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Date Printed: August 20, 2017: 01:54 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative 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.

04-70540-09

Original Effective Date: 10/15/04

Reviewed: 10/19/16

Revised: 11/15/16

Subject: Magnetic Resonance Imaging of the Breast

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Magnetic resonance imaging (MRI) of the breast is an imaging modality 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 should be bilateral except for individuals with a history of mastectomy or when the MRI is being performed expressly to further evaluate or follow findings in one breast. MRI findings should be correlated with clinical history, physical examination results, and the results of mammography and prior breast imaging. MRI of the breast is performed using MR scanners and intravenous magnetic resonance contrast agents. MRI examinations should be performed with a dedicated breast MRI coil unless obesity or other patient consideration requires modification of the imaging procedure.

POSITION STATEMENT:

Magnetic resonance imaging (MRI) of the breast meets the definition of medical necessity for the following indications:

Silicone Implants:

No History of Known Breast Cancer

For screening examination to detect breast cancer in any of the following:

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

History of known Breast Cancer

For screening examination to detect breast cancer for any of the following:

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

Pre-operative:

Computer-Aided Detection (CAD)

No proven indications for use of CAD with or without an approved MRI of the breast

Additional Information Related to Breast MRI:

Request for a follow-up study

A follow-up study may be needed to help evaluate a member’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.

MRI imaging

Metal devices or foreign body fragments within the body, such as indwelling pacemakers and intracranial aneurysm surgical clips that are not compatible with the use of MRI, may be contraindicated. Other implanted metal devices in the patient as well as external devices such as portable O2 tanks may also be contraindicated.

MRI as First-Line Screening Modality

Only recently has the use of MRI for screening been encouraged. It is now used for screening in patient with increased risk for breast cancer due to certain factors, e.g., history of mediastinal irradiation for Hodgkin disease, mutation in a breast cancer susceptibility gene, and familial clustering of breast cancer. Certain mutations, including BRCA1 and BRCA2 genes confer significantly elevated risk of breast cancer. Even when a member tests negative for BRCA mutations, this patient may still be at risk for breast cancer if the member has first degree relatives with a history of breast cancer or positive BRCA mutations.

MRI in Patient with Normal Physical Examination and Normal Mammogram but with Clinical Signs of Breast Cancer

Metastatic spread in the axillary lymph nodes suggests the breast as the site of the primary cancer even when the results of a mammogram are normal. MRI is useful in detecting primary breast malignancies in these cases. A negative MRI may also be used to prevent an unnecessary mastectomy.

MRI during or after Neoadjuvant Chemotherapy

Dynamic contrast material-enhanced MRI may be used to monitor response of a tumor to neoadjuvant chemotherapy used to shrink the tumor before surgery. This is very important in clinical decision making as alternative therapies may be selected based upon the results obtained from the MRI. It may also be used to depict residual disease after neoadjuvant chemotherapy.

MRI and Breast Implants

MRI may be used in patients with breast implants to evaluate breast implant integrity. It may also detect cancers arising behind an implant that may not be diagnosed with mammography.

MRI and Invasive Lobular Carcinoma

Invasive lobular carcinoma (ILC) is not the most common type of breast carcinoma but it is second to invasive ductal carcinoma. MRI is used in the evaluation of ILC and can measure the extent of the disease with high reliability.

BILLING/CODING INFORMATION:

CPT Coding

77058

Magnetic resonance imaging, breast, without AND/OR with contrast material(s); unilateral

77059

Magnetic resonance imaging, breast, without AND/OR with contrast material(s); bilateral

0159T

Computer aided detection, including computer algorithm analysis of MRI image data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation, breast, MRI

LOINC Codes:

The following information may be required documentation to support medical necessity: physician history and physical, physician progress notes, plan of treatment, radiographic study reports (e.g., mammography, breast ultrasound, MRI breast) and reason for magnetic resonance imaging of the breast.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit note or treatment notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Radiology Study Reports (e.g., mammography, breast ultrasound, MRI breast)

18726-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

Reimbursement for computer-aided detection (0159T) is included in the allowance of the magnetic resonance imaging breast (77058, and 77059).

Follow-up study

A follow-up study may be needed to help evaluate a member’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.

PROGRAM EXCEPTIONS:

Coverage for the radiology services referenced in this guideline performed and billed in an outpatient or office location will be handled through the BCBSF Radiology Management program for select products. The National Imaging Associates (NIA) will determine coverage for these services for select products. Refer to member's contract benefits.

Federal Employee Plan (FEP): FEP is excluded from the National Imaging Associates (NIA) review; follow FEP guidelines.

Medicare Advantage products:

No Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date. The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Magnetic Resonance Imaging, (220.2) located at cms.gov.

DEFINITIONS:

Bannayan-Riley-Ruvalcaba syndrome: a rare congenital inherited disorder characterized by excessive growth before and after birth; an abnormally large head (macrocephaly) that is often long and narrow (scaphocephaly); normal intelligence or mild mental retardation; and/or benign tumor-like growths (hamartomas) that, in most cases, occur below the surface of the skin (subcutaneously). The symptoms of this disorder vary greatly from case to case.

Cowden syndrome: (also known as multiple hamartoma syndrome) is a genetic disorder characterized by the development of multiple benign tumor-like malformations (hamartomas) in various areas of the body. Affected individuals also have a predisposition to developing certain cancers, especially cancer of the breast, thyroid or mucous membrane lining the uterus (endometrium). The specific symptoms of Cowden syndrome vary from case to case.

Li-Fraumeni syndrome (LFS): a familial syndrome of early breast carcinoma associated with soft tissue sarcomas and other tumors.

RELATED GUIDELINES:

Genetic Testing for Hereditary Breast or Ovarian Cancer, 05-82000-30

OTHER:

None.

REFERENCES:

  1. American Cancer Society recommendations for early breast cancer detection in women without breast symptoms, 10/20/15.
  2. ACR Practice Parameter for the Performance of Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast, Revised 2013.
  3. American Society of Breast Surgeons Position Statement on the Use of Magnetic Resonance Imaging in Breast Surgical Oncology, 07/27/10.
  4. Berg WA, Zhang Z, Lehrer D et al. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA 2012; 307(13): 1394-1404.
  5. Bruening W, Uhl S, Fontanarosa J et al. Noninvasive Diagnostic Tests for Breast Abnormalities: Update of a 2006 Review. Comparative Effectiveness Review No. 47. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. 290- 02-0019.) AHRQ Publication No. 12-EHC014-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2012.
  6. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination for MRI, Publication 100-3, Section 220.2; 06/03/10.
  7. Elsamaloty H, Elzawawi MS, Mohammad S et al. Increasing accuracy of detection of breast cancer with 3-T MRI. American Journal of Roentgenology 2009; 192(4): 1142-1148.
  8. Godinez J, Mortellaro VE, Marshall J et al. Breast MRI in the evaluation of eligibility for accelerated partial breast irradiation. American Journal of Roentgenology 2008; 191(1): 272-277.
  9. Houssami N, Ciattyo S, Martinelli F et al. Early detection of second breast cancers improves prognosis in breast cancer survivors. Annals of Oncology 2009; 20(9): 1505-1510.
  10. Khatcheressian JL, Hurley P, Bantug E et al. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. Journal of Clinical Oncology 2013; 31(7): 961-965.
  11. Mann RM, Hoogeveen YL, Blickman JG et al. MRI compared to conventional diagnostic work-up in the detection and evaluation of invasive lobular carcinoma of the breast: a review of existing literature. Breast Cancer Research and Treatment 2008; 107(1): 1-14.
  12. National Imaging Associates, Inc. Breast MRI Clinical Guideline, 2016.
  13. National Imaging Associates, Inc. CAD Breast MRI Clinical Guideline, 2016.
  14. National Cancer Institute Breast Cancer Risk Assessment Tool, 05/16/11.
  15. National Cancer Institute. Screening modalities-beyond mammography, 12/05/14.
  16. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology ® Breast Cancer 2.2016.
  17. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology ® Breast Cancer Screening and Diagnosis Version 1. 2016-July 17, 2016.
  18. Rockhill B, Spiegelman D, Byrne C et al. Validation of the Gail et al. model of breast cancer risk prediction and implications for chemoprevention. Journal of National Cancer Institute 2001; 73(5): 358-366.
  19. Saslow, D, Boetes C, Burke W, et al. American Cancer Society Guidelines for Breast Screening with MRI as an Adjunct to Mammography. CA Cancer J Clin 2007; 57: 75-89.
  20. Siu AL, on behalf of the U.S. Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Annals of Internal Medicine 2016; 164(4): 279-296.
  21. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, Plastic and Reconstructive Surgery Devices Branch, Division of General, Restorative, and Neurological Devices Offices of Device Evaluation-Guidance for Industry and FDA Staff, Saline, Silicone Gel, and Alternative Breast Implants, 11/17/06.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/19/16.

GUIDELINE UPDATE INFORMATION:

10/15/04

New Medical Coverage Guideline.

10/15/05

Annual review. Added detection of local tumor recurrence in individuals with breast cancer who have radiographically dense breasts or old scar tissue from previous breast surgery that compromises the ability of combined mammography and ultrasonography to when services are covered. Updated references.

08/15/06

Scheduled review. Added 0159T (July CPT update). Updated references.

01/01/07

HCPCS update. Deleted 76093 and 76094. Added 77058 and 77059.

07/01/07

Scheduled review; revised position statements; reformatted guideline; updated references.

11/15/07

Added Li-Fraumeni syndrome or Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome or who have a first-degree relative with one of these syndromes to position statement. Updated definitions and references.

01/21/08

Updated Program Exceptions.

07/15/08

Revised position statement to indicate that MRI of breast may be considered medically necessary for the following indications for screening for breast cancer in the following patients: known BRCA1 or BRCA2 mutation in patient or relative; high risk (lifetime risk about 20 to 25 percent or greater) of developing breast cancer as identified by models that are largely defined by family history (breast, ovarian) annual screening 10 years after therapeutic chest irradiation; or Li-Fraumeni syndrome or Cowden syndrome or Bannayan-Riley-Ruvalcaba syndrome or who have a first-degree relative with one of these syndromes. Added the following indications to the position statement (meets the definition of medical necessity): for evaluation of the contralateral breast in patients with a new diagnosis of breast cancer who have normal clinical and mammographic findings in the contralateral breast 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 Deleted “in order to avoid biopsy” for the diagnosis of a suspicious breast lesion. Added “i.e., indeterminate breast lesion” for the diagnosis of a suspicious breast lesion. Added ipsilateral to the definitions section. Updated references.

09/15/08

Added criteria for detection of tumor recurrence.

05/21/09

Removed Federal Employee Plan (FEP) from BCBSF Radiology Management program exception statement. Added FEP program exception statement: FEP is excluded from the National Imaging Associates (NIA) review; follow FEP guidelines.

07/01/09

Updated BCBSF Radiology Management program exception; added BlueSelect.

10/15/09

Revised position statement (experimental or investigational), to clarify diagnosis of suspicious breast lesion. Added position statement for evaluation of residual tumor with positive margins after lumpectomy. Updated description section. Updated references.

01/01/10

Revised BCBSF Radiology Management program exception section.

10/15/10

Annual review: Revised position statement regarding mass, distortion, etc; added “or abnormality in breast”. Added position statement for evaluation of a documented abnormality of the breast prior to obtaining an MRI-guided biopsy when there is documentation that other methods (e.g., palpation, ultrasound) are not able to localize the lesion for biopsy. Revised position statement regarding the evaluation of residual tumor in individuals found to have positive margins after lumpectomy, and deleted “when lumpectomy was performed as the definitive surgery”. Updated references.

10/01/11

Revision; formatting changes.

10/15/11

Annual review; maintain position statements. Updated references.

06/15/12

Note added for MRI as first-line screening modality in women with increased risk for breast cancer.

01/15/13

Annual review; no change in position statements. Repositioned the statement for MRI a first-line screening modality in women with increased risk for breast (moved to the position statement section). Updated references.

01/01/14

Review. Updated program exception.

03/15/15

Annual review; revised position statement; updated description and references.

11/15/16

Revision; revised position statement. Added additional information related to breast MRI. Updated references.

Date Printed: August 20, 2017: 01:54 AM