Episode 25 – Cannabis in the Workplace

Mike Stull (0:00) 

Hi everyone and welcome to this month’s episode of the Employers Health HR Benecast, your source for expert commentary and insights on current health benefits related news and strategies. This is your host, Mike Stull. Before I introduce today’s guest, I want to tell you about a few great events we have coming up. 

First, if you haven’t already attended one of our virtual pharmacy benefits conference series webinars, I encourage you to do so. We’ve already had three great sessions covering strategies for optimizing self-funded plans, medical stop-loss, and PBM assessments. If you missed any of those sessions, they can be found on the recordings page of our website. 

Plus, there are still more to come covering the pharmacy pipeline, ERISA, and more. So if you haven’t already, be sure to register at employershealthco.com forward slash events. Again, it’s employershealthco.com forward slash events. 

On April 27th, representatives from IMED will share hot topics in eye health and vision care. They have some interesting info, including the latest vision benefits data, how telehealth is transforming vision care and more, and how eye exams can help detect diabetes. So join us again on April 27th. We’ll be joined by representatives from IMED to talk about hot topics in eye health and vision care.  

Finally, on April 28th, we’re excited to be joined by Marcel Baldwin, Enforcement Supervisor and Outreach and Training Manager with the Equal Employment Opportunity Commission’s Cleveland Field Office, as he presents what you should know about COVID-19 and the Americans with Disabilities Act, the Rehabilitation Act, and other EEO laws. We hope you’ll join us to hear the latest guidance on COVID-19 and vaccinations. 

Now for today’s guest, I recently sat down with Mark Bolton, Senior Director of Public Policy and Senior Legal Counsel at Greenwich Biosciences and Employers Health’s own VP of Clinical Solutions, Matt Harmon. Greenwich is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform. It is the first and only company to pursue and receive FDA approval for a plant-derived cannabinoid therapy that addresses difficult-to-treat conditions with significant unmet needs, and Mark will talk a little bit about that during the interview. 

So, I hope you enjoy this.

So, before we get started today, Mark, can you tell us a little bit about yourself and your company?  

Mark Bolton (3:12) 

Yeah, absolutely. Mike, my name is Mark Bolton. 

I serve as GW Pharmaceuticals Senior Director of Public Policy and in the legal counsel to the company. In my role, I oversee international and federal and state public policy issues for the company. My prior experience, for what it’s worth, I was a lawyer in private practice based in Denver, Colorado, and then also served as Deputy Legal Counsel and what was called the Director of Cannabis Coordination for John Hickenlooper during his second term as governor here in Colorado. 

So, in that capacity, oversaw all cannabis policy for the state of Colorado as legalized marijuana was being rolled out. GW is a small biosciences company that has spent the last quarter-century focused exclusively on researching and developing cannabinoid-based medicines that are approved by national medicines regulators like the FDA or the European Medicines Agency. And so today, I think we’re widely recognized as the world leader in the field of cannabinoid science. 

We’re, in fact, the only company in the world to develop an FDA-approved cannabis-derived medicine. So in 2018, our product Epidiolex, which is a CBD oral solution, cannabidiol oral solution, became the first cannabis-derived medicine ever approved by the FDA, and it’s indicated for the treatment of seizures associated with three truly catastrophic and treatment-resistant forms of childhood-onset epilepsy. And then we also have a deep pipeline of other cannabis-derived medicines that we’re currently studying in a variety of different neurological conditions like PTSD, autism, and schizophrenia. 

Mike Stull (4:47) 

Awesome. And we have Matt Harmon as well. Matt, I don’t know that there’s a lot of people that don’t know who you are, but for those that don’t, give a quick introduction. 

Matt Harmon (4:57) 

Yeah, thanks, Mike. Matt Harmon, vice president of clinical solutions at Employers Health. I’ve been with the company since 2013 now, based out of Columbus, Ohio, and really try to be that clinical resource for both our clients and our staff, lead our clinical team in providing solutions and insight on pharmacy benefit trends. 

Mike Stull (5:16) 

Very good. So we here at Employers Health, we recently conducted an employer roundtable on the use of cannabis and how it impacts the workplace, and one of the top employer concerns from that roundtable was how benefits and human resource professionals can talk to employees and answer their questions as to why the plan sponsor can’t cover cannabis through the benefit plan today. And so I was wondering, Mark, if you could start by just sharing some of the top concerns or reasons employers can’t cover it. 

Mark Bolton (5:51) 

Yeah, I think it was a great dialogue, a great conversation, and a variety of different issues came up or concerns came up. And the first one, I think, is that there is a lack, currently a lack, of clinical evidence supporting dispensary products, you know, non-FDA-approved cannabis products that are sold in dispensaries as safe and effective medicines. You’re right, the dispensary products that an employer would be paying for have not gone through a clinical trial program, they’ve not been reviewed and approved, and they’re not regulated by the FDA. 

And so with that, there has not been a full accounting of their risk and benefits that’s been developed, and they’ve not been subject to a risk-benefit analysis by the FDA like all other medicines. So their safety and efficacy aren’t fully understood, and they can lead to some unpredictable outcomes that put consumers at risk and may, in fact, end up increasing costs for employers.  

I think the second concern that came through was the dispensary products aren’t subject to the same quality and manufacturing standards as FDA-approved drugs, so they often go to market with quality deficiencies that can put consumers at risk. So there are now numerous studies out there that suggest that, or media exposés that suggest that there’s a frequency with which non-FDA-approved cannabis products sold in dispensaries do go to market contaminated with things like pesticides or fungus or residual solvents used in the manufacturing process or some other contaminant that may put consumers at risk.  

So the fact that those dispensary products are not subject to the same rigorous quality control standards as other FDA-approved medicines means consumers and healthcare professionals can’t rely on their quality or their consistency and identity. I think the third issue that came through quite often were certain legal considerations, right? Of course, marijuana still remains illegal at the federal level, and so does possession of marijuana. 

So, an employer, I think the employers that we heard from were concerned that paying for their employees’ marijuana as a healthcare benefit may, in fact, expose those employers to legal risks, and they’re right, I think, to be concerned about that. Within the workers’ compensation system, certain state courts have determined that covering the costs of an injured worker’s cannabis use may, in fact, constitute aiding and abetting the unlawful possession of cannabis under federal law. So I think some important legal considerations on the minds of employers. 

And then the last one, and I may have buried the lead here because I think this came through more than anything else, were concerns about workplace safety. You know, employers were concerned that paying for cannabis use would, in fact, serve as an endorsement of it, and that may actually lead to more widespread use by their employees, and that was concerning because there’s, you know, very clear evidence out there that cannabis use can impact an individual’s motor skills, their cognitive ability, their reaction times, and there’s clear evidence that employees who test positive for cannabis use have more industrial accidents and workplace injuries than those who don’t. So I think employers were concerned that covering cannabis as a benefit would, in fact, make their workplace less safe or lead to more accidents or injuries potentially. 

So, I think those were some of the main themes that came out of those roundtable discussions.  

Mike Stull (8:58) 

Great, thanks for that recap. As we think about what you were talking about, some of these products that aren’t necessarily regulated by the FDA and dispensed through different dispensaries that are out in the different states, could you talk to us a little bit about the unique nature of taking a cannabis drug through the FDA approval process, which is what your firm did?  

Mark Bolton (9:32) 

Yeah, of course, Mike. 

I mean, I think there are some elements of it that are unique and others that are just like drug development from any other molecule, right? So just like any other drug development, taking a cannabis-derived medicine through the FDA process is resource-intensive, it’s time-intensive, there’s obvious risk involved in it. You know, the unique element of it is that the time and resource considerations are certainly exacerbated for cannabis-derived medicine based on its Schedule I status under federal law, right? So that, of course, requires that for every trial site, just by way of example, where the drug is being administered, you have to have DEA registration for that site, and that site is going to be subject to some cumbersome controlled substances regulations like storage and record-keeping requirements and a variety of other regulatory considerations. So I think that’s how it’s unique. 

But we think, you know, as a company, obviously, we’ve made that investment because we tend to believe that the FDA approval process is the only way to answer important questions about a drug, you know, about the disease that drug seeks to treat and then the safety considerations that are unique to that patient population who will be taking the drug. So, of course, the process consists of a full battery of preclinical studies, right? Phase I through Phase III clinical trials. The Phase III trials, obviously, are the large-scale, large patient population, placebo-controlled, double-blind, randomized clinical trials that render the pivotal safety and efficacy data that the FDA reviews for our drug, for Epidiolex, for what it’s worth. 

We conducted five different Phase III trials in those various forms of epilepsy. But then even beyond those Phase I through Phase III trials, there’s obviously a host of other safety studies that go on in the background that further elucidate the drug’s full safety profile, right? So there are drug-drug interactions studies and food-drug interaction studies, studies that assess the drug’s impact on the kidney and the liver and the heart, for example. And then that data derived from those trials, of course, is critical to informed decision-making by stakeholders throughout the healthcare system, right?  

Most importantly, patients, healthcare professionals that are going to be prescribing and managing utilization of those drugs, and then payers who are going to be making decisions about coverage and trying to provide the most medically effective and cost-effective coverage program for their beneficiary. 

So despite the challenge, you know, we think it is important that these scientifically valid and well-controlled clinical trials are performed, you know, to assess the safety and efficacy of all drugs, not just potential cannabis products that are used for medical use.  

Mike Stull (12:17) 

And on the back end of that process, as individuals start using that medication, is there follow-up and monitoring and control that goes back to the FDA? So I think of the REMS programs.  

Mark Bolton (12:30) 

Yeah, it’s a good point. 

I mean, more and more often now, the FDA, after approval or requiring what’s typically referred to as Phase IV trials, right, those post-marketing safety requirements to understand the long-term safety and efficacy of a drug. And so we have a number of those going with our drug Epidiolex to understand some of the adverse effects that did show up in our clinical trial program. So what’s the impact of the drug on renal functioning? And some of the drug-drug interactions that showed up in our trial I think are now being studied in some of those Phase IV trials. 

Of course, there’s long-term adverse event monitoring and reporting to the FDA so that there’s a full accounting of the drug safety and efficacy, obviously, from preclinical all the way through approval, and then post-approval monitoring of those safety and efficacy outcomes. 

Mike Stull (13:24) 

Matt, anything from a clinical perspective you wanted to add. 

Matt Harmon (13:27) 

I think it’s very beneficial that companies like GW have gone through the scientific process to finally give us evidence on what are the potential side effects in a clinical trial setting and what are the potential drug-drug interactions. Because of the historical use of cannabis, we know that the patients are potentially using that medication with their other medications, but we aren’t really sure what those impacts are, so it’s absolutely critical that we have controlled trial studies to fully give a clinical picture for patient use. 

We’re very interested in finding out more information. I know that Epidiolex in particular is more of a CBD-type product, so differentiating between the different kinds of cannabis and the different aspects to it and how that will all play out within the patient population is very beneficial for us to know. I think it could eventually give argument to employers to cover medications, too, so we know if a patient’s taking another medication that could interact and give both the pharmacist and the prescriber a complete picture of that patient’s profile, so we know if cannabis could be reducing the benefits of their STAT medication, for example, because of how it’s metabolized in the body. 

We need to know those types of things, so because of how the drug has been classified historically as a Schedule I drug, as Mark mentioned, all the limitations that have been put in place for the ability to research this product, so we’re kind of behind the eight ball because of the widespread use of the product out in the marketplace.  

Mike Stull (15:12) 

I would think that the FDA approval process in terms of a prescription drug versus just covering, you know, cannabis generally, the safety concerns that employers have would be somewhat mitigated simply because of the dosing part of it and the prescribing part of it. Obviously, we know people can abuse prescription drugs, as we’ve painfully seen with the opioid crisis, but I think, you know, probably similar to other controlled medications, it at least gives employers more, I think, more footing from a safety perspective, would that be accurate to say?  

Matt Harmon (15:59) 

I would say absolutely. 

Yeah, dosing is a huge piece that is still to be determined, I think, you know, what’s the appropriate dose for, you know, if we think about down the road, you know, for medical marijuana in different states that can be used for pain and, you know, PTSD and potentially migraines, every state’s a little bit different in these indications, but what’s the appropriate dose for that?  

There’s really no good information and it could, you know, I’m sure there are good metabolizers and fast metabolizers and slow metabolizers just like there are with other products, so we need to really, you know, beef up the research so we can give patients, you know, the right information and then, you know, like you said, employers have, you know, trust in the system because, you know, we do cover products that have the potential for abuse, like you mentioned, with opioids and, you know, we cover amphetamines for, you know, different indications like ADHD, so there are already, you know, precedent for covering these type of products that have safety and abuse concerns, so that cannabis is trying to play catch up.  

Mark Bolton (17:05) 

Just to underscore that point, Mike and Matt, I mean, I think every cannabis formulation is different, right, and it’s going to deliver a unique safety and efficacy profile, and so just by way of example, you know, in our clinical trial program, I think this, you know, demonstrates why the clinical trial and drug development programs are so critical for these cannabis formulations. It wasn’t really known until our clinical trial program for Epidiolex that CBD can cause, has the potential to cause liver injury, drug-induced liver injury, right, and that it does have these drug-drug interactions that Matt discussed which can change the effect of other medications that a patient is taking and cause other adverse effects, but with that information, right, developed in our clinical trial program, now physicians know how to manage those risks, right, so for Epidiolex, physicians are conducting regular blood draws in order to monitor liver functioning for patients taking Epidiolex. 

They can monitor the other prescription drugs that a patient is taking and make sure that those drug-drug interactions aren’t affecting those, the outcomes from those other drugs or the effects of those other drugs, and so that’s why it’s critical that all drugs, again, including those cannabis formulations, go through a drug development program so that healthcare professionals know and can make informed decisions, you know, in prescribing those drugs and in managing their utilization.  

Mike Stull (18:32) 

Great, appreciate that. So, bringing it back to the employer, what should our clients as employers be thinking about regarding their cannabis policies going forward and any implications that are out there, should it become classified as a Schedule II drug?  

Matt Harmon (18:56) 

Absolutely, so I think, you know, employers need to consider the nature of their business and, you know, applicable state laws, so, you know, every state is kind of treating this a little bit differently, and so some states prohibit employment discrimination based, you know, against qualified medical marijuana users, so think about, you know, say like Arkansas. Employers kind of, they can discharge an employee if there’s a good faith reason they feel an employee was impaired, but a drug, positive drug test does not constitute that, and you also need to kind of have witness or some other piece to it, but in other states like California or Ohio, an employer can just fire an employee based on marijuana usage, even if it’s off duty, so every state is a little different, so considering the state that you have employees in is essential.  

Yeah, in terms of the reclassification of marijuana, right now it is Schedule I, which means it has no medical use, and I think we now know that that is, you know, not necessarily true, so eventually I think it will have to move to a Schedule II, and that will change a lot of different things in terms of it will allow, you know, pharmacy benefit managers to process prescriptions for potential, you know, cannabis usage. It also could open up from the American Disabilities Act potential, you know, in terms of discrimination for medical marijuana users, so that will be a big piece of it as well, since right now it is federally illegal. 

The ADA normally doesn’t, won’t take precedent because that is a federal law, so it’s important to consider, and then, you know, for employers, it’s really just trying to cut through the misinformation because, you know, you hear all the way on the good side of it is that, oh, this, you know, cannabis is a wonder drug. You’ll treat every single indication all the way down to, oh, it’s a gateway drug. Both of these, we know, aren’t true, so trying to cut through, you know, the stigma and the misinformation out there will be key in ensuring that the policies are up to date, since they can always change in regard to state law. 

Mark Bolton (21:11) 

Yeah, yeah, I think all good points that Matt raised. Probably the more likely outcome rather than rescheduling would be Congress, you know, at some point getting around to descheduling cannabis, you know, and legalizing it at the federal level. I would think that that may be what happens prior to, you know, and would preempt any sort of rescheduling of cannabis, although that certainly is on the table, but I think, you know, the concerns that the employers raised during those roundtables were prescient and sort of relevant, whether we’re talking about cannabis products that are available now under a Schedule I scenario, a Schedule II scenario, or a descheduled scenario, right?  

It’s holding those cannabis products to the same evidence-based standards as all other drugs that the company is considering for its formulary, you know, understanding the quality considerations and concerns, given the fact that those products are not subject to the same good manufacturing practices as FDA-approved drugs, right?  

The legal considerations certainly may change depending on what the change in legal status is, but then those workplace safety concerns that I think came up over and over again from employers and what that may mean for the safety of their workforce and the individuals, the people that their workforce interacts with are all, I think, relevant considerations regardless of the legal status of marijuana under federal law. 

Mike Stull (22:31) 

And I would imagine, and Mark, this might be more for you, I would imagine that there are also tax implications in terms of whether, you know, if an employer is going to cover medical marijuana, you know, is it a qualified medical expense under the tax rules that would allow an employer to deduct that as a plan expense and whether individuals could utilize some of their tax-free dollars in a health savings account or a flexible spending account to pay for it?  

Mark Bolton (23:05) 

Yeah, it’s a good question. I mean, under current law, the answer is no, right? Marijuana being an illegal substance under federal law, those expenses would not be deductible for employers. Certainly, and the IRS has been clear on this, they wouldn’t be eligible expenses under an HSA or an FSA, for example. 

And, you know, beyond those sort of criminal, you know, really sort of most concerning criminal implications that we talked about a I think employers would also have to take into consideration that, you know, there’s other financial relationships that would come into play, right? Banks have been very conservative, for example, in making decisions about whether they bank certain cannabis companies given its illegal status under federal law and what that may mean for their Bank Secrecy Act compliance considerations and their anti-money laundering law considerations.  

And so, you know, if a bank has an employer that they even perceive as involved in cannabis commerce, they may feel compelled to terminate that banking relationship. And so, you know, beyond those, you know, really concerning criminal implications, the sort of tax implications, there are some other real-world practical implications that could come into play for employers as they’re wrestling with those issues. 

Mike Stull (24:19) 

All right. Well, thanks for participating. I’m always fascinated by the conversations. 

Thanks to Mark and Matt for their good insights on this ever-changing and ever-relevant topic. 

Next, I’d like to congratulate this month’s keyword winner, Todd from American Trailer World. Todd submitted the keyword excellence from our last podcast and will receive a $50 gift card. 

If you’d like to be considered to win next month’s gift card, be sure to submit the keyword on the Employers Health’s podcast page. This month’s keyword is “spring.” Again, this month’s keyword is “spring.” So, if you’d like to be considered for that $50 gift card, please submit the keyword along with your name and email address on the landing page.  

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You can also check out our Benefits Insights blog on our website for relevant resources on trending topics. That will conclude this month’s episode. Thank you again to Mark and Matt for their insights and discussion on this, again, constantly evolving world of cannabis in the workplace. 

And thank you for taking the time to listen and for your continued membership, participation, and interest in Employers Health.