Medical Food / Enteral Nutrition - Medical Necessity Criteria
Criteria for documenting medical necessity of enteral nutrition (via tube feeding) and medical food given orally
Contents:
- What is medical food?
- What is enteral nutrition?
- Do health plans cover medical food, enteral nutrition, nutritional support, nutritional treatment, or nutritional therapy?
- When is enteral nutrition via tube medically necessary?
- When is medical food for oral feeding considered medically necessary?
- General criteria for considering enteral nutrition (oral/tube) medically necessary
- Is enteral nutrition covered by Medicare?
- What nutritional products are not covered by insurance?
- Documentation to submit
- Health plan criteria for medical food / enteral nutrition and other references
What is medical food?
Medical food is food that is specially formulated and processed to meet the distinctive nutritional requirements of a disease or condition. It must be consumed or administered enterally (through oral or tube feeding), it must be used under medical supervision, and it must be “specially formulated and processed” (as opposed to food that is in its naturally occurring state).
What is enteral nutrition?
In its broadest sense, enteral nutrition or enteral feeding refers to intake of food through the gastrointestinal (GI) tract. This is as opposed to intake of nutrients through other routes like the veins (parenteral nutrition). In this broad sense, enteral nutrition includes taking in food through the mouth (oral feeding) as well as administering food through a tube directly to the stomach or small intestine (tube feeding).
In medical settings, the term “enteral nutrition” usually refers to tube feeding.
Do health plans cover medical food, enteral nutrition, nutritional support, nutritional treatment, or nutritional therapy?
Health plans vary widely in their coverage of food products. Some health plans cover medical food when it is deemed to be medically necessary for a patient with a particular condition, regardless of whether it is given orally or through a tube. Other health plans cover oral nutrition only when it is mandated by the state. Some health plans cover food products (like formula) only up to a certain age when medically necessary, while others do not specify an age limit.
Health plans even vary in the terms that they use to state what they do or don’t cover, so make sure you check how they define their terms; for example, whether they use “enteral nutrition” to mean only tube feeding or also oral feeding.
When is enteral nutrition via tube medically necessary?
Enteral nutrition that is administered via tube feeding is considered medically necessary when the patient has a medical condition that either interferes with swallowing, obstructs the proximal GI tract, or otherwise makes it necessary to deliver nutrients straight to the patient’s stomach or small intestine. The general criteria for considering enteral nutrition medically necessary (below) must also be met.
Conditions for which enteral nutrition MAY be considered medically necessary include, but are not limited to, the following:
- Conditions that interfere with the ability to chew or swallow, such as:
- Jaw fracture
- Severe dysphagia after a stroke
- Anatomic defects or obstruction that prevents food from reaching the small intestine, such as:
- Obstruction caused by head or neck cancer
- Tumor/stricture of the esophagus or stomach
- Ulcer diathesis that causes obstruction of the gastric outlet
- Gastrointestinal cancer
- Intestinal atresia
- Intestinal disease that impairs digestion or absorption of an oral diet, such as:
- Allergic colitis and other allergic enteropathy
- Crohn’s disease (when absorption problems require the prolonged infusion of enteral nutrients)
- Food allergies that will cause severe morbidity or mortality if left untreated
- Gastroesophageal reflux with failure to thrive
- Gastrointestinal dysmotility
- Granulomatous colitis
- Hyperemesis gravidarum
- Intestinal malabsorption syndrome (when the formula is the sole or an essential source of nutrition)
- Ischemic bowel disease (when there has been massive bowel resection)
- Pancreatitis (when severe)
- Short bowel syndromes (under certain conditions)
- Ulcerative colitis (acute)
- Other conditions:
- Increased nutritional needs that cannot be met thru oral intake
- Severe chronic anorexia nervosa
When is medical food for oral feeding considered medically necessary?
Medical food for oral enteral nutrition MAY be considered medically necessary for patients who have inborn errors of metabolism or other medical disorders with distinctive nutritional requirements where failure to give nutritional therapy will result in malnutrition, disability, or death. The general criteria for considering enteral nutrition medically necessary (below) must also be met.
Conditions for which medical food given orally MAY be considered medically necessary include, but are not limited to, the following:
- Citrullinemia
- Cystic fibrosis
- Cystinosis
- Eosinophilic gastrointestinal disorders diagnosed by biopsy
- Fatty acid oxidation disorders
- Food protein induced enterocolitis syndrome
- Galactosemia
- Glycogen storage diseases
- Hereditary fructose intolerance
- Histidinemia
- Homocystinuria
- IgE and non-IgE mediated allergies to multiple food proteins
- Maple syrup urine disease (MSUD)
- Organic acidemias
- Phenylketonuria (PKU)
- Tyrosinemia
- Urea cycle defects
Note: Some health plans cover medical food for oral feeding only when mandated by state law.
General criteria for considering enteral nutrition (oral/tube) medically necessary
- The nutritional product must be the primary source of nutrition for the patient.
- The nutritional product must have been prescribed by the patient’s attending physician or other health care professional authorized to prescribe dietary treatments.
- The condition for which the nutritional product is being prescribed has persisted, or is expected to persist, for at least three months.
- Mere adjustment of the patient’s regular diet will not provide adequate nutrition.
Is enteral nutrition covered by Medicare?
Medicare covers enteral nutrition — that is, food delivered through nasogastric, jejunostomy, or gastrostomy, or other tubes — in patients who cannot be sustained through oral feeding because of a long-term impairment in the structures that normally permit food to reach their digestive tract.
* Long-term – Since coverage of nutritional therapy is under Medicare’s prosthetic device benefit provision, the impairment in the gastrointestinal tract must have been judged by the patient’s attending physician to be of a long and indefinite — though not necessarily permanent or lifetime — duration.
Medicare does not cover:
- Orally administered enteral nutrition products
- Enteral nutrition for temporary impairments
- Food thickeners, baby food, and other regular grocery products
- Self-blenderized formulas
- Electrolyte-containing fluids
What nutritional products are not covered by insurance?
These products are generally not covered by most, if not all, health plans:
- Baby food
- Banked breast milk
- Breast milk additive (when given orally)
- Dietary additives
- Encala mixable powder to increase fat absorptionFood supplements
- Food thickeners
- Gluten-free food products
- Grocery items
- Infant formula (when given orally)
- Lactose-free products
- Low carbohydrate diets
- Nutritional supplement puddings
- Oral rehydration therapy (ORT)
- Over-the-counter nutritional items
- Probiotic supplements
- Protein powders and mixes
- Self-blenderized formulas
- Vitamins and/or minerals (when taken/given orally)
- Weight-loss products
Documentation to submit
These are the things you can prepare documentation of in order to support your statement that medical food/enteral nutrition is medically necessary. Submit only those that apply.
Health plan criteria for medical food / enteral nutrition and other references
- ActiveHealth Management Policy on Enteral Tube Feedings
- Aetna Clinical Policy Bulletin on Nutritional Support
- Anthem Blue Cross Blue Shield Clinical UM Guideline on Home Enteral Nutrition
- Blue Cross Blue Shield of Michigan Medical Policy on Enteral Nutrition
- Blue Cross Blue Shield of North Carolina Corporate Medical Policy on Enteral Nutrition
- Blue Cross Blue Shield of Rhode Island Medical Coverage Policy on Enteral/Parenteral Nutrition Therapy
- Cigna Medical Coverage Policy on Nutritional Support
- Coordinated Care of Washington Clinical Policy on Oral Enteral Nutrition
- Food and Drug Administration (FDA) Guidance for Industry: Frequently Asked Questions About Medical Foods
- Geisinger Health Plan Medical Benefit Policy on Nutritional Supplements
- Harvard Pilgrim Health Care Medical Policy on Formulas and Enteral Nutrition
- Health Net Clinical Policy on Nutritional Supplementation Therapy
- Johns Hopkins HealthCare Medical Policy on Nutritional Treatment – Medically Necessary Food
- MassHealth Guidelines for Medical Necessity Determination for Enteral Nutrition and Special Medical Formulas
- Medicare Local Coverage Article
- Medicare Local Coverage Determination
- Medicare National Coverage Determination
- Medicare National Coverage Determinations Manual
- Northwood Medical Policy on Enteral Nutrition
- Ohio Medicaid Medical Policy Statement on Nutritional Supplements
- Paramount Healthcare Policy on Enteral and Parenteral Nutrition
- Premera Blue Cross Benefit Coverage Guideline on Home Nutritional Support
- Superior HealthPlan Clinical Policy on Enteral Nutrition
- Tufts Health Plan Medical Necessity Guidelines on Enteral Nutrition, Digestive Enzyme Cartridges and Special Medical Formulas