Neuromuscular Electrical Stimulation (NMES) for Spinal Cord Injury

CMS NCA document | source_status=Closed | review_type=1st Recon | public_comment_open=False | document_id=CAG-00153R

One type of NMES that is used to enhance functional activity of spinal cord injured (SCI) patients is commonly referred to as functional electrical stimulation (FES). These devices use electrical impulses to activate paralyzed or weak muscles in precise sequence and have been utilized to provide SCI patients with the ability to walk. Based on all of the evidence that we have reviewed, it is our intention to issue a positive national coverage determination for the use of NMES/FES limited to walking in SCI patients, but we will maintain the existing national non-coverage policy for the treatment of disuse atrophy in SCI patients. Use of NMES/FES poses a risk from falling for SCI patients. It also requires that a person possess certain abilities to successfully use these types of devices. In addition, patients require many sessions of physical therapy to learn how to use the device properly and the clinical studies report that many patients do not use NMES/FES long term. Therefore, we will cover an NMES/FES system when used by an SCI patient for walking in the home only after the patient has completed regular sessions of physical therapy with the device over a period of 3 months. This trial period of physical therapy will enable the clinician to properly evaluate the person’s ability to use these devices for the long term. The goal of this therapy must be to train SCI patients on the use of NMES/FES devices to achieve walking, not to reverse or retard muscle atrophy. The training program would be covered under the physician fee schedule, with no additional payment being made for the equipment used by the patient, as the equipment is in the practice expense portion of the payment. Consistent with the FDA labeling for Parastep®I and the inclusion criteria for most of the studies reviewed, coverage for NMES/FES for walking, whether in the setting of physical therapy or home use, will be limited to SCI patients with all of the following characteristics: 1) persons with intact lower motor units (L1 and below); 2) persons with muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently; 3) persons that demonstrate brisk muscle contraction to NMES and have sensory perception of electrical stimulation sufficient for muscle contraction; 4) persons that possess high motivation, commitment and cognitive ability to use such devices for walking; 5) persons that can transfer independently and can demonstrate standing tolerance for at least 3 minutes; 6) persons that can demonstrate hand and finger function to manipulate controls; 7) persons with at least 6-month post recovery spinal cord injury and restorative surgery; 8) persons without hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis; and 9) persons who have demonstrated a willingness to use the device long-term. NMES/FES for walking will not be covered in SCI patients with any of the following: 1) persons with cardiac pacemakers; 2) severe scoliosis or severe osteoporosis; 3) skin disease or cancer at area of stimulation; 4) irreversible contracture; or 5) autonomic dysreflexia. All uses of NMES other than for the treatment of disuse atrophy in neurologically intact patients and for walking in SCI patients remain non-covered.