,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #bcbf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #cj1 #bjai ,mr4  
,burr 7= himself1 ,mr4 ,b5net1 ,mr4     
,scott ( ,s\? ,c>ol9a1 & ,mr4 ,c>p]7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to am5d titles ,,xi
 & ,,xviii ( ! ,social ,security ,act to
 provide = exp$it$ cod+ & cov]age (     
novel m$ical products1 & = o!r purposes4
  #a4 ,%ort title  ,?is ,act may be cit$
 z ! ,new ,opportunities = ,value t     
,ext5d ,lives ,act ( #bjai or ! ,,novel 
,act ( #bjai4  #b4 ,exp$it$ cod+ ( novel
 m$ical products ,section               
#aagd7;b77#b77;,b7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4                    
#acbj;d-#c7;b77#b77;,b77 is am5d$ by    
add+ at ! end ! foll[+ new clauses3     
7iii7 ,exp$it$ cod+ ( novel m$ical      
products  7,i7 ,9 g5]al ,not)/&+        
p>agraph 7#a71 9 ! case ( a novel m$ical
 product 7z def9$ 9 clause 7iv771 !     
,secret>y %all make modifications to !  

,,hcpcs code set at lea/ once e qu>t]4  
7,,ii7 ,reque/ ,^u ! writt5 confid5tial 
reque/ ( a manufactur] ( a novel m$ical 
product1 ! ,secret>y %all make a        
det]m9ation :e!r to assign a ,,hcpcs    
code to su* product4 ,su* reque/ may    
occur on or aft] ! date on :i* ! product
 receives a designation z a break?r\gh  
!rapy "u section #ejf7;a7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef7;a771 a break?r\gh device
 "u section #eae;,b ( su* ,act 7#ba     
,u4,s4,c4 #cfj;e-#c71 or a reg5]ative   
advanc$ !rapy "u section #ejf7;g7 ( su* 
,act 7#ba ,u4,s4,c4 #cef7;g774  7,,iii7 
,deadl9e = det]m9ation2 notification ,! 
,secret>y %all-- 7aa7 n lat] ?an #ahj   
cal5d> days aft] receiv+ ! reque/ ( a   
manufactur] "u subclause 7,,ii71 make a 
det]m9ation "u su* subclause ) respect  
to ! reque/2 &  7bb7 n lat] ?an #cj     
cal5d> days aft] mak+ su* det]m9ation1  
notify ! manufactur] ( ! det]m9ation4   
7,,iv7 ,monitor+ utilization & outcomes 
,a ,,hcpcs code assign$ "u ?is clause   

%all all[ = ! reliable monitor+ (       
utilization & outcomes ( ! novel m$ical 
product z describ$ 9 clause 7vi74  7,v7 
,effective date ( code assignm5t ,if !  
,secret>y makes a det]m9ation to assign 
a ,,hcpcs code to a product "u subclause
 7,,ii71 su* code--  7aa7 may be assign$
 )9 ! fir/ qu>t] aft] ! manufactur]     
files1 ) respect to su* product1 a new  
drug application "u section #eje7;b7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7;b771 a biological  
product lic5se application "u section   
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a771 a prem>ket   
application "u section #eae7;c7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;e7c771 a report "u  
section #eaj7k7 ( su* ,act 7#ba         
,u4,s4,c4 #cfjk71 or a reque/ =         
classification "u section #eac7;f77#b7 (
 su* ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b772
 &  7bb7 may n take effect be=e ! date !
 product is approv$1 cle>$1 or lic5s$ by
 ! ,food & ,drug ,adm9i/ration4  7,,vi7 

,trade secrets & confid5tial in=mation  
,no in=mation submitt$ "u subclause     
7,,ii7 %all be con/ru$ z au?oriz+ !     
,secret>y to disclose any in=mation t is
 a trade secret or confid5tial in=mation
 subject to section #eeb7;b77#d7 ( title
 #e1 ,unit$ ,/ates ,code4  7iv7 ,novel  
m$ical product def9$ ,= purposes ( ?is  
subp>agraph1 ! t]m novel m$ical product 
means a drug1 biological product1 or    
m$ical device-- 7,i7 t has n be5 assign$
 a ,,hcpcs code2 &  7,,ii7 t has be5    
designat$ z a break?r\gh !rapy "u       
section #ejf7;a7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef7;a771 a break?r\gh device "u       
section #eae;,b ( su* ,act 7#ba         
,u4,s4,c4 #cfj;e-#c71 or a reg5]ative   
advanc$ !rapy "u section #ejf7;g7 ( su* 
,act 7#ba ,u4,s4,c4 #cef7;g774  7v7     
,,hcpcs def9$ ,= purposes ( ?is         
subp>agraph1 ! t]m ,,hcpcs means !      
,heal?c>e ,common ,proc$ure ,cod+       
,sy/em4  7vi7 ,inpati5t products ,!     
,secret>y %all e/abli% a code modifi] )9

 ! hospital inpati5t prospective paym5t 
sy/em "u section #ahhf7;d7 to track !   
utilization & outcomes ( novel m$ical   
products t are assign$ a ,,hcpcs code   
pursuant to ! exp$it$ cod+ process "u   
clause 7iii7 & are furni%$ by hospitals 
9 inpati5t sett+s4  4  #c4 ,cov]age     
det]m9ations = novel m$ical products    
,section #ahfb7l7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #aciey7l77 is am5d$ 
by add+ at ! end ! foll[+ new p>agraph3 
7#g7 ,cov]age pa?way = novel m$ical     
products  7,a7 ,9 g5]al ,! ,secret>y    
%all facilitate an effici5t cov]age     
pa?way to exp$ite a national cov]age    
decision = cov]age ) evid5ce developm5t 
process "u ?is title = novel m$ical     
products describ$ 9 subp>agraph 7,d74 ,!
 ,secret>y %all review su* novel m$ical 
products = ! cov]age process on an      
exp$it$ basis1 beg9n+ z soon z !        
,secret>y assigns a ,,hcpcs code to !   
product "u clause 7iii77,v77aa7 (       
section #aagd7;b77#b77;,b74  7,b7       
,det]m9ation ( cov]age ) evid5ce        

developm5t ,su* cov]age pa?way %all     
include1 ) respect to su* novel m$ical  
products1 if ! ,secret>y det]m9es       
cov]age ) evid5ce developm5t is         
appropriate1 issuance ( a national      
cov]age det]m9ation ( cov]age ) evid5ce 
developm5t = a p]iod up to1 b n to      
exce$1 #d ye>s f ! date ( su*           
det]m9ation4  7,c7 ,mod]niz+ paym5t     
options = novel m$ical products ,n lat] 
?an #d ye>s aft] issu+ su* national     
cov]age det]m9ation1 ! ,secret>y %all   
submit to ,congress & to ! manufactur] (
 ! novel m$ical product a report provid+
 options = alt]native paym5t models "u  
?is title = ! novel m$ical product or   
class ( su* products1 :i* may include ! 
utilization ( exi/+ models 9 ! comm]cial
 heal? insurance m>ket4 ,su* report %all
 include any recomm5dations =           
legislation & adm9i/rative action z !   
,secret>y det]m9es appropriate to       
facilitate su* paym5t arrangem5ts4  7,d7
 ,novel m$ical products describ$ ,=     
purposes ( ?is p>agraph1 a novel m$ical 

product describ$ 9 ?is subp>agraph is a 
novel m$ical product1 z def9$ 9 clause  
7iv7 ( section #aagd7;b77#b77;,b71 t is 
assign$ a ,,hcpcs code pursuant to !    
exp$it$ cod+ process "u clause 7iii7 (  
su* section4  7,e7 ,cl>ification ,no?+ 9
 ?is p>agraph %all prev5t ! ,secret>y f 
issu+ a noncov]age or a national cov]age
 det]m9ation = a novel m$ical product4  
4  #d4 ,enhanc+ coord9ation ) ! ,food & 
,drug ,adm9i/ration  7a7 ,public ,meet+ 
7#a7 ,9 g5]al ,n lat] ?an #ab mon?s aft]
 ! date ( ! enactm5t ( ?is ,act1 !      
,secret>y %all conv5e a public meet+ = !
 purposes ( discuss+ & provid+ input on 
improvem5ts to coord9ation betwe5 !     
,food & ,drug ,adm9i/ration & ! ,c5t]s =
 ,m$ic>e  ,m$icaid ,s]vices 9 prep>+ = !
 availability ( novel m$ical products 7z
 def9$ 9 section #aagd7;b77#b77;,b77iv7 
( ! ,social ,security ,act1 z add$ by   
section #b7 on ! m>ket 9 ! ,unit$       
,/ates4  7#b7 ,att5dees ,! public meet+ 
%all include-- 7,a7 repres5tatives (    
relevant ,f$]al ag5cies1 includ+        

repres5tatives f ea* ( ! m$ical product 
c5t]s )9 ! ,food & ,drug ,adm9i/ration &
 repres5tatives f ! cod+1 cov]age1 &    
paym5t (fices )9 ! ,c5t]s = ,m$ic>e     
,m$icaid ,s]vices2  7,b7 /akehold]s )   
exp]tise 9 ! rese>* & developm5t ( novel
 m$ical products1 includ+ manufactur]s (
 su* products2  7,c7 repres5tatives (   
comm]cial heal? insurance pay]s2  7,d7  
/akehold]s ) exp]tise 9 ! adm9i/ration &
 use ( novel m$ical products1 includ+   
physicians2 &  7,e7 /akehold]s repres5t+
 pati5ts & ) exp]tise 9 ! utilization ( 
pati5t exp]i5ce data 9 m$ical product   
developm5t4  7#c7 ,topics ,! public     
meet+ %all include a discussion (-- 7,a7
 ! /atus ( ! drug & m$ical device       
developm5t pipel9e relat$ to !          
availability ( novel m$ical products2   
7,b7 ! anticipat$ exp]tise necess>y to  
review ! safety & effectiv5ess ( su*    
products at ! ,food & ,drug             
,adm9i/ration & curr5t gaps 9 su*       
exp]tise1 if any2  7,c7 ! exp]tise      
necess>y to make cod+1 cov]age1 & paym5t

 decisions ) respect to su* products )9 
! ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices1 &
 curr5t gaps 9 su* exp]tise1 if any2    
7,d7 tr5ds 9 ! diff]5ces 9 ! data       
necess>y to det]m9e ! safety &          
effectiv5ess ( a novel m$ical product & 
! data necess>y to det]m9e :e!r a novel 
m$ical product meets ! reasonable &     
necess>y requirem5ts = cov]age & paym5t 
"u title ,,xviii ( ! ,social ,security  
,act pursuant to section                
#ahfb7;a77#a77;,a7 ( su* ,act 7#db      
,u4,s4,c4 #aciey7a77#a77;,a772  7,e7 !  
availability ( in=mation = sponsors (   
su* novel m$ical products to meet ea* ( 
^? requirem5ts2 &  7,f7 ! coord9ation ( 
in=mation relat$ to significant cl9ical 
improvem5t ov] exi/+ !rapies = pati5ts  
betwe5 ! ,food & ,drug ,adm9i/ration & !
 ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices )  
respect to novel m$ical products4  7#d7 
,trade secrets & confid5tial in=mation  
,no in=mation discuss$ z a "p ( ! public
 meet+ "u ?is section %all be con/ru$ z 
au?oriz+ ! ,secret>y to disclose any    

in=mation t is a trade secret or        
confid5tial in=mation subject to section
 #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates 
,code4  7b7 ,improv+ transp>5cy (       
crit]ia = ,m$ic>e cov]age  7#a7 ,updat+ 
guidance ,n lat] ?an #ah mon?s aft] !   
public meet+ "u subsection 7a71 !       
,secret>y ( ,heal? & ,human ,s]vices    
%all update ! f9al guidance entitl$     
,national ,cov]age ,det]m9ations ) ,data
 ,collection z a ,condition ( ,cov]age3 
,cov]age ) ,evid5ce ,developm5t to      
improve ! availability & coord9ation (  
in=mation z describ$ 9 subp>agraphs 7,d7
 ?r\gh 7,f7 subsection 7a77#c71 & cl>ify
 novel m$ical product cl9ical data      
requirem5ts to meet reasonable &        
necess>y requirem5ts = cov]age & paym5t 
"u title ,,xviii ( ! ,social ,security  
,act4  7#b7 ,f9aliz+ updat$ guidance ,n 
lat] ?an #ab mon?s aft] issu+ draft     
guidance "u p>agraph 7#a71 ! ,secret>y  
%all f9alize ! updat$ guidance4  #e4    
,report on cod+1 cov]age1 & paym5t      
processes "u ,m$ic>e = new m$ical       

products  7a7 ,9 g5]al ,n lat] ?an #ab  
mon?s aft] ! date ( enactm5t ( ?is ,act1
 ! ,secret>y ( ,heal? & ,human ,s]vices 
%all publi% a report on ! int]net       
website ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices reg>d+ processes "u ! ,m$ic>e  
program "u title ,,xviii ( ! ,social    
,security ,act 7#db ,u4,s4,c4 #acie et  
seq47 ) respect to ! cod+1 cov]age1 &   
paym5t ( m$ical products describ$ 9     
subsection 7b74 ,su* report %all include
 ! foll[+3  7#a7 ,a description (       
*all5ges 9 ! cod+1 cov]age1 & paym5t    
processes "u ! ,m$ic>e program = m$ical 
products describ$ 9 su* subsection4     
7#b7 ,recomm5dations to-- 7,a7          
incorporate pati5t exp]i5ce data 7su* z 
! impact ( a disease or condition on !  
lives ( pati5ts & pati5t treatm5t       
pref]5ces7 into ! cov]age & paym5t      
processes )9 ! ,c5t]s = ,m$ic>e         
,m$icaid ,s]vices2  7,b7 decrease ! l5g?
 ( "t to make national & local cov]age  
det]m9ations "u ! ,m$ic>e program 7z ^? 
t]ms are def9$ 9 subp>agraph 7,a7 &     

7,b71 respectively1 ( section           
#ahfb7l77#f7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciey7l77#f7772  7,c7   
/reaml9e ! cov]age process "u ! ,m$ic>e 
program & incorporate input f relevant  
/akehold]s into su* cov]age             
det]m9ations2 &  7,d7 id5tify pot5tial  
me*anisms to incorporate novel paym5t   
designs simil> to ^? 9 developm5t 9     
comm]cial insurance plans & ,/ate plans 
"u title ,,xix ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acifr et seq47 into
 ! ,m$ic>e program4  7b7 ,m$ical        
products describ$ ,= purposes (         
subsection 7a71 a m$ical product        
describ$ 9 ?is subsection is a m$ical   
product1 includ+ a drug1 biological     
7includ+ g5e & cell !rapy & g5e edit+71 
or m$ical device1 t has be5 designat$ z 
a break?r\gh !rapy "u section #ejf7;a7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cef7;a771 a break?r\gh 
device "u section #eae;,b ( su* ,act    
7#ba ,u4,s4,c4 #cfj;e-#c71 or a         
reg5]ative advanc$ !rapy "u section     

#ejf7;g7 ( su* ,act 7#ba ,u4,s4,c4      
#cef7;g774