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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 nine (9) months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for minimum of three (3) months." Others have contended that nine (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 FDA has recently approved labeling changes that do not impose a time frame for the diagnosis of nonunion.

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."

In the appendicular skeleton, electrical stimulation has been used primarily to treat tibial fractures, and thus this technique has often been thought of as a treatment of the long bones. This concept has led to controversy regarding what constitutes long versus short bones. According to orthopedic anatomy, the skeleton consists of long bones, short bones, flat bones, and irregular bones. Long bones act as levers to facilitate motion, while short bones function to dissipate concussive forces. Short bones include those composing the carpus and tarsus. Flat bones, such as the scapula or pelvis, provide a broad surface area for attachment of muscles. Thus the metatarsal is considered a long bone, while the scaphoid bone of the wrist is considered a short bone. Both the metatarsals and scaphoid bones are at a relatively high risk of nonunion after a fracture.

Despite their anatomic classification, all bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Cortical bone is always located on the exterior of the bone, while the trabecular bone is found in the interior. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. However, at a cellular level, both bone types are composed of lamellar bone and cannot be distinguished microscopically.

The non-invasive OrthoPak® Bone Growth Stimulator (BioElectron) received FDA premarket approval in 1984 for treatment of fracture nonunion. Pulsed electromagnetic field systems with FDA premarket approval (all non-invasive devices) include Physio-Stim® from Orthofix Inc., first approved in 1986, and OrthoLogic® 1000, approved in 1997, both indicated for treatment of established nonunion secondary to trauma, excluding vertebrae and all flat bones, in which the width of the nonunion defect is less than one-half the width of the bone to be treated; and the EBI Bone Healing System® from Electrobiology, Inc., which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses.

Note: Noninvasive electrical stimulation of the spine is addressed in the Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures policy.

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

• At least 3 months have passed since the date of fracture;
• Serial radiographs have confirmed that no progressive signs of healing have occurred;
• The fracture gap is 1 cm or less; and
• The patient can be adequately immobilized and is of an age likely to comply with non-weight bearing

Investigational applications of electrical bone growth stimulation include, but are not limited to, immediate post-surgical treatment after appendicular skeletal surgery, or for the treatment of fresh fractures or delayed union. Delayed union is defined as a decelerating fracture healing process, as identified by serial x-rays.

Implantable and semi-invasive electrical bone growth stimulators are considered investigational.

A fracture is most commonly defined as “fresh” for 7 days after the fracture occurs. Most fresh closed fractures heal without complications with the use of standard fracture care, i.e., closed reduction and cast immobilization.

Delayed Union

Delayed union is defined as a decelerating healing process as determined by serial x-rays, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention.

Nonunion

There is not a consensus for the definition of nonunions. One proposed definition is failure of progression of fracture-healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing).

The original FDA labeling of fracture nonunions defined nonunions as fractures that had not shown progressive healing after at least 9 months from the original injury. 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 fractures may show no signs of healing, based on serial radiographs as early as 3 months, while a fracture nonunion may not be diagnosed in others until well after 9 months. The current policy of requiring a 3-month timeframe for lack of progression of healing is consistent with the definition of nonunion as described in the clinical literature.

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.

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

2/18/2008: Policy concerning implantable electrical bone growth stimulators added

2/26/2008: CPT 20975, ICD-9 procedure codes 78.90-78.99, and HCPCS E0749 added to non-covered table. "Noninvasive" removed from policy title

9/30/2009: Code reference section updated. New ICD-9 diagnosis codes 813.46 and 813.47 added to covered table fracture of upper limb code range.

04/07/2010: Description section updated with FDA devices; Policy statement updated to add semi-invasive stimulators as investigational; and Policy Exceptions section updated to include FEP language.

10/21/2010: Policy reviewed; no changes.

12/13/2011:  Added "immediate post-surgical treatment after appendicular skeletal surgery" to the investigational policy statement.

01/09/2013:  Policy statement unchanged. Added the definitions of fresh fracture, delayed union, and nonunion to the policy guidelines.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes 

Non-Covered Codes

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