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DATE Via Facsimile to ________ NAME OF INSURANCE COMPANY ADDRESS Re: DEEMBED MEDICAL NECESSITY Subscriber’s Name: ________________ Group Number: __________________ ID Number: ____________ DOB: ___________ Patient Name and DOB: ___________________ Dear Sir or Madam: This is an appeal to the written denial we received from _______ with regard to the referenced patient (copy attached). We are writing to explain that ____ has Gastroesophageal Reflux Disease (ICD – 9 Code 530.81), and has not been able to tolerate any formula other than Neocate. We tried every type of formula on the market, but she was unable to digest all the other formulas (Similac Soy, Similac Alimentum, etc.) and therefore screamed in pain for 2 to 3 hours immediately after every feeding. She was also prescribed Zantac and Prevacid by her Pediatrician but neither worked. After beginning Neocate, her digestive system settled down, she began to have normal bowel movements, and the screaming stopped (with no medication). She is now a healthy, happy infant and growing strong. This is why Neocate is her sole source of nutrition at this time. Neocate formula is unique in that it is the only formula available in The United States that is not plant or animal protein based. Neocate Infant formula is an amino acid based nutritionally complete elemental formula. It is specifically designed to meet the nutritional needs of children from newborn to one year who are unable to digest a normal diet or other hypoallergenic products. Neocate is formulated with 100% free amino acids. It is milk free, gluten free, and soy protein free. It provides complete nutrition, and is _____’s sole source of nutrition. Please see the below Texas House Bill: Texas Bill Name: HB 2000 Effective date of the law: January 2010 Your coverage: Insurance reimbursement of amino acid-based formula for children diagnosed by a physical with milk protein allergy, eosinophilic esophagitis (EoE), short bowel syndrome (SBS) and enterocolitis. Insurance covers formula administered orally or by a feeding tube. Page 1 of 3 Product Neocate Infant DHA and ARA Nutricia Item 12595 Pediatric GI/Allergy NDC Reimbursement Code 49735-0125-95 Diagnosis Gastroesophageal reflux disease HCPCS Code B4161 ICD – 9 Code 530.81 Cause of acid reflux: At the entrance to your stomach is a valve, which is a ring of muscle, called the lower esophageal sphincter (LES). Normally, the LES closes as soon as food passes through it. If the LES does not close all the way or if it opens too often, acid produced by your stomach can move up into your esophagus. This causes the symptom known as acid reflux disease, also known as gastroesophageal reflux disease (GERD). Source: WebMD Attached please find two letters from ____’s pediatrician with regard to the necessity of her being on Neocate formula. Neocate formula is “to be used under the direction of a physician.” Neocate is not a drug, but is classified by the FDA as a “medical food,” which requires usage under strict medical supervision. Please see the below from the Food and Drug Administration: Exempt Infant Formula: Food and Drug Administration, HHS 21 CFR Ch. 1 (4-1-97 Edition) § 107.50 (c) Infant formulas not generally available at the retail level. (1) These exempt infant formulas are not generally found on retail shelves for general consumer purchase. Such formulas typically are prescribed by a physician and must be requested from a pharmacist, or are distributed directly to institutions such as hospitals, clinics, and state or federal agencies. Such formulas are also generally represented and labeled solely to provide dietary management for specific diseases or conditions that are clinically serious or life threatening and generally are required for prolonged periods of time. Medical Food: Food and Drug Administration, HHS 21 CFR C. 1 (4-1-95 Edition) § 101.9 (8) Medical foods as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3). A medical food is a food which is formulated to be consumed or administered externally under the supervision of a physician and which is intended for the specific dietary management of a Page 2 of 3 disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. A food is subject to this exemption only if: It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or feeding by tube; It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone; It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation; It is intended to be used under medical supervision; and It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food. From the Office of the Federal Register, National Archives and Records Administration Without this formula our child most likely will end up in the hospital and possibly require GI tube feeding. Our daughter’s health and well-being depends on her ability to receive Neocate formula as her sole source of nutrition. We are appealing to you in the hopes that you will approve this request for insurance coverage of Neocate Infant formula. This would make a significant positive impact on _______’s health. Thank you for your time and efforts in considering this appeal. Sincerely, _________________________ NAME (Mother) ADDRESS Page 3 of 3