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. 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