Magnetic Resonance Imaging (MRI) of the Breast
DESCRIPTION
Magnetic resonance imaging (MRI) is a non invasive test using a multiplanar imaging method based on an interaction between radiofrequency (RF) electromagnetic fields and certain nuclei in the body (usually hydrogen nuclei) after the body has been placed in a strong magnetic field. The magnetic resonance (MR) scanners and intravenous magnetic resonance contrast agents are used to create detailed pictures of areas inside the body. These pictures are intended to show the difference between normal and diseased tissue and to detected disease.
MRI of the breast has been investigated as a screening tool in specific higher risk subgroups of patients. Specialized breast coils are used during the imaging of the breast. MRI of the breast may be performed bilaterally or unilaterally. It is not meant to replace mammography, percutaneous biopsy or ultrasound in the screening for breast cancer in the general population or to differentiate cysts from solid lesions.
POLICY
Magnetic Resonance Imaging (MRI) of the Breast is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Magnetic Resonance Imaging (MRI) for the diagnosis of other conditions/diseases, including, but not limited to, the following: is considered investigational:
Routine breast cancer surveillance for an individual that failed to meet annual high risk MRI screening criteria with the following:
Woman with atypical hyperplasia
Woman with mutations (other than the human genes BRAC )
Serial follow up with breast MRI scans for an individual with mammographic or routine imaging abnormalities
Dense breast diagnosed by a mammogram (density 4) with a BI RADS™ designation of 1, 2, 3, 4, 5
To determine biopsy recommendations for indeterminate lesions readily able to be biopsied (e.g. palpable masses and microcalcifications)
Magnetic Resonance Imaging (MRI) for the diagnosis of other conditions/diseases, including, but not limited to, the following: is considered not medically necessary:
Routine surveillance for an individual that failed to meet annual high risk MRI screening criteria a history of the following:
Breast cancer
Ductal carcinoma in situ (DCIS)
Lobular Carcinoma In Situ (LCIS)
Premenopausal women with history of breast cancer
Low risk probably benign (Breast imaging Reporting and database system (Bi Rads TM 3) solid lesion on mammogram and/ or ultrasound
Suspicious (BI-RADS™ 4 or 5) solid lesion on mammogram and/ or ultrasound
Any Magnetic Resonance Imaging (MRI) device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
See also:
Computer-Aided Detection of Malignancy with Magnetic Resonance Imaging of the Breast
Genetic Testing for BRCA1, BRCA2 or CHEK2 for Breast or Ovarian Cancer
MEDICAL APPROPRIATENESS
Magnetic Resonance Imaging (MRI) of the Breast is considered medically appropriate if ANY ONE of the following are met:
When general MRI guidelines including ALL of the following are met:
Individual has a recent complete history and physical examination prior to requesting advanced imaging
Prior routine imaging results are equivocal and are re-read by a radiologist prior to a request for advanced imaging
There are concerns about an individual’s reaction to the computed tomography (CT) contrast as in cases of renal insufficiency or contrast allergy
MRI is used to clarify equivocal findings on previous imaging studies as determined on a case by case basis
For Breast Augmentation, Breast Reconstruction, Free Injection, and Capsular Contracture when ALL of the following are met:
Mammography or ultrasound results are uninterpretable
Uninterpretable findings are documented prior to starting Breast MRI surveillance
The original surgery was considered medically necessary
To evaluate or confirm breast implant (saline or silicone) rupture when ALL of the following are met:
For surveillance to rule out implant leakage at 1, 2, 4, 6, 8, and 10 years after placement (per the current FDA recommendations)
Implants were originally inserted for medical reason
ABSENCE of ALL of the following:
Initial surgery was considered cosmetic
Leaking implants have been removed
For annual screening of high risk individual when ANY ONE of the following are met:
Starting at age 25 for individual testing positive for BRCA 1 or BRCA 2 mutation
Untested Individual with a first degree relative with BRCA mutation when ANY ONE of the following are met:
Start screening studies 10 years before the relative with BRCA was diagnosed with cancer
Start screening studies at age 25. when the relative with BRCA was not diagnosed with cancer
Start screening studies at age 25 for high risk individual (See definition in Additional Information)
For Dense breast tissue diagnosed with a BI-RADS™ mammogram designation of “0” only
For individual with equivocal, occult, inconclusive or conflicting mammography, ultrasound, and clinical findings with ANY ONE of the following:
Evaluate individual who present with axillary metastases suspicious for primary breast cancer with ALL of the following:
Negative physical exam
Negative mammogram
To guide the biopsy of lesions seen only on MRI (e.g. ductal carcinoma in situ)
For Preoperative evaluation in individual with newly-diagnosed, biopsy-proven breast cancer with ANY ONE of the following:
Ductal Carcinoma In Situ (DCIS)
Lobular Carcinoma In Situ (LCIS)
Papillary Carcinoma
Infiltrating lobular cancer
Tumors with extensive intraductal component
Cancers in the contralateral breast undetected by clinical exam or mammogram
Assess response to neoadjuvant chemotherapy for locally advanced breast cancer only when a pre-chemotherapy MRI has been done
Assessment of residual tumor load in patients with ALL of the following:
Individual has undergone lumpectomy
Individual has close or positive margins
The findings indicate a significant change in surgical management
Evaluate suspicion of recurrence in a treated breast with ALL of the following:
Clinical, mammographic and ultrasound findings are inconclusive
Use to differentiate post-operative scar versus tumor recurrence
Evaluate suspected cancer recurrence in reconstructed breast tissue
Rule out chest wall recurrence
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Members's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
No controlled studies were found in the published literature that validates the application of magnetic resonance imaging of the breast for reasons other than those listed as medically necessary.
High Risk Individuals are defined starting at age 25 as 20%-25% or greater lifetime risk of developing breast Cancer as determined by the following:
Clinical lifetime risk estimated at greater than 20% using clinical risk estimator such as the Gail, Claus, or BRCAPRO models
Two or more first degree relatives (parent, sibling, child) with breast or ovarian cancer
One first degree relative with breast cancer or ovarian cancer diagnosed before age 50
One first degree relative with bilateral breast cancer or both breast and ovarian cancer
History of breast cancer in a male relative (not a distant relative)
Ashkenazi Jewish women from families with onset of breast cancer before age 40
Li-Fraumeni Syndrome and first degree relatives
Cowdan and Bannayan-Riley-Ruvalcaba Syndromes and first degree relatives
Women with history of radiation to the chest between ages 10 and 30. (If history of Hodgkin’s Disease, breast screening should start 8 to 10 years post-therapy, or at age 40, whichever comes first)
The American Cancer Society, the Society of Breast Imaging, and the National Comprehensive Cancer Network (NCCN) Clinical Guidelines in Oncology recommend that breast MRI be performed in facilities that have the capability to perform MRI-guided breast biopsies.
Breast MRI in the first 12 months after surgery has poor sensitivity and specificity due to post surgical edema, hemorrhage, inflammation, scarring, and fat necrosis. It is advisable to wait 6 to 12 months after chemotherapy before performing breast MRI. MRI prior to this time may give misleading results, as cancers may exhibit benign appearing kinetics. It is advisable to wait 6 to 12 months after radiation before performing breast MRI. MRI prior to this time may give misleading results due to edema, architectural distortion, and cancers may exhibit benign appearing kinetics. Hormonal replacement (other than low dose) may have a significant effect on breast MRI enhancement patterns and specificity. If there is an unacceptable amount of physiologic enhancement on MRI, it may be necessary to stop hormone replacement for several months and repeat the MRI. It is unknown how hormonal therapy for breast cancer affects breast MRI.
Evidence-based data does not support routine breast MRI screening for an individual with dense breasts by mammogram (density 4).The findings on the most recent mammogram should be obtained or documented. If the mammogram has been given a BI-RADS™ designation of BI-RADS™ 1, 2, 3, 4, or 5, then the radiologist has been able to interpret the mammogram and breast MRI is not indicated even if the mammogram report states the presence of dense breasts. If the mammogram has been given a BI-RADS™ 0 then further imaging is needed and MRI can be considered.
Breast MRI should be able to characterize a lesion as benign, probably benign, or as suspicious. If breast MRI was obtained because a mammogram or ultrasound was unclear, then a probably benign lesion on MRI (MRI BI-RADS 3) should undergo repeat mammography and one repeat breast MRI in 6 months. A report from The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program concluded that none of the four commonly used noninvasive tests for breast abnormalities (MRI, ultrasound, PET, scintimammography) is sufficiently accurate to preclude breast biopsy in average risk women with nonpalpable breast lesions. The data were insufficient to estimate the accuracy of these tests in women with only palpable lesions.
SOURCES
American College of Radiology (ACR). (2008, October). Practice Guidelines for the performance of contrast enhanced magnetic resonance imaging (MRI) of the breast. Retrieved August 12, 2010 from: http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/breast/mri_breast.aspx.
Bazzocchi, M., Zuiani, C., Panizza, P., DelFrate, C., Soldano, F., Isola, M., et al. (2006). Contrast-enhanced breast MRI in patients with suspicious microcalcifications on mammography: results of a multicenter trial. American Journal of Roentgenology, 186 (6), 1723 - 1732. (Level 4 Evidence)
Bedrosian, I., Mick, R., Orel, S., Schnall, M., Reynolds, C., Spitz, R., et al. (2003). Changes in the surgical management of patients with breast carcinoma based on preoperative magnetic resonance imaging. Cancer, 98 (3), 468 - 473. (Level 5 Evidence)
Godinez, J., Gombos, E., Chikarmane, S., Griffin, G., & Birdwell, R. (2008). Breast MRI in the evaluation of eligibility for accelerated partial breast irradiation. American Journal of Roentgenology, 191 (1), 272 - 277. (Level 4 Evidence)
Gokalp, G., & Topal, U. (2006). MR imaging in probably benign lesions (BI-RADS category 3) of the breast. European Journal of Radiology, 57 (3), 436 - 444. (Level 4 Evidence)
Hata, T., Takahashi, H., Watanabe, K., Takahashi, M., Taguchi, K., Itoh, T., et al. (2004). Magnetic resonance imaging for preoperative evaluation of breast cancer: a comparative study with mammography and ultrasonography. Journal of American College of Surgery, 198 (2), 190 - 197. (Level 2 Evidence)
Huff, J. (2007, October). Clinical applications of breast MRI: current Indications and examples. Presented at: Identification and Management of Breast Cancer, Nashville, TN.
Institute for Clinical Systems Improvement (ICSI). (2008, January). Health Care Guidelines: Diagnosis of breast disease. Retrieved August 12, 2010 from http://www.icsi.org/index.aspx.
Kolb, T., Lichy, J., & Newhouse, J. (2002). Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27, 825 patient evaluations. Radiology, 225 (1), 165 - 175. (Level 4 Evidence)
Lee, S., Orel, S., Woo, I., Cruz-Jove, E., Putt, M. Solin, L., et al. (2003). MR imaging screening of the contralateral breast in patients with newly diagnosed breast cancer: preliminary results. Radiology, 226 (3), 773 - 778. (Level 4 Evidence)
Lehman, C., Gatsonis, C., Kuhl, C., Hendrick, R., Pisano, E., Hanna, L., et al. (2007). MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. New England Journal of Medicine, 356 (13), 1295 - 1303. (Level 2 Evidence)
Liberman,L, Morris, E., Dershaw, D., Abramson, A., & Tan, L. (2003). MR imaging of the ipsilateral breast in women with percutaneously proven breast cancer. American Journal of Roentgenology, 180 (4), 901 - 910. (Level 5 Evidence)
Moy, L., Elias, K., Patel, V., Lee, J., Babb, J., Toth, H., et al. (2009). Is breast MRI helpful in the evaluation of inconclusive mammographic findings? American Journal of Roentgenology, 193 (4), 986 - 993. (Level 5 Evidence)
National Comprehensive Cancer Network (NCCN). (2010, January). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Retrieved August 12, 2010 from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
National Comprehensive Cancer Network (NCCN). (2010, January). NCCN Clinical Practice Guidelines in Oncology: Hodgkin Lymphoma. Retrieved August 12, 2010 from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
Saslow, D., Coetes, C., Burke, W., Harms, S., Leach, M., Lehman, C., et al. (2007). American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. Cancer Journal for Clinicians, 57 (2), 75 - 78.
Silverstein, M, Lagios, M., Recht, A., Allred, C., Harms, S., Holland, R., et al. (2005). Image-detected breast cancer: state of the art diagnosis and treatment. Journal of American College of Surgeons, 201 (4), 586 - 597. (Level 5 Evidence)
Solin, L., Orel, S., Hwang, W., Harris, E., & Schnall, M. (2008). Relationship of breast magnetic resonance imaging to outcome after breast-conservation treatment with radiation for women with early-stage invasive breast carcinoma or ductal carcinoma in situ. Journal of Clinical Oncology, 26 (3), 386 - 391. (Level 4 Evidence)
ORIGINAL EFFECTIVE DATE: 8/1/2001
MOST RECENT REVIEW DATE: 12/1/2010
ID_MS
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