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| NCA Tracking Sheet for 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 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.
|
| National Coverage Determination(s) |
240.4
|
| Benefit Category |
Pending |
| Requestor Name(s) |
Terence M. Davidson, MD |
| Requestor Letter(s) | View Letter
|
| Formal Request Accepted and Review Initiated |
4/8/2004 |
| Expected NCA Completion Date |
1/6/2005 |
| Public Comment Period |
6/25/2004 - 7/26/2004 |
| Lead Analyst(s) |
Francina C. Spencer
FSpencer@cms.hhs.gov
1-410-786-4614
|
| Lead Medical Officer(s) |
Tiffany Sanders, MD
TSanders@cms.hhs.gov
1-410-786-1948
|
| 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, second round of comments, and the MCAC Roster is available for review. |
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