Diagnosis: Ischemic stroke.
Treatment: Implantable vagus nerve stimulation.
The insurer denied coverage for implantable vagus nerve stimulation.
The denial is upheld.

According to the documents reviewed this is a female diagnosed with left spastic hemiplegia and a seizure disorder following a cerebrovascular accident (CVA). The patient underwent rehabilitation after her CVA. She was offered Vivistim, a vagus nerve stimulator (VNS) in order to treat her limb deficit.

All available medical documentation was reviewed.

The scientific evidence in peer-reviewed literature does not support an improvement in health outcomes. There is insufficient peer-reviewed literature to support the use of vagus nerve stimulation for spastic hemiplegia.

The vagus nerve stimulation has been approved by the Food and Drug Administration (FDA), based on the study by Dawson et al. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021; 397 15451553. for spastic hemiplegia. However, there are still limited studies for vagus nerve stimulation.

"VNS Rehab included 108 participants with moderate to severe arm /hand weakness, at least nine months after ischaemic stroke. They were randomised to receive rehabilitation paired with active VNS or rehabilitation paired with sham stimulation (Control). The primary outcome was the change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) score on the first day after completion of in-clinic therapy. We explored the effect of VNS treatment by sex (n=70 males; n=38 females), age (65 or >65 years)), time from stroke (median time, 2 years) and baseline FMA-UE score (<=33 severe, >33 moderate). We assessed whether there was any interaction with treatment. No hypotheses were specified prior to this analysis and no formal adjustment was made for multiplicity." (Dawson et al., 2022)

The patient is not a good candidate for implantable vagus nerve stimulation, given the lack of scientific evidence and clinical data to support it as a standard of care for spastic hemiplegia.

There is not enough clinical evidence to support the use of implantable vagus nerve stimulation for spastic hemiplegia in patients who have had deficits for a longer period of time. The participants in the studies had an average length of time since stroke as less than two years. Therefore, implantable vagus nerve stimulation is not the best available treatment at this time.

The adverse risks are increased over standard treatment/services, as it is an invasive procedure with known complications such as infection.

Studies are small and limited. Furthermore, studies are ongoing for implantable vagus nerve stimulator.

The requested service is not more likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of implantable vagus nerve stimulation should be upheld.