The FDA weighs MDMA prescription applications as the new American Medical Association psychedelic therapy codes take effect

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.

The AMA approved Current Procedural Terminology III (CPT III) codes for psychedelic medicine in July, after collaborating MAPS Public Benefit Corporation and COMPASS Pathways. These codes, which went into effect on Monday could be used by health providers to seek reimbursement and coverage for psychedelics treatments pending FDA approval.

In a Tuesday press release, Amy Emerson, CEO at MAPS PBC , said that these new CPT code are an important step in paving the way for future use, should the FDA approve it. It is important that the MDMA sessions are covered, as well as the medication sessions, should this new investigational approach be approved.

CPT III codes are now available in the U.S. for psychedelic assisted therapies. These codes allow HCPs to request reimbursement and coverage for providing psychedelic assisted therapy to their patients if the FDA approves such therapies. https://t.co/S78RBCkUSl pic.twitter.com/dQgifwzdzF

MAPS_PBC January 2, 2020

MAPS PBC stated that the CPT III code is a temporary designation meant to provide information on the use of emerging technologies and service “to facilitate reimbursements and support access to psychoedelic therapies in America, if these therapies receive FDA regulatory approval.” Once a sufficient amount of usage has been established, the CPT III codes can be permanently codified with a value assigned to cover widespread coverage and reimbursement.

One of the codes approved for reimbursement by AMA is for reimbursement to health care providers for monitoring and intervention during psychedelic assisted therapy. Two other codes are intended for reimbursements of secondary health professionals and staff.

There are currently no FDA approved psychedelic treatments, but that may change by 2024. The federal agency has already designated MDMA as a breakthrough therapy for treating post-traumatic disorder (PTSD) or severe depression.

After multiple clinical trials have shown that MDMA is effective in treating moderate to severe PTSD, the FDA has now decided to review MAP PBC’s new drug application.

FDA must decide by mid-February whether to accept the application. MAPS PBC, a wholly-owned subsidiary of nonprofit Multidisciplinary Association for Psychedelic Studies(MAPS), has requested that FDA expedite its review.

The Drug Enforcement Administration (DEA), if the NDA were to be approved, would have to reschedule MDMA. It would be the first time in history that a psychedelic was approved as a drug, administered along with psychotherapy or other supportive services.

MAPS reported the results of a Phase 3 trial published in Nature by MAPS , in September. The study found that MDMA significantly reduced PTSD symptoms compared to placebo therapy.

Researchers at the Langone Center for Psychedelic Medicine at New York University and the Centre for Psychedelic Research of Imperial College London found in a separate study that pairing MDMA or psilocybin with LSD or psilocybin helped people overcome “challenging” experiences when using psilocybin alone.

The Biden administration stated last year that it was “actively examining” the possibility to create a federal taskforce to investigate the therapeutic potency of psilocybin and MDMA, among others, ahead of anticipated approval of these substances for prescription use.

In California, Gov. Gavin Newsom, a Democrat from California, signed a law in October allowing doctors to immediately begin prescribing certain drugs that are currently illegal like MDMA and psilocybin once they were federally rescheduled.

Australia has legalized MDMA, psilocybin and their use on prescription.