Opioid treatment programs (OTPs) are licensed by the Department of Health (DOH) and use medications for opioid use disorder (OUD) that are approved by the U.S. Food and Drug Administration in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to individuals diagnosed with OUD.
- Medications to treat opioid use disorder (OUD)
There are three medications approved by the Food and Drug Administration to treat OUD.
- OTP Licensing and Accreditation
OTPs are clinics licensed by the Department of Health and federally accredited to provide medication-assisted treatment (MAT) services.
- Find an OTP
- Critical Incident and OTP Death Reporting
Critical Incident Reporting Requirements. Includes instructions and forms to report critical incidents as well as deaths of individuals enrolled in an OTP.
- Change of Program Sponsor or Medical Director
Under WAC 246-341-1000(7), “an agency providing opioid treatment program services must ensure that notification to the federal Substance Abuse and Mental Health Services Administration (SAMHSA) and the department is made within three weeks of any replacement or other change in the status of the program, program sponsor as defined in 42 C.F.R. Part 8, or medical director.
Notification of changes must be sent by the OTP Program administrator to DOH HSQA Facilities Credentialing with a "cc" to the Facilities Program Manager (email@example.com).
Include the following information in your notification:
- A brief description of the change, including the agency credential number along with the name, title, phone, and email of the new program sponsor or medical director.
- Notification for change of medical director must also include their Washington State medical license number.
SAMHSA notification – instructions on how to notify SAMHSA are online.
- Change of Program Administrator
Within 30 days of the administrator’s appointment, send a completed “Administrator Change Notification Form” (PDF) and the criminal background check results by the WA State Patrol completed within the previous three months of the application date to:
Department of Health
Behavioral Health Agencies
P.O. Box 47877
Olympia, WA 98504-7877
- File a Complaint
Anyone may submit a report to the department of an alleged violation of licensing and certification laws and rules.
- Laws and Regulations
Washington state regulations
- Chapter 246-341 WAC – Behavioral Health Agency Licensing and Certification Requirements.
- WAC 246-341-1000 – OTP - General
- WAC 246-341-1005 – OTP – Agency certification requirements
- WAC 246-341-1010 – OTP – Agency staff requirements
- WAC 246-341-1015 – OTP – Clinical record content and documentation requirements
- WAC 246-341-1020 – OTP – Medical director responsibility
- WAC 246-341-1025 – OTP – Medication management
Washington state laws
- RCW 71.24.560 – Opioid Treatment Programs – Pregnant Individuals – Information and education.
- RCW 71.24.585 – Opioid and substance use disorder treatment – State response.
- RCW 71.24.587 – Opioid use disorder treatment – Possession or use of lawfully prescribed medication – Declaration by state.
- RCW 71.24.589 – Substance use disorders – Law enforcement assisted diversion – Pilot project.
- RCW 71.24.590 – Opioid treatment – Program licensing or certification by department, department duties – Use of medications by program – Definition.
- RCW 71.24.593 – Opioid use disorder treatment – Care of individuals and their newborns – Authority recommendations required.
- RCW 71.24.594 – Opioid overdose reversal medications – Education – Distribution – Labeling – Liability (Effective January 1, 2022).
- RCW 71.24.595 – Statewide treatment and operating standards for opioid treatment programs – Evaluation and report.
- RCW 71.24.597 – Opioid overdose reversal medication – Coordinated purchasing and distribution.
- DOH released an Interpretive Statement (PDF) regarding the annual medical exam required in WAC 246-341-1020 (12) to allow Opioid Treatment Program (OTP) physicians to conduct the exam either in person or via telehealth technologies. The initial medical exam cited in 42 CFR 8.12(f)(2) is still required to be completed in-person. The department will revise Chapter 246-341 WAC to allow the use of telehealth for annual medical exams.
Federal regulations and guidance
- 42 CFR Part 8 – Medication Assisted Treatment for Opioid Use Disorders
- 21 CFR – Food and Drugs - Drug Enforcement Administration – Mobile Units
- Federal Guidelines for Opioid Treatment Programs – SAMHSA
- SAMHSA OTP Guidance Documents
Questions about OTP licensing and certification regulations
Michelle Weatherly (firstname.lastname@example.org)
Facilities program manager
Questions about the drug other controlled substance registration:
Questions about application status:
Questions about the DEA approval process: