Medical Policy: 06.01.30
Original Effective Date: August 2013
Reviewed: April 2016
Revised: April 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Osteoporosis, defined as low bone mass leading to an increased risk of fragility fractures, is an extremely common disease in the elderly due to age-related bone loss in both sexes and menopause-related bone loss in women.
According to the WHO (World Health Organization) diagnostic classification, osteoporosis is defined by bone mineral density (BMD) at the hip or lumbar spine that is less than or equal to 2.5 standard deviations below the mean BMD of a young adult.
The diagnosis of osteoporosis is established by measurement of bone mineral density (BMD) Bone mineral density can be measured with a variety of techniques (DXA/DEXA, CT based absorptiometry or ultrasound) in a variety of sites. Sites are broadly subdivided into central sites (i.e., hip or spine) and peripheral (i.e., wrist, finger, heel). The technique most commonly used to measure BMD is dual x-ray absorptiometry (DXA/DEXA).
Quantitative Ultrasound Densitometry (QUS)
Quantitative ultrasonography scanning measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. QUS results are reported as broadband ultrasound attenuation (BUA) and the speed of sound (SOS). These two parameters are sometimes combined to yield a “stiffness index”. QUS is a technique for measuring bone mass at peripheral sites such as heel, tibia and phalanges. It does not use ionizing radiation and has the advantage of being small, portable and relatively inexpensive. However, this technique has not been shown to be useful in monitoring skeletal response to different therapies used to treat osteoporosis. Therefore, this technology is considered investigational.
Vertebral Fracture Assessment using Dual X-ray Absorptiometry (DXA/DEXA)
Vertebral fractures are highly prevalent in the elderly population. Most vertebral fractures are asymptomatic when they first occur and often go undiagnosed for many years. Only 20-30% of vertebral fractures are recognized clinically, the rest are discovered incidentally on lateral spine radiographs.
The newest generation of fan beam DXA systems delivering “high-resolution” lateral spine images offers a potential practical alternative to radiographs for clinical vertebral fracture analysis. The advantages of using DXA over conventional radiographic devices are its minimal radiation exposure and high speed image acquisition. It also allows combined evaluation of vertebral fracture status and bone mass density, which could become a standard for patient evaluation of osteoporosis. However, the disadvantage of DXA use is the upper thoracic vertebrae cannot be evaluated in a substantial number of patients due to poor imaging quality. The clinical utility using dual x-ray absorptiometry (DXA/DEXA) for evaluation of vertebral fractures may help in screening patients, but technological improvements are necessary to improve image quality.
Studies comparing DXA/DEXA vertebral fracture assessment to lateral spine x-rays (considered the “gold standard” for diagnosis of vertebral fractures) have shown high levels of agreement between the two techniques. However, one basic principle of screening is that there must be clear treatment guidelines demonstrating improvement in health outcomes related to treatment of an asymptomatic condition. Currently treatment of osteoporosis is based on the presence of decreased bone mineral density (BMD). At this time, there is no clear guidance for the treatment of asymptomatic vertebral fracture in women with normal BMD. It is not known whether anti-resorptive therapy would improve the fracture risk in individuals with normal or near normal bone mineral density. There is insufficient evidence in the published peer reviewed scientific literature regarding the clinical utility using dual x-ray absorptiometry (DXA/DEXA) for evaluation of vertebral fractures. This technique may help in screening patients, but technological improvements are necessary to improve image quality. Also, there is insufficient evidence on health outcomes as there are no clear guidance for the treatment of asymptomatic vertebral fractures with normal BMD and whether or not anti-resorptive therapy would improve the fracture risk in individuals with normal or near normal bone mineral density. Therefore, screening for vertebral fracture assessment using dual x-ray absorptiometry as an adjunct to bone mineral density measurement is considered investigational.
Regulatory Status
Vertebral fracture assessment application packages that have received 510(k) marketing clearance are the Instant Vertebral Assessment (IVA) (Hologic, Inc.) and Dual Energy Vertebral Assessment (DVA) (previously known as Lateral Vertebral Assessment (LVA) (GE Lunar Medical Systems).
American College of Radiology (ACR) – Society of Skeletal Radiology (SSR) Practice Guideline for the Performance of Dual Energy X-ray Absorptiometry (DXA)
Summary of Recommendations:
Follow up treatment can be performed using DXA (dual x-ray absorptiometry) and QCT (quantitative computed tomography) only.
Not applicable.
Screening for vertebral fractures using dual x-ray absorptiometry (DXA or DEXA) as an adjunct to bone mineral density measurement is considered investigational.
There is insufficient evidence in the published peer reviewed scientific literature regarding the clinical utility using dual x-ray absorptiometry (DXA/DEXA) for evaluation of vertebral fractures. This technique may help in screening patients, but technological improvements are necessary to improve image quality. Also, there is insufficient evidence on health outcomes as there are no clear guidance for the treatment of asymptomatic vertebral fractures with normal BMD and whether or not anti-resorptive therapy would improve the fracture risk in individuals with normal or near normal bone mineral density. Therefore, screening for vertebral fracture assessment using dual x-ray absorptiometry as an adjunct to bone mineral density measurement is considered investigational. If a vertebral fracture is identified in an asymptomatic individual, studies do not report the impact of that finding on long-term health outcomes.
Several recent studies have compared the diagnostic accuracy of vertebral fracture assessment (VFA) and standard radiography. None of these reported findings separately for osteoporotic and nonosteoporotic patients, so conclusions cannot be drawn about diagnostic accuracy of VFA in patients without osteoporosis. Moreover, studies tended to use radiography as the reference standard and did not evaluate potential false positives or false negatives associated with radiography.
The use of quantitative ultrasound densitometry (QUS) to measure bone mineral density (BMD) is considered investigational for all applications.
QUS is a technique for measuring bone mass at peripheral sites such as heel, tibia and phalanges. QUS results are reported as broadband ultrasound attenuation (BUA) and the speed of sound (SOS). This technique has not been shown to be useful in monitoring skeletal response to different therapies used to treat osteoporosis. Therefore, this technology is considered investigational. Also, current diagnostic and treatment criteria for osteoporosis rely on DXA (dual x-ray absorptiometry) measurements only.
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.