LivaNova (NSDQ:LIVN) today announced that the US Centers for Medicare & Medicaid Services are reconsidering a National Coverage Determination covering the use of vagus nerve stimulation technology for treating treatment-resistant depression.
CMS last considered covering VNS treatment for TRD in 2007, but declined the coverage due to “insufficient evidence.”
“In 1999, CMS established coverage of vagus nerve stimulation for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. In 2007, CMS reconsidered the NCD and determined that, at that time, there was insufficient evidence to conclude that vagus nerve stimulation was reasonable and necessary for treatment resistant depression, and VNS for TRD was therefore non-covered,” CMS wrote in its newly posted tracking sheet.
The agency is now reconsidering coverage at the urging of LivaNova, who recommended it based on a wealth of new data which emerged since CMS last declined covering VNS treatment for TRD.
“In the intervening years since the NCD was considered in 2007, a significant body of new evidence has emerged about TRD and the role of VNS Therapy in its treatment. This compelling new evidence addresses the concerns expressed by the Centers for Medicare and Medicaid Services,” LivaNova wrote in its letter to CMS.
LivaNova goes on to provide evidence it believes supports reconsideration of VNS therapy for TRD “as reasonable and necessary for a defined patient subpopulation of medicare beneficiaries,” according to the company’s letter to CMS.
Evidence used to support coverage includes TRD being defined and characterized, that methods to study the effectiveness of TRD treatments have been defined and that new scientific data supports that VNS therapy can be beneficial to patients with TRD.
LivaNova is hopeful that Medicare will change its coverage status to include treatment of TRD, and encouraged others to comment and add evidence towards a shift in coverage.
“Over the last decade, a significant body of new evidence has emerged showing that the addition of VNS Therapy is effective in reducing symptoms in patients with TRD. We look forward to working with CMS as they consider a change in Medicare coverage,” LivaNova wrote in a press release.
Earlier this month, LivaNova saw shares fall despite beating the Street on earnings per share and sales with its first quarter earnings results.