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FDA Approval/Clearance CPAP, Bi PAP and related devices have been considered and cleared for marketing by the Food and Drug Administration (FDA) under a 510(k) process.The 510(k) is a notification of intent to market a specific device.(1) AHI ≥ 15, or (2) AHI ≥ 5 and ≥ 14 with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease or history of stroke.

Since the 1986 decision specifically addressed CPAP only, the Durable Medical Equipment Regional Carriers (DMERCs) have issued a respiratory assist devices regional medical review policy (RAD RMRP) that addresses Bi PAP devices and other accessories (last revised in 1999).Specifically for the treatment of OSA, a respiratory assist device with bilevel pressure capability, without backup rate feature, used with noninvasive interface (K0532) will be covered for the first three months of noninvasive positive pressure respiratory assistance (NPPRA) if the following criteria are met: CMS met with the American Academy of Sleep Medicine (AASM).AASM asked us to revise the national coverage policy and to include allowance for hypopneas in the diagnosis of patients with moderate or severe OSA.Mixed apnea refers to apnea with both central and obstructive characteristics.The pathogenesis and pathophysiology of OSA has been studied extensively.Central sleep apnea refers to apnea syndromes with origins in the central nervous system.

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