I 
112TH CONGRESS 
1ST SESSION H. R. 1311 
To provide for the coverage of medically necessary food under Federal health 
programs and private health insurance. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 1, 2011 
Ms. BALDWIN (for herself, Mr. POLIS, Ms. JACKSON LEE of Texas, Ms. 
EDDIE BERNICE JOHNSON of Texas, and Mr. JOHNSON of Georgia) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Ways and 
Means, Armed Services, and Education and the Workforce, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation 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 2011’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
(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 FEDERAL HEALTH PROGRAMS OF 
MEDICALLY NECESSARY FOOD AND FOOD 
MODIFIED TO BE LOW PROTEIN. 
(a) COVERAGE UNDER THE MEDICARE PROGRAM.— 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
(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: 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
‘‘(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 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
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 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
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) in paragraph (29), by striking the 
comma at the end and inserting ‘‘; and’’; 
and 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
(iv) by inserting after paragraph (29) 
the following new paragraph: 
‘‘(30) medically necessary food (as defined in 
subsection (ee)) 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,’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(ee) MEDICALLY NECESSARY FOOD DEFINED.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(30), the term ‘medically necessary food’— 
‘‘(A) means a food which is formulated to 
be consumed or administered enterally under 
the supervision of a physician and which is in-
tended for the specific dietary management of 
a disease or condition for which distinctive nu-
tritional requirements, based on recognized sci-
entific principles, are established by medical 
evaluation; and 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
‘‘(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. 
‘‘(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) EXCEPTION TO REBATE EXCLUSION.—Sec-
tion 1927(d)(2)(E) of the Social Security Act (42 
U.S.C. 1396r–8(d)(2)(E)) is amended by inserting 
‘‘, pharmacological doses of vitamins and amino 
acids used for the treatment of inborn errors of me-
tabolism, for the treatment of conditions as rec-
ommended by the Advisory Committee on Heritable 
Disorders in Newborns and Children and as pre-
scribed by a qualified medical provider,’’ after ‘‘pre-
natal vitamins’’. 
(3) 
CONFORMING
AMENDMENT.—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 (28)’’ and in-
serting ‘‘(28), and (30)’’. 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
(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.— 
(1) IN GENERAL.— 
(A) MEDICALLY NECESSARY FOOD.—Sec-
tion 2103(c) of the Social Security Act (42 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
U.S.C. 1397cc(c)) is amended by adding at the 
end the following: 
‘‘(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 physician and which is intended 
for the specific dietary management of 
a disease or condition for which dis-
tinctive 
nutritional 
requirements, 
based on recognized scientific prin-
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
ciples, are established by medical eval-
uation; 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.’’. 
(B) VITAMINS AND AMINO ACIDS.—Section 
2110(a)(6) of the Social Security Act (42 
U.S.C. 1397jj(a)(6)) is amended by striking 
‘‘and biologicals and the administration of such 
drugs and biologicals, only if such drugs and 
biologicals’’ and inserting ‘‘, 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 Heritable Disorders 
in Newborns and Children and as prescribed by 
a qualified medical provider, and biologicals, 
and the administration of such drugs, vitamins 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
and amino acids, and biologicals, only if such 
drugs, 
vitamins 
and 
amino 
acids, 
and 
biologicals’’. 
(2) 
CONFORMING
AMENDMENT.—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 inserting 
‘‘, (7), and (9)’’. 
(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(iii) 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-
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
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 
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. 716. 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 physician and which is in-
tended for the specific dietary management of 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
plan, or a health insurance issuer that provides 
health insurance coverage in connection with a group 
health plan, shall provide coverage for necessary 
medically necessary food and food modified to be low 
protein that is formulated to be consumed or admin-
istered under the supervision of a qualified medical 
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. 
‘‘(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 
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.’’. 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS
(B) 
CONFORMING
AMENDMENT.—The 
table of sections for subchapter B of chapter 
100 of such Code is amended by inserting after 
the item relating to section 9813 the following 
new item: 
‘‘Sec. 9814. Coverage of medically necessary food and food modified to be low 
protein.’’. 
(b) INDIVIDUAL MARKET.—Subpart 2 of part B of 
title XXVII of the Public Health Service Act (42 U.S.C. 
300gg–51 et seq.) is amended by adding at the end the 
following new section: 
‘‘SEC. 2754. COVERAGE OF MEDICALLY NECESSARY FOOD 
AND FOOD MODIFIED TO BE LOW PROTEIN. 
‘‘The provisions of section 2729 shall apply to health 
insurance coverage offered by a health insurance issuer 
in the individual market in the same manner as they apply 
to health insurance coverage offered by a health insurance 
issuer in connection with a group health plan in the small 
or large group market.’’. 
(c) AMENDMENT TO PPACA.—Section 1302(b)(1) of 
the Patient Protection and Affordable Care Act (42 
U.S.C. 18022(b)(1)) is amended by adding at the end the 
following: 
‘‘(K) Medically necessary food, as defined 
in section 2729 of the Public Health Service 
Act.’’. 
VerDate Mar 15 2010 
22:57 Apr 04, 2011
Jkt 099200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H1311.IH
H1311
emcdonald on DSK2BSOYB1PROD with BILLS