Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Major depressive disorder; Generalized anxiety
disorder
Treatment: Continued Transcranial Magnetic Stimulation Treatment (TMS) 20 additional units
The insurer denied the Continued Transcranial Magnetic Stimulation Treatment (TMS) 20 additional units
The denial is upheld. 

The patient is an adult male. He has a diagnosis of recurrent and severe major depressive disorder without psychotic features and generalized anxiety disorder. The patient has a history of depressive disorder with worsening and persistent symptoms of depression despite past treatments with SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin-norepinephrine reuptake inhibitor), as well as augmentation with ketamine. The patient's symptoms recurred and/or persisted with deterioration in functioning socially and occupationally, including a declined in ability to maintain activities of daily living. He was subsequently referred for repetitive transcranial magnetic stimulation (rTMS) therapy to include thirty-six treatment sessions with tapering over a three-week time frame per protocol.

The patient's PHQ-9 (Patient Health Questionnaire-9) improved to a score of 9 or 6; he was calm and cooperative. Mood was anxious and depressed with brighter affect and animated demeanor. Speech was normal and clear with organized thought patterns. There were no severe symptoms such as psychosis, cognitive impairment, perceptual disturbance or suicidal ideation.

In this case, there is no report of substance use disorder or other mental disorders. The patient has sleep disorders including restless leg syndrome and obstructive sleep apnea with history of PTSD (post-traumatic stress disorder)-like sleep disturbance. The patient has reportedly not been provided treatment with electro-convulsive therapy (ECT), and the documentation does not note whether CBT (cognitive behavioral therapy) or other evidence-based psychotherapy is ongoing or provided by a skilled and certified therapist.

The patient's current medications include Wellbutrin, Lamictal, Deplin, trazodone and Klonopin.

The health plan has denied authorization for coverage of rTMS (repetitive transcranial magnetic stimulation) on the basis of coverage exclusion and indicated that the requested treatment is considered as not medically necessary because the patient has improved with regard to symptoms of depression and functioning with a return to work. Additionally, the health plan notes that additional TMS (transcranial magnetic stimulation) therapy is not indicated in view of the current rating of depression as mild and in view of other treatments that are available and referenced in the peer review submitted for review.

No, the Continued Transcranial Magnetic Stimulation Treatment (TMS) 20 additional units is not medically necessary.

In this case, alternative therapeutic trials with augmentation, combination therapy, or these treatments together with other therapeutic measures are indicated and reasonable in order to address the residual symptoms of depression and PTSD (post-traumatic stress disorder)-like symptoms/sleep disturbance. Examples of other therapeutic measures for patient such as this include a course of cognitive behavioral therapy or a course of ECT (electroconvulsive therapy). Thus, in this case, the additional repetitive TMS transcranial magnetic stimulation) therapy is not likely to be more beneficial for the patient than any other available standard therapy, and medical necessity is not met in keeping with the instruction for this review. This answer is consistent with practice guidelines concerning major depressive disorder and the scientific literature pertaining to TMS (transcranial magnetic stimulation) therapy for major depressive disorder, and this answer is consistent with New York State instruction for this review.

Clinically appropriate approaches are available for continued treatment of depressive disorder in this case, including combination therapy or an established augmentation therapy, as well as specific forms of psychotherapy that would establish that the patient is treatment refractory. Moreover, the patient's symptoms are mild, and the patient's functioning has improved as outlined in the clinical summary. As noted in the answer to question 2, alternative, standard therapeutic options known to be effective in the treatment of Major Depressive Disorder are available to this patient to address the recrudescence or persistence of depressive symptoms. Thus, the health plan should not cover the Transcranial Magnetic Stimulation (TMS) with twenty additional treatments, and the health plan did act reasonably, with sound medical judgment and in the best interest of the patient in this case scenario.

This answer is consistent with practice guidelines concerning major depressive disorder and the scientific literature pertaining to TMS (transcranial magnetic stimulation) therapy for major depressive disorder, and this answer is consistent with New York State instruction for this mandated and binding review.