Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a functional electrical stimulation (FES) system (Bioness NESS L300 foot drop system). Van der Woude and colleagues explain that with increasing age and time since injury, patients with spinal cord injury may develop long-term medical complications including spasticity, osteoporosis, fractures, heterotopic ossification, limb edema, muscle atrophy, pressure sores, urinary and respiratory tract infections, contractures, extremity pain, obesity, diabetes, and cardiovascular disease. The authors note that these secondary health conditions associated with an inactive lifestyle may result in reduced societal participation, quality of life, and frequent hospitalizations and that avoiding this downward spiral course and improving physical and mental well-being are crucial in such patients. FES interventions with hand and leg neuroprostheses may be effective in preventing these secondary health conditions in incomplete injuries and in improving conditioning and the fitness levels of patients, increasing their participation in the community and improving quality of life. Current medical literature supports the benefit of FES system in achieving better outcomes for strengthening, reducing spasticity, and improving quality of life over other standard, traditional therapy modalities such as range of motion, stretching, positioning, progressive resistance training, activity based programs, or the use of orthotics and splinting for stretching and positioning. Giangregorio and colleagues report that FES stimulation for walking in patients with incomplete spinal cord injury may maintain muscle area in the long-term. The U.S. Food and Drug Administration (FDA) approves the use of the requested device for patients with foot drop following an upper motor neuron injury or disease to prevent muscle disuse atrophy, improve blood circulation, maintain or increase joint range of motion, and improve gait. In this case, the patient has an incomplete paraplegia spinal cord injury with neurological involvement, with secondary complications. The goal of rehabilitation treatment in this setting would be to maintain the patients mental and physical health, improve her quality of life, and prevent further deterioration of her function and health. In this clinical setting, the requested device allows the patients participation in daily life which otherwise would be difficult or impossible for patients with spinal cord injury. Therefore, a FES system (Bioness NESS L300 foot drop system) is likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested a FES system (Bioness NESS L300 foot drop system) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested equipment is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in physical medicine and rehabilitation and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.