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 upheld.

The patient is a male.  This patient has benign essential tremor, which is worse on the right side.  The surgeon recommends ultrasound thalamotomy.  A magnetic resonance
image (MRI) of the brain with and without intravenous (IV) contrast showed enhancing venous angioma in the right cerebellar hemisphere.  There were no enhancing lesions in the supratentorial compartment, no acute infarct, and no hydrocephalus.  The patient's neurologist had a telemedicine visit with the patient for a severe intention tremor.  The patient reported that the tremor was interfering with daily activities.  The neurologist noted an intermittent head tremor and a marked intention tremor of the right upper extremity.  The neurologist recommended a focused ultrasound thalamotomy treatment and an in-person office visit.

The patient's neurologist examined the patient for a disabling essential tremor.  The
patient reported increased presence of the tremor on the right upper extremity.  The
neurologist noted moderate to severe intention and positional tremor of both upper
extremities, with that tremor being worse on the right.  The neurologist recommended that the patient undergo a focused ultrasound thalamotomy.

No, the health plan should not cover the MRI guided ablation surgery (0398T).

Clinical studies are inadequate to show efficacy of focused ultrasound thalamotomy.  There is inadequate evidence of medical evaluation and treatment of tremor, including evaluation and treatment of Parkinson's disease.

Boutet et al. found magnetic resonance guided focused ultrasound (MRgFUS) thalamotomy to be a novel and minimally invasive ablative treatment for essential tremor.  The size and location of therapeutic lesions producing the optimal clinical benefits while minimizing adverse effects are not known.  These relationships were examined in patients with essential tremor undergoing magnetic resonance guided focused ultrasound (MRgFUS).  Sixty-six patients were studied with essential tremor who underwent magnetic resonance guided focused ultrasound (MRgFUS).  The Clinical Rating Scale for Tremor (CRST) scores was assessed at three months after the procedure and tracked the adverse effects (sensory, motor, speech, gait, and dysmetria) one day (acute) and three months after the procedure.  Clinical data associated with the postoperative Day 1 lesions were used to correlate the size and location of lesions with tremor benefit and acute adverse effects.  Diffusion-weighted imaging was used to assess whether acute adverse effects were related to lesions encroaching on nearby major white matter tracts (medial lemniscus, pyramidal, and dentato-rubro-thalamic).  The area of optimal tremor response at three months after the procedure was identified at the posterior portion of the ventral intermediate nucleus.  Lesions extending beyond the posterior region of the ventral intermediate nucleus and lateral to the lateral thalamic border were associated with increased risk of acute adverse sensory and motor effects, respectively.  Acute adverse effects on gait and dysmetria occurred with lesions inferolateral to the thalamus.  Lesions inferolateral to the thalamus or medial to the ventral intermediate nucleus were also associated with acute adverse speech effects.  Diffusion-weighted imaging revealed that lesions associated with adverse sensory and gait/dysmetria effects compromised the medial lemniscus and dentato-rubro-thalamic tracts, respectively.  Lesions associated with adverse motor and speech effects encroached on the pyramidal tract.  Lesions larger than 170 mm3 were associated with an increased risk of acute adverse effects.  Tremor improvement and acute adverse effects of magnetic resonance guided focused ultrasound (MRgFUS) for essential tremor are highly dependent on the location and size of lesions.  These novel findings could refine current magnetic resonance guided focused ultrasound (MRgFUS) treatment planning and targeting, thereby improving clinical outcomes in patients.

Sinai et al. found magnetic resonance guided focused ultrasound (MRgFUS) thalamotomy for essential tremor is an effective and safe procedure that provides long-term tremor relief and improvement in quality of life even in patients with medication-resistant disabling tremor.  However, additional studies with a larger group of patients is needed to substantiate these favorable results.

No, the magnetic resonance imaging (MRI) guided ablation surgery (0398T) is not likely to be more beneficial.

The patient has the treatment option of medical management, including betablockers for essential benign tremor.  In addition, there is an option of evaluation of Parkinson's disease and possible treatment of Parkinson's disease.