The Ohio Medical Board has adopted regulations in conjunction with the Ohio Pharmacy Board that would govern physicians who may elect to participate under the Ohio Medical Marijuana statutes.
The regulations adopted by the Medical Board are similar to the approach taken by the Medical Board in connection with the Pain Clinic rules which were issued several years ago. The Board imposes additional requirements on physicians to obtain a certificate from the Board, mandates education requirements, requires detailed written records and reporting requirements, and limits the potential practice to treat specific “qualifying medical conditions”. Physicians would “recommend” but not “prescribe” marijuana.
While it will be some months if not years before any product becomes legally available in Ohio, the Medical Board has begun the process of accepting applications from physicians for certificates.
The Medical Board Rules provide that a physician who applies for a certificate to “recommend” will need to meet the following requirements:
- Hold an active, unrestricted license and has never been disciplined for any matter involving prescription or use of controlled substances;
- The physician has completed two hours of pre-approved CME coursework in the field;
- The physician has no ownership, business or compensation relationship with any other medical marijuana business in Ohio which includes grow, processing or dispensary licenses;
- The physician who submits an application must submit the application under oath that they meet the prerequisites.
The physician, who submits the application, is granting the Board the right to conduct an investigation of the physician which might include a requirement for the physician to appear before the Board, or be subject to in person interviews by Medical Board investigators. Once an application is filed, the application may not be withdrawn without the prior consent of the Medical Board. In short, if they begin an investigation, the physician may not stop the investigation by withdrawing the application. The investigation is not limited to the matters related to the application and may include other areas. There is a process to appeal a denial of an application. If issued, the certificate must be renewed at the same time the physician’s license is renewed on an ongoing basis.
If a certificate is issued, the Rules impose specific requirements on the physician concerning recommending treatment with medical marijuana and have published a “Standard of Care”. The elements in the Standard of Care include:
- There must be a bona fide physician/patient relationship which includes an in person, face-to-face meeting between the patient and the physician and the physician must certify if they will provide ongoing care to that patient; and
- The physician is required to maintain a medical record that fully documents the provision of services for that patient which includes:
- Patient’s name and dates of office visits;
- The patient’s medical condition;
- A documented assessment of the patient’s medical history, including any history of substance abuse, documentation of relative diagnostic tests, documentation of prior treatment and the patient’s response to that treatment, documented review of patient’s current medication and identify possible drug interactions, including opioids, documented assessment that prior medical treatment has been attempted and the reasons why it was unsuccessful or would not be successful;
- Documentation of a physical examination;
- The physician’s diagnosis of the patient’s medical condition;
- The chart should include documentation of whether the physician believed that a drug screen may be appropriate for the patient;
- If the physician is seeing a patient who has been diagnosed by another physician of a qualifying condition, the physician may confirm the diagnosis provided the physician has obtained such documentation from the other physician that the physician can reasonably confirm the diagnosis and document the basis for that confirmation in the medical record;
- Obtain an OARRS Report;
- Documents the treatment plan; and
- Obtains written patient consent.
Under the Rules, a medical marijuana recommendation can only be made if a patient has been diagnosed with a “qualifying medical condition”. There are twenty currently defined conditions set out in the statute which includes things such as: cancer, Crohn’s disease, epilepsy, fibromyalgia, Parkinson’s, spinal cord diseases and other serious conditions. The statute also provides that the Medical Board can add additional conditions from time to time.
Once a physician has made the diagnosis or confirms the diagnosis that is only the first step. The physician is required again with full documentation, to prepare a written treatment plan, obtain OARRS report for the patient, document conversations with the patient regarding potential abuse or diversion issues, document the physician provided an explanation of risks and benefits, obtaining a patient’s written consent to the prospective written recommendation. In the event that patient requires a caregiver, further documentation is required of interactions between the physician and the caregiver.
Prior to the recommendation being issued, the physician is required to verify that the patient has registered under the patient medical marijuana registry system in Ohio. If the patient has not yet registered, the physician is required to assist the patient and submit the application for registration on behalf of the patient. The recommendation for treatment for the patient’s registry requires the physician to certify that there is bona fide physician/patient relationship, the patient has been diagnosed with a qualifying medical condition, verify if the condition is a terminal condition, and that the physician has obtained a report from the drug database. The physician who recommends treatment must represent they are available for follow-up care and treatment to the patient which includes ongoing physical examinations and must act to revoke or terminate the recommendation if the patient’s condition is changed, the physician’s certificate has been canceled or expires, or if the physician believes the patient is abusing or diverting the medical marijuana. The physician is required to maintain medical records for these patients for a minimum of three years. The physician is also required to submit to the Medical Board an annual report regarding the physician’s observations regarding the effectiveness of medical marijuana in treating patients. This report is on however on a de-identified information basis.
The State Pharmacy Board is the agency that controls the patient’s registration process for the patient to be placed on the registry and obtain the patient’s credentials in order to be eligible for treatment with medical marijuana. The patient registration rules require more details regarding the patient’s history, identity and the like. The Pharmacy Board further includes detailed requirements for a caregiver and what elements are essential for the caregiver to submit for the caregiver’s qualifications and the caregiver is likewise required to register. Both the patients and caregiver must be Ohio residents. While not in the Medical Board Rules, the Pharmacy Board Rules include a statement that a patient may not obtain more than a 90-day supply of medical marijuana in a 90-day period which also applies to the caregiver.
By statute, a physician who holds a license to recommend is not subject to professional disciplinary action in Ohio solely for engaging in professional activities related to medical marijuana. In short, if a physician is in full and complete compliance with the Ohio rules and regulations, at least the Ohio Pharmacy Board and Medical Board are prohibited from taking disciplinary actions. The State statute, however, does not provide any immunity for any claims that might be asserted under the Drug Enforcement Agency or any federal agencies.
The entire issue of state sanctioned use for medical applications will continue to evolve both as to the effectiveness of this approach to medical care within the medical community but will also be faced with the ongoing uncertainty presented by the conflicts between state and federal law. Please stay tuned as this matter continues to evolve.
Should you have any questions concerning these matters or would like a copy of the regulations or statutes, please contact Scott P. Sandrock at (330) 253-4367 or via e-mail at email@example.com.
Stark County Medical Society Newsletter, February, 2018