Little Health Law Blog
Many of our healthcare and business law firm’s clients have an interest in offering more flexibility to patients. Common flexibilities we see include offering alternative pay structures and virtual visits. Since COVID-19, the use of telemedicine visits has increased and remains higher than pre-pandemic levels. Complying with telemedicine rules requires analyzing federal, state, and payor requirements. Under the federal Ryan Haight Act of 2008, a prescribing provider may prescribe controlled substances only after an in-person evaluation. An exception to that rule is when the Secretary of the U.S. Department of Health and Human Services (“HHS”) declares a public health emergency (“PHE”). 21 C.F.R. § 1300.04(i)(4). During the COVID-19 PHE, the in-person requirement was waived. Although the PHE is over, the tele-prescribing flexibility for controlled substances remain. This post discusses the reasons why the DEA continues to allow the COVID-era flexibilities and what the Third Temporary Extension (issued November 19, 2024) does. If you have questions about tele-prescribing rules that may apply to your practice or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting https://www.littlehealthlaw.com/.
At the outset, here is a summary of the COVID-Era Flexibilities from the DEA’s March 20, 2020 press release, which our firm discussed in a previous blog post. DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, if all the following conditions are met:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and
- The practitioner is acting in accordance with applicable Federal and State laws.
Why Does the DEA Continue to Extend the COVID-Era Flexibilities?
The federal PHE expired on May 11, 2023. So why do the COVID-19-era flexibilities persist?
While the PHE was in effect, the DEA, with HHS, issued two proposed rules to take effect following the PHE: “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” and “Expansion of Induction of Buprenorphine via Telemedicine Encounter.” The two rules proposed to expand access to controlled substance prescriptions compared to the pre-COVID-19 strict in-person requirement “while maintaining effective controls against diversion.” The DEA received almost 40,000 comments to the proposed rules, many requesting changes to the proposed regulations.
To allow the DEA, with HHS, time to review the comments and determine whether and how to modify the rules, the DEA issued the First Temporary Extension on May 10, 2023. The first extension extended the COVID-19 flexibilities through November 11, 2023 with a one-year grace period through November 11, 2024 for any practitioner-patient relationship that was established before November 11, 2023.
Throughout 2023, the DEA continued to request and receive input concerning tele-prescribing and potential safeguards. On October 10, 2023, the DEA, with HHS, issued the Second Temporary Extension, which extended the full flexibilities through December 31, 2024, regardless of when the provider-patient relationship was established.
Throughout 2024, the DEA has continued to seek input and review of potential options to allow tele-prescribing with appropriate diversion safeguards. Meanwhile, the December 31, 2024 deadline was fast approaching.
What Does the Third Temporary Extension Do?
On November 19, 2024, the DEA, with HHS, issued the Third Temporary Extension to allow the DEA additional time to finalize regulations “that are consistent with public health and safety, and that also effectively mitigate the risk of possible diversion.” The DEA issued this one-year extension with the intent to also allow providers adequate time to come into compliance with the final regulations once published.
The takeaway is that providers that tele-prescribe controlled substances may continue to do so through December 31, 2025 and should stay alert for the DEA’s forthcoming rule. If you have questions about tele-prescribing rules that may apply to your practice or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting https://www.littlehealthlaw.com/.
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