The proposed amendments are intended to address recent legislation authorizing smokable medical marijuana. The proposed amendments incorporate the revised medical marijuana consent form and incorporate a new documentation form for use by qualified ...

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.018Mandatory Standarized Informed Consent for Medical Marijuana; Required Documentation for Comparable Medical Conditions

PURPOSE AND EFFECT: The proposed amendments are intended to address recent legislation authorizing smokable medical marijuana. The proposed amendments incorporate the revised medical marijuana consent form and incorporate a new documentation form for use by qualified physicians who determine that smoking marijuana is an appropriate route of administration for a qualified patient.

SUMMARY: The proposed rule amendments incorporate the revised medical marijuana consent form and incorporate a new documentation form for use by qualified physicians who determine that smoking marijuana is an appropriate route of administration for a qualified patient.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 381.986 FS.

LAW IMPLEMENTED: 381.986 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Claudia Kemp, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B8-9.018 Mandatory Standardized Informed Consent for Medical Marijuana; Required Documentation for Comparable Medical Conditions; Required Documentation for Smokable Medical Marijuana.

(1) Pursuant to section 381.986, F.S., the Board has approved form DOH-MQA-5026 (rev. 4/19 2/18), entitled “Medical Marijuana Consent Form,” which is hereby incorporated by reference and available from http://www.flrules.org/Gateway/reference.asp?No=Ref-         09314, or the Board’s website at http://www.flboardofmedicine.gov/forms/medical-marijuana-consent-form.pdf, as the mandatory standardized informed consent form that a qualified physician must use each time the qualified physician issues a certification for medical marijuana to a patient he or she has diagnosed with at least one qualifying medical condition.

(2) No change.

(3) Pursuant to section 381.986(4)(c), F.S., qualified physicians who determine that smoking marijuana is an appropriate route of administration for a qualified patient, other than a patient diagnosed with a terminal condition, are required to submit form DH-MQA-5035 (4/19), entitled “Documentation Required Under Section 381.986(4)(c), Florida Statutes, Supporting the Determination that the Smoking of Medical Marijuana is an Appropriate Route of Administration,” which is hereby incorporated by reference and available from http://www.flrules.org/Gateway/reference.asp?No=Ref-        , or the Board’s website at http:// www.flboardofmedicine.gov/forms.

Rulemaking Authority 381.986 FS. Law Implemented 381.986 FS. History–New 4-30-18, Amended        .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Joint Committee on Medical Marijuana

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 5, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 22, 2019