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July 25, 2018

Edwards Responds to MEDCAC Panel Meeting on Procedural Volume Requirements for TAVR

July 26, 2018—Edwards Lifesciences commented on the US Centers for Medicare & Medicaid Services’ (CMS) advisory panel regarding evidence pertaining to procedural volume requirements for transcatheter aortic valve replacement (TAVR) programs.

On July 25, CMS convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to seek MEDCAC's recommendations regarding procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. MEDCAC specifically focused on an appraisal of the evidence for TAVR, surgical aortic valve replacement, percutaneous coronary intervention, and other relevant structural heart disease procedural volume requirements.

Edwards issued the following statement:

“Today’s advisory panel meeting provided a review of current and possible future impacts of volume requirements on TAVR centers in the United States. In the absence of definitive evidence linking high volumes of procedures to high-quality outcomes for TAVR patients, we continue to believe the best course of action is to focus on defined quality measures for both new programs and also those continuing to offer this life-saving, less-invasive therapy.

“Our priority is assuring that all people with heart valve disease have equitable access to all treatment options. The primary risk for severe aortic stenosis patients face today does not come from complications during treatment; rather, it comes from not receiving treatment at all. We believe access to both TAVR and surgical valve replacement procedures should be thoughtfully expanded, based on the needs of the patient community, but restricted to programs that deliver high-quality outcomes.”

CMS opened the national coverage analysis (NCA) of the national coverage determination for TAVR in late June, and it is accepting initial public comments through July 27. CMS expects to complete the NCA within the next 12 months. The CMS tracking sheet for the TAVR NCA is online here. Background of the discussion was provided in the announcement of the panel meeting reported here on July 2.

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July 26, 2018

SCAI Comments on CMS MEDCAC Panel Regarding TAVR

July 26, 2018

SCAI Comments on CMS MEDCAC Panel Regarding TAVR