Growing Regularity and the Need for Guidance: FSMB Model Guidance for the Recommendation of Medical MarijuanaJanuary 17, 2019 – Legal Alerts
The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana. Given that states characterized as Republican-leaning or Democratic-leaning have legalized marijuana in some form, this green wave is unlikely to reverse or slow down.
This week in Ohio, the first sales of medical marijuana to patients have officially taken place. Additionally, the Ohio patient registry, which requires the information of patients receiving a marijuana recommendation to be entered into a database, has already amassed over 12,700 registrants since being activated on December 5, 2018. Also, over 370 Ohio physicians have received Certificates to Recommend from the State Medical Board of Ohio, which authorizes these providers to recommend medical marijuana to their patients.
As the use of medical marijuana continues to become legally permissible and widely accepted, important questions should be addressed, including whether physicians should recommend medical marijuana as part of their standard practice and what procedures should be in place to ensure compliance with regulatory expectations. The Federation of State Medical Boards (FSMB), an entity compromising over 70 medical boards across the country, has produced a set of guidelines to help physicians seeking to incorporate medical marijuana into their practices. These guidelines were developed after an in-depth nationwide review of the existing laws, regulations, policies, and disciplinary actions related to recommending medical marijuana. While physicians should always look first to state law for guidance on proper practice, where state law does not provide enough insight, FSMB guidance is particularly useful.[i]
The FSMB has adopted the following guidelines for the recommendation of marijuana:
1. Physician-Patient Relationship: As with any condition, establishing an existing and bona fide physician-patient relationship is fundamental to providing medical care. Thus, physicians should have documentation showing that a proper physician-patient relationship has been established prior to providing a recommendation for medical marijuana. As with other forms of medications, physicians should not recommend for themselves or family members.
2. Patient Evaluation: A documented in-person medical evaluation and collection of relevant medical history should be obtained before recommending medical marijuana. At a minimum, the evaluation should include the patient’s history of present illness, social history, past medical and surgical history, alcohol and substance abuse history, family history with an emphasis on addiction or mental illness/psychotic disorders, physical exam, documentation of therapies with inadequate response, and diagnosis requiring the marijuana recommendation.
3. Informed and Shared Decision Making: Physicians should discuss the risks and benefits of the use of medical marijuana with the patient. Patients should be advised of the variability and lack of standardization of marijuana preparations and the effect of marijuana. Patients should be reminded not to operate vehicles and other heavy machinery while under the influence of marijuana.
4. Treatment Agreement: A health care professional should document a written treatment plan that includes the following information.
- Review of other measures attempted to treat the condition at issue.
- Advice about other options for treating the condition.
- Determination that the patient may benefit from the treatment of marijuana.
- Advice about the potential risks of medical marijuana use, including:
- Variability of quality and concentration of marijuana;
- Risk of cannabis use disorder;
- Exacerbation of psychotic disorders and adverse cognitive effects for children and young adults;
- Adverse events, including falls or fractures;
- Use of marijuana during pregnancy or breast feeding;
- Need to safeguard all marijuana from children and pets; and
- Marijuana is only for the patient’s use and should not be shared with any other supplier or individual.
- Additional diagnostic evaluations or other planned treatments.
- A specific duration for the marijuana authorization for a period no longer than 12 months.
- A specific ongoing medical treatment plan as medically appropriate.
5. Qualifying Conditions: Recommending marijuana for certain medical conditions is at the professional discretion of the physician. The indication, appropriateness, and safety of the recommendation should be evaluated in accordance with the current standards of practice and in compliance with state laws, which specify the qualifying conditions for which a patient may receive medical marijuana.
In Ohio, for example, those qualifying conditions are the following:
- Amyotrophic lateral sclerosis;
- Alzheimer’s disease;
- Chronic traumatic encephalopathy;
- Crohn’s disease;
- Epilepsy or another seizure disorder;
- Hepatitis C;
- Inflammatory bowel disease;
- Multiple sclerosis;
- Chronic and severe or intractable pain;
- Parkinson’s disease;
- Positive status for HIV;
- Post-traumatic stress disorder;
- Sickle cell anemia;
- Spinal cord disease or injury;
- Tourette’s syndrome;
- Traumatic brain injury; and
- Ulcerative colitis.
However, the number of qualifying conditions may increase as the State Medical Board of Ohio has recently closed an application period to consider adding additional qualifying conditions.
6. Ongoing Monitoring and Adapting the Treatment Plan: The physician recommending marijuana should register with the appropriate oversight agency and provide the registry with the information each time a recommendation, attestation, authorization, or reauthorization is issued. Where available, the physician recommending medical marijuana should check the state Prescription Drug Monitoring Program (PDMP) each time a recommendation is issued.
The physician should regularly assess the patient’s response to the use of marijuana and overall health and level of functions. This assessment should include the efficacy of the treatment to the patient, goals of treatment, and the progress of those goals. This is when a physician should really question and determine whether recommending medical marijuana is appropriate for his or her practice. This guidance would indicate the answer to that question is not sufficiently addressed by the legal ability to recommend marijuana. For example, in Ohio, medical marijuana may be used to treat Crohn’s disease or epilepsy. While a psychiatrist or anesthesiologist who has received a Certificate to Recommend from the State Medical Board of Ohio would be legally authorized to recommend medical marijuana to patients with these conditions, it is questionable whether such providers can appropriately evaluate the efficacy medical marijuana is having on treating such conditions. In these situations, the provider may want to take additional steps to coordinate with other treatment specialists and be mindful to document these efforts and discussions in the patient’s medical records.
7. Consultation and Referral: In addition to coordinating with specialists for certain underlying conditions, a patient with a history of substance abuse disorder, or a co-occurring mental health disorder, may require specialized assessment and treatment before receiving a recommendation for medical marijuana. The physician should seek consultation with, or refer such a patient to, a pain management clinic, or psychiatric, addiction, or mental health specialist, as needed.
8. Medical Records: The physician should keep accurate and complete medical records. Information on these records should include at least the following:
- Patient’s medical history;
- Results of physical examination, evaluation, diagnostic, therapeutic, and laboratory results;
- Other treatments and prescribed medications;
- Authorization for medical marijuana, including the date of authorization, the date of expiration, and any other additional information required by state law;
- Instruction to the patient, including benefits, side effects, and risks;
- Results of ongoing assessments and patient’s response to treatment;
- A copy of the signed patient agreement referenced above.
9. Physician Conflicts of Interest: A physician should not have a professional office located at a dispensary or cultivation center or receive financial compensation from or hold a financial interest in dispensary or cultivation center. Nor should a physician be a director, officer, member, incorporator, agent, or retailer of a dispensary or cultivation center.
Physicians seeking to incorporate medical marijuana into patient treatment plans should first look to state law to ensure compliance. The above FSMB guidelines should be viewed as an additional resource in creating and adhering to best practices, as the above guidelines have been carefully formulated by members of medical boards across the country. Keeping the foregoing in mind, the decision to recommend marijuana should not be taken lightly. For more information and answers to questions regarding implementing medical marijuana into your practice, please contact a member of Dinsmore’s health care practice group.
[i] It should also be noted that the FSMB has stated, “These guidelines should in no way be construed as encouraging or endorsing physicians to recommend marijuana as part of their patient care.”