Newly introduced state insurance bills to cover expanded breast imaging include the following:
Screening
European Screening Flowchart, AI Risk Assessment Software Study
Newly Updated / European Resource
Just out, DenseBreast-info/Europe’s updated flowchart, European Screening Decision Support Tool.
New Study
Since the publication of the 2007 guideline from the American Cancer Society, one barrier to implementing supplemental screening MRI in high-risk women has been performing risk assessment. With expanding indications for MRI for women at intermediate risk (including many women with dense breasts), MRI capacity has become another major barrier. Just out in Radiology, van Winkel and colleagues in the Netherlands applied AI risk assessment software (Transpara, v. 1.7.0, ScreenPoint Medical) to the mammograms of 2819 women at intermediate risk who underwent screening MRI. An AI threshold that identified the top half of women at higher risk of cancer present identified:
- All 18 (100%) women with mammographically detected cancer
- 24/28 (86%) with MRI-detected cancer
- 13/19 (68%) with mammographically occult cancer
- This could have cut the number of MRI examinations in half (1409) (with AUC 0.72)
Other software tools such as iCAD, Mirai, and Mia have shown similarly good performance in identifying women likely to have mammographically occult cancer who might benefit from screening MRI.
New State Insurance Bills, New Review Article
State Insurance Bills
Newly introduced state insurance bills to cover expanded breast imaging include the following:
- Arkansas SB123
- Arkansas HB1309
- Florida S0372
- Idaho H0134
- Kansas SB219
- New York S04072
- New York S1773
- New York S03559
- Pennsylvania HB433
- South Dakota SB1070
Review Article
A recent review of supplemental screening in women with extremely dense breasts by Sitges and Mann concludes that 2D mammograms alone are inadequate screening, with more cancers missed, higher risk, and high rates of clinically detected cancers in the interval after a negative screen. Figure 2 (below) from their paper shows the added cancer yields from each type of supplemental screening. They also summarize recommendations from international societies, including the recommendations from the ACR to include annual MRI for women with dense breasts, or CEM or ultrasound if MRI is not possible, starting at age 40 (or earlier if there are other risk factors).
Updated Federal Breast Screening Recommendations
NEWS: Breast Cancer Screening – Updated Federal Recommendations
On 12/30/24, the Health Resources and Services Administration (HRSA) issued a notice, Update to the Health Resources and Services Administration’s (HRSA) Women’s Preventative Service Guidelines. One of the Guideline revisions relates specifically to “Breast Cancer Screening for Women at Average Risk” and will take effect in January 2026 for applicable insurance plans*.
Some details:
- “Women may require additional imaging to complete the screening process or to address findings on the initial screening mammography. If additional imaging (e.g., magnetic resonance imaging (MRI), ultrasound, mammography) and pathology evaluation are indicated, these services also are recommended to complete the screening process for malignancies.”
- “While there are currently no randomized controlled trials to support separate recommendations for women with dense breasts, the updated clinical recommendation supports additional testing to complete initial screening, if needed, which may be more common for women with dense breasts”
- “Non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage must cover without cost-sharing the services and screenings listed on the updated Women’s Preventive Services Guidelines for plan years (in the individual market, policy years) that begin 1 year after this date. Thus, for most plans, this update will take effect ….in 2026.”
*Clarification is pending on whether self-funded plans, federal plans (e.g., Medicare, VHA, TRICARE) and/or ERISA plans (a private sector retirement or health plan that’s governed by the Employee Retirement Income Security Act) are included. We will share more information as we learn it.
Flowchart Update; CEM Study
Who Needs More Screening? Flowchart
This popular screening decision support tool for health providers has just been updated, view it HERE.
CEM Study
A retrospective, single-institution study at Memorial Sloan Kettering Cancer Center reported results of several rounds of screening contrast-enhanced mammography (CEM) in 609 women with extremely dense breasts, most of whom also had other risks for breast cancer. Compared to low-energy images (similar to a standard 2D full-field digital mammogram), contrast enhancement:
- Increased cancer detection1
- Decreased specificity, which improved at follow up exams when prior images were available for comparison2
As summarized in an accompanying editorial by Marc Lobbes, MD, PhD, these results support the use of CEM as a safe and effective screening tool for women with dense breasts.
1The cancer detection rate after contrast enhancement vs. low-energy images was 12.7 per 1000 (16/1264) vs. 4.0 per 1000 (5/1264) for an incremental cancer detection rate of 8.7 per 1000 screens (11/1264). The sensitivity after contrast enhancement vs. the low energy images was 88.9% (95% CI: 65.3, 98.6) vs. 27.8% (95% CI: 9.7, 53.5) (P = .003).
2The specificity after contrast enhancement vs. low-energy images was 88.9% vs. 96.2%, P < .001. Specificity at follow-up improved to 90.7% (95% CI: 88.5, 92.7; P = .01).
Research Round Up
AI vs. ultrasound
A single-institution, retrospective study of 5707 women with dense breasts and a negative mammogram at Seoul National University Hospital found that adding artificial intelligence (AI) is less effective than adding screening ultrasound (US). Supplemental physician-performed whole breast handheld US found more cancers than 2D digital mammography (MG) plus AI with an added incremental cancer detection rate of 2.2 (95% CI 1.1, 3.8) per 1000 screens. All 12 additional cancers seen by US alone were invasive and node negative. While sensitivity was higher for MG plus US than for MG plus AI (97% vs. 60%, p=.002), specificity was lower (77.6% vs. 95.3%, p<.001). Further research is needed to better understand the role of AI in women with dense breasts.
Contrast-enhanced mammography
Patel and colleagues at Mayo Clinic, Scottsdale, AZ, reported results of the first round of screening contrast-enhanced mammography (CEM) after negative digital breast tomosynthesis (DBT) in 460 women at elevated risk, of whom 408 (89%) had dense breasts. CEM prompted biopsy in 37 (8.0%) women, with 11/37 (30%) found to have cancer, for a supplemental cancer detection rate of 24/1000. Specificity of CEM was 393/449 (87.5%). Of 14 total malignancies found, 10 were invasive, median size 9 mm, all node negative; there was one interval cancer found on screening MRI.
NEW Technology Tab Table
New – updated table for health professionals, Cancer Detection by Screening Method in Dense Breasts. By modality, the table shows results of supplemental screening after mammography in dense breasts in first and subsequent rounds of screening. It includes the added cancer detection benefit, change in false positive recall rate, and availability.
As a reminder, patient content on the topic is also available in DBI’s new very popular page Screening Tests After a Mammogram.
New Studies
Recently Published
Two recently published studies that might be of interest –
Patient Experience of Women with Dense Breasts Undergoing Screening Contrast-Enhanced Mammography:
A study from the University of Virginia, co-authored by DBI medical advisory board member Dr. Jennifer Harvey, found that most women with dense breasts who underwent contrast-enhanced mammography reported a positive experience. Over 90% reported minimal or no unpleasantness, indicated they would probably undergo CEM in the future if the cost was similar to a traditional mammogram, and that they would very likely recommend it to a friend.
AI-based selection of individuals for supplemental MRI in population-based breast cancer screening: the randomized ScreenTrustMRI trial:
A randomized study conducted by researchers at the Karolinska Institute found that using AI to select women for supplemental MRI screening rather than density alone resulted in 4 times as many cancers detected by MRI (64 vs. 16.5 per 1000). Selecting women based on a high AI score was cost effective, resulting in a cost per cancer detected similar to screening mammography. This study will ultimately report on the effect of MRI (if any) on reducing advanced breast cancers, including interval cancers.
New State Insurance Laws
State Insurance Laws
NEWS on insurance laws for expanded breast imaging in Louisiana, Mississippi, New Hampshire, and Nevada. Currently, 32 states + DC have insurance laws for expanded coverage for either screening or diagnostic imaging. Alaska may be next – that bill is on the governor’s desk – stay tuned!
Amended “Inform” Law, New Study
Rhode Island Density Inform Law Amended
In preparation for the FDA’s new dense breast reporting standard going into effect Sept 10, 2024, Rhode Island has amended its existing “inform” law. The Rhode Island inform law will now defer to the FDA’s national reporting standard. Please see DBI’s State Law Map or Table for details. As previously mentioned, existing state density inform laws may remain in effect in addition to the FDA requirement unless that state law specifically defaults to the new FDA standard, expires, or is repealed.
Just Published
A retrospective study just out in Radiology, Comparison of Mammography and Mammography with Supplemental Whole-Breast US Tomography for Cancer Detection in Patients with Dense Breasts, evaluated the performance of US tomography (UST) combined with full-field digital mammography (FFDM) in a reader study in women with dense breasts. The addition of UST improved cancer detection over FFDM alone and the detection rate was comparable to other ultrasound screening methods.
Canadian Taskforce Screening Guidelines
The Canadian Task Force on Preventive Health Care released updated guidelines last week and now recommend that people in their 40s should not get routine screening mammograms but can request one if they want. There was swift and vocal opposition to these guidelines.
Review Article
Newly Published
New review article out The paradox of MRI for breast cancer screening: high-risk and dense breasts—available evidence and current practice details the evidence supporting screening MRI for women with dense breasts. Should the evidence be enough for guidelines and implementation? As a reminder, in Europe, EUSOBI’s most recent screening recommendations call for supplemental MRI or ultrasound for women with category C or D (dense) breasts, with an explicit recommendation of MRI at a minimum of every 4 years for women with extremely dense breasts. In the USA, the American College of Radiology states “For women with dense breasts who desire supplemental screening, breast MRI is recommended.”
NEW Patient Technology Info
NEW! Screening Technology Info for Patients
The FDA requirement for density inform is around the corner, and with it will come new patient/provider conversations about what it means and what to do. To gear up, DBI has developed simplified, introductory content for patients, Screening Tests After a Mammogram. We extend thanks to our hardworking Patient Advisory Group who devoted much time and input into its development. Please visit and share the new page!
Breast Cancer Screening Updates from Canada
While Canadian breast cancer screening advocates celebrated the Canadian Cancer Society’s endorsement of lowering the screening age to 40, unfortunately the soon-to-be-released Canadian Task Force guidelines are unlikely to do the same. Ten out of twelve provinces with screening programs have lowered the screening age to 40, but it is still important that the Task Force do so as well, since Task Force guidelines would inform primary care providers who often discourage breast screening until the age of 50. Despite the increasing incidence of women in their 40s presenting with advanced breast cancers, the Task Force does not seem poised to lower the recommended screening age.
TOCEM Interim Analysis
Just Published in Radiology
Addition of Contrast-enhanced Mammography to Tomosynthesis for Breast Cancer Detection in Women with a Personal History of Breast Cancer: Prospective TOCEM Trial Interim Analysis. Women with a personal history of breast cancer are at higher risk for second cancers and for having that cancer missed on mammography. Interim analysis from the ongoing TOCEM study, led by DBI Chief Scientific Advisor Dr. Berg, shows very favorable results using annual screening contrast-enhanced mammography (CEM) after tomosynthesis, with added cancer yield of 7/1000 in year 1 and 4/1000 in years 2 and 3, small median invasive tumor size of 0.6 cm, mostly node negative. Added recalls occurred in 6.6% women year 1 and 5% in subsequent years.
Canada Inform, ILC Imaging, Research Grant
Density Inform / Canada
Good news from DenseBreastsCanada! Dense breast notification from coast to coast goes into effect this summer in Canada! Well done to advocates Jennie Dale and MAB member Dr. Paula Gordon for their tireless efforts.
JBI Article on Imaging for ILC
In an article co-authored by MAB members Drs. Wendie Berg and Lars Grimm, the majority of SBI member radiologists surveyed felt that additional screening beyond mammography was needed to detect ILC in dense breasts, to image extent, and in women of all breast densities with treated ILC.
New Research Grant
Congratulations to Dr. Wendie Berg on the award of a research grant from the PA Breast Cancer Coalition as co-PI with Dr. Shandong Wu to study the use of AI added to contrast-enhanced mammography to reduce false positives in screening!