Functional Neuromuscular Electrical Stimulation 

Medical Policy: 08.03.06 
Original Effective Date: November 2007 
Reviewed: October 2011 
Revised:  

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

Functional neuromuscular electrical stimulation (NMES) is a method being developed to restore function to patients with damaged or destroyed nerve pathways through use of an orthotic device with microprocessor-controlled electrical neuromuscular stimulation.

Neural prosthetic devices consist of an orthotic and a microprocessor-based electronic stimulator with one or more channels for delivery of individual pulses through surface or implanted electrodes connected to the neuromuscular system. Microprocessor programs activate the channels sequentially or in unison to stimulate peripheral nerves and trigger muscle contractions to produce functionally useful movements to allow patients to sit, stand, walk, and grasp. Functional neuromuscular stimulators are closed loop systems, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters which are required for complex activities such as walking. These are contrasted with open loop systems, which are used for simple tasks such as muscle strengthening alone, typically in healthy individuals with intact neural control.

One application of functional neuromuscular electrical stimulation (NMES) is to restore upper extremity functions such as grasp-release, forearm pronation, and elbow extension in patients with stroke, or C5 and C6 tetraplegia (quadriplegia). The Neurocontrol Freehand system received approval from the US Food and Drug Administration (FDA) in 1997 through the pre-market approval (PMA) process. The system is an implantable upper extremity neuroprosthesis intended to improve a patient’s ability to grasp, hold, and release objects and is indicated for use in patients who are tetraplegic due to C5 or C6 spinal cord injury. The implantable Freehand System is no longer marketed in the United States, although the company provides maintenance for devices already implanted. The Handmaster NMS I [neuromuscular stimulator] is another device that uses surface electrodes and is purported to provide hand active range of motion and function for patients with stroke or C5 tetraplegia. The Handmaster NMS I system was originally cleared for use in maintaining or improving range of motion, reducing muscle spasm, preventing or retarding muscle atrophy, providing muscle re-education, and improving circulation; in 2001, its 510(k) marketing clearance was expanded to include provision of hand active range of motion and function for patients with C5 tetraplegia.

Other neural prosthetic devices have been developed for functional NMES in patients with foot drop. Foot drop is weakness of the foot and ankle that causes reduced dorsiflexion and difficulty with ambulation. It can have various causes such as stroke or multiple sclerosis (MS). Functional electrical stimulation of the peroneal nerve has been suggested for these patients as an aid in raising the toes during the swing phase of ambulation. Examples of such devices used for treatment of foot drop are the Innovative Neurotonics’ WalkAide®, Bioness’ radiofrequency-controlled NESS L300™, and the Odstock Foot Drop Stimulator. The FDA summaries for these devices state that they are intended to be used in patients with drop foot by assisting with ankle dorsiflexion during the swing phase of gait.

Another application of functional electrical stimulation is to provide spinal cord-injured patients with the ability to stand and walk. Generally, only spinal cord injury patients with lesions from T4 to T12 are considered candidates for ambulation systems. Lesions at T1-T3 are associated with poor trunk stability, while lumbar lesions imply lower extremity nerve damage. Using percutaneous stimulation, the device delivers trains of electrical pulses to trigger action potentials at selected nerves at the quadriceps (for knee extension), the common peroneal nerve (for hip flexion), and the paraspinals and gluteals (for trunk stability). Patients use a walker or elbow-supported crutches for further support. The electrical impulses are controlled by a computer microchip attached to the patient’s belt that synchronizes and distributes the signals. In addition, there is a finger-controlled switch that permits patient activation of the stepping.

Functional neuromuscular stimulation used in conjunction with a recumbent ergometer attempts to replace stimuli from destroyed nerve pathways with sequential electrical stimulation of muscles to enable spinal cord-injured patients to rotate bicycle-like pedals with their legs. This therapy is purported to improve muscle strength, retard or reverse muscle atrophy or spasticity, and facilitate functional muscle movement. Various rehabilitative ergometers are marketed under trade names including, but not limited to,  ERGYS®, REGYS, SpectraSTIM 2000®, and NeuroEDUCATOR®.

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Prior Approval: 

Not applicable

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Policy: 

Neuromuscular stimulation is considered investigational as a technique to restore function following nerve damage or nerve injury. This includes its use in the following situations:

• As a technique to provide ambulation in patients with spinal cord injury
• To provide upper extremity function in patients with nerve damage (e.g., spinal cord injury or post-stroke)
• To improve ambulation in patients with foot drop caused by nerve damage (e.g., post-stroke or in those with multiple sclerosis)

The use of FNS with ergometers is considered investigational for the treatment of patients with spinal cord injury.

Evidence for neuromuscular stimulation to provide functional movement is limited by the small number of subjects and lack of data demonstrating utility outside the research setting.

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
• E1399 Durable medical equipment, miscellaneous

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Selected References: 

• Eser P, de Bruin ED, et al. Effect of electrical stimulation-induced cycling on bone mineral density in spinal cord-injured patients.  Eur J Clin Invest. 2003 May;33(5):412-9. Abstract obtained from Pub-Med.
• Szecsi J, Fornusek C, et al.  Low-frequency rectangular pulse is superior to middle frequency alternating current stimulation in cycling of people with spinal cord injury.  Arch Phys Med Rehabil. 2007 Mar;88(3):338-45.
• Thijssen DH, Ellenkamp R, et al.  Rapid vascular adaptations to training and detraining in persons with spinal cord injury.  Arch Phys Med Rehabil. 2006 Apr;87(4):474-81.
• Chen SC, Lai CH, et al.  Increases in bone mineral density after functional electrical stimulation cycling exercises in spinal cord injured patients.  Disabil Rehabil. 2005 Nov 30;27(22):1337-41.
• Trumbower RD, Faghri PD.  Kinematic analyses of semireclined leg cycling in able-bodied and spinal cord injured individuals.  Spinal Cord. 2005 Sep;43(9):543-9.
• Skold C, Lonn L, et al.  Effects of functional electrical stimulation training for six months on body composition and spasticity in motor complete tetraplegic spinal cord-injured individuals.  J Rehabil Med. 2002 Jan;34(1):25-32.
• Raymond J, Davis GM, van der Plas M.  Cardiovascular responses during submaximal electrical stimulation-induced leg cycling in individuals with paraplegia.  Clin Physiol Funct Imaging. 2002 Mar;22(2):92-8.
• Brosseau L, Wells GA, Finestone HM, Egan M, Dubouloz CJ, Graham I, Casimiro L, Robinson VA, Bilodeau M, McGowan J. Clinical practice guidelines for electrical stimulation. Top Stroke Rehabil 2006 Spring;13(2):54-60. Accessed March 16, 2009. Available at URL address: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=9918&nbr=005314&string=functional +AND+electrical+AND+stimulation
• ECRI. Neuromuscular Electrical Stimulation for Mobility and Motor Function following Spinal Cord Injury. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 October 8. 11p. (ECRI Hotline Response). Also available: http://www.ecri.org.
• Hamid S, Hayek R. Role of electrical stimulation for rehabilitation and regeneration after spinal cord injury: an overview. Eur Spine J 2008; 17(9):1256-69.
• Hausdorff JM, Ring H. Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil 2008; 87(1):4-13.
• Laufer Y, Hausdorff JM, Ring H. Effects of foot drop neuroprosthesis on functional abilities, social participation, and gait velocity. An J Phys Med Rehabil 2009; 88(1):14-20.
• Ring H, Tregor I, Gruendilinger L et al. Neuroprosthesis for footdrop compared with ankle-foot orthosis: effects on postural control during walking. J Stroke Cerebrovasc Dis 2009; 18(1):41-7
• Stein RB, Everaert DG, Thompson AK et al. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehail Neural Repair 2010; 24(2):152-67.
• Barrett CL, Mann GE, Taylor PN et al. A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Mult Scler 2009; 15(4):493-504.

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Policy History: 

Date                                        Reason                               Action

September 2010                     Annual review                     Policy renewed

October 2011                        Annual review                      Policy renewed

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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

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