Excessive Daytime Sleepiness denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for a sleep study with or without an esophageal pressure monitoring (PES) test.PES has shown benefit for patients with no witnessed respiratory pauses during sleep with excessive sleepiness, negative prior sleep study as well as patients with persistent sleepiness and suspected reflux. Although PES can strengthen treatment to improve clinical outcomes for the investigation of the pathophysiology of respiratory function, it is typically used in the context of suspected respiratory failure. A study found that a polysomnogram study is sufficient for the evaluation of patients with excessive sleepiness. In addition, the consideration of pulse oximetry in a sleep workup can be considered if there is suspicion of airway resistance.

Nature of Statutory Criteria/Case Summary: The patient has a history of obstructive sleep apnea and associated excessive daytime sleepiness. There is a past medical history of migraine, vasculitis and oromandibular dystonia. The patient reported doing well with Nuvigil 150 mg ½ tab twice daily but felt she could benefit from an increased dose. The patient reported Nuvigil 150 mg whole tablets caused headaches. The patient’s medication regimen includes Botox and vitamin B complex. Armodafinil was recommended. The Health Plan indicates that the requested medication is not medically necessary for the treatment of the patient’s medical condition. At issue in this case is whether Armodafinil 200 mg tablets are medically necessary for the treatment of this patient.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for prescription modafinil for treatment of the enrollee’s excessive daytime sleepiness. Findings: The physician reviewer found that Modafinil is U.S. Food and Drug Administration (FDA) approved for patients with excessive sleepiness associated with OSA, narcolepsy or shift work disorder. The documentation submitted for review does not support the patient has any of these diagnoses.

The patient is a 42-year-old female with a presumptive diagnosis of narcolepsy and symptoms of hypersomnolence. She has been maintained on Provigil for over six years. The patient underwent a sleep study in September 2000, which revealed a mild, non-positional sleep breathing disorder consistent with mild upper airway resistance syndrome. There was no specific evidence of narcolepsy or obstructive sleep apnea. The patient’s request for authorization of Provigil was denied by the Health Plan citing a lack of medical necessity.The FDA approved indications for Provigil include narcolepsy syndrome, sleepiness due to obstructive sleep apnea and sleepiness due to shift work sleep disorder. Additional off-label uses include the treatment of attention deficit disorder, fatigue associated with chronic diseases, psycho-stimulant abuse, and depressive disorders.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving excessive daytime sleepiness, then check the rights and deadlines that apply to your plan.