Transcatheter Aortic Valve Replacement (TAVR)

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.

May 10, 2018

May 22, 2018

July 18, 2018

July 24, 2018

July 26, 2018

December 12, 2018

• 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

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

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7:30 – 8:00 AM      

8:00 – 8:15 AM

8:15 - 8:25 AM     

8:25 – 8:55 AM        

8:55 – 9:25 AM

9:25 – 9:55 AM

9:55 – 10:25 AM

10:25 – 10:35 AM

10:35 – 11:45 AM

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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.

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11:45 – 12:00 PM

12:00 – 1:00 PM

1:00 – 2:00 PM  

2:00 – 3:00 PM

3:00 – 4:00 PM  

4:00 – 4:20 PM    

4:20 – 4:30 PM

Download scoresheet

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].

Hospital Requirements to Begin TAVR Programs

1. 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?



2. 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?



3. 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

4. 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?



5. 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?



6. 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

7. 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?



8. 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

9. To maintain proficiency, how confident are you that there is sufficient evidence that a certain threshold of TAVR procedural volumes must be required for:
   1. The principle cardiovascular surgeon on a TAVR heat team?
   2. The principle interventional cardiologist on a TAVR heart team?
   3. The combined experience of the principle cardiovascular surgeon and interventional cardiologist on a TAVR heart team?

• Do hospital volume requirements create unintended barriers to TAVR based on any of the following:
  1. Geographic location (both rural and urban)
  2. Gender
  3. Ethnicity
  4. Race
  5. Socioeconomic status
  6. 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)
  7. 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

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

• 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

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.