With less than three months before the clock runs out on telemedicine electronic prescribing flexibilities, Reps. Doris Matsui, D-California, and Earl "Buddy" Carter, R-Georgia, are leading a bipartisan charge to urge the U.S. Drug Enforcement Administration to strengthen and deliver a better proposal for a controlled substance registry for telehealth providers. 

WHY IT MATTERS

This past week, the DEA sent the White House Office of Management and Budget a third temporary extension of COVID-19 telemedicine flexibilities for the prescription of controlled medications as part of a larger Department of Justice unified agenda that would further extend flexibilities to date unavailable on OMB's website. 

The next day, 18 members of the House of Representatives wrote to express that not only is the agency running out of time before patients lose access to pandemic-era telehealth flexibilities, but said they are concerned the draft proposal excludes whole classes of medications that may unnecessarily risk patient care.

While they said they're encouraged that the DEA is "now seriously considering the option" – and has been reviewing thousands of comments and holding stakeholder listening sessions on a special registry for controlled substance prescribing in virtual care – time is nearly up.

"We strongly encourage you to act before the end of the year to ensure patients do not lose access to care on January 1, 2025," said the representatives in an October 11 letter addressed to Anne Milgram, the DEA's administrator.

The lawmakers are equally concerned about reports that the proposed rule will fail many patients, citing a (paywalled) Politico report that the U.S. Department of Health and Human Services did not concur with the DEA's unreleased proposal for a draft registry.

"The reports surrounding the content of DEA’s draft proposed rule to create a special registration process are deeply concerning," they said in the letter, noting weariness because the agency initially proposed a permanent framework for telemedicine prescribing of controlled substances in 2023 without the mandated "burdensome" special registry.

"If the reporting is true, the proposed content of the rule seems misaligned with Congressional intent in authorizing such a special registration process," they said. "We cannot condone such a potential interpretation of the special registration requirement."

With time running short, a third extension on telehealth prescribing flexibilities is needed to allow for a public comment period on the DEA's final rule in 2025, and as lawmakers pointed out, "the provider community would likely need an additional on-ramp period to allow for the implementation of the rules."

THE LARGER TREND

The lawmakers noted in their letter that Congress first directed the DEA to create a special registration in the Ryan Haight Online Consumer Protection Act of 2008 and then again in the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act in 2018, but the DEA has lagged on these mandates. 

Last year, the American Telemedicine Association applauded the agency's Drug Diversion Control Division for hosting listening sessions, effectively putting a telehealth-controlled substance registry on the table.

While senators were also pleased, six of them led by Mark Warner, D-Virginia, and John Thune, R-South Dakota, wrote to Milgram to remind her that Congress created a special registration under the SUPPORT Act "not as an option for DEA to utilize, but a requirement to do so" in order to protect patient care. 

The senators urged the agency to reconsider certain proposed requirements for the registry, including limiting supplies of controlled substances prescribed through telehealth to 30 days until a patient is seen in person by a mental health provider. 

That's not an easy feat when the reality is that access to behavioral health providers is a widespread problem nationally, and particularly difficult for patients in rural areas hard hit by the opioid epidemic. 

"According to [HHS], 163 million Americans live in Mental Health Care Health Professional Shortage Areas," the senators said. "Approximately 8,200 additional psychiatrists would be needed nationwide just to remove this shortage designation."

Because virtual care has helped to ease the rural mental health crisis, the well-attended listening sessions did include a discussion of ideas for how a special registration eliminating in-person evaluation requirements for medically necessary controlled substances might work. 

The agency then suggested a second comment period for this year on its proposed rulemaking.

ON THE RECORD

"DEA has avoided its statutory obligation to create such a process for 16 years," the 18 representatives of Congress said in their letter. "We maintain our belief that the special registration process is a viable option to allow for patient access to care via telemedicine while balancing DEA’s law enforcement mission." 

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