Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lower Limb Paralysis	

Treatment: Durable medical equipment (DME) MyoCycle Home FES (functional electrical stimulation) Cycling Therapy System

The insurer denied coverage for DME MyoCycle home FES cycling therapy system.

The denial is overturned.

According to the documentation submitted, this is a female with a history of lower limb paralysis from a spinal cord injury, multiple sclerosis (MS), and myelitis. She presented to the Neurologist's office for evaluation of myelitis. The patient started disease modifying MS therapy. She was treated with Avonex, Tysabri, and Gilenya. Symptoms were mild at that time. She was able to work, drive, and climb steps. The patient's presentation was consistent with meningoencephalitis complicated by arachnoiditis and vasculitis leading to medullary infarcts with conus medullaris. She had consistent paraparesis, urinary incontinence, spasticity, numbness, and neuropathic pain. The patient's Neurologist prescribed the MyoCycle home FES (functional electrical stimulation) cycling therapy system. 

The durable medical equipment (DME): MyoCycle home FES cycling therapy system is considered medically necessary for this patient to treat the secondary conditions concomitant to their primary diagnosis. The patient has lower limb paralysis resulting from spinal cord injury. This is a major cause of secondary health conditions including muscle atrophy, poor circulation, limited joint range of motion, and muscle spasticity. Advanced rehabilitation strategies are needed for managing disability accumulation in people with multiple sclerosis, 

The MyoCycle is a unique device that is capable of mobilizing actively the lower limbs to generate therapeutically significant metabolic demand, improve musculoskeletal and cardiovascular health. This is achieved through FES. Since the patient's peripheral nerve supply is intact, FES can achieve strong coordinated muscle contractions in the legs. This positive response is supportive of the future benefits of a home FES program. These benefits have been well documented and have made FES cycling a standard of care for neurorehabilitation patients. To achieve such benefit, they must engage in FES cycling for at least 30 minutes per day three days per week. Therefore, it is essential to receive a MyoCycle Home FES cycling therapy for regular use at home. Patient is extremely motivated and is an excellent candidate for this equipment. The progress notes from her physical therapist showed the tremendous gains she has had in functional mobility. Physical Therapy wrote that she has been making daily gains on her gait quality, gait speed and distance. She has good potential to reach and maintain her prior level of function. 

The MyoCycle is an Rx [medical prescription]-only Class II medical device that is approved for sale in the United States (US) by the Food and Drug Administration (FDA). Indications include: relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, and increasing or maintaining range of motion. Contraindications include cardiac pacemaker, implanted defibrillator or other implanted electronic device, unhealed bone fractures in the lower extremities, severe contractures, osteoporosis or osteogenic imperfecta. Several studies show that FES cycling has beneficial effects on cognition and symptoms of fatigue and pain in people with multiple sclerosis with mobility disability.

The health care plan did not act reasonably, with sound medical judgment, or in the best interest of the patient. This DME MyoCycle home FES cycling therapy system is medically necessary for this patient. 

This decision is based on the clinical standards of the plan, the information provided concerning the patient, the attending physician's recommendation, and applicable generally accepted practice guidelines developed by the federal government, national or professional medical societies, boards, and associations.

The insurer's denial of coverage for durable medical equipment (DME): MyoCycle home FES cycling therapy system is reversed. Medical necessity is substantiated.