(1) Newborns are screened for inborn errors of 
metabolism, but treatment for such conditions is not 
uniformly covered by insurance. 
(2) Each year approximately 2,550 children in 
the United States are diagnosed with an inborn 
error of metabolism disorder, requiring foods modi-
fied to be void of the nutrient or nutrients the 
child’s body is incapable of processing, or requiring 
supplementation with vitamins or amino acids. 
(3) More than 35 States have passed laws to at 
least partially address the inequity in coverage for 
medically necessary foods, critical treatment for such 
disorders. 
(4) The cost associated with providing medically 
necessary foods presents a large financial burden for 
many families. 
(5) There is no current cure for inborn errors 
of metabolism disorders and treatment is necessary 
during the entire lifespan of the individual. 
SEC. 3. COVERAGE IN CERTAIN FEDERAL HEALTH PRO-
GRAMS OF MEDICALLY NECESSARY FOOD 
AND FOOD MODIFIED TO BE LOW PROTEIN. 
(a) COVERAGE UNDER THE MEDICARE PROGRAM.— 
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(1) COVERAGE
OF
MEDICALLY
NECESSARY 
FOOD UNDER THE ORIGINAL MEDICARE FEE-FOR- 
SERVICE PROGRAM.— 
(A) IN GENERAL.—Section 1861(s)(2) of 
the Social Security Act (42 U.S.C. 1395x(s)(2)) 
is amended— 
(i) in subparagraph (EE), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (FF), by insert-
ing ‘‘and’’ at the end; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(GG) medically necessary food (as defined in 
subsection (iii)) and food modified to be low protein 
that is formulated to be consumed or administered 
under the supervision of a qualified medical pro-
vider, for the treatment of conditions as rec-
ommended by the Advisory Committee on Heritable 
Disorders in Newborns and Children, and the med-
ical equipment and supplies necessary to administer 
such food;’’. 
(B) DEFINITION.—Section 1861 of the So-
cial Security Act (42 U.S.C. 1395x) is amended 
by adding at the end the following new sub-
section: 
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‘‘(iii)(1) The term ‘medically necessary food’— 
‘‘(A) means a food which is formulated to be 
consumed or administered enterally under the super-
vision of a physician and which is intended for the 
specific dietary management of a disease or condi-
tion for which distinctive nutritional requirements, 
based on recognized scientific principles, are estab-
lished by medical evaluation; and 
‘‘(B) includes nutritionally modified counter-
parts of traditional foods and other forms of foods 
such as formulas, pills, capsules, and bars, so long 
as consumed or administered enterally. 
‘‘(2) For purposes of paragraph (1), the term 
‘enterally’ refers to consumption or administration 
through the gastrointestinal tract, whether orally or by 
tube.’’. 
(C) PAYMENT.—Section 1833(a)(1) of the 
Social Security Act (42 U.S.C. 1395l(a)(1)) is 
amended— 
(i) by striking ‘‘and’’ before ‘‘(Z)’’; 
and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘, and (AA) with 
respect to medically necessary food and 
pharmacological doses of vitamins and 
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amino acids under section 1861(s)(2)(GG), 
the amounts paid shall be 80 percent of 
the lesser of the actual charge for the serv-
ices or 85 percent of the amount deter-
mined under the fee schedule established 
under section 1848(b) for the same serv-
ices if furnished by a physician’’. 
(2) INCLUSION
OF
PHARMACOLOGICAL
DOSES 
OF VITAMINS AND AMINO ACIDS AS A COVERED PART 
D DRUG.— 
(A) IN GENERAL.—Section 1860D–2(e)(1) 
of the Social Security Act (42 U.S.C. 1395w– 
102(e)(1)) is amended— 
(i) in subparagraph (A), by striking 
‘‘or’’ at the end; 
(ii) in subparagraph (B), by striking 
the comma at the end and inserting ‘‘; or’’; 
and 
(iii) by inserting after subparagraph 
(B) the following new subparagraph: 
‘‘(C) pharmacological doses of vitamins 
and amino acids used for the treatment of in-
born errors of metabolism, for the treatment of 
conditions as recommended by the Advisory 
Committee on Heritable Disorders in Newborns 
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and Children and as prescribed by a qualified 
medical provider,’’. 
(B) EFFECTIVE DATE.—The amendments 
made by subparagraph (A) shall apply to plan 
years beginning on or after the date that is 6 
months after date of enactment of this Act. 
(b) COVERAGE UNDER THE MEDICAID PROGRAM.— 
(1) IN GENERAL.—Section 1905 of the Social 
Security Act (42 U.S.C. 1396d) is amended— 
(A) in subsection (a)— 
(i) in paragraph (12), by inserting 
‘‘including pharmacological doses of vita-
mins and amino acids used for the treat-
ment of inborn errors of metabolism, for 
the 
treatment 
of 
conditions 
as 
rec-
ommended by the Advisory Committee on 
Heritable Disorders in Newborns and Chil-
dren and as prescribed by a qualified med-
ical provider,’’ after ‘‘prescribed drugs,’’; 
(ii) in paragraph (28), by striking 
‘‘and’’ at the end; 
(iii) by redesignating paragraph (29) 
as paragraph (30); and 
(iv) by inserting after paragraph (28) 
the following new paragraph: 
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