BlueCross BlueShield of Tennessee Medical Policy Manual

Neuromuscular Electrical Stimulation

Does not apply to Medicare Advantage, please refer to the Medicare policy addressing this topic.

DESCRIPTION

Neuromuscular electrical stimulation (NMES) involves using a device that transmits an electrical impulse to activate muscle groups through electrodes. There are two broad categories of NMES. One type stimulates the muscle when the individual is at rest. The nerve supply to the muscle is intact and includes brain, spinal cord and peripheral nerve injury, as well as other non-neurological reasons for disuse atrophy. This could include a limb that is immobilized or contractured due to scarring of tissue or surgical procedure such as hip replacement.

The second type is used to enhance functional activity of individuals. Neuromuscular electrical stimulation is also proposed for motor restoration in hemiplegia and treatment of secondary dysfunction (e.g., muscle atrophy and alterations in cardiovascular function and bone density) associated with damage to motor nerve pathways.

Functional Neuromuscular Electrical 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 that allow individuals 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, and typically in healthy individuals with intact neural control.

One application of functional NMES is to restore upper extremity functions such as grasp-release, forearm pronation, and elbow extension in individuals with stroke, or C5 and C6 tetraplegia (quadriplegia). The Neurocontrol Freehand system is an implantable upper extremity neuroprosthesis intended to improve an individual's ability to grasp, hold, and release objects and is indicated for use in individuals who are tetraplegic due to C5 or C6 spinal cord injury. The implantable Freehand System is no longer marketed in the U.S., though 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 individuals with stroke or C5 tetraplegia.

Other neural prosthetic devices have been developed for functional NMES in individuals with footdrop. Footdrop is weakness of the foot and ankle that causes reduced dorsiflexion and difficulty with ambulation. It can have various causes such as cerebral palsy, stroke or multiple sclerosis (MS). Functional electrical stimulation of the peroneal nerve has been suggested for these individuals as an aid in raising the toes during the swing phase of ambulation. In these devices, a pressure sensor detects heel off and initial contact during walking. A signal is then sent to the stimulation cuff, initiating or pausing the stimulation of the peroneal nerve, which activates the foot dorsiflexors. Examples of such devices used for treatment of footdrop are the Innovative Neurotronics’s (formerly NeuroMotion Inc.) WalkAide®, Bioness’ radiofrequency controlled NESS L300™, and the Odstock Foot Drop Stimulator. An implantable peroneal nerve stimulator system (ActiGait) is being developed in Europe.

Another application of functional electrical stimulation is to provide spinal cord-injured individuals with the ability to stand and walk. Generally, only spinal cord injury individuals with lesions from T4 to T12 are considered candidates for ambulation systems. Lesions at T1 to 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). Individuals use a walker or elbow-support crutches for further support. The electrical impulses are controlled by a computer microchip attached to the individual’s belt that synchronizes and distributes the signals. In addition, there is a finger-controlled switch that permits individual activation of the stepping.

Other devices include a reciprocating gait orthosis with electrical stimulation. The orthosis used is a cumbersome hip-knee-ankle-foot device linked together with a cable at the hip joint. The use of this device may be limited by the difficulties in putting the device on and taking it off.

H-Wave Electrical Stimulation

H-wave stimulation is a distinct form of electrical stimulation that produces a direct, localized effect on the conduction of underlying peripheral nerves. It differs in wave form from transcutaneous electrical nerve stimulation (TENS). It has been evaluated primarily as a pain treatment from a variety of etiologies including diabetic neuropathy, muscle sprains, temporomandibular joint dysfunction (TMJ), and reflex sympathetic dystrophy (RSD). It has also has been studied for wound healing and improving post-surgical range of motion.

There are multiple devices approved through the FDA pre market approval process. The Neurocontrol Freehand system, Handmaster NMS, Parastep® Ambulation System, the H - Wave® muscle stimulator, and Neurotronics WalkAide have been cleared for various electrical stimulation applications.

Threshold Electrical Stimulation

Threshold electrical stimulation is described as the delivery of low-intensity electrical stimulation to target spastic muscles during sleep at home. The stimulation is not intended to cause muscle contraction. Although the mechanism of action is not understood, it is thought that low-intensity stimulation may increase muscle strength and joint mobility, leading to improved voluntary motor function. The technique has been used most extensively in children with spastic diplegia related to cerebral palsy, but also in those with other motor disorders, such as spina bifida.

Devices used for threshold electrical stimulation are classified as “powered muscle stimulators.” As a class, the U.S. Food and Drug Administration (FDA) describes these devices as “an electronically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.”

This policy does not refer to commercially available exercycles that use electrical muscle stimulation technology as a means of physical therapy and exercise for individuals with a spinal-cord-injury. These exercycles are sometimes called functional neuromuscular exercisers; however, these are not functional neuromuscular electrical stimulation devices. The individual's legs are wrapped in fabric strips that contain electrodes to stimulate the muscles, thus permitting the individual to pedal. This is a physical therapy modality.

POLICY

Policies with similar titles:

IMPORTANT REMINDERS

Does not apply to Medicare Advantage, please refer to the Medicare policy addressing this topic.

ADDITIONAL INFORMATION

A compliance monitor is not considered to be a necessary component of a therapeutic electrical stimulator device.

There is a lack of randomized controlled trials providing evidence of the efficacy of neuromuscular electrical stimulation (NMES) for the indications listed as investigational in the above policy and for functional neuromuscular stimulation (FNS). Validation of NMES requires controlled, randomized studies that can isolate the contribution of the electrical stimulation from other components of therapy. FNS devices (e.g., Parastep Ambulation System) are being tried as a mode of short-term ambulation. However, final health outcomes, such as ability to perform activities of daily living or quality of life, have also not been reported.

Studies to date have failed to demonstrate that threshold electrical stimulation is effective at reducing spasticity, weakness, decreased joint mobility or motor function.

This policy does not address transcutaneous electrical nerve stimulation (TENS).

SOURCES

BlueCross BlueShield Association. Medical Policy Reference manual. (2:2014). Functional neuromuscular electrical stimulation (8.03.01). Retrieved April 15, 2014 from Blue Web. (35 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference manual. (11:2012). H - wave electrical stimulation (1.01.13). Retrieved March 1, 2013 from Blue Web. (9 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2013). Threshold electrical stimulation as a treatment of motor disorders (1.01.19). Retrieved April 15, 2014 from BlueWeb. (8 articles and/or guidelines reviewed)

Complete Guide to Medicare Coverage Issues[Computer software]. (November, 2013). Neuromuscular electrical stimulation (NMES) (NCD 160.12, p. 2-79, 2-80). OptumInsight, Inc.

ECRI Institute. Health Technology Assessment Information Service. Evidence Report. (2009, April). H-wave device stimulation therapy for pain management. Retrieved February 1, 2011 from ECRI Institute. (61 articles and/or guidelines reviewed)

U. S. Food and Drug Administration. (2008, January). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K080219. Retrieved February 7, 2011 from  http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080219.pdf.

Walker, J., Ryan, S., & Coburn, T. (2011) Does threshold electrical stimulation benefit children with spina bifida? Clinical Orthopedics and Related Research. 469 (5), 1297-301. (Level 4 Evidence Independent)

Winifred S. Hayes Inc. Medical Technology Directory. (2009, July; last update search August 2012). Functional electrical stimulation (FES) for the upper extremity rehabilitation post stroke. Retrieved April 15, 2014 from www.Hayesinc.com/subscribers (42 articles and/or guidelines reviewed)

Winifred S. Hayes Inc. Medical Technology Directory. (2010, December; last update search December 2012). Functional electrical stimulation for rehabilitation following spinal cord injury. Retrieved April 15, 2014 from www.Hayesinc.com/subscribers (56 articles and/or guidelines reviewed)

Winifred S. Hayes Inc. Medical Technology Directory. (2010, December; last update search January 2013). Neuromuscular electrical stimulation for rehabilitation in patients with cerebral palsy. Retrieved April 15, 2014 from www.Hayesinc.com/subscribers (49 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  3/1980

MOST RECENT REVIEW DATE:  6/12/2014

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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