Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Treatment Refractory Depression.
Treatment: Vagus Nerve Stimulator.
The insurer denied the Vagus Nerve Stimulator.
The determination is overturned.

The patient has major depressive disorder and treatment refractory depression that spans several years. The patient has received multiple medication trials without a substantial clinical response or remission. The patient has received treatment with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake Inhibitors (SNRIs), Wellbutrin, Remeron, tricyclic antidepressants (TCAs) and Trintellix with augmentation and in combination with psychotherapy with a skilled therapist.
The patient and patient's treating clinician have recommended placement of a cranial nerve neurostimulator for vagal nerve stimulation (VNS) therapy for the treatment refractory depression (TRD). The adjunctive treatment with VNS therapy for depression is expected to result in significant and sustained benefit in concert with continued use of antidepressant medications which is currently Wellbutrin with consideration of the use of thyroid hormone (T3) and/or lithium. The treating clinician has ruled out the use of electroconvulsive therapy (ECT) due to a lack of durability and risk for adverse effects and VNS is favored over transcranial magnetic stimulation (TMS) or Ketamine/Spravato as an augmentation strategy.
The patient's most recently submitted documentation reveals a mental status examination with moderately severe to severe symptoms of depression scoring 27 on the Montgomery-Asberg Depression Rating Scale (MADRS) with normal appearance and behavior, clear speech and linear thought processing, thought content which is devoid of suicidal ideation or morbid thought content, and no severe symptoms of depression including anhedonia, guilt and low self-worth. The patient has a sad and constricted affect and depressed mood, and low levels of anxiety scoring 1 on the generalized anxiety disorder (GAD) 7.
The patient does not have co-morbid psychiatric disorders or co-occurring substance use disorder or an eating disorder. The patient is noted to have problems with regard to social, occupational and daily functioning though she is employed. She is divorced and is socially isolated and her life is devoid of any joy. The health plan has denied the VNS therapy. The health plan documents and correspondence and the plan's coverage language were reviewed. Appeal letters and case summary and consultation notes from the patient's clinician; other appeal documents; and submitted references and materials supporting the use of VNS therapy in this case were reviewed. At issue is the medical necessity for a Vagus Nerve Stimulator.
The requested health service/treatment of vagus nerve stimulator (VNS) is medically necessary for this patient. She has major depressive disorder and treatment refractory depression that spans several years. The existing literature supports the use of VNS therapy as an augmentation strategy for the treatment of refractory depression. The VNS therapy being requested is consistent with existing reports or trials that have evaluated the efficacy or effectiveness of VNS therapy in patients with major depressive disorder and treatment refractory depression. The use of VNS therapy for initial treatment and for maintenance treatment is an appropriate augmentation strategy for depressive disorder in this patient, especially in view of the clinical history and the treatment refractory nature of the case. The requested treatment and implantation of a vagal nerve neurostimulator electrode and VNS therapy is consistent with the current clinical use of VNS therapy in the approach to treatment refractory depressive disorder and in keeping the scientific literature with regard to maintenance therapy of depression. It is consistent with published practice guidelines and the scientific literature referenced below, as well as prevailing standards of professional practice.