Multiple psychedelic compounds are in the final phases of clinical trials and may soon gain FDA approval, and dozens more are in earlier phases of development. While there is mounting evidence that psychedelics are efficacious for treating some of the most common and intractable mental health disorders, the path from research to wide patient access requires care and coordination among psychedelic-assisted therapy (PAT) stakeholders. Expediting Psychedelic-Assisted Therapy Adoption in Clinical Settings outlines three key policy issues that will shape this path and identifies next steps that the field should take to ensure that PAT is accessible, affordable, and meets high quality standards.
FDA Approval and Safety Requirements
As the FDA considers whether to require risk evaluation and mitigation strategies (REMS) for these new medicines, it should ensure that REMS are consistent with or comparable to those in place for existing treatments for the targeted conditions with similar risk and safety profiles to psychedelics.
Payer Coverage and Payment Decisions
Public and private health insurance coverage of PAT is a prerequisite for equitable access by all patients who seek such care and for whom it is appropriate.
Ensuring Optimal Patient Outcomes through High Quality Standards
The field must coalesce around rigorous training standards for PAT providers and common measures to assess the quality of care.
The PAT field must align in four key areas:
Standards of Care: Designation of a specialty association or associations to set standards of care for PAT providers, including standards of quality, medical or clinical practice guidelines, medical review criteria, and performance measures.
Program Accreditation: Designation of a body to offer independent accreditation of PAT education programs, set standards for effective training, and monitor compliance with those standards.
Provider Certification: Designation of a certification board to offer independent evaluation and verification of a provider’s skills and expertise relative to PAT, to update certification criteria as the specialty evolves, and to provide patients with a trusted credential to help identify qualified providers.
Reimbursement Strategy: Alignment of stakeholders around a unified coding strategy and implementation plan to facilitate payer coverage determinations, simplify coding and billing processes, and improve access to care; development of parity education materials and briefing documents as free resources to stakeholders to support collective advocacy efforts.
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BrainFutures’ work in the field of psychedelic medicine is generously supported by:
Austin and Gabriela Hearst Foundation
Cammack Family Charitable Gift Fund
Darla Moore Foundation
Dick and Alex Simon
Steven & Alexandra Cohen Foundation
Walker Family Foundation