CMS Issues Reimbursement Ruling for Abbott Vascular’s MitraClip Device
August 3, 2016—Abbott Vascular announced that the Centers for Medicare & Medicaid Services (CMS) finalized and published its ruling for reimbursement for the company’s MitraClip transcatheter mitral valve repair system. The ruling reassigns MitraClip procedures to diagnosis-related groups 228–229 “Other Cardiothoracic Procedures, with and without major complications or comorbidities (MCCs)” and allows Medicare patients who may benefit from MitraClip to have broader access to the device. The ruling is published and available online in the Federal Register.
In October 2013, the MitraClip received US Food and Drug Administration approval for the treatment of patients with significant symptomatic degenerative mitral regurgitation (MR) who are at prohibitive risk for mitral valve surgery.
Abbott Vascular noted that in August 2014, CMS issued a National Coverage Determination, approval for a New Technology Add-on Payment, and physician reimbursement. Now, Medicare Severity Diagnosis-Related Group reassignment will make hospital MitraClip programs sustainable and demonstrates the government’s commitment to access to innovation for seniors and others in the Medicare program, stated Abbott Vascular.
The MitraClip clip-delivery system is indicated for the percutaneous reduction of significant symptomatic MR (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients in whom existing comorbidities would not preclude the expected benefit from reduced MR and those determined to be at prohibitive risk for mitral valve surgery by a heart team.
The percutaneous MitraClip procedure is a performed as a beating-heart procedure with no cardiopulmonary bypass required. It allows for real-time positioning and repositioning to optimize MR reduction and is designed to preserve surgical options, stated the company.