,i  #aahth ,,congress  #ast ,session    
,h4 ,r4 #ecgb  ,,in ,,the ,,house ,,of  
,,representatives  ,september #h1       
#bjbc,mr4 ,joyce of ,pennsylvania 7for  
himself and ,mr4 ,peters7 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 facilitate
 midyear formulary changes for          
biosimilars4  #a4 ,short title ,this    
,act may be cited as the ,expanding     
,seniors' ,access to ,lower ,cost       
,medicines ,act of #bjbc4  #b4          
,facilitating midyear formulary changes 
for biosimilars  7a7 ,in general        
,section #ahfj;,d-#d7;b7 of the ,social 
,security ,act 7#db ,u4,s4,c4           
#aciew-#ajd7;b77 is amended by adding at

 the end the following new paragraph3   
7#e7 ,mid-year changes in formularies   
permitted for certain biosimilar        
biological products and the reference   
product of such biosimilars ,if a ,,pdp 
sponsor of a prescription drug plan uses
 a formulary 7including the use of      
tiered cost-sharing71 the following     
shall apply3 7,a7 ,in general ,for plan 
year #bjbe1 and subsequent plan years1  
in the case of a covered part ,d drug   
that is the reference biological product
 7as defined in section                 
#ahdg;,a7c77#f77;,i77 with respect to a 
biosimilar biological product 7as       
defined in section                      
#ahdg;,a7c77#f77;,h771 the ,,pdp sponsor
 may1 with respect to a formulary1 at   
any time after the first #fj days of the
 plan year1 subject to paragraph        
7#c77;,e71 change the preferred or      
tiered cost-sharing status of such      
reference biological product if such    
,,pdp sponsor adds1 before or at the    
same time1 to such formulary such       

biosimilar biological product at the    
same or a higher preferred status1 or to
 the same or lower cost-sharing tier1 as
 that of such reference biological      
product immediately prior to such       
change4  7,b7 ,request for approval of  
change ,prior to making a change        
described in subparagraph 7,a71 the     
,,pdp sponsor shall submit to the       
,secretary a request to make such       
change4 ,if the ,secretary approves the 
request or has not provided a decision  
to the ,,pdp sponsor regarding such     
request within #cj days of receiving    
such request1 such ,,pdp sponsor may    
make such change4  4  7b7               
,administration  7#a7 ,implementation   
,notwithstanding any other provision of 
law1 the ,secretary of ,health and      
,human ,services may implement the      
amendment made by subsection 7a7 by     
program instruction or otherwise4  7#b7 
,non-application of the ,paperwork      
,reduction ,act ,chapter #ce of title   
#dd1 ,united ,states ,code 7commonly    

referred to as the ,paperwork ,reduction
 ,act of #aiie71 shall not apply to the 
implementation of the amendment made by 
subsection 7a74