Benefits for Prescription or Over-the-Counter Formula

Benefits for prescription or over-the-counter formula are available when a Physician issues a prescription or written order stating the formula or product is Medically Necessary for the therapeutic treatment of a condition requiring specialized nutrients and specifying the quantity and the duration of the prescription or order. The formula or product must be administered under the direction of a Physician or registered dietitian.

The member will be able to order one month’s supply at a time unless otherwise noted below

Clinical Guideline Coverage Criteria

Oral Administration

The Plan may cover oral enteral nutrition as medically necessary when member requires management of a specific condition, disease, and/or is at risk for developing malnutrition and meets ALL of the following:

1. The medical formula or enteral nutrition is expected to provide more than 50% of the individual’s daily nutritional intake, AND
2. The individual is under the supervision of a healthcare provider who is authorized to prescribe such dietary treatments, AND
3. Medical conditions related to interferences with nutrient absorption and assimilation and associated with one of the following:
   • Inborn errors of metabolism
     • Tyrosinemia
     • Homocystinuria
     • Maple syrup urine disease
     • Propionic acidemia
     • Methylmalonic acidemia
     • Urea cycle disorders
     • Phenylketonuria (PKU)
     • Other organic acidemias
   • Malabsorption resulting from one of the following conditions,
     • Crohn’s disease
     • Ulcerative colitis
     • Gastrointestinal dysmotility
     • Gastroesophageal reflux (GERD)
     • Chronic intestinal pseudo-obstruction
     • Inherited diseases of amino acids and organic acids
     • Cystic fibrosis
   • Allergy or hypersensitivity to cow or soy milk diagnosed through a formal food challenge
   • Allergy to specific foods including food-induced anaphylaxis
   • Diarrhea or vomiting resulting in clinically significant dehydration requiring treatment by a medical provider
   • Prematurity (authorized up to three months post-hospital discharge) when one of the following is met:
     • Specialized oral formula may be authorized for six months for members born at less than or equal to 35 completed weeks of gestation.
     • Specialized oral formula may be authorized for three months for members born at more than 35 weeks and less than or equal to 37 weeks gestation with one of the following:
       • A hospital discharge weight below the 10th percentile for age
       • Unable to tolerate cow milk-based formula (soy-based formula trial not required)
   • Note: Authorization past 3- or 6-months post-hospital discharge will be based on meeting the criteria for one of the conditions listed below
   • Gastroesophageal Reflux Disease Associated with either weight loss, lack of weight gain, severe or bloody regurgitation may be authorized based on the following:
     • Special formula may be authorized up to 9 months of age: a failed trial of cow-milk or soy- based formulas required
     • Re-authorization from 9-12 months of age: a failed trial of cow-milk or soy-based formulas required
     • Re-authorization over one year of life: A letter of medical necessity from the treating Gastroenterologist is required, which documents ongoing medical necessity of formula, any attempts to wean from formula, and the treatment plan.
   • Infant Formula Intolerance:
     • Protein hydrolysate formulas may be authorized for members from two (2) weeks to one (1) year of age who exhibit one of the following:
       • Symptoms of IgE-associated formula intolerance including angioedema, wheezing, rhinitis, urticaria, vomiting, eczema, and anaphylaxis
       • Conditions including hemosiderosis, malabsorption with villous atrophy, eosinophilic proctocolitis, enterocolitis, esophagitis, and colic

Amino Acid Preparations

Amino acid preparations may be authorized from age two (2) weeks to one (1) year of age for those members exhibiting any of the signs/symptoms noted above AND experienced a failed trial of protein hydrolysate formula.

Special Formula

1. Special Formula may be authorized for infants older than One Year when all of the following are met:
2. Consideration of a retrial of both cow-milk based foods/formulas and soy-based formula
3. A nutritionist consult including calorie counts
4. A consult with a pediatric allergist and/or gastroenterologist documenting the continued indication for special formula

Note: Authorizations subsequent to one (1) year of age will be for no more than six (6) month intervals.

Growth Failure

The Plan may authorize supplemental formulas or caloric supplements for members with growth failure when all the following criteria are met:

1. The member’s weight from a submitted growth chart is less than 75% of the median weight for age and gender (to calculate, divide the member’s weight by the average weight for age)
2. A complete evaluation has been performed to rule out medical causes of the growth failure. (e.g., GERD, malabsorption, heart disease, parasites, adenoid hypertrophy, cystic fibrosis, diabetes mellitus, immunodeficiency). This evaluation should include a detailed dietary history to ensure that the formula is properly diluted and/or the member is receiving adequate calories
3. The member must have failed other more basic forms of caloric supplementation (e.g., Carnation Instant Breakfast, addition of butter or cream to prepared foods, etc.)

Tube Administration

The Plan considers tube administration of medical formulas and enteral nutrition as medically necessary when the member meets oral administration criteria, with the exception of food type, provides justification for insufficiency of oral method, confirms the necessity for a tube, and meets ALL the following criteria:

1. The medical formula or enteral nutrition is expected to provide more than 50% of the individual’s daily nutritional intake; and
2. The member experiences difficulty swallowing due to a medical condition (e.g., tumors, neurological conditions, severe chronic anorexia nervosa) OR is associated with obstruction of the GI tract proximally and is unable to maintain weight and nutrition with oral administration; and
3. The individual is under the supervision of a healthcare provider who is authorized to prescribe such dietary treatments.

Covered Conditions

• Atopic Dermatitis
• Presence of Bloody stool with or without weight loss or other GI symptoms
• Eosinophilic Esophagitis
• Eosinophilic Gastroenteritis
• Failure to Thrive
• Gastroesophageal Reflux Disease (GERD)
• GI Irritability
• IgE Mediated Food Allergy
• Inborn Error of Metabolism:
  • Phenylketonuria (PKU)
  • Tyrosinemia
  • Homocystinuria
  • Maple Syrup Urine Disease
  • Propionic Acidemia
  • Other Organic Acidemia
  • Urea Cycle Disorders
• Uncontrolled Seizures using Ketogenic Formula
• Malabsorption
  • Crohn’s Disease
  • Ulcerative Colitis
  • Gastrointestinal Motility Disorders

Chronic Intestinal Pseudo Obstruction

• Cystic Fibrosis
• Prematurity

Note: Medical Formula or enteral nutrition (for diets requiring less than 50% for individuals daily nutritional intake) may be considered medically necessary in patients with the inability to maintain body weight and nutritional status prior to initiating or after discontinuing use of enteral supplements.

Note: Covered formulas include hypoallergenic (protein hydrolysate) formulas, transitional formulas for premature infants, extensively hydrolyzed formulas, amino acid-based formulas, ketogenic formulas, specific metabolic formulas and special medical formulas that are medically necessary to treat specific medical conditions.

Note: Food or nutritional supplements, including, but not limited to, FDA-approved medical foods obtained by prescription, as required by law and prescribed for members who meet HPHC policies for enteral tube feedings are considered medically necessary (Exclusions list applies).

Digestive Enzyme Cartridge (RELiZORB™)

RELiZORB™ is a digestive enzyme cartridge that contains the enzyme lipase. It is considered a first of its kind enzyme cartridge designed to mimic the action of pancreatic lipase for use in adults and children (ages 5 years and above) receiving enteral tube feedings. By hydrolyzing (digesting) fats from enteral formulas, RELiZORBTM allows for the delivery of absorbable fatty acids and monoglycerides to patients. This treatment can aid in normalization of fat absorption, improve symptoms commonly associated with fat malabsorption and enhance nutritional status in patients with cystic fibrosis receiving enteral feedings.

2- Digestive Enzyme Cartridge

The Plan may authorize coverage for RELiZORBTM when enteral nutrition is considered medically necessary, as evidenced by the above criteria and the following criteria are met:

1. Member meets age requirements:
   • In adults (≥ 18 years of age) and children (≥ 5 years of age)
2. Member has a diagnosis of Cystic Fibrosis
3. Body Mass Index (BMI) less than 50 percentile for the past 6 months on prescribed enteral nutrition via tubefeeding

Note: Initial authorization will be approved for 6 months

Reauthorization requests may be approved in up to 12-month intervals when the following criteria are met:

1. Member is continuing on enteral tube feedings
2. Documentation of no decrease in BMI, while maintained on enteral feedings and RELiZORBTM digestive enzyme cartridge therapy

Limitations

1. Infant formulas for indications not listed above, or when a medical history or physical examination has not been completed, and/or there is no documentation that supports the need for enteral nutrition products.
2. Special medical formulas and enteral nutrition solely for food preference
3. Nutritional and/or food supplements (e.g., Boost and Ensure)
4. Standard over-the-counter commercial formulas (cow and soy milk based) for members without GI disorders including, but not limited to: Similac, Similac Advance, Enfamil, Lipil, Enfamil Gentlease Lipil, Lacto Free, Parent's Choice and Carnation Good Start, Isomil, Prosobee, Similac Soy or Carnation Soy
5. Formula or food products used for dieting, or a weight-loss program
6. Banked breast milk
7. Food for a ketogenic diet when dietary needs can be met with regular, store-bought food
8. Dietary or food supplements, including fortifiers (e.g., Duocal, Benecalorie®)
9. Food thickeners
10. Supplemental high protein powders and mixes
11. Lactose free foods, or products that aid in lactose digestion
12. Gluten-free products
13. Baby foods
14. Oral vitamins and minerals
15. Oral Formula and Enteral Nutrition
16. Medical foods (e.g., Foltx, Metanx, Cerefolin, probiotics such as VSL#3) including FDA-approved medical foods obtained with or without prescription
17. Enteral electrolyte hydration fluids