DESCRIPTION
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.
Responsive neurostimulation shares some features with deep brain stimulation but is differentiated by its use of direct cortical stimulation and by its use in both monitoring and stimulation. The responsive neurostimulation system provides stimulation in response to detection of specific epileptiform patterns, while deep brain stimulation provides continuous or intermittent stimulation at preprogrammed settings.
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.
POLICY
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.
MEDICAL APPROPRIATENESS
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
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
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. (5:2023) Responsive neurostimulation for the treatment of refractory partial epilepsy (7.01.143). Retrieved January 29, 2024 from www.bcbsaoca.com/eps/. (27 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, 10, 2191–2200. (Level 1 evidence)
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)
Morrell, M, et al. (2011). Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 77, 1295. (Level 1 evidence)
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.
Xue-Ping, W., Hai-Jiao, W., Li-Na, Z., Xu, D., & Ling, L. (2019). Risk factors for drug-resistant epilepsy: A systematic review and meta-analysis. Medicine, 98 (30), e16402. (Level 1 evidence)
MOST RECENT REVIEW DATE: 3/14/2024
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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