,i #aaf? ,,congress #b;d ,session ,h4 ,r4 #hach ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #a1 #bjbj,mr4 ,biggs introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ,arm$ ,s]vices1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d ! ,orphan ,drug ,act ) respect to ! def9ition ( m$ical food1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pati5t ,access to ,m$ical ,foods ,act4 #b4 ,def9ition ( m$ical food = purposes ( ,orphan ,drug ,act 7a7 ,9 g5]al ,section #e7;b77#c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7b77#c77 is am5d$ to read z foll[s3 7#c7 ,! t]m m$ical food means a food :i*-- 7,a7 is =mulat$ to be consum$ or adm9i/]$ ent]ally1 includ+ tube fe$+ & oral intake1 & disp5s$ ^u a writt5 prescription ( a practition] lic5s$ "u ! laws ( ! ,/ate 9 :i* su* practition] practices to adm9i/] drugs2 & 7,b7 7i7 is int5d$ = ! specific diet>y managem5t ( a disease or condition = :i* di/9ctive nutritional requirem5ts1 includ+ conditions ( inborn errors ( metabolism1 bas$ on recogniz$ sci5tific pr9ciples1 are e/abli%$ by m$ical evaluation2 or 7ii7 9 ! case ( an individual = :om ! prescrib+ physician det]m9es ! individual has fail$ on traditional !rapies or det]m9es cont9u+ ! traditional !rapy is inappropriate = ! pati5t due to comorbidities or sev]e side effects t endang] ! heal? ( ! individual-- 7,i7 has be5 %[n to provide cl9ical b5efit 9 well-controll$ pe]-review$ cl9ical trials to pati5ts ) a disease or condition specifi$ 9 clause 7i72 & 7,,ii7 is det]m9$ by ! prescrib+ physician to be a saf] !rapeutic option or ! only effective cl9ical option = ! individual4 4 7b7 ,national ,drug ,code numb] ,section #e ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7 is am5d$-- 7#a7 by r$esignat+ subsection 7c7 z subsection 7d72 & 7#b7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,national ,drug ,code numb] ,m$ical foods %all be eligible = a ,national ,drug ,code numb]4 4 #c4 ,cov]age ( m$ically necess>y food "u ,f$]al heal? programs & private heal? insurance 7a7 ,cov]age "u ,m$ic>e program 7#a7 ,"p ,b cov]age 7,a7 ,9 g5]al ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$-- 7i7 9 subp>agraph 7,,gg71 by /rik+ & at ! end2 7ii7 9 subp>agraph 7,,hh71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,,ii7 m$ically necess>y food 7z def9$ 9 subsection 7kkk772 4 7,b7 ,def9ition ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7kkk7 ,m$ically ,necess>y ,food ,! t]m m$ically necess>y food has ! mean+ giv5 ! t]m m$ical food 9 section #e7;b77#c7 ( ! ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7b77#c774 4 7,c7 ,paym5t ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7i7 by /rik+ & be=e 7,,dd72 & 7ii7 by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 & 7,,ee7 ) respect to m$ically necess>y food 7z def9$ 9 section #ahfa7kkk771 ! am\nt paid %all be an am\nt equal to #hj p]c5t ( ! actual *>ge = ! s]vices44 7,d7 ,effective date ,! am5dm5ts made by ?is p>agraph %all apply to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjba4 7#b7 ,cov]age z cov]$ "p ,d drug 7,a7 ,9 g5]al ,section #ahfj;,d-#b7;e77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e77#a77 is am5d$-- 7i7 9 subp>agraph 7,a71 by /rik+ at ! end or2 7ii7 9 subp>agraph 7,b71 by /rik+ at ! end ! comma & ins]t+ 2 or2 & 7iii7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+ new subp>agraph3 7,c7 a m$ically necess>y food 7z def9$ 9 section #ahfa7kkk771 4 7,b7 ,effective date ,! am5dm5ts made by subp>agraph 7,a7 %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4 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#bi71 by /rik+ & at ! end2 7,b7 by r$esignat+ p>agraph 7#cj7 z p>agraph 7#ca72 & 7,c7 by ins]t+ aft] p>agraph 7#bi7 ! foll[+ new p>agraph3 7#cj7 m$ically necess>y food 7z def9$ 9 section #ahfa7kkk772 & 4 7#b7 ,m&atory b5efit ,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#bi7 & ins]t+ 7#bi71 & 7#cj74 7#c7 ,effective date 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! am5dm5ts made by ?is subsection %all apply ) respect to m$ical assi/ance furni%$ on or aft] ,july #a1 #bjba4 7,b7 ,exception if /ate legislation requir$ ,9 ! case ( a ,/ate plan = m$ical assi/ance "u title ,,xix ( ! ,social ,security ,act :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 7o!r ?an legislation appropriat+ funds7 9 ord] = ! plan to meet ! additional requirem5t impos$ 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[+3 7#aa7 ,m$ically necess>y food ,! *ild heal? assi/ance provid$ to a t>get$ l[-income *ild %all include cov]age ( m$ically necess>y food 7z def9$ 9 section #ahfa7kkk774 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+ 1 7#h71 & 7#aa74 7#c7 ,effective date 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! am5dm5ts made by ?is subsection %all apply ) respect to *ild heal? assi/ance furni%$ on or aft] ,july #a1 #bjba4 7,b7 ,exception 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 requirem5t 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 ,,tric>e ,p>agraph 7#b7 ( section #ajgg7;h7 ( title #aj1 ,unit$ ,/ates ,code1 is am5d$ to read z foll[s3 7#b7 ,9 ?is section1 ! t]m m$ically necess>y food has ! mean+ giv5 ! t]m m$ical food 9 section #e7;b77#c7 ( ! ,orphan ,drug ,act4 4 7e7 ,cov]age "u private heal? insurance 7#a7 ,9 g5]al ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgcj4 ,cov]age ( m$ically necess>y food ,a gr\p heal? plan & gr\p or individual heal? insurance cov]age (f]$ by a heal? insurance issu] %all provide cov]age = m$ically necess>y food 7z def9$ 9 section #ahfa7kkk7 ( ! ,social ,security ,act74 4 7#b7 ,effective date ,! am5dm5t made by p>agraph 7#a7 %all apply to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba4