Medical Policy: 01.01.23
Original Effective Date: November 2000
Reviewed: August 2016
Revised: August 2016
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.
Neuromuscular electrical stimulation (NMES) involves the use of a device that transmits an electrical impulse to the skin over selected muscle groups by way of electrodes. There are two categories of NMES. One type of device is used to treat muscle atrophy and stimulates the muscle when the individual is in a resting state. The second type, is also known as functional electrical stimulation (FES), which is used to enhance functional activity (e.g., grasping utensils for feeding or ambulation) of neurologically impaired individuals.
Neuromuscular Muscular Electrical Stimulators (NMES) for Muscular Disuse Atrophy
NMES is used as a treatment modality for disuse atrophy due to a condition such as limb casting or hip replacement surgery, where the nerve supply to the muscle is intact. The NMES device encompasses a portable stimulator with electrodes that are placed on the skin over targeted muscle or muscle group. The current passes through the electrodes into the body, and the motor nerves are stimulated, causing a muscle contraction. The intensity and frequency of stimulation can vary based on the level of muscular function and response to treatment.
The use of NMES was studied by the Office of Health Technology Assessment (OHTA) at the Public Health Service in cases where neural supply (including brain, spinal cord, and peripheral nerves) to the muscle was intact or where other non-neurological reasons for disuse were causing atrophy. The report excluded clinical situations where the cause of the disuse was considered permanent or was characterized by a non-reversible pathology. Based upon their complete assessment of all relevant literature, OHTA concluded that the use of NMES for the treatment of disuse atrophy is considered effective therapy when the cause of the muscle disuse is not permanent and there is no nervous system involvement. In this situation, the treatment of disuse atrophy was considered a surrogate health outcome (that is, an intermediate outcome as opposed to an eventual outcome, such as the ability to ambulate), since the treatment of disuse atrophy generally leads to a full recovery of function.
Functional Electrical Stimulators for the Treatment of Neuromuscular Conditions
The second type of NMES is FES (functional electrical stimulation), which is used to enhance functional activity in neurologically impaired patients. The objective of FES is to activate targeted muscle groups to facilitate performance of functional activities (e.g., grasping utensils for feeding) or movements (e.g., ambulation). The use of FES has primarily been proposed for individuals with neurological conditions such as spinal cord injury (SCI), multiple sclerosis, cerebrovascular accident (CVA), and cerebral palsy (CP).
An application of FES is to provide individuals with a spinal cord injury (SCI) with the ability to stand and walk. The FES device delivers a precise sequence of electrical pulses to trigger action potential at selected nerves at the quadriceps (for knee extension), common peroneal nerve (for hip flexion), and the paraspinals and gluteals (for trunk stability). The individual uses 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. Additionally, there is a finger controlled switch that permits activation of the stepping by the individual. The Parastep® Ambulation System (Therapeutic Alliances, Inc, Fairborn, OH) is the only device to receive approval by the FDA and is indicated to “enable appropriately selected skeletally mature spinal cord injured patients (C6-T12) to stand and attain limited ambulation and/or management of spinal cord injury.”
How the Parastep System Works
The Parastep® Ambulation System works by delivering microcomputer-controlled electrical pulses through surface (skin) applied electrodes to nerves and muscles, causing muscle contractions. The computer is programmed to control the sequence of muscle contractions in the lower extremities that enable the functions of sit-to-stand, right and left step, and stand-to-sit. Users are taught to initiate functions by activating commands through switch modules mounted on the walker.
The system is designed to provide up to 6 channels of stimulation (i.e. stimulate up to 3 muscle groups on each leg/side). However, some individuals may require only 4 channels of stimulation to stand and ambulate.
The user initiates and controls the intensity of stimulation to the muscles and nerves through the keypad on the stimulator/control unit or through two switch modules mounted on the walker handle bars. The walker provides balance and stability during standing and walking.
Physical therapy is a key component to the Parastep® Ambulation System. Thirty-two sessions of physical therapy including instruction on system use and gait training, are provided to users when they purchase a system. The training is provided by hospital based physical therapists who have completed Sigmedics, Inc.’s clinical training program.
Each user’s progress is carefully monitored with frequent adjustments made in the training program to accomadate each user’s individual requirements. Treatment sessions progress at a pace set by each user’s ability, skill and proficiency.
To acquire a Parastep® Ambulation System an individual must participate in an approved Parastep® clinical training program and obtain a physicians prescription.
Other FES Devices
Other (FES) devices have been developed for individuals with foot drop. Foot drop is caused by weakness in the foot and ankle, which is activated by the peroneal nerve that results in a decreased dorsiflexion and causes difficulty with ambulation. It can be caused by neurological conditions that include spinal cord injury (SCI), multiple sclerosis (MS), cerebrovascular accident (CVA) and cerebral palsy (CP). WalkAide® and the Bioness NESS L300TM (Innovative Neurotronics, Inc., Bethesda, MD) are examples of FES devices for foot drop. The NESS L300TM consists of three components: a functional stimulation cuff is worn by the individual by the individual just below the knee and holds the stimulation device and electrodes. The gait sensor is worn inside the individuals shoe and automatically detects different walking speeds and surface and sends a signal to the functional stimulation cuff to adjust the stimulation to the peroneal nerve to allow the individual’s gait to be adjusted. The control device allows the individual to turn the NESS L300TM on and off, as well as make stimulation adjustments.
There have been small studies that have focused on FES devices for foot drop. However, these studies did not demonstrate that the use of such devices provide a clinically significant improvement in ambulation. A single randomized controlled trial examining FES for foot drop individuals with MS did not demonstrate a clinically significant benefit when compared with no stimulation or a program of exercise. Studies with a larger number of individuals over a longer duration are needed to permit conclusions concerning the safety and effectiveness of this technology on health outcomes in individuals with foot drop (gait disturbances).
The use of FES has been used in an effort to increase muscle strength in children with cerebral palsy (CP). Several randomized trials have failed to show clinically significant improvement in muscle strength or function.
Another application of FES is to restore upper extremity functions such as grasp-release in individuals with CVA or SCI. An example of FES device for the upper extremity is the NESS H200TM (Innovative Neurotronics, Inc., Bethesda, MD). It consists of two components, an orthosis and a control device. The orthosis fits on the individual’s hand and forearm and maintains the wrist in position to perform functional hand movements. It has electrodes that are in direct contact with the individuals forearm muscles. The control device has microprocessor that sends electrical impulses from the control device to the electrodes and stimulates the forearm muscles, causing muscle activation and the ability to pinch, grasp, and release. Based on the peer reviewed literature, the evidence for the use of FES devices for upper extremity function is limited by a small number of subjects and limited data demonstrating its utility outside the clinical setting. The available evidence is insufficient to conclude the safety and effectiveness that FES improves health outcomes of providing upper extremity function.
Microcurrent Electrical Nerve Stimulation (MENS)
MENS involves the use of a device that delivers small amounts of electrical current (millionths of an amp) to help relieve pain and heal soft tissues of the body. The application of microcurrent stimulation to an injured area is proposed to realign the body’s electrical current and increase the production of adenosine triphosphate, resulting in increased healing and recovery and blocking of perceived pain. The electrical current is subsensory and usually not felt.
Transcutaneous electrical modulation pain reprocessing (eg, scrambler therapy, TEMPR therapy)
Transcutaneous electrical modulation pain reprocessing (TEMPR), also called Scrambler therapy or Calmare® pain therapy, delivers electrical stimulation via the nerve fibers to convey a message of normality to the central nervous system (CNS) by a procedure defined as “scrambling” or “tricking” of information. The device is proposed to send a very low current of electrical stimulation through the nerve fibers, which carries a "no pain" signal to the brain that overrides the previous pain signal.
Regulatory Status
The Neurocontrol Freehand system received approval from the U.S. Food and Drug Administration (FDA) in 1997 through the premarket approval (PMA) process. 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.
The WalkAide device first received 510(k) marketing clearance from FDA in the 1990s; the current version of the WalkAide device received 510(k) marketing clearance in September 2005. The Odstock Foot Drop Stimulator received 510(k) marketing clearance in 2005. The Bioness NESS L300 received 510(k) marketing clearance in July 2006. FDA summaries for the 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.
To date, the Parastep® Ambulation System is the only noninvasive functional walking neuromuscular stimulation device to receive PMA from FDA. The Parastep device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6-T12) to stand and attain limited ambulation and/or take steps, with assistance if required, following a prescribed period of physical therapy training in conjunction with rehabilitation management of spinal cord injury.”
Not applicable.
Neuromuscular Electrical Stimulation (NMES)
Neuromuscular Electrical Stimulation (NMES) may be considered medically necessary for disuse atrophy where the nerve supply to the muscle is intact and the member has any of the following non-neurological reasons for disuse atrophy:
Neuromuscular Electrical Stimulation (NMES) for all other indications for disuse atrophy, including use where the nerve supply to the muscle is not intact, are considered investigational and, therefore, not covered because their safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
Functional Electrical Stimulation (FES) Lower Extremities
Functional neuromuscular stimulation (FNS)/functional electrical stimulation (FES) (e.g, Parastep® Ambulation System) may be considered medically necessary to enable members with spinal cord injury (SCI) to ambulate when all of the following criteria are met:
In addition to meeting all the above criteria, individuals with spinal cord injury (SCI) must have completed physical therapy (PT) training with the Parastep® Ambulation System. A physical therapy evaluation may be requested as part of any medical necessity review determination.
Individuals with a spinal cord injury (SCI) with the following conditions would not be considered candidates for the functional nerve stimulation (FNS)/functional electrical stimulation (FES) (e.g. Parastep® Ambulation System):
Functional electrical stimulation (FES) for indications other than listed above as medically necessary is considered investigational. Based on the peer reviewed literature there is insufficient evidence demonstrating the devices impact on safety and effectiveness on health outcomes for any other indications.
All Other FES Devices
FES devices including but not limited to the following are considered investigational for all indications including those listed below as the safety and effectiveness of these devices has not been established based on review of the peer reviewed medical literature.
ERGYS (leg cycle ergometer), REGYS (leg cycle ergometer), RT200 Elliptical, RT300 RES cycle ergometer (also referred to as FES bicycle), StimMaster Galaxy (FES exercise bike) or the RT600 Step and Stand Rehabilitation Therapy System for stationary exercise to prevent or reduce muscle atrophy in upper and lower extremities in individuals with hemiplegia or quadriplegia; OR
NESS H200 Handmaster NMS1 system or the RT300 FES cycle ergometer used for upper limb paralysis or hemiplegia; OR
NESS L300 Foot Drop System or NESS L300 Plus System used for foot drop in children and adults, as a result of cerebral palsy (CP), multiple sclerosis (MS), traumatic brain injury (TBI), stroke (CVA) or an incomplete spinal cord injury; OR
Walkaide or ODFS Dropped Foot Stimulator used for foot drop as a result of cerebral palsy (CP), multiple sclerosis (MS), traumatic brain injury (TBI), stroke (CVA), or an incomplete spinal cord injury.
Miscellaneous Electrical Devices
Microcurrent Electrical Nerve Stimulation (MENS), including frequency-specific microcurrent (FSM) is considered investigational.
FES and NMES are investigational for all other indications, including but not limited to the following:
Wellmark's policy is based on:
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