Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Intractable epilepsy. 
Treatment: Laser interstitial thermal therapy (LITT). 
The insurer denied coverage for laser interstitial thermal therapy. 
The denial is upheld. 

This case involves a subject of review for the coverage of inpatient procedure for laser interstitial thermal ablation of the brain. The diagnosis of the patient is documented as tuberous sclerosis (TS) and intractable epilepsy. 

Magnetic resonance imaging (MRI) brain revealed moderate size region of encephalomalacia and gliosis within the right parietal, temporal, and occipital lobes. 3 millimeter (mm) enhancing focus within the right caudothalamic groove without significant change in size from prior examination. Linear like foci of T2/FLAIR hyperintensities (reflects the difference in the brain tissue at one part of the brain compared to the rest) within the bilateral supratentorial compartment, likely corresponding to areas of prior stereotactic electroencephalogram (sEEG) placement. Suggestion of decreased caliber of the right optic tract compared to the left. 

The patient was seen status post stereo electroencephalography (SEEG) and a pre-operative visit for laser ablation of epileptic focus. The provider discussed and planned to laser ablate tumors at the right frontal region with the Robotic Stereotactic Assistance (ROSA) assistance for both placement. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

The evidence for laser interstitial thermal therapy/thermotherapy (LITT) appears to have some promise for the future, but overall, the evidence is lacking, of low quality, and requires more substantial, randomized trials with long-term results. As such, it is likely not more beneficial than any of the standard treatments/procedures for this patient. 

The device was approved by the Food and Drug Administration (FDA) on October 26, 2016. 

In this case, the patient has been diagnosed with tuberous sclerosis (TS) and intractable epilepsy. She was born full-term and started to have infantile spasms a few weeks after birth. She has had numerous seizures and underwent open surgical resection of a right posterior tuber. She did well when her seizures started again. She also underwent a stereotactic EEG, followed by a right occipital lobectomy. However, it did not stop her seizures and she developed hemianopsia. Her seizures have continued since then. She has tried multiple antiseizure medications including Phenobarbital, Klonopin, Keppra, Vimpat, phenytoin, Onfi, oxcarbazepine, Depakote and Fycompa, and has tried a ketogenic diet as well. Her seizures are localization-related with impairment of consciousness. She is currently on Onfi and Epidiolex. She uses Diastat as a rescue medication for prolonged seizures. Her seizures have caused her to lose development. She had numerous big seizures which have caused her to regress and lose developmental milestones for the past 6-12 months. She has 12-15 seizures per day every day. Due to her continued seizures and loss of development she underwent another SEEG which revealed 11 clinical seizures which seem to start at tumors in her right frontal lobe. The patient has already had multiple open craniotomies which makes another open surgery significantly riskier for her, as the dura will be scarred to the parenchyma in the vessels of the brain's surface will be very friable. Plus, because she has already had significant brain resection, they want to preserve the brain tissue the patient has. 

The insurer's denial of LITT should be upheld as the procedure is not likely to be more beneficial.