,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #geah  ,,in ,,the ,,house ,,of  
,,representatives  ,july #i1 #bjbj,mr4  
,michael ,f4 ,doyle of ,pennsylvania    
7for himself and ,mr4 ,kelly of         
,pennsylvania7 introduced the following 
bill2 which was referred to the         
,committee on ,ways and ,means  ,a      
,,bill  ,to amend title ,,xviii of the  
,social ,security ,act to promote       
preparedness and ,medicare beneficiary  
access to safer1 more accurate sterile  
intravenous drug preparations through   
automated hospital infrastructure4  #a4 
,short title ,this ,act may be cited as 
the ,safer ,compounding in ,hospitals   
,act of #bjbj4  #b4 ,promoting          
preparedness and ,medicare beneficiary  
access to safer1 more accurate sterile  
intravenous drug preparations through   
automated hospital infrastructure  7a7  
,in general ,section #ahhf7;d77#e7 is   
amended by adding at the end the        
following new subparagraph3  7,n7 7i7   
,subject to clause 7iv71 in the case of 

a subsection 7d7 hospital and with      
respect to a discharge of an individual 
occurring on or after ,october #a1      
#bjbj1 and before ,october #a1 #bjbf1   
who was furnished a sterile intravenous 
treatment prepared with closed system   
automation device technology 7as defined
 in clause 7v77 by such hospital in     
compliance with all applicable          
requirements and regulations of the     
,food and ,drug ,administration1 the    
,secretary shall provide an additional  
payment to such hospital of #be for each
 such treatment so furnished4  7ii7 ,the
 ,secretary shall establish a method to 
identify sterile intravenous treatments 
prepared with closed system automation  
device technology through the use of    
,,icd #aj ,,pcs codes1 diagnosis codes1 
condition codes1 or such other means as 
determined appropriate by the           
,secretary4  7iii7 ,the ,secretary shall
 make such adjustments to payments under
 this subsection as the ,secretary      
determines necessary to ensure that     

aggregate expenditures under this       
subsection with respect to a fiscal year
 with application of this subparagraph  
are estimated to be equal to such       
expenditures under this subsection with 
respect to such year without application
 of this subparagraph4  7iv7 ,aggregate 
payments made under this subparagraph   
with respect to discharges occurring    
during a fiscal year may not exceed     
#dj1jjj1jjj4  7v7 ,for purposes of this 
subparagraph1 the term closed system    
automation device technology means      
equipment that is cleared or approved by
 the ,food and ,drug ,administration and
 that-- 7,i7 aseptically compounds      
ready-to-administer compounded sterile  
preparations without direct human       
manipulation2  7,,ii7 creates1 monitors1
 and assures an uncompromised ,,iso #e  
environment1 with continuous isolation  
of its interior from the external       
environment2  7,,iii7 demonstrates      
unidirectional air within the           
compounding chamber and loading area or 

areas2  7,,iv7 incorporates barcode     
verification of all drug ingredients1   
which are comprised solely of finished  
sterile drug products approved by the   
,food and ,drug ,administration2  7,v7  
assures drug dose accuracy and control  
using gravimetric 7or comparable7       
analysis2  7,,vi7 provides photographic 
evidence of all supply containers2      
7,,vii7 applies labels to compounded    
sterile preparations within ,,iso #e    
environment2  7,,viii7 maintains        
detailed compounding1 cleaning1 and     
other operational records2 and  7,,ix7  
is developed1 manufactured1 and serviced
 as a pharmacy compounding device or    
system per guidance promulgated by the  
,food and ,drug ,administration4  4