Catheter Ablation for the Treatment of Atrial Fibrillation

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=50 | meeting_date=2009-10-21

CMS has called this meeting for the panel to discuss the adequacy of the available evidence for the use of catheter ablative techniques to treat patients with atrial fibrillation. Medicare does not currently have national coverage policy for the use of catheter ablation for the treatment of atrial fibrillation. In the absence of national policy, coverage of this procedure is at the discretion of local Medicare contractors (Medicare Administrative Contractors). Atrial fibrillation is an abnormal cardiac rhythm that is triggered by aberrant electrical activity in the cardiac tissue that is near the entrance to the pulmonary veins in the left atrium. It is a common arrhythmia that increases in prevalence with age. Strategies for the treatment of atrial fibrillation center on rate control or rhythm control. The goal of rhythm control is to restore and maintain normal sinus rhythm using drugs and/or an ablative procedure to disrupt the aberrant electrical activity. The ablative procedure can be performed using surgical methods or a less invasive catheter technique.

Actions Taken: September 1, 2009 The term "radiofrequency" has been deleted from the Issues section of this tracking sheet as the MEDCAC will review all methods of catheter ablation for the treatment of atrial fibrillation. September 3, 2009 Posted questions to panel. October 1, 2009 Posted Federal Register notice. October 14, 2009 Posted agenda , roster and speaker list for meeting. October 20, 2009 Link to AHRQ TA - Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation October 26, 2009 Posted scoresheet [PDF, 164KB] from meeting. December 9, 2009 Posted minutes [PDF, 1MB] and transcript [PDF, 428KB] from meeting. Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee October 21, 2009 7:30 AM - 4:30 PM CMS Auditorium Clifford Goodman, PhD, Chair Saty Satya-Murti, MD, Vice Chair Marcel Salive, MD, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:20 AM Opening Remarks— Maria Ellis/ Marcel Salive, MD/Clifford Goodman, PhD 8:20 - 8:35 AM CMS Presentation & Voting Questions - JoAnna Baldwin 8:35 - 9:05 AM Yves D. Rosenberg, MD, MPH, Acting Branch Chief, Atherothrombosis and Coronary Artery Disease Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute 9:05 - 10:00 AM TA Presentation: Ann C. Garlitski, MD , Assistant Professor of Medicine, Co-Director, Cardiac Electrophysiology and Pacemaker Laboratory, Tufts Medical Center and Stanley Ip, MD , Center for Clinical Evidence Synthesis, Institute of Clinical Research and Health Policy Studies, Tufts Medical Center 10:00 - 10:15 AM BREAK 10:15 - 11:00 AM Scheduled Public Comments (Refer to Speaker List) 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. 11:00 - 11:30 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:35 - 12:35 PM LUNCH (on your own) 12:35 - 1:35 PM Questions to Presenters 1:35 - 2:45 PM Initial Open Panel Discussion: Dr. Goodman 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. Goodman 4:25 - 4:30 PM Closing Remarks/Adjournment: Dr. Salive & Dr. Goodman 4:30 PM ADJOURN Issue: CMS has called this meeting for the panel to discuss the adequacy of the available evidence for the use of catheter ablative techniques to treat patients with atrial fibrillation. Medicare does not currently have national coverage policy for the use of catheter ablation for the treatment of atrial fibrillation. In the absence of national policy, coverage of this procedure is at the discretion of local Medicare contractors (Medicare Administrative Contractors). Atrial fibrillation is an abnormal cardiac rhythm that is triggered by aberrant electrical activity in the cardiac tissue that is near the entrance to the pulmonary veins in the left atrium. It is a common arrhythmia that increases in prevalence with age. Strategies for the treatment of atrial fibrillation center on rate control or rhythm control. The goal of rhythm control is to restore and maintain normal sinus rhythm using drugs and/or an ablative procedure to disrupt the aberrant electrical activity. The ablative procedure can be performed using surgical methods or a less invasive catheter technique. Minutes: Download meeting minutes [PDF, 1MB]. Other Material: Transcript 1 Panel Voting Questions: MEDCAC Panel Questions Catheter Ablation for the Treatment of Atrial Fibrillation October 21, 2009 Discussion Questions Clinical Comparators What is the appropriate clinical comparison for catheter ablation? Does the evidence use appropriate comparison groups? Population What subpopulations of patients with atrial fibrillation should be considered for treatment of catheter ablation (paroxysmal, persistent, permanent, first-line, second-line treatment, etc.)? Does the evidence address the appropriatepatient populations? Outcomes What are the outcomes of interest (ex., survival,termination of arrhythmia, hospitalization, medications [heart rate, rhythm,anticoagulants], recurrence of atrial fibrillation, adverse events, scarring)? Does the available evidence assess these outcomes? Have the adverse events been both qualitatively and quantitatively characterized? What is the appropriate duration of follow up? Does the available evidence follow patients for the appropriate period of time? Device characteristics and physician training What is the importance of the varying devices and techniques used for ablation? Should the procedure be limited to physicians with specialized training (e.g, electrophysiologists, surgeons)? Voting Questions For each question assign a number from 1 to 5 to indicate your vote. A lower number indicates lower confidence; a higher number indicates higher confidence. How confident are you that the evidence is adequate to draw conclusions about the health outcomes of interest to patients treated with catheter ablation for atrial fibrillation? How confident are you that catheter ablation for the treatment of atrial fibrillation improves health outcomes compared to other therapies or treatments in the following populations: As first-line therapy? As second-line therapy? For first detected atrial fibrillation? For long-standing (greater than 1 year) atrial fibrillation? For paroxysmal atrial fibrillation? For persistent atrial fibrillation? How confident are you that ablation improves long-term (greater than 1 year) health outcomes? How confident are you that the outcomes can be extrapolated to: Patients outside a controlled clinical study? The Medicare beneficiary population (age 65 years and older, 56% female)? How confident are you that additional evidence is needed? Discussion Additional evidence, if needed What type of additional evidence is needed to determine health outcomes? What study designs are most appropriate to obtain this additional evidence? Download scoresheet [PDF, 164KB] Roster: October 21, 2009 MEDCAC Roster Clifford Goodman, PhD Chair Senior Vice President The Lewin Group Saty Satya-Murti, MD,FAAN Vice Chair Health Policy Consultant Virginia C. Calega, MD, MBA Vice President Medical Management and Policy Highmark, Inc. Mark D. Carlson, MD, MA Chief Medical Officer Senior Vice President Clinical Affairs St. Jude Medical Cardiac Rhythm Management Division Gregory J. Dehmer, MD Director, Cardiology Division Scott & White Clinic Mercedes K.C. Dullum, MD Section of Cardiothoracic Surgery Cleveland Clinic in Florida William H. Maisel, MD, MPH Cardiovascular Division Beth Israel Deaconess Medical Center Harvard Medical School Mauro Moscucci, MD Clinical Vice Chairman Department of Medicine Chief and Professor of Medicine Cardiovascular Division University of Miami Miller School of Medicine Craig Umscheid, MD, MSCE University of Pennsylvania School of Medicine Patient Advocate Phyllis Atkinson, RN, MS, GNP-BC Gerotological Nurse Practitioner Co-Owner, Advanced Geriatric Education & Consulting, LLC Industry Representative Neal Thomas, PhD Senior Director Statistical Consulting and Research Center Pfizer Inc. Guest Panel Members Stephen C. Hammill, MD, FACC, FHRS Professor of Medicine Director Electrocardiography Laboratory Mayo Clinic Douglas L. Packer, MD Professor of Medicine Cardiovascular Disease Mayo Clinic Guest Speakers Yves D. Rosenberg, MD, MPH Acting Branch Chief Atherothrombosis and Coronary Artery Disease Branch Division of Cardiovascular Sciences National Heart, Lung and Blood Institute CMS Liaison Marcel Salive, MD Director Division of Medical & Surgical Services Coverage and Analysis Group Executive Secretary Maria A. Ellis Speaker List: Medicare Evidence Development & Coverage Advisory Committee October 21, 2009 SPEAKER LIST *7 MINUTES PER SPEAKER* David J. Wilber, MD, Director, Cardiology and the Cardiovascular Institute, Loyola University Medical Center, for the Thermocool AF Investigators Marshall Stanton, MD, Vice President, Cardiac Rhythm Disease Management, Clinical Research and Reimbursement, Medtronic Matthew R. Reynolds, MD, SM, VA Boston Healthcare System, Beth Israel Deaconess Medical Center, Harvard Clinical Research Institute Bradley Knight, MD, FACC, FHRS, American College of Cardiology Marcia S. Yaross, PhD, Vice President, Clinical, Regulatory and Health Policy, Biosense Webster, Inc. Hugh Calkins, MD, Professor of Medicine, Director of Electrophysiology, Johns Hopkins Medical Institutions, for the Heart Rhythm Society