HR5684-119

1. Short title This Act may be cited as the Medical Foods and Formulas Access Act of 2025.

2. Findings Congress finds the following: 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. 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. 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. Insurance 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. Even when insurance 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. Vitamins are essential micronutrients that play critical roles in metabolism, cellular function, and overall health. Amino acids serve as the building blocks of proteins and function as critical metabolic intermediates. Both vitamins and amino acids require careful assessment and monitoring in patients with GI and metabolic disorders, as their absorption, metabolism, and utilization may be significantly impacted by the underlying disease processes. 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. The 2022 formula shortage demonstrated the essential nature of specialty formulas for those with digestive 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.

3. Coverage of medically necessary food, vitamins, and individual amino acids for digestive and inherited metabolic disorders under Federal health programs Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended— in subparagraph (II), by striking and at the end; in subparagraph (JJ), by inserting and at the end; and by adding at the end the following new subparagraph: 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; Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection: 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— 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; 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; 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; intended to be used under medical direction, which may include in a home setting; and intended only for an individual receiving active or ongoing medical care under the supervision of a physician, physician assistant, or nurse practitioner. For purposes of paragraph (1), the term medically necessary food does not include the following: Foods, including vitamins and amino acids, 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. Foods marketed as gluten-free for the management of celiac disease or non-celiac gluten sensitivity. Foods marketed for the management of diabetes. Other products determined appropriate by the Secretary. In this subsection, the term covered disease or condition means the following diseases or conditions: Inherited metabolic disorders, including the following: Conditions included on the Recommended Uniform Screening Panel Conditions list of the Department of Health and Human Services. Organic acid conditions. Fatty acid oxidation disorders. Amino acid disorders. Urea cycle disorders. Glycogen storage disorders. Biotinidase deficiency. Guanidinoacetate methyltransferase deficiency. Inherited disorders of mitochondrial functioning. Medical and surgical conditions of malabsorption, including the following: 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. Malabsorption due to liver or pancreatic disease. Immunoglobulin E and non-Immunoglobulin E-mediated allergies to food proteins, including the following: Immunoglobulin E and non-Immunoglobulin E-mediated allergies to food proteins. Food protein-induced enterocolitis syndrome. Eosinophilic disorders, including eosinophilic esophagitis, eosinophilic gastroenteritis, eosinophilic colitis, and post-transplant eosinophilic disorders. Inflammatory or immune mediated conditions of the alimentary tract, including the following: Inflammatory bowel disease, including Crohn’s disease, ulcerative colitis, and indeterminate colitis. Gastroesophageal reflux disease that is nonresponsive to standard medical therapies. Any other disease or condition determined appropriate by the Secretary, in consultation with appropriate scientific entities. 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. Such term does not include foods that are naturally low in protein, such as some fruits or vegetables. Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended— by striking and before (HH); and by inserting before the semicolon at the end the following: and (II) 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.. 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. Section 1905(a) of the Social Security Act (42 U.S.C. 1396d(a)) is amended— in paragraph (31), by striking and at the end; by redesignating paragraph (32) as paragraph (33); and by inserting after paragraph (31) the following new paragraph: 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 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 (32). Section 1903(i)(27) of the Social Security Act (42 U.S.C. 1396b(i)(27)) is amended— by inserting or for equipment and supplies described in section 1905(a)(32), after 2018,; and by striking such items each place such phrase appears and inserting such items, equipment, or supplies. 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: 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. 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. 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. 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: 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. 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 (13). 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. 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. Section 8902 of title 5, United States Code, is amended by adding at the end the following: 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. 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. It is the sense of Congress that— medically necessary food (as defined in subsection (nnn) of section 1861 of the Social Security Act (42 U.S.C. 1395x), as added by subsection (a)(2)) can be life-sustaining and life-saving; and all health plans, including private health plans offered by health insurance issuers, should provide coverage of, and access to, medically necessary food (as so defined) for individuals with certain digestive and metabolic disorders and conditions, when prescribed or ordered by a physician, physician assistant, nurse practitioner, or other health care practitioner, in a manner similar to the required coverage of medically necessary food for such individuals under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), the State Children’s Health Insurance Program under title XXI of the Social Security Act (42 U.S.C. 1397aa et seq.), and chapter 89 or title 5, United States Code, as amended by subsections (a), (b), (c), and (d), respectively. 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 (nnn) of section 1861 of the Social Security Act, as added by subsection (a)) that exceeds the requirements for coverage under such provisions and amendments. Nothing in the provisions of, or the amendments made by, this section shall limit coverage of a medically necessary food (as defined in subsection (nnn) 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. (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;. (nnn)Medically Necessary Food (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, including vitamins and amino acids, 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)Conditions included on the Recommended Uniform Screening Panel Conditions list of the Department of Health and Human Services. (ii)Organic acid conditions. (iii)Fatty acid oxidation disorders. (iv)Amino acid disorders. (v)Urea cycle disorders. (vi)Glycogen storage disorders. (vii)Biotinidase deficiency. (viii)Guanidinoacetate methyltransferase deficiency. (ix)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. (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.. (32)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. (9)Medically necessary foodNotwithstanding 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.. (13)Medically necessary foodThe 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.. (q)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..