New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. As reported by the Associated Press on Sept. 20, 2024 ("US will let more people take methadone at home"):
"For decades, strict rules required most methadone patients to line up at special clinics every morning to sip their daily dose of the liquid medicine while being watched. The rules, built on distrust of people in the grip of opioid addiction, were meant to prevent overdoses and diversion — the illicit selling or sharing of methadone.
"The COVID-19 pandemic changed the risk calculation. To prevent the spread of the coronavirus at crowded clinics, emergency rules allowed patients to take methadone unsupervised at home.
"Research showed the looser practice was safe. Overdose deaths and drug diversion didn’t increase. And people stayed in treatment longer.
"With evidence mounting, the U.S. government made the changes permanent early this year. Oct. 2 is the date when clinics must comply with the new rules — unless they’re in a state with more restrictive regulations."
According to the notice published in the Federal Register on Feb. 2, 2024, "Medications for the Treatment of Opioid Use Disorder":
"The final rule draws on experience from the COVID-19 Public Health Emergency (PHE), as well as more than 20 years of practice-based research. The COVID-19 PHE necessitated changes to policy guidance and legal exemptions to protect the public's health, promote physical distancing and to preserve patient and OTP staff safety. In March 2020, SAMHSA published guidance regarding flexibilities that could be leveraged in the provision of unsupervised doses of methadone and the use of telehealth when initiating buprenorphine.[7] These flexibilities represented the first substantial change to OTP treatment and medication delivery standards in more than 20 years, and their role in facilitating access to treatment is supported by research.
"This final rule not only makes these COVID-19-related flexibilities permanent, but also updates standards to reflect an accreditation and treatment environment that has evolved since part 8 went into effect in 2001. Accordingly, the Department is updating part 8 to promote practitioner autonomy; remove discriminatory or outdated language; create a patient-centered perspective; and reduce barriers to receiving care. These elements have been identified in the literature and in feedback as being essential to promoting effective treatment in OTPs.[8 9 10]
"To this end, the definition of a practitioner has been modified to refer to a provider who is appropriately licensed by the State to prescribe (including dispense) medications. Admission criteria have been updated, as required by section 1252(b) of the `Consolidated Appropriations Act, 2023', to remove significant barriers to entry, such as the one-year requirement for opioid use disorder (OUD),[11] while also defining the scope and purpose of the `initial' and `periodic' medical examinations. The final rule also includes new definitions to expand access to evidence-based practices such as split dosing, telehealth and harm reduction activities. In addition, outdated terms such as `detoxification' have been revised to remove stigmatizing language.
"The Department promotes practitioner autonomy and individualized care by finalizing the provision containing the criteria for unsupervised doses of methadone. This includes removal from sole consideration the length of time an individual has been in treatment and requirements for rigid reliance on toxicology testing results that demonstrate complete and sustained abstinence from all substances prone to misuse. Based on the clinical judgment of the treating provider, patients may be eligible for unsupervised, take-home doses of methadone upon entry into treatment. This change recognizes the importance of the practitioner-patient relationship and is consistent with modern substance use disorder treatment standards.[12] It also allows for greater flexibility in creating plans of care that promote recovery activities such as employment or education, while also eliminating the barrier of frequent OTP visits for individuals without access to reliable transportation.[13]"
