Indications and limitations of Coverage and/or Medical Necessity
For any item to be covered by Medicare, it must: 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted to the DMERC. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

INITIAL COVERAGE:

A single level continuous positive airway pressure (CPAP) device (E0601) is covered if the patient has a diagnosis of obstructive sleep apnea (DSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

1. The AHI is greater than or equal to 15 events per hour, or
2. The AHI is from 5 to 14 events per hour with documented symptoms of:
   1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
   2. Hypertension, ischemic heart disease, or history of stroke.

If a continuous positive airway pressure device (f=0601) is provided and the criteria above have not been met, it will be denied as not medically necessary.

For the purpose of this policy, polysomnographit studies must be performed in a facility based sleep study laboratory, and not in the home or in a mobile facility. These labs must be qualified providers of Medicare services and comply with all applicable state regulatory requirements,

For the purpose of this policy, polysomnagraphic studies must not be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0601 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of an E0601 device beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device.