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| Medical Policy: | S-51-004 |
| Topic: | Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy |
| Section: | Surgery |
| Effective Date: | April 9, 2018 |
| Issue Date: | July 9, 2018 |
| Last Reviewed: | June 2018 |
Responsive neurostimulation (RNS) for the treatment of epilepsy involves the use of one (1) or more implantable electric leads that serve as 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 U.S. Food and Drug Administration (FDA) approval for the treatment of refractory partial epilepsy. |
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. |
RNS may be considered medically necessary for individuals with partial epilepsy who meet ALL of the following criteria:
- Are 18 years of age or older; and
- Have a diagnosis of partial-onset seizures with one (1) or two (2) well-localized seizure foci identified; and
- Have an average of three (3) or more disabling seizures (e.g., motor partial seizures, complex partial seizures, or secondary generalized seizures) per month over the prior three (3) months; and
- Are refractory to medical therapy (have failed two (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 eloquent cerebral cortex; have bilateral temporal epilepsy); and
- Do not have any of the following contraindications for RNS placement :
- Three or more specific seizure foci; or
- Presence of primary generalized epilepsy; or
- Presence of a rapidly progressive neurologic disorder.
RNS is considered experimental investigational and/or unproven for all other indications. Scientific evidence does not support the use of RNS for all other indications.
| Place of Service: Inpatient/Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
10/2015, New clinical criteria established for Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
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