Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Epilepsy.
Treatment: Empatica Embrace 2 Smart Watch (wearable device for seizure tracking).

The insurer denied the Empatica Embrace 2 Smart Watch (wearable device for seizure tracking).  The denial is upheld. 

The patient is a female who has benign Rolandic epilepsy. The request is for Empatica Embrace2.

No, the health plan should not cover the Empatica Embrace 2 Smart Watch (wearable device for seizure tracking).

No, the Empatica Embrace 2 Smart Watch (wearable device for seizure tracking) is not likely to be more beneficial.

Per the company's website, the Embrace2 is a prescription only device that is indicated for use as an adjunct to seizure monitoring in patients who have epilepsy.  It is FDA (United States Food and Drug Administration)-cleared (but not FDA [United States Food and Drug Administration]-approved) for adults and children ages six and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses electrodermal activity (EDA) and motion data to detect patterns that may be associated with generalized tonic-clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The system records and stores data from Accelerometer, EDA (electrodermal activity), and Temperature sensors for subsequent review by a trained healthcare professional.

Hayano and colleagues assessed the ability of a wearable device to detect sleep apnea.  The authors did not assess the device's ability to detect convulsive seizures.

Nasseri and colleagues asked patients to rate the usability and comfort of noninvasive wearable devices in several categories. Patients showed a significant preference for wristworn devices, and the Empatica device was preferred most often. The authors concludes, "Current wearable devices can provide highquality data and are acceptable for routine use, but continued development is needed to improve data quality, consistency, and management, as well as acceptability to patients."

Solveig and colleagues "continuously recorded multiday wristband data including electrodermal activity (EDA), temperature (TEMP) and heart rate (HR) from 66 people with epilepsy".  EDA [electrodermal activity] signal entropy was increased prior to seizures in a small subset of patients. The authors concluded, "Further validation and investigation of potential causes of the observed changes are needed."  Weakness of this study are its small size and cohort design.  There was no randomization or a control group.

Bruno and colleagues wrote, "In patients with epilepsy, the potential to prevent seizure-related injuries and to improve the unreliability of seizure selfreport have fostered the development and marketing of numerous seizure detection devices for home use."  They concluded, "A joint effort of clinical and nonclinical experts, patients, and caregivers is required to ensure an optimal level of acceptability and usability, which are key aspects for a successful continuous monitoring aimed at seizure detection at home."

Based on the above literature, while the Empatica Embrace 2 has the potential to detect convulsive seizures, the technology is unproven and requires further development.  The studies published thus far are small and lacking in scientific rigor.  As such, the Empatica Embrace 2 is not medically appropriate or standard of care.