TN Rule 0940-05-35

TN Rule 0940-05-35 changed

TN Rule 0940-05-35 Minimum Program Requirements for Nonresidential Office-Based Opiate Treatment Facilities

Jurisdiction: TN Agency: Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS)

OTP (100%) OUTPATIENT (80%)

Plain-English summary

This Tennessee regulation establishes minimum program requirements for licensure and operation of Nonresidential Office-Based Opiate Treatment Facilities (OBOTs) by TDMHSAS. Covered facilities prescribe buprenorphine or other controlled substances to treat opioid use disorder for 25% or more of their patients or 150 or more patients. Operators must comply with detailed requirements for admissions screening and assessment, individualized treatment planning, counseling, medication management, drug screening, diversion control, patient records, staffing, and discharge/aftercare planning. The chapter explicitly excludes facilities licensed as nonresidential opioid treatment programs (methadone clinics) under Rule 0940-05-42.

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Regulation text

September, 2025 (Revised) 1
RULES
OF
THE DEPARTMENT OF MENTAL HEALTH AND SUBSTANCE ABUSE SERVICES
DIVISION OF ADMINISTRATIVE AND REGULATORY SERVICES

CHAPTER 0940-05-35
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL OFFICE-BASED OPIATE
TREATMENT FACILITIES

TABLE OF CONTENTS

0940-05-35-.01 Purpose
0940-05-35-.02 Definitions
0940-05-35-.03 Application of the Rules
0940-05-35-.04 Licensing Procedures
0940-05-35-.05 Policy and Procedures
0940-05-35-.06 Admissions and Discharges and Best
Practices Utilized
0940-05-35-.07 Patient Record Requirements
0940-05-35-.08 Patient Transfers
0940-05-35-.09 Individualized Treatment Plan
0940-05-35-.10 Phases of Treatment
0940-05-35-.11 Special Populations
0940-05-35-.12 Counseling
0940-05-35-.13 Medication Management
0940-05-35-.14 Drug Screens
0940-05-35-.15 Detoxification and Medically Supervised
Withdrawal
0940-05-35-.16 Diversion Control Plan
0940-05-35-.17 Reporting Requirements
0940-05-35-.18 Patient Rights
0940-05-35-.19 Community Relations
0940-05-35-.20 Personnel and Staffing Requirements

0940-05-35-.01 PURPOSE.

The rules in this chapter implement the law relative to licensure and regulation of nonresidential office-
based opiate treatment facilities pursuant to Chapter 912 of the Public Acts of 2016.

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) “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.
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(Rule 0940-05-35-.02, continued)
September, 2025 (Revised) 2

(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.

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(Rule 0940-05-35-.02, continued)
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(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.

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(Rule 0940-05-35-.02, continued)
September, 2025 (Revised) 4
(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
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(Rule 0940-05-35-.02, continued)
September, 2025 (Revised) 5
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.

0940-05-35-.03 APPLICATION OF THE RULES.

(1) The licensee of an OBOT shall comply with the following rules:

(a) Chapter 0940-05-02 Licensure Administration and Procedures;

(b) Applicable Minimum Program Requirements for All Services and Facilities found in
Chapter 0940-05-06; and

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(Rule 0940-05-35-.03, continued)
September, 2025 (Revised) 6
(2) If any provision of these rules, or the application thereof to any person or circumstance, is
held invalid, such invalidity shall not affect other provisions or applications of these rules
which can be given effect without the invalid provision or application, and to that end the
provisions of these rules are declared severable.

0940-05-35-.04 LICENSING PROCEDURES.

(1) An OBOT, as defined in 0940-05-35-.02(2)(a) and T.C.A. § 33-2-402, shall be licensed by the
Tennessee Department of Mental Health and Substance Abuse Services (TDMHSAS or
Department).

(2) An OBOT shall include, as part of its ownership structure, a physician who holds an
unrestricted license from the Tennessee Board of Medical Examiners or the Tennessee
Board of Osteopathic Examination. “Ownership Structure” means any entity, group, or
individual(s) having legal ownership of the OBOT, directing its functions and operations. This
includes, but is not limited to, a sole proprietor, general partner, board member of a non- profit
or for -profit corporation, or managing member of a limited liability company. Final
determination as to whether ownership structure requirements for an OBOT are being met is
in the sole discretion of the Department.

(3) A public benefit non- profit/charitable corporation, registered with the Tennessee Secretary of
State, shall have a physician who holds an unrestricted license from the Tennessee Board of
Medical Examiners or the Tennessee Board of Osteopathic Examination and is on its Board
of Trustees.

(4) A corporate entity doing business as an OBOT in the State of Tennessee shall not provide,
hold itself out as providing, or advertise that it provides substance use disorder treatment for
opioid use disorder in the form of opioid agonist therapy, or office- based opiate treatment,
unless it complies with the following requirements:

(a) Is appropriately registered with the Tennessee Secretary of State to operate in the
State of Tennessee and/or is and remains current with corporate or non-
profit/charitable registration requirements of the Tennessee Secretary of State;

(b) In the case of a for -profit corporate entity, includes, as a member of its Board of
Trustees, the Facility’s medical director; and

(c) In the case of a multisite entity, the inclusion of a sole physician that would meet the
qualifications for a medical director, pursuant to 0940- 05-35-.20(2)(b), shall be on such
Board.

(5) The OBOT shall make application with the Department’s Office of Licensure by providing the
following information, at a minimum:

(a) Application on the Office of Licensure’s designated forms to include the:

1. Initial Application;

2. Fact Sheet; and,

3. Financial Statement;
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(Rule 0940-05-35-.04, continued)
September, 2025 (Revised) 7

(b) Applicable fees as defined in Tennessee Administrative Procedures Rule 0940- 05-02-
.05;

(c) Evidence of all prescribers contracted and/or currently employed at the Facility holding
a license from the Tennessee Board of Medical Examiners or the Tennessee Board of
Osteopathic Examination or the Health Related Boards for any non- physician
prescribers;

(d) Comprehensive listing of all members of the organization’s ownership structure;

(e) Evidence of the Facility Director’s experience in managing individuals showing at least
one (1) year of supervisory type responsibilities; and

(f) Any other item the Department believes is necessary and proper for application
purposes.

(6) Prior to renewal of the license, the OBOT shall be required to develop written policies and
procedures that substantially comply with the provisions of this c hapter, as well as with
Administrative Chapter 0940-05-06.

(7) The Department may release to and/or gather information from the Tennessee Department of
Health Board of Medical Examiners (BME) as is necessary for licensing and/or investigation
of complaints against an OBOT.

(8) With or without notice, the Department, or its representatives, shall have the right to access
electronic information of the Facility and/or enter upon or into the premises of an OBOT in
order to make inspections and/or investigations deemed necessary to determine compliance
with applicable law. The OBOT shall comply with all reasonable requests of the Department
and allow it to obtain information from third parties as is necessary.

(9) The Department shall be given the authority to access electronic information of and/or enter
upon the premises of an unlicensed Facility prescribing buprenorphine- type products to
better determine that unlicensed Facility’s need for TDMHSAS oversight. The Department
shall attempt to conduct inspections and investigations in the least intrusive manner needed
in order to obtain necessary information. The Facility shall be required to provide reasonable
amounts of information to the Department for this determination.

(a) “Reasonable amounts of information,” in this context, may be considered aggregate,
non-patient identifying information to include, but not be limited to:

1. Patient de-identified identifiers;

2. Lists of medications prescribed to that de-identified patient; and

3. The total number of patients seen at the physical location in question.

(10) The governing body of an OBOT shall designate a Facility director (as defined in 0940-05-35-
.02(2)(j)), who is responsible for the operation of the Facility. Non- physician Facility directors
shall not supervise medical staff.

(11) Should a Facility operate in such a fashion that the physicians working at the same physical
location are unassociated and/or unaffiliated to one another in some type of business
arrangement, then the unassociated and/or unrelated physicians shall designate a Facility
director.
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(Rule 0940-05-35-.04, continued)
September, 2025 (Revised) 8

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017 . Amendments filed March 29, 2019; effective June 27, 2019. Amendments
filed June 27, 2025; effective September 25, 2025.

0940-05-35-.05 POLICY AND PROCEDURES.

(1) The governing body of the Facility shall ensure the OBOT is administered and operated in
accordance with written policies and procedures in the below listed subject areas and in
accordance with these rules. Each Facility shall clearly identify the governing body, as
defined in Rule 0940- 05-01-.01(18) and Rule 0940- 05-35-.02(2)(l), in its policies and
procedures manual including the name and contact information of the governing body.

(a) Admissions and Discharges and Best Practices Utilized (0940-05-35-.06);

(b) Patient Record Requirements (0940-05-35-.07);

(d) Individualized Treatment Plan (0940-05-35-.09);

(e) Phases of Treatment (0940-05-35-.10);

(f) Special Populations (0940-05-35-.11);

(g) Counseling (0940-05-35-.12);

(h) Medication Management (0940-05-35-.13);

(i) Drug Screens (0940-05-35-.14);

(j) Medically Supervised Withdrawal (0940-05-35-.15);

(k) Diversion Control Plan (0940-05-35-.16);

(l) Reporting Requirements (0940-05-35-.17);

(m) Patient Rights (0940-05-35-.18);

(n) Community Relations (0940-05-35-.19); and

(o) Personnel and Staffing Requirements (0940-05-35-.20).

0940-05-35-.06 ADMISSIONS AND DISCHARGES AND BEST PRACTICES UTILIZED.

(1) Initial Screening. Prior to admission to the Facility, each prospective patient shall be
evaluated by the medical director or program provider or staff who have been determined to
be qualified by education, training, and experience to perform or coordinate the provision of
such screening. The purpose of such screening shall be to determine, and document,
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(Rule 0940-05-35-.06, continued)
September, 2025 (Revised) 9
whether the patient meets the diagnostic criteria for an opioid use disorder as defined in the
most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and
whether the Facility will be the most appropriate treatment modality for the patient. No
prospective patient shall be processed for admission until it has been verified that the patient
meets all applicable criteria.

(2) Initial Assessment. Within seven days of admission, the Facility shall complete an initial
assessment. The initial assessment shall focus on the individual’s eligibility and need for
treatment and shall provide indicators for the service recipient’s disease severity and the
need for any appropriate referrals. Whenever possible and with service recipient written
consent, the initial assessment shall include a family member or significant other to assist in
the provision of accurate information and a full understanding and retention of instructions
given to the service recipient. The initial assessment shall include, but not be limited to, the
following:

(a) A physical examination that includes a review of systems, vital signs, a pain
assessment, and laboratory testing, unless otherwise specifically exempt pursuant to
state or federal regulation, consistent with 42 C.F.R. § 12 (2025);

(b) A past medical history;

(c) A substance use history that includes type, frequency, and amount of substances used,
including illicit substances, tobacco, and alcohol;

(d) A list of currently prescribed or over-the-counter medications;

(e) A personal and family history of substance use;

(f) A confirmation of the opioid use disorder diagnosis;

(g) An initial observed drug screen to identify the current use of drugs including, but not
limited to, opioids (including fentanyl, buprenorphine, and methadone), amphetamines,
cocaine, barbiturates, and benzodiazepines;

(h) A screening shall be conducted for sexually transmitted infections (STIs) and
tuberculosis. The medical director may screen for other communicable diseases based
on their discretion. The Facility shall maintain a documented policy and procedure for
screening for communicable diseases, which includes the process for screening
methods used by the Facility and the process for providing referrals for patients for
further communicable disease screening, testing, or treatment, as appropriate. Patient -
specific factors that warrant a deviation from these rules or the Facility’s policy and
procedures shall be documented in the patient’s medical record;

(i) Any additional screening tests, such as pregnancy screenings, as necessary or
appropriate; and

(j) A determination if the prospective service recipient needs special services, such as
treatment for alcohol use disorder or psychiatric services, and determination that the
Facility is capable of addressing these needs either directly or through referral. If
referral to an outside provider is deemed necessary, efforts of the Facility in making the
referral shall be documented in the patient’s medical chart.

(3) The Facility may utilize components of the initial assessment performed by an outside
provider if conducted within 14 days preceding the admission and obtained by the Facility
within 7 days of admission.
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(Rule 0940-05-35-.06, continued)
September, 2025 (Revised) 10

(4) Prior to receiving treatment at the Facility, the patient shall acknowledge in writing having
received education on the following:

(a) Treatment options, including detoxification, and the benefits and risks associated with
each treatment option;

(b) The risk of neonatal abstinence syndrome and use of voluntary long- acting reversible
contraception for all female patients of child bearing age and potential;

(d) Expected therapeutic benefits and adverse effects of treatment medication;

(e) Risks for overdose, including drug interactions with CNS depressants, such as alcohol
and benzodiazepines, and relapsing after periods of abstinence from opioids; and

(f) Overdose prevention and reversal agents.

(5) A Facility shall only admit and retain patients whose known needs can be met by the Facility
in accordance with its licensed program purpose and description and applicable federal and
state statutes, laws, and regulations.

(6) Drug dependent pregnant females shall be given priority for admission and services.

(7) No Facility shall provide a bounty or other reward to a third party for referral of potential
patients to the clinic.

(8) Comprehensive Assessment. Within 30 days of admission, the Facility shall have completed
a comprehensive assessment. The comprehensive assessment shall include information
obtained by the patient, family members, friends, peers, and other collateral sources, where
appropriate and with the service recipient’s written consent. The comprehensive assessment
shall include, but not be limited to, the following:

(a) A review of the information collected from the initial assessment;

(b) Follow up tests as necessary or appropriate based on initial screening (e.g., CBC,
EKG, chest x -ray, hepatitis B, hepatitis C, HIV testing, pregnancy testing). The Facility
is responsible for obtaining and maintaining documentation of required laboratory tests
performed by an alternative provider;

(d) A social and family history;

(e) A criminal justice history, including any current criminal justice involvement; and

(f) A psychosocial assessment that shall include information about the service recipient’s:

1. Motivation for treatment;

2. Personal treatment goals;

3. Personal strengths;
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(Rule 0940-05-35-.06, continued)
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4. Individualized needs;

5. Urgent needs, including suicide risk;

6. Abilities and/or interests;

7. Presenting problems including a thorough analysis of the service recipient’s high-
risk behaviors such as:

(i) Licit and illicit drugs used, including alcohol, including;

(I) Amount(s) and method(s) used;

(II) Frequency of use; and

(III) Duration of use;

(ii) Symptoms of physical dependence or withdrawal;

(iii) History of treatment for addictive behaviors;

(iv) Adverse consequences of use; and

(v) Inappropriate use of prescribed substances;

8. Previous behavioral health services, including:

(i) Diagnostic information;

(ii) Treatment information; and

(iii) Efficacy of current or previously used medication;

9. Mental status;

10. Current level of functioning;

11. Need for, and availability of, social supports;

12. Adverse childhood experiences;

13. Adjustment to disabilities/disorders; and

14. Level of education.

(9) Discharge and Aftercare Plans. A Facility shall complete an individualized discharge and
aftercare plan for patients who complete their course of treatment.

(a) All discharge and aftercare plans shall include documentation that the Facility’s
qualified counseling providers and/or program providers have discussed with the
patient an individualized medically supervised withdrawal plan appropriate to the
patient.

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(Rule 0940-05-35-.06, continued)
September, 2025 (Revised) 12
(b) The patient’s discharge planning shall include the development of a menu of
appropriate treatment resources available to the patient in his or her community. This
menu shall be developed in consultation with the patient and shall be in writing and
made available to the patient upon discharge. The Facility shall assist the patient in
obtaining the appropriate referrals, as necessary.

(c) The discharge plan shall be completed at the time of the patient’s discharge by the
person who has primary responsibility for coordinating or providing for the care of the
service recipient. It shall include a final assessment of the patient’s status at the time of
discharge and aftercare planning. If applicable, parents or guardian, or responsible
persons may participate in discharge and aftercare planning. The reason for any
patient not participating in discharge and aftercare planning shall be documented in the
patient’s medical record.

(10) The Facility shall document when a patient discontinues services at an OBOT. Determination
of the events that constitute a patient’s discontinuation of services at an OBOT shall be at the
OBOT’s discretion.

(11) If a patient is observed to have experienced multiple relapses, the Facility shall consider the
appropriateness for a referral of the patient to more intensive levels of care, to include but not
be limited to, intensive outpatient, methadone treatment, or residential substance use
disorder treatment. The Facility’s consideration for a referral shall be documented in the
patient’s medical chart. Considerations for subsequent referrals should be discussed in line
with ITP review frequency, as outlined in 0940-05-35-.09(5).

0940-05-35-.07 PATIENT RECORD REQUIREMENTS.

(1) Each Facility shall have a specific policy and procedure outlining the Facility’s duties and
responsibilities regarding any service recipient medical record requirements that are listed
herein and in the minimum requirements of Chapter 0940-05-06.

(2) Facilities shall organize and coordinate patient medical and billing records in a manner which
demonstrates that all pertinent patient information is accessible to all appropriate staff and to
TDMHSAS surveyors.

(3) Should the licensee plan to close its operations, written notice shall be given to the patient or
the new provider prior to the planned closure of the Facility. Patient medical records shall be
transferred to the patient or to the new provider within ten (10) business days of the last
scheduled visit of the patient.

(4) The Facility shall ensure that adequate billing and medical records are maintained in
accordance with T.C.A. § 33-2-403(e), (f), and (g).

(5) Except as otherwise authorized by law, no person shall be admitted for treatment without
written consent from the patient and, if applicable, parent, guardian, or responsible party. A
documented, voluntary, written, program- specific informed consent to treatment from each
patient at admission shall include:

(a) Information about all treatment procedures, services, and other policies and regulation
throughout the course of treatment, including clinic charges in the form of a fee
agreement signed by the patient. This fee agreement shall include an explanation of
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.07, continued)
September, 2025 (Revised) 13
the financial aspects of treatment and the consequences of nonpayment of required
fees, including the procedures for the patient (or patient’s legal representative) in the
event they are unable to pay for treatment;

(b) Consent to the individualized, prescribed therapy before dosing begins, including
information about potential interactions with and adverse reactions to other substances,
including those reactions that might result from interactions and adverse reactions to
alcohol, other prescribed or over -the-counter pharmacological agents, other medical
procedures and food;

(d) Acknowledgement that the patient has been informed of the Facility’s rules regarding
patient conduct and responsibilities;

(e) Acknowledgement that the patient has been informed of client rights as found in 0940-
05-35-.18, as well as 0940-05-06-.06;

(f) Information that at regular intervals, in full consultation with the patient, the program
shall discuss the patient’s present level of functioning, course of treatment, and future
goals; and

(g) Information that the patient may choose to withdraw from or be maintained on the
medication as the client desires unless medically contraindicated.

(6) The patient’s medical chart shall also include documentation of the following:

(a) Documentation that the patient’s initial screening and comprehensive assessment are
completed and documented in the patient’s medical record prior to the development of
the patient’s individualized treatment plan;

(b) The individualized treatment plan, including any reviews, changes or amendments to
the plan;

(c) Documentation that services listed in the individualized treatment plan are available
and have been provided or offered;

(d) A record of correspondence with the patient, family members, and other individuals and
a record of each referral for services and its results;

(e) A discharge and aftercare plan pursuant to 0940- 05-35-.06(9), including reasons for
discharge and any referral. In the case of death, the reported cause of death shall be
documented; and

(f) Documentation of coordination of care should be present in those clinical situations
which require consultations or coordination of care.

MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

September, 2025 (Revised) 14
0940-05-35-.08 PATIENT TRANSFERS.

(1) If a prospective patient has previously been discharged, inside of the previous twelve (12)
months, at a minimum, from treatment at another Facility or other type of treatment program,
the admitting Facility, after having the patient sign a release of information, shall initiate an
inquiry into the prospective patient’s prior treatment history, inquiring of the last Facility or
other type of treatment program attended and the reasons for discharge from treatment.

0940-05-35-.09 INDIVIDUALIZED TREATMENT PLAN.

(1) A Facility shall develop an individualized treatment plan (ITP) for each patient within thirty
(30) days of admission. The ITP shall be developed in accordance with peer reviewed
medication assisted treatment guidelines, developed by nationally recognized organizations,
such as SAMHSA and the American Society of Addiction Medicine or the Tennessee
Nonresidential Buprenorphine Treatment Guidelines. The initial and comprehensive
assessments listed in 0940- 05-35-.06 shall be completed, unless extenuating prohibitive
circumstances exist, prior to the finalization of an initial ITP. Any significant findings from the
initial or comprehensive assessments that impact the service recipient’s success in treatment
and recovery shall be documented and addressed in the ITP. The ITP, at minimum, shall
contain: S.M.A.R.T. goals for identified service needs of the patient, listing of the services
provided in- house (including but not limited to: office visit, counseling, case management,
drug screen), external services and the frequency of those in- house and external services.
The Facility may use alternative treatment planning methods provided that the methodology
is evidence-based and provides similar details to that of the S.M.A.R.T. goals as defined by
these rules. The initial ITP and all reviews shall be signed, either in person, electronically, or
by documented verbal acknowledgment, by the service recipient, qualified counseling
provider, and program provider.

(2) Medical care, including referral for necessary medical service, and evaluation and follow -up
of patient complaints, shall be compatible with current and accepted standards of medical
practice. All patients shall receive a physical exam, in accordance with federal and state
controlled substance prescribing laws, medical evaluation at least annually as part of the
initial assessment. A physical exam shall then be offered, either by the Facility or through a
referral, as clinically indicated. Subsequent physical exams shall be documented in the
medical record. Any physical examination shall be consistent with 42 CFR 12 requirements.
The program provider shall record the results of the examinations and tests in the patient’s
medical record. Any significant findings of the physical exam or other testing that may
complicate a patient’s treatment at the Facility shall be included in the patient’s medical
record.

(3) Each Facility shall take steps to ensure that a comprehensive range of rehabilitative services,
including vocational, educational, legal, mental health, alcoholism, and social services, are
made available to the patients who demonstrate a need for such services. The Facility can
fulfill this responsibility by providing support services directly or by appropriate referral.
Support services that are recommended and/or utilized shall be documented in the patient’s
medical record. Each Facility shall have policies for matching a patient’s needs to treatment.

(4) If the patient experiences a return to drug use, his or her ITP shall document evidence of
intensified services provided. Such evidence may include, but is not limited to, a “move back”
to more intensive phases of treatment (as detailed by 0940- 05-35-.10), an increase in
individual or group counseling session(s), or more frequent drug screens.

MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.09, continued)
September, 2025 (Revised) 15
(5) A patient’s ITP shall be reviewed at least every six (6) months and a discussion shall be held
with the patient regarding his or her continued desire to remain in the program for
maintenance treatment. Alternatives such as medically supervised withdrawal shall be
presented to the patient at the time of the discussion and documented in the patient’s
medical record. The patient shall sign and date a statement on the ITP indicating that she or
he wishes to remain within the program in a maintenance phase. If the patient wishes to
enter medically supervised withdrawal, the ITP shall reflect that choice.

0940-05-35-.10 PHASES OF TREATMENT.

(1) Requirements for services according to phases of treatment:

(a) The patient’s most current phase of treatment, according to the patient’s specific
documented history (e.g. patient coming to Facility following transfer from other
provider and who may be already under a different phase of treatment), along with
rationale for the assigned phase, shall be clearly documented in the patient’s medical
record.

(b) For the purposes of this section, the following definitions apply:

1. “Induction or stabilization” means the phase of treatment when the patient is new
to treatment or exhibits active symptoms of substance use disorder and receives
more frequent treatment services. The Facility staff should more closely evaluate
the patient for signs of reduced symptoms of their substance use disorder,
including but not limited to: reduced or eliminated illicit drug use, reduced
cravings for illicit substances, suppression of withdrawal symptoms, evaluation of
medication side effects, or patient reports of treatment needs.

2. “Maintenance” means the phase of treatment when the patient demonstrates
treatment stability and their substance use disorder is considered to be in
remission. Treatment stability is determined by evaluating, but not limited to, the
following: stable dosing of the treatment medication, favorable drug screens,
reduced or eliminated cravings for illicit substances, regular clinic attendance,
participation in counseling, and absence of illegal activity related to illicit
substance use.

1. Have weekly program provider -interactive visits scheduled with the ability for 1-
on-1 therapeutic discussions between the patient and program provider;

2. Be scheduled to receive appropriate counseling sessions with a qualified
counseling provider at least twice a month;

3. Be administered one (1) observed drug screen initially, and then a drug screen at
least weekly, for a minimum of three (3) weeks; and

4. Be scheduled to receive case management services weekly.

(d) A patient in the maintenance phase of treatment for less than one (1) year shall:
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.10, continued)
September, 2025 (Revised) 16

1. Have a scheduled program provider -interactive visit at least every two (2) to four
(4) weeks with the ability for 1- on-1 therapeutic discussions between the patient
and program provider;

2. Be scheduled to receive counseling sessions with a qualified counseling provider
at least monthly;

3. Be administered a random drug screen at least eight (8) times annually; and

4. Be scheduled to receive case management services at least monthly.

(e) A patient in the maintenance phase of treatment for one (1) year or more shall:

1. Have a scheduled program provider-interactive visit at least every two (2) months
with the ability for 1- on-1 therapeutic discussions between the patient and
program provider;

2. Scheduled to receive counseling sessions with a qualified counseling provider at
least monthly;

3. Be administered a random drug screen at least eight (8) times annually; and

4. Be offered case management services at least every six (6) months. In addition
to case management services provided, any offers for case management shall
also be documented in the patient’s medical record.

(2) All drug screens, regardless of patient phase of treatment, shall be done in accordance with
the procedures as detailed in 0940-05-35-.14.

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, and 33- 2-407. Administrative History: New rule filed March 29, 2019; effective
June 27, 2019. Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.11 SPECIAL POPULATIONS.

(1) Pregnant Women/Women of Child Bearing Age and Potential. Upon the initial screening, the
Facility shall screen all women of child bearing age and potential for pregnancy. For this
purpose, a woman of child bearing age and potent ial is aligned with Tennessee Code
Annotated § 53-11-308(h). The Facility will ensure that pregnant women and women of child
bearing age and potential shall be treated using nationally recognized best practice
guidelines and within all applicable federal and state rules and regulations. If the Facility does
not provide prenatal care to pregnant patients, the Facility shall ensure that there is
coordination of care between the Facility and the pregnant patient’s prenatal care provider.
The Facility shall document, in the patient’s medical record, that the Facility has informed all
pregnant women and women of child bearing age and potential, initially and at regular
intervals, of the risks and benefits of the utilization of voluntary, reversible, long- acting
contraception, of the risks and benefits of medication assisted treatment and detoxification
treatment with buprenorphine containing products, and of the risks associated with the
continued use of opioids, including neonatal abstinence syndrome. The information provided
to pregnant women and women of child bearing age and potential shall be based on current
best practices and research.

(2) Pain Management. The Facility shall ensure that program providers are knowledgeable in the
management of opioid use disorder in a context of chronic pain and pain management. The
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.11, continued)
September, 2025 (Revised) 17
Facility shall ensure continuity of care and communication between treatment programs or
physicians regarding patients receiving treatment in both a nonresidential office- based opiate
treatment facility and a licensed pain management clinic or a pain management specialist’s
office for purposes of pain management, with patient consent.

(3) Co-Occurring Disorders. The Facility shall ensure that patients with mental health needs are
identified through the initial screening and comprehensive assessment processes and are
referred to, or provided, appropriate treatment.

(a) The Facility shall monitor, assess, and document in the patient’s medical record the
emergence of symptoms of mental illness during treatment.

(b) The Facility shall establish relationships with mental health providers in the community
for referral/additional treatment services as indicated. See 0940-05-35-.09(3).

(4) Polysubstance Misuse. The Facility shall address misuse of alcohol and other non- opioid
substances within the context of the medication- assisted therapy effort. Ongoing
polysubstance misuse is not necessarily a reason for discharge; however, the Facility shall
facilitate a referral of the patient, with documentation of the referral in the patient’s medical
record, to more intensive levels of care, as indicated, to include but not be limited to,
intensive outpatient or residential alcohol and drug use treatment.

(5) Criminal Justice. The Department encourages each Facility to work with local law
enforcement, probation officers, and courts, including recovery (drug) courts, to act as a
resource for individuals in the criminal justice system to receive the necessary treatment
services including medications and counseling. The Facility shall document in their policy the
extent of its work with this community.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.10 but was renumbered 0940-05-
35-.11 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.12 COUNSELING.

(1) Counseling is a mandatory component of treatment and the Facility shall determine the best
counseling option for each individual patient based upon the patient’s history and
assessments, agreeance with the patient, and the goals of the patient’s individualized
treatment plan.

(2) The Facility shall be responsible to determine and receive documentation that counseling is
being received and the patient is progressing towards meeting the goals listed in the
individualized treatment plan. The Facility shall review and modify the individualized
treatment plan if it is determined that a patient is not following through with counseling
referrals.

(3) If the Facility utilizes its own staff to provide counseling:

(a) The Facility staff shall be sufficient in number and in training to:

1. Allow the Facility to provide adequate:

(i) Psychosocial assessment;

MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.12, continued)
September, 2025 (Revised) 18
(ii) Treatment planning; and

(iii) Individualized counseling.

2. Allow for regularly scheduled counseling sessions; and

3. Allow patients access to their counselor if more frequent contact is merited by
need or is requested by the patient.

(4) For Facilities referring patients for counseling, the Facility shall provide the patient, with the
patient’s written consent, a list of available licensed treatment providers in the community and
assist the patient in receiving these services by offering to make appointments on the
patient’s behalf and by coordinating care after initiation of services at the outside provider.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.11 but was renumbered 0940-05-
35-.12 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.13 MEDICATION MANAGEMENT.

(1) Opioid Drugs. Facilities shall develop and implement written policies and procedures for the
prescription of opioid drugs. Any changes to these policies and procedures shall be done in
consultation with the Facility’s medical director. These policies and procedures shall include
the following:

(a) Prescribing.

1. The proper initial dose, medication type, and dosage form shall, in consultation
with the patient, be based on the clinical judgment of the program provider who
has examined the patient and who has considered all available relevant patient -
specific information including, but not limited to, drug screens, initial screenings,
and medication availability and cost.

2. No standardized routines or schedules of increases or decreases of medication
doses may be established or used.

3. Facilities shall comply with requirements for prescribing higher doses of
buprenorphine, pursuant to Tennessee Code Annotated § 53- 11-311(d)(1). For
purposes of these rules, a patient dose greater than sixteen milligrams (16mg),
or its equivalent, per day, shall be considered a high dose.

4. A patient dose of thirty -two milligrams (32mg), or its equivalent, per day shall be
considered a maximum dose. Doses greater than the maximum dose may only
be used with prior written approval from the State Opioid Treatment Authority.
Documentation of this approval shall be kept in the patient’s medical chart or
otherwise be readily retrievable upon request or Facility inspection.

5. A copy of all prescriptions for a patient at the Facility shall be documented in the
patient’s medical chart.

6. The program provider shall demonstrate to the patient appropriate techniques for
administering the particular prescribed treatment medication.

MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.13, continued)
September, 2025 (Revised) 19
(b) Dispensing. An office-based opiate treatment facility without dispensing authorization is
prohibited from dispensing buprenorphine-containing products.

1. The patient’s medical chart shall include documentation of rationale that it is
clinically appropriate for the patient to receive a high dose of the treatment
medication.

2. The program provider shall have a discussion with the patient and the patient
shall provide written consent acknowledging that the patient will receive a high
dose of the treatment medication and associated risks. The program provider
shall document that this discussion included an assessment of the patient’s
administration technique and that the patient is using the appropriate technique
for the prescribed medication.

3. The program provider shall not establish or use standardized routines or
schedules of increases or decreases of treatment medication doses for the
patient. Decisions about dosing should be individualized with documentation of
reasons for choice of dosing.

(d) Program Provider -Initiated-and-Led Tapering Discussions. Program provider shall
initiate and lead a discussion with the patient regarding patient readiness to taper down
or taper off treatment medications employed in the patient’s treatment with each patient
at any time upon the patient’s request but no later than one (1) year after initiating
treatment and then every six (6) months thereafter. Documentation of this discussion
shall be placed in the patient’s medical chart.

(2) CSMD Check. The Facility shall check the CSMD upon every visit of the patient with a
program provider. The patient’s medical record shall include documentation of the check of
the CSMD and the date upon which it occurred.

(3) Benzodiazepine Use. Benzodiazepines should only be prescribed to a patient after careful
evaluation while utilizing caution and good judgment. Benzodiazepines may be prescribed to
a patient on buprenorphine or a buprenorphine and naloxone combination under the following
conditions:

(a) Benzodiazepines shall not be initiated with a patient with opioid use disorder or the
disease of addiction who has never been prescribed these products or has a history of
misusing these products. Notwithstanding, in rare circumstances:

1. Patients who present with a longstanding prescription for benzodiazepines for a
medical condition from another prescriber may be prescribed buprenorphine
products by a program provider. Contact should be initiated with the prescriber of
the benzodiazepine to coordinate care and clear documentation should be
recorded in the patient’s medical record.

2. A program provider at an OBOT may assume management of a patient’s
benzodiazepine prescribing from another physician if the patient is willing to
initiate a program of tapering.

3. If a patient presents at an OBOT with a dual diagnosis of opioid use disorder and
a clear history of benzodiazepine use disorder, the duration and extent of the
misuse should be clearly documented in the medical record. A program provider
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.13, continued)
September, 2025 (Revised) 20
at an OBOT may prescribe a long- acting benzodiazepine, such as clonazepam
or its equivalent, under the following conditions:

(i) A patient may continue on benzodiazepine therapy as medically indicated
as long as there is an ongoing effort to taper the patient to the lowest
effective dose in order to prevent benzodiazepine withdrawal syndrome
and clear documentation of this effort is made in the patient’s medical
record.

(I) Prescribing more than two (2) milligrams of clonazepam or its
equivalent daily is considered “high dose therapy.”

(II) Patients receiving high dose therapy should have justification for the
dosing clearly documented in the patient’s medical record.

(III) Patients receiving high dose therapy should be tapered as rapidly as
tolerable to two (2) milligrams or less of clonazepam, or its
equivalent, daily. If the taper is unsuccessful, the reason(s) shall be
clearly documented in the patient’s medical record.

(IV) Patients receiving high dose therapy for a period of longer than six
(6) weeks shall be managed by a physician who is board certified in
addiction medicine or who is board certified or fellowship trained in
addiction psychiatry, or by a physician who has obtained a formal
consult from a physician who is board certified in addiction medicine
or who is board certified or fellowship trained in addiction psychiatry.
The formal consult shall be clearly documented in the patient’s
medical record.

(4) The Facility shall have a policy and procedure developed for reviewing prescriptions from
other providers, including:

(a) Procedures to ensure that a patient’s prescriptions from outside providers will be
reported to the medical staff and reviewed by the program provider at admission and
annually thereafter;

(b) Procedures describing the Facility’s response when information about prescriptions
from outside providers is not reported to ensure compliance with this rule; and,

(c) Documentation of the Facility’s efforts to obtain information about prescriptions from
outside providers in the patient’s medical record, if a Facility is unable to acquire
information about a patient’s prescriptions.

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- 2-406, 33- 2-407, and 53- 11-311. Administrative History: Original rules filed
October 14, 2016; effective January 12, 2017. Emergency rule filed December 20, 2018 to become
effective January 1, 2019; effective through June 30, 2019. Rule was previously numbered 0940- 05-35-
.12 but was renumbered 0940- 05-35-.13 with the introduction of a new rule 0940- 05-35-.10 filed March
29, 2019; effective June 27, 2019. Amendments filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

September, 2025 (Revised) 21
0940-05-35-.14 DRUG SCREENS.

(1) Random drug screenings shall be conducted for every patient according to their phase of
treatment as described in 0940- 05-35-.10. All patients, regardless of phases of t reatment,
shall be subject to at least one randomly observed drug screen per year.

(2) More frequent collection and analysis of drug samples during episodes of relapse or
medically supervised or other types of withdrawal may occur.

(3) Collection and testing shall be done in a manner that assures that samples collected from
patients are unadulterated. Such collection and testing shall include random direct
observation, as may be warranted and determined at the program provider’s discretion, that
is conducted professionally, ethically, and in a manner which respects service recipients’
privacy.

(4) A positive test is a test that results in the presence of any drug or substance that is illegal or
for which the patient cannot provide a valid prescription or any drug or substance prohibited
by the Facility. Any refusal to participate in a random drug test assigned by the Facility shall
also be considered a positive result.

(5) The Facility shall document all results of toxicological tests in the patient’s medical record.

(6) Absence of medications prescribed by the Facility for the service recipient shall be
considered evidence of possible medication diversion and evaluated by the program provider
accordingly.

(7) Nothing contained in this rule shall preclude any Facility from administering any additional
drug tests it determines necessary.

Authority: T.C.A. §§ 4 -3-1601, 4- 1-103, 33- 1-302, 33- 1-305, 33- 1-309, 33- 2-301, 33- 2-302, 33- 2-402,
33-2-403, 33- 2-404, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.13 but was renumbered 0940-05-
35-.14 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.15 DETOXIFICATION AND MEDICALLY SUPERVISED WITHDRAWAL.

(1) Medically supervised withdrawal occurs as a voluntary and therapeutic withdrawal agreed
upon by staff and patient. In some cases, the withdrawal may be initiated against the advice
of clinical staff (against medical advice).

(a) The Facility shall work with the patient to taper the patient’s dose at a rate that is well
tolerated by the patient.

(b) The Facility may offer supportive treatment including increased counseling sessions or
referrals to a self -help group or other counseling provider as appropriate during a
medically supervised withdrawal.

(c) The Facility shall make provisions for continuing care (e.g., referral to other community
resources for counseling) for each patient completing care at the Facility and for re-
entry to the Facility if relapse occurs or if the patient should reconsider treatment at the
Facility.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.14 but was renumbered 0940-05-
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.15, continued)
September, 2025 (Revised) 22
35-.15 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; eff ective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.16 DIVERSION CONTROL PLAN.

(1) Each Facility shall prepare a Diversion Control Plan that contains specific measures to
reduce the possibility of diversion of controlled substances from legitimate medical treatment
use and that assigns specific responsibility to the medical and administrative staff of the
Facility for carrying out the diversion control functions described in the Diversion Control
Plan. These measures may include patient call backs. The Diversion Control Plan shall
address, at a minimum, the following scenarios that may indicate diversion:

(a) The patient has been reported to be diverting medication.

(b) The patient’s recent drug screen results show an absence of the treatment medication.

(d) Results from the patient’s CSMD check demonstrate significant variation from the
patient’s treatment plan.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.15 but was renumbered 0940-05-
35-.16 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.17 REPORTING REQUIREMENTS.

(1) Upon request or inspection, the Facility shall submit the following information to the
Department:

(a) All reports, forms, and correspondence submitted to or received from the health- related
boards of the Tennessee Department of Health, FDA, DEA, SAMHSA or any other
applicable federal agencies, or accreditation organizations shall be provided to the
Office of Licensure within five (5) business days of sending or receiving such
documents.

(b) Such reports and information which may be required by the Department to conduct
evaluations of medication assisted treatment effectiveness or monitor service delivery.

(2) The Facility shall report any significant occurrence, as defined in the TDMHSAS Office of
Licensure Reportable Incident Form Instructions, to the Office of Licensure. This shall include
any unexpected occurrence or accident that results in death or serious injury to a patient or
any action taken against the Facility by the DEA, accrediting body, or other state (not to
exclude any state related boards and/or commissions), local, or federal agency. Additional
reporting requirements may be found in Chapter 0940-05-02-.20.

(3) The Facility shall be required to respond in writing following the citation of the Office of
Licensure or other s tate entity. The Facility will be given an appropriate amount of time to
respond and their response should encapsulate at least the following:

(a) The actions implemented to address current citation and to prevent the recurrence of
the event;
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.17, continued)
September, 2025 (Revised) 23

(b) The time frames for the action(s) to be implemented;

(d) The strategies for the measurements of effectiveness to be established.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.16 but was renumbered 0940-05-
35-.17 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.18 PATIENT RIGHTS.

(1) Patients shall have a right to present complaints, either orally or in w riting, and to have their
complaints addressed and resolved as appropriate in a timely manner.

(2) All applications, certificates, records, reports, and all legal documents, petitions and records
made or information received pursuant to treatment in a Facility directly or indirectly
identifying a patient shall be kept confidential in accordance with T.C.A. § 33- 3-103; Health
Insurance Portability and Accountability Act of 1996 (HIPAA) regulations at 45 Code of
Regulations (CFR) Parts 160 and 164, Subparts A and E; and Confidentiality of Alcohol and
Drug Abuse Patient Records regulations at 42 CFR Part 2.

(3) Patients have the right to a humane treatment environment that affords reasonable protection
from harm, exploitation, and coercion.

(4) In addition to the above Patient Rights, Facility shall follow the Patient Rights requirements
that apply to nonresidential settings as detailed in 0940-05-06.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.17 but was renumbered 0940-05-
35-.18 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.19 COMMUNITY RELATIONS.

(1) The Facility shall identify Facility personnel who are responsible for developing and
implementing a community relations plan.

(2) A Facility shall take proactive efforts to limit disruption outside of its Facility and that may
relate to patients it serves.

(3) Each Facility shall provide TDMHSAS, when requested, with a specific plan describing the
efforts it will make to ensure responsiveness to community needs.

(4) Each Facility shall document community relations efforts and community contacts, including
the resolution of issues identified by community members or patients.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.18 but was renumbered 0940-05-
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.19, continued)
September, 2025 (Revised) 24
35-.19 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed June 27, 2025; effective September 25, 2025.

0940-05-35-.20 PERSONNEL AND STAFFING REQUIREMENTS.

(1) A personnel record for each staff member of a Facility shall include an application for
employment and/or resume and a record of any disciplinary action taken by the Facility. A
licensee shall maintain written records for each employee and volunteer utilized by the
Facility.

(2) Staffing.

(a) Facility Director. The governing body of each Facility shall designate in writing a Facility
director who is responsible for the operation of the Facility and overall compliance with
federal, state and local laws and regulations regarding the operation of nonresidential
office-based opiate treatment programs, and for all employees at the Facility. However,
non-physician Facility directors shall not supervise medical staff. Facilities shall notify
the TDMHSAS Office of Licensure in writing within ten (10) calendar days whenever
there is a change in Facility director.

(b) Medical Director. The governing body of each Facility shall designate in writing a
medical director to be responsible for the supervision of all medical staff at the Facility
and the administration of all medical services at the Facility, including compliance with
all federal, state, and local laws and regulations regarding the medical treatment of
opioid use disorder. The medical director shall be physically present at the Facility the
equivalent of twenty-five (25) percent of the time the Facility is open to the public each
week. On a monthly basis, the medical director shall review ten (10) percent of the
medical charts for patients currently admitted at the Facility and document each chart
review. No physician may serve as medical director of more than three (3) Facilities
without the prior written approval of the TDMHSAS Office of Licensure.

(c) Program Physician. Facilities are required to provide sufficient physician services to
provide the medical treatment and oversight necessary to serve patient need. A
Program Physician may be the same individual as the Medical Director, should the
Facility so choose and all qualification requirements for a medical director are still met.

(d) Physician Assistants and Advanced Practice Registered Nurses. Licensed physician
assistants and advanced practice registered nurses with a certificate of fitness with
privileges to write and sign prescriptions and/or issue legend drugs may perform any
functions under federal and Tennessee laws or regulations. Any physician assistants
and/or advanced practice registered nurses issuing prescriptions at the Facility shall
have their supervising or collaborating physician clearly documented in their personnel
file, if applicable. Physician assistants and advanced practice registered nurses shall
maintain an unrestricted license with their applicable Health Related Board.

(e) Case Management/Care Coord ination. Each Facility shall provide case
management/care coordination services by a person who has received appropriate
training and education, and:

1. Who has at least a Bachelor degree or equivalent education; or

2. Who is supervised by a qualified counseling provider or program provider who
has received training and education to provide case management services.

(3) Staff Qualifications.
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.20, continued)
September, 2025 (Revised) 25

(a) Staff Training. Prior to working with patients, all staff with direct patient
interaction/responsibility shall be oriented in accordance with all applicable
administrative rules (as listed in 0940- 05-35-.03), reporting requirements, and their
individual position responsibilities. All staff shall receive ongoing training and
development activities. Record of all staff training activities shall be noted in their
personnel record.

(b) Medical Director. A medical director shall be licensed to practice medicine or
osteopathy in Tennessee, shall maintain an unrestricted license to practice medicine or
osteopathy, be designated by the OBOT’s governing body, and shall have the following
experience and/or credentials:

1. Certification in addiction psychiatry by the American Board of Psychiatry and
Neurology or exam eligible in addiction psychiatry; and two (2) years of
documented experience in the treatment of persons who are addicted to alcohol
or other drugs; or

2. Certification as an addiction medicine specialist by the American Board of
Addiction Medicine (ABAM) or the American Board of Preventive Medicine
(ABPM) or exam eligible for certification as an addiction medicine specialist and
two (2) years of documented experience in the treatment of persons who are
addicted to alcohol or other drugs; or

3. Meet the Tennessee Department of Health definition of addiction specialist as
outlined in Rule 0880-02-.14; or

4. For an OBOT that is accredited by a national accrediting healthcare organization
listed in Rule 0940 -05-02-.12(1)(a) or (b) in a behavioral health or opioid
treatment service category, or equivalent, the medical director shall be exempted
from the requirements of 1.–3. above.

(c) Program Physician. A program physician shall be licensed to practice medicine or
osteopathy in Tennessee, and shall maintain an unrestricted license to practice
medicine or osteopathy.

(d) Facility Directors. All Facility directors shall have at least one (1) year of supervisory or
administrative experience in the field of opioid use disorder treatment.

(e) Program Provider. A program provider shall be duly licensed, certified or registered as
required by the State of Tennessee for the profession and shall only perform those
duties that are within the scope of their applicable professional practice acts and
Tennessee license.

(4) Direct Care Drug Screening. Facilities shall implement drug screenings for all persons
providing direct services on behalf of the Facility regardless of whether persons are
employed, contracted, or volunteering. Drug screens shall be completed initially, prior to any
service provision, and randomly each year thereafter.

(5) In addition to the above Personnel and Staffing Requirements, the Facility shall follow the
Personnel and Staffing Requirements as detailed in 0940-05-06.

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, and 33- 2-407. Administrative History: Original rules filed October 14, 2016;
effective January 12, 2017. Rule was previously numbered 0940-05-35-.19 but was renumbered 0940-05-
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES

(Rule 0940-05-35-.20, continued)
September, 2025 (Revised) 26
35-.20 with the introduction of a new rule 0940- 05-35-.10 filed March 29, 2019; effective June 27, 2019.
Amendments filed March 29, 2019; effective June 27, 2019. Amendments filed June 27, 2025; effective
September 25, 2025.