Letter of Medical Necessity s3

LETTER OF MEDICAL NECESSITY TEMPLATE: VITAFLO FRUITVITS (Ketogenic) DATE: TO: FROM: PATIENT NAME: DOB: ICD DIAGNOSIS CODE: Ht: Wt: MEDICAL FOOD ORDER: INSURANCE ID: SUBSCRIBER: GROUP NO:

To Whom It May Concern:

______is a ______year old patient diagnosed with [disorder]. [Disorder] causes uncontrollable seizures. When anticonvulsant therapies have failed to control seizures, the standard of care is to follow a [ketogenic/modified Atkins/low glycemic index] diet (1). The nature of this diet is to eliminate or restrict carbohydrates from the diet. As a result, the diet alone does not contain enough vitamins and minerals to meet the daily DRI recommendations (2). The purpose of this letter is to explain the medical necessity of FruitiVits and request insurance coverage for this treatment.

The [ketogenic diet/modified Atkins/low glycemic index diet] is a special high-fat diet that is used to treat seizures. It also eliminates or restricts the amount of carbohydrates in the diet. The metabolic change that occurs in the body as a result of the diet improves or cures the intractable seizures (2). Achieving the optimal balance of vitamins, minerals and trace elements is difficult for children on restrictive therapeutic dietary regimens. Reports of vitamin and mineral deficiencies with these restricted diets are commonly documented in scientific literature. In particular, the reported nutritional deficiencies of thiamine, vitamin D, selenium, and vitamin C have led to optic neuropathy, reduced bone mass, cardiomyopathy, and scurvy respectively (3-8). To ensure nutritional adequacy of the diet, a multivitamin/mineral that is very low carbohydrate is prescribed to meet the DRIs or specific nutrient needs of the individual.

FruitiVits is a medical food which is a flavored, powdered mix of vitamins, minerals and trace elements low in carbohydrate (0.5 gm/packet), and lactose, fructose and sucrose free. It can be used orally or given via a bolus enteral/tube. It is indicated in children 4 years or older.

I have prescribed FruitiVits to meet my patient’s requirements for essential nutrients and prevent vitamin/mineral deficiencies and subsequent deficiency treatments. As a result of the restrictive nature of his/her diet, I have specifically noted [lab values, evidence of vitamin, mineral or trace element deficiency and/or inadequate intake]. FruitiVits is medically necessary to ensure that their specific nutrient needs are met.

FruitiVits is manufactured in the UK for Vitaflo USA, LLC (1-888-848-2356.) HCPCS: B4014 Reimbursement Code: NDC: 50600-0553-85 for 30 packets (6 g ea.) /box. FruitiVits is a medical food available ONLY by prescription (not “over the counter”) to be used under strict medical supervision.

I appreciate your consideration of this request. Your authorization of this prescribed order will provide this patient the treatment needed to improve his/her medical condition.

Please feel free to contact me if you have additional questions.

Sincerely, Name of Physician Institution Contact Information Attachments: Prescription Clinic Notes

1. Kossof EH, Zupec-Kania BA, Amark PE, et al. (2009). Optimal clinical management of children receiving the ketogenic diet: recommendations of the international ketogenic diet study group. Epilepsia;50(2):304-317 2. Chapple J (2012). Managing dietary treatment; further dietetic issues. Chapter 12 in: ‘Dietary treatment of epilepsy – practical implementation of ketogenic therapy. Editor: Elizabeth Neal. Wiley-Blackwell, Oxford UK. ISBN 978-0-470-67041-5. 3. Hoyt CS, Billson FA (1979). Optic neuropathyin ketogenic diet. British J Opthalmol 63 (3), 191-4 4. Hahn T, Halstead L, DeVivo D. (1979), Disordered mineral metabolism produced by ketogenic diet therapy, Calcified Tissue International 28, 17-22 5. Berquist AGC, Chee CM, Lutha L, Rychik J, Stallings VA (2003). Selenium deficiency associated with cardiomyopathy: a complication of the ketogenic diet. Epilepsia 44 (4):618-620 6. Bergqvist AG, Schall JI, Stallings VA (2007). Vitamin D status in children with intractable epilepsy, and impact of the ketogenic diet. Epilepsia 48 (1):66-71 7. Bergqvist AG, Schall JI, Stallings VA, Zemel BS (2008). Progressive bone mineral content loss in children with intractable epilepsy treated with the ketogenic diet. Am J Clin Nutr. 88 (6):1678-84 8. Willmott NS, Bryan RD (2008). Case report: scurvy in an epileptic child on a ketogenic diet with oral complications. Eur Arch Paediatr Dent 9 (3):148-52