V-07-006

Medical Policy:

V-07-006

Topic:

Magnetic Resonance Imaging (MRI) of the Breast

Section:

Radiology

Effective Date:

March 30, 2020

Issued Date:

March 29, 2021

Last Revision Date:

March 2020

Annual Review:

March 2021

This policy version was replaced July 4, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

NOTE: THIS POLICY APPLIES TO MEMBERS WHO ARE ENROLLED IN BLUE ADVANTAGE FAMILIES AND CHILDREN (FORMERLY KNOWN AS PREPAID MEDICAL ASSISTANCE PROGRAM (PMAP) MINNESOTACARE, SECURE BLUE (MSHO), AND MINNESOTA SENIOR CARE PLUS (MSC+) PROGRAMS ONLY.

Magnetic resonance imaging (MRI) of the breast is an important tool for detection of breast cancer. MRI of the breast is performed using scanners and intravenous imaging contrast agents, together with specialized breast coils. This policy addresses the use of breast MRI as a screening tool in specific higher risk subgroups of patients and for diagnostic uses in the detection and treatment of breast cancer as well as to assess the integrity of silicone breast implants.

Definitions

High Risk of Breast Cancer

There is no standardized method for determining a woman’s risk of breast cancer that incorporates all possible risk factors. There are validated risk prediction models, but they are based primarily on family history.

Some known individual risk factors confer a high risk by themselves. The following list includes factors known to indicate a high risk of breast cancer:

lobular carcinoma in situ; or
a known BRCA1 or BRCA2 mutation; or
another gene mutation associated with high risk, e.g., TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, STK11 (Peutz-Jegher’s syndrome), ATM, CHEK2, and PALB2;
or high risk (lifetime risk about ≥20%) of developing breast cancer as identified by models that are largely defined by family history; or
received radiotherapy to the chest between 10 and 30 years of age.

A number of other factors may increase the risk of breast cancer but do not by themselves indicate high risk. It is possible that combinations of these factors may be indicative of high risk, but it is not possible to give quantitative estimates of risk. As a result, it may be necessary to individualize the estimate of risk taking into account numerous risk factors. A number of risk factors, not individually indicating high risk, are included in the National Cancer Institute Breast Cancer Risk Assessment Tool, also called the Gail model. Risk factors in the model can be accessed online (http://www.cancer.gov/bcrisktool/Default.aspx). Other commonly cited risk models that are largely defined by family history include the Claus, Tyrer-Cuzick, and BRCAPRO (BRCA “probability”) models.

Family history for the purpose of this policy is someone who is related by blood from the same side of the family.

First degree relative: A family member who shares about 50 percent of their genes with a particular individual in a family. First degree relatives include parents, offspring, and siblings.
Second degree relative: A family member who shares about 25 percent of their genes with a particular individual in a family. Second degree relatives include grandparents, grandchildren, uncles, aunts, nephews, nieces, and half-siblings
Third degree relative: A family member who shares about one-eighth of their genes, such as first cousins, great-grandparents, great-aunts, great-uncles.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Screening Uses

MRI of the breast may be considered MEDICALLY NECESSARY AND APPROPRIATE for screening on an annual basis if ONE of the following criteria is met indicating high risk:

Personal history
- Previous diagnosis of breast cancer, including lobular carcinoma in situ, atypical hyperplasia, and neoplasia; OR
- Previous diagnosis of ovarian cancer; OR
- Received radiation therapy to the chest between the ages of 10 and 30 years old; OR
- Presence of mutation in BRCA1 or BRCA2; OR
- Presence of another genetic syndrome linked to high risk breast cancer including ONE of the following: TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, STK11 (Peutz-Jeghers syndrome), ATM, CHEK2, and PALB2;

Family history of breast cancer indicating high risk defined as:
- First, second, or third degree relative with a genetic syndrome linked to high risk breast cancer including mutation in BRCA1 or BRCA2, TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, STK11 (Peutz-Jeghers syndrome), ATM, CHEK2, and PALB2 but member untested; OR
- Two or more first-degree relatives or two or more first and second-degree relatives meeting ONE of the following criteria:
  - Breast cancer, diagnosed before menopause; OR
  - Breast cancer in one relative diagnosed at any age AND ovarian cancer in one relative diagnosed at any age;

Risk model assessment indicates lifetime risk of 20% or greater of developing breast cancer as identified by models largely defined by family history (e.g. Gail, Claus, Tyrer-Cuzick, BRCAPRO).

II. Diagnostic or Detection Uses

MRI of the breast may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients with a diagnosis of breast cancer when ONE of the following criteria are met:

For the detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam); OR
For patients with a new diagnosis of breast cancer to evaluate the contralateral breast when clinical and mammographic findings are normal; OR
To confirm the clinical diagnosis of rupture of silicone breast implants; OR
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; OR
For presurgical planning in patients with locally advanced breast cancer before and after completion of neoadjuvant chemotherapy to permit tumor localization and characterization; OR
To determine the presence of pectoralis major muscle/chest wall invasion in patients with posteriorly located tumors; OR
To evaluate a documented abnormality of the breast before 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.

III. MRI of the breast is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of evidence demonstrating an impact on improved health outcomes including but not limited to:

For screening in an individual of average risk;
For the detection of breast cancer when the sensitivity of mammography is limited, e.g. due to the following:
- Dense breasts;
- Breast implants;
- Scarring after treatment for 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 suspicious breast lesion in order to avoid biopsy;
To monitor the integrity of silicone gel-filled breast implants when there are no signs or symptoms of rupture.

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Documentation Submission

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. The following clinical notes must be submitted:

For Screening Purposes:

Patient clinical history including specific condition indicating high-risk of breast cancer; OR
Family clinical history including specific condition(s) indicating high-risk of breast cancer; OR
BOTH of the following:
- Risk model assessment indicating lifetime risk of 20% or greater of breast cancer including risk model used; AND
- If a previous MRI of the breast was done, date of previous MRI of the breast

For Diagnostic or Detection Purposes:

Diagnosis and clinical features of the diagnosis; AND
Proposed surgical planning, if indicated.

Link to Minnesota Government Programs Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2021-12/BCBSMN-Pre-Auth-Request-fillable-X18509R07.pdf

Denial Statements

No additional statements.

Links

Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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