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MEDCAC Meeting 11/14/2012 - Management of Heart Failure with the Use of Ventricular Assist Devices

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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

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.

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.

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 AMOpening Remarks— Maria Ellis/Jyme Schafer, MD/Rita Redberg, MD
8:15 - 8:25 AMCMS 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 AMRobert 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 PMInitial 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 PMClosing Remarks/Adjournment: Dr. Schafer & Dr. Redberg

Download meeting minutes. [PDF, 117KB]

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
Low
Confidence		 2 3
Intermediate		 4 5
High
Confidence


Voting Questions
  1. 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
Low
Confidence		 2 3
Intermediate		 4 5
High
Confidence
    Discussion

    1. If there is at least intermediate confidence (mean score ≥ 2.5 in question 1), what prospective patient criteria predict:

      1. clinically meaningful improvements in health outcomes,
      2. equivalent health outcomes, and/or
      3. clinically meaningful worsening of health outcomes?

    2. Do these criteria vary if the intended use of the VAD at the time of implantation is:

      1. bridge-to-transplantation, or
      2. destination therapy?

  1. 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
Low
Confidence		 2 3
Intermediate		 4 5
High
Confidence
    Discussion

    1. 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?
    2. Please discuss the role, if any, of facility VAD specific certification to assure attainment and maintenance of any characteristics identified in question 2a.
    3. Please discuss the role, if any, of the heart team concept in the management of patients who receive a VAD.

  1. How confident are you that these conclusions are generalizable to the Medicare beneficiary population?
1
Low
Confidence		 2 3
Intermediate		 4 5
High
Confidence
    Discussion

      Which conclusions are likely or unlikely to be generalizable to the Medicare beneficiary population?


  1. How confident are you that clinically significant evidentiary gaps remain regarding the use of VADs?
1
Low
Confidence		 2 3
Intermediate		 4 5
High
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]

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

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
4