Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Essential tremor.
Treatment:  MRI (Magnetic Resonance Imaging) Guided Ablation Surgery (0398T).

The insurer denied the MRI (Magnetic Resonance Imaging) Guided Ablation Surgery (0398T).  The denial is overturned.

The patient is a male with essential tremor requesting magnetic resonance imaging (MRI) guided high intensity focused ultrasound (MRgFUS) ablation.

Yes, the health plan should cover the MRI guided ablation surgery (0398T).

Yes, the requested health service or procedure is likely to be more beneficial than any standard treatment or treatments for the insured's condition or disease.

The patient has a long history of disabling essential tremor involving the right arm and intermittently the head refractory to multiple medications.  MRI guided high intensity focused ultrasound (MRgFUS) ablation of the thalamus is requested for treatment.

MRI guided high intensity focused ultrasound (MRgFUS) is Food and Drug Administration (FDA)-approved.  A search on PubMed.com was performed regarding the use of MRgFUS for the treatment of essential tremor.  A randomized controlled trial (RCT) by Harary, states that "The predominant neurosurgical approach to medication-refractory essential tremor is thalamic deep brain stimulation (DBS).  The emergence of magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy has reawakened the debate surrounding the use of DBS (deep brain stimulation) versus thalamotomy for this indication.  Herein, we aimed to provide a contemporary comparison between DBS (deep brain stimulation) and MRgFUS (magnetic resonance-guided focused ultrasound)." They conclude, "In context of prior literature, both DBS (deep brain stimulation) and MRgFUS (magnetic resonance-guided focused ultrasound) significantly improve tremor control and QoL." 

A randomized controlled trial (RCT) by Chang, states that "Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated.  This study reports results at a 2-year followup after MRgFUS (magnetic resonance-guided focused ultrasound) thalamotomy for ET (essential tremor)."  They conclude, "Tremor suppression after MRgFUS (magnetic resonance-guided focused
ultrasound) thalamotomy for ET (essential tremor) is stably maintained at 2 years.  Latent or delayed complications do not develop after treatment."

The American Society for Stereotactic and Functional Neurosurgery Position Statement on Magnetic Resonance-Guided Focused Ultrasound for the Management of Essential Tremor, states that "Magnetic resonance-guided focused ultrasound thalamotomy is a novel tool in the neurosurgical armamentarium for management of essential tremor (ET).  Given the recent introduction of this technology, the American Society of Stereotactic and Functional Neurosurgery (ASSFN), which acts as the joint section representing the field of stereotactic and functional neurosurgery on behalf of the Congress of Neurological Surgeons and the American Association of Neurological Surgeons, provides here the expert consensus opinion on evidence-based best practices for the use and implementation of this treatment modality." 

The use of MRgFUS (magnetic resonance-guided focused ultrasound) to perform a thalamotomy and treat essential tremor (ET) has been proven in randomized controlled trials (RCT).  This patient fulfills all the indications for MRgFUS (magnetic resonance-guided focused ultrasound), as he has confirmed ET (essential tremor), he has failed at least two medications, and he has an appendicular tremor that interferes with quality of life.

The request for MRgFUS (magnetic resonance-guided focused ultrasound) could be efficacious for this patient.