Positron Emission Mammography
DESCRIPTION
Positron emission mammography (PEM) is a form of positron emission tomography (PET) that uses a high spatial resolution and a small field of view mini-camera for close range spot imaging of the breast. A radiotracer is administered and the detectors are mounted on compression paddles to allow for gentle compression of the breast during the imaging study. PEM provides functional rather than anatomic information on the breast and the PEM images can be easily compared with mammography since they are acquired in the same anatomic position. This policy will address the use of PEM for pre-surgical planning and staging, monitoring response to therapy, and monitoring for recurrence of breast cancer.
POLICY
The use of positron emission mammography (PEM) is considered investigational.
See also: Magnetic Resonance Imaging (MRI) of the Breast
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
In the absence of randomized, controlled trials or meta-analyses no conclusions can be drawn to determine whether the use of positron emission mammography can improve clinical outcomes. Prospective studies that have been published comparing PEM to existing modalities are limited by single site investigations and lack of blinding.
If future studies reveal that the addition of PEM to MRI improves accuracy this finding must be weighed against potential risk from radiation exposure associated with PEM and the lack of a full chain of evidence for these findings (e.g. that improved accuracy results in better patient outcomes).
SOURCES
American College of Radiology. ACR Appropriateness Criteria® (2009). Breast microcalcifications – Initial diagnostic work-up. Retrieved March 22, 2011 from http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/ExpertPanelonWomensImagingBreastWorkGroup/BreastMicrocalcificationsDoc1.aspx.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2011). Positron Emission Mammography (6.01.52). Retrieved March 21, 2011 from BlueWeb. (10 articles and/or guidelines reviewed)
O’Connor, M., Rhodes, D., Hruska, C., Clancy, C., & Vetter, R. (2010). Comparison of radiation exposure and associated radiation-induced cancer risks from mammography and molecular imaging of the breast. Medical Physics, 37 (12), 6187-6198.
Schilling, K., Narayanan, D., Kalinyak, J., The, J., Velasquez. M., Kahn, S., et al. (2010) Positron emission mammography in breast cancer pre-surgical planning: comparisons with magnetic resonance imaging. European Journal of Nuclear Medicine and Molecular Imaging, 38 (1), 23-36. (Level 3 evidence – Industry sponsored)
U. S. Food and Drug Administration. (2003. August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K032063. Retrieved March 22, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/k032063.pdf.
U. S. Food and Drug Administration. (2008. November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082354. Retrieved March 22, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082354.pdf.
ORIGINAL EFFECTIVE DATE: 7/9/2011
MOST RECENT REVIEW DATE: 7/9/2011
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