2023 Tennessee Code › Title 53 - FOOD, DRUGS AND COSMETICS (§§ 53-1-101 — 53-15-103) › Chapter 10 - LEGEND DRUGS (§§ 53-10-101 — 53-10-401) › Part 3 - TENNESSEE PRESCRIPTION SAFETY ACT OF 2016 (§§ 53-10-301 — 53-10-312) › Section 53-10-306 - Confidentiality - Disclosure of information - Penalties

(a)
Information sent to, contained in, and reported from the database in any format is confidential and not subject to title 10, chapter 7, regarding public records, and not subject to subpoena from any court and shall be made available only as provided for in §
53-10-308
and to the following persons in accordance with the limitations stated and rules promulgated pursuant to this part, or as otherwise provided for in §§
53-10-304
and
53-10-311
:
(1)
Personnel of the committee specifically assigned to conduct analysis or research;
(2)
Authorized committee, board, or department personnel engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities;
(3)
A healthcare practitioner conducting medication history reviews who is involved in the care of a patient or making decisions regarding patient care or patient enrollment; a healthcare practitioner or supervising physician of a healthcare practitioner conducting a review of all medications dispensed by prescription attributed to that healthcare practitioner or a healthcare practitioner having authority to prescribe or dispense controlled substances, to the extent the information relates specifically to a current or bona fide prospective patient of the healthcare practitioner, to whom the healthcare practitioner has prescribed or dispensed, is prescribing, dispensing, approving of the prescribing or dispensing, or considering prescribing or dispensing any controlled substance. Each authorized individual referenced under this subdivision (a)(3) shall have a separate identifiable authentication for access;
(4)
A healthcare practitioner under review by a quality improvement committee, as defined in §
63-1-150
, who submits information contained in, and reported from the database to a quality improvement committee;
(5)
A licensed pharmacist conducting drug utilization or medication history reviews who is actively involved in the care of the patient or making decisions regarding care of the patient or patient enrollment. Each authorized individual referenced under this subdivision (a)(5) shall have a separate identifiable authentication for access;
(6)
The state chief medical examiner, a deputy or assistant state medical examiner appointed pursuant to §
38-7-103
, a county medical examiner or deputy county medical examiner appointed pursuant to §
38-7-104
, or a forensic pathologist under the control or direction of the chief medical examiner or a county medical examiner when acting in an official capacity as established in §
38-7-109
; provided, that any access to information from the database is subject to the confidentiality provisions of this part, except where information obtained from the database is appropriately included in any official report under §
38-7-110(c)
;
(7)
Personnel of the following entities actively engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities related directly to the TennCare program:
(A)
The office of inspector general;
(B)
The medicaid fraud control unit; and
(C)
The bureau of TennCare's chief medical officer, associate chief medical directors, director of quality oversight, and directors of pharmacy;
(8)
Personnel of the bureau of TennCare who request deidentified controlled substances prescribing information from the database which does not contain personally identifiable data but only on request by the following personnel of the bureau:
(A)
The chief medical officer;
(B)
Associate chief medical directors;
(C)
Director of quality oversight; and
(D)
Directors of pharmacy;
(9)
A quality improvement committee, as defined in §
63-1-150
, of a group practice that is engaged in the provision of healthcare services, as part of the committee's confidential and privileged activities under §
63-1-150(c)(3)
with respect to the evaluation of the safety, quality, appropriateness, or necessity of healthcare services performed by a healthcare practitioner, if the information is furnished to a quality improvement committee by the healthcare practitioner that is the subject of review by the quality improvement committee;
(10)
A quality improvement committee, as defined in §
68-11-272
, of a hospital licensed under title 68 or title 33, as part of the committee's confidential and privileged activities under §
68-11-272(b)(4)
with respect to the evaluation, supervision, or discipline of a healthcare provider employed by the hospital or any of its affiliates or subsidiaries, who is known or suspected by the hospital's administrator to be prescribing controlled substances for the healthcare practitioner's personal use;
(11)
(A)
Law enforcement personnel; provided, that such personnel are engaged in the official investigation and enforcement of state or federal laws involving controlled substances or violations under this part; and that any law enforcement personnel receiving information from the database pursuant to this section shall comply with this subsection (a);
(B)
Any law enforcement personnel; provided, that for an officer or agent to have the authorization to request information from the database, the officer or agent shall first be preapproved. Preapproval shall require:
(i)
Agents of a judicial drug task force employed by the United States department of justice, law enforcement officers certified pursuant to §
38-8-107
, and law enforcement officers certified by other states to require:
(a)
The list of preapproved agents to be sent to the district attorney general in the judicial district in the district in which the task force has jurisdiction; and
(b)
By December 1 of each year, each district attorney general shall send to the director a list of applicants authorized to request information from the database from that general's judicial district; or
(ii)
Tennessee bureau of investigation (TBI) agents or drug enforcement administration agents to require:
(a)
Preapproval by the assistant special agent in charge or the agent's immediate supervisor and division head. Approved applicants shall be sent to the board by the director; and
(b)
By December 1 of each year, the TBI director or the assistant special agent in charge shall send to the director of the controlled substance database, committee, or commissioner a list of applicants authorized to request information from the database;
(C)
An application submitted by law enforcement personnel shall include, but not be limited to, the:
(i)
Applicant's name; title; agency; agency address; agency contact number; agency supervisor; and badge number, identification number, or commission number; and the business e-mail address of each applicant officer or agent, the appropriate district attorney general, DEA agent, and, if a TBI agent, the TBI director and their business e-mail addresses; and
(ii)
Signatures of the applicant, the applicant's approving supervisor, and the district attorney general of the judicial district, assistant special agent in charge in which the applicant has jurisdiction, or the approving division head and the TBI director; and
(D)
It shall be a duty of the committee or commissioner, through the director, as part of the duties to maintain the database pursuant to §
53-10-305(e)
, to receive and verify the lists of authorized applications sent to it by the district attorneys general, assistant special agent in charge, and the director of the TBI pursuant to this subsection (a);
(12)
The judge of a drug court treatment program, created under the Drug Court Treatment Act of 2003, compiled in title 16, chapter 22, and pursuant to this part to the extent the information relates specifically to a current participant in the drug court treatment program. Any judge or personnel of a drug court treatment program receiving information from the database pursuant to this subdivision (a)(12) shall comply with this subsection (a) and the following:
(A)
Any judge of a participating drug court requesting information from the database shall submit an application to the director pursuant to subdivision (a)(12)(B) that must include acknowledgment by the district attorney general of the judge's judicial district that the judge is seeking information from the database on a current participant in the drug court treatment program;
(B)
An application submitted by the judge of a drug court treatment program shall include:
(i)
The applicant's name, title, agency, agency address, and business e-mail address;
(ii)
The signatures of the judge and the district attorney general of the judicial district in which the judge has jurisdiction; and
(iii)
The names of any current participants in the drug court treatment program that the judge has a reasonable belief may not be in compliance with the guidelines or rules of participation in the drug court treatment program as they pertain solely to the participant's unauthorized use or misuse of controlled substances. Such information shall not be considered a public record as defined by §
10-7-503
; and
(C)
The commissioner, through the director, shall, as part of the duty to maintain the database pursuant to this part, receive the authorized application sent by the judge of the participating drug court treatment program pursuant to this subsection (a); and
(13)
A healthcare practitioner delegate, who is acting under the direction and supervision of a healthcare practitioner as an agent of a healthcare practitioner. Each authorized individual shall have a separate identifiable authentication for access.
(b)
When requesting information from the database, law enforcement personnel shall provide a case number as part of the process for requesting information from the database. The case number entered shall correspond with an official investigation involving controlled substances and information requested should directly relate to the investigation.
(c)
The commissioner, in consultation with the committee, may, by rule, establish a fee for providing information to a law enforcement agency, judicial district drug task force, TBI, or a judge of a drug court treatment program pursuant to this section. In determining the fee and type of fee to be charged, the commissioner may consider options such as an annual fee or a per use, incremental cost basis fee, or other methods as the commissioner deems appropriate.
(d)
Law enforcement personnel, who are authorized to request information from the database, shall resubmit their identifying application information that was submitted pursuant to this section to the appropriate district attorney, United States attorney, TBI director, or assistant special agent in charge by November 20 of each year. Such resubmitted applications shall be sent by the appropriate district attorney general, TBI director, or assistant special agent in charge to the board by December 1 of each year. If during the calendar year a name is added to the list, removed from the list, or information about a person on the list changes, the appropriate district attorney, or special agent in charge, shall immediately notify the director of the controlled substance database, committee, or commissioner of any changes to the list submitted or in the information submitted for each attorney, officer, or agent on the list application.
(e)
(1)
Information obtained by law enforcement personnel from the database may be shared with other law enforcement personnel or prosecutorial officials only upon the direction of the officer or agent who originally requested the information and may only be shared with law enforcement personnel from other law enforcement agencies who are directly participating in an official joint investigation.
(2)
Any information obtained from the database that is sent to law enforcement personnel shall also be sent to the district attorney general of the judicial district to the district in which such officer or agent has jurisdiction. Likewise, any database information sent to a TBI agent or DEA agent shall also be sent to the TBI director or the assistant special agent in charge.
(3)
(A)
Information obtained from the database by the judge of a drug court treatment program may be shared with personnel of a drug court treatment program.
(B)
For the purposes of this subdivision (e)(3), "personnel of a drug court treatment program" includes a judge of a drug court and any person employed by the drug court and designated by the judge to require access to the information in order to efficiently administer the drug court treatment program.
(4)
Any information obtained from the database that is sent to a judge of a drug court treatment program shall also be sent to the district attorney general of the judicial district in which the judge has jurisdiction.
(f)
(1)
To ensure the privacy and confidentiality of patient records, information obtained from the database by law enforcement personnel shall be retained by the law enforcement personnel's respective department or agency. The information obtained from the database shall not be made a public record. Any information used in a criminal or administrative action from the controlled substance monitoring database shall be placed under seal or have patient names and all other personally identifying information of patients redacted. Information obtained from the database shall be maintained as evidence in accordance with each law enforcement agency's respective procedures relating to the maintenance of evidence.
(2)
To ensure the privacy and confidentiality of patient records, information obtained from the database by a drug court treatment program shall be retained by the program director of the drug court treatment program. The information obtained from the database shall not be made a public record, notwithstanding the use of the information in court for prosecution purposes.
(g)
Any information disseminated pursuant to subdivisions (a)(1)-(3) and (a)(5)-(8) shall be released to the individual or entity requesting the information by the database manager or by password-protected internet access.
(h)
(1)
Any healthcare practitioner or healthcare practitioner delegate receiving patient-specific information pursuant to subdivision (a)(1), (a)(2), (a)(3), or (a)(5) shall not disclose the information to any person other than:
(A)
The patient to whom the information relates;
(B)
Other healthcare practitioners who are involved or have a bona fide prospective involvement in the treatment of the patient, or healthcare practitioners identified by the information for the purpose of verifying the accuracy of the information; or
(C)
Any law enforcement personnel to whom reporting of controlled substances being obtained in a manner prohibited by §
53-11-401
, or §
53-11-402(a)(3) or (a)(6)
, is required by §
53-11-309
, or any agent of the healthcare practitioner who is directed by the healthcare practitioner to cause a report to law enforcement to be made in accordance with §
53-11-309(a) and (d)
.
(2)
A healthcare practitioner or healthcare practitioner delegate may place a copy of a patient's report obtained from the database pursuant to this section in that patient's medical records, with the exception of information reported to the database by a Part 2 Program. Once a copy of a patient's report obtained from the database pursuant to this section is placed in the patient's medical records, the copy is subject to disclosure on the same terms and conditions as medical records under §§
63-1-117
and
63-2-101
. A patient's information reported to the database by a Part 2 Program shall not be placed in the patient's medical records unless doing so complies with the privacy requirements of 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to §
53-10-304(e)
.
(i)
If law enforcement personnel or a judge of a drug court treatment program has probable cause to believe, based upon information received from a database request, that a healthcare practitioner may be acting or may have acted in violation of the law, the officer, agent, or judge shall consult with the appropriate licensing board as established under title 63 or title 68.
(j)
(1)
(A)
At least every six (6) months, the committee or commissioner or their designee shall send a list to each district attorney general containing all requests made for database information during the previous six (6) months.
(B)
The list shall include:
(i)
The name of the requesting attorney, officer, or agent;
(ii)
The attorney, officer, or agent's agency;
(iii)
The date of the request; and
(iv)
The nature of the request, including the case number for each attorney, officer, or agent making a request in such district attorney's judicial district.
(C)
Likewise, a list shall be sent to the director of the TBI for all TBI agents or the assistant special agent in charge for all DEA agents making requests during the previous six (6) months.
(2)
Each district attorney general, or assistant special agent in charge and the TBI director shall use the list to perform an audit to determine if the database information requests made during the preceding six-month period correspond to specific cases under investigation in the applicable judicial district or by the bureau and if the information requested is relevant and pertinent to an investigation.
(3)
Each district attorney general, assistant special agent in charge, and the TBI director shall verify all database information requests contained on the list received and send it back to the board within sixty (60) days of receipt. If a database information request does not correspond to an investigation in the applicable jurisdiction or if the information requested was not relevant or pertinent to the information requested, the district attorney general, assistant special agent in charge, or TBI director shall so note on the verified list and shall investigate the discrepancy and make a report back to the director of the controlled substance database within a reasonable period of time.
(4)
The results of the audit conducted pursuant to subdivision (j)(2) shall be discoverable by a healthcare practitioner or healthcare practitioner delegate charged with violating any state or federal law involving controlled substances or under a notice of charges proffered by an appropriate licensing board for a violation of any law involving controlled substances, but only the results pertaining to that healthcare practitioner or healthcare practitioner delegate are discoverable. If, however, there is an active criminal investigation involving a healthcare practitioner or healthcare practitioner delegate or the healthcare practitioner or healthcare practitioner delegate is under investigation by any investigations or prosecution unit of the appropriate licensure board, the results of the audit conducted pursuant to subdivision (j)(2) shall not be discoverable by the healthcare practitioner or the healthcare practitioner delegate during either such period.
(k)
(1)
Any person who obtains or attempts to obtain information from the database by misrepresentation or fraud is guilty of a Class A misdemeanor.
(2)
Any person who knowingly uses, releases, publishes, or otherwise makes available to any other person or entity any information submitted to, contained in, or obtained from the database for any purpose other than those specified in this part is guilty of a Class A misdemeanor.
(3)
Intentional unauthorized use or disclosure of database information by law enforcement personnel is a Class A misdemeanor.
(4)
Any law enforcement personnel whom the department has reason to suspect of violation of this section or who has been charged with a violation of this section shall have such person's authorization to request information from the database suspended. Any law enforcement personnel, found guilty of a violation of this subsection (k) shall have such person's authorization to request information from the database permanently revoked.
(5)
Where an individual authorized under subsection (a) acts in good faith in accessing or using information from the database in accordance with the limitations under this part, that person shall not incur any civil or criminal liability as a result of that use or access.
(l)
(1)
The following personnel of the department of mental health and substance abuse services actively engaged in analysis of controlled substances prescription information as a part of their assigned duties and responsibilities shall have access to the database for controlled substances prescription information for specific patients or healthcare practitioners:
(A)
The chief pharmacist;
(B)
The state opioid treatment authority (SOTA) or SOTA designee; and
(C)
The medical director.
(2)
Deidentified controlled substances prescribing information from the database may be provided upon request by the following personnel of the department of mental health and substance abuse services, who are actively engaged in analysis of controlled substances prescription information as provided in this subsection (
l
), and may be provided upon request to other personnel of the department of mental health and substance abuse services and other state government agencies as needed to fulfill assigned duties and responsibilities:
(A)
The chief pharmacist;
(B)
The SOTA; or
(C)
The medical director.
(m)
Where an investigation is conducted under §
38-7-109
, and information within the database is obtained pursuant to the requirements of this part, there exists a rebuttable presumption that the county medical examiner is acting in good faith.
(n)
Authorized committee, board, or department personnel and any designee appointed by the committee engaged in analysis of controlled substances prescription information as a part of the assigned duties and responsibilities of their employment may publish, or otherwise make available to healthcare practitioners and to the general public, deidentified personal data contained in or derived from the database for the purpose of educational outreach.
(o)
Prohibited access to, an inappropriate request for, or illegal disclosure of information from the database by a judge of a drug court treatment program shall be considered a violation of the canons of the Code of Judicial Conduct, including Rules 1.2, 1.3, and 3.5.
(p)
Deidentified information from the database must not include the identifying information of any patient, healthcare practitioner, healthcare practitioner delegate, or healthcare facility.
(q)
Notwithstanding subsections (a)-(p), information reported to the database by a Part 2 Program, as well as a subsequent disclosure of such information, may only be made available in accordance with 42 CFR Part 2 and the rules promulgated by the commissioner pursuant to §
53-10-304(e)
.
Amended by 2022 Tenn. Acts, ch. 825, Secs.s8, s9, s10, s11 eff. 4/14/2022.
Amended by 2021 Tenn. Acts, ch. 136, Secs.s4, s5, s6, s7, s8 eff. 4/13/2021.
Amended by 2019 Tenn. Acts, ch. 124, Secs.s 1, s 2 eff. 4/9/2019.
Acts 2002, ch. 840, § 1; 2004, ch. 673, § 27; 2005, ch. 474, § 7; 2007 , ch. 498, §§ 1, 2; 2007 , ch. 518, § 4; 2008 , ch. 914, § 1; 2011 , ch. 310, § 3; 2012 , ch. 575, § 1; 2012 , ch. 880, §§ 7 - 15; 2012 , ch. 915, § 1; 2012 , ch. 924, §§ 1 - 5; 2014 , ch. 622, §§ 1 - 4; 2014 , ch. 791, §§ 1 - 6.