(a) No later than July 31, 2013, and at least annually thereafter but more often at the discretion of the commissioner, the department of health shall:
Terms Used In Tennessee Code 68-1-128
Contract: A legal written agreement that becomes binding when signed.
Record: means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in a perceivable form. See Tennessee Code 1-3-105
signed: includes a mark, the name being written near the mark and witnessed, or any other symbol or methodology executed or adopted by a party with intention to authenticate a writing or record, regardless of being witnessed. See Tennessee Code 1-3-105
State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
Subpoena: A command to a witness to appear and give testimony.
written: includes printing, typewriting, engraving, lithography, and any other mode of representing words and letters. See Tennessee Code 1-3-105
(1)(A) Identify the top fifty (50) prescribers who have unique DEA numbers of controlled substances, other than buprenorphine formulations that have not received approval for pain applications from the federal food and drug administration, in the previous calendar year, or if implemented more frequently for the relevant time period as determined by the department, from the data available in the controlled substances database established pursuant to the Tennessee Prescription Safety Act of 2016, compiled in title 53, chapter 10, part 3;(B) Identify the top twenty (20) prescribers who have unique DEA numbers of buprenorphine products or equivalent products in the previous calendar year, or if implemented more frequently for the relevant time period as determined by the department, from the data available in the controlled substances database established pursuant to the Tennessee Prescription Safety Act of 2016. The department may organize the list of prescribers required by this subdivision (a)(1)(B) in any manner as may be appropriate to reflect levels of service, training, or other relevant factors by a healthcare provider. These factors may include, but not be limited to, whether the provider is board-certified;(2) Send a letter through registered mail to each prescriber identified in subdivision (a)(1), and to the collaborating physician as found on the provider’s profile established in title 63, chapter 32 of each advanced practice registered nurse and each physician assistant identified in subdivision (a)(1) that notifies the prescribers and, where appropriate, the collaborating physician that the prescriber has been identified pursuant to subdivision (a)(1) and includes the following information:
(A) The significant controlled substances prescribed by the prescriber;(B) The number of patients prescribed these controlled substances by the prescriber;(C) The total milligrams in morphine equivalents of controlled substances prescribed during the relevant period of time; and(D) Any other relevant information sought by the department; and(3) If there is an active investigation against the prescriber or, where appropriate the collaborating physician on the lists of prescribers identified in subdivision (a)(1), the department is authorized to withhold any communication required under this section until such time as charges are brought or the investigation is closed.(b)(1)(A) At the discretion of the department, each prescriber and each collaborating physician of an advanced practice registered nurse and physician assistant who appear on the lists of the top twenty (20) prescribers of buprenorphine products, the top fifty (50) prescribers of controlled substances in the state, and the top ten (10) prescribers of controlled substances in all of the counties combined having a population of less than fifty thousand (50,000), according to the 2010 federal census or any subsequent federal census in the relevant period of time shall submit to the department within fifteen (15) business days through registered mail or electronic mail an explanation justifying the amounts of controlled substances prescribed in the relevant period of time by the prescriber demonstrating that these amounts were medically necessary for the patients treated and that, for advanced practice registered nurses and physician assistants, the collaborating physician had reviewed and approved the prescribing amounts. The department shall consider the prescriber’s specialty and the patients’ ages to make a determination as to whether the explanation of the prescriber and, where appropriate the collaborating physician for the prescribing habits of the prescriber of controlled substances is justifiable.(B) The department is authorized to develop a model form to assist the prescriber and where appropriate the collaborating physician in completing the explanation required by this subsection (b).(C) The department is authorized to contract with an expert reviewer to determine if the explanation is acceptable. Should charges ultimately be filed against the prescriber or, where appropriate the collaborating physician any report of the expert reviewer shall be discoverable by the licensee.(2) If the department is not satisfied with any explanation by the prescriber or where appropriate a collaborating physician it shall communicate via registered mail such concerns to the prescriber and, if appropriate, the collaborating physician. The prescriber and, if appropriate, the collaborating physician shall have fifteen (15) business days to attempt to rectify the department’s stated concerns.(3) If the department remains unsatisfied after receiving a justification pursuant to subdivision (b)(2), the department may submit its concerns to the member of the controlled substance database committee who represents the board which has licensed the individual. This member shall have access to all of the documents pertaining to the concerns of the department and the expert reviewer. If that member also believes that the explanations which have been provided are not sufficient to justify the prescribing pattern of the prescriber, the concerns may be forwarded to the department’s office of investigations. Investigations are conducted by the entity responsible for licensure of that prescriber.(c)(1) In addition to identifying prescribers pursuant to subsections (a) and (b), beginning July 1, 2017, and annually thereafter, the department shall identify high-risk prescribers based on clinical outcomes, including patient overdoses. The determination of which providers are high-risk prescribers, including the criteria to make such determination, shall be made by the department. Providers determined to be high-risk prescribers pursuant to this subdivision (c)(1) shall be subject to selected chart review and investigation by the department.(2) If a prescriber is identified as a high-risk prescriber pursuant to subdivision (c)(1), the department shall submit the high-risk prescriber’s information to the board that issued the prescriber’s license for appropriate action.(3) Upon receiving information pursuant to subdivision (c)(2), the licensing board shall notify the prescriber and, if applicable, the prescriber’s collaborating physician of the prescriber’s identification as a high-risk prescriber and, as applicable, require the prescriber to:
(A) Participate in continuing education that is designed to inform providers about the risks, complications, and consequences of opioid addiction. The specific continuing education courses and number of hours to be completed by the prescriber shall be determined by the licensing board;(B) Make available, in the prescriber’s waiting room and clinic areas where the prescriber’s patient can view, educational literature that warns persons of risks, complications, and consequences of opioid addiction. The specific literature to be made available pursuant to this subdivision (c)(3)(B) shall be determined by the department and made available on the department’s website;(C) Obtain written consent on a form that explains the risks of, complications of, medical and physical alternatives to, and consequences of opioid therapy and addiction to any patient who will receive opioid therapy for more than three (3) weeks with daily dosages of sixty (60) morphine milligram equivalents (MME) or higher. The consent shall include a certification from the patient that the patient understands the information. In order to continue to treat the patient, the provider must assure that the consent is signed by the patient and made part of the patient’s health record; and(D) Renew the consent described in subdivision (c)(3)(C) at four-week intervals for patients who continue to receive opioid therapy. In order to continue to treat the patient, the provider must assure that the consent is signed by the patient and made part of the patient’s health record.(4) An identified high-risk prescriber must comply with the requirements set out in subdivision (c)(3) for a period of one (1) year from the time the provider was notified of the provider’s identification as a high-risk prescriber of opioids. Failure of a prescriber to comply with the requirements set out in subdivision (c)(3) shall be treated as an act constituting unprofessional conduct for which disciplinary action may be instituted under the authority of the board that issued the prescriber’s license.(5) All costs associated with this subsection (c) shall be paid by the identified provider.(6) If the provider disputes the identification of the provider as a high-risk prescriber of opioids, the provider may request the department conduct an internal review of the identification, which shall be done by the commissioner or the commissioner’s designee. Any such internal review is not subject to title 4, chapter 5, part 3.(d) All data, reports and correspondence under this section shall be confidential and shall not be considered to be a public record for purposes of title 10, chapter 7.(e) All correspondence and reports can be used by the department’s office of investigations and/or the respective entity responsible for licensure to develop a disciplinary case against the prescriber and, where appropriate, the collaborating physician of an advanced practice registered nurse or physician assistant.(f) The failure of a prescriber or, where appropriate, a collaborating physician to respond to the department’s request for information in a timely fashion may be a cause for disciplinary action by the prescriber’s, or where appropriate the collaborating physician’s licensing board, and may include a penalty of up to one thousand dollars ($1,000) per day for failure to respond or failure to respond in a timely manner.(g) All correspondence shall be maintained for five (5) years and kept organized by prescriber so that information on a prescriber who appears on multiple lists compiled pursuant to subsection (a) may be aggregated.(h)(1) After the completion of the study provided for in subdivision (i)(1), and no later than July 31 of each subsequent year, in consultation with the controlled substance database, the department of health shall identify licensed prescribers whose prescribing patterns of controlled substances represent statistical outliers in addition to top prescribers and high-risk prescribers identified pursuant to this section.(2) The department of health shall inquire of the appropriate licensing board concerning any action taken against a prescriber identified by the department pursuant to subdivision (h)(1). Each board shall respond within thirty (30) days concerning the status of any action or lack of action against an identified prescriber.(3) Each board shall also report on the total numbers of prescribers disciplined each year and the general categories of discipline imposed on the prescribers, including consent agreements, as well as reasons for declining to exercise discipline.(4) The commissioner of health shall report a summary of the data concerning prescribers identified under this subsection (h), including a summary of any disciplinary action taken or pending by a licensing board against a prescriber, to the chairs of the health and welfare committee of the senate and the health committee of the house of representatives.(i)(1) On or before January 1, 2020, the comptroller of the treasury shall complete a study of the incidence of significantly statistically abnormal prescribing patterns by prescribers licensed under title 63 and the disciplinary response of the licensing boards to those prescribers. The comptroller shall report findings and recommendations of the study to the chairs of the health and welfare committee of the senate and the health committee of the house of representatives.(2) Notwithstanding any other state law, the department of health, the controlled substance database, and a licensing board of any prescriber of opioids shall disclose to the comptroller of the treasury any relevant information in order for the comptroller to complete this study from July 1, 2018, through June 30, 2020. Any record that personally identifies a patient or a healthcare practitioner that is disclosed to the comptroller shall be confidential and shall not be disclosed as a public record at any time and shall not be subject to a subpoena.
