Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a Functional Neuromuscular Electrical Stimulating Ergometer (The RT300 FES Therapy System).Findings:  Two out of three physician reviewers found that the requested Functional Neuromuscular Electrical Stimulating Ergometer (The RT300 FES Therapy System) is not likely to be more beneficial than any other available standard therapy for the patients condition.In a systematic review and meta-analysis, Eraifej and colleagues evaluated the effectiveness of post-stroke upper limb functional electrical stimulation (FES) on activities of daily living (ADL) and motor outcomes. A systematic review of randomised controlled trials (RCTs) was carried out. However, due to the very low quality evidence of these analyses, firm conclusions could not be drawn about the effectiveness of FES or its optimum therapeutic window. These researchers stated that there is a need for high quality large-scale RCTs of upper limb FES after stroke.An additional study done on the prevention and treatment of osteoporosis after spinal cord injury by Soleyman-Jahi and colleagues revealed very low-quality evidence that low- intensity cycling (3 days per week) with FES provided a benefit for reducing bone mineral density (BMD) loss in individuals with chronic Spinal cord injury (SCI). A 2016 study by Allison and colleagues involved a before and after cohort of 10 adults with SCI for more than 6 months using the RT300 FES-LE cycle (FES system for legs and core muscles) 3 times per week. The results showed that despite a substantial improvement in exercise performance and corresponding improvements in peripheral blood flow, 12 weeks of thrice weekly FES cycling was not sufficient to cause a corresponding reduction in clinical risk in terms of any hematological or immunological markers of cardiovascular disease. The study was also limited by a very small sample size.The evidence for the effectiveness of the RT300 functional electrical stimulation (FES) cycling in this patient with left sided hemiparesis, hypertonicity and impaired motor control from hemiparesis from brain tumor resection with cerebrovascular accident is limited. The literature does not reveal sufficient evidence for the RT300 FES in patients with hemiparesis from upper motor neuron disease, brain injury, stroke, or spinal cord injury. There is insufficient evidence in the literature that supports that the use of the RT300 FES will be effective for this patients condition or in individuals with hemiplegia. There is insufficient evidence of long-term improvement of muscle strength, vascular blood flow, bone mineral density, reduction of spasticity and atrophy, facilitation of functional motor movement or reduction muscle atrophy in the upper and lower extremities for hemiparesis caused by a cerebrovascular accident. Accordingly, the requested Functional Neuromuscular Electrical Stimulating Ergometer (The RT300 FES Therapy System) is not likely to be more beneficial than any other available standard therapy for the patients condition.Final Result: The reviewers determined that the requested device is not likely to be more beneficial than any other available standard therapy for the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, and 3 are board certified in physical medicine and rehabilitation and are actively practicing. Physician reviewer 2 is board certified in physical medicine and rehabilitation, with subspecialty certification in neuromuscular medicine, and is 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.