A quartet of physicians’ groups jointly petitioned the Centers for Medicare & Medicaid to request a reimbursement rule for transcatheter mitral valve repair technologies, citing the FDA’s recent approval of Abbott’s (NYSE:ABT) MitraClip mitral valve repair system.
CMS acknowledged the request and launched a national coverage analysis, expecting to issue its formal decision by Aug. 16, 2014. The agency is now seeking public perspectives during a 30-day comment period ending Dec. 18, 2013.
The Medicare regulators are examining TMVR technologies in treatment of mitral valve regurgitation in patients who are too sick or otherwise ineligible for open surgery. That’s great news for Abbott’s MitraClip device, which just last month won FDA approval with that indication and is the only such device on the U.S. market.
Other devices in development include Mitralign’s Mitraalign Annuloplasty, MiCardia’s enCorSQ and TransCardiac Therapeutics’ MitraFlex technologies.
The doc groups estimated that there will likely be fewer than 5,000 TMVR cases performed each year, the vast majority of them for Medicare patients. The technology stands to address some significant concerns in mitral valve repair and to offer new treatment options for patients who have few alternatives.
"TMVR technology is timely as invasiveness and recovery time for the patient have recently become an issue," they wrote in their CMS petition. "Directed coverage of the TMVR procedures will allow previously untreated or untreatable Medicare patients with a diagnosis of mitral regurgitation to receive safe and effective treatment of their disease that has not been available until now."
The letter was signed by the Society of Thoracic Surgeons, the American College of Cardiology, the Society for Cardiovascular Angiography & Interventions and the American Assn. for Thoracic Surgery.