DESCRIPTION
Electrical bone growth stimulation is intended to hasten or facilitate the healing process for certain types of fractures, osteonecrosis or bone fusions. Non-invasive, semi-invasive, and invasive methods of electrical bone growth stimulation are available.
Non-invasive bone growth stimulators utilize direct current or pulsed electromagnetic fields to generate a weak electrical current in the underlying tissue. Semi-invasive or percutaneous bone growth stimulators use an external power supply and electrodes that are inserted through the skin and into the bone, where growth is desired. Examples of non-invasive devices are the SpinalPak® II Spinal Fusion Stimulator, EBI Bone Healing System® and Cervical-Stim®.
Invasive bone growth stimulators require surgical implantation of a current generator in an intramuscular or subcutaneous space. An electrode is implanted within the fragments of bone graft at the fusion site. Invasive devices use direct current. Invasive bone growth stimulation is typically used as an adjunct to spinal fusion surgery and is implanted at the time of surgery. A second surgical procedure is required to remove the power source. Examples of invasive/implantable devices are the OsteoStim®, SpF® XL IIb Spinal Fusion Stimulator, SpF® Plus-Mini Spinal Fusion Stimulator and EBI® OsteoGen™ Implantable Bone Growth Stimulator.
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.
POLICY
Non-invasive electrical bone growth stimulation for the treatment of nonunion fractures or congenital pseudoarthroses of the tibia, fibula, femur, humerus, ulna, radius, clavicle, phalanges, metatarsals or metacarpals is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Either non-invasive electrical bone growth stimulation or invasive electrical bone growth stimulation as an adjunct to lumbar spinal fusion surgery is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Noninvasive electrical bone stimulation for the treatment of a failed lumbar spinal fusion is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Electrical bone growth stimulation (invasive, semi-invasive, and non-invasive) for the treatment of other conditions/diseases, including, but not limited to, the following are considered investigational:
fresh fractures
delayed union
avulsions fractures
osteochondral lesions
fractures of the skull, pelvis, lunate, scaphoid, and sesamoid bones
Invasive and semi-invasive electrical bone growth stimulation for bones of the appendicular skeleton is considered investigational. (Note: See Additional Information section for description of appendicular skeleton.)
Invasive electrical bone growth stimulation for the treatment of nonunion long bone fractures is considered investigational.
Semi- invasive electrical bone stimulation for the treatment of conditions/diseases including but not limited to the following is considered investigational:
As an adjunct to lumber fusion surgery
Failed lumbar fusion
Non union fractures of the long bones
Non traumatic avascular necrosis of the femoral head
Electrical bone growth stimulation (invasive, semi-invasive, and non-invasive) as an adjunct to cervical fusion surgery and for failed cervical spinal fusion is considered investigational.
Any electrical bone growth stimulator used for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
See also: Ultrasound Accelerated Fracture Healing Device
MEDICAL APPROPRIATENESS
Electrical bone growth stimulation is considered medically appropriate when ANY ONE of the following criteria are met:
As a non-invasive treatment of an individual with a nonunion fracture or congenital pseudoarthroses of the tibia, fibula, femur, humerus, ulna, radius, clavicle, phalanges, metatarsals or metacarpals and ALL of the following:
At least 3 months without clinical evidence of progressive signs of healing (i.e., 2 or more appropriate imaging studies with multiple views 90 days apart with written documentation by treating physician)
The fracture gap is one (1) cm or less
The individual can be adequately immobilized and is likely to comply with non-weightbearing
ABSENCE of ALL of the following:
Osteomyelitis
Motion at the fracture site
Demand-type pacemaker
Implantable cardiac defibrillator
Pregnancy
Paget’s Disease (bone)
Osteogenesis Imperfecta
As a noninvasive or invasive adjunct treatment to lumbar spinal fusion for an individual with ALL of the following:
Individual is high risk for failed spinal fusion due to ANY ONE of the following:
One (1) or more failed spinal fusions
Grade III or worse spondylolisthesis
Fusion to be performed at two (2) or more levels
Current smoker
Diabetes
Renal disease
Alcoholism
Long-term systemic steroid use (i.e., daily enteral or parenteral use for greater than 3 months)
ABSENCE of ALL of the following:
Demand-type pacemaker
Implantable cardiac defibrillator
Pregnancy
Paget’s disease (bone)
As a noninvasive treatment of a failed lumbar spinal fusion with serial x-rays documenting a spinal fusion that has not healed at a minimum of six (6) months after the original surgery
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The appendicular skeleton includes bones of the shoulder girdle, upper extremities, pelvis and lower extremities.
A delayed union is defined as a decelerating fracture healing process, as identified by serial x-rays.
Factors that should be addressed prior to the use of the electrical bone growth stimulation include infection, metabolic problems such as diabetes, poor nutrition, particularly protein deficiency and smoking.
A compliance monitor is not considered to be a necessary component of an electrical bone growth stimulation device.
No controlled studies were found in the published literature that validate the application of electrical bone growth stimulation for the treatment of conditions / indications listed as investigational in the above policy.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2009). Electrical stimulation of the spine as an adjunct to spinal fusion procedures (7.01.85). Retrieved December 27, 2010 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2010). Electrical bone growth stimulation of the appendicular skeleton (7.01.07). Retrieved December 27, 2010 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, November). Osteogenic stimulation (NCD 150.2, p 2-69).
Phieffer, L. S., & Goulet, J. A. (2006, January). Delayed unions of the tibia. The Journal of Bone and Joint Surgery, 88-A (1), 206-216.
Punt B, den Hoed P, Stijnen T. Electromagnetic field stimulation for the treatment of delayed union or non-union of long bones. The Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD004960. DOI: 10.1002/14651858.CD004960.
U. S. Food and Drug Administration (1998, July). Center for Devices and Radiological Health. Pre-Market approval decisions for July 1998. Retrieved March 8, 2005 from http://www.fda.gov/cdrh/pma/pmajul98.html.
Winifred S. Hayes. Medical Technology Directory. (2009, September). Electrical Bone Growth Stimulation, Noninvasive. Retrieved March 15, 2010 from www.Hayesinc.com/subscribers. (65 articles and/or guidelines reviewed)
Winifred S. Hayes. Medical Technology Directory. (2009, September). Electrical Bone Growth Stimulation, Invasive. Retrieved March 15, 2010 from www.Hayesinc.com/subscribers. (69 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 6/11/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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