Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major Depressive Disorder.
Treatment: Transcranial Magnetic Stimulation (TMS).

The insurer denied Transcranial Magnetic Stimulation.  The determination is overturned.

The patient has a longstanding history of major depressive disorder, recurrent and severe without psychotic features. The patient has a documented history of multiple medication treatments for depression including treatment with more than two disparate classes of medication and at least four or more trials with antidepressant medications (selective serotonin reuptake inhibitor (SSRI), serotonin norepinephrine reuptake inhibitor (SNRI), trazodone, and Wellbutrin), as well as combination treatment with an SSRI and Wellbutrin and augmentation with Ketamine nasal spray without a positive response. Additionally, the patient has received combined treatment with psychotherapy including cognitive behavioral therapy.

Due to adverse effects or a lack of efficacy, the patient has continued to experience severe symptoms of depression and functional impairments that impact her quality of life and day-to-day functioning. The patient's psychiatric evaluation indicated ethyl alcohol (ETOH) use and that the patient used to be a social drinker but states she is drinking more than she should be, typically drinks like 2-3 shots of Southern Comfort 5-6 nights per week. She has sought out treatment with Alcoholics Anonymous (AA) in the past and just feels like if she could address the depression she doesn't feel the alcohol would be an issue. Despite this history, the evaluation concluded that there is no diagnosed co-morbid psychiatric disorders or co-occurring substance use disorders in this case with the evaluation that only diagnosed major depressive disorder of moderate severity. The psychiatric evaluationdid not affirm a diagnosis of alcohol use disorder. Case records also characterize the patient as a "social drinker." The patient has no significant or acute general medical issues.

Mental status examination reveals depressed mood, sad affect with anxiety, and anhedonia together with negative thoughts/depressive ruminations. She has loss of interest and low energy and motivation with decreased concentration and bouts of insomnia. Patient Health Questionnaire (PHQ)-9 score was at 18 at the time of evaluation for TMS therapy reflecting moderately severe symptoms of depression. The PHQ-9 has been as high of 21 reflecting severe depression. The patient is divorced and employed and lives alone. There are no legal issues or trauma history in this case.
The patient's clinician recommended treatment with a course of repetitive transcranial magnetic stimulation (rTMS) therapy that would generally include up to 36 treatment episodes/TMS sessions. The recommendation is in the context of the ongoing episode of depression that is treatment-resistant/refractory despite current treatment with Prozac and Wellbutrin together with cognitive behavioral therapy (CBT) and as needed (prn) use of lorazepam.

The case summary and records were reviewed including the psychiatric evaluation provided by the clinician, health plan documents, correspondence from the patient's mental health clinicians and the health plan , as well as appeal documents and case notes from the health plan, the health plan's coverage policy pertaining to transcranial magnetic stimulation (TMS) therapy and excerpts from the Certificate of Coverage. 
At issue is the medical necessity of transcranial magnetic stimulation (TMS) therapy for major depressive disorder.

The requested health service/treatment of transcranial magnetic stimulation (TMS) is medically necessary for this patient.

The requested benefit of repetitive transcranial magnetic stimulation (rTMS) is reasonable, clinically appropriate, medically necessary, and in the patient's best interest. The patient has demonstrated that her depressive disorder is treatment refractory with multiple failed trials of antidepressant medications of disparate mechanisms of action with augmentation, as noted in the clinical summary. The patient has also failed to achieve a sustained clinical response or remission of symptoms with combined treatment with psychotherapy (CBT) and medication regimens including current treatment. Thus, the proposed treatment of recurrent moderately severe to severe major depressive disorder using rTMS therapy with a clinically appropriate number of sessions of adequate dose including a maintenance taper is medically necessary in this case.
The requested TMS service is backed by credible scientific study and is consistent with prevailing standards of medical practice for the condition under treatment in this case, recurrent major depressive disorder and treatment refractory/resistant depressive disorder.

The proposed treatment can reasonably be expected to provide the patient with greater net health benefit than any other standard therapy in this case scenario. Repetitive TMS therapy as a primary or adjunctive therapy for treatment of depression has generally been evaluated in patients who have had treatment resistant or treatment refractory depression, as defined by one or more, treatment failures with or without augmentation. TMS therapy for depression is established as a safe treatment by the Food and Drug Administration (FDA), and the data as reflected in peer reviewed medical literature supports this assertion. Specifically, when treatments with antidepressant medication with or without augmentation, or electroconvulsive therapy, and/or psychotherapy (especially cognitive behavioral therapy) have failed, then TMS is clinically appropriate. This assertion is also noted in the American Psychiatric Association Practice Guideline for the assessment and treatment of major depressive disorder, referenced below.
This answer is consistent with the scientific literature and published guidelines, referenced below.