Transcranial Magnetic Stimulation (TMS) Coverage Criteria
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This policy describes clinical evidence, coverage stance, and authorization expectations for use of transcranial magnetic stimulation (TMS) for psychiatric and neurological indications, and applies to Wellmark/Blue Cross Blue Shield - Iowa members and providers seeking coverage. It highlights investigational indications and protocol-specific guidance.
No material clinical or coverage changes in this revision.
Coverage Criteria and Evidence Summary
Investigational Indications (outside MDD)
TMS for conditions other than major depressive disorder is considered investigational.
Evidence is insufficient to determine improvement in net health outcomes.
Investigational Types/Protocols
Certain TMS types and protocols are specifically considered investigational.
Evidence is insufficient to determine improvement in net health outcomes for these protocols.
Combination TMS + Esketamine
Investigational/Not established
Policy states combination TMS + esketamine is investigational and would risk denial if billed as established therapy.
TMS Modalities and Scheduling
Modalities and general application
Definitions and scheduling guidance from policy.
Evidence: Migraine indications
Evidence for migraine and device‑specific indications
See systematic review and Cerena pivotal trial limitations.
Summary coverage evidence nodes
Evidence summarized for clinical effect and limitations in migraine and OCD:
See systematic review and Cerena trial.
See Carmi et al. (2019) and pooled analyses.
Evidence-summary coverage groups
Evidence‑summary based coverage considerations (indication‑specific; often limited):
Additional larger trials with longer follow‑up are needed.
Hayes assessment rated evidence insufficient (D2).
Evidence limited by bias and heterogeneity.
Additional high‑quality studies needed.
Population differences and heterogeneity limit generalizability.
Safety analyses indicate increased transient adverse events (headache) but low seizure prevalence.
Evidence and applicability
Evidence‑based coverage considerations for miscellaneous TMS indications
Heterogeneous protocols and limited durability of effects are recurrent limitations.
Treatment course details
Treatment planning considerations
Scheduling guidance from conventional TMS definitions.
Device‑specific protocols apply.
Miscellaneous newer/accelerated and connectivity‑guided TMS — evidence and coverage considerations
Evidence summary and coverage stance for miscellaneous newer TMS protocols
Shi 2024; Hayes evolving evidence; heterogeneous protocols and limited long‑term follow‑up.
Lan et al. 2023 systematic review; Cole RCT and single‑arm studies; durability concerns noted.
Results do not support superiority; additional adequately powered trials needed.
Yu et al. 2024 DRMA.
See INS/NANS and other guideline statements.
Transcranial magnetic stimulation (TMS) is considered investigational for all indications outside of major depressive disorder (MDD). The policy explicitly lists anxiety, bipolar disorder, chronic pain, fibromyalgia, migraine, obsessive‑compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and schizophrenia among conditions for which evidence is insufficient to conclude a net health benefit.
Device labeling and use limitations for migraine-specific TMS systems are important to observe: the FDA-cleared device for migraine is intended only for patients with migraine with aura and should not be used for headaches due to underlying pathology or trauma, nor for medication‑overuse headaches. FDA labeling also indicates the device has not been demonstrated as safe or effective for cluster headache, chronic migraine, or treatment during the aura phase, and has limitations in special populations (e.g., pregnancy, children <18, some older adults).
FDA labeling statements note device-specific limitations: while some systems have evidence from pivotal trials, those trials had methodologic limitations (for example, high dropout and post‑hoc analyses in the Cerena trial), and the FDA labeling indicates the device has not been demonstrated safe or effective for cluster headache, chronic migraine, or migraine during the aura phase and does not relieve associated migraine symptoms such as photophobia, phonophobia, or nausea.
Conclusions about clinical significance and durability are limited across many non‑depression indications: for OCD, pooled analyses show small‑to‑moderate short‑term improvements (effects lasting up to about 4 weeks in many studies) and the pivotal deep TMS trial showed benefit in modified ITT but not consistently in full ITT analyses; for many pain and other indications systematic reviews report small short‑term effects that frequently do not reach minimal clinically important differences.
Evidence gaps are substantial and the policy does not provide prescriptive exclusions beyond investigational status: many trials are small, heterogeneous in stimulation parameters, and lack long‑term follow‑up, so absence of established stimulation parameters and limited high‑quality data imply restricted coverage for numerous indications even when explicit exclusions are not listed.
No randomized controlled trials were identified that directly evaluate combined use of TMS with esketamine to determine whether the combination improves long‑term health outcomes; as a result, combined/simultaneous administration remains unsupported by RCT evidence.
External guideline positions (NICE) recommend limiting some TMS uses to research settings: NICE has stated that evidence on efficacy for auditory hallucinations and for obsessive‑compulsive disorder is inadequate and recommends these procedures only be used in the context of research.
The coding and descriptive sections of the policy list CPT codes for accelerated theta‑burst/SNT protocols (0889T–0892T) and standard therapeutic rTMS (90867–90869) but do not themselves define explicit medical‑necessity coverage criteria tied to those codes in the cited coding descriptors.
Novel or accelerated protocols (for example, accelerated TMS, SNT/accelerated theta‑burst, MRI‑guided theta‑burst) and combination treatments are considered investigational in this policy because available studies are heterogeneous, often small, and lack consistent, durable outcome evidence; the policy therefore does not support routine coverage of these approaches outside research or clearly documented exceptions.
Simultaneous or combination use of TMS with esketamine is explicitly considered investigational by the policy and would be treated as not meeting Wellmark technology assessment criteria for established therapy.
For many psychiatric and non‑migraine neurologic indications the evidence consists of numerous small, low‑quality trials or meta‑analyses with high heterogeneity; these syntheses typically report small short‑term effects and provide limited or uncertain data on longer‑term benefit and clinical meaningfulness.
Overall, the policy states there is insufficient evidence to support routine use of rTMS for most psychiatric disorders other than MDD (and in some cases OCD where evidence is mixed) and for non‑migraine neurological conditions; claims for these uses are vulnerable to denial given lack of large, high‑quality trials demonstrating durable clinical benefit.
Newer protocols are characterized by widely heterogeneous stimulation parameters (pulses per session, sessions/day, total pulses) and the policy highlights limited long‑term data; therefore, durability and optimal dosing/targeting remain unresolved for accelerated, high‑dose, and connectivity‑guided approaches.
Billing and CPT/HCPCS Codes
| see Codes table | Refer to policy's Codes table for specific CPT/HCPCS/diagnosis codes |
| 0889T | Personalized target development for accelerated, repetitive high-dose functional connectivity MRI-guided theta-burst stimulation derived from a structural and resting-state functional MRI, including data preparation and transmission, generation of the target, motor threshold-starting location, neuronavigation files and target report, review and interpretation. |
| 0890T | Accelerated, repetitive high-dose functional connectivity MRI-guided theta- burst stimulation, including target assessment, initial motor threshold determination, neuronavigation, delivery and management, initial treatment day. |
| 0891T | Accelerated, repetitive high-dose functional connectivity MRI-guided theta- burst stimulation, including neuronavigation, delivery and management, subsequent treatment day. |
| 0892T | Accelerated, repetitive high-dose functional connectivity MRI-guided theta- burst stimulation, including neuronavigation, delivery and management, subsequent motor threshold redetermination with delivery and management, per treatment day. |
| 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. |
| 0889T | Personalized target development for accelerated, repetitive high-dose functional connectivity MRI-guided theta-burst stimulation derived from a structural and resting-state functional MRI, including data preparation and transmission, generation of the target, motor threshold-starting location, neuronavigation files and target report, review and interpretation. |
| 0890T | Accelerated, repetitive high-dose functional connectivity MRI-guided theta- burst stimulation, including target assessment, initial motor threshold determination, neuronavigation, delivery and management, initial treatment day. |
| 0891T | Accelerated, repetitive high-dose functional connectivity MRI-guided theta- burst stimulation, including neuronavigation, delivery and management, subsequent treatment day. |
| 0892T | Accelerated, repetitive high-dose functional connectivity MRI-guided theta- burst stimulation, including neuronavigation, delivery and management, subsequent motor threshold redetermination with delivery and management, per treatment day. |
| 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. |
Authorization, Documentation, and Billing Guidance
Prior Authorization Required
Prior approval is required.
- Prior approval required for TMS services (see Wellmark Authorization Table/InterQual for MDD criteria).
- Prior authorization is recommended for non-standard or investigational indications (e.g., accelerated, high-dose, MRI‑guided theta‑burst, deep TMS for non‑FDA indications).
- Prior authorization is recommended for newer or nonconventional TMS protocols (accelerated, high‑dose, Stanford Neuromodulation Therapy, MRI‑guided theta burst) to document rationale, device/modal parameters, and supporting evidence.
- Prior authorization requests should specify the TMS modality, device, stimulation parameters, proposed schedule (frequency, pulses per session, total sessions), and treatment target to allow clinical review.
Documentation: Baseline Severity and Prior Treatment
Baseline severity and prior treatment must be documented as used in clinical trials and InterQual guidance.
- Document baseline symptom severity with a validated rating scale (e.g., MADRS, HAM‑D, YBOCS for OCD) and record baseline scores.
- Document prior treatment history including adequate trials of pharmacotherapy, psychotherapy, ECT (when relevant), and reasons for failure/intolerance or contraindication.
- Record patient‑reported outcomes and trial measures used in studies (daily headache diaries for migraine trials; motor threshold and cortical mapping for TMS sessions).
Required Clinical and Trial-Based Documentation
Clinical documentation supporting a TMS authorization should include indication, prior therapies tried and outcomes, rationale for TMS, and a detailed treatment plan.
- Indication and diagnosis with relevant ICD code and supporting history.
- Prior conservative therapy attempts (medications, psychotherapy, device‑specific prior treatments) with dates and outcomes.
- Rationale for chosen TMS modality and why standard therapies were inadequate, intolerable, or contraindicated.
- Treatment plan: target brain region, frequency (Hz or iTBS), intensity (% resting motor threshold), pulses per session, sessions per day/week, total planned sessions, and taper schedule if applicable.
- Provider and device details: FDA‑cleared device model (when applicable) and clinician qualifications/training.
- Baseline and planned outcome measures (e.g., MADRS, response/remission thresholds, YBOCS), and schedule for assessment during and after treatment.
Billing and Code Reporting for Authorization
Use appropriate CPT/HCPCS/ICD codes when requesting authorization and when billing; missing or incorrect codes may lead to denial.
- Report relevant CPT codes for TMS: e.g., 90867 (initial mapping and delivery), 90868/90869 equivalents for subsequent sessions as applicable; report specific Category III codes for accelerated fcMRI‑guided theta‑burst (0889T–0892T) when used.
- Include HCPCS, revenue, and ICD‑10 diagnosis codes consistent with the indication and site of service.
- Codes must match the modality billed (conventional rTMS vs deep TMS vs accelerated/experimental protocols) — mismatched or omitted codes increase coding‑related denial risk.
Combination TMS + Esketamine Investigational
Combination therapy with simultaneous TMS plus esketamine is not covered and is considered investigational.
- Concurrent or simultaneous administration of TMS with esketamine is investigational and lacks sufficient evidence for safety, optimal regimen, or standard‑of‑care recognition.
- Authorization requests for combined TMS + esketamine should indicate investigational status and will generally be denied.
Regulatory/Labeling Limitations
FDA labeling limitations and device/indication notes should be acknowledged in requests.
- Confirm FDA‑cleared indications for the device being used (e.g., MDD, OCD, certain migraine indications) and note age/label limits (e.g., NeuroStar approval for adolescents 15–21 as adjunct for MDD per March 2024).
- FDA labeling warns devices have not been demonstrated effective/safe for cluster headache, chronic migraine, or migraine during aura phase in some device labels.
- Specify whether the device is FDA‑cleared for the requested indication; non‑cleared indications are considered investigational.
Auditory Hallucinations — Research Use Only
Use of TMS for auditory hallucinations should be considered research‑only per NICE guidance and may be denied outside of clinical trials.
- NICE (2020) concluded evidence is inadequate for efficacy of TMS for auditory hallucinations and recommended use only in research settings.
- Authorization requests for auditory hallucinations should reference the research‑only status and include trial enrollment information if applicable.
Reference-Only Material and Cross-References
Some sections of the source are reference‑only and do not establish utilization, authorization, or specific denial rules; reviewers should use this policy together with Wellmark Authorization Table and InterQual criteria.
- InterQual criteria are referenced for MDD — follow Wellmark Authorization Table for operational prior authorization rules.
- Where the policy is silent on prior authorization specifics for certain items, follow payer's authorization table/process ("Prior authorization: not specified in this section").
- Reference lists and background evidence (systematic reviews, ongoing trials) are informational and do not by themselves authorize coverage.
Trial-Based Documentation Expectations
Trial documentation expectations mirror published studies and should include validated outcome measures and session‑level records.
- Record motor threshold determination and cortical mapping per initial session.
- Document each treatment day: device used, settings (intensity, frequency, pulses), site targeted, session duration, and any adverse events.
- Use validated scales for outcomes and specify response/remission definitions used in trials (e.g., MADRS response = ≥50% reduction; remission = MADRS ≤10; OCD response = ≥30% reduction in YBOCS).
Ongoing and Unpublished Trials
Ongoing or unpublished clinical trials may change evidence and coverage; cite clinicaltrials.gov identifiers when relevant.
- Include references to ongoing trials if the request relies on emerging evidence; list NCT numbers if available.
- Acknowledgement that newer protocols lack long‑term durability and larger trials are pending (e.g., SNT trials) should be included in rationale for experimental protocols.
Step Therapy and Comparators
No step therapy rules are specified in this section; use Wellmark Authorization Table and InterQual for step requirements and sequencing relative to other therapies.
- Where step therapy or sequencing is relevant (e.g., failure of adequate pharmacologic trials before rTMS for MDD), follow the payer's authorization criteria rather than this narrative section.
- VA/DoD guidance suggests rTMS as an adjunctive option after pharmacologic trial(s) in bipolar depression but is a weak recommendation with very low confidence; document pharmacologic treatment attempts when applicable.
Background and Definitions
Transcranial magnetic stimulation (TMS) is a noninvasive method that uses a magnetic field generated by a coil placed on the scalp to induce electrical currents and modulate neuronal activity. It is primarily investigated and used for treatment‑resistant major depressive disorder, but has been studied across a range of psychiatric and neurologic conditions with variable evidence supporting benefit.
Outpatient (inventory group)
Outpatient treatment setting considerations
Refer to device regulatory status and treatment modality definitions.
Outpatient / procedural (inventory group)
Outpatient procedural considerations
Policy recommends documenting modality and planned schedule for authorization.
Outpatient / Inpatient (depending on study)
Setting may vary by study population
Trial populations vary; assess applicability to member's care setting.
Outpatient (procedural TMS sessions)
Procedural session context
Document planned per‑day session counts and total course in authorization.
Outpatient/TMS treatment (inventory)
Outpatient treatment considerations
Refer to trial documentation expectations and device labeling.
TMS Treatment Modalities and Protocols
TMS (Conventional, Deep, Theta Burst)
Modalities: conventional, deep, and theta‑burst described
See policy guidelines and device regulatory status.
Theta-burst
Theta‑burst considerations
SNT/accelerated protocols described in policy (Cole et al.).
Deep TMS
Deep TMS modality
Refer to device regulatory status for indication specifics.
rTMS / deep TMS (clinical comparisons)
Clinical comparisons and evidence context
Heterogeneity in stimulation targets and parameters across studies.
rTMS / deep TMS (evidence nodes)
Evidence nodes for rTMS and deep TMS
Additional larger RCTs with longer follow‑up are required.
Conventional TMS, Deep TMS, Accelerated/High-dose/Combination TMS
Conventional, deep, and newer protocols
Evidence heterogeneity noted across systematic reviews.
SNT, accelerated/high‑dose rTMS, connectivity‑guided iTBS
SNT, accelerated/high‑dose, and connectivity‑guided iTBS specifics
Evidence derived from Cole et al. RCT and single‑arm studies; durability uncertainty.
See Yu et al. DRMA (2024).
rTMS / iTBS
rTMS and iTBS comparative evidence
See THREE‑D trial and referenced systematic reviews.
TMS/rTMS and related neuromodulation (references)
References and related neuromodulation topics
See policy reference list for detailed citations.
Stanford Neuromodulation Therapy (SNT) / accelerated theta-burst
SNT evidence summaries and limitations
See Cole et al. RCT and subsequent single‑arm and pooled analyses.
Repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS) overview
Clinical application and motor threshold determination described in policy background.
Session and Visit Limits
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