The HHS and SAMHSA have permanently implemented the flexibilities in OUD treatment introduced during COVID-19 to increase patient access to care.
In its final rule, the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS) is permanently implementing the changes and flexibilities put forth during the COVID-19 pandemic to remove burdens for Opioid Treatment Programs (OTPs) and providers in treating patients with opioid use disorder (OUD). The effective date of this final rule is April 2, 2024 and compliance begins October 2, 2024.
The prior HHS standards limited administration and dispensing of methadone for unsupervised or at-home use. In addition, the criteria for determining patient eligibility for take-home doses were restrictive and required patients to visit the OTP daily to receive medication and demonstrate sustained stability. According to the SAMHSA, these standards “can pose disruption to employment, education and other daily activities for patients, and several of the criteria reflect outdated biases that promote stigma and discourage people from engaging in care in OTPs.”
However, in response to the COVID-19 pandemic, SAMHSA issued exemptions to the take-home methadone restrictions in March 2020. These changes allowed OTPs to dispense up to 28 days of unsupervised methadone doses for “stable” patients and 14 days of doses for “less stable” patients. Given the widespread support for these exemptions, the HHS has now permanently adopted these changes. “By reducing the burden on patients to visit the OTP daily, this flexibility may reduce stigma for those seeking treatment, while also providing more equitable access to care as telemedicine in OTPs is expanded,” report authors stated.
Along those lines, the HHS is also amending its standards to allow providers to prescribe controlled medications to treat OUD via telehealth without requiring an initial in-person physical evaluation of the patient. While buprenorphine may be prescribed using audio-only telehealth, SAMHSA still requires audio-visual telehealth for methadone prescriptions given the higher risk profile for sedation in patients presenting with mild somnolence.
Furthermore, the HHS is amending its OTP admission criteria to include patients diagnosed with OUD less than 1 year and expanding the definition of “treatment practitioner” to encompass any provider who is appropriately licensed to dispense and/or prescribe approved medications for the treatment of OUD.
Previously, the Controlled Substances Act (CSA) required practitioners to obtain a waiver to prescribe certain schedule III and V medications for the treatment of OUD. This waiver limited the number of patients (up to 275) the provider could treat with this type of medication. However, the HHS has now removed language that references or implicates the DATA waiver process/requirements for medications for the treatment of OUD.
This final rule was based on practice-based research and draws upon the successful policy flexibilities introduced during the COVID-19 pandemic for the treatment of OUD. These changes represent the first substantial updates to OTP treatment and medication delivery criteria in over 20 years. The report’s authors concluded, “The final rule, therefore, supports OTPs in their on-going provision of equitable and evidence-based care to often marginalized patients with OUD.”