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CMS Expands Coverage for Continuous Positive Airway Pressure Devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, April 7, 2008

CMS issued a final coverage policy affording coverage of continuous positive airway pressure (CPAP) devices for patients with obstructive sleep apnea diagnosed with a home sleep test in a March 13 press release. CMS previously covered a CPAP device only for patients diagnosed using a polysomnography test performed in a sleep laboratory.

CPAPs apply air pressure through a mask to keep breathing passages open during sleep to alleviate sleep apnea, which is periodic break in breathing during sleep. The new coverage is limited to 12 weeks, however, because not all patients respond to CPAP treatment. If the patient does respond to CPAP treatment, long term coverage is provided.

CMS will monitor use of CPAPs to detect any fraud and abuse. The agency is deleting a requirement that the patient's obstructive sleep apnea must be moderate to severe and that surgery is the likely alternative.

A patient is eligible for coverage for a CPAP device if testing reveals he or she has15 or more apnea episodes or respiratory disturbances per hour or five to 14 such events in an hour and also experience other symptoms such as insomnia, excessive daytime sleepiness, difficult cognition, hypertension, heart disease, or history of stroke.

CMS issued two compliance reminders with its coverage decision:

• Suppliers must provide beneficiaries with information on how to use the device
• Diagnostic tests used to diagnose sleep apnea are only covered when ordered by a physician

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