In a significant shift, the first major update to U.S. methadone regulations in 20 years will expand access to the life-saving addiction treatment starting next month, including in Alabama. While the new federal guidelines aim to simplify and increase access to methadone, experts warn that the changes may not reach their full potential unless state governments and clinics adjust accordingly.
Previously, methadone patients were required to visit specialized clinics daily to receive their doses under supervision, a policy based on concerns about potential overdoses and diversion — the illegal sharing or selling of methadone. However, during the COVID-19 pandemic, emergency measures allowed patients to take methadone home unsupervised. The results were promising: research found that overdose rates and drug diversion did not increase, and patient retention in treatment improved.
This evidence prompted the U.S. government to make these pandemic-era changes permanent earlier this year, with an October 2 deadline for clinic compliance. States like Alabama, where around 7,000 people rely on methadone for opioid use disorder, are expected to align with the new federal rules, according to Nicole Walden, a state official overseeing substance use services. “People don’t have to show up every day to get a medication that can help save their lives,” said Walden, highlighting the shift in attitudes toward methadone treatment.
Methadone: A Lifesaving Opioid
Methadone is an opioid itself, capable of quelling drug cravings without inducing a high. When administered correctly, it reduces the risk of overdose and transmission of diseases like hepatitis C and HIV. However, due to its potency, methadone is strictly regulated and can only be dispensed at one of the nation’s 2,100 specialized clinics, which serve nearly 500,000 patients daily.
Under the new rules, patients who are stable in their recovery can now take home up to 28 days’ worth of methadone. States such as Colorado, New York, and Massachusetts are already working to update their regulations to reflect the federal guidelines, while others, like West Virginia and Tennessee, are lagging.
In Arizona, Medicaid payments currently favor in-person dosing, paying clinics $15 per in-person dose compared to $4 for take-home doses. The state is exploring options to equalize these payments or move to a “bundled payment” model, where treatment costs are reflected as a whole. New York has already adopted this model, removing financial incentives for in-person dosing.
A Push to ‘Liberate Methadone’
The current methadone clinic system has been in place since 1974, when overdose deaths were relatively low. With annual overdose deaths now exceeding 107,000, there is growing support for broader access to methadone. Advocates, including some longtime patients, are pushing for legislation that would allow addiction specialists to prescribe methadone, and pharmacies to fill those prescriptions.
While the new federal rules don’t go that far, they do include several key changes:
- Patients will no longer need to prove a one-year history of opioid addiction before starting methadone treatment in states that adopt the new rules.
- Mandatory counseling will be optional for some patients.
- Telehealth can be used for patient assessments, which could improve access in rural areas.
- Nurse practitioners and physician assistants will be authorized to initiate methadone treatment, expanding care provider availability.
However, not all states are adopting these changes. Tennessee, for instance, is drafting new rules that are more restrictive than the federal guidelines. These include mandatory counseling, increased random drug screenings, and a requirement for clinics to hire pharmacists to oversee take-home doses.
Implementation Challenges Ahead
Even in states that adopt the new federal rules, methadone clinics face significant challenges. Some clinic leaders may resist the changes, especially if they disagree with the shift toward a more patient-centered approach. Additionally, the legal risks associated with allowing patients to take methadone at home could deter some clinics from fully embracing the new rules.
As the October 2 deadline approaches, the success of this long-overdue reform will depend on how well clinics and state governments adapt to the updated regulations and the needs of patients.