DEA Extends Prescribing Flexibilities Until 2025

The Drug Enforcement Administration (DEA) announced a second extension of the temporary Covid-era exceptions to the Ryan Haight Act requirements for prescribing controlled substances. 

In the text of the new temporary rule, announced October 6, 2023, the DEA put forth the details of the new, second temporary rule that extends prescribing flexibilities first allowed under the public health emergency (PHE). This second extension gives practitioners and patients certainty on DEA telemedicine prescribing through at least the end of 2024. 

DEA Temporary Rule Timeline:

From April 2009 to March 2020, federal law required physicians and providers to have an in-person visit with a patient prior to prescribing any controlled substances for that patient.   

Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), in-person evaluation, conducted by the prescriber, is required before any controlled substances may be prescribed, with very limited exceptions. 

One of those exceptions under the Ryan Haight Act includes public health emergencies declared by the Secretary of Health and Human Services (HHS). With the federal PHE set to expire May 11, 2023, the DEA needed to address the real-world implications of ending an exception so abruptly, creating what many are calling a “prescribing cliff” for patients and providers who have come to rely on the PHE exception. 

On May 10, 2023, the DEA issued an extension of the telemedicine prescribing flexibilities through November 10, 2023 (first extension). 

The First Temporary Rule-May 2023:

While the language of the May extension is more technical, here were the effects:

The full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE would remain in place through December 31, 2024. Most significantly, under the PHE flexibilities:

1. in-person visits were not required before prescribing or administering controlled substances; and
2. Providers were not required to obtain additional state DEA registrations in the state where the dispensing occurs (including prescribing AND administering.

In the words of the DEA:

• Under the Controlled Substances Act (CSA), a prescription for a controlled substance issued by means of the Internet must generally be predicated on an in-person medical evaluation. See 21 U.S.C. § 829(e)(1). This requirement does not apply, however, when a practitioner is practicing telemedicine as defined by the CSA. The CSA’s definition of the practice of telemedicine includes multiple different categories of telemedicine. For several of these categories, the CSA specifically requires a practitioner to have a DEA registration in the state in which the patient is located. See, e.g., 21 U.S.C. § 802(54)(A), (B). But the practice of telemedicine during a public health emergency pursuant to 21 U.S.C. § 802(54)(D) does not include this requirement. On March 16, 2020, the Secretary of the United States Department of Health & Human Services, with concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States.
• DEA-registered practitioners are not required to obtain additional registration(s) with DEA in the additional state(s) where the dispensing (including prescribing and administering) occurs, for the duration of the public health emergency declared on January 31, 2020, if authorized to dispense controlled substances by both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs. Practitioners, in other words, must be registered with DEA in at least one state and have permission under state law to practice using controlled substances in the state where the dispensing occurs.

The Second Temporary Rule-October 2023:

On August 7, 2023, DEA announced that it would host Telemedicine Listening Sessions on September 12 and 13, 2023 to receive additional input concerning the practice of telemedicine with regards to prescribing controlled medications and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. 

The DEA and HHS, with the publication of this Second Temporary Rule are stating that they need more time to develop updated regulations that will allow prescribing of controlled substances through the practice of telemedicine while also effectively mitigating the risks that caused the passage of the Ryan Haight Act in the first place. 

The Second Temporary Rule extends the full set of telemedicine flexibilities, including the language above, regarding prescription of controlled medications as were in place during the COVID–19 PHE, through December 31, 2024. This extension authorizes all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023-when the First Temporary Rule was scheduled to lapse. 

Conclusion and Key Takeaways

DEA is working to promulgate new standards or safeguards by the fall of 2024. Industry insiders are expecting at least one more extension into 2025. 

Keep in mind that all prescriptions issued under these exceptions are still subject to continuing requirements, including the requirements that were in place during the COVID-19 PHE:

• First, the prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
• Second, the prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3)—that is, audio and video equipment permitting two-way, real-time interactive communication or, for prescriptions to treat a mental health disorder – which include, but are not limited to, prescriptions for buprenorphine for opioid use disorder – a two-way, real-time audio-only communication if the distant site physician or practitioner is technically capable of using an interactive audio-video telecommunications system, but the patient is not capable of, or does not consent to, the use of video technology.
• Third, the practitioner must be authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled medications specified on the prescription or exempt from obtaining a registration to dispense controlled medications under 21 U.S.C. 822(d).
• Fourth, the prescription must be consistent with all other requirements of 21 CFR Part 1306.  

In the meantime, DEA bought itself time to review public comments on its first attempt at rulemaking and anticipates the implementation of a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion.  The stated goal of this temporary rule is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as to allow adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in one or more final rules. 

Final Thoughts

Due to the temporary rule, Providers do not need to see patients in-person before prescribing most controlled substances through at least December 31, 2024. 

Prescriptions still must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, among other requirements.

This does allow telemedicine providers some additional flexibility for prescribing controlled substances while still observing laws around state licensing for telemedicine.