Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major Depressive Disorder.
Treatment: Transcranial Magnetic Stimulation.
The insurer denied coverage for Transcranial Magnetic Stimulation.
The denial is overturned. 

This is a male patient who reportedly had depressive symptoms including depressed mood, anhedonia, low energy with difficulty getting out of bed, hopelessness, concentration problems, decreased libido, and he had a diagnosis of Major Depressive Disorder in addition to Generalized Anxiety Disorder. He also had a past reported suicide attempt. The patient had multiple past antidepressant trials without sustained efficacy or with side effects including Fluoxetine, Sertraline, Venlafaxine, Desvenlafaxine, Duloxetine, Fetzima, Viibryd, Trintellix, and Amitriptyline, as well as augmenting medications of Aripiprazole, Rexulti, Quetiapine, Olanzapine, Vraylar, and Lamotrigine. He reportedly had successful transcranial magnetic stimulation (TMS) therapy in the past. He had a history of seizures and takes anti-seizure medications Depakote and Vimpat. The request was for TMS again.

The insurer denied the request for TMS stating that having a history of seizures is a contraindication for TMS. This reviewer disagrees with the decision to deny the request for TMS therapy. 

TMS therapy has been cleared by the Food and Drug Administration (FDA) and is indicated for the treatment of Major Depressive Disorder in patients who failed or who did not have satisfactory improvement from 1 past antidepressant medication at or above minimal effective dose and duration in the current episode. In this case this patient had another major depressive episode after reported remission from major depression after past TMS therapy so TMS was considered appropriate and medically necessary treatment again. He reportedly tried and failed multiple classes of antidepressant medication. He reportedly responded to past TMS therapy and had no reported adverse effects and had not reported a seizure for many years as he was being treated with anti-seizure medications. 

Stultz and Osburn, state seizures if present are usually self-limiting and that they are rare. They noted that most treatment recommendations are supportive in nature and that the risk of TMS related seizures is less than 1% and that TMS therapy has successfully been used in patients with epilepsy/seizures, traumatic brain injury (TBI), and prior TMS related seizures. They stated that the rate of TMS related seizures was comparable to most psychotropic medications; and they also stated that while having a seizure is a rare adverse effect of TMS, the benefits of treating refractory depression with TMS may outweigh risks of possible adverse effects. The only reported absolute contraindication of TMS is a ferromagnetic metal in the head or neck as epilepsy is considered a relative contraindication and not an absolute contraindication. It was reported that the FDA stated that patients with seizures should be closely monitored when having TMS therapy. 

Although the health care plan acted reasonably and with sound clinical judgment, it did not appear that denying TMS was in the best interests of the patient considering the risks of worsened depression and suicide risk. The patient had past efficacy and no past reported seizures after TMS therapy and is being treated for seizures and has not had one for many years. The risk of treatment refractory depression in a patient with current major depressive episodes with a history of a past suicide attempt is higher than the medical risks of potential seizures in a patient being treated for seizures who did not have a past TMS related seizure from his past TMS treatment.

The carrier's denial of coverage for Transcranial Magnetic Stimulation is overturned. The medical necessity is substantiated.