,,ii  #aai? ,,congress  #a/ ,session    
,s4 #ccjd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #b1 #bjbe,mr4 
,wick] 7= himself1 ,ms4 ,klobu*>1 ,mr4  
,grassley1 & ,mr4 ,:iteh\se7 introduc$ !
 foll[+ bill2 :i* 0 read twice & ref]r$ 
to ! ,committee on ,f9ance  ,a ,,bill   
,to provide = ! cov]age ( m$ical food & 
vitam9s & individual am9o acids =       
dige/ive & inh]it$ metabolic disord]s "u
 ,f$]al heal? programs1 to ensure ,/ate 
& ,f$]al protection = exi/+ cov]age1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,m$ical ,foods &   
,=mulas ,access ,act ( #bjbe4  #b4      
,f9d+s ,congress f9ds ! foll[+3 7#a7    
,ea* ye>1 ?\s&s ( *ildr5 & adults 9 !   
,unit$ ,/ates are diagnos$ ) c]ta9      
dige/ive or inh]it$ metabolic disord]s t
 prev5t _! bodies f dige/+ or metaboliz+
 ! food !y ne$ to survive4 ,= !m1       
m$ically necess>y food1 :i* c (t5 be    
adm9i/]$ z an orally consum$ =mula1 is  
_! treatm5t4  7#b7 ,)\t m$ically        
necess>y food1 ^! pati5ts risk          

malnutrition1 surg]y1 & repeat$         
hospitalizations4 ,!y may suff]         
intellectual disability or ev5 dea?4    
,risks 9 p$iatric populations are       
p>ticul>ly pr(\nd & (t5 sev]e & also    
include inadequate gr[?1 abnormal       
developm5t1 cognitive impairm5t1 &      
behavioral disord]s4 ,specializ$        
m$ically necess>y food is /&>d-(-c>e    
!rapy = ^! pati5ts & is ess5tial to     
prev5t+ su* outcomes4  7#c7 ,:ile n e   
p]son diagnos$ ) ^! conditions ne$s to  
be treat$ ) m$ically necess>y food = a  
prolong$ p]iod1 x is critical t pati5ts 
& _! physicians be able to consid] !    
full range ( options & select ! treatm5t
 t w be mo/ effective = ea* pati5t4     
7#d7 ,insurance w typically cov]        
ph>maceuticals or biologics = treatm5t (
 _m ( ^! conditions1 if !re is a !rapy  
approv$ by ! ,food & ,drug              
,adm9i/ration4 ,h[ev]1 ^! types (       
treatm5ts may n be ! fir/-l9e !rapy a   
physician w\ld recomm5d1 d n "w = all   
pati5ts1 & c h undesirable risks1 su* z 

c]ta9 canc]s or suppression ( ! immune  
sy/em1 :i* c increase a pati5t's risk ( 
infection4  7#e7 ,ev5 :5 insurance does 
cov] m$ically necess>y food1 x c come ) 
! /ipulation ! =mula be adm9i/]$ ?r\gh a
 fe$+ tube1 plac$ ?r\gh ! nose into !   
/oma* or surgically plac$ directly into 
! /oma* or jejunum1 ev5 if a pati5t is  
capable ( tak+ ! =mula orally )\t ^!    
devices4 ,surgical placem5t ( fe$+ tubes
 unnecess>ily results 9 increas$ risk to
 ! pati5t & increas$ co/ to ! heal? c>e 
sy/em4  7#f7 ,vitam9s are ess5tial      
micronutri5ts t play critical roles 9   
metabolism1 cellul> function1 & ov]all  
heal?4 ,am9o acids s]ve z ! build+      
blocks ( prote9s & function z critical  
metabolic int]m$iates4 ,bo? vitam9s &   
am9o acids require c>eful assessm5t &   
monitor+ 9 pati5ts ) ,,gi & metabolic   
disord]s1 z _! absorption1 metabolism1 &
 utilization may be significantly       
impact$ by ! und]ly+ disease processes4 
7#g7 ,te/+ = select inh]it$ metabolic   
disord]s is requir$ 9 all ,/ates1 &     

approximately #b1jjj babies p] ye> are  
diagnos$ ) "o ( ^! disord]s t requires  
treatm5t ?r\gh m$ically necess>y food4  
,yet1 policies on m$ically necess>y food
 v>y significantly & d n always make x  
possible = families to get suffici5t    
nutrition = _! affect$ *ildr5 :i* c lead
 to delay$ developm5t1 bra9 damage1 &   
ev5 dea?4  7#h7 ,! #bjbb =mula %ortage  
demon/rat$ ! ess5tial nature ( specialty
 =mulas = ^? ) dige/ive & metabolic     
conditions & ! dire m$ical consequ5ces t
 c result :5 ^! =mulas are inaccessible4
 ,dur+ ! %ortage1 pati5ts lack+ access  
to _! =mulas fac$ m$ical consequ5ces su*
 z fe$+ intol]ance1 weight loss1 rectal 
ble$+1 rapid ga/ric empty+1 acute kidney
 injury1 & electrolyte di/urbances1 all 
( :i* result$ 9 increas$ physician &    
em]g5cy dep>tm5t visits4 ,*ildr5 )      
metabolic disord]s :o 7 hospitaliz$ due 
to lack ( =mula fac$ simil> *all5ges due
 to lack ( =mula supply & _h to be plac$
 on ,,iv nutrition4  #c4 ,cov]age (     
m$ically necess>y food1 vitam9s1 &      

individual am9o acids = dige/ive &      
inh]it$ metabolic disord]s "u ,f$]al    
heal? programs  7a7 ,cov]age "u !       
,m$ic>e program  7#a7 ,9 g5]al ,section 
#ahfa7s77#b7 ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$--
 7,a7 9 subp>agraph 7,,ii71 by /rik+ &  
at ! end2  7,b7 9 subp>agraph 7,,jj71 by
 ins]t+ & at ! end2 &  7,c7 by add+ at !
 end ! foll[+ new subp>agraph3  7,,kk7  
m$ically necess>y food 7z def9$ 9       
subsection 7nnn77 &1 if requir$1 !      
m$ical equipm5t & supplies necess>y to  
adm9i/] su* food1 o!r ?an su* food1     
equipm5t1 & supplies furni%$ to an      
individual t w\ld o!rwise be cov]$ = su*
 individual "u "p ,b )\t application (  
?is subp>agraph2  4  7#b7 ,def9ition    
,section #ahfa ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #aciex7 is am5d$ by 
add+ at ! end ! foll[+ new subsection3  
7nnn7 ,m$ically ,necess>y ,food  7#a7   
,subject to p>agraph 7#b71 ! t]m        
m$ically necess>y food means food1      
includ+ a l[ prote9 modifi$ food        

product1 an am9o acid prep>ation        
product1 a modifi$ fat prep>ation       
product1 a nutritional =mula1 a vitam91 
or an individual am9o acid1 t is-- 7,a7 
furni%$ pursuant to ! prescription or   
ord] ( a physician1 physician assi/ant1 
nurse practition]1 or o!r heal? c>e     
practition] act+ )9 ! practition]'s     
scope ( practice1 = ! diet>y managem5t (
 a cov]$ disease or condition2  7,b7 a  
specially =mulat$ & process$ product 7z 
oppos$ to a naturally occurr+ food/uff  
us$ 9 its natural /ate7 = ! p>tial or   
exclusive fe$+ ( an individual by means 
( oral intake or ent]al fe$+ by tube2   
7,c7 int5d$ = ! diet>y managem5t ( an   
individual :o1 because ( a specifi$     
disease or condition1 has limit$ or     
impair$ capacity to +e/1 dige/1 absorb1 
or metabolize ord9>y food/uffs or c]ta9 
nutri5ts1 or :o has o!r special m$ically
 det]m9$ nutri5t requirem5ts1 ! diet>y  
managem5t ( :i* _c be a*iev$ by !       
modification ( ! normal diet alone2     
7,d7 int5d$ to be us$ "u m$ical         

direction1 :i* may include 9 a home     
sett+2 &  7,e7 int5d$ only = an         
individual receiv+ active or ongo+      
m$ical c>e "u ! sup]vision ( a          
physician1 physician assi/ant1 or nurse 
practition]4  7#b7 ,= purposes (        
p>agraph 7#a71 ! t]m m$ically necess>y  
food does n include ! foll[+3 7,a7      
,foods1 includ+ vitam9s & am9o acids1   
tak5 z "p ( an ov]all diet design$ to   
r$uce ! risk ( a disease or m$ical      
condition or z weight loss products1 ev5
 if !y are recomm5d$ by a physician or  
o!r heal? pr(essional4  7,b7 ,foods     
m>ket$ z glut5-free = ! managem5t (     
celiac disease or non-celiac glut5      
s5sitivity4  7,c7 ,foods m>ket$ = !     
managem5t ( diabetes4  7,d7 ,o!r        
products det]m9$ appropriate by !       
,secret>y4  7#c7 ,9 ?is subsection1 !   
t]m cov]$ disease or condition means !  
foll[+ diseases or conditions3 7,a7     
,inh]it$ metabolic disord]s1 includ+ !  
foll[+3 7i7 ,conditions includ$ on !    
,recomm5d$ ,uni=m ,scre5+ ,panel        

,conditions li/ ( ! ,dep>tm5t ( ,heal? &
 ,human ,s]vices4  7ii7 ,organic acid   
conditions4  7iii7 ,fatty acid oxidation
 disord]s4  7iv7 ,am9o acid disord]s4   
7v7 ,urea cycle disord]s4  7vi7 ,glycog5
 /orage disord]s4  7vii7 ,biot9idase    
defici5cy4  7viii7 ,guanid9oacetate     
me?yltransf]ase defici5cy4  7ix7        
,inh]it$ disord]s ( mito*ondrial        
function+4  7,b7 ,m$ical & surgical     
conditions ( malabsorption1 includ+ !   
foll[+3 7i7 ,impair$ absorption (       
nutri5ts caus$ by disord]s affect+ !    
absorptive surface1 functional l5g?1 &  
motility ( ! ga/ro9te/9al tract1 includ+
 %ort b[el syndrome & *ronic inte/9al   
pseudo-ob/ruction4  7ii7 ,malabsorption 
due to liv] or pancreatic disease4  7,c7
 ,immunoglobul9 ,e & non-,immunoglobul9 
,e-m$iat$ all]gies to food prote9s1     
includ+ ! foll[+3 7i7 ,immunoglobul9 ,e 
& non-,immunoglobul9 ,e-m$iat$ all]gies 
to food prote9s4  7ii7 ,food            
prote9-induc$ ent]ocolitis syndrome4    
7iii7 ,eos9ophilic disord]s1 includ+    

eos9ophilic esophagitis1 eos9ophilic    
ga/ro5t]itis1 eos9ophilic colitis1 &    
po/-transplant eos9ophilic disord]s4    
7,d7 ,inflammatory or immune m$iat$     
conditions ( ! alim5t>y tract1 includ+ !
 foll[+3 7i7 ,inflammatory b[el disease1
 includ+ ,crohn's disease1 ulc]ative    
colitis1 & indet]m9ate colitis4  7ii7   
,ga/roesophageal reflux disease t is    
nonresponsive to /&>d m$ical !rapies4   
7,e7 ,any o!r disease or condition      
det]m9$ appropriate by ! ,secret>y1 9   
consultation ) appropriate sci5tific    
entities4  7#d7 7,a7 ,9 ?is subsection1 
! t]m l[ prote9 modifi$ food product    
means a type ( m$ical food t is modifi$ 
to be l[ 9 prote9 & =mulat$ = oral      
consumption = individuals ) inborn      
errors ( prote9 metabolism4  7,b7 ,su*  
t]m does n include foods t are naturally
 l[ 9 prote91 su* z "s fruits or        
vegetables4  4  7#c7 ,paym5t ,section   
#ahcc7;a77#a7 ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #aciel7a77#a77 is       
am5d$-- 7,a7 by /rik+ & be=e 7,,hh72 &  

7,b7 by ins]t+ be=e ! semicolon at ! end
 ! foll[+3 & 7,,ii7 ) respect to        
m$ically necess>y food 7z def9$ 9       
section #ahfa7nnn771 ! am\nt paid %all  
be an am\nt equal to #hj p]c5t ( ! less]
 ( ! actual *>ge = ! s]vices or ! am\nt 
det]m9$ "u a fee s*$ule e/abli%$ by !   
,secret>y = purposes ( ?is subp>agraph44
  7#d7 ,effective date ,! am5dm5ts made 
by ?is subsection %all apply to items & 
s]vices furni%$ on or aft] ! date t is  
#c ye>s aft] ! date ( ! enactm5t ( ?is  
,act4  7b7 ,cov]age "u ! ,m$icaid       
program  7#a7 ,9 g5]al ,section         
#aije7;a7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acif;d7a77 is am5d$--   
7,a7 9 p>agraph 7#ca71 by /rik+ & at !  
end2  7,b7 by r$esignat+ p>agraph 7#cb7 
z p>agraph 7#cc72 &  7,c7 by ins]t+ aft]
 p>agraph 7#ca7 ! foll[+ new p>agraph3  
7#cb7 m$ically necess>y food 7:i* %all  
include at lea/ ! items & s]vices       
includ$ 9 su* t]m = purposes ( section  
#ahfa7nnn77 & ! m$ical equipm5t &       
supplies necess>y to adm9i/] su* food2 &

  4  7#b7 ,con=m+ am5dm5ts  7,a7        
,m&atory b5efits ,section               
#aijb7;a77#aj77;,a7 ( ! ,social         
,security ,act 7#db ,u4,s4,c4           
#acif;a7a77#aj77;,a77 is am5d$1 9 !     
matt] prec$+ clause 7i71 by /rik+ &     
7#cj7 & ins]t+ 7#cj71 & 7#cb74  7,b7    
,application ( co/ limits ,section      
#aijc7;i77#bg7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acif;b7i77#bg77 is 
am5d$-- 7i7 by ins]t+ or = equipm5t &   
supplies describ$ 9 section             
#aije7;a77#cb71 aft] #bjah12 &  7ii7 by 
/rik+ su* items ea* place su* phrase    
appe>s & ins]t+ su* items1 equipm5t1 or 
supplies4  7,c7 ,application to b5*m>k &
 b5*m>k-equival5t cov]age ,section      
#aicg7;b7 ( ! ,social ,security ,act    
7#db ,u4,s4,c4 #acifu-#g7;b77 is am5d$  
by add+ at ! end ! foll[+ new p>agraph3 
7#i7 ,m$ically necess>y food ,not)/&+ ! 
previ\s provisions ( ?is section1 a     
,/ate may n provide = m$ical assi/ance  
?r\gh enrollm5t ( an individual ) b5*m>k
 cov]age or b5*m>k-equival5t cov]age "u 

?is section unless su* cov]age includes 
cov]age ( m$ically necess>y food 7:i*   
%all include at lea/ ! items & s]vices  
includ$ 9 su* t]m = purposes ( section  
#ahfa7nnn77 & ! m$ical equipm5t &       
supplies necess>y to adm9i/] su* food4  
4  7#c7 ,effective date  7,a7 ,9 g5]al  
,subject to subp>agraph 7,b71 ! am5dm5ts
 made by ?is subsection %all take effect
 on ! date t is #b ye>s aft] ! date ( ! 
enactm5t ( ?is ,act4  7,b7 ,exception to
 effective date if ,/ate legislation    
requir$ ,9 ! case ( a ,/ate plan =      
m$ical assi/ance "u title ,,xix ( !     
,social ,security ,act :i* ! ,secret>y (
 ,heal? & ,human ,s]vices det]m9es      
requires ,/ate legislation 7o!r ?an     
legislation appropriat+ funds7 9 ord] = 
! plan to meet ! additional requirem5ts 
impos$ by ! am5dm5ts made by ?is        
subsection1 ! ,/ate plan %all n be      
reg>d$ z fail+ to comply ) ! requirem5ts
 ( su* title solely on ! basis ( its    
failure to meet ?is additional          
requirem5t be=e ! fir/ day ( ! fir/     

cal5d> qu>t] beg9n+ aft] ! close ( !    
fir/ regul> session ( ! ,/ate           
legislature t beg9s aft] ! date ( !     
enactm5t ( ?is ,act4 ,= purposes ( !    
previ\s s5t5ce1 9 ! case ( a ,/ate t has
 a #b-ye> legislative session1 ea* ye> (
 su* session %all be deem$ to be a      
sep>ate regul> session ( ! ,/ate        
legislature4  7c7 ,cov]age "u ,,*ip     
7#a7 ,9 g5]al ,section #bajc7;c7 ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#acig;cc7c77 is am5d$ by add+ at ! end !
 foll[+ new p>agraph3  7#ac7 ,m$ically  
necess>y food ,! *ild heal? assi/ance   
provid$ to a t>get$ l[-income *ild "u ! 
plan %all include cov]age ( m$ically    
necess>y food 7:i* %all include at lea/ 
! items & s]vices includ$ 9 su* t]m =   
purposes ( section #ahfa7nnn77 & !      
m$ical equipm5t & supplies necess>y to  
adm9i/] su* food4  4  7#b7 ,con=m+      
am5dm5t ,section #bajc7;a7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#acig;cc7a77 is am5d$1 9 ! matt] prec$+ 
p>agraph 7#a71 by /rik+ & 7#h7 & ins]t+ 

7#h71 & 7#ac74  7#c7 ,effective date    
7,a7 ,9 g5]al ,subject to subp>agraph   
7,b71 ! am5dm5ts made by ?is subsection 
%all take effect on ! date t is #a ye>  
aft] ! date ( ! enactm5t ( ?is ,act4    
7,b7 ,exception to effective date if    
,/ate legislation requir$ ,9 ! case ( a 
,/ate *ild heal? plan = *ild heal?      
assi/ance "u title ,,xxi ( ! ,social    
,security ,act :i* ! ,secret>y ( ,heal? 
& ,human ,s]vices det]m9es requires     
,/ate legislation 7o!r ?an legislation  
appropriat+ funds7 9 ord] = ! plan to   
meet ! additional requirem5ts impos$ by 
! am5dm5ts made by ?is subsection1 !    
,/ate *ild heal? plan %all n be reg>d$ z
 fail+ to comply ) ! requirem5ts ( su*  
title solely on ! basis ( its failure to
 meet ?is additional requirem5t be=e !  
fir/ day ( ! fir/ cal5d> qu>t] beg9n+   
aft] ! close ( ! fir/ regul> session ( !
 ,/ate legislature t beg9s aft] ! date (
 ! enactm5t ( ?is ,act4 ,= purposes ( ! 
previ\s s5t5ce1 9 ! case ( a ,/ate t has
 a #b-ye> legislative session1 ea* ye> (

 su* session %all be deem$ to be a      
sep>ate regul> session ( ! ,/ate        
legislature4  7d7 ,cov]age "u ,,fehbp   
7#a7 ,9 g5]al ,section #hijb ( title #e1
 ,unit$ ,/ates ,code1 is am5d$ by add+  
at ! end ! foll[+3  7q7 ,a contract = a 
plan "u ?is *apt] %all require ! c>ri]  
to provide cov]age = m$ically necess>y  
food 7z def9$ 9 section #ahfa7nnn7 ( !  
,social ,security ,act7 & ! m$ical      
equipm5t & supplies necess>y to adm9i/] 
su* food4  4  7#b7 ,effective date ,!   
am5dm5t made by p>agraph 7#a7 %all apply
 ) respect to contract ye>s beg9n+ on or
 aft] ! date t is #a ye> aft] ! date (  
enactm5t ( ?is ,act4  7e7 ,s5se (       
,congress reg>d+ cov]age "u private     
heal? insurance ,x is ! s5se ( ,congress
 t-- 7#a7 m$ically necess>y food 7z     
def9$ 9 subsection 7nnn7 ( section #ahfa
 ( ! ,social ,security ,act 7#db        
,u4,s4,c4 #aciex71 z add$ by subsection 
7a77#b77 c be life su/a9+ & life sav+2 &
  7#b7 all heal? plans1 includ+ private 
heal? plans (f]$ by heal? insurance     

issu]s1 %\ld provide cov]age (1 & access
 to1 m$ically necess>y food 7z s def9$7 
= individuals ) c]ta9 dige/ive &        
metabolic disord]s & conditions1 :5     
prescrib$ or ord]$ by a physician1      
physician assi/ant1 nurse practition]1  
or o!r heal? c>e practition]1 9 a mann] 
simil> to ! requir$ cov]age ( m$ically  
necess>y food = su* individuals "u !    
,m$ic>e program "u title ,,xviii ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#acie et seq471 ! ,m$icaid program "u   
title ,,xix ( ! ,social ,security ,act  
7#db ,u4,s4,c4 #acif et seq471 ! ,/ate  
,*ildr5's ,heal? ,insurance ,program "u 
title ,,xxi ( ! ,social ,security ,act  
7#db ,u4,s4,c4 #acig;aa et seq471 &     
*apt] #hi or title #e1 ,unit$ ,/ates    
,code1 z am5d$ by subsections 7a71 7b71 
7c71 & 7d71 respectively4  7f7          
,nonpreemption ( ,/ate laws t provide   
great] cov]age ,no?+ 9 ! provisions (1  
or ! am5dm5ts made by1 ?is section %all 
preempt a ,/ate law t requires cov]age (
 m$ically necess>y food 7z def9$ 9      

subsection 7nnn7 ( section #ahfa ( !    
,social ,security ,act1 z add$ by       
subsection 7a77 t exce$s ! requirem5ts =
 cov]age "u su* provisions & am5dm5ts4  
7g7 ,m$ically necess>y nutrition cov]age
 includes comb9ations & supplies ,no?+ 9
 ! provisions (1 or ! am5dm5ts made by1 
?is section %all limit cov]age ( a      
m$ically necess>y food 7z def9$ 9       
subsection 7nnn7 ( section #ahfa ( !    
,social ,security ,act1 z add$ by       
subsection 7a77 or ! m$ical equipm5t &  
supplies necess>y to adm9i/] su* food :5
 prescrib$1 ord]$1 or recomm5d$ 9       
comb9ation ) ano!r m$ically necess>y    
food 7z s def9$7 or o!r necess>y m$ical 
equipm5t & supplies4