(109) Implementing Revised Methadone Treatment Regulations at NYS Opioid Treatment Programs

Background & Introduction: The ongoing opioid overdose crisis prompts an urgent need for improved opioid use disorder treatment delivery. Methadone decreases overdose death by more than 50%, in addition to improving other important clinical and social outcomes. Methadone treatment dosing schedules have been tightly regulated, limiting the potential of methadone’s effectiveness as opioid use disorder (OUD) treatment. In Mar. 2020, temporary regulatory exemptions were made allowing for opioid treatment programs (OTPs; where methadone treatment for OUD is provided) to provide a greater number of daily methadone doses to take at home than had previously been permitted.

In Feb. 2024, permanent revisions to the federal regulations were made. Revisions aimed to improve methadone effectiveness including through making the temporary changes to take home flexibilities permanent. Revisions also seek to allow OTPs to be more responsive to patient need. These sweeping, permanent revisions were informed by decades of high-quality efficacy and effectiveness data and from experience from the temporary regulation change. As the state agency that oversees and regulates the largest OTP network in the US, we surveyed New York State (NYS) OTPs to assess progress towards full implementation of the revised federal regulations.

Methods: In Oct. 2024, electronic surveys were distributed via email to all NYS OTP directors (administrative and/or clinical) by the State Opioid Treatment Authority (SOTA) team at the NYS Office of Addiction Services and Supports (OASAS). The SOTA team, led by a primary care physician with decades of experience in at the intersection of harm reduction and OUD treatment, oversees OTP compliance to federal and state methadone treatment regulations in NYS. Survey questions included perceptions of OTP administrative and clinical leadership regarding the degree to which their affiliated OTPs had implemented revised federal regulations as of Sept. 2024. Questions also sought to understand barriers related to implementation in order to identify how best NYS could support OTPs to align their clinical care and programing with revised federal regulations. We also included a question on OTP willingness to serve as mentors to OTPs that may be facing implementation barriers. Descriptive statistics are presented.

Results: The survey response proportion was 84.1% (n, 90 [total n, 107 OTPs]) of which 76.7% (n, 69 [total n, 90 OTPs reporting]) were completed by a healthcare administrator (e.g., Program Director). Among OTPs reporting, 77.8% (n, 70) reported that they had implemented revised regulations whereas 18.8% (n, 17) and 3.3% (n, 3) reported having partially implemented or not having implemented revised regulations, respectively. The most frequently cited initial regulation changes implemented were providing take home dose flexibilities that are clinically based and considered at treatment initiation (96.6%, n, 84 [of 87]) and not requiring complete abstinence for take home dose flexibilities (98.9%, n, 86 [of 87]). The most frequently cited reasons for challenges to implementation were provider disagreements with specific aspects of the revisions (45.6%, n, 41 [of 90]), workforce shortages (28.6%, n, 26 [of 90]), and difficulty in understanding revisions (16.7%, n, 15 [of 90]). Among OTPs that reported having fully implemented revised regulations, 35.7% (n, 25 [of 70]) stated willingness to serve as an OTP mentor to an OTP that had not yet fully implemented the revised regulations.

Conclusion & Discussion: Federal methadone regulation changes represent a sustainable and unprecedented opportunity transform methadone treatment delivery and to improve access, utilization, retention, and outcomes for those with OUD. Understanding the degree to which OTPs adapted to initial revised regulations is important to guide efforts to support programs to leverage regulatory and financing changes to expand flexible methadone dosing. The majority of OTPs in NYS reported implementing the revised federal methadone regulations in Sept. 2024. Willingness among OTPs that have implemented regulations to serve as mentors to OTPs that had not yet fully implemented revised regulations suggests the potential for collaborative capacity building within the OTP network to facilitate statewide methadone treatment change. It is essential for state agencies overseeing SUD treatment to support OTPs support to leverage this opportunity, which will improve access, engagement, and retention in methadone treatment, and ultimately reduce overdose deaths.

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