,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #dahg  ,,in ,,the ,,house ,,of  
,,representatives  ,march #aa1 #bjad    
,mr4 ,roskam 7for himself and ,mr4      
,danny ,k4 ,davis of ,illinois7         
introduced the following bill2 which was
 referred to the ,committee on ,ways and
 ,means1 and in addition to the         
,committee on ,energy and ,commerce1 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 encourage the         
development and use of new antimicrobial
 drugs1 and for other purposes4  #a4    
,short title ,this ,act may be cited as 
the ,developing an ,innovative ,strategy
 for ,antimicrobial ,resistant          
,microorganisms ,act of #bjad and as the
 ,,disarm ,act of #bjad4  #b4           
,encouraging the development and use of 
new antimicrobial drugs  7a7 ,additional

 payment for new antimicrobial drugs    
under ,medicare  7#a7 ,in general       
,section #ahhf7;d77#e7 of the ,social   
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77 is amended by adding at 
the end the following new subparagraph3 
7,m7  7i7 ,effective for discharges     
beginning on or after ,october #a1      
#bjad1 the ,secretary shall1 after      
notice and opportunity for public       
comment 7in the publications required by
 subsection 7e77#e7 for a fiscal year or
 otherwise71 recognize the costs of new 
antimicrobial drugs under the payment   
system established under this           
subsection4  7ii7 ,pursuant to clause   
7i71 the ,secretary shall provide for   
additional payment to be made under this
 subsection with respect to discharges  
involving new antimicrobial drugs in the
 amount provided for under section      
#ahdg;,a for drugs and biologicals that 
are described in section                
#ahdb7o77#a77;,c74  7iii7 ,for purposes 
of this subparagraph1 the term new      

antimicrobial drug means a product that 
is approved for use1 or a product for   
which an indication is first approved   
for use1 by the ,federal ,food and ,drug
 ,administration on or after ,january   
#a1 #bjad1 and that--  7,i7 is indicated
 to treat an infection caused by1 or    
likely to be caused by1 a qualifying    
pathogen 7as defined under section      
#eje;,e7f7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cee;f7f777 for which there is an unmet 
medical need and which is associated    
with high rates of mortality or         
significant patient morbidity 7as       
determined by the ,secretary1 in        
consultation with the ,director of the  
,centers for ,disease ,control and      
,prevention and the infectious disease  
professional community72 and  7,,ii7 is 
used in facilities that participate in  
the ,antimicrobial ,use and ,resistance 
,module of the ,national ,healthcare    
,safety ,network of the ,centers for    
,disease ,control and ,prevention 7or1  

in the case that such ,module is not    
available1 is used in facilities that   
participate in such successor or similar
 reporting module or program relating to
 antimicrobials as the ,secretary shall 
specify to the extent available to such 
facilities1 as determined by the        
,secretary74  7iv7 ,not later than ,july
 #a1 #bjad1 the ,secretary shall first  
publish in the ,federal ,register a list
 of the new antimicrobial drugs4  4     
7#b7 ,budget neutrality ,section        
#ahhf7;d77#c77;,c7 of the ,social       
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#c77;,c77 is amended by      
adding at the end the following new     
clause3  7iii7 ,maintaining budget      
neutrality for certain antimicrobial    
drugs ,for discharges occurring in a    
fiscal year beginning with fiscal year  
#bjae1 the ,secretary shall further     
reduce each of the average standardized 
amounts in an amount equal to the amount
 of the net additional expenditures1 if 
any1 in such fiscal year resulting from 

the application of paragraph 7#e77,m74  
4  7b7 ,study and report on removing    
barriers to development of new          
antimicrobial drugs  7#a7 ,study ,the   
,comptroller ,general of the ,united    
,states shall1 in consultation with the 
,director of the ,united ,states ,patent
 and ,trademark ,office1 the ,director  
of the ,national ,institutes of ,health1
 the ,commissioner of ,food and ,drugs1 
and the ,director of the ,centers for   
,disease ,control and ,prevention1      
conduct a study to--  7,a7 identify and 
examine the barriers that prevent the   
development of new antimicrobial drugs1 
as defined in section                   
#ahhf7;d77#e77,m77iii7 of the ,social   
,security ,act 7#db ,u4,s4,c4           
#acieww7d77#e77,m77iii772 and  7,b7     
develop recommendations for actions to  
be taken in order to overcome any       
barriers identified under subparagraph  
7,a74  7#b7 ,report ,not later than one 
year after the date of the enactment of 
this ,act1 the ,comptroller ,general    

shall submit to ,congress a report on   
the study conducted under paragraph     
7#a74