Medical policy: Electrical Bone Growth Stimulation of the Appendicular Skeleton

Número de política: MP 1.024

Fecha de entrada en vigor: 9/1/2026

Política

Noninvasive electrical bone growth stimulation may be considered medically necessary for the treatment of fracture nonunions or congenital pseudoarthrosis in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities). The diagnosis of fracture nonunion must meet ALL of the following criteria:

• at least 3 months have passed since the date of fracture;
• serial radiographs have confirmed that no progressive signs of healing have occurred;
• the fracture gap is 1 cm or less;
• the individual can be adequately immobilized; and
• the individual is of an age likely to comply with nonweight bearing for fractures of the pelvis and lower extremities.

Investigational applications of electrical bone growth stimulation include, but are not limited to, delayed union, fresh fracture, stress fractures, immediate postsurgical treatment after appendicular skeletal surgery, arthrodesis, or failed arthrodesis. No hay pruebas suficientes para apoyar una conclusión general con respecto a los resultados o beneficios para la salud asociados con este procedimiento.

Implantable and semi-invasive electrical bone growth stimulators are considered investigational. Actualmente no hay evidencia suficiente para llegar a una conclusión general sobre los resultados o beneficios para la salud asociados con estos procedimientos.

Directrices de la política

Fracture Nonunion

No consensus on the definition of fracture nonunion currently exists. One proposed definition is failure of progression of fracture healing for at least 3 consecutive months (and for at least 6 months following the fracture), accompanied by clinical symptoms of delayed union or nonunion (pain, difficulty bearing weight) (Bhandari et al, 2012).

The original U.S. Food and Drug Administration (FDA) labeling of fracture nonunions defined them as fractures that had not shown progressive healing after at least 9 months from the original injury. The labeling states: "A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for minimum of 3 months." This timeframe is not based on physiologic principles but was included as part of the research design for FDA approval as a means of ensuring homogeneous populations of patients, many of whom were serving as their own controls. Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables that are present in fractures (i.e., degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock). Some fractures may show no signs of healing, based on serial radiographs, as early as 3 months, while a fracture nonunion may not be diagnosed in others until well after 9 months. The current policy of requiring a 3-month timeframe for lack of progression of healing is consistent with the definition of nonunion as described in the clinical literature.

Delayed Union

Delayed union is defined as a decelerating healing process as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention. In contrast, nonunion serial radiographs (described above) show no evidence of healing. When lumped together, delayed union and nonunion are sometimes referred to as "ununited fractures."

Fresh Fracture

A fracture is most commonly defined as "fresh" for 7 days after its occurrence. Most fresh closed fractures heal without complications with the use of standard fracture care (i.e., closed reduction, cast immobilization).

Cross-references:

• MP 1.150 Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures
• MP 6.021 Low Intensity Pulsed Ultrasound Fracture Healing Device

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas del FEP. The FEP Medical Policy manual can be found at: FEP Medical Policy Manual.

Descripción/Antecedentes

Treatment of Delayed and Nonunion Fractures

Individuals with recognized delayed fracture unions might begin by reducing the risk factors for delayed unions or nonunions but may progress to surgical repair if it persists.

Electrical and Electromagnetic Bone Growth Stimulators

Different applications of electrical and electromagnetic fields have been used to promote healing of delayed and nonunion fractures: invasive, noninvasive, and semi-invasive.

Invasive Stimulators

Invasive stimulation involves the surgical implantation of a cathode at the fracture site to produce direct current electrical stimulation. Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation, and although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.

Noninvasive Stimulators

Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and worn for 24 hours a day until healing occurs or up to 9 months. In contrast, pulsed electromagnetic fields are delivered via treatment coils placed over the skin and worn for 6 to 8 hours a day for 3 to 6 months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field. This device involves a 30-minute treatment per day for 9 months. Patient compliance may be an issue with externally worn devices.

Semi-Invasive Stimulators

Semi-invasive (semi-implantable) stimulators use percutaneous electrodes and an external power supply, obviating the need for a surgical procedure to remove the generator when treatment is finished.

Situación reglamentaria

Table 1 summarizes the FDA cleared or approved electrical bone growth stimulator devices. No semi-invasive electrical bone growth stimulator devices with the FDA approval or clearance were identified.

The FDA has approved labeling changes for electrical bone growth stimulators that remove any time frame for the diagnosis. In September 2020, FDA considered the reclassification of noninvasive electrical bone growth stimulators from Class 3 to the lower-risk Class 2 category. As of March 2026, however, the devices remain Class 3.

FDA product code LOF.

Table 1. U.S. Food and Drug Administration-Approved Electrical Bone Growth Stimulator Devices

Fundamento

Summary of evidence

Noninvasive Electrical Bone Growth Stimulation

For individuals who have fracture nonunion who receive noninvasive electrical bone growth stimulation, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The U.S. Food and Drug Administration has approved noninvasive electrical bone growth stimulation for fracture nonunions, congenital pseudoarthrosis, and failed fusions in the appendicular skeleton, based largely on studies with patients serving as their controls. There is also evidence from 2 small sham-controlled randomized trials that noninvasive electrical stimulators improve fracture healing for patients with fracture nonunion. There are few nonsurgical options in this population, and the pre-post studies of patients with nonhealing fractures support the efficacy of the treatment. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have delayed fracture union who receive noninvasive electrical bone growth stimulation, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. RCTs on the delayed union of fractures were limited by small sample sizes and did not show significant differences in outcomes between study groups. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

For individuals who have fresh fracture(s) who receive noninvasive electrical bone growth stimulation, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. A meta-analysis of 5 RCTs found no statistically significant benefit of electrical bone growth stimulation for fresh fractures. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

For individuals who have stress fracture(s) who receive noninvasive electrical bone growth stimulation, the evidence includes an RCT. Relevant outcomes are symptoms, change in disease status, and functional outcomes. This well-conducted RCT found that, although an increase in the hours of use per day was associated with a reduction in the time to healing, there was no difference in the rate of healing between treatment and placebo. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

For individuals who have had surgery of the appendicular skeleton who receive noninvasive electrical bone growth stimulation, the evidence includes 2 small RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Although the results of 1 trial suggest benefits to the bone stimulation in decreased time to union, clinical outcomes were not assessed. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

Implantable and Semi-Invasive Bone Growth Stimulation

For individuals who have fracture, pseudoarthrosis, or who have had surgery of the appendicular skeleton who receive implantable and semi-invasive electrical bone growth stimulation, the evidence includes a small number of case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. La evidencia es insuficiente para determinar los efectos de esta tecnología en los resultados de salud.

Definiciones

Appendicular Skeleton consists of the bones of the limbs and their girdles, attached to the axial skeleton.

Axial Skeleton consists of bones in the head and trunk of the human body. It is composed of five parts: the human skull, the ossicles of the inner ear, the hyoid bone of the throat, the rib cage, and the vertebral column.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: esta lista de códigos puede no ser exhaustiva y los códigos están sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered, implantable and semi-invasive electrical bone growth stimulation:

Covered when medically necessary, noninvasive electrical bone growth stimulation:

Note: Any fracture diagnosis could potentially meet criteria.

Referencias

1. Administración de Medicamentos y Alimentos (FDA) de los EE. UU. Summary Minutes: Center for Devices and Radiological Health Orthopaedic and Rehabilitation Devices Panel (2020). Accessed March 17, 2026.
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