Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures

POLICY NUMBER

A.7.01.85

DESCRIPTION

Electrical Bone Growth Stimulators

Both invasive and noninvasive electrical bone growth stimulators have been investigated as an adjunct to spinal fusion surgery, with or without associated instrumentation, to enhance the probability of obtaining a solid spinal fusion. Noninvasive devices have also been investigated in patients who are at normal risk of failed fusion and to treat a failed fusion.

Electrical and electromagnetic fields can be generated and applied to bones through surgical, noninvasive, and semi-invasive methods.

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 either 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 are worn for 24 hours a day until healing occurs, or for up to nine months. In contrast, pulsed electromagnetic fields are delivered via treatment coils that are placed into a back brace or directly onto the skin and are worn for 6 to 8 hours per day for 3 to 6 months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying field onto an additional static magnetic field. This device involves 30 minutes of treatment daily for nine 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 and implantable electrical bone growth stimulator devices. No semi-invasive electrical bone growth stimulator deviceswith 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 codes: LOE (invasive bone growth stimulator), LOF (noninvasive bone growth stimulator).

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

Note: Noninvasive electrical bone growth stimulation of the appendicular skeleton is addressed in the  Electrical Bone Growth Stimulation of the Appendicular Skeleton policy.

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

POLICY

Either invasive or noninvasive methods of electrical bone growth stimulation may be considered medically necessary as an adjunct to lumbar spinal fusion surgery in individuals at high risk for fusion failure, defined as any one of the following criteria:

Noninvasive electrical bone growth stimulation may be considered medically necessary as a treatment for individuals with failed lumbar spinal fusion surgery. Failed spinal fusion is defined as a spinal fusion that has not healed at a minimum of six (6) months after the original surgery, as evidenced by serial radiographs over a course of three (3) months.

Semi-invasive electrical bone growth stimulation is considered investigational as an adjunct to lumbar spinal fusion surgery and for failed lumbar fusion. 

Invasive, semi-invasive, and noninvasive electrical bone growth stimulation are considered investigational as an adjunct to cervical fusion surgery and for failed cervical spine fusion.

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.

Noninvasive and Invasive 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 "Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures" policy

7/19/2007: Policy reviewed and approved by Medical Policy Advisory Committee (MPAC)

8/18/2008: Policy reviewed, no changes.

04/26/2010: Policy description updated regarding FDA-approval status of devices. Policy statement updated to add "lumbar" to the statements. Steroid use added as a high-risk condition for non-fusion. New policy statements added that semi-invasive stimulators are investigational for lumbar spine fusion and that electrical bone-growth stimulators are investigational for use in cervical spine fusion. Added FEP verbiage added to the Policy Exceptions section. Added CPT code 20974.

04/18/2011: Policy reviewed; no changes.

01/17/2012: Policy reviewed. "Current smoking habit" changed to "Current tobacco use" in the policy statement.

12/13/2012: Policy reviewed; no changes.

01/20/2014: Policy reviewed; no changes.

02/06/2015: Policy reviewed; description updated regarding devices. Policy statement unchanged.

08/28/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 99.86.

05/31/2016: Policy number A.7.01.85 added. Policy Guidelines updated to add medically necessary and investigative definitions.

07/22/2016: Policy description updated. Policy statements updated to change "x-rays" to "radiographs" and "electrical stimulation" to "electrical bone growth stimulation."

04/28/2017: Policy description updated. Policy statements unchanged.

05/04/2018: Policy description updated. Policy statements unchanged.

05/13/2019: Policy reviewed; no changes.

05/26/2020: Policy reviewed; no changes.

07/22/2021: Policy description updated regarding devices. Medical policy link updated. Second medically necessary statement updated to change "lumbar spinal fusion" to "lumbar spinal fusion surgery." Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/06/2022: Policy description updated regarding noninvasive bone growth stimulators. Policy statements unchanged.

05/22/2023: Policy reviewed. Policy statements updated to change "patients" to "individuals." First investigational statement updated to change "lumbar fusion surgery" to "lumbar spinal fusion surgery."

05/22/2024: Policy reviewed; no changes.

08/14/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 7.01.85

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

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