Essential tremor (ET) is the most common movement disorder, causing involuntary, rhythmic shaking that typically affects the hands and arms, making simple daily activities like writing or drinking difficult. When initial drug therapy fails, many patients seek advanced treatment options. Focused Ultrasound (FU) has emerged as a non-invasive alternative for individuals struggling with this condition. Because the procedure is relatively new and carries a high upfront cost, insurance coverage, particularly through Medicare, is a major concern.
Understanding Essential Tremor and Focused Ultrasound
Essential tremor originates from abnormal electrical activity in specific deep brain structures. The tremor is usually postural or kinetic, meaning it occurs when holding a position or during movement, but often not when the limb is fully at rest. As the condition worsens, the inability to control fine motor movements can significantly impact a person’s independence and quality of life.
Focused Ultrasound is a technique that treats the tremor without requiring a surgical incision or radiation. The procedure uses a helmet-like device to emit over 1,000 beams of high-intensity sound waves. These waves pass harmlessly through the skull, converging precisely on a target deep within the brain, heating and destroying the small area of tissue responsible for the abnormal signals.
The process is guided by Magnetic Resonance Imaging (MRI), allowing the neurosurgeon to visualize the brain and monitor the temperature in real-time. This MRI guidance ensures the energy is accurately delivered to the ventralis intermedius nucleus (Vim) of the thalamus, the key relay center for motor signals. Creating a tiny thermal lesion interrupts the faulty circuit, often resulting in immediate and lasting tremor relief on the treated side.
Medicare National Coverage Determination Status
The Centers for Medicare & Medicaid Services (CMS) has established coverage for this procedure. Magnetic Resonance-guided Focused Ultrasound (MRgFUS) for the treatment of medication-refractory essential tremor is a covered benefit under Medicare Part B. This is a significant development, as the procedure was initially approved by the FDA in 2016.
Coverage was not immediate or universal across the country; instead, it was rolled out through a phased process involving local decisions. Medicare Administrative Contractors (MACs), which manage regional Medicare claims, gradually issued Local Coverage Determinations (LCDs). This incremental approach led to a period where coverage was available only in certain states.
Today, the MRgFUS procedure for essential tremor is considered a covered benefit for eligible beneficiaries in all 50 states. The coverage falls under Medicare Part B because the treatment is performed on an outpatient basis. Although a specific National Coverage Determination (NCD) number may not be cited, the service is universally covered through the collective action of all regional MACs.
Criteria for Coverage Eligibility
While the procedure is covered, a patient must meet specific clinical and procedural criteria. The first requirement is a confirmed diagnosis of essential tremor by a neurologist specializing in movement disorders. Furthermore, the patient must have “medication-refractory” tremor, meaning that initial pharmacological treatments have failed.
To meet the refractory standard, patients must have tried and failed to adequately respond to, or have been unable to tolerate, at least two standard oral medications. Tremor severity must be documented to show a functional disability that significantly interferes with daily living activities. The patient must be at least 22 years of age, aligning with the initial FDA approval criteria.
The treatment must target the Vim nucleus of the thalamus, confirmed through pre-operative and intra-operative imaging. Patients must also be capable of fully tolerating the MRI environment and communicating with the medical team during the procedure. This communication is necessary because the physician assesses the patient’s tremor improvement and any side effects in real-time before making the final thermal lesion.
The facility performing the procedure must be an approved site with qualified personnel. Treatment must be performed on only one side of the brain at a time. If the patient has disabling tremor on both sides, the procedure on the second side requires a waiting period, typically at least nine months, to allow for full assessment of the first side’s results and reduce the risk of potential side effects.
Patient Cost Sharing and Out-of-Pocket Expenses
Even with confirmed coverage, patients are responsible for cost-sharing obligations under Medicare Part B. The procedure is typically performed in an outpatient hospital setting, meaning the patient must first satisfy the annual Part B deductible. After the deductible is met, the patient is responsible for 20% of the Medicare-approved amount, which is the Part B coinsurance.
The institutional payment for the procedure is substantial, with the CMS-approved amount for the facility fee being approximately $10,000. This means the patient’s 20% coinsurance can amount to several thousand dollars, not including separate professional fees for the physician and surgeon. These costs can be offset if the patient has a supplemental insurance plan, often called Medigap, which is designed to cover the Part B deductible and coinsurance.
Patients enrolled in a Medicare Advantage (Part C) plan will have their coverage managed differently. These private plans must cover all services provided by Original Medicare, but they may have different deductible, copayment, or coinsurance structures. It is important for patients with Medicare Advantage to confirm their specific plan’s cost-sharing details and ensure the facility and physicians are within the plan’s network to minimize out-of-pocket expenses.