Appeal type: Medical Necessity
Decision: Overturned

The patient is a 63-year-old man who was originally diagnosed with obstructive sleep apnea (OSA) in 1998. At that time he had symptoms of excessive daytime fatigue, periodic leg movement and hypertension.  He had a sleep study with an apnea index of 23 events per hour and oxygen desaturations to 85%.  CPAP was prescribed at a pressure of 9 cm of H2O and was clinically effective. As an added benefit, the patients hypertension resolved with the use of CPAP.    The patient had a recurrence of his daytime fatigue and repeat polysomnography was performed in 2003.  The apnea index was 7.2 without CPAP and 9.9 with CPAP and he had oxygen desaturations of 85.8 without CPAP and 88.7 with CPAP.  The study also documented periodic leg movements.  As a result of this study, his CPAP pressure was increased to 11 cm of H2O.  The patients CPAP device apparently wore out, and a replacement unit was provided.  The Health Plan has denied coverage for the replacement device, stating it is not medically necessary.Authorization and coverage for a CPAP device has been denied in this case on the basis that the patient does not meet objective requirements for authorization of CPAP, that is, polysomnography with an apnea index of greater than 15, or an apnea index of five events or greater and excessive daytime sleepiness, impaired cognition or hypertension. The American Thoracic Societys consensus statement recognizes a single overnight polysomnographic study as sufficient to exclude clinically important sleep apnea, and states that in patients with severe or unambiguous sleep apnea, the initiation of treatment with nasal CPAP may be incorporated into the diagnostic study.  The Society also recognizes that difficulties may be encountered in comparing records because different laboratories use different definitions of what constitutes a respiratory event.  In particular, there are differences in the criteria used to define a hypopnea.  The Society recommends the field of polysomnography would be advanced with the creation of standard definitions.In this particular case, there are two qualified polysomnography records indicating that the patient has OSA and restless leg syndrome. The issue seems to be the number assigned to the apnea index. The first study indicated an apnea index of 23, while the second study indicated an apnea index between 7 and 10.  In both studies the patient had significant oxygen desaturations. Both studies also demonstrated that the patient improved with CPAP therapy.The focus on the apnea index of less than 10 in the second study to suggest that CPAP is not medically necessary ignores that fact that the patient is clearly symptomatic and clinically improved with CPAP therapy. Furthermore, he does meet medical necessity criteria by having an apnea index of greater than five along with his symptoms of excessive daytime sleepiness and hypertension prior to the prescribed use of CPAP.  The higher apnea index requirement of 15 should only be applied when evaluating a patient who is asymptomatic.  Based upon the information set forth above, I have determined the requested device is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.