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Ultrasound treatment can be self-administered with one daily 20-minute treatment, continuing until the fracture has healed. The mechanism of action at the cellular level is not precisely known, but is thought to be related to a mechanical effect on cell micromotion/deformation causing an increase in stimulation of transmembrane cell adhesion molecules and upregulation of cyclooxygenase-2.

The Sonic Accelerated Fracture Healing System, SAFHS® (also referred to as Exogen 2000®) was initially cleared for marketing by the U.S. Food and Drug Administration (FDA) in October 1994 as a treatment of fresh, closed, posteriorly displaced distal radius (Colles) fractures and fresh, closed, or grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. In February 2000, the labeled indication was expanded to include the treatment of established nonunions, excluding skull and vertebra. According to the FDA labeling, a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Note: Electrical stimulation of bone healing is considered separately in the Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton and Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures  policies.

Patient comorbidities:

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

Fracture locations:

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

Low-intensity ultrasound treatment may be considered medically necessary as a treatment of delayed union of bones, excluding the skull and vertebra.

Low-intensity ultrasound treatment may be considered medically necessary as a treatment of fracture nonunions of bones excluding the skull and vertebra (See Policy Guidelines below for definition of nonunion).

Other applications of low-intensity ultrasound treatment are investigational, including but not limited to treatment of congenital pseudarthroses, or open fractures, or stress fractures.

None

A fracture is most commonly defined as “fresh” for 7 days after the fracture occurs. Most freshly 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.

Nonunions

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 FDA labeling simply suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without giving any guidance regarding the time frame of observation. However, it is suggested that a reasonable time period for lack of visible signs of healing is 3 months. The following patient selection criteria are suggested, consistent with those proposed for electrical stimulation as a treatment of nonunions:

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

Ultrasound Accelerated Fracture Healing devices are covered as part of the Durable Medical Equipment (DME) benefit, and are subject to any applicable DME co-insurance and benefit 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)

2/15/2008: Policy reviewed, no changes

9/30/2009: Code reference section updated. New ICD-9 diagnosis codes 813.46 and 813.47 added to covered table.

04/20/2011: Policy description updated.  Moved information regarding risk factors for delayed healing or nonunion from the policy guidelines to the policy statement.

12/01/2011: Policy statement revised to state that low-intensity ultrasound treatment may be considered medically necessary as a treatment of delayed union of bones, excluding the skull and vertebra. Added the definition of delayed union to the policy guidelines.

01/09/2013: Policy statement unchanged. Clarified the definitions of fresh fracture, delayed union, and nonunion in 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