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Navigating the Medical Marijuana Landscape
Currently, 28 states and the District of Columbia have approved the use of marijuana for medical purposes, according to the National Conference of State Legislatures. A recent Quinnipiac poll of voters nationwide found that 93% of Americans are in favor of medical marijuana if prescribed by a doctor. Despite growing legal adoption of medical marijuana and favor among Americans, its use presents clinical and legal challenges for health care professionals, payers, and other stakeholders.
Legal and Regulatory Issues
Legal and regulatory roadblocks in the prescribing and dispensing of medical marijuana are ongoing. Marijuana cannot be prescribed under federal law because it is classified as a Schedule I substance under the Controlled Substances Act of 1970, meaning that the federal government considers marijuana as a substance with no medicinal purposes and a high potential for addiction and prohibits research by the medical field.
For now, clinicians in a state with a medical marijuana law who follow state law face little chance of being prosecuted by the federal government. The US Department of Justice (DOJ) updated its marijuana enforcement policy in 2013 advising states and local governments that “authorize marijuana-related conduct to implement strong and effective regulatory and enforcement systems to address any threat those laws could pose to public safety, public health, and other interests. Should these state efforts be insufficient, the policy warns, the federal government reserves the right to challenge the regulatory structure and enforce actions against individuals, such as physicians, who may be violating federal law,” wrote Humayun J Chaudhry, DO, MS, and colleagues in a Viewpoint article published in JAMA.
In a February briefing, White House Press Secretary Sean Spicer drew a clear distinction between medical and recreational marijuana and stressed that medical marijuana was not a concern for President Trump because “he understands the pain and suffering that many people go through who are facing especially terminal diseases and the comfort that some of these drugs, including medical marijuana, can bring to them.” However, it remains to be seen what changes may come under Attorney General Jeff Sessions who has voiced his opposition to legalization of marijuana.
Because the DOJ has left regulation of marijuana to individual states, payers have to keep up with each state’s legislation and regulation. “Given the current conflict between state and federal law, and the ambiguity of how such conflicts will be resolved under the current administration, it is unlikely carriers will actively pursue covering medical marijuana under health plan benefits offered in this state,” Charlie Sheffield, executive director of Colorado Association of Health Plans, told First Report Managed Care.
“I find it will be challenging for physicians and pharmacists to really get involved with medical marijuana because it is a super-controlled drug and it is going to lead to a lot of regulatory issues, paperwork, and concerns,” said Arthur F Shinn, PharmD, FASCP, president of Managed Pharmacy Consultants, LLC, in an interview with First Report Managed Care.
“The majority of states do not require insurers to reimburse patients for medical marijuana costs, or leave reimbursement to the insurer’s discretion,” wrote Robert Goldberg, MD, FACOEM, chief medical officer of Healthesystems, in a white paper. To date, there are only a few states in which workers’ compensation insurers have reimbursed a medical marijuana claim.
Data and Education Gap
Medical marijuana is being used as a treatment option for a range of medical conditions including but not limited to cancer, glaucoma, HIV/AIDS, multiple sclerosis, Alzheimer’s disease, posttraumatic stress disorder, Parkinson’s disease, mood disorders, and chronic pain. Risks associated with marijuana include driving impairment, addiction, hyperemesis syndrome, myocardial infarction, anxiety, paranoia, and psychotic episodes, according to a medical marijuana presentation at the recent AMCP Managed Care & Specialty Pharmacy Annual Meeting. The presentation was given by Babette S Edgar, PharmD, MBA, FAMCP, principal for BluePeak Advisors and immediate past president of AMCP, and Greg Miller, RPh, senior consultant with BluePeak Advisors.
“Research on the clinical efficacy and safety of marijuana has been very limited, and medical marijuana training is not yet included as part of the standard medical curriculum,” according Dr Goldberg.
“The largest issue is the American Medical Association and FDA stances. It is a controlled class I medication that has not been adequately studied,” said Jeffrey D Dunn, PharmD, MBA, chief financial office/senior vice president for VRx Pharmacy Services. Dr Dunn believes for payers to cover medical marijuana policies will need to change along with development of well-defined appropriate use guidelines. He noted that “employer groups will also likely be slow to authorize coverage via their health plan and/or pharmacy benefit management.”
“I don’t think we have had enough use of medical marijuana to clearly be able to judge clinical efficacy vs the potential issues around it. Another thing that has not been clearly shown is what is the appropriate dosage range, and what are we looking at for utilization patterns,” added Dr Shinn, who is not an advocate of medical marijuana. “[However,] I would not deny it if it was available for one of my patients and if the diagnosis and treatment plan was appropriate. [But] I would not be the first to recommend its use.”
In an interview with First Report Managed Care before her presentation, Dr Edgar said there is a definite lack of education among managed care in its understanding of medical marijuana. “Education often occurs when we are forced to learn about it due to how it affects our daily work,” she explained. “Since medical marijuana is not often reimbursed by managed care, many physicians are uncomfortable prescribing or unable to prescribe due to law.”
Education and research initiatives on medical marijuana for stakeholders is under way. Thomas Jefferson recently announced the creation of the Center for Medical Cannabis Education & Research, which will provide expert-developed, unbiased information and guidance to clinicians and patients about the medical uses of marijuana and cannabinoid focused-therapies. Programs for pharmacists include The Cannabis Training Institute and the National Association of Cannabis Based Medicine established by the National Association of Specialty Pharmacy.
Managed Care Pharmacist Role
Because pharmacists are on the frontlines of medical care, they will be called upon for their expertise to educate, dispense, and oversee the dispensing of medical marijuana. “Managed care pharmacists will be relied upon to make coverage decisions and policy decisions on the safety and efficacy of medical marijuana,” said Dr Edgar. “These changes in laws may require managed care to cover medical marijuana. The public looks toward pharmacists to be the educators of all things medicinal and this will not be an exception.”
Managed care professionals’ role in the recommendation and training of medical marijuana is also crucial. “As with all medications, managed care pharmacists will review the clinical, economic, and outcomes data to determine coverage of medical marijuana as the law allows. Clinicians and insurers will demand outcomes data to determine coverage decisions and the drug will most likely undergo utilization management such as prior authorizations and quantity limits if paid for by insurance,” said Dr Edgar. “Since this is a relatively ‘new’ practice of medical marijuana, much training is needed for pharmacists, physicians, and the public on safety, efficacy, dosing, and appropriate use and abuse.”
As the medical marijuana landscape continues to evolve—both clinically and legally—Dr Edgar emphasized that “medical marijuana is here to stay. It is important that we get educated on the safety, efficacy, and any other data that are out there since it is very likely that we will need to deal with insurance coverage issues sooner rather than later.”