North Carolina Breast Density Patient Notification

North Carolina is the 12th state where all health care facilities that perform mammography examinations must include in the summary of the report information that identifies the patient's individual breast density classification based on the Breast Imaging Reporting and Data System established by the American College of Radiology (BI-RADS®). Previously, breast density information was only reported as part of the mammogram interpretation that was sent to the patient's physician.

The American College of Radiology's BI-RADS® reporting of breast parenchymal composition describes the amount of fatty tissue to fibroglandular tissue as one of four categories (see the ACR Breast Density Brochure for examples):

1. The breast is almost entirely fat.

2. There are scattered fibroglandular densities.

3. The breast tissue is heterogeneously dense, which could obscure detection of small masses.

4. The breast tissue is extremely dense. This may lower the sensitivity of mammography.

Starting January 1, 2014, North Carolina law (Session Law 2013-321) requires that that every woman who has a mammogram be informed of her breast tissue type and its potential impact. Specifically, women who have dense breast tissue will also receive the following statement in writing as part of their mammogram result:

"Your mammogram indicates that you may have dense breast tissue. Dense breast tissue is relatively common and is found in more than forty percent (40%) of women. The presence of dense tissue may make it more difficult to detect abnormalities in the breast and may be associated with an increased risk of breast cancer. We are providing this information to raise your awareness of this important factor and to encourage you to talk with your physician about this and other breast cancer risk factors. Together, you can decide which screening options are right for you. A report of your results was sent to your physician."

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Key Points on Breast Density for Patients and Providers

Since January 1, 2014, North Carolina law requires that all patients who have a mammogram be informed of their breast tissue density. Further, the legislation requires the following be added if the breasts are dense: We are providing this information to raise your awareness of this important factor and to encourage you to talk with your physician about this and other breast cancer risk factors. Together, you can decide which screening options are right for you.

Breast density is the mixture of normal breast fibrous and glandular tissue and fatty tissue. Breasts are considered mammographically dense if a patient has a good deal of fibrous or glandular tissue without much fat.

The only way to verify if you/your patient may have dense breasts is via the mammographic report. The interpreting radiologist now assigns specific breast density (one of four ACR BI-RADS® categories) in the mammogram report. Both heterogeneously dense and extremely dense categories are considered dense.

As many as 50% of women in the U.S. have dense breast tissue and the other half have non-dense tissue (more fatty tissue). Of those women with dense breast tissue, 10% have extremely dense breast tissue.

Dense breast tissue may make it more difficult for radiologists to detect cancer on mammograms. Normal dense tissue, cancer, and benign masses may all appear white on the mammogram. This accounts for the phenomenon called masking. The cancer/benign lesion is obscured by the normal surrounding breast tissue. Hence, the sensitivity of mammography is reduced by 10-20%, making screening mammograms less precise in women with dense breasts.

The recommendations for mammography are the same for women with dense breasts as non-dense breast women. Many cancers are still detected on mammograms even if you/your patient have dense breast tissue.

A mammogram is the only screening test that has demonstrated a reduction in breast cancer deaths. There is no recommendation that it be replaced with another screening test at this time.

If you/your patient has dense breast tissue and are interested in additional screening options, a breast cancer assessment may be useful. This will allow a discussion of whether supplemental tests will be helpful, and if so, what tests to order.

Screening breast MRI (magnetic resonance imaging) in HIGH RISK patients (>20% lifetime risk of developing breast cancer) has been shown to increase the cancer detection rate. It is recommended by the American Cancer Society for high risk patients in addition to a yearly screening mammogram.

For patients at INTERMEDIATE RISK (15-20% lifetime risk), such as those with a personal history of breast cancer or a prior biopsy with a diagnosis of atypia, the American Cancer Society reports that there is not enough data at this time to recommend a MRI in these patients. However, a patient-centered shared decision-making approach is recommended and it should be discussed with the patient that the additional test may detect other findings (non-cancers/false positives) that may lead to follow-up testing or biopsy.

The data on screening ultrasound is limited; therefore, there is no formal approval from the radiology community at this time. Screening breast ultrasound is not offered at many centers and you/your patient may be charged additional out of pocket expenses.

Breast tomosynthesis (3D mammography) expands the technology of conventional mammography. Some centers are currently using it in addition to screening mammography since preliminary results on its performance are positive. However, we do not know how well tomosynthesis performs in women with extremely dense breasts. Also, at this time you/your patient may be charged additional out of pocket expenses.

The North Carolina legislature did not mandate insurance coverage for any supplemental breast cancer screening tests. There are no insurance billing codes for screening breast ultrasound or tomosynthesis. Screening breast MRI is usually covered for HIGH RISK women, but not for the average risk patient. Consequently, women who want other types of screening may be asked to pay out of pocket.

Risk Factors for Breast Cancer

A risk factor is anything that increases the risk of developing a disease such as breast cancer. Different cancers have different risk factors. But having a risk factor, or several, does not mean that one will get the disease. Most women who have one or more breast cancer risk factors never develop the disease, while many women with breast cancer have no apparent risk factors.

• The main risk factor for developing breast cancer is simply being a woman.

• The risk of developing breast cancer increases with increasing age.

• Genetic: about 5-10% of breast cancers are hereditary (gene mutations)

• Breast cancer is higher among women who have 1st degree relative with breast cancer (mother, sister or daughter)

• Personal history of breast cancer: 3 to 4 fold increase risk of a new cancer.

• Race: Caucasians are slightly more likely to develop breast cancer than African-American women, but African-American women are more likely to die of breast cancer.

• Dense breast tissue may be associated with an increased risk of breast cancer: A number of factors can affect breast density, such as age, menopausal status, hormone therapy, pregnancy and genetics.

• Previous chest wall radiation during childhood or as a young adult have a significant increased risk for breast cancer.

• Benign conditions such as proliferative lesions can raise a woman's risk 1.5 to 2 times normal.

• Proliferative lesions with atypia can increase risk 3½ to 5 times higher than normal.

• Lobular carcinoma in situ has a 7 to 11 fold increased risk of developing cancer in either breast.

• Women with menstrual periods that begin early (before age 12) or ended after age 55 have a slightly higher risk due to longer lifetime exposure to hormones.

• Lifestyle-related risk factors include: Combined hormone replacement therapy, consumption of more than 1 alcoholic drink a day, being overweight or obese, lack of physical activity