Section 1200-34-01-.10 - MEDICAL DIRECTOR RESPONSIBILITIES(1) Clinic Operation and Personnel. (a) The Medical Director of a pain management clinic shall: 1. Oversee all of the pain management services provided at the clinic;2. Be on-site at the clinic at least twenty percent (20%) of the clinic's weekly total number of operating hours;3. Ensure that each supervising physician for each of the health care providers working at the clinic complies with the supervision requirements contained in Tenn. Comp. Rules and Regulations Chapter 0880-03 and Chapter 0880-06, or Rule 1050-02-.15, as applicable, and is a pain management specialist;4. Ensure that all health care providers employed by or working at the pain management clinic comply with applicable state and federal laws and rules relative to the prescribing of controlled substances in the pain management clinic;5. Ensure the establishment of protocols for the health care providers employed by or working at the pain management clinic as provided in Tenn. Comp. Rules and Regulations Chapter 0880-03 and Chapter 0880-06 and ensure that providers comply with such protocols, as well as any other established policies and procedures;6. Identify a pain management specialist who has agreed to provide coverage in the event that the Medical Director is unable to fulfill his or her duties on a temporary basis because of illness, vacation, or unavailability. Such coverage may be provided on a temporary, short-term basis and serving in this capacity will not be considered to count against the limit of four (4) pain management clinics at which a pain management specialist may serve as medical director. The Medical Director maintains all responsibility during any period where coverage is provided, but the covering physician shall only share responsibility for those times during which he or she is providing coverage;7. Establish quality assurance policies and procedures, which, at a minimum, include, but are not limited to:(i) Documentation of the background, training, licensure, and certifications for all pain management clinic staff providing patient care;(ii) A written drug screening policy and compliance plan for patients to include random urine drug screening as clinically indicated, but at a minimum, upon each new admission and once every six (6) months thereafter;(iii) Use of substance use disorder risk assessment tools upon new patient admission and periodic review or re-assessment;(iv) Evaluating and monitoring the quality and appropriateness of patient care, the methods of improving patient care as well as identifying and correcting deficiencies, and the opportunities to improve the clinic's performance and quality of care;(v) Medication counts for any controlled substances prescribed by the clinic to the clinic's patients;(vi) Use of pain agreements and periodic review of such agreements;(vii) Health care provider access to and review of patient information contained in the controlled substance monitoring database in accordance with T.C.A. §§ 53-10-301 - 53-10-309, as clinically indicated, but at a minimum upon each new admission and once every six (6) months thereafter;(viii) Documentation of requests for records from other health care providers;(ix) Creation of a written process for clinical practice evaluation and evidence of regular appropriate supervisory action based on results of the clinical practice evaluation;8. Establish an infection control program to provide a sanitary environment for the prevention, control, and investigation of infections and communicable diseases, including, but not limited to: (i) Written infection control policies and procedures;(ii) Creation of written policies that are consistent with the Centers for Disease Control and Prevention's guidelines for minimum prevention for outpatient settings; and(iii) A log of incidents related to infectious and communicable diseases and the corrective action taken;9. Establish written policies and procedures to assure patient access to their medical records and continuity of care should the pain management clinic close.(2) Records, Reporting Requirements, and Patient Billing Procedures. (a) The Medical Director shall ensure that each health care provider employed by or working at a certified or licensed pain management clinic shall maintain complete and accurate medical records of patient consultation, examination, diagnosis, and treatment, which shall include, but not be limited to the following: 1. Patient medical history and physical examination;2. Diagnostic, therapeutic, and laboratory results, evaluations and consultations, and records from other health care providers, as available, or attempts to obtain such;3. Documentation of informed consent and discussion of risks and benefits of treatment provided;4. Treatments, treatment options, and treatment objectives;5. Medications prescribed (including date, type, dosage and quantity prescribed);6. Instructions and agreements;8. A notation indicating whether the controlled substance monitoring database had been accessed for a particular patient;9. Results of urine drug screens to be performed as clinically indicated, but at a minimum upon each new admission and once every six (6) months thereafter.(b) The Medical Director's responsibilities shall include having a system in place to ensure adequate medical documentation and responsibility for addressing inadequate documentation. Medical records must at all times be available to clinicians to review onsite, but may be maintained at a separate location.(3) The Medical Director shall take appropriate steps, including having a system in place, to ensure that adequate billing records are maintained for the pain management clinic and shall ensure that adequate billing records are maintained for all patients and for all patient visits. Billing records shall be made for all methods of payment. Billing records shall be made available to the Department upon request. Billing records shall include, but not be limited to the following:
(a) The amount paid for the co-pay and/or remainder of services;(c) Date of the delivery of services;(e) Description of services.(4) The Medical Director shall ensure that patient medical records shall be maintained for ten (10) years from the date of the patient's last treatment at the clinic.(5) The Medical Director shall ensure that patient billing records shall be maintained for seven (7) years from the date of the patient's last treatment at the clinic.(6) The Medical Director shall ensure that all health care providers employed by or working at the pain management clinic are properly licensed and certified at all times.(7) The Medical Director shall ensure the delivery of quality care and quality services at the clinic.(8) The Medical Director shall ensure that all monetary transactions at the pain management clinic shall be in accordance with T.C.A. § 63-1-310 which provides that a pain management clinic may accept only a check or credit card in payment for services provided at the clinic; except that payment may be made in cash or money order for a co-pay, coinsurance, or deductible when the remainder of the charge for the services will be submitted to the patient's insurance plan for reimbursement.(9) The Medical Director shall ensure that patients have access to their medical records at any time upon request of the patient in keeping with T.C.A. §§ 63-2-101, et seq. and especially in the event that the clinic closes. The Medical Director shall also ensure that the Department has access to the records upon request.Tenn. Comp. R. & Regs. 1200-34-01-.10
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, and 63-1-310.