Magnetic resonance imaging (MRI) of the breast is a useful tool for the detection and characterization of breast disease, assessment of local extent of disease, evaluation of treatment response, and guidance for biopsy and localization. Breast MRI should be bilateral except for those with a history of mastectomy or when the MRI is being performed expressly to further evaluate or follow findings in one breast. MRI findings should be correlated with clinical history, physical examination, and the results of mammography and any other prior breast imaging.
Staging of newly diagnosed breast cancer- The decision to use breast MRI as an adjunct to clinical exam, mammography and ultrasound should be made by the physician on a case-by-case basis, taking into account frequent false positives, increased time to treatment, and increased mastectomy rates. “There is no convincing evidence that MRI reduces re-excision Lumpectomy rates, local recurrence, or overall survival in patients with invasive breast cancer or ductal carcinoma in situ”.
MRI and dense breasts- Women with extremely dense breasts are 4-6x more likely to develop breast cancer than women with fatty tissue. Between 40- 50% of US women aged 40-74 years have dense breast tissue. Breast density decreases the sensitivity of mammography and is associated with aggressive tumors and worse outcomes. A movement to notify women of their breast density is now expanded, as of April 2019 to 38 states and the District of Columbia. Although there has been an increase in notification and awareness of breast density, no clear guidelines have been established for supplemental screening in this subset of women. A recent study showed that the majority of practices are utilizing supplemental screening, but the modalities used and referral patterns are variable depending on several factors including location, type of practice ie. private or academic, and whether the practice has breast specialists. Also, the exact notification requirements vary as well as insurance coverage from state to state. Screening ultrasound was most utilized (53%) and most available in the Northeast (80%). Connecticut requires insurance to cover supplemental ultrasound exams. In this study 19.5% had MRI for supplemental screening and 87% of these were private practice settings.
There are four categories for breast density- almost entirely fatty, scattered areas of fibroglandular tissue, heterogeneously dense, and extremely dense. The last two are considered dense. Women with dense breasts and a BCSC risk of ≥ 2.5% (about 21%) are at greatest risk for interval stage IIb or higher cancers. Thus, knowing a women’s risk along with density idenitifies subgroups who will benefit most from supplemental testing such as ultrasound or MRI. Without considering overall breast cancer risk, MRI could result in more harm than good in terms of anxiety, overdiagnosis and increased benign breast biopises. For women whose only risk is increased breast density, ultrasound can be considered for adjunctive screening. At the present time, except in states that require it, more research is needed before approval of MRI for supplemental screening based on breast density alone, without other risk factors
MRI and Breast Cancer Risk Associated with certain Syndromes- Lynch Syndrome- Women with Lynch syndrome and mismatch repair genes MLH1 and MSH2 may be at increased risk for breast cancer, however breast screening is not recommended beyond what is recommended for an average risk patient.
NF-1- Mammography starting at age 30; breast MRI may be considered.
There is currently no evidence that RAD51C and RAD51D genes are associated with increased risk of breast cancer. Insufficient evidence for FANCC, MRE11A, or MUTYH heterozygotes, or RECQL4, RAD50, RINT1, SLX4, SMARCA4, or XRCC2.
For STK11 (associated with Peutz-Jeghers syndrome) breast cancer risk is 8% at age 40, 13% age 50 and 31% at age 60, 45% age 70.
Abbreviated Breast MRI- Among women with dense breasts undergoing screening, this technique, compared with digital breast tomosynthesis, was associated with significantly higher rate of detection of invasive cancer and further research is needed. A clinical trial is now underway (ClinicalTrials.gov:NCT02933489). A total acquisition time of 10 minutes is needed to image the breasts.
Surgical excision vs MRI- Select patients may be suitable for monitoring in lieu of excision (although MRI is not indicated) e.g., Flat epithelial hyperplasia, papillomas without atypia, fibroepithelial lesions favoring fibroadenoma, radial scars adequately sampled or incidental. Other pathologies that may require excision include mucin-producing lesions, potential phylloides tumor, papillary lesions, radial scar, or other histologies of concern to the pathologist.
MRI during or after Neoadjuvant Chemotherapy – Dynamic contrast enhanced MRI may be used to monitor response of a tumor to neoadjuvant chemotherapy used to shrink the tumor before surgery. This is very important in clinical decision making as alternative therapies may be selected based upon the results obtained from the MRI. It may also be used to depict residual disease after neoadjuvant chemotherapy. MRI-compatible localization tissue markers should be placed prior to neoadjuvant chemotherapy to evaluate the location of the tumor in the event of complete response.
MRI and Breast Implants – For asymptomatic women with silicone implants, no imaging is recommended for evaluation. However, MRI may be used in asymptomatic patients with silicone breast implants to evaluate breast implant integrity when a mammogram and/or ultrasound is suspicious for implant rupture.
For evaluation of unexplained axillary adenopathy in a patient under age 30, ultrasound (US) of the axilla is the recommended initial test. For age over 30, a mammogram and/or US of the axilla are recommended.
MRI after mastectomy - Most breast tissue is removed after mastectomy; however recurrence may occur in residual tissue. The majority occur in the skin, subcutaneous tissues or deep to the pectoralis muscle and are reported to be about 1-2% annually. Clinical evaluation is the mainstay of the post mastectomy breast. For a palpable lump or pain on the side of mastectomy with or without reconstruction, or a high risk patient post bilateral prophylactic mastectomy with reconstructions, MRI is not indicated. There is no relevant literature to support MRI to screen the post mastectomy breast (although may be indicated for contralateral native breast based on breast cancer risk). MRI may be useful for a palpable lump to help characterize malignancy once identified by ultrasound. Note that tissue expanders may be a contraindication to MRI.
Breast pain - Breast pain is a common complaint with the incidence of breast cancer with breast pain as the only symptom, 0-3%. Clinically insignificant breast pain is cyclical, non-focal or diffuse. There is no relevant literature regarding the use of MRI for focal or non-cyclical breast pain at any age
MRI for a mass - “Any highly suspicious breast mass detected by imaging should be biopsied, irrespective of palpable findings; and any suspicious breast mass detected by palpation should be biopsied, irrespective of imaging findings”.
MRI and Known Breast Cancer - “The ASBrS does not recommend routine diagnostic MRI in newly diagnosed breast cancer patients except as part of a scientific study…..Routine annual MRI is not indicated for screening of women with a prior history of breast cancer unless they have a known genetic or other significant risk factor placing them at high-risk for a new breast cancer …”. Clinical indications and applications per NCCN state that Breast MRI may be used for staging evaluation to define extent of cancer or presence of multifocal or multicentric disease in the ipsilateral breast, or as screening of the contralateral breast at time of initial diagnosis (Category 2B), however there are no high level data to demonstrate that the use of MRI to facilitate local therapy decision-making improves local recurrence or survival. False positive findings are common and surgical decisions shou8ld not be based solely on MRI, tissue sampling of areas of concern recommended.
MRI and breast cancer in men - Breast MRI is generally not indicated for palpable masses or axillary adenopathy prior to biopsy. Studies are limited as to the diagnostic accuracy or clinical usefulness of MRI in male patients.
Nipple Discharge - Nipple discharge is a common complaint with at least 80% of women having at least 1 episode. Discharge that is considered pathologic is unilateral, spontaneous, from one duct orifice and serous or bloody. Physiologic discharge will be bilateral, from multiple ducts, and white, green, or yellow in color. “In general, MRI should be considered in cases in which other approaches have failed to identify an underlying cause of pathologic nipple discharge. The sensitivities of breast MRI for detection of underlying cause of pathologic nipple discharge are 86% to 100% for invasive cancer and 40% to 100% for noninvasive disease”. Ductography (galactography) has the ability to demonstrate very small lesions in the specific duct that is secreting the pathologic nipple discharge. However, it is invasive and may cause discomfort and pain. It can be time-consuming and technically challenging and the rate of incomplete ductography is as high as 15%. The discharge must be present on the day of the study so that a cannula can be placed in the appropriate duct. Failure to cannulate the discharging duct may occur and cannulation of the wrong duct may cause a false-negative ductogram.
BI-RADS 3 (Probably Benign) MRI and Follow-up - A follow up MRI study may be indicated to confirm stability of a probably benign mass seen only on prior MRI. In a review of sixteen studies of high-risk patients the frequency of MRI examinations reported as BI-RADS 3 was between 6 and 12%. In an average risk screening population of 2120 women and 3,861 MRI exams 4.9% of MRI exams were BI-RADS 3. Specific features of what constitutes a BI-RADS 3 lesion were not described in these studies, is at the discretion of the reporting radiologist, and the definition was still evolving during the study periods. At this writing the appropriate use of BI-RADS 3 for breast MRI has not been fully defined. “The most appropriate and common use of BI-RADS 3 assessment is for a round- or oval-shaped mass with circumscribed margins and hyperintense T2 signal, which has either homogeneous enhancement or dark internal septations on a baseline examination. A mass meeting these criteria is most likely an intramammary lymph node or fibroadenoma”. The reported malignancy rate is ≤ 2% for lesions classified as BI-RADS 3.
BREAST MRI is considered MEDICALLY NECESSARY for the following indications::
NO HISTORY OF KNOWN BREAST CANCER:
For screening examination to detect breast cancer in any of the following situations:
- A Breast Cancer Risk Assessment (preferably using the Breast Cancer Consortium Risk Model (BCSC) which incorporates breast density, the International Breast Cancer Intervention Study model (IBIS); the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm model (BOADICEA), the modified Gail (also known as Breast Cancer Risk assessment tool (BCRAT), or Tyler-Cusick or other validated risk assessment models) that identifies the patient as having a lifetime risk of 20% or greater of developing breast cancer.
- Approve annually beginning 10 years prior to youngest family member’s age at diagnosis but not before age 30
- Patients with history of extensive chest irradiation (usually as treatment for Hodgkin’s or other lymphoma between ages ten and thirty).
- Begin ten years after radiation, but not prior to age 25.
- Patients with known BRCA 1/2 mutation.
- Approve annually starting at age 25
- Patients not yet tested for BRCA gene, but with known BRCA mutation in first degree relative.
- Approve annually starting at age 25
- Personal history of germline mutations known to predispose to a high risk of breast cancer:
- Li-Fraumeni syndrome (TP53 mutation)
- Begin age 20-29 or age at earliest diagnosed breast cancer in family)
- Cowden syndrome (PTEN) or Bannayan-Riley-Ruvalcaba syndrome (BRRS)
- Begin 30-35 or 5-10 y before earliest breast cancer in family),
- Peutz-Jeghers Syndrome (STK 11)
For evaluation of identified lesion, mass or abnormality in breast in any of the following situations:
- Evaluation of suspected breast cancer when other imaging examinations, such as ultrasound and mammography, and physical examination are inconclusive for the presence of breast cancer, and biopsy could not be performed (e.g., seen only in single view mammogram without ultrasound correlation).
- Includes skin changes of suspected inflammatory breast cancer if conventional imaging and skin biopsies are first performed and negative
- Inconclusive or conflicting findings on a screening mammogram or ultrasound when the finding is not a palpable or a discrete mass.
- For cases of new nipple inversion when mammographic and sonographic findings are inconclusive and a biopsy cannot be performed
- Patients diagnosed with biopsy-proven lobular neoplasia , i.e., ADH/ALH (atypical ductal hyperplasia/Atypical Lobular Hyperplasia) or LCIS (Lobular Carcinoma in Situ)
- Spontaneous unilateral serous or bloody nipple discharge when conventional imaging is normal and there is no palpable mass
- Paget’s disease of the nipple: to detect underlying ductal carcinoma when conventional imaging is normal and there is no palpable mass.
- For a phylloides tumor diagnosed by biopsy, breast MRI may help determine extent of disease and resectability in selected cases. However routine use for surgical planning is controversial
- Follow-up of a probably benign (BI-RADS 3) lesion seen only on prior MRI (when prior mammogram and ultrasound did not show the abnormality)
HISTORY OF KNOWN BREAST CANCER:
- Yearly surveillance for history of breast cancer and dense breast tissue on mammography
- Yearly surveillance for individuals with personal history of breast cancer diagnosed before age 50
- To identify primary cancer in a patient with axillary nodal adenocarcinoma and unidentified primary tumor
Staging, treatment, and surveillance of patients with a known history of Breast Cancer:
- Approve initial staging when conventional imaging is indeterminate in defining multifocal, multicentric, contralateral cancer or there is a discrepancy in estimated tumor size between physical exam and imaging.
- For invasive lobular carcinoma that is poorly defined by mammography, ultrasound and physical exam
- During or after treatment: To identify candidates for breast conserving therapy or evaluate response to treatment, including preoperative neoadjuvant therapy [within three (3) months]
- Yearly surveillance in patients with genetic or other risk factors placing them at high risk for a new cancer or recurrence
For evaluation of identified lesion, mass or abnormality in breast in any of the following situations:
- For evaluation of breast lesion, identifying whether single or multi-focal, in patient with newly diagnosed breast cancer
- For evaluation of suspicious mass, lesion, distortion or abnormality of breast in patient with history of breast cancer when other imaging is inconclusive.
MRI is not indicated for evaluation of saline implant complications or for asymptomatic silicone implants.
- Confirmation of suspected silicone gel-filled breast implant ruptures in asymptomatic patients, after an abnormal or indeterminate finding on mammography or breast ultrasound.
- MRI is considered the gold standard for evaluation of symptomatic silicone implant rupture
- For postoperative evaluation of silicone breast implant complications when other imaging is inconclusive
- For preoperative evaluation for known breast cancer when surgery planned within thirty (30) days to be determined on a case-by-case basis
- A follow-up study may be needed to help evaluate a patient’s progress after treatment, procedure, intervention or surgery. Documentation requires a medical reason that clearly indicates why additional imaging is needed for the type and area(s) requested.
All other uses of this technology are investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY
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- American College of Radiology (ACR). ACR Appropriateness Criteria® - Evaluation of Nipple Discharge. 2016.
- American College of Radiology (ACR). ACR Appropriateness Criteria® Imaging after Mastectomy and Breast Reconstruction. 2020.
- American College of Radiology (ACR). ACR practice parameter for the performance of contrast-enhanced magnetic resonance imaging (MRI) of the breast. ACR Appropriateness Criteria; resolution 34: 2018. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/mr-contrast-breast.pdf. Accessed November 8, 2018.
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- Brennan ME, McKessar M, Snook K, et al. Impact of selective use of breast MRI on surgical decision-making in women with newly diagnosed operable breast cancer. Breast. 2017; 32:135-143.
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- Comstock, CE, Gatsonis, C, et al. Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women with Dense Breasts Undergoing Screening. JAMA;. 2020; 323 (8):746-756.
- Destounis SV, Santacroce A, et al. Update on Breast Density, Risk Estimation, and Supplemental Screening. AJR.: 2020; 214.
- Elsamaloty H, Elzawawi MS, Mohammad S, et al. Increasing accuracy of detection of breast cancer with 3-T MRI. AJR Am J Roentgenol. 2009; 192:1142-1148.
- Förnvik D, Kataoka M, Lima M, et al. The role of breast tomosynthesis in a predominantly dense breast population at a tertiary breast centre: breast density assessment and diagnostic performance in comparison with MRI. Eur Radiol. 2018; 28(8):3194-3203.
- Geiss CS, Chikarmane SA, Dorothy A Sippo DA, et al. Clinical utility of breast MRI in the diagnosis of malignancy after inconclusive or equivocal mammographic diagnostic evaluation. AJR Am J Roentgenol. 2017; 208:1378-1385.
- Godinez J, Gombos EC, Chikarmane SA, et al. Breast MRI in the evaluation of eligibility for accelerated partial breast irradiation. American Journal of Roentgenology. 2008; 191(1): 272-277.
- Grau, AM, Chakravarthy, AB,. Chugh R, et al. Phylloides Tumor of the breast.; Up to Date., January 2020.
- Grobmyer SR, Mortellaro VE, Marshall J, et al. Is there a role for routine use of MRI in selection of patients for breast-conserving cancer therapy? J Am Coll Surg. 2008; 206(5):1045.
- Guindalini RS, Zheng Y, Abe H, et al. Intensive surveillance with bi-annual dynamic contrast-enhanced magnetic resonance imaging downstages breast cancer in BRCA1 mutation carriers. Clin Cancer Res. 2018; pii:0200.2018.
- Hartmann LC, Degnim AC, Santen RJ, et al. Atypical hyperplasia of the breast--risk assessment and management options. N Engl J Med. 2015; 372(1):78-89.
- Harvey JA, Mahoney MC, Newell MS, et al. ACR Appropriateness criteria palpable breast masses. J Am Coll Radiol. 2016; 13(11S):e31-e42.
- Houssami N, Ciattyo S, Martinelli F, et al. Early detection of second breast cancers improves prognosis in breast cancer survivors. Ann Oncol. 2009; 20(9):1505-1510.
- Kerlikowski K, Miglioretti, DL, et al. Discussions of Dense Breasts, Breast Cancer Risk, and Screening Choices in 2019. JAMA. 2019; 322 (1): 69-70.
- 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. Journal of Clinical Oncology. 2013; 31(7):961-965.
- Killelea B, Sowden M. Nipple Inversion. Up to Date. Jan 28, 2019.
- Kuhl CK, Strobel K, Bieling H, et al. Supplemental breast MRI screening of women with average risk of breast cancer. Radiology. 2017; 283(2):361-370.
- Lam DL, Houssami N, Lee JM. Imaging surveillance after primary breast cancer treatment. AJR Am J Roentgenol. 2017; 208(3):676-686.
- Lee DH, 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. JACR. 2010; 7(1):18–27.
- Lee KA, Talati N, Oudsema R, et al. BI-RADS 3: Current and future use of probably benign. Curr Radiol Rep. 2018; 6(2):5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5787219/.
- Lehman CD, Lee AY, Lee CI. Imaging management of palpable breast abnormalities. AJR Am J Roentgenol. 2014; 203(5):1142-53.
- Lepori D. Inflammatory breast disease: The radiologist’s role. Diagn Interv Imaging. 2015 Oct; 96(10):1045-64.
- Levitan DE. Which Breast Cancer Risk Models are Most Accurate? Breast Cancer News., February 27, 2019
- Lourenco AP, Moy L, Baron P, et al. ACR Appropriateness criteria® - Breast implant evaluation. J Am Coll Radiol. 2018; 15(5S):S13-S25.
- Mainiero MB, Lourenco A, Mahoney MC, et al. ACR Appropriateness criteria breast cancer screening. J Am Coll Radiol. 2016; 13(11S):R45-R49.
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- Mann RM, Hoogeveen YL, Blickman JG, et al. MRI compared to conventional diagnostic work-up in the detection and evaluation of invasive lobular carcinoma of the breast: A review of existing literature. Breast Cancer Res Treat. 2008;107:1-14.
- Marino MA, Riedl CC, Bernathova M, et al. Imaging phenotypes in women at high risk for breast cancer on mammography, ultrasound, and magnetic resonance imaging using the Fifth Edition of the Breast Imaging Reporting and Data System. Eur J Radiol. 2018; 106:150-159.
- McLaughlin, SA. Current controversies surrounding MRI screening for breast cancer. Am J Hematol Oncol. 2015; 11(8).
- Miller JC, Rafferty EA, Specht MC, et al. When is breast magnetic resonance imaging recommended for cancer detection? J Am Coll Radiol. 2008; 5(3): 224-226.
- Monticciolo, DL, Newell MS, et al. Breast Cancer Screening in Women at Higher-than-Average Risk: Recommendations from the ACR. JACR. 2018 Mar; 15(3):408-414.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer v.3.2018. Fort Washington, PA. 2018.
- Oeffinger KC, Fontham ET, Etzioni R, et al. Breast cancer screening for women at average risk: 2015 Guideline update from the American Cancer Society. JAMA. 2015; 314(15):1599-614.
- Panigrahi B, Harvey, SC, Mullen LA, et.al. Characteristics and outcomes of BI-RADS 3 lesions on Breast MRI. 2019 Feb; 19(1):e152-9.
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- Susnik B, Schneider L, Swenson KK, et al. Predictive value of breast magnetic resonance imaging in detecting mammographically occult contralateral breast cancer: Can we target women more likely to have contralateral breast cancer? J Surg Oncol. 2018; 118(1):221-227.
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- Yadav P, Chauhan S. Effectivity of combined diffusion-weighted imaging and contrast-enhanced MRI in malignant and benign breast lesions. Pol J Radiol. 2018; 83:e82-e93.
- Yu J, Park A, Morris E, et al. MRI screening in a clinic population with a family history of breast cancer. Ann Surg Oncol. 2008; 15(2):452-461.
- Zhou P, Wei Y, Chen G, et al. Axillary lymph node metastasis detection by magnetic resonance imaging in patients with breast cancer: A meta-analysis. Thorac Cancer. 2018; 9(8):989-996.
||77046 (effective 01/01/2019)
Magnetic resonance imaging, breast, without contrast material; unilateral
||77047 (effective 01/01/2019)
Magnetic resonance imaging, breast, without contrast material; bilateral
||77048 (effective 01/01/2019)
Magnetic resonance imaging, breast, without and with contrast material(s); including computer-aided dtection (CAD real-time lesion detection, characterization and pharmacokinetic analysis) When performed; unilateral
||77049 (effective 01/01/2019)
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
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.
"Current Procedural Terminology © American Medical Association. All Rights Reserved"
History From 2014 Forward
Annual review, updating policy for clarity also updating description and references.
Updating annual review date to coincide with NIA review.
Updating annual review date to coincide with NIA review.
Interim review, policy reformatted for clarity, no change to policy intent.
Annual review, no change to policy intent.
Updated code 77049.
Updating with 2019 codes.
Updated policy with 2019 coding. No other changes made.
Annual review, no change to policy intent.
Interim review to add medical necessity criteria for preoperative testing. No other changes made.
Annual review, significant revision to policy verbiage for clarity and consistency. Also updating description, guidelines, rationale and references.
Annual review, no change to policy intent.
Annual review, no change to policy intent. Updated background, description, rationale and references. Added guidelines and coding.
Added disclaimer regarding implants that were placed for cosmetic reasons: NOTE** When implants are initially placed for cosmetic purposes, contract language may indicate that related subsequent services, such as magnetic resonance imaging (MRI), would also be considered a cosmetic service. Thus, contract language must be reviewed when requests for MRI are related to silicone implants placed for cosmetic purposes.**
Annual review. Updated background, description, rationale and references. No change to policy intent. Correcting typographical errors.