,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #ehhb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,febru>y #ab1         
#bjbj,mr4 ,s*rad] 7= himself1 ,mr4      
,m>%all1 ,mr4 ,cr[1 ,mr4 ,mull91 ,mr4   
,b]a1 ,mr4 ,kelly ( ,p5nsylvania1 & ,mr4
 ,s*weik]t7 introduc$ ! foll[+ bill2 :i*
 0 ref]r$ to ! ,committee on ,en]gy &   
,comm]ce  ,a ,,bill  ,to am5d title     
,,xix ( ! ,social ,security ,act to     
provide ,/ates ) ! option "u ! ,m$icaid 
program to pay = cov]$ outpati5t drugs  
?r\gh risk-%>+ value-bas$ agreem5ts1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,g5]at+ ,effective 
& ,novel ,evid5ce = ,!rapy ,paym5t ,act 
or ,,g5e ,!rapy ,paym5t ,act4  #b4      
,risk-%>+ value-bas$ paym5t agreem5ts = 
cov]$ outpati5t drugs "u ,m$icaid  7a7  
,9 g5]al ,section #aibg ( ! ,social     
,security ,act 7#db ,u4,s4,c4 #acifr-#h7
 is am5d$ by add+ at ! end ! foll[+ new 
subsection3  7l7 ,/ate option ,to pay = 
cov]$ outpati5t drugs ?r\gh risk-,%>+   
value-,bas$ agreem5ts  7#a7 ,9 g5]al    

,beg9n+ ,janu>y #a1 #bjbb1 a ,/ate %all 
h ! option to pay 7:e!r on a            
fee-=-s]vice or manag$ c>e basis7 =     
cov]$ outpati5t drugs t are pot5tially  
curative treatm5ts int5d$ = "o-"t use t 
are adm9i/]$ to individuals "u ?is title
 by ent]+ into a risk-%>+ value-bas$    
paym5t agreem5t ) ! manufactur] ( ! drug
 9 accordance ) ! requirem5ts ( ?is     
subsection4  7#b7 ,secret>ial approval  
7,a7 ,9 g5]al ,a ,/ate %all submit a    
reque/ to ! ,secret>y to ent] into a    
risk-%>+ value-bas$ paym5t agreem5t1 & !
 ,secret>y %all n approve a propos$     
risk-%>+ value-bas$ paym5t agreem5t     
betwe5 a ,/ate & a manufactur] = paym5t 
= a cov]$ outpati5t drug ( ! manufactur]
 unless ! foll[+ requirem5ts are met3   
7i7 ,manufactur] has 9 effect a rebate  
agreem5t & is 9 compliance ) all        
applicable requirem5ts ,! manufactur]   
has a rebate agreem5t 9 effect z requir$
 "u subsections 7a7 & 7b7 ( ?is section 
& is 9 compliance ) all applicable      
requirem5ts "u ?is title4  7ii7 ,no     

increase to project$ net ,f$]al sp5d+   
7,i7 ,9 g5]al ,! ,*ief ,actu>y c]tifies 
t ! project$ paym5ts = ea* cov]$        
outpati5t drug "u a propos$ risk-%>+    
value-bas$ paym5t agreem5t is n expect$ 
to result 9 great] e/imat$ ,f$]al sp5d+ 
"u ?is title ?an ! net ,f$]al sp5d+ t   
w\ld result 9 ! abs5ce ( su* agreem5t4  
7,,ii7 ,net f$]al sp5d+ def9$ ,=        
purposes ( ?is subsection1 ! t]m net    
,f$]al sp5d+ means ! am\nt ( ,f$]al     
paym5ts ! ,*ief ,actu>y e/imates w\ld be
 made "u ?is title = adm9i/]+ a cov]$   
outpati5t drug to an individual eligible
 = m$ical assi/ance "u a ,/ate plan or a
 waiv] ( su* plan1 r$uc$ by ! am\nt (   
all rebates ! ,*ief ,actu>y e/imates    
w\ld be paid ) respect to ! adm9i/]+ (  
su* drug1 includ+ all rebates "u ?is    
title & any supplem5tal or o!r          
additional rebates1 9 ! abs5ce ( su* an 
agreem5t4  7,,iii7 ,in=mation ,! ,*ief  
,actu>y %all make ! c]tifications       
requir$ "u ?is clause bas$ on ! mo/     
rec5tly available & reliable drug pric+ 

& product in=mation4 ,! ,/ate &         
manufactur] %all provide ! ,secret>y & !
 ,*ief ,actu>y ) all necess>y in=mation 
requir$ to make ! e/imates ne$$ = su*   
c]tifications4  7iii7 ,laun* & li/ price
 ju/ifications ,! manufactur] submits   
all relevant in=mation & support+       
docum5tation necess>y = pric+ decisions 
z deem$ appropriate by ! ,secret>y1 :i* 
%all be tru?ful & non-mislead+1 includ+ 
manufactur] in=mation & support+        
docum5tation = laun* price or li/ price 
increases1 & any applicable ju/ification
 requir$ "u section #aabh,l4  7iv7      
,confid5tiality ( in=mation2 p5alties ,!
 provisions ( subp>agraphs 7,c7 & 7,d7 (
 subsection 7b77#c7 %all apply to a     
manufactur] t fails to submit !         
in=mation & docum5tation requir$ "u     
clauses 7ii7 & 7iii7 on a timely basis1 
or t kn[+ly provides false or mislead+  
in=mation1 9 ! same mann] z su*         
provisions apply to a manufactur] ) a   
rebate agreem5t "u ?is section4  7,b7   
,consid]ation ( ,/ate reque/ = approval 

7i7 ,9 g5]al ,! ,secret>y %all treat a  
,/ate reque/ = approval ( a risk-%>+    
value-bas$ paym5t agreem5t 9 ! same     
mann] t ! ,secret>y treats a ,/ate plan 
am5dm5t1 & subp>t ,b ( "p #dcj ( title  
#db1 ,code ( ,f$]al ,regulations1       
includ+1 subject to clause 7ii71 ! tim+ 
requirem5ts ( section #dcj4af ( su*     
title 7z 9 effect on ! date ( enactm5t (
 ?is subsection71 %all apply to a reque/
 = approval ( a risk-%>+ value-bas$     
paym5t agreem5t 9 ! same mann] z su*    
subp>t applies to a ,/ate plan am5dm5t4 
7ii7 ,tim+ ,! ,secret>y %all consult ) !
 ,commission] ( ,food & ,drugs z requir$
 "u subp>agraph 7,c7 & make a           
det]m9ation on :e!r to approve a reque/ 
f a ,/ate = approval ( a propos$        
risk-%>+ value-bas$ paym5t agreem5t 7or 
reque/ additional in=mation necess>y to 
all[ ! ,secret>y to make a det]m9ation )
 respect to su* reque/ = approval7 )9 ! 
"t p]iod1 to ! ext5t practicable1       
specifi$ 9 section #dcj4af ( title #db1 
,code ( ,f$]al ,regulations 7z 9 effect 

on ! date ( enactm5t ( ?is subsection71 
b 9 no case %all ! ,secret>y take m ?an 
#ahj days aft] ! receipt ( su* reque/ = 
approval or response to su* reque/ =    
additional in=mation to make su* a      
det]m9ation 7or reque/ additional       
in=mation74  7,c7 ,consultation ) !     
,commission] ( ,food & ,drugs ,9        
consid]+ :e!r to approve a risk-%>+     
value-bas$ paym5t agreem5t1 ! ,secret>y1
 to ! ext5t necess>y1 %all consult ) !  
,commission] ( ,food & ,drugs to det]m9e
 :e!r ! relevant cl9ical p>amet]s       
specifi$ 9 su* agreem5t are appropriate4
  7#c7 ,in/allm5t-bas$ paym5t /ructure  
7,a7 ,9 g5]al ,a risk-%>+ value-bas$    
paym5t agreem5t %all provide = a paym5t 
/ructure "u :i*1 = e in/allm5t ye> ( !  
agreem5t 7subject to subp>agraph 7,b771 
! ,/ate %all pay ! total in/allm5t ye>  
am\nt 9 equal in/allm5ts to be paid at  
regul> int]vals ov] a p]iod ( "t t %all 
be specifi$ 9 ! agreem5t4  7,b7         
,requirem5ts = in/allm5t paym5ts  7i7   
,tim+ ( fir/ paym5t ,! ,/ate %all make !

 fir/ ( ! in/allm5t paym5ts describ$ 9  
subp>agraph 7,a7 = an in/allm5t ye> n   
lat] ?an #cj days aft] ! end ( su* ye>4 
7ii7 ,l5g? ( in/allm5t p]iod ,! p]iod ( 
"t ov] :i* ! ,/ate %all make ! in/allm5t
 paym5ts describ$ 9 subp>agraph 7,a7 =  
an in/allm5t ye> %all n be long] ?an #e 
ye>s4  7iii7 ,nonpaym5t or r$uc$ paym5t 
( in/allm5ts foll[+ a failure to meet   
cl9ical p>amet] ,if1 prior to ! paym5t  
date 7z specifi$ 9 ! agreem5t7 ( any    
in/allm5t paym5t describ$ 9 subp>agraph 
7,a7 or any o!r alt]native date or "t   
frame 7z o!rwise specifi$ 9 ! agreem5t71
 ! cov]$ outpati5t drug :i* is subject  
to ! agreem5t fails to meet a relevant  
cl9ical p>amet] ( ! agreem5t1 ! agreem5t
 %all provide t-- 7,i7 ! in/allm5t      
paym5t %all n be made2 or  7,,ii7 !     
in/allm5t paym5t %all be r$uc$ by a     
p]c5tage specifi$ 9 ! agreem5t t is bas$
 on ! outcome a*iev$ by ! drug relative 
to ! relevant cl9ical p>amet]4  7#d7    
,notice ( int5t  7,a7 ,9 g5]al ,subject 
to subp>agraph 7,b71 a manufactur] ( a  

cov]$ outpati5t drug %all n be eligible 
to ent] into a risk-%>+ value-bas$      
paym5t agreem5t "u ?is subsection )     
respect to su* drug unless ! manufactur]
 notifies ! ,secret>y t ! manufactur] is
 int]e/$ 9 ent]+ into su* an agreem5t ) 
respect to su* drug4 ,! decision to     
submit & tim+ ( a reque/ to ent] into a 
propos$ risk-%>+ value-bas$ paym5t      
agreem5t %all rema9 solely )9 !         
discretion ( ! ,/ate & %all only be     
effective ^u ,secret>ial approval z     
requir$ "u ?is subsection4  7,b7        
,treatm5t ( subsequ5tly approv$ drugs   
7i7 ,9 g5]al ,9 ! case ( a manufactur] (
 a cov]$ outpati5t drug approv$ "u      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act or lic5s$ "u section #cea
 ( ! ,public ,heal? ,s]vice ,act aft] ! 
date ( enactm5t ( ?is subsection1 n m   
?an #ij days aft] meet+ ) ! ,food &     
,drug ,adm9i/ration foll[+ phase ,,ii   
cl9ical trials = su* drug 7or1 9 ! case 
( a drug describ$ 9 clause 7ii71 n lat] 
?an ,m>* #ca1 #bjbb71 ! manufactur] mu/ 

notify ! ,secret>y ( ! manufactur]'s    
int5t to ent] into a risk-%>+ value-bas$
 paym5t agreem5t "u ?is subsection )    
respect to su* drug4 ,if no su* meet+   
has occurr$1 ! ,secret>y may use        
discretion z to :e!r a pot5tially       
curative treatm5t int5d$ = "o-"t use may
 qualify = a risk-%>+ value-bas$ paym5t 
agreem5t "u ?is section4 ,a manufactur] 
notification ( int]e/ %all n h any      
influ5ce on a decision = drug approval  
by ! ,food & ,drug ,adm9i/ration4  7ii7 
,application to c]ta9 subsequ5tly       
approv$ drugs ,a drug describ$ 9 ?is    
clause is a cov]$ outpati5t drug ( a    
manufactur]-- 7,i7 t is approv$ "u      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act or lic5s$ "u section #cea
 ( ! ,public ,heal? ,s]vice ,act aft] ! 
date ( enactm5t ( ?is subsection2 &     
7,,ii7 ) respect to :i*1 z ( ,janu>y #a1
 #bjbb1 m ?an #ij days h pass$ aft] !   
manufactur]'s meet+ ) ! ,food & ,drug   
,adm9i/ration foll[+ phase ,,ii cl9ical 
trials = su* drug4  7iii7 ,p>allel      

approval ,! ,secret>y1 9 coord9ation ) !
 ,adm9i/rator ( ! ,c5t]s = ,m$ic>e      
,m$icaid ,s]vices & ! ,commission] (    
,food & ,drugs1 %all1 to ! ext5t        
practicable1 approve a ,/ate's reque/ to
 ent] into a propos$ risk-%>+ value-bas$
 paym5t agreem5t t o!rwise meets !      
requirem5ts ( ?is subsection at ! "t t  
su* a drug is approv$ by ! ,food & ,drug
 ,adm9i/ration to help provide t no     
,/ate t wi%es to ent] into su* an       
agreem5t is requir$ to pay = ! drug 9   
full at "o "t if ! ,/ate is seek+ to pay
 ov] a p]iod ( "t z outl9$ 9 ! propos$  
agreem5t4  7iv7 ,rule ( con/ruction     
,no?+ 9 ?is p>agraph %all be appli$ or  
con/ru$ to modify or affect ! timeframes
 or factors involv$ 9 ! ,secret>y's     
det]m9ation ( :e!r to approve or lic5se 
a drug "u section #eje ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act or section #cea
 ( ! ,public ,heal? ,s]vice ,act4  7#e7 
,special paym5t rules  7,a7 ,9 g5]al    
,except z o!rwise provid$ 9 ?is         
p>agraph1 ) respect to an individual :o 

is adm9i/]$ a unit ( a cov]$ outpati5t  
drug t is reimburs$ "u a ,/ate plan by a
 ,/ate ,m$icaid ag5cy "u a risk-%>+     
value-bas$ paym5t agreem5t 9 an         
in/allm5t ye>1 ! ,/ate %all rema9 liable
 to ! manufactur] ( su* drug = paym5t = 
su* unit )\t reg>d to :e!r ! individual 
rema9s enroll$ 9 ! ,/ate plan "u ?is    
title 7or a waiv] ( su* plan7 = ea*     
in/allm5t ye> = :i* ! ,/ate is to make  
in/allm5t paym5ts = cov]$ outpati5t     
drugs pur*as$ "u ! agreem5t 9 su* ye>4  
7,b7 ,dea? ,9 ! case ( an individual    
describ$ 9 subp>agraph 7,a7 :o dies dur+
 ! p]iod describ$ 9 su* subp>agraph1 !  
,/ate plan %all n be liable = any rema9+
 paym5t = ! unit ( ! cov]$ outpati5t    
drug adm9i/]$ to ! individual :i* is ow$
 "u ! agreem5t describ$ 9 su*           
subp>agraph4  7,c7 ,)drawal ( approval  
,9 ! case ( a cov]$ outpati5t drug t is 
! subject ( a risk-%>+ value-bas$ paym5t
 agreem5t betwe5 a ,/ate & a manufactur]
 "u ?is subsection1 includ+ a drug      
approv$ 9 accordance ) section #ejf7;c7 

( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act1 & su* drug is ! subject ( an      
application t has be5 )drawn by !       
,secret>y1 ! ,/ate plan %all n be liable
 = any rema9+ paym5t t is ow$ "u !      
agreem5t4  7,d7 ,alt]native arrangem5t  
"u agreem5t ,subject to approval by !   
,secret>y1 ! t]ms ( a propos$ risk-%>+  
value-bas$ paym5t agreem5t submitt$ =   
approval by a ,/ate may provide t       
subp>agraph 7,a7 %all n apply4  7,e7    
,guidance ,n lat] ?an ,janu>y #a1 #bjbb1
 ! ,secret>y %all issue guidance to     
,/ates e/abli%+ a process = ,/ates to   
notify ! ,secret>y :5 an individual :o  
is adm9i/]$ a unit ( a cov]$ outpati5t  
drug t is pur*as$ by a ,/ate plan "u a  
risk-%>+ value-bas$ paym5t agreem5t     
ceases to be enroll$ "u ! ,/ate plan "u 
?is title 7or a waiv] ( su* plan7 or    
dies be=e ! end ( ! in/allm5t p]iod     
applicable to su* unit "u ! agreem5t4   
7#f7 ,treatm5t ( paym5ts "u risk-%>+    
value-bas$ agreem5ts = purposes ( av]age
 manufactur] price2 be/ price ,!        

,secret>y %all treat any paym5ts made to
 ! manufactur] ( a cov]$ outpati5t drug 
"u a risk-%>+ value-bas$ paym5t agreem5t
 "u ?is subsection dur+ a rebate p]iod 9
 ! same mann] t ! ,secret>y treats      
paym5ts made "u a ,/ate supplem5tal     
rebate agreem5t "u sections             
#ddg4ejd7;c77#ai7 & #ddg4eje7;c77#g7 (  
title #db1 ,code ( ,f$]al ,regulations  
7or any successor regulations7 =        
purposes ( det]m9+ av]age manufactur]   
price & be/ price "u ?is section )      
respect to ! cov]$ outpati5t drug & a   
rebate p]iod & = purposes ( (fsets      
requir$ "u subsection 7b77#a77;,b74     
7#g7 ,assessm5ts & report to ,congress  
7,a7 ,assessm5ts  7i7 ,9 g5]al ,n lat]  
?an #ahj days aft] ! end ( ea* assessm5t
 p]iod ( any risk-%>+ value-bas$ paym5t 
agreem5t = a ,/ate approv$ "u ?is       
subsection1 ! ,secret>y %all conduct an 
evaluation ( su* agreem5t :i* %all      
include an evaluation by ! ,*ief ,actu>y
 to det]m9e :e!r program sp5d+ "u !     
risk-%>+ value-bas$ paym5t agreem5t     

align$ ) ! projections = ! agreem5t made
 "u p>agraph 7#b77;,a77ii71 includ+ an  
assessm5t ( :e!r actual ,f$]al sp5d+ "u 
?is title "u ! agreem5t 0 less or m ?an 
net ,f$]al sp5d+ w\ld h be5 9 ! abs5ce (
 ! agreem5t4  7ii7 ,assessm5t p]iod ,=  
purposes ( clause 7i7-- 7,i7 ! fir/     
assessm5t p]iod = a risk-%>+ value-bas$ 
paym5t agreem5t %all be ! p]iod ( "t ov]
 :i* paym5ts are s*$ul$ to be made "u ! 
agreem5t = ! fir/ #aj individuals :o are
 adm9i/]$ cov]$ outpati5t drugs "u !    
agreem5t except t su* p]iod %all n exce$
 ! #e-ye> p]iod aft] ! date on :i* !    
,secret>y approves ! agreem5t2 &  7,,ii7
 ea* subsequ5t assessm5t p]iod = a      
risk-%>+ value-bas$ paym5t agreem5t %all
 be ! #e-ye> p]iod foll[+ ! end ( !     
previ\s assessm5t p]iod4  7,b7 ,results 
( assessm5ts  7i7 ,t]m9ation option ,if 
! ,secret>y det]m9es z a result ( !     
assessm5t by ! ,*ief ,actu>y "u         
subp>agraph 7,a7 t ! actual ,f$]al sp5d+
 "u ?is title = any cov]$ outpati5t drug
 t 0 ! subject ( ! ,/ate's risk-%>+     

value-bas$ paym5t agreem5t 0 great] ?an 
! net ,f$]al sp5d+ t w\ld h result$ 9 ! 
abs5ce ( ! agreem5t1 ! ,secret>y may    
t]m9ate approval ( su* agreem5t & %all  
imm$iately conduct an assessm5t "u ?is  
p>agraph ( any o!r ongo+ risk-%>+       
value-bas$ paym5t agreem5t to :i* ! same
 manufactur] is a p>ty4  7ii7 ,repaym5t 
requir$  7,i7 ,9 g5]al ,if ! ,secret>y  
det]m9es z a result ( ! assessm5t by !  
,*ief ,actu>y "u subp>agraph 7,a7 t !   
,f$]al sp5d+ "u ! risk-%>+ value-bas$   
agreem5t = a cov]$ outpati5t drug t 0   
subject to su* agreem5t 0 great] ?an !  
net ,f$]al sp5d+ t w\ld h result$ 9 !   
abs5ce ( ! agreem5t1 ! manufactur] %all 
repay ! diff]5ce to ! ,/ate & ,f$]al    
,gov]nm5ts 9 a timely mann] z det]m9$ by
 ! ,secret>y4  7,,ii7 ,t]m9ation =      
failure to pay ,! failure ( a           
manufactur] to make repaym5ts requir$ "u
 subclause 7,i7 9 a timely mann] %all   
result 9 imm$iate t]m9ation ( all       
risk-%>+ value-bas$ agreem5ts to :i* !  
manufactur] is a p>ty4  7,,iii7         

,additional p5alties ,9 ! case ( a      
manufactur] t fails to make repaym5ts   
requir$ "u subclause 7,i71 ! ,secret>y  
may treat su* manufactur] 9 ! same mann]
 z a manufactur] t fails to pay requir$ 
rebates "u ?is section1 & ! ,secret>y   
may-- 7aa7 susp5d or t]m9ate !          
manufactur]'s rebate agreem5t "u ?is    
section2 &  7bb7 pursue any o!r rem$y t 
w\ld be available if ! manufactur] _h   
fail$ to pay requir$ rebates "u ?is     
section4  7,c7 ,report to congress ,n   
lat] ?an #e ye>s aft] ! fir/ risk-%>+   
value-bas$ paym5t agreem5t is approv$ "u
 ?is subsection1 ! ,secret>y %all submit
 to ,congress & make available to !     
public a report t includes-- 7i7 an     
assessm5t ( ! impact ( risk-%>+         
value-bas$ paym5t agreem5ts on access = 
individuals :o are eligible = b5efits "u
 a ,/ate plan or waiv] "u ?is title to  
m$ically necess>y cov]$ outpati5t drugs 
& relat$ treatm5ts2  7ii7 an analysis ( 
! impact ( su* agreem5ts on ov]all ,/ate
 & ,f$]al sp5d+ "u ?is title2  7iii7 an 

assessm5t ( ! impact ( su* agreem5ts on 
drug prices1 includ+ laun* price & price
 increases2 &  7iv7 su* recomm5dations  
to ,congress z ! ,secret>y deems        
appropriate4  7#h7 ,guidance &          
regulations  7,a7 ,9 g5]al ,n lat] ?an  
,janu>y #a1 #bjbb1 ! ,secret>y %all     
issue guidance to ,/ates seek+ to ent]  
into risk-%>+ value-bas$ paym5t         
agreem5ts "u ?is subsection t includes a
 model template = su* agreem5ts4 ,!     
,secret>y may issue any additional      
guidance or promulgate regulations z    
necess>y to implem5t & en=ce !          
provisions ( ?is subsection4  7,b7      
,model agreem5ts  7i7 ,9 g5]al ,if a    
,/ate expresses an int]e/ 9 pursu+ a    
risk-%>+ value-bas$ paym5t agreem5t "u  
?is subsection ) a manufactur] = !      
pur*ase ( a cov]$ outpati5t drug1 !     
,secret>y may %>e ) su* ,/ate any       
risk-%>+ value-bas$ agreem5t betwe5 a   
,/ate & ! manufactur] = ! pur*ase ( su* 
drug t has be5 approv$ "u ?is           
subsection4 ,:ile su* %>$ agreem5t may  

s]ve z a template = a ,/ate t wi%es to  
propose1 ! use ( a previ\sly approv$    
agreem5t %all n affect ! submission &   
approval process = approval ( a propos$ 
risk-%>+ value-bas$ paym5t agreem5t "u  
?is subsection1 includ+ ! requirem5ts "u
 p>agraph 7#b77;,a74  7ii7              
,confid5tiality ,9 ! case ( a risk-%>+  
value-bas$ paym5t agreem5t t is disclos$
 to a ,/ate by ! ,secret>y "u ?is       
subp>agraph & t is only 9 effect )      
respect to a s+le ,/ate1 !              
confid5tiality ( in=mation provisions   
describ$ 9 subsection 7b77#c77;,d7 %all 
apply to su* in=mation4  7,c7 ,,oig     
consultation  7i7 ,9 g5]al ,! ,secret>y 
%all consult ) ! ,(fice ( ! ,inspector  
,g5]al ( ! ,dep>tm5t ( ,heal? & ,human  
,s]vices to det]m9e :e!r !re are        
pot5tial program integrity conc]ns      
7includ+ issues relat$ to compliance )  
sections #aabh;,b & #ahgg7 ) agreem5t   
approvals or templates & address        
accord+ly4  7ii7 ,,oig policy updates z 
necess>y ,! ,inspector ,g5]al ( !       

,dep>tm5t ( ,heal? & ,human ,s]vices    
%all review & update1 z necess>y1 any   
policies or guidel9es ( ! ,(fice ( !    
,inspector ,g5]al ( ! ,dep>tm5t ( ,heal?
 & ,human ,s]vices 7includ+ policies    
relat$ to ! en=cem5t ( section #aabh;,b7
 to accommodate ! use ( risk-%>+        
value-bas$ paym5t agreem5ts 9 accordance
 ) ?is section4  7#i7 ,rules (          
con/ruction  7,a7 ,modifications ,no?+ 9
 ?is subsection or any regulations      
promulgat$ "u ?is subsection %all       
prohibit a ,/ate f reque/+ a            
modification f ! ,secret>y to ! t]ms ( a
 risk-%>+ value-bas$ paym5t agreem5t4 ,a
 modification t is expect$ to result 9  
any increase to project$ net ,/ate or   
,f$]al sp5d+ "u ! agreem5t %all be      
subject to rec]tification by ! ,*ief    
,actu>y z describ$ 9 p>agraph           
7#b77;,a77ii7 be=e ! modification may be
 approv$4  7,b7 ,rebate agreem5ts ,no?+ 
9 ?is subsection %all be con/ru$ z      
requir+ a ,/ate to ent] into a risk-%>+ 
value-bas$ paym5t agreem5t or z limit+  

or sup]s$+ ! ability ( a ,/ate to ent]  
into a supplem5tal rebate agreem5t = a  
cov]$ outpati5t drug4  7,c7 ,,ffp =     
paym5ts "u risk-%>+ value-bas$ paym5t   
agreem5ts ,f$]al f9ancial p>ticipation  
%all be available "u ?is title = any    
paym5t made by a ,/ate to a manufactur] 
= a cov]$ outpati5t drug "u a risk-%>+  
value-bas$ paym5t agreem5t 9 accordance 
) ?is subsection1 except t no ,f$]al    
f9ancial p>ticipation %all be available 
= any paym5t made by a ,/ate to a       
manufactur] "u su* an agreem5t on & aft]
 ! effective date ( a disapproval ( su* 
agreem5t by ! ,secret>y4  7,d7 ,cont9u$ 
application ( o!r provisions ,except z  
expressly provid$ 9 ?is subsection1 no?+
 9 ?is subsection or 9 any regulations  
promulgat$ "u ?is subsection %all affect
 ! application ( any o!r provision ( ?is
 ,act4  7#aj7 ,appropriations ,= fiscal 
ye> #bjbj & ea* fiscal ye> !reaft]1 !re 
are appropriat$ to ! ,secret>y          
#e1jjj1jjj = ! purpose ( c>ry+ out ?is  
subsection4  7#aa7 ,def9itions ,9 ?is   

subsection3 7,a7 ,*ief ,actu>y ,! t]m   
,*ief ,actu>y means ! ,*ief ,actu>y ( ! 
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices4    
7,b7 ,in/allm5t ye> ,! t]m in/allm5t ye>
 means1 ) respect to a risk-%>+         
value-bas$ paym5t agreem5t1 a #ab-mon?  
p]iod dur+ :i* a cov]$ outpati5t drug is
 adm9i/]$ "u ! agreem5t4  7,c7          
,pot5tially curative treatm5t int5d$ =  
"o-"t use ,! t]m pot5tially curative    
treatm5t int5d$ = "o-"t use means a     
treatm5t t consi/s ( ! adm9i/ration ( a 
cov]$ outpati5t drug t-- 7i7 is a =m (  
g5e !rapy = a r>e disease1 z def9$ by ! 
,commission] ( ,food & ,drugs1 designat$
 "u section #ebf ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act1 & approv$ "u   
section #eje ( su* ,act or lic5s$ "u    
subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act to treat a 
s]i\s or life-?reat5+ disease or        
condition2  7ii7 if adm9i/]$ 9          
accordance ) ! label+ ( su* drug1 is    
expect$ to result 9 ei!r-- 7,i7 ! cure (
 su* disease or condition2 or  7,,ii7 a 

r$uction 9 ! symptoms ( su* disease or  
condition to ! ext5t t su* disease or   
condition is n expect$ to lead to e>ly  
mortality2 &  7iii7 is expect$ to a*ieve
 a result describ$ 9 clause 7ii71 :i*   
may be a*iev$ ov] an ext5d$ p]iod ( "t1 
aft] n m ?an #c adm9i/rations4  7,d7    
,relevant cl9ical p>amet] ,! t]m        
relevant cl9ical p>amet] means1 )       
respect to a cov]$ outpati5t drug t is !
 subject ( a risk-%>+ value-bas$ paym5t 
agreem5t-- 7i7 a cl9ical endpo9t        
specifi$ 9 ! drug's label+ or support$  
by "o or m ( ! comp5dia describ$ 9      
section #ahfa7t77#b77;,b77ii77,i7 t--   
7,i7 is able to be measur$ or evaluat$  
on an annual basis = ea* ye> ( !        
agreem5t on an indep5d5t basis by a     
provid] or o!r entity2 &  7,,ii7 is     
requir$ to be a*iev$ 7bas$ on obs]v$    
metrics 9 pati5t populations7 "u ! t]ms 
( ! agreem5t2 or  7ii7 a surrogate      
endpo9t 7z def9$ 9 section #ejg7;e77#i7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act71 includ+ ^? develop$ by           

pati5t-focus$ drug developm5t tools1 t--
 7,i7 is able to be measur$ or evaluat$ 
on an annual basis = ea* ye> ( !        
agreem5t on an indep5d5t basis by a     
provid] or o!r entity2 &  7,,ii7 has be5
 qualifi$ by ! ,food & ,drug            
,adm9i/ration4  7,e7 ,risk-%>+          
value-bas$ paym5t agreem5t ,! t]m       
risk-%>+ value-bas$ paym5t agreem5t     
means an agreem5t betwe5 a ,/ate plan & 
a manufactur]-- 7i7 = ! pur*ase ( a     
cov]$ outpati5t drug ( ! manufactur] t  
is a pot5tially curative treatm5t int5d$
 = "o-"t use2  7ii7 "u :i* paym5t = su* 
drug %all be made pursuant to an        
in/allm5t-bas$ paym5t /ructure t meets !
 requirem5ts ( p>agraph 7#c72  7iii7 :i*
 conditions paym5t on ! a*ievem5t ( at  
lea/ #b relevant cl9ical p>amet]s 7z    
def9$ 9 subp>agraph 7,c772  7iv7 :i*    
provides t-- 7,i7 ! ,/ate plan w        
directly reimburse ! manufactur] = !    
drug2 or  7,,ii7 a ?ird p>ty w reimburse
 ! manufacture 9 a mann] approv$ by !   
,secret>y2 &  7v7 is approv$ by !       

,secret>y 9 accordance ) p>agraph 7#b74 
7,f7 ,total in/allm5t ye> am\nt ,! t]m  
total in/allm5t ye> am\nt means1 )      
respect to a risk-%>+ value-bas$ paym5t 
agreem5t = ! pur*ase ( a cov]$ outpati5t
 drug & an in/allm5t ye>1 an am\nt equal
 to ! product (-- 7i7 ! unit price ( !  
drug *>g$ "u ! agreem5t2 &  7ii7 ! numb]
 ( units ( su* drug adm9i/]$ "u !       
agreem5t dur+ su* in/allm5t ye>4  4  7b7
 ,con=m+ am5dm5ts  7#a7 ,section        
#aijc7;i77#aj77;,a7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#acif;b7i77#aj77;,a77 is am5d$ by /rik+ 
or unless section #aibg7;a77#c7 applies 
& ins]t+ 1 section #aibg7;a77#c7 applies
 ) respect to su* drugs1 or su* drugs   
are ! subject ( a risk-%>+ value-bas$   
paym5t agreem5t "u section #aibg7l74    
7#b7 ,section #aibg7;b7 ( ! ,social     
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;b77 is am5d$-- 7,a7 9        
p>agraph 7#a77;,a71 by ins]t+ b exclud+ 
any drugs = :i* paym5t is made by a     
,/ate "u a risk-%>+ value-bas$ paym5t   

agreem5t "u subsection 7l77 aft] =      
cov]age ( su* drugs2 &  7,b7 9 p>agraph 
7#c7-- 7i7 9 subp>agraph 7,c77i71 by    
ins]t+ or subsection 7l77#b77;,a7 aft]  
subp>agraph 7,a72 &  7ii7 9 subp>agraph 
7,d71 9 ! matt] prec$+ clause 7i71 by   
ins]t+ 1 "u subsection 7l77#b77;,a71    
aft] "u ?is p>agraph4