I thought I would update everyone on some recent developments that were discussed at ISNR, which may be of interest/concern to many. There was an impromptu meeting held the first night, which was very enlightening for those of us who know little about FDA and State regulations concerning neurofeedback and the devices we use. As some of you may have heard, there is a FNS or FLEXYX (which is an earlier version of the LENS) practitioner in Maryland, Mary Lee Esty, PhD, who was given a Cease and Desist order by the State Medical Board in Maryland. This is an experienced and respected practitioner who has conducted impressive research on head injury and fibromyalgia using this method. She brought her attorney, Rick Jaffe, who specializes in defending Alternative Medicine practitioners, to the meeting to address the 40 or so of us who attended this unscheduled meeting.I will attempt to recap what he said using direct quotations whenever possible. I had Mary Lee look this over and make changes and she sent it to Rick Jaffe who edited it also. So this is as close to “the horse’s mouth” as we can get. I know it is long but we think it is important for all of us to hear. Feel free to circulate widely among any other list serve.
The meeting started off by Rick Jaffe asking how many of us were licensed MDs (no hands went up). He then asked how many were licensed as psychologists (a few hands went up). Then he asked how many were licensed as social workers or counselors (most of the hands went up). Then he asked how many were not licensed in anything (about 3 hands went up). He said something to the effect of “Well, you unlicensed folks do not have a leg to stand on in the event that something like this happens to you”, and went on to say how if even an experienced, licensed clinician can get into trouble, then it could happen to anyone.
Mary Lee told us how the complaint was filed – long story but suffice it to say that she did everything correctly, and The Board of Social Work as well as the BCIA cleared her of practice charges. (It is important to note that the client was so pleased with the FNS treatment that she wanted to work in Mary Lee’s office.) However this client had charged that the Neurofeedback (Flexyx Neurotherapy System–FNS) constituted the practice of medicine. So the SW board referred that point to the Board of Physicians that, without getting any other information, sent a Cease and Desist letter. There was also no mention of the right to a hearing or other recourse. The attorney indicated it was unusual for such drastic action to be served on a licensed professional. He stated, “Once something like this happens in one state, it will start in other states as well.” MDs want to assert control over aspects of our field even though they do not practice this specialty, as evidenced by the lack of MDs at this meeting and the small representation in the professional bio/neurofeedback organizations.
Rick explained that there are two levels of government that affect us- 1) The Feds which have the FDA which governs only drugs and devices and their manufacturers (not the clinicians) and 2) State Boards of Health Professions which govern the practice of all licensed providers of health services, and the State’s Attorneys General that govern unlawful and criminal acts of non-licensed and licensed providers. He advised us that, according to most State Medical Boards, “anything we do to alleviate any type of suffering” is considered by them to be practicing medicine without a license. The definitions of the practice of medicine are extremely broad, giving those Boards wide scope for taking action.
He strongly recommended that we licensed professionals change any written statements on our websites and promotional materials to read that we treat the symptoms of ADHD, Autism, depression, etc. It is very important to know our state’s definition of scope of practice with the licensure. We cannot state that we treat ADHD, depression, etc. unless we are an MD. Anyone else claiming to directly treat these disorders is opening themselves up for trouble with the Medical Boards unless their state licensing board gives the practitioner to right to diagnose and/or treat certain kinds of conditions. Even then, the Boards can still try to go after the practitioner. We can say that we treat the symptoms of various conditions that we are otherwise licensed to deal with. And then he said that all non-licensed folk can ever state is that all they do is “have clients come in for a social visit to pass the time” and cannot imply even indirectly that they have anything to do with clinical populations. The reason for being careful is that Rick related that even winning a fight with the medical board or a state attorney general is still losing. They are expensive, time consuming and emotionally draining proceedings.
What may ultimately protect this practitioner is her license, as most of these devices state somewhere that they are only to be used or dispensed under the care of a licensed health provider. Also, Maryland law gives her the right to diagnose and treat basically any disease listed in DSMIV.
The Board’s concern is whether any kind of brain stimulation constitutes the practice of medicine. The Board made this conclusion without any specific information or public hearing, and without Mary Lee being able to offer any evidence to the contrary. However, Rick and Mary Lee are going to be fighting this determination. In fact that will be the central issue in an administrative law case, if it comes to that. This charge about stimulation was met with a lot of dissent stating that the LENS/FLEXYX’s radiated power is so miniscule as to be almost undetectable, and certainly far less than that involved in a device such as the Alpha Stim. To this point Jaffe responded that the FDA cares only about the intended use. They don’t care about regular frequency-based neurofeedback devices or peripheral neurofeedback devices, all of which involve the display of biological information for the volitional control by the client- so most of us are safe with these. The FDA does not care what the individual providers do as they only regulate devices and drugs and the manufacturers that build them and sell them.
It is the State Boards and Attorneys General however, that go after the providers using the devices illegally (unlicensed folks treating clinical populations or licensed practitioners using devices off label and outside of their scope of practice). The device manufacturers are limited only to the use for which the FDA has approved their devices. But these devices (he mentioned Class I, II, and III) can be used off-label by the providers as long as it is within their scope of practice to do so. He used the example that, according to the FDA, we can use neurofeedback devices to treat cancer but the manufacturer cannot say this. It is the intended use by the manufacturer that is an important issue for the FDA. And even though the FDA doesn’t care if devices are used off label, it is the State Boards of Health Professions that will get us if we claim to treat something we are not authorized or competent to treat. Most of these cases come to light after a client complains. The risk to the patient is what both the FDA and the State Boards are most concerned with. And it is the State Medical Boards in particular, who are the most aggressive and have the most restrictive definitions of what constitutes the practice of medicine.
This led to the discussion to the importance of the definition of biofeedback. Our profession has no agreed-upon definition of the interventions that constitute biofeedback and neurofeedback. He recommended we not limit ourselves to the volitional control of psychophysiological mechanisms and recommended that our profession band together and come to a broader more inclusive consensus as to what the definition is while being mindful that FDA definitions change over time and could become more restrictive. Given the technological changes that are taking place now in the field, HRV, HEG, and the recent reintroduction of Direct Current Stimulation, the field should be looking to the future in anticipation of technological advances, and define the field broadly. “If you don’t do it, someone else will and you’ll be stuck with that definition.” The attorney mentioned that in the current administration, there may even be less emphasis on going after manufacturers (the FDA has recently downsized significantly) and may be less focused on the consumer and but that this climate may indeed change with a new administration which could be more consumer-based and less tolerant of unsafe business practices.
Several types of interventions were mentioned – the Alpha Stim, for example. This manufacturer was used as a good example of how to get full FDA approval and be above reproach by the FDA. Dan Kirsch, the inventor of the Alpha Stim has obtained Class II and III medical device status on all his devices which means that he can sell only to licensed health providers although I stated that I don’t know of any State Board that would allow any non-MD to put electrical voltage in one’s client. So it behooves us to be aware of what the scope of our particular license allows us to do. Even though Alpha Stim is the ONLY version of Cranio-electrical stimulation (CES) device to have full FDA approval for their machines, it is up to the provider to use it legally. Using any other type of invasive device that has no FDA approval is an even bigger problem than using an approved one- you are skating on thin ice using an invasive non-approved device if you are not an MD. Even with an FDA approved device like the Alpha Stim one could end up in hot water if they are not an MD (who are the only ones legally allowed to put currents in brains, according to most State Boards). If you are not sure what you are allowed to do, you should ask your licensing board.
At the conclusion of the meeting, it was decided that some leaders in our field should convene to define a broader scope of practice for the licensed professionals who provide biofeedback to include the “invasive” methods as defined by the members of the biofeedback societies. Rick told of how initially the MDs took control of the acupuncture field in Texas, only to find that very few MDs provided this service so this action was deemed illegal by the state. They then broadened the scope to include a new profession of Licensed Acupuncturists which has made this service more accessible to the public.
Another example in the other direction was how one profession—the colonic irrigators in Texas—was literally wiped out (no pun intended). There were a few injuries/deaths associated with this so they no longer allow the practice of this in Texas due to the medical intervention of this field. So we need to have a united front and approach our State licensing boards of Social Work, Counseling and Psychology to broaden our scope of what biofeedback is in order that we can continue to provide LENS, CES and other modalities and allow for technological innovations yet to be developed. If other non-MDs (chiropractors and Licensed acupuncturists, for example) can do invasive work, we should be able to expand our use of technologies as well since there are virtually no MDs doing neurofeedback even tho they may want to “assert jurisdiction” over our field.
So in closing, I will relate an interesting discussion I had with Dan Kirsch (Alpha Stim inventor). He mentioned that he had heard from several folks who’d attended this meeting and that after going through all the time, effort and expense to get his products FDA registered, he is well aware of how the FDA thinks. He said with regard to invasive devices such as CES, FDA equates any unregistered device as equivalent to a street drug. One needs to play by the rules in order not to run into trouble. If you are secretive about how your machines work, if they are not manufactured in an FDA-approved facility and if you have not at least done studies demonstrating safety, then these devices and the practitioners who use them all run the risk of getting shut down. He used the example of speeding in your car and being pulled over and asked for the registration of the car and your license to operate it. If you produce these documents, you are maybe given a warning or fine and sent on your way. If you have no registration for your vehicle and no license to operate it, you are carted off.
Rick said that if we could get numerous letters (1,000?) from satisfied clients, that would probably help the case of Mary Lee, and by proxy, all of us, and perhaps prevent this from being an issue in the future for those of us acting responsibly. And anyone interested in contributing to the legal defense fund is encouraged to do so. Send any letters and checks made out to “EEG Defense Fund” and send to: Rick Jaffe/EEG Defense Fund/Phoenix Tower/3200 Southwest Freeway Suite 3200/ Houston, TX 77027. (phone is 713-626-3550). I think that, despite our different opinions, disciplines and practices, we all need to support Mary Lee in whatever way we can as this could be an important time of enlightenment for all. Personally, I do not use LENS or FNS in my practice but if it were not for the FLEXYX, I would not be in the field. Mary Lee basically “cured” a long-standing chronic fatigue (the brain fog and heavy head) seven years ago in just a few sessions, and the results were magical and thus far permanent. So let’s get busy and reach consensus as to what this valuable service is that we provide. Best of luck, Mary Lee!
Deborah Stokes, PhD, BCIA-EEG
Neurofeedback Consultants, Inc.
2121 Eisenhower Ave. Suite 604
Alexandria, VA 22314