
negotiat$ price ( ! select$ insul9      
product net ( all price concessions     
receiv$ by or on behalf ( ! plan or     
cov]age1 includ+ price concessions      
receiv$ by or on behalf ( ?ird-p>ty     
entities provid+ s]vices to ! plan or   
cov]age1 su* z ph>macy b5efit managem5t 
s]vices4  7b7 ,def9itions ,9 ?is        
section3 7#a7 ,select$ insul9 products  
,! t]m select$ insul9 products means at 
lea/ "o ( ea* dosage =m 7su* z vial1    
pump1 or inhal] dosage =ms7 ( ea*       
diff]5t type 7su* z rapid-act+1         
%ort-act+1 int]m$iate-act+1 long-act+1  
ultra long-act+1 & premix$7 ( insul9 7z 
def9$ bel[71 :5 available1 z select$ by 
! gr\p heal? plan or heal? insurance    
issu]4  7#b7 ,insul9 def9$ ,! t]m insul9
 means insul9 t is lic5s$ "u subsection 

7a7 or 7k7 ( section #cea & cont9ues to 
be m>ket$ "u su* section1 includ+ any   
insul9 product t has be5 deem$ to be    
lic5s$ "u section #cea7;a7 pursuant to  
section #gjjb7;e77#d7 ( ! ,biologics    
,price ,competition & ,innovation ,act (
 #bjji 7,public ,law #aaa-adh7 &        
cont9ues to be m>ket$ pursuant to su*   
lic5sure4  7c7 ,out-(-,network provid]s 
,no?+ 9 ?is section requires a plan or  
issu] t has a network ( provid]s to     
provide b5efits = select$ insul9        
products describ$ 9 ?is section t are   
deliv]$ by an out-(-network provid]1 or 
precludes a plan or issu] t has a       
network ( provid]s f impos+ high]       
co/-%>+ ?an ! levels specifi$ 9         
subsection 7a7 = select$ insul9 products
 describ$ 9 ?is section t are deliv]$ by
 an out-(-network provid]4  7d7 ,rule ( 
con/ruction ,subsection 7a7 %all n be   
con/ru$ to require cov]age (1 or prev5t 
a gr\p heal? plan or heal? insurance    
cov]age f impos+ co/-%>+ o!r ?an !      
levels specifi$ 9 subsection 7a7 on1    

insul9 products t are n select$ insul9  
products1 to ! ext5t t su* cov]age is n 
o!rwise requir$ & su* co/-%>+ is o!rwise
 p]mitt$ "u ,f$]al & applicable ,/ate   
law4  7e7 ,application ( co/-,%>+ t[>ds 
d$uctibles & out-(-,pocket maximums ,any
 co/-%>+ paym5ts made pursuant to       
subsection 7a77#b7 %all be c\nt$ t[>d   
any d$uctible or out-(-pocket maximum t 
applies "u ! plan or cov]age4  4  7b7   
,,erisa  7#a7 ,9 g5]al ,subp>t ,b ( "p  
#g ( subtitle ,b ( title ,i ( !         
,employee ,retirem5t ,income ,security  
,act ( #aigd 7#bi ,u4,s4,c4 #aahe et    
seq471 z am5d$ by sections #aja & #cja1 
is fur!r am5d$ by add+ at ! end ! foll[+
 new section3  #gbh4 ,requirem5ts )     
respect to co/-%>+ = c]ta9 insul9       
products  7a7 ,9 g5]al ,= plan ye>s     
beg9n+ on or aft] ,janu>y #a1 #bjbg1 a  
gr\p heal? plan or heal? insurance issu]
 (f]+ gr\p heal? insurance cov]age %all 
provide cov]age ( select$ insul9        
products1 & ) respect to su* products1  
%all n-- 7#a7 apply any d$uctible2 or   

7#b7 impose any co/-%>+ 9 excess ( !    
less] (1 p] #cj-;day supply-- 7,a7 #ce2 
or  7,b7 ! am\nt equal to #be p]c5t ( ! 
negotiat$ price ( ! select$ insul9      
product net ( all price concessions     
receiv$ by or on behalf ( ! plan or     
cov]age1 includ+ price concessions      
receiv$ by or on behalf ( ?ird-p>ty     
entities provid+ s]vices to ! plan or   
cov]age1 su* z ph>macy b5efit managem5t 
s]vices4  7b7 ,def9itions ,9 ?is        
section3 7#a7 ,select$ insul9 products  
,! t]m select$ insul9 products means at 
lea/ "o ( ea* dosage =m 7su* z vial1    
pump1 or inhal] dosage =ms7 ( ea*       
diff]5t type 7su* z rapid-act+1         
%ort-act+1 int]m$iate-act+1 long-act+1  
ultra long-act+1 & premix$7 ( insul9 7z 
def9$ bel[71 :5 available1 z select$ by 
! gr\p heal? plan or heal? insurance    
issu]4  7#b7 ,insul9 def9$ ,! t]m insul9
 means insul9 t is lic5s$ "u subsection 
7a7 or 7k7 ( section #cea ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7
 & cont9ues to be m>ket$ "u su* section1

 includ+ any insul9 product t has be5   
deem$ to be lic5s$ "u section #cea7;a7 (
 su* ,act pursuant to section           
#gjjb7;e77#d7 ( ! ,biologics ,price     
,competition & ,innovation ,act ( #bjji 
7,public ,law #aaa-adh7 & cont9ues to be
 m>ket$ pursuant to su* lic5sure4  7c7  
,out-(-,network provid]s ,no?+ 9 ?is    
section requires a plan or issu] t has a
 network ( provid]s to provide b5efits =
 select$ insul9 products describ$ 9 ?is 
section t are deliv]$ by an             
out-(-network provid]1 or precludes a   
plan or issu] t has a network ( provid]s
 f impos+ high] co/-%>+ ?an ! levels    
specifi$ 9 subsection 7a7 = select$     
insul9 products describ$ 9 ?is section t
 are deliv]$ by an out-(-network        
provid]4  7d7 ,rule ( con/ruction       
,subsection 7a7 %all n be con/ru$ to    
require cov]age (1 or prev5t a gr\p     
heal? plan or heal? insurance cov]age f 
impos+ co/-%>+ o!r ?an ! levels specifi$
 9 subsection 7a7 on1 insul9 products t 
are n select$ insul9 products1 to !     

ext5t t su* cov]age is n o!rwise requir$
 & su* co/-%>+ is o!rwise p]mitt$ "u    
,f$]al & applicable ,/ate law4  7e7     
,application ( co/-,%>+ t[>ds d$uctibles
 & out-(-,pocket maximums ,any co/-%>+  
paym5ts made pursuant to subsection     
7a77#b7 %all be c\nt$ t[>d any d$uctible
 or out-(-pocket maximum t applies "u ! 
plan or cov]age4  4  7#b7 ,cl]ical      
am5dm5t ,! table ( cont5ts 9 section #a 
( su* ,act is am5d$ by ins]t+ aft] !    
item relat+ to section #gbg 7z ins]t$ by
 section #cja7 ! foll[+ new item3  ,sec4
 #gbh4 ,requirem5ts ) respect to co/-%>+
 = c]ta9 insul9 products4  4  7c7 ,,irc 
7#a7 ,9 g5]al ,sub*apt] ,b ( *apt] #ajj 
( ! ,int]nal ,rev5ue ,code ( #aihf1 z   
am5d$ by sections #aja & #cja1 is fur!r 
am5d$ by add+ at ! end ! foll[+ new     
section3  #ihbh4 ,requirem5ts ) respect 
to co/-%>+ = c]ta9 insul9 products  7a7 
,9 g5]al ,= plan ye>s beg9n+ on or aft] 
,janu>y #a1 #bjbg1 a gr\p heal? plan    
%all provide cov]age ( select$ insul9   
products1 & ) respect to su* products1  

%all n-- 7#a7 apply any d$uctible2 or   
7#b7 impose any co/-%>+ 9 excess ( !    
less] (1 p] #cj-;day supply-- 7,a7 #ce2 
or  7,b7 ! am\nt equal to #be p]c5t ( ! 
negotiat$ price ( ! select$ insul9      
product net ( all price concessions     
receiv$ by or on behalf ( ! plan1       
includ+ price concessions receiv$ by or 
on behalf ( ?ird-p>ty entities provid+  
s]vices to ! plan1 su* z ph>macy b5efit 
managem5t s]vices4  7b7 ,def9itions ,9  
?is section3 7#a7 ,select$ insul9       
products ,! t]m select$ insul9 products 
means at lea/ "o ( ea* dosage =m 7su* z 
vial1 pump1 or inhal] dosage =ms7 ( ea* 
diff]5t type 7su* z rapid-act+1         
%ort-act+1 int]m$iate-act+1 long-act+1  
ultra long-act+1 & premix$7 ( insul9 7z 
def9$ bel[71 :5 available1 z select$ by 
! gr\p heal? plan4  7#b7 ,insul9 def9$  
,! t]m insul9 means insul9 t is lic5s$  
"u subsection 7a7 or 7k7 ( section #cea 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7 & cont9ues to be m>ket$ 
"u su* section1 includ+ any insul9      

product t has be5 deem$ to be lic5s$ "u 
section #cea7;a7 ( su* ,act pursuant to 
section #gjjb7;e77#d7 ( ! ,biologics    
,price ,competition & ,innovation ,act (
 #bjji 7,public ,law #aaa-adh7 &        
cont9ues to be m>ket$ pursuant to su*   
lic5sure4  7c7 ,out-(-,network provid]s 
,no?+ 9 ?is section requires a plan t   
has a network ( provid]s to provide     
b5efits = select$ insul9 products       
describ$ 9 ?is section t are deliv]$ by 
an out-(-network provid]1 or precludes a
 plan t has a network ( provid]s f      
impos+ high] co/-%>+ ?an ! levels       
specifi$ 9 subsection 7a7 = select$     
insul9 products describ$ 9 ?is section t
 are deliv]$ by an out-(-network        
provid]4  7d7 ,rule ( con/ruction       
,subsection 7a7 %all n be con/ru$ to    
require cov]age (1 or prev5t a gr\p     
heal? plan f impos+ co/-%>+ o!r ?an !   
levels specifi$ 9 subsection 7a7 on1    
insul9 products t are n select$ insul9  
products1 to ! ext5t t su* cov]age is n 
o!rwise requir$ & su* co/-%>+ is o!rwise

 p]mitt$ "u ,f$]al & applicable ,/ate   
law4  7e7 ,application ( co/-,%>+ t[>ds 
d$uctibles & out-(-,pocket maximums ,any
 co/-%>+ paym5ts made pursuant to       
subsection 7a77#b7 %all be c\nt$ t[>d   
any d$uctible or out-(-pocket maximum t 
applies "u ! plan4  4  7#b7 ,cl]ical    
am5dm5t ,! table ( sections = sub*apt]  
,b ( *apt] #ajj ( ! ,int]nal ,rev5ue    
,code ( #aihf1 z am5d$ by sections #aja 
& #cja1 is fur!r am5d$ by add+ at ! end 
! foll[+ new item3  ,sec4 #ihbh4        
,requirem5ts ) respect to co/-%>+ =     
c]ta9 insul9 products4  4  7d7 ,no      
effect on o!r co/-,%>+ ,section         
#acjb7;d77#b7 ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act 7#db ,u4,s4,c4      
#ahjbb7;d77#b77 is am5d$ by add+ at !   
end ! foll[+ new subp>agraph3  7,d7     
,special rule relat+ to insul9 cov]age  
,! exemption ( cov]age ( select$ insul9 
products 7z def9$ 9 section             
#bgii;,a-#ac7;b7 ( ! ,public ,heal?     
,s]vice ,act7 f ! application ( any     
d$uctible pursuant to section           

#bgii;,a-#ac7;a77#a7 ( su* ,act1 section
 #gbh7;a77#a7 ( ! ,employee ,retirem5t  
,income ,security ,act ( #aigd1 or      
section #ihbh7;a77#a7 ( ! ,int]nal      
,rev5ue ,code ( #aihf %all n be consid]$
 :5 det]m9+ ! actu>ial value ( a        
qualifi$ heal? plan "u ?is subsection4  
4  7e7 ,cov]age ( c]ta9 insul9 products 
"u cata/rophic plans ,section #acjb7;e7 
( ! ,pati5t ,protection & ,af=dable ,c>e
 ,act 7#db ,u4,s4,c4 #ahjbb7;e77 is     
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#d7 ,cov]age ( c]ta9 insul9 
products  7,a7 ,9 g5]al ,not)/&+        
p>agraph 7#a77;,b77i71 a heal? plan     
describ$ 9 p>agraph 7#a7 %all provide   
cov]age ( select$ insul9 products1 9    
accordance ) section #bgii;,a-#ac ( !   
,public ,heal? ,s]vice ,act1 = a plan   
ye> be=e an enroll$ individual has      
incurr$ co/-%>+ exp5ses 9 an am\nt equal
 to ! annual limitation 9 effect "u     
subsection 7c77#a7 = ! plan ye>4  7,b7  
,t]m9ology ,= purposes ( subp>agraph    
7,a7-- 7i7 ! t]m select$ insul9 products

 has ! mean+ giv5 su* t]m 9 section     
#bgii;,a-#ac7;b7 ( ! ,public ,heal?     
,s]vice ,act2 &  7ii7 ! requirem5ts (   
section #bgii;,a-#ac ( su* ,act %all be 
appli$ by deem+ ea* ref]5ce 9 su*       
section to individual heal? insurance   
cov]age to be a ref]5ce to a plan       
describ$ 9 p>agraph 7#a74  4