,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #iceh  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,novemb] #bi1         
#bjbb,ms4 ,b>ragn 7= h]self & ,mr4      
,joyce ( ,p5nsylvania7 introduc$ !      
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,ways & ,means1 & 9       
addition to ! ,committee on ,en]gy &    
,comm]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 am5d title ,,xviii ( !     
,social ,security ,act to provide a     
review process = adv]se national cov]age
 det]m9ations ) respect to drug cov]age 
"u ! ,m$ic>e program4  #a4 ,%ort title  
,?is ,act may be cit$ z ! ,access to    
,innovative ,treatm5ts ,act ( #bjbb4    
#b4 ,provid+ a review process = adv]se  
national cov]age det]m9ations ) respect 
to drug cov]age "u ! ,m$ic>e program    
7a7 ,9 g5]al ,section #ahfb7l7 ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#aciey7l77 is am5d$-- 7#a7 by r$esignat+

 p>agraphs 7#e7 & 7#f7 z p>agraphs 7#g7 
& 7#h71 respectively2 &  7#b7 by ins]t+ 
aft] p>agraph 7#d7 ! foll[+ new         
p>agraphs3  7#e7 ,review ( national     
cov]age det]m9ations = drugs &          
biologicals  7,a7 ,9 g5]al ,subject to  
subp>agraph 7,d71 n lat] ?an #cj days   
aft] receiv+ a reque/ = a review ( a    
specifi$ national cov]age det]m9ation 7z
 def9$ 9 subp>agraph 7,e771 ! ,secret>y 
%all initiate su* a review 9 accordance 
) ! provisions ( ?is p>agraph4  7,b7    
,public comm5t p]iod ,beg9n+ on ! date (
 ! initiation ( a review ( a specifi$   
national cov]age det]m9ation "u         
subp>agraph 7,a71 ! ,secret>y %all      
provide = a #cj-;day public comm5t p]iod
 z to :e!r su* det]m9ation %\ld be      
affirm$1 rev]s$1 or o!rwise modifi$4    
7,c7 ,f9al decision ,n lat] ?an #cj days
 aft] ! conclusion ( ! #cj-;day p]iod   
describ$ 9 subp>agraph 7,b7 ) respect to
 a specifi$ national cov]age            
det]m9ation1 ! ,secret>y %all-- 7i7 make
 a f9al decision z to :e!r su*          

det]m9ation %\ld be affirm$1 rev]s$1 or 
o!rwise modifi$2  7ii7 include 9 su*    
f9al decision summ>ies ( ! public       
comm5ts receiv$ & responses to su*      
comm5ts2  7iii7 make available to !     
public ! cl9ical evid5ce & o!r data us$ 
9 mak+ su* decision :5 su* decision     
diff]s f ! recomm5dations ( ! ,m$ic>e   
,cov]age ,advisory ,committee2 &  7iv7 9
 ! case ( a f9al decision "u clause 7i7 
to rev]se or modify su* det]m9ation1 !  
,secret>y %all assign a tempor>y or     
p]man5t code 7:e!r exi/+ or unclassifi$7
 & implem5t ! cod+ *ange z applicable4  
7,d7 ,limitation on successive reviews  
,subp>agraph 7,a7 %all n apply ) respect
 to a reque/ = a review ( a specifi$    
national cov]age det]m9ation if !       
,secret>y has made a f9al decision )    
respect to a previ\s review ( su*       
det]m9ation "u ?is p>agraph dur+ !      
#b-ye> p]iod end+ on ! date ( ! receipt 
( su* reque/4 ,no?+ 9 ! prec$+ s5t5ce   
%all be con/ru$ to limit ! au?ority ( ! 
,secret>y to review or reconsid] a      

national cov]age det]m9ation if det]m9$ 
appropriate by ! ,secret>y4  7,e7       
,specifi$ national cov]age det]m9ation  
def9$ ,9 ?is p>agraph1 ! t]m specifi$   
national cov]age det]m9ation means a    
national cov]age det]m9ation made )     
respect to a drug or biological approv$ 
"u section #eje7;c7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act or lic5s$ "u    
section #cea ( ! ,public ,heal? ,s]vice 
,act "u :i* cov]age ( su* drug or       
biological "u ?is title 0 d5i$ or       
o!rwise limit$ 9 a mann] inconsi/5t )   
su* approval or lic5sure4  7#f7         
,prohibition on application ( c]ta9     
exi/+ national cov]age det]m9ations to  
newly-approv$ drugs & biologicals ,!    
,secret>y may n1 ) respect to a drug    
approv$ "u section #eje7;c7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act or a     
biological lic5s$ "u section #cea ( !   
,public ,heal? ,s]vice ,act1 apply a    
national cov]age det]m9ation t 0 made   
prior to ! date ( su* approval or       
lic5sure 7z applicable7 to ! ext5t t su*

 application w\ld result 9 a d5ial or   
o!r limit ( cov]age "u ?is title = su*  
drug or biological 9 a mann] inconsi/5t 
) su* approval or lic5sure4  4  7b7     
,nonreliance on c]ta9 ,n,c,ds "u "p ,d  
,section #ahfj;,d-#b7;e77#c7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#ajb7;e77#c77 is am5d$ by add+ at
 ! end ! foll[+ new s5t5ce3 ,9 det]m9+  
:e!r paym5t w\ld n be made ) respect to 
a cov]$ "p ,d drug if section #ahfb7;a7 
appli$ to ?is "p1 a prescription drug   
plan or ,,ma-,,pd plan may n base su*   
det]m9ation on a national cov]age       
det]m9ation made ) respect to su* drug  
if su* det]m9ation is a specifi$        
national cov]age det]m9ation 7z def9$ 9 
section #ahfb7l77#e7744