Description:
It is an expectation that all patients receive care/services from a licensed clinician. All appropriate supporting documentation, including recent pertinent office visit notes, laboratory data, and results of any special testing must be provided.  If applicable: All prior relevant imaging results and the reason that alternative imaging cannot be performed must be included in the documentation submitted. 

Where a specific clinical indication is not directly addressed in this guideline, medical necessity determination will be made based on widely accepted standard of care criteria. These criteria are supported by evidence-based or peer-reviewed sources such as medical literature, societal guidelines and state/national recommendations.

Purpose
Breast MRI
Magnetic resonance imaging (MRI) of the breast is a useful tool for the detection and characterization of breast disease, assessment of local extent of disease, evaluation of 
treatment response, and guidance for biopsy and localization. Breast MRI is typically bilateral to allow for assessment of symmetry between the breasts. MRI findings should be correlated with clinical history, physical examination, and the results of mammography and any other prior breast imaging.

NOTE: The age of a family member’s diagnosis is only relevant for patients under the age of 40. Anyone 40 or over should be getting annual mammograms and breast MRIs if their lifetime risk is 20% or greater.

Policy  
INDICATIONS 
For screening examination to detect breast cancer in any of the following situations. It is appropriate to perform screening breast MRI at routine intervals in patients at increased risk who are lactating.

Contrast-enhanced MRI is not recommended during pregnancy due to the trans-placental passage of gadolinium and potential concern for the exposure of the fetus to gadolinium.

No History of Known Breast Cancer
Dense Breast Tissue on Mammography

• Inconclusive screening mammogram when category 0 has been specifically assigned due to breast characteristics limiting the sensitivity of mammography (e.g., extremely or heterogeneously dense breast, implants obscure breast tissue)

High-Risk Breast Cancer Screening

• A Breast Cancer Risk Assessment (including the Breast Cancer Consortium Risk Model (BCSC) which incorporates breast density, the International Breast Cancer Intervention Study (IBIS)/ Tyrer-Cuzick model, the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm model (BOADICEA), the modified Gail (also known as the Breast Cancer Risk assessment tool (BCRAT)) or other validated risk assessment models) that identifies the patient as having a lifetime risk of 20% or greater of developing breast cancer¹
  • Approve annually beginning 10 years prior to youngest family member’s age at diagnosis or at age 40, whichever comes first, but not before age 25^2,3,4,5
• Patients with lifetime risk of 20% or greater of developing breast cancer based on history of lobular neoplasia (LCIS/ALH (Lobular Carcinoma in Situ /Atypical Lobular Hyperplasia)) or ADH (atypical ductal hyperplasia)
  • Approve annually beginning at age of diagnosis of LCIS/ALH or ADH but not prior to age 25²
• Patients with intermediate lifetime risk (15% – 20%) of developing breast cancer based on a history lobular neoplasia (LCIS/ALH [Lobular Carcinoma in Situ/Atypical Lobular Hyperplasia]) or ADH (atypical ductal hyperplasia) AND have dense breast tissue on mammography
  • Approve annually beginning at age of diagnosis of LCIS/ALH or ADH but not prior to age 25^2,6
• Patients with history of extensive chest irradiation (usually as treatment for Hodgkin’s or other lymphoma between ages 10 and 30)
  • Begin eight years after radiation, but not prior to age 25²
• Patients with known BRCA 1/2 mutation
  • Approve annually starting at age 25^2,4
• Patients not yet tested for BRCA gene, but with known BRCA mutation in first-degree relative
  • Approve annually starting at age 25^2,4
• Personal history of germline mutations known to predispose to a high risk of breast cancer:¹
  • Li-Fraumeni syndrome (TP53 mutation)
    • Begin age 20-29 or age at earliest diagnosed breast cancer in family, if younger than age 20
  • Cowden syndrome (PTEN) or Bannayan-Riley-Ruvalcaba syndrome (BRRS)
    • Begin age 35 or 10 years before earliest breast cancer diagnosis in family, whichever comes first (NCCN 2022)
  • ATM
    • Begin age 30 – 35 years
  • BARD1
    • Begin age 40
  • CDH1
    • Begin age 30
  • CHEK2
    • Begin age 30 – 35 years
  • NF1
    • Begin age 30, end age 50²
  • PALB2
    • Begin age 30
  • Peutz-Jeghers Syndrome (STK11)
    • Begin age 30
  • RAD51C
    • Begin age 40
  • RAD51D
    • Begin age 40

For Evaluation of Identified Lesion, Mass or Abnormality

• Evaluation of suspected breast cancer when other imaging examinations, such as ultrasound and mammography, and physical examination are inconclusive for the presence of breast cancer, and biopsy could not be performed (e.g., seen only in single view mammogram without ultrasound correlation)
  • Includes skin changes of suspected inflammatory breast cancer if conventional imaging and skin biopsies are first performed and negative⁴
• For evaluation of suspicious mass, lesion, distortion, or abnormality of the breast in patient with history of breast cancer when other imaging is inconclusive
• For cases of new nipple inversion when mammographic and sonographic findings are inconclusive, and a biopsy cannot be performed⁷
• Patients diagnosed with biopsy-proven lobular neoplasia, i.e., LCIS/ALH (Lobular Carcinoma in Situ/Atypical Lobular Hyperplasia) or ADH (atypical ductal hyperplasia)^2,4,8
• Spontaneous unilateral serous or bloody nipple discharge when conventional imaging is interpreted as BI-RADS 1 – 3 and there is no palpable mass thought to be related to the discharge^2,4
• Paget’s disease of the nipple: to detect underlying ductal carcinoma when conventional imaging is interpreted as BI-RADS 1 – 3 and there is no palpable mass⁴
• For a phyllodes tumor diagnosed by biopsy, breast MRI may help determine extent of disease and resectability in selected cases. However routine use for surgical planning is controversial^9,10
• Follow-up of a probably benign (BI-RADS 3) lesion seen only on prior MRI (when prior mammogram and ultrasound did not show the abnormality)¹¹

History of Known Breast Cancer
Staging, Treatment, and Surveillance

• Yearly Surveillance for:^3,4,12,13
  • History of breast cancer and dense breast tissue on mammography
  • Individuals with personal history of breast cancer diagnosed before age 50
  • Patients with genetic or other risk factors placing them at high risk for a new cancer or recurrence
  • Individuals with a mammographically occult primary breast cancer
• For initial staging when conventional imaging is indeterminate in defining the extent of cancer, or presence of multifocal, multicentric, or contralateral cancer, or if there is a discrepancy in estimated tumor size between physical exam and imaging^2,4,8,14
• For invasive lobular carcinoma that is poorly or inadequately defined by mammography, ultrasound, or physical exam^2,8,14
• To identify primary cancer in a patient with axillary nodal adenocarcinoma and unidentified primary tumor²
• Prior to treatment: To serve as a baseline for comparison prior to a patient starting planned neoadjuvant chemotherapy¹⁵
• During or after treatment: To identify candidates for breast conserving therapy or evaluate response to treatment, including preoperative neoadjuvant therapy [within three months]⁴

Silicone Implants

• MRI is not indicated for evaluation of saline implant complications¹⁶
• Confirmation of suspected silicone gel-filled breast implant ruptures in asymptomatic patients, after an abnormal or indeterminate finding on mammography or breast 
• ultrasound
• MRI is considered the gold standard for evaluation of symptomatic silicone implant rupture. Prior imaging is not required in patients with silicone implants and 
• symptoms of possible rupture.^3,4,16
• For postoperative evaluation of silicone breast implant complications when other imaging is inconclusive
• For evaluation of asymptomatic silicone implants, initial imaging 5 – 6 years after placement, with follow-up every 2 – 3 years after initial negative imaging¹⁶
• As initial imaging to evaluate suspected silicone implant complications¹⁶

Pre and Post Procedural Evaluations
Pre-Operative/Procedural Evaluation

• For preoperative evaluation for known breast cancer when surgery planned within 30 days to be determined on a case-by-case basis^4,8

Post-Operative/Procedural Evaluation

• A follow-up study may be needed to help evaluate a patient’s progress after treatment, procedure, intervention, or surgery. Documentation requires a medical reason that clearly indicates why additional imaging is needed for the type and area(s) requested^3,13

Prior Imaging
Further Evaluation of Indeterminate Findings on Prior Imaging
Unless follow up is otherwise specified within the guideline:

• For initial evaluation of an inconclusive finding on a prior imaging report that requires further clarification
• One follow-up exam of a prior indeterminate MR/CT finding to ensure no suspicious interval change has occurred (No further surveillance unless specified as highly suspicious or change was found on last follow-up exam.)

Rationale/Background
Contraindication and Preferred Studies

• Contraindications and reasons why a CT/CTA cannot be performed may include: impaired renal function, significant allergy to IV contrast, pregnancy (depending on trimester).
• Contraindications and reasons why an MRI/MRA cannot be performed may include: impaired renal function, claustrophobia, non-MRI compatible devices (such as non-compatible defibrillator or pacemaker), metallic fragments in a high-risk location, patient exceeds wight limit/dimensions of MRI machine.

References:  

1. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Version 3.2024. 2024.
2. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Breast Cancer Screening and Diagnosis Version 2.2024. 2024.
3. American College of Radiology. ACR practice parameter for the performance of contrast-enhanced magnetic resonance imaging (MRI) of the breast. 2023.
4. American Society of Breast Surgeons. Consensus Guideline on Diagnostic and Screening Magnetic Resonance Imaging of the Breast. 2018.
5. American College of Radiology. ACR Appropriateness Criteria: Transgender Breast Cancer Screening. Journal of the American College of Radiology. 2021; 18: S502 - S515. 10.1016/j.jacr.2021.09.005. 
6. American College of Radiology. ACR Appropriateness Criteria: Supplemental Breast Cancer Screening Based on Breast Density. Journal of the American College of Radiology. 2021; 18: S456 - S473. 10.1016/j.jacr.2021.09.002. 
7. Del Riego J, Pitarch M, Codina C, Nebot L, Andreu F et al. Multimodality approach to the nipple-areolar complex: a pictorial review and diagnostic algorithm. Insights Imaging. Aug 5, 2020; 11: 89. 10.1186/s13244-020-00896-1. 
8. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Breast Cancer Version 2.2024. 2024.
9. Li X, Guo H, Cong C, Liu H, Zhang C et al. The Potential Value of Texture Analysis Based on Dynamic Contrast-Enhanced MR Images in the Grading of Breast Phyllode Tumors. Front Oncol. 2021; 11: 745242. 10.3389/fonc.2021.745242. 
10. Ma W, Guo X, Liu L, Qi L, Liu P et al. Magnetic resonance imaging semantic and quantitative features analyses: an additional diagnostic tool for breast phyllodes tumors. Am J Transl Res. 2020; 12: 2083-2092. 
11. Spick C, Bickel H, Polanec S, Baltzer P. Breast lesions classified as probably benign (BI-RADS 3) on magnetic resonance imaging: a systematic review and meta-analysis. Eur Radiol. May 2018; 28: 1919-1928. 10.1007/s00330-017-5127-y. 
12. Park V, Kim E, Kim M, Moon H, Yoon J. Breast magnetic resonance imaging for surveillance of women with a personal history of breast cancer: outcomes stratified by interval between definitive surgery and surveillance MR imaging. BMC Cancer. Jan 22, 2018; 18: 91. 10.1186/s12885-018-3998-1. 
13. American College of Radiology. ACR Appropriateness Criteria® Imaging after Breast Surgery. 2022.
14. American College of Radiology. ACR Appropriateness Criteria: Imaging of Invasive Breast Cancer. 2023.
15. American College of Radiology. ACR Appropriateness Criteria: Monitoring Response to Neoadjuvant Systemic Therapy for Breast Cancer: 2022 Update. Journal of the American College of Radiology. 2023; 20: S125 - S145. 10.1016/j.jacr.2023.02.016. 
16. American College of Radiology. ACR Appropriateness Criteria: Breast Implant Evaluation: 2023 Update. Journal of the American College of Radiology. 2023; 20: S329 - S350. 10.1016/j.jacr.2023.08.019. 
17. Connecticut General Assembly. Connecticut General Assembly: § 38a-530. Mandatory coverage for mammography, breast ultrasound and magnetic resonance imaging. 2022: 
18. Illinois General Assembly. Illinois General Assembly. Senate Bill 0162: 215 ILCS 5/356g (a)(4); 215 ILCS 125/4-6.1 (a)(4); and 305 ILCS 5/5-5 (D)(E). Effective date January 1, 2020. 2022: 
19. NC Medicaid Division of Health Benefits. NC Medicaid Division of Health Benefits. Breast Imaging Procedures. Clinical Coverage Policy No: 1K-1; 3.2.1(c). Breast Magnetic Resonance Imaging. Accessed November 20, 2022. 
20. Ohio General Assembly. House Bill Number 371 (Amendment). Section 1: (a)3;(C)(2)(a);(C)(2)(b). Effective September 23, 2022.
21. Pennsylvania G A o. The General Assembly of Pennsylvania Senate Bill No. 8 Session of 2023. May 1, 2023; 2023: 
22. Washington State Health Care Authority. WSHCA Health Technology Clinical Committee: Health Technology Assessment 20100820A - Breast MRI. [Final Adoption: October 22nd, 2010]. 2010; https://www.hca.wa.gov/assets/program/adopted_findings_decision_bmri_102510 [1].pdf. 
23. Washington State Health Care Authority. WSHCA Health Technology Assessment 20150116B Appropriate Imaging for Breast Cancer Screening in Special Populations. 2015; https://www.hca.wa.gov/about-hca/programs-and-initiatives/health-technology-assessment/appropriate-imaging-breast-cancer-screening-special-populations

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community,  and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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