With three states voting this past November to legalize medical marijuana, more than half of the states plus the District of Columbia now permit marijuana use for medicinal purposes.
We spoke with Winn Halverhout, Steve Levine, and Fred Miles of Husch Blackwell LLP about the main challenges facing providers related to medical marijuana, how the new administration might change the legal landscape, and more.
Question: What are the main challenges facing providers related to medical marijuana?
Answer: Because marijuana is still considered a Schedule I drug at the federal level, providing marijuana of any type can technically be treated as a felony. The U.S. Drug Enforcement Administration (DEA) has taken a hands-off approach to enforcement over the past few years and allowed states to enforce their own laws around marijuana use.
In some states, providers may only discuss or verbally recommend marijuana as a treatment option. In others, like Colorado, providers can write a formal medical recommendation. The patient is then responsible for taking his or her medical recommendation to a regulatory body for registration, and then for purchasing the marijuana at a licensed dispensary.
Why are marijuana tourists ending up in the ED?
The DEA’s hands-off approach may have eased providers’ minds about whether they could discuss the merits of marijuana for clinical purposes or even recommend its use, it has done nothing to change their positions on actually dispensing the drug. Should the federal government decide to start enforcing its law, providers could face regulatory sanctions from CMS for dispensing marijuana.
Because of the federal risks involved in dispensing the drug, in addition to onerous "safekeeping" laws specific to medical marijuana, hospitals do not dispense it the way they do other controlled substances. Hospitals do not consider investment in on-campus dispensaries to be a worthwhile risk, especially considering the substantial disagreement in the medical community as to the scientific basis of the medicinal value of medical marijuana.
Q: It seems like more research is needed to determine the clinical value of marijuana, but the drug is classified as an illegal substance. How do researchers address that?
A: There are specific protocols for clinical research that uses illegal substances. For example, there is currently one facility in the country that is licensed to grow medical marijuana for research purposes, located at the University of Mississippi. Any clinical trials using marijuana, then, need to obtain their sample from that facility. This has the potential to create a supply problem – not only could it limit how the amount of research that can be done at a time, but a kink in the supply chain could affect the execution of approved studies. FDA is trying to increase the number of licensed facilities to avoid problems like these. Furthermore, there are carefully monitored clinical trials under way to test the benefits of medical marijuana.
Q: Are there special considerations for different demographic groups when it comes to medical marijuana use?
A: Yes. Medical marijuana use among non-autonomous groups such as seniors living in organized housing and children under the age of 18 creates some unique situations.
- Using marijuana for physical and mental conditions with associated chronic pain related to aging isn't a new concept, but it is still murky to navigate, especially for patients residing in senior living facilities. For example, many assisted living residences are open to permitting marijuana use within their premises under very limited conditions and circumstances. This is because most residences are not regulated by federal law. Granting this permission potentially opens them up to liability issues in case of an adverse event related to a resident's marijuana use, so the facility ultimately has discretion over residents' use.
- On the other hand, skilled nursing facilities still face significant obstacles in knowingly allowing marijuana use by their residents, because they are subject to federal certification requirements in order to accept Medicare and Medicaid patients. At this point, most SNFs do not allow its use, although some operators espouse an unspoken "don't ask—don't tell" attitude. Without a definitive policy statement from CMS regarding marijuana use and federal program certification, this situation is not likely to change in the near future.
- This is a fairly untested field and a largely unregulated one. Many parents of pediatric patients have come to Colorado seeking treatment that they perceive–often correctly–wouldn't be available to them in other states. Parents are able to consult their child's doctors to understand a general treatment plan, then purchase and administer the medicinal marijuana on their own. A strain of marijuana developed in Colorado colloquially referred to as "Hippie’s Lament" has shown demonstrable benefits to children who suffer from grand mal seizures, prompting parents to flock to states like Colorado where the strain is easy to obtain. Hippie's Lament has a heightened level of cannabinoids–compounds thought to provide the medicinal benefit–with a far lower level of THC, the hallucinogenic substance in marijuana.
Q: Does recreational legalization affect the regulatory environment around medical marijuana?
A: Not really: the government still classifies marijuana as a Schedule I drug, so the risks to the provider stay the same. What legalization does do is make it easier for patients to obtain the drug. We described the procurement process earlier; if patients don't want to go through that whole process, they can forego the procurement step and purchase marijuana from a retail recreational dispensary in states that allow it (although it will cost them more).
Q: What can providers expect out of the new administration?
A: President Trump is unpredictable, but so far he has not publicly taken a prohibitionist stance on cannabis. Instead, he has advocated for leaving the issue up to the states. Further, the recent fiscal year 2016 omnibus appropriations bill, supported by the GOP-controlled Congress, contains language prohibiting the Department of Justice from interfering with state medical cannabis laws.
The real questions will be: Does the Trump administration leave marijuana legalization up to the states and treat it like alcohol? Or does newly-confirmed Attorney General Jeff Sessions, a known opponent of marijuana legalization, unwind years of hands-off federal policy towards state-legal cannabis? We'll just have to wait and see.
Preparing for a presentation? Download slides on the latest health care trends
We updated our most popular slides depicting the important market forces affecting your business in 2016, so you're ready for your next strategy presentation.
Whether you're speaking to your board, C-suite, or community, you'll have access to the latest data, pre-formatted and ready to present. Across 53 slides, we collected everything you need to know about payment reform, the provider market, purchaser behavior, and provider selection trends.
GET THE SLIDES
Next in the Daily Briefing
Advisory panel: It's OK to edit heritable traits in human genomes—sometimes