Understanding the DEA’s New Telemedicine Rules: FAQ for Healthcare Providers and Telehealth Companies

The U.S. Drug Enforcement Administration (DEA) recently announced new rules that will impact telemedicine practices, especially concerning remote prescribing of controlled substances.

A proposed rule includes new special registration classes to prescribe Section II-V substances (the Proposed Rule), and two final rules include expanded ability to prescribe buprenorphine and continuity of care for Veterans Affair patients. These rules will only apply if a patient has never been seen in-person by the prescribing medical provider and the patient is being prescribed controlled medication.

This FAQ aims to provide healthcare providers and telehealth companies with a high-level understanding of these changes and their implications.

Background: The Ryan Haight Act and COVID-19 Flexibilities

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) provides that a medical provider may only dispense controlled substances via telemedicine with a valid prescription issued after an in-person medical evaluation of the patient.

However, the Ryan Haight Act also provides certain exceptions to the in-person medical evaluation requirement, including when the prescribing activity takes place during a public health emergency (PHE).

During the COVID-19 PHE, the DEA issued waivers temporarily permitting medical providers to prescribe controlled substances via telemedicine without an in-person medical evaluation. After three extensions of the waivers, these temporary flexibilities are currently in effect through 2025.

Now, the DEA’s Proposed Rule, described below, allows for some of these flexibilities to permanently continue.

What types of special registrations are required under the Proposed Rule?

The Proposed Rule sets out more rigid registration requirements, and special registration classes as a pathway for medical providers to prescribe controlled substances via telemedicine:

• Telemedicine Prescribing Registration: Authorizes medical providers to prescribe Schedule III-V controlled substances to patients without ever having an in-person medical evaluation.
• Advanced Telemedicine Prescribing Registration: Authorizes board certified medical providers (psychiatrists, hospice care physicians, physicians rendering treatment at long term care facilities, and pediatricians) to prescribe Schedule II-V controlled substances to patients without ever having an in-person medical evaluation.
• Telemedicine Platform Registration: Requires telemedicine platforms that facilitate connections between patients and medical providers that result in medication prescriptions to register with the DEA.
• National PDMP: Requires the establishment of a national prescription drug management program (PDMP) to provide pharmacists and medical providers with visibility of a patient’s prescribed medication history.

What additional requirements are being considered for prescribing Schedule II controlled substances?

The DEA is seeking public comment on potential additional safeguards to the Advanced Telemedicine Prescribing Registration (under the Proposed Rule), including:

• Requiring medical providers to be physically located in the same state as the patient when prescribing Schedule II controlled substances.
• Requiring medical providers to limit their telemedicine prescriptions for Schedule II controlled substances to less than 50% of all of such provider’s prescriptions for Schedule II controlled substances.
  • Mandating the presence of a minor’s parent or guardian during the prescription process for minors.

How are online buprenorphine prescriptions changing?

The first final rule expands buprenorphine treatment via telemedicine and will allow patients to receive a 6-month supply of buprenorphine, a medication used to treat opioid use disorder, through an audio-only or audio-video telemedicine consultation with a provider.

Under the rule:

• DEA-registered providers must review the PDMP database of the state where the patient is located.
• An initial six-month supply of buprenorphine can be prescribed, divided across several prescriptions.
• Subsequent prescriptions require either an in-person medical exam or meeting one of the seven exceptions under the Ryan Haight Act.

How will these rules impact Veterans Affairs practitioners?

The second final rule exempts Veterans Affairs (VA) practitioners from special registration requirements, allowing patients to receive continued care through virtual visits with other VA prescribers after a single in-person encounter.

The aim of this rule is to:

• Ensure consistent and flexible access to care for veterans regardless of geographic location.
• Maintain continuity of care through the VA system.

What impact will these new rules have on healthcare providers and telehealth companies?

If the Proposed Rule is adopted as is, online telemedicine platforms will need to register with the DEA to facilitate the prescribing of controlled substances. In doing so, they’ll need to adhere to strict security and privacy standards while complying with both federal and state clinical guidelines. The DEA believes this will help ensure a safer and more regulated environment for the delivery of telehealth services.

These new regulations will introduce more compliance burdens on healthcare providers, requiring careful planning for transactions and operations, which will lead to higher administrative and maintenance costs.

Healthcare providers might face some challenges due to the limited ability to prescribe certain controlled substances without an in-person visit. Furthermore, the new registration requirements and the need to follow enhanced security and reporting standards will demand meticulous attention and robust systems to ensure everything is compliant.

What is the timeline for implementing the new rules?

The two final rules will be effective February 18, 2025. The Proposed Rule is expected to take effect following the expiration of the COVID-19 flexibilities on December 31, 2025.

Stakeholders have until March 18, 2025, to submit comments on the Proposed Rule. If you have comments, you can submit them here.