Medical policy: Vertebral Fracture Assessment and Biomechanical Computed Tomography

Policy number: MP 5.046

Effective date: 4/1/2026

Policy

Screening for vertebral fractures using dual-energy x-ray absorptiometry (DXA) or biomechanical computed tomography (BCT) is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-reference

MP 5.037 Whole Body Dual X-Ray Absorptiometry to Determine Body Composition

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/background

Vertebral fracture assessment

Per the Bone Health and Osteoporosis Foundation (BHOF), formerly the National Osteoporosis Foundation, vertebral fracture in an adult aged 50 years or older is diagnostic of osteoporosis, even in the absence of a bone mineral density threshold. Unfortunately, most vertebral fractures are subclinical or completely asymptomatic. As a result, they may go undiagnosed for many years. At the same time, a high proportion of women with asymptomatic vertebral fractures have bone mineral density (BMD) levels that would not warrant treatment based on BMD alone. The finding of a previously unrecognized vertebral fracture may change a patient’s diagnostic classification, alter fracture risk calculations, and determine treatment decisions. Proactive investigation is required to detect these fractures so that further bone damage can be prevented.

Only 20% to 30% of vertebral fractures are recognized clinically; the rest are discovered incidentally on lateral spine radiographs or other imaging studies. Lateral spine radiographs have not been recommended as a component of risk assessment for osteoporosis because of the cost, radiation exposure, and the fact that radiographs would require a separate procedure in addition to the bone mineral density study using dual-energy x-ray absorptiometry (DXA). However, several densitometers with specialized software can perform vertebral fracture assessment (VFA) in conjunction with DXA. The lateral spine scan is performed by using a rotating arm. Depending on the densitometer used, the patient can either stay in the supine position after the bone density study or is required to move to the left decubitus position.

Vertebral fracture assessment differs from radiologic detection of fractures because VFA uses a lower radiation exposure and can detect only fractures, while traditional radiographic images can detect other bone and soft tissue abnormalities in addition to spinal fractures. Manufacturers have also referred to this procedure as instant vertebral assessment, radiographic vertebral assessment, dual-energy vertebral assessment, or lateral vertebral assessment.

For both lateral spine radiographs and images with densitometry, vertebral fractures are assessed visually. A number of grading systems have been proposed, and the Genant semiquantitative method is commonly used. This system grades deformities from I to III, with grade I (mild) representing a 20% to 24% reduction in vertebral height, grade II (moderate) representing a 25% to 39% reduction in height, and grade III (severe) representing a 40% or greater reduction in height. The location of the deformity within the vertebra may also be noted. For example, if the mid height of the vertebra is affected, the deformity is defined as an endplate deformity; if both the anterior and mid heights are deformed, it is a wedge deformity; and if the entire vertebra is deformed, it is classed as a crush deformity. A vertebral deformity of at least 20% loss in height is typically considered a fracture. Accurate interpretation of both lateral spine radiographs and VFA imaging depends on radiologic training. Thus, device location and availability of appropriately trained personnel may influence diagnostic accuracy.

Biomechanical computed tomography

Biomechanical computed tomography (BCT) is another method of performing VFA that also minimizes radiation exposure. Previously obtained CT scans can be used for BCT analysis in many cases. Exceptions include spinal images performed with contrast and images in which metal is present in the transverse plane of the bone of interest. Analysis is performed in a centralized laboratory, to which clinicians must send CT scans. The BCT calculation involves a non-linear finite element analysis to simulate a fracture event, with outputs including T-score and Z-score of the femoral neck and hip, femoral strength, vertebral strength, vertebral trabecular volume, and vertebral Z-score. Patients are classified as high risk if fragile bone strength (defined as ≤3000 to 6500 Newtons depending on patient sex and location [hip or spine]) or osteoporosis at the hip or spine is found. The classification of increased risk is assigned if low bone strength or bone mass is identified at the hip or spine.

Regulatory status

Additional software is needed to perform VFA with a densitometer or BCT, and it must be cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. Products cleared for marketing for densitometry and BCT include, but are not limited to, GEHC DXA Bone Densitometers with enCORE version 18, Aria, GE Lunar DXA Bone Densitometers with enCORE version 17, TBS iNsight, QCT Pro Asynchronous Calibration Module Clinilink, Encore version 16 Software for Lunar DXA bone densitometers, and VirtuOst. Food and Drug Administration product code KGI.

Rationale

Summary of evidence

For individuals who are at risk of having vertebral fractures but are not known to have them who receive VFA with densitometry by dual-energy x-ray absorptiometry, the evidence includes diagnostic accuracy studies and subgroup re-analyses of treatment studies. Relevant outcomes are test accuracy, test validity, and morbid events. There is a lack of direct evidence from randomized trials that use densitometry with VFA improves health outcomes. Because direct evidence was not available, a chain of evidence was sought. Evidence was examined on the diagnostic accuracy for VFA in non-osteoporotic patients (i.e., those not already eligible for treatment), the ability of VFA to identify patients for treatment who would not otherwise be identified, and the effectiveness of treatment in this population. Diagnostic accuracy studies have reported variable findings; recent studies have suggested higher diagnostic accuracy of VFA overall compared with standard radiographs than older studies. Studies have found that VFA can identify patients without osteoporosis who may be appropriate candidates for treatment according to recommendations from the Bone Health and Osteoporosis Foundation. However, there is limited evidence on the effectiveness of treatment in this population. No treatment data have been published on patients whose vertebral fractures were identified using VFA software with densitometry. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are at risk of having vertebral fractures but are not known to have them who receive VFA with biomechanical computed tomography, the evidence includes retrospective studies. Relevant outcomes are test accuracy, test validity, and morbid events. The available studies demonstrated that BCT has similar efficacy to DXA in detecting osteoporosis. There is a lack of direct evidence from clinical trials that the use of BCT for VFA improves health outcomes. No treatment data have been published on patients whose vertebral fractures were identified using BCT. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

Bone density or bone mineral density (BMD) is the average mineral concentration of a specimen of bone, skeletal mass. Bone mineral density is reduced in osteopenia and osteoporosis.

Dual x-ray absorptiometry (DXA) is probably the most commonly used technique to measure BMD, because of its ease of use, low radiation exposure, and its ability to measure BMD at both the hip and spine. DXA generates two x-ray beams of different energy levels to the same region of interest and measures the difference in attenuation as the low- and high-energy beams pass through the bone and soft tissue.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered for:

References

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