Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD

This LCD addresses use of Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the treatment of neurologic conditions. MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patients with all following: Medication refractory (ONE) Essential Tremor (ET)- defined as refractory to at least two trials of medical therapy, including at least one first-line agent Tremor-Dominant Parkinson’s disease (TDPD) (BOTH) refractory (or intolerant) to levodopa or levodopa equivalent daily dosage (LEDD) ≥ 900 mg On-medication Unified Parkinson’s Disease Rating Scale (UPDRS) ratio of the mean score for tremor items (items 16, 20, and 21) to the mean postural instability/gait disorder score (items 13-15, 29, and 30) of ≥ 1.5 Moderate to severe postural or intention tremor of the dominant hand (defined by a score of ≥2 on the Clinical Rating Scale for Tremor (CRST) Disabling tremor (defined by a score of ≥2 on any of the eight items in the disability subsection of the CRST Not a surgical candidate for deep-brain stimulation (DBS) (e.g., advanced age, anticoagulant therapy, or surgical comorbidities) Limitations (not covered) Treatment of head or voice tremor Bilateral thalamotomy Conditions other neurodegenerative condition unstable cardiac disease untreated coagulopathy risk factors for deep-vein thrombosis severe depression (defined by a score ≥20 on Patient Health Questionnaire 9 (PHQ-9), or Beck Depression Inventory score (BDI-II) >14) cognitive impairment (defined by a score of previous brain procedure (transcranial magnetic stimulation, DBS, stereotactic lesioning, or electroconvulsive therapy) a skull density ratio (of cortical to cancellous bone) MRI contraindicated Drug-induced Parkinsonism history of seizures, brain tumor, intracranial aneurysm or arteriovenous malformation requiring treatment.