Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Major Depressive Disorder.
Treatment: continuation of transcranial magnetic stimulation sessions.
The insurer denied coverage for continuation of transcranial magnetic stimulation sessions.
The denial is upheld.

This patient was approved for 36 sessions of Transcranial magnetic stimulation (TMS)  treatment for major depressive disorder (MDD). Treatment response was monitored by administering three scales throughout the treatment: Patient Health Questionnaire (PHQ-9), Beck Depression Inventory-II (BDI-II) and World Health Organization (WHO) - Five Well-Being Index (WHO-5) . 

PHQ-9: 16; 7; 12
PHQ=9 score: 5-9 - mild; 10-14 - moderate; 15-19 - moderately severe; 20-27 - severe.

BDI-II: 38; 14, 19

WHO-5: 0; 19, 5

Repetitive transcranial magnetic stimulation (TMS) is indicated for patients with unipolar major depression who have failed at least one antidepressant medication; in many studies, patients have failed multiple courses of pharmacotherapy and psychotherapy as well as a trial of electroconvulsive therapy, and most patients have suffered prior episodes of major depression. Use of repetitive TMS for treatment resistant/refractory depression is consistent with treatment guidelines from the American Psychiatric Association. In addition, TMS is indicated for patients who responded to a prior course of TMS. The patient was approved for 36 sessions of TMS treatment. 

In TMS gained Food and Drug Administration (FDA) approval for patients with treatment resistant depression. Average number of sessions 30-36. 

Evidence has shown that repetitive transcranial magnetic stimulation (rTMS) can be effective as an acute treatment for major depressive disorder (MDD). However, few studies have examined the safety and feasibility of rTMS as a long-term\continuation treatment. Deep-TMS is a novel tool enabling deeper stimulation than standard coils. The current study examined the safety and feasibility of repetitive deep-TMS continuation treatment for MDD over the course of 18 weeks, following 4 weeks of acute treatment.

The patient showed a partial response after 36 sessions of TMS. electroconvulsive therapy ECT is a very effective treatment for treatment resistant depression. However, because no additional medical records are available, this reviewer is unable to comment if continuation of TMS is the best available treatment for the patient at this time. It is unclear if this is likely to be more beneficial than any standard treatment the adverse risks are not increased.

Repetitive transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. The most serious adverse effect of repetitive TMS is a generalized tonic-clonic seizure. However, the risk of seizure appears to be comparable to that for antidepressant medications, and seizures probably occur in less than 0.1 to 0.5 percent of patients when safety guidelines regarding patient selection and stimulation parameters are followed. Seizures that have occurred were self-limited, required no medications, and did not recur. 

Hypomania and mania have been described in randomized trials as well as case reports of patients with major depression (both unipolar and bipolar) who were treated with repetitive TMS. However, the clinical significance is not known because patients with bipolar major depression can switch to mood elevated states in the absence of an antidepressant treatment. Treatment of unipolar major depression with repetitive TMS does not appear to increase suicidal ideation or behavior. 

Common side effects of repetitive TMS include Headache and scalp pain (generally resolve over the first two weeks). Another potential side effect is vasovagal syncope; management generally consists of reassurance, Transient (<4 hours) increase in auditory threshold. Repetitive TMS in patients with major depression does not impair cognition. 

In sum due to the absence of medical records to support the conclusion that TMS is the best treatment at this time, the carrier's denial of the continuation of transcranial magnetic stimulation sessions should be upheld.