The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays for procedures using MitraClip for degenerative or primary mitral regurgitation.
The Society of Thoracic Surgeons, the American College of Cardiology, the American Association for Thoracic Surgery, and the Society for Cardiovascular Angiography & Interventions wrote a letter to CMS requesting the change. The letter cites new evidence of the benefits of TMVR for secondary mitral valve regurgitation patients, highlights a need for continued data collection on TMVR and reiterates that TMVR patients should be cared for by a heart team.
CMS said it is also considering scaling back the requirement for randomized controlled trials of non-FDA approved indications of TMVR “to reduce burden and encourage innovation in this space.” They agency is also mulling whether to open the door to covering other TMVR treatments “as this field continues to evolve in the future.”
Abbott acquired MitraClip in the $410 million acquisition of Evalve back in 2009. The device, which is designed to reshape the mitral valve to prevent blood from flowing backward through the valve, won its first FDA nod in 2013.
The medical societies also cited startlingly positive results from the COAPT clinical trial of MitraClip, which were reported in The New England Journal of Medicine in September 2018. And they referenced the March 2019 FDA approval of MitraClip to treat secondary mitral regurgitation.
“As part of an ongoing, patient-centric product development cadence around MitraClip, last month we announced approval for the fourth-generation MitraClip device, MitraClip G4, that puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real-time to offer doctors further options when treating mitral valve disease,” Abbott said in an email to MassDevice.
Abbott’s MitraClip is the only FDA-approved TMVR device, and several companies are vying to bring their own TMVR devices to market. (Read more about them here.) The procedure involves clipping together a portion of the mitral valve leaflets to reduce mitral regurgitation to improve recovery of the heart from overwork, improve function and potentially halt the progression of heart failure.
CMS is seeking public comment on both proposals.