CMS to Cover TAVR for Symptomatic AS

Issue: July/August 2012

Three months after issuing a proposed plan on the coverage of transcatheter aortic valve replacement, CMS has released a decision memo stating it will cover the procedure for patients with symptomatic aortic stenosis.

Similar to the proposed plan, the decision stipulates that five conditions must be met to qualify for reimbursement, some of which have been modified from the proposal:

The procedure is furnished with a complete valve and implantation system that has received FDA premarket approval for the indication.
Two cardiac surgeons have independently examined the patient face-to-face and evaluated the patient’s suitability for surgical aortic valve replacement.
The patient is under the care of a heart team and the procedure is furnished in a facility that meets a determined criteria of experience performing TAVR and surgical aortic valve replacement.
The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
The heart team and hospital are participating in a prospective, national, audited registry that meets an established criteria.

TAVR will also be covered for uses that are not listed as an FDA-approved indication provided all of the following criteria are met:

The heart team’s interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR.
The study must critically evaluate not only each patient’s quality of life pre- and post-TAVR for a minimum of 1 year, but also must address the rates 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 clinical study must adhere to the set standards of scientific integrity and relevance to the Medicare population.
The researcher must submit the complete study protocol, identify the relevant CMS research question(s), cite the location of the detailed analysis plan for those questions in the protocol, and provide a statement addressing how the study satisfies each of the standards of scientific integrity.

The memo also stated that TAVR will not be covered for patients with existing comorbidities that would preclude the expected benefit from the procedure.

Howard C. Herrmann

For those of us who have participated in the PARTNER trials, we are very gratified that CMS has recognized the value of TAVR procedures for our sickest patients with aortic stenosis who are either inoperable or at extreme risk for open aortic valve replacement. It’s not entirely clear from the decision memo whether transapical procedures are going to be covered, but I am hopeful that they will be, as transapical insertion remains an important adjunctive technique that is often needed for patients with inadequate femoral vascular access for the Sapien device (Edwards Lifesciences). Although some payment is better than no payment, TAVR is not a highly profitable procedure for hospitals currently due to the high cost of the valve and the resources needed for safe implantation. However, it is critical to be able to offer this life-extending procedure to our highest-risk patients and the CMS coverage decision will help to expand patient access to it.

– Howard C. Herrmann, MD

Cardiology Today Intervention Editorial Board member

Disclosure: Dr. Herrmann has received research funding to the institution and speaker honoraria from Edwards Lifesciences and is a consultant for and has equity in Micro-Interventional Devices.