Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: right frontal arteriovenous malformations (AVM)
Treatment:  implantation of Vivistim paired vagus nerve neurostimulator 
The health plan denied the implantation of Vivistim paired vagus nerve neurostimulator.
The health plan's determination is overturned.

The patient is a female with a past medical history of migraines and right frontal arteriovenous malformations (AVM) status/post (s/p) multiple embolizations and gamma knife radiation. She presented for cerebral angioembolization followed by craniectomy with resection complicated with intra cranial hemorrhage and underwent right hemicraniectomy, Left intracranial (ICP) bolt monitor and evacuation of intracerebral hemorrhage (ICH). The patient developed left sided hemiparesis and dysphagia. She was discharged to a neurorehabilitation center with some improvement. The request is for Vagal nerve stimulator using Vivistim technology for left upper extremity weakness.

The proposed health service or treatment is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

There is literature supporting the use of vagus nerve stimulation (VNS) with patients with ischemic stroke complications in Randomized controlled studies below. The patient has exhausted conservative management options and her only option would be a VNS device. Given the literature and outcomes, the VNS is medically necessary for this patient.

Background: Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke.
Methods: In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the United Kingdom (UK) and the United States of America (USA), participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned one to one (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by Research Point Global (Austin, Texas, USA) using statistical analysis software (SAS) Institute Software, with stratification by region (USA versus (vs) UK), age (less than or equal to (<=)30 years vs greater than (>)30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20-35 vs 36-50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were done with the intention to treat. This trial is registered at ClinicalTrials.gov, National Clinical Trial (NCT) 03131960.
Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5 points (standard deviation (SD) 44) in the VNS group and by 2 to 4 points in the control group (between group difference 2 to 6, 95 percent (%)). After 90 days of in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%). There was one serious adverse event related to surgery (vocal cord paresis) in the control group.

Interpretation: Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke. (Dawson 2022.) 

The health plan's determination regarding the proposed health service or treatment is overturned in whole.