The Centers for Medicare & Medicaid Services has approved an add-on payment for NeuroPace’s RNS System, an implantable closed-loop responsive neurostimulator for treating epilepsy.

Add-on payments are awarded to new technologies that provide substantial clinical improvement over current therapies and are in addition to the standard diagnosis-related group payment for a device.

The RNS System received FDA approval last November for the treatment of adults with partial onset seizures in one or two seizure onset zones whose seizures aren’t controlled with two or more antiepileptic drugs.

Physicians can program the detection and stimulation parameters of the implanted neurostimulator to customize therapy for the patient — a unique feature, as other neurostimulation therapies continuously or intermittently stimulate the brain without monitoring the patient’s response or determining the amount of treatment needed, the Mountain View, Calif., company said.

NeuroPace CEO Frank Fischer praised CMS’ decision, saying it would increase access to a needed alternative for people suffering from uncontrolled seizures. “To date, 35 Comprehensive Epilepsy Centers that meet all the qualifications for the highest level of epilepsy care have completed required training and are able to implant the RNS System,” he added.

Of the roughly 2.3 million adults in the U.S. with epilepsy, a third have seizures that are not controlled by existing therapies, according to NeuroPace. — Kellen Owings

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