0930-AA38 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0930 Substance Abuse and Mental Health Services Administration SAMHSA 0900 Department of Health and Human Services HHS Treatment of Opioid Use Disorder With Buprenorphine Utilizing Telehealth

In the face of an escalating overdose crisis and an increasing need to reach remote and underserved communities, extending the buprenorphine telehealth flexibility is of paramount importance. To permanently continue this flexibility among OTPs after the COVID-19 public health emergency ends, SAMHSA proposes to revise OTP regulations under 42 CFR part 8.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Yes No 42 CFR 8.11 (h) The Controlled Substances Act, as amended by the Ryan Haight Act (21 U.S.C. sec. 802(54)(G)) Yes

This change will help facilitate access to Medications for Opioid Use Disorder (MOUD) in SAMHSA-regulated opioid treatment programs (https://www.samhsa.gov/medication-assisted-treatment/become-accredited-opioid-treatment-program). Research details that many patients are unable to regularly access OTPs due to unreliable transportation, geographic disparity, employment or required activities of daily living. Providing buprenorphine via telehealth will allow more patients to receive comprehensive treatment.

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To be determined.

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In the absence of congressional action, rulemaking is required.

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This change will help facilitate access to and ensure continuity of medication treatment for opioid use disorder in SAMHSA-regulated opioid treatment programs. The change will likely reduce long-term costs at the practice level, while also facilitating access to treatment. However, a minority of providers may face upfront technology costs as they scale-up the provision of treatment via telehealth. We expect that since many providers have now shifted in part to telehealth services during the COVID-19 Public Health Emergency, their costs should now be related to equipment upgrades and software updates. The cost to patients would involve either use of Wi-Fi, data usage with their respective cellular devices or landline telephone service. We expect that many patients already have acquired some of these services, so the cost would be monthly maintenance of such services.

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Patients seeking this care might still be required to have an in person visit, as specified by their provider’s plan of care, so to receive comprehensive treatment. Without this provision, there is risk of patients receiving a lower standard of care and increased risk of diversion of the prescribed medications.

]]> NPRM 09/00/2022 No Businesses None No No No No Neeraj Gandotra Dr. Chief Medical Officer 0930 Substance Abuse and Mental Health Services Administration SAMHSA 202 823-1816 neeraj.gandotra@samhsa.hhs.gov 5600 Fishers Lane, 18E67, Rockville MD 20857