Are You Considering Offering Ketamine Treatment Services?
Ketamine has been used as an anesthetic in medical settings for decades, but in recent years, there has been increasing interest in the use of low-dose ketamine as a treatment for PTSD, depression, and anxiety. This interest has led to increased demand for ketamine clinics – specialized medical facilities that offer ketamine infusions as a treatment option for these conditions.
Our firm has experience helping clinicians wade through available regulatory guidance, licensing and supervision requirements, and other considerations in preparation for offering ketamine for the treatment of depression and other mental health issues.
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Who Can Own a Ketamine Clinic?
In Texas, ownership of a ketamine clinic is governed by Corporate Practice of Medicine (CPOM) doctrine. This doctrine limits who can open medical practices and provide medical services. Because ketamine treatment is considered the practice of medicine in Texas, the CPOM doctrine requires that ketamine clinics be owned by a licensed physician.
That said, many people can be involved in operating a ketamine clinic, including non-licensed physicians. In particular, a non-licensed physician may own a management company that provides physician-owned ketamine clinics with administrative services, provided it is properly structured.
Who Can Administer Ketamine?
A licensed physician with current unrestricted DEA registration (schedules II-V) can administer ketamine treatments. A physician can also delegate administration to a certified registered nurse anesthetist (CRNA). However, because ketamine is a scheduled drug, the physician must be present during the administration.
The Texas Medical Board has additional requirements that adhere with the American Society of Anesthesiologists’ Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who are Not Anesthesia Professionals. Physicians must also ensure that each administration of ketamine involves a documented therapeutic benefit for the patient.
Your healthcare attorney can guide you on Texas Medical Board and other regulatory requirements for the administration and supervision of ketamine treatments.
Is Ketamine an FDA-Approved Treatment for Depression?
Currently, the FDA has only approved ketamine as a sole anesthetic agent for diagnostic and surgical procedures (note: esketamine, a nasal spray, has been approved for use in treatment-resistant depression cases). This does not mean that it cannot be used, at the discretion of the administering or prescribing physician, for other non-FDA-approved indications (this is called off-label use).
Due to increased interest in ketamine’s off-label use possibilities, the American Psychiatric Association (APA) Council of Research Task Force on Novel Biomarkers and Treatments has released a consensus statement to help clinicians safely provide ketamine infusion therapy.
The APA guidance outlines key areas such as:
- Appropriate patient selection
- Suitable treatment settings
- Clinician experience and training
- Treatment plans
Which Licenses Do You Need to Open a Ketamine Clinic in Texas?
In Texas, only licensed physicians can own a ketamine clinic. Clinicians working under the supervision of a physician or anesthesiologist to monitor patients during moderate sedation can be a registered nurse or a licensed physician assistant.
There are no facility license requirements for ketamine clinics; however, the APA has made recommendations on how to appropriately equip and staff a ketamine treatment facility in its consensus statement. For example, clinical settings should provide sufficient means of monitoring the patient’s basic cardiovascular and respiratory function and provide for immediate care if necessary.
What Is the Best Structure & Entity Selection for a Ketamine Clinic?
How to structure your ketamine clinic will depend on the specific licensing held by the interested investors. Physician-owned clinics are frequently set up as PLLCs, while a non-physician-owned management services organization should typically be established as an LLC. At the same time, a management services agreement can establish a service relationship between the two entities.
Reminder: A management company established by non-physicians may only operate the non-clinical aspects of the ketamine clinic. This company may also provide nursing services to the clinic through an employment or independent contractor agreement. That said, the ketamine clinic itself must be owned by a licensed physician. That physician must also be responsible for all patient care and setting the fees for all medical services provided by the clinic.
Can Ketamine Be Administered via a Mobile Clinic?
The Texas Administrative Code does address mobile anesthesia providers in Rule §192.5. However, when the rules were written, the Texas Medical Board did not envision ketamine as a treatment for depression.
