National Coverage Analysis (NCA) Tracking Sheet

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

CAG-00093R

Issue

The Centers for Medicare & Medicaid Services is reviewing its national coverage decision regarding the diagnosis of patients with OSA requiring CPAP therapy. Current national coverage guidelines specify that only a polysomnography done in a facility-based sleep study laboratory be used to identify patients with OSA requiring CPAP (CIM 60-17). CMS has received a Request [PDF, 80KB] from Dr Terence M. Davidson, MD, of the University of California San Diego, School of Medicine to modify this decision to include the use of portable multi-channel home sleep testing devices as an alternative to facility-based polysomnography in the evaluation of OSA.

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Terence M. Davidson, MD View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/08/2004
Expected NCA Completion Date
04/07/2005
Public Comment Period
06/25/2004 - 07/26/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
01/07/2005
Proposed Decision Memo Public Comment Period
01/07/2005 - 02/07/2005
Decision Memo Released
04/04/2005
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Francina C. Spencer
Lead Medical Officers
Tiffany Sanders, MD

Medicare Benefit Category Determination Date

Actions Taken

April 8, 2004

CMS began a modified NCD process on January 1, 2004 (See Changes to the National Coverage Determination Process). This Tracking Sheet template will shortly be modified to reflect those changes. Until that time the Expected Completion Date above is the date by which we will post the draft decision memorandum for public comment. We are also beginning, as of this posting date, our standard, initial 30 day comment period on this NCD and are interested in scientific input relevant to the issue under consideration.

June 25, 2004

Comments from the first 30-day comment period are now available.

CMS would like to invite the public to participate in a second 30-day comment period beginning today. We are interested in receiving comments on the following questions:

How does the diagnostic test performance of unattended portable multi-channel home sleep testing compare to facility-based polysomnography in the diagnosis of obstructive sleep apnea?

a. If unattended portable multi-channel home sleep testing is as effective as polysomnography in the diagnosis of obstructive sleep apnea which parameters of sleep and cardiorespiratory function (i.e. sleep staging, body position, limb movements, respiratory effort, airflow, oxygen saturation, ECG) are required?

b. If unattended portable multi-channel home sleep testing is as effective as polysomnography in the diagnosis of obstructive sleep apnea what conditions (i.e. patient education, technician support) are required so that it is done correctly in the home?

Comments may be made through our Public Comments Website.

July 29, 2004

A Federal Register Notice will be published shortly announcing that this issue will be presented to our MCAC. The public meeting will be held on Tuesday, September 28, 2004 from 7:30 a.m. until 4:30 p.m. EDT at the Holiday Inn Inner Harbor, 301 West Lombard Street, Baltimore, MD 21201. Additional information will be available shortly including the Federal Register Notice, instructions for public commenters, and the panel questions.

August 27, 2004

Federal Register notice published announcing MCAC.

September 2, 2004

The MCAC panel questions are available for review. Instructions for presenters are given in the Federal Register notice.

September 7, 2004

The Technology Assessment Report and the MCAC Roster is available for review.

December 10, 2004

The September 28, 2004 MCAC Transcript and Minutes are available for review.

January 7, 2005

We are posting our proposed decision memorandum. We invite comments on the decision memorandum.

Instructions for submitting comments can be found at http://www.cms.hhs.gov/coverage/8h.asp

April 4, 2005