Are Federal Agencies Coming for Ketamine Clinics?

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Joshi is a physician. Chapman is a federal criminal defense attorney.

Could existing pills for certain manifestations of mental health disorders soon become old-fashioned approaches to treat such things as PTSD, depression, anxiety, and even chronic pain?

The potential replacement: ketamine, and the clinics popping up everywhere to serve it.

Ketamine clinics have gained popularity in recent years by offering ketamine infusion treatments to patients suffering from debilitating mental health disorders. Some patients may seek out these services to avoid the side effects of other more commonly prescribed drugs, or in cases when their mental health condition is seen as “treatment-resistant” — ketamine’s fast-acting properties make it an attractive option for patients who have not responded well to traditional treatments.

The public response has been nothing less than explosive: Ketamine therapies have now become a $3.1 billion industry, with nearly 50% of the market maintained online as telehealth services.

However, the lack of rigorous scientific research — compared to other treatment modalities — supporting its long-term effectiveness and safety has raised eyebrows among medical professionals. Only one ketamine product is FDA-approved for treating mood disorders — the nasal spray esketamine (Spravato). It’s specifically indicated for use in conjunction with an oral antidepressant for adults with treatment-resistant depression, and it’s only available through a Risk Evaluation and Mitigation Strategy (REMS) program. Yet, that hasn’t stopped many clinics from jumping ahead of the evidence. Now, other eyebrows are being raised: notably, among regulatory authorities. Agencies — the FDA and the Department of Justice (DOJ) — are starting to ask questions.

First in February 2022 and then again in October 2023, FDA issued cautionary statements regarding the potential risks associated with the utilization of compounded ketamine, warnings that should be seen as the first red flag waved at providers who offer the treatment. Compounded medications are sourced from independent pharmacies and used off-label, or in ways that are not directly approved by the FDA. Ketamine providers that operate through telemedicine are a source for compounded ketamine supplied to patients. Notably, telehealth providers are also increasingly becoming targets in government healthcare investigations.

The FDA’s warnings are underscored by reports of negative incidents linked to off-label usage of ketamine, which has led to heightened risks of severe psychiatric reactions. Ketamine use can also lead to other health complications: hypertension, respiratory dysfunction, and serious urinary tract issues including incontinence.

It bears repeating that ketamine clinics should view the FDA’s warning as a bellwether for potential regulatory action. The DOJ has already begun taking action against individual physicians.

Just a few months ago, two St. Louis-based physicians running a ketamine clinic were jointly indicted on an array of felony charges ranging from allegedly conspiring to commit healthcare fraud to dispersing controlled substances illegally.

Last year, a physician who built a nationwide ketamine telemedicine practice was shut down by the Drug Enforcement Agency (DEA).

The timing of this is not by any means random. The increasing vigilance over ketamine clinics can largely be attributed to its escalating popularity. Within the healthcare sector, such trends tend to evoke scrutiny as the popularity of a particular patient model or therapeutic modality burgeons. Consider Medicare Advantage plans, which gained significant traction in recent years — today, they face an unprecedented level of inquiry from federal regulators. Ketamine clinics and their operators should anticipate a similar trajectory.

Some argue that ketamine clinics provide a much-needed alternative for individuals who have exhausted other treatment options. For patients who have suffered from treatment-resistant depression or chronic pain, ketamine infusions have shown promising results, providing them with relief and a renewed sense of hope.

Yet, ketamine-clinic critics express concerns regarding the absence of standardized protocols and guidelines. Without a clear framework in place, there exists a high risk that some clinics may prioritize profit over patient safety, potentially exposing individuals to unnecessary harm — especially when ketamine therapies are offered online without a physician’s proper oversight and care.

Additionally, the misuse and abuse of ketamine, both in and outside of these clinics, further compounds these concerns.

Ketamine is a powerful dissociative anesthetic that can induce hallucinations and alter perception. When used outside of its intended clinical scope, ketamine can have serious consequences for individuals’ physical and mental health. It carries the risk of addiction, psychosis, and cognitive impairments. The lax regulations within many ketamine clinics could inadvertently contribute to the accessibility and diversion of this potent substance, increasing the chances of misuse and addiction.

In order to address these concerns, it is crucial that ketamine clinics implement a robust compliance system. Establishing standardized protocols, training requirements for medical professionals, and monitoring systems can help ensure that these clinics deliver safe and effective care to patients. Additionally, public awareness campaigns and educational initiatives can help inform people about the risks associated with ketamine misuse and abuse.

Health associations and regulatory bodies are looking closely at the practices and operations of ketamine clinics across the country. Their aim is to ensure that these clinics are adhering to proper medical standards, and this increased scrutiny could potentially lead to stricter regulations, including mandatory training and certification for ketamine providers, as well as more frequent inspections and oversight.

The cost of building a framework for compliance upfront is far more economic than doling out legal fees to attorneys to adjudicate regulatory compliance in court.

As the medical community continues to explore the benefits and risks of ketamine treatment, regulators and healthcare professionals should find ways to work together to establish clear guidelines and standards. Only then can we ensure that ketamine therapy continues to be a viable option for those in need.

Jay K. Joshi, MD, is a practicing physician and entrepreneur in Northwest Indiana. He is also an advocate for physicians to ensure they receive proper due diligence in civil and criminal litigation. He is the author of the book Burden of Pain, and he regularly blogs on his site, Daily Remedy. Ron Chapman II, JD, LLM, is a federal criminal defense attorney and president of Chapman Consulting Group.

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