ModifiedFidelis CarePolicy FC.CP.BH.200

Transcranial Magnetic Stimulation (TMS) for Treatment‑Resistant Major Depression

Policy governing medical necessity review and coverage criteria for repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) for adults with treatment‑resistant major depressive disorder for Fidelis Care and affiliated Centene health plans.

Policy Summary

PayerFidelis Care

PolicyTranscranial Magnetic Stimulation (TMS) for Treatment‑Resistant Major Depression

Policy CodePolicy FC.CP.BH.200

Change TypeMaterial clinical revisions — step therapy reduction and psychotherapy language update

Effective Date

Next Review Date

Key ActionObtain prior authorization for an initial course (up to 36 rTMS or up to 30 TBS sessions) with documentation of age, DSM diagnosis, medication trials, psychotherapy trial, and standardized pre‑treatment depression score for medical director review.

SourceLink

POLICY UPDATE CHANGES

Failure of 2 psychopharmacologic agent trials required vs. 4 agents.

Requirement for trial and/or documentation of ECT removed.

Requirement for evidence-based psychotherapy changed to evidence of psychotherapy.

Up to 36/30initial course limits reviewed case-by-case

≥18minimum age

2 trialsrequired medication trials

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Coverage Criteria for rTMS and TBS

Initial Therapy

Covered when ALL of the following are met and reviewed by a medical director for an initial course:

Initial TMS coverage criteria: Member is age ≥ 18 years; treatment is administered using an FDA-cleared device and utilized in accordance with labeled indications; confirmed DSM diagnosis of severe major depressive disorder (single or recurrent) without psychosis; planned use of a standardized depression rating scale with pre-TMS score documented; MDD is not part of a presentation with multiple psychiatric comorbidities and there is no evidence of psychosis; direct supervision of treatment is provided by a licensed psychiatrist present in the area; failure of or intolerance to psychopharmacologic therapy per policy (either two adequate trials from two different drug classes in the current episode, or documented intolerance with two trials from different classes); failure of a trial of psychotherapy of adequate frequency and duration without significant improvement as evidenced by the documented pre-TMS rating scale; and no listed contraindications (see exclusions).all

TBS Session Limit

TBS session limit statement:

TBS session limit: There is insufficient evidence to support the safety and efficacy of more than 30 sessions of TBS.all

Retreatment

Retreatment criteria (case-by-case by Medical Director):

Retreatment with rTMS: Initial criteria for TMS continue to be met AND there is either prior positive response to TMS (≥50% reduction in depression severity on PHQ-9 or other standardized depression scale) OR current major depressive symptoms have worsened by 50% from the prior best response on PHQ-9 (or other standardized scale).all

Maintenance Therapy

Maintenance therapy stance:

Maintenance rTMS/TBS: Maintenance treatment with rTMS or TBS is not medically necessary due to insufficient evidence in the published peer-reviewed literature.all

Contraindications to repetitive transcranial magnetic stimulation (rTMS) and theta burst stimulation (TBS) include a history of seizures and the presence of conductive, ferromagnetic, or other magnetic-sensitive metals implanted or embedded in the head or neck within 30 cm of the coil (dental fillings excluded). Examples include cochlear implants, implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, and metallic tattoo dyes. Also exclude members with vagus nerve stimulator leads in the carotid sheath or other implanted stimulators that use electrical or magnetic signals (for example, deep brain stimulators, cardiac pacemakers, implantable cardioverter defibrillators, intracardiac lines, or medication pumps).

Additional exclusions relevant to patient safety are less than three months of substantiated remission from substance use disorder, concomitant esketamine intranasal, ketamine infusion, or other infusion therapies, severe dementia, severe cardiovascular disease, known non-adherence with previous depression treatment, acute psychotic disorders in the current depressive episode, and active suicidal ideation with intent. These contraindications should be reviewed and documented prior to authorizing TMS/TBS.

Coverage determinations guided by this clinical policy remain subject to the member's plan documents and applicable laws. Specifically, coverage decisions are subject to all terms, conditions, exclusions, and limitations of the coverage documents (for example, evidence of coverage or certificate of coverage) and to state and federal requirements. When state Medicaid provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should confirm plan-level prior authorization, benefit, and regulatory requirements before submitting requests.

Maintenance treatment with rTMS or TBS is not medically necessary. The policy states there is insufficient evidence in the published peer-reviewed literature to support routine maintenance rTMS or TBS, and such courses should not be authorized as maintenance therapy.

Procedure and Coding References

Procedure/CPT and HCPCS codes referencedmixed

90867	Therapeutic repetitive transcranial magnetic stimulation (tms) treatment; initial, including cortical mapping, motor threshold determination, delivery and management.
90868	Therapeutic repetitive transcranial magnetic stimulation (tms) treatment; subsequent delivery and management, per session.
90869	Therapeutic repetitive transcranial magnetic stimulation (tms) treatment; subsequent motor threshold re-determination with delivery and management.
97014	Application of a modality to 1 or more areas; electrical stimulation (unattended).
97032	Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes.
G0295	Electromagnetic therapy, to one or more areas, for wound care other than described in G0329 or for other uses.

Typical rTMS treatment course — session counts, parameters and typical regimen

Typical total sessions20–30 sessions over 4–6 weeks is typical for a standard rTMS course; policy allows up to 36 sessions for an initial rTMS course (includes 6 tapered treatments)

Session frequencyFive times per week (daily weekday treatments) for 4–6 weeks

Session durationApproximately 37.5–40 minutes per session for conventional high‑frequency rTMS (example trial used 37.5 minutes, 75 trains, 3000 pulses)

Stimulation parameters (common example)120% of resting motor threshold, 10 Hz stimulation, ~3000 pulses per session (as used in major randomized trials)

Tapering allowancePolicy notes initial rTMS course may include up to 6 tapered treatments within the up to 36‑session allowance

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for an initial course of rTMS or TBS. A medical director will review requests for an initial course of up to 36 rTMS sessions (includes 6 tapered treatments) or up to 30 TBS sessions on a case-by-case basis when the policy criteria are met.

Initial course: up to 36 rTMS sessions (includes 6 tapered treatments)
Initial course: up to 30 TBS sessions
Medical director review required for initial course

Documentation Required

Medical Necessity Guidance — Prior Authorization Likely Required

Prior authorization is likely required and requests will be evaluated for medical necessity against the policy criteria (age ≥18, FDA-cleared device used per labeled indications, confirmed MDD diagnosis without psychosis, documented pre-TMS standardized depression rating, adequate prior pharmacologic and psychotherapy trials, absence of contraindications). Requests that do not meet these criteria may be denied.

Background and Evidence Context

Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique used to treat major depressive disorder (MDD) by delivering focused electromagnetic pulses to cortical targets, most commonly the dorsolateral prefrontal cortex, to modulate neuronal activity. Repetitive TMS (rTMS) typically delivers trains of pulses at frequencies ≥10 Hz in sessions that are approximately 40 minutes long and are commonly delivered five times per week over 4–6 weeks (20–30 sessions). Theta burst stimulation (TBS) is a patterned form of rTMS that uses short bursts of pulses (e.g., three to five pulses at ~50 Hz within bursts) to produce an overall lower stimulation frequency and markedly shorter sessions (often on the order of a few minutes), with clinical trials demonstrating comparable short-term efficacy to conventional rTMS in some settings.

Definitions and Modality Descriptions

rTMS definition — delivery details, session length and frequency

DefinitionRepetitive transcranial magnetic stimulation (rTMS) is delivery of repeated magnetic pulses (trains of pulses) via a coil placed over the scalp to stimulate cortical neurons, typically targeting the dorsolateral prefrontal cortex

Typical frequencyOften delivered at a frequency ≥ 10 Hz for conventional high‑frequency protocols

Target and mechanismCoil positioned over scalp to penetrate ~2–4 cm and modulate superficial neuronal activity in mood‑regulating regions

Session length and scheduleProcedures typically take ~40 minutes per session and are given five times weekly for 4–6 weeks (total commonly 20–30 sessions)

FDA‑cleared device requirementPolicy requires use of an FDA‑cleared device and utilization consistent with labeled indications

TMS Treatment Modalities

TMS (rTMS and TBS)

Modalities described: rTMS and TBS are described; rTMS is typically delivered as repeated trains of pulses (often ≥10 Hz) with sessions around 40 minutes given five times weekly for 4–6 weeks (commonly 20–30 sessions); TBS is a form of rTMS delivering short bursts (3–5 pulses at 50 Hz with interburst intervals) with overall lower stimulation frequency and sessions that can be completed in minutes.any

TMS/rTMS

Evidence base referenced: Randomized controlled trials, systematic reviews, and clinical resources (including UpToDate and VA guidance) are cited regarding rTMS/TBS for major depressive disorder and treatment-resistant depression.any

Visit and Course Limits

rTMS / TBS visit limits — Up to 36 sessions for rTMS (including 6 tapered) or up to 30 sessions for TBS for initial course

rTMS visit limit (initial course)Up to 36 sessions for an initial rTMS course (this includes up to 6 tapered treatments)

TBS visit limit (initial course)Up to 30 sessions for an initial TBS course (policy states insufficient evidence for >30 TBS sessions)

Review processInitial course session allowances are reviewed on a case‑by‑case basis by a Medical Director as part of prior authorization

Maintenance therapy stanceMaintenance rTMS/TBS is considered not medically necessary and is excluded from coverage