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ModifiedOptumPolicy BH803TMS112025

Transcranial Magnetic Stimulation (TMS) Coverage Criteria

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This policy governs medical necessity criteria, utilization management, coding, and exclusions for TMS treatment of major depressive disorder for Optum members across lines of business. It affects providers who order, supervise, or administer TMS and payers adjudicating coverage.

Policy Summary

PayerOptum

PolicyTranscranial Magnetic Stimulation (TMS) Coverage Criteria

Policy CodePolicy BH803TMS112025

Change TypeCoverage Rationale revised (age eligibility expanded)

Effective Date01/01/2026

Last ReviewNov 18, 2025

Next Review DateApr 21, 2026

Key ActionObtain prior authorization documenting age, required medication trials, validated baseline depression score, and device FDA clearance before initiating TMS.

SourceLink

POLICY UPDATE CHANGES

Updated Coverage Rationale section; Effective 01/01/2026 expanding age requirements to 15 years of age or older.

Update to Coverage Rationale section for ages 15-17 years and medication trials.

Added clarification language for navigated TMS (nTMS) and retreatment requirements in a prior update.

30 + 6max acute TMS sessions

>=15 yrsminimum age (effective)

2failed med trials required (adults)

50%prior TMS response threshold

90867-90869applicable CPT codes

Coverage Criteria for Transcranial Magnetic Stimulation (TMS)

inv-01: Initial and Retreatment Coverage Criteria

Covered when ALL of the following are met for Major Depressive Disorder (MDD):

Primary inclusion: Confirmed diagnosis of Major Depressive Disorder (MDD) and meets age requirements (effective 01/01/2026: >=15 years; prior to 01/01/2026: >=18 years).

Medication trial requirement (by age): A lack of clinically significant response and/or intolerance to two (2) evidence‑based antidepressant medication regimen trials in the current depressive episode. For ages >=18, the two trials must be from at least two different medication classes.two trials

Medication side effects considered intolerable when not expected to diminish with continued administration.

Measurement and device criteria: Documented baseline depression score on a validated rating scale (e.g., BDI, HAM‑D, MADRS); TMS provided using an FDA‑approved device for MDD; motor threshold (MT) determined prior to initiation; TMS ordered, supervised, and administered by a qualified psychiatrist or a PMHNP practicing within state scope (FPA where applicable).

Policy Summary

PayerOptum

PolicyTranscranial Magnetic Stimulation (TMS) Coverage Criteria

Policy CodePolicy BH803TMS112025

Change TypeCoverage Rationale revised (age eligibility expanded)

Effective Date01/01/2026

Last ReviewNov 18, 2025

Next Review DateApr 21, 2026

Key ActionObtain prior authorization documenting age, required medication trials, validated baseline depression score, and device FDA clearance before initiating TMS.

SourceLink

On This Page

Treatment course limits: TMS is considered reasonable and necessary for up to 30 acute treatment sessions followed by 6 tapering sessions.30 + 6

Retreatment eligibility: Retreatment may be considered when relapse occurs >=6 months after the most recent course, the member originally met initial criteria and previously responded to prior TMS (>50% improvement on a standardized depression scale), and relapse has occurred despite ongoing evidence‑based treatments (psychotherapy, pharmacotherapy, etc.).>=6 months

inv-02: Evidence summaries (not prescriptive coverage criteria)

Evidence summaries and comparative outcomes reported across modalities (rTMS, TBS, accelerated TMS, navigated TMS, maintenance) — key findings:

Acute rTMS evidence for MDD/TRD: Multiple randomized trials and meta‑analyses report standard high‑frequency rTMS and some theta‑burst protocols reduce depressive symptoms compared to sham in adults with MDD/TRD; response and remission rates vary by trial and protocol (examples reported across trials and reviews).

See RCTs and meta‑analyses cited

TBS/accelerated evidence: Theta‑burst stimulation (TBS) and accelerated TMS show promising results in some meta‑analyses and RCTs (including trials reporting superior response versus sham), but pooled analyses are heterogeneous and durability data are limited, restricting definitive conclusions about routine use.

See Voight 2021; Chen 2021; Cai 2023; Joseph 2025

Maintenance rTMS evidence: Maintenance rTMS data are limited and of low/very low quality; randomized comparisons (e.g., weekly rTMS versus lithium) have not shown consistent superiority and overall evidence is insufficient to confirm maintenance efficacy for prevention of recurrence.

See Noda 2025; Hayes assessment 2023

Navigated targeting: Meta‑analytic comparisons of targeting methods report larger effect sizes for neuronavigation and 5‑cm methods versus sham in some analyses, but higher adverse event rates and inconsistent RCT results mean the clinical benefit of neuronavigation remains uncertain.

See Millet 2025; Wang 2025

OCD-related findings: For obsessive‑compulsive disorder, multiple meta‑analyses and RCTs report small‑to‑moderate effect sizes for rTMS/dTMS versus sham, but heterogeneity in targets, protocols, and concurrent treatments limits standardization and durability is variable.

See Tseng 2025; Grassi 2023; Steuber & McGuire 2023

inv-03: OCD — Evidence and applicability

Evidence synthesis and expert guidance summarized — coverage considerations based on diagnosis and evidence strength

OCD evidence summary: Systematic reviews and meta‑analyses report small‑to‑moderate (and in some analyses moderate) effect sizes for rTMS and deep TMS in adults with OCD, typically in treatment‑resistant samples; protocols, stimulation targets, and durability vary widely, and guideline/coverage statements (e.g., Clinical TMS Society) provide specific administration recommendations where applicable.

References include Tseng 2025; Grassi 2023; Steuber & McGuire 2023; Clinical TMS Society 2021/2023

inv-04: Conditions with insufficient evidence

Other diagnoses

Non‑MDD behavioral diagnoses: Insufficient evidence (limited studies, small samples, heterogeneous designs) to conclude TMS is safe and/or effective for behavioral conditions other than MDD; investigated conditions include child depression (ages 14 and younger), Alzheimer’s/dementia, anxiety disorders, autism spectrum disorder, bipolar disorder, borderline personality disorder, PTSD, schizophrenia, smoking cessation, and substance use disorders. Routine coverage is not supported by current evidence.

See chunk 44 and policy exclusions

TMS is considered not medically necessary for individuals who are pregnant or nursing, those with acute suicidality, acute psychosis, or other psychiatric emergencies requiring rapid response (for example catatonia or imminent suicide risk), and for situations that fall outside the policy’s evidence-based coverage criteria. Documentation should note that these conditions raise safety or appropriateness concerns and may prompt denial or further clinical review.

TMS is contraindicated for individuals with conductive, ferromagnetic, or other magnetic‑sensitive metal implanted in the head within 30 cm of the treatment coil (examples: metal plates, aneurysm coils, ocular implants, cochlear implants, deep brain stimulators, stents). Active or inactive implants and device leads (including deep brain stimulators, cochlear implants, and vagus nerve stimulators) and persons with prior serious adverse reactions or seizure risk during TMS are also excluded from treatment.

Maintenance rTMS—defined as periodic sessions after an acute response to prevent relapse—has limited and low‑quality evidence. Randomized trials and technology assessments show heterogeneous protocols, small sample sizes, and high attrition; one randomized trial found no difference versus lithium at 24 weeks. Because the body of evidence is rated very low to insufficient, maintenance TMS/booster therapy is not established as effective and claims for routine maintenance may be denied or require strong additional justification.

Use of TMS to treat behavioral conditions other than major depressive disorder (MDD) is unsupported by sufficient high‑quality evidence. The policy lists multiple investigated diagnoses—such as child depression (≤14 years), Alzheimer’s/dementia, autism spectrum disorder, bipolar disorder, PTSD, schizophrenia, substance use disorders, and smoking cessation—where available studies are limited, heterogeneous, and insufficient to conclude safety and effectiveness; requests for these indications may be denied.

Decisions about coverage must reference the member’s specific benefit plan. If the requested TMS service is limited, excluded, or defined differently in the member’s benefits, the member’s plan provisions and any applicable federal or state regulations supersede this guideline; reviewers must verify eligibility and member benefits before applying policy criteria.

Accelerated TMS (aTMS), theta‑burst stimulation (TBS), and navigated TMS (nTMS) are considered investigational or not routinely covered in this policy. Evidence across systematic reviews and trials is mixed—some studies report benefit while others show no clear superiority or have limited durability data—and protocols are heterogeneous; nTMS has not consistently demonstrated improved outcomes versus standard targeting in RCTs. Use of these modalities for non‑MDD primary behavioral indications is not supported by the evidence and is treated as unproven/not medically necessary absent compelling, device‑specific FDA labeling or protocol‑level evidence.

Reiterating limitations: maintenance rTMS evidence is characterized by small, heterogeneous studies with methodological limitations and high attrition. Technology assessments and randomized trials provide inconsistent findings and generally do not establish maintenance rTMS as effective to prevent recurrence; reviewers should require robust justification and supporting documentation when maintenance or booster courses are requested.

Evidence for rTMS in obsessive‑compulsive disorder (OCD) is described as low to uncertain quality in several reviews. Meta‑analyses and systematic reviews report small‑to‑moderate effect sizes in some analyses but heterogeneity in targets, protocols, concurrent treatments, and limited durability; overall, the literature is insufficiently consistent to support broad coverage of rTMS as monotherapy or add‑on for OCD without device‑specific indications or clear protocol alignment with guidance.

Applicable Procedure, Diagnosis, and Device Codes

Applicable procedure codesCPT

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

Applicable diagnosis codesICD-10

F32.2	Major depressive disorder, single episode, severe without psychotic features.
F33.2	Major depressive disorder, recurrent severe without psychotic features.

No explicit codes in this excerptmixed

No codes listed

FDA 510(k) device clearances (examples)mixed

K122288	Brainsway Deep TMS System 510(k) number (example listed among FDA clearances)
K193006	Magventure TMS Therapy System - For treatment of OCD 510(k)
K083538	NeuroStar TMS Therapy System 510(k) (multiple entries listed)

Prior documented TMS response (retreatment) / key thresholds

Prior documented TMS response> 50% improvement on a standardized depression rating scale

Retreatment timing thresholdRelapse >= 6 months after most recent treatment

Documentation required for prior responseRecord of prior TMS course meeting initial treatment guidelines and documented >50% improvement

Baseline measurement requirementDocument current baseline depression score using validated scale (e.g., BDI, HAM-D, MADRS)

Qualified provider for TMSTMS must be ordered/supervised/administered by a qualified psychiatrist or PMHNP practicing within state scope (FPA where applicable)

rTMS pulses per session — examples and study notes

Example rTMS pulses per session1000 pulses per session (example from RCT)

Example rTMS pulses per session2000 pulses per session (example from RCT)

Example rTMS pulses per session4000 pulses per session (example from RCT)

Study course example20 sessions over 4 weeks in dose-comparison trial

Reported outcome noteHigher dose (4000 pulses) showed larger early treatment effect but no durability data reported

Prior Authorization

Prior authorization required for TMS (CPT 90867–90869)

Prior authorization is required for TMS services billed with CPT codes 90867, 90868, and 90869; the request must document that coverage criteria are met including age eligibility, required failed medication trials, a validated baseline depression score, use of an FDA‑cleared device, and that a qualified psychiatrist or PMHNP (where permitted) will order/supervise/administer treatment. Coverage is limited to an acute course of up to 30 treatment sessions plus 6 tapered sessions unless retreatment criteria are met.

CPT codes requiring prior authorization: 90867, 90868, 90869.
Document age eligibility per Coverage Rationale (effective 01/01/2026: ≥15 years; previously ≥18 years).
Document failure or intolerance of required medication trials (two trials in current episode; class requirements apply for adults).
Provide baseline depression score on a validated scale (e.g., BDI, HAM-D, MADRS).
Identify the FDA‑approved device used and ensure treatment aligns with device labeling.
Confirm ordering/supervising clinician is a qualified psychiatrist or PMHNP practicing within scope (FPA states where applicable).
Adhere to visit limits: up to 30 sessions + 6 tapering sessions.

Provider Requirements, Documentation, and Prior Authorization

Prior Authorization

Include prior treatment history for accelerated/TBS or neuronavigation requests

When requesting prior authorization for accelerated/TBS protocols or neuronavigation-guided TMS, include the member's prior treatment history, prior TMS response (if any), and explicit justification for using the advanced protocol because evidence shows heterogeneous protocols and mixed efficacy.

Document prior antidepressant trials and outcomes.
Provide prior TMS response and rationale for accelerated/TBS or neuronavigation.

Note

Confirm alignment with society guidance and FDA labeling

Prior authorization review should confirm that the proposed treatment plan aligns with relevant society guidance (for example, Clinical TMS Society recommendations) and with FDA-labeled indications for the device selected.

Reference Clinical TMS Society guidance where applicable (e.g., OCD protocols).
Identify the FDA-cleared device and ensure indication matches the planned use.

Prior Authorization

Document updated age eligibility (>=15 years effective 01/01/2026)

Prior authorization documentation must demonstrate the updated age eligibility effective 01/01/2026 (individuals 15 years of age and older) when applicable to the member's request.

If request concerns ages 15–17, include documentation meeting the age-specific medication trial criteria.

Prior Authorization

Verify member eligibility and benefits prior to authorization

Verify member-specific eligibility and benefit provisions before approving TMS; prior authorization decisions must reference the member's benefit plan and any applicable federal or state regulatory requirements.

Confirm member eligibility and plan coverage definitions.
If service is limited or excluded by the benefit, the member's benefit supersedes this guideline.

Step Therapy

Document two failed/intolerant evidence-based antidepressant trials

Prior authorization requires documentation of failure or intolerance to evidence-based antidepressant medication trials: two trials in adults (from at least two different classes) in the current depressive episode; the same two-trial requirement applies for ages 15–17 as specified.

Adults (≥18): two trials from at least two different medication classes.
Ages 15–17: two evidence-based medication regimen trials in the current episode.

Step Therapy

Consider and document pharmacologic trial/contraindication before maintenance TMS

Before approving maintenance TMS requests, consider and document intolerance or contraindication to standard maintenance pharmacotherapy (e.g., lithium) because randomized evidence compared rTMS to pharmacologic maintenance.

Document prior maintenance pharmacotherapy trials and reasons for intolerance or failure.
Include rationale for choosing maintenance TMS over standard pharmacologic options.

Step Therapy

Document prior failed treatments consistent with treatment‑resistant populations

Prior treatment history should demonstrate that many trials enrolled treatment‑resistant patients; prior adequate trials of standard therapies (pharmacotherapy and psychotherapy as appropriate) should be documented before approval.

Document number and classes of prior antidepressant trials and any psychotherapy.
State if patient meets definitions of treatment resistance used in trials (e.g., ≥2 failed antidepressants).

Step Therapy

Follow updated adolescent (15–17) medication trial requirements

Follow the updated stepwise medication trial requirements for ages 15–17 as specified in the Coverage Rationale; prior authorization must reflect compliance with these adolescent medication trial criteria.

Ensure documentation shows two evidence-based medication regimen trials in the current episode for ages 15–17.

Note

Documentation Required

Provide validated baseline depression score and prior response data

Include baseline depression measurement using a validated rating scale (for example, BDI, HAM-D, MADRS) in prior authorization documentation and, when applicable, prior documented response (>50% improvement) from a previous TMS course.

Provide baseline score and scales used.
If retreatment requested, include prior acute response data (>50% improvement).

Documentation Required

Document motor threshold (MT) determination before treatment

Document motor threshold (MT) determination prior to initiating treatment and indicate plans for reassessment as needed per the treatment protocol.

Record MT value and method used to determine it.
Note schedule for MT reassessment if CPT 90869 or protocol requires re-determination.

Documentation Required

Document prior acute response and rationale for maintenance/retreatment

When requesting maintenance or retreatment, include documentation of prior acute response status, reason for reintroduction, and duration of follow-up because durability and follow-up data are limited.

Show prior response (>50% improvement) and time since last treatment (retreatment eligibility ≥6 months).
Explain clinical rationale for maintenance or reintroduction.

Documentation Required

Document FDA-cleared device and confirm labeled indication

Identify and document the FDA-cleared device used for treatment and ensure the planned use is consistent with the device's labeled indications in the prior authorization request.

Name the device and provide applicable FDA 510(k)/de novo clearance reference.
Confirm treatment indications align with device labeling.

Documentation Required

Reference policy history updates in supporting documentation

Supporting documentation should reflect compliance with recent Coverage Rationale updates and clarifications (for example, navigated TMS and retreatment requirements) as noted in the policy history.

Cite relevant Policy History effective dates if relying on updated criteria (e.g., age expansion effective 01/01/2026).

Note

Reviewer workflow: verify eligibility, benefits, and regulatory requirements first

Reviewers should first identify member eligibility, member-specific benefit coverage, and any federal or state regulatory requirements that supersede benefits before applying the guideline.

Confirm whether member benefit limits or exclusions apply to the requested service.
Check for applicable federal/state regulations or parity requirements.

Denial Risk

Requests for unproven or not medically necessary indications may be denied

TMS requests for indications listed as unproven or not medically necessary (for example, pregnancy or nursing, acute suicidality/psychiatric emergency, maintenance/booster therapy, accelerated/TBS protocols, navigated TMS for mapping/planning, or primary non‑MDD behavioral diagnoses) may be denied.

List of unproven/not medically necessary indications includes: pregnancy/nursing; acute suicidality or psychiatric emergency; maintenance/booster TMS; accelerated/TBS protocols; navigated TMS for mapping; TMS for primary diagnoses other than MDD.

Denial Risk

Caution: low-quality evidence for maintenance rTMS

Evidence for maintenance rTMS is rated very low quality with heterogeneity, small samples, and high attrition; exercise caution and require additional justification when evaluating maintenance requests.

Documentation should address limitations of maintenance evidence and provide rationale for clinical need.

Denial Risk

Possible denial for non‑MDD behavioral diagnoses due to insufficient evidence

Requests for TMS to treat behavioral conditions other than major depressive disorder may be denied due to insufficient evidence of safety and effectiveness for those diagnoses.

Examples include child depression (≤14), Alzheimer's/dementia, bipolar disorder, PTSD, schizophrenia, substance use, and smoking cessation.

Denial Risk

Denial risk if coverage criteria (age, medication trials, documentation) are not met

Denials may be triggered if coverage rationale criteria are not met, including failure to meet updated age eligibility or medication trial requirements specified in the Coverage Rationale.

Check age eligibility, documented medication trials, baseline score, and device/clinician criteria.

Billing Rule

Follow member‑specific benefit limitations and exclusions

If the requested TMS service is limited or excluded by the member's benefit, follow the member‑specific provisions; a benefit exclusion or different benefit definition may preclude authorization.

Prior authorization decisions must reference the member's benefit plan language.
When conflict exists, the member's benefit supersedes this guideline.

Background and Evidence Context

Background: Transcranial magnetic stimulation (TMS) is a noninvasive neuromodulation therapy that delivers focused magnetic pulses to stimulate targeted brain regions. It is an FDA‑cleared treatment modality for major depressive disorder and is typically provided as a daily outpatient course over several weeks; emerging protocols and indications are actively studied but vary widely in evidence quality and durability.

inv-50: Outpatient evidence and context (inventory grouping for outpatient)

Outpatient setting considerations and utilization management context for TMS delivery:

Admission: Coverage rationale criteria (see coverage section) are met and suicide risk has been evaluated; motor threshold (MT) determination performed prior to initiating outpatient TMS to permit accurate treatment location and dosing.

Admission assessment should include diagnosis, current suicidal ideation/plan/means, history of suicidal behavior, and familial/clinical precipitants.

Treatment course and continued stay: Outpatient TMS typically consists of a defined acute course with motor threshold established and a maximum of 30 sessions plus 6 tapering sessions; continued treatment requires documentation of tolerability and response monitoring.30 + 6

inv-51: Outpatient context (additional inventory grouping)

Additional outpatient context — patient selection and monitoring considerations:

Candidate characteristics: Outpatient candidates commonly are adults with MDD or treatment‑resistant depression (≥2 failed antidepressant trials in many trials); many trials permitted concurrent pharmacotherapy.

Session examples and schedules: Clinical trials report a range of acute schedules (commonly 10–30 sessions over 1–6 weeks); accelerated protocols deliver multiple sessions per day over ~1–3 weeks.

Cross‑referenced evidence summaries: randomized controlled trials, systematic reviews, and meta‑analyses summarized elsewhere in this policy inform the background and coverage rationale. These sources include trials comparing pulse doses and session schedules, maintenance trials versus pharmacologic comparators, meta‑analyses of theta‑burst and accelerated protocols, neuronavigation targeting studies, and multiple meta‑analyses addressing TMS for OCD and MDD; they collectively demonstrate meaningful heterogeneity in effects, protocols, and follow‑up.

TMS Modalities and Delivery Methods

inv-52: TMS (repetitive TMS/rTMS) — modality node

Modality: repetitive transcranial magnetic stimulation (rTMS) — core modality node:

rTMS (core modality): FDA‑cleared rTMS devices used per device labeling and therapy manuals under qualified clinical supervision are supported for treatment of MDD when coverage criteria are met; rTMS is typically delivered daily in an outpatient setting over an acute course.

inv-53: TMS variants (rTMS, TBS, accelerated, navigated, dTMS) — modality node summarizing variants

Variants and alternative TMS approaches discussed in the evidence:

Modality variants: Modalities studied include high‑frequency unilateral rTMS, bilateral/sequential rTMS, deep TMS (dTMS), intermittent/continuous theta‑burst stimulation (iTBS/cTBS), accelerated/aiTBS protocols, and neuronavigation‑guided targeting; evidence quality and consistency vary across these variants.

See cited trials and reviews for protocol details

inv-54: TMS (rTMS, dTMS, iTBS/cTBS) — modality node

Comparative modality considerations relevant to clinical choice:

iTBS versus 10 Hz rTMS: Clinical TMS Society guidance and trials indicate iTBS delivered to left DLPFC has similar acute outcomes to 10 Hz rTMS for MDD and may be considered an alternative, though clinicians should exercise caution when switching protocols for an individual patient.

See Clinical TMS Society statement and supporting RCTs

inv-55: TMS modalities discussed across literature (rTMS, theta-burst, accelerated, deep TMS)

Modalities referenced across cited literature:

Modalities referenced: High‑frequency rTMS, intermittent theta‑burst stimulation (iTBS), continuous theta‑burst (cTBS), accelerated protocols, and deep TMS are discussed across randomized trials, systematic reviews, and consensus statements.

inv-56: TMS including rTMS, theta-burst, accelerated, deep TMS — broader modality node referencing multiple evidence sources

Broader modality synthesis and evidence sources:

Broad modality evidence: Multiple randomized controlled trials, systematic reviews, meta‑analyses, and consensus statements addressing rTMS, theta‑burst, accelerated, and deep TMS are cited in the appendix and inform comparative and practical considerations for these modalities.

See appendix references for study‑level details

Definitions and Key Terms

Motor Threshold (MT) definition

DefinitionMotor Threshold (MT) is the individualized measurement established prior to TMS to estimate magnetic field intensity and provide a head surface landmark for the treatment location

PurposeUsed to set stimulation intensity and guide accurate coil placement/navigation

DocumentationMT determination must be performed prior to initiating treatment and reassessed as needed per protocol

Accelerated TMS (aTMS) and Theta Burst Stimulation (TBS) definition

DefinitionAccelerated TMS (aTMS) and Theta Burst Stimulation (TBS) are faster, higher-frequency protocols delivering magnetic pulses in rapid bursts over shorter session durations

Status in policyEmerging/investigational approaches under active study; considered unproven/not medically necessary for routine coverage in this policy

Typical session durationOften only a few minutes per session compared with conventional up to ~40 minutes

Accelerated TMS / aiTBS

DefinitionAccelerated TMS / aiTBS: delivery of multiple TMS sessions per day over a shortened overall treatment period (e.g., 1–3 weeks), sometimes using theta-burst protocols

Example schedulesTrials have used compressed schedules (e.g., multiple sessions/day over 10 days or 1–3 weeks)

Evidence noteMeta-analyses and RCTs show mixed results and limited durability data; protocols are heterogeneous

Neuronavigation / navigated TMS (nTMS) definition

DefinitionNeuronavigation / navigated TMS (nTMS): TMS targeting method using MRI- or functional-guidance to localize dorsolateral prefrontal cortex sites versus standard scalp-based approaches

Contrast to scalp methodsProvides more anatomically precise targeting compared with 5-cm or F3 scalp-based methods

Clinical findingsRCTs and meta-analyses show inconsistent superiority and may increase adverse event rates; clinical utility remains under investigation

Maintenance rTMS definition

DefinitionMaintenance rTMS: periodic rTMS sessions delivered after an acute response to prevent relapse or recurrence of depressive episodes

Evidence strengthAvailable studies are heterogeneous and of very low quality; evidence insufficient to establish effectiveness for routine maintenance

Comparative trialsRandomized trials comparing rTMS to pharmacologic maintenance (e.g., lithium) have shown no clear superiority with methodological limitations

YBOCS definition

DefinitionYale‑Brown Obsessive Compulsive Scale (YBOCS): primary outcome scale used to assess OCD symptom severity in TMS trials

Use in trialsFrequently used to measure pre/post TMS changes with follow-up typically 4–12 weeks

InterpretationMeta-analyses report small-to-moderate reductions in YBOCS scores with active TMS versus sham in OCD trials

TMS modalities list

Modalities listedrTMS (standard high-frequency), intermittent theta-burst stimulation (iTBS), continuous theta-burst stimulation (cTBS), accelerated TMS/aiTBS, navigated TMS (nTMS), and deep TMS (dTMS)

Evidence contextThese modalities are variably represented across RCTs, meta-analyses, and guidance documents with differing quality and outcomes

Clinical implicationProtocol selection should align with FDA-cleared device labeling and evidence/guidance where applicable

Theta-burst / accelerated TMS (literature description)

DefinitionTheta-burst and accelerated TMS: alternative delivery schedules that apply bursts of high-frequency stimulation (TBS) or multiple sessions per day (accelerated) to shorten overall treatment time

Evidence summarySystematic reviews and RCTs show TBS can be superior to sham and similar to standard rTMS in some trials, but heterogeneity and limited durability data persist

StatusConsidered emerging; policy treats accelerated/TBS approaches as investigational/not routinely covered absent strong supporting evidence

Deep TMS definition

DefinitionDeep TMS (dTMS): a variant of transcranial magnetic stimulation designed to stimulate deeper brain regions and evaluated in randomized controlled trials for major depression

Regulatory noteSome dTMS systems have FDA marketing clearances (e.g., Brainsway) for specific indications

EvidenceRCTs demonstrate efficacy in depression in some trials; protocol heterogeneity exists across studies

Level of Care Considerations

inv-49: Outpatient TMS — inventory placeholder for outpatient-level criteria

Outpatient-level operational criteria for TMS delivery:

Outpatient TMS admission readiness: Candidate meets coverage rationale criteria, suicide risk evaluated, and motor threshold established prior to first outpatient session.

Outpatient TMS course limits: Treatment limited to a maximum acute course of 30 sessions plus 6 tapering sessions unless otherwise justified by documented clinical trial participation or other evidence-based protocols.30 + 6

inv-50: Outpatient — additional outpatient grouping for coverage context

Additional outpatient context on session schedules and trial examples:

Session schedule examples: Clinical trials report acute courses ranging from ~10 to 30 sessions delivered over 1–6 weeks; accelerated protocols deliver multiple sessions per day over 1–3 weeks in some studies.

Monitoring and documentation: Outpatient delivery should include validated baseline and periodic outcome measures, motor threshold documentation, and record of concurrent treatments to support continued authorization.

inv-51: Outpatient — further outpatient context nodes

Outpatient considerations for OCD TMS delivery when supported by evidence/guidance:

OCD outpatient guidance: When OCD treatment is pursued consistent with evidence and device labeling, outpatient administration is typically prescribed by a psychiatrist trained in TMS; Clinical TMS Society recommends 5 days/week for 6 weeks (≈29 sessions) after initial criteria are met.~29 sessions

Ongoing monitoring for OCD: Continued outpatient treatment should document symptom improvement with validated scales (e.g., YBOCS) and tolerability to justify ongoing or repeat courses.

Treatment Course and Visit Limits

TMS treatment — maximum covered acute sessions

Maximum covered acute sessions30 sessions plus 6 tapering sessions (total: 30 + 6)

Typical trial rangesClinical trials commonly report 10–30 sessions delivered over 1–6 weeks

DocumentationMT must be determined prior to initiation and treatment limited to stated maximum acute sessions

rTMS/TBS — examples of session numbers used in trials

Trial examplesTrials have used treatment courses ranging from 10 to 30 sessions (examples include 20 sessions over 4 weeks; accelerated 10-day schedules)

TBS/rTMS comparisonsSome RCTs compare TBS to standard rTMS showing similar acute outcomes; response rates vary by protocol and study

Accelerated schedulesAccelerated protocols deliver multiple sessions/day and have been studied in randomized trials but durability data are limited

TMS treatment course — example guidance

Example guidance for course lengthClinical TMS Society recommends performing TMS 5 days per week for 6 weeks for OCD (total ~29 sessions)

Trial-based examplesMany OCD and depression trials used up to ~29–30 sessions as an initial course; durations and session counts vary by protocol

MonitoringOngoing documentation of symptom improvement (e.g., YBOCS, validated depression scales) and tolerability is required to justify continued treatment

References and Evidence Sources

Evidence citations and appendices include numerous systematic reviews, randomized controlled trials, and consensus statements cited in the policy appendix. These references (for example, Perera et al., Grassi et al., Chen et al., Fitzgerald et al., and others) provide the underlying trial and review data used to summarize efficacy, safety, and limitations for the TMS modalities discussed in this guideline.

Metrics and evidence synthesis: meta‑analyses summarized in this policy report pooled trial counts and participants across targeting‑method and OCD trials (examples include 63 RCTs/3,080 participants for targeting‑method analyses and 34 RCTs/1,089 participants for OCD network meta‑analysis). These aggregated data inform the policy’s evidence grading and highlight both the size of the literature and its heterogeneity.

Policy History and Revisions

2026-04-21interim_updateLatest

Updated Coverage Rationale for ages 15–17 years and clarified medication trial requirements.

2026-03-17interim_update

Interim update to policy (details not specified in summary).

2025-11-18annual_review

Updated Coverage Rationale; effective 01/01/2026 expanded age eligibility to individuals 15 years of age or older; references and appendix updated; approvals by Optum committees recorded.

2024-12-17interim_update

Updated language in the Coverage Rationale section without changes to coverage criteria.

2024-10-15annual_review

Clarified language in the Coverage Rationale section with no changes to coverage criteria; updated references and appendix.

2024-04-16interim_update

Clarified language in the Coverage Rationale section with no changes to coverage criteria; updated references and appendix.

2023-12-12interim_update

Updated Coverage Rationale with retreatment requirements effective 01/01/2024 and added clarification language for navigated TMS (nTMS); updated references and appendix.

2023-10-17annual_review

Annual review completed (summary of changes recorded).

2023-02-21interim_update

Interim update effective 02/21/2023: updated Coverage Rationale regarding psychopharmacologic agent trials, removed psychotherapy requirement, and updated references/sources.

2022-10-18annual_review

Annual review completed (summary of changes recorded).

Policy history: revisions recorded from 10/18/2022 through 04/21/2026 document annual and interim updates, including an approved expansion of age eligibility to ≥15 years effective 01/01/2026, interim clarifications to navigated TMS and retreatment criteria, and other editorial and evidence‑based updates. Providers should reference the policy history for effective dates of specific changes.