The Minnesota Department of Health Releases Draft Rules for Medical Cannabis Registry: Patient Enrollment and Health Care Practitioners

On October 9, 2014, the Minnesota Department of Health (“MDH”) published the draft rules for medical cannabis registry for patient enrollment in healthcare practitioners for informal comment. A summary of the draft rules provided below.

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Some important definitions are:

Healthcare Practitioner: the draft rules use the same definition for healthcare practitioner that is found in Minn. Stat. § 152.22, subd. 4, which states “healthcare practitioner means a Minnesota licensed doctor of medicine, a Minnesota licensed physician assistant acting within the scope of authorized practice, or a Minnesota licensed advanced practice registered nurse who has the primary responsibility for the care and treatment of the qualifying medical condition of a person diagnosed with a qualifying medical condition.”

Medical Cannabis: means “any species of the genus cannabis plant, or any mixture or preparation of them, including whole plant extracts and resins, and is delivered in the form of: (1) liquid, including, but not limited to, oil; (2) pill; (3) vaporized delivery method with use of liquid or oil but which does not require the use of dried leaves or platform; or (4) any other method, excluding smoking, approved by the commissioner.”

Patient: a patient means, “a Minnesota resident who has been diagnosed with a qualifying medical condition by a healthcare practitioner and who has otherwise met any other requirements for patients under sections 152.22 to 152.37 to participate in the registry program under sections 152.22 to 152.37.”

Qualifying Patient: a qualifying patient means “a resident of Minnesota with been diagnosed by a health care practitioner as having a qualifying medical condition and who possesses of valid registry verification…”

Medical Relationship: means “a treatment or counseling relationship, in the course of which the healthcare practitioner has completed a full assessment of the patient’s medical history and current medical condition.

Transport: means “the movement of medical cannabis products from a manufacturers distribution site to the residents of a registered qualified patients, or otherwise provided by law.

Process For Adding A Qualifying Medical Condition

Minnesota’s medical cannabis statute allows for the Commissioner to periodically revise the list of qualified medical conditions that are eligible for treatment with medical cannabis. Any revisions will be due to advances in medical science, peer-reviewed research demonstrating treatment efficacy, or other therapeutic factors that will improve patient care. The Commissioner will way the adequacy of available evidence and the absence of other treatment options when determining whether a condition should be added to the list. In order for the condition to ultimately be included as a qualifying condition, the Commissioner must forward the condition to be added to the chairs and ranking minority members of the legislative policy committees that have jurisdiction over health and public safety.

In addition to the Commissioner adding a qualifying condition any person may request that the Commissioner add a qualifying medical condition that is not currently listed. The person who makes the request must apply on a form that is provided to the Commissioner. Once the form is submitted the Commissioner has sixty days to respond to the request and applies the same criteria that is described above. The Commissioner has three choices in the response to the request, 1) approved the request and forward the condition it to be added to the chairs and ranking minority members of the legislative policy committees having jurisdiction over health and public safety, 2) reject the condition, or 3) to further the condition for further review.

Patient Application

A patient, or a patient’s parent or legal guardian has to apply for the registry and to prove Minnesota residency. The registrant must also pay a non-refundable annual enrollment fee. Each applicant, if approved, will then get a unique registry number. The Commissioner will then notify the patient’s health care practitioner and the registered manufacturers that the patient has been approved.

Caregiver Application

A caregiver applying for an application has to go through the same process as a patient and also has to submit to a background check, as well as pay for the cost of the background check. Additionally, the designated caregiver must notify the commissioner of a change of any information regarding the qualifying patient within 30 days of the change. If the patient passes away, the caregiver must notify the MDH within 10 days and dispose of all unused medical cannabis within 10 days after the patient is no longer enrolled.

The designated care giver can transport the registered patient to and from a distribution center and can transport the cannabis on behalf of the patient.

Revocation of Patient Enrollment

A patient’s registration with the Commissioner as a qualifying patient can be revoked by the Commissioner. This can happen if the qualifying patient becomes incarcerated, the qualified patient provided false or misleading information on the application, or the qualifying patient obtains more than a 30-day supply of cannabis in a 30 day period and the Commissioner believes the patient is abusing or diverting medical cannabis.

Revocation of Caregiver Status

A caregiver’s registration can be revoked if the qualifying patient’s registration has been revoked, the qualifying patient’s physician notifies the MDH that the patient is no longer in need of a designated caregiver, the patient registers a different caregiver, the caregiver has a disqualifying felony offense, or the designated caregiver’s patient obtains more than a 30 day supply of cannabis within a 30 day period and the Commissioner believes the patient is abusing or diverting medical cannabis.

The rules reiterate that a caregiver cannot grow cannabis, purchase cannabis from a non-authorized source, or obtain medical cannabis from other registered qualifying patients.

Disposing of Medical Cannabis

A patient or caregiver must dispose of the medical cannabis within 10 days of no longer being registered or enrolled by doing one of the following: (1) depositing it with a medical cannabis distribution site in Minnesota, (2) depositing it with a law enforcement agency having local jurisdiction for destruction, (3) disposing of the medical cannabis at a government recognized drug take-back program in Minnesota, (4) rendering it non-recoverable consistent with the Commissioner’s proper disposal instructions, which are available at the MDH’s medical cannabis program website.

Annual Fees

A qualifying patient must pay an initial registration fee and also a fee with each registration annual renewal. A reduced fee is available to patients who are on Social Security Disability Income, Supplemental Security Income, or receiving medical assistance.

Health Care Practitioner Requirements

The Commissioner can only accept certifications from healthcare practitioners recommending a patient’s therapeutic use of cannabis if the healthcare practitioner has an active license and is in good standing, as well has a DEA registration certificate.

In addition, the healthcare practitioner cannot recommend the therapeutic use of cannabis unless the practitioner has a medical relationship with the patient, conducts a full assessment of the patient’s medical history and current medical condition. In order to assess the patient’s current medical condition, a practitioner must perform an in a person physical examination (it cannot be performed by any remote means, including the Internet or telemedicine), gather the medical history of the patient, provide consultations about the patient’s qualifying medical condition before the patient applies for enrollment in the cannabis registry, give a diagnosis of the patient’s current medical condition, and develop a treatment plan for the patient.

Once the patient is enrolled in the registry program and that practitioner receives confirmation of such, the practitioner must participate in the patient registry reporting system and transmit patient treatment, outcomes and medical findings in a form and at intervals as prescribed by the Commissioner. The practitioner must also be available to provide continuing treatment to the patient, maintain health records, report health record data, make copies of health records and supply them to the Commissioner, annually assess whether the patient continues to suffer from a qualifying medical condition, and notify the Commissioner within fourteen days of becoming aware of the death of a qualifying patient or if the patient has a change in status (if that change in status of facts the patient’s ability to participate in the program).

Written Certification of Qualifying Condition

The healthcare practitioner must provide the qualifying patient with a written certification of a qualifying condition that includes confirmation that the qualifying patient is under the healthcare practitioner’s care, the patient has a qualifying medical condition, an indication of which symptom or side effects the condition or its treatment has produced in the patient, and any additional comments the healthcare practitioner believes would be useful.

Healthcare Practitioner Prohibitions

Healthcare practitioner is prohibited from examining a qualified patient to issue a written certification at a location were medical cannabis is manufactured, sold, or dispensed, refer a patient to manufacturer or distributor, refer a patient to a designated caregiver, issue a written certification for themselves, hold a financial interest in an enterprise that provides or distributes medical cannabis, directly or indirectly except solicit or receive anything of value from a manufacturer, employee of a manufacturer, or any other person associated with the manufacturing facility, offer discounts to qualifying patient who uses or agrees to use a particular designated caregiver, distribution facility, or cannabis product, or directly or indirectly benefit from a patient obtaining a written certification (such prohibition does not prohibit a healthcare practitioner from charging an appropriate fee for the patient visit).

Records Maintained By the Certifying Health Care Practitioner

The healthcare practitioner must maintain health records for each patient for whom the healthcare practitioner has recommended medical cannabis. The records need not be maintained separately from the healthcare practitioner’s established records for the patient’s ongoing medical relationship. As well as being legible and accurate, the records must include the patient’s name and dates of visits and treatments, the patient’s case history and health condition, the results of all diagnostic tests and examinations, the patient’s plan of care, and a list of drugs prescribed and the quantity of the drugs.

The practitioner must keep records for each qualifying patient for at least three years after lessening the patient or seven years, whichever is greater.