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NCA Tracking Sheet for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2)


Issue

The Centers for Medicare & Medicaid Services is reviewing its national coverage determination (NCD) regarding the diagnosis of patients with OSA requiring CPAP therapy.  Current national coverage policy specifies that only polysomnography done in a facility-based sleep study laboratory can be used to identify patients with OSA requiring CPAP (240.4).

CMS has received a complete formal written Request [PDF, 339KB] from the American Academy of Otolaryngology-Head and Neck Surgery 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.

In addition, CMS has received an incomplete request from a Medicare beneficiary, numerous informal requests from stakeholders, and interest from Medicare contractors concerning the criteria for determining the Apnea-Hypopnea Index (AHI). The current NCD at section 240.4 states in part “…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).”  It has been suggested by some that this requirement be changed to “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 or less, if the actual number of AHI episodes recorded is 30 or more in less than 2 hours, recorded by polysomnography using actual recorded hours of sleep (i.e., the AHI may not be extrapolated or projected).

We are also aware of recently published research suggesting a benefit for the use of CPAP without prior sleep testing in selected populations (trial of CPAP). 

The scope of this reconsideration includes all aspects of this NCD.

 
National Coverage Determination(s)
240.4
 
Benefit Category
Durable Medical Equipment
 
Requestor Name(s)
American Academy of Otolaryngology-Head and Neck Surgery
 
Requestor Letter(s)
View Letter
 
Formal Request Accepted and Review Initiated
3/14/2007
 
Expected NCA Completion Date
3/13/2008
 
Proposed Decision Memo Due Date
12/14/2007
 
Proposed Decision Memo Released
12/14/2007
 
Decision Memo Released
3/13/2008
 
Lead Analyst(s)
Francina C. Spencer
 
Lead Medical Officer(s)
Ross Brechner, MD
 
Actions Taken
March 14, 2007 CMS opens this reconsideration of the NCD on CPAP for OSA. The formal request is to remove the current requirement for facility based polysomnography. CMS will reconsider this and all aspects of the NCD. The initial 30-day public comment period begins with this posting date and ends after 30 calendar days. 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 http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage

May 29, 2007 CMS will convene the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to consider this issue. The public meeting will be held on Tuesday, September 12, 2007 from 7:30 a.m. until 4:30 p.m. EDT at the Centers for Medicare and Medicaid Services, 7500 Security Blvd, Windsor Mills, MD 21244. Additional information will be available shortly including the Federal Register Notice, instructions for public commenters, and the panel questions.
December 14, 2007

Posted Proposed Decision Memorandum. We invite comments on the Proposed Decision Memorandum.

Instructions on submitting comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp.

March 13, 2008 Posted Final Decision Memorandum.


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