Electrical Bone Growth Stimulation of the Appendicular Skeleton

POLICY NUMBER

A.7.01.07

DESCRIPTION

In the appendicular skeleton, electrical stimulation with either implantable electrodes or non-invasive surface stimulators has been investigated to facilitate the healing of fresh fractures, stress fractures, delayed union, nonunion, congenital pseudarthrosis, and arthrodesis.

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 devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, with an accompanying electrode implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation. 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 are 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.

The table below summarizes the FDA cleared or approved noninvasive electrical bone growth stimulator devices. No implantable or 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, the FDA considered the reclassification of noninvasive electrical bone growth stimulators from Class 3 to the lower-risk Class 2 category. As of March 2025, however, the devices remain Class 3.

FDA product code LOF.

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

Note: Noninvasive electrical stimulation of the spine is addressed in the  Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures policy.

Note: Ultrasound devices for bone growth stimulation is addressed in the Low Intensity Pulsed Ultrasound Fracture Healing Device policy.

POLICY

Noninvasive electrical bone growth stimulation may be considered medically necessary for the treatment of fracture nonunions or congenital pseudarthrosis 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:

Investigational applications of electrical bone growth stimulation include, but are not limited to, delayed union, fresh fracture, stress fractures, immediate post-surgical treatment after appendicular skeletal surgery, arthrodesis, or failedarthrodesis. Delayed union is defined as a decelerating fracture healing process, as identified by serial x-rays.

Implantable and semi-invasive electrical bone growth stimulators are considered investigational.

POLICY EXCEPTIONS

Federal Employee Program: 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.

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 or nonunion (pain, difficulty bearing weight).

The original FDA labeling of fracture nonunions defined them as fractures not showing 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 time frame 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 trial participants, 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 present in fractures (ie, 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 and cast immobilization).

Electrical Bone Growth Stimulators are covered as part of the Durable Medical Equipment (DME) benefit, and are subject to any applicable DME co-insurance maximums.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

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

6/6/2007: Policy added. The "Fracture Healing Devices: Electrical Bone Growth Stimulation & Ultrasound-Accelerated Healing" policy has been replaced with the "Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton" policy.

7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC).

2/18/2008: Policy concerning implantable electrical bone growth stimulators added.

2/26/2008: CPT 20975, ICD-9 procedure codes 78.90-78.99, and HCPCS E0749 added to non-covered table. "Noninvasive" removed from policy title.

9/30/2009: Code reference section updated. New ICD-9 diagnosis codes 813.46 and 813.47 added to covered table fracture of upper limb code range.

04/07/2010: Description section updated with FDA devices; Policy statement updated to add semi-invasive stimulators as investigational; and Policy Exceptions section updated to include FEP language.

10/21/2010: Policy reviewed; no changes.

12/13/2011: Added "immediate post-surgical treatment after appendicular skeletal surgery" to the investigational policy statement.

01/09/2013: Policy statement unchanged. Added the definitions of fresh fracture, delayed union, and nonunion to the policy guidelines.

03/12/2014: Policy statement updated for clarification of compliance with non-weight bearing. Added "stress fractures, arthrodesis or failed arthrodesis" to the investigational policy statement.

01/30/2015: Policy description updated regarding methods in which electrical and electromagnetic fields can be generated and applied to bones. Policy statements unchanged. Policy guidelines updated regarding delayed union and nonunion.

08/28/2015: Code Reference section updated for ICD-10.

05/31/2016: Policy number A.7.01.07 added. Policy Guidelines updated to add medically necessary and investigative definitions.

06/17/2016: Policy description updated. Policy statements unchanged.

07/06/2017: Policy description updated regarding delayed fracture healing and treatment. Policy statements unchanged. Policy Guidelines updated to change "nonunion" to "fracture nonunion."

05/02/2018: Policy reviewed; no changes.

05/09/2019: Policy reviewed; no changes.

05/18/2020: Policy description updated. "Pseudoarthroses" changed to "pseudarthosis" throughout policy.

07/07/2021: Policy description updated regarding noninvasive electrical bone growth stimulators. Medical policy link updated. Minor edit made to medically necessary policy statement; intent unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

05/26/2022: Policy reviewed; no changes.

05/09/2023: Policy reviewed; no changes.

05/13/2024: Policy description updated regarding devices. Policy statements updated to change "patient" to "individual." Policy Guidelines updated.

08/13/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.07

CODE REFERENCE

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

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

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