Medicare Guidelines

ACAA & Civil Rights - BiPAP - Compliance - Glossary - Medicare - Supplies - Survey - Supply Refill

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 neccessity.

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. 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 (OSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

1. The apnea-hyponea index (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:
• Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
• Hypertension, ischemic heart disease, or history of stroke.

If a claim for a CPAP device (E0601) is submitted and the criteria above have not been met, it will be denied as not medically necessary.

For the purpose of this policy, polysomnographic 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, polysomnographic studies must not be performed by a DME supplier. The 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, related accessories and supplies.

Continued Coverage Beyong 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.

If the above criterion is not met, continued coverage of an E0601 device and related accessories will be denied as not medically necessary.

Appendices

A respiratory cycle is defined as an inspiration, followed by an expiration.

Polysomnographic is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep with physician review, interpretation, and report. It must include sleep staging, which is defined to include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), and a submental electromyogram (EMG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry. it may be performed as either a whole night study for diagnosis only or as a split night study to diagnose and initially evaluate treatment.

Apnea is defined as the cessation of airflow for at least 10 seconds documented on a polysomnogram.

Hyponea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least 4% decrease in oxygen stauration.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hyponea per hour and must be based on a minum of 2 hours of sleep without the use of a positive airway pressure device, reported by polysomnography using actual recorded hours of sleep.