DEA Likely to Further Extend Flexibilities on Controlled Substances and Telehealth Prescribing Beyond 2024
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During the first year of the COVID-19 pandemic, the provision of medical care through telehealth increased by 154%, and much of that increase occurred in behavioral health. This trend, combined with COVID risk mitigation strategies and temporary flexibilities in licensure and regulatory requirements, resulted in substantial growth in virtual-only medical practices.
In the field of behavioral health, temporary flexibilities allowing telehealth-only prescribing of controlled substances has allowed these practices to flourish by allowing them to treat a full spectrum of conditions through remote-only care. However, as the COVID pandemic ended, an important question arose as to whether telehealth-only prescribing of controlled substances would continue past 2024.
Now, physicians who prescribe controlled substances to new patients through telehealth-only medical encounters may have additional time before having to contemplate in-person care.
On October 10th the U.S. Drug Enforcement Agency (DEA) submitted a proposed rule to the White House Office of Management and Budget (OMB); the rule is entitled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for the Prescription of Controlled Substances.” While the text of the proposed rule has not been publicized, it is expected to further extend the current COVID-era flexibilities for prescribing controlled substances through telehealth for an additional 1-2 years past 2024.
Background:
As previously reported, in May 2023 the DEA temporarily extended the COVID-19 telemedicine flexibilities for prescribing controlled substances, which had been set to expire at the end of the federal COVID Public Health Emergency (PHE). The flexibilities affected an important requirement of The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which requires prescribers to conduct an in-person examination (i.e. in a medical office) to evaluate each new patient at least once before prescribing a controlled substance.
During the COVID pandemic, the DEA formally announced a temporary rule that allowed prescribers to perform the required initial evaluation through real-time videoconferencing. Since then, prescribers have been able to form new treatment relationships and prescribe Schedule II-V controlled substances to patients whom they have never examined in person.
The COVID flexibilities had been set to expire with the PHE in May 2023, and in March 2023 the DEA published two proposed rules that would allow limited telehealth prescribing of controlled substances after the PHE expiration. For details on those proposed rules, please see MIEC’s article DEA Announces Proposed Telemedicine Rule Change for Controlled Substances.
Briefly, the proposed rules would have changed the Ryan Haight Act to allow telemedicine-only prescribing after the PHE has ended, but they would have allowed only 30-day prescriptions of certain controlled substances before an in-person visit was required. The proposed rules did not include opioid pain medications or any Schedule II medications (such as Adderall and Vyvanse), which would still require an in-person visit before prescribing.
During the public comment period, the DEA received over 38,000 comments largely criticizing the proposed rules. Of the criticisms, stakeholders including the American Psychiatric Association focused on the DEA’s failure to institute a telehealth registration system for controlled substance prescribers, as required by law under the Ryan Haight Act, as well as the proposed restrictions on buprenorphine prescribing for the treatment of addiction. Some commenters suggested that the DEA should focus more on the investigation and prosecution of illegitimate controlled substance prescriptions, rather than imposing restrictive rules that would substantially reduce all controlled substance prescriptions through telehealth. In response to the public comments, the DEA extended the COVID flexibilities through 2024 while it worked on a revised set of rules, which were to be announced formally this Fall.
Recent Developments:
At the end of August 2024, a former DEA official reportedly leaked the contents of the pending rules to media outlets. Those proposed rules, which were submitted to the OMB in June and would have gone into effect after the current extension expires at the end of 2024, reportedly contained several significant changes:
- Schedule II medications would be excluded without an in-person visit or would be subject to significant limitations.
- Providers would be required to check prescription drug monitoring database (PDMP) histories for each new patient in all 50 states before prescribing through telehealth.
- Providers must prescribe at least 50% of all controlled substances through in-person visits.
Following news of these proposed rules, over 300 stakeholders sent letters to the federal government and demanded that it further delay and/or change the draft rules. In addition to the objections to the proposed limitations, it was noted that there would be insufficient time for public comment and review prior to the end of 2024, given that the DEA has yet to formally publish the proposed rules. This led the DEA to file a further extension last week.
Current Status:
Pending further developments, prescribers are still able to continue seeing new patients and prescribing controlled substances through real-time videoconferencing without the need for an in-person medical evaluation, as long as the prescriptions are otherwise legitimate and appropriate, and within the course and scope of the prescriber’s medical practice.
Finally, it is especially important to note that these requirements only address federal law under the Controlled Substance Act. Additionally, controlled substance prescribers must always:
- Ensure that they are properly licensed, or have legal practice authority, in the state in which the patient is physically located at the time of treatment or prescription.
- Be aware of and comply with state laws pertaining to controlled substances.
- Comply with all applicable standards of care, including conducting in-person evaluations when appropriate, even if not specifically required by law.
MIEC will continue to keep our members updated with additional developments on this important topic.