2014 Kentucky Revised Statutes CHAPTER 218A - CONTROLLED SUBSTANCES 218A.202 Electronic system for monitoring controlled substances -- Required registration and reporting -- Penalty for illegal use of system -- Pilot or continuing project -- Continuing education programs -- Reports of failure to comply with section -- Administrative regulations.
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218A.202 Electronic system for monitoring controlled substances -- Required
registration and reporting -- Penalty for illegal use of system -- Pilot or
continuing project -- Continuing education programs -- Reports of failure
to comply with section -- Administrative regulations.
(1)
(2)
(3)
(4)
The Cabinet for Health and Family Services shall establish an electronic
system for monitoring Schedules II, III, IV, and V controlled substances that are
dispensed within the Commonwealth by a practitioner or pharmacist or
dispensed to an address within the Commonwealth by a pharmacy that has
obtained a license, permit, or other authorization to operate from the Kentucky
Board of Pharmacy. The cabinet may contract for the design, upgrade, or
operation of this system if the contract preserves all of the rights, privileges,
and protections 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.
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 this section and shall maintain such registration 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.
Every dispenser within the Commonwealth who is licensed, permitted, or
otherwise authorized to prescribe or dispense a controlled substance to a
person in Kentucky shall report to the Cabinet for Health and Family Services
the data required by this section, except that reporting shall not be required for:
(a) 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;
(b) A drug, other than any Schedule II controlled substance or a Schedule III
controlled substance containing hydrocodone, dispensed by a practitioner
at 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; or
(c) 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.
Data for each controlled substance that is dispensed shall include but not be
limited to the following:
(a) Patient identifier;
(b) National drug code of the drug dispensed;
(c) Date of dispensing;
(d) Quantity dispensed;
(e) Prescriber; and
(5)
(6)
(f) Dispenser.
The data shall be provided in the electronic format specified by the Cabinet for
Health and Family Services unless a waiver has been granted by the cabinet to
an individual dispenser. The cabinet 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.
The Cabinet for Health and Family Services shall only disclose data to persons
and entities authorized to receive that data under this section. 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 section. The
Cabinet for Health and Family Services shall be authorized to provide data to:
(a) 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;
(b) Employees of the Office of the Inspector General of the Cabinet for
Health and Family Services 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, 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 peace officer whose duty is to
enforce the laws of this Commonwealth, of another state, or of the United
States relating to drugs and who is engaged in a bona fide specific
investigation involving a designated person;
(c) A state-operated Medicaid program in conformity with subsection (7) of
this section;
(d) A properly convened grand jury pursuant to a subpoena properly issued
for the records;
(e) 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 requests information and certifies that the requested
information is for the purpose of:
1.
Providing medical or pharmaceutical treatment to a bona fide
current or prospective patient; or
2.
Reviewing and assessing the individual prescribing or dispensing
patterns of the practitioner or pharmacist or to determine the
accuracy and completeness of information contained in the
monitoring system;
(f) 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
(7)
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;
(g) In addition to the purposes authorized under paragraph (a) of this
subsection, the Kentucky Board of Medical Licensure, for any physician
who is:
1.
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;
2.
In a designated geographic area for which a trend report indicates a
substantial likelihood that inappropriate prescribing or dispensing
may be occurring; or
3.
In a designated geographic area for which a report on another
physician in that area indicates a substantial likelihood that
inappropriate prescribing or dispensing may be occurring in that
area;
(h) In addition to the purposes authorized under paragraph (a) of this
subsection, the Kentucky Board of Nursing, for any advanced practice
registered nurse who is:
1.
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;
2.
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 prescribing
practices;
3.
In a designated geographic area for which a trend report indicates a
substantial likelihood that inappropriate prescribing or dispensing
may be occurring; or
4.
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;
(i) 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; or
(j) A medical examiner engaged in a death investigation pursuant to KRS
72.026.
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:
(a) Appropriately managed by a single outpatient pharmacy or primary care
physician; or
(b)
Indicative of improper, inappropriate, or illegal prescribing or dispensing
practices by a practitioner or drug seeking by a Medicaid recipient.
(8) A person who receives data or any report of the system from the cabinet 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:
(a) A person specified in subsection (6)(b) of this section who is authorized to
receive data or a report may share that information with any other
persons specified in subsection (6)(b) of this section authorized to receive
data or a report if the persons specified in subsection (6)(b) of this section
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 paragraph 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;
(b) A representative of the Department for Medicaid Services may share data
or reports regarding overutilization by Medicaid recipients with a board
designated in subsection (6)(a) of this section, or with a law enforcement
officer designated in subsection (6)(b) of this section;
(c) The Department for Medicaid Services may submit the data as evidence
in an administrative hearing held in accordance with KRS Chapter 13B;
(d) 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 Chapter 13B, with the board and
licensee taking all necessary steps to prevent further disclosure of the
data; and
(e) A practitioner, pharmacist, or employee who obtains data under
subsection (6)(e) of this section may share the report with the patient or
person authorized to act on the patient's behalf and place the report in the
patient's medical record, with that individual report then being 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.
(9) The Cabinet for Health and Family Services, all peace officers specified in
subsection (6)(b) of this section, 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.
(10) The data and any report obtained therefrom 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
(11)
(12)
(13)
(14)
(15)
(16)
13B.
Intentional failure by a dispenser to transmit data to the cabinet as required by
subsection (3), (4), or (5) of this section shall be a Class B misdemeanor for the
first offense and a Class A misdemeanor for each subsequent offense.
Intentional disclosure of transmitted data to a person not authorized by
subsection (6) to subsection (8) of this section or authorized by KRS 315.121,
or obtaining information under this section not relating to a bona fide specific
investigation, shall be a Class B misdemeanor for the first offense and a Class
A misdemeanor for each subsequent offense.
(a) The Commonwealth Office of Technology, in consultation with the
Cabinet for Health and Family Services, may submit an application to the
United States Department of Justice for a drug diversion grant to fund a
pilot or continuing project to study, create, or maintain a real-time
electronic monitoring system for Schedules II, III, IV, and V controlled
substances.
(b) The pilot project shall:
1.
Be conducted in two (2) rural counties that have an interactive
real-time electronic information system in place for monitoring
patient utilization of health and social services through a federally
funded community access program; and
2.
Study the use of an interactive system that includes a relational data
base with query capability.
(c) Funding to create or maintain a real-time electronic monitoring system for
Schedules II, III, IV, and V controlled substances may be sought for a
statewide system or for a system covering any geographic portion or
portions of the state.
Provisions in this section that relate to data collection, disclosure, access, and
penalties shall apply to the pilot project authorized under subsection (13) of this
section.
The Cabinet for Health and Family Services may, by promulgating an
administrative regulation, limit the length of time that data remain in the
electronic system. Any 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.
(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 and uses of the
electronic system for monitoring established in this section.
(b) 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.
(c) 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 uses of the electronic system for
monitoring established in this section.
(17) If the cabinet becomes aware of a prescriber's or 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 licensee.
(18) The cabinet shall promulgate administrative regulations 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 subsection (8) of this section to request the correction of
inaccurate information contained in the system relating to that patient; and
(b) Beginning July 1, 2013, a requirement that data be reported to the system
under subsection (3) of this section within one (1) day of dispensing.
Effective:March 4, 2013
History: Amended 2013 Ky. Acts ch. 2, sec. 3, effective March 4, 2013. -Amended 2012 (1st Extra. Sess.) Ky. Acts ch. 1, sec. 4, effective July 20, 2012.
-- Amended 2010 Ky. Acts ch. 85, sec. 43, effective July 15, 2010. -- Amended
2007 Ky. Acts ch. 85, sec. 252, effective June 26, 2007; and ch. 124, sec. 4,
effective June 26, 2007. -- Amended 2006 Ky. Acts ch. 5, sec. 5, effective July
12, 2006. -- Amended 2005 Ky. Acts ch. 85, sec. 627, effective June 20, 2005;
and ch. 99, sec. 543, effective June 20, 2005. -- Amended 2004 Ky. Acts ch. 68,
sec. 1, effective July 13, 2004; and ch. 107, sec. 1, effective July 13, 2004. -Amended 2002 Ky. Acts ch. 295, sec. 1, effective April 9, 2002. -- Created 1998
Ky. Acts ch. 301, sec. 13, effective July 15, 1998.
Legislative Research Commission Note (7/13/2004). This section was amended
by 2004 Ky. Acts. chs. 68 and 107. Where these Acts are not in conflict, they
have been codified together. Where a conflict exists, Acts. ch. 107, which was
last enacted by the General Assembly, prevails under KRS 446.250.
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