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

Functional neuromuscular electrical stimulation is a closed-loop form of electrical stimulation that attempts to restore function in individuals with damaged or destroyed nerve pathways. The prosthetic device delivers individuals pulses through surface or implanted electrodes connected to the neuromuscular system. The stimulation of the peripheral nerves trigger muscle contractions to produce functionally useful movements. One application of NMES is to restore upper extremity functions in individuals with strokes, and C5 - C6 tetraplegia (quadriplegia).  Other applications of functional NMES include treatment for foot drop by assisting with ankle dorsiflexion and gait training in spinal cord injuries.

H-wave stimulation 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 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. (2:2012). Functional neuromuscular electrical stimulation (8.03.01). Retrieved March 1, 2013 from Blue Web. (28 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. (11:2012). Threshold electrical stimulation as a treatment of motor disorders (1.01.19). Retrieved March 1, 2013 from BlueWeb. (8 articles and/or guidelines reviewed)

Complete Guide to Medicare Coverage Issues[Computer software]. (November, 2012). Neuromuscular electrical stimulation (NMES) (NCD 160.12, p. 2-78, 2-79). 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 February 1, 2011 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 March 25, 2013 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 March 25, 2013 from www.Hayesinc.com/subscribers (49 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  3/1980

MOST RECENT REVIEW DATE:  5/9/2013

ID_BA

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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