On July 14, 2026 the Health Resources and Services Administration (HRSA) published a Request for Information carrying the title: “Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings.” There was almost no press coverage and the comment period ran thirty days and closed on August 13.
I have obtained and read all fifty-nine comments that were posted. Some run to twenty pages and some are a single line pointing to a PDF. Together they are the most honest picture I have seen of where this field actually stands.
There were fifty-nine chances to tell the federal government that psychedelic therapy is unproven, and not a single correspondent took it. The associations and the psychiatrists did not take it. The skeptics, if any remained, stayed home. What the letters argue about instead is staffing ratios, square footage, encounter rates, and who is legally permitted to sit in a room with a person for seven hours while the medicine does its work. That is what a movement looks like when it stops arguing for legitimacy and starts arguing over the details.
The docket follows Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” signed April 18. HRSA does not approve drugs. That is the FDA’s work. HRSA runs the safety net, and so the question it put to the public was narrower than the one the movement is used to answering. Not whether psilocybin heals but whether a community health center in a county with one psychiatrist could administer it on a Tuesday.
The answers split, and they do not split where you would expect.
On one side we have the operators, and they come armed with numbers. Althea, which runs infrastructure for state-regulated psilocybin services, produced the count for participants across Oregon and Colorado. The Healing Advocacy Fund put Oregon’s total above 22,000 and its severe adverse event rate at 0.15 percent. Numia Healing Center in Denver did something better than cite a study. It opened its own books: 162 documented sessions, zero adverse medical reactions, and an offer to let HRSA staff walk through their building. These arguments are not philosophical. It is that trained facilitators without medical degrees have already done this work safely, at scale, under state regulation, for years, and that the burden of proof has quietly changed hands.
On the other side stand the physicians and the professional societies. The American Psychiatric Association wants psychiatrists leading diagnosis and selection and a physician physically present and immediately available during administration. The National Association of Social Workers wants training standards federally recognized and housed inside accredited programs rather than left to the private training market that has grown up around this field over the last decade. In reading that comment closely I could feel an entire cottage industry being shown the door.
Then there are the individual clinicians, who scramble the map entirely. Rebecca Allen, a principal investigator on multiple Phase 2 and 3 trials, wrote in to argue for fewer rules. She suggests treating these drugs like any other medication, let physicians exercise ordinary judgment, and skip the psychedelic-specific apparatus altogether. Mindbloom, a telehealth company with more than 800,000 at-home ketamine treatments behind it, argued that the clinician does not need to be in the room at all, only on the screen, with a non-clinical support person present. Nearly every profession in American medicine filed to claim its seat at the table. Nurses, mid-level providers, pharmacists, psychologists, social workers, and peer support specialists weighed in. If you have ever wondered what professionalization sounds like, it sounds like this.
The input from the field that will decide the outcome are the ones about money. Numia reported that its sessions average seven hours, that thirteen percent run past eight, and that a single administration room therefore serves exactly one patient per day. Community Health Center, Inc. supplied the other half of that equation. Federally qualified health centers are paid a flat daily encounter rate. Their clinical director wrote that being paid one flat rate for the day “will make this fiscally impossible.” Those two comments outline the entire problem.
Everything else in the docket is an attempt to reconcile the issue of what gets left behind in the expansion of above ground psychedelic access. Suggestions were made for group dosing, hub-and-spoke arrangements, and remote monitoring. A request is made, repeated by several correspondents independently, that HRSA simply publish a sample payment structure separating the cost of the drug from the professional time from the facility time, so that a clinic director can run the arithmetic before committing. A figure of 35 to 51 percent cost reduction for group administration appears in at least four separate letters, which tells me everyone is reading the same underlying analysis and everyone is frightened by the same math.
The most interesting submission in the docket is not a comment letter at all. The neuroscientist Gül Dölen filed her 2026 Annual Review of Neuroscience paper instead of writing one. Her argument is that these compounds work by reopening critical periods and remodeling the extracellular matrix, a learning model rather than a chemical imbalance model, and that the psychological setting is therefore mechanically load-bearing rather than a pleasant addition to the pharmacology. The patient, she notes, is returned to something like a childlike state of openness and requires safeguarding while there. Filed into a docket about staffing ratios, that paper becomes an argument rather than a review. If the context is part of the mechanism, then stripping it out is not cost saving. It is a different treatment wearing the same name. The VALOR veteran’s coalition made the identical point in policy language, warning HRSA against efficiency-driven modifications adopted before anyone has evaluated whether they work.
That, and not the medical-versus-non-medical quarrel, is the real fracture running through this discussion. It is fidelity against scale. The people who have watched this work up close, from every side of the credentialing fight, are afraid of what gets cut on the way to volume.
A coalition including BrainFutures, Mental Health America, the National Council for Mental Wellbeing, and the Meadows Institute has told HRSA it will deliver a set of interdisciplinary core competencies by the end of this year. Whoever writes that document will define what the word “trained” means in this field for a generation. It is being drafted right now, outside this docket, and almost entirely out of view.
AI (Claude Cowork) was used to facilitate access to submitted comments referenced in this post and provide error checking.
i don't think so