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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.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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 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.
08/28/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 99.86.
05/31/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
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.