CMS MEDCAC Panel Reviews Evidence for Hospital and Heart Team Requirements for TAVR Programs

 

July 30, 2018—The Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on July 25 to seek recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain transcatheter aortic valve replacement (TAVR) programs.

As noted in the July 2 announcement of the meeting, the panel specifically focused 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. The CMS National Coverage Analysis tracking sheet is available online here.

Peter Bach, MD, serves as Committee Chair and Aloysius Cuyjet, MD, is Committee Vice Chair. The voting members of the MEDCAC panel are Dr. Cuyjet; Michael P. Cinquegrani, MD; Gregory Joseph Dehmer, MD; Anita Fernander, PhD; Naftali Zvi Frankel (patient and consumer advocate); Smadar Kort, MD; Sandra J. Lewis, MD; Daniel A. Ollendorf, PhD; and Zoltan Turi, MD. The panel heard presentations from practicing medical specialists, researchers, patient advocates, and industry representatives.

Using a scale identifying levels of confidence (1 indicating the lowest level or no confidence, 3 indicating an intermediate level of confidence, and 5 a high level of confidence), the panel voted on questions of hospital and operator requirements to begin and maintain TAVR programs. The MEDCAC scoresheet outlining the voting is available online here.

Regarding hospital requirements to begin TAVR programs, the average of the panel voting members' level of confidence was:

  • 3.78 that there is sufficient evidence that a certain threshold of SAVR procedural volumes must be required for hospitals without previous TAVR experience;
  • 3.44 that there is sufficient evidence that a certain threshold of PCI procedural volumes must be required for hospitals without previous TAVR experience;
  • 3.11 that the benefits of meeting procedural (ie, SAVR, PCI) volume requirements outweigh the harms of limiting access to TAVR to only hospitals that meet volume requirements.

Regarding hospital requirements to maintain TAVR programs, the average level of confidence was:

  • 3.56 that there is sufficient evidence that a certain threshold of SAVR procedural volumes must be required for hospitals with TAVR experience;
  • 3.33 that there is sufficient evidence that a certain threshold of PCI procedural volumes must be required for hospitals with TAVR experience;
  • 3.67 that the benefits of meeting procedural (ie, SAVR, TAVR, PCI) volume requirements outweigh the harms of limiting access to TAVR to only hospitals that meet volume requirements.

Regarding operator requirements to begin TAVR programs, the level of confidence was:

  • 4.33 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;
  • 4.22 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.

Regarding whether there is sufficient evidence that a certain threshold of TAVR procedural volumes must be required, the confidence levels were:

  • 3.33 for the principle cardiovascular surgeon on a TAVR heart team;
  • 4.11 for the principle interventional cardiologist on a TAVR heart team;
  • 3.78 for the combined experience of the principle cardiovascular surgeon and interventional cardiologist on a TAVR heart team.
 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.