Harvard Pilgrim HealthCare Medical Policy

Transcatheter Mitral Valve Repair (TMVR)

Subject: Transcatheter Mitral Valve Repair (TMVR)

Background: The Plan may cover FDA approved mitral valve system for Members who meet specific guidelines. Mitral regurgitation (MR) is a backflow of blood from the left ventricle to the left atrium due to mitral valve insufficiency. Transcatheter mitral valve repair is sometimes recommended for primary mitral valve disease (MVD) e.g., degenerative mitral regurgitation (DMR), which is usually due to direct damage or wear of the MV leaflets, attached chords, or adjacent supporting tissues. The procedure involves clipping together a portion of the mitral valve leaflets as a treatment for reducing MR with the intended outcome to improve recovery of the heart from overwork, improve function, and potentially halt the progression of heart failure.

Policy and Coverage Criteria:

Tufts Health Plan may authorize an elective transcatheter mitral valve repair when ALL of the following are met:

• The Member has NYHA class III or IV* functional capacity due to Mitral Valve Disease.
• A cardiologist has documented that the Member remains severely symptomatic in spite of optimal medical management and recommends an interventional procedure.
• A cardiothoracic surgeon has documented that the Member is a prohibitive risk for an open mitral valve operation.

New York Heart Association Classification System

Functional Capacity

1. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
2. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
3. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.
4. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Objective evidence of severe cardiovascular disease.

Exclusions:

The Plan does not cover TMVR for members who have moderate or severe mitral valve (MV) regurgitation but are suitable candidates for conventional open MV repair surgery