On June 30, CMS proposed to update its national coverage policy for a procedure known as transcatheter edge-to-edge repair (TEER) of the mitral valve to include patients with functional mitral regurgitation (MR).  TEER is a less invasive treatment option that involves clipping together a portion of the mitral valve leaflets for patients with a condition where their mitral valves do not close properly.

The current national coverage determination, effective since August 2014, established coverage of TEER of the mitral valve only for Medicare patients with significant symptomatic degenerative MR under coverage with evidence development (CED) and did not cover patients with functional MR.

Under the coverage proposal announced today, CMS will expand coverage to patients with functional MR so more patients will have access to this procedure. Today’s proposal aligns with the FDA’s 2019 expansion of approved indications for Abbott Vascular’s MitraClip and provides coverage to patients with functional MR.  Additionally, CMS proposes to remove the coverage with evidence development designation  and proposes local Medicare Administrative Contractor (MAC) discretion for coverage of TEER of the mitral valve for patients with degenerative MR.  As a result, providers would no longer need a registry or to participate in a clinical study to furnish this heart procedure to Medicare patients.

“Over the last several years CMS has been closely monitoring the evolution of TEER for the mitral valve and today’s proposed decision is another example of our commitment to ensuring Medicare patients have access to the latest technology,” said CMS Administrator Seema Verma. “We recognize that patients with functional MR have limited treatment options beyond medical therapy and we believe this decision provides them with access to a new treatment option that may lead to improved health outcomes.”

In developing the proposed decision, CMS met with numerous stakeholders including medical professional societies who support the expansion to functional MR and continue to recommend requirements for providers to perform a certain volume of heart procedures.  The proposal is generally consistent with the 2019 Consensus Statement from the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

CMS is seeking comments on the proposed national coverage determination. All public comments may be submitted at https://www.cms.gov/medicare-coverage-database/indexes/nca-open-for-public-comment-index.aspx. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.

To read the proposed decision, visit the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=297

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