Systems and Policies
Federal and state laws and policies can affect the implementation of methadone programs.
Barriers
In the U.S., methadone can only be dispensed at federally certified opioid treatment programs (OTPs). This means that OTPs are frequently geographically limited and may not be close to where an individual lives or works, and that building new OTPs is a complex and challenging process.
There are additional federal requirements for individuals to receive ongoing methadone treatment from an OTP. These include requirements that the individual receive adequate substance use disorder counseling and psychoeducation (although the individual can refuse these services) and undergo random drug testing (although the OTP is not required to take action on these results).
In addition to federal requirements, individual states may impose requirements relating to either the opening of new OTPs or the patient experience of receiving methadone from an OTP. These include regulations on the opening of new OTPs or medication units, co-licensing and staffing of the OTP as a pharmacy, and requirements for the frequency of random drug screening.
Provision of methadone and other medications for opioid use disorder can be hindered by a lack of patient insurance or insufficient coverage among those patients who do have insurance (i.e., insurance plans are not universally accepted among all providers, and some patient insurance plans do not cover certain medications).
Societal stigma around methadone is pervasive, with common misconceptions about methadone including the idea that methadone replaces one addiction for another. As a result, providers may be hesitant to work in OTPs, patients may be hesitant to seek methadone, and neighborhoods may be resistant to having methadone clinics in their backyard.
Facilitators
In April 2024, the federal government reduced requirements for new methadone inductions, such as allowing methadone to be started outside of an OTP (such as in a hospital) and allowing the initial medical examination to be performed by telehealth. This increases opportunities to create innovative solutions to methadone access.
In April 2024, the federal government extended previous allowances for take-home methadone doses from OTPs and clarified that methadone can be dispensed from affiliated off-site "medication units," including both brick-and-mortar and mobile locations. These revised regulations can increase access to daily medication dosing.
In addition to federal requirements, individual states may impose additional requirements relating to either the opening of new OTPs or the patient experience of receiving methadone from an OTP. In many cases, these state-specific regulations serve as barriers, but in others, they serve as facilitators. For example, some states require that OTPs be located in close proximity to public transportation and be open outside of regular business hours. Other states allow for mobile medication units that enable OTPs to dispense methadone to specific communities through a mobile van service.