How Medicare Decides National Coverage, as TAVR Review for Aortic Regurgitation Advances

The public comment period on whether Medicare should pay for transcatheter aortic valve replacement (TAVR) in patients with aortic regurgitation closed on Oct. 10, 2026, according to the CMS tracking sheet for the review. The Centers for Medicare & Medicaid Services has posted 25 comments on the analysis's public comment page.

The review is a national coverage analysis, the process CMS uses to write a national coverage determination, or NCD. It shows the gap between FDA approval, which allows a device to be marketed, and Medicare coverage, which decides whether the program pays for its use.

Why a separate review

CMS opened the analysis, numbered CAG-00430R3, on Sept. 10, 2026. The tracking sheet says the agency launched it alongside a final NCD on TAVR for aortic stenosis released the same day, and cites public comments and FDA's March 2026 approval of the JenaValve Trilogy system for aortic regurgitation as reasons. The sheet states: "This NCA will only address indications for TAVR for AR." The review was generated internally by CMS rather than by an outside request.

According to CMS's coverage determination process page, Medicare covers items and services that are "reasonable and necessary for the diagnosis or treatment of an illness or injury" and fall within a benefit category. NCDs set national policy through "an evidence-based process, with opportunities for public participation." Where no national policy exists, regional Medicare contractors can decide coverage through local coverage determinations.

The clock

CMS's process page sets deadlines. For a request that does not need an outside technology assessment or a review by its advisory committee, a proposed decision is due no later than six months after the review opens; with either, nine months. The proposed decision is then open for a 30-day comment period, and a final decision follows "not later than 60 days after the conclusion of the comment period."

The TAVR tracking sheet follows that pattern. It lists a proposed decision memo due March 10, 2027, six months after the Sept. 10 start, and an expected completion date of June 8, 2027.

A national decision can also attach conditions. Under coverage with evidence development, or CED, CMS's CED page says the agency "may determine coverage of an item or service only in the context of a clinical study." Coverage then depends on study participation until CMS removes that requirement.

What commenters asked for

The comment page lists submissions from hospitals, physician groups and manufacturers. JenaValve Technology asked for coverage of TAVR for symptomatic severe native aortic regurgitation with FDA-approved valves, either outright or under registry-based CED, and argued surgical risk should be set by the heart team. Edwards Lifesciences recommended a streamlined, time-limited CED with a path to routine coverage. AdvaMed, the device industry group, backed time-limited CED with clear exit criteria. Boston Scientific supported a focused analysis, noting that aortic regurgitation differs from aortic stenosis in anatomy and disease course. Abbott asked CMS to drop mandatory operator volume requirements.

Several clinical groups, including Texas Cardiovascular Specialists and the Miami Cardiac & Vascular Institute at Baptist Health South Florida, supported coverage limited to symptomatic severe cases in patients at high or prohibitive surgical risk, with heart-team evaluation and registry participation.

CMS has not yet released a proposed decision. Once it does, the tracking sheet will open a second comment period before any final memo.