,,ii  #aaeth ,,congress  #ast ,session  
,s4 #bjdb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #ca1  
#bjag,ms4 ,klobuchar 7for herself1 ,mr4 
,grassley1 ,mr4 ,durbin1 and ,mrs4      
,shaheen7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,finance  ,a ,,bill   
,to authorize a joint action plan and   
report on drug waste4  #a4 ,short title 
,this ,act may be cited as the ,reducing
 ,drug ,waste ,act of #bjag 4  #b4      
,findings ,congress finds as follows3   
7#a7 ,on ,may #bc1 #bjag1 the           
,department of ,health and ,human       
,services1 acting through the ,office of
 the ,inspector ,general in a letter to 
,senators ,klobuchar1 ,durbin1 and      
,shaheen1 found that different vial     
sizes in addition to those currently    
approved and marketed in the ,united    
,states could sometimes significantly   
reduce the amount of drug discards1 or  
waste1 from single-use vials4  7#b7 ,the
 ,office of ,inspector ,general analyzed

 #bj single-use vial drugs with the     
highest amounts of identifiable         
reimbursement for discarded drugs during
 #bjac and #bjad and found that the     
,medicare ,part ,b program paid         
#aa1fjj1jjj1jjj for these drugs1        
#b1ajj1jjj1jjj of which was for drugs   
billed in increments of other-than-full 
vials1 and #aie1jjj1jjj1 or nearly #aj  
percent1 of the #b1ajj1jjj1jjj billed in
 increments of other-than-full vials was
 reimbursed for discarded drugs4  7#c7  
,during the ,food and ,drug             
,administration's review process for a  
drug's safety and efficacy before a drug
 is approved for marketing in the       
,united ,states1 the ,food and ,drug    
,administration reviews the             
manufacturer's proposed vial size4  7#d7
 ,as of ,january #a1 #bjag1 the ,centers
 for ,medicare  ,medicaid ,services     
requires all physicians1 hospitals1 and 
other providers submitting claims to    
,medicare to separately identify the    
discarded amount of a drug from a       

single-use vial 7the ,,jw modifier7 on  
its claim for reimbursement by          
,medicare4 ,the new requirement does not
 change the amount the providers are    
reimbursed for single-use drugs4  7#e7  
,an ,october #bjag investigation by     
,pro,publica found that many            
pharmaceutical companies produce        
eye-drops in over-sized doses1 in some  
cases more than twice what the eye can  
hold1 resulting in drug waste and excess
 spending4  #c4 ,joint action plan and  
report on drug waste  7a7 ,joint action 
plan ,the ,commissioner of ,food and    
,drugs1 in coordination with the        
,administrator of the ,centers for      
,medicare  ,medicaid ,services1 shall   
develop a joint action plan1 in         
consultation with healthcare providers  
and patient advocates 7including        
relevant ,federal advisory committees7  
that--  7#a7 utilizes data from         
,medicare claims on how much of a       
single-use drug was not administered1   
examines single-use vial sizes in other 

countries1 and analyzes the drug        
approval process for alternative vial   
size safety and efficacy approaches1 to 
reduce drug waste and better manage     
costs with respect to drug vial sizes   
and other drug delivery systems1 as     
appropriate2 and  7#b7 includes         
quantifiable metrics and specific       
timelines4  7b7 ,report ,not later than 
#a year after the date of enactment of  
this ,act1 the ,commissioner of ,food   
and ,drugs1 in coordination with the    
,administrator of the ,centers for      
,medicare  ,medicaid ,services1 shall   
submit to ,congress the joint action    
plan described in subsection 7a7 and a  
report containing recommendations for   
any legislative action needed to reduce 
drug waste and better manage costs with 
respect to drug vial sizes and other    
drug delivery systems1 as appropriate4