Medical Foods Equity Act of 2013 - Amends titles XVIII (Medicare), XIX (Medicaid), and XXI (Children's Health Insurance) (CHIP) of the Social Security Act to provide coverage of medically necessary food and food modified to be low protein 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 (the Advisory Committee), and the medical equipment and supplies necessary to administer such food. Provides coverage under the Department of Defense (DOD) TRICARE and Federal Employees Health Benefits (FEHBP) programs for such health benefits.
Defines "medically necessary food" as a food formulated to be consumed or administered through the gastrointestinal tract orally or by tube under the supervision of a physician and 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. Includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars.
Provides Medicare, Medicaid, and CHIP prescription drug coverage of 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, and as prescribed by a qualified medical provider. Provides similar coverage of such items under the TRICARE and FEHBP programs, without regard to the age of the patient.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3665 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 3665
To provide for the coverage of medically necessary food under Federal
health programs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 5, 2013
Mr. Delaney (for himself, Mr. Goodlatte, Mr. Polis, Mr. Johnson of
Georgia, and Ms. Moore) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committees on Ways and Means, Armed Services, and Oversight and
Government Reform, 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 for other purposes.
Be it enacted by the Senate and House of Representatives 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 2013''.
SEC. 2. FINDINGS.
Congress finds the following:
(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 modified 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 PROGRAMS OF MEDICALLY
NECESSARY FOOD AND FOOD MODIFIED TO BE LOW PROTEIN.
(a) Coverage Under the Medicare Program.--
(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 inserting
``and'' at the end; and
(iii) by adding at the end the following
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 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 the Social
Security Act (42 U.S.C. 1395x) is amended by adding at
the end the following new subsection:
``(iii)(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 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 counterparts 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 amino
acids under section 1861(s)(2)(GG), the amounts
paid shall be 80 percent of the lesser of the
actual charge for the services or 85 percent of
the amount determined under the fee schedule
established under section 1848(b) for the same
services 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 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,''.
(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 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,'' 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:
``(29) 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 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; and''; and
(B) by adding at the end the following new
subsection:
``(ee) Medically Necessary Food Defined.--
``(1) In general.--For purposes of subsection (a)(29), 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 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 counterparts
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 administration through the
gastrointestinal tract, whether orally or by tube.''.
(2) Exception to rebate exclusion.--Section 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
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,''
after ``prenatal 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
inserting ``(28), and (29)''.
(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 determines requires State
legislation (other than legislation appropriating funds) in
order for the plan to meet the additional requirement imposed
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 requirement 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.--Section 2103(c) of
the Social Security Act (42 U.S.C. 1397cc(c)) is
amended by adding at the end the following:
``(9) Medically necessary food.--
``(A) In general.--The child health assistance
provided to a targeted low-income child under the plan
shall include coverage of medically necessary 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.
``(B) Definitions.--In this paragraph--
``(i) the term `medically necessary food'--
``(I) means a food which is
formulated to be consumed or
administered enterally under the
supervision of a physician 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
``(II) includes nutritionally
modified counterparts of traditional
foods and other forms of foods such as
formulas, pills, capsules, and bars, so
long as consumed or administered
enterally; and
``(ii) the term `enterally' refers to
consumption 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 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)''.
(3) Exception to effective date if state legislation
required.--In the case of a State child health plan for child
health assistance under title XXI of the Social Security Act
which the Secretary of Health and Human Services determines
requires State legislation (other than legislation
appropriating funds) in order for the plan to meet the
additional requirement imposed by the amendments made by this
subsection, the State child health 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 requirement
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.
(d) Availability of Medically Necessary Food, Food Modified To Be
Low Protein, and Related Items Under the TRICARE Program.--Section 1077
of title 10, United States Code, is amended--
(1) in subsection (a)(8), 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) In accordance with subsection (g), medically
necessary food (as defined in section 1861(iii) of the
Social Security Act) 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.
``(C) In accordance with subsection (g),
pharmacological doses of vitamins and amino acids used
for the treatment of inborn errors of metabolism and
other conditions as recommended by the Advisory
Committee on Heritable Disorders in Newborns and
Children and as prescribed by a qualified medical
provider.''; and
(2) by adding at the end the following new subsection:
``(g) Treatments described in subparagraphs (B) and (C) of
subsection (a)(8) may be provided under this section to a patient
regardless of the age of the patient.''.
(e) Coverage Under FEHBP.--
(1) In general.--Section 8904 of title 5, United States
Code, is amended by adding at the end the following new
subsection:
``(c)(1) Any health benefits plan offered under this chapter shall,
in accordance with paragraph (2), include benefits for--
``(A) medically necessary food (as defined in section
1861(iii) of the Social Security Act) 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; and
``(B) 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.
``(2) Benefits for treatments described in subparagraphs (A) and
(B) of paragraph (1) shall be provided under such a health benefits
plan to an individual regardless of the age of the individual.''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to contract years beginning after the date that is
9 months after the date of enactment of this Act.
SEC. 4. EFFECTIVE DATE.
Subject to subsections (b)(4) and (c)(3) of section (3), the
amendments made by section 3 (other than subsection (e) of such
section) shall apply to plan years and contract years beginning after
the date that is 6 months after the date of enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Armed Services, and Oversight and Government Reform, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Armed Services, and Oversight and Government Reform, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Armed Services, and Oversight and Government Reform, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Armed Services, and Oversight and Government Reform, 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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Military Personnel.
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