Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Major depressive disorder, treatment refractory depression.
Treatment: Vagus Nerve Stimulation (Pre-Service).
The insurer denied the Vagus Nerve Stimulation (Pre-Service).
The denial is overturned.

This case involves an adult male diagnosed with major depressive disorder and
treatment refractory depression that spans several decades. The patient has had
recurrent episodes of major depressive disorder with multiple medication trials
without response or remission, as well as treatment with electroconvulsive therapy
(ECT) and repetitive transcranial magnetic stimulation (rTMS). The patient has
received treatment with selective serotonin reuptake inhibitors (SSRIs), Wellbutrin,
tricyclic antidepressant, and Remeron with augmentation and in combination with
psychotherapy including cognitive behavioral therapy (CBT). The treatment with
electroconvulsive therapy (ECT) resulted in adverse effects with memory loss or
impairment resulting in discontinuation of treatment, and transcranial magnetic
stimulation (TMS) with a total of 36 treatment sessions resulted in a lack of
response despite tolerability for the procedures. Augmentation with mood stabilizers
including lithium, divalproex, and gabapentin were not beneficial, and did not
produce a sustained response or remission of symptoms. The patient is currently
treated with lorazepam and continued psychotherapy. Additionally, the patient has a
history of at least one psychiatric hospitalization for severe depression.

The patient has comorbid chronic neck pain which had onset at the same time of
the depressive disorder. The patient is prescribed meloxicam. There are no other
comorbid conditions including substance use disorder.

The patient's treating clinician has recommended placement of a cranial nerve
neurostimulator for vagal nerve stimulation in order to address the treatment
refractory depression (TRD). The adjunctive treatment with vagus nerve stimulation
(VNS) therapy for depression is expected to result in significant and sustained
benefit in concert with continued use of antidepressant medication and/or other
medications currently prescribed, as well as ongoing psychotherapy and pain
management.

Yes, the health plan should cover the proposed vagus nerve stimulation.
The requested treatment is reasonable, in the best interest of the patient and
reflects sound medical judgment. The use of vagus nerve stimulation (VNS) therapy
in this case scenario is consistent with prevailing standards of medical practice.
Thus, the request for vagal nerve stimulator placement and related services with
vagus nerve stimulation (VNS) therapy should be covered under the plan.

Yes, the requested vagus nerve stimulation is more beneficial than any standard
treatment for the insured's condition or disease.
Based on sound medical judgment, the requested implantation of a vagal nerve
neurostimulator electrode (64568) and initial and continued vagus nerve stimulation
(VNS) therapy (revenue codes 95976 and 95977) for the adjunctive treatment of
recurrent and severe major depressive disorder associated with treatment
refractory depression is clinically appropriate, in the best interest of the patient and
reasonable, as the existing scientific literature does support the use of adjunctive
vagus nerve stimulation (VNS) therapy for treatment refractory depression in this
case scenario.

The existing scientific literature does support the use of vagus nerve stimulation
(VNS) therapy as an augmentation strategy for the treatment of refractory
depression. The procedure being requested, placement of a stimulator and use of
vagus nerve stimulation (VNS) therapy, is consistent with existing reports or trials
that have evaluated the efficacy of this type of therapy in patients with major
depressive disorder and treatment refractory depression. The use of vagus nerve
stimulation (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, and
accordingly in view of the patient's lack of durability with electroconvulsive therapy
(ECT) or repetitive transcranial magnetic stimulation (rTMS). The requested
implantation of a vagal nerve neurostimulator electrode for vagus nerve stimulation
(VNS) therapy is consistent with the current clinical use of this type of therapy in the
approach to treatment of refractory depressive disorder and in keeping with the
scientific literature with regard to maintenance therapy of depression in this case
scenario. In summary, the requested benefit of vagus nerve stimulation (VNS)
therapy in this case is not considered experimental or investigational or unproven
as the health plan asserts in the denial. The requested service is consistent with
prevailing standards of medical practice for the treatment of recurrent and severe
major depressive disorder and refractory depressive disorder.

As indicated in the appeal, the argument that the scientific literature supports the
medical necessity for the procedure and that vagus nerve stimulation (VNS) therapy
is clinically appropriate and medically necessary is a reasonable one. The patient's
clinician argues that vagal neurostimulator placement is medically necessary to
achieve and continue more effective treatment in view of the patient's history of
refractory depression and long-term major depressive disorder and treatment failure
with multiple medication trials with augmentation as indicated in the clinical
summary as well as failure to benefit from electroconvulsive therapy (ECT),
transcranial magnetic stimulation (TMS) and psychotherapy support the use of
vagal neurostimulator placement and therapy.

Thus, the requested treatment does provide greater net benefit than any other
standard treatment available in keeping with the scientific literature and published
guidelines, referenced below.