mp-723 - Medical Policies - Alabama
Screening Magnetic Resonance Imaging (MRI) for Evaluation of Breast Implant Integrity in Asymptomatic Individuals
Policy Number: MP-723
Effective for dates of service on or after August 16, 2020, refer to: PET, MRI, MRA, CT, CTA/CCTA (Advanced Imaging Guidelines)
Latest Review Date: August 2020
Policy Grade: A
Effective for dates of service on or after August 16, 2020, refer to:
PET, MRI, MRA, CT, CTA/CCTA - Advanced Radiology Imaging Guidelines
Effective for dates of service prior to August 16, 2020:
Magnetic Resonance Imaging (MRI) of the breast, with or without computer-aided detection, to evaluate the integrity of silicone gel-filled breast implants when there is no signs or symptoms of rupture, is considered not medically necessary and investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
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.
Leaks of silicone can occur at various levels: contained within the fibrous capsule that commonly forms around the silicone implant (intracapsular); outside the capsule if there is a rupture, which leads to macroscopic silicone leakage into surrounding tissues (extracapsular; about 10%-20% of ruputures); or the silicone may “bleed” through the silicone envelope that contains it without any gross holes or tears. Extracapsular ruptures are of particular concern because silicone may occasionally migrate to different parts of the body (e.g., to the axillary lymph nodes, arms, and abdomen) and may form silicone granulomas. Surgery is sometimes needed to remove the silicone deposits in other parts of the body. The design of implants has changed over time, with the potential for different rupture rates and rupture patterns with each generation of implants. The age of the implant is a known risk factor for rupture.
The most recent literature update was performed through July 8, 2019.
Summary of Evidence
For individuals who are asymptomatic with silicone breast implants who receive screening with MRI, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are test accuracy and validity, morbid events, and treatment-related morbidity. Studies of MRI screening for silent rupture in asymptomatic women with silicone implants have demonstrated reasonably high sensitivity and specificity compared with explantation and these studies reported reasonably high sensitivity and specificity compared with surgical explantation. However, the studies have generally been conducted in select populations (eg, women who want implants removed), and the data lacks screening populations. Moreover, the clinical utility of MRI screening for silent rupture is unclear, i.e., complications that may result from asymptomatic leakage of silicone are not well-characterized. The evidence is insufficient to determine the effects of the technology on health outcomes.
Pratice Guidelines and Position Statements
American Society of Breast Surgeons
The American Society of Breast Surgeons (2017) updated its guidelines on diagnostic and screening magnetic resonance imaging (MRI) of the breast. The guidelines stated that MRI may be used “for evaluation of suspected breast implant rupture, especially in patients with silicone implants, if the MRI findings will aid the decision-making for implant removal or aid the diagnostic evaluation of indeterminate clinical or conventional imaging findings”. However, the Society did not recommend routine MRI screening in asymptomatic patients with silicone or saline implants.
Magnetic resonance imaging (MRI), Breast, Screening silicone breast implants
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Magnetic resonance imaging, breast, without contrast material; unilateral
Magnetic resonance imaging, breast, without contrast material; bilateral
Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis), when performed; unilateral
Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis), when performed; bilateral
- American Society of Breast Surgeons (ASBrS). Consensus Guideline on Diagnostic and Screening Magnetic Resonance Imaging of the Breast. 2017; Available at: www.breastsurgeons.org/about/statements/PDFStatements/MRI.pdf. Accessed August 13, 2018.
- Brown SL, Silverman BG, Berg WA. Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis. Lancet. Nov 22 1997;350(9090):1531-1537.
- Cher DJ, Conwell JA, Mandel JS. MRI for detecting silicone breast implant rupture: meta-analysis and implications. Ann Plast Surg. Oct 2001;47(4):367-380.
- Collis N, Litherland J, Enion D, et al. Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity. Plast Reconstr Surg. Oct 2007;120(5):1401-1406.
- Expert Panel on Breast I, Lourenco AP, Moy L, et al. ACR Appropriateness Criteria((R)) Breast Implant Evaluation. J Am Coll Radiol. May 2018;15(5S):S13-S25.
- Food and Drug Administration (FDA). FDA Update on the Safety of Silicone Gel-Filled Breast Implants. 2011; Available at: www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastI mplants/UCM260090.pdf. Accessed July 26, 2018.
- Gorczyca DP, Gorczyca SM, Gorczyca KL. The diagnosis of silicone breast implant rupture. Plast Reconstr Surg. Dec 2007;120(7 Suppl 1):49S-61S.
- Holmich LR, Vejborg I, Conrad C, et al. Untreated Silicone Breast Implant Rupture, Plastic &Reconstructive Surgery: July 2004; 114(1):204-214 Accessed November 21, 2017. Available at: journals.lww.com/plasreconsurg/Abstract/2004/07000/Untreated Silicone Breast Implant Rupture.37.aspx.
- McCarthy CM, Pusic A, and Kerrigan CL. Silicone breast implants and magnetic resonance imaging screening for rupture: do U.S. food and drug administration recommendations reflect an evidence based practice approach to patient care? Plastic & Reconstructive Surgery: April 2008; 121(4):1127-1134. Accessed November 21, 2017. Available at: insights.ovid.com/pubmed?pmid=18349629
- Maijers MC, Niessen FB, Veldhuizen JF, et al. Magnetic resonance imaging screening results compared with explantation results in poly implant prothese silicone breast implants, recalled from the European market in 2010. Plast Reconstr Surg. Feb 2014;133(2):114e-120e.
- Maijers MC, Niessen FB, Veldhuizen JF, et al. MRI screening for silicone breast implant rupture: accuracy, inter- and intraobserver variability using explantation results as reference standard. Eur Radiol. Jun 2014;24(6):1167-1175.
- Monticciolo DL, Nelson RC, Dixon WT, et al. MR detection of leakage from silicone breast implants: value of a silicone-selective pulse sequence. AJR Am J Roentgenol. Jul 1994;163(1):51-56.
- Quinn SF, Neubauer NM, Sheley RC, et al. MR imaging of silicone breast implants: evaluation of prospective and retrospective interpretations and interobserver agreement. J Magn Reson Imaging. Jan-Feb 1996;6(1):213- 218.
- Rietjens M, Villa G, Toesca A, et al. Appropriate use of magnetic resonance imaging and ultrasound to detect early silicone gel breast implant rupture in postmastectomy reconstruction. Plast Reconstr Surg. Jul 2014;134(1):13e-20e.
- Scaranelo AM, Marques AF, Smialowski EB, et al. Evaluation of the rupture of silicone breast implants by mammography, ultrasonography and magnetic resonance imaging in asymptomatic patients: correlation with surgical findings. Sao Paulo Med J. Mar 4 2004;122(2):41-47.
- Song JW, Kim HM, Bellfi LT, et al. The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis. Plast Reconstr Surg. Mar 2011;127(3):1029-1044.
Medical Policy Panel, September 2018
Medical Policy Group, January 2019 (5) New Policy Created , This indication has always been considered non-covered and investigational.
Medical Policy Administration Committee, January 2019
Medical Policy Panel, September 2019
Medical Policy Group, October 2019 (2): Updates to References; no change to Policy Statement.
Medical Policy Group, August 2020 (2): Policy transitoned to AIM Radiology. Effective for dates of service on or after August 16, 2020, please refer to PET, MRI, MRA, CT, CTA/CCTA - Advanced Radiology Imaging Guidelines.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.