#1



DatePhysician Name, MDInstitutionAddressCity, State and Zip CodeMedical Director/Physician Name, MDInsurance Company NameAddressCity, State and Zip CodeRe: Patient NameDOB: MM/DD/YYYYMember ID:Group ID:To whom it may concern:I am writing this letter on behalf of the above-referenced patient to request coverage for [DEKAs Essential Liquid/Aqua-E Concentrate]. This patient has a diagnosis of [disease, relevant ICD-10 codes], a cholestatic liver disease that results in an impairment of bile formation and/or bile flow. The absorption of vitamins A, D, E and K is strongly dependent on adequate hepatic secretion of bile acids into the intestinal lumen. Childhood cholestatic liver diseases result in deficiencies of fat soluble vitamins due to the lack of critical micellar formation by bile acids which is necessary to facilitate transport of these vitamins across the brush border membrane and into the enterocyte [Sokol RJ, 1987a].Fat-soluble vitamin deficiencies have severe adverse effects on this population that can be irreversible. Vitamin E (α-tocopherol) deficiency in children with chronic cholestatic hepatobiliary diseases has been associated with a progressive distinctive neurologic syndrome composed of cerebellar ataxia, posterior column dysfunction, and peripheral neuropathy [Sokol RJ, 1984]. Bone disease (rickets and osteopenia) is a common complication of chronic childhood cholestatic liver disease [Glasgow JFT, 1976; Roberts CC, 1981]. Vitamin A deficiency can lead to impaired dark adaptation of the eyes and night blindness as well as growth retardation and infections [Johnson LE, 2016]. Vitamin K deficiency leads to easy bruisability and mucosal bleeding (especially epistaxis, gastrointestinal hemorrhage, and hematuria).D-α-tocopheryl polyethylene glycol 1000 succinate (TPGS) is a water-soluble form of vitamin E. TPGS administered orally in a dose of 15-25 IU/kg day has been proven to be a safe and effective form of vitamin E for prevention and correction of vitamin E deficiency during severe childhood cholestasis [Sokol RJ 1987a, Sokol RJ 1987b, Sokol RJ 1993]. TPGS can also enhance the absorption of other fat -soluble vitamins in cholestatic liver disease [Argao EA, 1992].The European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines for the treatment of fat-soluble vitamin deficiency in cholestatic liver disease patients recommend the oral administration of a vitamin supplement containing TPGS [Plauth M, 1997]. The European Association for the Study of the Liver (EASL) Clinical Practice Guidelines on Management of Cholestatic Liver Diseases also recommend the supplementation of vitamin A, E and K should be supplemented enterally [EASL: Clinical Practice Guidelines, 2009]. Furthermore, vitamin supplementation with a TPGS product is the standard of care in this population as advised in the 2014 edition of the textbook Liver Disease in Children [Feranchak A, 2014].Therefore, it is my conclusion that Aqua-E Concentrate [NDC68176-0000-17], a specially formulated patented water soluble form of vitamin E (TPGS) containing 75 IU of vitamin E per mL, is medically necessary in this patient.Therefore, it is my conclusion that DEKAs Essential Liquid [NDC68176-0000-13], containing 70 IU of vitamin E as TPGS, 2000 IU of vitamin A, 2000 IU of vitamin D and 2000 mcg of vitamin K per ml is medically necessary in this patient.Sincerely,__________________________________?Treating Physician?__________________________________?Treating DietitianReferences:Argao EA, Heubi JE, Hollis BW, et al, d-Alpha-tocopheryl polyethylene glycol-1000 succinate enhances the absorption of vitamin D in chronic cholestatic liver disease of infancy and childhood. Pediatr Res, 1992; 31(2):146-50.EASL Clinical Practice Guidelines: Management of cholestatic liver diseases European Association for the Study of the Liver, Journal of Hepatology, 2009. Vol 51(2), 237 – 267. DOI: AP, Sokol RJ (2007). Medical and nutritional management of cholestasis in infants and children. In: Suchy F, Balistreri W, Sokol R, eds. Liver Disease in Children. New York, NY: Cambridge University Press; 2007:190–231Feranchak AP, Suchy F, Sokol RJ (2014). Medical and nutritional management of cholestasis in infants and children. In: Suchy F, Sokol RJ, Balistreri W (Eds.). Liver Disease in Children (pp. 111-139). Cambridge: Cambridge University Press. doi:10.1017/CBO9781139012102.010Glasgow JFT, Thomas PA. The osteodystrophy of prolonged obstructive liver disease in childhood. Acta Paediatr Scand, 1976, 65:57-64.Johnson, LE, Vitamin D, In : MSD Manual, Professional Version, accessed 3 November 2017. M, Merli , Kondrup J, Weimann A, Ferenci P, Muller MJ. ESPEN guidelines for nutrition in liver disease and transplantation. Clin Nutr. 1997 Apr;16(2):43-55. DOI 10.1016/s0261-5614(97)80022-2.Roberts CC, Book LS, Chan GM, Matlak ME, Rickets in children with cholestatic liver disease: evaluation and treatment. Pediatr Res, 1981, 15:544 (abstr)Sokol RJ, Heubi JE, Iannaccone ST, et al, Mechanism causing vitamin E deficiency during chronic childhood cholestasis. Gastroenterology 1983; 85: 1172-82.Sokol RJ, Heubi JE, Iannaccone ST, Bove KE, Balistreri WF. Vitamin E deficiency with normal serum vitamin E concentrations in children with chronic cholestasis. N Engl J Med, 1984;310:1209-12.Sokol RJ, Heubi JE, Butler Simon N , et al, Treatment of vitamin E deficiency during chronic childhood cholestasis with oral d-alphatocopheryl polyethylene glycol-1000 succinate. Gastroenterology, 1987a; 93(5):975-85 Sokol RJ, et al, Tocopheryl polyethylene glycol 1000 succinate therapy for vitamin E deficiency during chronic childhood cholestasis: Neurologic outcome. J. Pediatr., 1987b;111:830-836Sokol RJ, et al, Multicenter trial of d-alpha-tocopheryl polyethylene glycol 1000 succinate for treatment of vitamin E deficiency in children with chronic cholestasis. Gastroenterology, 1993; 104(6):1727-35 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download