By: Susan St. John
As you have probably heard, Governor Scott signed Senate Bills 6A and 8A on June 23, 2017. What this means for practitioners is an increased opportunity to help patients that might derive benefit from treatment with medical marijuana. However, with increased opportunity comes increased scrutiny. Although these laws open up treatment options, practitioners need to ensure they strictly abide by the statutes and rules to be implemented by the Department of Health (“Department”). The Department has already published notice of the first conference call on Senate Bill 8A and emergency rule making authority, with the first conference call scheduled for Friday, July 14, 2017. Practitioners should also keep in mind that marijuana is still a schedule 1 controlled substance under federal law, thus, insurance companies are not covering treatment with medical marijuana.
Medical Marijuana Law: The Act
Senate Bill 8A, Chapter 2017-232, Laws of Florida, is an act relating to the medical use of marijuana (the “Act”). The Act implements Section 29, Article X of the Florida Constitution (Amendment 2 approved by voters November 8, 2016), which expanded medical marijuana use to patients with other conditions besides a terminal illness with a prognosis of less than a year. The Act includes the addition of several definitions to Section 381.986, Florida Statutes, including “qualified patient,” “qualified physician,” and “physician certification.” The Act adds 13 qualifying medical conditions, and a patient must be diagnosed with at least one of the 13 conditions to qualify to receive marijuana or a marijuana delivery device.
Now, lets take a quick look at the three definitions enumerated in the previous paragraph.
- Physician certification means a qualified physician’s authorization for a qualified patient to receive marijuana and a marijuana delivery device from a medical marijuana treatment center.
- A qualified patient is 1) a resident of Florida, 2) has been added to the medical marijuana use registry by a qualified physician to received marijuana or a marijuana delivery device, and 3) who has a qualified patient identification card.
- A qualified physician under the Act is a “person who holds an active, unrestricted license as an allopathic physician under Chapter 458 or as an osteopathic physician under Chapter 459, and is in compliance with education requirements set forth in the Act. Education requirements consist of a 2-hour course and subsequent examination offered by either the Florida Medical Association or Florida Osteopathic Medical Association, and encompasses the requirements of the Act and any rules adopted pursuant to the Act. Further, a qualified physician may not have any direct or indirect economic interest in a medical marijuana treatment center or testing laboratory, including as an employee.
There are at least 8 things a qualified physician must due in order to issue a physician certification to a qualified patient. This is where the rubber starts to meet the road with medical marijuana law. A physician must be diligent in examining and explaining to a potential qualified patient the diagnoses that are appropriate for medical marijuana use and potential side effects from the use of medical marijuana. The use of medical marijuana must outweigh the potential risk associated with treatment using medical marijuana. For patients younger than 18 years of age, a second physician must concur that treatment with medical marijuana is appropriate. In addition to examining the patient and explaining risks and benefits of use, the physician will need to check the patient’s controlled drug prescription history and review the medical marijuana registry to ensure that the patient does not have an active physician certification already in place. The physician will need to register as the issuer of the physician certification on the medical marijuana use registry, and include all information regarding the patient in the registry, and timely update the registry for any changes to the physician certification. If the patient should no longer benefit from medical marijuana and its use is discontinued, the physician must deactivate the registration of the qualified patient and patient’s caregiver. And of course, the physician must obtain voluntary and informed written consent from the patient regarding the use of medical marijuana each time the qualified physician issues a physician certification for the patient, with such written consent being maintained in the patient’s medical record. The Department of Health will develop a standardized informed consent form that must be used by qualified physicians when issuing physician certifications.
Additionally, the qualified physician must submit the following documentation to the applicable board if he or she issues a physician certification: 1) documentation supporting the physician’s opinion that the patient’s medical condition falls within the scope of conditions that are enumerated in the Act; 2) documentation that establishes the efficacy of treatment with medical marijuana for the patient’s condition; 3) documentation that the benefits of medical marijuana outweigh the potential risks for the patient; and 4) any other documentation required by board rule (rules are yet to be developed and promulgated).
Generally, a physician can issue a physician certification for not more than three 70-day (210 days in total) supply limits of medical marijuana; however, exceptions to the daily dose amount can be requested. The exception requests require descriptions of the patient’s medical condition, current use and ineffectiveness, how an increase in daily dose would benefit the patient, and the minimum daily does that would be sufficient for the particular patient.
Before issuing another physician certification, the physician must meet with a qualified patient no less than every 30 weeks and determine if the patient still meets qualifications, whether there have been any adverse reactions from use, whether the patients use of other controlled substances has been reduced, and then submit a report of findings to the Department of Health.
Because some patients may already being using low THC cannabis or medical cannabis under former Section 381.986, Florida Statues, registration with the compassionate use registry before the effective date of this Act, will be deemed a physician certification and all patients possessing such orders are deemed qualified patients until the Department begins issuing medical marijuana use registry identification cards. Additionally, the Department will monitor physician registration with the medical marijuana use registry and issuance of physician certifications to ensure practitioners are not facilitating unlawful diversion or misuse of marijuana or a marijuana delivery device. Both the Board of Medicine and the Board of Osteopathic Medicine will create review panels to review all physician certifications submitted to the medical marijuana use registry.
Potential Pitfalls for Providers
And with all opportunity, there are pitfalls to be aware of, including criminal penalties. A qualified physician could find himself or herself having to defend against a first degree misdemeanor if that physician issues a physician certification for medical marijuana use to a patient without a reasonable belief that the patient is suffering from a qualifying medical condition. Also, a physician is subject to disciplinary action pursuant to Section 456.072(1)(n), Florida Statutes, if he or she receives compensation from a medical marijuana treatment center related to the issuance of a physician certification. A physician may also be subject to disciplinary action under Section 456.072(2), Florida Statues, if he or she issues a physician certification in a manner not in compliance with the Act.
As the Department develops rules pursuant to the Act, it will be vitally important that qualified physicians keep abreast of developing or newly implemented rules to ensure compliance with the Act to allow the physician to develop a healthy, compliant practice related to prescribing medical marijuana.