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  • From Charlotte’s Web to Amendment 2: Considerations for Doctors Attempting to Fly High with Medical Marijuana
  • By: Kristin K. Morris

    The legalization of marijuana, especially the medicinal use of marijuana has been the subject of national public debate during the past few years. Now, the issue has come to Florida in the form of a new law, effective January 1, 2015, and a proposed constitutional amendment that failed in the November 2014 general election. This article explores these recent developments especially with regards to medical doctors.
    Current Law

    On June 16, 2014, the Governor signed into law Senate Bill 1030 (“Charlotte’s Web Bill”), which was codified in Section 381.986, Florida Statutes making Florida the twenty-third (23rd) State to pass legislation supporting the use of some form of marijuana for medicinal purposes.1 Effective January 1, 2015, a physician licensed to practice medicine under Chapter 458, Florida Statutes or osteopathic medicine under Chapter 459, Florida Statutes may order low-THC cannabis2 for patients.3 However, these physicians must follow very strict protocols: (1) the physician must examine and treat the patient; (2) the patient must be suffering from cancer or a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms; (3) the low-THC cannabis must be prescribed to treat the disease or condition or to alleviate the symptoms of the disease or condition; (4) there can be no other satisfactory alternative treatment options; (5) the patient must be a permanent resident of Florida; (6) the physician must determine that the risks of ordering the low-THC cannabis are reasonable, when compared the potential benefit to the patient;4 (7) the physician must register as the prescriber of low-THC cannabis for the patient on the compassionate use registry and update the registry to reflect both the order and the termination of treatment; (8) the physician must maintain a patient treatment plan including the dose, route of administration, duration, and monitoring of the patient’s symptoms; (9) the physician must submit the patient treatment plan to the University of Florida College of Pharmacy quarterly so research can be conducted regarding the safety and efficacy of low-THC cannabis; and (10) the physician must obtain the voluntary informed consent from the patient to treatment with low-THC cannabis.5 Further, prior to ordering the low-THC, the physician must successfully complete an eight (8) hour course and examination given by the Florida Medical Association or Florida Osteopathic Medical Association.6 If the doctor wishes to serve as the medical director of an authorized dispensing organization, the physician must also complete a two (2) hour course and exam encompassing the appropriate safety procedures and knowledge of low-THC cannabis. 7

    Proposed Constitutional Amendment

    On January 27, 2014, the Florida Supreme Court approved a proposed amendment to the Florida Constitution for placement on the ballot in November 2014 (“Amendment 2”).8 The proposed amendment would have created Article X, Section 29 of the Florida Constitution, which would essentially allow the medical use of marijuana by exempting a physician issuing a “physician certification” and the recipient-user from criminal or civil liability, or sanctions, if the marijuana is used by a qualifying patient.9 A qualifying patient was defined as a person who (1) has been diagnosed with a “debilitating medical condition;” (2) has a physician certification; and (3) valid qualifying patient identification.10 Under Amendment 2, a debilitating medical condition included cancer, glaucoma, positive status for HIV, hepatitis C, ALS, Chrohn’s disease, Parkinson’s disease, multiple sclerosis or other conditions, where a physician believes the benefits of medical marijuana outweigh the risks.11 This definition would have expanded the class of patients eligible to receive medical marijuana to include significantly more patients than are currently eligible for low-THC cannabis under Section 381.986.12 Under Amendment 2, a physician certification was defined as a document written and signed by a physician, which provided that in the physician’s professional opinion the patient has a debilitating medical condition and the potential benefits of medical marijuana would likely outweigh the health risks to the patient and the recommended length of use of the medical marijuana.13 Finally, the definition of marijuana in Amendment 2 was much broader than low-THC cannabis (in fact excluding low-THC cannabis) and including any part of any plant of the genus Cannabis.14

    While Amendment 2 would have de-criminalized and erased penalties for medicinal use of marijuana, Amendment 2 would not have: affected laws regarding non-medicinal use, possession, production, or sale of marijuana; authorized the use of marijuana by anyone other than a qualifying patient; allowed for the operation of any type of motor operated vehicle while using marijuana; given immunity under federal law; require any accommodation of any on-site medical use of marijuana in a school or workplace or in any public place; or required a health insurance provider to reimburse a person for expenses related to medical marijuana.15

    On November 4, 2014, Amendment 2 failed to garner the necessary 60% support of required for passage under the Florida Constitution. However, it appears a majority of Floridians are in favor of less restrictive legalization of medical marijuana, as Amendment 2 did garner 57% of the vote. Therefore, it is likely that Florida has not seen the last of new legislation or constructional amendments providing for less restrictive legalization of medical marijuana.

    Considerations for Physicians

    With Section 381.986, Florida Statutes on the books and the likely reappearance of Amendment 2 in some form in the future, physicians looking to operate under these conditions need to carefully consider the implications prescribing low-THC cannabis or medical marijuana and/or operating or dispensing organizations would have on their practice and business. A few of these implications are outlined below. First, for those physicians looking to prescribe low-THC cannabis, Section 381.986, Florida Statutes imposes strict requirements on physicians and/or operating a dispensing organization. Failure to comply with these provisions will result in penalties to the non-complying physician.16 Specifically, if a physician orders low-THC cannabis for a patient without a reasonable belief that the patient is suffering from cancer or a physical medical condition that chronically produces symptoms of seizures or severe and persistent muscle spasms, the physician could be found guilty of a first degree misdemeanor, which is punishable by up to one (1) year in prison or a $1,000.00 fine.17 The physician will also be subject to discipline by his or her professional licensing board.18 Similar provisions are likely to appear if a less restrictive medical marijuana law were to pass.

    Another major implication is the interplay between Florida and federal law regarding low-cannabis THC and medical marijuana. While the use and prescription of medical marijuana under Section 381.986, Florida Statutes and the recently defeated Amendment 2 is presumably legal in Florida, Federal Law provides otherwise.19 While the current U.S. Attorney General has stated that physicians following state law regarding medical marijuana would not be the focus of federal prosecutions, such physicians would in no way be exempted from prosecution.20 Thus, physicians operating under these provisions could open themselves up to prosecution and/or penalties by the federal government.21

    Third, under Section 381.986, Florida Statutes, physicians looking to open a dispensing organization or have some relationship with a dispensing organization must consider the laws prohibiting self-referral. Self-referral and fees for referral are illegal and highly disfavored under Florida and federal law.22

    Further, malpractice insurers may be cautious or reluctant to insure or cover physicians engaging in the medical marijuana field; therefore, physicians should contact their medical malpractice carriers to see if the above outlined activities would be covered.

    Finally, if Amendment 2, or other similar legislation, does appear again in the future, physicians will need to consider the interplay between that Amendment or legislation and Section 381.986, Florida Statutes, and the legal affects an amendment or legislation with significantly broader application than Section 381.986, Florida Statutes would have on the statute.

    This article is just a brief summary of some of the major considerations physicians should consider before engaging in the practice of prescribing medical marijuana. If you have any questions regarding the contents of this article, please contact Pat McNamara at pmcnamara@dgfirm.com or Kristin Morris at kmorris@dgfirm.com.

    1 http://floridamarijuanainfo.org/law-featured/florida-became-23nd-state-to-legalize-medical-marijuana-today/. If Washington D.C. is included, Florida became the 24th state to legalize and/or decriminalize medical marijuana in some capacity.
    2 “Low-THC Cannabis” is defined as a “plant of genus Cannabis, the dried flowers of which contain 0.8 percent or less of tetrahydrocannabinol and more than 10% of cannabidiol weight for weight…” §381.986(1)(b), Fla. Stat.
    3 §381.986(2), Fla. Stat.
    4 Special requirements exist for a patient who is under the age of 18. Specifically, a second physician must concur with the determination and it must be documented in the patient’s medical record.
    5 §381.986(2), Fla. Stat. Although not provided for in the Statute, the best practice is to put the informed consent in writing, have it signed by the patient and incorporated into the patient’s medical records.
    6 §381.986(4), Fla. Stat. The topics of the course and exam include the following topics: the appropriate use of low-THC cannabis, the appropriate delivery mechanisms, the contradictions for the use, and the relevant state and federal laws governing the substance. §381.986(4), Fla. Stat.
    7 §381.986(5), Fla. Stat. As the law is currently written, there will only be five (5) dispensing organizations statewide in specific regions to provide low-THC cannabis to those patients registered in the compassionate use registry and whose physicians order low-THC cannabis. The dispensing organizations are also subject to strict regulation including but not limited to: employing a medical director who is a physician licensed under Chapter 458 or 459; demonstrating financial responsibility; demonstrating a long history as a registered nursery; passing level 2 screening checks; and paying significant fees. §381.986(5), Fla. Stat. and 64-4.001-64-4.009, F.A.C.
    8 Advisory Opinion to the Attorney General Re: Use of Marijuana for Certain Medical Conditions, No SC13-2006 (Fla. 2014). The opinion does not go to the merits of the proposed amendment. Id.
    9 Proposed Amendment Article X, Section 29 (a)(1)-(2).
    10 Id. (b)(10).
    11 Id. (b)(1).
    12 Compare §381.986(2), Fla. Stat.
    13 Id. (b)(9). The physician certification can only be issued after the physician conducts a full physical examination and assessment of the patient and his or her medical history. Id.
    14 Id. (b)(4) citing §893.02(3), Fla. Stat.
    15 Id. (c)(1)-(6).
    16 §381.986(3)(4)(c), Fla. Stat.
    17 §381.986(3), Fla. Stat; 775.082-775.083, Fla. Stat.
    18 §381.986(4)(c), Fla. Stat.
    19 21 CFR §1300.04; 21 CFR §802; 21 CFR §829.
    20 David W. Ogden, Memorandum for Selected United States Attorneys, October 19, 2009.
    21 21 CFR §1300.04
    22 §458.331(1), Fla. Stat.; Federal Anti-Kickback 42 USC §1320(b) and Stark Laws 42 USC §1395(nn).
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