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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6892 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 6892

 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

                           December 22, 2023

Mr. McGovern (for himself and Mr. Rutherford) 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 
  Accountability, 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 
2023''.

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 
        certain cancers 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 2022 formula shortage demonstrated the essential 
        nature of specialty formulas for those with GI and metabolic 
        conditions and the dire medical consequences that can result 
        when these formulas are inaccessible. During the shortage, 
        patients lacking access to their formulas faced medical 
        consequences such as feeding intolerance, weight loss, rectal 
        bleeding, rapid gastric emptying, acute kidney injury, and 
        electrolyte disturbances, all of which resulted in increased 
        physician and emergency department visits. Children with 
        metabolic disorders who were hospitalized due to lack of 
        formula faced similar challenges due to lack of formula supply 
        and had to be placed on IV nutrition.

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) In general.--Section 1861(s)(2) of the Social Security 
        Act (42 U.S.C. 1395x(s)(2)) is amended--
                    (A) in subparagraph (II), by striking ``and'' at 
                the end;
                    (B) in subparagraph (JJ), by inserting ``and'' at 
                the end; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(KK) medically necessary food (as defined in subsection 
        (nnn)) and, if required, the medical equipment and supplies 
        necessary to administer such food, other than such food, 
        equipment, and supplies furnished to an individual that would 
        otherwise be covered for such individual under part B without 
        application of this subparagraph;''.
            (2) 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

    ``(nnn)(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, a 
nutritional formula, a vitamin, or an individual amino acid, that is--
            ``(A) furnished pursuant to the prescription or order of a 
        physician, physician assistant, nurse practitioner, or other 
        health care practitioner acting within the practitioner's scope 
        of practice, 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 direction, which 
        may include in a home setting; and
            ``(E) intended only for an individual receiving active or 
        ongoing medical care under the supervision of a physician, 
        physician assistant, or nurse practitioner.
    ``(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.''.
            (3) Payment.--Section 1833(a)(1) of the Social Security Act 
        (42 U.S.C. 1395l(a)(1)) is amended--
                    (A) by striking ``and'' before ``(GG)''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``and (HH) with respect to medically 
                necessary food (as defined in section 1861(nnn)), 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.''.
            (4) Effective date.--The amendments made by this subsection 
        shall apply to items and services furnished on or after the 
        date that is 3 years 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 
                (32); and
                    (C) by inserting after paragraph (30) the following 
                new paragraph:
            ``(31) medically necessary food (which shall include at 
        least the items and services included in such term for purposes 
        of section 1861(nnn)) and the medical equipment and supplies 
        necessary to administer such food; 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), and (31)''.
                    (B) Application of cost limits.--Section 
                1903(i)(27) of the Social Security Act (42 U.S.C. 
                1396b(i)(27)) is amended--
                            (i) by inserting ``or for equipment and 
                        supplies described in section 1905(a)(31),'' 
                        after ``2018,''; and
                            (ii) by striking ``such items'' each place 
                        such phrase appears and inserting ``such items, 
                        equipment, or supplies''.
                    (C) Application to benchmark and benchmark-
                equivalent coverage.--Section 1937(b) of the Social 
                Security Act (42 U.S.C. 1396u-7(b)) is amended by 
                adding at the end the following new paragraph:
            ``(9) Medically necessary food.--Notwithstanding the 
        previous provisions of this section, a State may not provide 
        for medical assistance through enrollment of an individual with 
        benchmark coverage or benchmark-equivalent coverage under this 
        section unless such coverage includes coverage of medically 
        necessary food (which shall include at least the items and 
        services included in such term for purposes of section 
        1861(nnn)) and the medical equipment and supplies necessary to 
        administer such food.''.
            (3) Effective date.--
                    (A) In general.--Subject to subparagraph (B), the 
                amendments made by this subsection shall take effect on 
                the date that is 2 years 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 new paragraph:
            ``(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 (which 
        shall include at least the items and services included in such 
        term for purposes of section 1861(nnn)) and the medical 
        equipment and supplies necessary to administer such food.''.
            (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), and (12)''.
            (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 medically necessary food (as defined in 
section 1861(nnn) of the Social Security Act) and the medical equipment 
and supplies necessary to administer such food.''.
            (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 new section:

``SEC. 2729A. COVERAGE OF MEDICALLY NECESSARY FOOD, VITAMINS, AND 
              INDIVIDUAL AMINO ACIDS.

    ``A group health plan and a health insurance issuer offering group 
or individual health insurance coverage shall provide coverage for 
medically necessary food (as defined in section 1861(nnn) of the Social 
Security Act) and the medical equipment and supplies necessary to 
administer such food.''.
            (2) Inclusion as an essential health benefit.--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 new subparagraph:
                    ``(K) Medically necessary food (as defined in 
                section 1861(nnn) of the Social Security Act) an the 
                medical equipment and supplies necessary to administer 
                such food.''.
            (3) Effective date.--The amendments made by this subsection 
        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 (as defined in subsection (lll) of section 1861 of the Social 
Security Act, as added by subsection (a)) 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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