The COVID-19 pandemic accelerated the widespread adoption of telemedicine modalities, making healthcare more accessible to patients across the United States. In response to the pandemic and the need for remote medical consultations and treatments, the United States Drug Enforcement Administration (“DEA”) granted temporary exceptions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“the Ryan Haight Act”) allowing healthcare providers to prescribe controlled medications via telemedicine without the need for an in-person medical examination. On March 1, 2023, the DEA, in concert with the Department of Health and Human Services (“HHS”), announced two new Proposed Rules in advance of the conclusion of the Public Health Emergency (PHE) on May 11, 2023. The Proposed Rules kept some of the flexibilities granted during the PHE, but set forth a much more restrictive framework for prescribing controlled medications via telemedicine. The DEA received a record 38,369 public comments during the comment period. Due to the number of comments received, on May 9, 2023, the DEA issued a temporary rule entitled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” (“Temporary Rule”). The implications and benefits of this extension for patients and healthcare providers are significant.

Under the Ryan Haight Act, a prescribing practitioner – subject to certain exceptions – may prescribe controlled medications to a patient only after conducting an in-person examination of the patient. In response to the COVID-19 PHE, in March 2020, the DEA granted temporary exceptions under the Ryan Haight Act that allowed healthcare providers to prescribe schedule II to V controlled substances, and FDA approved schedule III to V narcotic controlled medications for maintenance and withdrawal management treatment of opioid use disorder to patients via telemedicine without the need for an in-person examination. The temporary flexibilities were issued pursuant to the PHE exception under the Ryan Haight Act (21 U.S.C. 802(54)(D)) and were initially intended to last only for the duration of the PHE. The Proposed Rules issued by the DEA in advance of the conclusion of the PHE maintained some flexibility but were far more restrictive than the flexibilities in place during the PHE. Due to the record number of public comments, and to ensure that patients can continue to receive necessary medications without incurring unnecessary risks, the DEA decided to issue the Temporary Rule while it continues to carefully evaluate the comments received.

The Temporary Rule took effect on May 11, 2023, and extends the full set of telemedicine flexibilities adopted during the PHE for 6 months (through Nov. 11, 2023). The Temporary Rule, issued pursuant to 21 U.S.C. §802(54)(G), aims to ensure that patients can continue to receive their prescriptions for controlled medications without the need for in-person visits. This includes medications such as opioids, stimulants, and sedatives, which are essential for many patients dealing with chronic pain, ADHD, and anxiety disorders. Significantly, for any practitioner-patient telemedicine relationship that has been or will be established on or before Nov. 11, 2023, the full set of COVID-19 PHE telemedicine flexibilities regarding prescription of controlled medications will be extended for a one-year grace period – through Nov. 11, 2024. In other words, if a patient and practitioner establish a telemedicine relationship on or before Nov. 11, 2023, the same telemedicine flexibilities that governed the relationship up to that point are permitted until Nov. 11, 2024. Under the Temporary Rule, a practitioner and a patient have a telemedicine relationship established via COVID-19 telemedicine prescribing flexibilities if: (1) the practitioner has not conducted an in-person medical evaluation of the patient; and (2) the practitioner has prescribed one or more controlled substances to the patient. The full text of the Temporary Rule can be found here.

This extension benefits not only patients, but also healthcare providers by allowing them to continue providing essential care remotely. This is particularly important as the healthcare system continues to adapt to the evolving landscape as the PHE concludes and prioritizes reducing the risk of exposure for both patients and providers.

Benefits of Telemedicine for Controlled Medications:

1. Increased access to care: Telemedicine allows patients in rural or remote areas to receive prescriptions for controlled medications without the need for long-distance travel. This can be particularly beneficial for those with limited mobility or transportation options;

2. Reduced exposure risk: By receiving their prescriptions via telemedicine, patients can avoid crowded waiting rooms and potential exposure to the virus;

3. Cost-effective healthcare: Telemedicine appointments can be more cost-effective for both patients and healthcare providers, reducing the overall cost of healthcare;

4. Improved patient adherence: Telemedicine can make it easier for patients to receive their prescriptions, increasing the likelihood that they will take their medications as prescribed; and

5. Enhanced privacy: Some patients may feel more comfortable discussing sensitive health issues via telemedicine rather than in person, leading to more open and honest communication with their healthcare providers.

The temporary extension of COVID-19 telemedicine flexibilities for prescriptions of controlled medications is a necessary measure to ensure that patients continue to receive essential care. According to the DEA, the “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 allowing 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.” DEA plans to issue one or more final rules based upon the two Proposed Rules published in March 2023. We should expect that the final rules will be more restrictive than the full set of flexibilities granted under the COVID-19 PHE. Telemedicine providers must continue to prepare for the end of the Temporary Rule (Nov. 11, 2023) and the one-year grace period (Nov. 11, 2024).