TCPR: And how many treatments does a patient receive?
Dr. Lanocha: Some patients respond in as few as 20 treatments; some patients may require longer courses. But the standard course of treatment that was approved by the FDA for the NeuroStar device is 36 treatments delivered daily for four to six weeks, and then tapered over two or three weeks, rather than being stopped abruptly. The total number of treatments using the Brainsway device tends to be fewer—about 25 to 30 on average, and treatments are usually scheduled four days a week instead of five.
TCPR: What determines how many treatments are required?
Dr. Lanocha: It is a decision based on careful assessment using standardized measurement tools. This is a very important part of TMS. All insurance companies, for example, require the regular use of a standardized rating instrument such as the PHQ-9 or the QIDS before, during, and after treatment. So that is one of the main methods used to determine patients’ response. But not after each treatment—it takes about two to three weeks before most patients begin to notice improvement. Those instruments are usu-ally administered on a weekly basis over the course of the treatment.
TCPR: How long is an individual session and what is the patient’s experience with it?
Dr. Lanocha: The first treatment is a bit longer than subsequent ones because that is when all of the necessary set-up needs to be done, including determining the correct magnetic field strength and placement of the magnet. But a typical standard treatment lasts about 40 minutes start to finish. There are modifications in the treatment protocol that are different than the standard 3,000 pulses per session, which is what was approved by the FDA, and sometimes treatment sessions can run a bit longer. Because different pulse frequencies with different pulse train intervals are used, treatments with the Brainsway device are shorter (about 20 minutes) compared to 37 minutes with the NeuroStar.
TCPR: How much does the office get reimbursed for each session?
Dr. Lanocha: Well, I think the net reimbursement varies from region to region, and even from practice to practice within each region, based on negotiated rates. But I would say that if one is efficient, reimbursement more than covers the cost of providing the treatment. If a person had to pay out of pocket, a full course of treatment would probably cost about $12,000 for 36 treatment sessions.
TCPR: How has insurance coverage of TMS evolved over the years?
Dr. Lanocha: It has changed dramatically in the past couple of years and continues to improve all the time. At the moment there are over 100 million covered lives in the United States with written TMS coverage policies. All the major carriers cover it, although their authorization criteria do vary from one to the other. The exceptions are Medicare and Medicaid, which are administered on a regional basis and not consistent across the country. The VA and the Department of Defense provide TMS to both active duty personnel, veterans, and civilians.
TCPR: In general what do insurance companies look for in approving this treatment?
Dr. Lanocha: A pretty typical set of criteria would be four failed antidepressant medical trials, plus two failed augmentation strategies, all of this in addition to at least some form of psychotherapy, preferably cognitive behavioral therapy.
TCPR: If a practitioner or a practice wants to be involved, what sort of training or certification is necessary?
Dr. Lanocha: The device manufacturers provide training and ongoing customer support for their respective devices. But I think that anyone who is curious about this should, and could, easily obtain more advanced training at one of several courses that are offered. These are available at Beth Israel Deaconess Medical Center in Boston, Columbia University, and the Medical University of South Carolina. Also, the Society for Biological Psychiatry sponsors a course in TMS and other neuromodulation therapies that is held every year coincident with the APA meeting. There is also a National Clinical TMS Society that provides ongoing training and support in a number of areas. In addition, the Journal of Brain Stimulation is devoted to TMS and related neuromodulation treatments, and there are several very recent textbooks and other references.
TCPR: Do you have any idea of how many psychiatrists offer TMS?
Dr. Lanocha: Well I can tell you that there are over 500 NeuroStar systems currently in use and about 70, I believe, Brainsway devices in use. TMS is available in private offices, hospitals, academic medical centers, and stand-alone clinics. There are parts of the country where it is more accessible than elsewhere and the reimbursement landscape does vary, too, from one region of the country to another. I think that the interest in TMS has steadily increased over the past few years and continues to do so.
TCPR: Must it be a psychiatrist performing the procedure, or is it something that psychologists or nurse practitioners can offer?
Dr. Lanocha: No, this is a medical procedure that must be prescribed and administered by, or under, the supervision of a psychiatrist.
Any patient who has failed to respond to initial antidepressant treatment is potentially a candidate for TMS.
~ Karl Lanocha, MD
TCPR: Are there any developments in TMS technology or protocols that we should be watching for?
Dr. Lanocha: There is quite a bit going on. There is research into coil design, changes that would allow for different patterns of stimulation and perhaps deeper levels of penetration, and research on neuronavigation and other methods that might allow more precise localization of the magnets. There is a lot of research looking at optimizing the pulse sequences. The standard approach, for example, involves using high frequency TMS applied to the left side of the brain, but an equally effective treatment for depression involves the use of low frequency, low TMS, applied to the right side. A lot of research is looking at how to optimize those different pulse parameters and whether or not there are specific biomarkers, EEG signals for example, that might be useful in helping to determine which particular protocol might work better for a given patient. There is an altogether new kind of TMS called “synchronized TMS,” which is currently undergoing research and is entering the final stages of the development process. And, finally, there is even a TMS device that has been cleared for home use. However, that is not for the treatment of depression, but for the treatment of migraine with aura, so that is an entirely different application.
TCPR: Thank you, Dr. Lanocha.