American Medical Association to Issue First New Code for Psychedelic Therapies

COMPASS Pathways and MAPS PBC submitted joint application for new code to facilitate access to psychedelic therapy in the US, if approved

LONDON and SAN JOSE, Calif., May 02, 2023 (GLOBE NEWSWIRE) — COMPASS Pathways plc (Nasdaq: CMPS) (COMPASS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, and MAPS Public Benefit Corporation (MAPS PBC), a clinical-stage company dedicated to changing the way mental health conditions are treated, today announced that the American Medical Association (AMA) has approved a Current Procedural Terminology (CPT^®) III code for psychedelic therapies. The full details of the code are expected to be released by the AMA in July 2023 and the code will go into effect when it is published on January 1, 2024. Once effective, the CPT code will provide physicians and other qualified healthcare professionals a means to code and seek reimbursement for delivering psychedelic therapies.

The application for the new CPT III code was the result of a collaboration between MAPS PBC and COMPASS Pathways to facilitate reimbursement and ultimately access to psychedelic therapies in the US, if approved by the US Food Drug Administration (FDA). Both companies are working to develop and, subject to FDA approval, commercialize psychedelics as part of a new treatment paradigm for individuals with mental health conditions. COMPASS Pathways is conducting a phase 3 program of investigational COMP360 psilocybin therapy in treatment-resistant depression (TRD), having already published positive results in the New England Journal of Medicine from its phase 2b study of COMP360 in TRD, in the largest study of its kind. MAPS PBC has completed two phase 3 clinical trials evaluating MDMA-assisted therapy as a potential treatment for post-traumatic stress disorder (PTSD), both of which met their pre-specified primary and secondary endpoints. This new code may provide a mechanism by which these new treatments being developed by COMPASS and MAPS PBC could be reimbursed if they are approved by the FDA.

“This is a major step forward to enabling broad and equitable access to psychedelic therapies,” said Kabir Nath, CEO, COMPASS Pathways. “This collaboration with MAPS PBC to develop a new CPT code aims to ensure that psychedelic therapies, if approved, could be integrated into healthcare systems, reimbursed by payers, and made available to the people who need them.”

On March 3, 2023 the AMA published the Summary of Panel Actions which included the acceptance of the new CPT III code. The application was titled, “Continuous In-Person Monitoring and Intervention during Psychedelic Medication Therapy.” CPT III codes are a set of temporary codes assigned to emerging technologies, services and procedures. They are intended to be used for data collection to substantiate more widespread usage or to provide documentation for the FDA approval process.

“Psychedelic-assisted therapies represent a potential new frontier in the treatment of mental health conditions and our top priority is ensuring there is a path forward to integrate them into the healthcare system, if FDA approved,” said Amy Emerson, CEO, MAPS PBC. “Strong collaborations like this one demonstrate that by working together, we can move closer to our collective goal of helping people currently underserved by existing treatments for mental health conditions.”

About COMPASS Pathways                
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com.

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) is focused on developing and commercializing prescription psychedelics to bring better treatments to those living with mental health conditions. Founded in 2014, MAPS PBC is a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) non-profit organization. For more information, please visit www.mapsbcorp.com.