Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
211.332,
218B.010,
218B.015,
218B.050,
218B.080,
314.011,
314.042,
314.085,
314.089,
314.091
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
314.131 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 the procedures,
process, and conditions for authorization to provide written certifications,
continuing education requirements for medical cannabis practitioners, and
minimal standards of care. This administrative regulation establishes the
professional standards for an APRN practicing as a medicinal cannabis
practitioner.
Section 1. Definitions.
(1) "Advanced Practice Registered Nurse" or
"APRN" is defined by KRS
314.011(7).
(2) "Authorization" means a credential that
authorizes the APRN to provide written certifications under
KRS
218B.050 and this administrative
regulation.
(3) "Bona fide
practitioner-patient relationship" is defined by
KRS
218B.010(1).
(4) "Cabinet" is defined by
KRS
218B.010(2).
(5) "Controlled substance" means any Schedule
II, III, IV, or V controlled substance and does not include medicinal
cannabis.
(6) "Good standing" means
a license that at the time of initial application or renewal, is not:
(a) Limited, suspended, probated, revoked, or
otherwise disciplined;
(b) Under
investigation;
(c) Subject to
monitoring, alternative discipline, or peer assistance; or
(d) Held by a person who has ever been
subject to disciplinary action by any licensing entity, including the board of
any jurisdiction or the United States Drug Enforcement Administration (DEA)
that was based, in whole or in part, on the person's inappropriate prescribing,
personally furnishing, dispensing, diverting, administering, supplying, or
selling a controlled substance or other dangerous drug.
(7) "Immediate family member" is defined by
201 KAR 20:057, Section
1(5).
(8) "Medicinal cannabis" is
defined by KRS
218B.010(15).
(9) "Medicinal cannabis practitioner" means
an APRN who is holds an authorization under this administrative
regulation.
(10) "Minor" is defined
by KRS
218B.010(19).
(11) "Prescription Drug Monitoring Program"
or "PDMP" is defined by
201 KAR 20:057, Section
1(11).
(12) "Qualified patient" is
defined by KRS
218B.010(25).
(13) "Qualifying medical condition" is
defined by KRS
218B.010(26).
(14) "Telehealth" is defined by
KRS
211.332(5).
(15) "Use of medicinal cannabis" is defined
by KRS
218B.010(37).
(16) "Written certification" means a written
certification for the use of medicinal cannabis and is defined by
KRS
218B.010(39).
Section 2. Applicability. The procedures and
standards established in this administrative regulation shall not apply to an
APRN who recommends treatment with cannabis or a drug derived from cannabis in
accordance with KRS
218B.050(11).
Section 3. Eligibility for an Authorization
to provide written certifications.
(1) An APRN
applicant for an authorization pursuant to
KRS
218B.050 shall:
(a) Hold an active, unrestricted Kentucky
license as an APRN that is in good standing;
(b) Have a valid DEA registration and a
current registration certificate is on file with the board;
(c) Have an active account with the PDMP with
a current PDMP registration certificate on file with the board;
(d) Have not been denied a license to
prescribe, possess, dispense, administer, supply, or sell a controlled
substance by the DEA or appropriate issuing body of any state or jurisdiction,
based, in whole or in part, on the applicant's inappropriate prescribing,
personally furnishing, dispensing, administering, supplying, or selling a
controlled substance or other dangerous drug;
(e) Have not held a license issued by the DEA
or a state licensing administration in any jurisdiction, under which the person
may prescribe, personally furnish, dispense, possess, administer, supply, or
sell a controlled substance, that has ever been restricted, based, in whole or
in part, on the applicant's inappropriate prescribing, dispensing,
administering, supplying, or selling a controlled substance or other dangerous
drug;
(f) Have not been subject to
disciplinary action by any licensing entity that was based, in whole or in
part, on the applicant's inappropriate prescribing, personally furnishing,
dispensing, diverting, administering, supplying, or selling a controlled
substance or other dangerous drug;
(g) Have completed the continuing education
requirements in Section 6 of this administrative regulation; and
(h) Have no ownership or investment interest
in or compensation agreement with a cannabis business licensed under KRS
Chapter 218B.
(2) The
board shall provide the cabinet with the names of all APRNs authorized to
provide written certifications.
(3)
An APRN who fails to renew the authorization or is otherwise unable to legally
practice as a registered nurse or APRN shall not practice as or use the title
of medicinal cannabis practitioner until an authorization has been issued by
the board.
(4) An APRN shall not
provide written certifications unless authorized to do so under this
section.
(5) It is not within the
scope of practice for an APRN to provide written certifications, unless the
APRN is authorized to do so under this section.
(6) The board shall notify the cabinet
immediately with the name of any APRN whose authorization is lapsed,
surrendered, suspended, revoked, or otherwise not renewed.
Section 4. Procedures for submitting an
initial or renewal application for authorization to provide written
certifications.
(1) An applicant for a
certificate to recommend medicinal cannabis shall:
(a) Submit to the board an Authorization to
Provide Written Certifications for the Use of Medicinal Cannabis-Initial
Application or Renewal Application;
(b) Submit to the board a copy of the APRN's
DEA registration certificate;
(c)
Submit a copy of the PDMP master account registration certificate to the
board;
(d) Submit proof of
completion of the education requirements in Section 6(1) of this administrative
regulation; and
(e) Pay a
nonrefundable fee of $100.
(2) An application shall be considered
complete if:
(a) Evidence of all the
requirements in subsection (1) of this section are received by the board;
and
(b) The APRN is not under
investigation pursuant to
201 KAR 20:161 of evidence
appearing to show that the applicant has violated
KRS
314.091(1).
(3) Upon receipt of the application:
(a) The board shall review all application
materials submitted; and
(b) The
board may contact individuals, agencies, or organizations for information about
the applicant. As part of the application process, the board may request an
applicant to appear before the board to answer questions or provide additional
information.
(4) The
following processes apply if an application is not complete within (6) six
months of the date the application is received by the board:
(a) If the application is not complete
because required information or materials have not been received by the board,
the board may notify the applicant in writing that it intends to consider the
application abandoned if the application is not completed. If an application is
abandoned, the board may close the application.
1. The notice shall specifically identify the
information or materials required to complete the application and inform the
applicant that the information or materials shall be received by a specified
date.
2. The notice shall also
inform the applicant that if the application remains incomplete at the close of
business on the specified date the application may be deemed to be
abandoned.
3. If all of the
information or materials are received by the board by the specified date and
the application is determined to be complete, the board shall process the
application. The board may require updated information, as it deems
necessary.
(b) If the
application is not complete because the board is investigating the applicant
for a violation of KRS 314.091(1),
the board shall:
1. Notify the applicant that
although otherwise complete, the application shall not be processed pending
completion of the investigation; and
2. Upon completion of the investigation and
the determination that the applicant is not in violation of
KRS
314.091(1), process the
application. The board may require updated information, as it deems
necessary.
(5)
Once submitted, the Authorization to Provide Written Certifications for the Use
of Medicinal Cannabis, either the Initial Application or Renewal Application,
shall follow the periods for length and renewal in accordance with
201 KAR 20:085, Sections 1 and
2.
(6) An applicant shall not
withdraw an Initial or Renewal Application for Authorization to Provide Written
Certifications for the Use of Medicinal Cannabis without the approval of the
board.
(7) All supporting
documentation required under this section shall be submitted via the KBN Nurse
Portal at
https://kbn.ky.gov.
Section 5. Renewal and Lapse of
the Authorization.
(1) If the APRN fails to
renew the authorization in accordance with
201 KAR 20:085, Sections 1 and 2,
the authorization shall lapse.
(2)
If the APRN fails to timely renew the authorization, the APRN may reapply as an
initial applicant in accordance with the procedures set forth in Section 4 of
this administrative regulation.
(3)
The authorization may be renewed after an APRN's license to practice has been
renewed or restored, if the APRN:
(a) Meets
the requirements in Section 3 of this administrative regulation;
(b) Pays a nonrefundable fee of $100;
and
(c) Has completed the
continuing education requirements in Section 6(2) of this administrative
regulation.
(4) All
supporting documentation required under this section shall be submitted via the
KBN Nurse Portal at
https://kbn.ky.gov.
Section 6. Continuing Education.
(1) An applicant for an initial authorization
shall have completed within the immediate twelve (12) months a one (1) time
requirement of six (6) contact hours in the following subjects:
(a) Diagnosing qualifying medical
conditions;
(b) Treating qualifying
medical conditions with medicinal cannabis;
(c) The pharmacological characteristics of
medicinal cannabis and possible drug interactions; and
(d) Indications of cannabis use
disorder.
(2) Thereafter,
an APRN renewing the authorization shall have obtained during the earning
period three (3) continuing education hours in the subjects listed in
subsection (1) of this section.
Section 7. Sanctions.
(1) The board may probate, restrict, suspend,
revoke, or otherwise discipline an APRN's license or credential to issue
authorizations for violations of
KRS
314.091(1), or violations in
accordance with KRS
218B.015(3)(b).
(2) An investigation against the APRN under
this administrative regulation shall be conducted in accordance with
201 KAR 20:161.
(3) A disciplinary proceeding against the
APRN under this administrative regulation shall be conducted in accordance with
KRS
314.091 and
201 KAR 20:162.
(4) APRN may be ordered by the board to
undergo a substance use evaluation or be subject to an immediate temporary
suspension, in accordance with
KRS
218B.015(4),
314.085, and
314.089.
Section 8. Professional Standards of Care for
Providing Written Certifications.
(1) An APRN
authorized by the board to provide written certifications may only provide a
qualified patient with a written certification after the APRN 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) An APRN shall comply with the written
certification requirements established in
KRS
218B.050(6).
(4)
(a) An
APRN who provides written certifications shall comply with the professional
standards established in this subsection.
(b) Prior to providing a written
certification, the APRN shall:
1. Obtain,
review, and record a complete and appropriate evaluation of the patient, which
shall include:
a. The patient's
name;
b. Date or dates of office
visits or treatments, and responses to treatments;
c. The patient's medical history, including
relevant prescription history and diagnostic results;
d. 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;
e. Based on evidence or behavioral
indications of addiction or drug abuse, the APRN shall obtain a drug screen on
the patient. It is within the APRN's discretion to decide the nature of the
screen and which type of drug to be screened;
f. The patient's social and family
history;
g. A physical examination
relevant to the current medical condition;
h. The patient's psychiatric
history;
i. A focused physical
examination of the patient relevant to the patient's current medical
condition;
j. Documented review
that standard medical treatment has been attempted or considered. If standard
medical treatment is not attempted, the APRN shall document the reasons that
standard medical treatment is not appropriate for this patient;
k. The APRN's diagnosis of the qualified
patient's qualifying medical condition; and
l. If the patient has been previously
diagnosed with a qualifying medical condition by another health care provider
pursuant to KRS
218B.050(4), the APRN may
confirm the diagnosis if:
(i) The APRN
obtains a copy of the medical records or a detailed written summary indicating
the diagnosis;
(ii) The APRN is
satisfied that those records confirm a diagnosis of a qualifying
condition;
(iii) The APRN maintains
a copy of any record or report of any medicinal cannabis practitioner on which
the practitioner relied for purposes of meeting the requirements under this
paragraph;
(iv) The APRN documents
a plan to obtain the patient's consent to obtain and discuss the patient's
prior medical records within thirty (30) days of initiating treatment. Upon
receipt of the medical records, the APRN shall review and incorporate the
information from the records into the evaluation and treatment of the patient.
If the APRN is unable, despite best efforts, to obtain the patient's prior
medical records, the APRN shall document those efforts in the patient's
chart;
(v) The APRN obtains and
reviews a PDMP report for that patient for the twelve (12) month period
immediately preceding the initial patient encounter and appropriately utilizes
that information in the evaluation and treatment of the patient;
(vi) The APRN explains treatment
alternatives, the risks, and the benefits of medicinal cannabis with the
patient;
(vii) The APRN obtains
written informed consent from the patient for treatment;
(viii) The APRN discusses and documents the
patient's treatment with the patient's other providers; and
(ix) The patient is a female of childbearing
potential and age, and meets the requirements of subparagraph 2. of this
paragraph.
2.
a. Prior to initiating treatment, the APRN
shall recommend that female patients of childbearing age submit to a pregnancy
test and, if pregnant, the APRN shall provide counseling. The APRN shall
document a patient's decision to decline to take a pregnancy test and the
stated rationale for the patient's decision.
b. Prior to providing a written certification
to a patient who is pregnant or breastfeeding, the APRN shall document the
patient's decision to decline consultation referenced in this subsection, and
the stated rationale for the patient's decision.
(5) The written
certification shall include a statement from the APRN certifying that:
(a) A bona fide practitioner-patient
relationship exists between the APRN and qualified patient.
(b) The qualified patient has been diagnosed
with at least one (1) qualifying medical condition for which the APRN believes
the patient may receive medical, therapeutic, or palliative benefit;
and
(c) In the APRN's professional
medical opinion, the qualified patient may receive medical, therapeutic, or
palliative benefit from the use of medicinal cannabis.
(6) An APRN who authorizes a written
certification shall be available to provide follow-up care and treatment to the
qualified patient, including physical examinations relevant to the qualified
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 APRN shall
confirm whether the qualified patient's condition continues to be a terminal
illness.
(7) The APRN shall
terminate or decline to issue a new written certification under any of the
following circumstances:
(a) The patient no
longer has the diagnosis of, or symptoms of, the qualifying medical
condition;
(b) The APRN is not
authorized to issue a written certification;
(c) Based on the APRN's clinical judgement,
the patient or caregiver is abusing or diverting medicinal cannabis;
or
(d) The qualified patient is
deceased.
(8) The APRN
shall notify the cabinet in writing within thirty (30) days the name of any
patient for whom the APRN has terminated or declined to issue a written
certification.
(9) The records
required for the recommendation for a written certification may be kept with
the patient's other medical records and shall be retained for at least five (5)
years following the last office visit by the patient.
(10) An APRN medicinal cannabis practitioner
shall not:
(a) Dispense medicinal cannabis;
or
(b) Provide a written
certification to an immediate family member or for himself or
herself.
Section
9. Documented Deviation from Professional Standards for Providing
Written Certifications. If an APRN is unable to conform to professional
standards for providing written certifications set forth in this administrative
regulation due to circumstances beyond the APRN's control, or the APRN makes a
professional determination that it is not appropriate to comply with a specific
standard, based upon the individual facts applicable to a specific patient's
diagnosis and treatment, the APRN shall document those circumstances in the
patient's record and only provide a written certification to the patient if the
patient record appropriately justifies the providing of a written certification
under the circumstances.
Section
10. Material Incorporated by reference.
(1)
(a)
"Authorization to Provide Written Certifications for the Use of Medicinal
Cannabis-Initial Application", 01/2024; and
(b) "Authorization to Provide Written
Certifications for the Use of Medicinal Cannabis-Renewal Application",
01/2024.
(2) This
material may be inspected, copied, or obtained, subject to applicable copyright
law, at the Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300,
Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m. This
material is also available on the Board's Web site at
https://kbn.ky.gov/document-library/Pages/default.aspx.
STATUTORY AUTHORITY:
KRS
218B.010,
218B.050,
314.131