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HB 681

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2025 Regular Session Introduced by Gabriel Acevero and 12 co-sponsors

NC to rewrite OTP rules to align with federal 42 CFR Part 8, boosting patient-centered care: more take-home doses, fewer tests/counseling, cross-OTP dosing with verification.

Approved by the Governor - Chapter 578
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Bill Summary · HB 681

Summary — HB 681: Update Opioid Treatment Program Rules

Status: Committee substitute adopted (Amend Adopted A1); third edition engrossed 5/7/2025
Introduced: 2024-11-12
Primary sponsors (NC): Representatives Crawford, Reeder, Chesser
Subject areas: Mental health, substance use treatment regulations, controlled substances, administrative rules

Purpose

Direct the Commission for Mental Health, Developmental Disabilities, and Substance Use Services (the Commission) to amend the State rules governing outpatient opioid treatment programs (OTPs) — specifically 10A NCAC 27G .3600–.3605 — so those rules are more consistent with federal OTP regulations (42 C.F.R. Part 8). The goal is to increase alignment with federal standards and improve access to patient-centered medication treatment for opioid use disorder (OUD).

Key provisions

  • Require the Commission to amend OTP rules in 10A NCAC 27G .3600–.3605 to align with 42 C.F.R. Part 8.
  • Minimum changes the Commission must adopt (as revised in the committee substitute):
    • Remove "stability of a patient's home environment and social relationships" as an eligibility criterion for take‑home medication.
    • Require the State Opioid Treatment Authority (SOTA) to review facility discharge policies related to continued substance use, missed doses, and nonparticipation in ancillary services (rather than an outright prohibition of administrative discharge).
    • Remove structured/mandatory counseling schedules to allow more individualized, patient‑centered counseling approaches.
    • Reduce the number and frequency of required drug tests to align with federal requirements.
    • Explicitly permit OTPs to administer methadone to patients who are not enrolled at that OTP provided the patient can be verified as a current patient at another OTP (e.g., via contact with the home OTP, a central registry, or other Commission‑established methods).
  • Stakeholder engagement: the Commission must seek input from current and former OTP clients and OTP providers when considering additional changes, but may not adopt any changes inconsistent with state or federal law.
  • Publication timeline: the Commission must publish the proposed text of the amended OTP rules by January 1, 2026 (deadline in the adopted version).
  • Effective date: the act becomes effective when it becomes law.

Who is affected

  • Patients with opioid use disorder who receive medications for OUD (methadone, etc.) — potential for expanded take‑home access and reduced barriers to care.
  • Outpatient opioid treatment programs (OTPs) and their staff — will need to revise policies and operations to reflect amended rules and verification procedures for cross‑OTP dosing.
  • State Opioid Treatment Authority (SOTA) and the Commission — responsible for reviewing discharge policies, convening stakeholder input, and completing rule amendments.
  • Regulators and payers may be indirectly affected by changes in service delivery and monitoring.

Timeline & procedural notes

  • Directive to the Commission to amend administrative rules; proposed rule text must be published by Jan 1, 2026 (as adopted).
  • Changes are regulatory: the Commission will engage in rulemaking under existing authority; final rule adoption will follow the State Administrative Procedure Act processes.
  • Alignment with 42 C.F.R. Part 8 is a stated legislative objective; any state rule must still comply with federal law.

Potential impacts and considerations

  • Likely benefits: increased treatment flexibility and access (more take‑home dosing; fewer mandatory counseling visits/tests), improved retention in care, more patient‑centered approaches.
  • Potential risks: concerns about diversion or safety associated with broader take‑home privileges and less frequent testing; these risks are typically managed by OTP clinical protocols and federal oversight.
  • Implementation will hinge on rule text, verification systems (e.g., central registry), and how SOTA and OTPs operationalize discharge policy reviews and monitoring.

This bill directs a targeted regulatory update intended to modernize North Carolina OTP rules to reflect federal standards and to promote more individualized, accessible OUD medication treatment.

Compiled from official sources — confirm details with the bill’s official record.

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