"Every time there's a headline about psychedelics, patients start coming in asking about treatments," says Dr. Will Sauve, Chief Medical Officer at Osmind. "After an executive order, I expect that volume to go up significantly—and most clinicians haven't had time to parse what this order actually does."

April 18th’s executive order clears federal roadblocks that have slowed psychedelic treatments for decades. But approval (if and when it comes) doesn't equal access. This piece breaks down what the order actually does, what it doesn't, what patients are likely asking, and what your practice can do now to prepare.

What the executive order does – and what it doesn't

The order, titled "Accelerating Medical Treatments for Serious Mental Illness," moves four levers at once. It directs the Food and Drug Administration (FDA) to expedite review of psychedelics with breakthrough therapy designation and adds three compounds to the Priority Review Voucher pilot program. It allocates $50 million in Department of Health and Human Services(HHS) matching funds for state-level psychedelic research. It instructs the FDA and Drug Enforcement Administration (DEA) to create an expanded-access pathway under the Right to Try Act. And it orders the DEA to evaluate the continued appropriateness of Schedule I classification for compounds showing clinical promise.

What it does not do is equally important. No drug became legal on 4/18/26. FDA and DEA oversight remain fully intact. No reimbursement model changed. No scheduling was reclassified. The executive order is a regulatory forcing function: it compresses political and bureaucratic timelines that had been measured in years into months. But it does not touch the operational path between approval and a patient actually receiving treatment at an independent practice.It also doesn't change the evidence-based process itself. Clinical trials, post-marketing surveillance, and real-world evidence generation still have to happen—and life sciences companies developing these treatments need partners on the ground who can support that work in community practice settings.

What practices can do now

You don't need to wait for FDA approval to start preparing.

Assess your current interventional treatment readiness. Your experience with Spravato, TMS, and ketamine is the closest proxy for what psychedelic treatment delivery will require. If you're already navigating REMS, buy-and-bill, and extended monitoring workflows, you're further along than most.

Start capturing structured outcome data. The executive order specifically calls for real-world evidence generation. Structured outcomes data will drive payer coverage decisions, expand access beyond initial indications, and demonstrate that these treatments work across diverse patient populations – not just in trial conditions.

Understand the billing code landscape. Appropriate billing codes for psychedelic treatments will need to be established and added—a process that historically takes months. Practices that get credentialed early and understand the coding requirements will have a significant head start.

Get credentialed and reimbursement-ready now. Independent practices deliver the same care as large health systems but often wait 6–12 months to credential and get paid less. Osmind helps with credentialing, billing, and a psychiatry-tailored platform ready for novel treatments. Learn more →

Train your team on patient conversations. Front-desk staff and clinicians need a consistent, accurate way to respond to patient questions about investigational treatments. The FAQ above is a starting point.

Watch CMS. The Innovation Center payment model is the most consequential near-term policy decision for independent practice economics. When it drops, be ready to evaluate it immediately.
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What about CMS and reimbursement?

Buried in April 18th’s signing ceremony was perhaps the most consequential detail for independent practices: Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz confirmed that the CMS Innovation Center is drafting a psychedelic-specific payment model, expected by the end of 2026.

Conventional fee-for-service billing wasn't designed for treatments where a single session can run six to eight hours—a reality for several compounds currently in development. Without a new payment model, even successful FDA approvals will be capacity-constrained—limited to large health systems that can absorb the operational cost, academic medical centers with research funding, or cash-pay concierge practices. Independent practices, where most patients actually receive their mental health care, will be left behind.

"Reimbursement is the real bottleneck," says Lucia Huang. "You can have the best clinical protocol in the world, but if a practice can't get paid for an eight-hour session, the treatment doesn't get delivered. The CMS payment model is the single most important decision on the horizon for independent practices, and it's barely being discussed."

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The questions your patients will be asking and how to answer them

I heard about a psychedelic treatment; would that be effective for me?

The best response is to bring the patient in for a diagnostic assessment or reassessment—not to answer the question in the abstract. Walk through the usual diagnostic considerations, educate them on what these treatments actually are, and discuss why they may or may not be appropriate for their specific situation.

"Mostly, I'm explaining to a long-time chronic MDD patient who has had many treatment trials that any novel mechanism is a decent bet, if only because it's a different approach," says Dr. Will Sauve. "But you still have to do the clinical work—assess the diagnosis, review what they've tried, and have an honest conversation about what we know and don't know yet."

For patients who meet inclusion criteria and are specifically interested in psychedelics today, referral to a clinical trial is the evidence-based path forward. Osmind Psychiatry Collective members get access to clinical trials and research studies.

"When will FDA-approved psychedelic treatments be available?"

Multiple compounds are in late-stage clinical development. Compass Pathways recently reported two positive Phase 3 trials for a synthetic psilocybin treatment for treatment-resistant depression, with a rolling FDA submission underway. Other programs are progressing across psilocybin, MDMA, and LSD—which is currently in Phase 3 trials for generalized anxiety disorder and major depressive disorder.

"The approval date gets all the attention, but what matters for our patients is when a treatment is actually deliverable in a community practice setting," says Jimmy Qian. "With Spravato, that lag was measured in years. We're working to make sure it's shorter with future evidence-based treatments."

"I will welcome FDA-approved psychedelic therapeutics into my practice when the evidence base supports it for a specific indication in a specific patient," says Dr. Brittany Albright, a psychiatrist who treats veterans. "My patients with treatment-resistant depression, PTSD, and substance use disorders deserve better options—their suffering is real and carries catastrophic consequences. But urgency cannot substitute for evidence. Breakthrough Therapy designation and Right to Try pathways accelerate access, but they do not generate the durability data or post-marketing surveillance that responsible prescribing requires. And they do not guarantee insurance coverage. Speed is not a substitute for science, and hope is not a substitute for data."

For clinicians fielding this question directly from patients, Dr. Will Sauve offers a practical framing: "When a patient asks 'when can I have this,' the honest answer is: we don't know yet. What I tell them is that I will be delighted to advocate for them. Once a treatment is FDA-approved and available in the clinic, we'll get after the process — but FDA approval does not mean insurance pays, and we all know that part could take a while."

"Can I access psychedelic treatments through Right to Try?"

The executive order expands Right to Try access for investigational psychedelics that have cleared Phase I safety thresholds. But Right to Try is not a prescription pathway: it's a narrow legal framework that allows terminally or seriously ill patients to request access to investigational drugs outside of clinical trials. It requires manufacturer willingness to supply the drug, physician agreement to administer it, and patient acknowledgment that the treatment is experimental. It does not guarantee insurance coverage, and it does not mean these treatments are broadly available.

"This is so often misunderstood," says Dr. Will Sauve. "All Right to Try really does is enable experimental treatments to be provided to certain categories of patients who aren't going to be included in a trial and are in need and can accept the risks. It almost never means an unapproved treatment is going to be available in a typical clinical setting. The vast majority of clinicians practicing around the country wouldn't have a feasible way of getting their hands on an unapproved treatment to then provide under Right to Try. Patients hear 'Right to Try' and assume they can ask their doctor for psilocybin next week. The reality is much narrower, and clinicians need a clear way to explain that without discouraging patients who may genuinely benefit from these treatments in the future."

"What about state psychedelic programs?"

Oregon and Colorado have established regulated frameworks for psilocybin-assisted therapy outside the FDA approval pathway. Texas has committed $100 million to ibogaine research. Several other states — Arizona, Tennessee, North Carolina, Georgia — are developing their own programs. These operate independently of the FDA process, with their own eligibility criteria, provider requirements, and oversight structures. They are not interchangeable with FDA-approved treatments, and availability varies significantly by state.

"I'd tell a patient asking about this that a great deal of research is called for," says Dr. Will Sauve. "Each state that has a program is different — risks and benefits are handled differently, costs can be unpredictable, and there will probably be travel involved. The only thing I'd ask as their doctor is that I be kept in the loop, so I have some idea what's going on with their care."

"Should I consider traveling internationally for treatment?"

International psychedelic retreats carry real safety risks – ibogaine in particular is associated with serious cardiac complications including QT prolongation – and are not covered by U.S. insurance. Clinicians should help patients weigh the evidence honestly without either endorsing or dismissing these options.

Dr. Brittany Albright: “International psychedelic retreats carry real safety risks—ibogaine in particular is associated with serious cardiac complications including QT prolongation—and are not covered by U.S. insurance. The quality of care varies widely and the evidence base for these programs is limited. Clinicians should exercise caution in discussing these options, as referrals to unregulated international programs carry liability implications.”

"Will my insurance cover psychedelic treatments?"

Not yet – and not automatically even after FDA approval. Spravato is the instructive example: six years post-approval, payers still impose tiered prior authorization, and many practices report ongoing reimbursement challenges for mandatory monitoring time. Insurers can classify newly approved therapies as "experimental" even after FDA clearance. The CMS payment model under development is the most important variable – without it, coverage will be inconsistent and practice-level economics will determine access more than clinical need.

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We've seen this before: what we can learn from SPRAVATO®

The clearest preview of what's ahead is already playing out across hundreds of independent practices.

Spravato (esketamine) was FDA-approved in 2019 and crossed $1 billion in annual sales last year. By most measures, it's the most successful novel interventional psychiatric treatment to reach market in decades. And independent practices still struggle to deliver it sustainably.

Every healthcare setting and pharmacy must be REMS-certified. Every patient must be individually enrolled. Every dose requires a mandatory two-hour on-site monitoring period. Payers impose tiered prior-authorization requirements. Practices report multi-year fights over billing codes, single-case agreements, and reimbursement for observation time.

"We talk to practices every day that want to offer interventional treatments but can't make the economics work," says Lucia Huang, Osmind's CEO. "The drug is approved, the evidence is strong, patients are in need of it—and practices still can't deliver it because the operational infrastructure wasn't built to support them. That's the gap we're trying to close at Osmind."

One reason the economics don't work: independent practices pay more for medications and get reimbursed less than large health systems—even when they deliver the same care. "That's what group purchasing changes," says Katie Passanisi, Managing Director of CareNet GPO. "Collective buying power on specialty medications so practices can actually afford to offer the treatments their patients need. And that gap is only going to get wider with the next wave of treatments."

The operational demands of what's coming are considerably larger. Psilocybin dosing sessions run six to eight hours. MDMA-assisted therapy can last up to eight hours with concurrent psychotherapy. Analysts estimate a full treatment of MDMA-assisted therapy course could cost $10,000 to $15,000 per patient. The complexity is an order of magnitude greater than Spravato.

​​"If we're being honest, most independent practices aren't ready for what approved psychedelic treatments will require operationally," says Jimmy Qian, Co-Founder and President of Osmind. "Not because they lack the clinical skill—they don’t—but because the infrastructure around billing, procurement, compliance, and staffing hasn't been built yet. That's true even for treatments that are already approved. That's why we're building it—drawing on what we've learned across thousands of practices so that independent clinicians don't have to figure it out alone."

The starting line, not the finish line

The executive order compressed the regulatory timeline.
The practices that start preparing now—shoring up credentialing, billing, compliance, and clinical infrastructure—will be the ones ready to deliver when approvals come.

You don't have to figure it out alone. Over 2,500 clinicians in the Psychiatry Collective are already navigating these questions together. They’re sharing playbooks, asking hard questions, and learning from each other as the field evolves.

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