Section 0940-05-35-.02 - 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) "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.(c) "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.(d) "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.(e) "Counseling" or "Counseling Session" means a face-to-face individual therapeutic counseling session lasting not less than twenty (20) minutes with a qualified 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 provider. Counseling shall be focused on issues related to the patient's opioid use disorder 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. The Facility shall document each counseling session in the patient's medical chart.(f) "DATA 2000 Waiver" means the registered authority given to a qualified health care professional by the U.S. Drug Enforcement Administration to prescribe FDA-approved narcotic medication for opioid detoxification or maintenance treatment pursuant to 21 U.S.C. § 823(g).(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 non-residential 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.(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) "Multidisciplinary Treatment Team" or "Treatment Team" means professionals, which may include a licensed physician, licensed physician assistant, licensed nurse, qualified alcohol and drug treatment personnel, and/or mental health professionals, who assess, evaluate, or treat a patient.(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) "Observed Drug Screen" or "Observed Urine Drug Screening" means a test used to determine the presence of illicit drugs in an individual's body conducted by and in the presence of a Facility medical or lab staff or contracted medical or lab staff so as to ensure against the tampering with or falsification of the results.(u) "Patient" or "Service Recipient" shall refer to an individual receiving treatment for opioid use disorder at an OBOT.(v) "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.(w) "Phases of Treatment" means the induction, stabilization, and maintenance phases associated with office-based opioid treatment as described in the Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction: A Treatment Intervention Protocol published by the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment (CSAT).(x) "Program Physician" means any physician, including the medical director, who provides medical services to patients at the Facility.(y) "Qualified Provider" means a qualified mental health professional as defined in T.C.A. § 33-1-101(20), or a qualified alcohol and drug abuse treatment personnel as defined in 0940-05-01-.16(7).(z) "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.(aa) "Taper", "Tapering", and "Medically Supervised Withdrawal" are interchangeable terms for the purposes of these rules.(bb) "TDMHSAS" or "Department" means the Tennessee Department of Mental Health and Substance Abuse Services.(cc) "Treatment" or "Substance Abuse 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 abuse as a contributing factor to physical, psychological, and social dysfunction and to arrest or reverse the progress of any associated problems.(dd) "Treatment program" or "Substance Abuse 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.Tenn. Comp. R. & Regs. 0940-05-35-.02
Original rules filed October 14, 2016; effective January 12, 2017. Amendments filed March 29, 2019; effective 6/27/2019.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, 33-2-402, 33-2-403, 33-2-404, 33-2-407, Chapter 912 of the Public Acts of 2016, and Chapter 978 of the Public Acts of 2018.