Appeal type: Medical necessity
Decision: Overturned

This is a patient with a complex medical history including the following: arthrogryposis, Moebius syndrome, congenital diaphragmatic hernia/eventration, chronic lung disease with chronic respiratory failure and micrognathia status post tracheostomy tube placement and dependence on mechanical ventilation, severe central and obstructive sleep apnea, feeding difficulty status post gastrostomy tube placement with dependence on gastrostomy feedings, ocular abnormalities, scoliosis, phimosis, undescended testes, status post idiopathic ischemic stroke in the perinatal period, hearing loss, and global developmental delay. He receives albuterol four times daily, Diuril every twelve hours, hypertonic saline treatments three times daily, budesonide twice daily, and Ciprodex via tracheostomy twice daily alternating with gentamicin nebulized treatments. He has poor airway clearance and has had multiple lower respiratory tract infections including tracheitis. He is frequently seen in the emergency department (ED) for fevers and respiratory distress and has been hospitalized multiple times. Synagis for prevention of RSV infection has been prescribed. The health plan's determination is overturned.
The American Academy of Pediatrics issued new guidelines for the administration of Synagis for RSV prophylaxis based on review of current peer-reviewed literature related to burden of RSV in infants and children with emphasis on those at highest risk of severe disease. The following groups of patients are considered at highest risk, with recommendations for administration of Synagis: infants born before 29 weeks' gestation younger than 12 months of age at the start of RSV season; infants with chronic lung disease of prematurity born before 32 weeks' gestation during the first year of life, with some consideration during the second year of life if continued medical support is necessary; infants 12 months of age or younger with hemodynamically significant congenital heart disease (excluding those with lesions adequately corrected by surgery unless medication is necessary for ongoing congestive heart failure); consideration for infants 12 months of age or younger with anatomic pulmonary abnormalities or neuromuscular disorders that have difficulty clearing secretions; consideration for infants less than 24 months of age that are profoundly immunocompromised; and consideration for infants with Down syndrome or cystic fibrosis that have evidence of other risk factors such as chronic lung disease or congenital heart disease. 
 However, there remain groups of patients at increased risk of morbidity as a result of RSV infection. These patients fall outside of the guidelines because of the complexity of their medical problems and difficulties studying RSV infection in small groups. This patient falls into this category. His myriad medical conditions with associated complications place him at significant risk for severe RSV disease. According to the literature, children with chronic medical conditions that contract RSV infection are more likely to be hospitalized, hospitalized for longer periods of time, and on supplemental oxygen for longer periods of time. Children with severe motor and cognitive disability are at even greater risk of severe infection and are at increased risk of death from RSV. In these cases, the standard guidelines cannot be applied. These patients fall well outside of the underlying medical conditions upon which the current recommendations have been made. Based on this particular child's medical condition, Synagis is medically necessary and appropriate.