October 25, 2022
By Morgan Godvin
This summer, a young woman was revived by paramedics after an overdose at her home in Upstate New York. She refused transport to the hospital, a common occurrence among people who use drugs who have been historically mistreated by the health care system. Two years prior, emergency responders would have noted her as “refusing treatment” and swiftly left her. Instead, she was given a completely different option—one she actually wanted.
A mere 20 minutes after the paramedics left, from the comfort of her own living room, she was able to meet virtually with an addiction medicine prescriber, who offered her a prescription for buprenorphine.
“An example like that happens every day,” Dr. Joshua Lynch, founder and medical director of NY MATTERS, told Filter. It was his clinic that was able to see the woman in the minutes after her overdose. Buprenorphine reduces mortality by 37 percent when prescribed to people with opioid use disorder (OUD). And yet this lifesaving intervention is bound by so many regulations that most people who need it still struggle for access.
One of the most pivotal addiction treatment shifts in decades came about almost by accident. The COVID-19 pandemic exposed gaping holes in the US health care system and left people who use drugs, among others, more isolated and vulnerable than ever. However, there was one bright spot in the darkness: Shuttered clinics inspired a herculean effort to move care to telemedicine.
“I needed to get that first step in order to get out of that cycle.”
Telemedicine was initially thought of as a way for people already receiving care to continue receiving it despite shutdowns. But it accomplished something else, too: It brought in people who, for a variety of reasons, were unwilling or unable to receive in-person health care.
“I felt that I needed to get that first step in order to get out of that cycle,” Red, a Portland resident, told Filter. A chef by trade, he lost his job and his housing several years before the pandemic. “Homelessness and addiction make it hard to keep appointments.”
Red received buprenorphine for the first time during the pandemic. Photograph courtesy of Red.
He painted the scenario like this: Without electricity or a phone, he had no alarm clock. Without transportation, he struggled to get anywhere. How was he supposed to show up for in-person appointments?
His lack of access wasn’t for lack of want. “I wasn’t even getting high anymore. I was so sick of everything revolving around drugs. It gets tiring.”
Without the internet, he heard only flickers about the pandemic descending on the globe. It wasn’t until the laundromat near his encampment closed, with huge signs reading, “CLOSED DUE TO COVID-19,” that he realized how big this had become.
The Huge Barriers of US Regulation
When people who use drugs are known to avoid health care settings due to stigma, why wasn’t telehealth buprenorphine prescribing available long ago? It’s a question many in the harm reduction field have been asking.
The direct answer, dispiritingly, is a byzantine US regulatory structure—in which compliance and control, not access or efficiency, have been the goals.
In 2002, right after the FDA approved buprenorphine for the treatment of OUD, the DEA rescheduled it into a more restrictive category
The Controlled Substance Act of 1970 placed all regulated substances into one of five schedules, with Schedule I the most highly restricted (considered to have no accepted medical use and high potential for “abuse”). Both the Drug Enforcement Agency and the Food and Drug Administration play roles in categorization and enforcement. Buprenorphine was originally in the restricted Schedule II (“high potential for abuse”). However, after an injectable formulation was approved for pain treatment in the 1980s, it was moved to the least restricted Schedule V (“low potential for abuse”).
Most tellingly, it was in 2002—right after the FDA approved buprenorphine (Suboxone and Subutex) for the treatment of OUD—that the DEA rescheduled it into a more restrictive category, Schedule III.
By then, the opioid-involved overdose crisis was already headline news. A singular focus on prescription opioids led to broad crackdowns on prescribing; a shift to unregulated opioids would follow, culminating in the unprecedented deaths, mostly involving illicit fentanyl, that we see today. Lawsuits against opioid manufacturers, pharmacies and distributors have meanwhile led to settlements totalling in the billions.
Policies misguidedly designed to reduce harm by making opioids hard to access are increasing harm, paradoxically restricting OUD treatment. Though any DEA-registered physician can prescribe opioids for pain, buprenorphine to treat OUD requires a special “X-waiver” and additional training.
Buprenorphine is a partial opioid agonist and a partial antagonist, acting differently in the brain to full opioid agonists like heroin, oxycodone or methadone. Bupe has a very high affinity to mu opioid receptors—but low intrinsic activity at the site, hence the “partial” agonist. This means it will displace other opioids in the receptors.
Its antagonist properties mean it has a very low risk of respiratory depression, the most commonly fatal symptom of opioid overdose. Its effects do not increase linearly with increased dosage, making it less desirable (a mere 4 percent of respondents in one study reported it as their drug of choice). For some, this means it can also be less effective in treating OUD, with methadone showing higher reduction in mortality and higher patient retention. But unlike methadone, buprenorphine prescriptions can be obtained via a regular provider, picked up from the pharmacy and dosed daily from home.
The specter of “diversion,” in a political landscape bent on restricting all opioids, has consistently been used to hold buprenorphine access back.
In August, on a panicked Dept. of Health and Human Services (HHS) and DEA call about reduced buprenorphine access at pharmacies nationwide, a DEA officer referred to the sharing or selling of bupe among people who use opioids as “righteous diversion.”
Yet the specter of “diversion,” in a political landscape bent on restricting all opioids, has consistently been used to hold buprenorphine access back. In reality, diverted buprenorphine is most often used in ways aligned with its clinical indications. Diverted bupe can decrease the risk of fatal overdose and improve treatment outcomes.
The X-waiver, created by Congress in 2000, is the most salient example of the addiction treatment paradox. It meant that buprenorphine, uniquely, could only be prescribed by “X-waivered” prescribers, whose special registration with the DEA required eight hours (for physicians) or 24 hours (for all other providers) of additional training.
Last year, the federal government finally recognized these requirements as a “perceived barrier” to buprenorphine prescribing. It eliminated them—but only for providers who wish to be capped at 30 buprenorphine patients. For those seeking the standard cap of 100 patients the first year, 275 patients all subsequent years, the requirements around training, counseling and psychosocial services remain. A true X-waiver fix would require legislative action.
Technology has developed much faster than our laws. The Ryan Haight Consumer Protection Act of 2008 was a response to online pharmacies occasionally prescribing in an unscrupulous manner, pumping out opioids with little oversight, which did result in some fatal overdoses. In keeping with anti-opioid sentiment, the sweeping law covered not only full agonist opioids but all controlled substances, including buprenorphine. It mandated an in-person evaluation to first begin medication, and then an in-person follow up every 24 months, at a minimum. The law severely hindered the ability to prescribe any controlled substance, no matter its schedule, via telehealth.
Access to buprenorphine was better than for methadone, which in the United States is administered under a shockingly high-barrier and quasi-carceral system of clinics—but that’s a very low bar.
The COVID Emergency
The public health response to the COVID emergency brought more than mask mandates and testing regimens. It also supplied the political momentum to enable broad but temporary suspensions of certain regulations as enforced by the DEA.
On January 31, 2020, the federal government officially declared a public health emergency (PHE). On March 16 that year, the DEA sent out a letter to registered prescribers of controlled substances, activating the PHE exemption to the Ryan Haight Act and permitting the prescription of controlled substances without first conducting an in-person visit. On March 25, the DEA suspended its requirement that prescribers be registered with the agency in each individual state, allowing for nationwide prescribing. (The DEA cannot affect state regulations, but independently many states also loosened their requirements on where prescribers must be located and registered.)
On March 30, the DEA expanded this guidance so that a regular phone call could satisfy the requirements to receive a controlled substance prescription, eliminating the barrier of requiring a smart phone and high-speed internet. Though the Ryan Haight Act technically remained in effect, the PHE ushered in broad exemptions.
Addiction medicine providers immediately saw an opportunity to improve access to buprenorphine, and telehealth clinics sprouted coast-to-coast. Providers who were already X-waivered were largely allowed to prescribe into other states, as long as their or their patient’s state didn’t prohibit it. Access was later expanded by the 2021 loosening of X-waiver requirements, making “getting X-waivered” for up to 30 patients as simple as filling out an online form.
“Having a 30-minute video conference and then picking up the script is far easier than chasing the bag all day or hustling to get money.”
In Portland, Red was an early beneficiary of the changing regulations. Of course, he had no phone. But he learned about the opportunity by word-of-mouth. A friend would bike to meet him at his encampment so that he could connect for virtual visits with the Portland-based HRBR clinic, using her smart phone. He was able to pick up his buprenorphine prescription at the nearest pharmacy.
Photograph courtesy of Red.
It gave him just the “first step” he needed to get his life in order. “I could try and start making it to appointments, start looking for a job, cleaning up, instead of just worrying about the addiction part,” he said.
Within a few months of being on the medication, he moved into a city-sanctioned camp with services, and was hired on as staff. With his own phone, he could reliably track and attend his scheduled virtual appointments. Two years later, he recognizes that low-barrier buprenorphine access is what enabled him to break the “vicious cycle” of addiction.
“It turned a negative into a positive,” he said of how the pandemic increased OUD treatment access. Red switched to methadone maintenance after moving to a place with a clinic nearby, but it was low-barrier buprenorphine access that first brought him towards stability.
As many people have pointed out, the overdose crisis is unlikely to abate until treatment—whether it’s medications, safe supply or other evidence-based strategies—is easier to access than the adulterated street supply.
“Having a 30-minute video conference and then picking up the script is far easier than chasing the bag all day or hustling to get money,” Red said of the calculus. If it had required hours on public transit, the potential for missed appointments, urine screenings or other barriers, it’s unlikely he would have reached the same conclusion.
Telehealth is more than just addiction medicine, though. Long before the pandemic, Red began having other health problems but struggled to access care. Now, he has hip surgery scheduled and regularly receives general health care in addition to his medication maintenance.
Access for People Who Never Had It
Dr. Joshua Lynch, on the opposite coast, had mirror-image experiences from the provider end of telehealth. In late March, 2020, his initial push was simply to open a virtual emergency department. But the project rapidly evolved based on demand for services.
“We realized that patients with substance use disorder, primarily opioid use disorder, were the ones using the telemedicine platform that we put out there,” he said.
Digging into the data, he realized his new platform had attracted not people whose care had been disrupted by the pandemic, but people who had not yet been receiving care anywhere.
That realization refutes a concern that’s sometimes aired: that telemedicine could result in lower levels of care compared to in-person visits. This operates on the assumption that you’re comparing people receiving care in person with people receiving care virtually. That, as both Red and Dr. Lynch suggest, simply isn’t how it played out for people with substance use disorder. (In fact, research confirms that telehealth outcomes and perceived patient experience are on par with in-person care.)
Telehealth increased buprenorphine access for rural and various underserved populations, including many people who previously had no access. Yet severely diminished in-person and inpatient care offset this, meaning there was no significant whole-population increase in bupe uptake.
A great paradox of American medicine has long been that the people most in need of care are the least likely to receive it.
The pandemic initially decreased the amount of people starting new prescriptions, though numbers then rebounded. Racial and ethnic minorities experienced greater decreases in buprenorphine uptake than white people, showing the unequal burden and systemic racism of the system. Despite increases over time, buprenorphine is still utilized less frequently in neighborhoods where more people are Black, Brown, Indigenous or poor. One study estimated that 87 percent of people who need medications for OUD are not receiving them.
A great paradox of American medicine has long been that the people most in need of care are the least likely to receive it. Many people—people who are likely to be poorer, and therefore likelier to suffer poor health—don’t have insurance. Among those who do (for example, in states with expanded Medicaid coverage), the system can be so complex that severe barriers remain.
For people who use drugs, poor health care access and quality are artifacts of de jure and de facto systems of stigmatization. Health care professionals are known to perpetuate stigma, and many people who inject drugs, especially, report negative, even traumatizing, experiences in medical settings.
For those on the margins, obstacles can be insurmountable. Imagine if Red had been asked to get his past medical records faxed from various clinics, or if he needed a pre-authorization from a primary care physician that he did not have. Any one of those commonplace barriers would have derailed his attempt at treatment.
Uncertainty and Impending Threats
As patients and providers look to the future, everyone is wary. The temporary exemptions to the Ryan Haight Act and other requirements are set to expire when the public health emergency does. Without further intervention, the system will revert to its February 2020 state, decimating buprenorphine access and leading to yet more unnecessary deaths as the overdose crisis only grows.
Rapidly shifting regulations have the potential to leave patients stranded.
The onerous and uncertain federal regulatory structure is further compounded by individual states whose legislatures have made even more restrictive guidelines, and may not stick to the pandemic-era loosening.
Rapidly shifting regulations, whether from the government or pharmacies, have the potential to leave patients stranded without access to their medications. In Ohio, for example, patients at Boulder Care, a telehealth provider, are routinely denied the ability to fill their legitimate prescriptions. This has led to documented cases of patients returning to the street supply.
According to Ben McClean, Boulder Care’s general counsel, Ohio is the most prescriptive state when it comes to rules that further complicates buprenorphine prescribing. The state’s medical board has determined what an evaluation should look like, what types of screenings are required, visit cadence, maximum days’-worth of medication, and myriad other requirements not seen for any other type of medical treatment. If a patient refuses a referral to mental health counseling, the law says they must be mandated to a 12-step program—an abstinence-based modality with far lower chances of keeping someone alive.
Nationwide, Walmart pharmacies are becoming notorious for refusing to fill buprenorphine prescriptions, and/or for simply running out of the medication. This is not merely another tale of a mega-corporation acting from malice, but rather reflects the interplay between corporations and government bureaucracy within a disjointed system.
Having been subjected to multi-million-dollar lawsuits for filling legitimate opioid prescriptions, large chain pharmacies have adopted risk-averse policies, fearing further backlash. The distributors have initiated quotas for buprenorphine, again in response to DEA-initiated policy that arbitrarily quantified what was and was not an appropriate amount of opioids.
“It smells of legal protectionism, at the expense of people who need care the most.”
The DEA has several more unwritten policies that evoke fear among pharmacies, such as the dreaded “red flag” system. Unofficially, it is well known that a person filling a prescription hours away from their doctor’s office is a “red flag,” indicative of “doctor shopping” or otherwise frowned-upon behavior, and likely to draw DEA scrutiny.
Yet having providers who are physically located hundreds of miles from the filling pharmacy is par-for-the-course in telemedicine. Some Walmarts seem to be imposing the Ryan Haight Act requirement and refusing to fill prescriptions if that patient has not seen that provider in person within the past 24 months, perhaps in preparation for the impending expiration of the PHE. The DEA has refused to make a clarifying statement.
“It smells of legal protectionism, at the expense of people who need care the most,” Dr. Liz Ryan, Boulder Care’s medical director, told Filter. That some of the most acute access issues are coming not directly from government policy but from corporate policy shaped by fear of government intervention makes for a complicated situation.
Health care professionals asked the DEA to publicly announce a moratorium on enforcing buprenorphine-related restrictions, such as going after prescribers or pharmacies for “overprescribing”—or even to implement measures as simple as putting its guidelines in writing to mitigate the nebulous fears of corporations. So far, nothing.
The DEA is notoriously unresponsive. But the call it convened in August between HHS (whose public health emergency declaration enabled the increased access) and impacted providers might indicate a shift in tact.
“There is general agreement among pharmacist societies, drug wholesalers, and telehealth SUD clinicians that buprenorphine needs to be viewed differently than other controlled substances,” University of Austin Professor Lucas Hill, a pharmacist, told Filter. He insists there is a simple solution to what’s sometimes framed as an intractable problem. “The most efficient way to achieve that would be to deschedule buprenorphine. This would immediately exempt orders and prescriptions for buprenorphine from the increased scrutiny that is being applied to controlled substances as a result of federal and local opioid-related lawsuits.”
Don’t count on it, however. The DEA, it should be noted, was supposed to create special rules for telemedicine registration per the Ryan Haight Act a decade ago. The 2012 deadline came and went. The DEA was again instructed to create the rules by fall of 2019, following passage of the SUPPORT Act of 2017. The deadline came and went and the rules—the only way to create a framework for legal telehealth prescribing of controlled substances—never came. Nobody knows for sure if DEA will finally do what Congress has repeatedly mandated it to do, or if Congress will make the DEA’s role irrelevant by superseding the Ryan Haight Act.
The public health emergency proved to be a unique, instructive example of deregulation. But how much will regulators learn?
The current public health emergency is set to expire in January of 2023. On October 13, HHS Director Xavier Becerra extended it yet again, having previously reaffirmed providers will be given 60 days’ notice ahead of its final expiration. But Donald Trump declared the “opioid crisis” a public health emergency in 2017, and it has been extended ever since. It is theoretically possible that the pandemic-related prescribing guidelines could simply be ported over to the other public health emergency declaration.
The rules could be made permanent, which would quell the uncertainty currently gripping providers. As for the attorney whose job it is to understand the nuts and bolts of this complex issue, Ben McClean reports being “personally optimistic.” There are numerous, tiered solutions at the disposal of regulators, he said, from temporary public health emergency extensions to permanent rule changes to the de-scheduling of buprenorphine.
Amid corrosive uncertainty, there is one thing everyone knows for sure: telehealth prescribing of buprenorphine was a game-changer. People who had long been excluded from care found access.
The public health emergency proved to be a unique, instructive example of deregulation. But how much will regulators learn? If rules ostensibly designed to “reduce harm” exponentially increase it, why are they so hard to get rid of?
On October 19, when Filter asked the DEA about the future of buprenorphine regulations, a spokesperson said they “have nothing further to announce at this time.” That same day, based on CDC rolling averages, it is likely that nearly 300 Americans died of overdose.