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A.7.01.140
As part of the treatment of localized breast cancer, breast-conserving surgery is optimally achieved by attaining tumor-free margins around the surgical resection site. Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins (eg, MarginProbe) is intended to increase the probability that the surgeon will achieve clear margins in the initial procedure, thus avoiding the need for a second surgery to excise more breast tissue.
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 to determine definitively 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.
A device to detect positive margins should have a high sensitivity, indicating the ability to accurately detect any tumor found in the margins, ideally above 95%. While specificity is less important, excess false-positive margin detection would lead to additional unnecessary tissue removal. A new device should have a specificity at least matching current standard best practices, estimated at 85%.
The MarginProbe in an intraoperative device which uses radiofrequency spectroscopy to measure the dielectric properties of tissue into which it comes in contact. Cancer cells and normal breast tissues produce different signals. A handheld probe is applied to a small area of the lumpectomy specimen and analyzes whether the tissue is likely malignant or benign. The device gives a positive or negative reading for each touch. If any touch on a particular margin gives a positive reading, the margin is considered to be positive and more tissue should be re-excised if possible. The device can only be used on the main lumpectomy specimen; it cannot be used on shavings or in the lumpectomy cavity of the patient’s breast. Use of the MarginProbe is intended to increase the probability that the surgeon will achieve clear margins in the initial surgery, thus avoiding the need for a second procedure to excise more breast tissue.
In December 2012, MarginProbe® (Dune Medical Devices, Caesarea, Israel) was approved by the U.S. Food and Drug Administration through the premarket approval process as an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤1 mm) of the main ex-vivo lumpectomy specimen after primary excision. It is indicated for intraoperative use in conjunction with standard methods (eg, 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.
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.
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.
04/01/2016: Policy description updated. Policy statements unchanged.
05/31/2016: Policy number A.7.01.140 added.
03/01/2017: Policy description updated. Policy statement unchanged.
03/07/2018: Policy description updated regarding devices. Policy statement unchanged.
03/20/2019: Policy description updated regarding devices. Policy statement unchanged.
06/20/2019: Code Reference section updated to add new CPT code 0546T, effective 07/01/2019.
03/11/2020: Policy reviewed; no changes.
05/20/2021: Policy description updated. Policy statement unchanged.
04/21/2022: Policy reviewed; no changes.
03/20/2023: Policy reviewed; no changes.
03/20/2024: Policy reviewed; no changes.
04/10/2025: Policy reviewed; no changes.
Blue Cross and Blue Shield Association Policy # 7.01.140
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
0546T | Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report |
19499 | Unlisted procedure, breast |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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