Blog

New State Insurance Bills

Three new state bills were introduced this week for expanded coverage for breast imaging: Alabama SB117, West Virginia SB518 and SB519.

For details on existing state insurance laws, visit the DenseBreast-info.org MAP.

Federal Guideline for Insurance Coverage

Effective Jan 1, 2026, Affordable Care Act compliant plans are now required to cover, for women at average risk, “additional” breast imaging in the Health Resources Services Administration (HRSA)-supported Women’s Preventive Services Initiative (WPSI) recommendations. The new guidelines state,  “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 are also recommended to complete the screening process for malignancies.”

More details:

• “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 most plans, this update will take effect in 2026.

Our input:

• Federal plans such as Medicare, VHA, and TRICARE and grandfathered plans appear to be exempt. Furthermore, while these updates focus on women at ‘average’ risk, they do not address the supplemental imaging requirements for those at increased or high risk. In contrast, the federal Find It Early Act addresses both of these gaps; we remain committed to advancing that legislation.
• Since federal guidelines are frequently codified through state-level legislation, we anticipate a continued influx of state insurance bills designed to mirror or expand on these federal requirements.

State Insurance Bills

New legislation for insurance coverage of expanded breast imaging:

Arizona  SB1165

California AB1570

Florida  SB1494
Rhode Island  S2032

South Carolina S0820

Insurer Breast Imaging Expansion

Blue Cross Blue Shield affiliated organization Highmark Inc. has announced plan members across 4 states will receive 100% coverage for diagnostic breast studies and MRIs. More HERE.

U.S. State Insurance Bills

New 2026 insurance bill introductions for expanded breast imaging include: Indiana HB1112 and Kentucky HB135

BRAID RSNA Presentations and Automated US Study

Additional BRAID Trial Results

Several sessions at RSNA 2025 showed second round results from the UK BRAID trial led by Dr. Fiona Gilbert.  The initial trial enrolled 9361 women age 50-70 from October 2019-March 2024 with dense breasts and a negative mammogram who were randomized to receive supplemental screening with automated breast ultrasound (ABUS), abbreviated MRI (AB-MRI), or contrast-enhanced mammography (CEM), with results published in The Lancet in May 2025.  Women with a negative result from the initial supplemental screen who enrolled by 3/31/23 were invited to have a second round of screening 18 months later that included mammography (MG).

• Cancer detection rates in the second round of screening were similar for each of ABUS, AB-MRI, and CEM arms at about 8/1000.¹
• Recall rates decreased for both AB-MRI and CEM in the second round but were similar to the first round for ABUS.²

¹ Cancer detection rates were 15/1572 (9.5/1000) for ABUS+MG; 9/1051 (8.6/1000) for AB-MRI+MG; and 6/870 (7.0/1000) for CEM in the second round. [By comparison, cancer detection rates in the first round were 4.2/1000 for ABUS; 17.4/1000 for AB-MRI; and 19.2/1000 for CEM after a negative mammogram.]

² Recall rates in the second round were 4.3% for ABUS; 3.5% for AB-MRI; and 4.7% for CEM.  In the first round, recall rates were 4.0% for ABUS; 9.7% for AB-MRI; and 9.7% for CEM.

 

ABUS in Non-dense Breasts

Two referral centers in Korea retrospectively reviewed results of screening women with non-dense breasts and compared performance of digital mammography (DM) alone vs DM + automated breast ultrasound (ABUS). They reviewed 2904 paired screening examinations among 1683 women with non-dense breasts.

• Adding ABUS to DM slightly increased cancer detection in women with scattered fibroglandular density, but not in women with fatty breasts.¹
• The small increase in cancer detection was accompanied by a small increase in false positive recalls.²

• Women diagnosed with breast cancer were older (63 ± 9 years vs. 59 ± 10 years, P = 0.04) and tended to have risk factors (19.2% vs. 4.2%, P < 0.001) compared to those without breast cancer.

¹ Cancer detection rates were 9.0/1000 for DM+ABUS and 7.9/1000 for DM alone (P<.001), with 3/26 (11%) cancers seen only on ABUS, all invasive T1, node-negative tumors; the added yield of 1.1/1000 was all in the 1569 women with scattered fibroglandular density [cancer detection rate 8.5/1000 for DM+ABUS and 7.4/1000 for DM alone (P<.001)].  Six cancers were visible only on DM, including 2 invasive cancers and 4 DCIS.

² False-positive recall rate increased from 61/2878 (2.1%) for DM alone to 143/2878 (5.0%) for DM+ABUS (P<.001).

New State Insurance Law

A new insurance law in Pennsylvania expands no-cost breast imaging coverage. Please see the Pennsylvania legislative analysis from DenseBreast-info HERE.

New Study

Esserman et al published results from the WISDOM (Women Informed to Screen Depending on Measures of Risk) trial in JAMA. The authors sought to demonstrate that reduced screening based on lower risk was safe.  Due to low adherence to recommended screening (with contamination in the annual arm), as indicated in the accompanying editorial, the effectiveness of such an approach remains uncertain. Breast density and other characteristics of women with symptomatic or advanced cancers were not specified. The approach of not screening “low-risk” women in their 40s is particularly problematic for Black, Hispanic, and Asian women who have earlier peak onset of breast cancer and more frequent distant disease at presentation.  See also the commentary by the Society of Breast Imaging.

A total of 28,732 women age 40-74 from all 50 states were randomized to risk-based screening or annual mammography.¹  Women were followed a median of 5.1 years (up to 10) and cancers, biopsies, and screening were self-reported.

• There was no significant difference in rate of stage IIB or higher breast cancers.²  Similar numbers of stage 0, stage I, and stage IIA cancers were seen in both groups (see eTable 5 in Supplement 1).
• The rate of breast biopsies was not different.³
• Reported adherence to recommended screening was less than 50% even in the first year for all participants and declined each year.
• Women in the annual arm were given risk assessment and told they were at elevated risk if they had BCSC 5-year risk > 5% but were not changed screening assignments.
  • While MRI use was more frequent in the risk-based arm (but was lower than expected), a substantial number of MRI examinations were performed in the annual arm.⁴

Women in the elevated and high-risk groups were counseled on risk-reducing medications, but use remained very low (5.6% at baseline, increasing to 10.3% with intervention, in the highest-risk group and 3.5% increasing to 4% in the elevated risk group).

¹ A total of 14212 women were randomized to risk-based screening based on the BCSC Risk Assessment Tool (which includes breast density) and polygenic risk score genetic testing, with 2% (291) “high risk” (≥6% 5-year risk or carrier of known pathogenic variant) and recommended to have alternating 6-month mammography and MRI; 8% (1121) “elevated risk” (top 2.5% of risk by age or extremely dense breasts, or intermediate genetic risk variant) assigned to annual mammography; 63% (8796) “average risk” assigned biennial mammography beginning at age 50; and 27% (3716) “low risk” (women less than 50 with <1.3% 5-year risk).  The other 14160 women were randomized to annual mammography screening.

² There were 41 stage IIB or higher cancers in the risk-based arm (63.1/100,000 person-years) and 43 (68.2/100,000 person-years) in the annual arm (rate ratio 0.92, 95%CI 0.60 to 1.43).

³ There were 1029 biopsies in the risk-based arm (1371/100,000 person-years) and 943 in the annual arm (1272/100,000 person-years, rate ratio 1.08 (95%CI 0.99 to 1.18).

⁴ Rate of MRI per 100,000 person-years was 1187 in the risk-based arm and 795 in the annual arm (rate ratio 1.49, 95%CI 1.34 to 1.66).

Announced at SABCS

At the San Antonio Breast Cancer Symposium last week, Astrin Biosciences presented encouraging results from an AI-proteomics-based liquid biopsy to detect breast cancer.  Specifically:

• High sensitivity and specificity of over 92% each were found in the validation set of 202 cancer cases and 195 controls, with AUC of 0.975.¹
• Sensitivity was maintained across all stages² and subtypes.³
• Patient demographics did not significantly affect results, though further study is warranted.
• They confirmed they were indeed identifying cancer-associated proteins and pathways versus inflammatory markers.

Sources of false positives will be important to understand and mitigate.

¹ A training set of 379 cancer cases and 466 controls was used, and all cases were treatment naïve.  Training used 5-fold cross validation and showed AUC of 0.961.

² 85% (11/13) for stage 0; 88% (61/69) for stage I; 97% (95/98) for stage II; 88% (14/16) for stage III; and 100% (2/2) for stage IV (no significant differences, but relatively small subsets).

³ 100% (20/20) for invasive lobular carcinoma; 94.8% (145/153) for invasive ductal carcinoma; 95.9% (116/121) for hormone receptor +/HER2-; 94% (15/16) for triple negative; 67% (4/6) for triple positive; and 100% (3/3) hormone receptor -/HER2+ (small numbers in most subsets).

New European Education Supporter

Join us in welcoming Dr. Thiemo van Nijnatten as DBI’s European Education Supporter from The Netherlands! T. van Nijnatten is a Breast and Nuclear Radiologist at Maastricht UMC+ and Dutch Expert Center for Screening (LRCB). He is also executive board member of the European Society of Breast Imaging (EUSOBI) and the current chair of the EUSOBI Young Club Committee.

Ready for Patient Conversations?

DBI’s Breast Cancer Awareness Month education outreach include this article in Applied Radiology, FDA Breast Density Reporting is in Effect. Ready for Patient Conversations?  by executive director JoAnn Pushkin.

New MBI Study

Annual Molecular Breast Imaging Improves Cancer Detection in Dense Breasts: Hruska et al reported results from the prospective multicenter Density MATTERS (Molecular Breast Imaging and Tomosynthesis to Eliminate the Reservoir) trial in Radiology. Among nearly 3000 women with dense breasts, 87% of whom were not at high risk, adding ^99mTc-sestamibi molecular breast imaging (MBI) to tomosynthesis (DBT) each year for two years, with one additional year of follow-up showed:

• Improved detection of early breast cancer each year.^1,2
• Reduced false positive recalls with the second round of screening.³
• Interval cancer rates were very low with combined screening DBT+MBI.⁴

Specifically:

¹ In year 1, the incremental cancer detection rate from adding MBI to tomosynthesis was 6.7/1000 (95%CI 4.2, 10.6), with tomosynthesis alone depicting 5.0/1000.  In year 2, the incremental cancer detection rate from adding MBI to tomosynthesis was 3.5/1000 (95%CI 1.7, 6.8), with tomosynthesis alone depicting 5.8/1000.

² Of 29 women with cancer seen only on MBI, 21 (72%) were invasive (median size 0.9 cm, range 0.4 to 2.6) and 18/21 (86%) were node negative. Six women (20%) had locally advanced breast cancers.

³ False positive recall rate in year 1 was 16.9% after combined DBT+MBI screening, compared to 8.1% for DBT alone (added false positive recall rate due to MBI of 8.8% in year 1), and 12.9% after combined DBT+MBI screening in year 2, compared to 8.4% for DBT alone (added recall rate due to MBI of 4.5% in year 2).

⁴ Symptomatic interval cancer rate was 2/2978 (0.7%) in year 1 and 2/2590 (0.8%) in year 2.

Oh, What a World Dense Breast Day!

• World Dense Breast Day Campaign Delivers Impressive Results: The campaign generated massive awareness reaching 53.6 million unique viewers across social media, web and news platforms. The hashtag sparked nearly 4,000 mentions and drove 76,200 interactions (likes/shares) across all platforms. The numbers demonstrate significant public engagement with the dense breast tissue awareness message.
• DBI’s Owned Accounts Showcase the Power of an Engaged Community: While the broader campaign reached tens of millions, DBI’s own social channels revealed the exceptional quality of our dedicated audience. Most notably, DBI achieved a 6.32% engagement rate – significantly outperforming industry benchmarks and proving that our community is not only large – but also deeply invested in our mission. DBI has cultivated an authentic, activated community that actively participates in advancing dense breast awareness.

 

European News / The Netherlands

The Dutch National Institute for Public Health and the Environment has published a feasibility study on a temporary extension of the National Programme for Breast Cancer Screening to include MRI scans for women with density level D,  and has also outlined scenarios to accelerate implementation with a timeline.

Screening Decision Tools

We have been asked to provide descriptions/links  to our new and updated screening decision tools. We are delighted that so many of you found these a valuable resource:

• For a comparison of screening guidelines for individuals determined to be at high/increased risk, see our High/Increased-Risk Screening Guidelines page.
• For a comparison of screening guidelines for individuals with dense breasts and no other risk factors, see our and Dense Breast Screening Guidelines page.
• For evidence-based screening recommendations designed to optimize cancer detection in different risk categories, including dense breasts, see our Screening Decision Support Tool

World Dense Breast Day

A reminder that Wednesday, Sept 24^th is World Dense Breast Day!  DBI will launch 120 educational posts across 5 social media channels. To engage participants in every global time zone, our “digital day of action” will run from midnight to midnight. For more info, please see our PRESS RELEASE.

EUSOBI 2025, Sept 25-27

The European Society of Breast Imaging Annual Scientific Meeting takes place 25-27 September in Aberdeen.  The DenseBreast-info.org/Europe exhibition stand will be located at R8.  DBI’s Cheryl Cruwys, European Education Coordinator and Dr. Athina Vourtsis, European Liaison will be in attendance.  If you would like to schedule a ‘meet up’, please email us or contact Cheryl at +33 643 88 67.

#WorldDenseBreastDay

#WDBD is less than 2 weeks away and work is almost done on the 100+ posts that will launch! See our Press Release for more info.

Medical Advisory Board

Congratulations! DBI MAB member Dr. Priscilla Slanetz is the new Editor-in-Chief of Academic Radiology.

 

Society of Nuclear Medicine and Molecular Imaging, Use Criteria

Appropriate Use Criteria for Molecular Breast Imaging were published August 26 in the Journal of Nuclear Medicine Technology. The criteria were developed by a workgroup of 10 experts convened by the Society of Nuclear Medicine and Molecular Imaging and included representatives from the American College of Radiology, the American College of Nuclear Medicine, the Society of Breast Imaging, the American Society of Breast Surgeons, the American Society of Clinical Oncology, and the European Association of Nuclear Medicine. An abbreviated SNMMI AUC Fact Sheet is available HERE.  

 

Patient Fact Sheet

DBI has patient resources in 25+ languages, one of the most popular is our fact sheet, Why a Conversation About Your Breast Density Matters. The fact sheet is now available in Hindi!  The fact sheets are useful office and/or event handouts.