New Rule Finalizes Flexibilities for Prescribing Medications for the Treatment of Opioid Use Disorder If Your Organization is an Accredited Opioid Treatment Programs (OTPs) and Your State Agrees.

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In its first meaningful update to opioid treatment standards in over 20 years, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) has published its final rule that modifies and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (“OUD”) with Medications for Opioid Use Disorder (“MOUD”) in OTPs. This includes making flexibilities put forth during the COVID–19 Public Health Emergency (“PHE”) permanent, as well as expanding access to care and evidence-based treatment for OUD. Highlights from this final rule include the following: 

  • Take-home Doses.  Based on the clinical judgment of the treating practitioner, patients may receive take-home doses upon entry into treatment.  
  • Telehealth. Expands telehealth services for people seeking care from OTPs. It makes permanent the ability of OTPs to initiate buprenorphine via telehealth, both audio-visual and audio-only, and adds initiation of treatment with methadone through audio-visual telehealth platforms.  
  • Qualifying Practitioner. The definition of a qualifying practitioner has been expanded to include a practitioner who is appropriately licensed by the state to prescribe (including dispense) covered medications in OTPs. 
  • Admission Criteria.  Updated to remove significant barriers to entry, while also defining the scope and purpose of the ‘initial’ and ‘periodic’ medical examinations. Specifically, the rule removed the requirement for one year of opioid addiction before admission to an OTP, in favor of consideration of a person’s problematic patterns of opioid use. It also removed the requirement that people under the age of 18 must have completed two unsuccessful episodes of treatment. 
  • Models of Care.  The final rule also includes new definitions to expand access to evidence-based practices such as split dosing, telehealth, and harm reduction activities, and it promotes the chronic disease model of management. Outdated terms such as “detoxification” have been revised to remove stigmatizing language. 
  • Plans of Care. The final rule allows for greater flexibility in creating plans of care that promote recovery activities such as employment, while also eliminating the barrier of frequent visits for individuals without access to reliable transportation.  

Our Take: We are excited about the changes SAMHSA has made for OTPs and believe they’re long overdue. But we’re not throwing confetti just yet. Whether these flexibilities will see the light of day may depend on your state’s laws. States may have or may promulgate regulations that are more restrictive than what this final rule allows. We recommend reaching out to your state health department supporting substance use treatment programs and confirm whether these flexibilities are consistent with local requirements.

The provisions of this final rule shall be effective beginning on April 2, 2024, and the compliance date is October 2, 2024For more information, check out SAMHSA’s FAQs and other resources on the regulatory changes. 



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