Updated to include that the CMS NTAP also covered Edwards Lifescience’s Intuity suturless aortic valve
The Centers for Medicare and Medicaid Services today released its Final Rule for FY2018 Medicare Inpatient Payment and Policy, granting New Technology Add-On Payment reimbursement for rapid deployment valves, including LivaNova‘s (NSDQ:LIVN) Perceval and Edwards Lifesciences‘s (NYSE:EW) Intuity aortic valves.
London-based LivaNova said that the Perceval sutureless valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technologies.
With the reimbursement approval, CMS will begin to reimburse hospitals for the Perceval valve procedure with the normal Medicare Severeity Diagnosis Related Group payment as well as an additional $6,110.23, LivaNova said.
“We are pleased CMS recognized the significant value of the Perceval valve in the management of aortic valve disease. Numerous publications in the medical literature have demonstrated the benefits of the Perceval valve compared to traditional surgical valves, and this decision will provide greater access to this important new technology. We look forward to continuing to provide the latest and most clinically beneficial technologies to cardiac surgeons and their patients,” cardiac surgery biz medical affairs VP Dr. Brian Duncan said in a press release.
LivaNova said that clinical data from trials of the valve showed that its use resulted in reduced procedure time, decreased postoperative complications and shorter hospital stays. The valve can be used in traditional open surgery as well as minimally invasive surgical approaches.
Edwards also touted the reimbursement decision for its Intuity rapid deployment aortic heart valve, which won FDA approval for the rapidly deployable aortic valve in August, and won CE Mark approval in the European Union in April 2014.
“We are very pleased that CMS has granted an NTAP for the Edwards Intuity valve. This determination reflects that the Edwards Intuity valve represents a new, substantial clinical improvement over conventional technologies. With this decision, we believe that CMS has demonstrated support for patient-focused innovation, enabling hospitals to incorporate advanced technologies into their therapeutic offerings that can help to facilitate minimally invasive surgeries and streamline complex valve procedures for patients,” an Edwards spokesperson wrote to MassDevice.com in an email.
