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As I discussed in my October 2022 article1, the COVID-19 pandemic prompted the DEA to temporarily waive certain requirements of the Ryan Haight Online Pharmacy Consumer Protection Act. Traditionally, this Act required an in-person medical evaluation before a provider could prescribe controlled substances like ketamine via telemedicine. The pandemic waiver allowed clinicians to prescribe controlled substances after a two-way, real-time telemedicine visit, provided the prescription served a legitimate medical purpose and complied with state and federal law.

This flexibility fueled innovation in mental health care delivery. Clinics and telemedicine platforms began offering remote psychiatric evaluations and, in some cases, mailing oral or sublingual ketamine to patients’ homes. For many with depression or trauma resistant to conventional treatments, this was a lifeline.

The Pending Rule: Continuity or Change?

As of this writing, the DEA’s new rule is under review and not yet available for public comment. However, its title and timing suggest a likely extension of telemedicine flexibilities for controlled substances. If adopted, this would allow ketamine clinics to continue leveraging telehealth for patient care, at least for the near future.

But uncertainty remains: Will the extension be short-term or signal a pathway toward permanent reform? Will the requirements for telemedicine prescribing change? Clinic operators must be ready to adapt.

Key Considerations for Ketamine Clinics

  1. Stay Informed and Agile
    • Regulatory requirements are evolving. Clinics should closely monitor DEA announcements and state medical board guidance. Changes may come quickly, and compliance is non-negotiable.
  2. Review and Update Protocols
    • Ensure that telehealth prescribing practices align with the latest federal and state laws. This includes confirming that all practitioners are properly licensed, and that your clinic holds any necessary facility-level DEA registrations or pharmacy permits.
  3. Document, Document, Document
    • Detailed records are your best defense in the event of a DEA audit or legal challenge. Maintain comprehensive documentation of telemedicine visits, patient selection and informed consent, prescription records, and post-treatment monitoring.
  4. Prepare for Operational Risks
    • Clinics must guard against risks ranging from the corporate practice of medicine doctrine (which varies by state), to fraud and abuse laws, to medical malpractice liability. Written policies and regular staff training are essential.
  5. Patient Safety Remains Paramount
    • Telemedicine can expand access, but it also raises unique safety concerns. Clinics should have robust protocols for patient screening, emergency procedures, and post-treatment follow-up, especially when patients self-administer ketamine at home.

The Road Ahead

The ongoing extensions of telemedicine flexibilities reflect the growing recognition of mental health needs and the value of innovative care models. For ketamine clinics, these changes present both opportunities and responsibilities. By staying proactive – monitoring legal developments, updating operational protocols, and prioritizing patient safety – clinics can continue to serve those in need while minimizing legal risks.

As we await the final DEA rule, now is the time for clinic operators, legal counsel, and providers to work together to ensure ongoing compliance and quality of care.

  1. This article first appeared in the October 2022 issue of ABA Health eSource with the title “Legal Precautions for Owners and Operators of Ketamine Clinics.” ↩︎