Safe Psychedelic Care

Patient. I came home from the Marines with post-traumatic stress and a depression my clinicians called treatment-resistant, and the system could not hold me. For well over a decade since, I have sat with altered states in structured settings with competent guides, across a range of substances. MDMA and psilocybin were a major part, and others were too. More than any one substance, what helped was the support around the ceremonies, the preparation before and the integration after. The first time these medicines opened me all the way, no one present understood what was happening. I came through. Not everyone does. That is the seat this comment is most loyal to.

Operator. I am a former diplomat, and I spent fifteen years building systems and software in healthcare, including as an executive of a company whose FDA-cleared device supports nervous system regulation through a hybrid of biofeedback, AI and therapeutic care delivered by telemedicine. Before that, my firm in Silicon Valley facilitated healthcare innovation initiatives for executives of major pharmaceutical companies. I know what it takes to carry a regulated product to patients, and I have watched good programs fail for want of an owner. That is why each recommendation here names a precedent, who would carry it, and the evidence that would retire it. I am now building integration software, disclosed below.

Guide. I work with adults twenty-one and older, within the harm reduction tradition, and I do not supply any controlled substance. Across nearly five hundred ceremonies I have sat with people through the treatment, called a ceremony in my practice, and stayed for the months after through preparation and integration sessions. I serve as an integration partner to a ketamine clinic network, where the medicine is prescribed and the setting licensed, and I have mentored more than a hundred and fifty guides one on one. Hundreds of the people I serve have used seven published readiness, experience and outcome measures as self-assessments, to see where they stand and how they change over time.

Why it matters to me. The Department of Veterans Affairs' 2026 annual report counted 6,488 suicides among veterans in 2024, an average of 17.7 a day. Those are my brothers and sisters. And I know, as too many families now know, what it costs when the people deciding a family's future cannot tell a person trying to heal from a person who is a danger. A clear, public standard of safe practice would give everyone who has to judge this work something true to judge it by.

Disclosure of financial interests. The Agency asked everyone who requested to speak at the hearing to disclose financial relationships, and I hold myself to the same. I own Hyparxis LLC, through which I am paid for integration coaching, retreats, and integration services to a ketamine clinic network. I have consulted for Homecoming, a records and screening platform for psychedelic care, and I am developing integration software built on it. The minimum standard in Attachment 3 names Homecoming as one example of such a platform. My recommendations point toward the part of care I do. Weigh them accordingly.

Training. Judge competence, not hours alone. Rate recorded treatments against a published bar before a facilitator sits alone and again each year. Precedent: MAPS adherence and competence ratings in sponsored trials.

Training. Treat preparation, the treatment and integration as one offering. The facilitator joins screening with the client and the medical team, leads at least two preparation sessions, and at least a few integration sessions after, ideally with months of support beyond. Precedent: Agency trial guidance, Oregon and Colorado facilitator rules, New Mexico proposed rule.

Safety. One trained, sober facilitator present throughout, with a second person added as the person, the substance and the risk require. Video does not substitute. Precedent: Oregon OAR 333-333-5200, Colorado Rules 6.11 and 6.18.

Safety. Find out what happened by asking: two contacts, within three days and at six to eight weeks, each with a free validated measure, a missed contact recorded as data. Precedent: Oregon OAR 333-333-5250 (72-hour contact), Korthuis et al. 2026.

Safety. Consent that names the power imbalance and the chance of a hard experience, and a complaint path that reaches beyond the facilitator, including for facilitators no board licenses. Precedent: The notice's own consent language, Oregon OAR 333-333-5040 (consent) and 5120 (conduct).

Safety. The dose is taken in the room under observation. Nothing goes home. Precedent: Esketamine REMS.

Access. Certify a setting by what happens inside it, permit groups with a stated ratio, and pay for preparation, the treatment and integration as one episode. Precedent: Colorado Rule 6.18 and its integration fee rule, CPT 0820T to 0822T.

Data. Adopt existing consensus measures, add the few missing fields, keep records at the site under pseudonyms and return only summary answers. Precedent: OPEN consensus measures, FDA Sentinel.

The Agency held its hearing on 14 September 2026. Its roster lists eighty public commenters, each given two minutes, across the four topics. No transcript has been posted. At the last check, on 5 October, the docket showed 280 posted comments, the newest posted 30 September. All 280 comment bodies were read for this comment, with every attachment the site would serve as text, 96 of the 110 files. The rest are image-only scans or files the site did not serve.

Where the record converges. Care is a course, not a single dose, and follow-up matters. Filers drafted schedules running from a first contact within one to three days to contacts at twelve weeks, twelve months or longer (0042, 0050, 0086, 0216, 0279), and I found none opposing follow-up. Competence should be shown, not assumed from hours, a point made on both sides of the license question (0035, 0234). Data elements should be defined before registries and workflows are built (0279, 0092). Misconduct, including boundary violations, belongs in the safety record and needs a reporting path outside the provider (0017, 0152, 0170, 0209). Payment should cover preparation, the treatment and integration together, not the drug alone (0035, 0041, 0086, 0216, 0280).

Where it divides. License or competence: one view treats a license as accountability and cites a participant abused by an attendant who answered to no board (0017), while another asks that credentials rest “on competencies, not on discipline” (0035). One monitor or two: some ask for two trained people in the room throughout (0176, 0022), one notes that the Spravato REMS requires one provider (0055), and one asks that a trained peer under clinical supervision fill the second seat (0203). Access or restriction: one asks for certified settings and no telehealth-only screening or follow-up (0274), while another warns that clinic-only care could exclude people in advanced illness and asks for home and hospice settings (0262). Technology: some would let video or remote monitoring stand in for a second person or reduce staff (0036, 0136), while others would allow technology only beside a trained person and reject fully remote or AI-only monitoring (0086). Data custody: some ask for a national or shared registry (0107, 0268, 0274), others for pseudonymous records or existing local records in place of a new central registry (0006, 0028).

What the notice set aside. The notice placed religious, ceremonial and personal use outside its questions. As jurisdiction that is sound. As a description of the room it is not, because the meaning people meet in that state arrives whether or not a rule names it. One filer, an Oregon-licensed facilitator, wrote that “psychedelic policy often cites centuries of entheogenic practice while excluding living religious and sacramental communities” (0012). Respondents to the Congressional PATH Caucus request for information asked that Indigenous and religious rights to ceremony be preserved without government intrusion and without requiring that knowledge be handed over. I bring the sacred back only where the notice allows it, as patient safety.

What is thin. Many propose follow-up schedules, but few treat finding out what happened as its own safety element, separate from integration care (0120 comes closest), or say who makes the contact (0042 names a coordinator). I found no filer asking that the person keeping watch be sober, though Colorado already requires it. Chaplains are named as team members (0219) and the risk of a clinician becoming a spiritual authority is named (0096), but I found none joining the two into a role with a guardrail. I found few that pair care outside clinics with a written safety floor, few that say how a complaint against an unlicensed facilitator would be heard, and few that address moral injury. This comment is written into those gaps.

The evidence on the hours after. In the Oregon cohort led by Korthuis and colleagues, 346 adults were followed through twenty-four licensed service centers. Of four serious behavioral reactions, two showed nothing to the facilitator who sat the whole treatment. A third showed only mild stomach upset. Three of the four came to light only through the study's follow-up, and reports of thoughts of dying or suicide were highest at the last point measured, three months. The authors note that state rules collect safety events only within three days of services, and that this underestimates them over time. Oregon's own 2025 review counted 5,935 clients, nine severe reactions requiring transport to a hospital, and thirteen calls to emergency services. Among 608 people who reported difficulties lasting beyond a day, Evans and colleagues found about a third reported difficulties lasting more than a year.

What follows from it. Harm is rare. In the Oregon cohort, half the serious reactions were invisible in the room, and three of the four were found only because someone asked. One filer put it plainly: “Missing follow-up is a limitation in knowledge, not evidence that no adverse event occurred” (0120). Finding out what happened is the least the care around a treatment owes, and it can be adopted now.

Evidence base for curricula. Anchor curricula in competencies, and require the subjects the evidence says are missing.

• The states have already set curricula: Oregon 128 hours of instruction across nine subject areas, Colorado 150, and New Mexico's proposed rule a hundred supervised hours, eighty of them in the room during treatments.

• The evidence linking hours to outcomes is thin.

• A meta-analysis of sixteen psilocybin studies found no significant link between therapy hours and depression outcomes.

• A 2026 study of thirteen US training programs found most dedicate no curriculum to spiritual, religious or existential topics.

• In a 2023 survey of 608 people with extended difficulties after a psychedelic, about a third described spiritual ones.

• Require that content, and require training in screening referral, crisis response and follow-up contact.

• No single body yet covers the field. A consensus panel on the model of the OPEN e-Delphi, drawing state program regulators, clinicians, facilitators, peer supporters, chaplains and Indigenous practitioners, could set the competencies, with state programs and professional bodies such as the Board of Psychedelic Medicine and Therapies reviewing and endorsing them.

Precedent: Oregon OAR 333-333-3050, Colorado 4 CCR 755-1, New Mexico 7.35.3 NMAC (proposed), Hultgren et al. 2025, Palitsky et al. 2026, Evans et al. 2023.

Personnel by phase of care. One facilitator carries the person through every phase, with clinicians where the risk calls for them.

• Screening: a licensed clinician reviews medical and psychiatric history and every medication, and the facilitator joins that screening with the client and the medical team.

• Preparation sessions: at least two, one on one with the facilitator who will sit the treatment, the last at least a day before it.

• Treatment: one trained, sober facilitator present throughout, a second person where the person, the substance or the setting calls for one, as with complex or sexual trauma, serious medical or psychiatric illness, a first high dose, groups, or the dying, whose families need tending too, a clinician reachable quickly, and a named backup facilitator.

• Integration sessions: at least a few with the facilitator after the treatment, ideally with months, if not years, of support beyond, and follow-up contacts made by the facilitator, a peer support specialist or a coordinator under clinical supervision.

• The workforce for a documented follow-up call exists.

• A peer support line evaluated with university researchers found that 65.9 percent of 848 callers surveyed said the call de-escalated their distress.

• Licensed counselors can hold preparation, integration and the warm handoff where a clinical need is present, and peer support specialists can make follow-up contacts and staff support lines under clinical supervision.

Precedent: Agency trial guidance (on-call physician), Oregon OAR 333-333-5200 (backup facilitator), Fireside Project (0203).

Training for care coordination and continuity. Treat psychedelic competence and a clinical license as different, complementary skills, and keep the person's own team in the loop.

• A license certifies the treatment of illness.

• Navigating altered states asks for something else: staying non-directive while a person is highly suggestible and the power imbalance the notice names is amplified (0096), telling a hard but useful experience from an emergency, holding hours of non-verbal or mystical material without interpreting it, and deciding about touch in the moment.

• The ethics of non-ordinary states is its own subject, for licensed and unlicensed practitioners alike (0080).

• In my experience, therapists with psychedelic training are still uncommon, and demonstrated psychedelic competence is rarer.

• The Board of Psychedelic Medicine and Therapies told this docket it is still developing its national certification exam (0058), and most of the thirteen training programs studied teach nothing on spiritual or existential material.

• So the facilitator and the person's existing clinicians work as one team.

• With consent, the facilitator shares the plan before the treatment and makes a warm handoff after it, calling the person's own therapist or doctor rather than handing over a phone number.

• Name spiritual care as a competency too. Board-certified chaplains are trained, and bound by their professional code, not to impose belief.

• Where screening finds risk factors, a therapist or integration coach should be in place for the weeks after the treatment.

• In my experience, that is where most harm occurs, and most benefit is lost, when no one is there.

Precedent: Oregon OAR 333-333-5080 (safety and support plan), Palitsky et al. 2026, Board of Psychedelic Medicine and Therapies, 0080, 0096.

Credentialing requirements. Credential competence shown, sobriety and accountability, through more than one pathway.

• The competencies that matter most are the capacity to listen, to care, to hold a steady presence for hours, and to understand the complexity of altered states from the inside, as a client and not only as a provider.

• I encourage that no facilitator sit for a client without significant personal experience with the particular medicine, gained where that is lawful.

• A skilled facilitator encourages the person to make their own decisions about dose, intentions and self-assessment, so that the work builds their own agency, self-reflection and self-direction, and directs as little as possible.

• Where safety is at stake, as with a contraindication, the facilitator leans in and guides more.

• Choosing when and how to intervene is itself the competence.

• Complete non-intervention can be a harm of its own, and a skilled facilitator knows the difference.

• Rate a recorded treatment against a published bar before a facilitator sits alone and again each year.

• MAPS-sponsored trials already rated recorded therapy sessions against a written adherence and competence manual.

• State in writing that the person keeping watch must be sober.

• Colorado already does (Rule 6.11), and every program should.

• Require a background check, peer consultation as a condition of practice so a facilitator always answers to someone besides themselves, and a complaint channel that reaches someone other than the facilitator.

• Allow more than one pathway in, as a white paper prepared for the bipartisan Congressional PATH Caucus recommends: licensed clinicians, trained facilitators, peer support practitioners and Indigenous experts.

• Ministers, chaplains, nurses, emergency medical technicians and coaches already do this work well, and a mandate tied to a single clinical license would turn many of them away.

• Ask each facilitator to name the traditions they draw from and honor them, and to leave peyote to the Indigenous peoples who steward it.

Precedent: MAPS adherence manual, Colorado Rule 6.11 (facilitator sobriety), white paper prepared for the Congressional PATH Caucus, Oregon practicum guidance (credit for taking part in an administration session).

Patient education and informed consent. Prepare before consenting, and make consent name what the notice names.

• The notice asks about “the potential for an amplified power imbalance between patient and provider” and “the risk of psychological distress or a challenging psychedelic experience.”

• Consent should name both in plain words, along with what the facilitator is and is not trained to do, any recording or software used, any touch, that difficult effects can last months or longer, that it may change what they believe, and that the treatment may not help.

• Education should cover set and setting in practical terms: the person's intentions, expectations and current stressors, and a room chosen for safety, privacy and comfort.

• Side effects are assessed at every contact with the same short checklist, so changes can be compared.

• Prepare every person for meaning that may arrive uninvited.

• Johns Hopkins researchers found a mystical-type experience in about two of three volunteers at the highest dose, so it is a frequent event, not a rare one, and a person who meets it with no words for it has a safety problem.

• Every agreement is made before dosing, while the person is sober: any additional dose, any touch, any recording, and the plan for leaving.

• Touch is never sexual. No additional dose is given unless it was agreed before the first.

• Attachment 4 shows what this looks like from the participant's side.

Precedent: Oregon OAR 333-333-5040 (informed consent).

Pre-treatment screening. Screen with a named tool, and record which tool was used.

• Washington's task force found no validated risk assessment tool for this setting.

• Until one exists, every program should name the tool it uses so outcomes can be compared.

• Screen for personal or family history of psychosis or bipolar I disorder, heart disease and blood pressure, pregnancy, and current thoughts of harming oneself or others.

• Review every medication and supplement. Lithium stops the plan.

• Antidepressants bring the prescriber into the decision.

• No facilitator should advise starting, stopping or tapering a prescription.

• Published readiness measures help the person see where they stand before a treatment: the Psychedelic Preparedness Scale and the Self-Compassion Scale, with the PHQ-9, GAD-7 and PCL-5 as a baseline to repeat after.

• They inform the conversation and never replace clinical screening.

Precedent: Washington Psilocybin Task Force report (2023).

Monitoring during administration. Match the protocol to the substance, and keep a person in the room until the person in their care is steady.

• Psilocybin, MDMA, LSD, mescaline, ketamine, ibogaine and 5-MeO-DMT differ in duration, physiology and interactions.

• Classic psychedelics and MDMA raise blood pressure.

• Ibogaine can disturb cardiac rhythm for more than a day and belongs in a medical setting.

• One filer describes wood-lover paralysis, muscle weakness setting in hours after ingestion at a licensed Oregon center (0142), a reason to test products and to let no one leave unsteady.

• Oregon ties the minimum length of the treatment to dose, requires visual and audio contact throughout, and bars video as a substitute.

• Colorado runs the treatment until the participant shows no obvious adverse effects and requires a second facilitator or a recording outside a healing center.

• Record every treatment with consent, reviewable by someone outside the room, and give the person a copy.

• A hard night is not an emergency, and touch is used only as agreed beforehand or to keep someone from harm.

• One filer asks to be left alone with the medicine (0102), and a person who knowingly chooses that should be free to, so presence is a standard offered to everyone and refused only by informed choice.

• Require basic life support certification, a written emergency plan, a discharge and transport plan written before the treatment, and a stability check before anyone leaves.

Precedent: Oregon OAR 333-333-5200 and 5250, Colorado Rule 6, esketamine REMS.

Follow-up and its coordination. Two safety contacts after every treatment, alongside the integration sessions.

• One contact within three days and one at six to eight weeks, each with a free validated measure, a missed contact recorded as data, and a referral path ready for anything that lingers, including the 988 Suicide and Crisis Lifeline and local crisis services named in the safety plan before the treatment.

• Oregon already requires a facilitator to attempt contact within seventy-two hours and ask about reactions since the treatment.

• The second contact reaches into the weeks after, when the cohort and the survey data show that difficulties can still surface.

• Call this ascertainment: the minimum contact capable of finding out what happened.

• It does not replace integration. Make it active, a call or a video visit, since one filer reports that only about 15 to 25 percent completed emailed questionnaires (0224).

• Treat two contacts as a floor. Filers propose longer schedules, to twelve weeks (0086), twelve months (0022, 0274) and twenty-four months (0042).

• The first weeks after a treatment deserve extra attention.

• In mice, psilocybin, MDMA, LSD and ibogaine reopened a critical period for social learning that lasted from two to four weeks or more, while ketamine's lasted about a day (Nardou and colleagues, 2023).

• Human evidence is still emerging, so this is a reason for closer care in that window, not a promise of change.

Precedent: Oregon OAR 333-333-5250, Korthuis et al. 2026, Evans et al. 2023.

Diversion. The dose is taken in the room, under observation. Nothing goes home.

• This is already how the Agency handles esketamine, and it narrows the main path to diversion without new machinery.

Precedent: Esketamine REMS.

Detecting ethical violations. Make misconduct visible and reportable, including where no board licenses the facilitator.

• Put boundaries in writing: no romantic or sexual relationship with a client during services or for a year after.

• Let a recording, held with consent, be reviewed by someone outside the room.

• Give every person a complaint channel that reaches someone other than the facilitator.

• Report boundary violations, coercion and imposed beliefs through the same path a state uses for serious adverse events.

• On imposed belief, I support Dr. Matthew Johnson's point that it belongs in safety surveillance, not only in licensing (0096).

• Each state's reporting path should carry it too.

• Where a person asks for spiritual care, make it available, offered openly, given in keeping with the person's own beliefs and free to decline, as Medicare hospice rules already require.

• The Veterans Health Administration already pairs chaplains with clinicians in moral injury groups.

• Whoever gives spiritual care should be trained not to direct belief.

Precedent: Oregon OAR 333-333-5120, 42 CFR 418.56 and 418.64(d)(3).

Coverage and reimbursement. Pay for the episode, not the dose.

• CPT Category III codes 0820T to 0822T describe continuous in-person monitoring during administration, carry no relative value units, and no psychedelic-specific code covers the follow-up contact.

• Preparation sessions, the treatment and integration sessions should be priced and covered as one episode of care, never sold apart, with at least two preparation sessions and a few integration sessions in every episode.

• Colorado already bars a separate fee for the first integration session.

• Payers will need evidence of the whole episode: outcomes at the follow-up contacts, emergency and hospital use, and the cost of preparation and integration.

• Health-economic analyses should price the episode, since a dose-only model hides the cost of the care that keeps it safe, and one filer asks that outcomes be reported with cost and utilization data (0268).

Precedent: CPT 0820T, 0821T, 0822T, Colorado 4 CCR 755-1.

Provider and payer coordination. Let the follow-up contact count as care and as data at once.

• A follow-up contact made by trained staff under clinical supervision, with a validated measure, produces the outcome data payers ask for.

• Coordinate with the person's primary clinician through the warm handoff in Topic 1.

Precedent: Peer support and care coordination models (0203, 0042).

Implementation logistics. Certify a setting by what happens inside it, not by its building type, and support group care with a stated ratio.

• Groups deserve more study, not less. Healing together is one of the oldest forms of this work, and it has practical value: people who share an experience can support one another through it, integration deepens when participants learn from each other, and care costs less when one trained team serves several people.

• Research on groups is still early. In Arizona, the Scottsdale Research Institute’s FDA-authorized phase one trial, funded by the state, doses police officers, firefighters and veterans together in groups of eight from the same line of work, with four trained facilitators. Its results are not yet published. More trials like it should follow.

• For groups I propose twelve at most, one trained facilitator for every three, tighter as the dose climbs. State rules range from one facilitator per two to one per twenty-five by dose in Oregon, one per four in Colorado, and one per two in New Mexico’s proposed rule. Until studies compare ratios directly, any ratio should be treated as a starting point and revisited as the data arrive.

• Colorado permits the treatment in a hospice or care facility, or in the participant’s own home, for people who are dying, disabled or homebound. A list of approved building types becomes an access rule by accident.

• Schedule the treatment as a full-day block, with preparation and integration on the same calendar, so no one is booked for the dose alone.

• Store, log and dispose of the drug as its federal schedule requires, with locked storage and a dose record for every treatment.

• Veterans heal in units and couples arrive in twos, so prepare, consent and follow up each person.

• Allow longer phase-in periods in HRSA workforce shortage areas.

• Medical approval is one path among several, alongside state-regulated services and protected religious and ceremonial use, and guidance should be written so it does not close the others.

Precedent: Colorado Rule 6.18, Oregon OAR 333-333-5230, Scottsdale Research Institute trial, HRSA shortage data.

Telehealth. Telehealth for screening, preparation and integration, never for the treatment itself.

• Medical screening should be in person where the history calls for it.

• Follow-up by phone or video reaches people who cannot travel, which is often the difference between a contact made and a contact missed.

Precedent: Oregon OAR 333-333-5200 (video may not satisfy monitoring).

Common data elements. Adopt the consensus measures that already exist, and add the few fields still missing.

• The OPEN consensus set, developed with experts from clinical trials, psilocybin services, and ceremonial and Indigenous practice, defines 39 core measures and recommends a brief safety checklist from the facilitator within a day and from the client at one week.

• Add the fields the consensus set lacks: facilitator sobriety attested, contact outcome at each follow-up (completed, declined, unreachable), referral sent and accepted, and product source and lot, as filers asked (0050, 0077, 0170).

• Before and after the treatment, use the free measures already in wide use: PHQ-9, GAD-7, PCL-5 and WHO-5.

• Before it, add readiness: the Psychedelic Preparedness Scale and the Self-Compassion Scale.

• After it, add the thirty-item Mystical Experience Questionnaire (MEQ-30) and the Psychological Insight Questionnaire, both from Johns Hopkins researchers.

• For veterans, add the fourteen-item Moral Injury Outcome Scale.

• I have offered seven of these to hundreds of clients over many years as self-assessments, a way for each person to see their own change.

• Record drug, product and dose, indication or purpose, setting type (clinical, state-regulated service, ceremonial or other) and core patient characteristics, including comorbidities and medications, in the same fields across sources.

Precedent: OPEN consensus measures (Journal of Psychopharmacology, 2024).

Adverse event reporting. Leave reporting rules to the states, and encourage each to find harm by asking.

• Where serious events are reported, and how fast, is a decision each state is already making.

• Colorado asks facilitators to report serious events within twenty-four hours, and New Mexico's proposed rule asks for two days.

• What I would encourage everywhere is that events be found by asking, through the follow-up contacts, that boundary violations, coercion and imposed beliefs travel the same path, and that the window reach past three days, since a three-day window misses what arrives later.

• Define adverse events on two clocks: acute, during the treatment and the days after, and long-term, as difficulties lasting beyond a day and tracked through the second contact, as Evans and colleagues did.

Precedent: Colorado (24 hours), New Mexico proposed rule (2 days).

Repositories and interoperability. Keep records at the site, under pseudonyms, and send back only summary answers.

• A coordinated registry network can be built on the distributed design the Agency already runs in Sentinel.

• Link sources rather than build one store: health records and claims for clinical care, state program data from Oregon and Colorado, adverse event reports, peer support line data, and federally funded surveys such as the National Survey on Drug Use and Health, which together describe both medical and non-medical use.

• Use one common format so sites can answer the same question.

• Add a Certificate of Confidentiality wherever follow-up runs as research.

• Privacy shapes who is willing to report. In 2016 the Ninth Circuit upheld federal guidance that treats a state medical marijuana card as reasonable cause to refuse a firearm sale (Wilson v.

• Lynch). In June 2026 the Supreme Court limited how the underlying ban applies to drug users not shown to be intoxicated or dangerous (United States v.

• Hemani). The law is still settling, and veterans weigh it before reporting anything.

• A voice is not a pseudonym, so recordings stay encrypted, belong to the person, and are deleted on request unless the law or an open complaint requires keeping them.

Precedent: FDA Sentinel, Wilson v. Lynch (9th Cir. 2016), United States v. Hemani (2026).

1.

Name ascertainment as its own element in guidance: a contact within three days and at six to eight weeks, with the data fields in Topic 4, named alongside the preparation and integration sessions that make the treatment whole.

2.

Use the minimum standard in Attachment 3 as a working checklist, and test it against the settings already operating under state rules in Oregon and Colorado, and against New Mexico's program as it opens, before codifying any line of it.

3.

Bring practitioners who work outside clinics, peer supporters, chaplains and veterans' programs into the next stage of listening, so the guidance is written with the people who keep watch.

4.

Treat every requirement as provisional, with the evidence that would retire it named at the start.

I am not asking for one template across compounds, a single brand of psychotherapy written into a label, a license requirement for the person who keeps watch, a registry that becomes a list of names, or a chaplain assigned to anyone who did not ask.

I would welcome a conversation with staff about any of this, and I will keep the standard public and revise it as this record and the evidence grow.

• I know of no controlled evidence that follow-up contact prevents harm. The case for it is ascertainment, and detection is not mitigation.

• Research on group care is still early. The Arizona trial named in Topic 3 is among the first to study it directly and has not yet published results, so the ratio proposed here is a starting point to be tested, not a finding.

• The estimate in my attachments that fewer than one ketamine clinic in six offers integration is my own count from clinic partners.

• My view comes from my own practice, a caseload that chose me, with no control group.

Every source cited in this comment, with a link to the original. Docket comments are listed by number in the last entry.

1.

Federal Register notice. Considerations for Potential Future Therapeutic Use of Psychedelic Drugs. 91 FR 43095, 14 July 2026. federalregister.gov/d/2026-14155

2.

Korthuis PT et al. Safety and Mental Health Outcomes of Oregon State-Regulated Psilocybin Services. JAMA Network Open 9(8): e2630608, 2026. doi.org/10.1001/jamanetworkopen.2026.30608

3.

Oregon Health Authority. Oregon Psilocybin Services, 2025 Year in Review. oregon.gov/oha/PH/PREVENTIONWELLNESS/Documents/2025-Year-in-Review.pdf

4.

Evans J et al. Extended difficulties following the use of psychedelic drugs. PLOS ONE 18(10): e0293349, 2023. doi.org/10.1371/journal.pone.0293349

5.

Oregon Administrative Rules. OAR 333-333-3050, 5040, 5080, 5120, 5200, 5230, 5250. law.cornell.edu/regulations/oregon/chapter-333/division-333

6.

Colorado. 4 CCR 755-1, Natural Medicine rules, Rule 6, including 6.11, 6.17, 6.18, 6.19 and 6.23. law.cornell.edu/regulations/colorado/4-CCR-755-1-6

7.

New Mexico Department of Health. Proposed 7.35.3 NMAC, medical psilocybin program. nmhealth.org/publication/view/rules/9904

8.

FDA. Psychedelic Drugs: Considerations for Clinical Investigations, guidance for industry, 2026. fda.gov/media/169694/download

9.

FDA. Spravato (esketamine) prescribing information and REMS. www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s019lbl.pdf

10.

MAPS. Adherence Ratings Manual for MDMA-assisted therapy, version 6, 2021. maps.org/wp-content/uploads/2022/09/AdherenceRatingsManualVersion6_3AUG2021.pdf

11.

Code of Federal Regulations. 42 CFR 418.56 and 418.64(d)(3), hospice interdisciplinary group and spiritual counseling. ecfr.gov/current/title-42/part-418

12.

FDA. Sentinel Initiative. fda.gov/safety/fdas-sentinel-initiative

13.

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14.

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