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Functional neuromuscular electrical stimulation (NMES) involves the use of an orthotic device with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function to patients with damaged or destroyed nerve pathways (eg, stroke, spinal cord injury, multiple sclerosis [MS], cerebral palsy).
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 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 (eg, walking). These systems are contrasted with open-loop systems, which are used for simple tasks (eg, 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 patients with stroke, or C5 and C6 tetraplegia (quadraplegia). NeuroControl Corp. developed the Freehand System, an implantable upper-extremity neuroprosthesis, to improve a patient's ability to grasp, hold, and release objects for patients with tetraplegia due to C5 or C6 spinal cord injury. NeuroControl Corp. is no longer in business, but NMES centers in the United States and United Kingdom provide maintenance for implanted devices. The NESS H200 (previously known as the Handmaster NMS I system) is an upper- extremity device that uses a forearm splint and surface electrodes. The device, controlled by a user-activated button, is intended to provide hand function (fine finger grasping, larger palmer grasping) for patients with C5 tetraplegia or stroke.
Other neural prosthetic devices have been developed to provide functional NMES for patients 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. 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. 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’ (formerly NeuroMotion Inc.) WalkAide, Bioness’s radiofrequency controlled NESS L300, MyGait (Otto Bock HealthCare), 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 patients with spinal cord injury the ability to stand and walk. Generally, only spinal cord injury patients with spinal 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-support crutches for further support. The electrical impulses are controlled by a computer microchip attached to the patient’s belt, which synchronizes and distributes the signals. In addition, there is a finger-controlled switch that permits patient 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.
Other devices, such as the ReGrasp (Rehabtronics), are used for rehabilitation rather than home use. Neuromuscular stimulation is also proposed for motor restoration in hemiplegia and treatment of secondary dysfunction (e.g., muscle atrophy, alterations in cardiovascular function and bone density) associated with damage to motor nerve pathways. These applications are not addressed in this policy.
In 1997, the Freehand® (NeuroControl Corp.) was approved by the U.S. Food and Drug Administration (FDA) through the pre-market approval (PMA) process. The implantable Freehand® System is no longer marketed in the United States. The Handmaster NMS I system (now named NESS H200®) was originally cleared for marketing by FDA through the 510(k) process 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® System (Innovative Neurotronics) first received 510(k) marketing clearance from the 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. The MyGait® Stimulation System (Otto Bock HealthCare) received 510(k) marketing clearance in 2015. The FDA summaries for the devices state that they are intended to be used in patients with footdrop 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 premarket approval (PMA) from the U.S. Food and Drug Administration (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.”
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:
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
9/1992: Approved by Medical Policy Advisory Committee (MPAC)
8/2000: Reviewed by MPAC, investigational status maintained.
10/17/2000: Description and Sources section updated.
6/11/2001: Management Care Requirements section deleted and Code Reference section updated
7/5/2001: ICD-9 procedure code 93.39 added
2/11/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
6/5/2002: Code Reference section updated, CPT code 97032 deleted, ICD-9 diagnosis codes 952.00-952.9 and V57.1 deleted, ICD-9 procedure code 93.39 deleted
8/17/2004: Code Reference section updated, HCPCS E0745 term date added, HCPCS K0600 added
3/28/2006: Coding updated. HCPCS 2006 revisions added to policy
3/29/2006: Policy reviewed, no changes
1/10/2008: Policy reviewed, no changes
05/13/2010: Policy title changed from “Functional Neuromuscular Stimulation to Provide Ambulation” to “Functional Neuromuscular Electrical Stimulation.” Policy description updated regarding treatment approaches and devices. Policy statement updated to remove “to provide ambulation” and to add “to restore function.” Additional applications (hand and foot) were added to the policy statement. FEP verbiage added to the Policy Exceptions section. Added HCPCS code E0770.
04/25/2011: Policy reviewed; no changes.
03/27/2012: Policy reviewed; no changes.
07/18/2013: Policy reviewed; no changes.
04/01/2014: Policy reviewed; policy statement updated to add "congenital disorders (eg, cerebral palsy)" to investigational statement.
03/19/2015: Policy description updated regarding devices. Policy statement unchanged.
08/25/2015: Code Reference section updated for ICD-10.
05/27/2016: Policy number A.8.03.01 added. Investigative definition updated in Policy Guidelines section.
09/23/2016: Policy description updated regarding devices. Policy statement unchanged.
Blue Cross Blue Shield Association policy #8.03.01
This may not be a comprehensive list of procedure codes applicable to this policy.