Ethos Healthcare Professional Liability Blog

The New Landscape: Ketamine and TMS Treatment in the U.S. Market

Written by TJ Payne | Dec 2, 2025 10:08:09 PM

The New Landscape: Ketamine and TMS Treatment in the U.S. Market

Across the United States, ketamine infusion clinics and transcranial magnetic stimulation (TMS) centers have moved from fringe experiments to visible parts of the mental health system. News coverage from NPR and KFF Health News reports that more than five hundred for-profit ketamine clinics have opened, and some market research estimates between five hundred and seven hundred fifty clinics nationwide.

At the same time, psychiatry practices and behavioral health groups are adding TMS devices and esketamine (Spravato) programs. For retail insurance agents, this is the beginning of a durable new category of outpatient healthcare risk. This first article in a three-part Ethos series explains what these treatments are, who is providing them, and how large the U.S. market has become.

 

What is Ketamine in the Mental Health Context?

Ketamine is a Schedule III anesthetic that received FDA approval in 1970. For decades it was used mainly in operating rooms and emergency departments. Over the last fifteen to twenty years, researchers have shown that low dose ketamine can rapidly improve depressive symptoms and suicidal thoughts in some patients with severe, treatment resistant depression.

Most psychiatric ketamine use is off-label. That means clinicians are using an approved drug for a non-approved indication. Intravenous or intramuscular ketamine for depression is not specifically approved by the FDA, but it is permitted under general prescribing rules. Clinics usually deliver a series of infusions over several weeks, followed by maintenance treatments.

In 2019, the FDA approved esketamine nasal spray (Spravato) for treatment resistant depression. Spravato must be administered in a certified medical setting under a Risk Evaluation and Mitigation Strategy (REMS). Unlike generic ketamine infusions, Spravato is often reimbursed by Medicare and commercial insurers. Analysts who follow the pharmaceutical market describe Spravato as a fast growing antidepressant franchise for Johnson and Johnson, with global sales moving toward the billion dollar range, according to Healing Maps.

For agents, the key distinction is that:

  • IV or IM ketamine for mental health is typically cash pay and off-label.
  • Spravato is FDA approved for depression and often billed to insurers.

Both, however, involve ketamine’s pharmacology and similar clinical risks.

 

What is TMS and How is it Used?

Transcranial magnetic stimulation is a noninvasive neuromodulation technique. A TMS device uses a magnetic coil placed over the scalp to deliver pulses that stimulate targeted brain regions. TMS was cleared by the FDA in 2008 for major depressive disorder that has not responded to at least one antidepressant, and later for obsessive compulsive disorder and other indications.

TMS is delivered as a series of daily sessions, typically five days per week for four to six weeks, followed by taper or maintenance. There is no systemic medication involved, and the most common side effects are scalp discomfort and headache. The most serious known risk is a provoked seizure, which is rare when protocols are followed.

Because TMS has specific FDA indications and a well-defined protocol, payers are more comfortable reimbursing it. A 2025 market outlook from Covenant Health Advisors notes that TMS and Spravato have become mainstream revenue lines for many outpatient psychiatry practices, backed by Medicare and commercial coverage when criteria are met.

For insurers, TMS looks more like other device-based procedures. For agents, it means a growing number of psychiatry clients now operate both office-based therapy and interventional equipment.

 

Market Size and Growth

Multiple research firms now publish dedicated U.S. ketamine clinic market reports. A 2024 analysis by Grand View Research estimated the U.S. ketamine clinics market at about 3.41 billion dollars in 2023, with a forecast compound annual growth rate of roughly 10.6 percent through 2030. Other analysts such as IMARC Group and Nova One Advisor provide similar figures, with projections that U.S. ketamine clinic revenue could double again by the early 2030s.

On the TMS side, exact U.S. revenue figures are less visible but follow a similar pattern. Device manufacturers and practice development firms report steady double-digit growth in TMS volumes as more clinics install systems and referral patterns mature. A 2025 neuromodulation market article from NeuroMod Health describes TMS and Spravato as two of the most significant growth drivers for outpatient depression treatment.

In plain terms, this is no longer a boutique service. It is a multibillion-dollar treatment segment that is expected to grow faster than the general behavioral health market.

 

Who is Providing Ketamine and TMS Services?

Providers fall into several broad categories.

  1. Standalone ketamine clinics
    • Some standalone clinics are founded by anesthesiologists, psychiatrists, or nurse practitioners (NPR).
    • Most clinics focus on mental health treatment (Grand View Research).
    • Patients typically pay out of pocket (NPR).

  2. Psychiatry practices with interventional services
  3. Behavioral health and hospital systems
    • Academic medical centers and large health systems that run ketamine or TMS programs as part of broader service lines (NPR).
    • Tend to follow more formal protocols, with multidisciplinary teams and quality oversight (Yale Newhaven Health).

  4. Telehealth and hybrid models
    • Companies that combine virtual visits with at-home oral or intranasal ketamine under remote supervision (Reagan-Udall Foundation).
    • This segment is particularly sensitive to DEA telemedicine rules and state licensing requirements (Reagan-Udall Foundation).

Each provider type presents a different risk profile for underwriters. Standalone clinics may have leaner infrastructure and shorter track records. Hospital based programs may have more robust governance but also higher claim severity potential.

 

Why This Matters for Insurance Agents

From an insurance perspective, the growth of ketamine and TMS matters for several reasons.

  • New classes of insureds: Thousands of patients now receive off-label ketamine or TMS in free standing clinics, according to a survey of practice types in Psychology Today. Each of those clinics, and many psychiatry practices that add TMS or Spravato, needs a mix of malpractice, general liability, property, workers’ compensation, and cyber coverage.
  • Shifting risk profile in behavioral health: Behavioral health used to be dominated by talk therapy and medication management. These new interventions introduce IV sedation, device risk, and higher acuity patients into outpatient settings. That changes the loss picture, even for long-standing psychiatry clients.
  • Premium potential in a specialized niche: Because these treatments involve high clinical severity and evolving standards, many clinics place coverage with specialty or surplus lines carriers. Policies can command higher premiums than simple office-based psychiatry, and they create room to bundle multiple lines.

 

Next Steps

Ethos Insurance Partners works with retail agents across the country who want to grow in healthcare professional liability (HPL) and related lines. If you have existing behavioral health accounts or you are starting to see ketamine or TMS providers in your territory, you do not need to navigate this alone.

  • Learn how Ethos supports agents in the healthcare professional liability space by visiting our Learning Center.
  • Talk with an Ethos representative about current carrier appetites and submission requirements for ketamine and TMS risks.
  • Share this article with your team as a primer before they approach these prospects.

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