NCD 240.4.1

Item/Service Description

A. General

Obstructive sleep apnea (OSA) is the collapse of the oropharyngeal walls and the obstruction of airflow occurring during sleep. Diagnostic tests for OSA have historically been classified into four types. The most comprehensive is designated Type I attended facility based polysomnography (PSG), which is considered the reference standard for diagnosing OSA. Attended facility based polysomnogram is a comprehensive diagnostic sleep test including at least electroencephalography (EEG), electro-oculography (EOG), electromyography (EMG), heart rate or electrocardiography (ECG), airflow, breathing/respiratory effort, and arterial oxygen saturation (SaO2) furnished in a sleep laboratory facility in which a technologist supervises the recording during sleep time and has the ability to intervene if needed. Overnight PSG is the conventional diagnostic test for OSA. The American Thoracic Society and the American Academy of Sleep Medicine have recommended supervised PSG in the sleep laboratory over 2 nights for the diagnosis of OSA and the initiation of continuous positive airway pressure (CPAP).

Three categories of portable monitors (used both in attended and unattended settings) have been developed for the diagnosis of OSA. Type II monitors have a minimum of 7 channels (e.g., EEG, EOG, EMG, ECG-heart rate, airflow, breathing/respiratory effort, SaO2)-this type of device monitors sleep staging, so AHI can be calculated). Type III monitors have a minimum of 4 monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation. Type IV devices may measure one, two, three or more parameters but do not meet all the criteria of a higher category device. Some monitors use an actigraphy algorithm to identify periods of sleep and wakefulness.

Indications and Limitations of Coverage

B. Nationally Covered Indications

Effective for claims with dates of service on and after March 3, 2009, the Centers for Medicare & Medicaid Services finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA, that the use of such sleep testing technologies demonstrates improved health outcomes in Medicare beneficiaries who have OSA and receive the appropriate treatment, and that these tests are thus reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act.

1. Type I PSG is covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed attended in a sleep lab facility.

2. Type II or Type III sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

3. Type IV sleep testing devices measuring three or more channels, one of which is airflow, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

4. Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility.

C. Nationally Non-Covered Indications

Effective for claims with dates of services on and after March 3, 2009, other diagnostic sleep tests for the diagnosis of OSA, other than those noted above for prescribing CPAP, are not sufficient for the coverage of CPAP and are not covered.

D. Other

N/A

(This NCD last reviewed March 2009.)

Revision History

07/2009 - Previously, although CPAP was nationally covered for beneficiaries with OSA if diagnosed with specific tests, coverage of the tests themselves was left to local contractor discretion. As a result of this recent NCD, effective for claims with dates of service on and after March 3, 2009, Medicare will allow for coverage of the sleep testing devices, specifically: Type 1 PSG when the test is attended in a sleep lab facility, Type II or Type III if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility, or Type IV measuring 3 or more channels, one of which is airflow, if performed unattended in or out of a sleep lab facility or attended in a sleep lab facility. Effective Date: 03/03/2009 Implementation Date: 08/10/2009 (TN 103) (CR6534)