Mobile but still tied down: Challenges to scaling mobile methadone through a regulatory thicket.

Methadone is a highly effective treatment for opioid use disorder. However, its public health impact in the U.S. has long been constrained by strict regulations requiring dispensing through specialty opioid treatment programs (OTPs). In 2021, the U.S. Drug Enforcement Administration authorized mobile medication units (MMUs) to dispense methadone in community settings, raising hopes that mobile delivery could expand access for underserved populations. This commentary examines New York State's early experience implementing MMUs as a case study of both the opportunities and persistent challenges associated with this care delivery model in the U.S. We discuss how burdensome methadone requirements, high start-up and operating costs, complex staffing and logistical burdens, community opposition, and a continued emphasis on diversion control over patient access have limited the ability to effectively scale MMUs as a low-threshold treatment option. Although MMUs have and will continue to improve convenience and access for some patients, their potential to substantially improve geographic access, provide lower-threshold care, and deliver comprehensive OUD services is inhibited by the broader U.S. "methadone exceptionalism" framework, which silos methadone as a separate and more restrictive treatment modality requiring excessive vigilance and oversight . We argue that without greater regulatory clarity, flexibility, and alignment with patient-centered care goals, MMUs may likely remain a welcomed but modest, rather than transformative, innovation in addressing methadone gaps in the United States.