,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #ddjj  ,,in ,,the ,,house ,,of  
,,representatives  ,september #ai1      
#bjai,mr4 ,bucshon 7for himself and ,mr4
 ,engel7 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 the ,public ,health ,service ,act 
to provide for an internet website to   
provide educational materials for health
 care providers1 patients1 and          
caregivers1 regarding the meaning of the
 terms1 and the standards for review and
 licensing of1 biological products1 and 
for other purposes4  #a4 ,short title   
,this ,act may be cited as the          
,advancing ,education on ,biosimilars   
,act of #bjai4  #b4 ,education on       
biological products  7a7 ,website2      

continuing education ,subpart #a of part
 ,f of title ,,iii of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bfb et seq47 is amended by adding at   
the end the following3  #ceb;,a4        
,education on biological products  7a7  
,internet website  7#a7 ,in general ,the
 ,secretary shall maintain and operate  
an internet website to provide          
educational materials for health care   
providers1 patients1 and caregivers1    
regarding the meaning of the terms1 and 
the standards for review and licensing  
of1 biological products1 including      
biosimilar biological products and      
interchangeable biosimilar biological   
products4  7#b7 ,content ,educational   
materials provided under paragraph 7#a7 
may include-- 7,a7 explanations of key  
statutory and regulatory terms1         
including biosimilar and                
interchangeable1 and clarification      
regarding the use of interchangeable    
biosimilar biological products2  7,b7   
information related to development      

programs for biological products1       
including biosimilar biological products
 and interchangeable biosimilar         
biological products and relevant        
clinical considerations for prescribers1
 which may include1 as appropriate and  
applicable1 information related to the  
comparability of such biological        
products2  7,c7 an explanation of the   
process for reporting adverse events for
 biological products1 including         
biosimilar biological products and      
interchangeable biosimilar biological   
products2 and  7,d7 an explanation of   
the relationship between biosimilar     
biological products and interchangeable 
biosimilar biological products licensed 
under section #cea7k7 and reference     
products 7as defined in section         
#cea7;i771 including the standards for  
review and licensing of each such type  
of biological product4  7#c7 ,format    
,the educational materials provided     
under paragraph 7#a7 may be-- 7,a7 in   
formats such as webinars1 continuing    

medical education modules1 videos1 fact 
sheets1 infographics1 stakeholder       
toolkits1 or other formats as           
appropriate and applicable2 and  7,b7   
tailored for the unique needs of health 
care providers1 patients1 caregivers1   
and other audiences1 as the ,secretary  
determines appropriate4  7#d7 ,other    
information ,in addition to the         
information described in paragraph 7#b71
 the ,secretary shall continue to       
publish the following information3  7,a7
 ,the action package of each biological 
product licensed under subsection 7a7 or
 7k74  7,b7 ,the summary review of each 
biological product licensed under       
subsection 7a7 or 7k74  7#e7            
,confidential and trade secret          
information ,this subsection does not   
authorize the disclosure of any trade   
secret1 confidential commercial or      
financial information1 or other matter  
described in section #eeb7;b7 of title  
#e4  7b7 ,continuing education ,the     
,secretary shall advance education and  

awareness among health care providers   
regarding biological products1 including
 biosimilar biological products and     
interchangeable biosimilar biological   
products1 as appropriate1 including by  
developing or improving continuing      
education programs that advance the     
education of such providers on the      
prescribing of1 and relevant clinical   
considerations with respect to1         
biological products1 including          
biosimilar biological products and      
interchangeable biosimilar biological   
products4  4  7b7 ,application under the
 ,medicare ,merit-,based ,incentive     
,payment ,system ,section               
#ahdh7q77#e77;,c7 of the ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#d7q77#e77;,c77 is amended by    
adding at the end the following new     
clause3  7iv7 ,clinical medical         
education program on biosimilar         
biological products ,completion of a    
clinical medical education program      
developed or improved under section     

#ceb;,a7b7 of the ,public ,health       
,service ,act by a ,,mips eligible      
professional during a performance period
 shall earn such eligible professional  
one-half of the highest potential score 
for the performance category described  
in paragraph 7#b77;,a77iii7 for such    
performance period4 ,a ,,mips eligible  
professional may only count the         
completion of such a program for        
purposes of such category one time      
during the eligible professional's      
lifetime4  4