,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #bjfi  ,,in ,,the ,,house ,,of  
,,representatives  ,april #c1 #bjai,mr4 
,horsford 7for himself and ,mr4 ,reed7  
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 ,,xi of the ,social         
,security ,act to provide for drug      
manufacturer price transparency4  #a4   
,short title ,this ,act may be cited as 
the ,stopping the ,pharmaceutical       
,industry from ,keeping drugs ,expensive
 ,act or the ,,spike ,act4  #b4 ,drug   
manufacturer price transparency ,title  
,,xi of the ,social ,security ,act 7#db 
,u4,s4,c4 #acja et seq47 is amended by  
inserting after section #aabh,k the     
following new section3  #aabh,l4 ,drug  

manufacturer price transparency  7a7 ,in
 general ,with respect to each year1    
beginning with #bjba1 the ,secretary    
shall1 at least once during such year1  
determine if there is a triggered       
,,spike increase 7in accordance with    
subsection 7b77 with respect to an      
applicable drug 7as defined in          
subsection 7f77#a774 ,if the ,secretary 
determines1 with respect to a year1     
there is such an increase with respect  
to an applicable drug1 the manufacturer 
of the applicable drug shall submit to  
the ,secretary the justification        
described in subsection 7c71 subject to 
subsection 7b77#c71 for each such       
triggered ,,spike increase in accordance
 with the timing described in subsection
 7d74  7b7 ,triggered ,,spike increase  
7#a7 ,in general ,a triggered ,,spike   
increase occurs1 with respect to an     
applicable drug and year 7beginning with
 #bjba71 in any of the following cases3 
7,a7 ,if there is a #aj percent 7or     
#aj1jjj7 increase with respect to the   

wholesale acquisition cost 7or          
alternative cost measure specified by   
the ,secretary under paragraph 7#b77 of 
such drug during any #ab-month period   
beginning and ending within the lookback
 period that is the #e-year period      
preceding #bjba or #bjbb1 respectively4 
7,b7 ,if there is a #be percent 7or     
#be1jjj7 increase with respect to the   
wholesale acquisition cost 7or such     
alternative cost measure7 of such drug  
during any #cf-month period beginning   
and ending within such respective       
lookback period4  7,c7 ,in the case of  
such a drug that is first covered under 
title ,,xviii with respect to such year1
 if the estimated cost or spending under
 such title per individual or per user  
of such drug 7as estimated by the       
,secretary7 for such year 7or per course
 of treatment1 as defined by the        
,secretary7 is at least #bf1jjj4  7#b7  
,alternative to ,,wac ,the ,secretary   
may1 for purposes of making             
determinations under paragraph 7#a71 in 

addition to using the wholesale         
acquisition cost for an applicable drug1
 use alternative cost measures of such  
drug4  7#c7 ,exception ,a justification 
under subsection 7c7 shall not be       
required for a triggered ,,spike        
increase described in paragraph 7#a7 of 
an applicable drug of a manufacturer if 
there is any portion of the lookback    
period described in the respective      
subparagraph of such paragraph for such 
increase that is included within the    
lookback period for another triggered   
,,spike increase 7or combination of such
 increases7 for which a justification is
 made under this section for such drug  
by such manufacturer4  7#d7 ,unit       
determination ,for purposes of          
determining the wholesale acquisition   
cost in carrying out this section1 the  
,secretary shall determine a unit 7such 
as a unit size7 to apply4  7#e7 ,public 
posting ,beginning with respect to      
#bjba1 the ,secretary shall publicly    
post on the ,internet website of the    

,department of ,health and ,human       
,services--  7,a7 alternative           
percentages1 dollar amounts1 and        
lookback periods that1 if applied under 
paragraph 7#a71 would be projected to   
increase the number of applicable drugs 
for which a triggered ,,spike increase  
would occur for such year2 and  7,b7 the
 number of applicable drugs for which a 
triggered ,,spike increase would occur  
for such year of such an alternative    
percentage1 dollar amount1 or period    
were applied for such year4  7c7        
,justification described  7#a7 ,in      
general ,the justification described in 
this subsection1 with respect to a      
triggered ,,spike increase described in 
subsection 7b77#a7 of an applicable drug
 of a manufacturer1 is--  7,a7 all of   
the information described in paragraph  
7#b72  7,b7 all of the information and  
supporting documentation described in   
paragraph 7#c71 as applicable to the    
increase and drug2 and  7,c7 a          
certification described in paragraph    

7#d74  7#b7 ,required information ,for  
purposes of paragraph 7#a71 the         
information described in this paragraph 
is the following3  7,a7 ,the individual 
factors that have contributed to the    
increase in the wholesale acquisition   
cost4  7,b7 ,an explanation of the role 
of each factor in contributing to such  
increase4  7#c7 ,information as         
applicable ,for purposes of paragraph   
7#a71 the information and supporting    
documentation described in this         
paragraph is the following3  7,a7 ,total
 expenditures of the manufacturer on--  
7i7 materials and manufacturing for such
 drug2  7ii7 acquiring patents and      
licensing for each drug of the          
manufacturer2 and  7iii7 costs to       
purchase or acquire the drug from       
another company1 if applicable4  7,b7   
,the percentage of total expenditures of
 the manufacturer on research and       
development for such drug that was      
derived from ,federal funds4  7,c7 ,the 
total expenditures of the manufacturer  

on research and development for such    
drug4  7,d7 ,the total revenue and net  
profit generated from the applicable    
drug for each calendar year since drug  
approval4  7,e7 ,the total costs        
associated with marketing and           
advertising for the applicable drug4    
7,f7 ,additional information specific to
 the manufacturer of the applicable     
drug1 such as--  7i7 the total revenue  
and net profit of the manufacturer for  
the period of such increase1 as         
determined by the ,secretary2  7ii7     
metrics used to determine executive     
compensation2  7iii7 total expenditures 
on--  7,i7 drug research and            
development2 or  7,,ii7 clinical trials 
on drugs that failed to receive approval
 by the ,food and ,drug ,administration2
 and  7iv7 any additional information   
related to drug pricing decisions of the
 manufacturer4  7,g7 ,any other relevant
 information and supporting             
documentation necessary to justify the  
triggering ,,spike increase4  7,h7 ,any 

other relevant information and          
supporting documentation1 as specified  
by the ,secretary4  7#d7 ,certification 
,for purposes of paragraph 7#a71 the    
certification described in this         
paragraph is a certification1 that all  
such information and documentation is   
accurate and complete1 by one of the    
following3  7,a7 ,the chief executive   
officer of the manufacturer4  7,b7 ,the 
chief financial officer of the          
manufacturer4  7,c7 ,an individual who  
has delegated authority to sign for1 and
 who reports directly to1 such chief    
executive officer or chief financial    
officer4  7d7 ,timing  7#a7             
,notification ,not later than #fj days  
after the date on which the ,secretary  
makes the determination that there is a 
triggering ,,spike increase with respect
 to an applicable drug1 the ,secretary  
shall notify the manufacturer of the    
applicable drug of such determination4  
7#b7 ,submission of justification ,not  
later than #ij days after the date on   

which a manufacturer receives a         
notification under paragraph 7#a71      
subject to subsection 7b77#c71 the      
manufacturer shall submit to the        
,secretary the justification required   
under subsection 7a71 including a       
summary of such justification1 in a form
 and manner specified by the ,secretary4
 ,in specifying such form1 with respect 
to the summary required under the       
previous sentence1 the ,secretary shall 
provide that such summary shall be in an
 easily understandable format1 as       
specified by the ,secretary1 and shall  
permit the manufacturer to exclude      
proprietary information from such       
summary4  7#c7 ,posting on ,internet    
website ,not later than #cj days after  
receiving the complete justification    
under paragraph 7#b71 the ,secretary    
shall post on the ,internet website of  
the ,centers for ,medicare  ,medicaid   
,services the summary included for such 
justification4  7e7 ,penalties  7#a7    
,failure to submit timely justification 

,if the ,secretary determines that a    
manufacturer has failed to submit a     
justification as required under this    
section1 including in accordance with   
the timing and form required1 with      
respect to an applicable drug1 the      
,secretary shall apply a civil monetary 
penalty in an amount of #aj1jjj for each
 day the manufacturer has failed to     
submit such justification as so         
required4  7#b7 ,false information ,any 
manufacturer that submits a             
justification under this section that   
knowingly provides false information in 
such justification is subject to a civil
 monetary penalty in an amount not to   
exceed #ajj1jjj for each item of false  
information4  7#c7 ,application of      
procedures ,the provisions of section   
#aabh;,a 7other than subsections 7a7 and
 7b77 shall apply to a civil monetary   
penalty under this subsection in the    
same manner as such provisions apply to 
a penalty or proceeding under section   
#aabh;,a7a74 ,civil monetary penalties  

imposed under this subsection are in    
addition to other penalties as may be   
prescribed by law4  7f7 ,definitions ,in
 this section3 7#a7 ,applicable drug    
7,a7 ,in general ,subject to paragraph  
7#b71 the term applicable drug means1   
with respect to a lookback period       
described in paragraph 7#b71 a covered  
outpatient drug 7as defined in paragraph
 7#b7 of section #aibg7k71 without      
application of paragraph 7#c7 of such   
section7 that is covered under title    
,,xviii and is not a low cost drug4     
7,b7 ,exclusion of low cost drugs ,for  
purposes of subparagraph 7,a77iii71 not 
later than ,january #a1 #bjba1 the      
,secretary shall specify a threshold    
7such as a cost or spending threshold7  
for identifying 7and shall identify7 low
 cost drugs to be excluded from the     
definition of the term applicable drug1 
such as a drug that has a wholesale     
acquisition cost of less than #aj per   
unit or less than #ajj in average       
estimated expenditures under title      

,,xviii per individual per year or per  
user of such drug per year4 ,for        
purposes of this section1 a drug shall  
not be considered specified as a low    
cost drug for a lookback period         
described in paragraph 7#b7 with respect
 to a year unless such drug is          
identified as being below the specified 
threshold for the entirety of the       
lookback period4  7#b7 ,manufacturer    
,the term manufacturer has the meaning  
given that term in section              
#ahdg;,a7c77#f77;,a74  7#c7 ,wholesale  
acquisition cost ,the term wholesale    
acquisition cost has the meaning given  
that term in section                    
#ahdg;,a7c77#f77;,b74  4