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HHS/SAMHSA RIN: 0930-AA38 Publication ID: Fall 2021 
Title: ●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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 8.11 (h)   
Legal Authority: The Controlled Substances Act, as amended by the Ryan Haight Act (21 U.S.C. sec. 802(54)(G))   
Legal Deadline:  None

Statement of Need:

This change will help facilitate access to Medications for Opioid Use Disorder (MOUD) in SAMHSA-regulated opioid treatment programs ( 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.

Summary of the Legal Basis:

To be determined.


In the absence of congressional action, rulemaking is required.

Anticipated Costs and Benefits:

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.


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.

Action Date FR Cite
NPRM  09/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. Neeraj Gandotra
Chief Medical Officer
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, 18E67,
Rockville, MD 20857
Phone:202 823-1816