National Coverage Analysis (NCA) Tracking Sheet

Transcatheter Aortic Valve Replacement (TAVR)



Transcatheter aortic valve replacement (TAVR) is a technology for use in treating aortic stenosis. A bioprosthetic valve is inserted via transfemoral, transapical or transaortic approaches using a catheter and implanted in the opening of the native aortic valve or in failed surgical bioprosthetic aortic valves.

Section 20.32 of the Medicare National Coverage Determinations (NCD) Manual states conditions of coverage for TAVR. In 2012, the Centers for Medicare & Medicaid Services (CMS) established coverage of TAVR under Coverage with Evidence Development (CED). For TAVR procedures used to treat symptomatic aortic valve stenosis when furnished according to Food and Drug Administration (FDA)-approved indications, 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 an FDA-approved indication to be performed in clinical studies that meet requirements set forth in the NCD and are approved by CMS.

On July 25, 2018, CMS is convening a panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Through this meeting we are seeking the MEDCAC's recommendations regarding the evidence on procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. For more information see:

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Peter Pelikan, MD, Richard Wright, MD, John Robertson, MD View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
06/27/2018 - 07/27/2018
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
03/26/2019 - 04/25/2019
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Sarah Fulton, MHS
Lead Medical Officers
Joseph Hutter, MD, MA
Carl Li, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

June 27, 2018

CMS initiates this national coverage analysis for TAVR. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at:

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

March 26, 2019

June 21, 2019

Posted final decision memo