IV-161-003

Medical Policy:

IV-161-003

Topic:

Responsive Neurostimulation for the Treatment of Refractory Focal (Partial) Epilepsy

Section:

Surgery

Effective Date:

September 28, 2020

Issued Date:

September 28, 2020

Last Revision Date:

September 2020

Annual Review:

September 2020

This policy version was replaced on November 1, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Focal seizures (previously referred to as partial seizures) arise from a discrete area of the brain and can cause a range of symptoms, depending on the seizure type and the brain area involved. Standard therapy for seizures includes treatment with one or more of various antiepileptic drugs (AEDs). Currently, response to AEDs is less than ideal; as a result, a substantial number of patients do not achieve good seizure control with medications alone.

Responsive neurostimulation (RNS), also known as responsive cortical stimulation, for the treatment of epilepsy involves the use of one or more implantable electric leads that serve both a 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 (FDA) approval for the treatment of refractory focal epilepsy in individuals ≥18 years of age. The system consists of an implantable neurostimulator, a cortical strip lead, a depth lead, a programmer and telemetry wand, and a patient data management system.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Responsive neurostimulation (RNS) may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients with focal epilepsy who meet ALL of the following criteria:

Are 18 years or older; AND
Have a diagnosis of focal seizures with 1 or 2 well-localized seizure foci identified; AND
Have an average of 3 or more disabling seizures (e.g., motor focal seizures, complex focal seizures, or secondary generalized seizures) per month over the prior 3 months; AND
Are refractory to medical therapy (have failed 2 or more appropriate antiepileptic medications at therapeutic doses); AND
Are not candidates for focal resective epilepsy surgery (e.g., have an epileptic focus near the eloquent cerebral cortex; have bilateral temporal epilepsy); AND
Do not have contraindications for RNS device placement (e.g., high risk for surgical complications, such as active systemic infection; patients who have medical devices implanted that deliver electrical energy to the brain).

II. Responsive neurostimulation is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

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Denial Statements

No additional statements.

Links

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Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

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