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DESCRIPTIONPositron emission mammography (PEM) is a form of positron emission tomography (PET) that uses a high-resolution, mini-camera detection technology for imaging the breast. As with PET, PEM provides functional rather than anatomic information about the breast. PEM has been studied primarily for use in presurgical planning and staging; it also has been used to monitor response to therapy and recurrence of breast cancer.
Positron emission mammography (PEM) is a form of positron emission tomography (PET) that uses a high-resolution, mini-camera detection technology for imaging the breast. As with PET, a radiotracer, usually 18F-fluorodeoxyglucose (FDG), is administered and the camera is used to provide a higher resolution image of a limited section of the body than would be achievable with FDG-PET. Gentle compression is used, and the detector(s) are mounted directly on the compression paddle(s). PEM was developed to overcome the limitations of PET for detecting breast cancer tumors. Patients usually are supine for PET procedures, and breast tissue may spread over the chest wall, making it potentially difficult to differentiate breast lesions from other organs that take up the radiotracer. PET’s resolution is generally limited to approximately 5 mm, which may not detect early breast cancer tumors. PEM allows for the detection of lesions as small as 2 to 3 mm and creates images that are more easily compared with mammography, because they are acquired in the same position. Three-dimensional reconstruction of PEM images is also possible. As with PET, PEM provides functional rather than anatomic information about the breast. In PEM studies, exclusion criteria included some patients with diabetes. PET may be used for other indications in patients with breast cancer, namely, detecting loco-regional or distant recurrence or metastasis (except axillary lymph nodes) when suspicion of disease is high and other imaging is inconclusive.
In August 2003, the PEM 2400 PET Scanner (PEM Technologies, Inc., Ridgefield, NJ) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for “medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.” In March 2009, the Naviscan PEM Flex™ Solo II High Resolution PET Scanner (Naviscan, Inc., San Diego, CA) was cleared for marketing by the FDA through the 510(k) process for the same indication. The PEM 2400 PET Scanner was the predicate device. The newer device is described by the manufacturer as “a high spatial resolution, small field-of-view PET imaging system specifically developed for close-range, spot, i.e., limited field, imaging.”
There was a class 2 recall of the Naviscan PET Systems Inc. PEM Flex™ Solo II PET Scanner on September 11, 2008, due to “a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the pre-scan positioning of the patient.” Software for the PEM Flex™ Solo I and PEM Flex™ Solo II PET scanners was recalled in August 2007. One report indicated that the Mexican medical company, Compañía Mexicana de Radiología SA de CV (CMR), acquired Naviscan in December 2013 and plans to file a new marketing approval application with FDA to sell the PEM Flex™ Solo II PET Scanner in the U.S. However, no applications from CMR were found on FDA websites.
Also, refer to related medical policy, Scintimammography/Breast-Specific Gamma Imaging/Molecular Breast Imaging.
POLICYThe use of positron emission mammography (PEM) is considered investigational for all indications.
POLICY EXCEPTIONSFederal 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 GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/31/2011: Approved by Medical Policy Advisory Committee.
07/17/2012: Policy reviewed; no changes.
10/23/2013: Policy reviewed; no changes.
08/06/2014: Policy reviewed; description updated. Added "for all indications" to the policy statement.
SOURCE(S)Blue Cross Blue Shield Association policy # 6.01.52
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.