As the country enters a new phase of the COVID-19 pandemic, some states have begun to make permanent changes to expand telehealth policies implemented under the public health emergency. Others have passed laws restricting them.
Prescribing controlled substances, including medications for opioid use disorder (MOUD), via telemedicine has been possible during the pandemic due to an exemption to the Ryan Haight Act. The law generally does not allow such a prescription without a prior in-person exam of the patient. Recent data has found that the use of telehealth to prescribe MOUD has increased access to opioid recovery treatment.
But unclear regulatory requirements have complicated operations for providers and pharmacies alike. According to 2018 guidance issued by the Drug Enforcement Administration (DEA), the Ryan Haight Act provides an exception to in-person exams for MOUD prescribed via telemedicine. Yet earlier this year, the DEA publicly indicated such an exception has only been provided temporarily under the public health emergency.
The DEA could not clarify this discrepancy when Fierce Healthcare reached out for comment.
The public health emergency is not due to expire until mid-October. Yet Walmart is no longer accepting prescriptions for controlled substances issued via telehealth without an in-person visit in the prior 24 months, Fierce Healthcare has learned. This policy, introduced in July, has implicated virtual providers of opioid use disorder treatment—whose prescribers practice remotely—and their patients.
The company was one of two major pharmacies to begin curbing certain telehealth prescriptions in May.
Walmart did not respond to multiple requests for comment, but one Walmart pharmacy employee confirmed the existence of the policy applicable to all Walmart and Sam’s Club pharmacies that began in July.
The DEA would not comment on the policy. In a March press release, the agency's administrator said "we want medication-assisted treatment to be readily and safely available to anyone in the country who needs it."
“This is an ongoing theme we’ve been experiencing with pharmacies since the beginning of the pandemic,” said Stephanie Strong, founder and CEO of Boulder Care, a telehealth addiction treatment provider.
In 2020, the Justice Department filed a lawsuit against Walmart for allegedly unlawfully dispensing controlled substances during the height of the opioid crisis and failing to report suspicious orders placed by its pharmacies. Its latest policy, Strong believes, is the pendulum swinging the other way.
“We’ve always had challenges with pharmacies,” echoed Ankit Gupta, founder and CEO of Bicycle Health, a virtual addiction medicine clinic. “There are regulations that make it challenging for pharmacies to dispense controlled medications.”
When prescribers are questioned by pharmacies, they typically call them to explain who they are and why they believe the prescription is legitimate. Independent pharmacies are more amenable to that conversation, virtual addiction treatment providers say.
“They often have a lot of questions, they often have a lot of skepticism, but they also have a lot more leverage to make their own decisions,” said Emily Behar, vice president of clinical operations at virtual opioid use disorder provider Ophelia. Lately, with Walmart, that approach “has been a brick wall.” Boulder, Bicycle and Ophelia patients have been transferred away from Walmart pharmacies to prevent disruptions in treatment.
Other retailers that have recently rejected telehealth scripts from the providers include Walgreens, Costco and CVS locations.
CVS Health told Fierce Healthcare it has no policy requiring telehealth prescriptions of controlled substances to have an in-person exam. “Our policies require pharmacists to exercise their professional judgment in determining whether or not to fill a controlled substance prescription, regardless of whether the prescription was written during an in-person visit or a telehealth visit,” a spokesperson said.
Though Walgreens would not confirm or deny the existence of a formal policy, it responded that it “follows all applicable federal and state laws and regulations related to the dispensing of controlled substances.” That “includes verifying that there is a valid relationship between the patient and the prescriber. If a prescription presents red flags that cannot be resolved, our pharmacists will refuse to fill it.”
Creating more barriers for patients
Finding an alternative pharmacy presents many challenges, providers say. They must make sure a pharmacy won’t stigmatize their patients but also carries the right formulation of a given medication that's also covered by the patient's insurance.
Often, there is no other pharmacy in a patient’s vicinity that carries buprenorphine, meaning they have to travel many miles to get the medication. Large chains “are some of the most critical resources for these patients,” Strong said.
Not only is distance an access barrier for patients, but it can also be considered a red flag “that doesn’t actually have to do with diversion or increased concern for the patient clinically,” Behar noted. “It is just a terrible hindrance for them and potentially could lead to a lot of destabilization,” she said about patients. Withdrawal could lead to relapse.
All of these considerations keep providers from scaling, which could help boost access to treatment. “We can’t necessarily grow as quickly as we would otherwise,” Strong said. This approach could also damage patients’ trust in telehealth as a model.
“It’s also sort of about our patients feeling like addicts, feeling like they've done something wrong by being a part of a telemedicine model of care. Which, in fact, is not the case,” Gupta said.
Providers worry that once a major retailer like Walmart implements a policy, others might follow suit. “It really can be a chilling effect across an entire set of care that keeps people alive,” said Rose Bromka, chief operating officer of Boulder Care. Being denied a prescription “can make the difference between someone staying in care and someone not staying in care.”
Connecting a disparate system
Walmart and other chains’ recent stance is the product of years’ worth of fear and confusing federal and state laws, experts say.
Despite buprenorphine’s proven reduction of the risk of overdose, it is an opioid itself, leading the DEA to take an especially aggressive stance on the medication. As a result, wholesalers and pharmacists worry about exceeding volume caps on orders, so as not to get flagged by the DEA. One CVS pharmacy told Fierce Healthcare it has exceeded its vendor’s limit and can no longer order controlled substances like buprenorphine.
Corporate policies that limit telehealth prescriptions “are a threat to patient safety and recovery,” said Anna Legreid Dopp, senior director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists. “It is a step backward in leveraging virtual care to increase patient access to medications for opioid use disorder and to address the opioid crisis.”
Between regional DEA offices, state pharmacy associations and boards of pharmacy, many players are involved in regulating and informing pharmacists. The only way to clarify discrepancies in rules is to work together. “It’s just a loop of as much transparent communication as possible,” said Ronna Hauser, SVP of policy and pharmacy affairs at the National Community Pharmacists Association. “You never want the day to be where our members have a fear factor from the DEA.”
More multidisciplinary education with prescribers and providers on buprenorphine would also help, she added.
“We hope Walmart and these other large chains will recognize that we empathize so much with what they're trying to do,” Strong said. “But we hope that they’ll look to us, multi-state clinicians who are focused on access and patient care, to find that path forward.”
In an emailed statement, a spokesperson from the Substance Abuse and Mental Health Services Administration (SAMHSA) said medications for opioid use disorder are “vital” and said Health and Human Services “is working within its public-sector authority to increase access and availability for such medications as part of a concerted campaign across federal agencies to decrease overdose deaths.”
In a letter to the Office of National Drug Control Policy from mid-July, Ophelia suggested creating guidance for a mail-order pharmacy that can ship controlled substance medications nationwide. It also urged ONDCP to encourage the DEA to remove buprenorphine from its Suspicious Orders Monitoring System and create an incentive program for large chain pharmacies to partner with high-quality providers, both telehealth and in-person.