Bone Growth Stimulation Devices*

Medical Policy: 07.01.05 
Original Effective Date: August 1992 
Reviewed: April 2012 
Revised: May 2010 

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

Generally, bone fractures heal normally with standard fracture care. Occasionally, the healing process stops due to added risks or complications.  It has been proven that electric current can stimulate bone growth and enhance the healing process.

Several electrical bone growth stimulators are available.  The noninvasive type of stimulator is comprised of coils or electrodes, which are placed on the skin near the fracture site.  The semi-invasive type involves current applied to a cathode that has been percutaneously inserted into the site of the non-union. It is anchored to bone to prevent dislodging. The device requires minimal dissection to remove. The invasive type includes percutaneous and implanted devices.  The percutaneous type involves electrode wires inserted through the skin into the bone while implanted devices include a generator placed under the skin or in the muscles near the gap between the ends of the bones, which have not fused.  The implanted devices are surgically placed and later surgically removed.

The ultrasound fracture-healing device uses sound waves to heal bones.  This device sends out low frequency sound waves to promote faster healing of fresh fractures.  An opening is created in the cast and the device is applied to the skin.  The device is typically used for twenty minutes each day.

Definition of nonunion:

The definition of a fracture nonunion has remained controversial. The original U.S. Food and Drug Administration (FDA) labeling defined nonunion as follows: "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 timeframe 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 patients, many of whom were serving as their own controls. Some have contended that 9 months represents an arbitrary cut-off point that does not reflect the complicated variables that are present in fractures, i.e., degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock. Other proposed definitions of nonunion involve 3 to 6 months’ time from original healing, or simply when serial x-rays fail to show any further healing. The current policy of requiring a 3-month timeframe is consistent with the definition of nonunion as described in the clinical literature.

Definition of delayed union: Delayed union refers to a decelerating bone healing process, as identified in serial x-rays. (In contrast, nonunion serial x-rays show no evidence of healing.) When lumped together, delayed union and nonunion are sometimes referred to as "ununited fractures."

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Prior Approval: 

Prior approval is recommended. Submit a prior approval now.

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Policy: 

• Treatment of fracture nonunions; The diagnosis of fracture nonunion must meet all of the following criteria:

• At least three months have passed since the date of fracture
• Serial radiographs confirm that no progressive signs of healing have occurred
• The fracture gap is one cm or less, and 
• The patient can be adequately immobilized and is of an age likely to comply with non-weight bearing

• Treatment of congenital pseudoarthroses in the appendicular skeleton (the appendicular skeleton includes the bones in the shoulder girdle, upper extremities, pelvis and lower extremities).
• Treatment of failed lumbar spinal fusion. Failed spinal fusion is defined as a spinal fusion that has not healed at a minimum of 6 months after the original surgery, as evidenced by serial x-rays over a course of 3 months.

Invasive or noninvasive electric bone growth stimulators may be considered medically necessary as an adjunct to lumbar spinal fusion surgery for patients with any of the following high risks for failed spinal fusion

• One or more failed spinal fusions. Failed spinal fusion is defined as a spinal fusion that has not healed at a minimum of 6 months after the original surgery, as evidenced by serial x-rays over a course of 3 months.
• Grade III or worse spondylolisthesis
• Multi-level fusions
• Current tobacco use
• Diabetes
• Renal disease
• Alcoholism
• Steroid therapy

Low intensity ultrasound treatment may be considered medically necessary when used as an adjunct to conventional management (i.e. closed reduction and cast immobilization) for the treatment of fresh, closed fractures when there is high risk for delayed fracture healing or nonunion have at least one of the following risk factors from either category, fracture locations or comorbidities:

Fracture locations:

• Jones fracture
• Fracture of the navicular bone in the wrist
• Fracture of the metatarsal
• Fractures associated with extensive soft tissue or vascular damage

Co-morbidities:

• Diabetes
• Steroid therapy
• Osteoporosis
• History of alcoholism
• History of smoking

Low intensity ultrasound treatment may be considered medically necessary as a treatment of fracture nonunions of bones when all of the following criteria are met:

• At least three months have passed since the date of fracture
• Serial  radiographs have confirmed that no progressive signs of healing have occurred
• The fracture gap is one cm or less
• The patient can be adequately immobilized and is of an age where they are likely to comply with non-weight bearing, and 
• The fracture does not involve the skull and vertebra.

Invasive and non-invasive electrical bone growth stimulators are considered investigational when:

• The fracture is fresh 
• The fracture shows delayed union, i.e. x-ray of the fracture shows decelerating healing process
• Patients with active osteomyelitis 
• Fractures due to cancer

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

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

Low intensity ultrasound treatment is considered investigational for any condition not listed above, including but not limited to:

• Delayed union or congenital pseudoarthrosis or 
• Open fractures

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
• 20974 electrical stimulation to aid bone healing; non-invasive (non-operative)
• 20975 electrical stimulation to aid bone healing; invasive (operative)
• 20979 low intensity ultrasound stimulation to aid bone healing, non-invasive
• E0747 osteogenesis stimulator, electrical, noninvasive, other than spinal application
• E0748 osteogenesis stimulator, electrical, noninvasive, spinal applications
• E0749 osteogenesis stimulator, electrical, surgically implanted
• E0760 osteogenesis stimulator, low intensity ultrasound

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Selected References: 

• Summary of Safety and Effectiveness Data. Exogen 2000® or Sonic Accelerated Fracture Healing System (SAFHS®). Exogen 2000®, a Smith and Nephew Co., 10 Constitution Avenue, Piscataway, N.J.
• Busse JW, Bhandari M, Kulkarni AV et al. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: a meta-analysis. CMAJ 2002;166(4):437-41.
• Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am 1984;15(1):89-106.
• Akai M, Kawashima N, Kimura T et al. Electrical stimulation as an adjunct to spinal fusion: a meta-analysis of controlled clinical trials. Bioelectromagnetics 2002;23(7):496-504.
• Agency for Healthcare Research and Quality (AHRQ).  Technology Assessment Program. The role of bone growth stimulating devices and orthobiologics in healing nonunion fractures. [09/21/2005]
• ECRI. Electrical Bone Growth Stimulation to Enhance Cervical Vertebrae Fusion. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2007 January 29. 7 p. (ECRI Hotline Response). Also available: http://www.ecri.org.
• ECRI. Electrical Bone Growth Stimulation for the Wrist, Ankle, and Short Bones. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 August 18. 9 p. (ECRI Hotline Response). Also available: http://www.ecri.org.
• ECRI. Ultrasonic Bone Growth Stimulation for Fracture Healing. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2008 August 22. 14 p. (ECRI Hotline Response). Also available: http://www.ecri.org.
• ECRI Institute. Electrical Bone Growth Stimulation to Enhance Cervical Vertebrae Fusion. Plymouth Meeting (PA): ECRI Institute; 2009 April 1. 6 p. [ECRI hotline response]. Also available: http://www.ecri.org.
• ECRI Institute. Electrical Bone Growth Stimulation for Long Bones. Plymouth Meeting (PA): ECRI Institute; 2009 April 7. 7 p. [ECRI hotline response]. Also available: http://www.ecri.org. 

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Policy History: 

Date                                        Reason                              Action

August 2011                           Annual review                    Policy renewed

April 2012                              Annual review                    Policy renewed

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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.