Medical Policy: 10.01.15
Original Effective Date: May 2010
Reviewed: June 2018
Revised: June 2018
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
The U.S. Food and Drug Administration (FDA) defines a medical food in the Orphan Drug Amendment as a food which is formulated to be consumed or administered under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
In 1994, the American Academy of Pediatrics Committee on Nutrition issued its recommendations on reimbursement for medical foods for inborn errors of metabolism. In-born errors of metabolism are a group of rare disorders resulting in the excessive accumulation of an amino acid or other product along the metabolic pathway for lack of a natural enzyme required to digest certain foods. Manifestations of these disorders generally include central nervous system dysfunction, developmental delay, seizures and liver dysfunction.
The clinical manifestations in many of these disorders can be prevented if diagnosis is achieved early and necessary treatment with dietary protein or amino acid restriction is instituted immediately. These disorders are named for the accumulating amino acid and include, but are not limited to, phenylketonuria (PKU), maple syrup urine disease, citrullinemia, cystinosis, homocystinuria, methylmalonic acidemia, propionic acidemia, isovaleric acidemia type I, tyrosinemia types I and II, and urea cycle disorders.
Treatment might include restriction of specific amino acids, restriction of total nitrogen intake, or supplementation of certain substances. For some of the inborn errors of metabolism, special formulas and medical foods have been developed which eliminate the amino acid that cannot be metabolized from the protein context of the food. As adults, they must avoid certain foods as well. Geno typical women with classic PKU desiring pregnancy need to alter their diet by using a special maternal dietary supplement low in phenylalanine. The use of this supplement reduces the risk of severe retardation in the infant of a mother with PKU.
Inborn errors of metabolism (IEM) are inherited genetic disorders that interfere with specific metabolic pathways. These interferences may result in either a deficiency or excess of a particular product. There are three major categories of IEMs: protein disorders, fatty acid oxidation disorders, and carbohydrate disorders. Special food products are required to treat inborn errors of metabolism in order to avoid long-term complications which can result in mental retardation, seizures, coma or death.& Inborne errors of metabolism are considered present at birth and permanent.
Examples of an inherited metabolic disorder (inborn errors of metabolism) include, but are not limited to:
Individuals with inborn errors of metabolism require "exempt" specialized metabolic infant formulas. The FDA has requirements for the minimum and maximum amount of nutrients in infant formulas; if these requirements are not met, the infant formula may be "exempt" from these nutrient requirements. "An exempt infant formula is any infant formula which is represented and labeled for use by an infant who has an inborn error of metabolism (IEM), or low birth weight, or who otherwise has an unusual medical or dietary problem." Exempt amino acid-based metabolic formulas require a prescription. Examples include:
Food allergies are not considered an inborn error of metabolism.
Medical Foods can be classified into the following categories:
Food products are not considered medical food items, regardless of their intended use. Food products include food thickeners, baby food, gluten-free food products, high protein powders and mixes, low carbohydrate diets, grocery items, nutritional supplement puddings, weight-loss foods and formula, grocery items that are used in specialized diets or have been modified for a special nutritional need or other regular grocery products that can be mixed in blenders and used with an enteral system regardless of whether these regular food products are taken orally or parenterally.
Relizorb™ immobilized lipase cartridge was recently approved for in-line use to include digestive enzymes into the enteral feeding. It is designed to mimic the action of pancreatic lipase for use in adults receiving enteral tube feedings. Large studies with human subjects are not available.
Not applicable
Medical foods are not considered a covered benefit for any other diagnosis than inborne errors of metabolism which are present at birth, and permanent in nature.
Conditions associated with an inborn error of metabolism interfere with the metabolism of specific nutrients. Examples of an inherited metabolic disorder (inborn errors of metabolism) include, but are not limited to:
There are currently no medical food requirements for mitochondrial disease that averts the development of serious physical or mental disabilities or promotes normal development or function. The use in this condition is not considered a covered benefit.
The purchase of food and formula that is modified for special diets is not considered a medical food. This includes low protein/low phe groceries and over the counter formula. The coverage of over the counter foods are not considered a covered benefit.
Medical foods for conditions other than permanent inborne errors of metabolism, including but not limited to the following products and conditions, are not considered a covered benefit:
Oral enteral nutrition is considered not a covered benefit when the criteria above have not been met.
Digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding is considered investigational (eg, Relizorb™ immobilized lipase cartridge). Efficacy and necessity has not been shown in current literature.
For further information on medical formula, please refer to policy 01.02.01 Enteral Nutrition and Oral Formula.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.