Vertebral Fracture Assessment with Densitometry or Biomechanical Computed Tomography

POLICY NUMBER

A.6.01.44

DESCRIPTION

Vertebral fracture assessment (VFA) with densitometry is a technique to assess vertebral fractures at the same time as bone mineral density, using additional software with dual-energy x-ray absorptiometry. The addition of vertebral fracture assessment to bone mineral density may augment diagnostic information on fracture risk. Another method of determining vertebral fracture risk is biomechanical computed tomography (BCT), which evaluates both bone density and strength.

Diagnosis

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 the radiograph would require a separate procedure in addition to the bone mineral density study using dual-energy x-ray absorptiometry. However, several densitometers with specialized software can perform vertebral fracture assessment (VFA) in conjunction with dual-energy x-ray absorptiometry. 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 radiograph 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 vertebrae may also be noted. For example, if only the mid-height of the vertebrae 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 vertebrae 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 (BCT) is another method of performing VFA which 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 low bone mass is identified at the hip or spine.

To perform vertebral fracture assessment with a densitometer, additional software is needed, and it must be cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Products cleared for marketing are shown in the table below.

Vertebral Fracture Assessment Devices Cleared by the U.S. Food and Drug Administration

See separate medical policy for Bone Mineral Density Studies .

POLICY

Screening for vertebral fractures using dual-energy x-ray absorptiometry or biomechanical computed tomography is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

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.

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

3/31/2005: Approved by Medical Policy Advisory Committee (MPAC).

6/6/2005: Code Reference section completed.

3/16/2006: Policy reviewed, no changes.

1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.

5/15/2007: Policy reviewed, description updated. Morphometric absorptiometry changed to dual x-ray absorptiometry in policy statement. Policy name changed to "Vertebral Fracture Assessment with Densitometry." Previously named "Screening for Vertebral Fracture with Dual X-ray Absorptiometry (DEXA)."

04/19/2011: Policy description and statement unchanged. Added FEP verbiage to the Policy Exceptions section. Removed deleted CPT code 76077 from the Code Reference section.

03/02/2012: Policy reviewed; no changes.

04/03/2013: Policy reviewed; no changes.

03/21/2014: Policy reviewed; no changes.

06/17/2014: Policy reviewed; description updated. Policy statement unchanged.

12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 77086.

07/23/2015: Code Reference section updated for ICD-10.

09/25/2015: Policy reviewed; policy statement unchanged. Investigative definition updated in the Policy Guidelines section.

05/31/2016: Policy number A.6.01.44 added. Removed deleted CPT code 77082 from the Code Reference section.

10/13/2016: Policy description updated. Policy statement updated to change "dual x-ray" to "dual-energy x-ray."

10/17/2017: Policy description updated. Policy statement unchanged.

10/04/2018: Policy reviewed; no changes.

10/22/2019: Policy description updated regarding devices. Policy statement unchanged.

10/14/2020: Policy description updated regarding devices. Policy statement unchanged.

12/30/2021: Policy reviewed; no changes.

03/08/2023: Policy reviewed; no changes.

10/12/2023: Policy description updated. Policy statement unchanged.

03/01/2025: Policy title changed from "Vertebral Fracture Assessment with Densitometry" to "Vertebral Fracture Assessment with Densitometry or Biomechanical Computed Tomography." Policy description updated regarding biomechanical computed tomography. Policy statement updated to state that screening for vertebral fractures using dual-energy x-ray absorptiometry or biomechanical computed tomography is considered investigational. Code Reference section updated to add CPT code 0743T.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 6.01.44

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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