Management of Heart Failure with the Use of Ventricular Assist Devices

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=65 | meeting_date=2012-11-14

The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on the use of ventricular assist devices (VADs), a clinical strategy for the management of heart failure. VADs are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood. Medicare currently provides coverage for VADs for three indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (when patients are not candidates for heart transplantation). Patients must meet eligibility criteria which vary based on the indication for use. In addition, devices can only be implanted in facilities and by operators meeting criteria intended to ensure optimal health outcomes for Medicare beneficiaries. This meeting will focus on how outcomes can be optimized for patients with heart failure, especially the appropriate selection of those who are likely to benefit from the placement of VADs and the facility and operator characteristics which predict improved health outcomes for patients receiving a VAD. It will also serve to identify areas where further research may be warranted, and include an evaluation of the generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of VADs in section 20.9 of the national coverage determination (NCD) manual (Pub. 100-03) entitled National Coverage Determination (NCD) for Artificial Hearts and Related Devices ( 20.9 ). The NCD is available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246

Actions Taken: August 2, 2012 Posted meeting announcement on CAG website. August 30, 2012 Posted link to meeting registration. September 4, 2012 Posted questions to panel November 9, 2012 Posted agenda , roster and speakers list . November 13, 2012 Posted presentations for meeting. November 27, 2012 Posted scoresheet from meeting February 11, 2013 Posted minutes and transcript from meeting. Webcast of meeting Registration Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee November 14, 2012 7:30 AM – 4:30 PM CMS Auditorium Rita Redberg, MD, MScC , Chair Art Sedrakyan, MD, PhD , Vice Chair Jyme Schafer, MD, MPH , Division Director, Division of Medical and Surgical Services, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:15 AM Opening Remarks— Maria Ellis/Jyme Schafer, MD/Rita Redberg, MD 8:15 - 8:25 AM CMS Presentation & Voting Questions – Kimberly Smith, MD, MS 8:25 – 8:35 AM Lynne Warner Stevenson, MD , Professor of Medicine, Harvard Medical School, Director, Heart Failure Program, Brigham and Women’s Hospital 8:35 – 8:45 AM Robert Kormos, MD, Professor of Surgery, University of Pittsburgh Medical Center; Director, Artificial Heart Program; Co-Director, Heart Transplantation 8:45 – 9:15 AM Keith Aaronson, MD, MS, Professor of Medicine, University of Michigan Health Systems; Medical Director, Heart Failure Program 9:15 – 10:00 AM James Kirklin, MD, Professor of Surgery, University of Alabama at Birmingham; Director, Division of Cardiothoracic Surgery and David C. Naftel, PhD, Professor of Surgery, Professor of Biostatistics, University of Alabama at Birmingham 10:00 – 10:15 AM Lynne Warner Stevenson, MD, Professor of Medicine, Harvard Medical School; Director, Heart Failure Program, Brigham and Women’s Hospital 10:15 – 10:25 AM BREAK 10:25 – 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 – 11:05 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:05 – 12:00 PM Questions to Presenters 12:00 – 1:00 PM LUNCH (on your own) 1:00 – 2:00 PM Initial Open Panel Discussion: Dr. Redberg 2:00 – 3:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 3:00 – 4:00 PM Final Open Panel Discussion: Dr. Redberg 4:00 – 4:30 PM Closing Remarks/Adjournment: Dr. Schafer & Dr. Redberg Issue: The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on the use of ventricular assist devices (VADs), a clinical strategy for the management of heart failure. VADs are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood. Medicare currently provides coverage for VADs for three indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (when patients are not candidates for heart transplantation). Patients must meet eligibility criteria which vary based on the indication for use. In addition, devices can only be implanted in facilities and by operators meeting criteria intended to ensure optimal health outcomes for Medicare beneficiaries. This meeting will focus on how outcomes can be optimized for patients with heart failure, especially the appropriate selection of those who are likely to benefit from the placement of VADs and the facility and operator characteristics which predict improved health outcomes for patients receiving a VAD. It will also serve to identify areas where further research may be warranted, and include an evaluation of the generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of VADs in section 20.9 of the national coverage determination (NCD) manual (Pub. 100-03) entitled National Coverage Determination (NCD) for Artificial Hearts and Related Devices ( 20.9 ). The NCD is available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246 Minutes: Download meeting minutes . [PDF, 117KB] Other Material: Transcript 1 Presentations Panel Voting Questions: November 14, 2012 MEDCAC Management of Heart Failure with the Use of Ventricular Assist Devices The primary focus of this MEDCAC meeting is the consideration of evidence that may support prospective identification of patients who are likely to experience clinically meaningful changes in outcomes from placement of a ventricular assist device (VAD.) We also seek the panel's input on whether or not the published evidence identifies facility and/or operator characteristics that predict clinically meaningful improvements in outcomes of patients who receive a VAD. Among outcomes, CMS is most interested in mortality, adverse events, patient function and quality of life. For the purposes of this meeting, optimal medical therapy is defined as treatment of contributing comorbidities, standard lifestyle modifications including dietary interventions, optimization of pharmacotherapy, and appropriate use of other devices such as implantable cardiac resynchronization devices, cardioverter-defibrillators or pacemakers. For the purposes of this meeting, the heart team concept is defined as a cohesive, multi-disciplinary team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Instructions: For the voting questions, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Voting Questions How confident are you that there is adequate evidence that specific patient criteria can be used to prospectively identify clinically meaningful changes in the health outcomes listed above (improved, equivalent or worsened) that are likely to be experienced by patients who receive a VAD in addition to optimal medical therapy compared with optimal medical therapy alone? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion If there is at least intermediate confidence (mean score ≥ 2.5 in question 1), what prospective patient criteria predict: clinically meaningful improvements in health outcomes, equivalent health outcomes, and/or clinically meaningful worsening of health outcomes? Do these criteria vary if the intended use of the VAD at the time of implantation is: bridge-to-transplantation, or destination therapy? How confident are you that there is adequate evidence that one or more facility and/or operator characteristics predict clinically meaningful improvements in the health outcomes listed above for patients who receive a VAD in addition to optimal medical therapy compared with optimal medical therapy alone? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion If there is at least intermediate confidence (mean score ≥ 2.5 in question 2), what facility and/or operator characteristics predict clinically meaningful improvements in health outcomes? Please discuss the role, if any, of facility VAD specific certification to assure attainment and maintenance of any characteristics identified in question 2a. Please discuss the role, if any, of the heart team concept in the management of patients who receive a VAD. How confident are you that these conclusions are generalizable to the Medicare beneficiary population? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion Which conclusions are likely or unlikely to be generalizable to the Medicare beneficiary population? How confident are you that clinically significant evidentiary gaps remain regarding the use of VADs? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Discussion If there is at least intermediate confidence (mean score ≥ 2.5 in question 4), please discuss any significant gaps identified and how CMS might support their closure. Download scoresheet [PDF, 21KB] Roster: Rita Redberg, MD, MS Chair Professor of Medicine UCSF School of Medicine Division of Cardiology University of California, San Francisco Medical Center Art Sedrakyan, MD, PhD Vice Chair Associate Professor & Director Patient Centered Comparative Outcomes Research Program Weill Cornell Medical School Ralph Brindis, MD, MPH, MACC Regional Senior Advisor for Cardiovascular Diseases Oakland Kaiser Permanente Medical Center Raymond E. Faught, Jr., MD Professor of Neurology Associate Chief of Service Chief, Neurology Service Emory Neurology Emory University Hospital Midtown Mark D. Grant, MD, MPH Director, Technology Assessment Technology Evaluation Center Blue Cross Blue Shield Association Peter Heseltine, MD Professor of Clinical Medicine University of California, Irvine Curtis Mock, MD, MBA Senior Medical Director Vice President Medicare Advantage UnitedHealthcare Medicare & Retirement Jeffrey B. Rich, MD CardioThoracic Surgeon Mid-Atlantic Cardiothoracic Surgeons, Ltd. J. Sanford Schwartz, MD Professor of Medicine Health Management & Economics University of Pennsylvania J. Sanford Schwartz, MD Professor of Medicine Health Management & Economics University of Pennsylvania Robert L. Steinbrook, MD Professor Adjunct of Internal Medicine Yale School of Medicine Industry Representative Shamiram R. Feinglass, MD, MPH Vice President Global Medical and Regulatory Affairs Zimmer, Inc. Guest Panel Members G. Kevin Donovan, MD, MA Director Center for Clinical Bioethics Georgetown University Medical Center Robert Kormos, MD Director, UPMC Artificial Heart Program Co-Director UPMC Heart Transplantation Program Associate Director, Residency Program University of Pittsburgh School of Medicine Division of Cardiothoracic Surgery Medical Director, Vital Engineering Ileana L. Piña, MD, MPH, FAHA, FACC Professor of Medicine Epidemiology and Population Health Albert Einstein College of Medicine Associate Chief for Academic Affairs Division of Cardiology Staff Heart Failure/Transplant Montefiore Medical Center Invited Guest Speakers Keith Aaronson, MD Professor, Department of Internal Medicine Medical Director, Heart Failure Program University of Michigan Health Systems Cardiovascular Center James Kirklin, MD Professor of Surgery Director, Division of Cardiothoracic Surgery University of Alabama at Birmingham David C. Naftel, PhD Professor of Surgery Professor of Biostatistics University of Alabama at Birmingham Lynne Warner Stevenson, MD Professor of Medicine Harvard Medical School Director Heart Failure Program Brigham and Women’s Hospital Advanced Heart Disease Program CMS Liaison Jyme Schafer, MD Director Division of Medical & Surgical Services Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Speakers List: Medicare Evidence Development & Coverage Advisory Committee November 14, 2012 SPEAKER LIST *5 MINUTES PER SPEAKER* Darrel J. Scott, FACHE , Senior Vice President, Regulatory & Legal Affairs, DNV Healthcare Inc. - No Powerpoint Presentation Jeffrey Teuteberg, MD, Chair, Mechanical Circulatory Council, International Society for Heart and Lung Transplantation Francis Pagani, MD, PhD, Professor of Surgery, Department of Cardiac Surgery, University of Michigan Health System, Representing: The Society of Thoracic Surgeons Sean Pinney, MD, Associate Professor of Medicine, Mount Sinai Medical Center , Representing: Heart Failure Society of America Wayne C. Levy, MD, FACC, Medical Director, UW Regional Heart Center Clinic, Professor of Medicine/Cardiology, University of Washington Lee R. Goldberg, MD, MPH, FACC , Chair, Heart Failure and Transplant Council, American College of Cardiology, Medical Director, Heart Failure and Cardiac Transplant Program, University of Pennsylvania Mariell Jessup, MD, FAHA, President-Elect, American Heart Association, Professor of Medicine, University of Pennsylvania