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Breast Density Statute

Former Massachusetts Governor Deval Patrick signed the state’s breast density inform bill (Chapter 150), a law that requires mammography providers to notify women categorized as having dense breast tissue about their condition.

Useful Resources

www.acr.org
www.cancer.org
www.areyoudense.org
http://www.cancer.gov/bcrisktool/
https://tools.bcsc-scc.org/BC5yearRisk/intro.htm
http://ww5.komen.org/BreastCancer/GailAssessmentModel.html

Frequently Asked Questions

Why is this new law different from the past?
Radiologists have routinely reported the breast density as part of their interpretation for years, which is in the report sent to the patient's physician or available on an electronic medical database. However, from now on, women with dense breast will be informed regarding their breast density as part of the standard letter that women receive when their mammogram is negative.

What categories of women need to be informed of breast density under this new law?
Those with heterogeneously dense & extremely dense breasts as seen on the mammogram.

What states is this law in effect?
In 21 states; Connecticut, Texas, Virginia, New York, California, Hawaii, Maryland, Tennessee, Alabama, Nevada, Oregon, North Carolina, Pennsylvania, New Jersey, Arizona, Minnesota, Rhode Island, Ohio, Missouri, Massachusetts and Michigan.

What should the notification text include?

The patient's mammogram shows dense breast tissue;
Dense breast tissue is common and not abnormal, but may increase the risk of breast cancer;
Dense breast tissue can make it difficult to find cancer on a mammogram and sometimes additional testing is needed for reliable breast screening;
Whether or not the interpreting physician determines additional testing is recommended;
The patient's right to discuss the results of the mammogram with the interpreting radiologist or physician;
A report of the mammogram has been sent to the referring physician and will become part of the patient's medical record.

What are the implications of mammographic breast density?
There are two primary implications of mammographic breast density. One implication is the effect on mammographic sensitivity (i.e., the test's ability to identify a clinically-occult malignancy) this concept is known as masking. The second implication is the increase in breast cancer risk imparted by dense breasts. Overall, the potential masking effect of breast density is likely more important than the minor increase in breast cancer risk.

How much does the cancer risk change with breast density?
In women with extremely dense breast (that is approximately 10% of the population) the relative risk is a 2 fold increase and in women with heterogeneously dense breast (approximately 40 % of the population) it is a 1.2 fold increase.

Should my patients who receive this letter and have dense breasts continue to get mammograms?
Yes. Mammography is the only screening tool that has been demonstrated through large randomized trials to lower breast cancer mortality. Those trials included all breast densities. While mammography sensitivity is somewhat lower in women with extremely dense breasts, it is still the best modality for population-based screening. Also, mammography is the only test that can reliably detect suspicious calcifications. Such calcifications are often the first sign of in-situ cancers, which (in 20% of cases) co-exist with otherwise invisible invasive cancers.

If my patients with dense breasts want to have additional tests done, what are the "screening options" referred to in the new letter language?
Among the additional tests that are available, screening breast MRI and screening breast ultrasound have been tested extensively. Background breast density has less impact on the ability of MRI and ultrasound to detect cancer than it does for mammography, which is why either of these tests increases cancer detection over mammography alone, MRI much more so than ultrasound. However, both MRI and ultrasound are associated with a much higher rate of benign biopsies and a much higher rate of recommendation for short-interval follow-up than mammography. Therefore, choosing to have one of these tests in addition to mammography involves the benefit/risk trade-off of early cancer detection versus increased false positives. The higher the cancer risk, the more likely there will be benefit, so the trade-off is more favorable for high-risk women than for average-risk women who simply have dense breasts.

Are any supplemental screening tests recommended by radiologists for high risk women?
In high risk women, supplemental screening tests are recommended in addition to mammography. Studies support the use of screening MRI in women who are known to have a very high-risk (>20% lifetime or >5% 10-year) of breast cancer, regardless of their breast density. This examination is widely recommended by radiologists.

If a woman has dense breasts, is a risk assessment helpful?
For the great majority of women informed that they have dense breasts under the law, breast density in itself has only a small impact on their overall risk. But there are other important risk factors that also may come into play, and knowing a specific patient's risk level can help to determine whether supplemental screening is appropriate. If a woman is at very high-risk, a screening MRI would likely be helpful.

What are the strongest risk factors for breast cancer, other than age and sex?
a) personal or family history (especially a first degree relative with premenopausal breast or ovarian cancer). b) personal history of atypia on prior biopsy (ADH, ALH, LCIS). c) while neither of these risks, nor dense breasts, individually place a woman in the very high-risk category, they may identify those who would likely benefit from a full risk assessment.

What about women with dense breasts but not at high-risk for breast cancer? Should they be recommended for additional MRI testing ?
Screening MRI has not been studied in average-risk women with no known cancer diagnosis. However, if a patient expresses a desire to be screened with MRI, then a full risk assessment would be helpful. Even if a patient does not have strong risk factors for breast cancer, there are a number of minor risk factors, including breast density, which together may raise her to a sufficiently high-risk. The American Cancer Society states that for intermediate risk women, with a 15-20% lifetime risk (this may include women with a history of atypia on biopsy or with a personal history of breast cancer), the decision to have a screening MRI should be made on a case-by-case basis using a shared decision-making approach.

How useful is screening breast ultrasound in women with dense breasts?
Mammography typically finds 6 to 8 breast cancers in every 1000 women screened for the first time. In women with dense breasts at average-risk, small studies have shown ultrasound can detect 1.6 to 4 mammographically occult cancers for every 1000 women screened for the first time. Therefore, supplemental ultrasound adds substantially to the cancer yield in some studies. The majority of invasive cancers found on ultrasound are smaller than 1 cm. It is a moot point whether a subsequent mammogram would have picked up these cancers without affecting outcome. Ultrasound generates a number of false positive biopsies (almost 90%). “Automated Screening Breast Ultrasound” or ABUS facilities are not available at the UMass Breast Imaging Division.

How useful is screening 3D tomosynthesis in women with dense breasts?
Tomosynthesis uses similar technology to conventional mammography and many centers are currently in the process of adopting it because it has shown promising early results. Recent data suggest that, in general, tomosynthesis reduces false positive findings and may also permit detection of additional cancers in the screening population (similar to ultrasound but not as much as MRI). However, we do not yet know how well tomosynthesis performs, specifically, in the small group of women with extremely dense breasts because results thus far have been reported only for all studied women. 3D tomosynthesis is considered a supplemental test. This technology is available at UMass centers located at ACC and the Memorial complex. Despite having had this supplemental screening test, women with dense breast will continue to receive the above mentioned letter.

What will the cost of supplemental screening tests be to the patient and to the healthcare system?
The Massachusetts legislature did not mandate insurance coverage for any supplemental breast cancer screening tests. Currently, there are no insurance billing codes for screening breast ultrasound. CMS has just approved a code for tomosynthesis. However most payers still consider this test experimental and do not reimburse the expense. At UMass, 3D tomosynthesis is performed on a need basis and no cost burden is passed on to the patient. Screening breast MRI is usually covered for high-risk women, but may not be for women at average-risk who simply have dense breasts. As such, women who desire certain types of supplemental screening may be asked to pay out of pocket.

Reference:
Jafi A. Lipson, MD, Jonathan Hargreaves, MD, and Elissa R. Price, MD. "Frequently Asked Questions About Breast Density, Breast Cancer Risk, and the Breast Density Notification Law in California: A Consensus Document". BreastDensity.Info. California Breast Density Information Group (CBDIG), March 2013. Web. February 2015.