With less than three months left before the clock runs out on electronic prescribing flexibility in telemedicine, 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 push for and come up with a better proposal for a controlled substance registry for telehealth providers.
WHY IT’S IMPORTANT
Last week, the DEA sent a notice to the White House Office of Management and Budget third temporary extension of COVID-19 telemedicine flexibility for controlled drug prescribing as part of a larger unified Department of Justice agenda that would further expand flexibility previously unavailable on OMB’s website.
The next day, 18 members of the House of Representatives wrote to indicate that not only is the agency running out of time before patients lose access to pandemic-era telehealth flexibilities, but that they are concerned that the draft proposal excludes entire classes of medications that potentially unnecessarily endangering patient care.
While they said they were encouraged that the DEA is “now seriously considering the option” — and has reviewed thousands of comments and held listening sessions with stakeholders about a dedicated registry for prescribing controlled substances in virtual care — time is running out.
“We strongly encourage you to take action before the end of the year to ensure that patients do not lose access to care on January 1, 2025,” the representatives said in an October 11 report. letter addressed to Anne Milgram, the administrator of the DEA.
Lawmakers are also concerned about reports that the proposed rule will leave many patients in the lurch, citing a (paywalled) Politics report that the U.S. Department of Health and Human Services disagreed with the DEA’s unreleased proposal for a draft registration.
“The reports surrounding the content of DEA’s draft proposed rule to establish a special registration process are deeply concerning,” they said in the letter, noting the fatigue as the agency initially proposed a permanent framework for telemedicine prescribing of controlled substances in 2023 without the mandatory “burdensome” special register.
“If the reporting is true, the proposed content of the rule does not appear to be consistent with Congress’ intent in authorizing such a special registration process,” they said. “We cannot endorse such a possible interpretation of the special registration requirement.”
With time running out, a third extension of telehealth prescribing flexibility is needed to allow for a public comment period on the DEA’s final rule in 2025 for implementation of the rules.”
THE BIG TREND
The lawmakers noted in their letter that Congress first directed the DEA to create a special registry 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 Patient and Communities Act of 2018. but the DEA has lagged behind these mandates.
Last year, the American Telemedicine Association praised the agency’s Drug Diversion Control Division for hosting listening sessions, essentially bringing a telehealth controlled substance registry to the table.
While the 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 registry under the SUPPORT Act “not as an option for DEA, but a requirement to do so” to protect patient care.
The senators urged the agency to reconsider certain proposed requirements for the registry, including limiting the supply of controlled substances prescribed via telehealth to 30 days until a patient is seen in person by a mental health provider.
That’s no easy feat when the reality is that access to behavioral health care providers is a widespread problem nationwide, and especially difficult for patients in rural areas hit hard by the opioid epidemic.
“According to (HHS), 163 million Americans live in areas with a shortage of mental health professionals,” the senators said. “Approximately 8,200 additional psychiatrists would be needed nationally to eliminate this shortage designation.”
Because virtual care has helped alleviate the rural mental health crisis, the well-attended listening sessions also included a discussion of ideas about how a special registry that eliminates requirements for in-person evaluation of medically necessary controlled substances would can work.
The agency then proposed a second comment period this year on its proposed rulemaking.
ON THE RECORD
“DEA has evaded its legal obligation to establish such a process for 16 years,” the 18 congressional representatives said in their letter. “We remain confident that the special registration process is a viable option to provide patients with access to care via telemedicine while balancing DEA’s law enforcement mission.”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.