Tenn. Comp. R. & Regs. 0940-05-35-.04

Current through June 10, 2024

Section 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 and holds an active DATA 2000 waiver. "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 holds an active DATA 2000 waiver 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; and,

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

(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;

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

(c) Evidence of a contracted and/or currently employed physician with a DATA 2000 waiver;

(d) Evidence of all physicians 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;

(e) Comprehensive listing of all members of the organization's ownership structure; 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 Rule, 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 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 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.

(a) 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.

Tenn. Comp. R. & Regs. 0940-05-35-.04

Original rules filed October 14, 2016; effective January 12, 2017. Amendments filed March 29, 2019; effective 6/27/2019.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, 33-2-402, 33-2-403, 33-2-404, 33-2-407, and Chapter 912 of the Public Acts of 2016.