[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2013 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2013

 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 SENATE OF THE UNITED STATES

                             June 10, 2021

    Mr. Casey (for himself, Ms. Ernst, Mr. Grassley, and Ms. Rosen) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 Food and Drug Administration-approved 
        therapy. 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 healthcare 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 striking the 
                        period and inserting ``and''; 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:
    ``(q) 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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