This document addresses “medical food” or commercially available processed enteral products (please see the Definitions section for further information regarding medical food) when used in the home to meet basic metabolic needs in a variety of conditions affecting either the mechanical or metabolic process of digestion. Enteral nutrition consists of nutritional support given via the gastrointestinal (GI) tract, either directly or through any of a variety of tubes used in specific medical circumstances. This includes oral feeding, sip feeding, and tube feeding using nasogastric, gastrostomy, jejunostomy, or other tubes. This document does not address standard food (not for medical purposes), although it is technically an enteral nutritional product.

Note: Some benefit plans exclude products available without prescription, sometimes referred to as ‘over the counter’, even when prescribed by a physician or other healthcare provider. Enteral food products are often available without prescription. Please see the text in the footnote of this document regarding Federal and State mandates and contract language, as these documents often specifically address the topic of enteral nutrition.

Note: For criteria related to Relizorb^™, refer to applicable guidelines used by the plan.

Note: Please see the following related document for additional information:

• CG-MED-37 Intensive Programs for Pediatric Feeding Disorders

Clinical Indications

I. Oral Enteral Nutrition

Medically Necessary:

Oral enteral nutrition (oral feeding) is considered medically necessary when all of the following criteria are met:

1. The product must be a medical food for oral feeding; and
2. The product is the primary source of nutrition (that is, constitutes more than 50 percent of the intake for the individual); and
3. The product must be labeled and used for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements to avert the development of serious physical or mental disabilities or to promote normal development or function as listed in 1. or 2. below:
   1. Conditions associated with an in-born error of metabolism that interfere with the metabolism of specific nutrients, including, but not limited to:
      1. Phenylketonuria (PKU); or
      2. Homocystinuria; or
      3. Methylmalonic acidemia; or
   2. Conditions that interfere with nutrient absorption and assimilation, including, but not limited to:
      1. Allergy or hypersensitivity to cow or soy milk diagnosed through a formal food challenge; or
      2. Allergy to specific foods including food-induced anaphylaxis; or
      3. Allergic or eosinophilic enteritis (colitis/proctitis, esophagitis, gastroenteritis); or
      4. Cystic fibrosis with malabsorption; or
      5. Diarrhea or vomiting resulting in clinically significant dehydration requiring treatment by a medical provider; or
      6. Malabsorption unresponsive to standard age appropriate interventions when associated with failure to gain weight or meet established growth expectations; or
      7. Failure to thrive unresponsive to standard age appropriate interventions (for example, nutritionally complete liquid meal supplements) when associated with weight loss, failure to gain weight or to meet established growth expectations, including but not limited to:
         1. Premature infants who have not achieved the 25^th percentile for weight based on their corrected age; or
         2. Individuals with end-stage renal disease and an albumin less than 4 gm/dl; and
4. The product must be used under the supervision of a physician or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments.

Oral enteral nutrition is considered medically necessary when the diet consists of less than 50 percent enteral nutrition and more than 50 percent standard diet for age when:

1. The enteral product is used as part of a defined and limited plan of care in transition from a diet of more than 50 percent enteral products to standard diet for age; or
2. Medical records document a medical basis for the inability to maintain appropriate body weight and nutritional status prior to initiating or after discontinuing use of an enteral supplement as well as ongoing evidence of response to the enteral nutrition.

Not Medically Necessary:

Oral enteral nutrition is considered not medically necessary when the criteria above have not been met.

Oral enteral nutrition is considered not medically necessary when use of a product is based on the convenience or preference of the individual or provider.

II. Enteral Nutrition Via Tube

Medically Necessary:

Enteral nutrition via tube feeding is considered medically necessary when all of the following criteria are met:

1. Enteral nutrition comprises the majority (greater than 50 percent) of the diet; and
   1. The product is used under the supervision of a physician or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments; and
   2. Nutrients cannot be ingested orally due to a medical condition which either:
      1. Interferes with swallowing (for example, dysphagia from a neurological condition, severe chronic anorexia nervosa unable to maintain weight and nutritional status with oral nutrition); or
      2. Is associated with obstruction of the proximal GI tract (for example, tumor of the esophagus).
2. Enteral nutrition via tube is considered medically necessary when:
   1. The diet consists of less than 50 percent enteral nutrition and more than 50 percent standard diet for age; and
   2. When all of the following criteria are met:
      1. The product is used under the supervision of a physician or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments; and
      2. The enteral product is used, as part of a defined and limited plan of care in transition from a diet of more than 50 percent enteral products to standard diet for age; and
      3. Medical records document a medical basis for the inability to maintain appropriate body weight and nutritional status prior to initiating or after discontinuing use of an enteral supplement as well as ongoing evidence of response to the enteral nutrition.

Not Medically Necessary:

Enteral nutrition via tube is considered not medically necessary the criteria above have not been met .

III. Other Considerations

Not Medically Necessary:

The use of formulas and other food products is considered not medically necessary when the criteria above have not been met including, but not limited to:

1. Used primarily for convenience or for features which exceed that which is medically necessary (for example, pre-packaged, liquid vs. powder, etc.).
2. When used for individuals with disorders of swallowing where non-medical food is tolerated.

Continuation of home enteral nutrition, regardless of route of administration, is considered not medically necessary when documentation demonstrates the applicable medical necessity criteria above are no longer met.