The United States Department of Health and Human Services officially declared the opioid crisis a national public health emergency in October 2017. Since then, overdose deaths have continued to increase; each year, more than 100,000 people die from accidental overdoses, with fentanyl being a primary driver. States have worked to address the opioid crisis by increasing access to medications for opioid use disorder (MOUD) such as methadone and buprenorphine.New flexibilities for delivering MOUD, especially methadone, can be a crucial intervention for helping stimy overdoses. The use of methadone decreases a person’s likelihood of overdose death by 59%. Clinicians have found methadone to be essential in avoiding precipitated withdrawal (a rapid onset of debilitating withdrawal symptoms), which is a serious potential risk of initiating treatment with buprenorphine. Methadone also is critical for patients for whom buprenorphine is not effective.Expanding access to methadone is key to decreasing the risk of opioid overdose. But three factors — access, scheduling, and transportation — make expansion difficult.

Unlike other MOUD, methadone must be administered in the controlled environment of an opioid treatment provider (OTP), also known as a methadone clinic.
In addition to having to visit an OTP (often daily at the onset of treatment), clinics don’t always accept new patients.
Only about a quarter of individuals being treated with MOUD receive methadone, and 80% of U.S. counties do not have an OTP. To find a clinic that can accept new patients, individuals need to drive 39 miles, on average.

To mitigate some of these barriers, the federal government introduced new regulatory changes to help states increase access to methadone. The Substance Abuse and Mental Health Services Administration (SAMHSA) final ruling on 42 CFR part 8 (which took effect April 2024) allows for flexibility in methadone prescribing. For states, these changes include:

administering higher starting doses for new methadone patients,
giving patients take-home medication (thus decreasing the need for daily trips to the clinic), and
maintaining the telehealth allowances made available during the COVID-19 pandemic.

Given the risks associated with fentanyl (i.e., the higher drug potency increases opioid tolerance and risk of overdose death), these changes allow for easier access to methadone treatment and enable providers to use their clinical judgment in determining the most appropriate treatment path for patients. Taking these updated regulations one step further, in 2023, Congress introduced the Modernizing Opioid Treatment Access Act (MOTAA), a bipartisan bill that would enable states to expand dispensing options for methadone and allow board-certified addiction medicine physicians to prescribe methadone outside of an OTP. New federal regulations and MOTAA highlight the need for states to develop comprehensive strategies that address provider shortages, prescribing practices, and pharmacy policies to ensure equitable access to methadone. States should consider the following health workforce factors that may impact the effectiveness of new flexibilities.

Many states still experience addiction medicine provider shortages. It will be critical for these states to prioritize strategies to expand their workforce and treatment infrastructure to increase the number of addiction medicine providers.
As it currently stands, advanced practice practitioners such as nurse practitioners and physician assistants cannot prescribe methadone (but they can prescribe buprenorphine). States could go one step further than MOTAA and allow these clinicians to prescribe methadone, creating a larger pool of available prescribing providers.
Depending on the state, pharmacies may refuse to carry a specific medication, and pharmacists hold varying degrees of autonomy to reject and not fill a prescription. States can consider establishing pharmacy-focused policies that ensure equal access to methadone and all MOUD.

The dynamic nature of the opioid crisis demands a sustained commitment to policy evaluation and innovation to prevent loss of life and promote recovery for individuals grappling with this disease. The regulatory and legislative changes are important steps forward. However, their efficacy will be measured by how states translate and adopt these policies into practice. We will continue to monitor the impact of changes at the federal level and assess states’ ability to build a robust continuum of care. If you are interested in learning more about our services and approaches related to opioid policy and equitable access to substance use treatment, please contact Aurrera Health Managing Principal Kelly Murphy.