CMS to Cover Transcatheter Mitral Valve Repair Under CED
The Centers for Medicare & Medicaid Services announced August 7 in a decision memo for coverage of transcatheter mitral valve repair (TMVR) that “there is promising but inconclusive evidence whether TMVR improves health outcomes for a defined subset of the Medicare population.”
In light of a national coverage analysis, initiated November 2013, CMS will cover TMVR under Coverage of Evidence (CED) for the treatment of significant symptomatic degenerative MR when furnished according to FDA-approved indications and several other conditions are met (please see the decision memo for details).
MR, according to the decision memo, is the most common type of heart valve insufficiency in the United States. The mitral valve comprises two valve leaflets. MR occurs when these leaflets do not close properly, allowing blood to flow from the left ventricle back into the left atrium. This causes the heart to work harder to pump blood through the body, slowly increasing the size of the left ventricle, and potentially leading to heart failure.
Symptoms can include shortness of breath, fatigue, lightheadedness, cough, heart palpitations, swollen feet or ankles, and excessive urination.
Treatment for TMVR involves reducing MR by clipping together a portion of the mitral valve leaflets. To date, the only U.S. Food and Drug Administration (FDA) approved device is the Abbott Vascular’s MitraClip®.
CMS received 83 comments during the 30-day comment period following the May 15 proposed decision memo. In general, CMS said commenters support coverage of TMVR with CED for FDA-approved indications with specific conditions, and also support coverage of TMVR for non-FDA-approved indications in a clinical study.
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