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Transcranial Magnetic Stimulation for Treatment Resistant Major Depression (PDF)

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Defines medical necessity criteria, contraindications, device requirements, session limits, and review processes for initial, adolescent, retreatment, and maintenance use of rTMS, dTMS, and iTBS for major depressive disorder.

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CurrentAmbetter NevadaPolicy CP.BH.200

Transcranial Magnetic Stimulation for Treatment Resistant Major Depression (PDF)

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Policy Summary

PayerAmbetter Nevada

PolicyTranscranial Magnetic Stimulation for Treatment Resistant Major Depression (PDF)

Policy CodePolicy CP.BH.200

Change TypeRevisedAddedClarified

Effective Date

Next Review Date

Key ActionDocument PHQ-9/PHQ-A (or equivalent) pre-treatment and throughout, document the specific rTMS/iTBS/dTMS protocol and ensure referral and comprehensive psychiatric evaluation are provided.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed, updated, and adopted as Centene Corporate policy; multiple historical revisions documented.

Added policy statement II: insufficient evidence to support safety and efficacy of more than 30 sessions of TBS.

Replaced 'TMS' with 'repetitive transcranial magnetic stimulation (rTMS)' and added iTBS and dTMS protocols and documentation requirement.

Added planned use and documentation of a standardized depression severity rating scale with pre-TMS score.

Removed psychosis exclusion and replaced with exclusion for schizophrenia/schizoaffective/bipolar disorders.

Clarified prior therapy requirements: failure/intolerance to two antidepressant trials from at least two classes; psychotherapy trial required.

MRI-guided theta burst designated experimental and investigational.

No changes to psychotropic treatment during TMS unless clinically justified; earlier contraindication of concurrent esketamine/ketamine infusion removed in favor of requiring documentation if such therapy is used.

Added contraindication for acute active suicidal ideation with intent.

36Maximum sessions requested (per request)

≤30TBS session limit

>=15PHQ threshold for severity

Adults ≥18Eligible population

9FDA-cleared devices listed

MRI-guided TBSInvestigational procedure

Coverage Summary

Overview: This policy defines medical necessity criteria for use of transcranial magnetic stimulation modalities for treatment‑resistant major depressive disorder. Eligible populations include adults (≥18 years) meeting diagnostic and treatment‑trial requirements; select adolescent requests (ages 15–17) are reviewed case‑by‑case by a medical director per FDA‑labeled NeuroStar indication. Covered TMS modalities include repetitive transcranial magnetic stimulation (rTMS), intermittent theta burst stimulation (iTBS/TBS), and deep TMS (dTMS) when administered with an FDA‑cleared device in accordance with labeled indications and the policy criteria.

Session limits and exclusions: Routine courses are limited to up to 36 sessions (recommended schedule five days/week for six weeks with optional six tapering sessions). A specific limit applies to theta burst protocols: TBS sessions are limited to ≤30 sessions. MRI‑guided accelerated theta burst protocols (e.g., SAINT / MRI‑guided TBS) are considered experimental/investigational and are not supported due to insufficient evidence.

Key thresholds and quick facts

PHQ-9 / PHQ-A threshold>=15 indicating moderately severe to severe depression

Adequate antidepressant trial duration>=6 weeks per trial

Substance use remission required>=3 months substantiated remission (less than 3 months is a contraindication)

Typical maximum rTMS courseUp to 36 sessions; recommended 5 days/week for 6 weeks with optional 6 tapering sessions

Theta Burst Stimulation (TBS) session limit<=30 sessions (insufficient evidence to support >30)

Eligible populationAdults >=18 years

Medical Necessity Criteria

I. Initial treatment for adults (≥18 years)

Covered when ALL of the following are met:

ALL of the following

Member has a confirmed diagnosis of major depressive disorder (MDD), severe (single episode or recurrent), per most recent DSM edition
Member does not have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
ONE OF
- Failure of two trials of evidence-based antidepressants from at least two different antidepressant classes administered as an adequate course with a recognized standard therapeutic dose of at least six weeks duration within the last 24 months>= 6 weeks per trial

Policy Statements & Limits

Policy Statement I - Coverage Criteria for Adults (≥18 years)

Covered when ALL of the following are met:

ALL of the following

Member/enrollee is an adult (≥ 18 years of age)>= 18 years
Diagnosis of major depressive disorder (MDD); member does not have schizophrenia, schizoaffective disorder, or bipolar disorder
Psychosis exclusion removed; replaced by specified diagnoses
Failure or intolerance to two trials of antidepressants from at least two different agent classesTwo trials from >=2 classes; intolerance requires documentation per policy
Documented intolerance requires meeting both subcriteria

Contraindications & Exclusions

Contraindications and Exclusions

Not covered or contraindicated when ANY of the following apply:

ANY of the following

Member has a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Listed as exclusion/contraindication
Presence of conductive or ferromagnetic or other magnetic-sensitive metals implanted or embedded in head or neck within 30 cm of TMS coil placement (other than dental fillings) including cochlear implant, implanted electrodes/stimulators, aneurysm clips/coils, stents, bullet fragments, metallic dyes in tattoosWithin 30 cm of coil placement
Vagus nerve stimulator leads in the carotid sheath

Coding

CPT codes referenced (informational)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.

Removed HCPCS/Coding tablemixed

No codes listed

Provider Actions & Billing Guidance

Prior Authorization

Medical director review for adolescents and retreatment

Initial treatment for adolescents (ages 15-17) and all retreatment requests are reviewed case-by-case by a medical director; all initial criteria must be met prior to requests for additional sessions. Ensure referral and required documentation are provided before authorizing adolescent or retreatment TMS.

Documentation Required

Document standardized rating scores and TMS protocol

Document a standardized depression severity score (PHQ-9 or PHQ-A or equivalent) prior to treatment and monitor scores throughout the course. Also document the specific TMS protocol to be used (rTMS, iTBS, or dTMS) and the treating/referring provider.

Documentation Required

Background, Evidence & Definitions

Background: Transcranial magnetic stimulation (TMS) is a non‑invasive neuromodulation therapy used for major depressive disorder when psychotherapy and pharmacologic treatments are inadequate or not tolerated. rTMS delivers repeated pulse trains to modulate cortical excitability; iTBS (theta burst) uses short high‑frequency bursts to produce an overall lower stimulation frequency; and dTMS uses H‑coils to stimulate deeper brain structures (~4 cm).

Regulatory context and evidence limits: Multiple TMS modalities have received FDA clearances over time — conventional rTMS (2008), deep TMS (2013), and iTBS (2018) — and NeuroStar received adolescent labeling more recently. While FDA‑cleared devices and manufacturer protocols demonstrate acceptable safety when used per labeling, evidence is insufficient to support routine maintenance rTMS and insufficient to support MRI‑guided accelerated theta burst protocols such as SAINT; maintenance rTMS and MRI‑guided TBS/SAINT are therefore not supported by the published peer‑reviewed literature per this policy.

Source	Takeaway
Guideline & regulatory citations (Clinical TMS Society, APA, FDA, AACAP, Hayes)
Professional bodies endorse TMS for selected patients; FDA has cleared devices and indications (including iTBS and adolescent NeuroStar approval); guidelines and HTAs referenced in policy

Definitions

Thresholds / Key Numeric Criteria

Revision History

12/18administrative

Policy reviewed, updated, and adopted as Centene Corporate policy; multiple historical revisions documented.

02/23policy_added

Added policy statement II: insufficient evidence to support safety and efficacy of more than 30 sessions of Theta Burst Stimulation (TBS).

02/23policy_revised

Replaced 'TMS' with 'repetitive transcranial magnetic stimulation (rTMS)', added statement limiting TBS to up to 30 sessions, and added planned use of standardized rating scale with pre-TMS score documented.

Policy Summary

PayerAmbetter Nevada

PolicyTranscranial Magnetic Stimulation for Treatment Resistant Major Depression (PDF)

Policy CodePolicy CP.BH.200

Change TypeRevisedAddedClarified

Effective Date

Next Review Date

Key ActionDocument PHQ-9/PHQ-A (or equivalent) pre-treatment and throughout, document the specific rTMS/iTBS/dTMS protocol and ensure referral and comprehensive psychiatric evaluation are provided.

SourceLink

On This Page

Inability to tolerate four trials of evidence-based antidepressants from at least two different antidepressant classes (documentation of major adverse interactions or intolerable side effects)

Documentation required

Member has participated in an adequate trial of evidence-based psychotherapy (e.g., weekly CBT and/or interpersonal therapy) during the current episode of illness without significant improvement; this therapy should overlap with the antidepressant trials

Member is referred for TMS treatment by the provider treating the member's MDD

QUALIFIED PROVIDER

Psychiatrist (MD, DO, MBBS)
Psychiatric Mental Health Nurse Practitioner (PMHNP)

Direct supervision of treatment is provided by a licensed psychiatrist trained in TMS therapy, except where state scope of practice allows other provider types to supervise

Request is for up to 36 sessions; recommended schedule five days/week for six weeks, with an optional six sessions for taperingup to 36 sessions

Recommended schedule noted

Treatment is administered using an FDA-cleared device and utilized in accordance with FDA labeled indications

Examples of FDA-cleared devices listed in policy

Member does not have any contraindications (ALL of the following absent): presence of conductive/ferromagnetic/magnetic-sensitive metals implanted or embedded in head or neck within 30 cm of coil placement (other than dental fillings) including cochlear implant, implanted electrodes/stimulators, aneurysm clips/coils, stents, bullet fragments, metallic dyes in tattoos; vagus nerve stimulator leads in the carotid sheath; less than three months of substantiated remission from substance use disorder>= 3 months remission required

No changes to psychotropic treatment during course of TMS treatment unless clinical documentation justifies the change (e.g., concomitant ketamine, esketamine, or other infusion therapy)

Documentation required if changes occur

Documentation of rTMS, iTBS, or dTMS protocol used

Planned use of an evidence-based standardized depression rating scale (including severity), documenting the score prior to treatment and monitored throughout course of treatmentPHQ-9 >= 15 indicative of moderately severe to severe depression

Pre-treatment score required

II. Initial treatment for adolescents (ages 15-17)

Reviewed case-by-case by a medical director; all initial criteria must be met prior to request for additional sessions. Criteria informed by ALL of the following:

ALL of the following

Treatment is administered using the NeuroStar TMS Therapy System as an adjunct for MDD per FDA-labeled indication
NeuroStar required for adolescents
Confirmed diagnosis of MDD, severe (single episode or recurrent), per most recent DSM edition
Member does not have a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Member has failed a trial of (or has intolerance to) psychopharmacologic therapy as evident by PHQ-A score ≥ 15 throughout the current course of psychopharmacologic and psychotherapeutic treatment (or equivalent standardized scale), evidenced by either failure of two trials of evidence-based antidepressants from at least two different classes administered as an adequate course of at least six weeks within last 24 months OR inability to tolerate two trials of evidence-based antidepressants from at least two different antidepressant classes within last 24 monthsPHQ-A >= 15; >=6 weeks per trial
Member has participated in an adequate trial of evidence-based psychotherapy during current episode without significant improvement; therapy should overlap with antidepressant trials
Referral by provider treating the adolescent's MDD
QUALIFIED PROVIDER
- Psychiatrist (MD, DO, MBBS)
- Psychiatric Mental Health Nurse Practitioner (PMHNP)
Direct supervision provided by a licensed psychiatrist trained in TMS therapy, except where state scope allows other provider types
Request is for up to 36 sessions; recommended schedule 5 days/week for 6 weeks, with optional six tapering sessionsup to 36 sessions
Member does not have contraindications: conductive/ferromagnetic metals within 30 cm of coil (except dental fillings); vagus nerve stimulator leads in carotid sheath; less than three months substantiated remission from substance use disorder
No changes to psychotropic treatment during TMS unless clinical documentation justifies change
Documentation required if change occurs
Documentation of rTMS protocol used
Planned use of an adolescent, evidence-based, standardized depression rating scale, documenting score prior to treatment and monitored throughoutPHQ-A >= 15 pre-treatment
Pre-treatment score required

III. Retreatment for adults (≥18 years)

Retreatment requests reviewed case-by-case by a medical director and considered when ALL of the following are met:

ALL of the following

Confirmed diagnosis of MDD, severe (single episode or recurrent), per DSM
No diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Current depressive symptoms worsened to PHQ-9 severity score ≥ 15 (or equivalent)PHQ-9 >= 15
Prior treatment response demonstrated at least 50% improvement in baseline standardized depression rating scores with documented 6-month duration of response>=50% improvement; documented 6-month duration
6-month duration required
Referral by provider treating the member's MDD
QUALIFIED PROVIDER
- Psychiatrist (MD, DO, MBBS)
- Psychiatric Mental Health Nurse Practitioner (PMHNP)
Member has participated in an adequate trial of evidence-based psychotherapy during current episode without significant improvement
Direct supervision provided by a licensed psychiatrist trained in TMS therapy, except where state scope allows other provider types
Request is for up to 36 sessions; recommended schedule 5 days/week for 6 weeks, with optional six tapering sessionsup to 36 sessions
Treatment administered using an FDA-cleared device in accordance with FDA labeled indications
Examples listed in Section I
No contraindications: conductive/ferromagnetic metals within 30 cm of coil (except dental fillings); vagus nerve stimulator leads in carotid sheath; less than three months substantiated remission from substance use disorder>= 3 months remission required
No changes to psychotropic treatment during course of TMS unless clinical documentation justifies change
Documentation required if change occurs
Documentation of rTMS, iTBS, or dTMS protocol used
Planned use of an evidence-based standardized depression rating scale, documenting score prior to treatment and monitored throughout
If not achieving remission, consider treatment augmentation or alternative treatment such as Electroconvulsive Therapy (ECT)

IV. Retreatment for adolescents (15-17 years)

Reviewed case-by-case by a medical director; considered when ALL of the following are met:

ALL of the following

Requested treatment is with the NeuroStar TMS Therapy System, as an adjunct for MDD per FDA-labeled indication
NeuroStar required for adolescents' retreatment
Confirmed diagnosis of MDD, severe (single episode or recurrent), per DSM
No diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Current depressive symptoms worsened to PHQ-A severity score ≥ 15 (or equivalent)PHQ-A >= 15
Prior treatment response demonstrated at least 50% improvement in baseline standardized depression rating scores with documented 6-month duration of response>=50% improvement; documented 6-month duration
6-month duration required
Referral by provider treating the adolescent's MDD
QUALIFIED PROVIDER
- Psychiatrist (MD, DO, MBBS)
- Psychiatric Mental Health Nurse Practitioner (PMHNP)
Member has participated in an adequate trial of evidence-based psychotherapy during current episode without significant improvement
Direct supervision provided by a licensed psychiatrist trained in TMS therapy, except where state scope allows other provider types
Request is for up to 36 sessions; recommended schedule 5 days/week for 6 weeks, with optional six tapering sessionsup to 36 sessions
No contraindications: conductive/ferromagnetic metals within 30 cm of coil (except dental fillings); vagus nerve stimulator leads in carotid sheath; less than three months substantiated remission from substance use disorder>= 3 months remission required
No changes to psychotropic treatment during course of TMS unless clinical documentation justifies change
Documentation required if change occurs
Documentation of rTMS protocol used
Planned use of an adolescent evidence-based standardized depression rating scale, documenting score prior to treatment and monitored throughoutPHQ-A >= 15 pre-treatment
If not achieving remission, consider augmentation or alternative treatment such as ECT

V. Maintenance treatment

Not medically necessary when used as maintenance

ALL of the following

Maintenance treatment with rTMS, iTBS, or dTMS is considered not medically necessary due to insufficient evidence of benefit

VI. MRI-guided TBS / SAINT

Not supported due to insufficient evidence

ALL of the following

Insufficient evidence to support safety and efficacy of MRI-guided theta burst stimulation including Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)
Experimental/Investigational

Participation in an adequate trial of evidence-based psychotherapy during the current episode without significant improvement

Therapy should overlap with antidepressant trials

Referral for TMS treatment by the provider treating the member's MDD

Comprehensive psychiatric evaluation completed by a qualified licensed provider (MD, DO, MBBS)

Planned use of a depression severity standardized rating scale by the TMS provider to monitor response during treatment, with pre-TMS score documentedPre-treatment standardized score required (e.g., PHQ-9)

Monitor throughout treatment

Documentation of rTMS, iTBS (intermittent Theta Burst Stimulation) or dTMS protocol used

Frequency and maximum sessions: up to 36 sessions; recommended schedule five days a week for six weeks with optional six sessions for taperingup to 36 sessions

Policy Statement II separately limits TBS sessions to 30

No changes to psychotropic treatment during the course of TMS treatment unless clinical documentation justifies the change

Providers must document justification for any psychotropic changes during TMS

Policy Statement II - Theta Burst Stimulation (TBS) Session Limit

Coverage limitation:

ALL of the following

There is insufficient evidence to support the safety and efficacy of more than 30 sessions of Theta Burst Stimulation (TBS)<= 30 sessions for TBS
Policy Statement II: explicit TBS sessions limit

Policy Statement III - Maintenance/Continuation

Conditions for continuation/maintenance:

ALL of the following

Documented clinical response with a 6-month duration of response is required for maintenanceDocumented >= 6-month duration of response
Statement added: 'with a documented 6-month duration of response'

Policy Statement VI - Experimental/Investigational

Not covered when experimental/investigational:

ALL of the following

MRI-guided theta burst stimulation is considered experimental and investigational
Includes SAINT and similar MRI-guided accelerated protocols

Less than three months of substantiated remission from substance use disorder

< 3 months remission is contraindication

Required >= 3 months remission to proceed

Acute active suicidal ideation with intent

Added as contraindication

MRI-guided theta burst (considered experimental/investigational)

Experimental technique excluded

Changes to psychotropic therapy during TMS without clinical documentation justifying the change

Policy consistently requires documentation/justification if psychotropic changes or concomitant therapies are used

Psychiatric evaluation and referral documentation

Provide a comprehensive psychiatric evaluation by a qualified licensed provider (e.g., Psychiatrist MD/DO/MBBS or Psychiatric Mental Health Nurse Practitioner) and include documentation of referral from the provider treating the member's MDD.

Billing Rule

Session limits

Requests should be for up to 36 sessions (recommended schedule: five days/week for six weeks with an optional six taper sessions). Maintenance treatments and MRI-guided SAINT (MRI-guided theta burst) are not covered.

Denial Risk

Contraindications must be absent

Claims may be denied if the member has disqualifying implanted conductive/ferromagnetic or magnetic-sensitive metals within 30 cm of coil placement (excluding dental fillings), vagus nerve stimulator leads in the carotid sheath, or less than three months of substantiated remission from a substance use disorder.

Prior Authorization

Documentation and referral required

The provider treating the member's MDD must refer for TMS and supply documentation including: comprehensive psychiatric evaluation, evidence of prior antidepressant trials from ≥2 classes (or intolerance documentation), an adequate psychotherapy trial, planned standardized rating scale with pre-TMS score, and the specific TMS protocol to be used.

Documentation Required

Monitor depression severity

Planned use of a depression severity standardized rating scale (PHQ-9 for adults, PHQ-A for adolescents, or equivalent) by the TMS provider to monitor response during treatment, with the pre‑TMS score documented and monitored throughout the course.

Billing Rule

Session limits enforcement

Claims for more than 30 Theta Burst Stimulation (TBS) sessions are considered not supported by the evidence; routine TMS courses should adhere to up to 36 sessions unless otherwise specified by policy.

Denial Risk

Experimental procedure exclusion

MRI-guided theta burst stimulation, including protocols such as SAINT, is considered experimental/investigational and will be denied as not medically necessary.

Documentation Required

Psychotropic medication changes

No changes to psychotropic treatment during the course of TMS unless clinical documentation justifies the change. If psychotropic medications are changed or therapies such as ketamine/esketamine or other infusion therapies are used concomitantly, document the clinical justification.

03/24policy_revised

Added contraindication language referencing concomitant esketamine intranasal, ketamine infusion or other infusion therapies in contraindication list (later removed in subsequent revisions) and added requirement for documentation of depression rating scale; removed HCPCS coding table.

02/25policy_revised

Policy restructured; deep TMS (dTMS) added as a form of TMS; psychosis exclusion removed and replaced with exclusion for schizophrenia, schizoaffective disorder, or bipolar disorder; documentation of rTMS, iTBS, or dTMS protocol required; frequency updated to up to 36 sessions with recommended 5 days/week for 6 weeks and optional six tapering sessions.

02/26policy_revisedLatest

Current review: clarified prior therapy and psychotherapy trial requirements (failure/intolerance to antidepressants from ≥2 classes and psychotherapy trial required); removed psychosis exclusion; added documentation requirements including planned standardized depression rating scale with pre‑TMS score and documentation of protocol; removed 'concomitant esketamine/ketamine' from contraindication list and replaced with requirement that any psychotropic changes be clinically justified and documented; MRI-guided theta burst (SAINT) designated experimental/investigational; added contraindication for acute active suicidal ideation with intent; specified no changes to psychotropic treatment during TMS unless justified; clarified TBS session limit referenced in Policy Statement II (≤30).