1. (1) Definitions of general terms used in these rules can be found in Rules Chapter 0940-05-01.

2. (2) Definitions specific to this chapter are as follows:

   1. (a) “Opioid Treatment Program (OTP)” or “Alcohol & Drug Non-Residential Opioid Treatment Program” (also may be referred to herein as “Facility” or “Program,” previously referred to as “Non-Residential Substitution-Based Treatment Center for Opiate Addiction”) includes, but is not limited to, standalone clinics offering methadone, products containing buprenorphine, or products containing any other formulation approved by the FDA for detoxification and maintenance treatment of opioid use disorder by preventing symptoms of withdrawal, with the goal of the service recipient becoming free from any drug which is not medically indicated.
   2. (b) “Advanced Practice Nurse” means a person qualified by the Tennessee Board of Nursing under Rules Division 1000-04 as an advanced practice nurse with a certificate of fitness with privileges to write and sign prescriptions and/or issue legend drugs. Advanced practice nurses may perform any and all functions allowed by current federal and state laws and regulations within this practice setting and within their scope of allowed professional licensure.
   3. (c) “Buprenorphine” means a partial opioid agonist used as an analgesic and as a medication treatment in the management of opioid use disorder. It has been approved by the FDA for maintenance treatment of opioid use disorder.
   4. (d) “Central Registry” means an electronic system used to register service recipients currently receiving medication-assisted treatment at an OTP. The Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS or department) or State Opioid Treatment Authority (SOTA) may require Facilities to initiate a clearance inquiry and service recipient registration into an approved central OPIOID TREATMENT PROGRAM FACILITIES registry for the purpose of gathering Facility information, evaluating treatment outcomes, collecting demographic information, and preventing simultaneous enrollment in other Facilities.
   5. (e) “Coordination of Care” means the process of coordinating care, treatment, or services provided by an organization, including referral to appropriate community resources and liaison with others involved in care, treatment, or services (for example, with an individual’s physician, primary care provider, or another healthcare organization or agency) to meet the ongoing identified needs of the individual served, to ensure implementation of the plan of care, treatment, or services, and to avoid unnecessary duplication of services. The aim is to facilitate the appropriate and efficient delivery of healthcare services both within and across systems.
   6. (f) “Counseling Session” means a therapeutic discussion between service recipient(s) and a Facility counselor for a period of no less than thirty (30) minutes designated to address a service recipient’s opioid use disorder, coping strategies, and Individualized Treatment Plans. Therapeutic discussions may be delivered across different platforms but must be in compliance with all applicable state and federal regulations.
   7. (g) “DEA” means the United States Drug Enforcement Administration.
   8. (h) “Detoxification” or “Short-Term Withdrawal Management” means the dispensing of treatment medication in decreasing doses to the service recipient to alleviate adverse physical or psychological effects incident to withdrawal from the continuous or substantial use of an opioid drug and as a method of bringing the service recipient to a drug-free state.
   9. (i) “Dispense” or “Dispensing” means to prepare and give out dose(s) of a medication for opioid use disorder to a service recipient at the Facility.
   10. (j) “Diversion Control Plan” means specific measures, including assigning responsibilities to medical and administrative staff, to reduce the possibility of diversion of controlled substances.
   11. (k) “FDA” means the United States Food and Drug Administration.
   12. (l) “Guest Dose” means any treatment dose provided on a temporary basis at a Facility other than the service recipient’s home clinic.
   13. (m) “Home Clinic” means the Facility where an individual is admitted and primarily treated as a Facility service recipient.
   14. (n) “Inspection” means any examination, either onsite or by virtual means, by the department, or its representatives, of a Facility including, but not limited to, the premises, staff, persons in care, and documents pertinent to initial and continued licensing, so that the department may determine whether or not a Facility is operating in compliance with licensing requirements. The term “inspection” includes any survey, monitoring visit, complaint investigation, or other inquiry conducted for the purposes of making a compliance determination with respect to licensing requirements.
   15. (o) “Maintenance Treatment” means the dispensing of a medication intended to treat opioid use disorder, at relatively stable dosage levels, for a continuous, open-ended period deemed medically necessary by a program provider or medical director. The medication shall be provided in conjunction with efforts to address the service recipient’s needs and goals for treatment, and with the intention to restore normal OPIOID TREATMENT PROGRAM FACILITIES function in a service recipient’s life and improve family and community relationships. The maintenance dose, or dose rendered as part of a service recipient’s maintenance treatment, is the individualized dose of the treatment medication considered to consistently suppress signs or symptoms of withdrawal from opioid drugs and opioid drug cravings for individuals with opioid use disorder.
   16. (p) “Medical Director” means a physician licensed by the Tennessee Board of Medical Examiners or the Tennessee Board of Osteopathic Examination who has been designated by the governing body of the Facility to be responsible for the administration of all medical services performed by the Facility, including compliance with all federal, state, and local laws and rules regarding medical treatment of opioid use disorder. The medical director shall have the experience and credentials specified in paragraph 0940-05-42-.29(4) of these rules.
   17. (q) “Medical Record” means medical histories, records, reports, summaries, diagnoses, prognoses, records of treatment and medication ordered and given, entries, x-rays, radiology interpretations and other written electronics, or graphic data prepared, kept, made, or maintained in a Facility that pertains to services rendered to service recipients.
   18. (r) “Medication-Assisted Treatment” means the use of FDA approved medications for the purpose of detoxification and maintenance treatment of opioid use disorder in combination with counseling and behavioral therapies.
   19. (s) “Methadone” means a synthetic opioid agonist which has been approved by the FDA for detoxification and maintenance treatment of opioid use disorder.
   20. (t) “Mobile Unit” or a “Mobile Methadone Unit,” refers to the operation of a “mobile narcotic treatment program” as described in 21 C.F.R. Part 1301.
   21. (u) “Multidisciplinary Treatment Team” or “Treatment Team” means professionals, which may include a licensed physician, licensed advanced practice nurse, licensed physician assistant, licensed nurse, or qualified counseling provider, who assess service recipient progress.
   22. (v) “Office of Licensure” means the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS) Office of Licensure.
   23. (w) “Opiate/Opioid” means a drug that contains opium, derivatives of opium or any of several semi-synthetic or synthetic drugs with opium-like activity.
   24. (x) “Opioid Use Disorder” means a problematic pattern of opioid use leading to problems or distress, with at least two (2) present symptoms listed within the current DSM in a twelve (12)-month period. It is a chronic, lifelong disorder, with serious potential consequences including disability, return to illicit drug use, and death.
   25. (y) “Observed Drug Screen” means testing conducted and witnessed by a Facility staff person to ensure against falsification of, or tampering with, the results of a drug screen.
   26. (z) “Patient” or “Service Recipient” shall refer to an individual receiving treatment for opioid use disorder at an OTP.
   27. (aa) “Physician Assistant” means a person licensed by the Tennessee Board of Physician Assistants, with authorization from their supervising physician, to write and sign prescriptions and/or issue legend drugs. Physician assistants may perform any and all OPIOID TREATMENT PROGRAM FACILITIES functions allowed by the current federal and state regulations within this practice setting and within their scope of allowed professional licensure.
   28. (bb) “Program Director” means the person designated by the Facility’s governing body who is responsible for the operation of the Facility, for the overall compliance with federal, state, and local laws, rules, and regulations, and for all Facility employees including practitioners, agents, or other persons providing services at the Facility.
   29. (cc) “Program Provider” means any physician, physician assistant, pharmacist, or advanced practice nurse, including the medical director, who is employed by the Facility to provide medical services to service recipients. Any Facility program provider who is not a medical director shall work under the supervision of the Facility’s medical director.
   30. (dd) “Prescription Monitoring Program” or “PMP” means a program established by the Tennessee Department of Health to monitor the prescribing and dispensing of Schedule II, III, IV and V controlled substances.
   31. (ee) “Psychiatrist” means a physician, who specializes in the assessment and treatment of individuals having psychiatric disorders, is certified by the American Board of Psychiatry and Neurology or has the documented equivalent in education and training, and who is fully licensed to practice medicine in the State of Tennessee.
   32. (ff) “Qualified Counseling Provider” means an individual qualified by education and/or experience for the specific duties of their position as outlined in Subparagraph 0940- 05-42-.29(4)(f) of these rules to provide counseling services to individuals receiving treatment at a Facility. Qualified Counseling Providers may only perform those duties within the scope of their applicable professional practice acts and Tennessee licensure requirements.
   33. (gg) “Random Testing” means drug screens conducted by the Facility that lack a definite pattern of which service recipients are tested and when they are tested; indiscriminate testing.
   34. (hh) “Service Recipient Transfer” means any service recipient who changes locations of their home clinic without receiving a discharge status or without a break in treatment between clinics.
   35. (ii) “S.M.A.R.T. goals” means objective goals created using the S.M.A.R.T. goal framework that aids in creating personal and professional goals for service recipients. These goals are intended to be utilized in a service recipient’s treatment plan or individual counseling sessions to track achievement of short- and long-term goals and progress at the Facility. S.M.A.R.T. goals shall be specific, measurable, achievable, relevant, and time-sensitive.
   36. (jj) “State Opioid Treatment Authority,” “SOTA,” or “Office of the SOTA” means any individual person(s) designated by the Commissioner of Mental Health and Substance Abuse Services to exercise the responsibility and authority for governing the treatment of opioid use disorder in accordance with all applicable state and federal regulations. The individual(s) also serve(s) as a liaison with the appropriate federal agencies.
   37. (kk) “Supervising Physician” means a licensed and actively practicing physician who has been identified as accepting the responsibility for supervising physician assistants and advanced practice nurses. OPIOID TREATMENT PROGRAM FACILITIES
   38. (ll) “TDMHSAS” means the Tennessee Department of Mental Health and Substance Abuse Services.
   39. (mm) “Telehealth” means the distribution of health-related services and information via electronic information and telecommunication technologies. Telehealth services are intended to remotely support and facilitate the delivery of both clinical and non-clinical services to its recipients. Telehealth technologies include, but are not limited to, live video conferencing, mobile health applications, and phone calls.
   40. (nn) “Treatment” means a broad range of services including outreach, identification, assessment, diagnosis, short-term withdrawal management, therapy, medical services, lectures/seminars, group process social services, and follow-up or aftercare for individuals with opioid use disorder. The overall goal is to eliminate the opioid use disorder as a contributing factor to physical, psychological, and social dysfunction and to decrease or reverse the progress of any associated problems.
   41. (oo) “Treatment Plan,” “Individualized Treatment Plan,” or “ITP” means a comprehensive, progressive, personalized plan that includes all prescribed treatment services. It is person-centered, recovery oriented, culturally competent and addresses personalized goals and objectives.
   42. (pp) “Volunteer” means a person who is not paid by the licensee and whose varied skills are used by the licensee to support and supplement the efforts of the paid Facility staff.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, 33-2-404, and 33-2-407. Administrative History: Original rule filed June 8, 1999; effective August 22, 1999. Amendment filed February 18, 2003; effective May 4, 2003. Amendment filed April 11, 2003; effective June 25, 2003. Per Executive Order 44 (February 23, 2007), rule was transferred from 1200-08-21 on May 15, 2008. Repeal and new rule filed September 20, 2012; effective December 19, 2012. Amendments filed June 6, 2025; effective September 4, 2025.