Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

240.4

Version Number

Effective Date of this Version

4/4/2005

Ending Effective Date of this Version

3/13/2008

Implementation Date

6/6/2005

Benefit Category

Durable Medical Equipment

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

CPAP is a non-invasive technique for providing single levels of air pressure from a flow generator, via a nose mask, through the nares. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in OSA.

Indications and Limitations of Coverage

B. Nationally Covered Indications

The use of CPAP is covered under Medicare when used in adult patients with moderate or severe OSA for whom surgery is a likely alternative to CPAP. The use of CPAP devices must be ordered and prescribed by the licensed treating physician to be used in adult patients with moderate to severe OSA if either of the following criterion using the Apnea-Hypopnea Index (AHI) are met:

AHI greater than or equal to 15 events per hour, or
AHI greater than or equal to 5 and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of 2 hours of sleep recorded by polysomnography using actual recorded hours of sleep (i.e., the AHI may not be extrapolated or projected).

Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30 percent reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4 percent oxygen desaturation.

The polysomnography must be performed in a facility - based sleep study laboratory, and not in the home or in a mobile facility.

Initial claims must be supported by medical documentation (separate documentation where electronic billing is used), such as a prescription written by the patient's attending physician that specifies:

A diagnosis of moderate or severe obstructive sleep apnea, and
Surgery is a likely alternative.

The claim must also certify that the documentation supporting a diagnosis of OSA (described above) is available.

C. Nationally Non-covered Indications

Effective April 4, 2005, the Centers for Medicare & Medicaid Services determined that upon reconsideration of the current policy, there is not sufficient evidence to conclude that unattended portable multi-channel sleep study testing is reasonable and necessary in the diagnosis of OSA for CPAP therapy, and these tests will remain noncovered for this purpose.

D. Other

N/A

(This NCD last reviewed April 2005.)

Cross Reference

See Section 280.1, Durable Medical Equipment Reference List

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/transmittals/downloads/R35NCD.pdf

Revision History

12/1986 - Provided coverage when used in adult patients with moderate or severe obstructive sleep apnea who have failed to obtain relief from other non-invasive therapies. Effective date 01/12/1987. (TN 12)

06/1987 - Revised indications for treatment to include patients for whom surgery is a likely alternative to CPAP, and deleted documentation requirements. Effective date 01/12/1987. (TN 15)

12/2001 - Expanded coverage for use in obstructive sleep apnea. Effective and implementation dates 04/01/2002. (TN 150) (CR 1949)

05/2005 - Found insufficient evidence to conclude that unattended portable multi-channel sleep study testing is reasonable and necessary in diagnosis of OSA for CPAP therapy, and these tests remain non-covered for this purpose. Effective date 04/04/2005. Implementation date 06/06/2005. (TN 35) (CR 3843)

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.