As the Food and Drug Administration (FDA) considers an application to approve MDMA as a prescription drug, new standards from the American Medical Association (AMA) have officially taken effect that assign psychedelics-specific codes to collect data on the novel therapies.
AMA approved Current Procedural Terminology (CPT) III codes for psychedelic medicines in July after collaborating with the psychedelics-focused MAPS Public Benefit Corporation (MAPS PBC) and COMPASS Pathways. Those codes, which took effect on Monday, could eventually be used for health providers seeking coverage and reimbursement for psychedelics treatments, pending FDA approval.
“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.”
The CPT III codes are temporary designations meant to provide data on the usage of emerging technologies and services “to facilitate reimbursement and support access to psychedelic therapies in the United States, if such therapies receive regulatory approval by the FDA,” MAPS PBC said. If sufficient usage is established, they can be codified as permanent CPT I codes with a valuation assigned for widespread coverage and reimbursement purposes.
One of the codes approved by AMA is meant for reimbursements to health care professionals for monitoring and intervention in psychedelic-assisted therapy. Two others are for reimbursements to secondary health professionals and clinical staff.
Currently, there are no FDA-approved psychedelic therapies—but that could change in 2024. The federal agency has already designated MDMA and psilocybin as breakthrough therapies for the treatment of post-traumatic stress disorder (PTSD) and severe depression, respectively.
Now FDA is considering MAP PBC’s new drug application for MDMA-assisted therapy following the completion of multiple clinical trials that supported the drug’s effectiveness as a therapeutic for moderate and severe PTSD.
FDA has until mid-February to decide whether it will accept the application. MAPS PBC—which is a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS)—has requested an expedited review so that the agency would have to complete its work within six months, instead of a standard 10-month review.
If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with psychotherapy and other supportive services.
MAPS published the results of a recent Phase 3 trial in the journal Nature in September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”
Meanwhile, a separate study, by researchers at New York University’s Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that pairing MDMA with either psilocybin or LSD helped people overcome the “challenging experiences” associated with use of psilocybin or LSD alone.
Last year, the Biden administration said it was “actively exploring” the possibility of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.
In California, meanwhile, Gov. Gavin Newsom (D) signed a bill in October that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled.
In February of this year, Australia legalized MDMA and psilocybin for use by prescription. (Full Story)