SAMSHA Releases Final Rule on Opioid Use Disorder Treatment following Proposed COVID-19 PHE Telehealth Rollbacks
Health Policy News has been closely covering the both Drug Enforcement Administration (DEA)’s plans to roll-back PHE flexibility related to pre-pandemic restrictions on several prescribing practices, and the Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule that, if promulgated, would permanently permit Opioid Treatment Program (OTP) providers to prescribe treatment via telehealth in certain circumstances and extend methadone take-home dose flexibility, among other changes. Both rules were previously proposed in anticipation of the COVID-19 federal Public Health Emergency (PHE) ending on May 11th, 2023.
Following a public comment period that received a record 38,000 public comments, both SAMHSA and the DEA issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” On January 31st, 2024, SAMHSA issued a final rule updating certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. In this article, we outline the highlights of the final rule and its potential impacts on individuals seeking services for Opioid Use Disorder (OUD).
Reducing Barriers to Treatment for OUD
The final rule removed all language pertaining to the DATA waiver requirement, or “X-waiver,” which was previously required for all providers prescribing medication for opioid use disorder (MOUD) and was eliminated in 2022 with President Biden’s signing of the Consolidated Appropriations Act of 2023. The removal of the DATA waiver significantly expands the pool of providers available to prescribe MOUD medications and allows for these services to be more widely available. With the DATA waiver requirement removed, SAMHSA added additional language on required staff credentials. Every individual involved in the treatment of OUD should possess adequate education, training, licensure, and practical experience, either individually or in combination, to effectively fulfill their responsibilities.
The proposed rule by SAMHSA also aims to amend admission criteria for OTPs to better align with evidence-based standards. Under the new rule, individuals with a moderate to severe OUD diagnosis, including those in remission or at high risk for recurrence or overdose, will be eligible for treatment. Importantly, the requirement for a one-year history of OUD has been removed for specific populations, including individuals recently released from correctional settings, pregnant patients, and those previously enrolled in treatment programs. By loosening admission criteria and incorporating evidence-based practices, SAMHSA seeks to enhance access to OUD treatment and support more individuals in need of care, particularly for vulnerable populations or those at heightened risk of overdose. The changes in admission requirements could represent a significant step towards ensuring that OUD treatment programs are responsive to the diverse needs of individuals affected by opioid addiction.
Additionally, the rule permits screening and full examinations via telehealth for patients admitted for treatment with buprenorphine or methadone, provided that an adequate evaluation can be conducted. Public comments overwhelmingly supported maintaining telehealth changes implemented during the COVID-19 PHE, citing their success in reducing barriers to treatment access and engaging communities impacted by OUD, especially in rural areas. Strengthening telehealth services was attributed to reducing stigma by offering more convenient and comfortable access to care. When conducting telehealth evaluations for patients requiring treatment with schedule II medications, such as Methadone, audio-visual platforms are mandated, with audio-only devices permitted only if audio-visual options are unavailable, and in the presence of a licensed practitioner registered to prescribe controlled medications. The practitioner must review examination results and prescribe treatment accordingly. For patients needing treatment with schedule III medications like Buprenorphine or non-controlled medications such as Naltrexone, both audio-visual and audio-only platforms are acceptable for evaluations, with the practitioner similarly responsible for reviewing examination findings and prescribing treatment accordingly.
Destigmatizing OUD
The new SAMHSA final rule represents a significant step forward in reducing stigma for individuals seeking services for OUD. By amending admission criteria and permitting telehealth evaluations for OUD treatment, the rule aims to make treatment more accessible and convenient. In addition to these fundamental changes, the rule also removes antiquated and stigmatizing language, such as replacing “Medication-Assisted Treatment (MAT)” with “Medications for Opioid Use Disorder (MOUD).” This change reflects a shift towards more person-centered and empowering language, which can help individuals feel more comfortable seeking treatment without fear of judgment or stigma. Additionally, the rule includes updated definitions for terms such as “Care Plan,” “Harm Reduction,” “Recovery Support Services,” “Split Dosing,” and “Withdrawal Management,” which provide clearer and more inclusive frameworks for OUD treatment and represent an understanding of the many paths to care within the substance use treatment continuum.
Centering the Health and Wellbeing of People Who Use Drugs (PWUD)
Several updates in the final rule signify a shift towards prioritizing the health-related social needs (HRSNs) of people who use drugs and creating opportunities to allow more harm reduction principles to be integrated in outreach and treatment options. These include:
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- Required Services: Opioid Treatment Programs (OTPs) are required to offer comprehensive services, including medical, counseling, vocational, educational, and other screenings and treatments, tailored to each patient’s needs. This customization is based on individualized assessments and care plans developed through shared decision-making between patients and the clinical team.
- Initial and Period Assessments: Assessments are now required to include social determinants of health (SDOH), community and recovery supports, and available harm reduction resources.
- Drug testing supplies, such as Fentanyl Test Strips (FTS) are no longer prohibited. In 2021 during the COVID-19 PHE, the CDC and SAMHSA allowed the use of federal funding for the purchasing of FTS.
- Take-home Methadone Doses: The final rule solidifies the flexibilities initially introduced by SAMHSA in March and April 2020, making them permanent features. Among these changes is the endorsement of take-home doses of methadone upon entry into treatment, including 7 days of take-home doses during first 14 days of treatment, 14 take-home does from 15 days of treatment, and up to 28 take-home doses from 31 days in treatment. Unlike previous criteria, which mandated lengthy treatment periods and relied heavily on toxicology testing results, the revised guidelines afford treating practitioners’ greater discretion in determining take-home dose eligibility. This shift acknowledges the significance of the practitioner-patient relationship and aligns with evidence-based treatment principles emphasizing shared decision-making and individualized, person-centered care.
