Therapeutic ketamine has emerged as a beacon of hope for patients suffering from treatment-resistant mental health conditions such as depression and post-traumatic stress disorder. While its benefits are promising, health care providers must navigate a complex web of legal and regulatory requirements to offer ketamine therapy responsibly.
Understanding Ketamine’s Controlled Substance Status
Ketamine is a Schedule III controlled substance under federal law. While the U.S. Food and Drug Administration (“FDA”) approved use as an anesthetic is well established, its off-label application for mental health treatment falls under the purview of federal and state regulations.
This dual-layered regulatory framework presents a challenge for providers seeking to integrate ketamine therapy into their practices. To prescribe ketamine, a provider must be registered with the Drug Enforcement Administration (“DEA”). Additionally, the practice must also develop and meet strict requirements for secure storage, accurate record-keeping, and reporting to ensure compliance with federal laws.
Beyond federal regulations, states impose additional requirements to govern the administration of ketamine therapy. These vary widely, adding another layer of complexity. While some states have embraced ketamine as a therapeutic tool, others have implemented stricter oversight.
How Ketamine Therapy is Offered
Offering ketamine therapy is not as simple as administering a dose. Legally, it constitutes the practice of medicine, requiring adherence to well-defined protocols. Physicians must establish a valid doctor-patient relationship before prescribing ketamine, which involves conducting a thorough initial evaluation, documenting the patient’s condition, and obtaining informed consent. This process ensures that the treatment is medically necessary and that patients are aware of the potential risks and benefits.
Physician’s engaging in low-dose ketamine therapy should refer to the American Psychiatric Association’s Consensus Statement, which addresses issues such as patient selection and dealing with adverse reactions. While these are not binding guidelines, they provide good insight into the treatment if you are considering integrating it into your practice, and to confirm you are practicing within the standard of care.
In some states, physicians can delegate the administration of ketamine to nurse practitioners or physician assistants. However, this delegation often requires written agreements and supervision protocols to align with state laws.
Corporate Structure for Ketamine Clinics
For those considering opening a ketamine clinic, understanding ownership laws is critical. Some states have the Corporate Practice of Medicine (“CPOM”) doctrine. CPOM generally restricts non-physicians from owning medical practices or limits their ownership interest. The concept of this doctrine is designed to ensure that clinical decisions are driven by physicians using their medical expertise rather than non-physicians focused on business interests.
Management Services Organizations
Despite these restrictions, non-physicians can participate in the business side of ketamine clinics by establishing a Management Services Organization (“MSO”). An MSO handles administrative functions such as marketing, billing, and operations, leaving clinical decisions solely to licensed physicians. However, structuring an MSO requires careful planning to avoid inadvertently crossing legal boundaries.
Understanding Texas Ketamine Laws
Texas continues to be a significant hub for ketamine therapy, with recent regulations shaping the industry. Texas recently shifted to treat ketamine use as an anesthesia service. Anesthesia standards must consequently be followed for all ketamine treatments. The biggest impact of these changes in Texas is that a physician must be present to administer therapeutic ketamine.
Navigate Ketamine Therapy Regulations with ByrdAdatto
At ByrdAdatto, we help health care professionals understand therapeutic ketamine laws to build compliant, patient-focused practices. Our legal team can guide you through changing regulations so that providers can focus on delivering safe and effective care. Reach out to ByrdAdatto to learn how we can help you structure your ketamine clinic.
