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HHS/SAMHSA | RIN: 0930-AA39 | Publication ID: Spring 2023 |
Title: Medications for the Treatment of Opioid Use Disorder | |
Abstract:
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. In response to the Consolidated Appropriations Act of 2023, which removed the requirement to obtain a waiver in order to prescribe certain schedule III-V medications for the treatment of OUD, SAMHSA issued a supplemental notice of proposed rulemaking on Feb. 13, 2023, (88 FR 9221) calling for additional public comment on SAMHSA’s plans to remove reference to the Drug Addiction Treatment Act of 2000 ( DATA 2000-Waiver) from 42 CFR part 8. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final 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 |
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Timetable:
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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 Email: neeraj.gandotra@samhsa.hhs.gov |