,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #egfh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #ag1 #bjbe,mr4
 ,c>t] ( ,georgia 7= himself1 ,mr4      
,veasey1 ,mr4 ,/eube1 & ,mr4            
,mc,cormick7 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 title      
,,xviii ( ! ,social ,security ,act to   
adju/ paym5t = sk9 sub/itute products "u
 ! ,m$ic>e program4  #a4 ,%ort title    
,?is ,act may be cit$ z ! ,sk9          
,sub/itute ,access & ,paym5t ,re=m ,act4
  #b4 ,paym5t re=m = sk9 sub/itute      
products  7a7 ,cov]age ( sk9 sub/itute  
products ,section #ahfa7s77#b7 ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#aciex7s77#b77 is am5d$-- 7#a7 9        
subp>agraph 7,,jj71 by add+ & at ! end2 
&  7#b7 by ins]t+ aft] subp>agraph      

7,,jj7 ! foll[+ new subp>agraph3  7,,kk7
 sk9 sub/itute products 7z def9$ 9      
section #ahdg;,a7c77#f77;,j774  4  7b7  
,paym5t  7#a7 ,paym5t am\nt ,section    
#ahdg;,a ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #aciew-#c;a7 is am5d$-- 7,a7 
9 subsection 7a77#a7-- 7i7 by /rik+ !   
p]iod at ! end & ins]t+ 2 &2  7ii7 by   
/rik+ %all apply to & ins]t+ %all       
apply-- 7,a7 to  2 &  7iii7 by add+ at !
 end ! foll[+ new subp>agraph3  7,b7 to 
paym5t = sk9 sub/itute products 7z def9$
 9 subsection 7c77#f77;,j77 t are       
furni%$ on or aft] ,janu>y #a1 #bjbf4  2
  7,b7 9 subsection 7b7-- 7i7 9 p>agraph
 7#a7-- 7,i7 9 ! text prec$+ subp>agraph
 7,a71 by ins]t+ or a sk9 sub/itute     
product aft] drug or biological2  7,,ii7
 9 subp>agraph 7,b71 by /rik+ or at !   
end2  7,,iii7 9 subp>agraph 7,c71 by    
/rik+ ! p]iod at ! end & ins]t+ 2 or2 & 
7,,iv7 by add+ at ! end ! foll[+ new    
subp>agraph3  7,d7 9 ! case ( a sk9     
sub/itute product 7z def9$ 9 subsection 
7c77#f77;,j771 ! am\nt det]m9$ "u       

p>agraph 7#i74  2 &  7ii7 9 p>agraph    
7#b7-- 7,i7 9 subp>agraph 7,a71 by      
ins]t+ or a sk9 sub/itute product aft]  
drug or biological2 &  7,,ii7 9         
subp>agraph 7,b71 by ins]t+ 1 &1 )      
respect to a sk9 sub/itute product1 a   
squ>e c5timet] aft] p]ta9+ to liquids2 &
  7iii7 by add+ at ! end ! foll[+3  7#i7
 ,sk9 sub/itute products  7,a7 ,paym5t  
am\nt  7i7 ,initial paym5t am\nt ,=     
#bjbf1 ! am\nt det]m9$ "u ?is p>agraph =
 a sk9 sub/itute product is !           
volume-weight$ av]age ( ! ,m$ic>e paym5t
 all[ance limits = sk9 sub/itute        
products1 z det]m9$ "u subp>agraph 7,b74
  7ii7 ,annual update ,= #bjbg & ea*    
subsequ5t ye>1 ! am\nt det]m9$ "u ?is   
p>agraph = a sk9 sub/itute product = su*
 ye> is equal to ! am\nt det]m9$ "u ?is 
p>agraph = ! previ\s ye>1 adju/$ by !   
p]c5tage increase 9 ! ,consum] ,price   
,index = ,all ,urban ,consum]s 7,unit$  
,/ates city av]age7 = ! #ab-mon? p]iod  
end+ ) ,june ( su* previ\s ye>4  7,b7   
,volume-weight$ av]age paym5t limit ,=  

purposes ( subp>agraph 7,a77i71 !       
volume-weight$ av]age ( ! ,m$ic>e paym5t
 all[ance limits = sk9 sub/itute        
products is det]m9$ by-- 7i7 calculat+1 
) respect to ea* bill+ & paym5t code    
li/$ 9 ! ,octob] #bjbc ,,asp ,pric+     
,file = ea* sk9 sub/itute product1 an   
am\nt equal to ! product (-- 7,i7 !     
paym5t limit includ$ 9 su* file )       
respect to su* code2 &  7,,ii7 ! numb] (
 units 7z specifi$ "u p>agraph 7#b77--  
7aa7 bill$ ) respect to su* code = a    
date ( s]vice 9 #bjbc2 &  7bb7 li/$ 9 ! 
,,cms ,integrat$ ,data ,repository = ,"p
 ,b 7,c>ri]  ,,dme7 claims data2  7ii7  
calculat+ ! sum ( all am\nts det]m9$ "u 
clause 7i72 &  7iii7 divid+ ! sum       
calculat$ "u clause 7ii7 by ! total     
numb] ( units det]m9$ "u clause         
7i77,,ii74  4  7#b7 ,con=m+ am5dm5ts    
,section #ahcc7;a77#a7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciel7a77#a77 is am5d$-- 7,a7 9        
subp>agraph 7,s77i71 by /rik+ subject to
 subp>agraph 7,,ee7 & ins]t+ subject to 

subp>agraphs 7,,ee7 & 7,,ii72  7,b7 by  
/rik+ & 7,,hh7 & ins]t+ 7,,hh72 &  7,c7 
by ins]t+ 1 & 7,,ii7 ) respect to sk9   
sub/itute products "u section           
#ahfa7s77#b77,,kk71 ! am\nt paid %all be
 #hj p]c5t ( ! less] ( ! actual *>ge or 
! paym5t am\nt e/abli%$ "u section      
#ahdg;,a7b77#i7 be=e ! semicolon at !   
end4  7c7 ,sk9 sub/itute product def9$  
,section #ahdg;,a7c77#f7 ( ! ,social    
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77 is am5d$ by add+ at 
! end ! foll[+3  7,j7 ,sk9 sub/itute    
products ,! t]m sk9 sub/itute product-- 
7i7 means a cellul>1 tissue1 biological 
or syn!tic mat]ial t-- 7,i7 is appli$ to
 a w\nd & int5d$ to rema9 )9 ! w\nd b$2 
&  7,,ii7 is m>ket$ pursuant to section 
#eaj7k71 #eac7;f77#b71 or #eae ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
or section #cfa ( ! ,public ,heal?      
,s]vice ,act2 &  7ii7 does n include--  
7,i7 a product t is int5d$ to tempor>ily
 protect or cov] ! w\nd b$ & be remov$  
be=e complete resorption 7su* z a       

dress+72 or  7,,ii7 a liquid1 gel1 p[d]1
 or o!r simil>ly con/itut$ item4  4  7d7
 ,exclusion f report+ requirem5ts       
,section #ahdg;,a7f77#b77;,a7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#c;a7f77#b77;,a77 is am5d$ by    
ins]t+ 7except t1 beg9n+ ,janu>y #a1    
#bjbf1 a drug or biological s describ$  
does n include a sk9 sub/itute product  
7z def9$ 9 subsection 7c77#f77;,j777    
aft] products t are payable "u ?is "p z 
a drug or biological4  7e7 ,consolidat$ 
bill+ & paym5t code ,n lat] ?an ,janu>y 
#a1 #bjbf1 ! ,secret>y ( ,heal? & ,human
 ,s]vices %all e/abli% a new bill+ &    
paym5t code = all sk9 sub/itute products
 7z def9$ 9 subp>agraph 7,j7 ( section  
#ahdg;,a7c77#f7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f771
 z add$ by subsection 7b774  #c4        
,enhanc+ program integrity = sk9        
sub/itute products ,section #ahcd ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#aciem7 is am5d$ by add+ at ! end !     
foll[+ new subsection3  7aa7 ,special   

paym5t rules = sk9 sub/itute products   
7#a7 ,id5tification ( outli] provid]s ( 
sk9 sub/itute products  7,a7 ,9 g5]al ,n
 lat] ?an ,decemb] #a1 #bjbe1 & e #b    
ye>s !reaft] ?r\gh ,decemb] #a1 #bjce1 !
 ,secret>y %all det]m9e ! #c p]c5t ( !  
total numb] ( provid]s ( sk9 sub/itute  
products t are outli] provid]s ( sk9    
sub/itute products4  7,b7 ,outli]       
provid]s ( sk9 sub/itute products ,!    
det]m9ation ( an outli] provid] ( sk9   
sub/itute products "u ?is p>agraph %all 
be bas$ ^u ! provid]s 7z id5tifi$ by    
national provid] id5tification numb]7 t 
receiv$ ! greate/ total paym5t "u ?is   
title = sk9 sub/itute products furni%$ 9
 ! ye> prec$+ ! ye> 9 :i* ! det]m9ation 
"u subp>agraph 7,a7 is made4  7,c7      
,ref]ral to oig ,! ,secret>y %all-- 7i7 
make publicly available ! li/ ( outli]  
provid]s ( sk9 sub/itute products       
id5tifi$ "u ea* det]m9ation "u          
subp>agraph 7,a72 &  7ii7 transmit su*  
li/ to ! ,inspector ,g5]al ( ! ,dep>tm5t
 ( ,heal? & ,human ,s]vices = !         

assessm5t ( pot5tial fraud1 wa/e1 or    
abuse4  7#b7 ,initial prepaym5t claim   
review = c]ta9 outli] provid]s  7,a7 ,9 
g5]al ,beg9n+ ,janu>y #a1 #bjbf1 !      
,secret>y %all conduct prepaym5t review 
( claims = sk9 sub/itute products       
submitt$ "u ?is title by an outli]      
provid] ( sk9 sub/itute products unless 
#a or m ( ! conditions describ$ 9       
subp>agraph 7,b7 is met ) respect to su*
 provid]4  7,b7 ,limitation ,= purposes 
( subp>agraph 7,a71 ! conditions        
describ$ 9 ?is subp>agraph are1 )       
respect to an outli] provid] ( sk9      
sub/itute products1 ! foll[+3 7i7 ,sk9  
sub/itute products furni%$ by ! provid] 
are subject to prior au?orization "u    
p>agraph 7#c74  7ii7 ,! rate ( approval 
= claims = sk9 sub/itute products       
furni%$ by su* provid] t are subject to 
prepaym5t review "u ?is p>agraph exce$s 
#ij p]c5t 7z det]m9$ ov] a p]iod ( "t or
 numb] ( claims specifi$ by !           
,secret>y74  7iii7 ,! ,secret>y det]m9es
 t ! bill+ practices ( ! provid] are    

consi/5t ) ! applicable cov]age crit]ia 
& requirem5ts "u ?is title4  7#c7 ,prior
 au?orization = outli] provid]s ( sk9   
sub/itute products  7,a7 ,9 g5]al       
,beg9n+ n lat] ?an ,janu>y #a1 #bjbg1   
subject to subp>agraph 7,b71 ! ,secret>y
 %all1 = a p]iod det]m9$ appropriate by 
! ,secret>y1 apply prior au?orization = 
sk9 sub/itute products t are furni%$ by 
an outli] provid] ( sk9 sub/itute       
products id5tifi$ "u p>agraph 7#a74     
7,b7 ,removal f prior au?orization ,9 ! 
ev5t t ! ,secret>y det]m9es1 ) respect  
to an outli] provid] ( sk9 sub/itute    
products1 t ! rate ( approval = reque/s 
= prior au?orization "u ?is p>agraph =  
sk9 sub/itute products furni%$ by su*   
provid] exce$s #ij p]c5t 7z det]m9$ ov] 
a p]iod ( "t or numb] ( claims specifi$ 
by ! ,secret>y71 ! ,secret>y %all cease 
to apply prior au?orization "u ?is      
p>agraph = sk9 sub/itute products       
furni%$ by su* provid]4  7,c7 ,fund+ ,= 
purposes ( c>ry+ out ?is p>agraph1 !    
,secret>y %all provide = ! transf]1 f ! 

,f$]al ,supplem5t>y ,m$ical ,insurance  
,tru/ ,fund "u section #ahda1 to !      
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices     
,program ,managem5t ,acc\nt1 (          
#e1jjj1jjj = ea* ( fiscal ye>s #bjbg    
?r\gh #bjcj1 to rema9 available until   
exp5d$4  7#d7 ,enrollm5t revocation or  
exclusion ( noncompliant outli] provid]s
  7,a7 ,9 g5]al ,beg9n+ ,janu>y #a1     
#bjbh1 if ! rate ( d5ial = reque/s =    
prior au?orization "u p>agraph 7#c7 =   
sk9 sub/itute products furni%$ by an    
outli] provid] ( sk9 sub/itute products 
exce$s #ge p]c5t ov] a p]iod ( #f or m  
consecutive mon?s1 ! ,secret>y %all     
det]m9e t an abuse ( bill+ privileges   
exi/s ) respect to su* provid] =        
purposes ( section #dbd4ece7;a77#h77;ii7
 ( title #db1 ,code ( ,f$]al            
,regulations4  7,b7 ,ref]ral = exclusion
 ,if ! ,secret>y det]m9es "u subp>agraph
 7,a7 t an abuse ( bill+ privileges     
exi/s ) respect to an outli] provid] (  
sk9 sub/itute products1 ! ,secret>y %all
 direct ! ,inspector ,g5]al ( !         

,dep>tm5t ( ,heal? & ,human ,s]vices to 
det]m9e :e!r su* provid] %\ld be exclud$
 f p>ticipation 9 any ,f$]al heal? c>e  
program "u section #aabh7;b77#f74  7#e7 
,m$ic>e cov]age crit]ia = sk9 sub/itute 
products ,any sk9 sub/itute product     
def9$ 9 section #ahdg;,a7c77#f77;,j7 ( !
 ,social ,security ,act & furni%$ dur+  
#bjbf %all be subject to ! same cov]age 
crit]ia :5 det]m9+ :e!r ! sk9 sub/itute 
product is cov]$ "u section             
#ahfb7;a77#a77;,a71 unless su* product  
is det]m9$ by ! ,secret>y to be unsafe  
bas$ on evid5ce ( contam9ation1 s]i\s   
infecti\s disease1 or s]i\s adv]se      
reactions caus$ by ! product4 ,nei!r !  
,secret>y nor any ,m$ic>e adm9i/rative  
contractor may det]m9e1 includ+ ?r\gh a 
det]m9ation made pursuant to ! prepaym5t
 review program or prior au?orization   
program describ$ 9 p>agraphs 7#b7 &     
7#c71 t a specific sk9 sub/itute product
 furni%$ 9 #bjbf is n cov]$ by ,m$ic>e  
bas$ solely on analysis ( ! cl9ical     
evid5ce relat+ to t sk9 sub/itute       

product4  7#f7 ,sk9 sub/itute product   
def9$ ,9 ?is subsection1 ! t]m sk9      
sub/itute product has ! mean+ giv5 su*  
t]m 9 section #ahdg;,a7c77#f77;,j74  4