,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #hach  ,,in ,,the ,,house ,,of  
,,representatives  ,september #a1       
#bjbj,mr4 ,biggs introduced the         
following bill2 which was referred to   
the ,committee on ,energy and ,commerce1
 and in addition to the ,committees on  
,ways and ,means1 and ,armed ,services1 
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 ,orphan ,drug ,act with       
respect to the definition of medical    
food1 and for other purposes4  #a4      
,short title ,this ,act may be cited as 
the ,patient ,access to ,medical ,foods 
,act4  #b4 ,definition of medical food  
for purposes of ,orphan ,drug ,act  7a7 
,in general ,section #e7;b77#c7 of the  
,orphan ,drug ,act 7#ba ,u4,s4,c4       
#cfj;ee7b77#c77 is amended to read as   
follows3  7#c7 ,the term medical food   
means a food which-- 7,a7 is formulated 

to be consumed or administered          
enterally1 including tube feeding and   
oral intake1 and dispensed upon a       
written prescription of a practitioner  
licensed under the laws of the ,state in
 which such practitioner practices to   
administer drugs2 and  7,b7 7i7 is      
intended for the specific dietary       
management of a disease or condition for
 which distinctive nutritional          
requirements1 including conditions of   
inborn errors of metabolism1 based on   
recognized scientific principles1 are   
established by medical evaluation2 or   
7ii7 in the case of an individual for   
whom the prescribing physician          
determines the individual has failed on 
traditional therapies or determines     
continuing the traditional therapy is   
inappropriate for the patient due to    
comorbidities or severe side effects    
that endanger the health of the         
individual-- 7,i7 has been shown to     
provide clinical benefit in             
well-controlled peer-reviewed clinical  

trials to patients with a disease or    
condition specified in clause 7i72 and  
7,,ii7 is determined by the prescribing 
physician to be a safer therapeutic     
option or the only effective clinical   
option for the individual4  4  7b7      
,national ,drug ,code number ,section #e
 of the ,orphan ,drug ,act 7#ba         
,u4,s4,c4 #cfj;ee7 is amended-- 7#a7 by 
redesignating subsection 7c7 as         
subsection 7d72 and  7#b7 by inserting  
after subsection 7b7 the following3  7c7
 ,national ,drug ,code number ,medical  
foods shall be eligible for a ,national 
,drug ,code number4  4  #c4 ,coverage of
 medically necessary food under ,federal
 health programs and private health     
insurance  7a7 ,coverage under ,medicare
 program  7#a7 ,part ,b coverage  7,a7  
,in general ,section #ahfa7s77#b7 of the
 ,social ,security ,act 7#db ,u4,s4,c4  
#aciex7s77#b77 is amended-- 7i7 in      
subparagraph 7,,gg71 by striking and at 
the end2  7ii7 in subparagraph 7,,hh71  
by striking the period at the end and   

inserting 2 and2 and  7iii7 by adding at
 the end the following new subparagraph3
  7,,ii7 medically necessary food 7as   
defined in subsection 7kkk772  4  7,b7  
,definition ,section #ahfa of the       
,social ,security ,act 7#db ,u4,s4,c4   
#aciex7 is amended by adding at the end 
the following new subsection3  7kkk7    
,medically ,necessary ,food ,the term   
medically necessary food has the meaning
 given the term medical food in section 
#e7;b77#c7 of the ,orphan ,drug ,act    
7#ba ,u4,s4,c4 #cfj;ee7b77#c774  4  7,c7
 ,payment ,section #ahcc7;a77#a7 of the 
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7a77#a77 is amended-- 7i7 by      
striking and before 7,,dd72 and  7ii7 by
 inserting before the semicolon at the  
end the following3 1 and 7,,ee7 with    
respect to medically necessary food 7as 
defined in section #ahfa7kkk771 the     
amount paid shall be an amount equal to 
#hj percent of the actual charge for the
 services44  7,d7 ,effective date ,the  
amendments made by this paragraph shall 

apply to items and services furnished on
 or after ,january #a1 #bjba4  7#b7     
,coverage as covered part ,d drug  7,a7 
,in general ,section #ahfj;,d-#b7;e77#a7
 of the ,social ,security ,act 7#db     
,u4,s4,c4 #aciew-#ajb7;e77#a77 is       
amended-- 7i7 in subparagraph 7,a71 by  
striking at the end or2  7ii7 in        
subparagraph 7,b71 by striking at the   
end the comma and inserting 2 or2 and   
7iii7 by inserting after subparagraph   
7,b7 the following new subparagraph3    
7,c7 a medically necessary food 7as     
defined in section #ahfa7kkk771  4  7,b7
 ,effective date ,the amendments made by
 subparagraph 7,a7 shall apply with     
respect to plan years beginning on or   
after ,january #a1 #bjba4  7b7 ,coverage
 under ,medicaid program  7#a7 ,in      
general ,section #aije7;a7 of the       
,social ,security ,act 7#db ,u4,s4,c4   
#acif;d7a77 is amended-- 7,a7 in        
paragraph 7#bi71 by striking and at the 
end2  7,b7 by redesignating paragraph   
7#cj7 as paragraph 7#ca72 and  7,c7 by  

inserting after paragraph 7#bi7 the     
following new paragraph3  7#cj7         
medically necessary food 7as defined in 
section #ahfa7kkk772 and  4  7#b7       
,mandatory benefit ,section             
#aijb7;a77#aj77;,a7 of the ,social      
,security ,act 7#db ,u4,s4,c4           
#acif;a7a77#aj77;,a77 is amended1 in the
 matter preceding clause 7i71 by        
striking and 7#bi7 and inserting 7#bi71 
and 7#cj74  7#c7 ,effective date  7,a7  
,in general ,subject to subparagraph    
7,b71 the amendments made by this       
subsection shall apply with respect to  
medical assistance furnished on or after
 ,july #a1 #bjba4  7,b7 ,exception if   
state legislation required ,in the case 
of a ,state plan for medical assistance 
under title ,,xix of the ,social        
,security ,act which the ,secretary of  
,health and ,human ,services determines 
requires ,state legislation 7other than 
legislation appropriating funds7 in     
order for the plan to meet the          
additional requirement imposed by the   

amendments made by this subsection1 the 
,state plan shall not be regarded as    
failing to comply with the requirements 
of such title solely on the basis of its
 failure to meet this additional        
requirement before the first day of the 
first calendar quarter beginning after  
the close of the first regular session  
of the ,state legislature that begins   
after the date of the enactment of this 
,act4 ,for purposes of the previous     
sentence1 in the case of a ,state that  
has a #b-year legislative session1 each 
year of such session shall be deemed to 
be a separate regular session of the    
,state legislature4  7c7 ,coverage under
 ,,chip  7#a7 ,in general ,section      
#bajc7;c7 of the ,social ,security ,act 
7#db ,u4,s4,c4 #acig;cc7c77 is amended  
by adding at the end the following3     
7#aa7 ,medically necessary food ,the    
child health assistance provided to a   
targeted low-income child shall include 
coverage of medically necessary food 7as
 defined in section #ahfa7kkk774  4     

7#b7 ,conforming amendment ,section     
#bajc7;a7 of the ,social ,security ,act 
7#db ,u4,s4,c4 #acig;cc7a77 is amended1 
in the matter preceding paragraph 7#a71 
by striking and 7#h7 and inserting 1    
7#h71 and 7#aa74  7#c7 ,effective date  
7,a7 ,in general ,subject to            
subparagraph 7,b71 the amendments made  
by this subsection shall apply with     
respect to child health assistance      
furnished on or after ,july #a1 #bjba4  
7,b7 ,exception if state legislation    
required ,in the case of a ,state child 
health plan for child health assistance 
under title ,,xxi of the ,social        
,security ,act which the ,secretary of  
,health and ,human ,services determines 
requires ,state legislation 7other than 
legislation appropriating funds7 in     
order for the plan to meet the          
additional requirement imposed by the   
amendments made by this subsection1 the 
,state child health plan shall not be   
regarded as failing to comply with the  
requirements of such title solely on the

 basis of its failure to meet this      
additional requirement before the first 
day of the first calendar quarter       
beginning after the close of the first  
regular session of the ,state           
legislature that begins after the date  
of the enactment of this ,act4 ,for     
purposes of the previous sentence1 in   
the case of a ,state that has a #b-year 
legislative session1 each year of such  
session shall be deemed to be a separate
 regular session of the ,state          
legislature4  7d7 ,coverage under       
,,tricare ,paragraph 7#b7 of section    
#ajgg7;h7 of title #aj1 ,united ,states 
,code1 is amended to read as follows3   
7#b7 ,in this section1 the term         
medically necessary food has the meaning
 given the term medical food in section 
#e7;b77#c7 of the ,orphan ,drug ,act4  4
  7e7 ,coverage under private health    
insurance  7#a7 ,in general ,subpart    
,,ii of part ,a of title ,,xxvii of the 
,public ,health ,service ,act 7#db      
,u4,s4,c4 #cjj;gg-#aa et seq47 is       

amended by adding at the end the        
following3  #bgcj4 ,coverage of         
medically necessary food ,a group health
 plan and group or individual health    
insurance coverage offered by a health  
insurance issuer shall provide coverage 
for medically necessary food 7as defined
 in section #ahfa7kkk7 of the ,social   
,security ,act74  4  7#b7 ,effective    
date ,the amendment made by paragraph   
7#a7 shall apply to plan years beginning
 on or after ,january #a1 #bjba4