Should the Drug Enforcement Administration (DEA) require a prior in-person visit before allowing clinicians to prescribe controlled substances via telemedicine? That was one of the issues that DEA officials heard conflicting testimony on during a “listening session” Tuesday.
“Arbitrary one-time in-person evaluation requirements do not prevent abuse and diversion,” said Helen Hughes, MD, medical director of the Office of Telemedicine at Johns Hopkins Medicine, in Baltimore. “Telemedicine controlled substance prescribing happens in a variety of settings across Johns Hopkins Medicine, often without a previous in-person encounter,” such as pediatric patients being prescribed attention deficit-hyperactivity disorder (ADHD) medications and elderly patients who are receiving palliative care.
“The ability for these providers to prescribe controlled substances and use their medical judgment for telemedicine without a prior in-person visit allows patients to receive clinically appropriate, essential care via a convenient and patient-centered modality, and we strongly believe the in-person medical requirement should be removed in its entirety,” she said. “While the proposed rule would prevent or limit prescribing in the above scenarios, it does nothing to prevent a provider who saw a patient one time in person — even 10 years ago — from recklessly prescribing controlled substances via either telemedicine or in-person care.”
Two-Day Session
Dan Reck, CEO of MATClinics, an opioid use disorder treatment company that uses mainly buprenorphine products, disagreed. “Without proper oversight of patients prescribed controlled substances, including regular in-person visits combined with definitive toxicology testing, there is no reason to believe that some telemedicine-only providers won’t become buprenorphine mills, just as painkiller mills once flourished,” he said. “We are concerned that the consequences of unregulated buprenorphine will contribute further to the already deadly opioid epidemic.”
The listening session — which will last for 2 days — came about because of the large volume of comments the agency received on two proposed regulations, DEA administrator Anne Milgram, JD, said at the start of the proceedings. “This past March, in concert with the Department of Health and Human Services, DEA issued two sets of proposed telemedicine regulations,” she explained. “Those regulations would have allowed for telemedicine prescribing of certain controlled substances subject to safeguards, and would have imposed an initial limit on telemedicine prescriptions to a 30-day supply. To prescribe more … the prescribing practitioner generally would have been required to evaluate the patient in person.”
“We received over 38,000 public comments in response to those proposed regulations, and we read every single one,” she continued. “We believe that it is among the highest number of comments we have gotten in the DEA’s history. A significant majority of those comments expressed concerns that the proposed regulations place limitations on the supply of controlled substances that could be prescribed prior to an in-person evaluation. After evaluating these comments, DEA wanted to reopen this conversation about telemedicine prescribing and to allow for a public listening session.”
Psychiatrists’ Concerns
Psychiatry groups were among those concerned about the proposed 30-day prescribing limit. “The 30-day initiation period would not be adequate given the current wait times” for psychiatric care in many places, said Shabana Khan, MD, a psychiatrist who spoke on behalf of both the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatrists. She noted that 55% of counties in the U.S. have no psychiatrists and 70% of counties have no child psychiatrists.
The psychiatry groups also oppose a DEA proposal to require telemedicine prescribers to note on the prescription that it was accessed via telemedicine. “[Designating] prescriptions as telemedicine increases pharmacist hesitancy to fill the medications without good reason,” Khan said. “We are already finding this in our practice. So adding that telemedicine indication on there could potentially make it even more difficult for our patients to access care.”
Sterling Ransone, MD, past president and current board chair of the American Academy of Family Physicians, said that while telemedicine has worked very well at his practice when it comes to treating established patients, the academy had concerns about the way in which use of telemedicine-only companies can lead to fragmentation of care. “I practice in a rural area with my wife, who’s a pediatrician, and we frequently will have patients come in to see us for follow-up” after a visit with a telehealth-only provider; the patients have no record of the other provider’s diagnosis or treatment plan, he said.
“We’ll see these folks coming in on antibiotics or other substances which we personally wouldn’t have used because we know these patients … plus we know the bacteria that are in our area,” Ransone continued. “I ask, ‘What did they do?’ ‘Well, they put me on a white pill.’ ‘Do you have it with you?’ Usually they don’t bring it, and then I’m scrambling trying to figure out what medication they were placed on, so that I don’t do harm by prescribing a medication that might interact with the drug that they’ve been given … So that fragmentation of care — the fragmentation of care has been quite concerning for us.”
Exceptions Proposed
Other speakers argued for exceptions to the proposed rules. David Hoffman, JD, assistant professor of bioethics at Columbia University in New York City, urged the DEA to treat terminally ill patients differently than other patients when it comes to prescribing controlled substances to treat pain.
“If all the DEA had to be concerned about was elimination of opportunities for drug diversion, then the proposed ban on telemedicine for first-prescribing of narcotics might make some sense,” he said. “But the interests of patients in need of relief from pain and suffering, particularly those patients with terminal illnesses — and therefore limited ability to travel to doctor’s appointments — must be considered a strong balancing consideration.”
Robert Krayn, CEO of Talkiatry, a telemedicine provider specializing in psychiatry, suggested that hospitals and nonprofit healthcare entities be exempt from some of the data reporting requirements in the proposed rule.
“They have limited resources on the nonprofit side, and when you look at the potential for diversion, it really stems from people who are gaining a profit from making the prescriptions and with a lot of not-for-profits, that is just simply not the case,” he said. “The data reporting requirements are cumbersome, and for certain doctors who work at multiple, not-for-profit organizations treating many patients, those records are scattered everywhere; they do not have the money, the resources, or the technology know-how to make this an easily reportable component.”
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