Transcranial Magnetic Stimulation for Treatment Resistant Major Depression
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Clinical coverage and criteria for repetitive TMS (including rTMS, iTBS, dTMS) for treatment-resistant major depressive disorder; intended for providers requesting authorization and for payer review.
Theta burst stimulation (iTBS) and deep TMS (dTMS) are explicitly referenced as forms of TMS with specified session limits.
Initial and additional session counts and review processes were changed repeatedly (e.g., initial sessions revised between 20, 30, and up to 36; additional sessions revised between 20, 10, 6).
Criteria were clarified to require oversight by a licensed psychiatrist (with allowance for state scope) and to require standardized depression severity rating scales with pre-TMS scores documented.
A policy statement declares MRI-guided theta burst experimental and investigational.
Contraindication added: concurrent esketamine intranasal, ketamine infusion, or other infusion therapies.
Added deep TMS (dTMS) as a form of TMS for adults ≥ 18 years of age.
Removed psychosis exclusion from diagnosis criteria and replaced comorbidity exclusion with explicit exclusion of schizophrenia, schizoaffective disorder, and bipolar disorder.
Added requirement that member has participated in an adequate trial of evidence-based psychotherapy during the current episode.
Specified frequency limit 'up to 36 sessions' with recommended schedule five days/week for six weeks plus optional six tapering sessions.
Added requirement that documentation include the rTMS, iTBS or dTMS protocol used.
Added statement that the member is referred for TMS by the provider treating the member's MDD and that a comprehensive psychiatric evaluation must be completed by a qualified licensed provider (MD, DO or MBBS).
Coverage and Medical Necessity Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
inv-02: Continuation / Additional Sessions
Authorization of additional sessions (case-by-case):
Confirm current allowed quantity at authorization
inv-03: Experimental / Investigational Treatments
Not covered / experimental:
inv-04: Coverage criteria
Covered when ALL of the following are met
Concurrent administration of other rapid-acting neuropsychiatric infusion or intranasal therapies is a contraindication to TMS under this policy. Specifically, concomitant esketamine intranasal, ketamine infusion, or other infusion therapies are listed as a contraindication and providers must not initiate or continue those therapies simultaneously with TMS unless clinically justified and documented in the medical record.
This policy excludes members with certain primary diagnoses from coverage. Coverage is limited to major depressive disorder and members with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder are not eligible for TMS under this policy. The diagnostic scope was revised to remove a broad psychosis exclusion and to explicitly list these three diagnoses as exclusions.
Ongoing or maintenance courses of TMS beyond the defined acute treatment course are not supported by sufficient evidence. Therefore, maintenance treatment with TMS is considered not medically necessary under this policy.
The policy designates MRI-guided theta burst stimulation as not covered due to insufficient evidence. MRI-guided theta burst is considered experimental and investigational and therefore is not medically necessary per this policy.
Procedure and Coding References
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for all Transcranial Magnetic Stimulation (TMS) sessions (including rTMS, iTBS, and dTMS) prior to initiation of treatment. Requests must include a comprehensive psychiatric evaluation by a qualified licensed provider (MD, DO, MBBS, or where state scope allows, appropriately credentialed advanced practice clinicians), planned TMS protocol (rTMS, iTBS, or dTMS), recommended schedule (typical recommendation: 5 days/week for 6 weeks), and documentation of prior treatments as described in step therapy prerequisites. Authorization requests for initial courses, additional sessions, or taper sessions will be reviewed against policy criteria and medical director review may be required for requests exceeding standard session limits.
- A comprehensive psychiatric evaluation (MD/DO/MBBS or permitted licensed provider) documenting diagnosis and treatment history is required.
- Specify the TMS protocol planned: rTMS, intermittent Theta Burst Stimulation (iTBS), or deep TMS (dTMS).
- Include the proposed treatment schedule and total number of sessions (e.g., up to 36 sessions with optional up to 6 taper sessions when criteria met).
- Attach standardized depression severity scores (pre-TMS score) and documentation of planned use of a standardized rating scale to monitor response.
Step Therapy / Prerequisites
Step therapy prerequisites must be documented before authorization will be granted. Documentation must show trials of antidepressant medications and adequate psychotherapy during the current depressive episode, and overlap of TMS with medication trials is expected. Failure to document required trials or to meet step therapy prerequisites may result in denial of the request.
- At least two trials of antidepressant medications from different pharmacologic classes, given at recognized therapeutic doses for an adequate duration (typically ≥6 weeks) during the current episode. Where intolerance is claimed, documentation must meet intolerance criteria.
- A trial of evidence-based psychotherapy during the current episode (for example, weekly cognitive behavioral therapy or interpersonal therapy) without significant improvement.
- If applicable, documentation of at least 4 antidepressant trials representing at least 2 different drug classes when required by specific intolerance clauses.
- Requests must indicate whether prior ECT or other neurostimulation therapies were attempted if relevant to clinical history.
Denial Risk: Missing Documentation or Exceeding Session Limits
Prior authorization requests for TMS that do not include required documentation or that exceed policy session limits (initial, additional, or taper sessions) are at risk for denial. Ensure all requested sessions align with policy limits and that prior treatments, standardized rating scales, and the specific TMS protocol are clearly documented.
- Requests exceeding standard session limits (as defined by the policy or medical director guidance) may be denied or require medical director review.
- Lack of documentation of required antidepressant trials, psychotherapy, or comprehensive psychiatric evaluation may trigger denial.
- Failure to specify the TMS protocol (rTMS, iTBS, dTMS) or to provide baseline severity scores and planned monitoring may result in incomplete review or denial.
Required Documentation
Documentation must include evidence of prior treatments and specific TMS protocol details. For continuation or additional sessions, include documentation of response duration (e.g., documented 6-month response if requesting maintenance/retreatment) and objective measures of clinical response.
- Document prior treatments: antidepressant trials (agents, doses, durations), psychotherapy type and duration, and outcomes.
- Specify the TMS modality used (rTMS, iTBS, or dTMS) and protocol parameters.
- For taper or additional sessions, include objective evidence of prior response (for example >50% reduction in baseline severity scores) and rationale for additional sessions (e.g., relapse within 6 months).
Allowed and Included TMS Modalities
inv-25: TMS (rTMS, iTBS, dTMS)
TMS (rTMS, iTBS, dTMS) is included when ALL of the following are documented:
inv-26: TMS modalities
Modality-specific notes and limits:
Setting and Care Level
inv-23: Outpatient
Outpatient setting criteria:
Recommended schedule: 5 days/week × 6 weeks; up to specified session limits.
inv-24: Outpatient
Additional outpatient considerations:
Session Limits and Scheduling
Terms and Modalities Defined
Clinical Background and Evidence
Transcranial magnetic stimulation (TMS) encompasses multiple device-based modalities used to treat major depressive disorder, including conventional repetitive TMS (rTMS), patterned theta-burst stimulation such as intermittent TBS (iTBS), and deep TMS (dTMS). The policy notes that devices and protocols have received regulatory clearances over time (for example, FDA clearances for conventional rTMS and later approvals expanding indications), and that iTBS and dTMS are explicitly included as forms of TMS addressed by the coverage criteria. The document also summarizes that randomized trials and systematic reviews support iTBS as superior to sham and comparable to conventional rTMS, while some newer approaches (for example, MRI-guided theta burst) lack sufficient evidence and are designated experimental. The policy requires that the treating provider document which protocol (rTMS, iTBS, or dTMS) will be used and specifies course recommendations (for example, a recommended acute course of five days per week for six weeks with defined session limits).
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