In 2014, Hebrew Home at Riverdale’s Medical Director Zachary Palace was faced with a perplexing question: By permitting residents to exercise their full rights as citizens of the state, could he put the senior care center at risk for non-compliance?
At that time the Compassionate Care Act, New York’s medical cannabis law, had just been signed – making therapeutic cannabis more accessible to New York residents than ever before. Yet federal law still presented a hurdle to promoting medical marijuana use in health care settings that received government funding, including nursing homes.
Since cannabis remained an illegal Schedule I drug on the federal level, any SNF that actively dispensed marijuana products would risk losing Medicare and Medicaid reimbursements – a death sentence for facilities.
But that might soon be changing.
Earlier this month, President Joe Biden pardoned all prior federal offenses of simple possession of marijuana and urged state governors to follow suit. Additionally, the president asked the U.S. Department of Health and Human Services and the attorney general to initiate an administrative process to review how marijuana is scheduled under federal law.
This announcement comes at a time when medical cannabis use is markedly destigmatized; once widely criminalized, marijuana is now gaining acceptance as a treatment for a variety of conditions seen in nursing homes, including Parkinson’s disease, seizure disorders and chronic pain.
Many say that a review of the Schedule I classification, meant for the most dangerous substances — including heroin and LSD — is long overdue. To date, 37 states have approved medical cannabis and 19 have legalized it for recreational use.
If they haven’t already, medical professionals and health care providers will eventually need to adjust to the growing demand for cannabis treatment; however, those in the long-term care sector have questions about how it will all shake out.
Promising treatment, limited infrastructure
Palace knows firsthand the compliance risks associated with skilled nursing facilities and cannabis treatment. Yet as a geriatrician, he also saw the potential benefits of cannabis treatment for his patients at Bronx, N.Y.-based Hebrew Home.
So, in 2014, Palace and RiverSpring Health CEO Daniel Reingold set out to create a medical cannabis program at Hebrew Home, which requires residents to clear multiple regulatory steps.
“Residents can obtain the medication via recommendation from a physician such as myself, and they’re able to maintain it in their own space in their room,” Palace said. They get a lock box that only they have the key to. It’s truly their property. And it’s not in the facility’s possession, but it’s in their own personal possession.”
Another participation condition requires residents to self-administer the cannabis — unless they have a companion or family member who can administer it for them, he added.
Hebrew Home’s program does not risk non-compliance due to the fact that the substance is not in the facility’s possession or being administered by facility nurses or staff.
The program, although limited to 10 patients, has shown initial promise – 9 out of 10 patients reported improvements with treatment.
However, the high cost bars many residents from participation.
“There are no insurances that cover it, ” he said. “So, it’s really very much an out of pocket cost to them. And, you know, elderly seniors, older adults living in a skilled nursing facility are of limited means, and for many, even though they’d like to participate in the program, due to the fact that it’s not covered by insurance, they are not able to afford it.”
Palace added that if the federal classification changes, he expects to see growing interest in the program, given that treatment could be covered by insurance.
“I think that by reclassifying it, it would significantly open the door to insurers covering it,” he said. “And we would see, you know, an increase in its use in our population.”
The regulatory process
The Drug Enforcement Administration has long designated cannabis as a Schedule I substance, which by definition maintains that it has no currently accepted medical use.
Yet past FDA rulings have challenged this notion.
In the past 30 years, the FDA has recognized and approved the use of multiple cannabinoid medications, including Marinol, Dronabinol, and, most recently, Epidiolex, which is used for the treatment of seizures and covered by commercial insurances and federal healthcare programs.
In 2018, the FDA approved the drug Epidiolex to be moved from Schedule I and placed in Schedule V of the Controlled Substance Act. Schedule V drugs, such as Robitussin AC, Lomotil and Motofen, are defined as having lower potential for abuse.
“Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit,” a DEA news release issued back in 2018 stated. “In those instances, such as here, the drug will be made appropriately available to the public for medical use.”
Health care attorney Mark Reagan of Hooper Lundy & Bookman said the 2018 Epidiolex reclassification sets a precedent for reassessing cannabinoid treatments that may serve as a guide for rescheduling or de-scheduling the substance at large.
“Basically, what the DEA said was FDA approved drugs containing CBD with no more than .1% THC could fit within Schedule V,” Reagan said.
He predicted that if cannabis is rescheduled, it will be moved to Schedule V and treated like any other controlled substance in a SNF.
“If the substance were physician prescribed, pharmacy dispensed and nurse administered and secured at the facility, that would make it so that you don’t have some of the risks associated with an alternative mode of storage,” Reagan said.
A Schedule V designation could incite a shift away from programs like the one at Hebrew Home, where patients self-administer and store the substance. Yet Palace said that the dosages prescribed to residents at Hebrew Home have little to no THC content, which mitigates potential risks.
“What we’re using is really predominantly CBD with a very small amount of THC. We don’t want the negative effects of psychoactive impact that THC can have on patients so we’re not giving patients medications that would put them at risk for fall,” he said. “There is very little likelihood of diversion because there’s little reason to divert the medication. Because it’s not a psychoactive medication, there’s less of a concern that it might be diverted for recreational use.”
If cannabis is rescheduled, as Reagan predicts it will be, long-term care providers and legislators will have to create infrastructure for disbursement and administration in the post-acute care setting.
“The biggest challenge, I think, associated with all of this is that you know, if it’s a Schedule V drug, let’s say that it goes the same way as the 2018 Epidiolex rulemaking, you’re still going to need a physician to write a prescription,” Reagan said. “You’re still going to need a pharmacy to dispense it. And then you’ll still need a nurse to administer it. That’s probably the best scenario for facility operators.”
A long road ahead
Given the various regulatory hoops that will have to be jumped through by different branches of the federal government, PharMerica’s T.J. Griffin does not think cannabis will be rescheduled by an executive order or administered on a large-scale in
SNFs anytime soon.
Griffin is senior vice president of LTC Operations and Chief Pharmacy Officer at PharMerica.
“Since the DEA is a law enforcement agency, they have some very particular structures that they have to go through,” he told Skilled Nursing News. “I’m not sure this can be done by executive order, so I think it’ll have to be a process through which the Drug Enforcement Administration puts it through their rigors. So I wouldn’t expect anything by the spring.”
Griffin said a two-year timeline will be more likely given the amount of public input needed to enact such a change.
“If [cannabis] stays a scheduled item, then it’s got to come through the pharmacy. That’s going to be tricky for pharmacies to deal with because dispensaries are not pharmacies.” he said. “They’re not registered through the Board of Pharmacy, they’re registered through different business regulations by each state.”
Currently, since marijuana is still illegal on a federal level, most federally-insured banks don’t accept deposits from or give loans to marijuana businesses. This could change if the substance were to be rescheduled; however, marijuana businesses and distributors would need to scale up quickly to meet demands from the health care sector.
“It’s a cash industry is the way I understand it,” he said. “So the banking laws would have to change. Some of that could be going in tandem so that a facility could utilize the products more freely or have their patients use it more freely – but I think the supply chain issues are gonna have to be worked out before that happens.”