I 
111TH CONGRESS 
2D SESSION 
H. R. 4926 
To provide for the coverage of medically necessary food under Federal health 
programs and private health insurance. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 24, 2010 
Ms. BALDWIN (for herself, Mr. EDWARDS of Texas, Mr. POLIS of Colorado, 
Mr. SARBANES, and Mr. JOHNSON of Georgia) introduced the following 
bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committees on Ways and Means, Education and Labor, 
and Armed Services, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To provide for the coverage of medically necessary food under 
Federal health programs and private health insurance. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Foods Equity 
Act of 2010’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(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 30 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 FEDERAL HEALTH PROGRAMS 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 (DD), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (EE), by insert-
ing ‘‘and’’ at the end; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(FF) medically necessary food (as defined 
in subsection (hhh)) and food modified to be 
low protein that is formulated to be consumed 
or administered under the supervision of a 
qualified medical provider, for the treatment of 
conditions as recommended by the Advisory 
Committee on Heritable Disorders in Newborns 
and Children, and the medical equipment and 
supplies necessary to administer such food.’’. 
(B) DEFINITION.—Section 1861 of such 
Act (42 U.S.C. 1395x) is amended by adding at 
the end the following new subsection: 
‘‘(hhh)(1) The term ‘medically necessary food’— 
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‘‘(A) means a food which is formulated to be 
consumed or administered enterally under the super-
vision of a qualified medical provider and which is 
intended for the specific dietary management of a 
disease or condition for which distinctive nutritional 
requirements, based on recognized scientific prin-
ciples, are established 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 ‘‘(W)’’; 
and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘, and (X) with 
respect to medically necessary food and 
pharmacological doses of vitamins and 
amino acids under section 1861(s)(2)(FF), 
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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’’; 
(ii) in subparagraph (B), by striking 
the comma at the end and inserting ‘‘, or’’; 
and 
(iii) by adding at the end the fol-
lowing 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) DEFINITION
OF
MEDICAL
ASSISTANCE.— 
Section 1905 of the Social Security Act (42 U.S.C. 
1396d) is amended— 
(A) in subsection (a)— 
(i) by redesignating paragraph (28) as 
paragraph (30); 
(ii) in paragraph (27), by striking at 
the end ‘‘and’’; and 
(iii) by inserting after paragraph (27) 
the following new paragraphs: 
‘‘(28) medically necessary food (as defined in 
subsection (y)) 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-
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ical equipment and supplies necessary to administer 
such food; 
‘‘(29) pharmacological doses of vitamins and 
amino acids used for the treatment of inborn errors 
of metabolism, for the treatment of conditions as 
recommended by the Advisory Committee on Heri-
table Disorders in Newborns and Children and as 
prescribed by a qualified medical provider; and’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(y) MEDICALLY NECESSARY FOOD DEFINED.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(28), the term ‘medically necessary food’— 
‘‘(A) means a food which is formulated to 
be consumed or administered enterally under 
the supervision of a qualified medical provider 
and which is intended for the specific dietary 
management of a disease or condition for which 
distinctive nutritional requirements, based on 
recognized scientific principles, are established 
by medical evaluation; and 
‘‘(B) includes nutritionally modified coun-
terparts of traditional foods and other forms of 
foods such as formulas, pills, capsules and bars, 
so long as consumed or administered enterally. 
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‘‘(2) ENTERALLY.—For purposes of paragraph 
(1), the term ‘enterally’ refers to consumption or ad-
ministration through the gastrointestinal tract, 
whether orally or by tube.’’. 
(2) 
MANDATORY
BENEFITS.—Section 
1902(a)(10)(A) of the Social Security Act (42 
U.S.C. 1396a(a)(10)(A)) is amended, in the matter 
preceding clause (i), by striking ‘‘and (21)’’ and in-
serting ‘‘, (21), (28), and (29)’’. 
(3) CONFORMING AMENDMENTS.— 
(A) 
MEDICALLY
NEEDY.—Section 
1902(a)(10)(C)(iv) of such Act (42 U.S.C. 
1396a(a)(10)(C)(iv)) is amended by striking 
‘‘and (17) of section 1905(a) or the care and 
services listed in any 7 of the paragraphs num-
bered (1) through (24)’’ and inserting ‘‘(17), 
(28), and (29) of section 1905(a) or the care 
and services listed in any 7 of the paragraphs 
numbered (1) through (24) or (28) or (29)’’. 
(B) EXCEPTION TO REBATE EXCLUSION.— 
Section 1927(d)(2)(F) of the Social Security 
Act (42 U.S.C. 1396r–8(d)(2)(F)) is amended 
by inserting ‘‘, pharmacological doses of vita-
mins and amino acids used for the treatment of 
inborn errors of metabolism, for the treatment 
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of conditions as recommended by the Advisory 
Committee on Heritable Disorders in Newborns 
and Children and as prescribed by a qualified 
medical provider,’’ after ‘‘prenatal vitamins’’. 
(4) EXCEPTION TO EFFECTIVE DATE 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 (referred to in this Act as the 
‘‘Secretary’’) determines requires State legislation 
(other than legislation appropriating funds) in order 
for the plan to meet the additional requirement im-
posed by the amendments made by this subsection, 
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 re-
quirement 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 Act. For purposes of 
the previous sentence, in the case of a State that has 
a 2-year legislative session, each year of such session 
shall be deemed to be a separate regular session of 
the State legislature. 
(c) COVERAGE UNDER CHIP.— 
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(1) REQUIRED COVERAGE.—Section 2103(c) of 
the Social Security Act (42 U.S.C. 1397cc(c)) is 
amended by inserting after paragraph (8) the fol-
lowing: 
‘‘(9) MEDICALLY NECESSARY FOOD.— 
‘‘(A) IN GENERAL.—The child health as-
sistance provided to a targeted low-income child 
under the plan shall include coverage of medi-
cally necessary food and food modified to be low 
protein that is formulated to be consumed or 
administered under the supervision of a quali-
fied medical provider, for the treatment of con-
ditions as recommended by the Advisory Com-
mittee on Heritable Disorders in Newborns and 
Children, and the medical equipment and sup-
plies necessary to administer such food. 
‘‘(B) DEFINITIONS.—In this paragraph— 
‘‘(i) the term ‘medically necessary 
food’— 
‘‘(I) means a food which is for-
mulated to be consumed or adminis-
tered enterally under the supervision 
of a qualified medical provider and 
which is intended for the specific die-
tary management of a disease or con-
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dition for which distinctive nutritional 
requirements, based on recognized sci-
entific principles, are established by 
medical evaluation; and 
‘‘(II) includes nutritionally modi-
fied counterparts of traditional foods 
and other forms of foods such as for-
mulas, pills, capsules and bars, so 
long as consumed or administered 
enterally; and 
‘‘(ii) the term ‘enterally’ refers to con-
sumption or administration through the 
gastrointestinal tract, whether orally or by 
tube. 
‘‘(10) VITAMINS AND AMINO ACIDS.—The child 
health assistance provided to a targeted low-income 
child under the plan shall include coverage of phar-
macological doses of vitamins and amino acids used 
for the treatment of inborn errors of metabolism, for 
the treatment of conditions as recommended by the 
Advisory Committee on Heritable Disorders in 
Newborns and Children and as prescribed by a 
qualified medical provider.’’. 
(2) CONFORMING AMENDMENTS.— 
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(A) 
MANDATORY
BENEFITS.—Section 
2103(a) of the Social Security Act (42 U.S.C. 
1397cc(a)) is amended, in the matter preceding 
paragraph (1), by striking ‘‘, and (7)’’ and in-
serting ‘‘, (7), (9), and (10)’’. 
(B) DEFINITION
OF
CHILD
HEALTH
AS-
SISTANCE.—Section 2110(a) of such Act (42 
U.S.C. 1397jj) is amended— 
(i) by redesignating paragraph (28) as 
paragraph (30); and 
(ii) by inserting after paragraph (27) 
the following: 
‘‘(28) Medically necessary food (as defined in 
section 2103(c)(9)(B)(i)) and food modified to be 
low protein that is formulated to be consumed or ad-
ministered under the supervision of a qualified med-
ical provider, 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. 
‘‘(29) Pharmacological doses of vitamins and 
amino acids used for the treatment of inborn errors 
of metabolism, for the treatment of conditions as 
recommended by the Advisory Committee on Heri-
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table Disorders in Newborns and Children and as 
prescribed by a qualified medical provider.’’. 
(d) AVAILABILITY OF MEDICALLY NECESSARY FOOD, 
FOOD MODIFIED TO BE LOW PROTEIN, AND RELATED 
ITEMS
UNDER
THE
TRICARE PROGRAM.—Section 
1077(a)(8) of title 10, United States Code, is amended 
by striking ‘‘including’’ and all that follows and inserting 
‘‘including the following: 
‘‘(A) Well-baby care that includes one 
screening of an infant for the level of lead in 
the blood of the infant. 
‘‘(B) Medically necessary food (as defined 
in section 1861(hhh) of the Social Security Act) 
and food modified to be low protein that is for-
mulated to be consumed or administered under 
the supervision of a qualified medical provider, 
for the treatment of conditions as recommended 
by the Advisory Committee on Heritable Dis-
orders in Newborns and Children, and the med-
ical equipment and supplies necessary to admin-
ister such food. 
‘‘(C) Pharmacological doses of vitamins 
and amino acids used for the treatment of in-
born errors of metabolism and other conditions 
as recommended by the Advisory Committee on 
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Heritable Disorders in Newborns and Chil-
dren.’’. 
SEC. 4. COVERAGE IN THE PRIVATE INSURANCE MARKET 
OF MEDICALLY NECESSARY FOOD AND FOOD 
MODIFIED TO BE LOW PROTEIN. 
(a) GROUP HEALTH PLANS.— 
(1) AMENDMENTS TO ERISA.— 
(A) IN GENERAL.—Subpart B of part 7 of 
title I of the Employee Retirement Income Se-
curity Act of 1974 (29 U.S.C. 1185 et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 715. COVERAGE OF MEDICALLY NECESSARY FOOD 
AND FOOD MODIFIED TO BE LOW PROTEIN. 
‘‘(a) DEFINITION.—In this section— 
‘‘(1) the term ‘medically necessary food’— 
‘‘(A) means a food which is formulated to 
be consumed or administered enterally under 
the supervision of a qualified medical provider 
and which is intended for the specific dietary 
management of a disease or condition for which 
distinctive nutritional requirements, based on 
recognized scientific principles, are established 
by medical evaluation; and 
‘‘(B) includes nutritionally modified coun-
terparts of traditional foods and other forms of 
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foods such as formulas, pills, capsules and bars, 
so long as consumed or administered enterally. 
‘‘(2) the term ‘enterally’ refers to consumption 
or administration through the gastrointestinal tract, 
whether orally or by tube. 
‘‘(b) COVERAGE.— 
‘‘(1) MEDICALLY NECESSARY FOOD AND FOOD 
MODIFIED TO BE LOW PROTEIN.—A group health 
plan, or a health insurance issuer that provides 
health insurance coverage in connection with a group 
health plan, shall provide coverage for medically nec-
essary food and food modified to be low protein that 
is formulated to be consumed or administered under 
the supervision of a qualified medical provider, for 
the treatment of conditions as recommended by the 
Advisory Committee on Heritable Disorders in 
Newborns and Children, and the medical equipment 
and supplies necessary to administer such food. 
‘‘(2) VITAMINS
AND
AMINO
ACIDS.—A group 
health plan, or a health insurance issuer that pro-
vides health insurance coverage in connection with a 
group health plan, that provides prescription drug 
coverage shall provide coverage for pharmacological 
doses of vitamins and amino acids used for the 
treatment of inborn errors of metabolism, for the 
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treatment of conditions as recommended by the Ad-
visory 
Committee 
on 
Heritable 
Disorders 
in 
Newborns and Children and as prescribed by a 
qualified medical provider, to the same extent as 
other prescription drug coverage under such plan or 
coverage.’’. 
(B) 
CONFORMING
AMENDMENT.—The 
table of contents in section 1 of such Act is 
amended by inserting after the item relating to 
section 714 the following new item: 
‘‘Sec. 715. Coverage of medically necessary food and food modified to be low 
protein.’’. 
(2) AMENDMENTS
TO
THE
PUBLIC
HEALTH 
SERVICE ACT.—Subpart 2 of part A of title XXVII 
of the Public Health Service Act (42 U.S.C. 300gg– 
4 et seq.) is amended by adding at the end the fol-
lowing new section: 
‘‘SEC. 2708. COVERAGE OF MEDICALLY NECESSARY FOOD 
AND FOOD MODIFIED TO BE LOW PROTEIN. 
‘‘(a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘medically necessary food’— 
‘‘(A) means a food which is formulated to 
be consumed or administered enterally under 
the supervision of a qualified medical provider 
and which is intended for the specific dietary 
management of a disease or condition for which 
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