New breast density regulations and imaging alternatives for early breast cancer detection
Women’s health programs that offer breast health services and educational resources are critical for building patient trust, improving access to care and results in more positive outcomes. In this article, part of a series on comprehensive women’s health, we explore the impact of density on breast cancer diagnosis, imaging alternatives and updated policies and guidelines that may impact your program and patients.Read the article
Breast cancer diagnosis and updated screening guidelines
Breast cancer is a significant health concern affecting women worldwide. The impact of breast cancer on women's lives is monumental – from diagnosis to recovery – and warrants a comprehensive strategy that incorporates dynamic engagement and a wide range of services.
In 2023, an estimated 297,790 new cases of invasive breast cancer will be diagnosed in women, along with 55,720 new cases of ductal carcinoma in situ (DCIS While breast cancer incidence rates have been gradually increasing at a rate of about 0.5% per year, death rates have been declining since 1989. This decline can be attributed to early detection through screening, heightened awareness and advancements in treatment.1
While the median age at the time of a breast cancer diagnosis is 62, about 10% of cases are discovered in women under 45.1, 2 An additional 18.5% occur between ages 45-54.2
This year (2023) the United States Preventive Services Task Force (USPSTF) updated their guidelines, recommending that breast cancer screening should begin at age 40 rather than age 50,3 aligning with recommendations from other professional groups such as the American Cancer Society which recommends the opportunity to start screening between ages 40-44.4 Research from the USPSTF indicates that if all women ages 40 and over got a mammogram every other year, it would reduce breast cancer deaths by about 20%. 5
When women are diagnosed with breast cancer, in advanced stages, 30% survive their cancer for five-years or more, compared to nearly 100% survival rates for those found before the disease has progressed.6 The diagnosis data by age group and updated guidelines emphasize the need for timely screenings to detect breast cancer at its earliest stages to improve outcomes.
Coverage concerns and legislation for breast health
Knowing who and when to screen only moves the needle if women have access to care. Preventive screening services like mammograms are typically covered by commercial payers with no cost sharing for patients. However, recent court challenges to this provision have raised concerns about potential changes in coverage requirements. This uncertainty could result in some plans requiring cost sharing for mammograms, creating barriers for women who may struggle to afford these screenings.
On May 5, 2023, the Find It Early Act was introduced into Congress, aiming to address the issue of limited access to breast cancer screening for women due to financial constraints.7 This legislation, if passed, would require insurers to cover mammograms, diagnostic mammograms and additional screenings for women with risk factors (Table 1), with no cost sharing.
The Find It Early Act, if passed, would address these coverage challenges and make sure that women have access to recommended breast cancer screenings without financial barriers. By mandating coverage for mammograms, diagnostic mammograms and additional screenings for high-risk individuals, this legislation aims to improve early detection rates and save lives.
Improved imaging alternatives and the impact of breast density on diagnosis
Currently, mammography systems use integrated computer-aided breast density (CAD) analysis tools to aid radiologists in assessing breast density and detecting the presence of tumors. Cutting-edge techniques, such as the integration of artificial intelligence, are currently under development and investigation. These methodologies aim to improve Radiologists' interpretation skills by accurately segmenting dense breast tissue. The goal is to reduce false positive results and enable early detection of cancer. Some believe that artificial intelligence could surpass human experts in breast density prediction.
"Dense breast tissue is common, non-fatty tissue and is not abnormal, but dense breast tissue can make it harder to identify breast cancer and be associated with an increased risk of breast cancer. It has been reported that women with a high breast density compared to women with a low breast density have a fourfold increased risk of developing the disease."10 Table 2 shows relative risk for developing breast cancer by density category.
Table 2: Breast cancer risk by density category10
Increased access to screenings, combined with improvements in breast imaging such as 3D screening mammography, MRI and breast ultrasound, can make significant strides in detecting breast cancer at its earliest stages and improving outcomes for women across the country.
Research from the Radiological Society of North America (RSNA) explored the differences in examining breast tissue with standard digital mammography and that with tomosynthesis, also known as 3D mammography. The latter technique offers a more detailed image of possibly concerning lesions.
Findings from RSNA showed how a cancerous lesion was missed by two standard digital mammography imaging exams due to overlying densities.11 Tomosynthesis imaging works by moving the X-ray tube in an arcing plane across the anatomy. This technique blurs standard breast tissue textures and leaves tumors in-plane to be easily identified. The true-positive rate with digital breast tomosynthesis (DBT) was higher than that with digital mammography (DM) in all volumetric density groups (range, 12%–24%; P < .001 in women with scattered fibroglandular and heterogeneously dense breasts; P > .05 in women with almost entirely fatty and extremely dense breasts) and all age groups (range, 15%–35%; P < .05).
- The false-positive rate with DBT was lower than that with DM in all age groups (range, −0.6% to −1.2%; P < .01) and volumetric density groups (range, −0.7% to −1.0%; P < .005), except for women with extremely dense breasts (0.1%, P = .82).
- DBT showed a greater number of true-positive findings classified as spiculated masses or architectural distortions (P < .001 in women with scattered fibroglandular and heterogeneously dense breasts, P < .05 in women aged 55–69 years) and a reduction of false-positive findings classified as asymmetric densities (P < .001, except in women with extremely dense breasts)."
As noted in Table 1, dense breasts are considered an independent risk factor for breast cancer, which raises additional concerns for the almost 47% of women in the United States who have them. The U.S. Food and Drug Administration (FDA) recently issued a national requirement that facilities report to patients and their referring providers if dense breasts are detected on a mammogram. All facilities will have to follow this requirement by September 10, 2024.12 This is a positive step forward since dense breast tissue can make it more challenging to detect abnormalities on mammograms. The FDA's support for providing patients and physicians with information about breast density is expected to enhance patient care. This is because dense breasts may require additional screening methods, such as breast MRI or ultrasound, when a mammogram alone is not sufficient.
The use of abbreviated MRI has shown promise in improving early detection rates. A recent study found when compared to other types of breast screening methods, breast MRI was superior at detecting breast cancer in women with dense breasts, adding to demand for this service.13 However, once again, coverage challenges may limit access to breast MRI for patients with dense breasts hindering early detection efforts.
Technology spotlight: GE Invenia 2.0 automated breast ultrasound
This system is the first FDA approved ultrasound supplemental screening technology designed to detect cancer in dense breast tissue.
Automated breast ultrasound (ABUS) technology provides improved detection of breast cancer, standardization and efficient workflow integration. ABUS covers the entire breast creating reproducible, wide field-of-view images for consistent image quality independent of the operator. The Invenia ABUS 2.0 system incorporates AI features aimed to reduce false biopsies, saving both healthcare costs and patients' experiences from unnecessary invasive procedures. The system has demonstrated a 35% increase in breast cancer detection for patients with dense breasts, significantly impacting early diagnosis and treatment outcomes.
GE Invenia ABUS 2.0 system - XR0918
Key trends impacting future use of breast health services
Changes to screening guidelines recommending earlier screening mammograms and coverage improvements will drive modest growth along the breast health screening and diagnostic care path. Imaging improvements associated with 3D screening mammography limit demand for diagnostic mammograms and breast biopsies. However, breast density awareness and reporting drive rapid growth in breast ultrasound and MRI services, as shown in Figure 1.
Figure 1. Sg2 10-year breast health forecast
Sources: Impact of Change®, 2023; Proprietary Sg2 All-Payer Claims Data Set, 2021; The following 2021 CMS Limited Data Sets (LDS): Carrier, Denominator, Home Health Agency, Hospice, Outpatient, Skilled Nursing Facility; Claritas Pop-Facts®, 2023; Sg2 Analysis, 2023.
Program considerations and recommendations
To optimize patient access and experience, it's essential to evaluate the system of care for breast imaging, breast cancer treatment and reconstruction services. When comprehensive care strategies are in place, your organization can have a positive impact on women's health outcomes. Evaluation of your program may include factors such as provider type and location. To help patients receive timely and effective care, healthcare providers can identify areas for improvement and implement necessary changes. By evaluating existing practices, pinpointing specific areas for improvement and making necessary adjustments, healthcare providers can enhance the quality of care. This approach enables patients to receive timely and appropriate care, leading to improved patient outcomes. The trends related to breast cancer highlight the need for healthcare organizations to implement a Comprehensive Breast Center program. In addition to promoting education and awareness to the community, Comprehensive Breast Centers provide a one-stop shop for screenings, diagnostic services, treatment and follow up care. Breast Centers provide coordination and continuity of care, providing faster treatment and improved clinical outcomes.
Breast cancer remains a significant health concern for women. However, advancements in technology, comprehensive care strategies and increased awareness have improved outcomes and reduced mortality rates.
When financial barriers are removed, more women can undergo regular screenings. This, in turn, leads to earlier detection of potential issues and improves outcomes for these women. Continued support for early screenings and financial coverage is essential to ensure that all women, regardless of their financial circumstances, can access the necessary screenings for early detection of breast cancer. This support should also include coverage for supplemental screenings, such as MRI, for women with dense breasts.
Healthcare providers can make significant strides in breast cancer prevention, early detection and treatment by actively implementing approaches that optimize the care pathway and utilizing insights from industry research. This proactive approach aims to create a future where breast cancer is no longer a leading cause of cancer-related deaths among women.
- Key Statistics for Breast Cancer. American Cancer Society. Sept. 14, 2023. Accessed Sept. 22, 2023. Breast Cancer Statistics | How Common Is Breast Cancer? | American Cancer Society
- Cancer Stat Facts: Female Breast Cancer. National Cancer Institute. Accessed Sept. 22, 2023. Female Breast Cancer — Cancer Stat Facts
- Task Force Issues Draft Recommendation Statement on Screening for Breast Cancer. U.S. Preventive Services Task Force Bulletin. Published May 9, 2023. Accessed September 25, 2023. www.uspreventiveservicestaskforce.org
- Oeffinger K, Fontham E, Etzioni R, et al. Breast Cancer Screening for Women at Average Risk. JAMA. 2015;314(15):1599-1614. doi:10.1001/jama.2015.12783
- New guidelines recommend earlier mammograms amid rise in breast cancer among younger women. PBS News Hour. Published May 9, 2023. Accessed Sept. 22, 2023. New guidelines recommend earlier mammograms amid rise in breast cancer among younger women | PBS NewsHour
- Why is early cancer diagnosis important? Cancer Research UK. Last reviewed March 30, 2023. Accessed September 25, 2023. https://www.cancerresearchuk.org/https%3A//www.cancerresearchuk.org/about-cancer/spot-cancer-early/why-is-early-diagnosis-important
- H.R. 3086: Find It Early Act. Govtrack. Accessed Sept. 22, 2023. Find It Early Act (H.R. 3086) - GovTrack.us
- Breast Cancer: The Basics of Diagnosis, Staging, and Treatment, MedPage Today. Accessed Sept. 22, 2023. Breast Cancer: The Basics of Diagnosis, Staging, and Treatment | MedPage Today
- What Are the Risk Factors for Breast Cancer. CDC. Published July 25, 2023. Accessed Sept. 22, 2023. What Are the Risk Factors for Breast Cancer? | CDC
- Saffari N, Rashwan H, Abdel-Nasser M, et al. Fully Automated Breast Density Segmentation and Classification Using Deep Learning. MDPI. 2020,10(11), 988; https://doi.org/10.3390/diagnostics10110988
- . Osteras B, Martinsen A, Gullien Randi, et al. Digital Mammography versus Breast Tomosynthesis: Impact of Breast Density on Diagnostic Performance in Population-based Screening. Published Aug. 13, 2019. Accessed Sept. 22, 2023. https://doi.org/10.1148/radiol.2019190425
- FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight. U.S. Food & Drug. March 9, 2023. Accessed Sept. 22, 2023. FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight | FDA
- Breast MRI Effective at Detecting Cancer in Dense Breast. RSNA. Accessed Sept. 22, 2023. MRI Detects Cancer In Dense Breasts | RSNA
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