Medications for the Treatment of Opioid Use Disorder

Scope.

This provision defines the scope of regulations for Opioid Treatment Programs, including certification, accreditation, and standards for dispensing medications for opioid use disorder.

Opioid Treatment Program certification.

This provision establishes the federal certification requirements, application procedures, and operational standards for Opioid Treatment Programs (OTPs) to dispense medications for opioid use disorder.

Federal Opioid Use Disorder treatment standards.

This provision establishes comprehensive operational, clinical, and quality standards for Opioid Treatment Programs, including requirements for patient assessment, medication management, counseling, and recordkeeping.

Revocation of accreditation and Accreditation Body approval.

This provision outlines the Secretary's authority to investigate and take action, including revocation of certification, following the revocation of an Opioid Treatment Program's accreditation.

Suspension or revocation of certification.

This provision details the grounds and procedures for the Secretary to suspend or revoke the certification of an Opioid Treatment Program.

Forms.

This provision identifies the specific application forms required for certification to use medications for opioid use disorder and for becoming an accreditation body.

;8.2 Definitions.

The following definitions apply to this part:

Applicability.

This provision defines the circumstances under which the administrative review procedures for suspension or revocation of certification apply.

Definitions.

This provision provides definitions for key terms used in the administrative review subpart, including appellant, respondent, and reviewing official.

Limitation on issues subject to review.

This provision restricts the scope of informal reviews to facts, interpretations, and laws relevant to the specific adverse action taken.

Specifying who represents the parties.

This provision requires parties to specify their legal or authorized representatives in the administrative review process.

Informal review and the reviewing official's response.

This provision outlines the timeline and requirements for submitting a request for informal review of an adverse certification action.

Preparation of the review file and written arguments.

This provision details the procedures for developing the review file, submitting written briefs, and handling discovery during the administrative review process.

Opportunity for oral presentation.

This provision establishes the procedures for requesting and conducting an oral presentation during the administrative review process.

Expedited procedures for review of immediate suspension.

This provision outlines the expedited review process for Opioid Treatment Programs (OTPs) facing immediate suspension of their certification.

Ex parte communications.

This provision prohibits unauthorized ex parte communications between parties and officials during informal review proceedings to ensure equity.

Application for approval as an Accreditation Body.

This provision defines the eligibility and application procedures for organizations seeking approval to serve as an Accreditation Body for Opioid Treatment Programs.

Transmission of written communications by reviewing official and calculation of deadlines.

This provision establishes standards for the transmission of official communications and the methodology for calculating deadlines in administrative review proceedings.

Authority and responsibilities of the reviewing official.

This provision outlines the powers and duties of the reviewing and presiding officials during administrative hearings for OTP certification.

Administrative record.

This provision defines the components that constitute the administrative record for review proceedings.

Written decision.

This provision specifies the requirements for issuing written decisions in administrative review proceedings and the subsequent notification requirements.

Court review of final administrative action; exhaustion of administrative remedies.

This provision mandates the exhaustion of administrative remedies before seeking judicial review of certification-related adverse actions.

Accreditation Body responsibilities.

This provision outlines the operational, reporting, and recordkeeping requirements for accreditation bodies overseeing opioid treatment programs.

Periodic evaluation of Accreditation Bodies.

The Secretary will periodically evaluate accreditation bodies by inspecting accredited opioid treatment programs and reviewing survey reports to ensure compliance.

Withdrawal of approval of Accreditation Bodies.

This provision establishes the procedures and consequences for the Secretary's withdrawal of approval for accreditation bodies due to major or minor deficiencies.