Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Trauma/Injuries/Spinal Cord Injury. 
Treatment: RT300 Functional Electrical Stimulation (FES) Therapy System. 

The health plan has denied the RT300 Functional Electrical Stimulation (FES) Therapy System. The health plan's determination is overturned. 

The patient is a young man who has no previous medical history. He sustained a severe spinal cord injury because of diving into a pool, hitting the shallow side. He had retropulsion of his head and neck, resulting in acute fractures of (cervical) C1 and C6.  An magnetic resonance imaging (MRI) showed extensive acute traumatic injury to the cervical spine, with a probably unstable fracture dislocation at C6, edema compatible with acute fracture at C1, and malalignment and retropulsion at C6, with severe spinal stenosis, cervical spinal compression, epidural hemorrhage and extensive cervical spinal cord contusion. 

The patient underwent a C6 corpectomy, and C5-T2 posterior spinal internal fixation and C5-7 laminectomy. He required intubation and ventilatory support for several days for respiratory failure. Chest imaging showed paralysis of the diaphragm. Bronchoscopy was performed, which showed Hemophilis influenzae pneumonia, for which he was treated with antibiotics. A lumbar drain was placed for a fluid collection on the anterior side of his neck, and repeated lumbar punctures were performed due to swelling and bulging of the anterior cervical wound. 

At the time of discharge from the acute care hospital, the patient's examination was significant for him using abdominal muscles to breathe. Power from C5-(thoracic) T1 ranged from 3/5 to 5/5. Power in the legs was 0/5 except for L5, which was 1/5. Sensation was diminished to light touch from C6 downwards, and there was severe sensory loss from T4 down. Deep tendon reflexes were 2+ in the arms, 1+ in the legs.  Plantar reflexes were upping bilaterally. He had a neurogenic bowel and bladder. The patient was transferred to a rehabilitation hospital. Documentation by his physical and occupational therapists describe that he has incomplete C5-7 tetraplegia. He had several spinal cord injury-related complications during his stay at the rehabilitation hospital including urinary tract infection, neuropathic pain, a sacral pressure area requiring a wound vacuum placement, and hypotension. Medications included Prozac for depression, Neurontin for neuropathic pain, Spiriva, Protonix, Midodrine, and Baclofen for spasticity, Colace, Senokot and enemas for bowel regimen. He also took zinc and multivitamin supplements. He was taught intermittent bladder catheterization. At the time of discharge  the patient required supervision for upper body dressing, and moderate assistance for lower body dressing. Elastic laces were used in his shoes. He required supervision for grooming. He was able to perform 60% of bathing tasks, requiring moderate assistance. He required supervision and set-up for eating. He required supervision for bed mobility and intermittent assistance when going from sitting to lying, and vice versa. He required significant assistance transferring from chair to bed, wheelchair, shower and toilet. He was fitted for a custom front-wheeled power wheelchair. 

The patient's parents arranged for modifications to be made to his home to make it wheelchair accessible. He and his family were instructed on topics including orthostatic hypotension, autonomic dysreflexia, body mechanics, energy conservation and home safety. 

As part of his rehabilitation, the patient received Functional Electrical Stimulation (FES).  A report by Restorative Therapies, the manufacturer of the RT300 Functional Electrical Stimulation (FES) Therapy System, indicated that he had 22 leg FES sessions and 2 arm therapy sessions. His physical therapist described that the benefits of the FES cycling included relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion. He tolerated FES therapy, demonstrating improvements in distance and endurance. 

The patient's neurologist and Physical Medicine and Rehabilitation specialist recommended that he be provided with a RT300 Functional Electrical Stimulation (FES) Therapy System, so that he could continue therapy at home. Whether the device is medically necessary is the issue at question in this review. 

The health plan's determination of medical necessity is overturned, in whole. 

The requested health service/treatment of RT300 Functional Electrical Stimulation (FES) Therapy System is medically necessary for this patient. 

The RT300 Functional Electrical Stimulation (FES) Therapy System has been prescribed by the treating physician, and is medically necessary to prevent the worsening and to treat or rehabilitate conditions and their associated symptoms, impairments or functional limitations that endanger life, cause suffering or pain, cause physical deformity or malfunction, threaten to cause or to aggravate a disability, result in illness/infirmity or result in worsening illness/infirmity, including cardiovascular reconditioning, pressure sores, osteoporosis, spasticity and muscle spasms. The device is in accordance with the generally accepted standards of medical practice, and is clinically appropriate, in terms of type. Peer review publications support that the device is considered effective for the patient's illness, injury or disease. 

Functional electrical stimulation (FES) is a technology that can be used on paralyzed muscles to enable them to move. It has been used in individuals with muscle paralysis or weakness, such as spinal cord injury (SCI). "The RT300 combines functional electrical stimulation (FES) with a motorized ergometer that allows repetitive cycling activity as part of a rehabilitation program for people with a spinal cord injury. It stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. It can stimulate muscle groups in 1 or both arms or legs and trunk in a coordinated cycling motion" [1]. 

The medical sequelae of a spinal cord injury are profound. The World Health Organization [2] describes that "Spinal cord injury is associated with a risk of developing secondary conditions that can be debilitating and even life-threatening-e.g. deep vein thrombosis, urinary tract infections, muscle spasms, osteoporosis, pressure ulcers, chronic pain, and respiratory complications.  Acute care, rehabilitation services and ongoing health maintenance are essential for prevention and management of these conditions."