While psychedelic trials continue to amass promising data on the clinical side, an important event has taken place as it relates to reimbursement. The American Medical Association‘s (AMA) Current Procedural Terminology (CPT) III codes for psychedelic-assisted therapies, as initially unveiled in July 2023, have officially been activated and went into effect January 1, 2024. These new codes represent a significant development, affording physicians and qualified healthcare providers a mechanism to pursue coverage and reimbursement for administering psychedelic-assisted therapy—pending approval by the U.S. Food and Drug Administration (FDA).
The AMA had previously granted approval to a novel code designed to enhance accessibility to psychedelic therapy in the United States in May. This approval followed a collaborative application submitted by COMPASS Pathways and MAPS Public Benefit Corporation (MAPS PBC), both of whom are conducting, or have conducted, Phase 3 trials of psychedelic-assisted medicine and protocols.
Upon implementation, the code will serve as a tool to monitor and document the administration of psychedelic treatments. The reporting will occur in one-hour intervals, encompassing a range of psychedelic compounds accompanied by psychological support models, subject to approval.
The code will also account for diverse staffing configurations, specifying the numbers and credentials of qualified healthcare professionals involved. Additionally, a sub-code catering to the participation of non-qualified health professional clinical staff will be made available. The temporary nature of these codes allows for data collection to substantiate usage, potentially leading to their conversion into permanent CPT I codes with assigned valuations for broad coverage and reimbursement.
The primary code (0820T) pertains to reimbursement for health care professionals providing monitoring and intervention during psychedelic-assisted therapy. Two additional modifiers (codes 0821 and 0822) cover reimbursement for a second qualified healthcare professional and clinical staff, respectively.
In a press release disseminated by MAPS PBC to highlight the occasion, Amy Emerson, CEO MAPS PBC Amy Emerson emphasized the significance of the new CPT codes, stating: “Having recently filed a new drug application for MDMA-assisted therapy for PTSD, these new CPT codes are an important step forward to pave the way for its future use should it be approved by the FDA. It is critical that there is a path to cover not only the MDMA but also the medication sessions should this novel
Given the Breakthrough Therapy designation granted to MDMA in 2017, MAPS PBC has formally requested Priority Review of the NDA from the FDA. The FDA holds a 60-day period to determine the acceptance and review status of the NDA, designating it either a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration would need to reschedule MDMA, allowing for prescription medical use.
TDR notes that to date, no psychedelic-based drug or associated protocol has been approved by the FDA. MAPS PBC recently submitted a New Drug Application (NDA) to the FDA for MDMA (capsules) in conjunction with MDMA-assisted therapy. This intervention includes psychotherapy along with additional supportive services administered by qualified healthcare providers.