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HHS/SAMHSA RIN: 0930-AA39 Publication ID: Fall 2022 
Title: Medications for the Treatment of Opioid Use Disorder 

The Substance Abuse and Mental Health Services Administration (SAMHSA) will revise 42 CFR part 8 to make permanent some regulatory flexibilities for Opioid Treatment Programs (OTPs) granted under the COVID-19 Public Health Emergency (PHE), and to expand access to care for people with Opioid Use Disorder (OUD). Specifically, SAMHSA will propose making permanent those flexibilities pertaining to unsupervised doses of methadone and also initiation of buprenorphine via telemedicine. To expand access to care, SAMHSA will also review admission criteria, particularly rules that may limit timely access to treatment in an OTP. To achieve this, sections of 42 CFR part 8 will require updating. SAMHSA’s changes will impact roughly 1900 opioid treatment programs and state opioid treatment authorities.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 8   
Legal Authority: 21 U.S.C. sec. 823(g)(1)   
Legal Deadline:  None

Statement of Need:

These proposed changes will help facilitate access to Medications for Opioid Use Disorder (MOUD) in SAMHSA-regulated opioid treatment programs ( Research and stakeholder feedback indicate that flexibilities granted under the COVID-19 PHE have been well received by treatment programs and patients. There are very few reports of diversion or overdose, and the flexibilities have been shown to facilitate patient engagement in activities, such as employment, that support recovery. Moreover, those with limited access to transportation benefit from these flexibilities since they are not required to attend the OTP as frequently. In this way, making permanent the methadone extended take home flexibility and buprenorphine initiation via telehealth flexibility will facilitate treatment engagement. To further support this and to help surmount increasing mortality and morbidity due to the growing fentanyl-driven overdose crisis, it is necessary to review OTP admission criteria. This will further expand access to care.

Summary of the Legal Basis:

The current OTP flexibilities allow OTPs to operate in a manner that is otherwise inconsistent with existing OTP regulations, and therefore, a permanent extension of such exemptions would effectively revise the OTP regulations.  If such action is pursued without rulemaking, it could be interpreted as inconsistent with SAMHSA’s exemption authority under 42 CFR 8.11(h) and the Administrative Procedures Act, which requires agencies to go through notice and comment rulemaking before establishing legally binding rules.  Therefore, incorporating the OTP flexibilities at issue into 42 CFR part 8 through rulemaking is the optimal approach for making the OTP flexibilities permanent.


Congressional action; allowing the flexibilities to lapse.

Anticipated Costs and Benefits:

This change will help facilitate access to opioid use disorder treatment in SAMHSA-regulated OTPs. Programs have already incorporated COVID-19 flexibilities into practice and have systems in place that support their delivery in a cost effective, safe, and patient centered manner. This proposed rule is not expected to impart a cost to patients. In fact, the proposed rule allows patients to more readily engage in employment and necessary daily activities. This supports patient workforce participation, income generation, and also recovery. Further to this, expanded access will potentially limit the long-term effects of opioid misuse among those seeking rapid access to treatment.


Patients seeking extended take-home doses of methadone or who have been reviewed via telehealth for initiation of buprenorphine should still be required to have an in-person visit at the OTP at intermittent intervals. Without this provision, there is risk of patients receiving a lower standard of care and increased risk of diversion of medications.

Action Date FR Cite
NPRM  12/00/2022 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
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