Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Intracerebral hemorrhage(s) affecting the left frontoparietal and left occipital lobes; intraventricular hemorrhage and midline shift. 
Treatment: Powered brace (for right arm) L8702. 

The insurer denied the Powered brace (for right arm) L8702. 
The denial is upheld. 

The patient is a left hand dominant female who sustained intracerebral hemorrhage(s) affecting the left frontoparietal and left occipital lobes postpartum.  There was also intraventricular hemorrhage and a midline shift.  She underwent left hemicraniectomy followed by inpatient rehabilitation, cranioplasty and further inpatient rehabilitation.  She was ultimately discharged to the community.  She received botulinum toxin injection therapy to the right upper limb to address tone. 

There has been chronic residual right-sided weakness.  The patient's right upper limb strength is in the 1/5 to 2/5 range.  There is mild spasticity at the right biceps brachia and the right wrist/finger flexors.  She has been performing self-care tasks using her left upper limb.  She has been receiving help from family, friends and home health aides.  She has been ambulating with an ankle foot orthosis on the right side.  She did have a fall due to impaired balance and her right-sided weakness.  She did return to work at a computer center. 

A myoelectric elbow-wrist-hand-wrist orthosis for the right upper limb has been recommended to improve her function at home and at work.  The patient hopes to engage in more care of her children, and type with both hands. 

No, the proposed treatment is not medically necessary. 

The proposed device for the right upper limb is not expected to practically assist the patient in performing her basic self-care tasks, instrumental activities of daily living, child care or mobility tasks any more efficiently or effectively than by using her left dominant upper limb alone.  The proposed device is not expected to meaningfully enhance the patient's independence or reduce her burden of care from others.  It is not expected to help her in a meaningful manner with respect to work, particularly with respect to typing using both hands.

The proposed device is also not proven as a treatment to help a person regain neurological/muscular strength or function after a cerebral event such as a hemorrhagic stroke, such that a person's innate ability to use the arm for functional tasks is improved when the orthosis is removed.  The current literature regarding the potential of the device to improve strength or function is limited to anecdotal literature and small trials, including industry-supported trials (e.g., Maciejasz P, et al., Proietti T, et al.; Peters HT, et al.; McCabe JP, et al.).  Larger trials are either in progress or planned.  It is not proven to improve other health outcomes following a stroke, such as reducing the incidence of overuse injury of the sound, unaffected limb. 

There are also safety concerns related to the use of this device.  The device, which is very heavy relative to the anatomical weight of the arm that will wear it, can cause the shoulder to sublux, which can cause or worsen pain (Harrison RA and Field TS; Arya KN, et al.).  The device may also cause a person with a hemiparetic gait to have greater instability while ambulating due to an unfavorable displacement of the center of gravity (superiorly and laterally) that wearing the device will cause.  There is no reasonable expectation that the upper extremity using the proposed device can handle a cane effectively and efficiently, such that the patient's gait and safety would be enhanced with use of the device. 

The proposed device, on balance, plays no evidence-based part in stroke management, rehabilitation or prevention of complications following stroke as noted on recent reviews (Winstein CJ, et al.; Belagaje SR; Jolliffe L, et al.; Stinear CM, et al.).  It does not enhance or 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.  While conventional orthoses cannot restore the functional deficits that a person with a stroke has sustained, the proposed device is not expected to provide any clinically or functionally significant marginal benefits over conventional orthotic therapy or any other standard therapy for the treatment of stroke-related functional deficits. 

As discussed above, the proposed device is not expected to improve the patient's health or function in a clinically significant manner.  It is not medically necessary.  Denial of coverage of the proposed device was reasonable.