With the COVID-19 Public Health Emergency set to expire on May 11, the U.S. Drug Enforcement Agency says it will temporarily extend telemedicine flexibilities around prescription of certain controlled medications as it sifts through comments on its proposed plans for post-PHE remote prescribing guardrails.

WHY IT MATTERS
In April, the agency, along with the U.S. Department of Health and Human Services, quietly submitted a temporary rule to the Office of Management and Budget on the topic – and said details would become public after its full publication in the Federal Register.

The DEA has received more than 38,000 comments on its proposed telemedicine rules – "a record," according to DEA Administrator Anne Milgram.

"We take those comments seriously and are considering them carefully," said Milgram in a statement. "We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards."

She added that it was "for this reason" that the DEA and the Department of Health and Human Services submitted "Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications" to OMB.

In February, the DEA proposed permanent changes to the e-prescribing of controlled medications and the draft rule would require patients to have in-person exams.

At issue for a large number in the telehealth, behavioral health and medical communities, as well as some policymakers, would be the barriers to care access many patients experienced before the pandemic.

While the extension is welcome news, the telehealth and behavioral health sectors wait with bated breath for further details. 

THE LARGER TREND

In 2022, more than 70 organization urged DEA to revise its telehealth controlled substance rules to avoid the so-called telehealth cliff.

"We urge policymakers to consider that, during the pandemic, telemedicine effectively increased access to necessary care for patients in their home or other location, without increased diversion related to the waiver," said Kyle Zebley, vice president of public policy at the American Telemedicine Association and executive director of ATA Action, said in a statement about the letter from a multitude of medical and healthcare organizations. 

The DEA's proposal to end the telehealth flexibilities at the end of the public health emergency on May 11 came as an unwelcome surprise to many that have been working to address concerns about prescribing controlled substances, like buprenorphine for opioid treatment, via telehealth.

"Unquestionably, the DEA’s proposal is not what most industry stakeholders were anticipating," Nathaniel Lacktman, partner and chair of the telemedicine and digital health-industry team at Foley & Lardner wrote in the firm's online legal guide on the proposed rulemaking published in late February. 

"The initial reaction is the rules are more restrictive than necessary and impose concerning limitations and burdens on clinicians and the patients they treat," he said. 

In response to the proposed rulemaking requiring a return to pre-pandemic restrictions for telehealth, ATA and others say that a registry for telemedicine providers similar to the existing electronic prescribing of controlled substances system would be an opportunity for pharmacists to easily identify legitimate telemedicine prescribers and prescriptions.

"Clinically, a valid prescription is a valid prescription and the fact that one was issued via telemedicine makes it no less so," the organization stressed. 

ON THE RECORD
ATA and ATA Action submitted substantial comments to the DEA this past March on the proposed post-PHE prescribing rules.

In a statement on Thursday, Zebley said the groups "welcome the possibility of an extension that would continue to allow remote prescribing of clinically appropriate controlled substances.

"We believe such an extension would be evidence of the fact that the present draft rules were unnecessarily restrictive," he said. "Our hope is that the DEA will use the time of an extension to be responsive to the concerns of telehealth advocates, patients and the American people to create rules that ensure access to clinical care that is not inappropriately restricted," he added.

Meanwhile, Geoffrey Boyce, CEO and cofounder of Array Behavioral Care, a telepsychiatry practice, said he is "glad to see the DEA taking the comments seriously and are relieved to know that our patients aren’t going to be unnecessarily limited in accessing care. We’d be even more pleased if we knew when to expect clarity and what to tell our patients and clinicians to expect."

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.