Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.  The physician reviewer found that the standard of rehabilitative care in the setting of central nervous system pathology such as stroke resulting in severe functional impairments is to directly address these impairments and optimize overall function, as well as to mitigate the risks of health complications. Depending on the impairments specific to a case, increased independence can be achieved using equipment, such as assistive speech technology, adaptive utensils, nonskid plates, gait/mobility implements, wheelchairs, and other adaptive equipment and accessibility/environmental modifications, if/when appropriate. When there are limits to function despite exhausting more direct interventions, or when efficiency or safety call require it, caregivers may be called upon to otherwise meet a personas functional needs.There is no proven role of the MyoPro elbow-wrist-hand-finger orthosis in stroke management or rehabilitation. The proposed device does not replace the role of conventional (i.e., passive, light and custom-fitted) orthoses, which can be employed as needed to manage the effects of tone, to reinforce therapeutic positioning, and to enhance functionality when applicable. The device in question is not expected to practically assist a user in self-care tasks such as grooming, bathing, dressing, or other tasks requiring dextrous upper extremity use. Given the weight, bulk, and delayed responses effectuated by the device in question, adoption of the device for regular functional use on a long-term basis is not expected to be likely.
There are, moreover, potential adverse sequelae and safety issues related to this device, including the potential to cause or exacerbate edema, skin injuries, musculoskeletal injuries or pain, including hemiplegic shoulder pain. Hemiplegic shoulder pain, in particular, is highly prevalent following stroke, affecting up to 50% of this population. Its etiology is multifactorial, but glenohumeral subluxation is an important factor. Risk factors for shoulder subluxation and hemiplegic shoulder pain include increased levels of weakness, i.e., shoulder muscles that are too weak to adequately support the weight of the upper limb against gravity. The device in question can add approximately 50% to the weight of an arm, which would increase the risk of subluxation and hemiplegic shoulder pain. 
In addition, the safety of using this device while standing or walking in persons who have impaired lower limb strength and balance due to stroke with hemiparesis is unclear. Falls could be potentially precipitated in device users with unexpected disturbances in their center of gravity that cannot be adequately compensated for while using the heavy device due to stroke-related impairments in balance and the hemiparetic trunk and lower limb.
There are, overall, no functional benefits that would be expected from the use of this device. There are potential risks of injury associated with use of this device, as discussed above.  There is a lack of proven health benefits associated with the use of this device. The available scientific evidence related to the type of orthotic device in question is limited to preclinical work and anecdotal literature.  The requested device is not likely to be more beneficial for treatment of the patientas medical condition than any available standard treatment and rehabilitation for chronic functional impairment following severe stroke, which would include the devices and supportive care discussed above. Therefore, the requested powered upper extremity range of motion assist device, elbow, wrist, hand and finger is not likely to be more beneficial than other methods of evaluating this patient.