Breast Elastography

POLICY NUMBER

L.2.04.458

DESCRIPTION

In the United States, about 1 in 8 women will develop invasive breast cancer over the course of her lifetime. Mammography remains the generally accepted standard diagnostic test for breast cancer screening and diagnosis. The incidence of breast cancer has led to research on new diagnostic imaging techniques for early diagnosis.

Elasticity is the property of a substance to be deformed in response to an external force and to resume its original size and shape when the force is removed. In evaluation of superficial tissue such as skin, breast or prostate, manual palpation can distinguish normal tissue from stiffer tissue. Elastography is a noninvasive technique that evaluates the elastic properties, or stiffness of tissues, and its application for diagnosing breast cancer is based on the principle that malignant tissue is less elastic than normal, healthy breast tissue. Elastography has been investigated as an additive technique to increase the specificity of ultrasound and magnetic resonance imaging. Other emerging applications include breast, thyroid, prostate, kidney and lymph nodes.

Ultrasound elastography (USE), also known as sonoelastography, is a noninvasive imaging technique that can be used to determine relative tissue stiffness. There are 2 main types of ultrasound elastography, strain and shear wave. Strain elastography uses a static force and is a qualitative technique of compression that provides information on the relative stiffness between one tissue and another. Shear wave elastography utilizes a dynamic force and is a quantitative method that provides an estimated value of the stiffness. The process involves comparing a normal ultrasound image to one in which the suspect area is compressed. In strain elastography, an ultrasound transducer generally provides the force. In shear wave elastography, a handheld probe that combines an ultrasound transducer with a mechanical vibrator is used. Sonographic measurements are made based on movement of the tissue in response to the compression and decompression waves. Generally, USE is considered to provide complementary information to conventional US. This technology has been widely utilized in staging hepatic fibrosis.

Magnetic resonance elastography is the 3-dimensional analysis of wave propagation and tissue deformation. The technique uses standard MRI equipment with some modifications. The main steps involved in MRE include generating mechanical waves in soft tissues, acquiring MR images of the propagation of the induced shear waves and processing the images of the shear waves to a quantitative map of tissue stiffness, the elastogram. Currently, MRE’s principal application is for staging hepatic fibrosis.

POLICY

Breast elastography by either ultrasound or magnetic resonance is considered investigational. There is insufficient evidence of the effectiveness of elastography in the screening or diagnosis of breast cancer.

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

03/15/2024: New policy added. Approved by the Medical Policy Advisory Committee.

07/24/2024: Policy reviewed; no changes.

03/27/2025: Policy reviewed; no changes.

SOURCE(S)

BlueCross BlueShield of Michigan

CODE REFERENCE

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

Investigational Codes

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