How do you market an emerging healthcare practice, without running afoul of regulatory walls, from federal and state advertising law to licensing laws, and the law governing unfair business practices? This is Part 5 in a 5-part series on neurofeedback as an emerging healthcare modality that triggers many legal issues also familiar to integrative care clinics, medical spas, wellness centers, and private practices of various therapeutic approaches to health and wellness.
Below are some case studies of how different healthcare providers, from chiropractors to nurses, use neurofeedback but face legal obstacles regarding their marketing practice.
What’s written below is not legal advice or opinion. It’s simply information and education using hypotheticals to tease out ideas. As always, do not rely on anything you read on this website as legal advice. If you need legal advice or opinion for your specific situation, consult an experienced neurofeedback lawyer or EEG attorney.
Neurofeedback Case Study 1—Psychologist Who Supervises a Non-Licensed Professional
Paul the Psychologist writes: “I had begun to mentor an individual with a Ph.D. in psychology, but someone who was/is not licensed in any mental health or health profession. They maintain their own office and had been operating a private practice solely doing educational evaluations. They have begun to do neurofeedback with children and adults with a wide variety of issues (ADHD, anger, oppositional behavior, sleep issues, anxiety, RAD). I became concerned that I had liability exposure for their activities and discontinued the consultation. Were my concerns well founded? How is liability for mentoring or consultation determined?”
Paul’s legal concerns are well-founded.
The situation here is a licensed psychologist who has an ambiguous professional relationship with a non-licensed practitioner of neurofeedback who has a “private practice.”
The non-licensed EEG practitioner purports to be “solely doing educational evaluations.” Note that there is a distinction between providing information and education on one hand, and clinical practice on the other. I can send you a web link saying that chicken soup is good for the soul, but if I wave my hands and tune in to the gods and tell you that you have chicken pox or need antibiotics, I’m practicing medicine.
Lawyers draft disclaimers—this is not medicine, it’s educational and informational only.
These may help mitigate liability, in part, at least with respect to the client or website user. But with respect to the medical board or prosecutor, simply calling something “educational” does not make it so. As Hamlet said: “words, words, words.”
The non-licensed practitioner is performing “neurofeedback with children and adults with a wide variety of issues (ADHD, anger, oppositional behavior, sleep issues, anxiety, RAD).”
This could be seen as diagnosing—and, assuming the practitioner makes recommendations—treating, these various disease conditions.
If the practitioner is engaged in unlicensed practice of medicine, does practicing “under” the psychologist save the practitioner?
No. As we have written before, while there might be some way to configure the relationship such that the psychologist has a technician operating a machine (but not engaged in unlawful practice of medicine or psychology), here, the psychologist is “mentoring” a non-licensed person. Perhaps the psychologist is merely engaged in teaching, but, the facts indicate a supportive role in the non-licensed person’s “private practice.”
This creates potential exposure to the psychologist for aiding and abetting unlicensed practice of medicine.
As Sigmund Freud said, sometimes a cigar is just a cigar. And sometimes “concern” is not “anxiety.”
Neurofeedback Case Study 2: Chiropractor Advertising Neurofeedback and EEG Services on His Website
Chris the Chiropractor has studied neurofeedback and wants to advertise on his website a spectrum of conditions that he can treat through neurofeedback, including not only stress, reduction and peak performance, but also: chronic pain, headaches, insomnia, mental fogginess, ADD/ADHD, autism, bruxism, chronic fatigue, cerebral palsy, fibromyalgia, IBS, Parkinson’s, PMS, TBI- Traumatic Brain Injury, stroke, tics, Tourette Syndrome, addictions, anxiety, anger, depression, irritability, mood swings, fear, phobias, PTSD, mental disorders.
What legal issues does Chris face?
First, Chris the chiropractor must stay within his scope of practice. If his scope of practice doesn’t include treating autism, for example, then he faces legal risk if he advertises that he treats autism.
Second, Chris the chiropractor must advertise services in a way that makes clear that he is offering services within his scope of practice.
There is some ambiguity here in that chiropractors can manipulate the spine and perform clinical activities within the scope of practice, but not treat disease. So for example, if clinically indicated, a chiropractor could offer chiropractic services to a patient who has cancer, but the chiropractor cannot treat cancer or advertise that he or she is treating cancer.
Note that as a chiropractor, Chris has a duty to refer the patient to an MD if the condition is beyond chiropractic. Chris can always ask, “are you seeing your oncologist?”
Now supposed Chris puts on his website: “One of the modalities I use is neurofeedback.
Neurofeedback trains the brain to enhance self-regulation and helps the body to find more efficient pathways so the body is better able to manage and heal itself. We do not ‘treat’ conditions with Neurofeedback, but assist the nervous system to make adjustments to improved function. As such, Neurofeedback has been shown to be profoundly helpful for improving, remediating, or alleviating, a wide spectrum of conditions.
These are the conditions that can be treated by neurofeedback: chronic pain, headaches, insomnia, mental fogginess, ADD/ADHD, autism, bruxism, chronic fatigue, cerebral palsy, fibromyalgia, IBS, Parkinson’s, PMS, TBI- Traumatic Brain Injury, stroke, tics, Tourette Syndrome, addictions, anxiety, anger, depression, irritability, mood swings, fear, phobias, PTSD, mental disorders.
“As a chiropractor, I can only provide chiropractic services; I cannot treat these conditions. I use +neurofeedback as an ancillary/adjunctive/supportive therapy. Consult your medical doctor or licensed mental health care provider regarding diagnosis or treatment of the underlying condition.”
Chris also modifies his consent form accordingly.
This might improve the legal risk Chris incurs, because the language better frames the understanding that as a chiropractor, Chris delivers services within his scope of practice.
Still, there are several legal risks:
One, the medical board or chiropractic board could see this website and make the case that Chris is treating or holding himself out as treating these medical conditions—and therefore is outside chiropractic scope of practice, and practicing medicine unlawfully.
Second, the patient could argue that Chris advertised that he treated these conditions, and that the patient was misled, and that Chris was negligent in providing services, because the condition did not improve, or got worse.
Third, someone could make a claim for false advertising, deceptive business practices, or some other generic rubric.
The most legally safe practice is for Chris to limit advertising of neurofeedback to conditions that chiropractors routinely treat. For example, sometimes a good chiropractic session can eliminate a back-ache—or a headache.
Remember that scope of practice is not a holistic concept—it’s an anti-holistic practice. The law carves the patient into parts. Healers put the patient back together—but they have to stay within the law.
Neurofeedback Case Study 3: Psychiatrist is Concerned that Offering Neurofeedback Increases Her Malpractice Liability Risk
Phyllis the Psychiatrist writes: “Thanks for this opportunity. As a psychiatrist, I wonder if my offering neurofeedback (NF) to clients increases the risk of being sued. For example, if someone comes in with an anxiety disorder, and I suggest a trial of NF instead of medication, then what is my risk? If the patient does not respond well, and in fact his condition deteriorates, I’m left very exposed — this is outside standard psychiatric guidelines. In fact most psychiatrists have never heard of NF. So my question is, how can I best protect myself?”
Good question, Phyllis.
I addressed this with colleagues, while on faculty at Harvard Medical School, in an article entitled Ethical Considerations of Complementary and Alternative Medical Therapies in Conventional Medical Settings (Annals of Internal Medicine); and, in a companion piece called, Potential physician malpractice liability associated with complementary and integrative medical therapies.
As a psychiatrist, your malpractice liability depends on the standard of care, which is set by your profession.
If the Board investigates, the Board will appoint an expert who will testify as to what the standard of care is for your patient with the anxiety disorder.
The best way to protect yourself is as follows:
1. Document the literature supporting the therapy you propose, in this case neurofeedback. If you can show that it is an accepted approach, you will be less at risk of being flagged for a standard of care violation.
Also, there’s a “respectable minority” defense to malpractice, which applies in various states. It states that you have a defense to malpractice if you are using a therapeutic approach adopted by a respected minority of clinicians, even if not the dominant approach that is considered standard of care.
2. Try neurofeedback for a limited, trial period as you indicated. Continue to monitor conventionally, and to intervene with the conventional standard of care if/as indicated or if the NF does not work.
3. Remember “do no harm.” Malpractice occurs when there is patient injury. And, good communication reduces liability risk.
4. Provide clear and adequate informed consent.
These are not guarantees of freedom from your own anxiety. They are liability risk management strategies.
Neurofeedback Case Studies—Thematic Variations
Here are additional questions presented before a talk on Neurofeedback Legal Issues. They reflect variations on the themes above.
1. Your example is a good one and I am going to add one curve ball, “Bob, a Clinical Psychologist in California, director of a private practice and Neurofeeedback clinic, has to determine whether he should allow Mary, an individual working toward certification in the Othmer Method, working under Bob’s license, to incorporate neurofeedback as part of their program. Also, would there be a difference before certification versus after completing certification? Bob is also working toward certification.”
2. My concern is that if NF gets some real mainstream traction, that the “law” will severely restrict its practice. It represents a great threat to “big medicine”.
3. Thankfully, I have never had a concern about this. My license, Marriage and Family Therapist, has to do with relationships, and I can use whatever modality I am trained in to promote better relationships. I have thought about it a lot, in case someone should suggest I am beyond my scope of practice, but I can explain how a given modality can improve relationships, even with the self. I don’t think it would ever go to court if I have carefully explained it up front. Of course there is the famous case of the San Francisco doctorwho dared to suggest that an anti-fungal drug might address ADHD…. got his license revoked, his practice ruined, and then was reinstated in 1996.. Dreadful. It is always helpful to have a “consent to treatment”, and if using neurofeedback, have it mentioned in the consent. Nice topic.
4. As an unlicensed provider, what are the potentially problematic areas I need to be aware of, especially as regards marketing and advertising?
5. I have a cash only practice, yet I’ve put that I accept insurance payments on my EEGinfo listing – because I will give people a form so they can ask their insurance for reimbursement, after they’ve paid me. I’ve had people be disgruntled with me for my unwillingness to bill their insurance – even though I’m clear about that before they make appts. Are there any legal issues with that?
Thanks for considering these issues in your presentation!
6. I also have training in The Listening Program – which is complimentary to neurofeedback. It’s not uncommon for me to offer a family member the opportunity to listen to TLP while the client is receiving neurofeedback. I haven’t charged for this to this point. Is there a legal issue with that? What should be in the consent to treat form about that? As some point I will charge a fee for this, how do I make the transition?
7. Can you advise or write out some examples “elevator speeches” for legal ways to talk about neurofeedback without creating scope of practice issues?
8. People have approached me to teach them neurofeedback. I refer them to online training. Even those who are licensed, insured professionals seem to be a risk to me as a potential supervisor, because of the dual relationship issues that are part of my professional ethical codes. Also, they may have different professional credentials than I have. Is there a way of exempting me from ethical codes because hands on neurofeedback supervision isn’t widely available geographically? Some of these people are parents of clients, therefore I have a dual relationship with them. How would I ethically train them for home training?
9. Is the referral program of ABC like a multilevel marketing program? They require a professional to be working with anyone who buys their product, and they give a kick back to providers. Plus, I have had good experiences using a couple of multilevel marketing products, yet that dual relationship issue comes up again when clients ask is they can buy those products from me. Thoughts?
10. I need to be clear on my website that I’m not treating medical conditions, yet people will write testimonials that the thing they value the most was the relief from their health issues. Can I tweak those testimonials, or ask clients to do so, to keep me in the clear?
11. Many people have issues with depression and anxiety PLUS physical ailments that leave me clueless as an MFT. Yet, NF has been helpful for these people through the self-regulation model (chronic migraines, stomach ailments, muscle twitching, seizures, allergies, sleeplessness, infertility, pornography addiction, etc.) Am I obligated (or just smarter) to get medical clearance to treat these people? If so, what is the best way to approach both the client and the physician? Is there a form letter you would recommend, that I could vary with details about the individual? What terms should I avoid? What information should I have in my consent to treat as a disclaimer?
If you have specific legal questions about neurofeedback legal issues, consult a healthcare and FDA lawyer.