AMA Rolls Out New Psychedelic Therapy Codes as FDA Mulls Over Prescription MDMA

The American Medical Association, aka the AMA, has recently implemented new standards to assign specific codes to psychedelic therapies. This move coincides with the Food and Drug Administration’s (otherwise known as the infamous FDA) ongoing review of an application to legalize MDMA as a prescription drug in the treatment of post-traumatic stress disorder (PTSD). These codes, known as Current Procedural Terminology (CPT) III, were established in July as a result of a collaboration between the AMA, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS), and COMPASS Pathways. 

On September 13, 2023, MAPS released the findings from their latest Phase 3 Trial, which investigates the effectiveness of MDMA-assisted therapy in treating PTSD. After intense expert peer review, these results were published in the esteemed journal Nature Medicine. The research involved 104 participants with PTSD. They were randomly assigned to receive either MDMA or a placebo pill across three sessions, each spaced a month apart, over a three-month period. Upon completion of the study, results found that 72% of the participants in the MDMA group no longer met the criteria for PTSD, in contrast to only 48% in the placebo group.

Effective starting on Monday, New Year’s Day of 2024, these codes aim to standardize psychedelic treatments and provide coverage and reimbursement for these therapies — contingent upon FDA approval, of course. 

Currently, it’s pretty impossible to get insurance to cover any psychedelic meds. This development would be a near miracle moment, an integration that previously seemed impossible to cover for many seekers or simply those trying to heal themselves. This added a financial barrier to entry for many people with PTSD, such as vets, who may have a more challenging time finding work to pay for the treatment, cruelly ironically, getting in their way of work and contributing to the economy in a way necessary to enjoy the treatment. 

The FDA is now evaluating a drug application submitted by MAPS. The FDA has a deadline of mid-February to determine whether to accept or reject this application. If granted, this would require the FDA to complete its evaluation within six months, as opposed to the typical 10-month review period.

“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,” Amy Emerson, CEO of MAPS PBC, said in a press release on Tuesday. “It is critical that there is a path to cover not only the MDMA but also the medication sessions should this novel investigational approach be approved.”

And now for some seemingly boring but crucial information: The CPT III codes are provisional classifications created to track the utilization of emerging technology. Their purpose is to make the reimbursement processes easier and support the accessibility of psychedelic therapies. If they’re deemed effective, these codes can become permanent CPT I codes, which would help facilitate the aforementioned coverage and reimbursement. Among the codes approved by the AMA, one is specifically designated for compensating healthcare professionals who oversee and intervene in psychedelic-assisted therapy. The other two are intended to reimburse ancillary health professionals and clinical staff involved in treatments.

If approved, MDMA would be the first FDA-approved psychedelic to treat a mental health condition. This comes after three decades of research into the medicine. Currently, ketamine, which is used off-label, is technically a dissociative anesthetic with hallucinogenic effects, but often embraced by the psychedelic community, it is the only federally legal similar medicine used to treat PTSD and treatment-resistant depression. 

Numerous studies have shown that psilocybin, the trippy ingredient in magic mushrooms, also has the potential to aid patients suffering from treatment-resistant depression, especially when combined with therapy.

In Oregon, the first state to legalize psilocybin (remember, it’s still illegal on a federal level), the demand for psilocybin services is so high that there are over 3,000 individuals on the waiting list to visit a legal psilocybin service center, which folks flocking from all over the world to seek treatment in a safe and monitored setting. Research also recently found that psilocybin could be a promising treatment for depression in bipolar patients.