ESSENTIAL TREMOR

How long has this Treatment been approved by the FDA?

Over five years. The FDA approved the Exablate Neuro device for treating Essential Tremor with Focused Ultrasound at the end of 2016.

How many patients have been treated?

More than 10,000 Essential Tremor patients have been treated worldwide with Insightec’s Focused Ultrasound.

What is the five-character CPT code for the Focused Ultrasound procedure?

The current CPT code for MRgFUS is 0398T; Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed. We are providing this code for general information purposes only; each provider is responsible for its own coding and billing activities.

What is the cost of the procedure if it’s not covered by my insurance?

The cost for cash paying patients is set by the treatment center. For a complete list of treatment centers and their contact information, click on the link below.
https://insightec.com/treatment-centers/

In which states is there Medicare Coverage for Focused Ultrasound treatment for Essential Tremor?

MR-guided focused ultrasound treatment for medication-refractory Essential Tremor is a Medicare covered benefit in all 50 states.

Is Focused Ultrasound covered under Medicare Part A, Medicare Part B, or a supplemental Medicare plan?

Magnetic Resonance guided Focused Ultrasound (MRgFUS), for the treatment of essential tremor is covered under Medicare Part B.

How do I know if my private health insurance plan covers the treatment?

Contact your health plan’s Member Service department by calling the phone number listed on the back of your insurance ID card. Ask whether or not MR-guided Focused Ultrasound for treating essential tremor (CPT code 0398T) is a covered benefit in an outpatient setting based on your health plan.

Do private health insurance plans cover the treatment?

Aetna, CIGNA, and Anthem plans cover focused ultrasound treatment of essential tremor (ET) that does not respond to medications. Also, 80% of Independent Blue Cross Blue Shield Association plans have adopted the National Medical Policy for coverage of MR-guided focused ultrasound to treat medication-refractory Essential Tremor.

Can I travel to other states to receive treatment if my state is not covered by Blue Cross Blue Shield?

It is our understanding that under the Blue Card Network, patients traveling outside of their home state for treatment at a facility providing MRgFUS would be subject to their home plan coverage decision. We recommend confirming coverage with your health plan and the treatment center prior to treatment.

Should I try medications first?

The first line of treatment for Essential Tremor is medications. If you have a confirmed diagnosis of essential tremor and prescribed medications (such as propranolol or primidone) have not provided satisfactory tremor improvement, you may be a candidate for Focused Ultrasound.

If I have tremor in both hands, can I get both sides treated? Do I need two treatments?

While the FDA approval for Exablate allows for both sides to be treated, the treatment is done in a staged unilateral (one side at a time) manner. After the first treatment, patients may be eligible for the second treatment after at least 9 months provided there was no clinically significant dysphagia (difficult swallowing), abnormal speech function, or gait abnormalities that are moderate to severe following the first side treatment.

How Is Essential Tremor treated?

Mild essential tremor may not require treatment. However, if essential tremor interferes with your ability to function or if you are uncomfortable in social situations, there are treatments that may improve symptoms.
Treatments may include medications (as the first line of treatment), the Focused Ultrasound treatment or surgical options. Please keep in mind that only a physician can advise you on the risks, benefits, and alternatives for treating your condition.

What is Focused Ultrasound?

Focused Ultrasound is a treatment option where sound waves can be focused through the skull to target a very specific location deep within the brain without the need for incisions or holes in the skull. This is the same target used for years with other more invasive surgery, but now can be reached without incisions or anesthesia.

Focused Ultrasound (FUS) waves converge at a focal point to create a small lesion in the targeted area of the brain.

The MRI system is the eyes of the treatment, enabling the physician to identify and target the treatment area with high precision as well as monitor the temperature during treatment.

Potential adverse reactions from use of the Exablate device, placement of headframe, or thalamotomy procedure include:

1. Transient events that resolve within three days, such as headache, ataxia, dysarthria, pain, dizziness, nausea, diplopia, imbalance, nystagmus, slurred speech, unsteady, numbness/tingling, tilting sensation, and warm sensation.
2. Adverse reactions associated with thalamotomy procedure such as numbness/tingling, dysarthria, ataxia, dysgeusia, gait disturbance imbalance, dysphagia, hypogeusia, dysmetria, fatigue, hypoesthesia.
3. Infrequent events (occurring in less than 1% of subjects participating in Insightec-sponsored clinical trials) such as decrease in synchronicity between hands, diplopia, dizziness, dry mouth, facial droop, headache, sialorrhea, voice change, and weakness.

Focused Ultrasound may be a treatment option for patients with medication-refractory essential tremor who are at least 22 years old.

What are some medications that can reduce the severity of the tremor in some patients?

Propranolol (Inderal®)is the only medication approved by the FDA for the treatment of essential tremor, but it is primarily used for treating high blood pressure

Primidone (Mysoline®) is an anti-seizure medicine

Anti-anxiety medications may be useful in patients who do not respond to other medications or who have associated anxiety

These medications can cause side effects, and you should ask your physician to learn more.

What is Deep Brain Stimulation (DBS) Surgery?

A common approach to treating essential tremor when medications no longer help is deep brain stimulation (DBS). This form of treatment consists of two staged surgeries to implant an electrode deep into the brain, tunnel the wires under the skin down the neck and implant a pulse generator below the skin near the collar bone. This treatment targets the same location as the Neuravive focused ultrasound treatment. DBS requires follow up throughout the patient’s life for adjustment of stimulation and eventual replacement of generator(s) to replace batteries. As an invasive surgery to access the brain, DBS poses risks typically associated with surgery, such as infection and bleeding in the brain, and with implantation of chronic hardware in the body, such as infection and potential equipment malfunction.

What is Thalamotomy?

Conventional, surgical thalamotomy is an invasive procedure where the target ( the Vim of the thalamus) is surgically destroyed (ablated). Neurosurgeons use specialized probes inserted deep into the brain to precisely locate the treatment target. Like DBS surgery and the Neuravive procedure, the patient is usually awake, and the area on the scalp where the surgical tools are inserted is numbed with an anesthetic. Different methods can be used to kill the brain cells, including radio-frequency heating or cooling with a special probe. As an invasive surgery to access the brain, thalamotomies pose risks inherent in any surgery, such as infection and bleeding in the brain.

Additional information about these treatment options is available at https://www.essentialtremor.org/treatments/ and https://www.webmd.com/brain/essential-tremor-stereotactic-thalamotomy.

What is Stereotactic Radiosurgery?

Stereotactic radiosurgery emits powerful, highly accurate gamma radiation beams to target the cells of the ventral intermediate nucleus (VIM) in the thalamus in order to destroy overactive cells that cause tremor. Surrounding areas remain untouched as 192 beams of focused radiation are combined with a low dose of radiation.

Why do I have to be awake during the treatment?

Your feedback is necessary as you will be asked to do tasks such as drawing spirals. This is so the physician can evaluate the improvement of your tremor and identify any potential side effects that you may be experiencing during the treatment.

How long do I have to stay for the treatment during and after?

The average treatment time is 2.5 hours. The treatment is usually performed on an outpatient basis; however the treating physician will decide when you can return home.

Will my tremor return?

There is the possibility that your hand tremor may return months or even years after Focused Ultrasound treatment, or that the tremor may not improve at all. And while the treatment may improve your tremor, it’s important to understand that it does not treat the underlying disease nor prevent its progression.

How soon can I return to work after treatment?

That depends on the type of work you do and how you feel. Please consult with your physician.

What side effects can I expect during the treatment?

You should have a detailed conversation with your physician regarding risks and benefits of treatment. Insightec-sponsored clinical studies have shown that the most common side effects are imbalance/gait disturbance, numbness/tingling, and headache/head pain. Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue, and vomiting.

What side effects can I expect after the treatment?

There is a small risk that you could develop temporary or permanent muscle weakness, unsteadiness when walking, sensory loss, or numbness or tingling in your fingers or elsewhere in your body.

Are there additional side effects I can expect after getting the second side treatment?

The safety profile of the treatment is similar to the treatment of the first side. 98% of adverse events were mild or moderate. Potential adverse reactions from use of the Exablate device, placement of headframe, or thalamotomy procedure include:

1. Transient events that resolve within three days, such as headache, ataxia, dysarthria, pain, dizziness, nausea, diplopia, imbalance, nystagmus, slurred speech, unsteady, numbness/tingling, tilting sensation, and warm sensation.
2. Adverse reactions associated with thalamotomy procedure such as numbness/tingling, dysarthria, ataxia, dysgeusia, gait disturbance imbalance, dysphagia, hypogeusia, dysmetria, fatigue, hypoesthesia.
3. Infrequent events (occurring in less than 1% of subjects participating in Insightec-sponsored clinical trials) such as decrease in synchronicity between hands, diplopia, dizziness, dry mouth, facial droop, headache, sialorrhea, voice change, and weakness.