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, 346KB] 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).
Steve Pearson, MD, MSc, Vice Chair
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Maria Ellis, Executive Secretary
CENTERS FOR MEDICARE AND MEDICAID SERVICES
MEDICARE EVIDENCE DEVELOPMENT AND COVERAGE
September 12, 2007
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Medicare Evidence Development and Coverage Advisory Committee (MedCAC)
Steve Pearson, M.D., M.Sc.
Gregory L. Barkley, MD
Karl E. Becker, MD, MBA
Mark V. Boswell, MD, PhD
Gregory J. Dehmer, MD
Marion Danis, MD
Saty Satya-Murti, MD, FANN
Mercedes K.C. Dullum, MD
Loren Hiratzka, MD
Marvin Konstam, MD
Louis Jacques, MD
Randel Richner, BSN, MPH
Peter Juhn, MD, MPH
Guest Expert Panelists
Doran Edwards, MD
Barry L. Whites MD FCCP MSHA
The MedCAC met on September 12, 2007, to discuss the evidence, hear presentations and pubic comment, and make recommendations regarding the diagnosis and treatment of obstructive sleep apnea (OSA) in Medicare beneficiaries who may be candidates for continuous positive airway pressure (CPAP) therapy, and alternatives to facility-based polysomnography in the diagnosis of OSA, including home sleep testing devices and clinical diagnosis without the use of sleep testing.
The meeting began with a reading of conflict of interest issues, opening remarks by the vice chair and CMS liaison, and introduction of the Committee.
CMS Summary and Presentation of Voting Questions. A CMS representative presented the discussion and voting questions to be considered by the panel.
Presentation on behalf of Requestor. The panel heard from a representative of the American Academy of Otolaryngology - Head and Neck Surgery supporting broadening the application and use of in-home sleep monitoring.
Presentation of the Technology Assessment. The results of a technology assessment performed by the Tufts new England Medical Center Evidence-Based Practice Center were presented.
Other Presentations. The panel heard presentations from a member of the CMS staff, and a Canadian researchers.
Scheduled Public Comments. Fifteen speakers, including professional society representatives, manufacturers' representatives, clinicians and other healthcare professionals, addressed the panel.
Open Public Comments. Following the scheduled public comments, the panel heard from four additional speakers.
Questions to Presenters. The panel conducted an extensive question and answer period with the various presenters and other speakers.
Initial Open Panel Discussion. There was an extensive period of discussion surrounding the initial discussion questions, as well as the form of the voting questions and definitions to be applied during the deliberations and voting.
Formal Remarks and Voting. The panel voted on the following questions.
One. How confident are you that there is sufficient evidence to determine that each of the following strategies can in routine use produce an accurate diagnosis of OSA for the prescription of CPAP?
Two. For each OSA diagnostic strategy for which there is enough evidence in question one, how confident are you about the sensitivity, ability to minimize false negatives, and specificity, ability to minimize false positives?
Three. Should each of the following be weighed as a criterion for the prescription of CPAP for the diagnosis of OSA?
Four. CPAP is currently a standard treatment for OSA. Defining successful treatment as combined subjective improvement of OSA clinical signs or symptoms and continued patient use of CPAP for two or more months, how confident are you that there is sufficient evidence to determine the ability of each of the following diagnostic strategies to accurately predict successful treatment of OSA with CPAP?
Five. How confident are you that each of the following diagnostic strategies will accurately predict successful treatment of OSA with CPAP?
Six. How confident are you that no clinically meaningful harm to patients will be caused by a trial CPAP strategy as an alternative to strategies that require a positive prior PSG or home sleep test before CPAP?
Seven. How confident are you that your conclusions can be generalized to, A, the Medicare population, and B, providers in community practice?
Adjournment. the meeting adjourned at 3:00 p.m.
I approve the minutes of this meeting
as recorded in this summary
Steven Pearson, M.D., M.Sc.
Download questions [PDF, 40KB] to panel.
Download score sheet [PDF, 23KB].
*5 MINUTES PER SPEAKER*
Thomas Kehoe, MD, Medical Director, SNAP Laboratories
Michael Coppola, MD, Associate Clinical Professor of Medicine
Tufts University School of Medicine
William C. Dement, MD, PhD, Professor of Psychiatry and Behavioral Sciences at the Stanford University School of Medicine
Jon Freudman, MD, Freudman Healthcare Consulting, LLC
Charles Atwood, Jr, MD, American College of Chest Physicians (ACCP)
David Gourley, RRT, MHA, American Association for Respiratory Care (AARC)
Lisa M. Getson, Executive Vice President, Clinical Services & Compliance, Apria Healthcare
Kelly Garber, CRT, Division Clinical Manager, Respiratory Services
Stephen Burton, PhD, Diplomat, American Board of Sleep Medicine
Alex Chediak, American Academy of Sleep Medicine (AASM)
Philip Westbrook, MD, Chief Medical Officer, Advanced Brain Monitoring, Inc.
Samuel Kuna, MD, Associate Professor, Philadelphia VA Medicare Center, American Thoracic Society (ATS)
James Parish, MD, The Mayo Clinic
Mark Goetting, MD, Sleep Health
David Kuhlmann, MD, ABSM, Medical Director, Sleep Medicine Bothwell Regional Health Center
Terence M. Davidson M.D., Professor of Surgery, Head and Neck Surgery, Associate Dean for Continuing Medical Education, University of California, San Diego, School of Medicine, Chief Head and Neck Surgery, VA San Diego Health Care System