Responsive neurostimulation (RNS) for the treatment of epilepsy involves the use of one or more implantable electric leads that serve both as seizure detection and neurostimulation function. The device is programmed using a proprietary algorithm to recognize seizure patterns from electrocorticography output and to deliver electrical stimulation with the goal of terminating a seizure. Generally, individuals who are candidates for RNS are severely debilitated and have few other treatment options.
One device, the NeuroPace RNS® System, has received U.S. Food and Drug Administration approval for treatment of refractory focal (also referred to as partial) epilepsy. The device includes a neurostimulator that is placed in the skull and leads that are placed in the seizure-originating areas of the brain.
Responsive neurostimulation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Responsive neurostimulation is considered investigational for all other indications.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Responsive neurostimulation is considered medically appropriate if ALL of the following are met:
Diagnosis of focal epilepsy
Age 18 years or older
Failure of two (2) or more antiepileptic medications
No more than two (2) well-localized foci identified
Average of three (3) or more disabling seizures per month over the prior three months
Not a candidate for focal resective epilepsy surgery
ABSENCE of ALL of the following:
Presence of a rapidly progressive neurologic disorder
Presence of primary generalized epilepsy
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
In November 2013, NeuroPace® received FDA marketing approval through the premarket approval process.
Bergey, G., Morrell, M., Mizrahi, E., Goldman, A., King-Stephens, D., Nair, D., et al. (2015). Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology, 84 (8), 810-817. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (4:2018) Responsive neurostimulation for the treatment of refractory focal epilepsy (7.01.143). Retrieved March 19, 2019 from http://www.evidencepositioningsystem.com. (24 articles and/or guidelines reviewed)
Cox, J., Seri, S., & Cavanna, A. (2014). Clinical utility of implantable neurostimulation devices as adjunctive treatment of uncontrolled seizures. Neuropsychiatric Disease and Treatment. 2014:10, 2191-2200. (Level 1 evidence)
ECRI Institute. Emerging Technology Evidence Report. (2015, May) Closed-loop implantable neurostimulation (RNS System) for reducing seizures in refractory epilepsy. Retrieved April 4, 2016 from ECRI Institute. (76 articles and/or guidelines reviewed)
ECRI Institute. Product Brief. (2018, September). NeuroPace RNS Systems (NeuroPace, Inc.) for treating epilepsy. Retrieved March 19, 2019 from ECRI Institute. (9 articles and/or guidelines reviewed)
Heck, C., King-Stephens, D., Massey, A., Nair, D., Jobst, B., Barkley, G, et al. (2013). Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial. Epilepsia. 55 (3), 432-441, (Level 1 evidence)
Larkin, M., Meyer, R., Szuflita, N., Severson, M., & Levine, Z. (2016). Post-traumatic, drug-resistant epilepsy and review of seizure control outcomes from blinded, randomized controlled trials of brain stimulation treatments for drug-resistant epilepsy. Cureus, 8 (8), e744. (Level 1 evidence)
Morrell, M, et al. (2011). Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 77, 1295. (Level 1 evidence)
Rolston, J., Englot, D., Wang, D., Shih, T., M.D. and Chang, E. (2012) Comparison of seizure control outcomes and the safety of vagus nerve, thalamic deep brain, and responsive neurostimulation. Neurosurgery Focus; 32 (3), e14.
U.S. Food & Drug Administration (2013, November). Center for Devices and Radiological Health. Premarket Notification Database P100026 (NeuroPace®). Retrieved January 22, 2015 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 7/11/2015
MOST RECENT REVIEW DATE: 4/11/2019
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