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

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=40 | meeting_date=2007-09-12

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).

Actions Taken: May 29, 2007 Announced September 12 MedCAC meeting. July 25, 2007 Posted questions [PDF, 61KB]to panel. July 27, 2007 Posted Federal Register notice [PDF, 177KB] August 7, 2007 Posted revised questions [PDF, 40KB] to panel. September 7, 2007 Posted Agenda , Roster and Speaker List . September 13, 2007 Posted score sheet [PDF, 23KB]. October 17, 2007 Posted transcript [PDF, 521KB] and meeting minutes . Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee September 12, 2007 8:00 AM – 4:30 PM CMS Auditorium Steve Pearson, MD, MSc, Vice Chair Steve Phurrough, MD, MPA, Coverage and Analysis Group Maria Ellis, Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:15 AM Opening Remarks—M. Ellis / S. Phurrough, MD, MPA/ Steve Pearson, MD, MSc 8:15- 8:25 AM CMS Presentation of the Voting Questions – Francina Spencer 8:25 – 8:45AM Eric Mair, MD, Representative, Sleep Disorders Committee American Academy of Otolaryngology – Head and Neck Surgery, Charlotte EENT Associates 8:45 – 9:30 AM TA Presentation: Thomas A. Trikalinos, MD, PhD Assistant Director, Tufts-New England Medical Center EPC Assistant Professor of Medicine, Tufts University 9:30 - 9:50 AM CMS Presentation – Ross Brechner, MD, MS, MPH 9:50 –10:20 AM Frank Ryan, MB, FRCPI, FRCPC, FCCP, Professor of Medicine, University of British Columbia 10:20 – 11:30AM Scheduled Public Comments (Refer to Speaker List ) 11:30 – 12:00PM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity ****************************************************************************** Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. ****************************************************************************** 12:00 – 1:00 PM LUNCH (on your own) 1:00 –1:30 PM Questions to Presenters 1:30 – 2:45PM Initial Open Panel Discussion: Dr. Pearson 2:45 – 3:30 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions 3:30 – 4:25 PM Final Open Panel Discussion: Dr. Pearson 4:25 – 4:30 PM Closing Remarks / Adjournment: Dr. Phurrough, Dr. Pearson 4:30 PM ADJOURN Associated Nca: 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, 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). Minutes: MEETING MINUTES OF THE CENTERS FOR MEDICARE AND MEDICAID SERVICES MEDICARE EVIDENCE DEVELOPMENT AND COVERAGE ADVISORY COMMITTEE September 12, 2007 Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland Medicare Evidence Development and Coverage Advisory Committee (MedCAC) September 12, 2007 Attendees Vice-Chair Steve Pearson, M.D., M.Sc. Voting Members 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 CMS Liaison Louis Jacques, MD Consumer Representative Randel Richner, BSN, MPH Industry Representative Peter Juhn, MD, MPH Guest Expert Panelists Doran Edwards, MD Barry L. Whites MD FCCP MSHA Executive Secretaries Maria Ellis Michelle Atkinson Wednesday, September 12, 2007, 8:05 a.m. 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? The results of the voting were recorded on individual tally sheets and compiled by staff. During the voting procedure, further discussion was held among the panelists concerning each question voted upon, and individual comments were made by panelists during each vote, amplifying their reasons for voting as they did. Adjournment. the meeting adjourned at 3:00 p.m. I certify that I attended the meeting of the MedCAC Committee on September 12, 2007, and that these minutes accurately reflect what transpired. /s/ Maria Ellis Executive Secretary, MedCAC, CMS I approve the minutes of this meeting as recorded in this summary /s/ Steven Pearson, M.D., M.Sc. Vice Chair Other Material: Transcript 1 Panel Voting Questions: Download questions [PDF, 40KB] to panel. Download score sheet [PDF, 23KB]. Roster: Steven Pearson, MD, MSc Vice Chair Director, Institute for Clinical and Economic Review Bethesda, Maryland Karl E. Becker, MD, MBA Dept of Anesthesiology Kansas University Medical Center Kansas City, KS Mark V. Boswell, MD, PhD Professor Department of Anesthesiology Texas Tech University Lubbock, TX Gregory J. Dehmer, MD Director, Cardiology Division Scott + White Clinic Temple, TX Marion Danis, MD Chief, Bioethics Consultation Service NIH Clinical Center Bethesda, MD Saty Satya-Murti, MD, FANN Health Policy Consultant Topeka, KS Mercedes K.C. Dullum, MD Section of Cardiothoracic Surgery Weston, FL Loren Hiratzka, MD Medical Director, Cardiac Surgery Bethesda North Hospital Cincinnati, Ohio Marvin Konstam, MD Chief of Cardiology Tufts University, New England Medical Center Boston, Massachusetts Gregory L. Barkley, MD Henry Ford Hospital Department of Neurology Detroit, MI Industry Rep Peter Juhn, MD, MPH Vice President, Evidenced-based Coverage and Regulatory Policy New Brunswick, NJ Consumer Rep Randel Richner, BSN, MPH President and Founder Neocure Group, LLC Newton, MA Guests Doran Edwards, MD Medical Director SADMERC Columbia, SC Barry L. Whites MD FCCP MSHA Contractor Medical Director TriSpan Health Services Medicare Part A Intermediary Jackson, MS CMS Liaison Steve Phurrough, MD, MPA Director, Coverage and Analysis Group Maria Ellis Coverage and Analysis Group Speaker List: Medicare Evidence Development & Coverage Advisory Committee September 12, 2007 SPEAKER LIST *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