Sleep Therapy

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Sleep Therapy Requirement

A. A face-to-face clinical evaluation by the treating physician prior to the sleep study test to assess the patient for OSA.

B. A Medicare-covered sleep test that meets either of the following:

1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events 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:

a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or

b. Hypertension, ischemic heart disease, or history of stroke.

C. The patient and/or their caregiver have received instruction from the supplier of the PAP device and accessories in the proper use and care of the equipment.

D. A HCPCS code E0601 device has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

The treating physician must perform a clinical reevaluation no sooner than the 31st day, but no later than the 91st day after initiating therapy, which documents the following:

• A face-to-face clinical reevaluation by the treating physician with documentation that symptoms of OSA are improved; and

• Objective evidence of adherence to use (defined as use of PAP devices for 4 or more hours per night on 70% of nights during a consecutive 30-day period anytime during the first 3 months of initial use) of the PAP device, reviewed by the treating physician.

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

1. Face-to-face clinical reevaluation by the treating physician to determine the etiology of the failure to respond to PAP therapy; and 2. Repeat sleep test in a facility-based setting (Type I study).

For patients who received a PAP device prior to enrollment in FFS Medicare and are seeking Medicare coverage of either rental of the device, a replacement PAP device, and/or accessories, both of the following coverage requirements must be met:

1. The patient had a documented sleep test prior to FFS Medicare enrollment that meets the Medicare AHI/RDI coverage criteria in effect at the time that the patient seeks Medicare coverage of a replacement PAP device and/or accessories; and

2. The patient had a face-to-face clinical evaluation following FFS Medicare enrollment by the treating physician who documented in the patient’s medical record that:

a. The patient has a diagnosis of OSA, and

b. The patient continues to use the PAP device. If either criteria 1 or 2 above are not met, the claim will be denied as not medically necessary. In these situations, there is no requirement for a clinical reevaluation or for objective documentation of adherence to use of the device.