Tenn. Comp. R. & Regs. 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.
Notes
Authority: T.C.A. ยงยง 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.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.