Transcatheter Aortic Valve Replacement (TAVR)

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=75 | meeting_date=2018-07-25

On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Through this meeting we are seeking the MEDCAC's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain transcatheter aortic valve replacement (TAVR) programs. The MEDAC will specifically focus on appraisal of the state of evidence for surgical aortic valve replacement (SAVR), TAVR, percutaneous coronary intervention (PCI) and other relevant structural heart disease procedural volume requirements. In May 2012, CMS finalized a national coverage determination (NCD) for TAVR (Pub. 100-03, 20.32 ) ( https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355 ) that established specific requirements for coverage, including procedural volume requirements hospitals must meet to begin and maintain TAVR programs. The MEDCAC panel will examine the scientific evidence pertaining to procedural volume requirements for SAVR, TAVR, PCI and other relevant structural heart disease procedures as they relate to TAVR programs. The MEDCAC panel will assess whether scientific evidence supports requiring hospitals and heart team members to meet pre-specified volume requirements for these procedures in order to begin and maintain TAVR programs. This meeting will also explore the challenges and potential unintended consequences that may result from such pre-specified procedural volume requirements. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS on procedural volume requirements for hospitals and heart team members with both new and continuing TAVR programs that treat Medicare beneficiaries. MEDCAC panels do not make coverage determinations, but CMS benefits from their advice.

Actions Taken: May 10, 2018 CMS posts MEDCAC meeting announcement. May 22, 2018 Posted questions to panel. July 18, 2018 Posted agenda , roster and speaker list for meeting. Also posted presentations and written comments/background materials . July 24, 2018 Posted Visitor Screening Procedures July 26, 2018 Posted scoresheet from meeting. December 12, 2018 Posted minutes and transcript from meeting. Webcast of meeting **(registration is not required to view the webcast)** Visiting Screening Procedures Registration Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee July 25, 2018 7:30 AM - 4:30 PM CMS Auditorium Peter Bach, MD , Committee Chair Aloysius Cuyjet, MD, MPH , Committee Vice-Chair Daniel Caños, PhD, MPH , Director, Evidence Development Division, Coverage and Analysis Group Maria Ellis , Executive Secretary - 7:30 - 8:00 AM Registration 8:00 - 8:15 AM Opening Remarks - Maria Ellis/Daniel Caños, PhD, MPH/Peter Bach, MD 8:15 - 8:25 AM CMS Presentation & Voting Questions - Sarah Fulton, MHS 8:25 - 8:55 AM Peter Pelikan, MD, FACC, FSCAI, Medical Director, Cardiac Catheterization Lab and Structural Heart Program, Pacific Heart Institute and Providence Saint Johns Health Center 8:55 - 9:25 AM Carl L. Tommaso, MD , Cardiologist, NorthShore Medical Group and Joseph E. Bavaria, MD , Past President, Society of Thoracic Surgeons, Brooke Roberts-William M. Measey, Professor of Surgery, Vice-Chief, Division of Cardiovascular Surgery Surgical, Director, Heart and Vascular Center, Director, Thoracic Aortic Surgery Program, Penn Heart and Vascular Center, Perelman Center for Advanced Medicine - Recommended Speakers By : American Association for Thoracic Surgery/American College of Cardiology/Society of Cardiovascular Angiography and Interventions/Society of Thoracic Surgeons 9:25 - 9:55 AM Martin B. Leon, MD, Professor of Medicine and Director, Center for Interventional Vascular Therapy, Columbia University/NY Presbyterian Hospital, Founder & Chairman Emeritus, Cardiovascular Research Foundation New York City 9:55 - 10:25 AM Aaron Horne, Jr. MD, MBA, MHS , Structural Interventionalist, Board Member, Association of Black Cardiologists 10:25 - 10:35 AM BREAK 10:35 - 11:45 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. ******************************************************************************************* 11:45 - 12:00 PM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 12:00 - 1:00 PM LUNCH (on your own) 1:00 - 2:00 PM Questions to Presenters 2:00 - 3:00 PM Initial Open Panel Discussion: Dr. Bach 3:00 - 4:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 4:00 - 4:20 PM Final Open Panel Discussion: Dr. Bach 4:20 - 4:30 PM Closing Remarks/Adjournment: Dr. Caños and Dr. Bach Associated Nca: Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R) Issue: On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Through this meeting we are seeking the MEDCAC's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain transcatheter aortic valve replacement (TAVR) programs. The MEDAC will specifically focus on appraisal of the state of evidence for surgical aortic valve replacement (SAVR), TAVR, percutaneous coronary intervention (PCI) and other relevant structural heart disease procedural volume requirements. In May 2012, CMS finalized a national coverage determination (NCD) for TAVR (Pub. 100-03, 20.32 ) ( https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355 ) that established specific requirements for coverage, including procedural volume requirements hospitals must meet to begin and maintain TAVR programs. The MEDCAC panel will examine the scientific evidence pertaining to procedural volume requirements for SAVR, TAVR, PCI and other relevant structural heart disease procedures as they relate to TAVR programs. The MEDCAC panel will assess whether scientific evidence supports requiring hospitals and heart team members to meet pre-specified volume requirements for these procedures in order to begin and maintain TAVR programs. This meeting will also explore the challenges and potential unintended consequences that may result from such pre-specified procedural volume requirements. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS on procedural volume requirements for hospitals and heart team members with both new and continuing TAVR programs that treat Medicare beneficiaries. MEDCAC panels do not make coverage determinations, but CMS benefits from their advice. Minutes: Download meeting minutes . Other Material: Transcript 1 Panel Voting Questions: Download scoresheet Medicare Evidence Development & Coverage Advisory Committee Transcatheter Aortic Valve Replacement July 25, 2018 The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel will examine the scientific evidence pertaining to procedural volume requirements for surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) as they relate to TAVR programs. The MEDCAC panel will assess whether scientific evidence supports requiring hospitals and heart team members to meet pre-specified volume requirements for these procedures in order to begin and maintain TAVR programs. This meeting will also explore the challenges and potential unintended consequences that may result from such pre-specified procedural volume requirements. TAVR is a technology for use in treating aortic stenosis. A bioprosthetic valve on a catheter is delivered through an intravascular or transapical approach and implanted in the orifice of the native aortic valve. Minimum procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs are included in the 2012 expert consensus statement on TAVR operator and institutional requirements [1] and are referenced in the 2012 national coverage determination (NCD) for TAVR (Pub. 100-03, 20.32) [2] . Voting Questions For each voting question, 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 Hospital Requirements to Begin TAVR Programs How confident are you that there is sufficient evidence that a certain threshold of SAVR procedural volumes must be required for hospitals without previous TAVR experience to begin TAVR programs? How confident are you that there is sufficient evidence that a certain threshold of PCI procedural volumes must be required for hospitals without previous TAVR experience to begin TAVR programs? How confident are you that the benefits of meeting procedural (i.e., SAVR, PCI) volume requirements to begin a TAVR program outweigh the harms of limiting access to TAVR to only hospitals that meet volume requirements? Hospital Requirements to Maintain TAVR Programs How confident are you that there is sufficient evidence that a certain threshold of SAVR procedural volumes must be required for hospitals with TAVR experience to maintain TAVR programs? How confident are you that there is sufficient evidence that a certain threshold of PCI procedural volumes must be required for hospitals with TAVR experience to maintain TAVR programs? How confident are you that the benefits of meeting procedural (i.e., SAVR, TAVR, PCI) volume requirements to maintain a TAVR program outweigh the harms of limiting access to TAVR to only hospitals that meet volume requirements? Operator Requirements to Begin TAVR Programs To begin performing TAVR , how confident are you that there is sufficient evidence that a certain threshold of SAVR and TAVR procedural volumes must be required for the principle cardiovascular surgeon on a TAVR heart team? To begin performing TAVR , how confident are you that there is sufficient evidence that a certain threshold of structural heart disease procedural volumes must be required for the principle interventional cardiologist on a TAVR heart team? Heart Team Requirements to Maintain TAVR Programs To maintain proficiency , how confident are you that there is sufficient evidence that a certain threshold of TAVR procedural volumes must be required for: The principle cardiovascular surgeon on a TAVR heat team? The principle interventional cardiologist on a TAVR heart team? The combined experience of the principle cardiovascular surgeon and interventional cardiologist on a TAVR heart team? Additional Discussion Topics Do hospital volume requirements create unintended barriers to TAVR based on any of the following: Geographic location (both rural and urban) Gender Ethnicity Race Socioeconomic status Provider preference (i.e., when a patient prefers to work with their long time/trusted physician whose hospital does not meet volume requirements instead of transferring to one that does with an unknown physician team) Hospital setting (community hospital vs. academic medical center/tertiary referral center) [1] Tommaso C, Bolman R, Feldman T, et al . SCAI/AATS/ACCF/STS multisociety expert consensus statement: operator & institutional requirements for transcatheter valve repair and replacement; part 1 TAVR. Journal of the American College of Cardiology 2012 February 29 [Epub ahead of print]. PMID: 22387052 [2] https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355 Roster: Committee Chair Peter Bach, MD, MAPP Attending Physician & Director Center for Health Policy and Outcomes Memorial Sloan-Kettering Cancer Center Committee Vice-Chair Aloysius B. Cuyjet, MD, MPH Medical Director HealthCare Partners, IPA MEDCAC Members Michael P. Cinquegrani, MD Professor Department of Medicine & Radiology Division of Cardiovascular Medicine Director of Heart and Vascular Service Line The Medical College of Wisconsin Gregory Joseph Dehmer, MD Director Quality and Outcomes Cardiovascular Institute Carilion Clinic - Cardiology Anita Fernander, PhD, ABPBC Associate Professor Director of Graduate Studies Chair, Lexington Fayette-County Health Disparities Coalition Department of Behavioral Science College of Medicine University of Kentucky Naftali Zvi Frankel Patient and Consumer Advocate Smadar Kort, MD, FACC, FASE, FAHA Professor of Medicine Director, Valve Center Director, Non-Invasive Cardiac Imaging Director, Echocardiography Stony Brook University Hospital Division of Cardiology, HSC T16-080 Sandra J. Lewis, MD Director Research and Prevention Northwest Cardiovascular Institute Daniel A. Ollendorf, PhD Chief Scientific Officer Institute for Clinical and Economic Review Zoltan Turi, MD, MPH, MSCAI Professor of Medicine Co-Director, Structural Heart Program Co-Director, Cardiac Catheterization Laboratory Hackensack University Hospital Seton Hall University Medical School Industry Representative Mark D. Carlson, MD, MA Division Vice President Chief Medical Officer Abbott Laboratories Guest Panel Members Patrice Desvigne-Nickens, M.D. Medical Officer Heart Failure and Arrhythmias Division of Cardiovascular Sciences National Heart, Lung, and Blood Institute Invited Guest Speakers Joseph E. Bavaria, M.D. Past President Society of Thoracic Surgeons Brooke Roberts-William M. Measey Professor of Surgery Vice-Chief Division of Cardiovascular Surgery Surgical Director, Heart and Vascular Center Director, Thoracic Aortic Surgery Program Penn Heart and Vascular Center Perelman Center for Advanced Medicine Aaron Horne, Jr., MD, MBA, MHS Structural Interventionalist Board Member Association of Black Cardiologists Martin B. Leon, MD Professor of Medicine and Director Center for Interventional Vascular Therapy Columbia University/NY Presbyterian Hospital Founder & Chairman Emeritus Cardiovascular Research Foundation NY City Peter Pelikan, MD, FACC, FSCAI Medical Director Cardiac Catheterization Lab and Structural Heart Program Pacific Heart Institute and Providence Saint Johns Health Center Carl L. Tommaso, MD Cardiologist NorthShore Medical Group CMS Liaison Daniel Arthur Caños, PhD, MPH Director Evidence Development Division Coverage and Analysis Group Center for Clinical Standards and Quality Executive Secretary Maria Ellis Coverage and Analysis Group Speaker List: Medicare Evidence Development & Coverage Advisory Committee July 25, 2018 SPEAKER LIST *5 MINUTES PER SPEAKER* Ted Feldman, MD, MSCAI, FACC, FESC - Representing: The Society for Cardiovascular Angiography and Interventions John D. Carroll, MD FACC MSCAI, Professor of Medicine, University of Colorado School of Medicine – Representing: The American College of Cardiology David M. Shahian, MD, Professor of Surgery, Harvard Medical School, Chair, STS Council on Quality, Research, and Patient Safety Thoralf Sundt, MD, Chief of Cardiac Surgery, Massachusetts General Susan Strong, Heart Valve Survivor, President, Heart Valve Voice-US – No PowerPoint Donnette Smith, Heart Valve Survivor, President, Mended Hearts Marilyn Serafini, Executive Director, Heart Valve Voice - Due to unforeseen circumstances Ms. Serafini will be unable to attend. Steven L. Goldberg, MD, Director, Structural Heart Disease, Tyler Heart Institute, Community Hospital of the Monterey Peninsula Larry L. Wood , Corporate Vice President, Edwards Lifesciences A. Pieter Kappetein, MD, PhD, Chief Medical Officer, Medtronic Structural Heart and Cardiac Surgery Megan Coylewright, MD, MPH, Associate Director, Structural Heart Disease Program, Heart & Vascular Center, Dartmouth-Hitchcock Medical Center Visitor Screening Procedures: Screening procedures will require visitors to empty pockets, remove belts, hats, outerwear jackets (not suit jackets nor sports coats), and large pieces of jewelry and place in provided bins for x-ray screening. Small and loose items (e.g., purses, laptop computers, cell phones) will be placed in bins and larger items (e.g. computer bags) may be placed directly onto the conveyer. All items being carried into the building will require x-ray screening. After all items are placed on the conveyer, visitors will proceed through the walk-through metal detector. If the detector alarms, a security guard will use a wand to clear the alarm. If that clears the alarm, screening is complete and the visitor may enter the facility. In the event that the wand does not clear the alarm, the security guard will physically check the area of the body where the alarm is located. Anytime there is an alarm over a sensitive area of a person's body, the officer will use the back of his/her hands to clear the area. If footwear alarms, then footwear will need to be removed and placed in a bin for x-ray screening. Disabled visitors using a mobility aid (e.g. wheel chair, motorized scooter) that cannot pass through the walk-through metal detector will bypass the device and undergo screening by the officer using a wand and/or pat down.