Codes provide avenue for qualified healthcare providers to seek reimbursement for delivering MDMA-assisted therapy if FDA approved
SAN JOSE, Calif. , Jan. 2, 2024 /PRNewswire/ -- MAPS Public Benefit Corporation ("MAPS PBC"), a clinical-stage company dedicated to changing the way mental health conditions are treated, announced that the American Medical Association ("AMA") current procedural terminology ("CPT") III codes for psychedelic-assisted therapies, first announced in July 2023, are now in effect. The new CPT codes will provide physicians and other qualified healthcare providers a means to seek coverage and reimbursement for delivering psychedelic-assisted therapy if approved by the U.S. Food and Drug Administration ("FDA").
In December 2023, MAPS PBC submitted a new drug application ("NDA") to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider. Investigational MDMA-assisted therapy is in development for individuals with post-traumatic stress disorder ("PTSD").
"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," said Amy Emerson, chief executive officer, MAPS PBC. "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."
These are temporary codes assigned to emerging technologies, services and procedures, to facilitate reimbursement and support access to psychedelic therapies in the United States, if such therapies receive regulatory approval by the FDA. The new CPT III codes are intended to be used for data collection to substantiate sufficient usage, which could lead to them to be converted to permanent CPT I codes with a valuation assigned for widespread coverage and reimbursement. MAPS PBC and COMPASS Pathways collaborated to work with the AMA to create these new CPT III codes. On March 3, 2023, the AMA published the Summary of Panel Actions which included the acceptance of the new CPT III codes. The application was titled, "Continuous In-Person Monitoring and Intervention during Psychedelic Medication Therapy." The first code (0820T) is for a health care professional to be reimbursed for monitoring and intervention during psychedelic-assisted therapy. There are two additional modifiers (code 0821 and 0822) that are for reimbursement for a second qualified healthcare professional and for clinical staff, respectively.
With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA has 60 days to determine whether the NDA will be accepted for review and whether it will be a priority or standard review (six months or ten months, respectively). If approved by the FDA, the U.S. Drug Enforcement Administration ("DEA") would be required to reschedule MDMA making it available for prescription medical use.
MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) envisions a world where mental health care is significantly better. With a mission to transform mental health care, MAPS PBC is focused on developing novel treatments. In 2014, MAPS, a 501(c)(3) non-profit organization, created MAPS PBC as a for-profit public benefit corporation to continue the research and education around the development of investigational MDMA-assisted therapy. For more information, please visit www.mapsbcorp.com and connect with the company on LinkedIn and Facebook.
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SOURCE MAPS Public Benefit Corporation