Date:  

To Whom It May Concern:

I am requesting insurance coverage and reimbursement for my patient (NAME) (D.O.B.), for whom I have prescribed the use of Neocate One + formula, which is manufactured by Nutricia North America.

Neocate is specifically designed to meet the nutritional needs of children ages 1-10 with severe cow milk protein or multiple food protein allergies who are unable to ingest a normal diet or other hypoallergenic products. (Nutramigen, Alimentum or Pregestimil) My patient has failed to tolerate cow’s milk, soy based and/or protein hydrolysate formulas.  

The unique formulation (100% free amino acids, milk free, gluten free, and soy protein free) provides complete nutrition and may be the sole source of nutrition for this patient, and may continue to be used for the next year of life. The elemental composition, which requires minimal digestion, is ideally suited for patients with compromised gastrointestinal function. The formula dilution depends on the age, body weight, and medical condition as prescribed by myself.
 
Neocate One+ formula is medically necessary for (NAME) and will provide the proper nutrition management for this patient. Without the use of an elemental formula, my patient may experience more complications of these conditions, which can result in hospitalization and/or costly parenteral nutrition.

(Patient’s Name) has been diagnosed with one or more of the following:

Diagnosis	ICD – 9 Code
□  bloody stool(s)	578.1
□  multiple food protein allergy	558.3
□  atopic dermatitis due to food allergy	693.1
□  allergic rhinitis due to food allergy	477.1
□  gastroesophageal reflux disease	530.81
□  malabsorption	271.3
□  failure to thrive/underweight	783.22
□  eosinophilic esophagitis	530.19
□  eosinophilic enteropathy	569.9

(Patient’s Name) present weight is __________kg and height is __________cm. He/She will require ____________ kcal/____________ounces per day. This amount may be adjusted as his/her nutritional needs change. Presently, (NAME) will be taking Neocate orally, however if he/she is unable to consume enough formula to meet the nutritional requirement for proper growth and development, we may consider alternate feeding methods, such as a feeding tube.

Clinical trials have shown that the use of Neocate promotes normal growth patterns in children who may otherwise experience failure to thrive. Neocate is not a drug, but the FDA classifies Neocate One + as a medical food which must be used under medical supervision and is not sold over the counter or at the retail level. Therefore, Neocate is only available through a pharmacy or through Nutricia North America directly (with medical consent). Neocate is classified under Category III (hydrolyzed protein/amino acid).

 I am prescribing one of the following:

Neocate One+: Product code: 11048, Medicare (HCPCS) code: B4161, Reimbursement code (NDC): 49735-0110-48.

In the future, because of the close medical supervision required with the use of an elemental formula,  (NAME) will need active and ongoing medical supervision to observe his/her growth and development and evaluate his/her dietary requirements. 

Your approval of this request for assistance with medical care and reimbursement of the formula would have a significant impact on this patient’s health.

Sincerely,

(PRESCRIBING DOCTOR’S NAME), M.D.

Cc: Current Growth Chart, Letter of Dictation, Reports, Prescription