,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #eiig  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,june #e1 #bjah,ms4   
,del,bene 7= h]self1 ,mrs4 ,walorski1   
,ms4 ,sewell ( ,alabama1 ,mr4           
,bilirakis1 & ,mr4 ,crd5as7 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 titles ,,xviii & ,,xix
 ( ! ,social ,security ,act to ensure   
prompt cov]age ( break?r\gh devices "u !
 ,m$ic>e & ,m$icaid programs1 & = o!r   
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,ensur+ ,pati5t ,access to 
,critical ,break?r\gh ,products ,act (  
#bjah4  #b4 ,cov]age & paym5t =         
break?r\gh devices "u ! ,m$ic>e program 
7a7 ,9 g5]al ,"p ,e ( title ,,xviii ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#aciex et seq47 is am5d$ by add+ at !   

end ! foll[+ new section3  #ahii;,c4    
,cov]age ( break?r\gh devices  7a7      
,break?r\gh devices  7#a7 ,9 g5]al ,=   
purposes ( ?is section1 ! t]m break?r\gh
 device means a m$ical device t is a    
device 7z def9$ 9 section #bja ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act7 &
 t is--  7,a7 provid$ ) review priority 
by ! ,secret>y "u subsection 7d77#e7 (  
section #eae ( su* ,act2 &  7,b7 approv$
 or cle>$ pursuant to section #eaj7k71  
#eac7;f71 or #eae ( su* ,act = use 9    
treat+ an indication4  7#b7 ,limitation 
on numb] ( #eaj7k7 devices ,) respect to
 a #e-ye> p]iod1 9 no case may m ?an    
five m$ical devices describ$ 9 p>agraph 
7#a7 t are classifi$ "u section #eaj7k7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act be cov]$ & paid = "u ?is title by  
reason ( ?is section dur+ ea* su* #e-ye>
 p]iod4  7b7 ,cov]age  7#a7             
,transitional cov]age  7,a7 ,9 g5]al    
,dur+ ! transitional cov]age p]iod 7z   
def9$ 9 subp>agraph 7,b77 a break?r\gh  
device %all be--  7i7 deem$ to be       

reasonable & necess>y = purposes (      
section #ahfb7;a77#a77;,a72  7ii7 deem$ 
to be approv$ = an additional paym5t "u 
section #ahhf7;d77#e77,k72  7iii7 deem$ 
to be approv$ = pass-?r\gh paym5t "u    
section #ahcc7t77#f7 & section          
#ahcc7;i72 &  7iv7 ins(> z su*          
break?r\gh device may be furni%$ 9 a    
sett+ = :i* paym5t is made "u an        
applicable paym5t sy/em describ$ 9      
subp>agraphs 7,d7 ?r\gh 7,i7 (          
subsection 7c77#d71 deem$ eligible = an 
additional paym5t pursuant to subsection
 7d77#c7 :5 furni%$ 9 a sett+ = :i*     
paym5t is made "u su* an applicable     
paym5t sy/em dur+ su* transitional      
cov]age p]iod4  7,b7 ,transitional      
cov]age p]iod def9$ ,z us$ 9 ?is        
section1 ! t]m transitional cov]age     
p]iod means1 ) respect to a break?r\gh  
device1 ! p]iod t-- 7i7 beg9s on ! date 
( ! approval "u section #eae ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act or ( !   
cle>ance "u section #eaj7k7 ( su* ,act1 
z applicable1 ( su* device by !         

,secret>y = ! indication describ$ 9     
subp>agraph 7,a77ii7 or 7,b7 (          
subsection 7a77#a71 respectively2 &     
7ii7 ends on ! la/ day ( ! #c-ye> p]iod 
t beg9s on ! date t ! ,secret>y1        
pursuant to subsection 7c77#b71 updates 
! relevant applicable paym5t sy/em 7z   
def9$ 9 subsection 7c77#d77 to recognize
 ! unique tempor>y or p]man5t code or   
codes assign$ "u subsection 7c77#a7 to  
su* break?r\gh device1 except z provid$ 
9 subsections 7d77#a77;,b7 &            
7d77#b77;,b74  7#b7 ,process = regul>   
cov]age ,= purposes ( ! application (   
section #ahfb7;a77#a77;,a7 to a         
break?r\gh device furni%$ aft] !        
transitional cov]age p]iod 7z def9$ 9   
p>agraph 7#a77;,b77 = su* device1 !     
,secret>y1 act+ ?r\gh ! ,c\ncil =       
,te*nology & ,innovation 7e/abli%$ "u   
section #ahfh7;b77 9 conjunction ) !    
,cov]age & ,analysis ,gr\p ( ! ,c5t]s = 
,m$ic>e  ,m$icaid ,s]vices1 %all e/abli%
 a process = ! cov]age ( su* break?r\gh 
devices "u ?is title aft] su* p]iod z   

foll[s3  7,a7 ,id5tification (          
additional evid5ce  7i7 ,9 g5]al ,)     
respect to a break?r\gh device1 n lat]  
?an #a ye> aft] ! date ( ! approval (   
su* device "u section #eae ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act or ( !   
cle>ance ( su* device "u section #eaj7k7
 ( su* ,act1 z applicable1 ! ,secret>y  
%all id5tify :e!r any additional data or
 evid5ce is requir$ ) respect to any    
indications = su* device = purposes ( ! 
application ( su* section               
#ahfb7;a77#a77;,a7 to su* device = su*  
indications4  7ii7 ,non-duplication (   
data reque/s ,9 c>ry+ out clause 7i7 )  
respect to a break?r\gh device1 !       
,secret>y %all ensure t data or evid5ce 
id5tifi$--  7,i7 does n duplicate data  
requir$ to be collect$ by ! ,food &     
,drug ,adm9i/ration ) respect to su*    
break?r\gh device2  7,,ii7 m9imizes !   
adm9i/rative burd5s ( data collection & 
report+ on provid]s ( s]vices1 suppli]s1
 & manufactur]s ( break?r\gh devices2 & 
7,,iii7 is n o!rwise unnecess>y or      

r$undant4  7,b7 ,proposal = cov]age aft]
 ! transitional cov]age p]iod ,n lat]   
?an #b ye>s aft] ! date ( ! approval or 
cle>ance ( a break?r\gh device by !     
,food & ,drug ,adm9i/ration1 ! ,secret>y
 %all develop a proposal = cov]age "u   
?is title ( su* break?r\gh device = su* 
indications z ! ,secret>y det]m9es to be
 appropriate1 bas$ on ! data & evid5ce  
collect$ "u subp>agraph 7,a71 = su*     
devices furni%$ aft] ! transitional     
cov]age p]iod "u p>agraph 7#a7 = su*    
device4 ,if ! ,secret>y does n1 on a    
date t is be=e ! end ( su* two-ye>      
p]iod1 take action to modify !          
indications = :i* cov]age ( a break?r\gh
 device may be provid$ "u ?is title aft]
 su* p]iod1 = purposes ( section        
#ahfb7;a77#a77;,a7 cov]age "u ?is title 
( su* break?r\gh device %all be made =  
all indications = :i* su* device is     
approv$ "u section #eae ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act or cle>$ 
"u section #eaj7k7 ( su* ,act4  7#c7    
,rules ( con/ruction ,no?+ 9 ?is section

 %all be con/ru$ to-- 7,a7 affect !     
ability ( ! manufactur] ( a break?r\gh  
device to seek approval = pass-?r\gh    
paym5t /atus "u section #ahcc7t77#f7 or 
to seek approval = an additional paym5t 
"u section #ahhf7;d77#e77,k7 ins(> z su*
 break?r\gh device does n qualify =     
transitional cov]age "u p>agraph 7#a72  
or  7,b7 affect ! application & approval
 process = pass-?r\gh paym5t /atus "u   
section #ahcc7t77#f7 or = an additional 
paym5t "u section #ahhf7;d77#e77,k7 9 ! 
case ( a m$ical device t is n approv$ by
 ! ,food & ,drug ,adm9i/ration z a      
break?r\gh device4  7c7 ,cod+  7#a7     
,prompt assignm5t ,n lat] ?an ?ree mon?s
 aft] ! date ( approval or cle>ance ( a 
break?r\gh device by ! ,food & ,drug    
,adm9i/ration1 subject to subp>agraph   
7,b71 ! ,secret>y %all assign a unique  
tempor>y or p]man5t code or codes =     
purposes ( cov]age & paym5t = su*       
break?r\gh device "u ! applicable paym5t
 sy/ems 7describ$ 9 p>agraph 7#d774     
7#b7 ,updates  7,a7 ,,ipps ,! ,secret>y 

%all provide = semiannual updates "u !  
applicable paym5t sy/em describ$ 9      
p>agraph 7#d77;,a7 7relat+ to ! inpati5t
 hospital prospective paym5t sy/em7 to  
recognize ! code or codes assign$ "u    
p>agraph 7#a74  7,b7 ,,opps ,! ,secret>y
 %all provide = qu>t]ly updates "u !    
applicable paym5t sy/em describ$ 9      
p>agraph 7#d77;,b7 7relat+ to !         
outpati5t hospital prospective paym5t   
sy/em7 to recognize ! code or codes     
assign$ "u p>agraph 7#a74  7#c7         
,transp>5cy ,! process = ! assignm5t ( a
 code or codes "u ?is subsection %all   
provide = public notice & a mean+ful    
opportunity = public comm5t f affect$   
p>ties4  7#d7 ,applicable paym5t sy/ems 
describ$ ,= purposes ( ?is subsection1 !
 t]m applicable paym5t sy/ems means--   
7,a7 ) respect to inpati5t hospital     
s]vices1 ! prospective paym5t sy/em =   
inpati5t hospital s]vices e/abli%$ "u   
section #ahhf7;d72  7,b7 ) respect to   
outpati5t hospital s]vices1 !           
prospective paym5t sy/em = cov]$ ,,opd  

s]vices e/abli%$ "u section #ahcc7t72   
7,c7 ) respect to ambulatory surgical   
c5t] s]vices1 ! fee s*$ule = su* s]vices
 e/abli%$ "u #ahcc7;i72  7,d7 ) respect 
to physicians' s]vices1 ! physician fee 
s*$ules e/abli%$ "u section #ahdh2  7,e7
 ) respect to cov]$ items ( durable     
m$ical equipm5t1 ! applicable fee       
s*$ules e/abli%$ "u section #ahcd2  7,f7
 ) respect to diagno/ic laboratory te/s1
 ! fee s*$ule e/abli%$ "u section       
#ahcd7;h71 ! paym5t am\nts "u section   
#ahcd;,a1 & ! fee s*$ules e/abli% "u    
section #ahdh1 z ! case may be2  7,g7 ) 
respect to inpati5t hospital s]vices    
furni%$ by rehabilitation facilities1 ! 
prospective paym5t sy/em e/abli%$ "u    
section #ahhf7;j72  7,h7 ) respect to   
inpati5t hospital s]vices furni%$ by    
long-t]m c>e hospitals1 ! prospective   
paym5t sy/em "u section #ahhf7m72 &     
7,i7 ) respect to inpati5t hospital     
s]vices furni%$ by psy*iatric hospitals 
& psy*iatric units1 ! prospective paym5t
 sy/em "u section #ahhf7s74  7d7 ,paym5t

  7#a7 ,inpati5t hospital prospective   
paym5t sy/em3 deem$ eligibility =       
break?r\gh paym5t ,! ,secret>y %all deem
 ea* break?r\gh device z approv$ = an   
additional paym5t "u section            
#ahhf7;d77#e77,k7 = ! #c-ye> p]iod t    
beg9s--  7,a7 except z provid$ 9        
subp>agraph 7,b71 on ! date t !         
,secret>y1 pursuant to subsection       
7c77#b77;,a71 updates ! paym5t sy/em "u 
section #ahhf7;d7 to recognize ! unique 
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
break?r\gh device2 or  7,b7 9 ! case ( a
 device t has n receiv$ approval or     
cle>ance z a break?r\gh device by !     
,food & ,drug ,adm9i/ration be=e su*    
paym5t sy/em is updat$ "u subsection    
7c77#b77;,a7 to recognize ! unique      
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
device1 on ! date ( su* approval or     
cle>ance4  ,no?+ 9 ?is p>agraph %all be 
con/ru$ to affect ! au?ority ( !        
,secret>y to use claims data to e/abli% 

new diagnosis or proc$ure codes =       
break?r\gh devices or to id5tify        
appropriate diagnosis-relat$ gr\ps = !  
assignm5t ( break?r\gh devices "u annual
 rulemak+ to c>ry out section           
#ahhf7;d77#e77,k74  7#b7 ,outpati5t     
prospective paym5t sy/em3 deem$         
eligibility = pass-?r\gh paym5t ,!      
,secret>y %all deem ea* break?r\gh      
device z approv$ = pass-?r\gh paym5t "u 
section #ahcc7t77#f7 7includ+ = purposes
 ( section #ahcc7;i77#b77;,d77 dur+ !   
#c-ye> p]iod t beg9s--  7,a7 except z   
provid$ 9 subp>agraph 7,b71 on ! date t 
! ,secret>y1 pursuant to subsection     
7c77#b77;,b71 updates ! paym5t sy/em "u 
section #ahcc7t7 to recognize ! unique  
tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
break?r\gh device2 or  7,b7 9 ! case ( a
 device t has n receiv$ approval or     
cle>ance z a break?r\gh device by !     
,food & ,drug ,adm9i/ration be=e su*    
paym5t sy/em is updat$ "u subsection    
7c77#b77;,b7 to recognize ! unique      

tempor>y or p]man5t code or codes       
assign$ "u subsection 7c77#a7 to su*    
device1 on ! date ( su* approval or     
cle>ance4  ,no?+ 9 ?is p>agraph %all be 
con/ru$ to affect ! au?ority ( !        
,secret>y to use claims data to e/abli% 
new ambulatory paym5t classification    
gr\ps = break?r\gh devices or to revise 
su* gr\ps to take into acc\nt break?r\gh
 devices "u annual rulemak+ to c>ry out 
section #ahcc7t74  7#c7 ,o!r paym5t     
sy/ems  7,a7 ,9 g5]al ,9 ! case (       
break?r\gh device t is furni%$ & = :i*  
paym5t may be made "u ! paym5t sy/em    
e/abli%$ "u section #ahai7;a71 #ahcd1   
#ahcd;,a1 #ahdh1 #ahhf7;j71 #ahhf7m71   
#ahhf7s71 or #ahie or any o!r relevant  
provision ( ?is title 7o!r ?an sections 
#ahcc7;i71 #ahcc7t71 & #ahhf7;d771 !    
,secret>y %all provide = an additional  
paym5t = su* break?r\gh device "u su*   
paym5t sy/em 9 an am\nt equal to #hj    
p]c5t ( ! co/s ( su* break?r\gh device4 
7,b7 ,rule ( con/ruction ,no?+ 9 ?is    
p>agraph %all be con/ru$ to affect !    

au?ority ( ! ,secret>y to use claims    
data to e/abli% new or modify exi/+     
ambulatory paym5t classification gr\ps1 
diagnosis-relat$ gr\ps1 level ,,ii      
,,hcpcs codes or su* o!r gr\ps or codes 
z ! ,secret>y may e/abli% "u ! annual   
rulemak+ au?ority "u ! provisions ref]r$
 to 9 subp>agraph 7,a74  7#d7 ,paym5t = 
break?r\gh devices aft] ! transitional  
cov]age p]iod ,paym5t = a break?r\gh    
device t is furni%$ aft] ! conclusion ( 
! transitional cov]age p]iod "u         
subsection 7b77#a7 = su* device %all be 
made pursuant to ! applicable paym5t    
sy/em involv$1 tak+ into acc\nt !       
additional evid5ce & data collect$ "u   
subsection 7b77#b74  7e7 ,treatm5t (    
break?r\gh devices "u alt]native paym5t 
models  7#a7 ,alt]native paym5t model   
def9$ ,9 ?is subsection1 ! t]m          
alt]native paym5t model means1 ) respect
 to items & s]vices = :i* paym5t is made
 "u ! applicable paym5t sy/ems "u ?is   
title1 paym5t initiatives design$ to    
improve ! quality1 effici5cy1 & ov]all  

value ( heal? c>e furni%$ to individuals
 entitl$ to b5efits "u "p ,a or enroll$ 
"u "p ,b ?r\gh f9ancial inc5tives to    
provid]s ( s]vices & suppli]s = meet+ or
 exce$+ c]ta9 quality or p]=mance       
measures or ?r\gh f9ancial p5alties on  
provid]s t fail to a*ieve specifi$ goals
 or co/ sav+s1 or bo?4 ,su* t]m         
includes--  7,a7 ! ,m$ic>e %>$ sav+s    
program "u e/abli%$ section #ahii2  7,b7
 %>$ sav+s programs te/$ by ! ,c5t] =   
,m$ic>e & ,m$icaid ,innovation "u       
section #aaae;,a2  7,c7 ! ,national     
,pilot ,program on ,paym5t ,bundl+ "u   
section #ahff;,d2  7,d7 bundl$ paym5t   
programs te/$ by ! ,c5t] = ,m$ic>e &    
,m$icaid ,innovation "u section         
#aaae;,a2 &  7,e7 any o!r simil> program
 conduct$ "u ?is title or "u applicable 
au?orities "u title ,,xi4  7#b7         
,exclusion ( additional co/s (          
break?r\gh devices ,ins(> z ! am\nt (   
paym5t = a break?r\gh device exce$s !   
am\nt ( paym5t t ! item or s]vice w\ld  
o!rwise receive "u an alt]native paym5t 

model = :i* %>$ sav+s or %>$ losses are 
calculat$1 ! ,secret>y %all exclude f ! 
calculation ( su* %>$ sav+s or losses "u
 su* program = su* p]iod ! am\nt by :i* 
! paym5t = ! break?r\gh device involv$  
exce$s ! paym5t am\nt = su* o!r item or 
s]vice t w\ld h be5 made b = ! use ( !  
break?r\gh device4  7#c7 ,adju/m5t to   
quality process measures = break?r\gh   
devices  7,a7 ,9 g5]al ,9 ! case t !    
furni%+ by a provid] ( s]vices or       
suppli] p>ticipat+ 9 an alt]native      
paym5t model ( a break?r\gh device to an
 individual entitl$ to b5efits "u "p ,a 
or enroll$ "u "p ,b & p>ticipat+ 9 su*  
program w\ld result 9 su* provid] or    
suppli]1 ) respect to ! condition &     
episode ( c>e = :i* su* device is       
furni%$1 receiv+ a poor or fail+ score =
 a quality measure "u su* program t     
measures :e!r su* provid] or suppli]    
gave ! treatm5t kn[n to give ! be/      
results = mo/ pati5ts ) a p>ticul>      
condition 7commonly kn[n z a cl9ical    
process ( c>e measure71 ! ,secret>y %all

 exclude su* quality measure f any      
det]m9ation ( :e!r su* provid] or       
suppli] met applicable quality p]=mance 
?re%olds "u su* program ) respect to su*
 condition & episode ( c>e ( su*        
individual4  7,b7 ,inapplicability to   
cl9ical outcomes measures ,no?+ 9       
subp>agraph 7,a7 may be con/ru$ to all[ 
= ! exclusion1 ) respect to a break?r\gh
 device furni%$ to an individual by a   
provid] or suppli] "u an alt]native     
paym5t model1 ( any quality measure     
design$ to reflect ! results ( c>e      
furni%$ to su* individual by su* provid]
 or suppli] 7commonly kn[n z a cl9ical  
outcome measure7 f a det]m9ation        
describ$ 9 su* subp>agraph4  4  7b7     
,/udy on limit ( #eaj7k7 break?r\gh     
devices  7#a7 ,/udy ,! ,secret>y (      
,heal? & ,human ,s]vices %all conduct a 
/udy on ! effect ( ! limit 7"u section  
#ahii;,c7a77#b7 ( ! ,social ,security   
,act1 z add$ by subsection 7a77 on !    
numb] ( devices cle>$ "u section #eaj7k7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   

,act 7#ba ,u4,s4,c4 #cfj7k77 t are      
break?r\gh devices = purposes ( su*     
section #ahii;,c4  7#b7 ,matt]s exam9$  
,9 conduct+ ! /udy describ$ 9 p>agraph  
7#a71 ! ,secret>y %all-- 7,a7 det]m9e ! 
numb] ( m$ical devices cle>$ "u su*     
section #eaj7k7 dur+ ! #e-ye> p]iod     
beg9n+ on ! date ( ! enactm5t ( ?is     
,act2  7,b7 det]m9e ! numb] ( su*       
devices t 7 n break?r\gh devices =      
purposes ( su* section #ahii;,c by      
reason ( ! limitation "u subsection     
7a77#b7 ( su* section2 &  7,c7 exam9e ! 
impact ( su* limitation on access to su*
 devices = individuals entitl$ to       
b5efits "u "p ,a or enroll$ 9 "p ,b (   
title ,,xviii ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie et seq474  7#c7   
,report ,n lat] ?an #f ye>s aft] ! date 
( ! enactm5t ( ?is ,act1 ! ,secret>y    
%all submit to ,congress a report on !  
/udy conduct$ "u ?is subsection & %all  
include su* recomm5dations = legislative
 or adm9i/rative *anges z ! ,secret>y   
det]m9es to be appropriate4  7c7        

,modifications to ! c\ncil = te*nology &
 innovation  7#a7 ,expansion ( duties   
,p>agraph 7#c7 ( section #ahfh7;b7 ( !  
,social ,security ,act 7#db ,u4,s4,c4   
#acie;ee7b77 is am5d$ by add+ at ! end !
 foll[+3 ,! ,c\ncil %all also coord9ate 
activities ( ! ,secret>y = !            
implem5tation ( section #ahii;,c 7relat+
 to break?r\gh devices71 especially )   
respect to timely cov]age1 cod+1        
evid5ce-ga!r+1 & paym5t = su* devices44 
7#b7 ,reorganization )9 ! ,,cmmi ,su*   
section is fur!r am5d$-- 7,a7 9 p>agraph
 7#a71 by /rik+ )9 ! ,c5t]s & all t     
foll[s ?r\gh ! end & ins]t+ )9 ! ,c5t] =
 ,m$ic>e & ,m$icaid ,innovation e/abli%$
 "u section #aaae;,a 79 ?is subsection  
ref]r$ to z ,,cmmi742 &  7,b7 9 p>agraph
 7#d71 by /rik+ ! ,adm9i/rator ( ,,cms &
 ins]t+ ! ,director ( ! ,,cmmi4  7d7    
,improvem5ts to ,,ntap paym5t adju/m5t  
"u ! inpati5t prospective paym5t sy/em  
7#a7 ,paym5t = co/s ( new te*nologies ,)
 respect to hospital dis*>ges = :i*     
paym5t is made "u section #ahhf7;d7 ( ! 

,social ,security ,act 7#db ,u4,s4,c4   
#acieww7d77 occurr+ on or aft] ,octob]  
#a1 #bjaf1 9 calculat+ ! am\nt ( !      
additional paym5t = a new m$ical s]vice 
or te*nology "u p>agraph 7#e77,k7 ( su* 
section ) respect to su* a dis*>ge1 !   
,secret>y ( ,heal? & ,human ,s]vices    
%all apply section #dab4hh ( title #db1 
,code ( ,f$]al ,regulations1 z if !     
ref]5ce to #ej p]c5t ea* place x appe>s 
9 su* section 7 a ref]5ce to #hj p]c5t4 
7#b7 ,cl>ification reg>d+ paym5ts = new 
te*nologies  7,a7 ,,ipps new te*nology  
paym5t ,section #ahhf7;d77#e77,k7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#acieww7d77#e77,k77 is am5d$ by add+ at 
! end ! foll[+ new clause3  7x7 ,dur+ ! 
p]iod ) respect to :i* a new m$ical     
s]vice or te*nology is eligible = an    
additional paym5t "u ?is subsection by  
reason ( ?is subp>agraph1 any local     
cov]age det]m9ation 7z def9$ 9 section  
#ahfi7;f77#b77;,b77 t w\ld affect !     
cov]age (1 or ! additional paym5t "u ?is
 subsection =1 su* new m$ical s]vice or 

te*nology %all h no =ce or effect 9 law 
or regulation4  4  7,b7 ,con=m+ am5dm5t 
= opps pass-?r\gh paym5t ,section       
#ahcc7t77#f7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciel7t77#f77 is am5d$  
by add+ at ! end ! foll[+ new           
subp>agraph3  7,g7 ,prohibition on use (
 local cov]age det]m9ations to affect   
cov]age ( & paym5t = pass-?r\gh devices 
,dur+ ! p]iod ) respect to :i* a drug1  
biological1 or m$ical device is eligible
 = an additional paym5t "u ?is p>agraph1
 any local cov]age det]m9ation 7z def9$ 
9 section #ahfi7;f77#b77;,b77 t w\ld    
affect ! cov]age (1 or ! additional     
paym5t "u ?is p>agraph =1 su* drug1     
biological1 or m$ical device %all h no  
=ce or effect 9 law or regulation4  4   
7,c7 ,effective date ,?is p>agraph1 & ! 
am5dm5ts made by ?is p>agraph1 %all     
apply ) respect to items & s]vices      
furni%$ on or aft] ! date ( ! enactm5t (
 ?is ,act1 includ+ any su* item or      
s]vice t is eligible on su* date = an   
additional paym5t "u section            

#ahcc7t77#f7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciel7t77#f77 or "u     
section #ahhf7;d7 ( su* ,act 7#db       
,u4,s4,c4 #acieww7d77 by reason (       
p>agraph 7#e77,k7 ( su* section1 or t   
w\ld h be5 s eligible on su* date b = a 
local cov]age det]m9ation t limits or   
d5ies cov]age ( & su* additional paym5t 
= ! item or s]vice4  7#c7 ,revision to !
 co/ ?re%old  7,a7 ,9 g5]al ,section    
#ahhf7;d77#e77,k77ii77,i7 ( ! ,social   
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77,k77ii77,i77 is am5d$ by 
/rik+ #ge p]c5t ea* place x appe>s &    
ins]t+ #ej p]c5t4  7,b7 ,effective date 
,! am5dm5t made by subp>agraph 7,a7 %all
 take effect on ! date ( ! enactm5t (   
?is ,act4  7#d7 ,use ( be/ available co/
 data = ,,ms-,,drg classification  7,a7 
,9 g5]al ,section #ahhf7;d77#e77,k7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acieww7d77#e77,k771 z am5d$ by p>agraph
 7#b77;,a71 is fur!r am5d$ by add+ at ! 
end ! foll[+ new clause3  7xi7 ,9 c>ry+ 
out ! requirem5t "u clause 7ii77,,iv7 = 

classification ( a new m$ical s]vice or 
te*nology to a new or exi/+             
diagnosis-relat$ gr\p aft] ! close ( !  
p]iod "u clause 7ii77,,ii71 ! ,secret>y 
%all use ! mo/ rec5tly available data & 
in=mation on ! co/s ( su* s]vice or     
te*nology 9 mak+ su* a classification = 
! s]vice or te*nology1 includ+ data &   
in=mation f surveys ( provid]s ( s]vices
 & suppli]s conduct$ by ! ,secret>y1    
private pay]s1 heal? plans1 physician   
specialty societies1 or manufactur]s z  
well z comm]cial price data & data f    
manufactur] invoices4  4  7,b7          
,effective date ,! am5dm5t made by      
subp>agraph 7,a7 %all take effect on !  
date ( ! enactm5t ( ?is ,act4  7#e7     
,crit]ia appli$ 9 mak+ sub/antial       
improvem5t det]m9ations  7,a7 ,9 g5]al  
,section #ahhf7;d77#e77,k7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77,k771 z am5d$ by         
p>agraphs 7#b77;,a7 & 7#d77;,a71 is     
fur!r am5d$ by add+ at ! end ! foll[+   
new clause3  7xii7  7,i7 ,9 mak+ a      

det]m9ation "u ?is subp>agraph :e!r a   
new m$ical s]vice or te*nology repres5ts
 an advance 9 m$ical te*nology t        
sub/antially improves ! diagnosis or    
treatm5t ( ,m$ic>e b5efici>ies relative 
to a m$ical s]vice or te*nology t 0     
previ\sly available1 ! ,secret>y %all   
also consid] :e!r su* new m$ical s]vice 
or te*nology meets "o or m ( ! foll[+   
crit]ia3  7aa7 ,! use ( ! new m$ical    
s]vice or te*nology c result 9 a        
r$uction ( ! l5g? ( a hospital /ay4     
7bb7 ,! use ( ! new m$ical s]vice or    
te*nology c improve pati5t quality (    
life4  7cc7 ,! use ( ! new m$ical s]vice
 or te*nology c create long-t]m cl9ical 
effici5cies 9 treatm5t4  7dd7 ,! use ( !
 new m$ical s]vice or te*nology c       
address pati5t-c5t]$ objectives 7z def9$
 by ! ,secret>y74  7ee7 ,! use ( ! new  
m$ical s]vice or te*nology decreases !  
numb] ( hospitalizations or physician   
visits4  7ff7 ,! use ( ! new m$ical     
s]vice or te*nology r$uces recov]y "t   
comp>$ to ! te*nologies previ\sly us$4  

7gg7 ,! use ( ! new m$ical s]vice or    
te*nology r$uces device-relat$          
complications4  7hh7 ,! use ( ! new     
m$ical s]vice or te*nology c result 9   
decreas$ rate ( subsequ5t diagno/ic or  
!rapeutic int]v5tions 7su* z due to !   
r$uc$ rate ( recurr5ce ( ! disease      
process74  7ii7 ,! use ( ! new m$ical   
s]vice or te*nology c result 9 m rapid  
b5eficial resolution ( ! disease process
 treatm5t4  7jj7 ,! use ( ! new m$ical  
s]vice or te*nology c result 9 decreas$ 
pa91 ble$+1 or o!r quantifiable symptom4
  7kk7 ,! use ( ! new m$ical s]vice or  
te*nology c meet su* o!r crit]ia z !    
,secret>y may specify4  7,,ii7 ,9       
consid]+ :e!r a new m$ical s]vice or    
te*nology pot5tially meets ! crit]ia "u 
subclause 7,i71 ! ,secret>y %all consid]
 ! foll[+ =ms ( evid5ce3  7aa7 ,evid5ce 
describ$ 9 well-docum5t$ case hi/ories1 
includ+ regi/ry data4  7bb7 ,/udies     
publi%$ 9 pe]-review$ j\rnals4  7cc7    
,data collect$ 9 c\ntries o!r ?an !     
,unit$ ,/ates s long z su* data o!rwise 

meet ! crit]ia specifi$ 9 ?is clause4  4
  7,b7 ,effective date ,! am5dm5t made  
by subp>agraph 7,a7 %all take effect on 
! date ( ! enactm5t ( ?is ,act4  7#f7   
,revision to ! newness crit]ion  7,a7 ,9
 g5]al ,section #ahhf7;d77#e77,k77vi7 ( 
! ,social ,security ,act 7#db ,u4,s4,c4 
#acieww7d77#e77,k77vi77 is am5d$--  7i7 
by ins]t+ 7,i7 aft] 7vi72 &  7ii7 by    
add+ at ! end ! foll[+ new subclauses3  
7,,ii7 ,"u ! crit]ia e/abli%$ "u ?is    
clause ) respect to ! det]m9ation ( :e!r
 a m$ical s]vice or te*nology is        
consid]$ new = purposes ( ?is           
subp>agraph & subp>agraph 7,l71 !       
,secret>y %all include devices t involve
 a significant te*nological *ange t d n 
raise diff]5t que/ions ( safety &       
effectiv5ess 79 a comp>ison to !        
pr$icate device7 & result 9 enhanc$     
cl9ical advantages or r$uc$ co/1 ev5    
?\gh !y use ! same or simil> me*anism ( 
action or are assign$ to ! same         
diagnosis-relat$ gr\p4  7,,iii7 ,"u !   
crit]ia e/abli%$ "u ?is clause ) respect

 to ! det]m9ation ( :e!r a m$ical s]vice
 or te*nology is consid]$ new = purposes
 ( ?is subp>agraph & subp>agraph 7,l71 !
 ,secret>y %all n disqualify a new      
m$ical s]vice or te*nology z n meet+ !  
newness crit]ion solely on ! basis ( a  
f9d+ ( a de m9imis numb] ( claims = su* 
m$ical s]vice or te*nology 9 ,m$ic>e    
claims data4 ,= purposes ( ?is          
subclause1 ! t]m de m9imis means1 )     
respect to claims1 an am\nt t is few]   
?an #ej4  4  7,b7 ,effective date ,!    
am5dm5t made by subp>agraph 7,a7 %all   
take effect on ! date ( ! enactm5t ( ?is
 ,act4  7#g7 ,revision to ! comm5cem5t (
 ! p]iod = collection ( co/ data = new  
te*nologies  7,a7 ,9 g5]al ,section     
#ahhf7;d77#e77,k77ii77,,ii7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77,k77ii77,,ii77 is am5d$  
by ins]t+ ! lat] ( ! date t is ! date ( 
! cle>ance or approval by ! ,commission]
 ( ,food & ,drugs ( ! s]vice or         
te*nology or aft] beg9n+ on4  7,b7      
,effective date ,! am5dm5t made by      

subp>agraph 7,a7 %all take effect on !  
date ( ! enactm5t ( ?is ,act1 & %all    
apply ) respect to hospital dis*>ges =  
inpati5t hospital s]vices = :i* paym5t  
is made "u section #ahhf7;d7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4 #acieww7 
occurr+ on or aft] ,octob] #a1 #bjaf4   
7#h7 ,p]mitt+ appeals ( ntap            
det]m9ations  7,a7 ,9 g5]al ,section    
#ahhf7;d77#e77,k7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acieww7d77#e77,k771
 z am5d$ by p>agraphs 7#b77;,a71        
7#d77;,a71 & 7#e77;,a71 is fur!r am5d$  
by add+ at ! end ! foll[+ new clause3   
7xiii7  7,i7 ,an individual or entity t 
submits an application = additional     
paym5t "u ?is subp>agraph = a new       
te*nology %all be entitl$ to            
adm9i/rative review ( an adv]se         
det]m9ation by ! ,secret>y ) respect to 
su* application4  7,,ii7 ,! ,secret>y   
%all e/abli% a process = adm9i/rative   
review = purposes ( subclause 7,i74 ,"u 
su* process1 adm9i/rative review %all be
 conduct$ by an (ficial ( ! ,dep>tm5t ( 

,heal? & ,human ,s]vices 7o!r ?an an    
(ficial ( ! ,c5t]s = ,m$ic>e  ,m$icaid  
,s]vices74 ,"u su* process1 ! ,dep>tm5t 
(ficial involv$ %all complete           
adm9i/rative review )9 #ij days (       
receipt ( a reque/ = su* review4        
7,,iii7 ,9 ! case ( an application =    
additional paym5t "u ?is subp>agraph = a
 new te*nology t is approv$ "u          
adm9i/rative review1 ! ,secret>y %all   
provide = su* additional paym5t = su*   
new te*nology dur+ ! p]iod t--  7aa7    
beg9s on ! date t is ! fir/ day ( ! fir/
 cal5d> qu>t] t beg9s aft] ! date ( !   
completion ( su* adm9i/rative review2 & 
7bb7 ends on ! date t is n less ?an #b  
ye>s & n m ?an #c ye>s aft] ! date      
ref]r$ to 9 item 7aa74  4  7,b7 ,con=m+ 
am5dm5t ,section #ahhf7;d77#g77;,b7 (   
su* ,act 7#db ,u4,s4,c4                 
#acieww7d77#g77;,b77 is am5d$ by ins]t+ 
b n includ+ a d5ial by ! ,secret>y ( an 
application = additional paym5t "u      
p>agraph 7#e77,k7 ) respect to a dis*>ge
 occurr+ on or aft] ! date ( ! date ( ! 

enactm5t ( ! ,ensur+ ,pati5t ,access to 
,critical ,break?r\gh ,products ,act (  
#bjah aft] p>agraph 7#d77;,d74  7,c7    
,effective date ,! am5dm5ts made by ?is 
p>agraph %all take effect on ! date ( ! 
enactm5t ( ?is ,act1 & %all apply )     
respect to hospital dis*>ges = inpati5t 
hospital s]vices = :i* paym5t is made "u
 section #ahhf7;d7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #acieww7 occurr+ on
 or aft] ,octob] #a1 #bjaf4  7e7 ,con=m+
 am5dm5ts  7#a7 ,inpati5t prospective   
paym5t sy/em ,section                   
#ahhf7;d77#e77,k77i7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77,k77i77 is am5d$ by add+ 
at ! end ! foll[+ new s5t5ce3 ,effective
 = dis*>ges occurr+ on or aft] ,octob]  
#a1 #bjaf1 9 ! case ( a new m$ical      
s]vice or te*nology t is a break?r\gh   
device 7z def9$ 9 section #ahii;,c7a77  
paym5t = su* break?r\gh device %all be  
made = ! #c-ye> p]iod applicable to su* 
break?r\gh device "u section            
#ahii;,c7d77#a744  7#b7 ,outpati5t      

prospective paym5t sy/em ,section       
#ahcc7t77#f77;,c7 ( su* ,act 7#db       
,u4,s4,c4 #aciel7t77#f77;,c77 is am5d$  
by add+ at ! end ! foll[+ new clause3   
7iii7 ,special rule = break?r\gh devices
 ,not)/&+ clause 7i7 or 7ii71 or any o!r
 provision ( ?is p>agraph to ! contr>y1 
9 ! case ( a break?r\gh device 7z def9$ 
9 section #ahii;,c7a77 t is furni%$ on  
or aft] ,janu>y #a1 #bjai1 paym5t "u ?is
 p>agraph = su* break?r\gh device %all  
be made = ! #c-ye> p]iod applicable to  
su* break?r\gh device "u section        
#ahii;,c7d77#b74 ,! provisions ( ?is    
clause %all also apply = purposes (     
transitional pass-?r\gh paym5t "u       
section #ahcc7;i77#b77;,d74  4  7f7     
,effective date ,?is section & !        
am5dm5ts made by ?is section %all take  
effect on ! date ( ! enactm5t ( ?is ,act
 &1 unless o!rwise specifi$ 9 ?is       
section 7or 9 an am5dm5t made by ?is    
section71 %all apply to break?r\gh      
devices 7z def9$ 9 section #ahii;,c7a71 
z add$ by subsection 7a77 approv$ on or 

aft] ,janu>y #a1 #bjai4