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INITIAL COVERAGE:

In this policy, the term PAP (positive airway pressure) device will refer to a single-level continuous positive airway pressure device (E0601) in the treatment of obstructive sleep apnea.

1. An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A – C are met:

A. The beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea.

B. The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2):

1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,

2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:

• Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
• Hypertension, ischemic heart disease, or history of stroke.

C.  The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.

Replacement:

If a PAP device is replaced following the 5 year RUL, there must be an in-person evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the PAP device. There is no requirement for a new sleep test or trial period. 

Restart:

Beneficiaries who fail the initial 12 week trial are eligible to re-qualify for a PAP device but must have both:

1. In-person clinical re-evaluation by the treating practitioner to determine the etiology of the failure to respond to PAP therapy; and,

2. Repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration or split-night study.

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