What Are the Referral Criteria for Deep TMS in Treatment-Resistant Depression?

Direct Answer

A deep TMS referral has to clear three separate gates, and they do not contain the same requirements. The first is FDA clearance, which is device-specific and indication-specific: the system being used must hold a clearance covering this condition and this patient’s age. The second is payer coverage, which is set by coverage policy rather than by clearance and typically requires a documented diagnosis of severe major depressive disorder, documented failure of or intolerance to antidepressant medication and an order from a psychiatrist who has examined the patient in person. The third is clinical candidacy, which is the treating psychiatrist’s judgment about whether this patient is likely to benefit and able to complete a course.

The most common surprise for referring clinicians is that clearance and coverage diverge. A condition can be FDA-cleared for treatment with a given device and still be excluded from coverage under the applicable policy. Verify both before telling a client that deep TMS is an option, and treat safety screening as a separate step that the service will conduct.

Three Different Gates, and They Do Not Line Up

Referring clinicians tend to hold one mental model of eligibility, usually built from what a device manufacturer or a clinic website says. In practice a client has to satisfy three independent sets of requirements owned by three different parties. The regulator determines what a device may be marketed to treat. The payer determines what it will fund. The treating psychiatrist determines whether this particular patient should have it.

Any of the three can be the binding constraint, and which one binds is not predictable from the clinical picture alone. A client who is an obvious clinical candidate can be blocked by a coverage policy. A client whose coverage is straightforward can be an inappropriate candidate. Knowing which gate is likely to be the problem changes what you prepare before making the referral.

What Deep TMS Is Actually Cleared to Treat

Clearances are held by manufacturers for specific devices and specific indications. BrainsWay states that its Deep TMS system has been FDA-cleared for major depressive disorder since 2013, obsessive compulsive disorder since 2018, smoking cessation since 2020 and anxious depression since 2021.¹ On November 12, 2025 the company announced a label expansion clearing Deep TMS as an adjunct therapy for adolescent patients aged 15 to 21 with major depressive disorder.²

That adolescent clearance matters for this population and it is not unique to one manufacturer. The FDA cleared the NeuroStar Advanced Therapy System as an adjunct for major depressive disorder in adolescent patients aged 15 to 21 on March 22, 2024.³ Two different systems, two different clearance dates, both adjunct rather than standalone. The practical instruction is to ask the service which device it operates and which cleared indication applies to your client, rather than assuming that what is true of one deep TMS system is true of all of them.

What a Payer Requires Is a Different List

Coverage policy is written independently of clearance. The Medicare local coverage determination for transcranial magnetic stimulation in adults with major depressive disorder, issued by Novitas Solutions with a revision effective December 11, 2022, considers treatment reasonable and necessary when three conditions are met: a confirmed diagnosis of severe major depressive disorder as defined by the current DSM, demonstrated failure of one or more trials of a pharmacological medication or demonstrated intolerance to psychopharmacologic medications and an order written by a psychiatrist who has examined the patient face to face.⁴ Coverage under that policy extends for up to six weeks.⁴

Note how modest the medication requirement is in that formulation. One or more failed trials, or intolerance, is a lower bar than the two-or-more standard many clinicians carry in their heads. Commercial policies frequently set a higher bar than Medicare does, sometimes requiring four failed trials across drug classes plus a documented course of psychotherapy. There is no single number, which is why the specific plan’s policy has to be read rather than assumed.

The Clearance and Coverage Gap Is the Practical Problem

The clearest illustration sits in the same policy. Deep TMS holds an FDA clearance for obsessive compulsive disorder, and the Novitas local coverage determination states that transcranial magnetic stimulation for conditions other than severe major depressive disorder, specifically including obsessive compulsive disorder, is not medically reasonable and necessary under that policy.⁴ A client can therefore have a condition the device is cleared to treat and still face a denial.

For a referring clinician this has one consequence worth internalizing. Do not tell a client that a condition is treatable with deep TMS on the strength of an FDA clearance alone. Say that the service will assess candidacy and verify coverage, and that both answers are needed. Yellowbrick provides neuroscience technologies and neuromodulation services through an agreement with its sister company Synchrony Brain Health, whose outpatient services include Deep TMS, and questions about which device, indication and coverage pathway apply to a given client should go to that service directly.

The Three Gates Side by Side

What to Document Before the Referral

• The current diagnosis and whether severity meets the threshold the payer’s policy uses, since severe MDD is a specific coverage requirement rather than a general description.
• Every antidepressant trial with agent, dose, duration, adherence and the reason it ended, presented as a table rather than as narrative.
• Which trials were adequate and which were interrupted, stated explicitly rather than left for the reviewer to infer.
• Any documented intolerance, since intolerance can satisfy the coverage requirement where failure alone has not been established.
• The psychotherapy history, including modality, frequency and duration, which some commercial policies require.
• Current functional impairment in school, work or relationships, described concretely.
• The client’s date of birth, since the adolescent clearances are adjunct clearances covering ages 15 to 21.
• Who is currently prescribing, and confirmation that they are aware of the referral.
• The client’s realistic availability for weekday sessions over four to six weeks.
• A release permitting the service to send the consultation outcome back to you.

Key Takeaway

Treat deep TMS eligibility as three separate questions rather than one. Confirm that the device holds a clearance covering the client’s condition and age, that the plan’s coverage policy will fund it and that the treating psychiatrist considers the client a candidate. Clearance and coverage genuinely diverge, and obsessive compulsive disorder is the standard example, cleared for treatment with the device yet excluded under the Medicare policy for transcranial magnetic stimulation. The medication-trial threshold varies by payer, from one failed trial or documented intolerance under that Medicare policy to four trials under some commercial policies, so read the applicable policy rather than relying on a remembered number. Document the medication history as a table with doses, durations and reasons for discontinuation, because that single document does more to move a referral than any other thing a referring clinician provides.

Clinical Note

This article is general guidance for referring clinicians. It is not a substitute for individual clinical judgment or an individualized assessment, it does not establish candidacy for any procedure and it does not constitute medical, coverage or benefits advice. Candidacy and device selection rest with the treating physician and the treating service. FDA clearances are device-specific and indication-specific. Coverage policies vary by payer and jurisdiction, and both change over time. Confirm current clearance, coverage and protocol directly with the service and the plan. Safety screening and contraindications are assessed separately by the treating service and are not covered here.

If a client is in immediate danger, direct them to emergency services. The 988 Suicide and Crisis Lifeline provides free, confidential crisis support 24 hours a day, seven days a week, by call or text to 988.⁵

Glossary

• Deep transcranial magnetic stimulation (deep TMS): transcranial magnetic stimulation delivered with coil designs intended to reach deeper cortical targets, marketed under device-specific FDA clearances.
• FDA clearance: authorization permitting a device to be marketed for a stated indication, which is not the same as a determination that a payer will fund the treatment.
• Adjunct indication: a cleared use alongside another treatment rather than as a standalone therapy.
• Local coverage determination (LCD): a Medicare contractor policy setting out when a service is considered reasonable and necessary within that jurisdiction.
• Medically reasonable and necessary: the coverage standard a payer applies, distinct from clinical appropriateness and from regulatory clearance.
• Adequate trial: a therapeutic dose of a medication sustained for a sufficient duration with documented adherence.
• Intolerance: discontinuation driven by adverse effects rather than by lack of efficacy, which under some policies satisfies a prior-treatment requirement on its own.

References

1. BrainsWay. “Which conditions is Deep TMS officially cleared to treat?” BrainsWay professionals FAQ. Accessed August 25, 2026. https://www.brainsway.com/professionals-faqs/what-mental-health-conditions-is-deep-tms-fda-cleared-to-treat/.
2. BrainsWay. “BrainsWay Receives FDA Clearance of Deep TMS as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21.” Company announcement, November 12, 2025. Accessed August 25, 2026. https://www.brainsway.com/news_events/brainsway-receives-fda-clearance-of-deep-tms-as-adjunct-therapy-for-major-depressive-disorder-mdd-in-adolescents-aged-15-to-21/.
3. U.S. Food and Drug Administration. “NeuroStar Advanced Therapy System, 510(k) Premarket Notification K231926.” Neuronetics, Inc., cleared March 22, 2024. Accessed August 25, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231926.pdf.
4. Centers for Medicare and Medicaid Services. “LCD – Transcranial Magnetic Stimulation (TMS) in the Treatment of Adults with Major Depressive Disorder (L34998).” Novitas Solutions, Inc., revision effective December 11, 2022. Accessed August 25, 2026. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=34998.
5. 988 Suicide and Crisis Lifeline. Operated in partnership with the Substance Abuse and Mental Health Services Administration and Vibrant Emotional Health. Accessed August 25, 2026. https://988lifeline.org/.

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