National Coverage Analysis (NCA) Tracking Sheet

Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)



The Centers for Medicare & Medicaid Services (CMS), formerly the Health Care Financing Administration, is reviewing the use of CPAP for the treatment of OSA to determine if the national coverage guidelines should be revised. CPAP is a non-invasive technique for providing low levels of air pressure from a flow generator, via a nose mask. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in OSA. The current diagnostic criteria for OSA require the documentation of at least 30 episodes of apnea, each lasting a minimum of 10 seconds, during 6-7 hours of recorded sleep. 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.

CMS received inquiries from manufacturers, clinicians, professional associations and groups, expressing concerns and requesting changes in the national coverage policy for CPAP in the treatment of OSA. Some requestors believe the national coverage policy criteria for establishing the diagnosis of OSA are inconsistent with current diagnostic techniques and standards.

There are also discussions concerning the definition and significance of partial cessation of breathing (hypopneas); specifically, that the medical necessity criteria may be too narrow (e.g., surgery is not the option it once was; hypopnea is more widely used and accepted as a diagnostic criteria).

CMS has been asked to revise the national coverage policy for CPAP to include Bi-level Positive Airway Pressure (BiPAP), as well as the diagnostic criteria for OSA to include consideration for hypopneas in the diagnosis of patients with moderate or severe obstructive sleep apnea.

CMS is in the process of exploring and/or reviewing clinical trials or other medical literature that will assist in determining future revisions to the current national coverage policy for CPAP.

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Durable Medical Equipment Regional Carriers (DMERCs) N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
07/05/2001 - 08/03/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released


Lead Analysts
Francina C. Spencer
Lead Medical Officers
Joseph Chin, MD

Medicare Benefit Category Determination Date

Actions Taken

September 14, 2001

On September 4, additional commentary and information was received from the requestor and other sources. In order to consider this new material, the due date is extended to October 15, 2001.

October 10, 2001

Correction: The new information received on September 4 was provided by the manufacturer of a CPAP device and a professional society, not the DMERC. We expect the decision memorandum to be posted by October 31, 2001.

October 30, 2001