[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3783 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 3783
To provide for the coverage of medically necessary food and vitamins
and individual amino acids for digestive and inherited metabolic
disorders under Federal health programs and private health insurance,
to ensure State and Federal protection for existing coverage, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 8, 2021
Mr. McGovern (for himself and Ms. Herrera Beutler) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Ways and Means,
Oversight and Reform, 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 and vitamins
and individual amino acids for digestive and inherited metabolic
disorders under Federal health programs and private health insurance,
to ensure State and Federal protection for existing coverage, 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 Nutrition Equity Act of
2021''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Each year, thousands of children and adults in the
United States are diagnosed with certain digestive or inherited
metabolic disorders that prevent their bodies from digesting or
metabolizing the food they need to survive. For them, medically
necessary food, which can often be administered as an orally
consumed formula, is their treatment.
(2) Without medically necessary food, these patients risk
malnutrition, surgery, and repeated hospitalizations. They may
suffer intellectual disability or even death. Risks in
pediatric populations are particularly profound and often
severe and also include inadequate growth, abnormal
development, cognitive impairment, and behavioral disorders.
Specialized medically necessary food is standard-of-care
therapy for these patients and is essential to preventing such
outcomes.
(3) While not every person diagnosed with these conditions
needs to be treated with medically necessary food for a
prolonged period, it is critical that patients and their
physicians be able to consider the full range of options and
select the treatment that will be most effective for each
patient.
(4) Insurance companies will typically cover
pharmaceuticals or biologics for treatment of many of these
conditions, if there is a therapy approved by the Food and Drug
Administration. However, these types of treatments may not be
the first-line therapy a physician would recommend, do not work
for all patients, and can have undesirable risks, such as
cancer or suppression of the immune system, which can increase
a patient's risk of infection.
(5) Even when an insurance company does cover medically
necessary food, it can come with the stipulation the formula be
administered through a feeding tube, placed through the nose
into the stomach or surgically placed directly into the stomach
or jejunum, even if a patient is capable of taking the formula
orally without these devices. Surgical placement of feeding
tubes unnecessarily results in increased risk to the patient
and increased cost to the health care system.
(6) Testing for select inherited metabolic disorders is
required in all States, and approximately 2,000 babies per year
are diagnosed with one of these disorders that requires
treatment through medically necessary food. Yet, policies on
medically necessary food vary significantly and do not always
make it possible for families to get sufficient nutrition for
their affected children which can lead to delayed development,
brain damage, and even death.
(7) The worsening of food insecurity during the COVID-19
pandemic has had a significant impact on patients who rely on
medical nutrition, and the cost of meeting their dietary needs
has been a major burden to individuals facing financial
challenges as a result of the pandemic.
SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITAMINS, AND INDIVIDUAL
AMINO ACIDS FOR DIGESTIVE AND INHERITED METABOLIC
DISORDERS UNDER FEDERAL HEALTH PROGRAMS AND PRIVATE
HEALTH INSURANCE.
(a) Coverage Under the Medicare Program.--
(1) Medically necessary food.--
(A) In general.--Section 1861(s)(2) of the Social
Security Act (42 U.S.C. 1395x(s)(2)) is amended--
(i) in subparagraph (GG), by striking
``and'' at the end;
(ii) in subparagraph (HH), by inserting
``and'' at the end; and
(iii) by adding at the end the following
new subparagraph:
``(II) medically necessary food (as defined in subsection
(lll)) and, if required, the medical equipment and supplies
necessary to administer such food (other than medical equipment
and supplies described in subsection (n));''.
(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:
``Medically Necessary Food
``(lll)(1) Subject to paragraph (2), the term `medically necessary
food' means food, including a low protein modified food product, an
amino acid preparation product, a modified fat preparation product, or
a nutritional formula (including such a formula that does not require a
prescription), that is--
``(A) furnished pursuant to the prescription, order, or
recommendation (as applicable) of a physician or other health
care professional qualified to make such prescription, order,
or recommendation, for the dietary management of a covered
disease or condition;
``(B) a specially formulated and processed product (as
opposed to a naturally occurring foodstuff used in its natural
state) for the partial or exclusive feeding of an individual by
means of oral intake or enteral feeding by tube;
``(C) intended for the dietary management of an individual
who, because of a specified disease or condition, has limited
or impaired capacity to ingest, digest, absorb, or metabolize
ordinary foodstuffs or certain nutrients, or who has other
special medically determined nutrient requirements, the dietary
management of which cannot be achieved by the modification of
the normal diet alone;
``(D) intended to be used under medical supervision, which
may include in a home setting; and
``(E) intended only for an individual receiving active and
ongoing medical supervision wherein the individual requires
medical care on a recurring basis for, among other things,
instructions on the use of the food.
``(2) For purposes of paragraph (1), the term `medically necessary
food' does not include the following:
``(A) Foods taken as part of an overall diet designed to
reduce the risk of a disease or medical condition or as weight
loss products, even if they are recommended by a physician or
other health professional.
``(B) Foods marketed as gluten-free for the management of
celiac disease or non-celiac gluten sensitivity.
``(C) Foods marketed for the management of diabetes.
``(D) Other products determined appropriate by the
Secretary.
``(3) In this subsection, the term `covered disease or condition'
means the following diseases or conditions:
``(A) Inherited metabolic disorders, including the
following:
``(i) Disorders classified as metabolic disorders
on the Recommended Uniform Screening Panel Conditions
list of the Secretary of Health and Human Services'
Advisory Committee on Heritable Disorders in Newborns
and Children.
``(ii) N-acetyl glutamate synthase deficiency.
``(iii) Ornithine transcarbamlyase deficiency.
``(iv) Carbamoyl phosphate synthestase deficiency.
``(v) Inherited disorders of mitochondrial
functioning.
``(B) Medical and surgical conditions of malabsorption,
including the following:
``(i) Impaired absorption of nutrients caused by
disorders affecting the absorptive surface, functional
length, and motility of the gastrointestinal tract,
including short bowel syndrome and chronic intestinal
pseudo-obstruction.
``(ii) Malabsorption due to liver or pancreatic
disease.
``(C) Immunoglobulin E and non-Immunoglobulin E-mediated
allergies to food proteins, including the following:
``(i) Immunoglobulin E and non-Immunoglobulin E-
mediated allergies to food proteins.
``(ii) Food protein-induced enterocolitis syndrome.
``(iii) Eosinophilic disorders, including
eosinophilic esophagitis, eosinophilic gastroenteritis,
eosinophilic colitis, and post-transplant eosinophilic
disorders.
``(D) Inflammatory or immune mediated conditions of the
alimentary tract, including the following:
``(i) Inflammatory bowel disease, including Crohn's
disease, ulcerative colitis, and indeterminate colitis.
``(ii) Gastroesophageal reflux disease that is
nonresponsive to standard medical therapies.
``(E) Any other disease or condition determined appropriate
by the Secretary, in consultation with appropriate scientific
entities, such as the Agency for Healthcare Research and
Quality.
``(4)(A) In this subsection, the term `low protein modified food
product' means a type of medical food that is modified to be low in
protein and formulated for oral consumption for individuals with inborn
errors of protein metabolism.
``(B) Such term does not include foods that are naturally low in
protein, such as some fruits or vegetables.''.
(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 ``(DD)'';
and
(ii) by inserting before the semicolon at
the end the following: ``and (EE) with respect
to medically necessary food (as defined in
section 1861(lll)), the amount paid shall be an
amount equal to 80 percent of the lesser of the
actual charge for the services or the amount
determined under a fee schedule established by
the Secretary for purposes of this
subparagraph.''.
(D) Effective date.--The amendments made by this
subsection shall apply to items and services furnished
on or after the date that is 1 year after the date of
the enactment of this Act.
(2) Inclusion of medically necessary vitamins and
individual 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) medically necessary vitamins and individual
amino acids used for the management of a covered
disease or condition (as defined in section
1861(lll)(3)) pursuant to the prescription, order, or
recommendation (as applicable) of a physician or other
health care professional qualified to make such
prescription, order, or recommendation,''.
(B) Effective date.--The amendments made by
subparagraph (A) shall apply to plan years beginning on
or after the date that is 1 year after the date of the
enactment of this Act.
(b) Coverage Under the Medicaid Program.--
(1) In general.--Section 1905(a) of the Social Security Act
(42 U.S.C. 1396d(a)) is amended--
(A) in paragraph (30), by striking ``and'' at the
end;
(B) by redesignating paragraph (31) as paragraph
(33); and
(C) by inserting after paragraph (30) the following
new paragraphs:
``(31) medically necessary food (as defined in section
1861(lll)) and the medical equipment and supplies necessary to
administer such food;
``(32) medically necessary vitamins and individual amino
acids used for the management of a covered disease or condition
(as defined in section 1861(lll)(3)) pursuant to the
prescription, order, or recommendation (as applicable) of a
physician or other health care professional qualified to make
such prescription, order, or recommendation; and''.
(2) Conforming amendments.--
(A) 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 (30)'' and inserting ``(30), (31), and
(32)''.
(B) Exception to coverage restriction.--Section
1927(d)(2)(E) of the Social Security Act (42 U.S.C.
1396r-8(d)(2)(E)) is amended by inserting ``and except
for medically necessary vitamins and individual amino
acids described in section 1905(a)(32)'' before the
period at the end.
(3) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall take effect on
the date that is 1 year after the date of the enactment
of this Act.
(B) 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 requirements 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.--Section 2103(c) of the Social Security Act
(42 U.S.C. 1397cc(c)) is amended by adding at the end the
following:
``(12) Medically necessary food.--The child health
assistance provided to a targeted low-income child under the
plan shall include coverage of medically necessary food (as
defined in section 1861(lll)) and the medical equipment and
supplies necessary to administer such food.
``(13) Certain vitamins and individual amino acids.--The
child health assistance provided to a targeted low-income child
under the plan shall include coverage of medically necessary
vitamins and individual amino acids used for the management of
a covered disease or condition (as defined in section
1861(lll)(3)) pursuant to the prescription, order, or
recommendation (as applicable) of a physician or other health
care professional qualified to make such prescription, order,
or recommendation.''.
(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 (8)'' and inserting
``(8), (12), and (13)''.
(3) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall take effect on
the date that is 1 year after the date of the enactment
of this Act.
(B) 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
requirements 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) Modification of Definition of Medically Necessary Food and
Covered Disease or Condition Under the TRICARE Program.--
(1) In general.--Section 1077(h) of title 10, United States
Code, is amended--
(A) in paragraph (2)(A), in the matter preceding
clause (i), by striking ``or an amino acid preparation
product'' and inserting ``, an amino acid preparation
product, a modified fat preparation product, or a
nutritional formula (including such a formula that does
not require a prescription)''; and
(B) in paragraph (3)--
(i) in subparagraph (D), by striking
``and'' at the end;
(ii) by redesignating subparagraph (E) as
subparagraph (F); and
(iii) by inserting after subparagraph (D)
the following:
``(E) Immunoglobulin E or non-Immunoglobulin E mediated
allergies to food proteins; and''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply to health care provided under chapter 55 of title
10, United States Code, on or after the date that is one year
after the date of the enactment of this Act.
(e) Coverage Under FEHBP.--
(1) In general.--Section 8902 of title 5, United States
Code, is amended by adding at the end the following:
``(p) A contract for a plan under this chapter shall require the
carrier to provide coverage for--
``(1) medically necessary food (as defined in section
1861(lll) of the Social Security Act) and the medical equipment
and supplies necessary to administer such food; and
``(2) medically necessary vitamins and individual amino
acids in the same manner provided for under section 1860D-
2(e)(1)(C) of the Social Security Act.''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply with respect to contract years beginning on or
after the date that is 1 year after the date of enactment of
this Act.
(f) Coverage Under Private Health Insurance.--
(1) In general.--Subpart II of part A of title XXVII of the
Public Health Service Act (42 U.S.C. 300gg-11 et seq.) is
amended by adding at the end the following:
``SEC. 2729A. COVERAGE OF MEDICALLY NECESSARY FOOD, VITAMINS, AND
INDIVIDUAL AMINO ACIDS.
``A health insurance issuer offering group or individual health
insurance coverage shall provide coverage for--
``(1) medically necessary food (as defined in section
1861(lll) of the Social Security Act) and the medical equipment
and supplies necessary to administer such food; and
``(2) medically necessary vitamins and individual amino
acids in the same manner provided for under section 1860D-
2(e)(1)(C) of the Social Security Act.''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to plan years beginning on or after the date that
is 1 year after the date of the enactment of this Act.
(g) Nonpreemption of State Laws That Provide Greater Coverage.--
Nothing in the provisions of, or the amendments made by, this section
shall preempt a State law that requires coverage of medically necessary
food and vitamins and individual amino acids for digestive and
inherited metabolic disorders that exceeds the requirements for
coverage under such provisions and amendments.
(h) Medically Necessary Nutrition Coverage Includes Combinations
and Supplies.--Nothing in the provisions of, or the amendments made by,
this section shall limit coverage of a medically necessary food (as
defined in subsection (lll) of section 1861 of the Social Security Act,
as added by subsection (a)) or the medical equipment and supplies
necessary to administer such food when prescribed, ordered, or
recommended in combination with another medically necessary food (as so
defined) or other necessary medical equipment and supplies.
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