CMS to cover TAVR for symptomatic aortic valve stenosis

Issue: June 2012

The CMS announced that transcatheter aortic valve replacement will be covered under Coverage with Evidence Development for the treatment of symptomatic aortic valve stenosis when furnished according to an FDA-approved indication.

Perspective from Peter C. Block, MD

The FDA-approved indications include the following five conditions:

The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval for that system’s FDA-approved indication.
Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for open aortic valve replacement surgery and have documented the rationale for their clinical judgment and the rationale is available to the heart team.
The patient is under the care of a heart team preoperatively and postoperatively and the hospital must be furnished with the appropriate infrastructure.
The heart team’s interventional cardiologists and cardiac surgeons must jointly participate in the intraoperative technical aspects of TAVR.
The heart team and hospital are participating in a prospective, national, audited registry that consecutively enrolls TAVR patients; accepts all manufactured devices; follows the patient for at least 1 year; and complies with relevant regulations relating to protecting human research patients.

However, TAVR is also covered for uses not listed as an FDA-approved indication when performed within a clinical study that fulfills the following criteria:

The heart team’s interventional cardiologists and cardiac surgeons must jointly participate in the intraoperative technical aspects of TAVR.
The clinical research study must critically evaluate each patient’s quality of life pre- and post-TAVR and address incidence of at least one of the following: stroke, all-cause mortality, transient ischemic attacks, major vascular events, acute kidney injury or repeat aortic valve procedures.
The study must adhere to standards of scientific integrity and relevance to the Medicare population.
The researchers must submit the complete study protocol, identify relevant CMS research questions that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, as well as providing a statement addressing how the study satisfies each of the standards of scientific integrity.

TAVR is not covered for patients in whom existing comorbidities would preclude the expected benefit from correction of the aortic stenosis.

This coverage approval follows a formal request to the CMS from The Society of Thoracic Surgeons and the American College of Cardiology, which was submitted in September.

Perspective

Peter C. Block, MD

There are both positive and negative issues with the new announcement about CMS coverage of TAVR. First, it will allow us to continue to use TAVR in a commercial way, but within the very restricted parameters that were set up by the PARTNER 1B trial. That will allow inoperable patients with adequate iliofemoral vessels and aortic stenosis to continue to have TAVR, and I am delighted with that. Unfortunately, like so many other things that have to do with payment and governmental oversight, the technology has already moved beyond that. Consequently, many patients who are currently able to have commercial TAVR devices placed via alternative routes, specifically subclavian, transaortic, transapical and transcarotid, because they have bad iliofemoral vascular disease simply will not be covered. Unfortunately, this will prohibit many candidates who could otherwise have safe and effective TAVR because they will not be covered financially. There is the possibility that we will see, in the very near future, a national, ongoing, postmarket-approval registry of all commercial TAVR patients, which may include off-label use.

Peter C. Block, MD

Cardiology Today Section Editor

Disclosures: Dr. Block works at a site (Emory University) for the PARTNER trials.