,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #dagh  ,,in ,,the ,,house ,,of  
,,representatives  ,august #i1 #bjai,mr4
 ,engel introduced the following bill2  
which was referred to the ,committee on 
,energy and ,commerce1 and in addition  
to the ,committee on ,ways and ,means1  
for a period to be subsequently         
determined by the ,speaker1 in each case
 for consideration of such provisions as
 fall within the jurisdiction of the    
committee concerned  ,a ,,bill  ,to     
amend title ,,xviii of the ,social      
,security ,act to require manufacturers 
of certain single-dose vial drugs       
payable under part ,b of the ,medicare  
program to provide rebates with respect 
to amounts of such drugs discarded1 and 
for other purposes4  #a4 ,short title   
,this ,act may be cited as the          
,recovering ,excessive ,funds for       
,unused and ,needless ,drugs ,act of    
#bjai or the ,,refund ,act of #bjai4    
#b4 ,requiring manufacturers of certain 
single-dose vial drugs payable under    

part ,b of the ,medicare program to     
provide rebates with respect to         
discarded amounts of such drugs  7a7 ,in
 general ,section #ahcd of the ,social  
,security ,act 7#db ,u4,s4,c4 #aciem7 is
 amended by adding at the end the       
following new subsection3  7x7 ,rebate  
for certain discarded single-,dose vial 
drugs  7#a7 ,in general ,the            
manufacturer 7as defined in section     
#ahdg;,a7c77#f77;,a77 of a rebatable    
single-dose vial drug furnished in a    
calendar quarter shall1 not later than  
#cj days after the date of receipt of   
information described in paragraph      
7#b77;,a77iii7 with respect to such     
quarter1 provide to the ,secretary a    
rebate that is equal to the amount      
specified in paragraph 7#c7 for such    
drug for such quarter4  7#b7            
,secretarial duties  7,a7 ,in general   
,for each calendar quarter1 the         
,secretary shall1 with respect to a     
rebatable single-dose vial drug of a    
manufacturer furnished during such      

quarter--  7i7 require1 through use of a
 modifier such as the ,,jw modifier used
 as of the date of enactment of this    
subsection 7or any such successor code  
that includes such data as determined   
appropriate by the ,secretary71 an      
indication on a claim for such drug of  
the amount of such drug that was        
discarded after such drug was furnished1
 if any2  7ii7 determine the rebatable  
amount 7as defined in subparagraph 7,b77
 with respect to such drug2 and  7iii7  
not later than #fj days after the end of
 such quarter1 provide to such          
manufacturer notice of--  7,i7 the total
 number of units of such drug discarded 
during such quarter 7as determined by   
the ,secretary based on the aggregate   
rebatable amount 7as so defined7 with   
respect to such drug for such quarter71 
if any2 and  7,,ii7 the rebate amount   
specified in paragraph 7#c7 for such    
drug and such quarter4  7,b7 ,rebatable 
amount ,the term rebatable amount means1
 with respect to a rebatable single-dose

 vial drug of a manufacturer furnished  
during a quarter1 #ij percent of the    
amount 7if any7 of such drug that was   
discarded as indicated pursuant to      
subparagraph 7,a77i74  7#c7 ,rebate     
amount ,the amount of the rebate        
specified in this paragraph is1 with    
respect to a rebatable single-dose vial 
drug of a manufacturer furnished in a   
calendar quarter1 an amount equal to the
 product of--  7,a7 the total number of 
units of such drug discarded during such
 quarter as determined under paragraph  
7#b77;,a77iii77,i72 and  7,b7 the lesser
 of-- 7i7 the average sales price 7as   
defined in section #ahdg;,a7c77#a77 for 
a unit of such drug for such quarter    
7or1 in the case of a drug subject to an
 agreement with such manufacturer under 
section #cdj;,b of the ,public ,health  
,service ,act1 the price for a unit of  
such drug for such quarter under such   
agreement72 or  7ii7 the wholesale      
acquisition cost 7as defined in section 
#ahdg;,a7c77#f77;,b77 for a unit of such

 drug4  7#d7 ,rebate deposits ,amounts  
paid as rebates pursuant to paragraph   
7#a7 shall be deposited into the        
,federal ,supplementary ,medical        
,insurance ,trust ,fund established     
under section #ahda4  7#e7 ,enforcement 
7,a7 ,audits ,each manufacturer of a    
rebatable single dose-vial drug that is 
required to provide a rebate under this 
subsection shall be subject to periodic 
audit with respect to such drug and such
 rebates by the ,secretary4  7,b7 ,civil
 money penalty  7i7 ,in general ,the    
,secretary shall impose a civil money   
penalty on a manufacturer of a rebatable
 single dose-vial drug who has failed to
 comply with the requirement under      
paragraph 7#a7 for such drug for a      
calendar quarter in an amount the       
,secretary determines is commensurate   
with the sum of--  7,i7 the amount that 
the manufacturer would have paid under  
such paragraph with respect to such drug
 for such quarter2 and  7,,ii7 #be      
percent of such amount4  7ii7           

,application ,the provisions of section 
#aabh;,a 7other than subsections 7a7 and
 7b77 shall apply to a civil money      
penalty under this subparagraph in the  
same manner as such provisions apply to 
a penalty or proceeding under section   
#aabh;,a7a74  7#f7 ,definitions ,in this
 subsection3 7,a7 ,rebatable single-dose
 vial drug ,the term rebatable          
single-dose vial drug means a single    
source drug or biological 7as defined in
 section #ahdg;,a7c77#f77;,d77 paid for 
under this part and furnished on or     
after ,january #a1 #bjbj1 from a        
single-dose vial4  7,b7 ,unit ,the term 
unit has the meaning given such term in 
section #ahdg;,a7b77#b77;,b74  4  7b7   
,collection of coinsurance only for     
portion of rebatable single-,dose vial  
drug administered ,section #ahcc of the 
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7 is amended--  7#a7 in subsection
 7a77#a77,s71 by inserting subject to   
subsection 7cc71 before with respect to2
 and  7#b7 by adding at the end the     

following new subsection3  7cc7         
,collection of coinsurance only for     
portion of rebatable single-,dose vial  
drug administered ,when processing a    
claim for a rebatable single-dose vial  
drug 7as defined in section             
#ahcd7w77#f771 the ,secretary1 acting   
through the relevant ,medicare          
administrative contractor with respect  
to such claim1 shall only collect       
coinsurance from a beneficiary1 taking  
into account any coverage under a       
,medicare supplemental policy certified 
under section #ahhb or any other        
supplemental insurance coverage of the  
beneficiary1 with respect to the portion
 of the drug administered 7as indicated 
by the ,j-portion of the claim for the  
drug used as of the date of enactment of
 this subsection1 or any successor code 
that includes such data as determined   
appropriate by the ,secretary71 in an   
amount equal to #bj percent of the      
amount of payment that would be made if 
payment for the claim was based only on 

the portion of the drug administered 7as
 so indicated74 ,nothing in the         
preceding sentence shall affect the     
amount paid to the provider of services 
or supplier with respect to the drug    
under this part 7as determined based on 
the total amount of the drug for which  
the claim was submitted1 including the  
portion of the drug administered and the
 portion discarded1 as indicated by the 
,j-portion of the claim and the ,,jw    
modifier1 respectively1 used as of such 
date of enactment or any successor codes
 that include such data as determined   
appropriate by the ,secretary74  4