Tenn. Comp. R. & Regs. 1200-34-01-.02 - LICENSURE PROCESS

(1) Before operating or practicing in a pain management clinic as defined in T.C.A. § 63-1-301(8) on or after July 1, 2017, the Medical Director of that clinic shall first obtain a Pain Management Clinic License from the Department, except as provided in Rule 1200-34-01-.04(2).

(2) An applicant shall obtain an application from the Administrative Office, respond truthfully and completely to every question or request for information contained in the application, and submit it along with all documentation and fees required by the application and rules to the Administrative Office. When available, this may be accomplished through an online application.

(3) An applicant shall submit all of the following as part of their application:

(a) The initial licensure fee, state regulatory fee, and inspection fee provided in Rule 1200-34-01-.06;

(b) Proof that the Medical Director meets the statutory requirements defined in T.C.A. § 63-1-301(9) to be a pain management specialist;

(c) The names, and if licensed by the Department, the licensure numbers, of every person with any ownership interest in the pain management clinic for which the applicant seeks licensure and each person's percentage of ownership;

(d) Information regarding the form of business entity the clinic will be established as and whether there is already an existing medical practice at the clinic's proposed location;

(e) The physical mailing address of the clinic for which the applicant seeks licensure;

(f) Identification of any other licenses or applications, including pending or denied applications, for pain management clinics associated with the applicant including as an owner, employee or contractor;

(g) The names, and if licensed by the Department, the licensure numbers, of every employee of the clinic;

(h) The names, and if licensed by the Department, the license numbers of every person with whom the clinic has contracted for services, including persons involved in daily operation of the clinic;

(i) The Drug Enforcement Administration ("DEA") Registration numbers for each individual employed by the clinic or with whom the clinic has contracted who holds a DEA registration;

(j) The result of a criminal background check, submitted to the Administrative Office, directly from the vendor identified in the application, for the following personnel:

1. The Medical Director;

2. Each person with any ownership interest;

3. Each person who holds a DEA registration who will be providing services at that clinic; and

4. Where any disclosure required in 1200-34-01-.02(4)(a)-(d) has yielded an affirmative answer, that employee or individual or company with whom the clinic has contracted who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities;

(k) The name, license number, and address, of every pharmacy in which either the Medical Director or any owner of the clinic has any ownership interest that is greater than one percent (1%), and the percentage of that ownership interest;

(l) Proof that all supervising physicians who are supervising any of the advanced practice registered nurses or physician assistants providing services at the pain management clinic are pain management specialists;

(m) A statement of verification that the Medical Director has read and understood the statutes and rules governing pain management clinics, as well as the Tennessee Chronic Pain Guidelines (http://www.tn.gov/assets/entities/health/attachments/ChronicPainGuidelines.pdf), and the Tennessee Pain Clinic Guidelines (http://www.tn.gov/assets/entities/health/attachments/Pain_Clinic_Guidelines.pdf); and

(n) Any other information requested by the Department.

(4) An applicant shall disclose the circumstances and produce any documentation requested by the Department surrounding any of the following:

(a) Whether any owner has ever been convicted of, pled nolo contendere to, or received deferred adjudication for an offense that constitutes a felony;

(b) Whether any employee, or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities has ever been convicted of any felony;

(c) Whether any owner, employee, or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities is under indictment for any offense involving the sale, diversion, or dispensing of controlled substances under any state or federal law;

(d) Whether any owner, employee, or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities has ever been convicted of any offense involving the sale, diversion, or dispensing of controlled substances under any state or federal law;

(e) Whether any owner, employee, or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities has ever applied for or held any license issued by any jurisdiction, under which that license holder may prescribe, dispense, administer, supply, or sell a controlled substance, which has been restricted, disciplined, or denied;

(f) Whether any owner, employee, or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities has ever been subject to disciplinary action by any licensing entity for conduct that was the result of inappropriately prescribing, dispensing, administering, supplying, or selling a controlled substance;

(g) Loss or restriction of privileges at any hospital or health care facility on the part of the Medical Director;

(h) Whether any owner, medical director, employee or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities is under any board order requiring advocacy from a professional assistance program that monitors for substance abuse;

(i) Whether any owner, employee, or person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities has ever had a DEA registration that was surrendered for cause or disciplined.

(5) Where appropriate, the applicant shall cause to be submitted from the DEA, documentation regarding any surrender for cause, revocation, or other discipline of a DEA registration certificate.

(6) An applicant shall submit a separate application for licensure for each clinic location regardless of whether the clinic is operated under the same business name, ownership, or management as another clinic. Each clinic location shall be licensed separately.

Notes

Tenn. Comp. R. & Regs. 1200-34-01-.02

Emergency rule filed September 30, 2011; effective through March 28, 2012. Emergency rule filed September 30, 2011 and effective through March 28, 2012; on March 29, 2012 the emergency rule expired and reverted to its previous status. Permanent rules 1200-34-01-.01 through .10 filed December 27, 2011; to have been effective March 26, 2012. The Government Operations Committee filed a seven-day stay of effective date of the rules; new effective date April 2, 2012. On March 26, 2012, the Government Operations Committee withdrew its stay; new effective date March 26, 2012. Emergency rule filed May 25, 2017 and effective through November 21, 2017. The emergency rule expired on November 22, 2017 and reverted to its previous status. Repeal and new rules filed August 28, 2017; effective 11/26/2017.

Authority: T.C.A. §§ 63-1-301, 63-1-303, 63-1-306, 63-1-309, 63-1-316, and 63-1-401.