Confusion Over DEA Controlled Substances Proposals For Telehealth
Two US Drug Enforcement Administration (DEA) proposals on how telehealth can be used going forward to prescribe controlled substances are drawing criticism from mental health and addiction treatment specialists.
The proposed rules — one for Schedule III-V substances, and the other for buprenorphine — are due to go into effect on May 11, when the COVID-19 public health emergency (PHE), and temporary flexibilities, end.
Essentially, both proposals would allow providers to prescribe a 30-day supply of a controlled substance or buprenorphine, but then require a face-to-face meeting for patients to receive additional prescriptions.
The DEA says that the rules are aimed at preventing abuse and diversion of the substances, but clinicians claim they are creating unnecessary hurdles that will probably lead to some patients dropping out of treatment.
“We were happy to see that there is ongoing flexibility to be able to initiate buprenorphine through telehealth, but we were disappointed to see that the DEA set an arbitrary timeframe, in this case, a 30-day timeframe after which the patient would have to be seen in person before ongoing care with buprenorphine for opioid use disorder could be provided,” Brian Hurley, MD, MBA, the president-elect of the American Society of Addiction Medicine told Medscape Medical News.
Hurley agreed that it is best practice to see patients in person for ongoing care, but he noted they have many reasons why they might not be able to make it into an office every month.
“What this rule would do if instituted as written is prevent me from continuing care for patients unless I can get them in in person, he said. “And while I’d make every effort as a clinician, it’s not always feasible to do so,” said Hurley.
The addiction specialist noted that only about 20% of Americans with opioid use disorder have access to medications for the disorder. “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion,” he said.
The DEA is also proposing to allow state laws to supersede its regulations, which concerns Hurley and other clinicians because some states are more restrictive. “Our position is that state laws that restrict access to medications for opioid use disorder through telehealth means are inconsistent with our policy recommendation. I certainly hope that the DEA hears our concerns and amends the proposal,” said Hurley.
A Potential ‘Telehealth Cliff’
Shabana Khan, MD, chair of the American Psychiatric Association’s (APA’s) telepsychiatry committee, said that “because of potential overlap with state rules that may be more stringent than these new regulations, APA is concerned that the proposed rules will create a telehealth cliff for those in most need of critical psychiatric and opioid use disorder treatment, particularly in communities where this specialty care is limited or nonexistent.”
In a statement, Khan noted that “clarification is necessary on how patients who started treatment during the PHE can continue treatment with a prescribing provider, if at all, through an in-person evaluation with a DEA-registered provider referral.”
Telehealth companies were also disappointed in the DEA proposals.
“The continuity of care for countless Americans will be severed, potentially leaving these patients to fall through the cracks of our healthcare system without access to needed medications,” said Kyle Zebley, the American Telemedicine Association’s senior vice president of public policy, in a statement.
“Requiring every patient who has initiated treatment via telemedicine during the pandemic to now visit a provider in-person clearly falls on the side of being overly restrictive,” Zebley added.
The DEA is proposing to allow patients who have been receiving telehealth over the past 3 years to continue to do so for 180 days after the PHE ends.
But the American Telemedicine Association and others said that they still want to see a change in the proposal as written. “Our hope is that the DEA works with us to avoid unnecessary and inappropriate restrictions on the prescription of essential medications for these vulnerable and underserved populations,” Zebley said in the statement.
DEA Administrator Anne Milgram said in a statement that the agency believes that “the telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder,” and that the DEA “is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”
In addition, Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said in a statement that “This proposed rule builds on President Biden’s historic move to eliminate the X-waiver that prevented many prescribers from treating patients with buprenorphine.” He added, “Thanks to these changes, millions of Americans will be able to access the lifesaving care they need.”
DEA estimated that there were 15.7 million prescriptions for buprenorphine in 2021 and that about 67,000 were for initial prescriptions.
The rule on controlled substances has also caused some consternation, especially given that it does not differentiate between racemic ketamine and esketamine, said Lisa Marie Harding, MD, vice president of the board of American Society of Ketamine Physicians, Psychotherapists & Practitioners.
Esketamine (Spravato) is approved by the US Food and Drug Administration (FDA) and, under a Risk Evaluation and Mitigation Strategy, can only be administered in FDA-monitored treatment facilities. Racemic ketamine is being prescribed — often for home use — with almost no regulatory oversight.
Harding, who is an approved Spravato provider and also administers intravenous ketamine in her practice, does not believe that ketamine should be used at home without supervision.
“I had a patient who had a very powerful dissociative experience in my office earlier this week,” Harding told Medscape Medical News. One of her staff asked what would happen if the patient had experienced that at home. “We don’t know. Nor do we want this to happen,” said Harding.
However, the DEA proposal would continue to allow for home use, at least initially. “If it’s open to interpretation, those people that prescribe ketamine for home use can use that leeway to then continue to do it,” she said. “That is not safe.”
Harding approves of the proposed DEA requirement for face-to-face visits. “It’s good patient care,” she said. But she wants the administration to adjust the rules to make it harder to offer home ketamine therapy.
“Lots of people are using racemic ketamine off-label for treating depression with success but doing it in treatment settings that are appropriate,” said Harding.
Hurley and Harding report no relevant financial relationships.
This report by Alicia Ault a St. Petersburg Florida-based freelance journalist first appeared on Medscape Medical News her work has appeared in publications including JAMA and Smithsonian.com. You can find her on Twitter @aliciaault.