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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, 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.”
In December 2013, Naviscan was acquired by Compañía Mexicana de Radiología SA (Queretaro, Mexico), which currently markets the PEM Flex™ Solo II PET Scanner in the United States (personal communication).
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 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.
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.
08/04/2015: Code Reference section updated for ICD-10.
10/27/2015: Policy description updated regarding devices. Policy statement unchanged. Investigative definition updated in the policy guidelines section.
05/31/2016: Policy number added.
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.