Karl Lanocha, MD
Neuropsychiatrist, Mindful Health Solutions, Sacramento, CA
Dr. Lanocha has disclosed that he received a $6,000 payment in the last year from the speakers’ bureau of Neuronetics, the makers of the NeuroStar TMS system. Dr. Carlat has reviewed this interview to ensure the absence of commercial bias, either in favor of any particular TMS product, or in favor of TMS over other treatment options. In a future issue of TCPR, we will review the most recent efficacy literature and will compare the pros and cons of specific TMS devices.
TCPR: Dr. Lanocha, please tell us briefly what TMS is and how it works.
Dr. Lanocha: TMS is transcranial magnetic stimulation, and it is basically a clinical application of Faraday’s Law, which states that a moving magnetic field can cause an electrical current to flow. TMS may work by modulating activity in the brain default mode network, which is a set of brain regions that oscillate in a synchronous manner and are thought to be involved in affective processing and mood regulation.
TCPR: And how is this related to depression?
Dr. Lanocha: Functional imaging studies have shown decreased activity in the left prefrontal region in patients with depression, and TMS may stimulate those underactive neurons, restoring them to a normal level of function, which can then persist long after the direct stimulation.
TCPR: Is there any pre-TMS imaging workup required to determine where to place the magnet?
Dr. Lanocha: No, brain imaging is not necessary in order to determine the correct placement of the magnet—there are other methods for determining that. The most common approach is to determine the patient’s motor threshold, which is the magnetic field strength required to produce a visible muscle movement. That is usually done by positioning the magnet over the motor cortex and stimulating the area that controls movement of the thumb. Then the magnet can be moved anteriorly by a certain amount and placed over the left dorsolateral prefrontal cortex.
TCPR: Who is the ideal TMS candidate and who is maybe not such a good candidate?
Dr. Lanocha: Any patient who has failed to respond to initial antidepressant treatment is potentially a candidate for TMS. The FDA product labeling for both the NeuroStar and Brainsway devices states that these treatments are appropriate for patients who have failed any number of antidepressants in the current episode. However, it is likely effective in patients who have not responded to treatments in more than just one episode. The most recent systematic review of rTMS for treatment-resistant depression (defined as depression that has been resistant to at least two prior antidepressant attempts) found that those receiving TMS were three times more likely to respond as those receiving sham TMS (Gaynes BN et al, J Clin Psychiatry 2014;75(5);477–489). As a general rule, TMS works best when it is given relatively early in the course of the illness before more severe treatment resistance develops. But in my experience it works remarkably well, even for patients with a high level of treatment resistance.
TCPR: So while the research shows that TMS works best in those who have failed antidepressants for a single episode of depression, it sounds like you will often treat people who have failed three or four trials for multiple episodes.
Dr. Lanocha: I have never treated a patient with TMS who has failed only one antidepressant. That just doesn’t happen. All of my patients have failed to respond to multiple medication trials, often over the course of many years. What is interesting is that the duration of illness, number of failed medications, and other factors, such as age, appear to be very weak predictors of response. So it is hard to say that there is an ideal candidate versus a patient who should not be considered for TMS. I don’t think that I or anyone would really advocate TMS as a first-line treatment, however. I think that medication and psychotherapy are still the preferred first line of treatment, and when a patient responds, it’s, great.
TCPR: A lot of us understand TMS as sort of a noninvasive form of ECT, perhaps even targeting the same brain areas. Is there a relationship between responsiveness to ECT and responsiveness to TMS?
Dr. Lanocha: No. ECT is a convulsive therapy that produces its therapeutic effect by inducing a generalized seizure that involves the entire brain from cortex to brain stem. TMS is a nonconvulsive treatment that does depolarize neurons, but acts in very discrete areas of the brain. It is also very focal compared to ECT, which is very diffuse. Although the data show that ECT is in general more effective than TMS, I have successfully used TMS in patients who had failed to respond to ECT.
TCPR: Can you walk us through what a practice might need to offer TMS to patients?
Dr. Lanocha: You don’t need a lot of space, but you do need a dedicated treatment room that’s probably at least 10 x 12 feet. Of the two devices that are currently available, the Neuronetics NeuroStar System requires a little bit more space because it is an integrated system that includes a reclining chair. In addition to the equipment and the treatment room, most people are also going to want to have a TMS technician to assist them with administering the treatment. It is necessary to track personnel costs in addition to the capital investment of the device itself.
TCPR: What is that capital investment and then what are the recurrent costs?
Dr. Lanocha: The capital investment for the system itself is about $65,000, and the devices can be either purchased or leased. The Neuronetics System, which I use, requires a single-use disposable component for each treatment, but operating costs for both systems are determined by use and are roughly equivalent over the course of the year assuming similar use.
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 usually 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.
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.
So You Want to Start a TMS Practice? Here’s How
Purchase or lease the TMS device—NeuroStar requires a purchase or lease (for around $60,000–70,000); Brainsway requires a lease (around $50,000/year). NeuroStar also requires a hefty additional cost per treatment. Contact the companies for the gory details.
Receive training—which typically lasts a day and takes place right in your office.
Set up a dedicated treatment room—a necessity for NeuroStar, which is like a huge dentist’s chair; more optional for Brainsway, which looks like an ultrasound machine on wheels.
Hire an assistant, called a TMS “technician.” No medical background necessary, since the assistant will receive the necessary training when you do. Technicians are often paid around $20/treatment.
Figure out how many patients you’ll need to treat per month to pay your expenses—which is generally at least two, depending on whether you’re getting paid by insurance companies (around $7000/treatment course) or cash (closer to $12,000).
Source: Discussions with psychiatrists who have set up TMS practices.