A rooftop panel of clinicians, researchers, and operators gathered in New York on May 20, 2026 to answer the question on everyone's mind: what does the White House Executive Order on psychedelic medicine actually change?
The conversation was candid, sometimes uncomfortable, and exactly what the field needed. Here is what was said - and what it means for clinicians, patients, and the future of psychedelic-assisted psychotherapy.
Who Was in the Room
The panel was moderated by Greg Kubin, General Partner and Co-founder of PsyMed Ventures and host of the Business Trip podcast. Panelists included:
- Myriam Barthes -— Co-founder and CEO of Journey Clinical, the largest psychedelic-assisted psychotherapy platform in the United States
- Jonathan Sabbagh - Co-founder and Executive Chairman of Journey Clinical
- Rachel Yehuda, PhD - Director of the Parsons Research Center for Psychedelic Healing at Icahn School of Medicine at Mount Sinai, and longtime VA researcher
- Rebecca Love, LCSW - Journey Clinical's first clinician member, KAP provider and educator at Fluence
The Executive Order: A Plain-Language Breakdown
In April 2026, the White House signed an executive order widely described as a watershed moment for psychedelic medicine. Greg Kubin outlined the four key provisions:
1. Priority Review Vouchers for FDA Applicants
Companies with Breakthrough Therapy Designation can qualify for a priority review voucher, compressing FDA review from 10-12 months to 1-2 months after a New Drug Application is submitted. That is meaningful acceleration for any company near the finish line.
2. Rescheduling Triggered by Phase 3 Completion
Previously, rescheduling a Schedule I substance required full FDA approval. Under the new order, completing a Phase 3 clinical trial initiates the rescheduling process automatically, a structural shift that removes one bureaucratic bottleneck from the path to legal availability.
3. Right to Try for Psychedelics
Patients with severe or terminal illnesses who have exhausted standard treatments may now qualify to receive a psychedelic compound with Phase 1 safety data completed. The open question: a company sponsor must agree to make the drug available. As of May 2026, it remains unclear which companies will actually do so.
4. $50 Million in Federal Matching Grants via ARPA-H
The Advanced Research Projects Agency for Health will match state-level psychedelic medicine initiatives dollar-for-dollar, up to $50 million total, a direct incentive for states already moving on their own regulatory frameworks.
What the Executive Order Actually Changes - and What It Doesn't
"A lot of the focus is on the clinical trial process, but a bit less so about what happens afterwards: access, insurance, who's actually going to pay for these things." - Greg Kubin, PsyMed Ventures
Kubin identified three gaps the order leaves that must be addressed:
- Access and insurance reimbursement: who pays, and for whom
- Right to Try implementation: which company will publicly commit to making a Phase 1 drug available under the provision
- Clinical trial complexity: issues with blinding, bias, and trial design persist and must be determined
Acknowledging the political goodwill, Rachel Yehuda noted that community clinics, VA settings, and private practices face structural barriers the executive order does not touch. For example, psilocybin and MDMA sessions run 6-8 hours; a clinician cannot see other patients that day. Monitoring is expensive. Specialized training needs to be accounted for.
"Well, except for Journey, the rest of the world is not ready for this." — Rachel Yehuda, PhD, Parsons Research Center for Psychedelic Healing, Mount Sinai
Journey Clinical is the exception, having spent five years building exactly that: a trained therapist network, medical oversight, insurance coverage, and care delivery protocols ready to scale when approvals arrive.
Why the Care Model Matters as Much as the Psychedelic Compound
One of the clearest points of alignment across the panel was this: psychedelic-assisted psychotherapy is not a drug with a therapy add-on. The therapeutic relationship (preparation, dosing, integration) is the treatment. The compound is an adjunct to psychotherapy, and sometimes a powerful catalyst for it.
That distinction has real stakes as the field scales. One open question the field is actively working through: as psychedelic compounds move toward FDA approval, what role should psychotherapy play in the treatment protocol, and how should that be defined? The MDMA approval process surfaced this tension directly. FDA does not regulate psychotherapy, which means the field itself (clinicians, researchers, professional guilds) will need to establish and uphold that standard.
The data is promising. Yehuda shared early findings from an ongoing comparative study at Mount Sinai tracking patients who received ketamine in an infusion suite against patients who received ketamine-assisted psychotherapy. Immediately after treatment, both groups showed similar symptom improvement. But at two weeks, four weeks, and six weeks out, the psychotherapy group maintained their gains while the infusion-only group's symptoms returned. The study is still in progress, and the team continues to follow patients over time.
This is why the therapeutic alliance, the relationship between therapist and patient built through preparation and sustained through integration, is not a nice-to-have. It is what makes outcomes durable. It is also why Journey Clinical has committed, since 2021, to delivering every treatment within that container. And it is why shared language across the field — about what these treatments are, how they work, and who should deliver them — matters as much as any regulatory development.
A Therapist's Honest Reaction: Fear, Then Purpose
Rebecca Love, Journey Clinical's first clinician member, was candid about the mixed feelings many clinicians brought to the announcement: a combination of hope for the field and concern about whether the infrastructure, the values, and the therapeutic framework would be preserved as the policy moves fast. Her response was to turn that concern into a sense of purpose: the community of trained therapists, not regulators or drug companies, are the ones responsible for how these treatments actually land.
On clinical preparation: Love described ketamine as an excellent entry point for patients whose systems cannot yet manage a more intense disruption. For example, she emphasized that the ketamine-assisted psychotherapy model teaches patients embodied consent: knowing what a genuine yes feels like in the body before moving to more involved interventions.
"We are training people how to find their embodied sense of consent. People who have been socialized and traumatized into saying yes when they mean no. Part of what we're doing in these smaller, manageable contexts is getting granular about how people feel their sense of yes." - Rebecca Love, LCSW
Her clinical experience with lower-dose, psycholytic approaches supports continuity of the therapeutic relationship: a prerequisite, she argued, for the deeper work that psilocybin and MDMA will eventually require. As she put it, "Ketamine is actually a really beautiful kind of gateway, a bite-sized chunk for someone whose system cannot manage a more intense disruption."
Journey Clinical: Building the Infrastructure Before the Approval
Myriam Barthes provided the operational ground truth. Journey Clinical has been preparing for this moment since 2021, and the outcomes data tells a specific story:
- Over 1 million hours of ketamine-assisted psychotherapy delivered
- 87% of patients showed clinical improvement
- 40% no longer meet diagnostic criteria for their presenting condition
- 3,000 therapy practices now delivering ketamine-assisted psychotherapy through the Journey Clinical model
- Active in 30 states, covered by major commercial insurers including Aetna, United, BCBS and more
The care model is structured around the therapeutic alliance with preparation, dosing, and integration. The psychedelic compound is always paired with psychotherapy.
Journey Clinical is one of several partners working with Compass Pathways on the rollout of COMP360, their psilocybin compound. While COMP360 will be delivered through various care models, Journey Clinical's commitment is specific: every treatment will be delivered within the preparation, dosing, and integration framework.
"We have been working every week with Compass Pathways to discuss the intricacies of care delivery for psilocybin-assisted psychotherapy. At Journey Clinical, we pair the psychedelic with psychotherapy. That's our commitment." - Myriam Barthes, Co-founder & CEO, Journey Clinical
The Spravato Bridge Strategy
For therapists who want to be ready for psilocybin and MDMA approvals, the clearest on-ramp available right now is Spravato (esketamine).
Spravato, an FDA-approved esketamine nasal spray from Janssen, is already covered by Medicare, Medicaid, and major commercial insurers. Its REMS (Risk Evaluation and Mitigation Strategy) requirements (monitoring, licensing, a clinician in the room) closely parallel what is expected for psilocybin REMS when approval comes.
Journey Clinical has built the infrastructure for psychotherapy practices to deliver Spravato with full insurance coverage, integrated with the psychotherapy component. The strategic logic: Spravato readiness is psilocybin readiness. The same trained therapist network, the same compliance infrastructure, the same payor relationships.
On Medicare and Medicaid Coverage
Journey Clinical is currently in-network with major commercial insurers across 30 states. Medicare and Medicaid coverage for ketamine-assisted psychotherapy is in progress.
From Washington: Three Takeaways from the Federal Summit
Myriam Barthes and Jonathan Sabbagh attended the Psychedelic Medicine Coalition's federal summit in Washington DC the week of the panel, a one-day convening of HHS representatives, ARPA-H, Senate staff, researchers, and operators. Barthes shared three takeaways:
1. It Takes a Village, and the Village Is Bigger Than You Think
The psychedelic medicine movement is bipartisan, distributed, and far larger than the clinical community in New York tends to realize. Government officials from the Senate to ARPA-H were, in her words, "all in." The field does not need every organization to be excellent at everything. It needs each to do its part well.
2. The Field Needs Shared Language
Tensions between boldness and caution, between clinical research and access, between safety and scale, cannot be navigated without common vocabulary. Creating that language, across researchers, operators, regulators, and therapists, is itself strategic work.
3. Call Your Legislator. Seriously.
Legislators and their staff are available and listening when it comes to psychedelic medicine. The policy window is open. Clinicians who believe in the therapeutic model have direct access to the people writing the rules.
What Clinicians Should Do Now
The panel closed with practical guidance for therapists preparing for the next phase of approvals. The consensus across all four panelists:
- Start with Spravato. The REMS framework, monitoring requirements, and therapy integration model are the closest available analog to what is coming for psilocybin and MDMA.
- Do not wait for full clarity. The therapists who have been doing this work since 2021 will be the pioneers on the new drugs.
- Insist on psychotherapy: in your practice, in your language, in your advocacy. "Facilitation" is not a synonym.
- Teach embodied consent before escalating to more involved interventions. The preparation work with ketamine is clinical preparation for what follows.
- Treatment adherence matters. Journey Clinical's data shows a 30% improvement in outcomes for patients who complete a full course of treatment versus those who stop early.
- The community of clinicians - not drug companies, not Congress - is the steward of what comes next.
Frequently Asked Questions
What did the 2026 Executive Order on psychedelic medicine do?
The April 2026 executive order created four key provisions: priority review vouchers that compress FDA review from 10-12 months to 1-2 months for qualifying companies; automatic initiation of rescheduling upon Phase 3 trial completion; Right to Try access for patients with severe or terminal illnesses; and a $50 million ARPA-H matching grant for state psychedelic medicine initiatives.
Does the executive order address insurance coverage for psychedelic therapy?
No. Insurance coverage and access were explicitly identified as gaps in the executive order. It focuses primarily on accelerating the clinical trial and FDA approval process. Journey Clinical currently accepts major commercial insurers in 30 states for ketamine-assisted psychotherapy. Spravato is already covered by Medicare and Medicaid.
When will psilocybin therapy be FDA-approved?
As of May 2026, FDA approval for psilocybin-assisted psychotherapy is anticipated in 2026 or 2027. Journey Clinical is actively preparing its 3,000-practice network through its research partnership with Compass Pathways.
What is Spravato and why should therapists care about it?
Spravato is an FDA-approved esketamine nasal spray from Janssen, currently covered by Medicare, Medicaid, and major commercial insurers. Its REMS safety requirements closely parallel expected requirements for psilocybin therapy. Journey Clinical has built the infrastructure for licensed therapists in private practice to offer Spravato with full insurance coverage and integrated psychotherapy, making it the most viable on-ramp for clinicians preparing for next-generation psychedelic approvals.
Does psychedelic-assisted psychotherapy require a licensed psychotherapist?
Yes. Research will be released soon from Rachel Yehuda's team at Mount Sinai, showing that ketamine delivered without psychotherapy produces short-term symptom reduction but fails to sustain improvement over time. In contrast, her study is expected to demonstrate that ketamine-assisted psychotherapy produces durable results. The same principle is expected to apply to psilocybin and MDMA.
What is Journey Clinical and how does it work?
Journey Clinical is the largest psychedelic-assisted psychotherapy platform in the United States. It serves both licensed mental health professionals and patients, enabling therapists to offer ketamine-assisted psychotherapy and Spravato in their own practices, with access to medical supervision, training, insurance coverage, and peer community, while connecting patients to quality care in their local communities. Currently active in 30 states, Journey Clinical has delivered over one million hours of ketamine-assisted psychotherapy, with 87% of patients showing clinical improvement, and holds a research partnership with Compass Pathways for psilocybin-assisted psychotherapy.
The Bottom Line
The April 2026 executive order is a meaningful signal: regulatory momentum, political validation, and structural acceleration for companies already in late-stage trials. But it does not build the clinical workforce, solve access questions, or guarantee that psychedelic treatments will be delivered within a genuine psychotherapeutic model.
That work falls to the clinicians in rooms like the one on that rooftop in New York, the therapists, researchers, and operators who have been doing this carefully, and who will determine whether the coming wave of approvals produces lasting change.
Speaking directly to clinicians, she said: "We're holding this — not the drug companies, not Congress, not the executive. It's us. We're the ones interfacing with the patient, and the buck begins and stops there." - Rachel Yehuda, PhD
Related Articles
- Toward a Shared Language for Psychedelic-Assisted Psychotherapy
- We Are at the Inflection Point for Psychedelic Medicine
- What Makes Ketamine-Assisted Psychotherapy Unique
- What Is the Therapeutic Alliance in Psychedelic Therapy
- Spravato in Private Practice: What Therapists Need to Know
- Journey Clinical and Compass Pathways Announce Research Collaboration for Psilocybin Treatment Delivery
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