Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for an exoskeleton device. Current medical literature does not support the use of powered exoskeletal ambulatory assistance devices as an efficient, reliable or practical means of mobility for persons with paraparesis/paraplegia or other neurological disorders impairing upright ambulation. Researchers found that the applicability and effectiveness of lower limb exoskeletons as assistive devices in the community have not been demonstrated. Additionally, researchers note that the weight of exoskeleton devices, the need for upper extremity supports, supervision requirements, and a limited range of movements are issues that restrict opportunities for using such devices in real-world contexts. Medical literature shows that the use of exoskeletons comes with considerable feasibility challenges. Regarding the experience of robotic exoskeleton use at four spinal cord injury model system centers, researchers noted that a typical episode of outpatient exoskeleton therapy comprised 20 to 30 sessions, with at least two staff members involved in each session. The authors further noted that potential risks included falls, skin irritation, and disappointed expectations, and that the ability to navigate stairs and uneven surfaces remained a challenge. The authors identified several risks, including falls, joint misalignment, skin damage, software malfunction, leading to uncontrolled behaviors, electrical and fire hazard, and user error. Additional medical literature explains that the risks of unexpected (technical) adverse events and the risk of fractures in the use of powered exoskeletons are not fully understood and presented the occurrence of two different cases of bone fracture during exoskeleton use. There is a lack of evidence on the health benefits 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. Authors report that there is strong, consistent evidence that exercise can improve cardiorespiratory fitness and muscular strength in people with spinal cord injuries resulting in tetraplegia or paraplegia. In this case, regular physical activity using volitionally active musculature, such as the propulsion of a manual wheelchair, wheelchair sports, and other adaptive sports/exercise activities are appropriate levels of cardiovascular and musculoskeletal exercise. In this clinical setting, given the increased exposure to potential adverse sequelae, lack of proven health benefits, and as a wheelchair is an established, reliable, efficient and safe therapy for this patients mobility needs, the requested equipment is not medically indicated. Therefore, an exoskeleton device is not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested equipment is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation and is actively practicing. The reviewer is an expert 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.