Functional Neuromuscular Electrical Stimulation

POLICY NUMBER

A.8.03.01

DESCRIPTION

Functional electrical stimulation (FES) involves the use of an orthotic device or exercise equipment with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function and improve health in patients with damaged or destroyed nerve pathways (eg, stroke, spinal cord injury, multiple sclerosis, cerebral palsy).

Functional Electrical Stimulation

There are 2 broad categories of neuromuscular electrical stimulation (NMES) devices: one targets muscle atrophy during rest, and the other enhances functional activity in neurologically impaired patients. These devices use electrical impulses to activate weak or paralyzed muscles in precise sequences. The technology often referred to as functional electrical stimulation (FES) is used for both upper and lower extremity rehabilitation, with a specific focus on enhancing mobility and independence. Functional electrical stimulation (FES) is an approach to rehabilitation that applies low-level electrical current to stimulate functional movements in muscles affected by nerve damage. It focuses on the restoration of useful movements, like standing, stepping, pedaling for exercise, reaching, or grasping.

Functional electrical stimulation 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, cycle, or grasp. Functional neuromuscular stimulators are closed-loop systems that 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); healthy individuals with intact neural control benefit the most from this technology.

Applications include upper-extremity grasping function after spinal cord injury and stroke, lifting the front of the foot during ambulation in individuals with foot drop, and ambulation and exercise for patients with spinal cord injury. Functional electrical stimulation devices vary in size and design based on the treatment area and goals. These devices typically include a neuromuscular electrical stimulator unit, wires or wireless connectors, and electrodes, which may attach to the skin, be inserted under the skin, or be inputted through surgery to target specific muscles or nerves. Some devices are used primarily for rehabilitation rather than home use. This policy focuses on devices intended for home use.

A variety of FES devices have been cleared by the U.S. Food and Drug Administration (FDA) and are available for home use. The table below provides examples of devices designed to improve hand and foot function as well as cycle ergometers for home exercise. The date of the FDA clearance is for the first 510(k) clearance identified for a marketed device. Many devices have additional FDA clearances as the technology evolved, each in turn listing the most recent device as the predicate.

Functional Electrical Stimulation Devices Cleared by the FDA

To date, the Parastep® Ambulation System (Sigmedics) is the only noninvasive functional walking neuromuscular stimulation device to receive premarket approval from the FDA. The Parastep device is approved to “enable appropriately selected skeletally mature spinal cord injured patients (level C6 to 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.”

Also, see the  Microprocessor-Controlled Prostheses for the Lower Limb  and the  Myoelectric Prosthetic and Orthotic Components for the Upper Limb medical policies.

POLICY

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:

• To provide upper-extremity function in individuals with nerve damage (e.g., spinal cord injury or post-stroke); or

• To improve ambulation in individuals with foot drop caused by congenital disorders (eg, cerebral palsy) or nerve damage (e.g., post-stroke or in those with multiple sclerosis); or

• As a technique to provide ambulation in individuals with spinal cord injury.

Functional electrical stimulation devices for exercise in individuals with spinal cord injury is considered investigational.

POLICY EXCEPTIONS

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.

POLICY GUIDELINES

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.

POLICY HISTORY

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.

09/20/2017: Policy description updated. Policy statement unchanged.

12/20/2017: Code Reference section updated to make note of deleted CPT code 64565 effective 12/31/2017.

04/09/2018: Policy description updated to define functional neuromuscular electrical stimulation. Policy statement unchanged.

11/15/2019: Policy description updated regarding applications and devices. Added statement that functional electrical stimulation devices for exercise in patients with spinal cord injury is considered investigational. Code Reference section updated to remove deleted CPT code 64565.

07/09/2020: Policy description updated regarding devices. Policy statements unchanged.

05/26/2021: Policy description updated regarding devices. Policy statements unchanged.

12/13/2021: Code Reference section updated to revise code description for CPT code 64580, effective 01/01/2022.

05/16/2022: Policy description updated regarding devices. Policy statements unchanged.

04/17/2023: Policy description updated regarding devices. Policy statements updated to change "patients" to "individuals."

04/23/2024: Policy description updated regarding devices. Policy statements unchanged.

04/22/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.03.01

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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