KRS 218A.202: Definitions for section -- Electronic system for monitoring controlled

substances -- Required registration and reporting -- Penalty for illegal use of

system -- Continuing education programs -- Reports of failure to comply with

section -- Procedures for monitoring medicinal cannabis -- Quarterly reviews

to identify patterns of improper prescribing or dispensing -- Administrative

regulations -- Collection and retention of drug conviction data.

(1) As used in this section:

(a) "Cabinet" means the Cabinet for Health and Family Services;

(b) "Cannabis business" has the same meaning as in KRS 218B.010;

(c) "Controlled substance" means any Schedule II, III, IV, or V controlled

substance and does not include medicinal cannabis;

(d) "Dispensary" has the same meaning as in KRS 218B.010;

(e) "Dispensary agent" has the same meaning as in KRS 218B.010;

(f) "Disqualifying felony offense" has the same meaning as in KRS 218B.010;

(g) "Medicinal cannabis" has the same meaning as in KRS 218B.010;

(h) "Medicinal cannabis practitioner" has the same meaning as in KRS 218B.010;

(i) "Registry identification card" has the same meaning as in KRS 218B.010;

(j) "State licensing board" has the same meaning as in KRS 218B.010;

(k) "Use of medicinal cannabis" has the same meaning as in KRS 218B.010; and

(l) "Written certification" has the same meaning as in KRS 218B.010.

(2) The cabinet shall establish and maintain an electronic system for monitoring

Schedules II, III, IV, and V controlled substances and medicinal cannabis. The

cabinet may contract for the design, upgrade, or operation of this system if the

contract preserves all of the rights, privileges, and protec tions guaranteed to

Kentucky citizens under this chapter and the contract requires that all other aspects

of the system be operated in conformity with the requirements of this or any other

applicable state or federal law.

(3) For the purpose of monitoring the prescribing and dispensing of Schedule II, III, IV,

or V controlled substances:

(a) A practitioner or a pharmacist authorized to prescribe or dispense controlled

substances to humans shall register with the cabinet to use the system

provided for in thi s section and shall maintain an active account with the

electronic monitoring system continuously during the practitioner's or

pharmacist's term of licensure and shall not have to pay a fee or tax

specifically dedicated to the operation of the system;

(b) Every practitioner or pharmacy which dispenses a controlled substance to a

person in Kentucky, or to a person at an address in Kentucky, shall report to

the cabinet the data required by this section, which includes the reporting of

any Schedule II controll ed substance dispensed at a facility licensed by the

cabinet and a Schedule II through Schedule V controlled substance regardless

of dosage when dispensed by the emergency department of a hospital to an

emergency department patient. Reporting shall not be required for:

1. A drug administered directly to a patient in a hospital, a resident of a

health care facility licensed under KRS Chapter 216B, a resident of a

child-caring facility as defined by KRS 199.011, or an individual in a

jail, correctional facility, or juvenile detention facility;

2. A Schedule III through Schedule V controlled substance dispensed by a

facility licensed by the cabinet provided that the quantity dispensed is

limited to an amount adequate to treat the patient for a maximum of

forty-eight (48) hours and is not dispensed by the emergency department

of a hospital; or

3. A drug administered or dispensed to a research subject enrolled in a

research protocol approved by an institutional review board that has an

active federalwide assurance number from the United States Department

of Health and Human Services, Office for Human Research Protections,

where the research involves single, double, or triple blind drug

administration or is additionally covered by a certificate of

confidentiality from the National Institutes of Health;

(c) In addition to the data required by paragraph (d) of this subsection, a

Kentucky-licensed acute care hospital or critical access hospital shall report to

the cabinet all positive toxicology screens that were perfor med by the

hospital's emergency department to evaluate the patient's suspected drug

overdose;

(d) Data for each controlled substance that is reported shall include but not be

limited to the following:

1. Patient identifier;

2. National drug code of the drug dispensed;

3. Date of dispensing;

4. Quantity dispensed;

5. Prescriber; and

6. Dispenser;

(e) The data shall be provided in the electronic format specified by the cabinet

unless a waiver has been granted by the cabinet to an individual dispenser.

The cab inet shall establish acceptable error tolerance rates for data.

Dispensers shall ensure that reports fall within these tolerances. Incomplete or

inaccurate data shall be corrected upon notification by the cabinet if the

dispenser exceeds these error tolerance rates;

(f) The cabinet shall only disclose data to persons and entities authorized to

receive that data under this subsection. Disclosure to any other person or

entity, including disclosure in the context of a civil action where the

disclosure is sough t either for the purpose of discovery or for evidence, is

prohibited unless specifically authorized by this section. The cabinet shall be

authorized to provide data to:

1. A designated representative of a board responsible for the licensure,

regulation, or discipline of practitioners, pharmacists, or other person

who is authorized to prescribe, administer, or dispense controlled

substances and who is involved in a bona fide specific investigation

involving a designated person;

2. Employees of the Office of the Inspector General of the cabinet who

have successfully completed training for the electronic system and who

have been approved to use the system, federal prosecutors, Kentucky

Commonwealth's attorneys and assistant Commonwealth's attorneys,

county attorneys and assistant county attorneys, a peace officer certified

pursuant to KRS 15.380 to 15.404, a certified or full -time peace officer

of another state, or a federal agent whose duty is to enforce the laws of

this Commonwealth, of another state, or of th e United States relating to

drugs and who is engaged in a bona fide specific investigation involving

a designated person;

3. A state-operated Medicaid program in conformity with paragraph (g) of

this subsection;

4. A properly convened grand jury pursuant t o a subpoena properly issued

for the records;

5. A practitioner or pharmacist, or employee of the practitioner's or

pharmacist's practice acting under the specific direction of the

practitioner or pharmacist, who certifies that the requested information

is for the purpose of:

a. Providing medical or pharmaceutical treatment to a bona fide

current or prospective patient;

b. Reviewing data on controlled substances that have been reported

for the birth mother of an infant who is currently being treated by

the practitioner for neonatal abstinence syndrome, or has

symptoms that suggest prenatal drug exposure; or

c. Reviewing and assessing the individual prescribing or dispe nsing

patterns of the practitioner or pharmacist or to determine the

accuracy and completeness of information contained in the

monitoring system;

6. The chief medical officer of a hospital or long -term-care facility, an

employee of the hospital or long -term-care facility as designated by the

chief medical officer and who is working under his or her specific

direction, or a physician designee if the hospital or facility has no chief

medical officer, if the officer, employee, or designee certifies that the

requested information is for the purpose of providing medical or

pharmaceutical treatment to a bona fide current or prospective patient or

resident in the hospital or facility;

7. In addition to the purposes authorized under subparagraph 1. of this

paragraph, the Kentucky Board of Medical Licensure, for any physician

who is:

a. Associated in a partnership or other business entity with a

physician who is already under investigation by the Board of

Medical Licensure for improper prescribing or dispensing

practices;

b. In a designated geographic area for which a trend report indicates

a substantial likelihood that inappropriate prescribing or

dispensing may be occurring; or

c. In a designated geographic area for which a report on another

physician in that area in dicates a substantial likelihood that

inappropriate prescribing or dispensing may be occurring in that

area;

8. In addition to the purposes authorized under subparagraph 1. of this

paragraph, the Kentucky Board of Nursing, for any advanced practice

registered nurse who is:

a. Associated in a partnership or other business entity with a

physician who is already under investigation by the Kentucky

Board of Medical Licensure for improper prescribing or

dispensing practices;

b. Associated in a partnership or oth er business entity with an

advanced practice registered nurse who is already under

investigation by the Board of Nursing for improper prescribing

practices;

c. In a designated geographic area for which a trend report indicates

a substantial likelihood that inappropriate prescribing or

dispensing may be occurring; or

d. In a designated geographic area for which a report on a physician

or another advanced practice registered nurse in that area indicates

a substantial likelihood that inappropriate prescribing or

dispensing may be occurring in that area;

9. A judge or a probation or parole officer administering a diversion or

probation program of a criminal defendant arising out of a violation of

this chapter or of a criminal defendant who is documented by the c ourt

as a substance abuser who is eligible to participate in a court -ordered

drug diversion or probation program; or

10. A medical examiner engaged in a death investigation pursuant to KRS

72.026;

(g) The Department for Medicaid Services shall use any data or reports from the

system for the purpose of identifying Medicaid providers or recipients whose

prescribing, dispensing, or usage of controlled substances may be:

1. Appropriately managed by a single outpatient pharmacy or primary care

physician; or

2. Indicative of improper, inappropriate, or illegal prescribing or

dispensing practices by a practitioner or drug seeking by a Medicaid

recipient;

(h) A person who receives data or any report of the system from the cabinet shall

not provide it to any other pe rson or entity except as provided in this

subsection, in another statute, or by order of a court of competent jurisdiction

and only to a person or entity authorized to receive the data or the report

under this section, except that:

1. A person specified in paragraph (f)2. of this subsection who is

authorized to receive data or a report may share that information with

any other persons specified in paragraph (f)2. of this subsection

authorized to receive data or a report if the persons specified in

paragraph (f)2. of this subsection are working on a bona fide specific

investigation involving a designated person. Both the person providing

and the person receiving the data or report under this subparagraph shall

document in writing each person to whom the data or report has been

given or received and the day, month, and year that the data or report

has been given or received. This document shall be maintained in a file

by each agency engaged in the investigation;

2. A representative of the Department for Medicai d Services may share

data or reports regarding overutilization by Medicaid recipients with a

board designated in paragraph (f)1. of this subsection, or with a law

enforcement officer designated in paragraph (f)2. of this subsection;

3. The Department for Medicaid Services may submit the data as evidence

in an administrative hearing held in accordance with KRS Chapter 13B;

4. If a state licensing board as defined in KRS 218A.205 initiates formal

disciplinary proceedings against a licensee, and data obtained by the

board is relevant to the charges, the board may provide the data to the

licensee and his or her counsel, as part of the notice process required by

KRS 13B.050, and admit the data as evidence in an administrative

hearing conducted pursuant to KRS Cha pter 13B, with the board and

licensee taking all necessary steps to prevent further disclosure of the

data; and

5. A practitioner, pharmacist, or employee who obtains data under

paragraph (f)5. of this subsection may share the report with the patient

or pe rson authorized to act on the patient's behalf. Any practitioner,

pharmacist, or employee who obtains data under paragraph (f)5. of this

subsection may place the report in the patient's medical record, in which

case the individual report shall then be deem ed a medical record subject

to disclosure on the same terms and conditions as an ordinary medical

record in lieu of the disclosure restrictions otherwise imposed by this

section;

(i) The cabinet, all peace officers specified in paragraph (f)2. of this subs ection,

all officers of the court, and all regulatory agencies and officers, in using the

data for investigative or prosecution purposes, shall consider the nature of the

prescriber's and dispenser's practice and the condition for which the patient is

being treated;

(j) Intentional failure to comply with the reporting requirements of this

subsection shall be a Class B misdemeanor for the first offense and a Class A

misdemeanor for each subsequent offense;

(k) If the cabinet becomes aware of a prescriber's o r dispenser's failure to comply

with this section, the cabinet shall notify the licensing board or agency

responsible for licensing the prescriber or dispenser. The licensing board shall

treat the notification as a complaint against the license; and

(l) A veterinarian licensed in Kentucky prescribing, administering, or dispensing

controlled substances to animals shall not be required by administrative

regulation or any other means to report the prescribing, administering, or

dispensing of controlled substances to:

1. The Controlled Substances Prescribing Council;

2. The cabinet; or

3. Any other governmental entity except the Kentucky Board of Veterinary

Examiners.

(4) For the purpose of monitoring the cultivation, processing, production,

recommending, and dispensing of medicinal cannabis:

(a) Every medicinal cannabis practitioner who is authorized pursuant to KRS

218B.050 to provide written certifications for the use of medicinal cannabis

and every cannabis business licensed under KRS 218B.080, 218B.085, and

218B.090 shall register with the cabinet to use the system provided for in this

section and shall maintain such registration continuously during the medicinal

cannabis practitioner's authorization to provide written certifications or a

cannabis business's term of licensure and shall not have to pay a fee or tax

specifically dedicated to the operation of the system;

(b) No later than July 1, 2024, the cabinet shall ens ure that the system provided

for in this section allows:

1. Medicinal cannabis practitioners to record the issuance of written

certifications to a patient as required by KRS 218B.050;

2. The cabinet, law enforcement personnel, and dispensary agents to veri fy

the validity of registry identification cards issued by the cabinet. When

verifying the validity of an identification card, the system shall only

disclose whether the identification card is valid and whether the

cardholder is a registered qualified pati ent, visiting qualified patient, or

designated caregiver;

3. Dispensary agents to record the amount of medicinal cannabis that is

dispensed to a cardholder during each transaction, as required by KRS

218B.110;

4. Law enforcement personnel and dispensary ag ents to access medicinal

cannabis sales data recorded by dispensary agents pursuant to KRS

218B.110;

5. The sharing of dispensing data recorded by dispensary agents, pursuant

to KRS 218B.110, with all licensed dispensaries in real time;

6. Licensed cannabis businesses to record data required by administrative

regulations promulgated pursuant to KRS 218B.140 to facilitate the

tracking of medicinal cannabis from the point of cultivation to the point

of sale to cardholders; and

7. The cabinet to track all medi cinal cannabis in the state from the point of

cultivation to the point of sale to a cardholder;

(c) The cabinet shall only disclose data related to the cultivation, production,

recommending, and dispensing of medicinal cannabis to persons and entities

authorized to receive that data under this subsection. Disclosure to any other

person or entity, including disclosure in the context of a civil action where the

disclosure is sought either for the purpose of discovery or for evidence, is

prohibited unless specifically authorized by this subsection. The cabinet shall

be authorized to provide data to:

1. Any person or entity authorized to receive data pursuant to paragraph

(b) of this subsection;

2. A designated representative of a state licensing board responsible for the

licensure, regulation, or discipline of medicinal cannabis practitioners

and who is involved in a bona fide specific investigation involving a

designated person;

3. Employees of the Office of the Inspector General of the cabinet who

have successfully completed training for the electronic system and who

have been approved to use the system, Kentucky Commonwealth's

attorneys and assistant Commonwealth's attorneys, and county attorneys

and assistant county attorneys who are engaged in a bona fide sp ecific

investigation involving a designated person;

4. A properly convened grand jury pursuant to a subpoena properly issued

for the records;

5. A medicinal cannabis practitioner or an employee of a medicinal

cannabis practitioner's practice acting under t he specific direction of the

medicinal cannabis practitioner, who certifies that the request for

information is for the purpose of complying with KRS 218B.050(4)(c);

6. The chief medical officer of a hospital or long -term-care facility, an

employee of the hospital or long-term-care facility as designated by the

chief medical officer and who is working under his or her specific

direction, or a physician designee if the hospital or facility has no chief

medical officer, if the officer, employee, or designee c ertifies that the

requested information is for the purpose of providing medical or

pharmaceutical treatment to a bona fide current or prospective patient or

resident in the hospital or facility;

7. In addition to the purposes authorized under subparagraph 2. of this

paragraph, the Kentucky Board of Medical Licensure, for any physician

who is:

a. Associated in a partnership, other business entity, or supervision

agreement established pursuant to KRS 311.854 with a physician

who is already under investigation by the Board of Medical

Licensure for improper issuance of written certifications;

b. Associated in a partnership or other business entity with an

advanced practice registered nurse who is already under

investigation by the Board of Nursing for improper i ssuance of

written certifications;

c. In a designated geographic area for which a trend report indicates

a substantial likelihood that inappropriate issuance of written

certifications may be occurring; or

d. In a designated geographic area for which a repo rt on another

physician in that area indicates a substantial likelihood that

inappropriate issuance of written certifications may be occurring in

that area;

8. In addition to the purposes authorized under subparagraph 2. of this

paragraph, the Kentucky Boa rd of Nursing, for any advanced practice

registered nurse who is:

a. Associated in a partnership or other business entity with a

physician who is already under investigation by the Kentucky

Board of Medical Licensure for improper issuance of written

certifications;

b. Associated in a partnership or other business entity wit h an

advanced practice registered nurse who is already under

investigation by the Board of Nursing for improper issuance of

written certifications;

c. In a designated geographic area for which a trend report indicates

a substantial likelihood that inapprop riate issuance of written

certifications may be occurring; or

d. In a designated geographic area for which a report on another

advanced practice registered nurse in that area indicates a

substantial likelihood that inappropriate issuance of written

certifications may be occurring in that area;

9. A judge or a probation or parole officer administering a diversion or

probation program of a criminal defendant arising out of a violation of

this chapter or of a criminal defendant who is documented by the court

as a substance abuser who is eligible to participate in a court -ordered

drug diversion or probation program;

10. A medical examiner engaged in a death investigation pursuant to KRS

72.026; or

11. The Legislative Research Commission, the University of Kentuc ky

College of Medicine, or the Kentucky Center for Cannabis established

in KRS 164.983 if the cabinet determines that disclosing data related to

the cultivation, production, recommending, and dispensing of medicinal

cannabis to the Legislative Research Com mission, the University of

Kentucky College of Medicine, or the Kentucky Center for Cannabis is

necessary to comply with the reporting requirements established in KRS

218B.020(8); and

(d) A person who receives data or any report of the system from the cabi net shall

not provide it to any other person or entity except as provided in this section,

in another statute, or by order of a court of competent jurisdiction and only to

a person or entity authorized to receive the data or the report under this

section, except that:

1. A person specified in paragraph (c)3. of this subsection who is

authorized to receive data or a report may share that information with

any other persons specified in paragraph (c)3. of this subsection

authorized to receive data or a report if the persons specified in

paragraph (c)3. of this subsection are working on a bona fide specific

investigation involving a designated person. Both the person providing

and the person receiving the data or report under this subparagraph shall

document in writing each person to whom the data or report has been

given or received and the day, month, and year that the data or report

has been given or received. This document shall be maintained in a file

by each agency engaged in the investigation;

2. If a stat e licensing board initiates formal disciplinary proceedings

against a licensee, and data obtained by the board is relevant to the

charges, the board may provide the data to the licensee and his or her

counsel, as part of the notice process required by KRS 13B.050, and

admit the data as evidence in an administrative hearing conducted

pursuant to KRS Chapter 13B, with the board and licensee taking all

necessary steps to prevent further disclosure of the data; and

3. A medicinal cannabis practitioner or an emp loyee of a medicinal

cannabis practitioner's practice acting under the specific direction of the

medicinal cannabis practitioner who obtains data under paragraph (c)5.

of this subsection may share the report with the patient or person

authorized to act on the patient's behalf. Any medicinal cannabis

practitioner or employee who obtains data under paragraph (c)5. of this

subsection may place the report in the patient's medical record, in which

case the individual report shall then be deemed a medical record subject

to disclosure on the same terms and conditions as an ordinary medical

record in lieu of the disclosure restrictions otherwise imposed by this

section.

(5) The data contained in, and any report obtained from, the electronic system for

monitoring established pursuant to this section shall not be a public record, except

that the Department for Medicaid Services may submit the data as evidence in an

administrative hearing held in accordance with KRS Chapter 13B.

(6) Intentional disclosure of transmitted data to a person not authorized by subsection

(3)(f) to (h) or (4)(c) and (d) of this section or authorized by KRS 315.121, or

obtaining information under this section not relating to a bona fide current or

prospective patient or a bona fide specific inve stigation, shall be a Class B

misdemeanor for the first offense and a Class A misdemeanor for each subsequent

offense.

(7) The cabinet may, by promulgating an administrative regulation, limit the length of

time that data remain in the electronic system. An y data removed from the system

shall be archived and subject to retrieval within a reasonable time after a request

from a person authorized to review data under this section.

(8) (a) The Cabinet for Health and Family Services shall work with each board

responsible for the licensure, regulation, or discipline of practitioners,

pharmacists, or other persons who are authorized to prescribe, administer, or

dispense controlled substances for the development of a continuing education

program about the purposes an d uses of the electronic system for monitoring

established in this section.

(b) The cabinet shall work with each board responsible for the licensure,

regulation, or discipline of medicinal cannabis practitioners for the

development of a continuing educatio n program about the purposes and uses

of the electronic system for monitoring established in this section.

(c) The cabinet shall work with the Kentucky Bar Association for the

development of a continuing education program for attorneys about the

purposes and uses of the electronic system for monitoring established in this

section.

(d) The cabinet shall work with the Justice and Public Safety Cabinet for the

development of a continuing education program for law enforcement officers

about the purposes and use s of the electronic system for monitoring

established in this section.

(e) The cabinet shall develop a training program for cannabis business agents

about the purposes and uses of the electronic system for monitoring

established in this section.

(9) The cabinet, Office of Inspector General, shall conduct quarterly reviews to identify

patterns of potential improper, inappropriate, or illegal prescribing or dispensing of

a controlled substance, issuance of written certifications, or cultivation, processing,

or dispensing of medicinal cannabis. The Office of Inspector General may

independently investigate and submit findings and recommendations to the

appropriate boards of licensure or other reporting agencies.

(10) The cabinet shall promulgate administrative r egulations in accordance with KRS

Chapter 13A to implement the provisions of this section. Included in these

administrative regulations shall be:

(a) An error resolution process allowing a patient to whom a report had been

disclosed under subsections (3) and (4) of this section to request the correction

of inaccurate information contained in the system relating to that patient; and

(b) A requirement that data be reported to the system under subsection (3)(b) of

this section within one (1) day of dispensing.

(11) (a) Before July 1, 2018, the Administrative Office of the Courts shall forward

data regarding any felony or Class A misdemeanor conviction that involves

the trafficking or possession of a controlled substance or other prohibited acts

under KRS Chapte r 218A for the previous five (5) calendar years to the

cabinet for inclusion in the electronic monitoring system established under

this section. On or after July 1, 2018, such data shall be forwarded by the

Administrative Office of the Courts to the cabine t on a continuing basis. The

cabinet shall incorporate the data received into the system so that a query by

patient name indicates any prior drug conviction.

(b) Before July 1, 2024, the Administrative Office of the Courts shall forward all

available data regarding any disqualifying felony offense for the previous five

(5) calendar years to the cabinet for inclusion in the electronic monitoring

system established under this section. On or after July 1, 2024, such data shall

be forwarded by the Administrativ e Office of the Courts to the cabinet on a

continuing basis. The cabinet shall incorporate the data received into the

system so that a query by patient name indicates any prior disqualifying

felony conviction.