DHHS and SAMHSA Announce New Methadone Rules
Overview
Originally Published: 02/07/2024
Post Date: 02/07/2024
by DHHS
Attachment Files
Federal Register - New Methadone Rules
Summary/Abstract
DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 42 CFR Part 8 RIN 0930-AA39. New Methadone Rules.
Content
The new SAMHSA Methadone rules have been finalized. The effective date of this final rule is April 2, 2024, and the compliance date is April 2, 2026.
The new rule is significant and includes the following updates:
-Expands the definition of practitioner to include, NPs, PAs, and other practitioners.
- Allows for the use of telehealth.
- Eliminates stigmatizing language throughout.
- Eliminates the current criteria for admission where an individual must have had an addiction to opioids for at least one year and replaces it with admission criteria where the person meets diagnostic criteria for a moderate to severe OUD, the individual has an active moderate to severe OUD, or OUD in remission, or is at high risk for reoccurrence or overdose.
- Eliminates the requirement that individuals under 18 must have had two documented unsuccessful attempts at treatment within one year to be eligible for MOUD.
- The current requirement of a medical examination is separated into an initial screening and a comprehensive examination to allow for treatment to begin sooner.
- Screenings can be undertaken by non-OTP practitioners who work outside of the OTP and telehealth is permitted.
- Comprehensive examinations can be undertaken by non-OTP practitioners who work outside the OTP and telehealth is permitted.
- Telehealth screenings and full examinations for methadone must be audio-visual.
- Telehealth screenings and full examinations for buprenorphine can be audio-visual or audio only.
- Allows the physician/practitioner to exceed the initial maximum dose of 50 mg when their clinical judgment calls for a higher dose to control withdrawal. This recognizes the impact of fentanyl where higher doses may be appropriate.
- Take home methadone schedules are significantly increased as follows:
Up to 7 days of take home doses for the first 14 days in treatment,
Up to 14 days of take home doses from days 15 to 30,
Up to 28 days of take home doses after day 31.
- Allows medication units to be community pharmacies and allows them to offer take home methadone.
Incorporates harm reduction principles and recovery and peer support services into OTP treatment.
- Allows for split-dosing where such a regimen is indicated.
- Allows medical directors to delegate responsibilities to other practitioners.
- Patient refusal of counseling shall not preclude them from receiving MOUD.