Telehealth practitioners must take note of the DEA’s proposed rule making that would impact the way telehealth practitioners can prescribe controlled substances.

The Proposed Rule

On March 1, 2023, the United States Drug Enforcement Administration (the “DEA”) issued a notice of proposed rulemaking that would provide a variation of flexibilities for telehealth providers following the expiration of the Covid-19 Public Health Emergency (the “PHE”) on May 11, 2023.

The proposed rules stem from The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”). The Act states that no controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription requires a practitioner to have conducted at least one in-person medical evaluation of a patient before issuing a prescription for a controlled substance. One of seven exceptions to this rule, which telehealth practitioners have become accustomed to over the past three years, provides that no in-person medical evaluation is necessary if the telemedicine consult is conducted during a public health emergency.

In response to the PHE, Secretary Azar of the Department of Health and Human Services declared that DEA-registered practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of 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.

However, once the PHE expires on May 11^th, so will telehealth practitioners’ ability to rely on the exception to the Act.

            The proposed rules will not affect telemedicine consultations that do not involve the prescribing of controlled medications and telemedicine consultations by a medical practitioner that has previously conducted at least one in-person medical examination of a patient. The proposed rule, however, will apply where a medical practitioner has never conducted an in-person evaluation of a patient, and that results in the prescribing of a controlled medication.

Application of the Proposed Rule

            The DEA has provided a summary of the proposed rule and example scenarios for how telemedicine practitioners will be impacted. Some of these include:

1. A telemedicine consultation of a patient when a telehealth practitioner has not evaluated the patient in person, but who was referred by a medical practitioner that previously conducted an in-person evaluation of the patient. In this scenario, if a medical practitioner has conducted at least one in-person evaluation of a patient and subsequently refers the patient in the manner described in the rule, a telehealth practitioner may prescribe that patient any scheduled controlled medication via telemedicine, so long as the prescription is otherwise authorized by applicable Federal and State law.
2. A first-time telemedicine consultation that results in a prescription of a Schedule III-V non-narcotic controlled medication. Here, a telehealth practitioner may prescribe up to a 30-day supply of a schedule III-V non-narcotic controlled medication. To issue more than a 30-day supply, a practitioner must first conduct an in-person medical evaluation of the patient. This can include the patient’s in-person visit with another practitioner while on an interactive video link with the prescribing practitioner.
3. A first-time telemedicine consultation that results in a prescription for buprenorphine as medication for opioid use disorder. To issue more than a 30-day supply would require a practitioner to conduct an in-person medical evaluation of the patient. This can include the same process for the prescribing Schedule III-V non-narcotic controlled medication as mentioned above.

Comment Period and Final Rule

The comment period for the proposed rules closes on March 31^st and a final rule will follow sometime thereafter. Telehealth practitioners will still be able to rely on the public health emergency exception for 180 days from its expiration on May 11^th. To continue prescribing a controlled medication to a patient beyond 180 days from the end of the PHE, a practitioner must conduct an in person medical evaluation of the patient.

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