Medical Policy

 

Subject: MRI of the Breast
Document #: RAD.00036 Publish Date:    12/12/2018
Status: Reviewed Last Review Date:    11/08/2018

Description/Scope

This document addresses the use of magnetic resonance imaging (MRI) of the breast. MRI is a diagnostic imaging modality that uses magnetic and radiofrequency fields to image body tissue non-invasively. MRI of the breast can be performed using MR scanners equipped with breast coils and intravenous MR contrast agents. MRI of the breast has been investigated for screening and diagnosis of breast cancer, and evaluation of breast implants. 

Position Statement

Medically Necessary:

Annual screening MRI of the breast using scanners equipped with breast coils with the ability to provide needle localization for biopsy is considered medically necessary in the following clinical situations:

A single repeat MRI of the breast using scanners equipped with breast coils with the ability to provide needle localization for biopsy is considered medically necessary 6 months following an MRI for individuals who have met criteria for MRI of the breast and the MRI revealed BIRADS 3 findings.

MRI of the breast using scanners equipped with breast coils with the ability to provide needle localization for biopsy is considered medically necessary as an alternative to screening mammography when all of the following criteria are met:

MRI of the breast using scanners equipped with breast coils is considered medically necessary for the following diagnostic or detection indications:

MRI of the breast using scanners equipped with breast coils to evaluate a documented breast abnormality prior to obtaining an MRI guided biopsy in individuals who do not meet other criteria for MRI of the breast (above) is considered medically necessary when there is documentation that other methods to guide biopsy, such as manual palpation or ultrasound, were not adequate to localize the lesion for biopsy.

Investigational and Not Medically Necessary:

Other applications of MRI of the breast are considered investigational and not medically necessary including, but not limited to the following:

Rationale

General Considerations
MRI of the breast is considered more sensitive than mammography in detecting abnormalities of the breast, particularly in individuals with dense breasts. Breast MRI is also considered relatively non-specific, resulting in an increase in recall rates and unnecessary breast biopsies for benign conditions. Indications for screening MRI of the breast are generally focused on individuals considered at high risk of breast cancer, based on either family or clinical history, or genetic testing. The incidence of unnecessary biopsy is considered acceptable in these individuals with high pre-test possibility of breast cancer.

Evaluations of other indications for breast MRI are based on a consideration of how the test will be used to direct and ultimately improve medical management. 

The following discussion is based on guidelines published by the American Cancer Society (ACS, 2017), the American Society of Clinical Oncology (ASCO, 2013), the American College of Radiology (ACR, 2017, 2018) and the National Comprehensive Cancer Network® (NCCN, 2018). Additionally, a literature search was conducted to identify any articles not considered by the various guidelines. A complete reference list is beyond the scope of this document. Additional references may be found in the referenced guidelines. 

Screening MRI
The majority of the screening indications listed in the position statement above describe subjects considered at an increased risk of breast cancer resulting in an acceptable ratio of sensitivity and specificity as well as an acceptable recall or biopsy rate. The ACS issued guidelines for breast screening with MRI (Saslow, 2007), which included a review of six screening studies of MRI (Kriege, 2004; Kuhl, 2005; Leach, 2005; Lehman, 2005; Sardanelli, 2007; Warner, 2004). The ACS recommendations for annual screening MRI are as follows:

Recommendations for Breast MRI Screening as an Adjunct to Mammography
Recommend Annual MRI Screening (Based on Evidence)

Recommend Annual MRI Screening (Based on Expert Consensus Opinion)

Insufficient Evidence to Recommend for or Against MRI Screening

Recommend Against MRI Screening (Based on Expert Consensus Opinion)

The 2018 National Comprehensive Cancer Network (NCCN) guidelines recommend annual MRI in addition to mammogram for those individuals with an increased risk of breast cancer, defined as those with a history suggestive of or known genetic predisposition for breast cancer, starting at age 25 and individuals who have received thoracic radiation therapy between 10 and 30 years of age.

A 2017 consensus guideline by the American Society of Breast Surgeons on diagnostic and screening magnetic resonance imaging of the breast also supports the use of MRI as a screening technique in women. The guideline particularly supports women age 25 or older with a BRCA gene mutation, women with other germline mutations known to predispose to a high risk of breast cancer, women with a history of chest irradiation, and women with a 20%-25% or greater estimated lifetime risk of breast cancer based on models primarily based on family history.

MRI findings can be classified using the Breast Imaging Reporting and Data System (BIRADS) categories. A finding on an MRI which is determined to be BIRADS 3 is probably a benign finding with a short-interval follow-up suggested. MRI findings assessed to be category 3 are highly unlikely for malignancy and should have a very high probability of being benign. However, observation with a short-interval follow-up of these lesions may be preferred over a biopsy (Eby, 2010).

MRI for Dense Breasts:
The majority of individuals with breasts dense enough to interfere with interpretation of a mammogram are those under the age of 40. MRI screening for these individuals would be appropriate for those at high risk. However, in individuals with a prior history of breast cancer, who are not otherwise at high risk, who also have dense breasts which interfere with interpretation of a mammogram, MRI may be able to identify additional disease.

The available data for MRI imaging is inconclusive for its use for routine screening in women who are not at high risk. As noted above, the ACS guidelines specifically recommended against annual MRI screening in women at less than a 15% lifetime risk of breast cancer and stated that there was insufficient data to recommend for or against screening in women with a lifetime risk between 15-20%. In 2013, ASCO addressed routine screening as a surveillance technique for individuals with prior breast cancer. These guidelines stated that:  

Although screening breast MRI seems to be more sensitive than conventional imaging at detecting breast cancer in high-risk women, there is no evidence that breast MRI improves outcomes when used as a breast cancer surveillance tool during routine follow-up in asymptomatic patients. The decision to use breast MRI in high-risk patients should be made on an individual basis depending on the complexity of the clinical scenario.

As noted above, mammography is recognized as the screening method of choice in women at average to intermediate risk of breast cancer. However, in a small subset of these individuals, the mammogram is uninterpretable. In this unusual situation, MRI may be considered an appropriate alternative to mammography. This indication must be carefully distinguished from MRI to further characterize indeterminate breast lesions, which is considered investigational when biopsy is possible (See further discussion below). In this situation, the mammogram can be interpreted and a breast lesion has been evaluated, but the characteristics of the breast lesion itself are indeterminate for the presence of cancer.

MRI to Detect Breast Cancer in the Contralateral Breast in Individuals with Breast Cancer
Kim and colleagues (2013) reported a study of 1323 women with unilateral breast cancer who underwent mammography and ultrasound compared to 1771 women with unilateral breast cancer who underwent mammography, ultrasound and MRI. The incidence of cancer in the contralateral breast was compared between the two groups. Twenty-five contralateral cancers were additionally detected by MRI in the MRI group of women. The cumulative incidence of contralateral breast cancer was 0.5% at 45 months in the MRI group compared to 1.4% in the group without MRI scanning. The 2018 ACR guidelines state that screening of the contralateral breast for those with a new breast malignancy is indicated, and note that MRI can detect occult malignancy in the contralateral breast in at least 3-5% of those with breast cancer.

MRI for Indeterminate Breast Lesions
Validation for MR imaging of indeterminate breast lesions requires data comparing its diagnostic performance compared to breast biopsy, i.e. the gold standard. Considering the relative ease of breast biopsy, the sensitivity of breast MRI would have to be virtually 100% to confidently avoid breast biopsy. While MRI performs well, it is clear that the sensitivity is not 100%. False-negative results tend to occur particularly in certain subcategories, such as ductal carcinoma in situ. Invasive carcinoma may fail to enhance on MRI, leading to false-negative findings as well. The potential harm to health outcomes of failing to diagnose breast cancer or at least delaying the diagnosis of breast cancer is of significant concern.

In April 2006 (updated 2010), the Agency for Healthcare Research and Quality (AHRQ) evaluated various imaging techniques for women with an average risk level for breast cancer. Based on their analysis, they concluded that for every 1000 women who had an abnormal mammogram and who subsequently underwent MRI imaging felt to be negative, about 962 women would have avoided an unnecessary biopsy, but 38 women would have missed cancers.

The 2018 ACR Practice Guideline states

MRI should not supplant careful problem-solving mammographic views or ultrasound in the diagnostic setting. Because MRI will miss some cancers that mammography will detect, it should not be used as a substitute for screening mammography. MRI should not be used in lieu of biopsy of a suspicious finding identifiable by mammography, ultrasound, or clinical examination.

Evaluation of suspicious microcalcifications is an example of one type of indeterminate lesions. Several studies have focused on whether or not MRI can help further characterize these lesions, but no study has specifically analyzed how this additional information could be used to direct treatment, specifically to determine whether an individual could forego the gold standard of biopsy. For example, Uematsu and colleagues (2007) performed MRI in 100 cases of microcalcifications detected with screening mammography. All participants underwent biopsy. The negative predictive value of MRI varied with the BI-RADS category of the mammography abnormality and ranged from 93-97%. The authors conclude that MRI may provide additional diagnostic information, but cannot replace biopsy. Bazzochi and colleagues (2006) performed MRI in 112 participants with microcalcifications, which were highly suspicious of cancer (that is, BI-RADs category IV and V). In this group of participants with a higher pretest probability of cancer, the negative predictive value of MRI was only 73%. The authors did not recommend the use of MRI to further characterize microcalcifications. 

The above discussion notes that biopsy is recommended to further evaluate indeterminate breast lesions. However, as noted in the ACR Practice Guidelines (2018), biopsy is not possible in a small subset of these individuals; for example, due to distortion on only one mammographic view without a sonographic correlate. In this unusual situation, where biopsy can only be performed with MRI guidance, MRI may be performed. 

MRI as a Technique to Evaluate Multicentric Disease
MRI has been used in those with breast cancer to evaluate the presence of multicentric disease and to aid in decision making regarding breast conserving surgery vs. mastectomy. Specifically, the presence of multicentric disease may prompt the individual and physician to seriously consider mastectomy. Multiple studies have confirmed that MRI of the breast has a better sensitivity and specificity for identifying multicentric and multifocal breast tumors compared to mammography or ultrasound. However, there is no evidence that mastectomy is associated with superior long term outcomes (i.e., recurrence or survival) in those with multicentric disease compared to breast conserving surgery with tumor bed radiation. Specifically, the pivotal trials that established the equivalency of the two procedures did not use MRI as part of the staging work-up, but rather relied on mammography, chest x-ray, liver enzymes and physical exam for pre-surgical staging.

Aside from contributing to the choice between mastectomy and breast conserving surgery, the presence of multicentric disease may contribute to the decision regarding axillary node dissection or the choice between partial breast and whole breast irradiation. Finally, MRI has been widely accepted as part of the preoperative work up for individuals with breast cancer. 

The 2018 ACR Practice Guidelines state:

Breast MRI may be useful to determine the extent of disease and the presence of multifocality and multicentricity in patients with invasive carcinoma and ductal carcinoma in situ … It remains to be shown conclusively, however, that this increased accuracy decreases posttreatment recurrence rates or surgical re-excision.

MRI to Determine Treatment Response in Individuals with Locally Advanced Breast Cancer Receiving Neoadjuvant Chemotherapy
Compared with conventional methods of evaluating tumor size and extent (i.e., mammography, clinical exam or ultrasound), MRI of the breast provides an estimation of tumor size and extent that is at least as good as or better than that based on alternatives. Drew and colleagues (2001) found MRI to be 100% sensitive and specific for defining residual tumor after chemotherapy. Conversely, mammography achieved 90% sensitivity and 57% specificity and clinical exam was only 50% sensitive and 85% specific. Similarly Partridge et al (2002) reported correlation of residual tumor size on MRI of 0.89 and clinical exam of 0.60. Knowledge of the response to chemotherapy is important to determine further therapy options.

A 2013 ASCO Clinical Practice Guideline Update for breast cancer follow-up and management after primary treatment does not recommend MRI of the breast in asymptomatic individuals with no specific findings on clinical exam (Khatcheressian, 2013).

The role of MRI to assess response during a course of neoadjuvant chemotherapy is less clear. The most important use would be to reliably identify individuals whose tumors are not responding to neoadjuvant chemotherapy to avoid the added morbidity of continued ineffective chemotherapy. Such chemotherapy may be discontinued or changed to an alternative and potentially effective regimen. MRI would be harmful when it falsely suggests a lack of response and leads to premature discontinuation of effective chemotherapy. There is insufficient evidence to determine whether breast MRI can reliably predict lack of response to neoadjuvant chemotherapy (Le-Petross, 2010).

MRI to Evaluate Suspected Chest Wall Involvement
Morris and colleagues (2000) prospectively studied 19 subjects with posteriorly located breast tumors suspected to involve the pectoralis major muscle based on either mammography or clinical exam. Thirteen of these tumors were thought to be fixed to the chest wall on clinical exam and 12 appeared to have pectoral muscle involvement on mammography. Results of MRI were compared with surgical and pathological findings. The presence of abnormal enhancement within the pectoralis major muscle on MRI was 100% sensitive and 100% specific for identifying the 5 tumors that actually involved the pectoralis major muscle. Given the high level of diagnostic accuracy for MRI as compared with reference standard and conventional alternative techniques, the evidence is considered sufficient to permit conclusions that breast MRI improves net health outcome.

MRI To Detect a Suspected Occult Breast Primary in Individuals with Positive Axillary Nodes
This indication for MRI represents a small subgroup of individuals, but the adjunctive use of breast MRI allows individuals to avoid the morbidity of mastectomy in a substantial portion of those with an acceptable risk of unnecessary biopsy (Orel, 1999). The use of positive MRI findings to guide breast-conserving surgery instead of presumptive mastectomy appears to offer the substantial benefit of breast conservation in true positive MRI cases.

MRI to Evaluate Residual Tumor after Lumpectomy with Positive Surgical Margins
For those considering breast-conserving surgery, complete removal of all gross tumor has been associated with improved local control. Therefore, re-excision may be considered if the initial lumpectomy specimen has positive surgical margins. Imaging to detect residual disease has been investigated as a technique to refine the selection criteria for re-excision. However, due to postoperative inflammation any type of imaging technique is limited. MRI has been investigated in this setting, with evaluation of different optimal postoperative time frames. For example, Frei and colleagues studied different time frames for MRI and reported that the negative predictive value was highest (86%) 35 days after surgery (Frei, 2000). It is not clear whether an 86% negative predictive value would be adequate to deselect individuals from re-excision.

MRI as a Technique to Evaluate the Integrity of Breast Implants
Imaging techniques to detect implant rupture include mammography and ultrasonography. When these techniques are inconclusive, studies have shown that MRI can detect implant integrity for these circumstances (Ahn, 1994). In 2011, the U.S. Food and Drug Administration (FDA) issued the FDA Update on the Safety of Silicone Gel-Filled Breast Implants. This publication provides the following guidance for MRI imaging in those individuals with silicone breast implants:

Recommendations for Health Care Providers:

  1. Provide women with copies of patient brochures and informed consent so that they have access to the critical information needed to make informed decisions about receiving and caring for breast implants. Labeling for Approved Breast Implants for patients and for physicians is available on FDA’s breast implant website.
  2. Maintain medical vigilance through follow-up and post-approval studies so that the long-term effects of silicone gel-filled breast implants can be better understood. Your contributions provide data that are used to evaluate how new surgical techniques, patient characteristics, and implant characteristics influence the cosmetic and health outcomes of patients undergoing breast implantation.
  3. Screen for silent rupture using MRI. Women with silicone gel-filled breast implants should undergo MRI screening for silent implant ruptures at 3 years post-implantation, and every 2 years thereafter.
  4. Report breast implant associated adverse events and deaths to FDA via MedWatch.

The FDA considered the following for its conclusions:

The ACR, in its Practice Guideline for the Performance of Contrast Enhanced Magnetic Resonance Imaging (MRI) of the Breast, addresses the appropriate MRI equipment required for breast MRI studies.

Background/Overview

MRI is a non-invasive imaging modality that uses magnetic and radiofrequency fields to image body tissue producing very detailed, cross-sectional pictures of the body. Unlike CT, MRI uses no ionizing radiation and is generally a safe procedure. Nonetheless, the strong magnetic fields and radio pulses can affect metal implants within the body. MRI is sometimes used in combination with mammography.

Definitions

Asymptomatic: The absence of signs or symptoms of disease.

Bannayan-Riley-Ruvalcaba Syndrome: Familial disorder associated with development of variety of benign/malignant tumors and fast-flow vascular anomalies.

BRCAPRO: A computer-based Bayesian probability model that uses first- and second-degree family history of breast or breast/ovarian cancers to determine the probability that a BRCA1 or BRCA2 gene mutation accounts for these cancers (Weitzel et al, 2007).

Breast Imaging Reporting and Data System (BIRADS): http://www.acr.org/Quality-Safety/Resources/BIRADS/About-BIRADS  

Contralateral: Taking place or originating in a corresponding part on the opposite side of the body.

Cowden Syndrome: A rare autosomal dominant inherited disorder characterized by multiple tumor-like growths called hamartomas and an increased risk of certain forms of cancer.

Gail Model: A computer based risk analysis tool that uses personal and family history to estimate a woman's chance of developing breast cancer; it does not have the capacity to analyze detailed family histories including first-degree and second-degree relatives on both the maternal and paternal sides.

Li-Fraumeni Syndrome: A family predisposition to multiple cancers, caused by a mutation in the p53 tumor-suppressor gene.

Lumpectomy: The surgical removal of a small tumor in the breast which may be benign or malignant; a lumpectomy differs from a mastectomy in which the breast is removed.

Microcalcification: A tiny deposit of calcium in the breast that cannot be felt but can be detected on a mammogram; a cluster of these very small specks of calcium may indicate that cancer is present.

Multicentric breast cancer: Breast cancer in which there is more than one tumor, all of which have formed separately from one another; tumors are likely to be in different quadrants (sections) of the breast.

Multifocal breast cancer: Breast cancer in which there is more than one tumor, all of which have arisen from one original tumor; the tumors are likely to be in the same quadrant (section) of the breast.

Neoadjuvant chemotherapy: Initial use of chemotherapy for those with localized cancer in order to decrease the tumor burden prior to treatment by other modalities.

Relative, first-degree: A 50% genetic link to the individual; examples are parents, brothers, sisters, or children of an individual.

Relative, second-degree: A 25% genetic link to the individual; examples are aunts, uncles, nieces, nephews, and grandparents of an individual.

Relative, third-degree: A 12.5% genetic link to the individual; examples are first cousins, great grandparents, great grandchildren, of an individual.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time for service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

77058

Magnetic resonance imaging, breast, without and/or with contrast material(s); unilateral [Note: code will be deleted 12/31/2018]

77059

Magnetic resonance imaging, breast, without and/or with contrast material(s); bilateral [Note: code will be deleted 12/31/2018]

 

The following CPT codes will be effective 01/01/2019:

77046

Magnetic resonance imaging, breast, without contrast material; unilateral

77047

Magnetic resonance imaging, breast, without contrast material; bilateral

77048

Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis) when performed; unilateral

77049

Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis) when performed; bilateral

 

 

HCPCS

 

C8903

Magnetic resonance imaging with contrast, breast; unilateral

C8904

Magnetic resonance imaging without contrast, breast; unilateral [Note: code will be deleted 12/31/2018]

C8905

Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral

C8906

Magnetic resonance imaging with contrast, breast; bilateral

C8907

Magnetic resonance imaging without contrast, breast; bilateral [Note: code will be deleted 12/31/2018]

C8908

Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:
For the codes listed above when criteria are not met; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Ahn CY, DeBruhl ND, Gorczyca DP, et al. Comparative silicone breast implant evaluation using mammography, sonography, and magnetic resonance imaging: experience with 59 implants. Plast Reconstr Surg. 1994; 94(5):620-627.
  2. Bazzocchi M, Zuiani C, Panizza P, et al. Contrast-enhanced breast MRI in patients with suspicious microcalcifications on mammography: results of a multicenter trial. AJR Am J Roentgenol. 2006; 186(6):1723-1732.
  3. Berg WA, Zhang Z, Lehrer D, et al. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 2012; 307(13):1394-1404.
  4. Chiarelli AM, Prummel MV, Muradali D, et al. Effectiveness of screening with annual magnetic resonance imaging and mammography: results of the initial screen from the Ontario high risk breast screening program. J Clin Oncol. 2014; 32(21):2224-2230.
  5. Drew PJ, Kerin MJ, Mahapatra T, et al. Evaluation of response to neoadjuvant chemoradiotherapy for locally advanced breast cancer with dynamic contrast enhanced MRI of the breast. Eur J Surg Oncol. 2001; 27(7):617-620.
  6. Eby PR, DeMartini WB, Gutierrez RL, Lehman CD. Probably benign lesions detected on breast MR imaging. Magn Reson Imaging Clin N Am. 2010; 18(2):309-321.
  7. Frei KA, Kinkel K, Bonel HM, et al. MR imaging of the breast in patients with positive margins after lumpectomy: influence of the time interval between lumpectomy and MR imaging. AJR Am J Roentgenol. 2000; 175(6):1557-1584.
  8. Kim JY, Cho N, Koo HR, et al. Unilateral breast cancer: screening of contralateral breast by using preoperative MR imaging reduces incidence of metachronous cancer. Radiology. 2013; 267(1):57-66.
  9. Kriege M, Brekelmans CT, Boetes C, et al. Efficacy of MRI and mammography for breast cancer screening in women with a familiar or genetic predisposition. N Eng J Med 2004; 351(5):427-437.
  10. Kuhl CK, Schrading S, Leutner CC, et al. Mammography, breast ultrasound, and magnetic resonance imaging for surveillance of women at high familial risk for breast cancer. J Clin Oncol. 2005; 23(33):8469-8476.
  11. Kuhl C, Weigel S, Schrading S, et al. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA Trial. J Clin Oncol. 2010; 28(9):1450-1477.
  12. Le-Petross HC, Hylton N. Role of breast MR imaging in neoadjuvant chemotherapy. Magn Reson Imaging Clin N Am. 2010; 18(2):249-258, viii-ix.
  13. Morris EA, Schwartz LH, Drotman MB, et al. Evaluation of pectoralis major muscle in patients with posterior breast tumors on breast MR images: early experience. Radiology. 2000; 214(1):67-72.
  14. Ng AK, Garber JE, Diller LR, et al. Prospective study of the efficacy of breast magnetic resonance imaging and mammographic screening in survivors of Hodgkin lymphoma. J Clin Oncol. 2013; 31(18):2282-2288.
  15. Orel SG, Weinstein SP, Schnall MD, et al. Breast MR imaging in patients with axillary node metastases and unknown primary malignancy. Radiology. 1999; 212(2):543-549.
  16. Park VY, Kim EK, Kim MJ, et al. Breast magnetic resonance imaging for surveillance of women with a personal history of breast cancer: outcomes stratified by interval between definitive surgery and surveillance MR imaging. BMC Cancer. 2018; 18(1):91.
  17. Partridge SC, Bibbs JE, Lu Y, et al. Accuracy of MR imaging for revealing residual breast cancer patients who have undergone neoadjuvant chemotherapy. AJR Am J Roentgenol. 2002; 179(5):1193-1199.
  18. Pilewskie M, King TA. Magnetic resonance imaging in patients with newly diagnosed breast cancer: a review of the literature. Cancer. 2014; 120(14):2080-2089.
  19. Saadatmand S, Obdeijn IM, Rutgers EJ, et al. Survival benefit in women with BRCA1 mutation or familial risk in the MRI screening study (MRISC). Int J Cancer. 2015; 137(7):1729-1738.
  20. Sardanelli F, Podo F, D'Agnolo G, et al. Multicenter comparative multimodality surveillance of women at genetic-familial high risk for breast cancer (HIBCRIT study): interim results. Radiology. 2007; 242(3):698-715.  
  21. Song JW, Kim HM, Bellfi LT, Chung KC. The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis. Plast Reconstr Surg. 2011; 127(3):1029-1044.
  22. Turnbull L, Brown S, Harvey I, et al. Comparative effectiveness of MRI in breast cancer (COMICE) trial: a randomised controlled trial. Lancet. 2010; 375(9714):563-571.
  23. Uematsu T, Yuen S, Kasami M, Uchida Y. Dynamic contrast-enhanced MR imaging in screening detected microcalcification lesions of the breast: is there any value?  Breast Cancer Res Treat. 2007; 103(3):269-281.
  24. Warner E, Plewes DB, Hill KA, et al. Surveillance of BRCA1 and BRCA 2 mutation carriers with magnetic resonance imaging, ultrasound, mammography and clinical breast examination. JAMA 2004; 292(11):1317-1325.
  25. Weitzel J, Lagos V, Cullinane C, et al. Limited family structure and BRCA gene mutation status in single cases of breast cancer. JAMA. 2007; 297(23):2587-2595.
  26. Wright FC, Zubovits J, Gardner S, et al. Optimal assessment of residual disease after neo-adjuvant therapy for locally advanced and inflammatory breast cancer--clinical examination, mammography, or magnetic resonance imaging? J Surg Oncol. 2010; 101(7):604-610.
  27. Zhang XH, Xiao C. Diagnostic value of nineteen different imaging methods for patients with breast cancer: a network meta-analysis. Cell Physiol Biochem. 2018; 46(5):2041-2055.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality (AHRQ). February 2010. Effectiveness of noninvasive diagnostic tests for breast abnormalities. Comparative Effectiveness Review No. 2. Rockville, MD. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/
    ?pageaction=displayproduct&productid=470
    . Accessed on October 9, 2018.
  2. American College of Radiology. ACR Appropriateness Criteria®. Available at: https://www.acr.org/
    Clinical-Resources/ACR-Appropriateness-Criteria
    . Accessed on October 9, 2018.
    • Breast Cancer Screening (2017).
  3. American College of Radiology. Practice Guideline for the Performance of Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast. Revised 2018. Available at: http://www.acr.org/Quality-Safety/Standards-Guidelines. Accessed on October 9, 2018.
  4. American Society of Breast Surgeons (ASBS). Consensus guideline on diagnostic and screening magnetic resonance imaging of the breast. 2017. Available at: https://www.breastsurgeons.org/new_layout/about/statements/PDF_Statements/MRI.pdf. Accessed on October 9, 2018.
  5. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Magnetic Resonance Imaging (MRI). NCD #220.2. Effective July 7, 2011. Available at: http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx?from2=index_chapter_list.asp&list_type=&. Accessed on October 9, 2018.
  6. Khatcheressian JL, Hurley P, Bantug E, et al. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013; 31(7):961-965.
  7. Lee CH, Dershaw DD, Kopans D, et al. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Am Coll Radiol. 2010; 7(1):18-27.
  8. Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: recommendations from the ACR. J Am Coll Radiol. 2018; 15(3 Pt A):408-414.
  9. NCCN Clinical Practice Guidelines in Oncology™. © 2018 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on October 9, 2018.
    • Breast Cancer (V.2.2018). Revised October 5, 2018.
    • Breast Cancer Screening and Diagnosis (V.3.2018). Revised October 4, 2018.
  10. Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007; 57(2):75-89.
  11. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analyses. January 2011. Available at: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm. Accessed on October 9, 2018.
  12. U.S. Food and Drug Administration (FDA). FDA Update on the safety of silicone gel-filled breast implants. Executive Summary. June 2011. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm259866.htm. Accessed on October 9, 2018.
Websites for Additional Information
  1. American Cancer Society. American Cancer Society recommendations for early breast cancer detection in women without breast symptoms. Last revised October 9, 2017. Available at: http://www.cancer.org/cancer/breastcancer/moreinformation/breastcancerearlydetection/breast-cancer-early-detection-acs-recs. Accessed on October 9, 2018.
  2. American Cancer Society. Mammograms and other breast imaging procedures. Last revised October 9, 2017. Available at: http://www.cancer.org/treatment/understandingyourdiagnosis/examsandtestdescriptions/mammogramsandotherbreastimagingprocedures/index. Accessed on October 9, 2018.
  3. National Cancer Institute (NCI). Breast Cancer Screening. Available at: http://www.cancer.gov/cancertopics/pdq/screening/breast/patient/page3. Accessed on October 9, 2018.
  4. National Cancer Institute. Breast cancer risk assessment tool. Available at: http://www.cancer.gov/bcrisktool/about-tool.aspx. Accessed on October 9, 2018.
  5. The National Breast Cancer Foundation. Available at: www.nationalbreastcancer.org. Accessed on October 9, 2018.
  6. The Susan G. Komen Breast Cancer Foundation. Available at: www.komen.org. Accessed on October 9, 2018.
Index

 

Breast, Magnetic Resonance Imaging

Breast, MRI

Magnetic Resonance Imaging, Breast

MRI, Breast

 

Document History

Status

Date

Action

Reviewed

11/08/2018

Medical Policy & Technology Assessment Committee (MPTAC) review.

Reviewed

10/31/2018

Hematology/Oncology Subcommittee review. Updated Rationale and References sections. Updated Coding section with 01/01/2019 CPT and HCPCS changes; added CPT 77046-77049, codes 77058, 77059, C8904, C8907 deleted 12/31/2018.

Revised

11/02/2017

MPTAC review.

Revised

11/01/2017

Hematology/Oncology Subcommittee review. Updated Rationale and References sections. Added additional genetic variations to Position Statement. The document header wording updated from “Current Effective Date” to “Publish Date.”

Reviewed

11/03/2016

MPTAC review.

Reviewed

11/02/2016

Hematology/Oncology Subcommittee review. Updated Rationale and References sections.

Revised

11/05/2015

MPTAC review.

Revised

11/04/2015

Hematology/Oncology Subcommittee review. Updated Rationale and Reference sections. Clarifications to Position Statement. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review.

Reviewed

11/12/2014

Hematology/Oncology Subcommittee review. Updated Rationale and Reference sections.

Reviewed

11/14/2013

MPTAC review.

Reviewed

11/13/2013

Hematology/Oncology Subcommittee review. Updated Rationale and Reference sections.

Revised

11/08/2012

MPTAC review. Medically necessary Position Statement updated to include a six month follow-up MRI when previous MRI results showed BIRADS 3. Updated Rationale and Definition sections.

Revised

11/07/2012

Hematology/Oncology Subcommittee review. Updated Rationale and Reference.

Revised

11/17/2011

MPTAC review.

Revised

11/16/2011

Hematology/Oncology Subcommittee review. Medically Necessary criteria updated to address the FDA guidance for MRI imaging in those with silicone breast implants. Medically necessary criteria for familial risk/family history clarified. Rationale, Definitions and Reference sections updated.

Reviewed

05/19/2011

MPTAC review.

Reviewed

05/18/2011

Hematology/Oncology Subcommittee review. Medically Necessary criteria clarified for dense breasts. Rationale, Definitions and Reference sections updated.

Reviewed

05/13/2010

MPTAC review.

Reviewed

05/12/2010

Hematology/Oncology Subcommittee review. Rationale, Definitions and Reference sections updated.

Revised

05/21/2009

MPTAC review.

Revised

05/20/2009

Hematology/Oncology Subcommittee review. Criteria updated for microcalcifications, MRI indications for dense breasts and inclusion of the Gail model. Rationale, Background, Definitions and Reference sections updated. 

Reviewed

05/15/2008

MPTAC review.

Reviewed

05/14/2008

Hematology/Oncology Subcommittee review. Definitions added. References and Coding sections updated.

 

02/21/2008

The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

 

11/15/2007

American Cancer Society (ACS) statement corrected in rationale.

Revised

05/17/2007

MPTAC review. 

Revised

05/16/2007

Hematology/Oncology Subcommittee review.  Criteria revised; Rationale and Reference sections updated.

Revised

03/08/2007

MPTAC review. MRI criteria clarified, rationale updated. References updated. 

 

01/01/2007

Updated Coding section with 01/01/2007 CPT/HCPCS changes; removed CPT 76093, 76094 deleted 12/31/2006.

Reviewed

03/23/2006

MPTAC review. References updated. 

 

11/21/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised

04/28/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc. Scientific Statement and AMWMR UM Criteria (Historical)

 

UM RAD 004 01/14/2005

Historical on 02/11/2005

UM guideline RAD 004

MRI of the Breast

 

WellPoint Health Networks, Inc

09/23/2004

4.01.15

MRI of the Breast