Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Automated Whole Breast Ultrasound

Description:

Automated Whole Breast Ultrasound (AWBUS) also referred to as Automated Breast Ultrasound (ABUS), is an alternative to the standard hand-held ultrasound. AWBUS is typically performed with robotic guidance of a standard ultrasound probe over the entirety of both breasts or a large transducer over the central portion of both breasts (Kelly, 2011).

AWBUS has been considered as an adjunct to mammography in breast cancer screening in patients with dense breast tissue.

On September 18, 2012, the U.S. Food and Drug Administration (FDA) approved the somo-v ABUS™ Dense Breast Screening (U-Systems) device. The device received approval for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.

Sonocine, Inc. (Reno, NV) received FDA 510K marketing clearance in 2008 for the SonoCiné® Automated Whole Breast Ultrasound System.

In 2009, Siemens Healthcare introduced the ACUSON S2000™ Automated Breast Volume Scanner (ABVS).

Coding

There is not a specific CPT code for this service. It is expected that this service may be billed with the following unspecified CPT code:

76999 Unlisted ultrasound procedure (e.g., diagnostic interventional)

Policy/
Coverage:

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of Automated Breast Ultrasound (ABUS) alone or in combination with mammography in the screening or diagnosis of breast cancer or for any other reason does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, the use of Automated Breast Ultrasound (ABUS) alone or in combination with mammography in the screening or diagnosis of breast cancer or for any other reason is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

Drukteinis et al published a review discussing current practices and imaging techniques for breast cancer screening (Drukteinis, 2013). Automated whole breast ultrasound is discussed as a promising new technology for breast cancer screening, among other new technologies. The author states, “While these advances are encouraging, it is improbable that any of the new technologies will replace mammography for population-based screening programs, because all have significant limitations (Drukteinis, 2013). There were no trials identified in the review that addressed the clinical utility of this testing.

Automated whole breast ultrasound was tested in 4419 women having routine mammography at eight clinical sites in the United States (Kelly, 2010). The performance and diagnostic yield of mammography alone versus an automated whole breast ultrasound plus mammography was compared in women with dense breasts and/or at elevated risk of breast cancer. There was an increase in diagnostic yield from 3.6/1000 with mammography alone to 7.2/1000 with the addition of AWBUS. Positive predictive value for biopsy based on mammography was 39% and for AWBUS 38.4%. The study was limited by the small number of participating facilities and radiologists and the open-label, non-randomized study design. The authors note that these results should not be compared with the general screening population because the participants in this study were difficult-to-image, high-risk subjects. The author of this publication is noted to be the Chief Medical Officer and Board Chairman of SonoCiné (SonoCiné website).

The somo-v ABUS™ Dense Breast Screening (U-Systems) device received FDA approval based on a non-randomized study of 200 breast screening cases retrospectively selected from on ongoing registry study (FDA.gov, 2013). Published results of this study were not identified.

Kim and colleagues reported results of a trial assessing the use of automated whole breast ultrasound compared to hand-held breast ultrasound in 38 breast cancer patients (Kim, 2013). The AWBUS data was independently reviewed by three radiologists. The detection rate of malignancies for hand-held ultrasound was 98% and 90%, 88% and 96% for the three readers of the automated whole breast ultrasounds. The authors concluded there was no significant difference in the detection rate, sensitivity or specificity of AWBUS for hand-held ultrasound.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

The NCCN Clinical Practice Guidelines in Oncology, Breast Cancer Screening and Diagnosis (V2.2013) gives the following considerations for breast cancer screening:

There are several studies supporting the use of ultrasound for breast cancer screening as an adjunct to mammography for high-risk women with dense breast tissue
Dense breasts limit the sensitivity of mammography. Dense breasts are associated with an increased risk for breast cancer, but there is insufficient evidence to support routine supplemental screening in women with dense breasts and no other risk factors.
The guidelines do not mention automated breast ultrasound.

American Cancer Society

The American Cancer Society does not address the use of Automated Whole Breast Ultrasound. The following statements are given to address the use of ultrasound (using a hand-held transducer) in screening for breast cancer.

“Breast ultrasound is sometimes used to evaluate breast problems that are found during a screening or diagnostic mammogram or on physical exam. Breast ultrasound is not routinely used for screening. Some studies have suggested that ultrasound may be a helpful addition to mammography when screening women with dense breast tissue (which is hard to evaluate with a mammogram), but the use of ultrasound instead of mammograms for breast cancer screening is not recommended.”

The U.S. Preventive Services Task Force (USPSTF)

The USPSTF recommendations on breast cancer screening do not address the use of ultrasound as an adjunct to mammography in the screening of breast cancer.

Ongoing Clinical Trials

The somo-v ABUS manufacturer’s website indicates that data analysis is ongoing on a multicenter nationwide trial designed to evaluate digital mammography plus ABUS versus digital mammography alone as part of the routine screening of patients with dense breast tissue. The website indicates primary results will be published in 2013. The clinicaltrials.gov website indicates this trial (NCT00816530) is ongoing but not recruiting patients. A search of the MEDLINE database did not identify any published results of this study.

An additional clinical trial was listed on clinicaltrials.gov (NCT00649337). The open label trial assessing AWBUS with screening mammography is sponsored bySonoCine. The completion date is estimated as January 2010 but the status on the website is listed as “unknown”.

In conclusion, there are no published reports of randomized controlled trials assessing the use of automated breast ultrasound compared to standard ultrasound using a hand-held transducer. There is a lack of scientific evidence that the use of automated breast ultrasound for screening for breast cancer improves health outcomes. Randomized controlled trials comparing this technology to standard hand-held breast ultrasounds as an adjunct to mammography are needed.

2014 Update

A literature search conducted through November 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Change and colleagues retrospectively evaluated the reproducibility of ABUS for mass localization, size measurement, and characterization (Chang, 2014). Bilateral whole breast US images were obtained twice using a commercially available ABUS within a mean interval of 1.3 days. In total, 24 patients were imaged before biopsy or surgery. There were 24 breast cancers and nine benign diagnoses. Two breast radiologists reviewed every paired three-dimensional dataset with regard to lesion visibility, reproducibility of documented location (clockface location, distance from nipple, and lesion depth), size of the lesions, and similarity for lesion characteristics. Lesion similarity was classified as being identical, similar, or different by consensus reading using the SomoVu workstation. Intraclass correlation coefficients (ICCs) and the Bland-Altman method were used to determine the amount of agreement between assessments of lesion location and size. Among 33 breast lesions, 31 lesions were depicted in both serial examinations. ICCs for the displayed lesion location (clock face location, distance from nipple), and the individual size of detected lesions were 0.994, 0.926, and 0.980, indicating excellent reliability. However, the ICC for lesion depth from the skin was 0.342 showing low reliability. For lesion similarity, 16 cancers and five benign lesions were classified as being identical, and six cancers and two benign lesions were classified as being similar. Two benign lesions were assessed to have different lesion characteristics and final assessment categories. The ABUS provided reproducible images for mass localization, size measurement, and characterization, which may be useful for follow-up studies.

Ho and colleagues wrote an article with objectives to discuss the Mammography Quality Standards Act (MQSA) and what it means for patients, define breast density and explain how it is measured, review the new state-based legislation regarding the reporting of dense breast tissue directly to patients and the possibility of an adjunct screening examination, describe possible supplemental screening options and the advantages and disadvantages of each, and outline the current shortcomings and unanswered questions regarding new legislation (Ho, 2014). Breast density is now established as an independent risk factor for developing breast cancer irrespective of other known risk factors. Women with breast density in the upper quartile have an associated four to five times greater risk of developing breast cancer relative to women with breast density in the lower quartile. Many states have enacted or proposed legislation requiring mammographers to report to patients directly if they have dense breast tissue and recommend discussing the possibility of a supplemental screening examination with their physicians. However, there is currently no consensus as to whether a supplemental screening examination should be pursued or which modality to use. Possible supplemental screening modalities include ultrasound, MRI, digital breast tomosynthesis, and molecular breast imaging. The U.S. Food and Drug Administration recently approved an automated breast ultrasound system for screening whole-breast ultrasound in patients with dense breasts. However, many questions are still unanswered including the impact on morbidity and mortality, cost-effectiveness, and insurance coverage.

2016 Update

A literature search conducted through November 2016 did not reveal any new published literature that would prompt a change in the coverage statement. Several clinical trials are still ongoing and one has been completed but no related publications were found.

The following is a summary of the ongoing and completed clinical trials identified:

NCT02661204- Diagnostic Performance of an Automated Breast Ultrasound System. The study, sponsored by the University of Zurich is a prospective, observational study to evaluate the diagnostic performance of a new ABUS system in: women undergoing screening for familial or genetic predisposition for breast cancer; women with newly diagnosed breast cancer; women with BI-RADS 3 or 4 lesions in a routine breast imaging examination; and women undergoing breast MRI for the assessment of breast implants integrity. The study began in January 2016 and has an estimated completion date of January 2021. The study is currently recruiting patients.

NCT02488187- Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients. The study, sponsored by the University of Kansas Medical Center is a non-randomized, open label, diagnostic comparison of preoperative ABUS and MRI in newly diagnosed breast cancer patients. The study began in April 2013 and has an estimated study completion date of December 2016. The study is currently listed as ongoing.

NCT02386176- Assessment of Automated Breast Ultrasound. Observational, perspective study to assess the value of ABUS as well as comparison of the use of ABUS with digital breast tomosynthesis. Study started August 2015 with an estimated completion date of November 2017. The study is currently recruiting patients.

NCT00816530)- A Prospective Multicenter Matched-pair Clinical Study to Evaluate the Sensitivity and Specificity of ABUS and Digital X-Ray Mammography (XRM) Together as a Breast Cancer Screening Method Compared to XRM Alone in Women With >50% Parenchymal Density, was noted to have completed in December 2014. The study has completed but no related publications were identified.

2017 Update

A literature search conducted using the MEDLINE database through October 2017 did not reveal any new information that would prompt a change in the coverage statement.

2018 Update

A literature search was conducted through November 2018. There was no new information identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

. Drukteinis JS, Mooney BP, Flowers CI, Gatenby RA.(2013) Beyond mammography: New frontiers in breast cancer screening. The American Journal of Medicine (2013) 126, 472-479.

American Cancer Society. Breast Cancer Early Detection. Available at http://www.cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-cancer-early-detection-other-screening-tests. Last accessed August 29, 2013.

Berg WA, Blume JD, Cormack JB, et al.(2008) Combined screening with ultrasound and mammography compared to mammography alone in women at elevated risk of breast cancer: results of the first-year screen in ACRIN 6666. JAMA. 2008 May 14; 299(18): 2151-2163.

Chang JM, Cha JH, Park JS, et al.(2014) Automated breast ultrasound system (ABUS): reproducibility of mass localization, size measurement, and characterization on serial examinations. Acta Radiol. 2014 Oct 3. pii: 0284185114551565

Ho JM, Jafferjee N, Covarrubias GM, et al.(2014) Dense breasts: a review of reporting legislation and available supplemental screening options. AJR Am J Roentgenol. 2014 Aug;203(2):449-56. doi: 10.2214/AJR.13.11969

Kelly KM, Brichwald GA.(2011) Automated Whole-Breast Ultrasound: Advancing the Performance of Breast Cancer Screening. Semin Ultrasound CT MRI 32:273-280.

Kelly KM, Dean J, Comulada WS, Lee S.(2010) Breast cancer detection using automated whole breast ultrasound and mammography in radiographically dense breasts. Eur Radiol (201) 20:734-742.

Kim SH, Kang BJ, Choi BG, et al.(2013) Radiologists’ performance for detecting lesions and the interobserver variability of automated whole breast ultrasound. Korean J Radiol. 2013 Mar-Apr;14(2):154-63.

NCT00649337. Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons. Available at http://clinicaltrials.gov. Last accessed Aug. 26, 2013.

NCT00816530. A clinical study to evaluate Somo-v and digital mammography together as a breast cnacer screening method, compared to digital mammography alone, in women with dense breasts. Available at http://clinicaltrials.gov. Last accessed Aug. 26, 2013.

SonoCiné® Automated Whole Breast Ultrasound. Available at http://www.sonocine.com/ourCompany.html. Last accessed Aug. 26, 2013.

U.S. Preventive Services Task Force. Screening For Breast Cancer. Available at http://www.uspreventiveservicestaskforce.org/recommendations.htm. Last accessed August 29, 2013.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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