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 overturned.

The patient is a female who suffered an ischemic stroke with resultant loss of function of her left arm. 

Testing was completed for Vivistim Vagus Nerve Stimulation (VNS). Action Research Arm Test (ARAT) was scored 3/18, grip 2/12, pinch 1/18, and gross movement 3; total ARAT total was 9. The Motor Activity Log noted a scale mean score of 10.5/29 and a How Well Scale mean score of 13/29. General Evaluation testing was completed. Fugl-Meyer Upper Extremity Scale noted a score of 7/18, Volitional Movement Mixing Synergy score 1/6, Volitional Movement with Little or No Synergy score 2/6; total score 10/36. Wrist score was 6/10, Hand score was 8/14; total score was 28/66. The Stroke Specific Quality of Life score was 70/100. The patient's Depression score was 34. 

The patient was seen by Physical Therapy for initial consultation for Vivistim and is part of the Vivistim VNS study. She received Botox injections in the left upper extremity with improved tone in her arm. She was noted to have difficulty with cleaning, opening cans and jars and placing dishes away above her head. She ambulated with a single cane. Her exam noted limited left upper extremity shoulder flexion/extension, elbow flexion/extension, wrist flexion/extension and finger extension due to increased flexor synergy. The assessment stated she would benefit from intensive rehabilitation programming and the plan was for 1-2 times a week for three weeks and to follow study protocol. 

In an appeal letter, the provider notes that the stroke has damaged the sensory/motor cortex and she has very limited function in her left arm after using traditional rehabilitation for six months after her stroke. She is left with permanent disability with no other treatment options for her. This impacts her activities of daily living and lifestyle, including parenting a young child and work. He notes the use of the vagus nerve stimulator for chronic upper limb deficit is well understood to improve function, activities, and quality of life. Emergency Care Research Institute (ECRI) issued a favorable technology assessment. There are three randomized clinical trials that demonstrate benefit. 

The U.S. Food and Drug Administration (FDA) approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke (a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms) using VNS in 2021. 

It appears that this young patient has had an ischemic stroke with resultant significant loss of function of her left upper extremity. She would meet FDA recommendation for vagus nerve stimulation and is a good candidate. 

Studies show that there is improvement with use with minimal side effects. She is young and is significantly limited. The vagus stimulator is the best available treatment for the patient at this time given that there are no other treatments available. 

There are no other standard treatment/services besides continued rehabilitation which has not been effective to which there are no adverse risks. VNS carries adverse effects including one wound infection from implantation with resolution, one case of shortness of breath and one case of hoarseness due to vocal cord palsy. There were no serious adverse effects associated with stimulation. 

The requested service is 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 overturned.