Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 23-year-old male enrollee has requested authorization and coverage for powered robotic lower body exoskeleton system. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrolleeas medical condition. The physician reviewer found that the published evidence indicates that the powered exoskeletal ambulatory assistance devices that are currently commercially available are not an efficient, reliable or practical means of mobility for persons with paraplegia and other neurological disorders who seek upright ambulation. This type of device is associated with high feasibility challenges and has not met usersa high expectations of benefits. Therapist or caregiver/companion supervision and assistance are almost always required for safety and sometimes for physical assistance. Environmental barriers, such as curbs/stairs/steps, and differing surfaces remain challenges. In fact, walking in any pattern outside of a straight line on a flat and level surface can be challenging. The devices, overall, fail to promote a general increase in user independence in everyday life contexts, and in fact can be more disabling than enabling. There are, more importantly, multiple risks associated with use of this device as a mobility device outside of very controlled environments such as a physical therapy gym, including but not limited to, the risk of falls and the risk of becoming stranded (due to mechanical failure, loss of power, etc.). The risk of accidents while using these types of devices in highly dynamic environments cohabitated by other humans and machines remains particularly understudied. Current screening protocols for fracture risk, such as tolerance for standing on a passive stander or DEXA bone densitometry testing, appear to remain inadequate to screen out individuals who develop fragility fractures due to use of these types of devices. There is no proven health benefit of standing and intermittent passive walking using an externally powered exoskeleton to passively move the lower limbs to favorably balance out the risks of using these types of devices. Standard of care for achieving appropriate levels of cardiovascular and musculoskeletal exercise in the setting of this patientas condition would be performing regular physical activity using volitionally active musculature, including, but not limited to, propulsion of a manual wheelchair, wheelchair sports and other adaptive sports/exercise activities. There is no expected health benefit of standing and ambulation using an externally powered exoskeletal device over natural, self-powered activity and exercise. The reported health benefits discussed in papers published with industry support are subjective in nature and have not been demonstrated in a scientifically rigorous manner. On balance, the increased exposure to potential adverse sequelae with use of the device under review is unnecessary given the lack of proven benefits and given that a much more established, reliable, efficient, useful and safe means of mobility and tool for active exercise is readily available, i.e., a wheelchair, which would represent readily available standard therapy for this patientas condition. The requested device is not likely to be more beneficial for treatment of the patientas health than standard treatment, which would include a properly fitted manual wheelchair and active cardiovascular and musculoskeletal exercises using volitionally intact motor function. Therefore, the requested powered robotic lower body exoskeleton system is not likely to be more beneficial than other available standard therapy.