On May 11, the COVID public health emergency (PHE) will end. As a result, prescribing of most controlled substances via telehealth, which was allowed during the PHE, will no longer be permitted without an in-person visit. If adopted, proposed rules released by the Drug Enforcement Administration (DEA) will permanently restrict prescribing of controlled substances via telemedicine. Many in the medical and advocacy communities are alarmed.
Controlled substances are a category of drugs that are more tightly regulated by the government because they may be dangerously misused or lead to addiction. While illicit drugs such as heroin and methamphetamine are classified as controlled substances, so are some useful and effective psychiatric treatments including medications used to manage symptoms of anxiety or to treat attention-deficit/hyperactivity disorder (ADHD), depression, and opioid use disorder (OUD).
Our chief concern with the proposed requirement is that it may limit access to medications that are considered the gold standard in treating opioid use disorder. Let's unpack why controlled substance prescribing is regulated in the first place, even for medications that are effective, and our concern with the proposed rollback of flexibilities instituted during the COVID PHE.
Some regulation of controlled substance medications make sense -- they are classified as controlled because of their inherent risk. In certain cases these treatments are not recommended as first-line interventions or even considered best practice. We need to look no further than the opioid epidemic to understand the enormity of the consequences when controlled substances, especially opioid pain medications, are not appropriately regulated, prescribed, and managed.
During the pandemic we saw the dark side of controlled substance flexibilities via telehealth. Take for example the Department of Justice and DEA investigations of tele-mental health companies for possible violations of the Controlled Substances Act for prescribing medicines like Adderall and alprazolam (Xanax) without properly screening patients. Put bluntly, the pandemic created the perfect storm for these alleged venture capitalist-backed virtual pill mills.
On the other hand, however, individuals genuinely impacted by mental health and substance use disorders also benefited from easier access to medications during this time through online providers who did follow best practices. Importantly, the growing psychiatrist shortage was partly alleviated by the innovative use of digital technology. These gains are likely to be reversed under the new proposed DEA regulations, which permanently restrict access to controlled substances via telemedicine. The regulations are up for public comment until March 31.
We're concerned that the proposed DEA rules put population health in jeopardy given the current state of the opioid epidemic. The medications that are considered the gold standard in treating opioid use disorder are controlled substances. Buprenorphine, one of those medications, was part of COVID PHE flexibilities that allowed virtual initiation and management of medications for patients with OUD. Buprenorphine has been shown to lower opioid-related mortality, improve treatment retention, and generally improve patient outcomes. Yet, even before the pandemic the availability of this medication to patients was limited due to provider shortages, with no access in many counties across the U.S.
The pandemic created a proving ground for telemedicine as a tool to expand access to underutilized treatments for OUD by experienced and specialized providers. For the first time, providers could see patients in rural counties who otherwise had to drive long distances for treatment, increasing provider capacity and reaching people in remote areas. In our experience, we saw some providers take this opportunity to become licensed and register with the DEA in additional states to help patients obtain access to this lifesaving care. During this time, new data showed that telemedicine access to buprenorphine does not increase buprenorphine overdoses, rather, it lowers the odds of medically treated overdoses and improves treatment retention.
And yet, despite the evidence, the DEA has proposed separate, more specific, highly restrictive and complex rules that will not maintain the current level of access to treatment. This problem is compounded by the reality that only a fraction of U.S. treatment centers offer medication for OUD. Furthermore, it limits progress from other recent policy wins that advance buprenorphine access, such as elimination of the X-waiver.
Specifically, the proposed rules require that within 30 days of receiving a buprenorphine prescription via telemedicine, the patient would have to either be examined in-person by the prescribing practitioner or practice, or the prescribing practitioner would have to examine the patient remotely while the patient is in the physical presence of another DEA-registered practitioner participating in an audio-video telemedicine encounter with the prescribing practitioner. This is suggested as a measure of diversion control but is not evidence-based and could be satisfied by more appropriate and accessible in-person clinical interactions (such as receiving a urine drug screen at a local lab).
During the pandemic, many patients connected with providers hundreds or even thousands of miles from their physical location. Ending this arrangement leaves the healthcare delivery system and patients in limbo and unable to provide or receive care via telehealth in a compliant manner. Furthermore, if patients have to be examined in person by another DEA-registered prescriber, most likely their primary care physician (PCP), additional concerns are raised. Many patients do not have a PCP. The wait for a face-to-face primary care new patient visit can be months. If patients do not have a PCP and can't schedule appointments concurrently, then coordinating schedules to be evaluated by another DEA-registered provider alongside the telemedicine provider may be extremely difficult and will likely create a bottleneck, further straining the already overextended emergency and crisis care services.
While the new rules do include some balanced measures for diversion control and patient safety, it cannot be ignored that the DEA's proposed measures would jeopardize access to lifesaving medication for thousands and worsen the still mounting opioid epidemic. Failure to act to preserve access to OUD treatment -- including initiation and maintenance of treatment -- by continuing to waive the requirement for an in-person visit, or by eliminating it altogether, would be devastating.
We encourage health professionals to comment and look forward to formal guidance aimed at strategies to address opioid misuse and, in turn, save lives via telemedicine.
Sam Arsenault Wilson, MA, is chief quality officer and co-founder at Confidant Health, a behavioral health platform and multidisciplinary provider network providing virtual psychiatry, therapy, and self-support services. Arthur Lazarus, MD, MBA, is a member of the Physician Leadership Journal editorial board and an adjunct professor of psychiatry at the Lewis Katz School of Medicine at Temple University in Philadelphia. He is a collaborating psychiatrist at Confidant Health.