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July 2, 2018

CMS to Convene MEDCAC Panel to Consider Procedural Volume Requirements for TAVR

July 2, 2018—The Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on July 25, 2018 to seek MEDCAC's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain transcatheter aortic valve replacement (TAVR) programs. 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.

The tracking sheet and full request letter are available online here.

CMS noted that in May 2012, the agency finalized a national coverage determination (NCD) for TAVR (Pub. 100-03, 20.32) that established specific requirements for coverage, including procedural volume requirements hospitals must meet to begin and maintain TAVR programs.

The NCD contains requirements including specific procedural volume requirements for heart teams and hospitals, as well as mandatory participation in a prospective, national, audited registry. The NCD requires TAVR procedures for uses that are not expressly listed as US Food and Drug Administration–approved indications to be performed in clinical studies that meet requirements set forth in the NCD and are approved by CMS.

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 panel will assess whether scientific evidence supports requiring hospitals and heart team members to meet prespecified volume requirements for these procedures in order to begin and maintain TAVR programs.

According to CMS, this meeting will also explore the challenges and potential unintended consequences that may result from such prespecified 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, noted the agency.

Edwards Lifesciences, which is focused on structural heart disease treatments (such as TAVR) as well as critical care and surgical monitoring, issued a press release commenting on the CMS announcement of the National Coverage Analysis. Edwards noted that this development was expected, and the analysis will examine the extensive body of evidence regarding the clinical, economic, and quality-of-life benefits of TAVR.

The company stated that its priority will be to ensure that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. Additionally, the company will continue to engage with CMS and other stakeholders in the finalization of this policy, which will define the future of heart valve patients' access to this life-saving care.

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