DEA Announces Three New Rules Expanding Telehealth Access

Last month, the DEA announced three new rules to permanently expand telehealth prescribing of controlled substances while implementing safeguards against misuse. These rules, which aim to make permanent the telehealth prescribing flexibilities introduced in response to the COVID-19 pandemic, mark a significant step forward in expanding telemedicine practices. Understanding these rules is crucial for telehealth providers, both to understand new federal guidelines for prescribing substances via telehealth and to stay abreast of key regulations that are on the horizon.

The Final Rules

Expanding Access to OUD Treatment Medications

Among the final rules, one has the potential to significantly improve access for patients undergoing treatment for opioid use disorder (OUD). Effective February 18, 2025, qualifying providers may prescribe up to a six-month initial supply of Schedule III-V medications, including buprenorphine, via audio-only telemedicine appointments. After six months, an in-person evaluation is required for additional prescriptions. The Final Rule eliminates the initial in-person visit requirement that was in effect prior to the COVID-19 pandemic, making OUD treatment more accessible for patients in rural or underserved areas.

Providers who treat OUD must meet certain requirements to take advantage of this prescribing flexibility. Among other requirements, the provider must be registered with the DEA and must review the Prescription Drug Monitoring Program (PDMP) data for the state in which the patient is located at the time of the telehealth appointment. The date and time of the review must also be noted in the patient’s electronic or paper health record.

While the Rule creates substantial flexibility for providers at the federal level, providers who treat OUD should take caution. Many states impose stricter prescribing requirements for controlled substances, and compliance with both federal and state laws is required to avoid legal risk and prioritize patient safety.

Continuity of Care for Veterans Affairs (VA) Patients

The second Final Rule imposes additional flexibilities for VA patients and providers alike. Under the DEA’s new rule, providers treating veterans may prescribe controlled substances via telemedicine without an initial in-person evaluation if the patient was previously evaluated by a VA practitioner. Further, VA providers are deemed exempt from Special Registration requirements in order to prescribe controlled substances via telemedicine, ensuring that veterans maintain uninterrupted access to necessary medications.

As with the OUD Final Rule, providers must thoroughly review the patient’s history with controlled substances, including the patient’s electronic health records and state PDMP, before prescribing any medication. The Rule also imposes strict documentation requirements, signaling that patient safety remains a top priority of the DEA.

The Proposed Rule: Special Telemedicine Registrations

Finally, the DEA’s Proposed Rule signals what may lie ahead for the future of registration for telehealth providers. The Proposed Rule introduces a new special registration process, a type of registration that, if granted, exempts providers from the Ryan Haight Act’s initial in-person evaluation requirement for prescribing controlled substances. The Rule proposes three types of special registrations:

• Telemedicine Prescribing Registration: The Telemedicine Prescribing Registration would authorize physicians and mid-level board certified practitioners providers to prescribe Schedule III-V medications remotely without an in-person visit.
• Advanced Telemedicine Prescribing Registration: The Advanced Telemedicine Prescribing Registration would permit certain specialists, including psychiatrists, hospice care physicians, pediatricians, and neurologists, to prescribe Schedule II-V medications.
• Telemedicine Platform Registration: Qualified covered online telemedicine platforms that facilitate telemedicine prescriptions would be eligible for a Telemedicine Platform Registration, allowing such platforms  to prescribe Schedule II-V medications virtually. Under the Rule, a “covered online telemedicine platform” is an entity that: (i) facilitates connections between patients and mid-level and physician practitioners via audio-video communications that may result in prescribing controlled substances, but is not a hospital, clinic, local in-person practice or insurer; and (ii) **satisfies at least one of the following criteria:
  • promotes or advertises the prescription of controlled substances through the platform;
  • has direct or indirect financial interests in volume of controlled substance prescriptions (including, e.g., ownership interest in pharmacies used to fill prescriptions);
  • exercises control or influence on clinical decision-making processes or prescribing related to controlled substances (e.g., prescribing guidelines or protocols); or
  • has control or custody of prescriptions or medical records of patients who are prescribed controlled substances through the platform.

Notably, providers that qualify and receive a special registration must still obtain a state telemedicine registration for every state in which a patient is treated, unless an exception applies. Additionally, providers working under special registrations are subject to heightened requirements governing their prescribing practices, including stricter geographic limitations, restrictions on the telehealth modality used in appointments, and increased recordkeeping and reporting obligations.

The DEA is currently accepting public comments on the Proposed Rule through March 18, 2025. If finalized, the Rule could significantly reduce the registration burdens providers face in virtually prescribing medications across state lines.

Key Considerations for Healthcare Providers

These rules signal significant changes to the delivery of telemedicine, providing insight into what’s to come for telehealth regulations in 2025. For many providers, these rules are unlikely to impact their day to day practice, as the Final Rules are tailored to specific services and provider types. Further, while the Proposed Rule imposes significant changes to the registration process for providers, the Rule is unlikely to be finalized until 2026 at the earliest.

However, these rules are a reminder of the compliance complexities of telehealth. Navigating both state and federal requirements remains a significant challenge, and one that can present serious legal risk for providers if not addressed appropriately. While the federal guidelines impose greater flexibility for prescribing many controlled substances remotely, many states, like Ohio, impose stricter buprenorphine limits than federal rules. Thus, it’s imperative that providers have a thorough understanding of the regulations governing controlled substance prescribing in their  states to ensure that prescriptions are appropriately written.

Additionally, providers will need to ensure that patients receiving controlled substances via telehealth understand the limitations of virtual prescribing. Practices should ensure that staff are trained on educating patients about these limitations and update patient consent forms to reflect same.

Conclusion

The DEA’s rules modernize telehealth access while reinforcing safeguards. The expansion of buprenorphine prescribing, exemptions for VA providers, and the potential for new regulations governing telemedicine provider registrations, stand to significantly improve access for patients. For providers, compliance with these new regulations requires concrete strategies to adapt, careful monitoring of patients’ prescription patterns, and a thorough understanding of both federal and state-specific laws on controlled substance prescribing practices. Our team at Health Law Alliance helps telehealth providers align their practices with new regulations, ensuring seamless care delivery for patients and reducing providers’ legal risk.

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