Rules & Regulations of the State of Tennessee
Title 0940 - Mental Health and Substance Abuse Services
Subtitle 0940-05 - Licensure
Chapter 0940-05-35 - Minimum Program Requirements for Nonresidential Office-Based Opiate Treatment Facilities
Section 0940-05-35-.13 - MEDICATION MANAGEMENT

Universal Citation: TN Comp Rules and Regs 0940-05-35-.13

Current through April 3, 2024

(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 be based on the clinical judgement of the program physician who has examined the patient and who has considered all available relevant patient-specific information including, but not limited to, drug screens, initial screenings, medication availability and cost, and in consultation with the patient.

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

3. A patient dose greater than sixteen milligrams (16mg), or its equivalent, per day shall be considered a high dose.

4. A patient dose of twenty-four milligrams (24mg), 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 written for a patient at the Facility shall be documented in the patient's medical chart.

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

(b) Dispensing. An office based opiate treatment facility without dispensing authorization is prohibited from dispensing buprenorphine-containing products.

(c) Protocols for initiating or switching a patient to a high dose of the treatment medication used at the facility.
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 prescriber 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.
(i) The 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 prescriber 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) Prescriber-Initiated-and-Led Tapering Discussions
1. Prescribers 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.
(i) 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 physician. 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 judgement. 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 or abusing these products. Notwithstanding, in rare circumstances:
1. Patients who present with a longstanding prescription for benzodiazepines for a legitimate medical condition from another prescriber may be prescribed buprenorphine products by a physician with a DATA 2000 waiver. 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 physician 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 abuse should be clearly documented in the medical record. A program physician 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 record.

(III) Patients receiving high dose therapy should be tapered as rapidly as possible to two (2) milligrams or less of clonazepam or its equivalent twice daily, and 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 with a DATA 2000 waiver 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 develop guidelines for review of prescriptions from other providers. These shall include:

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

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

(c) Documentation of the Facility's efforts to obtain information about prescriptions from outside physicians in the patient's 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, 33-2-407, Chapter 912 of the Public Acts of 2016, and Chapter 978 of the Public Acts of 2018.

Disclaimer: These regulations may not be the most recent version. Tennessee may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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