The use of telemedicine to prescribe controlled substances has seen a dramatic increase in recent years, accelerated by the COVID-19 pandemic and subsequent temporary flexibilities in regulations. The future of these practices hinges on proposed regulations that aim to create a more permanent framework. On January 15, 2025, the U.S. Drug Enforcement Administration (DEA) released proposed regulations regarding telemedicine prescribing of controlled substances.
Key aspects of the proposed regulations include:
Special Registration Pathways:
The DEA has established three special registration pathways for telemedicine prescribing of controlled substances. These pathways aim to create a permanent framework for this practice, moving beyond the temporary flexibilities that were in place during the COVID-19 pandemic.
The three types of special registrations are:
- Telemedicine Prescribing Registration: Allows qualified clinicians to prescribe Schedule III-V controlled substances via telemedicine.
- Advanced Telemedicine Prescribing Registration: Allows qualified specialists to prescribe Schedule II-V controlled substances via telemedicine.
- Telemedicine Platform Registration: Allows online telemedicine platforms to dispense Schedule II-V controlled substances.
Requirements for Special Registration:
Healthcare providers and telehealth platforms will need to apply for these special registrations and meet certain eligibility requirements. These requirements may include:
- Demonstrating a “legitimate need” for registration.
- Meeting specific practice standards.
- Adhering to prescription information and documentation requirements.
- Conducting Prescription Drug Monitoring Program (PDMP) checks.
- Using audio-video technology.
- Complying with restrictions on Schedule II controlled substances.
- Reporting data to the DEA.
State Telemedicine Registration:
In addition to federal special registration, providers will generally need to obtain a separate State Telemedicine Registration for each state in which they treat patients.
Effect on Relationships Established with In-Person Encounter:
The proposed rules only apply to the limited circumstance where a clinician intends to prescribe a controlled substance and has never conducted an in-person medical evaluation of the patient prior to issuing the prescription. The proposed rules would not apply to clinician-patient relationships in which the patient has received a prior in-person medical evaluation from the clinician.
Effective Date and Transition:
Comments on the proposed regulations must be submitted by March 18, 2025. If finalized, the regulations are expected to take effect after the current temporary flexibilities expire on December 31, 2025. This provides a transition period for healthcare providers and telehealth platforms to prepare for the new requirements.
Implications and Considerations:
- If finalized, these regulations will significantly impact the practice of telemedicine prescribing of controlled substances.
- Healthcare providers and telehealth platforms will need to review the final regulations carefully and ensure they are complying.
- The proposed regulations aim to balance patient access to necessary medications with patient safety and the prevention of drug diversion and abuse.
If you have any questions about how this may affect your practice, please do not hesitate to reach out to Stuart Vogelsmeier, or any member of Lashly & Baer’s Health Care Advisory Team. The article can be found HERE in PDF form.
This summary and legal alert is an overview of the new developments in the health care industry. It is not intended to be, and should not be construed as, legal advice for a specific factual situation.