Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) for Essential Tremor

Jurisdiction: J9 MAC Part B. States: Florida, Puerto Rico, US Virgin Islands. Type: Active LCD

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Historically, ultrasound has largely been performed as an extracranial diagnostic tool. However, more recently, intracranial therapeutic uses have been explored. One such use has been in the treatment of essential tremor (ET) that is refractory to more traditional treatment (e.g., medical therapy, deep brain stimulation [DBS]) through the use of focused ultrasound techniques. Magnetic-Resonance-Guided Focused Ultrasound Surgery (MRgFUS) is a non-invasive thermal ablation treatment that delivers a spherical array of converging beams using a cranial ultrasound unit that targets specific areas in the brain and heats and ablates the areas that are felt to be responsible for the ET. 1 Covered Indications MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all five of the following criteria: Presence of medication refractory ET 2,3 defined as refractory to at least two trials of medical therapy, including at least one first-line agent (i.e., propranalol or primidone); 2 and Presence of a moderate to severe postural or intention tremor (defined by a score greater than or equal to 2 on the clinical rating score for tremor [CRST] 2 or another nationally accepted clinical measure of tremor severity) of the dominant hand; and The tremor is disabling (defined by a score of greater than or equal to 2 on any of the eight items in the disability subsection of the CRST 2 or another nationally accepted clinical measure of tremor severity); and The beneficiary is not a candidate for deep brain stimulation (DBS) (e.g., advanced age, anticoagulant therapy, surgical comorbidities, or has failed DBS, but has no retained cranial implants); and The beneficiary is 22 years of age or older 3 Limitations The following are considered not medically reasonable and necessary: Treatment of head or voice tremor Bilateral thalamotomy Treatment of beneficiaries who have an advanced neurodegenerative condition 2 Treatment of beneficiaries with unstable cardiac disease 2 Treatment of beneficiaries suffering from depression sufficiently severe to compromise their ability to provide informed consent and limit likely clinical benefit of the treatment Treatment of beneficiaries with severe cognitive impairment (defined by a score of less than 24 on the Mini–Mental State Examination) 2 A skull density ratio (SDR) (the ratio of cortical to cancellous bone) less than 0.40 2 Treatment when contraindications to MRI are present (e.g. metallic foreign body in eye, pacemaker etc.) Provider Qualifications Consistent with the American Society for Stereotactic and Functional Neurosurgery (ASSFN) guidelines, physicians who perform MRgFUS must possess expertise and experience in functional and stereotactic neurosurgery. Additionally, physicians who perform these services should have underdone specialized training in MRgFUS. 2 Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.