Appeal type: Experimental/Investigational
Decision: Upheld

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

The patient is an adult female with a history of a stroke and residual deficit in the left arm. The patient has very limited function in her left arm. She had rehabilitation after her stroke after which she continued to have a deficit. The treating provider is requesting to implant a Vivistim, a vagus nerve stimulator (VNS). 
 
There is scientific evidence showing that implantable VNS can improve health outcomes. However, the studies for VNS were not large studies, the outcomes were not that significant when compared to rehabilitation alone, and not all individuals responded to the treatment with VNS. 

Vivistim has been approved by the Food and Drug Administration (FDA), based on a study done by Dawson et al., 2021: Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet, 397(10284): 1545-1553. Despite FDA approval, it is not standard of care. 

The patient has upper extremity deficits as in studies performed for VNS, however, the patient has had her deficit for about three years. The studies do not indicate there were participants with strokes greater than two or three years. Thus, this patient would not be a good candidate for the implantable vagus nerve stimulation. 

This is not the best available treatment at this time for this patient. There is not enough evidence in peer-reviewed literature to support VNS in a patient with a stroke approximately three years ago. 

The adverse risks are increased over standard treatment/services. As with any surgery, there are adverse risks, such as infection, or other complications. 

This is a young person with upper extremity motor deficit who failed conventional rehabilitation. Although promising, implantable vagus nerve stimulation is a novel treatment and is not well supported at this time. 

"One such targeted strategy uses brief bursts of VNS paired with rehabilitation to enhance plasticity and support recovery of upper limb function after chronic stroke. Stimulation of the vagus nerve triggers release of plasticity promoting neuromodulators, such as acetylcholine and norepinephrine, throughout the cortex. Timed engagement of neuromodulators concurrent with motor training drives task-specific plasticity in the motor cortex to improve function and provides the basis for paired VNS therapy. A number of studies in preclinical models of ischemic stroke demonstrated that VNS paired with rehabilitative training significantly improved the recovery of forelimb motor function compared to rehabilitative training without VNS. The improvements were associated with synaptic reorganization of cortical motor networks and recruitment of residual motor neurons controlling the impaired forelimb, demonstrating the putative neurobiological mechanisms underlying recovery of motor function. These preclinical studies provided the basis for conducting two multi-sites, randomized controlled pilot trials in individuals with moderate to severe upper limb weakness after chronic ischemic stroke. In both studies, VNS paired with rehabilitation improved motor deficits compared to rehabilitation alone. The trials provided support for a 120-patient pivotal study designed to evaluate the efficacy of paired VNS therapy in individuals with chronic ischemic stroke." (Engineer et al., 2019) 

The requested service is not 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.