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 53-10-305 - Submission of information - Data format

(a)
All healthcare practitioners who prescribe or dispense controlled substances in practice providing direct care to patients in this state by prescribing or dispensing on more than fifteen (15) days in a calendar year total and are required to have a federal drug enforcement administration (DEA) registration pursuant to federal law shall be registered in the controlled substance database. Healthcare practitioners or their agents shall have up to thirty (30) calendar days after receiving a DEA number to register in the database; such privilege shall apply equally to both prescribers and dispensers. Licensed veterinarians who never prescribe or dispense controlled substances in an amount intended to treat a nonhuman patient for more than five (5) days shall not be required to register in the database.
(b)
(1)
Each healthcare practitioner or healthcare practitioner's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information:
(A)
Prescriber identifier;
(B)
Dispensing date of controlled substance;
(C)
Patient identifier;
(D)
Controlled substance dispensed identifier;
(E)
Quantity of controlled substance dispensed;
(F)
Strength of controlled substance dispensed;
(G)
Estimated days' supply;
(H)
Dispenser identifier;
(I)
Date the prescription was issued by the prescriber;
(J)
Whether the prescription was new or a refill;
(K)
Source of payment;
(L)
The ICD-10 code for any prescription that contains an ICD-10 code; provided, that this shall not be mandatory prior to January 1, 2019, for a dispenser who has not updated the dispenser's software system to enable submission of ICD-10 codes;
(M)
A value signifying opioid treatment is occurring pursuant to a medical necessity under §
63-1-164
for any prescription containing the words "medical necessity." The value will be determined by the committee and published through the committee's website; and
(N)
Other relevant information as required by rule.
(2)
The information in the database, as required by subdivision (b)(1), shall be submitted by a procedure and in a format established by the committee, for each business day but no later than the close of business on the following business day; provided, that a veterinarian shall submit information at least once every fourteen (14) days and shall not be required to use a computerized system in order to submit required information pursuant to this section.
(c)
The commissioner, pursuant to §
53-10-311
, shall have the authority to change the length of time in which healthcare practitioners are required to submit information to the database through the promulgation of rules pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5. When the committee shortens the length of time in which healthcare practitioners are required to submit information to the database, the department shall provide notice to all healthcare practitioners who are registered in the database at least sixty (60) days prior to the date in which the rule goes into effect. If the committee, pursuant to §
53-10-311
, shortens the length of time in which healthcare practitioners must submit information to the database, a healthcare practitioner may provide to the committee a written statement indicating why it creates a hardship for that healthcare practitioner to submit information within that time period, and the committee may grant an extension of up to seven (7) days within which that healthcare practitioner shall submit the information to the database. Such a hardship extension shall be valid for two (2) years and may be renewed by the committee upon request of the healthcare practitioner.
(d)
Any healthcare practitioner, except veterinarian healthcare practitioners, that uses a computerized system to record information concerning the dispensing of controlled substances, shall submit the required information to the database utilizing nationally recognized pharmacy telecommunications format standards.
(e)
The commissioner, pursuant to §
53-10-311
, shall maintain the database in an electronic file or by other means established by the commissioner in such a manner so as not to infringe on the legal use of controlled substances, and in such a manner as to facilitate use of the database for identification of:
(1)
Prescribing and dispensing practices and patterns of prescribing and dispensing controlled substances; and
(2)
Individuals, facilities, or entities that receive prescriptions for controlled substances from healthcare practitioners, and who subsequently obtain dispensed controlled substances from a healthcare practitioner in quantities or with a frequency inconsistent with generally recognized standards of dosage for that controlled substance, or by means of forged or otherwise false or altered prescriptions.
(f)
The committee or the commissioner or a designee appointed by the committee or commissioner may review information in the database, subject to the privacy protections of 42 CFR Part 2 for information reported to the database by a Part 2 Program. If the committee or commissioner or their designee determines from review that a healthcare practitioner has committed a violation of the law, the committee or commissioner shall notify the entity responsible for licensure, regulation, or discipline of that healthcare practitioner and shall supply information required by the entity for an investigation of the violation of the law that may have occurred.
(g)
(1)
(A)
The commissioner, pursuant to §
53-10-311
, shall by rule establish the electronic format in which the information required under this section shall be submitted to the database, and the committee shall allow for waiver of electronic reporting for individual healthcare practitioners for whom it would cause undue hardship as determined by the committee. The waiver may be valid for two (2) years from ratification by the committee.
(B)
The committee may authorize a designee to initially approve a waiver subject to ratification by the committee.
(2)
The commissioner shall ensure the database system records and maintains for reference, for a period of at least one (1) year:
(A)
The identification of each person who requests or receives information from the database;
(B)
The information provided to each person; and
(C)
The date and time the information is requested or provided.
(h)
The commissioner, in consultation with the committee, shall make rules to:
(1)
Effectively enforce the limitations on access to the database as described in this part, including rules that ensure compliance with 42 CFR Part 2 for information reported to the database by a Part 2 Program; and
(2)
Establish standards and procedures to ensure accurate identification of individuals requesting information or receiving information from the database without a request.
Amended by 2022 Tenn. Acts, ch. 825, Secs.s6, s7 eff. 4/14/2022.
Amended by 2018 Tenn. Acts, ch. 1039, s 2, eff. 7/1/2018.
Acts 2002, ch. 840, § 1; 2004, ch. 673, § 26; 2012 , ch. 880, § 5; 2014, ch. 1011, §§ 1, 3.