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Florida Senate Bill 8A Effect on Physicians’ Medical Marijuana Practices

Under SB8A, a “qualified physician” is a person who holds an active and unrestricted license to practice medicine in compliance with the physician education requirements. In order to be approved as a qualified physician, the physician must successfully complete a 2-hour course and exam by either the Florida Medical Association or the Florida Osteopathic Medical Association. The exam will not cost more than $500. This requirement also applies to those seeking to become Medical Directors in medical marijuana treatment centers (“MMTC”).

Florida Senate Bill 8-A’s Effect on Physicians’ Medical Marijuana Practices

Background

President Trump he has not taken a firm stance publicly in favor of or opposed to the use of medical marijuana. Currently, he intends to leave the medical marijuana issue up to the individual states. The 2016 fiscal year  omnibus appropriations bill appears to be in line with Trump as it contains language prohibiting the Department of Justice from meddling in state medical marijuana laws.

According to a Department of Health report, the state registry now has 16,614 patients. A recent state revenue impact study projects that by 2022 there will be approximately 472,000 medical marijuana patients and $542 million in sales.

Many activists expect that there will be several lawsuits related to SB8A. Legislators anticipated this and have added language that divides SB8A so that if certain parts are held unconstitutional the court would only invalidate those parts without invalidating the entire law.

Qualified Physician

Under SB8A, a “qualified physician” is a person who holds an active and unrestricted license to practice medicine in compliance with the physician education requirements. In order to be approved as a qualified physician, the physician must successfully complete a 2-hour course and exam by either the Florida Medical Association or the Florida Osteopathic Medical Association. The exam will not cost more than $500. This requirement also applies to those seeking to become Medical Directors in medical marijuana treatment centers (“MMTC”).

A “Medical Marijuana Treatment Center” means an entity that acquires, cultivates, possesses, processes (including development of related products such as food, tinctures, aerosols, oils, or ointments), transfers, transports, sells, distributes, dispenses, or administers marijuana, products containing marijuana, related supplies, or educational materials to qualifying patients or their caregivers and is registered by the Department. As you can see, the definition of an MMTC is very broad and includes virtually every type of business in the medical marijuana industry.

A qualified physician may not be employed by, or have any direct or indirect economic interest in, a medical marijuana treatment center or marijuana testing laboratory. This sentence is important because it means that not every physician is bound by this rule. If you are a physician and you have not taken the course and exam to become certified so that you can certify marijuana to your terminally ill patients then this law doesn’t apply to you. For example, if you are a dermatologist who does not treat any terminally ill patients and you are not a “qualified physician” for purposes of providing marijuana to terminally ill patients then you are not prohibited from being employed by or having an economic interest in an MMTC or marijuana testing laboratory (“MTL”). An MTL or “Independent testing laboratory” means a laboratory, including the managers, employees, or contractors of the laboratory, which has no direct or indirect interest in a dispensing organization.

This aforementioned provision of SB8A places broad limits on the types of marijuana facilities and businesses that a qualified physician is permitted to have a financial interest in. MMTCs and MTLs are off-limits to qualified providers. Non-Qualified providers are thus able to work for or have a financial interest in medical marijuana retailers, medical marijuana delivery devices, and medical marijuana delivery companies to name a few.

A qualified physician may not authorize a patient to receive more than three 70-day supply limits of marijuana. However, a physician may request an exception to the daily dose amount limit electronically. Further, a physician must evaluate an existing patient at least once every 30 weeks prior to issuing a new physician certification.

Physician Certification

Physician’s Certification means that a physician may authorize a qualified patient to receive marijuana and a marijuana delivery device (i.e. vape pen) from a MMTC. A physician may certify that a patient is in need of medical marijuana only after she has:

  • Conducted a physical examination while physically present in the same room as that patient (Telemedicine is not permissible) and recorded a full assessment of the medical history of the patient.
  • Diagnosed the patient with at least one qualifying medical condition.
  • Determined that the use of medical marijuana would likely outweigh the potential health risks for the patient and it is documented as such in the patient’s medical record. If a patient is under 18 years old, a second physician must concur with this determination, and it too must be documented in the patient’s medical record.
  • Determined that the patient is pregnant. A pregnant patient may only receive low-THC cannabis.
  • Reviewed the patient’s controlled drug prescription history in the prescription drug monitoring program database.
  • Reviewed the medical marijuana use registry and confirmed that the patient is not currently receiving medical marijuana from another qualified physician.
  • Registers as the issuer of the certification to the patient on the medical marijuana use registry.
  • Obtains the voluntary and written consent of the patient, or their parent or legal guardian if they are a minor, only after the physician has sufficiently explained its content, for the medical use of marijuana each time the physician issues the certification to the patient.

A physician certifying the use of medical marijuana for their patient must use a standardized informed consent form adopted by the Board of Medicine or Board of Osteopathic Medicine, which must include, at a minimum the following:

  1. The Federal Government’s classification of marijuana as a Schedule I controlled Substance.
  2. The approval and oversight status of marijuana by the Food and Drug Administration.
  3. The current state of research on the efficacy of marijuana to treat the qualifying conditions.
  4. The potential for addiction.
  5. The potential effect that marijuana may have on a patient’s coordination, motor skills, and cognition, including a warning against operating heavy machinery, operating a motor vehicle, or engaging in activities that require a person to be alert or respond quickly.
  6. The potential side effects of marijuana use.
  7. The risks, benefits, and drug interactions of marijuana.

That the patient’s de-identified health information contained in the physician certification and medical marijuana use registry may be used for research purposes.

Medical Marijuana Use Registry

Physicians should be aware that a review panel will be created by their respective Boards to review all physician certifications submitted to the medical marijuana use registry. The panel will track and report the number of physician certifications and the qualifying medical conditions, dosage, supply amount, and form of marijuana certified. The panel will report the data by individual physician and in aggregate formats by county and statewide. On the surface, it appears that the Board is just collecting data from those who certify patients to receive medical marijuana. However, it also appears that the Board is analyzing patterns and potential abuse by physicians who over prescribe or prescribe at a much higher rate than other qualified physicians that are similarly situated. At this time, I am not sure what action the Board would take if any, if they determine that there is some irregularity with the prescribing pattern of a particular physician.

The medical marijuana use registry must be accessible to qualified physicians and MMTCs to verify the authorization of a qualified patient or a caregiver to possess marijuana or a marijuana delivery device and record the marijuana or marijuana delivery device dispensed. The goal of the registry is to prevent an active registration of a patient by multiple physicians who can then receive and possess an amount of marijuana that exceeds the legal limits. The fear is that this will lead to an abuse of the Schedule I drug.

Penalties

SB8A doesn’t contain many penalties for physicians apart from the other laws and Board rules that currently exist to which physicians are bound by. However, I’m confident that with the proliferation of medical marijuana use by terminal patients and the tracking of prescribing patterns by the Board that there will be additional penalties for physician-owners and qualified physicians on the horizon. A qualified physician who issues a physician certification for marijuana or a marijuana delivery device and receives compensation from a MMTC related to the issuance of the physician certification for marijuana or a marijuana delivery device is subject to disciplinary action under the applicable practice act and Fla. Statute. 456.072(1)(n).

 

***This blog post does not constitute legal advice and is only intended for educational purposes only. You should consult a licensed attorney in the State of Florida that specializes in healthcare law.***

Lighting Up Florida’s Medical Marijuana Industry

On November 8, 2016, Florida voters approved the use of Medical Marijuana in a constitutional ballot initiative called Amendment 2. This Amendment approved the use of Medical Marijuana in treatment for patients who suffer from specific debilitating medical conditions. These debilitating medical conditions include, but, are not limited to, cancer, AIDS, PTSD, glaucoma, Parkinson’s Disease, epilepsy, and Crohn’s disease. Physicians may also prescribe Medical Marijuana for “other debilitating medical conditions of the same kind or class” as those mentioned above and “for which a physician believes that the medical use of marijuana would likely outweigh the potential health risks for a patient.” Those looking to do business in the medical marijuana industry must proceed with some caution because even with the passage of Amendment 2 marijuana is still considered a controlled substance consumption of which is illegal under federal law creating several barriers to entry into the industry.

Seeing Through the Smoke of Florida’s Medical Marijuana Industry

As you may be aware, On November 8, 2016, Florida voters approved the use of Medical Marijuana in a constitutional ballot initiative called Amendment 2. This Amendment approved the use of Medical Marijuana in treatment for patients who suffer from specific debilitating medical conditions. These debilitating medical conditions include, but, are not limited to, cancer, AIDS, PTSD, glaucoma, Parkinson’s Disease, epilepsy, and Crohn’s disease. Physicians may also prescribe Medical Marijuana for “other debilitating medical conditions of the same kind or class” as those mentioned above and “for which a physician believes that the medical use of marijuana would likely outweigh the potential health risks for a patient.” Those looking to do business in the medical marijuana industry must proceed with some caution because even with the passage of Amendment 2 marijuana is still considered a controlled substance consumption of which is illegal under federal law.

Who Can Prescribe Medical Marijuana

Believe it or not, medical marijuana is a Schedule I drug and is regulated by the Florida Department of Health’s Office of Compassionate Use. In order to prescribe Medical Marijuana to a patient a physician must be licensed to practice medicine in Florida and certified by the Department of Health (“DOH”). Further, the physician must complete an 8-hour course and exam offered by either the Florida Medical Association (“FMA”) or Florida Osteopathic Medical Association (“FMOA”). Additionally, if the physician is a medical director of a Medical Marijuana Treatment Centers (“MMTC”) they are required to take a 2-hour course.

Restrictions on Use

Currently, Marijuana is only supposed to be used for the treatment of medical conditions and any recreational use is prohibited. Medical Marijuana may only be consumed in the form of food, tinctures, aerosols, oils, ointments, or related products. Notably missing is the permissibility to consume or use Medical Marijuana in a plant form that can be smoked.

Further, medical marijuana may only be prescribed to eligible patients as defined in Fla. Stat. §499.0295 as having a “terminal condition”. Patients will be classified as terminally ill only if two physicians designate them as such.

Additionally, Amendment 2 makes no accommodations for the use of medical marijuana at the workplace, public places, or school settings. Currently, federal and private program payors are not required to reimburse patients for medical marijuana treatment.

The DOH must register and regulate MMTCs that produce and distribute medical marijuana. Identification cards must be issued to patients and caregivers. In order to receive medical marijuana a patient must be: (1) a permanent Florida resident; (2) a patient of the ordering physician for at least three months; and (3) diagnosed with a debilitating medical condition.

Reaction to the Legalization of Medical Marijuana

The Trump Administration has stated that it intends to enforce federal law that prohibits the use of recreational marijuana, but they are unlikely to prohibit the legitimate use of medical marijuana for treatment purposes.

However, in some cities and counties throughout Florida, legislators and local officials are still trying to determine whether medical marijuana is even legal despite its overwhelming support by voters in Amendment 2. Throughout Florida, many cities are ill-prepared to regulate various aspects of the medical marijuana industry prior to the September deadline requiring its statewide availability. Even after the Trump Administration has made a public statement regarding medical marijuana officials are weary about implementing regulations because it is still federally prohibited. However, at least twenty-eight states have operated without significant intervention from the federal government after they have legalized either recreational or medical marijuana.

Many physicians welcome Amendment 2 and feel that it’s long overdue. Physicians are educating themselves on administering medical marijuana to their patients. For example, they are learning about the various strains of Cannabis and how certain illnesses may respond differently to a particularly strain and dosage. Many doctors prefer to prescribe medical marijuana rather than narcotics, which can be highly addictive to the patient. As a country, we are facing an opioid epidemic and by using medical marijuana as an alternative when appropriate may help to curb the addiction.

Medical Marijuana is Big Business

According to reports, there might be as many as 450,000 patients throughout Florida who may be eligible to receive medical marijuana treatment. That number is expected to rise as the types of illnesses that are treatable by marijuana becomes less narrow and not limited to debilitating medical conditions or terminal conditions. According to New Frontier’s projections, medical marijuana users in Florida will spend an estimated $200 million annually, and by 2020 Florida will account for 14% of the permissible marijuana use in the country.

There will likely be an expansion of dispensing organizations but it will not be easy. Currently, there are seven approved dispensing organizations in Florida. The following is a non-exhaustive list that the DOH considers when dispensing organizations apply:

  • The technical and technological ability to cultivate, process, and dispense low-THC cannabis;
  • The ability to secure the premises, resources, and personnel necessary to operate as a Dispensing Organization;
  • The ability to maintain accountability of all raw materials, finished products, and any byproducts to prevent diversion or unlawful access to or possession of these substances;
  • The financial ability to maintain operations for the duration of the 2-year approval cycle;
  • Passing a background check; and
  • Posting a performance bond.

Individuals seeking to enter the medical marijuana industry face several challenges due to federal laws that prohibit its manufacture, distribution, and use. Banks, insurance companies, and real estate brokers are hesitant to contract with medical marijuana companies due to the existing federal laws. Since it is illegal to operate a medical marijuana company on the federal level banks can’t or are unwilling to loan them money out of fear that there will be retribution  for funding an illicit enterprise. This will only change if Congress passes a measure to legalize the medical marijuana industry.

Conclusion

Legislators must quickly determine the ongoing medical marijuana education requirements for physicians and how it will be regulated. Providers will increasingly enter into the business because the law effectively shields them from civil or criminal actions that arise from their prescribing of medical marijuana. However, physicians may face discipline for wrongfully prescribing low-THC marijuana or medical marijuana. Physicians must ensure that they receive the requisite informed consent prior to prescribing medical marijuana. It’s still uncertain if Amendment 2 will expand the number of dispensaries and by how many. Also, if you are a non-physician looking to enter into the medical marijuana business it is not clear what role one can legally play in the medical marijuana industry other than owning a dispensing organization.

Representing the Physician: It Is Harder Than it Looks

Jamaal R. Jones is a Super Lawyer committed to representing the physician.

Mr. Jones recently attended a conference where Health Law attorneys from around Florida converged to discuss topics such as MACRA, HIPAA Audits, EMTALA, Medical Marijuana, Medicare and other Risk Contracts, and Structuring Medical Practices for Tax and Creditor Insulation.

If you would like to discuss any of these topics in greater detail contact us today!

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