BlueCross BlueShield of Tennessee Medical Policy Manual

Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy

DESCRIPTION

Responsive neurostimulation (RNS) for the treatment of partial 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. 

One device, the NeuroPace RNS® System, has received U.S. Food and Drug Administration approval for treatment of refractory 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

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

In November 2013, NeuroPace received FDA marketing approval through the premarket approval process.  As a condition of approval, NeuroPace is required to conduct five postmarket studies to evaluate the device’s long term safety and efficacy in routine clinical practice.

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 BlueSheild Association. Medical Policy Reference Manual. (4:2017) Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy (7.01.143). Retrieved April 28, 2017 from BlueWeb. (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. Health Technology Assessment Information Service. Emerging Technology Evidence Report. (2015, May) Closed-loop implantable neurostimulation (RNS System) for reducing seizures in refractory epilepsy. Retrieved April 4, 2016. (76 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 P100026A. Retrieved January 22, 2015 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.

ORIGINAL EFFECTIVE DATE:  7/11/2015

MOST RECENT REVIEW DATE:  8/12/2017

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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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