BALTIMORE, MD — The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memorandum (draft proposal) for covering the cost of transcatheter mitral-valve repair (TMVR) for the treatment of significant symptomatic mitral regurgitation.
This memo responds to a request of national coverage determination that was jointly issued by four societies—theSociety of Thoracic Surgeons (STS), the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), and the American Association for Thoracic Surgery (AATS)—last November, following the FDA approval of the MitraClip (Abbott Vascular) last October for patients with significant symptomatic mitral regurgitation (MR >3+) who are deemed too high risk for open surgery.
"The four societies stated the importance of establishing (1) regional centers of excellence for heart-valve diseases, (2) multidisciplinary heart teams, (3) a national registry, and (4) training and credentialing criteria," according to the memorandum.
"The scope of our review in this proposed decision memo focuses on the only FDA-approved TMVR device, MitraClip," the memo specifies. "In addition, [it] focuses only on the repair of the mitral valve specifically by clipping the mitral-valve leaflets rather than by annular reduction or by chordal implantation [and] does not include mitral-valve balloon annuloplasty or commissurotomy."
The CMS is seeking comments from the public until June 15 regarding this proposed coverage of TMVR. It will respond in its final decision memorandum.
The memo states that under the proposed coverage, institutions performing TMVR must meet five conditions:
The procedure is performed for an approved indication with an FDA-approved TMVR system.
A cardiac surgeon experienced in mitral-valve surgery and a cardiologist experienced in mitral-valve disease have each examined the patient and provided a rationale for the patient's suitability for the procedure.
Preoperatively and postoperatively, the patient is under the care of a patient-centered heart team, and the hospital has the appropriate infrastructure and heart-team members.
The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TMVR.
The heart team and hospital participate in a prospective, national, audited registry that tracks outcomes and adverse events for at least a year and helps determine long-term (five years or more) device durability and patient outcomes and adverse events.
To cover TMVR for non–FDA-approved indications, the procedure must be part of an FDA-approved randomized clinical trial and meet 13 standards of scientific integrity and relevance to the Medicare population.
"This national coverage proposal represents an important step in improving access to Abbott's MitraClip device for very sick patients, who often have no other treatment options," Dr Chuck Simonton, chief medical officer, Abbott Vascular, said in a statement.
Heartwire from Medscape © 2014 Medscape, LLC
Cite this: CMS Issues Proposed Mitral-Valve Repair Coverage Memo - Medscape - May 19, 2014.