Yesterday was a big day for Transcatheter Aortic Valve Replacement (TAVR) therapy in the U.S. The Centers for Medicare and Medicaid Services (CMS) announced approval of a National Coverage Determination (NCD) of TAVR. The announcement follows an analysis based on an NCD request from the ACC and The Society of Thoracic Surgeons (STS) in late 2011.

The NCD covers TAVR when performed with a FDA-approved device consistent with labeled indications and any other FDA requirements. In addition, it permits Medicare coverage only in facilities meeting certain requirements. The NCD also requires all patients to be included in a national TAVR registry. Medicare coverage will be available for non-FDA-approved indications when performed in a CMS-approved clinical study.

In a statement, the ACC commended CMS on its decision and its comprehensive approach to the introduction of TAVR. This means that this transformative technology will be available to Medicare patients who do not have other options for treating severe, debilitating aortic stenosis. We also agree with CMS’s decision to structure the NCD in a manner that supports access to TAVR while ensuring that services are performed by the best qualified team of physicians and hospitals. We hope this NCD proves to be a successful model for providing rapid access to promising new technologies for Medicare beneficiaries while focusing on patient safety, quality care and outcome.

Earlier in the day, I also participated in an STS/ACC joint Town Hall meeting to discuss the ASCERT study which was presented at ACC.12 (read a previous blog post on the study here and listen to a recording of the town hall meeting here). Although the study has caused some controversy, all of the panelists, which included Dr. Jeff Rich, president of STS, Drs. William Weintraub and Fred Edwards (principal investigators) and others,  underscored the importance of the heart team approach to shared decision making with patients and transparent discussions to determine which revascularization procedure is best suited for a particular patient with multivessel coronary artery disease.

This same “heart team” approach has been apparent throughout the introduction of TAVR into the U.S. Over the past year, the ACC has worked with STS, SCAI and other professional societies on several clinical documents and recommendations in order to effectively and appropriately introduce this new therapy. In addition, the STS/ACC TVT Registry was developed as a collaboration between STS and ACC, also working with CMS, the Food and Drug Administration, Edwards Lifesciences and others.

It is gratifying to see this “heart team” approach starting to take hold. Congratulations to all involved in making this a reality; a victory for our patients.

For more TAVR news and updates and links to additional clinical documents, visit CardioSource.org/TVT.

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