Does A Licensed Physician Need To Be Present During Ketamine Infusions? 2023 Update
This blog was originally published July 5, 2021
Latest update: July 29, 2023
In this blog we’re going to explore the nuanced answer to the following question we get all the time: Do regulations require that a licensed physician be present at all times or any time an infusion is being performed?
DISCLAIMER: Please note that this post is not legal advice. We recommend seeking legal counsel in your state to gain clarity into rules, requirements, and regulations.
Ketamine infusions are relatively new in the medical space. So are there regulations as to who can perform them?
Are There Regulations On Who Can Perform Ketamine Infusions?
As of the writing of this blog, there are no defined mandated Federal regulatory requirements for how or who can perform ketamine infusions for off-label purposes and not for anesthetic purposes (Ketamine for Non-Anesthetic Indications - KNAI). If utilizing ketamine and treating patients with mood and pain disorders are within your scope of practice, then there may not be anyone stopping you from starting a ketamine infusion clinic.
The ketamine infusion industry is a relatively new one. Ketamine is an old drug with a long safe history, however using ketamine for treating pain and mood disorders is new. Since it is an old and already FDA approved medication, it has so far been able to circumvent the regulations. Much like the regulations that ketamine’s psychedelic cousins, MDMA and psilocybin, are and will be facing as these innovative treatments will be soon available to the public.
Is there a need for a licensed physical to be present at all times during an infusion? The answer isn’t a simple yes or no.
So Does A Licensed Physician Need To Be In The Clinic During The Infusion?
The simple answer is MAYBE.
There are no Federal regulations that we are aware of that require a licensed physician to be present at all times or any time during a ketamine for non-anesthetic indications, although it can vary state to state. And there are a few additional things to consider:
Regulations of who can own and operate a medical clinic can vary between states.
Ketamine is a controlled substance, requiring a DEA license.
If the physician is not providing the infusion themselves (aka not physically located in the clinic) the healthcare professional (such as a CRNAs, PA, NP, MA, etc) who is should only be practicing within their scope of practice. For example, an MA should not be starting medications or placing IVs.
The physician’s licenses are always on the line - as any healthcare professional working under them is doing so under the physician's supervision.
Some states allow advanced practice providers (APPs) to own, run, and operate their own practice without a physician, therefore negating the need for a licensed physician.
Understanding these above items, it’s up to you to determine how much risk you can tolerate, and how you want to run your practice.
A New Law in Utah: Is Change Is On The Horizon for Ketamine Clinics?
As of this blog update (7/2023) most states do not have any laws specifically targeting ketamine clinics. However a Utah law may change the game. This year in 2023, SB 197, termed as "Anesthesia Amendments," was passed. Basically, this law is mandating that any clinic administering ketamine, including for non-anesthetic purposes such as treating chronic pain and mood disorders, must have an advanced airway trained individual in the clinic instead of having one in each room that is administering ketamine. To be clear, having an individual with advanced airway training is not the new issue, but rather not requiring one in each infusion room.
What Does This Utah Law Mean In Terms Of Who Needs To Be Present During A Ketamine Infusion?
First off, if you aren’t in Utah it doesn’t mean much. However if you are in Utah and you don't have advanced airway training, well you may need to get some additional training or have someone who is trained on staff. The bigger issue is that the ketamine industry is growing. It is growing to the extent that laws specifically aimed at ketamine clinics are not something of the distant future. Rather it is something that could be coming to your state sooner than later.
Explore more about What Licenses You Need To Open A Ketamine Clinic plus this Utah Law at our blog.
Each clinic has a different practice regarding administering ketamine infusions. Is there a best option?
What Are Current Ketamine Infusion Clinics Doing?
There is a wide variation of what is actually practiced. Some clinics, like ours, have only the physician administering the ketamine infusions. Sam is trained in emergency medicine thus advanced airway trained. Others have the physician in the clinic but a CRNA or APP (NP/PA) administering the infusion, or the physician is available via phone.
The follow up question then is if there is a best option or best practice. Only you can truly answer it. For us, the best option and what we recommend to our students, especially when starting out, is to have the licensed physician present during the infusion. That being said, to answer this question yourself, we recommend thinking about what is best for the patient? As physicians, we have taken the Hippocratic Oath. To do no harm and to do what is best for our patients. Whichever option you take, we hope that you can confidently act in your patients’ best interest.
Do you want to learn how to start your own ketamine clinic or add ketamine infusions to your current practice? If you answer “yes” to either option, we have a course to help you! Join our email list and be notified about the next free webinar and open registration for Ketamine StartUp.
Related questions:
Given the variation in who administers ketamine infusions across clinics, how do I determine what staffing model will best suit my clinic, especially considering patient safety and comfort?
After identifying the parameters of what your state allows for medical practice (are you in a state where APP’s can practice without a licensed provider like Washington or not?), then it is really up to you. Here are a couple things to consider while you make your decision: Ketamine infusion therapy is a psychedelic therapy, meaning just keeping your patient physically safe during the infusion is NOT ENOUGH. Psychedelic therapy includes creating a safe and supportive environment plus addressing your patient’s mindset going into the infusion, plus the integration of their experience afterwards. You would do more harm than good if you don’t address the psychedelic aspect of ketamine therapy.
Considering the new law in Utah, should I anticipate similar changes in regulations in other states? How might I prepare for such changes?
Yes, anticipate but don’t let that hold you back from starting your ketamine clinic. While you are on the journey of starting and operating your ketamine clinic stay informed and you can do so by joining our mailing list. Also we have found the Psychedelic Law blog of Harris Bricken to be very informative and well written! FYI we enjoy their blog and have no financial relationship with them.
If you found this blog helpful, check these out too:
Who Can Start A Ketamine Clinic?
You may be wondering if only medical professionals can start a clinic. The short answer is that it depends. There are several factors, such as state regulations, that determine who can start a clinic. In our blog, we answer this commonly asked question!
What Licenses Do You Need to Open a Ketamine Clinic?
You’ve committed to start a ketamine infusion clinic! Now you may be wondering what licenses or permits you need. Our blog is here to help get you started.
Can My City's Population Support A Ketamine Clinic?
As ketamine and other psychedelics get more and more popular, more clinics are going to open up. Maybe you want to open one, but will your city's population support such an endeavor? Check out our blog where we explore the answer to this question.
Find out what the regulations and considerations are in determining if a physician is required to be present during a ketamine infusion here at our blog.
Learn the four critical techniques to ensure patients are both mentally and physically prepared for their sessions, contributing to the success of their care and your ketamine clinic.