New Breast Density Notification Final Rule to Publish Soon

The FDA has confirmed that it will publish a new rule that will have a big impact on healthcare providers before the end of this month or early in 2023. The rule in question will update the Mammography Quality Standards Act of 1992 (MQSA) by making one key change requiring providers to inform patients about their breast density status, what it means for the patient’s risk of developing cancer, and extra screening options they can access.

"FDA’s intent is to provide patients and healthcare providers with additional information about their mammography and the potential limitations of their mammogram results, so patients and their healthcare providers can make informed healthcare decisions," an FDA spokesperson said in an emailed statement.

What Is the MQSA?

The MQSA, which became law in October 1992, was enacted to “ensure that all people have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages,” according to the FDA.¹ Further requirements were added via the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA). Congress passed legislation requiring the FDA to develop the breast density reporting rule—the Breast Density Mammography Act—as part of the 2019 funding bill.²

Why Is Breast Density Notification Important?

According to the National Cancer Institute (NCI), “dense breasts have relatively high amounts of glandular tissue and fibrous connective tissue and relatively low amounts of fatty breast tissue.”³ Notifying patients about their breast density is important, as women with dense breasts are at an increased risk of breast cancer and dense breast tissue makes it more difficult to spot cancer on mammograms, meaning additional screening options may be warranted. Dense breasts are also common, found in almost half of women age 40 and older, the NCI states.

As with most other types of cancer, early detection greatly increases a woman’s chance of survival, which is why letting a woman know if she has dense breasts, and what extra screening options are available, are important. However, such notification is inconsistent among healthcare providers, as only some states require it, and those that do have different rules.

How the New FDA Rule Came About

Currently, 38 states, as well as the District of Columbia, have enacted laws that require some level of breast density notification. However, the laws have varying requirements, meaning that patients and providers receive anywhere from general to detailed information.⁴ And not all state laws require insurance coverage for additional breast cancer screening, so not all women have access. Studies on the impact of such state laws show they can increase women’s understanding of dense breasts and encourage further screening, particularly in states that require insurance coverage of such additional testing.⁵

The first state breast density reporting legislation came about when teacher and administrator Nancy Cappello, PhD, was surprised to receive a diagnosis of stage 3c breast cancer, despite having undergone mammography screening each year. It was only when she received her cancer diagnosis via ultrasound that she learned she had dense breasts. Though both her radiologist and doctor were aware of her breast density status, they had never shared the information with her as it was not “standard practice,” according a 2015 article in the American Journal of Roentgenology (AJR).⁶ Concluding that her cancer might have been diagnosed earlier had she been aware of her breast density status and gone for extra screening with ultrasound sooner, Cappello lobbied senators in her home state, Connecticut, to introduce a bill that would require insurance coverage for whole-breast ultrasound screening for women with dense breasts, as a complement to mammography. The bill passed in 2005 and the first breast density notification law in the US passed in Connecticut in 2009, requiring providers to inform patients if they have dense breasts.

Since the passage of her state’s law, Cappello continued to advocate for further breast density notification legislation through her organization, Are You Dense?, a mission the organization has carried on since her 2018 passing from complications related to her earlier cancer treatment.⁷

Hence the push for federal legislation, the Breast Density and Mammography Reporting Act of 2013, introduced by Representatives Rosa DeLauro (D-CT) and Steve Israel (D-NY) in October 2013, along with companion legislation that was introduced in the Senate by Senators Dianne Feinstein (D-CA) and Kelly Ayotte (R-NH), and passed in 2019.² Now, after addressing the "over 350 distinct issues” brought forth by various industry stakeholders during the comment period for the proposed rule, the FDA is nearly ready to reveal its final rule on breast density notification, according to a letter the agency sent to DeLauro's office on Oct. 17.⁸

What Providers Will Need to Do to Prepare

So, what exactly will mammography facilities need to provide their patients? According to the FDA, current regulations require such facilities to:

• Provide a written report on each mammogram to the patient’s healthcare provider
• Provide a summary of that report in plain language to the patient

However, breast density notification is not currently required to be a part of either report. According to the FDA, once the new rule comes into effect, mammography facilities will need to:⁸

• Include in the “lay summary” to the patient whether they have one of two categories of breast density—either low or high density—along with an explanation of why breast density is important
• Use one of four categories established by the new regulations for reporting breast tissue density in the report for the patient’s referring healthcare provider

Healthcare providers that offer additional breast screening options, such as MRI and ultrasound, may also want to prepare for an increase in usage of these services, particularly if their states offer insurance coverage, based on research exploring the impact of such laws. For example, a May 2019 Journal of General Internal Medicine study showed that breast density notification laws led to a modest increase in “supplemental imaging and biopsy” in states that had enacted such legislation. However, the researchers added that “additional research is needed on these laws’ effects on cost and patient outcomes.”⁹

Do Breast Density Notification Laws Actually Help Improve Patient Outcomes?

A press release on the Journal of General Internal Medicine study notes that, while the intentions of such laws are good, there isn’t much evidence that additional screening helps, noting that such tests are pricier than mammograms and current research suggests they may not actually help detect cancer sooner.¹⁰

“Evidence shows that supplemental imaging tests are associated with false positives, unnecessary biopsies and possible overdiagnosis,” the UChicago Medicine press release says. “Breast ultrasound, the most popular option, only makes an additional 4.4 cancer detections out of 1,000.”

Given the added costs such legislation may bring about, more research on these additional procedures is needed, the article concludes.

Other research has also shown that the benefits of such legislation and whether it leads to earlier breast cancer detection and increased survival rates remain unclear. A 2020 AJR review of the impact of breast density notification laws on supplemental screening ultrasound 10 years after such laws were first implemented shows they led to an increase in such screening.¹¹ That review concluded that while such screening has meant “additional health care expense and false-positive interpretations” and that some researchers point out there’s not enough evidence that these costs outweigh the benefits, “robust data support improved detection of small node-negative invasive breast cancers with adjunctive ultrasound.”

Like the Journal of General Internal Medicine study, the AJR review stated that further research is required “to validate early data on the impact of screening ultrasound programs on interval cancers, advanced stage cancers, and long-term disease-free survival and overall survival.”

However, other experts in the field say such laws are an important step, according to Wendie Berg, MD, PhD, a professor of radiology at the University of Pittsburgh Medical Center’s Magee-Womens Hospital, in a recent Radiological Society of North America article.¹² In the article, Berg says the legislation will add much needed clarity and resolve the inconsistencies among state laws in terms of what patients are told about breast density. Berg, who is also co-founder and scientific director of DenseBreast-Info.org, a website that educates the public on breast density, provided comments with her colleagues to the FDA rule now about to publish.

In its analysis on the potential impact of the rule, the FDA notes several benefits of breast density notification and the additional screening it could spur, despite the costs. Though additional screening would not be recommended for all women with dense breasts, the FDA says that “the benefits that are expected to result from this provision would be potential reductions in cancer treatment costs due to early cancer detection as well as reductions in breast cancer mortality and morbidity,” estimating that 40 to 84 deaths per year could be averted thanks to the new rule.¹³

References:

1. https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/about-mammography-program
2. https://delauro.house.gov/media-center/press-releases/delauro-secures-timeline-fda-rollout-breast-density-notification-rule
3. https://www.cancer.gov/types/breast/breast-changes/dense-breasts
4. https://jamanetwork.com/journals/jama/article-abstract/2733521
5. https://www.g2intelligence.com/breast-tissue-density-reporting-should-cover-all-women/
6. https://www.ajronline.org/doi/10.2214/AJR.14.13558
7. https://www.areyoudense.org/
8. https://delauro.house.gov/sites/evo-subsites/delauro-evo.house.gov/files/2022%201013%20FDA%20Response%20Letter%20to%20Rep.%20DeLauro%20on%20MQSA%20Final%20Rule.pdf
9. https://link.springer.com/article/10.1007/s11606-019-05026-2
10. https://www.uchicagomedicine.org/forefront/cancer-articles/breast-density-notification-laws-could-affect-millions
11. https://www.ajronline.org/doi/10.2214/AJR.19.22275
12. https://www.rsna.org/news/2019/april/fda-breast-density-proposal
13. https://www.fda.gov/media/122866/download
14. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening