Appeal type: Medical necessity
Decision: Overturned

Diagnosis: failure to thrive, cow's milk protein allergy

Treatment B4160 [enteral formula for pediatrics] Kates Farms Peptide 1.2

The insurer denied coverage for B4160 Kates Farms Peptide 1.2

The denial is overturned

The patient is a male with a history of Down's syndrome, failure to thrive, cow's milk protein allergy, suspected Crohn's disease, anemia, patent foramen ovale, small ASD [atrial septal defect], aortic regurgitation, elevated right ventricular pressure, and obstructive sleep apnea status post tonsillectomy/adenoidectomy that has been managed on a restricted diet, probiotics and Remicade. He avoids dairy, gluten, citrus, processed foods, high calorie foods with added sugar and foods high in fiber. To supplement his oral intake and to mitigate his inflammatory bowel disease his treatment team and parents are requesting approval for Kate Farms Peptide 1.2 as medically necessary to treat his limited growth and inflammatory bowel disease.  Early attempts in infancy using complete nutritional formulas had failed. No reference is made to recently tried alternatives. His current height and weight are below standards. Weight trends have shown progressive weight gain on the requested formula and oral table foods.

In regards to his Crohn's diagnosis he had the following supportive studies:

. Colonoscopy that showed focal mild acute inflammation of the terminial ileum and regionally within the colon.
. stool calprotectin 1301
. Remicade infusions 
. C-Reactive Protein  43.83,  erythrocyte sedimentation rate 8

This patient suffers from poor weight gain in the setting of a restricted diet to address possible cow's milk protein allergy and/or inflammatory bowel disease (suspected Crohn's disease [CD]). Although growth trends have shown steady gain, he has been receiving both oral solids as well as 2-3 cans of formula per day. He plots on the Down's syndrome boy's growth chart (see attached pdf) between the 5th-10th percentile for age.
 
According to a review of the overall management of inflammatory bowel disease in children and adolescents from UptoDate the following points regarding nutritional management are made: "NUTRITIONAL THERAPY

Nutritional therapy has three distinct applications in the treatment of CD:

. Exclusive enteral nutrition (EEN) - Providing all nutritional needs through a liquid formula (EEN or primary nutritional therapy) can promote mucosal healing in a patient with active disease and suppress intestinal inflammation, possibly by altering the gut microflora. In this context, nutritional therapy is used as an alternative or supplement to antiinflammatory medications. Nutritional therapy may be particularly useful in motivated children and families who wish to avoid corticosteroids.

. Supplemental enteral nutrition - Enteral nutrition can also be used as a supplement to increase energy and nutrient intake and promote growth in a patient with growth failure while the patient continues to take food orally. Supplemental enteral nutrition may also maintain remission by suppressing intestinal inflammation.

. Micronutrient deficiencies - Children with CD are at risk for micronutrient deficiencies due to inadequate food intake and malabsorption, including deficiencies of iron, vitamin B12 [cobalamin], and zinc. Optimal care includes routine monitoring for these deficiencies and replacement as needed. Assurance of adequate intake of calcium and vitamin D [fat-soluble secosteroids] are particularly important to minimize risks of osteopenia and osteoporosis.
 
Partial enteral nutrition with specific exclusion diet - One study suggests that the combination of partial enteral nutrition (PEN) with a specific whole foods-based exclusion diet (CD exclusion diet [CDED]) is more easily accepted by patients than EEN and is at least as effective in inducing remission. In a randomized multinational trial of 74 children with CD, children were treated with 12 weeks of either PEN plus CDED (two six-week phases), or EEN for six weeks transitioning to PEN plus a free diet. Those treated with PEN plus the CDED were more likely to complete six weeks of therapy (98 versus 74 percent) and had similar rates of corticosteroid-free remission (80 versus 74 percent). Since this reflects an intention to treat analysis, the performance of the PEN plus the CDED is likely related to better acceptance with fewer dropouts from that group compared with EEN. The CDED used in this study consists of fruits, vegetables, and selected grains and limits exposure to other foods and food additives purported to induce intestinal dysbiosis (including animal fats, dairy, and gluten)."
 
The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for B4160 Kates Farms Peptide 1.2 is overturned. Medical Necessity is substantiated.