Description:
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.³⁴ Breast MRI should always be 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.

OVERVIEW
MRI and risk evaluation — 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.

Nipple discharge — Nipple discharge is a common complaint with at least 80% of women having at least 1 episode. Discharge that is considered pathologic is unilateral, spontaneous, from one duct orifice and serous or bloody. Physiologic discharge will be bilateral, from multiple ducts, and white, green, or yellow in color. “In general, MRI may be considered in cases in which mammography and US have failed to identify an underlying cause of pathologic nipple discharge. The sensitivities of breast MRI for detecting the cause of the pathologic nipple discharge are 86% to 100% for invasive cancer and 40% to 100% for noninvasive disease”.³⁵ Ductography (galactography) has the ability to demonstrate small lesions in the specific duct that is secreting the pathologic nipple discharge. However, it is invasive and may cause discomfort and pain. It can be time-consuming and technically challenging and the rate of inadequate or incomplete ductography is as high as 15%. The discharge must be present on the day of the study so that a cannula can be placed in the appropriate duct. Failure to cannulate the discharging duct may occur and cannulation of the wrong duct may cause a false-negative ductogram.³⁵
 

GENERAL INFORMATION

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.
 

Policy  
INDICATIONS FOR BREAST MRI

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 screening breast MRI

• 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 25^2,3,4,5,6
• 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 25^2,7,8
• 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 25^2,3
• Patients not yet tested for BRCA gene, but with known BRCA mutation in first-degree relative
  • Approve annually starting at age 25^2,3
• 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 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.

For evaluation of identified lesion, mass, or abnormality in breast in any of the following situations

• 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 negative^3,9,10
• 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 performed^11,12,13
• Patients diagnosed with biopsy-proven lobular neoplasia, i.e., LCIS/ALH (Lobular Carcinoma in Situ /Atypical Lobular Hyperplasia) or ADH (atypical ductal hyperplasia)^2,3,14,15
• 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^2,3,16
• 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 mass³
• 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^17,18,19
• 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)^20,21,22

HISTORY OF KNOWN BREAST CANCER

• Yearly surveillance for history of breast cancer and dense breast tissue on mammography⁴
• Yearly surveillance for individuals with personal history of breast cancer diagnosed before age 50⁴
• Yearly surveillance in patients with genetic or other risk factors placing them at high risk for a new cancer or recurrence^3,23
• Yearly surveillance for individuals with a mammographically occult primary breast cancer²⁴

Staging, treatment, and surveillance of patients with a known history of breast cancer

• Approve 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^2,3,14
• For invasive lobular carcinoma that is poorly or inadequately defined by mammography, ultrasound, or physical exam^2,14
• 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 chemotherapy²⁵
• During or after treatment: To identify candidates for breast conserving therapy or evaluate response to treatment, including preoperative neoadjuvant therapy [within three months]³

Silicone Implants
MRI is not indicated for evaluation of saline implant complications or for asymptomatic silicone implants.^4,26

• 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.^3,4 Prior imaging is not required in patients with silicone implants and symptoms of possible rupture.
• For postoperative evaluation of silicone breast implant complications when other imaging is inconclusive

Pre-operative

• For preoperative evaluation for known breast cancer when surgery planned within thirty (30) days to be determined on a case-by-case basis^3,14,27,28

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.⁴

Other Indications
 
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.)
   

References:  

28. Wong SM, Prakash I, Trabulsi N, et al. Evaluating the Impact of Breast Density on Preoperative MRI in Invasive Lobular Carcinoma. J Am Coll Surg. May 2018;226(5):925-932. doi:10.1016/j.jamcollsurg.2018.01.045
29. Pennsylvania GAo. The General Assembly of Pennsylvania Senate Bill No. 8 Session of 2023. June 1, 2023. Updated May 1, 2023. Accessed June 1, 2023. https://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?syear=2023&body=S&type=B&bn=0008
30. Connecticut General Assembly: § 38a-530. Mandatory coverage for mammography, breast ultrasound and magnetic resonance imaging. Accessed November 20, 2022. https://www.cga.ct.gov/current/pub/chap_700c.htm
31. 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. https://medicaid.ncdhhs.gov/media/7865/open
32. 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. Accessed November 20, 2022. https://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId=108&GA=101&DocTypeId=SB&Do cNum=162&GAID=15&LegID=&SpecSess=&Session=
33. Ohio General Assembly. House Bill Number 371 (amendment). Section 1: (A)3; (C)(2)(a); (C)(2)(b). Effective September 23, 2022. Accessed February 25, 2023. https://search- prod.lis.state.oh.us/solarapi/v1/general_assembly_134/bills/hb371/EN/06/hb371_06_EN?format=pdf
34. Panourgias E, Bourgioti C, Koureas A, Koutoulidis V, Metaxas G, Moulopoulos LA. MR imaging features and tumor biomarkers of screen-detected and non-screen detected breast cancers: preliminary results of a comparative study. Clin Imaging. Nov-Dec 2018;52:350-355. doi:10.1016/j.clinimag.2018.08.011
35. American College of Radiology. ACR Appropriateness Criteria® Evaluation of Nipple Discharge. Updated 2022. Accessed November 30, 2022, 2022. https://acsearch.acr.org/docs/3099312/Narrative/

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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