Last October, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) extended the COVID-era telehealth controlled substance prescribing flexibilities through December 31, 2024. They planned to introduce new standards by this fall. But the agencies need more time to consider all the feedback they have received and, on November 19, 2024, extended COVID-era flexibilities for another year.
Background
In March 2023, the DEA issued proposed regulations that would have brought telehealth prescribing of controlled substances to an abrupt end. The provider community sent nearly 40,000 comments to the DEA to explain why that was a bad idea.
Days before the end of the public health emergency (PHE) in May 2023, the DEA and HHS issued a temporary rule (First Temporary Rule). The First Temporary Rule extended all COVID-era telehealth controlled substance prescribing flexibilities through November 11, 2023. It also granted a one-year grace period for practitioner-patient telehealth relationships established before November 11, 2023.
On October 10, 2023, a month before the end of the flexibilities for new patient relationships, the DEA and HHS issued another temporary rule (Second Temporary Rule). The Second Temporary Rule extended flexibilities again through December 31, 2024, without regard to the patient’s status as new or existing.
In the Second Temporary Rule, the DEA indicated that it is working on promulgating new standards or safeguards which it expected to release by the fall of 2024.
Why the Need for More Time?
According to the DEA and HHS, the additional time will “ensure a smooth transition for patients and practitioners.” Further, it will permit the agencies to promulgate regulations that are “consistent with public health and safety, and that also effectively mitigate the risk of possible diversion.” Finally, the agencies are continuing to evaluate the tens of thousands of comments received during the 2023 rulemaking and listening sessions.
What is the Third Temporary Rule?
It’s much like the Second Temporary Rule, except it is effective through December 31, 2025. Specifically, it allows a DEA-registered practitioner to prescribe schedule II-V controlled substances via a telehealth visit to a patient without having conducted an in-person medical evaluation of the patient provided that certain conditions are met.
Those conditions are:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
- The prescription is issued pursuant to an audio-visual, two-way, real-time interactive communication between the provider and patient;
- The practitioner is registered with the DEA to prescribe the class of controlled substance at issue or is exempt from obtaining such a registration;
- The prescription is consistent with all other requirements of federal law for prescribing.
Conclusion
Providers relying on these flexibilities must pay close attention over the next twelve months to information issued by either agency on the subject. I suspect that the agencies ultimately will require an occasional in-person visit at some point during the care relationship so long as the Ryan Haight Act remains law. See my earlier blog posts for more information on the Ryan Haight Act’s requirements.
DEA Extends COVID Telehealth Controlled Substance Prescribing Flexibilities Again (October 2023)
Welcomed Last Minute Temporary Rule Extends Flexibilities for Controlled Substance Prescribing (May 2023)
The DEA’s Proposed Rules on Telehealth Prescribing of Controlled Substance Fall Short of Expectations (March 2023)