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 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 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. (6) 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. (7) 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. (8) 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.