Section 1200-34-01-.09 - NOTIFICATIONS AND REPORTING(1) A pain management clinic license shall not be assignable or transferable. However, the Department recognizes that some circumstances may cause a Medical Director to depart from a clinic. While best practice would be for the new Medical Director to seek licensure from the Department while the current Medical Director is still actively serving at his clinic's licensed location, in the event that the current Medical Director no longer meets the requirements contained in T.C.A. §§ 63-1-301, et seq. and these rules to be a Medical Director, or departs from a clinic, the Department will allow a grace period during which a clinic may continue to operate provided the following occurs: (a) The clinic may continue to operate on the current Medical Director's license for a grace period of up to thirty (30) calendar days from the date that the current Medical Director no longer met the requirements contained in T.C.A. §§ 63-1-301, et seq. and these rules to be a Medical Director, or the date the current Medical Director departs the clinic, provided the clinic notifies the Department, on a form prescribed by the Department, within ten (10) business days of the identity of another pain management specialist who will serve as the interim Medical Director for the clinic;(b) During this grace period after which the current Medical Director no longer meets the requirements of this part or has departed from the clinic, which shall total no more than thirty (30) calendar days, both the pain management clinic license and the interim Medical Director, are liable for any actions or inactions occurring at or caused by the pain management clinic;(c) The new Medical Director shall submit a completed pain management clinic application immediately upon agreement to assume the duties of medical director at the clinic;(d) Should the clinic have difficulty obtaining a new medical director, it may apply for a waiver of up to an additional sixty (60) calendar days in which to operate with the interim Medical Director. The waiver form shall be promulgated by the Department. The waiver will only be granted upon good cause shown, demonstrated reasonable efforts to locate and retain a new medical director, and a reasonable belief by the Department that public health will be harmed by not granting the waiver. Both the pain management clinic license and the interim Medical Director are liable for any actions or inactions occurring at or caused by the pain management clinic during any granted grace period;(e) Upon expiration of thirty (30) calendar days, or upon the expiration of ninety (90) calendar days if a waiver was applied for and granted, if a new pain management clinic license has not been issued by the Department, the clinic must cease operation. Each day of continued operation would constitute a separate violation for any licensee who continues to work in the clinic;(f) Notwithstanding these provisions, if the current Medical Director of a clinic chooses to inactivate the license, the clinic must cease operating as a pain management clinic immediately upon inactivation. Prior to inactivating the license, the Medical Director shall have the responsibility to notify all patients receiving care at the clinic and arrange for continuity of care; and(g) In the event the clinic is unable to find a permanent new Medical Director during the grace period, the individual serving as interim Medical Director may apply for a pain management clinic license to be issued for a term of six (6) months. At its discretion, and upon such request by the interim Medical Director applicant, the Department may issue a pain management clinic license for a term of six months. The fee for such a license shall be proportional to the annual fee, but other than the term, the license shall be modified in no other manner; upon issuance of the truncated license, the interim Medical Director applicant shall become the licensee.(2) The Medical Director shall notify the Department within thirty (30) days of the occurrence if any of the following occur to any person who owns, is an employee of, or is a person with whom the clinic contracts who has clinical contact with patients, contact with onsite patient information or specimens, and/or has management responsibilities: (a) That person has applied for any state or federal license, registration, or certificate that has been denied;(b) That person has held any state or federal license, registration, or certificate that has been restricted or subject to disciplinary action relative to prescribing, dispensing, administering, supplying or selling a controlled substance; or(c) That person has been convicted of a felony or any offense involving the sale, diversion, or dispensing of controlled substances under state or federal law related to operation of or work in the clinic.(3) In the event that the name of the clinic changes, the Medical Director shall notify the Department of the name change within ten (10) business days after the name change occurs.(4) In addition to the reporting requirements above, the Medical Director shall make an annual report to the Department on a form promulgated for such reporting. The report shall be due to the Department sixty (60) days prior to the pain management clinic's certificate or license anniversary date and shall cover the previous twelve (12) months. The report shall include the following: (a) Whether the pain management clinic is associated with a hospital;(b) Whether the pain management clinic is adjacent to a pharmacy;(c) The names of each physician, physician assistant, and advanced practice registered nurse who worked in the clinic each month during the preceding year along with their license numbers;(d) The number of patients seen by the clinic for each month in the preceding year;(e) The number of patients seen in each month who received controlled substances for chronic nonmalignant pain from a practitioner at the clinic;(f) A list of all controlled drug samples which were dispensed in the preceding year or a copy of the clinic's log pursuant to Title 21 C.F.R. § 1304.11, with regard to those samples;(g) A list of all owners of the clinic and their percentage of interest in the clinic for each month in the preceding year;(h) The names of any employees hired or separated within the preceding year as well as the license number of that employee if any are or were licensees; and(i) A summary of each advertisement for that clinic location and, where more than one location exists, each advertisement for the larger organization as a whole. For purposes of this rule, an advertisement is any material or spoken word, which is: (1) paid for in consideration of any kind; (2) intended to promote a clinic's services; or (3) created or given in any manner not in association with a bona fide, unpaid-other than customary coverage of expenses-media encounter, interview, or professional continuing medical education event.Tenn. Comp. R. & Regs. 1200-34-01-.09
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. §§ 63-1-303, 63-1-306, 63-1-309, 63-1-316, 63-1-317, and 63-1-319.