Section 0940-05-42-.01 - 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) "Opioid Treatment Program (OTP)" or "Non-Residential Substitution-based Treatment Center for Opiate Addiction" (also be referred to herein as "Facility" or "Program") includes, but is not limited to, standalone clinics offering methadone, products containing buprenorphine such as Subutex and Suboxone, or products containing any other formulation designed to treat opiate addiction by preventing symptoms of withdrawal, with the goal of the service recipient becoming free from any drug which is not medically indicated.(b) "Advanced Practice Nurse" means a person qualified by the Tennessee Board of Nursing under Rules Chapter 1000-04 as an advanced practice nurse with a certificate of fitness with privileges to write and sign prescriptions and/or issue legend drugs.(c) "Buprenorphine" means a synthetic opioid agonist-antagonist; the hydrochloride salt is used as an analgesic and as a substitute in the management of opioid addiction. It has been approved by the FDA for detoxification in maintenance treatment of opioid dependence.(d) "Central Registry" means an electronic system used to register service recipients currently receiving opioid replacement 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 OTPs to initiate a clearance inquiry and service recipient registration into an approved central registry for the purpose of gathering program information, performance data and to prevent simultaneous enrollment in other OTPs.(e) "Counseling Session" means face-to-face, therapeutic discussion between service recipient(s) and a Facility counselor in a private location for a period of no less than 30 minutes designated to address service recipient addiction issues or coping strategies and Individualized Program Plans.(f) "DEA" means the United States Drug Enforcement Administration.(g) "Detoxification" or "Detoxification Treatment" means the dispensing of an opioid agonist 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 within that period.1. "Administrative Detoxification" or "Administrative Withdrawal" means an involuntary withdrawal or discharge from opioid treatment that is usually relatively brief.2. "Long-Term Detoxification" means a period of opioid replacement therapy services or programs not to exceed 180 days.3. "Medical Detoxification", "Medical Withdrawal" or "Medically Supervised Withdrawal" means the voluntary and therapeutic withdrawal of the service recipient from opioid treatment.4. "30-Day Detoxification Treatment" or "Short-Term Detoxification" means a period of continuous detoxification treatment with narcotic replacement therapy not to exceed 30 days in length for the purpose of assisting the opioid dependent client in reaching a drug-free state. An episode of 30-day detoxification is any length of time in which the client receives narcotic replacement therapy for three or more days.(h) "Dispense" or "Dispensing" means, for purposes of these rules, to prepare and give out more than one single dose of an opioid drug to a service recipient at a non-residential opioid treatment facility.(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) "FDA" means the United States Food and Drug Administration.(k) "Guest Dose" means any dose provided on a temporary basis at a program other than the service recipient's home clinic.(l) "Home Clinic" means the program where an individual is admitted and primarily treated as a program service recipient.(m) "Inspection" means any examination by the department or its representatives of a provider 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 a provider 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) "Opioid Maintenance Treatment" means the dispensing of an opioid drug, at relatively stable dosage levels, for a continuous, open-ended period deemed medically necessary by a program physician or medical director, in the treatment of an individual for dependence on heroin or other opioid drug(s). A "maintenance dose" or dose rendered as part of a service recipient's maintenance treatment is the level of opioid replacement therapy considered to consistently suppress signs or symptoms of withdrawal from opioid drugs and opioid drug cravings for individuals with opioid addiction; it usually represents the end of the induction period. It is individualized for each service recipient and may gradually change over time. Clients will be admitted or readmitted to this modality only after careful clinical evaluation by a multidisciplinary team.(o) "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 OTP to be responsible for the administration of all medical services performed by the OTP, including compliance with all federal, state and local laws and rules regarding medical treatment of opioid addiction. The medical director shall have the experience and credentials specified in paragraph 0940-05-42-.29(4) of these rules.(p) "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.(q) "Methadone (trade name Dolophine)" means a synthetic opioid agonist which has been approved by the FDA for detoxification and maintenance treatment of opioid addiction.(r) "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 service recipient progress.(s) "Office of Licensure" means the Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS) Office of Licensure.(t) "Opiate/Opioid" means a drug that contains opium, derivatives of opium or any of several semi-synthetic or synthetic drugs with opium-like activity.(u) "Opioid Dependent" means an individual who physiologically needs opioid or other opiate-like drugs to prevent the onset of signs of withdrawal.(v) "Opioid Replacement Treatment" means the substitution of a prescription drug which has been approved by the FDA for the treatment of addiction to opioids or opiate-like drugs.(w) "Observed Testing" means testing conducted and witnessed by a Facility staff person to ensure against falsification or tampering or results of a drug screen.(x) "Prescriber" means a physician or physician assistant with prescribing privileges under the Tennessee Board of Medical Examiners Chapter 0880-02 or 0880-03, respectively, or an advanced practice nurse with a certificate of fitness with privileges to write and sign prescriptions and/or issue legend drugs under Tennessee Board of Nursing Rules Chapter 1000-04.(y) "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 and regulations regarding the operation of opioid treatment programs, and for all Facility employees including practitioners, agents, or other persons providing services at the Facility.(z) "Program Physician" means any physician, including the medical director, who is employed by an OTP to provide medical services to service recipients. Any Facility program physician who is not a medical director shall work under the supervision of the Facility's medical director.(aa) "Prescription Monitoring Program" or "PMP" means a program established by the Tennessee Department of Commerce and Insurance to monitor the prescribing and dispensing of Schedule II, III, IV and V controlled substances.(bb) "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.(cc) "Random Testing" means drug screens conducted by the Facility that lack a definite pattern of who and when service recipients are selected for testing; indiscriminate testing.(dd) "Relapse" means the failure of a service recipient to maintain abstinence from illicit drug use verified through drug screen.(ee) "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.(ff) "State Opioid Treatment Authority" or "SOTA" means any individual person designated by the commissioner to exercise the responsibility and authority for governing the treatment of opioid addiction in accordance with all applicable state and federal regulations. The individual also serves as a liaison with the appropriate federal agencies.(gg) "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.(hh) "TDMHSAS" means the Tennessee Department of Mental Health and Substance Abuse Services.(ii) "Treatment" means a broad range of services including outreach, identification, assessment, diagnosis, detoxification, therapy, medical services, lectures/seminars, group process social services, and follow-up or aftercare for individuals with alcohol and other drug problems. The overall goal is to eliminate the alcohol and drug use as a contributing factor to physical, psychological and social dysfunction and to arrest or reverse the progress of any associated problems.(jj) "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.Tenn. Comp. R. & Regs. 0940-05-42-.01
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.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.