Request for Information: Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings

Steph Leopold, a Nurse Anesthesiologist and founder of rural health organizations, supports the RFI's goal of developing safe psychedelic therapy models. She argues for a tiered safety framework based on specific drug risks, recommends utilizing the existing ambulatory surgery center model, and advocates for the inclusion of anesthesia-trained providers (specifically CRNAs) to ensure medical safety in rural and underserved areas.

Svetlana Yakov, a psychiatrist and owner of an independent practice in Montana, supports the RFI by providing specific operational guidance on delivering psychedelic therapies in rural and underserved settings. She advocates for a no-cost REMS certification framework, on-site psychiatric medical supervision, and policies that prevent insurance barriers from limiting access to these treatments.

Althea PBC, a technology infrastructure provider for state-regulated psilocybin services, supports the development of federal care models by providing operational evidence from Oregon and Colorado. They advocate for a competency-based facilitator workforce, group administration models to improve access, and the use of standardized digital infrastructure for screening and outcomes measurement.

A veteran-serving nonprofit in rural Montana supports the RFI and recommends a multi-phase screening process, standardized national certification for staff, and the use of telehealth to expand access. They emphasize the importance of trauma-informed care, community partnerships, and the use of AI as a support tool rather than a replacement for human clinical judgment.

The commenter, representing an organization serving veterans in rural Montana, supports the development of training and care delivery models for psychedelic therapies. They argue that these therapies should be integrated into a comprehensive "Whole Health" model that includes peer support, behavioral health counseling, and complementary services rather than being treated as standalone medical procedures.