Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Monoplegia of Upper Limb (following cerebral infarction). 
Treatment: 64568 Open Implantation of Cranial Nerve, C1827 Generator Neurostimulator (implantable) nonchargeable, with implantable stimulation lead and external paired stimulation controller. 
The insurer denied 64568 Open Implantation of Cranial Nerve, C1827 Generator Neurostimulator (implantable) nonchargeable, with implantable stimulation lead and external paired stimulation controller. 
The denial is upheld.

The records indicate that the patient is an adult male with a history that includes hypertension, hypercholesterolemia, and a posterior circulation stroke with residual left hemiparesis.  The etiology of his stroke was opined to be mechanical from "neck twisting."  He had a complicated course after his stroke which included intubation, tracheostomy, and gastrostomy tube placement.  He underwent extensive rehabilitation.  He ultimately returned to eating orally.  An intrathecal baclofen pump was placed.  He remained tetraparetic. As of 6 months ago, he was using a power mobility device.  He was undergoing ambulation training with a body weight supported, exoskeletal/robot-assisted, gait trainer.  He was using an application on his phone for communication as his voice was very strained.  He was opined to be a good candidate for vagus nerve stimulation for stroke recovery with the Vivistim System implant given his moderate to severe upper limb motor deficits and the lack of any limiting severe spasticity. The health plan denied coverage of the service under review, indicating that the service has not been proven to be effective for the patient's condition. The reason for appeal is that the patient's provider(s) feel that standard care to date has been ineffective and that the proposed intervention would be beneficial for the patient given the medical literature related to the service. 

The health plan should not cover the proposed Vivistim System implant. 

The available literature related to the proposed intervention derives primarily from industry and remains essentially preliminary in nature. The commercial interest behind the intervention, notably, funded and participated in the design and writing of the pivotal trial paper (Dawson J, et al., 2021) upon which the majority of the conclusions related to the intervention are derived. The other available data related to vagus nerve stimulation combined with rehabilitation for stroke recovery derive from mostly very small trials with heterogeneous study populations (ranging from acute to chronic post-stroke), disparate experimental group protocols (including transcutaneous instead of invasive stimulation), disparate control protocols, disparate rehabilitation strategies, and even unmasked outcome assessments (Abdullahi A, et al., 2023; Wang X, et al., 2023).  The authors of one recent review, interestingly, found that results from transcutaneous (noninvasive) vagal nerve stimulation were superior to invasive stimulation, such as the proposed Vivistim System implant, which was reported to the consistent with prior meta-analyses (Wang X, et al., 2023). 
Overall, there are insufficient disinterested data to establish the efficacy and clinical effectiveness of the proposed intervention to support its clinical use, particularly with respect to safety given that it is an invasive intervention. Accordingly, the proposed intervention plays no evidence-based role in stroke management, rehabilitation, or prevention of complications following stroke. A finding of no significant difference in adverse outcomes between experimental invasive and sham invasive arms in trials does not establish the safety of the proposed intervention. The health plan appropriately denied coverage of the requested service given that the service is not proven in the medical literature to be efficacious and clinically effective for this patient's condition to warrant an invasive intervention. The latter issue is especially relevant given that the extant medical literature suggests that noninvasive vagus stimulation therapy may, in fact, be more effective than the invasive intervention that is proposed.