Texas Ketamine Regulation Misses the Mark. Here's What Better Regulation Would Look Like

Texas Ketamine Regulation Misses the Mark. Here's What Better Regulation Would Look Like

The Texas Medical Board is preparing to vote in June on a sweeping set of new ketamine rules: a ban on in-home administration, a requirement that non-physician clinicians treat no more than two patients at a time without a physician on site, and mandatory mental health training for anyone administering the drug. The Texas Tribune has covered the proposal carefully, and theframing from regulators is what you'd expect: ketamine is a powerful anesthetic, the wellness industry has gotten ahead of itself, and tighter physician oversight will protect patients.

Industry sources have openly said this Texas framework is likely to become a template for other states. That makes this moment important; not just for Texas patients, but for the whole regulatory conversation that will unfold across the country over the next several years.

I want to write about why this proposal is correct in some of its instincts and wrong in some of its assumptions, why the way it's being written should concern anyone who actually does this work, and (most importantly) what – if we’re grabbing the bull by the horns – better regulation would look like.

A note on where I'm writing from: I'm a doctorally-trained PA who specializes in psychiatry. I practice in Chapel Hill, NC, and I run a small private practice that provides ketamine-assisted psychotherapy. I provide ketamine assisted psychotherapy (KAP) primarily to patients in-office, but I also offer medically-supervised home-based KAP under a formal protocol and full clinical infrastructure. I have a stake in this conversation. I'm telling you that up front because every voice in this debate has a stake, and the difference between honest and dishonest contributions to this effort starts with whether people disclose their perspective and motivations.

The first problem is who's writing the rules

Rep. Tom Oliverson, the most prominent legislative voice behind the Texas proposal, is an anesthesiologist and former medical board member. He is not a psychiatrist. He is not a psychologist. He is not an addictions specialist. He is not a therapist. He is not a PA, NP, nurse, or social worker working in mental health.

I want to be careful here, because I don't think Oliverson is wrong about everything. He's right that ketamine is a medical treatment. He's right that "physician-on-paper" supervision through a Zoom screen is not real supervision. He's right that medical spas and night clubs have made a mockery of the seriousness this work deserves.

But ketamine treatment for psychiatric indications is not a procedure that anesthesiology alone is best positioned to define. This work sits at the intersection of psychiatry, psychotherapy, anesthesia, addiction medicine, and (when done well)  integrative and trauma-informed practice. The patients choosing KAP are not surgical patients. They are people with treatment-resistant depression, complex PTSD, suicidal ideation, and long histories of relational trauma. The questions that matter most in their care– things like screening, preparation, dosing relative to therapeutic intent, integration, dependency monitoring, suitability of setting– are not anesthesia questions. They are interdisciplinary questions.

A regulatory framework written primarily by a single discipline is structurally limited in a field this complex. Good regulation requires psychiatrists, anesthesiologists, advanced practice providers, therapists, nurses, addiction specialists, ethicists, and patient voices at the table. Texas has not set that table.

A category error worth naming

Much of the public concern driving these rules traces back to high-profile cases like Matthew Perry's death. That case involved unsupervised, illicit, recreational use of ketamine. It was not in the context of clinical care. The two are not the same, and conflating them is exactly the category error that produces bad regulation. Rules written to address recreational misuse will inevitably miss the clinical context where most patients actually encounter this medicine.

The same problem appears throughout the Texas proposal. It treats "in-home ketamine" as a single category, when in reality it spans everything from mail-order troches with brief telehealth screening to medically-supervised home-based KAP with a licensed clinician in the room and a formal protocol on file. These are radically, categorically different practices. A rule that bans them all uniformly bans the responsible models alongside the irresponsible ones.

This is what happens when rules get written without clean definitions. And it's the patients in the responsible models, who are often the most vulnerable and often without other options, who will lose access first.

Where I agree with Peter Corbett, and where I don't

Peter Corbett's recentpiece in Relational Psychedelic Medicine makes the most articulate version of the case for why "more physician oversight" misses the point. He argues (and I largely agree) that ketamine in psychiatric doses is not functioning primarily as an anesthetic. It is functioning as a consciousness-altering medicine that opens a therapeutic window. What happens in that window is the treatment. Without preparation, presence, and integration, the medicine alone tends to produce temporary relief that doesn't translate into durable change. And, sometimes, it produces something worse: a destabilizing experience without a relational container to make sense of it.

This is the model I practice. It's the model I trained for. It's the model my doctoral dissertation was built around. I believe in it deeply.

And I also think Corbett's frame, taken alone, would build a regulatory floor that's too high.

Not every patient who benefits from ketamine will engage in psychotherapy. Spravato (esketamine) was approved by the FDA without any requirement for adjunctive psychotherapy, and the registration trials demonstrated meaningful symptom improvement. Real patients, with real treatment-resistant depression, got real relief from a medication-only protocol with appropriate medical monitoring. That is data. We have to take it seriously.

IV ketamine clinics, when run with proper screening, informed consent, medical monitoring, and follow-up, serve a legitimate patient population. Some of those patients will eventually move into a more relational model of care. Some won't. Some will use IV ketamine as a stabilization on-ramp that makes psychotherapy possible for the first time. Some will use it as episodic maintenance alongside ongoing care elsewhere.

The honest position is this: KAP is not the only valid model, and models that dispense ketamine without therapeutic or medical infrastructure are not acceptable substitutes for it. Both of those things are true, and good regulation has to make room for that complexity.

Where and what the actual lines should be

If I were drafting these rules, I'd start from a different place. Not "who has which letters after their name," but "what conditions must be met for this to be safe, ethical, and effective."

At-home ketamine without medical supervision is dangerous. This is true whether the patient is self-administering after a brief telehealth call or if a therapist alone is administering out of their office without medical supervision and monitoring. Cardiovascular events, dissociative crises, and emergent suicidality all require medical response capacity. Therapeutic rapport is not a substitute for clinical/medical infrastructure.

Telehealth-only ketamine prescribing for unsupervised at-home self-administration is also dangerous. It is not access. It is the appearance of access. The patients who get hurt in these models are disproportionately the patients who were already most vulnerable: trauma-loaded, dissociation-prone, isolated. A brief intake call and a shipment of compounded troches is not responsible care. Period.

Medically-supervised home administration is a different thing entirely. Good care means a licensed clinician is on site, vital signs are monitored, a formal protocol governs the visit, adverse event protocols are in place, and integration support follows. This is the standard of good KAP care. Lumping it together with mail-order self-administration in a categorical ban is sloppy regulation that punishes the responsible model alongside the irresponsible one.

Providers who don't use ketamine-specific informed consent are not doing this work responsibly. Ketamine consent has to address dissociation, emergence phenomena, the possibility of difficult psychological material, dependency potential, cardiovascular and urological risks, the difference between expected and concerning experiences, and what the patient should do if integration is destabilizing. A generic medication consent form does not cover this.

Providers who have not completed substantive training in psychedelic-assisted psychotherapy should not be administering psychedelic-assisted psychotherapy. A weekend workshop is not training. Reading a couple PubMed articles is not training. The field has real training programs (MAPS, IPI, KAPstone, Polaris, Fluence, among others), and the difference between someone who has done that work and someone who hasn't is visible in their practice within minutes.

Medical monitoring during sessions is not optional. Vital signs, observation of mental status, and the capacity to respond to acute events are baseline requirements regardless of setting.

Longitudinal harms deserve attention the current debate is mostly skipping. Ketamine carries real risks of dependency, dose escalation, and bladder toxicity (ketamine cystitis) with chronic use. Most current debates focus on acute session safety, but the harms most likely to actually injure patients over time come from inadequate dependency monitoring and unchecked frequency of use. Good regulation has to address this.

These are the actual lines.  None of them require an on-site MD for every session. 

None of them ban every form of out-of-clinic care.  None of them rest on a single profession's authority. 

Instead, they rest on what the work itself demands.

A roadmap for states that want to do this well (IMHO)

This is the part that matters most. Critique is easy. Construction is harder, and it's what we actually need.

Here is what I think an interdisciplinary, evidence-based, patient-centered framework for state ketamine regulation would actually contain. 

Build an empirical foundation before drafting rules. States should commission three studies before writing any framework: a current landscape assessment of who's actually providing ketamine treatment and to whom; a clinical adverse event study that distinguishes harms occurring inside licensed practices from recreational and accidental exposures captured by poison center data; and an access impact baseline showing who currently relies on which models and what restrictions would do to them. Most states are regulating without any of this.

Write definitions that hold. Frameworks should explicitly distinguish ketamine for psychiatric indications from ketamine for anesthesia, FDA-approved esketamine from compounded racemic ketamine, IV from intranasal from oral routes, medical-only models from KAP from hybrids, and critically: in-clinic from medically-supervised home administration from unsupervised self-administration. Categorical rules that collapse these distinctions will produce categorical harm.

Convene an interdisciplinary drafting body. At minimum: psychiatry, psychiatric APPs (PAs and NPs), anesthesiology, addiction medicine, psychotherapy disciplines, emergency medicine, nursing, pharmacy, bioethics, public health, and patient advocates. Every member should publicly disclose financial interests. No single voice with direct commercial stakes should drive the framework.

Include patient voices substantively. Not token public comment, but structured inclusion of patients across socioeconomic status, geography (especially rural), diagnosis, functional status, and outcomes. This should include patients who were helped, patients who experienced harm, and patients who left treatment.

Specify standards of care, not just structural rules. Ethical treatment frameworks should require comprehensive screening, ketamine-specific informed consent, defined training and competency standards for each role on the care team, and medical monitoring parameters during sessions regardless of setting. They should also specify preparation and integration appropriate to the treatment model, dose ceilings and frequency limits, ongoing dependency monitoring, standardized documentation, and adverse event reporting to a state registry. Standards should offer a definition and guidelines of what care must contain, not just state what discipline can deliver it. 

Require access impact analysis as a routine part of rulemaking. Every proposed rule should be evaluated for its likely effect on rural patients, low-income patients, Medicaid recipients, and patients whose current models would be restricted. Where access losses are projected, rules should be modified or paired with mitigation strategies.

Build for forward compatibility. MDMA-assisted therapy is back at the FDA after Lykos's CRL. Psilocybin is in late-stage trials. Other psychedelic compounds are coming. State frameworks built only for ketamine that don't anticipate this expansion will be rewritten under political pressure within five years. The same principles: definitions, multidisciplinary drafting, standards of care, access analysis, adverse event reporting — should be designed to extend to and accommodate for growth.

Engage formally with professional societies. APA, AAPA, APAP, AANP, APNA, ASA, ASKP3, APPA, ASAM, ACA, NASW, and others have policy positions, training standards, and practice guidelines that frameworks can build on. Structural engagement with these organizations beats one-off expert consultation.

Build in sunset and review. Every rule adopted should automatically come up for review within three years, with required data review and stakeholder reconvening. Particularly contested provisions should have explicit sunset dates. No regulatory framework gets it right on the first pass; frameworks should be designed to learn and adjust.

Affirm patient rights explicitly. The right to know which model of care they're in. The right to refuse treatment without coercion. The right to integration support. The right to documentation. The right to know providers' credentials, training, and conflicts of interest. The right to be screened for appropriateness, not just enrolled.

Texas is doing approximately none of this. The proposal is being driven primarily by a single individual representing a single discipline. It is not built on landscape, adverse event, or access impact studies. It conflates fundamentally different practices under categorical bans. It does not distinguish medically-supervised home administration from mail-order self-administration. It does not address the chronic-use harms (dependency, bladder toxicity) that the evidence base actually points to. It does not anticipate federal psychedelic developments. And the patients who will pay the highest price are the ones with the fewest other options.

What this means for the rest of us

What happens in Texas will not stay in Texas. The industry sources in the Tribune piece said it themselves: this framework will become a template. Other states will be looking at it.

We have an opportunity, before the template hardens, to push for something better: regulation written by the people who actually do this work and across the disciplines that actually do it well, with the patients who actually need it at the center.

Ketamine is a medical treatment. It deserves serious regulation. Serious regulation is interdisciplinary by definition, evidence-based by design, and built to learn and adapt over time. Anything less either fails to protect patients or restricts access for the people who need this treatment most (or worse, both).

States that get this right will protect patients, support responsible clinicians, and lay the foundation for the next generation of psychedelic medicine. States that get it wrong will close clinics that were doing good work, push patients toward less safe options, and find themselves rewriting their rules within five years under conditions far worse than today's.

This is the work. It's worth doing carefully.