By Trisha D. Bowles, JD, LHRM
Patients may be ready for medicinal marijuana oil but, at this time, no one else is. Governor Nathan Deal’s signature established Haleigh’s Hope Act in April 2015, which allows patients to possess medical marijuana oil, however, the law contains a number of caveats and conditions that the prescriber must navigate.
First, what type of oil? The law specifies that the applicable oil must not contain more than 5% by weight tetrahydrocannabinol (THC) and the cannabidiol (CBD) must be equal to or greater than the amount of THC. What is not in the law makes this factor more complicated. The law does not allow for the sale or dispensing of medicinal marijuana oil. Therefore, your patients risk violating state or federal law when they purchase it elsewhere and bring it back to Georgia. Furthermore, many states that allow the purchase require prescriptions from a physician licensed in that state and they have residency requirements as well. In addition, oil with this specific makeup may not be readily available in other markets; again, hampering access.
Second, how is eligibility determined based on medical condition? In order to qualify, a patient must have been diagnosed with one of eight medical diseases. Of the eight, five contain contingent factors — cancer, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson’s and sickle cell disease — which require the patient be at the end stage of the disease or that the condition be severe. Cancer patients are also eligible in the event of wasting illness, recalcitrant nausea and vomiting. Two conditions contain no secondary qualifiers, Crohn’s disease and mitochondrial disease. The final condition, seizure disorders, must be related to a diagnosis of epilepsy or trauma related head injuries.
Third, how is eligibility determined based on residency? In order to qualify for the registry, patients must be Georgia residents (determined by one year of residency) or have been born in the state within the last year.
Fourth, how is eligibility determined based on relationship? Any patient being certified by the physician must have a doctor-patient relationship and must be under your care for the qualifying medical condition.
As a physician, you will be required to certify to the Georgia Department of Public Health that the patient has the qualifying condition and that you are authorizing the use of the medicinal oil. The Department of Public Health is still developing the exact process for the certification of patients but they have indicated that the process will be online, most likely within the month of June 2015. The website address is currently: http://dph.georgia.gov/low-thc-oil-registry.
Physicians are also required to have all patients sign a release before they are registered. The Composite Medical Board is working to develop a standardized waiver form for use by physicians. The form will advise patients that the oil has not been approved by the FDA, the clinical benefits are unknown, and the product may cause harm.
Once a physician has registered a patient, the physician will also be obligated to tender quarterly reports to Georgia Composite Medical Board (GCMB). The reports will need to provide: dosages related to a particular condition, clinical responses, compliance, responses to treatment, side effects and drug interactions.
Physicians face several more issues of uncertainty because the law leaves us with several unanswered questions.
- When is the doctor-patient relationship established?
- With new patients will patient disclosure of symptoms be sufficient or will physicians be required to verify conditions through testing or prior medical records?
- As a family physician, are you responsible for treating the condition? Or is it managed by a specialist who should be handling the prescription process?
- Is the patient severe? What factors indicate severity? Must symptoms have continued for a designated duration to be deemed severe?
With so many gray areas, the current law leads us to wonder what will trigger GCMB investigations. Will the registry red flag physicians based on quantity of patients registered? Or quantity of prescriptions? Dosages? Results? Lack of compliance by the patient?
On the clinical side, there is little information available regarding dosage to guide physicians, but a not-for-profit organization called The Realm of Caring has established a website with helpful tools for healthcare providers (http://www.theroc.us/provider-portal). The site provides links to research and assists with dosing information as well as other educational materials.
As previously mentioned, the oil is not available for purchase in Georgia and finding oils with the correct ratio of THC to CBD may not be easy. For helpful information on getting access to the oils, patients can also visit the Realm of Caring’s client portal website (http://www.theroc.us/clients).
In the interim, to reduce your risk, providers must keep detailed records. Each patient’s record must document why the medicinal oil is necessary. The records must address all the pertinent parts identified above:
- Establish the doctor-patient relationship: When did the patient being treating with you?
- Establish the residency: How long have they lived in Georgia?
- Document their medical condition: Which of the eight conditions does the patient have? How did you determine that the patient had it? How long has the patient had it?
- Document the severity or end stage: How did you determine severity? Does it hamper ability to function, to work, etc? Is there research that describes levels of severity? What symptoms does the patient exhibit that clarify that the patient is in the end stage?
- Dosage: What dosage do you recommend? How did you come to that decision? Is there some research that establishes the dose?
- Release: Keep a signed copy of the release in the patient’s medical records. Advise the patient of the benefits but also that the risk is unknown and may cause harm. Be sure to document the conversation in the medical records and document any questions the patient may have.
Once you prescribe, keep detailed notes on each patient regarding dosages related to the particular condition, clinical responses, compliance, responses to treatment, side effects and drug interactions. This data will also need to be kept in a format that will allow you to export a report to the GCMB quarterly. Your EMR provider may be able to assist you in facilitating these types of reports.
From a risk perspective, Georgia physicians should be cautious, extremely cautious, about the use of the registry and medicinal marijuana oil until more information is available. The current law leaves us with many more questions than answers; however, MedMal Direct Insurance Company and the Georgia Academy of Family Physicians are following this law as it develops and will be updating you as new information arises.
Trisha D. Bowles, JD, LHRM is the Director of Claims & Risk Management at MedMal Direct Insurance Company. Prior to working with MedMal Direct, Mrs. Bowles worked in medical malpractice insurance defense in private practice and was a healthcare prosecutor for the Florida Department of Health. Mrs. Bowles earned a B.S. from the University of Florida and her J.D. from the University of Denver.
For questions or more information about this article or to request future articles on specific topics, please contact her at RiskManagement@mymedmal.com.
MedMal Direct Insurance Company offers healthcare providers the same coverage, with the same limits, with aggressive legal defense while reducing premiums by eliminating the commission normally associated with the traditional distribution model for medical malpractice insurance. It’s time to learn more! – http://www.mymedmal.com.