,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #iigb  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #bg1 #bjbf,mr4  
,sessions 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 ! ,am]ican      
,pati5ts ,fir/ ,act ( #bjbf4  #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 /rik+ & at ! end2
  7#b7 9 subp>agraph 7,,kk71 by add+ &  
at ! end2 &  7#c7 by ins]t+ aft]        
subp>agraph 7,,kk7 ! foll[+ new         

subp>agraph3  7,,ll7 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%$ dur+ ! p]iod beg9n+ on ,janu>y  
#a1 #bjbg1 & end+ on ,decemb] #ca1      
#bjcj4  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;,j77 furni%$
 dur+ ! p]iod beg9n+ on ,janu>y #a1     
#bjbg1 & end+ on ,decemb] #ca1 #bjcj1   
#deg p] squ>e c5timet]4  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        
liquids4  7#b7 ,con=m+ am5dm5ts ,section
 #ahcc7;a77#a7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #aciel7a77#a77 is   
am5d$-- 7,a7 9 subp>agraph 7,s77i71 by  
/rik+ subject to subp>agraph 7,,ee7 &   
ins]t+ subject to subp>agraphs 7,,ee7 & 
7,,ii72  7,b7 by /rik+ & 7,,hh7 & ins]t+
 7,,hh72 &  7,c7 by ins]t+ 1 & 7,,ii7 ) 
respect to sk9 sub/itute products "u    
section #ahfa7s77#b77,,ll7 furni%$ dur+ 
! p]iod beg9n+ on ,janu>y #a1 #bjbg1 &  
end+ on ,decemb] #ca1 #bjcj1 ! am\nt    
paid %all be #hj p]c5t ( ! less] ( !    
actual *>ge or ! paym5t am\nt e/abli%$  
"u section #ahdg;,a7b77#a77;,d7 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  7i7 ,9 g5]al ,subject to      
clause 7ii71 ! t]m sk9 sub/itute        
product--  7,i7 means a cellul>1 tissue1
 biological or syn!tic mat]ial t-- 7aa7 
is appli$ to a w\nd & int5d$ to rema9 )9
 ! w\nd b$2 &  7bb7 is m>ket$ pursuant  
to section #eaj7k71 #eac7;f77#b71 or    
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act1 or section #cfa ( !     
,public ,heal? ,s]vice ,act2 &  7,,ii7  
includes any products reimburs$ pursuant
 to sk9 sub/itutes codes "u ?is title at
 any "t prior to ,janu>y #a1 #bjbg4     
7ii7 ,exclusions ,! t]m sk9 sub/itute   
product does n include-- 7,i7 any       
product t is int5d$ to tempor>ily       
protect or cov] ! w\nd b$ & be remov$   
)\t resorption su* z a dress+2 or       
7,,ii7 any product t does n meet !      
dome/ic s\rc+ & di/ribution requirem5ts 

describ$ 9 clause 7iii71 unless a waiv] 
"u clause 7iv7 is 9 effect ) respect to 
su* product4  7iii7 ,dome/ic s\rc+ &    
di/ribution requirem5ts ,= purposes (   
clause 7ii71 ! dome/ic s\rc+ &          
di/ribution requirem5ts describ$ 9 ?is  
clause are1 ) respect to a product      
describ$ 9 clause 7i71 ! foll[+3  7,i7  
,all human cellul> or tissue mat]ial    
conta9$ 9 su* product 0 donat$ by       
citiz5s or nationals ( ! ,unit$ ,/ates1 
or ali5s lawfully admitt$ = p]man5t     
resid5ce 9 ! ,unit$ ,/ates1 & any su*   
donation 0 made )9 ! ,unit$ ,/ates 9    
accordance ) applicable ,f$]al law4     
7,,ii7 ,all h>ve/+ & process+ 7z        
applicable7 & all manufactur+ ( su*     
product occurr$ exclusively )9 ! ,unit$ 
,/ates1 & su* h>ve/+1 process+1 &       
manufactur+ 0 p]=m$ 9 compliance ) all  
applicable /&>ds ( ! ,food & ,drug      
,adm9i/ration & ! ,am]ican ,association 
( ,tissue ,banks4  7,,iii7 ,! product is
 di/ribut$ solely by ! entity hold+ !   
applicable cle>ance1 approval1 or       

regi/ration = su* product "u section    
#eaj7k71 #eac7;f77#b71 or #eae ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act1  
or section #cfa ( ! ,public ,heal?      
,s]vice ,act1 & no int]m$i>ies1 or ag5ts
 7 involv$ 9 ! di/ribution ( su* product
 to ! furni%+ provid]1 except t a       
?ird-p>ty di/ributor t adh]es to & is   
able to p]=m ! contractual requirem5ts  
associat$ ) ! scope ( "w & is qualifi$ &
 able to adh]e to ! legal & regulatory  
requirem5ts def9$ 9 ! scope ( "w may be 
involv$ 9 su* di/ribution4  7,,iv7 ,!   
entity describ$ 9 subclause 7,,iii7 )   
respect to ! product submits to !       
,secret>y1 9 su* =m & mann] z !         
,secret>y %all specify 7b n less        
frequ5tly ?an annually71 an atte/ation t
 ! product meets ea* ( ! requirem5ts "u 
subclauses 7,i7 ?r\gh 7,,iii74  7iv7    
,waiv] ,! ,secret>y may waive !         
requirem5ts "u clause 7iii7 ) respect to
 a specific product1 = a p]iod n to     
exce$ #ahj days1 if ! ,secret>y det]m9es
 t a dome/ic supply %ortage exi/s & t a 

waiv] is necess>y to protect pati5t     
access to c>e4  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    
#bjbg1 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 #bjbg1 ! ,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 7c774  #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  7bb7 ,special   

paym5t rules = sk9 sub/itute products   
7#a7 ,prepaym5t claim review & prior    
au?orization  7,a7 ,initial prepaym5t   
claim review = c]ta9 provid]s  7i7 ,9   
g5]al ,beg9n+ ,janu>y #a1 #bjbg1 !      
,secret>y %all conduct prepaym5t review 
( claims = sk9 sub/itute products       
submitt$ "u ?is title by a specifi$     
provid] ( sk9 sub/itute products unless 
#a or m ( ! conditions describ$ 9 clause
 7ii7 is met ) respect to su* provid]4  
7ii7 ,limitation ,= purposes ( clause   
7i71 ! conditions describ$ 9 ?is        
subp>agraph are1 ) respect to a specifi$
 provid] ( sk9 sub/itute products1 !    
foll[+3  7,i7 ,sk9 sub/itute products   
furni%$ by ! provid] are subject to     
prior au?orization "u subp>agraph 7,b74 
7,,ii7 ,! rate ( approval = claims = sk9
 sub/itute products furni%$ by su*      
provid] t are subject to prepaym5t      
review "u ?is subp>agraph exce$s #ij    
p]c5t 7z det]m9$ ov] a p]iod ( "t or    
numb] ( claims specifi$ by ! ,secret>y74
  7,,iii7 ,! ,secret>y det]m9es t !     

bill+ practices ( ! provid] are consi/5t
 ) ! applicable cov]age crit]ia &       
requirem5ts "u ?is title4  7,b7 ,prior  
au?orization = specifi$ provid]s ( sk9  
sub/itute products  7i7 ,9 g5]al ,beg9n+
 n lat] ?an ,janu>y #a1 #bjbh1 subject  
to clause 7ii71 ! ,secret>y %all1 = a   
p]iod ( #ahj days1 apply prior          
au?orization = sk9 sub/itute products t 
are furni%$ by a specifi$ provid] ( sk9 
sub/itute products4  7ii7 ,removal f    
prior au?orization ,9 ! ev5t t !        
,secret>y det]m9es1 ) respect to a      
specifi$ provid] ( sk9 sub/itute        
products1 t ! rate ( approval = reque/s 
= prior au?orization "u ?is subp>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 ,enrollm5t
 revocation or exclusion ( noncompliant 
outli] provid]s  7i7 ,9 g5]al ,beg9n+   

,janu>y #a1 #bjbi1 if ! rate ( d5ial 7z 
det]m9$ aft] ! exhau/ion ( all appeals &
 reviews7 = reque/s = prior au?orization
 "u subp>agraph 7,b7 = 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  7ii7 ,ref]ral =
 exclusion ,if ! ,secret>y det]m9es "u  
clause 7i7 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$]al heal? c>e  
program "u section #aabh7;b77#f74  7,d7 
,specifi$ provid] ( sk9 sub/itute       
products def9$  7i7 ,9 g5]al ,= purposes
 ( ?is p>agraph1 ! t]m specifi$ provid] 
( sk9 sub/itute products means--  7,i7  

an outli] provid] ( sk9 sub/itute       
products1 z det]m9$ "u clause 7ii72     
7,,ii7 a provid] ) respect to :i*1 ( all
 claims = paym5t "u ?is title submitt$ 9
 ! prec$+ ye>1 #ae p]c5t or m ( su*     
claims 7 = ! provision ( sk9 sub/itute  
products2 &  7,,iii7 z ! ,secret>y      
det]m9es appropriate1 a provid] ( sk9   
sub/itute products t-- 7aa7 is newly    
enroll$ "u section #ahff7;j72  7bb7 has 
und]gone a *ange 9 own]%ip dur+ ! prec$+
 ye>2  7cc7 is a high risk provid] 7z   
det]m9$ by ! ,secret>y "u section       
#dbd4eah ( title #db1 ,code ( ,f$]al    
,regulations72 or  7dd7 has a patt]n or 
practice ( noncompliance ) conditions ( 
p>ticipation "u ?is title or a high     
p]c5tage ( previ\sly d5i$ claims 7z     
det]m9$ by ! ,secret>y74  7ii7          
,id5tification ( outli] provid]s ( sk9  
sub/itute products  7,i7 ,9 g5]al ,n    
lat] ?an ,decemb] #a1 #bjbf1 & e #b ye>s
 !reaft] ?r\gh ,decemb] #a1 #bjcf1 !    
,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,,ii7 ,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$+ ! ye> 9 :i* ! det]m9ation 
"u subclause 7,i7 is made4  7,,iii7     
,ref]ral to ,,oig ,! ,secret>y %all--   
7aa7 make publicly available ! li/ (    
outli] provid]s ( sk9 sub/itute products
 id5tifi$ "u ea* det]m9ation "u         
subclause 7,i72 &  7bb7 transmit su* li/
 to ! ,inspector ,g5]al ( ! ,dep>tm5t ( 
,heal? & ,human ,s]vices = ! assessm5t (
 pot5tial fraud1 wa/e1 or abuse4  7,e7  
,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 ( 

#b1ejj1jjj = ea* ( fiscal ye>s #bjbh    
?r\gh #bjca1 to rema9 available until   
exp5d$4  7#b7 ,m$ic>e cov]age crit]ia = 
sk9 sub/itute products ,any sk9         
sub/itute product furni%$ dur+ #bjbg    
%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 #bjbg is n cov]$ "u ?is title
 bas$ solely on analysis ( ! cl9ical    
evid5ce relat+ to t sk9 sub/itute       
product4  7#c7 ,sk9 sub/itute product   
wa/age  7,a7 ,9 g5]al ,) respect to sk9 
sub/itute products furni%$ = ! treatm5t 

( *ronic or acute w\nds1 paym5t may only
 be made "u ?is title = ! reasonable &  
necess>y portion ( ! sk9 sub/itute      
product us$ 9 ! treatm5t ( ! w\nd1      
exclud+ wa/age4  7,b7 ,reasonable &     
necess>y def9$ ,= ! purpose (           
subp>agraph 7,a71 ! t]m reasonable &    
necess>y portion ( ! sk9 sub/itute      
product means ! great] (--  7i7 #cej    
squ>e c5timet]s2 or  7ii7 #abj p]c5t ( !
 size ( ! treat$ w\nd4  7#d7 ,limitation
 on repeat$ applications ,paym5t may n  
be made "u ?is title = m ?an #c di/9ct  
applications ( a sk9 sub/itute product )
 respect to ! same w\nd if1 9 ! cl9ical 
judgm5t ( ! provid] furni%+ su* product1
 !re has be5 no improvem5t 9 ! w\nd4    
7#e7 ,c]tification requirem5t ,paym5t   
may only be made "u ?is title = a sk9   
sub/itute product if ! provid] furni%+  
su* product is c]tifi$--  7,a7 by !     
,am]ican ,bo>d ( ,w\nd ,managem5t z a   
c]tifi$ w\nd speciali/ or a c]tifi$ w\nd
 c>e speciali/ physician2  7,b7 by !    
,w\nd1 ,o/omy & ,cont95ce ,nurs+        

,c]tification ,bo>d z a c]tifi$ w\nd c>e
 nurse practition]2  7,c7 by ! ,national
 ,alliance ( ,w\nd ,c>e & ,o/omy z w\nd 
c>e c]tifi$2 or  7,d7 by ! ,am]ican     
,foot ,c>e ,nurses ,association z a     
c]tifi$ foot c>e speciali/4  7#f7       
,limitation on provid] disc\nts ,= !    
p]iod beg9n+ on ,janu>y #a1 #bjbg1 &    
end+ on ,decemb] #ca1 #bjcj1 paym5t may 
n be made "u ?is title = a sk9 sub/itute
 product if ! provid] furni%+ su*       
product obta9$ su* product = less ?an   
#cdb4ge p] squ>e c5timet]4  7#g7 ,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  #d4 ,report   
7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1    
#bjcj1 ! ,secret>y ( ,heal? & ,human    
,s]vices %all submit to ! appropriate   
committees ( ,congress a report on !    
w\nd c>e indu/ry1 includ+ manufactur]s (
 sk9 sub/itute products1 w\nd dress+s1 &
 relat$ w\nd managem5t te*nologies4 ,su*
 report %all include an analysis (--    

7#a7 ! co/ ( produc+ sk9 sub/itute      
products 9 ! ,unit$ ,/ates2 &  7#b7     
pati5t access to sk9 sub/itute products1
 & ! evid5ce support+ ! effectiv5ess (  
su* products4  7b7 ,def9itions ,9 ?is   
section3  7#a7 ,appropriate committees (
 ,congress ,! t]m appropriate committees
 ( ,congress means-- 7,a7 ! ,committee  
on ,en]gy & ,comm]ce & ! ,committee on  
,ways & ,means ( ! ,h\se (              
,repres5tatives2 &  7,b7 ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
& ! ,committee on ,f9ance ( ! ,s5ate4   
7#b7 ,sk9 sub/itute product ,! t]m sk9  
sub/itute product has ! mean+ giv5 su*  
t]m 9 subp>agraph 7,j7 ( section        
#ahdg;,a7c77#f7 ( ! ,social ,security   
,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f771
 z add$ by section #b7;c74