Magnetic Resonance Imaging (MRI) of the Breast
DESCRIPTION
Magnetic resonance imaging (MRI) is a non-invasive test using a multiplanar imaging method based on an interaction between radiofrequency (RF) electromagnetic fields and certain nuclei in the body (usually hydrogen nuclei) after the body has been placed in a strong magnetic field. The magnetic resonance (MR) scanners and intravenous magnetic resonance contrast agents are used to create detailed pictures of areas inside the body.
These images are intended to differentiate between normal and diseased tissue. MRI of the breast has been investigated as a screening tool in specific higher risk subgroups of individuals. Specialized breast coils are used during the imaging of the breast. MRI of the breast may be performed bilaterally or unilaterally. MRI of the breast is not meant to replace mammography, percutaneous biopsy or ultrasound in the screening for breast cancer in the general population.
POLICY
Magnetic Resonance Imaging (MRI) of the breast is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Magnetic Resonance Imaging (MRI) of the breast for the evaluation of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
MEDICAL APPROPRIATENESS
Magnetic Resonance Imaging (MRI) of the breast is considered medically appropriate if ANY ONE of the following are met:
Breast abnormality evaluation as indicated by ANY ONE of the following:
Breast implant complication if ALL of the following are met:
Leak or rupture suspected
Mammography or ultrasound uninterpretable
Anatomic guidance during biopsy of breast lesion
Follow-up to MRI directed biopsy to ensure successful lesion sampling at least six months after MRI directed breast biopsy when histology is benign or uncertain
Discordance between imaging findings and core needle biopsy results
Equivocal mammogram results and ALL of the following:
Breast lesion is nonpalpable
Ultrasound findings indeterminate
Breast cancer, known, and ANY ONE of the following:
Phyllodes tumor when ALL of the following are met:
Diagnosis of malignancy confirmed by biopsy
Preoperatively to establish extent of disease
New diagnosis of ANY ONE of the following:
Multifocal or mutlicentric breast cancer
Invasive lobular carcinoma
Paget’s disease
Adenocarcinoma in axillary lymph node without a breast primary site identified on mammogram/ultrasound
Assessment of tumor response to neoadjuvant chemotherapy to determine resectability
Post-surgery follow-up after breast cancer diagnosis when ANY ONE of the following are met:
Breast or chest wall biopsy positive
Assessment of residual tumor with close or positive margins after lumpectomy
Assessment for suspected tumor recurrence at lumpectomy site and clinical mammography and/or ultrasound findings are negative or equivocal
Annual surveillance for individual with personal history of breast cancer not treated with bilateral mastectomy when ANY ONE of the following are met:
Individual with clinical lifetime risk estimated at greater than or equal to 20% using genetic risk or clinical risk estimator such as the Gail, Claus, Tyrer-Cuzick or BRCAPRO models prior to diagnosis
Individual with extremely dense breast tissue (category D) on mammography
Annual breast cancer screening for high-risk individuals (defined in Additional Information) with ANY ONE of the following:
Diagnosis of Li-Fraumeni Syndrome (TP53 mutation) and ANY ONE of the following:
MRI screening to begin at age 20
MRI screening to begin at age of earliest diagnosed breast cancer in family if below age 20
At diagnosis but not prior to age 25 for ANY ONE of the following histologies or characteristics:
Atypical ductal hyperplasia (ADH)
Atypical lobular hyperplasia (ALH)
Lobular carcinoma in situ (LCIS)
To begin at age 25 for individual positive for ANY ONE of the following:
BRCA 1 mutation
BRCA 2 mutation
STK11 mutation (Peutz-Jeghers syndrome)
To begin at age 30 for individual positive for ANY ONE of the following mutations:
CDH1 (hereditary diffuse gastric cancer)
PTEN (Cowden syndrome)
NF1
PALB2
To begin at age 40 for individuals positive for ANY ONE of the following mutations:
Ataxia telangiectasia mutated (ATM)
CHEK2
NBN
Previous history of pediatric cancer and therapeutic radiation when ALL of the following are met:
Documentation of ANY ONE of the following:
MRI screening to begin at age 25
MRI screening to begin 8 years post radiation
Radiation exposure to ANY ONE of the following areas:
Chest (thorax)
Whole lung
Mediastinal
Axilla
Mini-mantle, mantle, or extended mantle
Total (TLI) or subtotal (SLTI) lymphoid irradiation
Total body irradiation (TBI)
Other high-risk family history of breast cancer if ALL of the following are met:
MRI screening not to begin prior to age 25
Age to begin screening is ANY ONE of the following:
Screening to begin at age 40
Screening to begin 10 years before the age of relative when first diagnosed with breast cancer
Individual has ANY ONE of the following indications:
First degree relative (parent, sibling, child) with BRCA1 or BRCA2 genetic variance (if individual has not been tested for BRCA mutation)
Two or more first-degree relatives with breast cancer
Two or more first-degree relatives with ovarian cancer
One first degree relative with breast cancer diagnosed at or before age 50
One first-degree relative with ovarian cancer diagnosed at or before age 50
One first degree relative with bilateral breast cancer
One first degree relative with breast and ovarian cancer
One first or second-degree male relative (father, brother, uncle, grandfather) diagnosed with breast cancer
Clinical lifetime risk estimated at greater than or equal to 20% using genetic risk or clinical risk estimator such as Gail, Claus, Tyrer-Cuzick or BRCAPRO models
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
High Risk Individuals are defined as individuals with a 20% or greater lifetime risk of developing breast cancer.
The modified Gail model risk assessment is accessible at http://www.cancer.gov/bcrisktool/.
BI-RADS™ Categories:
Category 0 = incomplete, need additional imaging
Category 1 = negative, no findings
Category 2 = benign findings
Category 3 = probably benign findings, 6-month follow up recommended
Category 4 = suspicious abnormality, consider biopsy
Category 5 = highly suggestive of malignancy
Category 6 = known, biopsy proven malignancy
SOURCES
American College of Obstetricians and Gynecologists. (2015; Reaffirmed 2024). Committee Opinion. Management of women with dense breasts diagnosed by mammography. Retrieved April 11, 2024 from https://www.acog.org.
American College of Radiology. (2023). ACR appropriateness criteria. Breast cancer screening. Retrieved April 11, 2024 from https://acsearch.acr.org/list.
Children’s Oncology Group. (2018, October). Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Retrieved November 1, 2021 from http://survivorshipguidelines.org/pdf/2018/COG_LTFU_Guidelines_v5.pdf.
National Comprehensive Cancer Network. (2024, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast cancer screening and diagnosis. Version 2.2024. Retrieved April 10, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2024, February). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Genetic/familial high-risk assessment: breast, ovarian, and pancreatic. Version 3.2024. Retrieved March 6, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2024, January). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast Cancer, Version 1.2024. Retrieved March 6, 2024 from the National Comprehensive Cancer Network.
Sanders, L. M., El-Madany, M., Persing, A., & Mehta, A. (2019). Use of contrast-enhanced MRI in management of discordant core biopsy results. American Journal of Roentgenology, https://doi.org/10.2214/AJR.18.20157. Advance online publication. Abstract retrieved October 26, 2021 from PubMed database.
ORIGINAL EFFECTIVE DATE: 8/1/2001
MOST RECENT REVIEW DATE: 6/13/2024
ID_BT
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.
This document has been classified as public information.