Title 915 | Chapter 002 | Regulation 030REG
PROPOSED
This document is not yet current.
CABINET FOR HEALTH AND FAMILY SERVICES
Office of the Secretary
(New Administrative Regulation)
915 KAR 2:030.Written certifications.
Section 1.
Medicinal Cannabis Practitioners.(1)
The cabinet shall maintain a medicinal cannabis practitioner registry for the Kentucky Medical Cannabis Program as part of the state's designated electronic monitoring system.(2)
Medicinal cannabis practitioners shall register with the state's medicinal cannabis practitioner registry in accordance with written instructions provided by the cabinet and properly enter written certifications and dosage recommendations for qualified patients into the registry.(3)
Prior to providing a patient with a written certification, a medicinal cannabis practitioner shall comply with KRS 218B.050(4), including establishing a bona fide practitioner-patient relationship with the patient. A medicinal cannabis practitioner shall also comply with the respective administrative regulation promulgated by his or her state licensing board establishing professional standards for medicinal cannabis practitioners, 201 KAR 9:067 or 201 KAR 20:067, and be authorized to provide written certifications for use of medicinal cannabis to qualified patients by his or her state licensing board.Section 2.
Written Certification Form.(1)
When issuing a written certification for the use of medicinal cannabis to a patient, the medicinal cannabis practitioner shall use the form prescribed by the cabinet and available in the medicinal cannabis practitioner registry. The written certification form shall include:(a)
The medicinal cannabis practitioner's full name, license type (such as MD or APRN), license number, office address, telephone number, and email address;(b)
The date of the medicinal cannabis practitioner's examination of the qualified patient;(c)
The qualified patient's full name, date of birth, Social Security number, and email address;(d)
If the qualified patient is a minor, the custodial parent or legal guardian's full name, date of birth, Social Security number, email address, and phone number;(e)
Identification of the diagnosed qualifying medical condition(s);(f)
Attestations that the medicinal cannabis practitioner has:1.
Established a bona fide practitioner-patient relationship with the patient;2.
Diagnosed the patient, or confirmed a diagnosis provided by another healthcare provider, with a qualifying medical condition for which the medicinal cannabis practitioner believes that the patient may receive therapeutic or palliative benefit from the use of medicinal cannabis;3.
Reviewed a report of information from the electronic monitoring system established pursuant to KRS 218A.202 related to the patient for a period of time that covers at least the twelve (12) months immediately preceding the date of the report;4.
Consulted with the patient, or the patient's custodial parent or legal guardian responsible for providing consent to treatment if the patient is a minor, with respect to the possible risks and side effects associated with medicinal cannabis, including possible interactions between medicinal cannabis and any other drug or medication that the patient is taking at that time; and5. Obtained the consent of the patient's custodial parent or legal guardian responsible for providing consent to treatment if the patient is a minor;(g)
The medicinal cannabis practitioner's signature and the date signed.(2)
An initial written certification shall be provided by the medicinal cannabis practitioner to the qualified patient during the course of an in-person examination. Subsequent written certifications for the purpose of renewing a registry identification card may be provided electronically or during the course of a telehealth consultation.(3)
Pursuant to KRS 218B.050(6)(d), within twenty-four (24) hours of providing a patient with a written certification for the use of medicinal cannabis, a medicinal cannabis practitioner shall record the issuance of the written certification in the state's designated medicinal cannabis practitioner registry.(4)
Pursuant to KRS 218B.050(6)(c), for the purpose of initially applying for a registry identification card, a written certification shall be valid for a period of not more than sixty (60) days. A medicinal cannabis practitioner may renew a written certification for not more than three (3) additional periods of not more than sixty (60) days each. Thereafter, the medicinal cannabis practitioner may issue another written certification to the patient for use in the registry identification card application process only after an in-person examination or an examination conducted via telehealth of the patient by the medicinal cannabis practitioner.(5)
Pursuant to KRS 218B.055(10), for the purpose of renewing a registry identification card, a written certification issued by a medicinal cannabis practitioner shall be valid if issued within ninety (90) days immediately preceding the date of a renewal application.(6)
When entering a written certification into the state's designated medicinal cannabis practitioner registry, a medicinal cannabis practitioner shall enter any recommendation or limitation as to the form and dosage of medicinal cannabis that can be dispensed to the registered qualified patient.SAM FLYNN, Executive Director
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY March 6, 2024
FILED WITH LRC: March 14, 2024 at 11:50 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on May 22, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by May 15, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until May 31, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; Phone: 502-564-7476; Fax: 502-564-7091; CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to carry out the requirements of KRS Chapter 218B, specifically KRS 218B.140.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations for the medicinal cannabis program. This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
Not applicable. This is a new administrative regulation.
(b) The necessity of the amendment to this administrative regulation:
Not applicable. This is a new administrative regulation.
(c) How the amendment conforms to the content of the authorizing statutes:
Not applicable. This is a new administrative regulation.
(d) How the amendment will assist in the effective administration of the statutes:
Not applicable. This is a new administrative regulation.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This administrative regulation affects medicinal cannabis practitioners, patients, designated caregivers, and the Kentucky Medical Cannabis Program within the Cabinet for Health and Family Services.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Medicinal cannabis practitioners shall use the written certification form prescribed by the cabinet.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There is no anticipated cost to comply with this administrative regulation.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Medicinal cannabis practitioners can provide patients with written certifications required to become cardholders in the Kentucky Medical Cannabis Program.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation.
(b) On a continuing basis:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation on a continuing basis.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
State general funds provided by the commonwealth
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
It is not anticipated that an increase in funding will be necessary to implement this regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not establish or increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applied. All medicinal cannabis practitioners will be treated equally.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
This administrative regulation impacts the Kentucky Medical Cannabis Program within the Cabinet for Health and Family Services.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 218B.140.
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
This administrative regulation is not expected to generate revenue for state or local government in the first year.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
This administrative regulation is not expected to generate revenue for state or local government for subsequent years.
(c) How much will it cost to administer this program for the first year?
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation.
(d) How much will it cost to administer this program for subsequent years?
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation on a continuing basis.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Expenditures (+/-):
Other Explanation:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
The cabinet does not anticipate any cost savings in the first year.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
The cabinet does not anticipate any cost savings in subsequent years.
(c) How much will it cost the regulated entities for the first year?
The cabinet does not anticipate any cost for the first year.
(d) How much will it cost the regulated entities for subsequent years?
The cabinet does not anticipate any in subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] It is not anticipated that this administrative regulation will have an overall negative or adverse economic impact of $500,000 or more on the Cabinet for Health and Family Services.
CABINET FOR HEALTH AND FAMILY SERVICES
Office of the Secretary
(New Administrative Regulation)
915 KAR 2:030.Written certifications.
Section 1.
Medicinal Cannabis Practitioners.(1)
The cabinet shall maintain a medicinal cannabis practitioner registry for the Kentucky Medical Cannabis Program as part of the state's designated electronic monitoring system.(2)
Medicinal cannabis practitioners shall register with the state's medicinal cannabis practitioner registry in accordance with written instructions provided by the cabinet and properly enter written certifications and dosage recommendations for qualified patients into the registry.(3)
Prior to providing a patient with a written certification, a medicinal cannabis practitioner shall comply with KRS 218B.050(4), including establishing a bona fide practitioner-patient relationship with the patient. A medicinal cannabis practitioner shall also comply with the respective administrative regulation promulgated by his or her state licensing board establishing professional standards for medicinal cannabis practitioners, 201 KAR 9:067 or 201 KAR 20:067, and be authorized to provide written certifications for use of medicinal cannabis to qualified patients by his or her state licensing board.Section 2.
Written Certification Form.(1)
When issuing a written certification for the use of medicinal cannabis to a patient, the medicinal cannabis practitioner shall use the form prescribed by the cabinet and available in the medicinal cannabis practitioner registry. The written certification form shall include:(a)
The medicinal cannabis practitioner's full name, license type (such as MD or APRN), license number, office address, telephone number, and email address;(b)
The date of the medicinal cannabis practitioner's examination of the qualified patient;(c)
The qualified patient's full name, date of birth, Social Security number, and email address;(d)
If the qualified patient is a minor, the custodial parent or legal guardian's full name, date of birth, Social Security number, email address, and phone number;(e)
Identification of the diagnosed qualifying medical condition(s);(f)
Attestations that the medicinal cannabis practitioner has:1.
Established a bona fide practitioner-patient relationship with the patient;2.
Diagnosed the patient, or confirmed a diagnosis provided by another healthcare provider, with a qualifying medical condition for which the medicinal cannabis practitioner believes that the patient may receive therapeutic or palliative benefit from the use of medicinal cannabis;3.
Reviewed a report of information from the electronic monitoring system established pursuant to KRS 218A.202 related to the patient for a period of time that covers at least the twelve (12) months immediately preceding the date of the report;4.
Consulted with the patient, or the patient's custodial parent or legal guardian responsible for providing consent to treatment if the patient is a minor, with respect to the possible risks and side effects associated with medicinal cannabis, including possible interactions between medicinal cannabis and any other drug or medication that the patient is taking at that time; and5. Obtained the consent of the patient's custodial parent or legal guardian responsible for providing consent to treatment if the patient is a minor;(g)
The medicinal cannabis practitioner's signature and the date signed.(2)
An initial written certification shall be provided by the medicinal cannabis practitioner to the qualified patient during the course of an in-person examination. Subsequent written certifications for the purpose of renewing a registry identification card may be provided electronically or during the course of a telehealth consultation.(3)
Pursuant to KRS 218B.050(6)(d), within twenty-four (24) hours of providing a patient with a written certification for the use of medicinal cannabis, a medicinal cannabis practitioner shall record the issuance of the written certification in the state's designated medicinal cannabis practitioner registry.(4)
Pursuant to KRS 218B.050(6)(c), for the purpose of initially applying for a registry identification card, a written certification shall be valid for a period of not more than sixty (60) days. A medicinal cannabis practitioner may renew a written certification for not more than three (3) additional periods of not more than sixty (60) days each. Thereafter, the medicinal cannabis practitioner may issue another written certification to the patient for use in the registry identification card application process only after an in-person examination or an examination conducted via telehealth of the patient by the medicinal cannabis practitioner.(5)
Pursuant to KRS 218B.055(10), for the purpose of renewing a registry identification card, a written certification issued by a medicinal cannabis practitioner shall be valid if issued within ninety (90) days immediately preceding the date of a renewal application.(6)
When entering a written certification into the state's designated medicinal cannabis practitioner registry, a medicinal cannabis practitioner shall enter any recommendation or limitation as to the form and dosage of medicinal cannabis that can be dispensed to the registered qualified patient.SAM FLYNN, Executive Director
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY March 6, 2024
FILED WITH LRC: March 14, 2024 at 11:50 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on May 22, 2024, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by May 15, 2024, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until May 31, 2024. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; Phone: 502-564-7476; Fax: 502-564-7091; CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to carry out the requirements of KRS Chapter 218B, specifically KRS 218B.140.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations for the medicinal cannabis program. This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
Not applicable. This is a new administrative regulation.
(b) The necessity of the amendment to this administrative regulation:
Not applicable. This is a new administrative regulation.
(c) How the amendment conforms to the content of the authorizing statutes:
Not applicable. This is a new administrative regulation.
(d) How the amendment will assist in the effective administration of the statutes:
Not applicable. This is a new administrative regulation.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This administrative regulation affects medicinal cannabis practitioners, patients, designated caregivers, and the Kentucky Medical Cannabis Program within the Cabinet for Health and Family Services.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Medicinal cannabis practitioners shall use the written certification form prescribed by the cabinet.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There is no anticipated cost to comply with this administrative regulation.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Medicinal cannabis practitioners can provide patients with written certifications required to become cardholders in the Kentucky Medical Cannabis Program.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation.
(b) On a continuing basis:
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation on a continuing basis.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
State general funds provided by the commonwealth
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
It is not anticipated that an increase in funding will be necessary to implement this regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not establish or increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applied. All medicinal cannabis practitioners will be treated equally.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
This administrative regulation impacts the Kentucky Medical Cannabis Program within the Cabinet for Health and Family Services.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 218B.140.
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
This administrative regulation is not expected to generate revenue for state or local government in the first year.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
This administrative regulation is not expected to generate revenue for state or local government for subsequent years.
(c) How much will it cost to administer this program for the first year?
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation.
(d) How much will it cost to administer this program for subsequent years?
This administrative regulation creates a standardized written certification form for use by medicinal cannabis practitioners. There is no anticipated cost to implement this administrative regulation on a continuing basis.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Expenditures (+/-):
Other Explanation:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
The cabinet does not anticipate any cost savings in the first year.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
The cabinet does not anticipate any cost savings in subsequent years.
(c) How much will it cost the regulated entities for the first year?
The cabinet does not anticipate any cost for the first year.
(d) How much will it cost the regulated entities for subsequent years?
The cabinet does not anticipate any in subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] It is not anticipated that this administrative regulation will have an overall negative or adverse economic impact of $500,000 or more on the Cabinet for Health and Family Services.