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Low-intensity pulsed ultrasound has been investigated as a technique to accelerate healing of fresh fractures, delayed unions, and nonunions. Ultrasound is delivered with the use of a transducer applied to the skin surface overlying the fracture site.
Most bone fractures heal spontaneously over the course of several months following injury. However, approximately 5% to 10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of health care services. Ultrasound may accelerate healing of fractures by stimulating new bone growth, and therefore, has been proposed as a treatment for fractures with delayed healing or at high risk for nonhealing.
The current policy does not limit the use of the device to specific fracture sites. Depending on their function, bones are composed of a varying combination of cortical and trabecular bone. However, at the cellular level, the type of bone cannot be distinguished histologically. The inclusion of all bones regardless of the anatomic site is based on this histologic similarity of all bones; it is not anticipated that the efficacy of ultrasound-accelerated healing would vary according to the anatomic site and function of the bone.
The definition of a fracture nonunion has remained controversial. For electrical bone growth stimulators, the 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." Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables that are present in fractures, ie, 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 radiographs fail to show any further healing. According to the FDA labeling for a low-intensity pulsed ultrasound device, “a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.”
Delayed union is generally considered a failure to heal between 3 and 9 months after fracture, after which the fracture site would be considered to be a nonunion. Delayed union may also be defined as a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing.) Together, delayed union and nonunion are sometimes referred to as "ununited fractures." To determine the status of fracture healing, it is important to include both radiographic and clinical criteria. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation.
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.
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.
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 in skeletally mature individuals. Candidates for ultrasound treatment are those at high risk for delayed fracture healing or nonunion. These risk factors may include either locations of fractures or patient comorbidities and include the following:
Low-intensity ultrasound treatment may be considered medically necessary as a treatment of delayed union of bones, including delayed union of previously surgically-treated fractures, and excluding the skull and vertebra. (See Policy Guidelines for definition of delayed union.)
Low-intensity ultrasound treatment may be considered medically necessary as a treatment of fracture nonunions of bones, including nonunion of previously surgically-treated fractures, and 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, open fractures, fresh surgically-treated closed fractures, stress fractures, arthrodesis or failed arthrodesis.
Fresh (Acute) Fracture
There is no standard definition for a “fresh” fracture. A fracture is most commonly defined as fresh for 7 days after the fracture occurs, but there is variability. For example, one study defined fresh as less than 5 days after fracture, while another defined fresh as up to 10 days after fracture. Most freshly closed fractures heal without complications with the use of standard fracture care, i.e., closed reduction and cast immobilization.
Delayed union is defined as a decelerating healing process as determined by serial radiographs, 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.
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 consistent with those proposed for electrical stimulation as a treatment of nonunions:
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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
6/6/2007: Policy added. The "Fracture Healing Devices: Electrical Bone Growth Stimulation & Ultrasound-Accelerated Healing" policy has been replaced with the "Ultrasound Accelerated Fracture Healing Device" policy
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.
04/21/2014: Policy description updated. Revised the medically necessary policy statements to clarify delayed union and nonunion of previously surgically-treated fractures. Updated the investigational policy statement to add fresh surgically-treated closed fractures and arthrodesis or failed arthrodesis as other applications of low-intensity ultrasound treatment that are considered investigational.
03/23/2015: Policy guidelines updated to clarify definition of fresh fracture.
08/31/2015: Medical policy revised to add ICD-10 codes.
04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.
Blue Cross Blue Shield Association Policy # 1.01.05
This may not be a comprehensive list of procedure codes applicable to your policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.