On May 1, 2014, the New Jersey breast density law went into effect. It requires all radiology practices to include certain language in all mammography reports and letters to patients to make them aware of the significance of breast density.
As a result of this new legislation, you will now see this language in your patient’s mammography report and they will receive the information in their mammography results letter. More importantly, the law requires insurance companies to cover the cost of additional screening studies such as breast MRI, screening breast ultrasound and 3D mammography if your patient is at increased risk for breast cancer and/or she has dense breasts and would benefit from this additional testing.
If your patient has mammographically dense breasts (heterogeneously dense or extremely dense, per radiologist qualitative assessment), she will be notified of her breast density in her mammography results letter.
This notification may prompt questions regarding the need for supplemental breast cancer screening due to the decreased sensitivity of mammography and the increased risk of breast cancer associated with increased mammographic density.
If your patient has a breast symptom or abnormal physical exam, this should be evaluated based on established algorithms for symptomatic breast care.
Assuming your patient does not have a breast symptom or abnormal physical exam, first screen your patients for any of the following red-flag risk factors.
Strongly consider additional screening with breast MR which has been shown to be the most sensitive method to detect additional cancers missed at mammography.
You can reassure her regarding the minor incremental increase in risk associated with her breast density (Relative Risk = 1.2 for women with heterogeneously dense breasts and Relative Risk = 2 for women with extremely dense breasts, compared to women with average breast density), and encourage her to continue annual mammographic screening. Breast density limits the sensitivity of mammography in the detection of breast cancer.
For more information about the breast imaging program
at Atlantic Medical Imaging, please visit: women.myamihealth.com
The following provide answers to some of the frequently asked questions about breast density, breast cancer screening and the New Jersey Breast Density Law. (Presentation adapted from the RSNJ and California Breast Density Information Group (CBDIG) Scenarios for clinicians. March 2013.)
Q. What is the New Jersey breast density legislation?
A. A new law, effective May 1, 2014, that mandates that radiologists include the follow comment on all lay letters mailed to patients after their screening mammogram. “Your mammogram may show that you have dense breast tissue as determined by the Breast Imaging Reporting and Data System established by the American College of Radiology. Dense breast tissue is very common and is not abnormal. However, in some cases, dense breast tissue can make it harder to find cancer on a mammogram and may also be associated with a risk factor for breast cancer. Discuss this and other risks for breast cancer that pertain to your personal medical history with your healthcare provider. A report of your results was sent to your healthcare provider. You man also find more information about breast density at the website for the American College of Radiology, www.acr.org.”
Q. My patient received her screening mammogram lay letter. Now she is concerned about her breast density. Her first question is “Should I continue to have mammograms?”
A. Yes. All patients should continue to have annual screening mammograms. Mammograms have been shown to be effective in decreasing breast cancer mortality for all breast densities.
Q. My patient is concerned that her breast density places her at increased risk for breast cancer.
A. Reassure your patient that breast density alone has a small impact on the risk for breast cancer. More importantly, they are not at increased risk of dying from breast cancer when compared to women with fatty breasts.
Q. My patient asks “How dense are my breasts?”
A. Refer to the mammogram report (different from the lay letter). There are four classifications of breast density (A,B,C,D). This is determined subjectively by the interpreting radiologist.
Q. My patient does NOT have dense breasts but she still wants additional breast screening studies.
A. Assure the patient that she is not at increased risk for breast cancer and that annual screening mammography is the current best screening method for breast cancer for women of all breast densities.
Other supplemental screening studies exist (MRI, ultrasound, tomosynthesis) but will likely not be covered by insurance for patients that do not have dense breasts.
Q. My patient has dense breasts. Should she be screened with something different than mammography?
A. Explain that at this point, there is no other method recommended to replace mammography. There are certain signs of cancer (for example, calcifications) that are best seen on a mammogram. Other “screening” options are not meant to replace mammography. These studies are done as a supplement.
Q. What role does tomosynthesis play in breast cancer screening?
A. Tomosynthesis is an emerging imaging modality that has shown promise in early clinical trials. Its role in breast cancer screening is currently being evaluated. It improves specificity by decreasing recall rates. It may improve sensitivity, yet probably more for
heterogenous than extremely dense tissue.
Q. My patient has dense breasts and a normal mammogram. How does supplemental Ultrasound compare to supplemental MRI screening?
A. The American College of Radiology Imaging Network 6666 Study was the largest trial of screening ultrasound in which mammography and ultrasound were performed and read independently.
A subset of patients also had MRI. All patients were at least intermediate to high risk. More than half had a history of breast cancer (54%); others had a high risk profile using the Gail model (24%) or a lifetime risk >25% (19%). Mammography identified 7.6 cancers per 1000 patients. Adding Ultrasound found 4.3 more cancers per 1000 patients. MRI however found 14.7 more cancers per 1000 patients. Cancers seen only on ultrasound were evenly distributed across breast density categories, which included 0-20%, 20-40%, 40-60%, 60-80%, and 80-100%, in at least one quadrant on mammography.
5% patients screened by Ultrasound were recommended for biopsy with a low PPV of 7.4% compared to a PPV of 38 % for mammography with 2% sent for biopsy. By comparison, 19% of participants biopsied because of a finding solely identified on MRI were found to have cancer.
12.2% of all patients screened by ultrasound were classified as BIRADS 3 requiring serial follow-up studies versus 6.7% for mammography. 1.6% of those patients classified as BIRADS 3 on Ultrasound were diagnosed with cancer, however 60% of those cancers were found on mammography as well.
The number of screens needed to detect 1 cancer was 127 for mammography; 234 for supplemental ultrasound, and 68 for supplemental MRI after negative mammography plus ultrasound screening results.
An April 2014 Committee Opinion from The American College of Obstetricians and Gynecologists does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.
Q. My patient has dense breasts and she wants to get additional screening tests.
Q. My patient is in a high risk category. She has at least one of the following: Calculated >20% lifetime risk (as based upon a risk model)
Calculated >5% 10 year risk of breast cancer (as based upon a risk model)
BRCA mutation; History of mantle radiation at 30 years of age or younger
A. Recommend annual screening mammogram and annual screening breast MRI. Screening MRI is typically covered by insurance for high risk women. If a woman is being screening annually with a mammogram and MRI, no additional tests (such as ultrasound) are needed.
Q. My patient meets criteria of a high risk patient. I recommended continuing annual screening mammography and adding annual screening MRI. However, my patient is unable to have an MRI (claustrophobia, pacemaker, contrast allergy, or other reasons).
A. Recommend an annual screening mammogram and annual screening ultrasound, as the second best supplementary screening test for high risk women. Studies have shown some utility for ultrasound in high risk women if screening MRI is not performed.
