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Handheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery

Policy Number: MP-552

Latest Review Date: February 2022

Category: Surgery                                                                  

 

POLICY:

Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 (e.g., 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.

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. 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.

The MarginProbe® is an intraoperative device based on the principles of radiofrequency spectroscopy that measures 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 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.

KEY POINTS:

This policy was created in 2013 based on a TEC Assessment and updated with literature search through January 7 2022. 

Summary of Evidence

For individuals who have localized breast cancer or ductal carcinoma in situ undergoing breast-conserving surgery (lumpectomy) who receive handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins (e.g., MarginProbe), the evidence includes 1 randomized trial, several historical control studies, and 1 systematic review. Relevant outcomes are change in disease status (relapse rates) and morbid events (re-excision rates). In the randomized trial, histologic examination of surgical margins was not used in the control arm; the outcome measure (complete surgical resection) was not directly clinically relevant and was biased against the control arm; and patient follow-up was insufficient to assess local recurrence rates. The difference in re-excision rates between the 2 trial arms was not statistically significant. Diagnostic characteristics of the device showed only moderate sensitivity and poor specificity; thus, the device will miss some cancers and provide frequent false-positive results. Although several historical control studies have shown lower re-excision rates among patients in whom MarginProbe was used, the studies lacked adequate rigor to demonstrate whether the outcomes are attributable to MarginProbe. The studies did not report recurrence outcomes, which is important for assessing adequacy of resection. A randomized trial that assesses recurrence rates is required to evaluate whether the net health outcome improves with handheld radiofrequency spectroscopy compared with standard intraoperative surgical margin evaluation, including histologic techniques. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

Current National Comprehensive Cancer Network guidelines for breast cancer (version 1.2021) do not include recommendations for intraoperative assessment of surgical margins using radiofrequency spectroscopy for ductal carcinoma in situ or invasive breast cancer.

American Society of Breast Surgeons

The most current version of the American Society of Breast Surgeons' performance and practice guidelines for breast-conserving surgery (2015) mention that specimens should be submitted for margin assessment either intraoperatively or post-surgery, depending on each institution's protocol. A recommendation for one margin assessment method over another was not made.

In 2017, the American Society of Breast Surgeons issued a consensus guideline for breast cancer lumpectomy margins, providing an algorithm for re-excision surgery after lumpectomy or breast conservation for invasive or in-situ breast cancer. Margin definitions and treatment recommendations are based on inked specimen edges and do not include recommendations for the intraoperative assessment of surgical margins via radiofrequency spectroscopy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Handheld radiofrequency spectroscopy, MarginProbe

APPROVED BY GOVERNING BODIES:

In January 2013, MarginProbe® received premarket approval (PMA) from FDA. The Dune MarginProbe®™ System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤1 mm) of the main ex-vivo lumpectomy specimen after primary excision and is indicated for intraoperative use in conjunction with standard methods (e.g., intraoperative imaging and palpation) for patients undergoing lumpectomy for previously diagnosed breast cancer.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

Effective 07/01/19 and after:

0546T

Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report

 

PREVIOUS CODING:

CPT:

Prior to 07/01/19, there was no specific CPT code for Spectroscopy assessment. An unlisted code would have been used.

 

19499

Unlisted procedure, breast

REFERENCES:

  1. Allweis TM, Kaufman Z, Lelcuk S, et al. A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg. Oct 2008; 196(4):483- 489.
  2. American Society of Breast Surgeons. Consensus guidelines on breast cancer lumpectomy margins. 2017; https://www.breastsurgeons.org/docs/statements/Consensus-Guidelines-on-Breast-Cancer-Lumpectomy-Margins.pdf
  3. American Society of Breast Surgeons. Performance and Practice Guidelines for Breast-Conserving Surgery/Partial Mastectomy. https://www.breastsurgeons.org/statements/guidelines/PerformancePracticeGuidelines_Breast-ConservingSurgery-PartialMastectomy.pdf.
  4. Blohmer JU, Tanko J, Kueper J, et al. MarginProbe(c) reduces the rate of re-excision following breast conserving surgery for breast cancer. Arch Gynecol Obstet. Aug 2016; 294(2):361-367.
  5. Butler-Henderson K, Lee AH, Price RI, et al. Intraoperative assessment of margins in breast conserving therapy: a systematic review. Breast. Apr 2014; 23(2):112-119.
  6. Cen C, Chun J, Kaplowitz E, et al. Margin Assessment and Re-excision Rates for Patients Who Have NeoadjuvantChemotherapy and Breast-Conserving Surgery. Ann Surg Oncol. Sep 2021; 28(9): 5142-5148.
  7. Coble J, Reid V. Achieving clear margins. Directed shaving using MarginProbe, as compared to a full cavity shave approach. Am J Surg. Apr 2017;213(4):627-630.
  8. Geha RC, Taback B, Cadena L, et al. A Single institution's randomized double-armed prospective study of lumpectomy marginswith adjunctive use of the MarginProbe in nonpalpable breast cancers. Breast J. Nov 2020; 26(11): 2157-2162.
  9. Gooch JC, Yoon E, Chun J, et al. The relationship of breast density and positive lumpectomy margins. Ann. Surg. Oncol., 2019 Mar 20;26(6).
  10. Gray RJ, Pockaj BA, Garvey E, Blair S. Intraoperative margin management in breast-conserving surgery: a systematic review of the literature. Ann Surg Oncol. 2018;25:18-27. 
  11. Kupstas A, Ibrar W, Hayward RD, et al. A novel modality for intraoperative margin assessment and its impact on re-excision rates in breast conserving surgery. Am J Surg. Mar 2018; 215(3): 400-403.
  12. LeeVan E, Ho BT, Seto S, et al. Use of MarginProbe as an adjunct to standard operating procedure does not significantlyreduce re-excision rates in breast conserving surgery. Breast Cancer Res Treat. Aug 2020; 183(1): 145-151.
  13. Maloney BW, McClatchy DM, Pogue BW, et al. Review of methods for intraoperative margin detection for breast conserving surgery. J Biomed Optics. 2018;23(10). 
  14. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer.Version.2.2022. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
  15. Rivera RJ, Holmes DR, Tafra L. Analysis of the impact of intraoperative margin assessment with adjunctive use of marginprobe versus standard of care on tissue volume removed. Int J Surg Oncol. 2012; 2012:868623.
  16. Schnabel F, Boolbol SK, Gittleman M, et al. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. May 2014; 21(5):1589-1595.
  17. Sebastian M, Akbari S, Anglin B, et al. The impact of use of an intraoperative margin assessment device on re-excision rates. Springerplus. 2015; 4:198.
  18. St John ER, Al-Khudairi R, Ashrafian H, et al. Diagnostic accuracy of intraoperative techniques for margin assessment in breast cancer surgery: a meta-analysis. Ann Surg. Feb 2017; 265(2):300-310.
  19. Thill M, Dittmer C, Baumann K, et al. MarginProbe(R)--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ. Breast. Feb 2014; 23(1):94-96.
  20. Thill M, Roder K, Diedrich K, et al. Intraoperative assessment of surgical margins during breast conserving surgery of ductal carcinoma in situ by use of radiofrequency spectroscopy. Breast. Dec 2011; 20(6):579-580.
  21. U.S. Food and Drug Administration (FDA). Summary of safety and effectiveness data: MarginProbe System, issued 12/07/12. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P110014.

POLICY HISTORY:

Medical Policy Panel, August 2014

Medical Policy Group, August 2014(1): New Policy, previously only listed on Investigational Listing; remains investigational

Medical Policy Administration Committee, September 2014

Available for comment September 8 through October 22, 2014

Medical Policy Panel, August 2015

Medical Policy Group, August 2015 (2): Updates to Key Points and References, no change to policy statement.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (2): 2016 Updates to Description and Key Points; no change in policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (7): 2017 Updates to Description, Key Points, and References. No change in policy statement.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (7): 2018 Updates to Description, Key Points, and References. No change in policy statement.

Medical Policy Panel, February 2019

Medical Policy Group, April 2019 (7): 2019 Updates to Key Points and References. No change in policy statement.

Medical Policy Group, June 2019: July 2019 quarterly coding update.  Added new CPT code 0546T to Current Coding.  Created previous coding section and moved 19499 to previous coding.

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (7): 2020 Updates to Key Points and References. No change in policy statement.

Medical Policy Panel, February 2021

Medical Policy Group, February 2021 (7): Updates to Key Points and References. Policy section updated to remove not medically necessary from statement, no change to intent.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (7): Updates to Key Points and References. No change in Policy Statement.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.