Low Intensity Pulsed Ultrasound Fracture Healing Device

POLICY NUMBER

A.1.01.05

DESCRIPTION

Low-intensity pulsed ultrasound has been investigated as a technique to accelerate healing of fresh fractures, surgically treated closed fractures, delayed unions, nonunions, stress fractures, osteotomy sites, and distraction osteogenesis. Low-intensity pulsed ultrasound is administered using a transducer applied to the skin surface overlying the fracture site.

Bone Fractures

An estimated 178 million new fractures were reported worldwide in 2019. Most bone fractures heal spontaneously over several months following standard fracture care (closed reduction if necessary, followed by immobilization with casting or splinting). However, approximately 5% to 10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of health care services. Factors contributing to a nonunion include which bone is fractured, fracture site, the degree of bone loss, time since injury, extent of soft tissue injury, and patient factors (eg, smoking, diabetes, systemic disease).

Fracture Nonunion

There is no standard definition of a fracture nonunion. The U.S. Food and Drug Administration (FDA) has defined nonunion as when "a minimum of 9 months has elapsed since injury, and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months." Other definitions cite 3 to 6 months of time from the original injury, or simply when serial radiographs fail to show any further healing. These definitions do not reflect the underlying conditions in fractures that affect healing, such as the degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock.

Delayed Union

Delayed union is generally considered a failure to heal between 3 and 9 months post fracture, after which the fracture site would be considered a nonunion. The 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.) It is important to include both radiographic and clinical criteria to determine fracture healing status. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation.

Treatment

Low-intensity pulsed ultrasound has been proposed to accelerate healing of fractures. Low-intensity pulsed ultrasound is believed to alter the molecular and cellular mechanisms involved in each stage of the healing process (inflammation, soft callus formation, hard callus formation, and bone remodeling). The mechanism of action at the cellular level is not precisely known, but it is theorized that low-intensity pulsed ultrasound may stimulate the production or the activities of the following compounds that contribute to the bone healing process: cyclooxygenase-2, collagenase, integrin proteins, calcium, chondroblasts, mesenchymal cells, fibroblasts, and osteoblasts.

Low-intensity pulsed ultrasound treatment is self-administered, once daily for 20 minutes, until the fracture has healed.

In 1994, the Sonic Accelerated Fracture Healing System (SAFHS®; renamed Exogen 2000® and Exogen 4000+, now Exogen® Ultrasound Bone Healing System; Bioventus) was approved by the FDA through the premarket approval process for treatment of fresh, closed, posteriorly displaced distal radius (Colles) fractures, and fresh, closed, or grade 1 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. The AccelStim™ Bone Growth Stimulator (Orthofix US) was FDA approved in 2022 for accelerating time to healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed, or Grade I open tibial diaphysis fractures and for established non-unions in skeletally mature adults. FDA product code: LOF.

The table below summarizes the FDA cleared or approved low-intensity pulsed ultrasound devices.

U.S. Food and Drug Administration-Approved Low-Intensity Pulsed Ultrasound Devices

a The device was formerly named Sonic Accelerated Fracture Healing System Model 2A (SAHFS®)b 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  Electrical Bone Growth Stimulation of the Appendicular Skeleton and Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures policies.

POLICY

Low-intensity pulsed ultrasound 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:

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 pulsed ultrasound 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 pulsed ultrasound 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 pulsed ultrasound are investigational, including, but not limited to, treatment of congenital pseudarthroses, open fractures, fresh surgically-treated closed fractures, stress fractures, arthrodesis or failed arthrodesis.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 definitional variability. For example, one study defined fresh as less than 5 days after fracture, while another definedfresh as up to 10 days post-fracture. Most freshly closed fractures heal without complications using 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 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.

Nonunion

There is no consensus for the definition of nonunion. One definition is a 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 definition of nonunion used in the U.S. Food and Drug Administration (FDA) labeling suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without providing guidance on the time frame of observation. The following selection criteria are 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 individual can be adequately immobilized and, based on age, 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.

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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

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.

05/26/2016: Policy number A.1.01.05 added.

09/22/2016: Policy description updated. Policy statements updated to change "Low-intensity ultrasound" to "Low-intensity pulsed ultrasound."

09/30/2016: Code Reference section updated to add the following new ICD-10 diagnosis codes: S99.001A - S99.011S, S99.021A - S99.021S, S99.031A - S99.031S, S99.041A - S99.041S, S99.091A - S99.091S, and S99.209D - S99.209S.

08/18/2017: Policy description updated regarding bone fractures and treatment. Policy statements unchanged.

01/12/2018: Policy reviewed; no changes.

03/28/2018: Policy reviewed; no changes.

04/02/2019: Policy reviewed; no changes.

05/21/2021: Policy title changed from "Ultrasound Accelerated Fracture Healing Device" to "Low Intensity Pulsed Ultrasound Fracture Healing Device." Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

04/22/2022: Policy reviewed; no changes.

04/10/2023: Policy description updated regarding bone fractures and treatments. Policy statements unchanged. Policy Guidelines updated.

04/10/2024: Policy reviewed; no changes.

06/05/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 1.01.05

CODE REFERENCE

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.

Covered Codes

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