Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Depression
Treatment: Transcranial Magnetic Stimulation (TMS), Pre-service
The insurer denied the Transcranial Magnetic Stimulation (TMS), pre-service.
The denial is overturned. 

The patient is an adult male. He has a 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 three or more trials with antidepressant medications (SSRI [selective serotonin reuptake inhibitor], SNRI [serotonin-norepinephrine reuptake inhibitor] and trazodone), as well as augmentation with Abilify and Rexulti, in keeping with FDA (United States Food and Drug Administration) indicated use. Additionally, the patient has had treatment with an evidence-based psychotherapy for over five years combined with medication. Due to the lack of efficacy with those treatments, the patient was referred for TMS (transcranial magnetic stimulation) therapy and underwent repetitive TMS therapy for 3 months with an initial robust clinical response.

The patient's clinician has recommended treatment with another course of repetitive transcranial magnetic stimulation (rTMS) therapy with up to 36 treatment episodes. The recommendation is in the context of the recurrent episode of depression that is known to be treatment-resistant/refractory and had been ongoing for several years without sustained benefit from treatment and without a response of remission until the first course of TMS therapy.

Coverage of the TMS therapy is therefore requested on appeal from the denial by the health plan in view of the robust response to TMS therapy. The health plan has denied authorization for coverage of rTMS on the basis of coverage exclusion and indicates that the requested treatment is not a covered benefit with reference to the plan's InterQual medical necessity criteria and medical coverage policy/plan guidelines concerning TMS therapy for depressive disorder referencing that the patient did not have his course of TMS therapy 6 months prior to the request for another course of TMS therapy and that during the first course of TMS therapy, the patient did not show a significant reduction of 50% or greater on the measures of depression - as required in order to be approved for coverage. Moreover, the plan denial indicated that no information was submitted to suggest a recurrence of the major depressive disorder.

Yes, the requested transcranial magnetic stimulation is medically necessary for this patient.

In this case, the patient has a diagnosis of treatment refractory major depression, and at least three or more alternative therapeutic trials with augmentation together with other therapeutic measures have been provided without clinical benefit. The patient had a prior response to TMS therapy. He subsequently experienced a recurrent episode of major depression, scoring a 19 on the PHQ-9 (patient health questionnaire) as before.  Thus, in this case, the proposed TMS therapy is considered clinically appropriate and medically necessary in view of the scientific literature and guidelines for the evaluation of treatment of refractory major depressive disorder. Additionally, the proposed rTMS therapy is reasonable and in the best interest of the patient. The decision to proceed with another course of TMS therapy reflects sound medical judgment based upon the current scientific literature and American Psychiatric Association practice guideline concerning the assessment and treatment of major depressive disorder. The patient in this case has demonstrated that his depressive disorder is treatment refractory or resistant, and the proposed treatment of recurrent major depressive disorder with TMS therapy with a clinically appropriate number of sessions is reasonable and warranted in this case scenario, and is consistent with prevailing standards of medical practice and the definition of medical necessity.

Moreover, the plan reason for denial of coverage is not valid indicating on the basis of coverage exclusion that the requested treatment is not a covered benefit with reference to the plan's InterQual medical necessity criteria and medical coverage policy/plan guidelines concerning TMS therapy for depressive disorder referencing that the patient did not have his course of TMS therapy 6 months prior to the request for another course of TMS therapy and that during the first course of TMS therapy, the patient did not show a significant reduction of 50% or greater on the measures of depression - as required in order to be approved for coverage. Moreover, the plan denial indicated that no information was submitted to suggest a recurrence of the major depressive disorder. Indeed, as the treating clinician argues on appeal, the recommended treatment with another course of rTMS therapy with up to 36 treatment episodes is in the context of the recurrent episode of depression, as supported with submitted information is reasonable in a case that is known to be treatment-resistant/refractory and had been ongoing for several years without sustained benefit from other standard treatments and without a response of remission until the first course of TMS therapy, as well as the evidence for a robust response to TMS therapy with a 68% reduction in measures of depression as noted in the clinical summary.

This answer is consistent with prevailing standards of medical practice, practice guidelines concerning major depressive disorder, and the scientific literature pertaining to TMS therapy for major depressive disorder, referenced below, and with New York State instruction for this review.