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Functional Neuromuscular Electrical Stimulation (NMES), also referred to as functional electrical stimulation (FES), attempts to replace stimuli from destroyed nerve pathways with sequential electrical stimulation of muscles through surface electrodes. Upper extremity surface NMES devices are designed to activate muscles of the paralyzed forearm and hand, while lower extremity surface NMES devices are designed to improve or restore ambulation or to alleviate foot drop.
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." Using percutaneous stimulation, the Parastep 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 gluteal nerves (for trunk stability). In addition, 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 that synchronizes and distributes the signals. Moreover, there is a finger-controlled switch that permits patient activation of the stepping.
Foot drop is weakness of the foot and ankle, resulting in reduced dorsiflexion and difficulty with ambulation. Foot drop may be caused by stroke or nerve injury. Functional neuromuscular stimulation of the peroneal nerve has been suggested for patients with foot drop as an aid in raising the toes during the swing phase of ambulation. Examples of such devices are the Innovative Neurotronics’ (formerly NeuroMotion, Inc.) WalkAide, Bioness NESS L300, and the Odstock Dropped Foot Stimulator. All of these devices have received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA). The 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.
Devices that combine NMES with other forms of neurostimulation, most commonly TENS or interferential stimulation are marketed. Examples of combination devices include but are not limited to the Kneehab® XP for rehabilitation of tendon or ligament repair and knee replacement. Other devices used to provide ambulation include a reciprocating gait orthosis (RGO) with electrical stimulation. The orthosis used is a 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.
Definitions:
I. Upper Extremity Neuromuscular Stimulation in the Home Setting
Use of an upper extremity functional neuromuscular stimulation device (e.g., NESS H200 or the Handmaster) in the home setting may be considered MEDICALLY NECESSARY AND APPROPRIATE for the following indications when documented improvement has been shown in the supervised rehabilitation setting:
Use of an upper extremity functional neuromuscular electrical stimulation device (e.g., NESS H200 or the Handmaster) in the home setting for all other indications is considered EXPERIMENTAL/INVESTIGATIVE due to a lack of evidence demonstrating its impact on improved health outcomes.
II. Lower Extremity Neuromuscular Stimulation in the Home Setting
Use of a lower extremity functional neuromuscular stimulation device (e.g., ParaStep, NESS L300, WalkAide, Odstock Dropped Foot Stimulator) in the home setting is considered EXPERIMENTAL/INVESTIGATIVE as a technique to restore nerve function and provide ambulation following nerve damage or nerve injury in all situations, including but not limited to spinal cord injury and foot drop caused by nerve damage (e.g., post-stroke or in patients with multiple sclerosis).
E0731 E0745 E0764, E0770
Coverage
Neuromuscular electrical stimulation devices designed as ergometers, including but not limited to the FES Power Trainer, ERGYS, REGYS, NeuroEDUCATOR, STimMaster Galaxy, and RT300 motorized FES ergometer, are considered to be exercise equipment, non-medical self-care and/or self-help training. Most plans exclude coverage of exercise equipment, non-medical self-care and self-help training; please check benefit plan for details.
Documentation Submission
Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:
Link to Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2021-12/BCBSMN-Pre-Auth-Request-fillable-X18509R07.pdf
No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.
Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.
Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.
