ModifiedPremera BluecrossPolicy 2.01.50

Transcranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders

Defines when various types of TMS (deep TMS, standard/repetitive TMS, theta burst, accelerated TMS excluding SNT/SAINT) are considered medically necessary or investigational for depression, bipolar depression, and OCD, and lists contraindications, course parameters, maintenance, and repeat-course rules for providers and payers.

Policy Summary

PayerPremera Bluecross

PolicyTranscranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders

Policy CodePolicy 2.01.50

Change TypeExpanded coverage (theta-burst added), accelerated/maintenance authorization updates, contraindication clarification

Effective DateMar. 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, symptom severity or standardized rating scores, and prior medication trial details to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Expanded coverage and clarified criteria for accelerated TMS, including removal of the hardship requirement and specifying maximum daily treatments depending on TMS type, with no increase in total treatments.

Modified contraindication language for brain tumor and severe/repetitive head trauma to require documentation of neurologist/neurosurgeon clearance when history is present.

Added theta-burst stimulation (including accelerated protocols) as medically necessary for Major Depressive Disorder when criteria are met; SNT/SAINT remains not covered.

Updated maintenance TMS authorization periods: initial authorization up to 16 weeks (2/wk) or up to 26 weeks (<=1/wk); reauthorizations up to 26 weeks when improvement maintained.

Clarified that maintenance TMS or repeat full intensive TMS is not medically necessary if the preceding course was determined not medically necessary; also clarified resumption criteria for maintenance TMS when previously stopped.

Added multiple new references (items 98–138) and web resources supporting TMS, deep TMS, accelerated TMS, and related neuromodulation therapies.

Moved CPT codes 0889T-0892T into this policy.

30/36full-course treatments

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

≥3 medspharmacotherapy requirement (unipolar)

4-5/wkstandard frequency

≤7remission (HAM-D)

2026-03-01recent approval date

Multiplepolicy updates

Coverage Criteria

Initial TMS — Major Depressive Disorder (unipolar)

Covered when ALL of the following are met for first course of TMS for Major Depressive Disorder (unipolar):

Age: Individual is aged 15 years old and older>=15 years

Severity: Current episode of moderate to severe depression documented by symptoms or one or more standardized depression rating scales

Prior pharmacotherapy failure: Either failure of at least 3 antidepressant medications from at least 2 different classes OR failure of at least 2 antidepressant medications from at least 2 different classes plus failure with the addition of an augmenting agent to at least one failed antidepressant

Each failed medication must be identified with reason(s) for failure; a minimum of 30 continuous days is required for a trial to count as failed unless stopped for intolerable adverse effects

Initial TMS — Major depression as component of Bipolar Disorder

Covered when ALL of the following are met for first course of TMS for Bipolar Depression:

Age: Individual is aged 18 years and older>=18 years

Severity: Current episode of moderate to severe depression documented by symptoms or standardized rating scales

Medication failures specific to bipolar: Failure of at least 3 of the following: cariprazine (Vraylar); lamotrigine (Lamictal); lithium; lumateperone (Caplyta); lurasidone (Latuda); olanzapine‑fluoxetine combination (Symbyax); quetiapine (immediate release or XR); valproate (Depakote)

Theta burst stimulation is considered investigational for bipolar depression

Initial TMS — Obsessive-Compulsive Disorder

Covered when ALL of the following are met for first course of TMS for Obsessive-Compulsive Disorder (OCD):

Age: Individual is aged 18 years and older>=18 years

Severity: OCD currently moderate to severe documented by symptoms or a standardized rating scale

Medication failures: Failure of at least 3 medications including clomipramine or any SSRI

Full intensive course — parameters

Full intensive course parameters (covered when applicable criteria above are met):

Course length: A course of 30 treatments over 6–7 weeks delivered one treatment daily 4–5 days/week, with an optional 6‑treatment taper over 3 weeks (total 30 or 36 treatments)30 (or 36 with taper)

First session may include planning/mapping and initial motor threshold determination; 1–3 subsequent sessions may include motor threshold re‑determination

Motor threshold and planning: First session may include treatment planning, cortical mapping, and initial motor threshold determination; 1–3 subsequent sessions may include motor threshold re‑determination

More than one planning/mapping session is not medically necessary except for equipment problems or incorrect initial mapping

Single mapping limitation: More than one session including initial mapping is not medically necessary except for equipment failure, incorrect initial mapping, or change to a different TMS device

Extension of intensive course

Extensions of intensive course may be considered when ALL/ANY of these apply:

Indications for extension: Minimal or no improvement, partial response with residual moderate/severe symptoms, worsening during taper, or good response but goal to reach remission

Extension limits: Extension consists of one treatment daily 4–5 days/week for a maximum of 10 treatments if symptoms are mild, 15 if moderate, or 20 if severe; additional extensions allowed if prior extension showed improvement but not remission; extensions considered no longer necessary if no improvement or worseningmax 10/15/20

Accelerated intensive TMS

Accelerated intensive TMS (more than one treatment daily) covered when ALL are met:

Type criteria: Criteria for the underlying TMS type (standard/conventional rTMS, deep TMS, or theta burst) are met

Concurrent fMRI/neuronavigation with accelerated TMS remains investigational

Total treatments unchanged: No change in the total number of TMS treatments for the course (maximum total depends on TMS type; policy cites maximums of up to 36 or 44 total treatments depending on type)max 36 or 44 total

Daily maximums: Maximum daily treatments: up to 5/day for standard or deep TMS; up to 10/day for theta burst stimulation5 or 10 per day

Maintenance TMS

Maintenance TMS covered when ALL of the following are met:

Prior response: Prior intensive TMS resulted in symptom improvement to moderate, mild, or remission

Frequency is 2 treatments/week or less (on separate days); motor threshold re‑determination may occur no more often than every 10 treatment sessions<=2/week

Authorization limits: Initial authorization up to 16 weeks at 2/week or up to 26 weeks at ≤1/week; subsequent reauthorizations up to 26 weeks when improvement is maintained16 or 26 weeks

Documentation required for ongoing authorizations

Repeat full intensive course

Repeat full intensive course — covered when ANY of the following are met:

Prior positive response & relapse: Individual had a prior positive response to TMS, symptoms worsened to moderate/severe, and the last TMS treatment was at least 90 days ago>=90 days since last TMS

Only one repeat full intensive course is considered medically necessary after prior benefit

Switch modality after inadequate response: Individual failed to respond to a current course and a new course will use a different TMS type or coil location; only one repeat full intensive course allowed after failureonly one repeat allowed

Documented rationale: Provider documents why a repeat course might be effective and how application will differ from prior course; only one repeat allowedonly one repeat allowed

Initial and general coverage criteria

Covered when ALL of the following are met (as applicable to indication):

General requirements: Documentation of diagnosis, symptom severity (standardized rating scale or clinical notes), brief history, age, medication trials with outcomes (each medication identified and reason for failure), contraindications, CPT codes and session counts; medication trials require at least 30 continuous days unless stopped for intolerable adverse effects

See documentation requirements

Severity documentation: A diagnosis descriptor alone is insufficient; documentation of symptoms or standardized rating scale score is required; standardized scores of 'moderately severe' may be considered equivalent to severe

Medication trial dosing specifics: Trials of antidepressants commonly used for insomnia count only if given at minimum antidepressant doses (e.g., amitriptyline 150 mg; doxepin 150 mg; mirtazapine 15 mg; trazodone 150 mg) or if titration to antidepressant dose was planned but not completed due to adverse effects

TMS combined with Vagus Nerve Stimulation (VNS)

TMS in conjunction with VNS — conditional coverage:

TMS with VNS: TMS may be continued for up to 3 months after VNS implantation while awaiting VNS efficacy if individual just completed an intensive course and TMS has been partially but inadequately effective; may be extended for up to three additional 3‑month intervals if VNS has not produced improvement to mild or remission at each interval; continued TMS is not medically necessary when depression improves to mild/remission or after 12 months post‑implantationmax 12 months post-implant

Assessment recommended at 3‑month intervals

Evidence-informed coverage considerations

Coverage considerations informed by trial inclusion criteria and comparative effectiveness findings:

Typical trial-based inclusion logic: Trials commonly enrolled patients with major depressive disorder who had prior inadequate response to antidepressant treatment (definitions varied from ≥1 to ≥2 failed adequate trials); treatment delivered to specified target (e.g., left DLPFC) on schedules such as daily Monday–Friday for 4–6 weeksvaries by trial

Documentation should mirror definition used for selected treatment

Comparative effectiveness outcomes: RCTs and meta-analyses show modest benefit of high‑frequency left DLPFC rTMS over sham for some populations; deep TMS showed significant per‑protocol advantages in pivotal trial though ITT results were less consistent; ECT often produced higher remission rates than rTMS in head‑to‑head trials

Strength of evidence varies; consider ECT in highly refractory cases

Maintenance and retreatment considerations: Observational and smaller trials report benefit from maintenance schedules and retreatment for relapse, but durability without maintenance is limited in most RCTs (follow‑up short) and effect sizes diminish over longer follow‑up

Coverage conclusions by condition

Summary statements regarding rTMS for specified indications

Dysphagia after stroke: Small RCTs show some improvement in dysphagia measures with rTMS but larger studies are needed

Epilepsy: Single randomized trial reported decreased seizures with high‑intensity low‑frequency rTMS versus low‑intensity; promising but requires additional trials

Fibromyalgia: Several small trials reported pain reduction with rTMS but parameter variability prevents firm conclusions; more research needed

Migraine (Cerena device): Pivotal trial showed benefit in a subset treated during aura but had high dropout and limited labeling; device not demonstrated effective for cluster or chronic migraine

General coverage criteria for TMS

Covered when clinical evidence and sequencing criteria are met

Primary coverage logic: TMS is an appropriate intervention for adult unipolar Major Depressive Disorder when clinical evidence and sequencing criteria are met; TMS is positioned as an option after multiple failed antidepressant trials (commonly ≥3) and may follow or precede ECT depending on clinical circumstances and device labelingclinical sequencing

Device‑specific indications (e.g., NeuroStar: failure of one 6‑week antidepressant course) and Medicare NCD/LCD criteria must be satisfied

Modality-specific stance

Modality- and indication-specific coverage considerations

Theta burst stimulation is considered medically necessary for Major Depressive Disorder in adults when medical necessity criteria are met; evidence for bipolar depression and OCD is limited and remains investigationalevidence-based

SNT/SAINT protocol remains not covered/investigational

Deep and standard TMS for OCD: Credible evidence supports standard and deep TMS for Obsessive‑Compulsive Disorder in adults when criteria are met; other psychiatric/neurologic indications remain investigational absent larger trialsevidence-based

Brainsway H‑Coil has FDA clearance for depression; OCD evidence noted separately

Pediatric/adolescent coverage

Age and experimental-use criteria

Adolescents: TMS for adolescents is generally considered investigational due to limited high‑quality trials; treatment may be considered case‑by‑case for older adolescents after multiple failed medication trialsage-based

Policy notes safety data for older adolescents but randomized evidence limited

VNS timing guidance

Vagus nerve stimulation (VNS) temporal considerations

VNS timing and concurrent TMS: VNS typically demonstrates clinical effect beginning around 3 months post‑implant with maximum response by 6–12 months; continuing maintenance TMS while awaiting VNS effect may be reasonable with reassessment at 3‑month intervals and is limited to a maximum of 12 months post‑implant3–12 months assessment; max 12 months

Continued TMS not medically necessary when VNS achieves mild/remission or after 12 months

Accelerated TMS stance

Accelerated TMS

Accelerated TMS stance: Accelerated TMS protocols (multiple sessions/day) are covered when criteria for type are met and daily/total limits are observed; trials show non‑inferior efficacy and tolerability compared with once‑daily protocols but do not demonstrate faster or greater symptom reduction consistentlydaily sessions 2–10 depending on type; theta burst up to 10/day

Concurrent fMRI/neuronavigation with accelerated protocols is investigational; SNT/SAINT remains not covered

Medicare coverage and device indication criteria

Covered when ALL of the following are met for left prefrontal rTMS under Medicare NCD/LCD:

Medicare rTMS coverage criteria (lead-in): Patient diagnosed with severe Major Depression (single or recurrent) per DSM‑5 AND meets NCD/LCD‑specified additional criteria; device‑specific prior treatment requirements must be met

For NeuroStar: failure of one 6‑week antidepressant course; For Brainsway H‑Coil: failure to respond to antidepressant medications in current episode

All types of transcranial magnetic stimulation not explicitly listed as medically necessary in this policy are considered investigational. Examples include but are not limited to: any TMS with biomarkers, computer-assisted TMS of the prefrontal cortex (Group 8 technology), functional MRI–guided TMS, low field magnetic stimulation, magnetic seizure therapy, MeRT (quantitative EEG/EKG–guided TMS), EEG brain-mapping guided TMS, MRI-guided TMS, multiarray or navigated TMS, single-pulse TMS, synchronized TMS, and the SNT/SAINT (Stanford Neuromodulation Therapy/accelerated high‑dose connectivity MRI‑guided) protocol.

Consecutive or overlapping courses of TMS for different conditions (for example, treating Major Depressive Disorder and then concurrently treating Obsessive‑Compulsive Disorder), and provision of TMS by more than one provider or clinic at the same time, are considered not medically necessary. When a preceding course of TMS was performed under a non‑Company plan, documentation must show that medical necessity criteria were met for that prior course.

The use of TMS in conjunction with intranasal esketamine (Spravato), ketamine formulations, or any other psychedelic drug is considered investigational and is not an accepted medically necessary combination. More generally, combining TMS with other neuromodulation modalities (except the limited VNS context described elsewhere) is considered not medically necessary.

For several psychiatric and neurologic indications, published trials are inadequate, negative, or inconsistent. Examples in the evidence base include no demonstrated benefit for ADHD in small randomized studies, no evidence of efficacy for bulimia nervosa in a small trial, and limited or preliminary data for dysphagia after stroke, epilepsy, fibromyalgia, and other conditions. Because trials are small, heterogeneous, or underpowered, these indications lack sufficient evidence to support routine coverage.

Repetitive TMS (rTMS) is considered investigational for psychiatric and neurologic conditions other than depression due to insufficient high‑quality evidence and lack of large, replicated trials. Requests for rTMS in non‑depression indications will generally require prior review and may be denied as investigational.

Alternate or novel TMS modalities — including synchronized TMS, low field magnetic stimulation, and certain theta‑burst variants such as the SNT/SAINT accelerated protocol — are considered investigational. Although theta‑burst stimulation more broadly has accruing evidence for unipolar major depressive disorder, specific accelerated or neuronavigation/functional‑MRI–guided variants and SNT/SAINT lack sufficient replicated, high‑quality evidence to be considered standard therapy.

The Cerena device holds FDA De Novo clearance specifically for the acute treatment of pain associated with migraine headache with aura. Its labeling includes multiple warnings and contraindications (for example, not indicated for cluster headache, chronic migraine, medication‑overuse headache, pregnancy, children <18, or adults >65), and the device is therefore limited to that indication and not considered appropriate for routine treatment of depression or other psychiatric disorders.

The SNT/SAINT accelerated theta‑burst protocol remains not covered / investigational. Although some accelerated theta‑burst methods have received regulatory attention, the limited and underpowered published data for SNT/SAINT do not meet the standards required for routine coverage.

TMS is not medically necessary when predefined contraindications are present. These include uncontrolled seizure disorder (unless stable and well controlled on medication), non‑removable conductive or ferromagnetic implants in the head or neck within 30 cm of the coil (excluding dental fillings), active psychotic disorder or current psychotic symptoms, increased intracranial pressure, severe dementia, current substance abuse, and a brain tumor or unspecified brain lesion or history of severe/repetitive head trauma unless a neurologist or neurosurgeon has evaluated the individual and documented it is safe to proceed.

A short or brief intensive (mini‑intensive or booster) course is considered not medically necessary when symptoms are in remission or are mild and stable/not worsening. Additionally, repeat full intensive courses are considered not medically necessary if the preceding full course was previously determined to be not medically necessary by the Company.

Short or brief intensive courses are not medically necessary if depression or OCD symptoms are in remission or are mild and not worsening. The policy also states that a short or brief intensive course is not medically necessary if the preceding intensive or maintenance course was determined not medically necessary.

Coding

Covered CPT Codes (TMS procedural codes)CPT

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

Investigational (Not Eligible for Coverage)CPTNot Covered

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.

Noted technology-specific ICD-10 codeICD-10

X0Z0X18

ICD-10 code indicating computer-assisted transcranial magnetic stimulation of the prefrontal cortex (Group 8 Technology)

FDA-cleared devices (informational, not billing codes)mixed

Product-specific

NeuroStar TMS; MagPro 'R' series; MagVita; Magstim Rapid; Brainsway H-Coil (devices listed as FDA cleared)

No explicit CPT/HCPCS/ICD-10 codes listed in this sectionmixed

No codes listed

Moved CPT codesCPT

0889T	CPT code moved into this policy (as listed)
0890T	CPT code moved into this policy (as listed)
0891T	CPT code moved into this policy (as listed)
0892T	CPT code moved into this policy (as listed)

Clinical response threshold (HAM-D)

Clinical response (HAM-D)>= 50% improvement on the Hamilton Depression Rating Scale

Scale referencedHamilton Depression Rating Scale (HAM-D)

Use in continuation decisionsDocumented >=50% improvement may be used to define response and guide continuation or maintenance

Remission threshold (HAM-D)

Remission threshold (HAM-D)HAM-D score <= 7

Scale referenced

Provider Actions & Prior Authorization

Prior Authorization

Authorization timing and limits for maintenance and repeat courses

Initial authorization for maintenance TMS: approve up to 16 weeks when frequency is 2 treatments per week, or up to 26 weeks when frequency is one treatment per week or less; subsequent reauthorizations may be approved for up to 26 weeks when improvement is being maintained. Repeat full intensive course requests must document prior benefit and meet repeat-course criteria (including timing since prior course per policy).

Initial authorization: up to 16 weeks (2/week) or up to 26 weeks (≤1/week).
Subsequent reauthorizations: up to 26 weeks when improvement maintained.
Repeat full intensive course requires documentation of prior positive response and adherence to repeat-course criteria.

Prior Authorization

Prior authorization submission and CPT coding

Submit prior authorization with documentation of medical necessity and the relevant CPT codes; covered TMS procedure codes include 90867, 90868, and 90869. Investigational accelerated/theta-burst functional connectivity codes (0889T–0892T) are listed in the policy as investigational and must be reported as applicable.

Background

Transcranial magnetic stimulation delivers rapid magnetic pulses through an electromagnetic coil placed on the scalp to induce electrical currents in targeted brain regions involved in mood and behavior. TMS modulates neuronal activity and neurotransmitter release and is used primarily when standard pharmacologic treatments have failed. This policy distinguishes modalities that have sufficient evidence for specified indications (for example, standard rTMS, deep TMS, and theta‑burst for unipolar depression under defined criteria) from investigational or excluded techniques.

Definitions

TMS modalities

Included TMS modalitiesDeep transcranial magnetic stimulation (Deep TMS, H‑coil), standard/repetitive TMS (rTMS), theta burst stimulation, accelerated TMS (excluding SNT/SAINT)

SNT/SAINT statusSNT/SAINT (Stanford Neuromodulation Therapy) accelerated theta burst protocol is specifically excluded / investigational

Theta burst noteTheta burst stimulation is included among covered modalities when criteria met; accelerated theta burst protocols may have specific daily session limits

Clinical response

Clinical response definition>= 50% improvement on HAM-D

Measure sourceHamilton Depression Rating Scale (HAM-D) as defined in policy 'Definition of Terms'

Level of Care Criteria

Treatment Modalities

TMS variants (standard/repetitive, deep TMS, theta burst, accelerated)

TMS variants (standard/repetitive, deep TMS, theta burst, accelerated): Theta burst stimulation is covered for unipolar MDD (except SNT/SAINT which remains investigational); standard rTMS and deep TMS are covered for indicated disorders when medical necessity criteria are met

Concurrent fMRI/neuronavigation remains investigational

TMS combined therapies

TMS combined therapies: Use of TMS in conjunction with Spravato, ketamine, or other psychedelic drugs is investigational and not eligible for coverage; use of TMS concurrently with other neuromodulation modalities (e.g., ECT, DBS, CES) is not medically necessary except limited transitional/maintenance use with VNS as specified

rTMS (high-frequency, low-frequency, deep TMS)

Visit Limits & Session Parameters

TMS — maximum daily treatments and total treatment caps

Maximum daily treatments / course capsFull intensive course typically 30 treatments over 6–7 weeks (optional 6‑treatment taper to 36); accelerated protocols do not increase total treatments (max 36 or 44 depending on type)

Daily frequency in standard coursesOne treatment daily, 4–5 days per week for full intensive courses

Motor threshold and planning sessionsFirst session may include treatment planning, cortical mapping, and motor threshold determination; 1–3 subsequent sessions may include motor threshold re‑determination

TMS in conjunction with VNS

VNS conjunction maximum intervalsTMS may be continued for up to three additional 3‑month intervals (maximum total up to 12 months post‑VNS implant) while awaiting VNS effect if criteria met

Context

Revision History & Changes

2026-03-01policy_effectiveLatest

Policy effective date with multiple material updates including expanded coverage for accelerated TMS (removal of hardship requirement), addition of theta-burst stimulation as medically necessary for MDD, updated maintenance TMS authorization periods, clarified contraindication documentation, and movement of CPT codes 0889T–0892T into the policy.

2024evidence_update

Systematic reviews and meta-analyses on accelerated TMS and durability of accelerated protocols added to references informing policy (recent accelerated-TMS evidence cited).

Policy Summary

PayerPremera Bluecross

PolicyTranscranial Magnetic Stimulation as a Treatment of Depression and Other Psychiatric/Neurologic Disorders

Policy CodePolicy 2.01.50

Change TypeExpanded coverage (theta-burst added), accelerated/maintenance authorization updates, contraindication clarification

Effective DateMar. 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, symptom severity or standardized rating scores, and prior medication trial details to support medical necessity.

SourceLink

On This Page

Maintenance protocols vary across studies

Obsessive‑Compulsive Disorder (OCD): Meta-analysis reported higher response rates with rTMS augmentation versus sham (35% vs 13%); promising parameters include low‑frequency and non‑DLPFC targets but further focused trials needed

Other psychiatric/neurologic disorders: Available trials are small and heterogeneous; evidence insufficient for routine use and these indications are considered investigational

Hamilton Depression Rating Scale (HAM-D)

Use in coverage decisionsRemission (HAM-D <=7) used to determine end of continuation or that further intensive/maintenance TMS is not medically necessary

Failed medication trials before TMS or device-specific

Device labeling variesManufacturer indications differ; NeuroStar specifies failure of one 6-week antidepressant course while other devices/devices' clearances reference failure of antidepressant medications in the current episode

Clinical practice vs labelingClinical recommendations and trial entry criteria often require failure of multiple antidepressant trials (commonly >=2–4) despite some device labels requiring fewer trials

Documentation implicationAuthorization should document device used and prior medication history per device labeling

Prior antidepressant trial

NeuroStar prior antidepressant trial requirementFailure of one 6-week course of antidepressant medication (per NeuroStar labeling)

Brainsway (H‑Coil) prior trial wordingFailure to respond to antidepressant medications in the current episode (per Brainsway H‑Coil clearance)

Trial documentationDocument prior medication trials and reasons/outcomes consistent with device-specific indications

Required CPT procedure codes: 90867, 90868, 90869.
Investigational CPT codes for accelerated MRI-guided TBS: 0889T, 0890T, 0891T, 0892T (listed as investigational).

Documentation Required

Document prior antidepressant treatment failures

Document prior antidepressant treatment failures consistent with trial and policy definitions: indicate each medication that failed (or state reasons collectively) and provide the outcome for each trial per policy-specified definitions of adequacy.

Each failed medication must be identified and the reason(s) for failure specified; reasons may be stated per medication or collectively.
Adequate trial definition: minimum 30 continuous days unless stopped for intolerable adverse effects.
Trials in pivotal studies varied (failure defined as ≥1 to ≥2 adequate courses); documentation should mirror the definition used for the selected treatment.

Denial Risk

Investigational indications require prior review

rTMS for indications other than depression is considered investigational; prior authorization is likely required and claims for investigational indications may be denied.

Policy states rTMS is investigational for psychiatric/neurologic conditions other than depression.
Investigational uses (e.g., TMS for non-depression conditions) may require prior review and are subject to denial.

Prior Authorization

Coverage linked to NCD/LCD and device labeling

Coverage decisions for left prefrontal rTMS are linked to CMS national and local coverage determinations; device labeling differs (e.g., NeuroStar vs Brainsway) and those device-specific prior treatment requirements should be documented in authorization requests.

Medicare NCD/LCD criteria apply for left prefrontal rTMS under Medicare.
Device labeling differences (NeuroStar: failure of one 6-week antidepressant course; Brainsway H-Coil: failure to respond to antidepressant medications in current episode) should be documented.

Prior Authorization

Medicare prior authorization and coverage summary

For Medicare beneficiaries, coverage for left prefrontal rTMS requires meeting the Medicare NCD/LCD criteria for severe Major Depression; document device-specific prior treatment thresholds because regulatory indications differ by device.

Medicare NCD/LCD cover left prefrontal rTMS for severe Major Depression when NCD/LCD criteria are met.
Include documentation of device used and how patient meets that device's prior treatment requirement.

Prior Authorization

Maintenance TMS authorization specifics

Maintenance TMS authorization: initial approval may be up to 16 weeks when frequency is 2 treatments/week, or up to 26 weeks when frequency is one treatment/week or less; subsequent reauthorizations may be approved for up to 26 weeks when frequency is 2/week or less and improvement is maintained.

Initial authorization: up to 16 weeks (2/week) or up to 26 weeks (≤1/week).
Subsequent reauthorizations: up to 26 weeks when improvement is being maintained.

Step Therapy

Medication failure prerequisites for unipolar MDD

For unipolar Major Depressive Disorder, TMS coverage requires documented failure of the specified medication trials: either failure of at least 3 antidepressants from at least 2 classes, or failure of at least 2 antidepressants from at least 2 classes plus failure of augmentation to at least one failed antidepressant.

Option A: failure of ≥3 antidepressant medications from ≥2 different classes.
Option B: failure of ≥2 antidepressants from ≥2 different classes plus failure with addition of an augmenting agent to at least one failed antidepressant.

Documentation Required

Medication trial documentation and adequacy

Each failed medication trial must be documented with the medication name, reason(s) for failure, and duration; unless stopped for intolerable adverse effects, a minimum of 30 continuous days is required for a trial to count as failed.

Document each failed medication and reason(s) for failure (may be stated per medication or collectively).
Minimum duration to count as failed: 30 continuous days unless discontinued for intolerable adverse effects.

Note

Consider ECT for highly refractory depression

Evidence shows ECT often achieves higher remission rates than rTMS in some comparisons; consider ECT for highly refractory depression before or as part of sequencing when clinically appropriate.

Systematic reviews and trials reported higher remission with ECT versus rTMS in several comparisons.
Policy notes ECT remains most effective for treatment-resistant depression and may be considered in more refractory cases.

Note

Prior treatment expectations in TRD context

Clinical trial entry and referenced studies required failure of multiple antidepressant medications in the TRD context; prior treatment expectations for rTMS authorizations should reflect that trials commonly required multiple failed medication trials.

George et al. enrolled patients who had failed ≥3 antidepressant medication trials or were intolerant to ≥3 medications.
Trials vary but commonly required failure of ≥1 to ≥2 adequate trials; documentation should align with the applicable trial/device definition.

Note

Therapy sequencing expectations for TMS

TMS is generally positioned after multiple failed antidepressant trials and, for highly treatment-resistant cases, after ECT; document sequencing and rationale in the medical record when requesting authorization.

Policy indicates TMS is reasonable after 3–4 failed medication trials and/or after failed ECT in treatment-resistant depression.
Provide clinical rationale and sequencing history in authorization requests.

Documentation Required

Document device-specific prior medication trial

Device-specific prior treatment requirements must be documented: NeuroStar labeling specifies failure of one 6-week antidepressant course; Brainsway H‑Coil clearance references failure to respond to antidepressant medications in the current episode.

NeuroStar: failure of one 6‑week course of antidepressant medication per device labeling.
Brainsway H‑Coil (deep TMS): indicated for patients who failed to respond to antidepressant medications in the current episode.

Step Therapy

Step therapy—no new pathways added

No new step therapy pathways are introduced in this policy update; existing medication-failure and sequencing requirements apply as specified.

Policy explicitly states no new step therapy pathways were added in this section.

Documentation Required

Required documentation to support medical necessity

Authorization review requires medical records showing diagnosis, symptom severity (clinical notes or standardized scales), brief history, age, contraindications, medication trials with outcomes, CPT codes, and session counts to establish medical necessity.

Include diagnosis, symptom severity or standardized rating scale scores, brief history, age, contraindications.
List medication trials with outcomes for each medication and provide CPT codes with number of sessions.

Documentation Required

Obtain neurologic clearance for brain tumor or severe head trauma history

When a history of brain tumor or severe/repetitive head trauma is present, include documentation that a neurologist or neurosurgeon has evaluated and cleared the individual to undergo TMS to avoid contraindication-based denial.

Presence or history of brain tumor or severe/repetitive head trauma requires neurologist/neurosurgeon evaluation and documentation of clearance.
Lack of such documentation will render TMS not medically necessary per policy contraindications.

Billing Rule

Account for planning/mapping sessions in accelerated TMS totals

For accelerated TMS, document total daily treatments and total course treatments including sessions used for treatment planning, cortical mapping, motor threshold determination, and re-determination; policy clarifies these sessions count toward daily and total maximums.

Total daily and total treatments must include planning, mapping, initial motor threshold, and any motor threshold re-determination sessions.
Concurrent fMRI or neuronavigation for accelerated TMS remains investigational.

Documentation Required

Allow collective or per-medication failure reasons

Medication failure documentation may state reasons for failure either for each medication individually or collectively for all failed medications; ensure the record specifies adequacy and duration of trials.

Reason(s) for failure can be provided per medication or collectively.
Document adequacy (dose and duration) of each trial; minimum 30 days unless stopped for intolerable adverse effects.

Denial Risk

Contraindications that may trigger denial

Presence of listed contraindications (e.g., brain tumor without specialist clearance, unspecified brain lesion without clearance, severe head trauma without clearance, increased intracranial pressure, current psychotic disorder/symptoms, current substance abuse, non-removable magnetic-sensitive implants near coil, unstable seizure disorder, severe dementia) will render TMS not medically necessary and may lead to denial.

Contraindications include presence/history of brain tumor without clearance, unspecified brain lesion without clearance, severe/repetitive head trauma without clearance.
Other contraindications: increased intracranial pressure, current psychosis, current substance abuse, non-removable ferromagnetic implants within 30 cm of coil, seizure disorder unless stable, severe dementia.

Denial Risk

Avoid consecutive/overlapping courses or multiple providers

Consecutive or overlapping TMS courses for different conditions, or TMS provided by more than one provider/group/clinic at the same time, are considered not medically necessary and may be denied.

Consecutive/overlapping courses for different diagnoses are not medically necessary.
Concurrent provision by more than one provider/group/clinic is not medically necessary.

Denial Risk

TMS concurrent with Spravato/ketamine/psychedelics is investigational

Use of TMS in conjunction with Spravato, ketamine, or any other psychedelic drug is considered investigational and may trigger denial; document any concurrent use and expect prior authorization review.

Policy states TMS combined with Spravato or ketamine or other psychedelic drugs is investigational.
Such concomitant use may be denied; prior authorization review is likely required.

Denial Risk

Do not combine TMS with other neuromodulation modalities (except limited VNS cases)

Use of TMS concurrently with other neuromodulation modalities (e.g., ECT, DBS, CES) is considered not medically necessary and may be denied; limited exception exists for VNS per specified transitional maintenance context.

Concurrent use with ECT, DBS, CES is not medically necessary.
TMS with VNS may be medically necessary only in limited transitional/maintenance contexts per policy.

Denial Risk

Insufficient evidence may trigger non-coverage

If comparative evidence is insufficient (e.g., inadequate follow-up in relapse prevention phases) or evidence is weak for a condition, coverage may be denied on the basis of insufficient evidence.

Policy notes that insufficient comparative evidence or limited follow-up can lead to non-coverage conclusions.
Trials with limited relapse-prevention data or heterogenous results may not support coverage for given indications.

Denial Risk

Investigational indications for rTMS—likely denial

rTMS claims for psychiatric or neurologic indications other than depression are considered investigational and may be denied without prior review demonstrating medical necessity.

Policy explicitly classifies rTMS as investigational for conditions other than depression.
Claims for these investigational indications may be denied.

Denial Risk

Medicare NCD/LCD criteria must be met or coverage may be denied

Medicare beneficiaries: failure to meet NCD/LCD criteria for left prefrontal rTMS (severe Major Depression per DSM-5 and NCD/LCD-specified additional criteria) may result in denial of Medicare coverage for that indication.

Medicare NCD/LCD criteria must be met for coverage of left prefrontal rTMS in severe Major Depression.
Failure to meet these criteria may trigger Medicare denial.

Denial Risk

Prior outcome-based denial risk for maintenance/recurrence

Maintenance or repeat full/short intensive TMS courses will be considered not medically necessary if the preceding course was determined not medically necessary; document prior course determinations and rationale when requesting resumption.

If preceding course was determined not medically necessary, maintenance or repeat courses are considered not medically necessary.
Resumption of maintenance TMS may be considered if prior maintenance had resulted in clinical stability, but documentation is required.

UseDefines response for trial outcomes and helps guide continuation/extension decisions

Remission

Remission definitionHAM-D score <=7

UseUsed to determine remission and whether further TMS (extension/maintenance) is not medically necessary

ScaleHamilton Depression Rating Scale (HAM-D)

TRD definition

TRD definition variabilityTreatment‑resistant depression (TRD) is variably defined across studies; commonly defined as failure of at least one adequate antidepressant course but many trials enrolled patients failing >=2 courses

Trial enrollment practicesSome pivotal trials required 1–4 prior antidepressant trials or intolerance to medications

Implication for authorizationDocumentation should mirror the TRD definition relevant to the selected TMS modality or trial evidence

Target distinctions

Target distinctionsStimulation targets differ (primary motor cortex vs dorsolateral prefrontal cortex [DLPFC] and temporoparietal areas) and frequency (high‑ vs low‑frequency) which produce variable outcomes

Clinical consequenceEfficacy can depend on target and frequency selection (e.g., high‑frequency left DLPFC commonly used for MDD)

DocumentationAuthorization should document stimulation site and frequency consistent with evidence for the indication

SNT/SAINT

SNT/SAINT descriptionSNT/SAINT is an accelerated theta burst stimulation protocol consisting of 10 TBS sessions daily for 5 consecutive days; published studies are limited and it remains investigational per policy

Regulatory noteAlthough FDA 'approved' SNT/SAINT is discussed in updates, the policy treats SNT/SAINT as investigational due to limited and underpowered published studies

Coverage implicationSNT/SAINT is specifically excluded from coverage and considered investigational

Deep TMS — H‑coil description

H‑coil / Deep TMSDeep TMS delivered with an H‑coil (e.g., Brainsway) designed to stimulate deeper cortical regions; Brainsway H‑Coil received FDA clearance in 2013 with indication for depression after medication nonresponse

Pivotal trial summaryPivotal Brainsway trial enrolled 229 patients with 1–4 prior antidepressant trials; per‑protocol analyses showed significant response/remission advantages though ITT results were less consistent

Indication scopeBrainsway H‑Coil clearance wording references failure to respond to antidepressant medications in the current episode

Deep TMS — clearance background

Deep TMS clearance backgroundBrainsway H‑Coil received FDA clearance in 2013 for treating depression in patients who failed to respond to antidepressant medications in their current episode

Evidence nuancePer‑protocol analyses favored deep TMS; ITT analyses were less consistent — relevant for interpreting coverage evidence

Device-specific documentationAuthorization should note device and prior treatment history per device labeling

Standard rTMS

Standard rTMS definitionStandard/repetitive TMS (rTMS) typically refers to high‑frequency stimulation of the left dorsolateral prefrontal cortex for depression

Device examplesDevices include NeuroStar, MagPro 'R' series, MagVita, Magstim Rapid (listed as FDA‑cleared for standard rTMS)

Typical deliveryDelivered daily (Monday–Friday) over multiple weeks in trial protocols

rTMS (abbreviation)

AbbreviationrTMS = Repetitive transcranial magnetic stimulation

Reference locationAbbreviations listed in the policy appendix

TRD (abbreviation)

AbbreviationTRD = Treatment‑resistant depression

Reference locationAbbreviations listed in the policy appendix

High-frequency left DLPFC rTMS: Daily sessions (commonly Monday–Friday) for multiple weeks (4–6 weeks) at specified intensity; evidence shows modest benefit over sham in several trials and meta‑analysestreatment courses varied

Largest multicenter RCT n=325 and meta‑analyses report modest effect sizes

Deep TMS (Brainsway): Pivotal trial enrolled patients with 1–4 prior antidepressant trials or intolerance to ≥2 treatments and showed significant per‑protocol response/remission advantages; ITT results less consistent1–4 prior trials in pivotal study

Maintenance benefit reported in some analyses

Low-frequency right or bilateral rTMS: Mixed results across trials; some studies show improvement compared with sham or between right vs left stimulation; evidence heterogeneousvaries

Blinding and sample size issues noted in trials

rTMS (various targets and frequencies)

rTMS target/frequency notes: Different brain targets (DLPFC, primary motor cortex, temporoparietal area) and stimulation frequencies (high vs low) produce variable outcomes across disorders; parameter selection influences outcomes

Evidence heterogeneous across targets and frequencies

TMS / Theta burst / Accelerated TMS

Theta burst and accelerated TMS: Theta burst stimulation is supported by credible evidence for adult MDD and may be delivered in accelerated protocols (up to 10 daily sessions for TBS); SNT/SAINT accelerated protocol remains investigational and not coveredup to 10/day for theta burst

Accelerated protocols vary; concurrent neuronavigation/fMRI investigational

Vagus Nerve Stimulation (concomitant management)

VNS concomitant management: When initiating VNS, maintenance TMS may be continued for transitional purposes while awaiting VNS effect (assess at 3‑month intervals); maximum continuation with TMS is 12 months post‑implant if VNS not effectivemax 12 months

Continued TMS not medically necessary when VNS achieves mild/remission

rTMS / Deep TMS

Device‑specific indications: NeuroStar TMS indicated per device labeling for patients who have failed one 6‑week antidepressant course; Brainsway H‑Coil deep TMS indicated for patients who have failed to respond to antidepressant medications in the current episodedevice labeling applies

Medicare NCD/LCD criteria also apply for left prefrontal rTMS

Regulatory context: Multiple FDA‑cleared devices exist for standard and deep TMS; device indications and prior treatment requirements vary and should be documented

TMS variants (theta-burst, accelerated, SNT/SAINT, deep TMS)

Theta-burst vs SNT/SAINT: Theta‑burst stimulation is considered medically necessary for Major Depressive Disorder when criteria are met; the SNT/SAINT accelerated protocol remains not covered/investigational

Policy revisions expanded theta burst coverage but retained SNT/SAINT as investigational

Deep TMS is an accepted modality for depression (Brainsway H‑Coil cleared) with evidence supporting use after medication nonresponse

Applicable only when TMS is transitional/maintenance while initiating VNS and TMS was partially but inadequately effective

Stop criteriaContinued TMS is not medically necessary when depression improves to mild/remission or after 12 months post‑implant

rTMS session

Typical rTMS session scheduleDaily sessions Monday–Friday for 3–6 weeks are typical in clinical trials (commonly 4–6 weeks)

Trial examplesLargest multicenter rTMS RCT delivered daily sessions Monday–Friday for 6 weeks

Use for planningSchedules inform coverage of full intensive courses and expected session counts

Theta burst sessions (accelerated protocols)

Theta burst accelerated sessionsAccelerated theta burst protocols may permit up to 10 daily sessions per day

Protocol variabilityPublished accelerated protocols report 2–10 sessions/day; theta burst enables higher daily session counts

Tolerability noteTrials show similar tolerability to once‑daily TMS though minor side effects may increase

No visit/session limits specified

No explicit limits in this sectionThis section does not specify additional visit/session caps beyond course parameters elsewhere in the policy

InterpretationRefer to modality‑specific course and accelerated/maintenance rules for applicable limits

DocumentationProviders should submit CPT codes and session counts per documentation requirements

Accelerated TMS — daily limits and total treatments

Accelerated TMS daily maximumsMaximum daily treatments up to 5/day for standard/deep TMS or up to 10/day for theta burst stimulation for accelerated protocols; no increase in total number of treatments for the course

Total treatments unchangedAccelerated delivery shortens timeframe but does not increase the total allowable treatments (e.g., full course totals remain as specified: 30/36 or up to 44 depending on type)

Documentation requirementFor accelerated TMS, document total daily sessions and that total course treatments include planning and motor‑threshold sessions

Maintenance TMS — authorization and reauthorization

Initial maintenance authorization periodsInitial maintenance authorization up to 16 weeks when frequency is 2 treatments/week, or up to 26 weeks when frequency is <=1 treatment/week

ReauthorizationSubsequent reauthorizations may be granted up to 26 weeks when improvement is maintained and frequency is 2/week or less

Frequency limitsMaintenance frequency limited to 2 treatments/week or less; motor threshold re‑determination no more often than every 10 treatment sessions

Interim review clarified seizure-history contraindication language and related neurologic-clearance expectations for brain tumor or severe/repetitive head trauma.

2016-03-08annual_review

Annual literature review and references update performed and approved, with addition of multiple earlier references and guideline citations.

2013device_clearance_history

Brainsway H-Coil FDA clearance (deep TMS) noted in regulatory history and cited evidence base for device-specific indications.

This document includes revision‑range and effective date notes in the policy history. The policy was approved on February 23, 2026, and the effective date is March 1, 2026. Recent updates added expanded guidance on accelerated TMS (including maximum daily treatments and removal of the hardship requirement), clarified maintenance authorization periods, and modified contraindication and documentation language; concurrent fMRI or neuronavigation remains investigational.