,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dgfi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #ba1 #bjai,ms4
 ,s*ak[sky introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce1 & 9 addition to ! ,committee  
on ,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 "p ,d (    
title ,,xviii ( ! ,social ,security ,act
 to deliv] a mean+ful b5efit & l[]      
prescription drug prices "u ! ,m$ic>e   
program4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,m$ic>e ,prescription ,drug 
,sav+s & ,*oice ,act ( #bjai4  #b4      
,e/abli%m5t ( ,m$ic>e op]at$            
prescription drug plan option  7a7 ,9   
g5]al ,subp>t #b ( "p ,d ( title ,,xviii
 ( ! ,social ,security ,act is am5d$ by 
ins]t+ aft] section #ahfj;,d-#aa 7#db   
,u4,s4,c4 #aciew-#aaa7 ! foll[+ new     
section3  #ahfj;,d-#aa;,a4 ,m$ic>e      
op]at$ prescription drug plan option    

7a7 ,9 g5]al ,not)/&+ any o!r provision 
( ?is "p1 = ea* ye> 7beg9n+ ) #bjba71 9 
addition to any plans (f]$ "u section   
#ahfj;,d-#aa1 ! ,secret>y %all (f] "o or
 m ,m$ic>e op]at$ prescription drug     
plans 7z def9$ 9 subsection 7d77 ) a    
s]vice area t consi/s ( ! entire ,unit$ 
,/ates & %all ent] into negotiations 9  
accordance ) subsection 7c7 )           
ph>maceutical manufactur]s to r$uce !   
pur*ase co/ ( cov]$ "p ,d drugs =       
eligible "p ,d individuals :o enroll 9  
su* a plan4  7b7 ,enrollm5t ,not)/&+    
subp>agraphs 7,c7 & 7,d7 ( section      
#ahfj;,d-#a7;b77#a71 a ,m$ic>e op]at$   
prescription drug plan (f]$ "u ?is      
section %all s]ve z ! default           
prescription drug plan = all "p ,d      
enrollees unless ano!r prescription drug
 plan is select$4  7c7 ,negotiations    
,not)/&+ section #ahfj;,d-#aa7;i71 =    
purposes ( (f]+ a ,m$ic>e op]at$        
prescription drug plan "u ?is section1 !
 ,secret>y %all negotiate )             
ph>maceutical manufactur]s ) respect to 

! pur*ase price ( cov]$ "p ,d drugs 9 a 
,m$ic>e op]at$ prescription drug plan & 
%all enc\rage ! use ( m af=dable        
!rapeutic equival5ts to ! ext5t su*     
practices d n ov]ride m$ical necessity z
 det]m9$ by ! prescrib+ physician4 ,to !
 ext5t practicable & consi/5t ) !       
previ\s s5t5ce1 ! ,secret>y %all        
implem5t negotiation & inc5tive         
/rategies simil> to ^? us$ by o!r ,f$]al
 pur*as]s ( prescription drugs to r$uce 
! pur*ase co/ ( cov]$ ,"p ,d drugs1 &   
o!r /rategies1 z describ$ 9 subsection  
7f71 :i* may include ! use ( a pric+    
scale bas$ on an int]national price     
index4  7d7 ,m$ic>e op]at$ prescription 
drug plan def9$ ,= purposes ( ?is "p1 ! 
t]m ,m$ic>e op]at$ prescription drug    
plan means a compreh5sive prescription  
drug plan t (f]s qualifi$ prescription  
drug cov]age & access to negotiat$      
prices describ$ 9 section               
#ahfj;,d-#b7;a77#a77;,a74 ,su* a plan   
may (f] supplem5tal prescription drug   
cov]age 9 ! same mann] z o!r qualifi$   

prescription drug cov]age (f]$ by o!r   
prescription drug plans4  7e7 ,mon?ly   
b5efici>y premium  7#a7 ,qualifi$       
prescription drug cov]age ,! mon?ly     
b5efici>y premium = qualifi$            
prescription drug cov]age & access to   
negotiat$ prices describ$ 9 section     
#ahfj;,d-#b7;a77#a77;,a7 to be *>g$ "u a
 ,m$ic>e op]at$ prescription drug plan  
%all be uni=m nationally4 ,su* premium =
 mon?s 9 #bjba & ea* succe$+ ye> %all be
 bas$ on ! av]age mon?ly p] capita      
actu>ial co/ ( (f]+ ! ,m$ic>e op]at$    
prescription drug plan = ! ye> involv$1 
includ+ adm9i/rative exp5ses4  7#b7     
,supplem5tal prescription drug cov]age  
,ins(> z a ,m$ic>e op]at$ prescription  
drug plan (f]s supplem5tal prescription 
drug cov]age1 ! ,secret>y may adju/ !   
am\nt ( ! premium *>g$ "u p>agraph 7#a74
  7f7 ,use ( negotiation & b5efit design
 inc5tives  7#a7 ,9 g5]al ,) respect to 
! op]ation ( a ,m$ic>e op]at$           
prescription drug plan & 9 negotiat+ )  
respect to ! pur*ase price ( cov]$ "p ,d

 drugs 9 su* plan1 ! ,secret>y %all     
rew>d value1 increase appropriate use ( 
drugs1 & ensure pati5t safety & access  
to m$ications4  7#b7 ,role ( ,,ahrq ,!  
,director ( ! ,ag5cy = ,heal?c>e ,rese>*
 & ,quality1 9 coord9ation ) !          
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices1 %all be responsible =
 assess+ ! cl9ical b5efit ( cov]$ "p ,d 
drugs & mak+ recomm5dations to !        
,secret>y reg>d+ ! negotiat$ prices (   
cov]$ drugs & any appropriate ti]+ or   
inc5tive /rategies "u ! plan4 ,9        
conduct+ su* assessm5ts & mak+ su*      
recomm5dations1 ! ,director %all c>ry   
out ! foll[+ activities3  7,a7 ,consid] 
! comp>able int]national price ( su*    
drugs bas$ ^u ! m$ian retail li/ price (
 su* drug 7:i* %all be1 z practicable1 !
 volume-weight$ price = comp>able units 
& dosage =ms7 among a category ( at lea/
 ! foll[+ pe] ref]5ce c\ntries3 ,canada1
 ! ,unit$ ,k+dom1 ,france1 ,japan1      
,au/ralia1 & ,g]many4  7,b7 ,consid]    
safety conc]ns & po/-m>ket data1 includ+

 ^? id5tifi$ by ! ,food & ,drug         
,adm9i/ration & f national heal?        
regi/ries4  7,c7 ,use available data &  
evaluations1 includ+ f rese>* support$  
by ! ,national ,in/itutes ( ,heal?1 )   
priority giv5 to r&omiz$ controll$      
trials1 to exam9e cl9ical effectiv5ess1 
comp>ative effectiv5ess1 safety1 &      
enhanc$ compliance ) a drug regim54     
7,d7 ,use ! same classes ( drugs        
develop$ by ,unit$ ,/ates ,ph>macopeia =
 ?is "p4  7,e7 ,consid] evaluations made
 by--  7i7 ! ,director "u section #ajac 
( ! ,m$ic>e ,prescription ,drug1        
,improvem5t1 & ,mod]nization ,act (     
#bjjc2  7ii7 o!r ,f$]al entities1 su* z 
! ,secret>y ( ,vet]ans ,affairs2 &      
7iii7 o!r private & public entities1 :i*
 may include ! ,drug ,effectiv5ess      
,review ,project & ,m$icaid programs4   
7,f7 ,consid] recomm5dations made by !  
advisory committee pursuant to p>agraph 
7#c77;,f74  7,g7 ,recomm5d to !         
,secret>y ^? drugs 9 a class t provide a
 great] cl9ical b5efit1 includ+ few]    

safety conc]ns or less risk (           
side-effects1 ?an ano!r drug 9 ! same   
class4  7#c7 ,use ( advisory committee  
7,a7 ,9 g5]al ,! ,secret>y %all e/abli% 
& appo9t an advisory committee 79 ?is   
p>agraph ref]r$ to z ! advisory         
committee7--  7i7 to review petitions f 
drug manufactur]s1 heal? c>e provid]    
organizations1 pati5t gr\ps1 & o!r      
entities reg>d+ negotiat$ prices2 &     
7ii7 to recomm5d any *anges 9 ord] to   
fur!r negotiations ) respect to su*     
prices4  7,b7 ,composition ,subject to  
subp>agraph 7,c71 ! advisory committee  
%all be compos$ ( #i memb]s & %all      
include repres5tatives ( physicians1    
ph>maci/s1 consum]s1 & o!rs ) exp]tise 9
 evaluat+ prescription drugs4 ,!        
,secret>y %all select memb]s bas$ on _! 
k ( ph>maceuticals & ! ,m$ic>e          
population4 ,memb]s %all be deem$ to be 
special ,gov]nm5t employees = purposes (
 apply+ ! conflict ( int]e/ provisions  
"u section #bjh ( title #ah1 ,unit$     
,/ates ,code1 & no waiv] ( su*          

provisions = su* a memb] %all be        
p]mitt$4  7,c7 ,bann$ individuals  7i7  
,drug company lobbyi/s ,no =m] regi/]$  
drug manufactur] lobbyi/-- 7,i7 may be  
appo9t$ to ! advisory committee2 or     
7,,ii7 may be employ$ by ! advisory     
committee dur+ ! #f-ye> p]iod beg9n+ on 
! date on :i* ! regi/]$ lobbyi/ t]m9ates
 its regi/ration 9 accordance ) section 
#d7;d7 ( ! ,lobby+ ,disclosure ,act (   
#aiie 7#b ,u4,s4,c4 #afjc7;d77 or ! ag5t
 t]m9ates its /atus1 z applicable4  7ii7
 ,s5ior executives ( law-break+         
companies ,no =m] s5ior executive ( a   
cov]$ entity 7z def9$ 9 clause 7iii77-- 
7,i7 may be appo9t$ to ! ,advisory      
,committee2 or  7,,ii7 may be employ$ by
 ! ,advisory ,committee dur+ ! #f-ye>   
p]iod beg9n+ on ! lat] (-- 7aa7 ! date (
 ! settlem5t describ$ 9 item 7aa7 (     
clause 7iii77,,ii72 or  7bb7 ! date on  
:i* ! en=cem5t action describ$ 9 item   
7bb7 ( su* clause has conclud$4  7iii7  
,cov]$ entity ,! t]m cov]$ entity means 
any entity t is--  7,i7 a drug          

manufactur]2 &  7,,ii7 7aa7 op]at+ "u   
,f$]al settlem5t includ+ a ,f$]al cons5t
 decree2 or  7bb7 ! subject ( an        
en=cem5t action 9 a c\rt ( ! ,unit$     
,/ates or by an ag5cy4  7,d7            
,consultation ,! advisory committee %all
 consult1 z necess>y1 ) physicians :o   
are speciali/s 9 treat+ ! disease = :i* 
a drug is be+ consid]$4  7,e7 ,reque/ = 
/udies ,! advisory committee may reque/ 
! ,ag5cy = ,heal?c>e ,rese>* & ,quality 
or an academic or rese>* in/itution to  
/udy & make a report on a petition      
describ$ 9 subp>agraph 7,a77i7 9 ord] to
 assess co/-effectiv5ess1 cl9ical       
effectiv5ess1 comp>ative effectiv5ess1  
safety1 & compliance ) a drug regim54   
7,f7 ,recomm5dations ,! advisory        
committee %all make recomm5dations to ! 
,director ( ! ,ag5cy = ,heal?c>e ,rese>*
 & ,quality reg>d+ ! appropriate price  
at :i* to beg9 negotiations on a "p ,d  
drug pursuant to ?is section4  7,g7     
,limitations on review ( manufactur]    
petitions ,! advisory committee %all n  

review a petition ( a drug manufactur]  
"u subp>agraph 7,a77i7 ) respect to a   
cov]$ "p ,d drug unless ! petition is   
accompani$ by ! foll[+3  7i7 ,raw data f
 cl9ical trials on ! safety &           
effectiv5ess ( ! drug4  7ii7 ,any data f
 cl9ical trials conduct$ us+ active     
controls on ! drug or drugs t are !     
curr5t /&>d ( c>e4  7iii7 ,any available
 data on comp>ative effectiv5ess ( !    
drug4  7iv7 ,any o!r in=mation !        
,secret>y requires = ! advisory         
committee to complete its review4  7g7  
,in=m+ b5efici>ies ,! ,secret>y %all    
take /eps to in=m "p ,d eligible        
individuals n previ\sly enroll$ 9 a     
,m$ic>e op]at$ drug plan 7includ+ su*   
individuals :o are newly eligible to    
enroll "u ?is "p7 reg>d+ ! enrollm5t (  
su* individual 9 a ,m$ic>e op]at$ drug  
plan 9 accordance ) ?is section1 includ+
 provid+ in=mation 9 ! annual h&book &  
add+ in=mation to ! (ficial public      
,m$ic>e website relat$ to prescription  
drug cov]age available ?r\gh ?is "p4    

7h7 ,application ( all o!r requirem5ts =
 prescription drug plans ,except z      
specifically provid$ 9 ?is section1 any 
,m$ic>e op]at$ drug plan %all meet !    
same requirem5ts z apply to any o!r     
prescription drug plan1 includ+ !       
requirem5ts ( section                   
#ahfj;,d-#d7;b77#a7 relat+ to assur+    
ph>macy access4  4  7b7 ,con=m+ am5dm5ts
  7#a7 ,section #ahfj;,d-#c7;a7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#ajc7;a77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#d7        
,availability ( ! m$ic>e op]at$         
prescription drug plan ,a ,m$ic>e op]at$
 prescription drug plan 7z def9$ 9      
section #ahfj;,d-#aa;,a7d77 %all be (f]$
 nationally 9 accordance ) section      
#ahfj;,d-#aa;,a4  4  7#b7  7,a7 ,section
 #ahfj;,d-#c ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#ajc7 is am5d$ by 
add+ at ! end ! foll[+ new subsection3  
7c7 ,provisions only applicable 9 #bjjf 
?r\gh #bjbj ,! provisions ( ?is section 
%all only apply ) respect to #bjjf ?r\gh

 #bjbj4  4  7,b7 ,section               
#ahfj;,d-#aa7;g7 ( su* ,act 7#db        
,u4,s4,c4 #aciew-#aaa7;g77 is am5d$ by  
add+ at ! end ! foll[+ new p>agraph3    
7#h7 ,no au?ority = fallback plans aft] 
#bjbj ,a fallback prescription drug plan
 %all n be available aft] ,decemb] #ca1 
#bjbj4  4  7#c7 ,section                
#ahfj;,d-#ac7;c77#c7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#aac7;c77#c77 is am5d$--  7,a7 9 
! head+1 by ins]t+ & ,m$ic>e op]at$     
prescription drug plans aft] ,fallback  
plans2 &  7,b7 by ins]t+ or a ,m$ic>e   
op]at$ prescription drug plan aft] a    
fallback prescription drug plan4  7#d7  
,section #ahfj;,d-#af7;b77#a7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aaf7;b77#a77 is am5d$-- 7,a7 9  
subp>agraph 7,c71 by /rik+ & aft] !     
semicolon at ! end2  7,b7 9 subp>agraph 
7,d71 by /rik+ ! p]iod at ! end & ins]t+
 2 &2 &  7,c7 by add+ at ! end ! foll[+ 
new subp>agraph3  7,e7 paym5ts = exp5ses
 incurr$ ) respect to ! op]ation (      

,m$ic>e op]at$ prescription drug plans  
"u section #ahfj;,d-#aa;,a4  4  7#e7    
,section #ahfj;,d-#da7;a7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#aciew-#aea7;a77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#ai7       
,m$ic>e op]at$ prescription drug plan ,!
 t]m ,m$ic>e op]at$ prescription drug   
plan has ! mean+ giv5 su* t]m 9 section 
#ahfj;,d-#aa;,a7d74  4  7c7 ,rule (     
con/ruction ,no?+ 9 ?is section %all be 
int]pret$ to sup]s$e any o!r negotiation
 au?ority grant$ to ! ,secret>y "u      
,f$]al law ) respect to prescription    
drug prices4  #c4 ,improv$ appeals      
process "u ! ,m$ic>e op]at$ prescription
 drug plan ,section #ahfj;,d-#d7;h7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acjew-#ajd7;h77 is am5d$ by add+ at !  
end ! foll[+ new p>agraph3  7#d7        
,appeals process = ,m$ic>e op]at$       
prescription drug plan  7,a7 ,9 g5]al ,!
 ,secret>y %all develop a well-def9$    
process = appeals = d5ials ( b5efits "u 
?is "p "u ! ,m$ic>e op]at$ prescription 

drug plan 7z def9$ 9 section            
#ahfj;,d-#aa;,a7d774 ,su* process %all  
be effici5t1 impose m9imal adm9i/rative 
burd5s1 & ensure ! timely procurem5t (  
m$ications4 ,m$ical necessity %all be   
bas$ on pr(essional m$ical judgm5t1 !   
m$ical condition ( ! b5efici>y1 & o!r   
m$ical evid5ce4  7,b7 ,consultation 9   
developm5t ( process ,9 develop+ !      
appeals process "u subp>agraph 7,a71 !  
,secret>y %all consult ) consum] &      
pati5t gr\ps1 z well z o!r key          
/akehold]s1 to ensure ! goals describ$ 9
 subp>agraph 7,a7 are a*iev$4  4