The Drug Enforcement Administration (DEA) and the HHS announced they will extend pandemic-era telehealth prescribing flexibilities for controlled substances through 2024. The temporary extension marks the second time regulators have prolonged the relaxed prescribing rules for drugs like opioid use disorder medications or stimulants for ADHD, which allow clinicians to provide the drugs virtually without first conducting an in-person evaluation. The rule ensures “a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards,” the DEA and the HHS wrote. The DEA will work to write new regulations by the fall of 2024.
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Without this temporary rule, COVID-19 telemedicine flexibilities would expire on November 11, 2023, with respect to practitioner-patient relationships established after that date. The temporary rule continues the temporary extension of the “full set” of DEA’s COVID-19 waivers for prescribing controlled substances via telemedicine. Those waivers, which have been in place since March 2020, are now extended through December 31, 2024.
The news of the rule’s extension arrives on the back of a recent public listening session in which the DEA heard commentary from various provider, advocacy, and patient stakeholders, among others, regarding their concerns over the DEA’s proposed final rule released in March 2023. The proposed final rule would claw back much of the flexibility allotted during the Public Health Emergency (PHE) and would, in effect, push the practice of telehealth back to pre-PHE times. Specifically, the proposed rule would largely restrict healthcare providers from prescribing controlled substances through virtual encounters by either limiting prescribers to a single fill of a controlled substance without an in-person visit; or requiring a complex series of referrals from another in-person practitioner before the prescriber could issue a prescription via electronic means.
The rule’s publication drew significant opposition from the provider stakeholder community, with the DEA receiving more than 38,000 comments in response, most of which scrutinized DEA’s perceived shortsightedness and burdensome requirements for typical prescribing relationships. As a result, the DEA was pressured to keep the status quo until November 11, 2023 while it heard from stakeholders and took the impact of the proposed rule into further consideration.
Now, with this additional perspective in hand, the DEA appears to be going back to the drawing board to further revise the final rule to balance providers’ concerns with the need to ensure that controlled substances are appropriately prescribed and monitored.
In addition to the onslaught of provider comments, the DEA’s additional reprieve may have also resulted, in part, from mounting congressional pressure. In a bipartisan letter sent to the DEA in September 2023, several senators expressed concerns over both the potential impact of the DEA’s proposed rule and the fact that the DEA has yet to develop a special registration process for teleprescribing despite multiple legislative actions permitting, and in fact requiring, it to do so.
As envisioned by Congress, the special registration process would allow registered healthcare providers to use their clinical judgment to determine when a medical examination may be conducted via telehealth—as opposed to in person—for the purposes of prescribing controlled substances.
Furthermore, the ATA applauded the temporary rule. Kyle Zebley, senior vice president for public policy at the ATA and executive director of ATA Action, said in a statement that 2024 is “shaping up to be the Super Bowl for telehealth, with many of the telehealth flexibilities enacted during the public health emergency set to expire.” Organizations like the American Telemedicine Association and the American Hospital Association have argued in-person requirements could limit access to care, particularly for opioid use disorders, which soared during the pandemic.