Definitions

(1) Definitions of general terms used in these rules can be found in Rules Chapter 0940-05-01. (2) Definitions specific to this chapter are as follows: (a) “Nonresidential Office-Based Opiate Treatment Facility” or “Facility” or “OBOT” is a service entity that includes, but is not limited to, stand-alone clinics, treatment resources, individual physical locations occupied as the professional practice of a prescriber or prescribers licensed pursuant to Title 63, or other entities prescribing products containing buprenorphine, or products containing any other controlled substance designed to treat opioid use disorder by preventing symptoms of withdrawal to twenty-five percent (25%) or more of its patients or to one hundred fifty (150) or more patients. 1. “Nonresidential office-based opiate treatment facility” does not include any Facility that meets the definition of a nonresidential substitution-based treatment center for opiate addiction, otherwise referred to as a nonresidential opioid treatment program as licensed under Rule 0940-05-42. (b) “Advanced Practice Registered Nurse” means a person qualified by the Tennessee Board of Nursing under Rules Chapter 1000-04 as an advanced practice registered nurse with a certificate of fitness and privileges to write and sign prescriptions and/or issue legend drugs. Advanced practice registered 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. MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35 OFFICE-BASED OPIATE TREATMENT FACILITIES (c) “Buprenorphine” means a semi-synthetic opioid partial agonist that activates the opioid receptors but not to the same degree as full agonists such as morphine and heroin, as well as any FDA-approved pharmaceutical product that contains buprenorphine. (d) “Case Management/Care Coordination” means a collaborative process of assessment, planning, facilitation, care coordination, evaluation, and advocacy for options and services to meet an individual’s and family’s comprehensive health needs through communication and available resources to promote quality, cost-effective outcomes. (e) “Controlled Substance Monitoring Database” or “CSMD” means a program administered by the Tennessee Department of Health to monitor the prescribing and dispensing of Schedule II, III, IV and V controlled substances as set forth by T.C.A. Title 53, Chapter 10, Part 3. (f) “Counseling” or “Counseling Session” means any face-to-face individual therapeutic counseling session lasting not less than twenty (20) minutes with a qualified counseling provider, or a group educational session of no more than twenty (20) patients and lasting not less than fifty (50) minutes facilitated by a qualified counseling provider. Counseling shall be focused on issues related to the patient’s identified needs in their treatment plan and shall not include discussions related to administrative procedures. Telehealth, pursuant to the Tennessee Code Annotated, may be utilized to facilitate counseling. Attendance of a 12-step program, such as Narcotics Anonymous, shall not be considered counseling. Counseling is separate and apart from any other medical and/or clinical activities of the Facility. The Facility shall document each counseling session’s topic of focus and the duration of minutes of the counseling in the patient’s medical chart. (g) “DEA” means the United States Drug Enforcement Administration. (h) “Detoxification” or “Detoxification Treatment” means the use of an opioid agonist treatment medication in decreasing doses to the patient 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 patient to a drug-free state within that period. (i) “Diversion Control Plan” means specific measures, including assigning responsibilities to medical and administrative staff, to reduce the possibility of diversion of controlled substances from legitimate treatment to illicit use. (j) “Facility Director” means the person designated by the Facility’s governing body who is responsible for the operation of the Facility, for the Facility’s overall compliance with federal, state, and local laws and regulations regarding the operation of a nonresidential office-based opiate treatment facility, and for all Facility employees including practitioners, agents, or other persons providing services at the Facility. Non- physician Facility directors shall not supervise medical staff. (k) “FDA” means the United States Food and Drug Administration. (l) “Governing Body” means the person or persons with primary legal authority and responsibility for the overall operation of the OBOT and to whom a director/chief executive officer is responsible. Depending upon the organizational structure, this body may be an owner or owners; a board of directors or other governing members of the licensee; or state, city, or county officials appointed by the licensee. MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35 OFFICE-BASED OPIATE TREATMENT FACILITIES (m) “Inspection” means any examination by the Department or its representatives of an OBOT 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 an OBOT is operating in compliance with licensing requirements or has violated any 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. (n) “Medical Director” means a physician who meets the qualifications set out in 0940-05- 35-.20(3)(b) and who has been designated by the governing body of the Facility to be responsible for the supervision of all medical staff at the Facility and the administration of all medical services offered by the Facility, including compliance with all federal, state and local laws and rules regarding medical treatment of opioid use disorder. (o) “Medical Record” or “Medical Chart” 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 patients. (p) “Medication Assisted Treatment” means use of a medication approved by FDA, in combination with counseling and behavioral therapies, for the treatment of an opioid use disorder. (q) “Observed Drug Screen” means a test used to determine the presence of illicit drugs in an individual’s body conducted by and in the presence of staff with documented training on procedures of observing drug screens or contracted medical or lab staff so as to ensure against the tampering with or falsification of the results. (r) “Office of Licensure” means the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS) Office of Licensure. (s) “Opiate/Opioid” means a drug that contains opium, derivatives of opium, or any of several semi-synthetic or synthetic drugs with agonist activity at the opioid receptor. (t) “Patient” or “Service Recipient” shall refer to an individual receiving treatment for opioid use disorder at an OBOT. (u) “Physical Location” means real property on which is located a physical structure, whether or not that structure is attached to real property, containing one (1) or more units and includes an individual apartment, office, condominium, cooperative unit, mobile or manufactured home, or trailer, if used as a site for prescribing or dispensing products containing buprenorphine, or products containing any other controlled substance designed to treat opioid use disorder by preventing symptoms of withdrawal. (v) “Phases of Treatment” means the induction, stabilization, and maintenance phases of treatment a patient is in at a particular point in time as described in Rule 0940-05-35- .10. (w) “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 functions allowed by the current federal and state regulations within this practice setting and within their scope of allowed professional licensure. MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35 OFFICE-BASED OPIATE TREATMENT FACILITIES (x) “Program Physician” means any physician, including the medical director, who provides medical services to patients at the Facility. (y) “Program Provider” means any physician, including the medical director, physician assistant, pharmacist, or advanced practice registered nurse, who provides medical services on behalf of 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. (z) “Qualified Counseling Provider” means any individual meeting the following conditions: 1. Licensed by the State of Tennessee as one (1) of the following (with experience or supervision as described, where specified); or (i) Alcohol and Drug Abuse Counselor I or II (commonly referred to as LADAC I or LADAC II); (ii) Psychologist; (iii) Psychological examiner; (iv) Physician with experience or training in counseling; (v) Physician Assistant or Nurse Practitioner with experience or training in counseling; (vi) Registered nurse with experience or training in counseling; (vii) Social worker, meeting one of the following: (I) Licensed as a baccalaureate social worker (LBSW) with training in counseling and direct supervision by a master’s level social worker (LCSW or LMSW); (II) Licensed as a master social worker (LMSW); or (III) Licensed as a clinical social worker (LCSW). (viii) Professional Counselor; or (ix) Marriage and Family Therapist. 2. Actively engaged in a recognized course of study or another formal process for pursuing licensure of a discipline described in (i) above. Supervision shall be in accordance with the respective laws, rules, and regulations governing the professional licensure pursued; and 3. Be qualified by education and/or experience for the specific duties of their position and only perform those duties within the scope of their applicable professional practice acts and Tennessee license. (aa) “Referral” means a proactive effort by Facility personnel to guide a patient towards a healthcare provider or Facility for additional evaluation, treatment, or support. The Facility is responsible for documenting the referral attempt in the patient’s medical chart. To facilitate the referral, the Facility must complete a release of information with MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35 OFFICE-BASED OPIATE TREATMENT FACILITIES the referring Facility and the location appropriate for the referral completed on the document. The clinic personnel must document the referral outcome. If the patient declines, the Facility must keep a record of the attempted release of information indicating the patient declined to share records for continuity of care. (bb) “Relapse” means a process in which an individual who has established abstinence or sobriety experiences a recurrence of signs and symptoms of active addiction, often including resumption of the pathological pursuit of reward and/or relief through the use of substances and other behaviors. (cc) “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. (dd) “Taper,” “Tapering,” and “Medically Supervised Withdrawal” are interchangeable terms for the purposes of these rules. (ee) “TDMHSAS” or “Department” means the Tennessee Department of Mental Health and Substance Abuse Services. (ff) “Treatment” or “Substance Use Treatment” means a broad range of services intended to assess status, reduce symptoms, or mitigate the effects of substance misuse, substance use disorders, or co-occurring disorders; reduce risk of relapse and associated harm; or restore or establish well-being for individuals and families; provided, that said practice may include, but not be limited to, care coordination, case management, medical, pharmacological, psychological, psycho-educational, rehabilitative or social services and therapies. The overall goals are to eliminate the substance use as a contributing factor to physical, psychological, and social dysfunction and to arrest or reverse the progress of any associated problems. (gg) “Treatment Program” or “Substance Use Treatment Program” means an organized system of services containing a mission, philosophy, and model of substance use disorder treatment designed to address the needs of clients.