Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Seizures.
Treatment: Vagal Nerve Stimulator (procedure code 64568 x1), pre-service.

The insurer denied the Vagal Nerve Stimulator (procedure code 64568 x1), pre-service.  The denial is overturned.

The patient is a male with intractable epilepsy. He has three seizure types: generalized tonic clonic, staring with unresponsiveness, and tonic seizures. He receives treatment with epidiolex, valproic acid, clonazepam, clobazam, and levetiracetam.  His electroencephalogram (EEG) shows diffuse slowing with frequent bilateral independent and bisynchronous spikes and sharp waves. His neurologist recommended a vagus nerve stimulator. 

The request for the vagus nerve stimulator was denied by the plan, due to not meeting policy criteria requiring documentation that the patient had failed surgery for epilepsy or was not a surgical candidate. In addition the denial letter stated that the documentation did not show that the device which is requested is a Food and Drug Administration (FDA) approved device.   

This denial was appealed by the treating physician.  An addendum was made to a clinic note providing the following information: The patient has a multifocal epilepsy with electroencephalogram (EEG) features of Lennox-Gastaut syndrome. His magnetic resonance image (MRI) of the brain did not show any focal abnormalities. Based on the evaluation which included ictal and interictal electroencephalogram, magnetic resonance image, and the history and description of seizures, the patient is determined not to be a candidate for epilepsy surgery.  

Yes, the proposed treatment is medically necessary.

Vagus nerve stimulation (VNS) is a standard of care treatment for patients with intractable epilepsies who failed epilepsy surgery, are not candidates for epilepsy surgery or who decline epilepsy surgery.  Vagus nerve stimulation (VNS) is Food and Drug Administration (FDA) approved for treatment of focal epilepsies.  Though initially developed for focal epilepsies, this device is used in other epilepsy types, including generalized epilepsy and Lennox Gastaut syndrome (LGS). A systematic review and meta-analysis article published in 2021 found data supporting the vagus nerve stimulation (VNS) as safe and effective in patients with Lennox Gastaut syndrome. Another study published studied vagus nerve stimulation (VNS) use across multiple epilepsy types. Vagus nerve stimulation (VNS) is found to be effective both for focal and generalized epilepsies.  

The plan denied the vagus nerve stimulation (VNS) due to a lack of documentation showing the patient is not an epilepsy surgical candidate.  The treating physician addended the documentation and included a statement attesting that the patient is not a surgical candidate. Thus, with this additional information the patient is confirmed to be a candidate for vagus nerve stimulation (VNS). Therefore, the vagus nerve stimulation (VNS) is medically necessary.

The plan denied the vagus nerve stimulation, due to lack of documentation discussing the patient's candidacy for epilepsy surgery.  This documentation is important because vagus nerve stimulation should only be offered once epilepsy surgery has been considered and an evaluation for surgery has taken place.  The additional information provided by the requesting physician was dated the same date as the final denial letter. Thus, per the provided records, the plan had not been provided this information when the final adverse determination was made. Without the statement discussing the patient's candidacy for epilepsy surgery, denial of vagus nerve stimulation (VNS) was appropriate as it is in best interest for the patient to have epilepsy surgery considered prior to being offered a vagus nerve stimulation.