Editor’s note: Logan Davidson is Director of Policy & Advocacy at Veterans Exploring Treatment Solutions (VETS). VETS has been involved in advocacy efforts referenced in this piece, including in Massachusetts and Texas. This is an opinion column.
In November 2020, Oregon voters passed the first ballot measure in the country to create a legal, supervised psilocybin program, Measure 109. In June 2021, Texas enacted the first state legislation directing public funds toward psychedelic research for veterans, House Bill 1802. In December 2023, Reps. Dan Crenshaw and Morgan Luttrell secured the first federal victory, a provision in that year’s National Defense Authorization Act allowing the Department of Defense to fund clinical trials of MDMA, psilocybin, and ibogaine for service members. Then, in August 2024, the FDA rejected Lykos Therapeutics’ New Drug Application for MDMA-assisted therapy for PTSD, and years of accumulated momentum stopped cold. At each of those moments, it would have been reasonable to wonder whether this movement would ever reach the point of an actual FDA approval. The 2024 rejection made that question sharper than ever: not just if approval would come, but when, or whether “when” was even still the right word.
FDA approval of at least one psychedelic-assisted therapy is closer than it has ever been, and this time it looks durable. Compass Pathways’ COMP360, a synthetic psilocybin formulation for treatment-resistant depression, received a rolling New Drug Application review and a Commissioner’s National Priority Voucher from the FDA in April 2026, days after a presidential executive order directed the agency to accelerate review of psychedelic treatments. Compass has said it expects to complete its NDA filing by the fourth quarter of this year, with approval possible in early 2027. Resilient Pharmaceuticals, the company formerly known as Lykos Therapeutics, reportedly resubmitted its MDMA-assisted therapy application for PTSD, according to an August 9 report from Psychedelic Alpha citing anonymous sources. The company has not publicly confirmed the filing, which would come roughly two years after the FDA’s 2024 rejection and without a new Phase 3 trial. The FDA issued two other priority vouchers in that same April batch, to Usona Institute for psilocybin in major depressive disorder and to Transcend Therapeutics for methylone in PTSD, which means the pipeline behind Compass and Resilient is broader than either company alone.
This does not mean we have a guaranteed outcome, but it’s important to understand this is a fundamentally different moment than 2024. Lykos’s application was the first psychedelic drug approval application ever filed in the United States and the field’s most advanced approval bid to date. Lykos’s rejection was treated by many as a verdict on the entire field rather than one company’s data problem. Some of what went wrong was arguably the price of going first: every applicant that has followed Lykos has had the benefit of studying what the FDA flagged, a benefit Lykos itself didn’t have. This time, the regulatory posture, the political posture, and the clinical data are aligned in a way they weren’t before. It is reasonable to plan for approval, and planning for approval means confronting what happens the day after it’s granted.
Oregon, Colorado, and New Mexico have spent the last several years building psilocybin programs with no federal approval to lean on. Oregon’s model, created by the 2020 ballot measure, is deliberately non-clinical: adults 21 and older can access supervised psilocybin sessions without a diagnosis, and facilitators aren’t required to be licensed therapists. Colorado’s Natural Medicine Health Act layers a personal-use framework on top of a licensed healing-center system; the state had approved 34 licensed centers as of February 2026. New Mexico took a different path entirely, becoming the first state to authorize therapeutic psilocybin through the legislature rather than a ballot measure, with a medical model aimed at enrolling its first patients by the end of this year. That list is not fixed, and it won’t stop growing just because the FDA acts. Massachusetts and Iowa both considered their own regulated natural medicine programs this year: Iowa’s House passed a psilocybin licensing bill 84-6 in 2025, and while it stalled short of a Senate floor vote, a Senate subcommittee advanced a version of it as recently as March 2026. Massachusetts’s House passed an economic development omnibus that included a five-year psychedelic therapy pilot program 148-2 in July, and as of this writing the measure is before a conference committee reconciling it with the Senate for final passage and enactment. Other states are likely to keep joining this list well after the FDA has acted, which only adds another layer to the reconciliation problem below.
An FDA-approved psychedelic therapy would almost certainly arrive with a Risk Evaluation and Mitigation Strategy (REMS), the same federally mandated safety framework that today governs Spravato, an esketamine nasal spray approved for treatment-resistant depression. A REMS-governed clinical model looks structurally different from any of the state programs now in operation or under construction. It raises immediate questions with no obvious answer yet: whether a patient in Colorado chooses a state-licensed healing center or a REMS-certified clinic, whether insurance follows one pathway and not the other, and whether states amend their own programs to align with a federal framework or let multiple systems run in parallel indefinitely.
A drug approval does not automatically mean access for patients. It is the starting gun in the race for Medicare, Medicaid, TRICARE, and commercial insurers like Aetna and Blue Cross to figure out how, whether, and under what conditions they’ll pay for it.
The closest working model is Spravato, with administration billed under dedicated HCPCS codes. Medicare Part B typically covers 80% of the cost and commercial payers generally require documentation of two to four failed prior antidepressant trials before authorizing coverage. The Health Resource Services Administration (HRSA) issued a request for information soliciting stakeholder feedback on training and care delivery models that could be used to ensure safe and effective delivery of potential future FDA-approved psychedelic drugs, which suggests regulators are thinking about this ahead of approval rather than after it. But the billing codes built for psychedelic-assisted therapy specifically are still Category III, the American Medical Association’s tracking designation for emerging services, not the Category I status that makes a code reliably billable. That transition depends on utilization and outcomes data that, by definition, can’t fully exist until the therapy is actually being delivered at scale.
Multiply the Spravato precedent across every payer type, every state Medicaid program, every therapy modality, and every specialty of provider involved in administering it, and the scope of the task starts to come into focus. This is not a problem that gets solved by one company’s launch plan or one organization’s initiative. It’s a problem that gets solved by an entire insurance and reimbursement infrastructure catching up to a treatment model it has never had to price.
Veterans have been the leaders of this movement from its earliest days, and it would be reasonable to assume they’ll have equal access once a therapy is approved. History says otherwise. The VA’s own experience with Spravato, the only comparably novel rapid-acting psychiatric treatment the department has integrated in the last decade, is instructive: the VA’s Medical Advisory Panel voted not to add esketamine to the formulary in the ordinary way, restricting it instead to case-by-case prior authorization, and years later, not every VA facility offers it on-site, leaving some veterans to pursue a Community Care referral to a civilian provider instead. VA Secretary Doug Collins has been a visible and engaged advocate on this issue, signing a five-year research partnership with HHS in July, backing new VA-run psilocybin trials at medical centers in four states, and telling reporters the department is moving away from a “wait-and-see approach” to new treatments. His commitment reads as genuine, and there’s no indication anyone at VA wants to slow-walk this on purpose. But a department-wide clinical rollout still moves through formulary review, provider training, and facility-by-facility implementation, and Spravato’s history suggests that process could run over a period of years, not months.
None of the above matters if there aren’t enough qualified people to provide the therapy. As of mid-2026, the Health Resources and Services Administration counted 7,109 designated mental health professional shortage areas nationwide, more than 60% of them in rural counties, and estimated it would take nearly 7,800 additional practitioners to close every one of those gaps using existing models of care. Psychedelic-assisted therapy is a more labor-intensive model than a standard medication visit, requiring extended sessions, trained co-facilitators in many protocols, and integration support afterward. Perhaps most critically, it is entering a workforce that was already stretched before this therapy existed.
We will need tens of thousands of trained providers to meet the patient demand once these therapies are approved. Columbia University’s School of Social Work and the University of Pennsylvania’s School of Nursing are building psychedelic-assisted therapy training directly into their graduate curricula rather than treating it as a postgraduate specialty. Interstate licensure compacts, which now cover dozens of states for counselors and psychologists, are starting to make it easier for trained providers to practice across state lines. These are meaningful efforts. They are also, by any measure, small relative to the scale of what national implementation would require across physicians, nurses, therapists, and every other profession likely to touch this care.
Even with enough trained providers, states haven’t agreed on what those providers are allowed to do. Individual versus group administration, medical versus ceremonial framing, and the question of who is qualified to hold the room during a session will all be debated state by state, and an FDA approval doesn’t resolve any of it. Oregon’s facilitator model deliberately doesn’t require a clinical license. Other states are moving toward models where only licensed medical or mental health professionals can administer treatment. A national rollout will inherit every one of these disagreements rather than settle them, because scope-of-practice law has always been a state-by-state matter, and there’s no reason to expect psychedelics to be the exception.
Affordability is one part of building equitable access. Provider distribution is another, and the same rural shortage areas driving the workforce gap above are the places least likely to have a psychedelic-trained provider in the first years after approval, regardless of what insurance ultimately covers. Approval itself will also be narrow at first, covering specific indications like treatment-resistant depression or PTSD rather than the full range of conditions patients and advocates have spent years arguing these therapies could help. Every population waiting for an indication that isn’t first in line, and every community without a nearby trained provider, is a real gap between legal availability and actual access.
Think back to 2020, when the idea of a legal psilocybin program anywhere in the country was still a ballot measure away from existing. Think back to 2021, when a single state committing research dollars to psychedelic-assisted therapy for veterans was a genuine breakthrough. Think back to 2023, when a provision in a defense bill was the first time the federal government put its name on any of this. Think back even to 2024, when a single rejection letter made some wonder if any of this would happen at all. None of us building toward this moment could have promised we’d be arguing about REMS frameworks, CPT code categories, and interstate licensure compacts by 2026. Those are the problems of a movement that has already won its first fights and is now facing the harder, more mundane work of actually building something that reaches people.
We are lucky to have these problems. We need to remember that, because the work of solving them is going to be slow, technical, and often unglamorous. It will happen in licensing board hearings, insurance coverage reviews, and state legislative committees, and it will decide whether an American can actually access this treatment or they can only read about it.
