Coverage Policy Manual
Policy #: 2001028
Category: Radiology
Initiated: March 1999
Last Review: February 2019
  Magnetic Resonance Imaging (MRI), Breast

Description:
Magnetic resonance imaging (MRI) of the breast can be performed using MR scanners and intravenous MR contrast agents. Specialized breast coils are usually used. This policy addresses the use of breast MRI for a variety of clinical indications including either detection or diagnosis of breast cancer.
 
MRI of the breast has been investigated as a screening tool and a diagnostic instrument and has been compared to film screen mammography and also, for some conditions, to ultrasound.  In general, MRI is more sensitive, but less specific than mammography.  The increased sensitivity has allowed for the identification of earlier tumors, but has not yet been proven to improve survival, and for some diagnostic purposes, has not been shown to prevent the need for biopsy.  The decreased specificity has resulted in increased biopsy of benign lesions, potentially leading to increased unnecessary risks and complications.  
 
The following coverage is based on results from randomized controlled trials, where available, and on “expert opinion” where scientific evidence is lacking.
 
It should be remembered that all of the positive benefits of breast MRI have been obtained using MRI instruments specifically designed for the breast.  Whether these same results can be obtained with standard MRI is unknown.  It is also less well known if these same beneficial results can be obtained from MRI machines that have been configured with coils designed for the breast.
 
Gadolinium is the contrast used for breast MRIs.  In June 2006 the FDA notified healthcare professionals and consumers about a possible link between gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure.

Policy/
Coverage:
Effective April 2019
 
Breast MRI exams should be performed and interpreted by an expert breast imaging team working together with the multidisciplinary oncology treatment team.
 
Screening is recommended no more frequently than annually by the ACS, and is covered no more frequently than annually by Arkansas BCBS.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for screening for breast cancer in patients:
        • with a known BRCA1 or BRCA2 mutation or
        • at high risk of BRCA1 or BRCA2 mutation due to a known presence of the mutation in relatives or
        • who have Li-Fraumeni syndrome or Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome or who have a first-degree relative with one of these syndromes or
        • at high risk (greater than 20% lifetime risk) of developing breast cancer as identified by models that are largely defined by family history  or by the BRCAPRO or BOADICA risk model algorithms or
        • who received radiation therapy to the chest between 10 and 30 years of age or
        • with heterogeneously or extremely dense breast(s) when sensitivity of mammography is limited (women with extremely dense breast tissue demonstrated on at least 50% or more of the mammogram- density as determined by the American College of Radiology Breast Imaging Reporting and Data System).
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam).
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for presurgical planning in patients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy to permit tumor localization and characterization.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to determine the presence of pectoralis major muscle/chest wall invasion in patients with posteriorly located tumors.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in those with a new diagnosis of breast cancer to evaluate the contralateral breast when clinical and mammographic findings are normal.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the evaluation of physical findings or symptoms suggesting local recurrence of cancer in the ipsilateral breast following mastectomy and reconstructive surgery.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to evaluate a documented abnormality of the breast prior to obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, are not able to localize the lesion for biopsy.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to confirm clinical diagnosis of rupture of silicone breast implants.
  
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a screening technique in average-risk patients (15%-20% lifetime risk) or patients with a personal history of breast cancer. For contracts without primary coverage criteria, MRI of the breast is considered investigational as a screening technique in average-risk patients. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a screening technique in women with a personal history of breast cancer.  For contracts without primary coverage criteria, MRI of the breast is considered investigational as a screening technique in women with a personal history of breast cancer. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
  
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up. For contracts without primary coverage criteria, MRI of the breast is considered investigational for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for diagnosis of a suspicious breast lesion in order to avoid biopsy.  For contracts without primary coverage criteria, MRI of the breast is considered investigational for diagnosis of a suspicious breast lesion in order to avoid biopsy. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer. For contracts without primary coverage criteria, MRI of the breast is considered investigational to determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for evaluation of residual tumor in patients with positive margins after lumpectomy or breast conservation surgery.  For contracts without primary coverage criteria, MRI of the breast is considered investigational for evaluation of residual tumor in patients with positive margins after lumpectomy. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast to monitor  the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture  does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, MRI of the breast to monitor the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery. For contracts without primary coverage criteria, MRI of the breast as surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to April 2019
 
Note: All of the following policy statements refer to performing MRI of the breast with a breast coil. MRI of the breast without the use of a breast coil, regardless of the clinical indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and for contracts without primary coverage criteria, is considered investigational. Investigational services are specific contract exclusions.
 
Breast MRI exams should be performed and interpreted by an expert breast imaging team working together with the multidisciplinary oncology treatment team.
 
Screening is recommended no more frequently than annually by the ACS, and is covered no more frequently than annually by Arkansas BCBS.
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for screening for breast cancer in patients:
        • with a known BRCA1 or BRCA2 mutation or
        • at high risk of BRCA1 or BRCA2 mutation due to a known presence of the mutation in relatives or
        • who have Li-Fraumeni syndrome or Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome or who have a first-degree relative with one of these syndromes or
        • at high risk (greater than 20% lifetime risk) of developing breast cancer as identified by models that are largely defined by family history  or by the BRCAPRO or BOADICA risk model algorithms or
        • who received radiation therapy to the chest between 10 and 30 years of age or
        • with heterogeneously or extremely dense breast(s) when sensitivity of mammography is limited (women with extremely dense breast tissue demonstrated on at least 50% or more of the mammogram- density as determined by the American College of Radiology Breast Imaging Reporting and Data System).
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam).
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for presurgical planning in patients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy to permit tumor localization and characterization.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to determine the presence of pectoralis major muscle/chest wall invasion in patients with posteriorly located tumors.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in those with a new diagnosis of breast cancer to evaluate the contralateral breast when clinical and mammographic findings are normal.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the evaluation of physical findings or symptoms suggesting local recurrence of cancer in the ipsilateral breast following mastectomy and reconstructive surgery.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to evaluate a documented abnormality of the breast prior to obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, are not able to localize the lesion for biopsy.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to confirm clinical diagnosis of rupture of silicone breast implants.
  
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a screening technique in average-risk patients (15%-20% lifetime risk) or patients with a personal history of breast cancer. For contracts without primary coverage criteria, MRI of the breast is considered investigational as a screening technique in average-risk patients. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a screening technique in women with a personal history of breast cancer.  For contracts without primary coverage criteria, MRI of the breast is considered investigational as a screening technique in women with a personal history of breast cancer. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
  
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up. For contracts without primary coverage criteria, MRI of the breast is considered investigational for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for diagnosis of a suspicious breast lesion in order to avoid biopsy.  For contracts without primary coverage criteria, MRI of the breast is considered investigational for diagnosis of a suspicious breast lesion in order to avoid biopsy. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer. For contracts without primary coverage criteria, MRI of the breast is considered investigational to determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for evaluation of residual tumor in patients with positive margins after lumpectomy or breast conservation surgery.  For contracts without primary coverage criteria, MRI of the breast is considered investigational for evaluation of residual tumor in patients with positive margins after lumpectomy. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast to monitor  the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture  does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, MRI of the breast to monitor the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery. For contracts without primary coverage criteria, MRI of the breast as surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to February 2018
 
Note: All of the following policy statements refer to performing MRI of the breast with a breast coil. MRI of the breast without the use of a breast coil, regardless of the clinical indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and for contracts without primary coverage criteria, is considered investigational. Investigational services are specific contract exclusions.
 
Breast MRI exams should be performed and interpreted by an expert breast imaging team working together with the multidisciplinary oncology treatment team.
 
Screening is recommended no more frequently than annually by the ACS, and is covered no more frequently than annually by Arkansas BCBS.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for screening for breast cancer in patients:
        • with a known BRCA1 or BRCA2 mutation or
        • at high risk of BRCA1 or BRCA2 mutation due to a known presence of the mutation in relatives or
        • who have Li-Fraumeni syndrome or Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome or who have a first-degree relative with one of these syndromes or
        • at high risk (greater than 20% lifetime risk) of developing breast cancer as identified by models that are largely defined by family history  or by the BRCAPRO or BOADICA risk model algorithms or
        • who received radiation therapy to the chest between 10 and 30 years of age or
        • with heterogeneously or extremely dense breast(s) when sensitivity of mammography is limited (women with extremely dense breast tissue demonstrated on at least 50% or more of the mammogram- density as determined by the American College of Radiology Breast Imaging Reporting and Data System).
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam).
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for presurgical planning in patients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy to permit tumor localization and characterization.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to determine the presence of pectoralis major muscle/chest wall invasion in patients with posteriorly located tumors.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in those with a new diagnosis of breast cancer to evaluate the contralateral breast when clinical and mammographic findings are normal.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the evaluation of physical findings or symptoms suggesting local recurrence of cancer in the ipsilateral breast following mastectomy and reconstructive surgery.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to evaluate a documented abnormality of the breast prior to obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, are not able to localize the lesion for biopsy.
 
MRI of the breast meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to confirm clinical diagnosis of rupture of silicone breast implants.
  
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a screening technique in average-risk patients (15%-20% lifetime risk) or patients with a personal history of breast cancer. For contracts without primary coverage criteria, MRI of the breast is considered investigational as a screening technique in average-risk patients. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as a screening technique in women with a personal history of breast cancer.  For contracts without primary coverage criteria, MRI of the breast is considered investigational as a screening technique in women with a personal history of breast cancer. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
  
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up. For contracts without primary coverage criteria, MRI of the breast is considered investigational for diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for diagnosis of a suspicious breast lesion in order to avoid biopsy.  For contracts without primary coverage criteria, MRI of the breast is considered investigational for diagnosis of a suspicious breast lesion in order to avoid biopsy. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast meet does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy. For contracts without primary coverage criteria, MRI of the breast for preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes to determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer. For contracts without primary coverage criteria, MRI of the breast is considered investigational to determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for evaluation of residual tumor in patients with positive margins after lumpectomy or breast conservation surgery.  For contracts without primary coverage criteria, MRI of the breast is considered investigational for evaluation of residual tumor in patients with positive margins after lumpectomy. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast to monitor  the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture  does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For contracts without primary coverage criteria, MRI of the breast to monitor the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
MRI of the breast does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes as surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery. For contracts without primary coverage criteria, MRI of the breast as surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery is considered investigational. Investigational services are considered contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to March 2011
 
NOTE: All of the following policy statements refer to performing MRI of the breast with a DEDICATED breast MRI instrument or a configured machine using a breast coil and an MRI machine with 1.5 TESLA or larger magnet. MRI of the breast performed without the use of a breast coil, and/or performed on an MRI of less than 1.5 TESLA units, regardless of the clinical indication, does not meet member certificate of benefit primary coverage criteria and is considered investigational.
 
MRI of the breast, for screening or diagnostic purposes, meets primary coverage criteria for effectiveness and is covered only when performed in facilities with the capability to do MRI-guided breast biopsies.
 
MRI for SCREENING
(Note: The American Cancer Society convened an expert panel of physicians and developed guidelines for screening for breast cancer.  According to the ACS, “[B]ecause of the high false-positive rate of MRI screening, and because women at higher risk of breast cancer are much more likely to benefit than women at lower risk, screening should be recommended only to women who have a high prior probability of breast cancer).
 
Screening is recommended no more frequently than annually by the ACS, and is covered no more frequently than annually by Arkansas BCBS.
 
MRI of the breast is covered for screening for women
        • with a known BRCA1 or BRCA2 mutation;
        • at high-risk of BRCA-1 or BRCA2 mutation due to a known presence of the mutation in relatives;
        • with a pattern of breast cancer history in multiple first-degree relatives, often occurring at a young age, with bilaterality, consistent with a high probability of harboring BRCA mutations or other hereditary breast cancer  (i.e., Li-Fraumeni, Cowden, or Bannayan-Riley-Ruvalcaba syndromes and first-degree relatives) Features of the family history which suggest that a breast cancer may be due to a high-penetrance gene include 2 or more close (generally first- or second-degree) relatives with breast or ovarian cancer; breast cancer occurring before age 50 years (premenopausal) in a close relative; a family history of both breast and ovarian cancer; one or more relatives with 2 cancers (breast and ovarian or 2 independent breast cancers); and male relatives with breast cancer.  (ACS guidelines, March 2007);
        • with heterogeneously or extremely dense breast(s) when sensitivity of mammography is limited (women with extremely dense breast tissue demonstrated on at least 50% or more of the mammogram - density as determined by the American College of Radiology Breast Imaging Reporting and Data System);
        • with medical history of having received radiation therapy to the chest and/or mediastinum between 10 and 30 years of age
        • as a screening technique of the contralateral breast in patients who have newly diagnosed (within past 60 days) breast cancer.  Data supporting the effectiveness of this use of MRI, including the sensitivity, specificity, positive predictive value, and negative predictive value, were derived from studies done using dedicated breast MRI equipment.  The false positive rate is 10.9% using the best equipment; whether this rate is increased by using adapted MRI equipment or standard MRI is unknown, but the risk of inaccurate results of MRI of the breast using non-dedicated equipment may be significant, could lead to unnecessary invasive procedures and mastectomy, and is not covered.
        • as a screening technique for women with a lifetime risk of breast cancer >= 20%, as defined by the BRCAPRO or BOADICA risk model algorithms
 
MRI for DIAGNOSIS
MRI of the breast is covered for diagnostic purposes in the following circumstances:
        • For detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam);
        • For presurgical planning in patients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy. MRI is covered before and after completion of neoadjuvant chemotherapy to permit tumor localization and characterization when medically indicated;
        • To determine the presence of pectoralis major muscle/chest wall invasion in patients with tumors located adjacent to the chest wall;
        • For evaluation of rupture of silicone breast implants; and
        • For evaluation of an abnormality detected by mammography but not identified accurately enough to determine if biopsy indicated, and not localized accurately enough for mammographically or ultrasound guided biopsy;
        • For evaluation of physical findings or symptoms suggesting local recurrence of cancer in the ipsilateral breast following mastectomy and reconstructive surgery.
 
CONDITIONS FOR WHICH BREAST MRI IS NOT COVERED
The following uses of MRI of the breast are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness, and these uses of MRI are considered investigational and not covered for contracts without primary coverage criteria language:  
        • For screening of women with less than 15% risk of breast cancer;
        • For screening of women with a 15 -  19% lifetime risk of breast cancer;
        • For screening of women with a personal history of breast cancer;
        •  As a screening technique of the contralateral breast in patients who have newly diagnosed (within past 60 days) breast cancer.  
        • For diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up;
        • For diagnosis of a suspicious breast lesion in order to avoid biopsy;
        • For preoperative tumor mapping to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy;
        • To determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer; and
        • For evaluation of residual tumor in patients with positive margins after lumpectomy;
        • As surveillance or screening for recurrent breast cancer in the ipsilateral breast after mastectomy and reconstructive surgery.
To monitor the integrity of breast implants when there are no signs or symptoms of implant rupture. (Effective 12/2010)

Rationale:
Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
 
MRI for SCREENING
From the American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography, March 2007:
“Although the efficacy of breast MRI has been demonstrated, it does not achieve perfect sensitivity or specificity in women undergoing screening, and as such, the issue of adverse consequences for women who do, but especially those who do not, have breast cancer is important to address. As with mammography and other screening tests, false negatives after MRI screening can be attributed to inherent technological limitations of MRI, patient characteristics, quality assurance failures, and human error; false positives also can be attributed to these factors, as well as heightened medical-legal concerns over the consequence of missed cancers. A patient's desire for definitive findings in the presence of a low-suspicion lesion may also contribute to a higher rate of benign biopsies. The consequences of all these factors include missed cancers, with potentially worse prognosis, as well as anxiety and potential harms associated with interventions for benign lesions.
 
“The specificity of MRI is significantly lower than that of mammography in all studies to date, resulting in more recalls and biopsies. Call-back rates for additional imaging ranged from 8% to 17% in the MRI screening studies, and biopsy rates ranged from 3% to 15%. However, several researchers have reported that recall rates decreased in subsequent rounds of screening: prevalence screens had the highest false-positive rates, which subsequently dropped to less than 10%. Most call backs can be resolved without biopsy. The call-back and biopsy rates of MRI are higher than for mammography in high-risk populations; while the increased sensitivity of MRI leads to a higher call-back rate, it also leads to a higher number of cancers detected. The proportion of biopsies that are cancerous (positive predictive value) is 20% to 40%. Since false-positive results appear to be common, more data are needed on factors associated with lower specificity rates. “
 
Screening of High Genetic Risk Patients (Patients with BRCA1, BRCA2, Li Fraumeni syndrome and first degree relatives, Cowden and Bannayan-Riley-Ruvalcaba syndromes and first degree relatives, or patients with a lifetime risk for breast cancer of 20% or greater as determined by the BRCAPRO or BOADICA risk model algorithms
Families at high risk for harboring a BRCA1 or BRCA2 mutation are those in which the incidence of breast or ovarian cancer in first-degree (i.e.,     parent, sibling, offspring) or second-degree (i.e., grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling) relatives suggests an autosomal dominant inheritance, i.e., about half the family members are affected.
 
A pattern of breast cancer history that is consistent with a high probability of harboring BRCA mutations or other hereditary breast cancer would be defined as two or more first-degree relatives (i.e., parent, sibling, offspring) with a history of breast cancer that likely occurred under the age of 40 years and in both breasts.
 
When applied to high genetic-risk patients, the evidence appears to show at least equivalent performance for MRI in terms of sensitivity in detecting breast cancer compared to mammography. In 2 published studies, however, there were only 15 cases of cancer.  In both studies, MRI detected 100% of cancer cases, while mammography detected 33%. Recent abstracts show findings consistent with superior sensitivity of MRI and either equivalent of slightly inferior specificity.
  
Although direct benefit of MRI screening among this population has not been proven, such a benefit might be inferred by knowledge of the sensitivity and specificity of this test, along with knowledge of the benefits of mammography developed through several lines of evidence including randomized clinical trials.
 
Studies from 6 countries have found high sensitivity for MRI, ranging from 71% to 100% versus 16% to 40% for mammography in high risk populations.  
 
Screening of women with Heterogeneously or Extremely Dense Breast(s) when sensitivity of mammography is limited
Mammographic density has been shown to be a strong risk factor for the development of breast cancer, with women with dense tissue in 75% or more of the breast having a risk of breast cancer as great as the risk among with little or no dense tissue.  In the Boyd study, published in the NEJM in 2007, the attributable risk of breast cancer showed that mammographic density accounted for a substantial proportion of cases of breast cancer, particularly in younger women, in whom 26% of all breast cancers and 50% of cancers detected less than 12 months after a negative screening examination were associated with density in 50% or more of the mammogram (Boyd, 2007).  
 
MRI has a higher rate of detection of breast cancer (sensitivity for detection), but a lower rate of specificity (detects more abnormal lesions that are not cancer, potentially leading to more biopsies, more patient anxiety).  According to the ACS, “While the high rate of biopsies and further investigations is acceptable in women with a high risk of breast cancer, the number of such investigations in women at lower risk will be much higher than would be appropriate, leading to the need to counsel women in lower risk categories that MRI screening is not advisable and that the harms are believed to outweigh the benefits…Although there have been several trials reported looking at the accuracy and positive predictive value of MRI and mammography in women with high breast density, all these trials have been conducted in women with known or highly-suspected malignancies within the breast.  To this point there has been no Phase III randomized trial reported that has shown a reduction in either mortality or in the size of diagnosed breast cancer when comparing breast MRI with mammography in women with high mammographic density.”  According to the ACS, mammography is less effective in women with very dense breasts, and MRI screening may offer added benefit.
 
Screening of women with a medical history of receiving radiation therapy to the chest and/or mediastinum between 10 and 30 years of age
Several studies have demonstrated an increased risk of breast cancer in women between the ages of 10 and 30 fifteen to 30 years after receiving radiation therapy to the chest and mediastinum for treatment of Hodgkin’s disease.  Fortunately, this risk is declining with the advent of radiation delivery techniques which shield breast exposure.
 
According to the ACS, women who have received radiation treatment to the chest compose a well-defined group that is at high risk.  Although evidence of the efficacy of MRI screening in this group is lacking, and because of the high risk of secondary cancer in this group, MRI screening is recommended based on expert consensus opinion.
 
Screening of the Contralateral (Opposite) Breast of Patients with Breast Cancer
The absolute risk of contralateral breast cancer in women with a personal history of breast cancer is estimated to be 0.5% to 1% per year, or 5% to 10% during the 10 years following diagnosis, which is significantly higher than that of the general population.
 
The American College of Radiology Imaging Network-A6667 trial “MRI Evaluation of the Contralateral Breast in  Women with a Recent Diagnosis of Breast Cancer” investigated whether or not MRI of the contralateral breast could improve on clinical breast examination and mammography in detecting contralateral breast cancer soon after the initial diagnosis of unilateral breast cancer, and the results were reported in the March 29, 2007 issue of the New England Journal of Medicine.  Women were eligible to participate I the study if they were 18 years of age or older and had received a diagnosis of unilateral breast cancer within 60 days before the study MRI was performed.  All women were required to have had normal clinical and mammographic findings in the contralateral breast within 90 days before enrollment.  Women were excluded from the study if the breast cancer diagnosis was made more than 60 days before enrollment.  Nine hundred and sixty-nine women with a new diagnosis of breast cancer and a negative mammogram and clinical breast exam in the contralateral breast completed the study.  On the basis of the MRI, biopsies were recommended for 135 women and 121 of them underwent biopsy resulting in a finding of thirty cancers (24.8%) in the contralateral breast.  An additional three cancers, not predicted by MRI, were found at the time of mastectomy.  Ninety-one women, out of 135 for whom biopsy was recommended and 121 who actually had a biopsy based on MRI findings, had benign lesions.  The authors concluded, “Our study shows that MRI can improve the detection of cancer in the contralateral breast when added to a thorough clinical breast examination and mammographic evaluation at the time of the initial diagnosis of breast cancer.  The increased rate of detection of cancer comes with a false positive rate of 10.9% and a relatively low risk of detecting benign disease on biopsy (9.4%).”
 
Dr. Robert A. Smith, in an editorial in the same issue, states: “There may be arguments that the added sensitivity of MRI of the contralateral breast comes at high cost in terms of false positive results and overdiagnosis due to the high rate of detection of ductal carcinoma in situ.”  Nonetheless, the false positive rate and the predictive value of a positive test are in an acceptable range, and there is little persuasive evidence that most cases of ductal carcinoma in situ are not progressive.  Therefore, there is value in detecting and treating malignant tumors in the contralateral breast that were not identified by means of mammography and clinical breast exam.
 
Screening of women with less than 15% risk of breast cancer
Because the prevalence of breast cancer is extremely low in average-risk young women, screening with a test such as MRI that has inferior specificity would result in lower positive-predictive values and many more false-positive results. Compared to mammography, there would be greater numbers of workups, biopsies, anxiety, and morbidity if MRI screening were to be applied to young, average-risk women.
 
The ACS recommends against MRI screening based on Expert Consensus Opinion
 
Screening of women with a 15% to 19% risk of breast cancer
The ACS states there is insufficient evidence to recommend for or against MRI screening for women with a lifetime risk of 15-20%, as defined by BRCAPRO or other models that are largely dependent on family history.  The Arkansas BCBS member certificate of benefit coverage is based on Primary Coverage Criteria for effectiveness.  Part of the definition of “effective”, as defined by the member benefit certificate, is “If neither scientific evidence, expert opinion nor professional standards show that an existing intervention will achieve its intended purpose to cure, alleviate or enable diagnosis or detection of a medical condition, then the Company in its discretion may find that such existing intervention is not effective and on that basis fails to meet the Primary Coverage Criteria.”
 
Screening of women with a Personal History of Breast Cancer
In patients with or without a prior history of breast cancer, and who do not have a high genetic risk or a lifetime risk of >= 20%, evidence is insufficient to draw conclusions on the effects of adjunctive breast MRI on health outcomes.  In the average risk population, the incremental effects of adjunctive MRI screening are uncertain.
 
When the sensitivity of mammography is limited in patients after breast conservation therapy, there may be improvements in sensitivity with MRI; however, additional prospective studies are needed to confirm this and to identify the most useful subsets for MRI evaluation given the relatively low incidence of recurrence.
 
MRI for Diagnostic Uses
Detection of Suspected Occult Breast Primary when adenocarcinoma is detected in axillary lymph nodes but physical exam of the breast and mammography are negative
The adjunctive use of MRI in the detection of adenocarcinoma of unknown primary discovered in ipsilateral (same side) axillary lymph nodes, but exam of the breast by mammography and physical examination is negative, allows individuals in this small subgroup of patients to avoid the inappropriate use of mastectomy (25% - 61%) or biopsy (8%) when the MRI is negative for tumor.
 
For presurgical planning inpatients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy to permit tumor localization and characterization
Patients with locally advanced breast cancer are generally offered neoadjuvant chemotherapy in the hopes of reducing tumor size to permit Breast Conserving Therapy. Evaluation of tumor size and extent with conventional techniques (i.e., mammography, clinical exam, ultrasound) is suboptimal, and breast MRI has been proposed as a more accurate means of determining tumor size for surgical planning.
 
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 et al. found MRI to be 100% sensitive and specific for defining residual tumor after chemotherapy. Conversely, mammography achieved 90% sensitivity and 57% specificity (mammography results considered equivocal), and clinical exam was only 50% sensitive and 86% specific. Similarly, Partridge et al. reported correlation of residual tumor size on MRI of 0.89 and clinical exam of 0.60.
 
MRI results were well correlated with results of histopathological assessment (reference standard) with correlation coefficients of 0.72 to 0.98; however, MRI is not intended as a replacement for histopathological assessment.
  
Using breast MRI instead of conventional methods to guide surgical decision-making regarding the use of Breast Conserving Therapy versus mastectomy would be at least as beneficial and may more frequently lead to the appropriate surgical procedure.
 
Detection of extent of tumor penetration for patients with tumors located adjacent to the chest wall
Tumors located near the chest wall may invade the pectoralis major muscle or extend deeper into the chest wall tissues. Typically, modified radical mastectomy removes only the fascia of the pectoralis muscle; however, tumor involvement of the muscle would necessitate removal of the muscle (or a portion of it) as well. In smaller tumors, potentially eligible for BCT, it is necessary to determine how closely the tumor abuts the pectoralis muscle and whether it invades the muscle to know preoperatively if there is an adequate margin of normal breast tissue to permit BCT. Breast MRI has been suggested as a means of determining pectoralis muscle/chest wall involvement for surgical planning and to assist in the decision whether to use neoadjuvant chemotherapy.
 
Morris et al. 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.
 
 
Two other retrospective studies reported on 4 cases in which MRI was able to determine involvement of the chest wall with 100% accuracy. Given the high level of diagnostic accuracy for MRI, as compared with reference standard and conventional alternative techniques, “Expert opinion” has recommended this use of MRI.  
 
Evaluation of an abnormality detected by mammography but not identified accurately enough to determine if biopsy indicated, and not localized accurately enough for mammographically or ultrasound guided biopsy
Mammography may suggest an abnormality which cannot be localized by mammography or ultrasonography.  MRI may detect such lesions, and allow MRI guided biopsy.
 
Differentiation/Diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up
Patients with abnormal findings on mammography are categorized according to the level of suspicion of the findings. Those with low-suspicion findings are often recommended to undergo short-interval follow-up after 3–6 months instead of immediate biopsy. This follow-up may continue for a period of 2 years to demonstrate stability of benign findings or to detect progression, indicating the need for biopsy. MRI of the breast has been investigated as a technique to further characterize low-suspicion breast lesions, so that patients with MRI-negative lesions may be reassured and avoid the need for prolonged follow-up and those with MRI-positive lesions may be referred for early biopsy, possibly leading to earlier diagnosis and treatment.
 
Available evidence suggests that adjunctive MRI may be sensitive and specific in patients with low-suspicion findings on conventional testing and may provide a useful method to select patients for biopsy or to avoid prolonged short-interval follow-up. However, none of the available studies use prospective methods in the appropriate patient population to directly compare the sensitivity and specificity of short-interval mammographic follow-up with MRI and to determine the effects of adjunctive MRI on cancer detection rate and biopsy rate.
 
Well-designed prospective confirmatory studies would be necessary to permit conclusions regarding the effect this adjunctive use of breast MRI has on health outcomes.
 
This use of MRI is non-covered based on member benefit certificate primary coverage criteria and is considered investigational for contracts which do not include primary coverage criteria.
 
Diagnosis of suspicious breast lesion as substitute for biopsy
MRI of the breast as a technique to further characterize indeterminate or suspicious breast lesions has been proposed as a tool to reduce the need for biopsy of the indeterminate lesion noted on mammography/ultrasound.  This use of MRI is not covered based on the results of a multicenter trial of 821 patients who had abnormal indeterminate lesions on screen film mammography or clinical examination and had MRI prior to biopsy (Bluemke, et al.).  The positive predictive value of MRI was 85.4%.  The authors concluded that "MRI does not obviate the need for subsequent tissue sampling in this setting."   A 15% false negative rate is considered too high to recommend using MRI as a surrogate for biopsy of an indeterminate lesion.
 
Considering the relative ease of breast biopsy, the sensitivity of breast MR would have to be virtually 100% to confidently avoid 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, but invasive carcinomas may fail to enhance on MR, 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. The Blue Cross Blue Shield Association Technology Evaluation Center Assessment concluded that the potential benefit of sparing a fraction of patients from undergoing an unnecessary biopsy does not outweigh the potential harms considering the current level of diagnostic performance of breast MRI.
 
This use of MRI is non-covered based on member benefit certificate primary coverage criteria and is considered investigational for contracts which do not include primary coverage criteria.
 
MRI of the breast as a preoperative mapping technique to identify multicentric disease in patients with clinically localized breast cancer
Patients with localized breast cancer are considered candidates for breast-conserving surgery followed by radiation therapy. However, mastectomy may be considered in patients with multicentric disease. MRI has been investigated as a technique to assess the extent of tumor in the breast and specifically to detect multicentric disease as an aid to surgical planning.
 
Breast MRI is primarily used to identify multicentric breast tumors that have not been detected on conventional testing using mammography, clinical exam, or ultrasound.  Multiple studies confirm that MRI of the breast has a better sensitivity for identifying multicentric breast tumors compared to mammography and/or ultrasound. Approximately 2% to 15% of patients otherwise eligible for BCT may have multicentric disease seen on MRI.
 
In studies that examined the effect of MRI on patient management, MRI led to mastectomy in 13 of 184 cases (7%), although 2 of these 13 mastectomy cases (15%) were MRI false-positives and did not have multicentric cancer. Preoperative imaging guided (MRI or other) biopsy was not universally performed.
 
The effect on health outcomes of multicentric disease detected only on MRI has not been established. If MRI information is used to guide mastectomy, then the potential benefit of breast conservation will be decreased. The effects of multicentric disease on locoregional recurrence and survival have not been established after either BCT with whole-breast radiation or modified radical mastectomy.
 
Several studies have been published that report on MRIs performance in detecting multifocal and/or multicentric disease.  Examples of studies with at least 99 subjects include Berg et al., Deurloo et al., Sardanelli et al., Schelfout et al., and Schnall et al.  None of these studies evaluates the impact on outcomes of different treatment strategies stemming from the MRI results. Morrow has argued in several editorials that outcome data are needed to determine whether the additional lesions detected by mammography indicate the need for mastectomy or could be controlled with radiotherapy following BCT. Schnall et al. counter that there is little difference in the characteristics of incidental lesions detected by MRI or mammography and, therefore, women with additional MRI-detected cancerous lesions (about 10% of patients in their study) might benefit from avoiding BCT. Only empirical evidence can resolve this issue.
 
This use of MRI is non-covered based on member benefit certificate primary coverage criteria and is considered investigational for contracts which do not include primary coverage criteria.
 
To determine response during neoadjuvant chemotherapy in patients with locally advanced breast cancer
Breast MRI to evaluate response during neoadjuvant chemotherapy in patients with locally advanced breast cancer has been proposed as a method to reliably identify patients 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.   Tumors that respond to chemotherapy get smaller and may even disappear; however, actual reduction in size is a delayed finding and earlier changes in tumor vascularity in chemotherapy-responsive tumors have been observed. Reduction in the degree of contrast enhancement on MRI has been noted in tumors relatively early in the course of chemotherapy, and the role of this MRI finding as an early predictor of tumor response has been explored as a means to optimize choice of chemotherapeutic agents. The MRI scan before chemotherapy is used for comparison to demonstrate tumor location so that the tumor can be optimally evaluated after chemotherapy, especially if the size and degree of contrast enhancement is greatly reduced.
 
MRI would be harmful if it falsely suggested a lack of response and lead to premature discontinuation of effective chemotherapy.
 
High negative-predictive value (NPV) (i.e., ability to predict a nonresponsive tumor) would be most important in association with high sensitivity for detecting tumor response and high specificity for nonresponsive tumors.
 
A total of 6 studies, including a total of 206 subjects, reported use of breast MRI during the course of chemotherapy. MRI outcomes for response to chemotherapy were based on either reduction in tumor size or reduction in contrast enhancement.
 
Three of these studies report NPV results of 38%, 83%, and 100%; however, the 2 lower estimates were from prospective studies, while the highest estimate was from a retrospective study.
  
The available body of evidence is limited to a few small studies with inconsistencies in outcome measures, reporting, and use of statistical comparisons. Results are not consistent, and there is insufficient evidence to determine whether breast MRI can reliably predict lack of response to neoadjuvant chemotherapy.
 
Recently there was an ongoing trial, the “Contrast-Enhanced  Breast MRI for Evaluation of Patients Undergoing Neoadjuvant Treatment for Locally-Advanced Breast Cancer” (ACRIN Protocol A6657), which was later combined with CALGB 150007, Diagnostic Study of Contrast-Enhanced Magnetic Resonance Imaging and Correlative Molecular Studies in Women With Locally Advanced Breast Cancer Who Are Receiving Neoadjuvant Chemotherapy, but the trial has been suspended.  
 
This use of MRI is non-covered based on member benefit certificate primary coverage criteria and is considered investigational for contracts which do not include primary coverage criteria.
 
Breast MRI to evaluate residual tumor after lumpectomy with positive surgical margins
BCT includes complete removal of the primary tumor along with a rim of normal surrounding tissues. Pathological assessment of surgical margins is performed on excisional specimens to determine whether tumor extends to the margins of resection. Surgical specimens are generally oriented and marked to direct reexcision if margins are shown to contain tumor; however, when tumor is not grossly visible, the extent of residual tumor within the breast can only be determined through repeat excision and pathological assessment. MRI has been proposed to evaluate the presence and extent of residual tumor as a guide to reexcision when surgical margins are positive for tumor.
 
Seven studies have reported the diagnostic performance of MRI to determine the presence of residual disease after prior biopsy or lumpectomy. Histopathology on reexcision was used as the reference standard, only one of which was a prospective study. Most of these studies, including the single prospective study, report poor sensitivity and specificity of MRI for detection of residual disease, and the 2 studies that report more favorable results  have methodological concerns that limit the influence of reported results. Three of these studies were conducted at the same institution and accrued patients during similar time periods so overlap of reported patients may exist. The available evidence is not sufficient to permit conclusions whether MRI improves net health outcomes when used to identify the presence and/or extent of residual disease after lumpectomy and prior to reexcision.  Lee et al. prospectively studied 80 patients eligible for BCT who had  close or positive margins on lumpectomy and were scheduled for reexcision lumpectomy. In this study, MRI was 61% sensitive and 70% specific for detection of residual tumor. The finding of extensive tumor on MRI led to mastectomy in 6 patients (7.5%), but it is difficult to determine from the publication what proportion of these cases had false-positive MRI results.
 
Bedrossian et al. retrospectively studied 70 subjects prior to reexcision and found MRI had 57% sensitivity and 60% specificity. MRI prompted wider than initially planned surgical excision in 11 cases, but 10 of these turned out to be false-positive MRI results.
 
Kawashima et al. studied 50 subjects and reported 66% sensitivity and 81% specificity. Orel et al. included 47 patients with questionable or positive margins after biopsy and found that MRI had 54% sensitivity and 62% specificity for residual tumor at the biopsy site.  Similarly, sensitivity and specificity were low for identification of residual tumor anywhere in the breast (64% and 58%, respectively).
 
Weinstein et al. reviewed 14 cases of invasive lobular carcinoma that had prior excisional biopsy and found that MRI had 57% sensitivity and 0% specificity for identifying residual disease.
 
Frei et al.,  retrospectively studied 68 patients with positive margins and examined the relationship between when MRI was performed after initial surgery and diagnostic performance of MRI for residual disease. However, this study excluded 3 patients with technically inadequate MRI studies, and has discrepancies in reported results in the publication. Sensitivity of MRI  ranged from 89% to 95% with slight improvements noted with longer time intervals after initial surgery. Specificity was initially 52% for MRI  performed at least 7 days after lumpectomy; whereas, when analysis was restricted to MRI conducted at least 28 days after lumpectomy, the specificity of MRI increased to 75%.
 
Soderstrom et al., retrospectively examined 19  patients with various indications for MRI, including 11 patients with close or positive margins after surgery, and found MRI was 100% sensitive and 71% specific for identification of residual tumor. The authors note that MRI overestimated the extent of tumor in 1 patient that was counted as a true-positive in the results.
 
This use of MRI is non-covered based on member benefit certificate primary coverage criteria and is considered investigational for contracts which do not include primary coverage criteria.
 
2008 Update
Two recent reviews on MRI of the breast discuss the use of MRI of the breast for surveillance or screening of the ipsilateral breast following mastectomy and reconstructive surgery.  One review from the University of Maryland School of Medicine and Johns Hopkins Medical Institution (Vandemeer & Bluemke) concluded,
 
“Mastectomy followed by autogenous breast reconstruction is a widely used treatment option even in the setting of advanced cancers.  Transplantation of a rectus abdominis myocutaneous (TRAM) flap is most commonly used; however, latissimus dorsi and gluteal flaps also may be performed.  The overall incidence of local breast cancer recurrence following tissue flap reconstruction ranges from 2 to 15%.  Currently the primary method of surveillance for local cancer recurrence is regular clinical breast examination.  Opinions differ as to whether screening mammography should be routinely performed in this population, however small series have shown early mammographic detection of breast cancer recurrence in TRAM flaps to be technically feasible.  There is a paucity of data evaluating MRI in this setting. Studies have shown, however, that MRI is capable of reliably differentiating between benign and malignant findings in patients following TRAM flap reconstruction. Further study is needed to define whether MRI has a role as a screening modality in these patients.  Current recommendations advise the use of breast MRI as an adjunctive imaging modality in the evaluation of suspected recurrence following tissue flap reconstruction.” (Vandemeer, 2007)
 
A 2008 review article from the Department of Radiology/Breast Imaging Hospital at the University of Pennsylvania, (Orel, 2008) did not specifically address the issue of use of MRI of the breast following mastectomy and reconstruction, but  Dr. Orel and others published an article entitled “Breast Reconstruction with a Transverse Rectus Abdominis Myocutaneous Flap: Spectrum of Normal and abnormal MR Imaging Findings” which directly addressed the question (Devonk, RK, Rosen, MA, Mies, C, Orel, SG).  They evaluated 24 MRIs in 22 patients who had mastectomy followed by TRAM flap reconstruction.   They concluded, “Currently, surveillance of TRAM flap reconstructions occurs primarily by means of physical examination.  Multiple reports exist in the literature of nonpalpable recurrences that have been detected radiologically.  A recent article by Helvie et al. (Radiology, 2002; 224:211-216) advocates the routine mammographic screening of TRAM flap reconstructions.  The use of MR imaging of TRAM flaps in asymptomatic patients has not been studied, to our knowledge, and was not the intent of this retrospective evaluation.  However, our review of cases suggests that MR imaging may allow differentiation of benign from malignant findings in patients following breast reconstruction with a TRAM flap.  Further studies may be helpful to define whether routine evaluation of such patients with MR imaging would provide both earlier detection of local recurrence and more confident diagnosis of benign abnormalities without the need for invasive biopsy procedures.  Currently, we do not advocate the use of MR imaging as a screening modality in patients with TRAM flap reconstructions.  Instead, we believe MR imaging may be used as an adjunctive imaging modality for evaluation of newly apparent clinical abnormalities following TRAM flap reconstruction.”
 
2010 Update
An updated search for pivotal publications on the use of MRI of the breast did not find any studies that would provide strong evidence to alter the current coverage statements.  However, several recent studies, which will be described briefly, provide further evidence on some of the issues discussed. No studies were found supporting the use of MRI to screen for breast cancer among women at normal risk for breast cancer, other than those with dense breasts.
 
Use of MRI for cancer patients:
Controversy continues regarding the use of MRI preoperatively for patients diagnosed with breast cancer.  Preoperative MRI may be used to gauge the size of the tumor or identify additional lesions in the same quadrant, elsewhere in the ipsilateral breast, or in the contralateral breast. Some have suggested that MRI can reduce re-excision rates by more accurately identifying the extent of the initial tumor (Hollingsworth, 2008).  In a review of data on the use of MRI (Houssami, 2009), 1 randomized controlled trial (RCT) and 2 observational studies were identified that addressed this issue. None reported a statistically significant difference in re-excision rates or proportion of surgeries with positive margins around the tumor (i.e., where cancer remained) between patients who had a pre-operative MRI and those who did not. The evidence from an additional single-arm study was not strong (Hollingsworth, 2008).
The median prevalence of additional ipsilateral cancer foci detected by preoperative MRI is 16% (n=2,610; interquartile range, 11% to 24%) according to 1 meta-analysis (Houssami, 2008).  According to 1 study of 119 patients in 2005-2006 in Germany, the use of MRI prior to surgery changed clinical management in 40.3%; 17 patients had mastectomies instead of breast-conserving surgery, 8 had an extended excision, 21 lesions were examined using MRI-guided biopsy, and 2 ultrasound-detection lesions had negative MRI results and were not biopsied (Siegmann, 2009).  However, it is not clear whether these changes improved patient outcomes. For example, a patient may decide to have a mastectomy rather than breast-conserving surgery because of the detection of an additional lesion in the same breast on MRI that is proven to be malignant through biopsy. It is possible, however, that the additional cancer would have been eradicated by the radiation-therapy or chemotherapy following breast-conserving surgery, thus producing the same outcomes in terms of recurrence or survival as mastectomy.
 
A study of mastectomy rates at the Mayo Clinic in Rochester, Minn., declined from 1997 to 2003 (45% to 31%, p<0.0001), and then increased to 43% in 2006 among patients with TNM stage 0-2 breast cancer (Katipamula, 2009).  The use of preoperative MRI also rose from 2003 to 2006 (from 10% to 23%, p<0.001). While mastectomy rates rose among all patients, those undergoing MRI were more likely to have a mastectomy than those with no MRI (54% vs. 34%, p<0.001). The results of a multivariable model indicated that both MRI and surgical year were independent predictors of mastectomy.
 
Others have suggested that MRI might be useful before the use of accelerated partial breast irradiation (Morrow, 2009), by identifying those patients with multicentric tumors that would not fall within the radiotherapy field. However, neither the equivalence of APBI to whole breast irradiation nor the utility of MRI in this context have been demonstrated. In a consensus statement on APBI, a Task Group from the American Society for Radiation Oncology “agreed that there were insufficient data to justify recommendation of routine breast MRI for patients selected for APBI.” (Smith, 2009)
 
Brennan and colleagues, 2009, reported a meta-analysis of MRI screening of the contralateral breast in women with newly diagnosed breast cancer.  The authors concluded that MRI detected contralateral lesions in a substantial proportion of women but does not reliably distinguish benign from malignant findings.  The large proportion of in situ cancers detected by MRI raises an issue of whether such detection improves long-term outcomes and whether these lesions are clinically significant.  They reported a trend in some series of women undergoing bilateral mastectomy without biopsy when the MRI detected an abnormality in the contralateral breast.
 
In 2010 Turnbull and associates published results of the COMICE trial.  Of 1623 women with biopsy proven breast cancer who were scheduled to have wide local excision, 816 had a MRI, 807 did not.  Addition of the MRI was not associated with a reduced reoperation rate; 19% in each group needed reoperation within 6 months of the initial procedure.  
 
Weinstein and colleagues, 2010, reported ACRIN 6667 results.  Of 969 women with newly diagnosed breast cancer who underwent MRI of the contralateral breast, 106 were classified as having a 145 BI-RADS category 3 lesions.  Eighty-three (78.3f%) of the 106 patients had no evidence of malignancy in the study breast after 2 years of follow-up.  Seventeen women elected tissue biopsy and biopsy was recommend for 6 on the basis of follow-up imaging studies.  Eighteen had benign findings, 2 had atypical hyperplasia, 1 had DCIS.
 
Use of MRI to detect cancer in women with dense breasts:
In a retrospective study, the accuracy of MRI was evaluated among patients with dense breasts and suspected breast cancer or inconclusive evaluations who had a breast MRI at a single institution in Italy (Pediconi, 2009). The reference standard was histology of 6 and/or 18 month follow-up. MRI was compared to mammography or ultrasound. About half of the women were found to have breast cancer. Of 238 patients, 97 had all three imaging tests. The sensitivity and specificity of MRI was 98.2% and 95.2%, respectively; for mammography, 72.7% and 45.2%; and for ultrasound, 85.5% and 40.5%. In this study, MRI is used to evaluate patients suspected of having breast cancer or with equivocal results from other modalities, including clinical examination. Although the specificity is relatively high and the negative predictive value in this selected population is 97.6%, this study does not provide sufficient evidence to use MRI as a substitute for biopsy in these patients, as the authors themselves state.
 
2011 Update
 
A search of the Medline database was conducted through January 2011. There was no new literature identified that would prompt a change in the coverage statement.  The articles of interest that support the existing coverage statements are summarized below.  
 
Detection of a suspected occult breast primary tumor with axillary nodal adenocarcinoma
A meta-analysis of studies on the use of MRI in patients with mammographically occult breast cancer and an axillary metastasis evaluated 8 retrospective studies with a total of 220 patients (de Bresser, 2010). In 7 studies, a potential primary lesion was detected in a mean of 72% of cases (range: 36–86%). Pooling individual patient data yielded a sensitivity of 90% (range: 85–100%) in detecting an actual malignant tumor. The specificity, however, was a pooled value of 31% (range: 22–50%).
 
Preoperative tumor mapping in patients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy
In a retrospective study of 208 patients undergoing neoadjuvant therapy, 64 indicated complete response on MRI scans but 36 of them (56%) had residual disease on pathology (Straver, 2010). Conversely, 144 indicated residual disease on MRI, but no invasive cancer cells were found on pathology results in 14 of them, of whom 5 had DCIS. So the sensitivity of MRI to detect residual invasive cancer was 78% (95% CI: 0.71–0.83), and the specificity was 67% (95% CI: 0.51–0.79). Furthermore, in 22% of all patients, the tumor size on MRI differed by more than 20 mm from the pathology results. This could alter the treatment choice from mastectomy to BCT or more rarely, from BCT to mastectomy. MRI appeared to be most accurate in patients with triple-negative tumors, then HER-2 positive tumors, and least accurate in patients with ER-positive tumors. The patients in this study may overlap with participants in the study by Loo et al. (2011), described below.
 
To evaluate response during neoadjuvant chemotherapy in patients with locally advanced breast cancer
A study of 188 women who underwent MRI scans before and during neoadjuvant chemotherapy compared the ability of MRI to detect response to treatment by breast cancer subtype (Loo, 2011). They concluded that the change in the largest diameter of enhancement on MRI was associated with tumor response among patients with so-called triple negative and HER2-positive tumors but not among patients with the more commonly found ER-positive/HER-2 negative tumors.
 
There is insufficient evidence to determine whether breast MRI can reliably predict lack of response to neoadjuvant chemotherapy. Furthermore, evidence would be needed that any resulting change in patient management (e.g., discontinuation of chemotherapy or change to a different regimen) would improve outcomes.
 
Screening of High Risk Women
Recent joint recommendations from the Society of Breast Imaging and the American College of Radiology recommend that high risk women be screened annually with both MRI and mammography (Lee, 2010).
 
The American Cancer Society guide on early detection of breast cancer, last revised 12/16/2010, recommends the following regarding the use of MRI of the breast (see http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-detection):
 
Women at high risk (greater than 20% lifetime risk) should get an MRI and a mammogram every year. Women at moderately increased risk (15% to 20% lifetime risk) should talk with their doctors about the benefits and limitations of adding MRI screening to their yearly mammogram. Yearly MRI screening is not recommended for women whose lifetime risk of breast cancer is less than 15%.
 
2012 Update
This policy is being updated with a review of the literature through March 2012. A literature search did not identify any information that would prompt a change in the coverage statement. The summary of the literature below focuses on MRI of the breast as a preoperative mapping technique to identify multicentric disease in patients with clinically localized breast cancer.
 
In 2012, Plana et al. published another systematic review and meta-analysis of 50 publications reporting on 10,811 women (Plana, 2012). In this analysis, additional disease was detected in the ipsilateral breast in 20% of women and in the contralateral breast in 5.5%. Of the additional lesions detected, approximately 2/3 were malignant and 1/3 benign by final histopathology, for a PPV of 66%. Based on MRI findings, a total of 8.3% of women were appropriately referred for mastectomy rather than BCT, while 1.7% were inappropriately referred for mastectomy.
 
There have been 2 RCTs published that evaluate the short-term benefit of preoperative MRI in women with localized breast cancer. A multicenter RCT from the U.K. (the COMICE trial) examined the impact of presurgical MRI on the need for additional treatment within 6 months. This study was an open, parallel group trial conducted at 45 centers in the United Kingdom, and enrolled 1,623 women with biopsy-proven breast cancer who were scheduled for wide local excision BCT (Turnbull, 2010). Of the 816 patients in the MRI group, 7% (58/816) underwent mastectomy as a result of MRI results and/or patient choice, compared to 1% (10/787) in the no-MRI group that underwent mastectomy as a result of patient choice. There was no statistically significant reduction in reoperation rates in those who received MRI scans (19% in both groups; OR: 0.96; 95% CI: 0.75, 1.24, p=0.77). In the MRI group, 19 patients (2%) had a “pathologically avoidable” mastectomy, defined as a mastectomy based on MRI results that showed more extensive disease, when the histopathology reported only localized disease.. Twelve months after surgery, there was no statistically significant difference in quality of life between the 2 groups.
 
A second RCT, the MONET trial, was published by Peters et al. in 2011 (Peters, 2011). This study randomized 463 patients with suspicious, non-palpable breast lesions identified on mammography or ultrasound to either pre-biopsy MRI or usual care. Of 207 evaluable patients in the MRI group, there were 11 additional suspicious lesions identified on MRI that were occult on other imaging studies. All 11 of these additional lesions were biopsied, with 2/11 positive for malignancy. The rate of mastectomy was similar between the 2 groups (32% vs. 34%, p=NS), as was the rate of BCS (68% vs. 66%). The rate of re-excisions due to positive tumor margins was unexpectantly higher in the MRI group compared to the control group (34% vs. 12%, p=0.008).
 
 
The American Cancer Society guide on early detection of breast cancer, last revised December 16, 2010, makes no recommendation for MRI of the breast as a preoperative mapping technique to identify multicentric disease in patients with clinically localized breast cancer.
 
The overall evidence is uncertain on whether MRI may improve outcomes when used as part of a pre-operative assessment for localized disease. The coverage statement is unchanged.
 
2013 Update
This policy is being updated with a literature search through March 2013.  There was no new literature identified that would prompt a change in the coverage statement.  A summary of the key identified literature is as follows.
 
In a prospective Canadian screening trial of 496 women with known BRCA 1/2 mutations from 1997 to 2002, the sensitivity of MRI versus mammography was 74% and 35%, respectively, (p=0.02); sensitivity improved during the period of 2003 to 2009 to 94% versus 9%, respectively (p<0.0001). The authors attributed the decline in sensitivity for mammography to the fact that MRI was identifying very small cancers that are difficult to detect on mammography (Passaperuma, 2012). Although direct benefit of MRI screening among this population has not been proven, such a benefit might be inferred by knowledge of the sensitivity and specificity of this test, along with knowledge of the benefits of mammography developed through several lines of evidence including randomized clinical trials. A modeling study found that using MRI to screen women with BRCA 1/2 mutations confers a substantial mortality benefit among women between 25 and 60 (Heijnsdijk, 2012).
 
In the ACRIN (American College of Radiology Imaging Network) 6666 trial, mammography alone was compared to mammography plus ultrasound in women 25 years or older with at least heterogeneously dense breast tissue and at least one other breast cancer risk factor. There was a history of breast cancer in 54% of the women. In a substudy, women who completed the 3 rounds of screening and did not have contraindications or renal impairment were asked to undergo contrast-enhanced MRI within 8 weeks of the last screening mammography. Six hundred and twenty-seven women consented and were eligible for the substudy, and 612 completed the needed tests; 16 cancers were found in these women. The sensitivity increased from 44% (95% CI: 20% to 70%) for mammography plus ultrasound to 100% (95% CI: 79% to 100%; p=0.004) when MRI was added. The specificity declined from 84% (95% CI: 81% to 87%) for mammography plus ultrasound to 65% (95% CI: 61% to 69%; p<0.001) for all 3 tests. Over the 3-year study period, another 9 cancers were identified between screening tests, and 2 additional cancers were identified off-study (Berg, 2012).
 
A study of 188 women who underwent MRI scans before and during neoadjuvant chemotherapy compared the ability of MRI to detect response to treatment by breast cancer subtype (Loo, 2011). They concluded that the change in the largest diameter of enhancement on MRI was associated with tumor response among patients with so-called triple negative and HER2-positive tumors but not among patients with the more commonly found ER-positive/HER2-negative tumors.
    
2014 Update
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
King et al (2013) et al retrospectively reviewed the clinical course of 776 women at Memorial Sloan-Kettering who were diagnosed with lobular carcinoma in situ and offered screening by annual mammography alone (n=321) or mammography plus MRI (n=455) (King, 2013). At a median follow-up of 58 months, detection of incident cancers was similar between screening groups (13% each). The proportion of DCIS detected compared with invasive cancers detected also was similar between groups (p=0.69). In patients with lobular carcinoma in situ who are at increased risk for breast cancer, screening with MRI and mammography did not increase the detection of incident cancers compared with mammography alone.
 
Joint recommendations from the Society of Breast Imaging and ACR suggest that the addition of ultrasound to screening mammography “may be useful for incremental cancer detection” for women for whom dense breast is their only risk factor. MRI is not mentioned in this context. However, in the ACR’s 2012 Appropriateness Criteria for breast imaging, (ACR, 2013). MRI for intermediate-risk women (15-20% lifetime risk of breast cancer) was rated 7 on a scale from 1 to 9 (in which 7, 8, and 9 are considered usually appropriate); mammography was rated 9. In contrast, MRI was rated 9 for women with high lifetime risk of breast cancer (≥20%) and 3 (usually not appropriate) for average-risk women.
 
This RCT and 3 other comparative studies were included in a 2014 meta-analysis of individual patient data (total N=3180) (Houssami, 2014). Most patients (62-93%) had localized, invasive disease and received BCT and systemic chemotherapy. After a median follow-up of 2.9 years (IQR, 1.6-4.5), there was no difference in estimated 8-year ipsilateral local (adjusted hazard ratio [HR], 0.88 [95% CI, 0.52 to 1.51]; p=0.65) or distant (adjusted HR, 1.18 [95% CI, 0.76 to 2.27]; p=0.48) recurrence-free survival overall or in patients who received BCT only.
 
A second RCT, the MONET trial, was published by Peters et al in 2011 (Peters, 2011). This study randomized 463 patients with suspicious, non-palpable breast lesions identified on mammography or ultrasound to either pre-biopsy MRI or usual care. Of 207 evaluable patients in the MRI group, 11 additional suspicious lesions were identified on MRI and were occult on other imaging studies. All 11 of these additional lesions underwent biopsy, with 2 (18%) positive for malignancy. The incidence of mastectomy was similar between the 2 groups (32% vs 34%, p=NS), as was the incidence of BCS (68% vs 66%). The incidence of re-excisions due to positive tumor margins was unexpectedly greater in the MRI group compared with the control group (34% vs 12%, p=0.008).
 
 
Both RCTs and 7 other comparative studies were included in a 2013 meta-analysis (total N=3738) that compared preoperative MRI with standard preoperative assessment in women with newly diagnosed breast cancer (Houssami, 2013). Results were reported separately for 6 studies that included patients with breast cancers of any type (n=3112) and 3 studies that included patients with invasive lobular histology only (n=626). The proportion of patients who had mastectomy was significantly greater in preoperative-MRI groups, both for patients with any type of breast cancer (26% vs 18%; adjusted OR, 1.51 [95% CI, 1.21 to 1.89]; p<0.001) and for patients with invasive lobular cancer only (43% vs 40%; adjusted OR, 1.64 [95% CI, 1.04 to 2.59]; p=0.034). This increase was due to increased initial mastectomy because the odds of conversion from BCS to mastectomy were not significantly different between MRI and no-MRI groups. Similarly, the odds of having re-excision surgery after initial BCS did not differ statistically between groups, both for patients with any type of breast cancer and for those with invasive lobular cancer only. Statistical measures of between-study heterogeneity were not reported. In unadjusted analysis, the odds of re-excision surgery after initial BCS were significantly greater in patients with invasive lobular cancer who did not have preoperative MRI (11% vs 18%; unadjusted OR, 0.56 [95% CI, 0.33 to 0.95]; p=0.031); however, because the odds ratio was not statistically significant in adjusted analysis, this result is not considered definitive.
 
Fortune-Greeley et al (2014) retrospectively examined case records of 20,332 women with invasive breast cancer in the Surveillance Epidemiology and End Results (SEER)-Medicare linked dataset (Fortune-Greeley, 2014). Twelve percent of patients had a preoperative MRI. Among patients with invasive lobular carcinoma, but not with other histologic types, preoperative breast MRI was associated with lower odds of reoperation after initial partial mastectomy (adjusted OR, 0.59 [95% CI, 0.40 to 0.86]).
 
Marinovich et al (2013) conducted a systematic review with meta-analysis to assess the accuracy of MRI for predicting pathologic tumor size after neoadjuvant chemotherapy (Marinovich, 2013). Literature was searched to February 2011, and 19 studies were included (total N=958). Median correlation coefficient was 0.70 (range, 0.21-0.92). In pooled analysis of 5 studies (total N=528), MRI overestimated tumor size by a small amount (mean difference, 0.1 cm [95% CI, –0.1 to 0.3]). There was no evidence of statistical heterogeneity (I2=0%). By a pooled variance calculation, the authors determined that 95% of pathologic measurements fell within –4.2 cm to +4.4 cm of MRI measurements. In 2 studies that compared both MRI and ultrasound to pathologic tumor size (total N=256 and 220, respectively), performance of MRI and ultrasound was comparable.
 
Lobbes et al (2013) reported a systematic review of 35 studies (total N=2359) reporting on the ability of MRI to predict tumor size after neoadjuvant chemotherapy  (Lobbes, 2013). Literature was searched to July 1, 2012. Median correlation coefficient was 0.70 (range, 0.21-0.98). Variation in size between MRI and pathology ranged from –1.4 cm to +2.0 cm.
 
Marinovich et al (2012) reviewed the literature on this topic to February 2011. Thirteen studies were included. Studies were heterogeneous in MRI parameters used, thresholds for identifying response, and definitions of pathologic response. The authors could not reach definitive conclusions because of limitations in study design and data reporting. This group conducted a subsequent systematic review with meta-analysis in 2013 (Marinovich, 2013).Literature was searched to February 2011, and 44 studies (total N=2949) assessing the ability of MRI to discriminate residual breast tumor after neoadjuvant chemotherapy from pathological complete response (pCR) were identified. Median MRI sensitivity, defined as the proportion of patients with residual tumor correctly classified by MRI, and specificity, defined as the proportion of patients with pCR classified by MRI as absence of residual tumor, were 0.92 (IQR=0.85-0.97) and 0.60 (IQR=0.39-0.96), respectively. Specificity increased when a relative threshold for defining negative MRI (ie, contrast enhancement equal to or less than normal breast tissue) was used rather than an absolute threshold (complete absence of MRI enhancement) with little decrement to sensitivity. Pooled area under the ROC curve was 0.88, and diagnostic odds ratio was 17.9 (95% CI, 11.5 to 28.0) (A diagnostic odds ratio of 1 indicates no discriminatory ability; higher values indicate better test performance.) Accuracy decreased when residual DCIS was included in the definition of pCR. Statistical measures of between-study heterogeneity were not reported. A subset of studies compared MRI to other imaging modalities
 
De Los Santos et al (2013) conducted a retrospective review of 746 women who received neoadjuvant chemotherapy and preoperative MRI (De Los Santos, 2013). Incidence of pCR was 24%. Sensitivity, specificity, PPV, and NPV of MRI for detecting pCR were 83%, 47%, 47%, and 83%, respectively. Accuracy, defined as the correct proportion of all MRI results (true positive plus true negative, divided by the number of MRI scans performed), was 80%, (mammography and ultrasound) and clinical exam; however, 95% CIs for pooled analyses were very large, rendering conclusions uncertain.
 
The ACS guide on early detection of breast cancer, last revised January 31, 2014, recommends the following regarding use of MRI screening of the breast: (American Cancer Society, 2014)
  • Women at high risk (greater than 20% lifetime risk according to risk assessment tools that are based mainly on family history) should receive annual MRI and mammogram.
  • For women at moderately increased risk (15% to 20% lifetime risk), evidence is insufficient to make a recommendation for or against annual MRI screening . If MRI is used, it should be in addition to, not instead of, a screening mammogram.
  • Annual MRI screening is not recommended for women whose lifetime risk of breast cancer is less than 15%.
 
ASCO guidelines for follow-up and management after primary treatment of breast cancer were published in 2006 (Khatcheressian, 2006). In 2013, the guidelines were updated with systematic review of the literature through March 2012, and no revisions were made (Khatcheressian, 2013). The guidelines recommended against the use of breast MRI “for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination” (Khatcheressian, 2013). Furthermore, “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.” (Katcheressian, 2006).
 
In 2013, an International Guideline Harmonization Group from 9 countries published evidence-based recommendations for breast cancer surveillance in female survivors of childhood, adolescent, and young adult cancer who received chest irradiation before age 30 years and have no genetic predisposition to breast cancer (Mulder, 2013). The authors found concordance among previous guidelines to initiate annual breast MRI exams beginning at age 25 or 8 years after radiation. Based on systematic review of the literature to August 2011 and expert consensus, the authors recommended mammography, breast MRI, or both for surveillance. (Strong recommendation based on high quality evidence with a low degree of uncertainty.) The authors acknowledged that “no prospective studies have assessed the use of MRI screening in this population.” The recommendation is therefore based on extrapolation of evidence from patients with hereditary risk for breast cancer.
 
NCCN guidelines on breast cancer (NCCN, 2.2014) and breast cancer screening (NCCN, 2.2013) were most recently updated in 2014 and 2013, respectively. These guidelines list the following indications for breast MRI:
 
  • Screening
      • To consider annual MRI screening as an adjunct to mammography beginning at age 30 for women with lifetime risk of breast cancer >20% based on models depending primarily on family history (eg, Claus, BRCAPRO, BOADICEA, Tyrer-Cuzick).
      • Annual MRI screening is recommended as an adjunct to mammogram and clinical breast  exam for women who had prior thoracic radiotherapy between the ages of 10 and 30 years, beginning 8 to 10 years following radiation therapy, or starting at age 40, whichever comes first.
      • For women with a pedigree suggestive of or known genetic predisposition, annual mammogram and MRI are recommended beginning at age 25 or based on the earliest age of onset in the family.
      • Annual MRI screening also is recommended for those with Li-Fraumeni syndrome and their first-degree relatives, as well as those with Cowden and Bannayan-Riley-Ruvalcaba syndromes and their first degree relatives.
      • There is insufficient evidence to recommend for or against MRI screening among women with a lifetime risk of 15-20%; lobular carcinoma in situ or atypical lobular hyperplasia; atypical ductal hyperplasia; heterogeneously or extremely dense breast on mammography; or women with a personal history of breast cancer, including DCIS.
      • NCCN guidelines recommend against MRI screening of women with less than a 15% lifetime risk of breast cancer.
  • Diagnosis:
      • For women under 30 with nipple discharge and no palpable mass, as well as a BIRADS rating of 1-3 on mammography + ultrasound, MRI or ductogram from a single duct are optional.
      • To consider MRI for women with skin changes with a suspicion of inflammatory breast cancer or Paget’s disease with BIRADS 1-3 on mammogram + ultrasound and a benign punch biopsy of the skin or nipple.
  • Pretreatment evaluation
      • To define extent of cancer of presence of multifocal or multicentric cancer in the ipsilateral breast, or as screening of the contralateral breast cancer at time of initial diagnosis (category 2B). There are no high-level data demonstrating that use of MRI to guide choice of local therapy improves outcomes (local recurrence or survival).
      • May be useful to detect additional disease in women with mammographically dense breasts, but “available data do not show differential detection rates by any subset by breast pattern (breast density) or disease type (eg, DCIS, invasive ductal cancer, invasive lobular cancer).”
      • May be useful to identify primary cancer in women with axillary nodal adenocarcinoma breast and negative mammography, ultrasound, or clinical breast exam.
  • Treatment
      • Before and after neoadjuvant therapy to evaluate extent of disease, response to treatment, and potential for breast-conserving therapy.
  • Surveillance
      • Utility of follow-up screening in women with prior breast cancer is undefined. Generally, should only be considered for women with 20% lifetime risk of breast cancer.
 
False-positive findings on breast MRI are common. Surgical decisions should not be based solely on MRI findings. Additional tissue sampling of areas of concern identified by breast MRI is recommended.
  • There are other indications for which breast MRI is considered optional (eg, staging work-up for invasive cancer).
 
In its recommendation statement for breast cancer screening, updated in December 2009, USPSTF concluded that current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer.” (Recommendation Grade I: Evidence is currently insufficient to assess the balance of benefits and harms.) (USPSTF, 2009)
 
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement.  
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
MRI of the Breast as a Screening Test in Average Risk Patients
In a systematic review of literature conducted for the 2016 USPSTF breast cancer screening recommendation update, no RCTs or nonrandomized observational studies were identified evaluating MRI for screening average-risk women for breast cancer (Nelson, 2016). Thus, there is a lack of published evidence on MRI screening of average-risk women.
 
MRI of the Breast as a Preoperative Mapping Technique to Identify Multicentric Disease in Patients
With Clinically Localized Breast Cancer
A 2016 study by Parvaiz and colleagues evaluated change in surgical planning after MRI in 72 patients newly diagnosed with lobular carcinoma, and had relatively long-term findings (Parvaiz, 2016)

CPT/HCPCS:
77046Magnetic resonance imaging, breast, without contrast material; unilateral
77047Magnetic resonance imaging, breast, without contrast material; bilateral
77048Magnetic 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
77049Magnetic 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
77058Magnetic resonance imaging, breast, without and/or with contrast material(s); unilateral
77059Magnetic resonance imaging, breast, without and/or with contrast material(s); bilateral

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