National Coverage Analysis (NCA) Tracking Sheet

Sleep Testing for Obstructive Sleep Apnea (OSA)



We received an external request from Itamar Medical requesting a National Coverage Determination (NCD) on whether Home Sleep Testing (HST) devices measuring the peripheral arterial tone (PAT) signal (a measure of sympathetic activation), heart rate, blood oxygen saturation, and sleep time are reasonable and necessary for the diagnosis of obstructive sleep apnea (OSA).

CMS has addressed the coverage of CPAP is three separate decisions in October, 2001, April 2005, and March 2008. In each of those decisions, we limited coverage of CPAP in patients with OSA to those patients whose diagnosis was based on specific testing modalities. Initially, we limited coverage to OSA diagnosed with PSG. In the latest decision, we expanded coverage to OSA diagnosed with several types of HST. That decision is available at

However, we have not, at a national level, specifically addressed coverage of the tests themselves. In other words, we nationally cover CPAP for beneficiaries with OSA if diagnosed with these specific tests; however, coverage of the specific tests has historically been left to local contractor discretion.

Since Watch-PAT is only one of several diagnostic tests for OSA and we do not have an NCD on any of these tests, we have broadened the scope of this NCA to include other sleep test technologies. Since we have recently reviewed and commented on the evidence available that discusses the benefits of sleep testing for OSA, we are releasing our proposed decision concurrent with opening this NCD.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Itamar View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
12/23/2008 - 01/22/2009
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Jean M. Stiller, MA
Lead Medical Officers
Ross Brechner, MD, MS(Stat), MPH

Medicare Benefit Category Determination Date

Actions Taken

December 23, 2008

CMS is requesting public comments on the proposed decision memorandum for sleep testing for the diagnosis of obstructive sleep apnea (OSA). The 30-day public comment period begins with this posting date and ends 30-days following this posting. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at:

To submit a comment, please use the orange "Comment" button at the top of the page.

We strongly urge the use of the orange "Comment" button at the top of the page. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

March 3, 2009