Both companies won "New Technology Add-On Payment" (NTAP) coverage for their devices, a type of reimbursement that helps cover expensive, breakthrough products that aren’t sufficiently covered under regular classifications. NTAP coverage adds to existing reimbursement for a device through the standard diagnosis-related group classifications.
The coverage decisions will take effect at the beginning of October 2014.
CMS approved NTAP coverage for Abbott’s MitraClip heart valve repair device, which won FDA approval in October 2013 for patients with significant, symptomatic, degenerative mitral valve regurgitation who can’t have surgery to repair the valve. MitraClip is the only transcatheter mitral valve repair or replacement device on the U.S. market, and Medicare proposed coverage for the device earlier this year.
"Approval of this New Technology Add-On Payment recognizes the breakthrough medical innovation of MitraClip and the substantial clinical improvement this technology offers for very sick patients who have no alternative effective treatment options," Abbott Vascular CMO Dr Charles Simonton said in an email to MassDevice.com. "This decision is an important step forward in improving access to the therapy for these vulnerable patients while more appropriate hospital reimbursement for MitraClip is established."
St. Jude won NTAP coverage for the Champion HF implantable heart monitor, a technology it acquired through the $455 million acquisition of CardioMEMS, which just closed in June. The CardioMEMS device is the 1st and only heart failure monitor in the U.S. with FDA approval to help reduce hospital admissions, St. Jude said in prepared remarks.
"We are pleased CMS recognizes the substantial clinical benefit provided by the CardioMEMS HF System," St. Jude group president Dr. Eric Fain said. "This favorable decision helps ensure that Medicare patients have access to this innovative technology as we introduce CardioMEMS as a new treatment paradigm to proactively manage heart failure, improve patient outcomes and reduce hospital admissions."