Magnetic Resonance Imaging (MRI) of the Breast
DESCRIPTION
Magnetic resonance imaging (MRI) uses MR scanners and intravenous MR contrast agents to create detailed pictures of areas inside the body. These pictures are intended to show the difference between normal and diseased tissue. Specialized breast coils are usually used during the imaging of the breast. This policy addresses the use of MRI of the breast for a variety of clinical indications including either detection or diagnosis of breast cancer. This policy does not address the use of MRI of the breast as a screening technique in average risk women.
POLICY
MRI of the breast, as a screening technique for breast cancer, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
MRI of the breast, for detection of a suspected occult breast primary tumor with axillary nodal adenocarcinoma (e.g., negative mammography and physical exam), is considered medically necessary.
MRI of the breast, for pre-surgical planning for locally advanced breast cancer before and after completion of neoadjuvant chemotherapy, to permit tumor localization and characterization, is considered medically necessary.
MRI of the breast, for pre-surgical planning to evaluate for infiltrating ductal carcinoma, lobular carcinoma, or contralateral breast carcinoma is considered medically necessary.
MRI of the breast for the evaluation of postlumpectomy for residual disease is considered medically necessary.
MRI for determination of responsiveness of cancer during neoadjuvant chemotherapy for locally advanced breast cancer where no other imaging modality demonstrates the tumor is considered medically necessary.
MRI of the breast, to determine the presence of pectoralis major muscle/chest wall invasion with posteriorly located tumor, is considered medically necessary.
MRI of the breast, for the detection of breast cancer when the sensitivity of mammograph and ultrasound are limited (e.g., dense breast, breast implants, and scarring after treatment for breast cancer), is considered medically necessary.
MRI of the breast, for any of the following, is considered investigational:
Screening for the average-risk individual
Diagnosis of low-suspicion findings through conventional testing, with no indicated for immediate biopsy, and the individual is referred for short-interval follow-up
Diagnosis of a suspicious breast lesion, where the MRI is requested solely to avoid biopsy, since the sensitivity of the MRI is not 100%, and biopsy is not only the gold standard, but also the only definitive diagnostic test
Utilization without a breast coil, regardless of the clinical indication
Utilization of any device for this procedure that does not have FDA approval specific to the indication
For documentation of leakage from breast implants: See Breast Implant Removal.
See also:
Computer-Aided Detection of Malignancy with Magnetic Resonance Imaging of the Breast
Genetic Testing for BRCA1 or BRCA2 for Breast or Ovarian Cancer
MEDICAL APPROPRIATENESS
MRI of the breast, as a screening technique for breast cancer, is considered medically appropriate for individuals with any of the following:
Known BRCA1 or BRCA2 mutation; or
High-risk of BRCA1 or BRCA2 mutation due to a known presence of mutation in relatives; or
Families with a high-risk of BRCA gene mutation as defined according to the American Society of Clinical Oncology (ASCO) with any the following:
More than 2 breast cancer cases and one or more cases of ovarian cancer diagnosed at any age; or
More than 3 breast cancer cases diagnosed before age 30; or
ADDITIONAL INFORMATION
No controlled studies were found in the published literature that validate the application of magnetic resonance imaging of the breast for reasons other than those listed as medically necessary.
The use of magnetic resonance imaging of the breast, for reasons other than those listed as medically necessary, does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
American College of Obstetricians and Gynecologists (ACOG): Practice Bulletin. (2003, April). Breast cancer screening. Retrieved August 10, 2004 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=3990&nbr=3129&string=Magnetic%20AND%20resonance%20AND%20breast.
American Society of Breast Surgeons. (2004, September). Consensus statement on the use of magnetic resonance imaging in breast oncology. Retrieved September 1, 2006 from http://www.breastsurgeons.org/mri_statement.shtml.
American Society of Clinical Oncology. (2003, June). American Society of Clinical Oncology Policy Statement Update: Genetic Testing for Cancer Susceptibility. Journal of Clinical Oncology, 21 (12), 2397-2406.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2005). MRI of the breast (6.01.29). Retrieved September 1, 2006 from BlueWeb.
BlueCross BlueShield of Tennessee network physician. October 2006.
Complete Guide to Medicare Coverage Issues [Computer software]. (2005, November). Magnetic resonance imaging (NCD 220.2.1, p. 2-156). St. Anthony Publishing.
Harms, S. E., & Morris, E. (2004, October). ACR practice guideline for the performance of magnetic resonance imaging (MRI) of the breast. Retrieved September 1, 2006 from http://acr.org/s_acr/bin.asp?CID=549&DID=17775&DOC=FILE.PDF.
Nelson, M., Brandt, K., Luikens, B., & Tashjian, J. (2003), Institute for Clinical Systems Improvement: Technology Assessment Report. Magnetic resonance imaging (MRI) for the detection of breast abnormalities. Retrieved August 10, 2004 from http://www.icsi.org/knowledge/detail.asp?catID=107&itemID=1454.
The Technology Evaluation Center. (2002, February). Magnetic resonance imaging of the breast: Differential diagnosis of a breast lesion to avoid biopsy (Vol. 16, No. 15). Chicago: BlueCross BlueShield Association.
The Technology Evaluation Center. (2003, December). Magnetic resonance imaging of the breast in screening women considered to be at high genetic risk of breast cancer (Vol. 18, No. 15). Retrieved August 4, 2006 from http://www.bcbs.com/tec/Vol18/18_15.pdf.
The Technology Evaluation Center. (2004, April). Breast MRI for detection or diagnosis of primary or recurrent breast cancer (Vol. 19, No. 1). Retrieved August 4, 2004 from http://www.bcbs.com/tec/vol19/19_01.html.
The Technology Evaluation Center. (2004, September). Magnetic resonance imaging of the breast for preoperative evaluation in patients with localized breast cancer (Vol. 18, No. 8). Retrieved August 4, 2006 from http://www.bcbs.com/tec/Vol19/19_08.pdf.
U. S. Food and Drug Administration. (2001, February). Center for Devices and Radiological Health. 510(k) Summary for the AURORA Magnetic Resonance Diagnostic Device. Retrieved August 6, 2004 from http://www.fda.gov/cdrh/pdf3/k032678.pdf.
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EFFECTIVE DATE |
10/26/2006 |
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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