Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
13B.125,
218B.015,
218B.050,
218A.202,
218B.202,
311.592,
311.595,
311.599
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
311.565(1)(a) authorizes the
board to promulgate administrative regulations to regulate the conduct of its
licensees. KRS
218B.050(10) requires the
board to promulgate administrative regulations to establish procedures for
applying for authorization to provide written certifications; the conditions
that shall be met to be eligible for authorization to provide written
certifications; the process and procedures for renewing authorization to
provide written certifications; the continuing education requirements for
medicinal cannabis practitioners; the reasons for which authorization to
provide written certifications for the use of medicinal cannabis may be
suspended or revoked; and the minimal standards of care, including record
maintenance and follow up care requirements.
Section 1. Definitions.
(1) "Board" means the Kentucky Board of
Medical Licensure.
(2) "Bona fide
practitioner-patient relationship" is defined by
KRS
218B.010(1).
(3) "Cabinet" is defined by
KRS
218B.010(2).
(4) "Good standing" means a license that is
at the time of initial application or renewal:
(a) Active;
(b) Not the subject of a pending board
investigation;
(c) Not probated,
limited, restricted, suspended, revoked, or subject to peer assistance;
and
(d) Not held by a person who
has ever been subject to disciplinary action by a licensing entity of any
jurisdiction, including the board or the U.S. Drug Enforcement Administration
(DEA), that was based, in whole or in part, on the person's inappropriate
prescribing, dispensing, diverting, administering, supplying, or selling a
controlled substance or other dangerous drug.
(5) "Immediate family member" means husband
or wife; natural or adoptive parent; child or sibling; stepparent, stepchild,
stepbrother, or stepsister; father-in-law, mother-in-law, son-in-law,
daughter-in-law, brother-in-law, or sister-in-law; grandparent or grandchild;
spouse of a grandparent or grandchild; or any person residing in the same
residence as the medicinal cannabis practitioner.
(6) "Licensee" means a person licensed by the
board to practice medicine or osteopathy in the Commonwealth of
Kentucky.
(7) "Medicinal cannabis"
is defined by KRS
218B.010(15).
(8) "Medicinal cannabis practitioner" means a
medical or osteopathic physician who is authorized to prescribe controlled
substances and who is authorized by the board to provide written certifications
pursuant to KRS
218B.050 and this administrative
regulation.
(9) "Minor" is defined
by KRS
218B.010(19).
(10) "PDMP" means the electronic prescription
drug monitoring program system for monitoring scheduled controlled substances
and medicinal cannabis currently in use in Kentucky pursuant to
KRS
218A.202, including the Kentucky All Schedule
Prescription Electronic Reporting (KASPER) System.
(11) "Qualified patient" is defined by
KRS
218B.010(25).
(12) "Qualifying medical condition" is
defined by KRS
218B.010(26).
(13) "Telehealth" is defined by
KRS
211.332(5).
(14) "Use of medicinal cannabis" is defined
by KRS
218B.010(37).
(15) "Written certification" is defined by
KRS
218B.010(39).
Section 2. Applicability. The procedures and
standards established in this administrative regulation shall not apply to a
licensee who recommends treatment with cannabis or a drug derived from
cannabisin accordance with
KRS
218B.050(11).
Section 3. Eligibility for Authorization to
Provide Written Certifications. A licensee shall be eligible to provide written
certifications for the use of medicinal cannabis, pursuant to
KRS
218B.050 within the Commonwealth of Kentucky,
if the licensee:
(1) Holds a license issued by
the board to practice medicine or osteopathy in the Commonwealth of Kentucky in
good standing;
(2) Holds a valid
DEA permit;
(3) Is registered to
use any PDMP currently in use in the Commonwealth of Kentucky pursuant to
KRS
218A.202;
(4) Holds no ownership or investment interest
in or compensation agreement with a cannabis business licensed under KRS
Chapter 218B;
(5) Pursuant to
Section 6 of this administrative regulation, has completed the required number
of hours of education in a course or courses approved by the board specific to:
(a) Diagnosing qualifying medical
conditions;
(b) Treating qualifying
medical conditions with medicinal cannabis; and
(c) The characteristics of medicinal
cannabis, possible drug interactions and indications of cannabis use disorder;
and
(6) Has submitted an
initial or renewal application for authorization to provide written
certifications for the use of medicinal cannabis and received confirmation of
its process pursuant to Sections 4 and 5 of this administrative
regulation.
Section 4.
Procedures for Submitting an Initial Application for Authorization to Provide
Written Certifications.
(1) To become a
medicinal cannabis practitioner an initial applicant shall:
(a) Submit to the board a completed Initial
Application for Authorization to Provide Written Certifications for the Use of
Medicinal Cannabis;
(b) Submit
proof of completion of six (6) hours of education established in Section 6 of
this administrative regulation; and
(c) Submit payment of a non-refundable fee of
$100.
(2) Upon receipt of
an initial application, the board shall review all application materials
submitted and determine whether the licensee meets qualifications to become a
medicinal cannabis practitioner.
(a) The board
may contact individuals, agencies, or organizations for information about the
licensee.
(b) If deemed appropriate
by the board or its staff, the board may require a licensee to appear before
the board to answer questions or provide additional information deemed
appropriate for the board to make an informed decision about the licensee's
qualifications.
(c) If the board or
its staff determines that the licensee is not qualified to become a medicinal
cannabis practitioner or if the board or its staff is unable to independently
verify whether the licensee meets the qualifications to become a medicinal
cannabis practitioner, the board shall notify the licensee of the grounds upon
which the initial application shall not be approved.
(3) A licensee shall become an authorized
medicinal cannabis practitioner effective upon written or electronic
notification from the board that the initial application has been processed and
approved.
(4) Unless initially
issued or annually renewed between January 1 and March 1 in accordance with
Section 5 of this administrative regulation, the authorization to provide
written certifications for the use of medicinal cannabis shall expire on March
1.
(5) If a medicinal cannabis
practitioner fails to renew before March 1 of any subsequent year, the
practitioner may apply as an initial applicant in accordance with the
procedures established in this section.
Section 5. Process and Procedures for
Renewing Authorization to Provide Written Certifications.
(1) If a medicinal cannabis practitioner
fails to renew his or her medical license and authorization by March 1 of any
calendar year following the calendar year of initial application, the
authorization shall become inactive.
(2) On or about January 1 of each calendar
year after initial issuance, the board shall send notification to all medicinal
cannabis practitioners that annual renewal of their authorization shall be
executed on or before March 1. The notification shall indicate the annual
renewal fee and shall advise the medicinal cannabis practitioner that failure
to timely renew by March 1 shall cause his or her authorization to become
inactive.
(3)
(a) All notifications required to be sent by
this administrative regulation shall be sent:
1. By mail to the medicinal cannabis
practitioner's last known address of which the board has record; or
2. Electronically to the medicinal cannabis
practitioner 's last known email address of which the board has
record.
(b) Failure of
the medicinal cannabis practitioner to receive notice if sent to the last known
address or last known email address shall not excuse the medicinal cannabis
practitioner from compliance with KRS Chapter 218B or this administrative
regulation.
(4) To renew
an authorization to provide written certifications, a medicinal cannabis
practitioner shall:
(a) Submit to the board a
completed Renewal Application for Authorization to Provide Written
Certifications for the Use of Medicinal Cannabis;
(b) Attest to the completion of three (3)
hours of education established in Section 6 of this administrative regulation;
and
(c) Submit payment of a
non-refundable fee of $100.
Section 6. Continuing Education.
(1) A medicinal cannabis practitioner shall
not issue a written certification for use of medicinal cannabis to any patient
unless that licensee has completed the minimum hours of continuing medical
education established in this section.
(2) Within the immediate twelve (12) months
prior to submitting an initial application, a medicinal cannabis practitioner
shall complete at least six (6) hours of continuing medical education certified
in Category I specific to:
(a) Diagnosing
qualifying medical conditions;
(b)
Treating qualifying medical conditions with medicinal cannabis; and
(c) The characteristics of medicinal
cannabis, possible drug interactions, and indications of cannabis use
disorder.
(3) Within the
immediate twelve (12) months prior to submitting a renewal application, a
medicinal cannabis practitioner shall complete at least three (3) hours of
continuing medical education certified in Category I specific to:
(a) Diagnosing qualifying medical
conditions;
(b) Treating qualifying
medical conditions with medicinal cannabis; and
(c) The characteristics of medicinal
cannabis, possible drug interactions, and indications of cannabis use
disorder.
Section
7. Reasons for which Authorization to Provide Written
Certifications for the Use of Medicinal Cannabis may be Suspended or Revoked.
(1) The board may probate, restrict, suspend,
or revoke a medicinal cannabis practitioner's authorization to provide written
certifications upon proof that the medicinal cannabis practitioner has violated
any of the provisions established in
KRS
311.595 or committed violations in accordance
with KRS
218B.015(3)(b).
(2) The board may probate, restrict, suspend,
or revoke a medicinal cannabis practitioner's authorization to provide written
certifications upon proof that the medicinal cannabis practitioner has provided
a written certification to an immediate family member of the medicinal cannabis
practitioner.
(3) Notwithstanding
subsections (1) and (2) of this section, the board may issue an emergency
order, in accordance with
KRS
311.592 and
KRS
13B.125, suspending, limiting, or restricting
a medicinal cannabis practitioner's authorization to provide written
certifications at any time the board has probable cause to believe that:
(a) In accordance with
KRS
218B.015(3)(b), the
medicinal cannabis practitioner has violated any provision of KRS Chapter
218B;
(b) The medicinal cannabis
practitioner has actively engaged in the practice of medicine or osteopathy or
operated a motor vehicle while under the influence of or while consuming
medicinal cannabis;
(c) The
medicinal cannabis practitioner has become impaired by or otherwise abused
medicinal cannabis;
(d) The
medicinal cannabis practitioner has a medically diagnosable disease that is
characterized by chronic, habitual or periodic use of medicinal cannabis
resulting in interference with his or her professional, social, or economic
functions in the community or the loss of powers of self-control regarding the
use of medicinal cannabis;
(e) The
medicinal cannabis practitioner has violated the terms of an agreed order or a
disciplinary order; or
(f) The
medicinal cannabis practitioner's practice constitutes a danger to the health,
welfare, and safety of patients or the general public.
(4) A medicinal cannabis practitioner may be
ordered by the board to submit to a mental or physical examination, including
impairment evaluation, in accordance with
KRS
311.599.
Section 8. Minimal Standards of Care for
Providing Written Certifications.
(1) A
medicinal cannabis practitioner shall only provide a patient with a written
certification after the medicinal cannabis practitioner has complied with the
requirements established by
KRS
218B.050(4).
(2) A bona fide practitioner-patient
relationship may be established pursuant to
KRS
218B.050(5).
(3) A medicinal cannabis practitioner shall
comply with the written certification requirements established by
KRS
218B.050(6).
(4) A medicinal cannabis practitioner shall
comply with the professional standards established in this subsection.
(a) Prior to providing a written
certification, the medicinal cannabis practitioner shall obtain and document
all relevant information in a patient's medical record in a legible manner and
in sufficient detail to enable the board to determine whether the licensee is
conforming to the requirements of KRS Chapter 218B and this administrative
regulation. Relevant information shall include as appropriate:
1. The patient's medical history, including:
a. The patient's mental health and
psychiatric history;
b. The
patient's history of drug use, including a documented review of the patient's
current medication to identify possible drug interactions, including
benzodiazepines and opioids;
c.
Prior treatments; and
d.
Diagnostic, therapeutic, and laboratory results;
2. A focused physical examination relevant to
the patient's medical condition;
3.
Evaluations and consultations;
4.
Diagnosis of the patient's qualifying medical condition;
5. Treatment objectives with use of medicinal
cannabis;
6. Discussion of risk,
benefits, limitations, and alternatives to the of use of medicinal
cannabis;
7. Written informed
consent;
8. Instructions and
agreements;
9. Periodic reviews of
the patient's file;
10. Follow up
evaluations; and
11. Results and
analysis of the patient's PDMP information.
(b) Prior to providing an initial written
certification or renewing a written certification, the medicinal cannabis
practitioner shall query and review a PDMP report for the patient for the
twelve (12) month period immediately preceding the written certification and
appropriately utilize that information in the evaluation and treatment of the
patient.
(c) If the patient is a
female of childbearing potential and age, the medicinal cannabis practitioner
shall recommend the patient to submit to a pregnancy test and shall factor the
results of that test into the clinical decision as to the appropriateness of
the use of medicinal cannabis.
(d)
Based on evidence or behavioral indications of addiction or drug abuse, the
medicinal cannabis practitioner shall obtain a drug screen on the patient. It
shall be within the medicinal cannabis practitioner's discretion to decide the
nature of the screen and which type of drug to be screened.
(e) A medicinal cannabis practitioner shall
be available to provide follow-up care and treatment to the patient, including
physical examinations relevant to the patient's condition to determine the
efficacy of medicinal cannabis in treating the patient's qualifying medical
condition. If the qualifying condition was indicated as a terminal illness in
the prior six (6) months, the medicinal cannabis practitioner shall confirm
whether the patient's condition continues to be a terminal illness.
(f) A medicinal cannabis practitioner shall
terminate or decline to issue a new written certification to a patient, and
shall notify the cabinet in writing of the patient's name if:
1. The patient no longer has the diagnosis of
or symptoms of the qualifying medical condition;
2. The medicinal cannabis practitioner is not
authorized to issue a written certification;
3. The medicinal cannabis practitioner has
reason to believe that the patient or a caregiver is abusing or diverting
medicinal cannabis; or
4. The
patient is deceased.
(g)
If the medicinal cannabis practitioner is unable to conform to the professional
standards established in this administrative regulation due to circumstances
beyond the licensee's control, or the medicinal cannabis practitioner makes a
professional determination that it is not appropriate to comply with a specific
standard established in this administrative regulation based upon the
individual facts applicable to a specific patient's diagnosis and treatment,
the medicinal cannabis practitioner shall document those circumstances in the
patient's record and only provide a written certification to the patient if the
patient's record appropriately justifies the use of medicinal cannabis under
the circumstances.
Section
9. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Initial Application for
Authorization to Provide Written Certifications for the Use of Medicinal
Cannabis", 09/2023; and
(b)
"Renewal Application for Authorization to Provide Written Certifications for
the Use of Medicinal Cannabis", 09/2023.
(2) This material may be inspected, copied,
or obtained, subject to applicable copyright law, at the Kentucky Board of
Medical Licensure, 310 Whittington Parkway, Suite 1B, Louisville, Kentucky
40222, Monday through Friday, 8:00 a.m. to 4:30 p.m. This material is also
available on the board's Web site at
http://kbml.ky.gov.
STATUTORY AUTHORITY:
KRS
218B.050(10),
311.565(1)(a)