Breast Density Notification Laws Research Articles

Why the Federal Breast Density Notification Law Marks a Turning Point for Women’s Health

September 10, 2024, marked a historic shift in women’s healthcare when the first federal breast density notification and reporting mandate went into effect. This means that now, all women in the United States will be informed by their providers about whether they have dense breast tissue after a mammogram. While this law helps to inform women about their risks, it is just the beginning. We need to ensure that women can do something with this important information without facing financial or logistical roadblocks.

Implementing the National Dense Breast Reporting Standard, Expanding Supplemental Screening Using Current Guidelines, and the Proposed Find It Early Act.

Thirty-eight states and the District of Columbia (DC) have dense breast notification laws that mandate varying levels of patient notification about breast density after a mammogram, and these cover over 90% of American women. On March 10, 2023, the Food and Drug Administration issued a final rule amending regulations under the Mammography Quality Standards Act for a national dense breast reporting standard for both patient results letters and mammogram reports. Effective September 10, 2024, letters will be required to tell a woman her breasts are "dense" or "not dense," that dense tissue makes it harder to find cancers on a mammogram, and that it increases the risk of developing cancer. Women with dense breasts will also be told that other imaging tests in addition to a mammogram may help find cancers. The specific density category can be added (eg, if mandated by a state "inform" law). Reports to providers must include the Breast Imaging Reporting and Data System density category. Implementing appropriate supplemental screening should be based on patient risk for missed breast cancer on mammography; such assessment should include consideration of breast density and other risk factors. This article discusses strategies for implementation. Currently 21 states and DC have varying insurance laws for supplemental breast imaging; in addition, Oklahoma requires coverage for diagnostic breast imaging. A federal insurance bill, the Find It Early Act, has been introduced that would ensure no-cost screening and diagnostic imaging for women with dense breasts or at increased risk and close loopholes in state laws.

Abstract P5-04-08: Breast cancer screening using ultrasound increases recall, biopsy, and cancer detection rates

Abstract Background: Ultrasound is often used as an adjunct to mammography for breast cancer (BC) screening. Usage of screening ultrasound (US) varies by state, likely due to differences in state-specific breast density notification laws and mandates requiring insurance coverage of supplemental screening for women at elevated risk of breast cancer. Screening US can increase cancer detection rates among women with dense breasts, but may increase recalls and benign biopsies. As more states adopt policies mandating insurance coverage for “medically necessary” breast cancer imaging, it is important to understand the impact to screening US utilization and subsequent service utilization. This analysis examines use of screening US by state as well as associated rates of recall, biopsy, and cancer detection. Methods: We analyzed deidentified administrative claims. We included women aged 18-74 years with ≥1 claim for screening mammography in 2018. First claim was index date. Continuous enrollment was required in a commercial (COM) or Medicare Advantage (MA) plan from 1/2016 to index date (baseline period) and from index date to 6 months after (follow-up period). Recall, biopsy, and cancer detection rates were calculated for the follow-up period. Recall was defined as ≥1 claim for mammography, diagnostic ultrasound, or MRI in the follow-up period. We used CPT/HCPCS codes to identify procedures. Screening US was identified by CPT 76641 (complete) with modifier 50 (bilateral) or LT/RT (left/right). Using ICD codes, cancer detection was defined as ≥1 claim for DCIS or invasive BC. We examined screening US rates by insurance type, state, and age. Proportions were compared with chi-squared tests. Results: 939,410 women met study criteria (70% COM, 30% MA; Tables 1-2). In the COM population, recall, biopsy, and cancer detection rates with screening US were approximately two-fold higher than without (recall: 26.1% vs. 11.8%; biopsy: 5.0% vs 1.6%; cancer detection: 1.0% vs. 0.4%). In the MA population, recall, biopsy, and cancer detection rates with screening US were roughly three-fold higher than without (recall: 23.6% vs 9.0%; biopsy: 5.2% vs 1.6%; cancer detection: 1.9% vs 0.7%). In NY, NJ, and CT, the rate of screening US usage was > 14 times higher than in all other states (29.1% vs 1.9%). These three states had higher recall and biopsy rates, but similar cancer detection rates compared to all other states (recall: 14.4% vs. 11.4%; biopsy: 2.5% vs 1.7%; cancer detection: 0.6% vs. 0.5%). All proportion differences reached statistical significance (p < 0.001). Conclusion: Screening US was associated with increases in recall and biopsy, but modest increases in absolute cancer detection rates. Observed state by state variation of screening US is likely driven by laws requiring zero patient payment insurance coverage of “medically necessary” imaging which, as is the case with NY, NJ, and CT, is interpreted to include screening US. Our results demonstrate that screening US may lead to a large increase in recall rates and biopsies without consequentially improving the cancer detection rate. Table 1: Recall, biopsy, and cancer detection rates by age with and without use of adjunctive breast screening ultrasound in a commercially insured U.S. population * values are suppressed to comply with requirements for data release Table 2: Recall, biopsy, and cancer detection rates by age with and without use of adjunctive breast screening ultrasound in a Medicare Advantage (MA) U.S. population * values are suppressed to comply with requirements for data release Citation Format: James Staib, Rashna Soonavala, Stacey Dacosta Byfield, Kimberly Badal, Kierstin Catlett, Liz Maffey, Mi-Ok Kim, Kenneth Wimmer, Yiwey Shieh, Laura J. Esserman. Breast cancer screening using ultrasound increases recall, biopsy, and cancer detection rates [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-04-08.

Investigating the effectiveness of supplemental breast cancer screening tests considering radiologists’ bias

Breast density is known to increase breast cancer risk and decrease mammography screening sensitivity. Breast density notification laws require physicians to inform women with high breast density of these potential risks. The laws usually require healthcare providers to notify patients of the possibility of using more sensitive supplemental screening tests (i.e., ultrasound and MRI). Since the enactment of the laws, there have been controversial debates over (i) their implementations due to the potential radiologists’ bias in breast density classification of mammogram images and (ii) the necessity of supplemental screenings for all patients with high breast density. In this study, we formulate a finite-horizon, discrete-time partially observable Markov chain to investigate the effectiveness of supplemental screening and the impact of radiologists’ misclassification bias on patients’ outcomes. We consider the conditional probability of eventually detecting breast cancer in early states given that the patient develops breast cancer in her lifetime as the primary and the expected number of supplemental tests as the secondary patient’s outcome. Our results indicate that referring patients to a supplemental test solely based on their breast density may not necessarily improve their health outcomes and other risk factors need to be considered when making such referrals. Additionally, average-skilled radiologists’ performances are shown to be comparable with the performance of a perfect radiologist (i.e., 100% accuracy in breast density classification). However, a significant bias in breast density classification (i.e., consistent upgrading or downgrading of breast density classes) can negatively impact a patient’s health outcomes.

Association Between Lifestyle Changes, Mammographic Breast Density, and Breast Cancer.

In screening for breast cancer (BC), mammographic breast density (MBD) is a powerful risk factor that increases breast carcinogenesis and synergistically reduces the sensitivity of mammography. It also reduces specificity of lesion identification, leading to recalls, additional testing, and delayed and later-stage diagnoses, which result in increased health care costs. These findings provide the foundation for dense breast notification laws and lead to the increase in patient and provider interest in MBD. However, unlike other risk factors for BC, MBD is dynamic through a woman’s lifetime and is modifiable. Although MBD is known to change as a result of factors such as reproductive history and hormonal status, few conclusions have been reached for lifestyle factors such as alcohol, diet, physical activity, smoking, body mass index (BMI), and some commonly used medications. Our review examines the emerging evidence for the association of modifiable factors on MBD and the influence of MBD on BC risk. There are clear associations between alcohol use and menopausal hormone therapy and increased MBD. Physical activity and the Mediterranean diet lower the risk of BC without significant effect on MBD. Although high BMI and smoking are known risk factors for BC, they have been found to decrease MBD. The influence of several other factors, including caffeine intake, nonhormonal medications, and vitamins, on MBD is unclear. We recommend counseling patients on these modifiable risk factors and using this knowledge to help with informed decision making for tailored BC prevention strategies.

Physicians' perceptions of breast density notification laws and appropriate patient follow-up.

Breast density notification laws have been adopted in the absence of consistent guidelines for post-notification follow-up. This can lead to inconsistent and potentially deficient management of women's health due to inconsistent physician practices. We examined physicians' knowledge and practices regarding follow-up for patients who receive density notifications. Physicians who referred patients to a Michigan hospital network for screening mammograms were recruited to participate in survey study; 105 (29.8%) responded. The survey assessed physicians' demographics, knowledge, and awareness of breast density and breast cancer risk and of density notification laws, and perceptions of appropriate follow-up behaviors for their patients who received density notifications. Most physicians (75%) knew about the notification law, and they were generally comfortable responding to breast density questions and deciding on follow-up. Most indicated that additional breast imaging (68.0%), followed by assessing breast cancer risk (24.7%) were appropriate follow-up responses. Physicians who performed breast cancer risk assessments, and who were more comfortable with breast density questions and follow-up decision making, were more likely to propose additional imaging. Male physicians were less likely to propose assessing breast cancer risk, and less likely to propose clinical and/or breast self-examinations. Divergence between practice and guidelines when it comes to supplemental breast cancer screening, coupled with density notification language that promotes additional screening in the absence of consistent evidence, remains concerning. Improved understanding of how density notification recipients and their physicians make decisions about supplemental screening is warranted to ensure that breast cancer risk is properly considered.

Dense Breast Notification Laws' Association With Outcomes in the US Population: A Cross-Sectional Study.

Understanding whether states' breast density notifications are associated with desired effects, or disparities, can inform federal policy. We examined self-reported receipt of personal breast density information, breast density discussions with providers, knowledge about density's masking effect, and association with increased breast cancer risk by state legislation status and women's sociodemographic characteristics. Cross-sectional observational population-based telephone survey of women aged >40 years who underwent mammography within prior 2 years, had no history of breast cancer, and had heard the term "breast density." Among 2,306 women, 57% received personal breast density information. Multivariate regression models adjusted for covariates indicated that women in notification states were 1.5 times more likely to receive density information, and older Black and Asian women of lower income and lower health literacy were less likely. Overall, only 39% of women discussed density with providers; women in notification states were 1.75 times as likely. Older and Asian women were less likely to have spoken with providers; women with high literacy or prior biopsy were more likely. State legislation status was not associated with differences in density knowledge, but Hispanic women and women of lower income or low health literacy had less knowledge regarding density's masking effects; older women were more knowledgeable. Hispanic women and women of lower income or low health literacy were more likely, and middle-aged women less likely, to recognize increased breast cancer risk. Some positive effects were observed, but sociodemographic disparities suggest tailoring of future breast density communications for specific populations of women to ensure equitable understanding.

Abstract PO-238: Breast density knowledge and awareness among Latinas in a low-resource setting: A comparison nationally-representative sample of Latinas

Abstract Objective: Breast density notification laws aim to increase women’s awareness and knowledge about breast density (BD). This study’s aim was to compare BD knowledge and awareness in two Hispanic populations: a safety-net clinic serving Latina population in Maricopa County, Arizona (AZ) and a national sample of Hispanic women participating in an online research panel. Materials/Methods: Women ages 40-74 were recruited at the AZ clinic from 2016-2019 at a screening mammography appointment as part of a larger clinical trial (AZ cohort). Surveys were completed in person (English or Spanish) at enrollment to assess awareness of BD, understanding of BD risk, and mammography history. The same questions were asked in a nationally representative online panel survey conducted in 2017. All data from the national survey were weighted to adjust for probability of selection into the panel and post-stratified to match known U.S. Hispanic population distributions (NS cohort). Univariate comparisons between the clinic and the national panel were performed using Rao-Scott chi-square tests. Associations with awareness and correct knowledge were examined with multivariable logistic regression. All summaries and analyses are weighted, and were performed with SAS version 9.4 SURVEY procedures (SAS Institute Inc., Cary, NC). Results: The analysis included 1332 Hispanic women from the AZ clinic and 152 Hispanic women who completed the national survey. The AZ cohort was younger (mean age: 48.5 vs 52.8), had less education (less than high school: 68.7% vs 34.8% less than high school), more likely to prefer Spanish (92.3% vs 53.1%) and less likely to have had a prior mammogram as compared NS cohort (82.8% vs 90.4%) (all p≤ 0.03). NS cohort was more likely to have awareness of BD (32.6% vs 20.7%); correct understanding of the masking effect of BD, (67.8% vs 37.0%,) and breast cancer risk (72.2% vs 32.6%,), compared to the AZ cohort (all p < 0.004). When adjusted for differences in education, age, language, and screening mammography history, BD awareness was similar between the two cohorts (adjusted odds ratio [ORadj] 0.95, p=0.83). Awareness was positively associated with more education, previous mammogram history, and English language. However, differences in BD knowledge remained (ORadj=2.8 [p=0.03] and 7.2 [P<0.001] for knowledge of masking and risk, respectively). Conclusions: There were significant differences in BD awareness and knowledge between a nationally-representative sample of Latinas and Latinas in a low-resource setting. The differences in BD awareness, but not knowledge, could be explained by education, screening history and preferred language. These findings suggest that a one-size-fits-all approach to raising BD awareness and knowledge will not work. To ensure equitable dissemination of health care to Latina women undergoing screening mammography, future work should be aimed at developing effective tools and resources for educating Spanish-speaking women about BD and risk-based screening. Citation Format: Jillian Leaver, Bhavika K. Patel, Jennifer L. Ridgeway, Sarah Jenkins, Vera Suman, Deborah J. Rhodes, Aaron Norman, Karthik Ghosh, Bijan Borah, Carrie Hruska, Edna Ramos, Davinder Singh, Matt Jewett, Carmen Radecki-Breitkof, Celine Vachon. Breast density knowledge and awareness among Latinas in a low-resource setting: A comparison nationally-representative sample of Latinas [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-238.

Understanding the response of mammography facilities to breast density notification.

State-specific breast density notification legislation requires that women undergoing mammography be informed about breast density, with variation among states. Because mammography facilities are among the main points of contact for women undergoing mammography, research is needed to understand how facilities communicate information on breast density, cancer risk, and supplemental screening to women. A cross-sectional, 50-item, mailed survey of 156 American College of Radiology-certified mammography facilities in North Carolina was conducted in 2017 via the Tailored Design Method. Breast density notification practices, supplemental screening services, and patient educational materials were compared by supplemental screening availability via t tests and chi-square tests. All responding facilities (n=94; 60.3% response rate) notified women of their breast density in the mammography results letter. Breast cancer risk assessments were performed by 36.2% of the facilities, with risk information communicated in the final radiology report for the referring provider to discuss with the woman (79.4%) or in the results letter (58.8%). Supplemental breast cancer screening was offered by 63.8% of the facilities, with use based on multiple factors, including recommendations from the referring physician (63.3%) or reading radiologist (63.3%), breast density (48.3%), other risk factors (48.3%), and patient request (40.0%). Although 75.0% of the facilities offered breast density educational materials, only 36.6% offered educational materials on supplemental screening. In a state with a breast density notification law, mammography facilities communicate breast density, cancer risk, and supplemental screening information to women through various approaches. When supplemental screening is offered, facilities use multiple decision-making criteria rather than breast density alone.

Breast cancer supplemental screening: Women's knowledge and utilization in the era of dense breast legislation.

BackgroundGiven the growth in dense breast notification (DBN) legislation in the United States, we examined the association between different types of DBN laws and supplemental screening behaviors among women.MethodsWe surveyed in March–April 2018 a nationally representative sample of women aged 40‐59 years who received a routine screening mammogram in the past 18 months. Survey items included the following topics regarding supplemental screening: discussing risks or benefits with a provider, knowledge about the risk of false positives, and utilization. We grouped women by state DBN into non‐DBN, generic DBN (mentions breast density but not supplemental screening), DBN that mentions supplemental screening (DBN‐SS), and DBN with mandated insurance coverage for supplemental screening (DBN‐coverage), and estimated adjusted predicted probabilities for supplemental screening behaviors.ResultsOf 1641 women surveyed, 21.3% resided in non‐DBN, 41.2% in generic DBN, 25.8% in DBN‐SS, and 12.5% in DBN‐coverage states. Overall, 23.0% of respondents had discussed supplemental screening with a provider, 11.3% of whom discussed the risks, and 49.5% discussed the benefits. In adjusted analysis, women living in DBN‐coverage states were more likely to discuss supplemental screening (27.5%) than women in non‐DBN states (13.6%); pairwise contrast 13.8% (95% CI, 2.1% to 25.6%; P = .01). They were also more likely to have received supplemental screening for increased breast density (19.3%) compared to women living in non‐DBN (9.9%); contrast 9.4% (95% CI, 1.6% to 17.3%; P = .01), Generic DBN (7.3%); difference 12.0% (95% CI, 4.6% to 19.4%; P =< .001), and DBN‐SS (8.8%); contrast 10.5% (95% CI, 2.6% to 18.5%; P < .01) states.ConclusionsWomen in DBN‐coverage states were more likely to discuss supplemental screening with their providers, and to undergo supplemental screening, compared to women in states with other types of DBN laws, or without DBN laws.

Breast density notification with adjunctive digital breast tomosynthesis (DBT): A cost-effectiveness analysis.

7072 Background: Dense breasts increase a woman's risk of developing cancer while also raising the likelihood of a missed diagnosis from traditional mammography screening. Digital Breast Tomosynthesis (DBT) has been shown to identify positive breast cancer more accurately in women with dense breasts, but no study has estimated the cost-effectiveness of this screening mode under a notification requirement. Methods: Taking the perspective of a healthcare system, we estimated the incremental cost-effectiveness ratio (ICER) of providing DBT as an alternative to mammography for 40-year old women. Model parameters reflecting risk of breast cancer, detection rates, and costs were estimated from recent meta analyses, Tufts’ CEA registry, and Medicare Fee Schedules. We used probabilistic Markov Models to estimate the ICER under uncertainty, and a time-variant model in which breast density and cancer risk change over time. Additionally, a heterogeneity analysis included all women between the ages of 40-65, while also using 1st and 2nd degree family history to calculate cancer risk. Results: In the probabilistic model, adjunctive DBT has a cost differential of $12,203, with an increase of 0.0382 quality-adjusted life years (ICER = $319,491/QALY) compared to mammography. This result was most sensitive to the probability of a missed diagnosis for women with dense breasts. At a willing-ness to pay of $50,000, adjunctive DBT had a 57% chance of being more costly and less effective than standard mammography. Conversely, DBT only had a 20% chance of being cost-effective and a 9.9% chance of being less costly and more effective. The time-variant model reported an ICER of $174,218, but adjunctive DBT became even more cost-effective after expanding the population and including family history of cancer (ICER_All Ages = $157,146; ICER_FamHist = $153,388). Conclusions: Breast density notification laws which provide additional screening via DBT are not cost-effective at a willingness to pay of $50,000. Policymakers, however, should note that many modern cancer therapeutics also exceed this threshold. As an adjunctive screening technique, DBT would result in fewer deaths and increase quality of life, but the effect is minimal and carries a high cost. Including breast density within greater risk stratification protocols, however, may prove highly cost-effective, especially for older women with a family history of cancer.

Screening Breast Ultrasound: Update After 10 Years of Breast Density Notification Laws.

OBJECTIVE. Breast density notification laws have grown from the first state legislation in Connecticut in 2009 to a federally mandated update to the Mammography Quality Standards Act in 2019. CONCLUSION. The increasing recognition of limited mammographic sensitivity in women with dense breasts has led to greater utilization of supplemental screening ultrasound. Robust data support improved detection of small node-negative invasive breast cancers with adjunctive ultrasound. Digital breast tomosynthesis and other emerging modalities may also play a role in screening guidelines.

Dense Breast Notification Laws, Education, and Women’s Awareness and Knowledge of Breast Density: a Nationally Representative Survey

To date, 38 states have enacted dense breast notification (DBN) laws mandating that mammogram reports include language informing women of risks related to dense breast tissue. Nationally representative survey to assess the association between residing in a state with a DBN law and women's awareness and knowledge about breast density, and breast cancer anxiety. Internet survey conducted in 2018 with participants in KnowledgePanel®, an online research panel. English-speaking US women ages 40-59years without a personal history of breast cancer who had received at least one screening mammogram (N = 1928; survey completion rate 68.2%). (1) Reported history of increased breast density, (2) knowledge of the increased risk of breast cancer with dense breasts, (3) knowledge of the masking effect of dense breasts on mammography, and (4) breast cancer anxiety. Women residing in DBN states were more likely to report increased breast density (43.6%) compared with women residing in non-DBN states (32.7%, p < 0.01, adjusted odds ratio, 1.70, 95% CI,1.34-2.17). Interaction effect between DBN states and education status showed that the impact of DBN on women's reporting of dense breasts was significant for women with greater than high school education, but not among women with a high school education or less (p value = 0.01 for interaction). Only 23.0% of women overall knew that increased breast density was associated with a higher risk of breast cancer, and 68.0% of women understood that dense breasts decreased the sensitivity of mammography. There were no significant differences between women in DBN states and non-DBN states for these outcomes, or for breast cancer-related anxiety. State DBN laws were not associated with increased understanding of the clinical implications of breast density. DBN laws were associated with a higher likelihood of women reporting increased breast density, though not among women with lower education.

Knowledge and Perception of Breast Density, Screening Mammography, and Supplemental Screening: in Search of "Informed".

As of 2019, 37 US states have breast density notification laws. No qualitative study to date has examined women's perspectives about breast density in general or by states with and without notification laws. Explore women's knowledge and perceptions of breast density and experiences of breast cancer screening across three states with and without notification laws. Qualitative research design using four focus groups conducted in 2017. Forty-seven women who had a recent normal mammogram and dense breasts in registry data obtained through the Breast Cancer Surveillance Consortium. Focus groups were 90min, audio recorded, and transcribed for analysis. Data were analyzed using mixed deductive and inductive coding. Women reported variable knowledge levels of personal breast density and breast density in general, even among women living in states with a notification law. A number of women were aware of the difficulty of detecting cancer with dense breasts, but only one knew that density increased breast cancer risk. Across all states, very few women reported receiving information about breast density during healthcare visits beyond being encouraged to get supplemental imaging or to pay for new mammography technology (i.e., breast tomosynthesis). Women offered more imaging or different technology held strong convictions that these were "better," even though knowledge of differences, effectiveness, or harms across technologies seemed limited. Women from all states expressed a strong desire for more information about breast density. More research needs to be done to understand how the medical community can best assist women in making informed decisions related to breast density, mammography, and supplemental screening. Options to explore include improved breast density notifications and education materials about breast density, continued development of personalized risk information tools, strategies for providers to discuss evidence and options based on risk stratification, and shared decision-making.

Supplemental Breast Imaging Utilization After Breast Density Legislation in North Carolina

PurposeBreast density notification laws are increasingly common but little is known of how they affect supplemental screening use. The aim of this study was to investigate supplemental screening before and after density notification in North Carolina, where notification has been required since 2014. MethodsBreast screening data from Carolina Mammography Registry participants aged 40 to 79 years with no personal histories of breast cancer or breast implants were evaluated. Supplemental screening was defined as a nondiagnostic digital breast tomosynthesis (DBT), whole-breast ultrasound, or breast MRI performed within 3 months of negative or benign results on screening mammography (2-D or DBT). Supplemental screening before (2012-2013) and after (2014-2016) the notification law was compared using logistic regression. ResultsDuring the study period, 78,967 women underwent 145,279 index screening mammographic examinations. Supplemental screening use was similar before and after the notification law, regardless of breast density (dense breasts: adjusted odds ratio [aOR], 1.01; 95% confidence interval [CI], 0.58-1.75; nondense breasts: aOR, 0.63; 95% CI, 0.38-1.04). Although there was no change in supplemental screening, new use of any screening DBT from 2014 to 2016 was greater for women with dense breasts (versus nondense breasts; aOR, 1.15; 95% CI, 1.08-1.23). ConclusionsData suggest that supplemental screening use in North Carolina did not change after enactment of a breast density notification law, though the increase in new use of any screening DBT was greater for women with dense breasts. The short-term lack of change in supplemental screening should be considered as additional notification laws are developed.

The Impact of Breast Density Notification Laws on Supplemental Breast Imaging and Breast Biopsy

Dense breast tissue increases breast cancer risk and lowers mammography sensitivity, but the value of supplemental imaging for dense breasts remains uncertain. Since 2009, 37 states and Washington DC have passed legislation requiring patient notification about breast density. Examine the effects of state breast density notification laws on use of supplemental breast imaging and breast biopsies. Difference-in-differences analysis of supplemental imaging and biopsies before and after notification laws in 12 states enacting breast density notification laws from 2009 to 2014 and 12 matched control states. Supplemental imaging/biopsy within 6months following an index mammogram were evaluated during four time periods related to legislation: (1) 6months before, (2) 0-6months after, (3) 6-12months after, and (4) 12-18months after. Women ages 40-64years receiving an initial mammogram in a state that passed a breast density notification law or a control state. Mandatory breast density notification following an index mammogram. Use of breast biopsies and supplemental breast imaging (breast ultrasound, tomosynthesis, magnetic resonance imaging, scintimammography, and thermography), overall and by specific test. Supplemental breast imaging and biopsy increased modestly in states with notification laws and changed minimally in control states. Adjusted rates of supplemental imaging and biopsy within 6months of mammography before legislation were 8.5% and 3.1%, respectively. Compared with pre-legislation in intervention and control states, legislation was associated with adjusted difference-in-differences estimates of + 1.3% (p < 0.0001) and + 0.4% (p < 0.0001) for supplemental imaging and biopsies, respectively, in the 6-12months after the law and difference-in-differences estimates of + 3.3% (p < 0.0001) and + 0.8% (p < 0.0001) for supplemental imaging and biopsies, respectively, 12-18months after the law. As breast density notification laws are considered, policymakers and clinicians should expect increases in breast imaging/biopsies. Additional research is needed on these laws' effects on cost and patient outcomes.

Association of State Dense Breast Notification Laws With Supplemental Testing and Cancer Detection After Screening Mammography.

To evaluate the association of state dense breast notification (DBN) laws with use of supplemental tests and cancer diagnosis after screening mammography. We examined screening mammograms (n = 1 441 544) performed in 2014 and 2015 among privately insured women aged 40 to 59 years living in 9 US states that enacted DBN laws in 2014 to 2015 and 25 US states with no DBN law in effect. DBN status at screening mammography was categorized as no DBN, generic DBN, and DBN that mandates notification of possible benefits of supplemental screening (DBN+SS). We used logistic regression to examine the change in rate of supplemental ultrasound, magnetic resonance imaging, breast biopsy, and breast cancer detection. DBN+SS laws were associated with 10.5 more ultrasounds per 1000 mammograms (95% CI = 3.0, 17.6 per 1000; P = .006) and 0.37 more breast cancers detected per 1000 mammograms (95% CI = 0.05, 0.69 per 1000; P = .02) compared with no DBN law. No significant differences were found for generic DBN laws in either ultrasound or cancer detection. DBN legislation is associated with increased use of ultrasound and cancer detection after implementation only when notification of the possible benefits of supplemental screening is required.

Between-Race Differences in Supplemental Breast Cancer Screening Before and After Breast Density Notification Law

Guidelines recommend supplemental breast cancer screening for women at increased breast cancer risk; however, the passage of breast density notification laws may lead to supplemental screening that is incongruent with women’s risk. We examined supplemental screening (ie, MRI, ultrasound, or tomosynthesis within 6 months of screening mammogram) among a sample of 2,764 African American (AA) and 691 European American (EA) women with negative or benign screening mammograms for whom we had data from both before and after implementation of breast density notification laws in the state of Michigan. Results indicated a 5-fold increase (from 0.14% to 0.7% of women) in supplemental screening among screen-negative women after passage of the law, driven in large part by an increase in supplemental screening among AA women. Breast density was more predictive of supplemental screening and had a marginally greater explanatory role in between-race differences in supplemental screening after passage of the law. Subgroup analyses (n = 250) indicated that whereas 5-year breast cancer risk was positively associated with supplemental screening before the law and negatively associated after the law for EA women, 5-year risk was not associated with supplemental screening either before or after passage of the law for AA women. Our findings suggest that whereas passage of the breast density notification laws may have motivated supplemental screening among AA women in particular, it lessened the consideration of breast cancer risk in supplemental screening decision making.

Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.

Despite widespread implementation of mammographic breast density (MBD) notification laws, the impact of these laws on knowledge of MBD and knowledge of breast cancer risk is limited by the lack of tools to promote informed decision-making in practice. To develop and evaluate whether brief, personalized informational videos following a normal mammogram in addition to a legislatively required letter about MBD result can improve knowledge of MBD and breast cancer risk compared to standard care (i.e., legislatively required letter about MBD included with the mammogram result). Prospective randomized controlled trial of English-speaking women, age 40-74years, without prior history of breast cancer, receiving a screening mammogram with a normal or benign finding (intervention group n = 235, control group n = 224). brief (3-5min) video, personalized to a woman's MBD result and breast cancer risk. Primary outcomes were a woman's knowledge of her MBD and risk of breast cancer. Secondary outcomes included whether a woman reported that she discussed the results of her mammogram with her primary care provider (PCP). Relative to women in the control arm, women in the intervention arm had greater improvement in their knowledge of both their personal MBD (intervention pre/post 39.2%/ 77.5%; control pre/post 36.2%/ 37.5%; odds ratio (OR) 5.34 for change for intervention vs. control, 95% confidence interval (CI) 3.87-7.36; p < 0.001) and risk of breast cancer (intervention pre/post: 66.8%/74.0%; control pre/post 67.9%/ 65.2%; OR 1.42, 95% confidence interval (CI) 1.09-1.84; p = 0.01). Women in the intervention group were more likely than those in the control group to report discussing the results of their mammogram with their PCP (p = 0.05). Brief, personalized videos following mammography can improve knowledge of MBD and personal risk of breast cancer compared to a legislatively mandated informational letter. Trial Registration Clinicaltrials.gov (NCT02986360).

Dense Breast Notification Laws: Impact on Downstream Imaging After Screening Mammography.

Dense breast tissue is a common finding that decreases the sensitivity of mammography in detecting cancer. Many states have recently enacted dense breast notification (DBN) laws to provide patients with information to help them make better-informed decisions about their health. To test whether DBN legislation affected the probability of screening mammography follow-up by ultrasound and magnetic resonance imaging (MRI), we examined the proportion of times screening mammography was followed by ultrasound or MRI for a series of months pre- and post-legislation. The subjects were women aged 40 to 64 years, covered by private health insurance, undergoing screening mammography from 2007 to 2014. Except for Hawaii, Maryland, and New York, DBN legislation significantly increased the probability of ultrasound follow-up in all states that implemented DBN legislation before December 2014. It also increased the probability of MRI follow-up in California, North Carolina, Pennsylvania, and Texas. The financial and access consequences merit further study.