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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 chances of obtaining a solid spinal fusion. Noninvasive devices have also been investigated to treat a failed fusion.
Electrical and electromagnetic fields can be generated and applied to bones through the following methods:
The following implantable devices have received FDA premarket approval (PMA):
Noninvasive bone growth stimulators that have received FDA PMA include:
No semi-invasive electrical bone growth stimulator devices were identified with FDA approval or clearance.
Note: Noninvasive electrical bone growth stimulation of the appendicular skeleton is addressed in the Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton policy.
Note: Ultrasound devices for bone growth stimulation is addressed in the Ultrasound Accelerated Fracture Healing Device policy.
POLICYEither invasive or noninvasive methods of electrical bone growth stimulation may be considered medically necessary as an adjunct to lumbar spinal fusion surgery in patients at high risk for fusion failure, defined as any one of the following criteria:
Noninvasive electrical bone stimulation may be considered medically necessary as a treatment of patients with failed lumbar spinal fusion. 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 x-rays over a course of three (3) months.
Semi-invasive electrical stimulation is considered investigational as an adjunct to lumbar fusion surgery and for failed lumbar fusion.
Invasive, semi-invasive, and noninvasive electrical stimulation are considered investigational as an adjunct to cervical fusion surgery and for failed cervical spine fusion.
POLICY EXCEPTIONSFederal 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 GUIDELINESNoninvasive 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.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY6/6/2007: 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.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.85
CODE REFERENCEThis 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.