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Breast-conserving surgery as part of the treatment of localized breast cancer is optimally achieved by attaining margins around the surgical resection that are free from tumor cells. Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins (ie, MarginProbe®) is intended to increase the probability that the surgeon will achieve clear margins in the initial operation, thus avoiding the need for a second surgery to excise more breast tissue.
Breast-conserving surgery as part of the treatment of localized breast cancer is optimally achieved by attaining margins around the surgical resection that are free from tumor cells. Failure to achieve clear margins will often require additional surgery to re-excise breast tissue. Currently, histologic examination of excised tissues after completion of surgery is the only method of definitively determining whether clear margins were achieved. Intraoperative methods of assessing surgical margins, such as specimen imaging, frozen section pathology, and touch print cytology, are either not highly accurate, not commonly available, or require considerable time and resources.
MarginProbe® is a device based on the principles of radiofrequency spectroscopy that measures the dielectric properties of tissue that the device comes in contact with. Cancer cells and normal breast tissues produce different signals. A handheld probe is applied to a small area of the resected surgical specimen and analyzes the tissue as to whether it is likely malignant or benign. During the operation, the surgeon touches the MarginProbe® device to each surface of the biopsy specimen. The device gives a reading of positive or negative for each touch. If any one of the touches on a particular margin gives a positive reading, the margin is considered to be positive and should be re-excised if possible. The device can only be used on the main lumpectomy specimen, and cannot be used on shavings or in the lumpectomy cavity in the patient’s breast. Use of the MarginProbe® device is intended to increase the probability that the surgeon will achieve clear margins in the initial operation, thus avoiding the need for a second surgery to excise more breast tissue.
In January 2013, MarginProbe® received premarket approval (PMA) from the Food and Drug Administration (FDA). The Dune MarginProbe® System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use in conjunction with standard methods (such as intraoperative imaging and palpation) for patients undergoing lumpectomy for previously diagnosed breast cancer.
Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery is considered investigational.
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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
04/01/2014: Approved by Medical Policy Advisory Committee.
10/09/2014: Policy reviewed; description updated. Policy statement unchanged.
07/30/2015: Code Reference section updated for ICD-10.
11/02/2015: Policy reviewed. Policy statement unchanged. Investigative definition updated in the policy guidelines section.
Blue Cross and Blue Shield Association Policy # 7.01.140
This may not be a comprehensive list of procedure codes applicable to this policy.