CMS Expands Reimbursement for Abbott’s MitraClip to Treat Secondary Mitral Regurgitation

January 20, 2021—Abbott announced that the United States Centers for Medicare & Medicaid Services (CMS) revised its National Coverage Determination (NCD) to expand coverage for transcatheter edge-to-edge repair, also referred to as transcatheter mitral valve repair, to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure.

After MitraClip was first approved by the FDA in late 2013, CMS provided coverage for Medicare patients with primary (degenerative) MR who needed treatment with MitraClip. Similarly, this revised NCD comes after the FDA’s 2019 expanded indication for MitraClip to treat patients with secondary MR.

Additionally, the decision follows the highest MR reduction data for MitraClip reported to date. At the virtual PCR e-Course held online in June 2020, the company announced the presentation of data demonstrating that MR reduction was consistently achieved with MitraClip in patients with either primary MR (to ≤ 1+ in 87.1%) or secondary MR (to ≤ 1+ in 90.1%) at 30 days.

According to Abbott, this NCD revision is critically important to secondary MR patients because most of those impacted by MR are older—one in 10 adults ≥ 75 years experience MR—and therefore rely on Medicare for their health insurance, noted the company.