Breast density laws: Are you in compliance?

November 21, 2016

Meant to alert women that breast cancer may be more difficult to detect, the laws confuse physicians and patients alike.

by Jay Goldberg, MD, MSCP; Sara Mirghani, MD; and Sarah Woodman, MD

None of the authors has a conflict of interest to report with respect to the content of this article.

 

Many ob/gyns are confused or know little about multiple recently enacted state laws and proposed federal legislation related to screening mammograms that report increased breast density. These laws mandate or at least imply that a physician needs to take action when confronted with such a test result, but in general, they are not supported by known clinical facts.

The issue of mammographic breast density is well known in the radiology community whereas very little has been published about it in the ob/gyn and primary care literature. Failure to comply with your state’s breast density on mammography notification law, however, may place you at medico-legal risk if your patient later is diagnosed with breast cancer.

The Breast Imaging Reporting and Data System (BI-RADS) has 4 categories of parenchymal breast density on mammography: almost entirely fat, scattered fibroglandular densities, heterogeneously dense, and extremely dense (Figures 1 and 2). The last 2 categories, considered increased breast density, are noted in approximately half of mammography studies.

Dense breast tissue absorbs more radiation during mammography than does fatty breast tissue. This theoretically reduces the accuracy of mammography to detect breast cancer, but additional imaging of dense breasts does not statistically improve the diagnostic accuracy of mammography. In addition, compared to average breast density, the relative risks of breast cancer in women with heterogeneously dense and extremely dense breasts are reported to be increased by factors of 1.2 and 2.1, respectively.1

Connecticut enacted the first reporting law regarding mammographic breast density in 2009. Currently 24 states have similar laws requiring patient notification of increased breast density found on mammography. Many of these state laws also require or imply the need to offer patients the option of additional breast imaging. Only 4 states (Illinois, Indiana, Massachusetts, and New Jersey), however, mandate insurer financial coverage of additional breast imaging due to increased mammographic breast density (Figure 3).

The following 2 cases illustrate scenarios that many ob/gyns who order screening mammograms may face.

 

 

Case 1 

A 45-year-old woman had an appointment with her ob/gyn for an annual examination. She had no complaints and no family history of or risk factors for breast cancer. As part of the patient’s check-up, her physician performed a breast examination. It revealed no breast masses, nipple discharge, tenderness, or any other pathology. A screening bilateral mammogram recommended and ordered by the ob/gyn was performed.

The patient later received a letter from the radiologist that stated in bold at the top of the page, “We wish to inform you that the results of your recent mammography examination are normal.” Below, within a descriptive paragraph, it said, “Your mammographic breast density is considered dense. Dense breast tissue is a common finding and is not abnormal. A report of your results was sent to your physician.” The letter did not say anything about further discussing the significance of increased breast density with a provider.

The ob/gyn received a different mammography report from the radiologist, which stated that the screening mammogram was classified as “BI-RADS 1: Negative evaluation.” Listed under Impression were “1) No mammographic evidence of malignancy in either breast.” and “2) A bilateral mammogram is recommended in one year.” Within a descriptive paragraph in the body of the report was a statement “The breast tissue is extremely dense.” The ob/gyn was not provided with the letter that had been sent to the patient.

Image courtesy of Debra Somers Copit, MD, FACR

The ob/gyn, who knew about the requirement to notify a patient and offer additional breast imaging to patients with increased breast density, searched through the provider report to determine the patient’s breast density category. She then called the patient to discuss her increased mammographic breast density and offered her the option of additional breast imaging, either magnetic resonance imaging (MRI) or ultrasound. The patient initially was confused about why the ob/gyn was offering additional breast imaging, given the results letter from the radiologist telling her that her mammogram was normal. After the patient talked with her ob/gyn about her increased breast density, she asked to undergo a bilateral breast MRI despite having no symptoms.

Because the woman’s healthcare insurer was not required by state law to pay for additional testing, coverage was declined for the MRI and the ultrasound, with the rationale that additional breast imaging was not clinically indicated. The patient still had the option of undergoing additional imaging with an MRI or ultrasound but would be personally responsible to pay $2400 or $250, respectively.

The patient was unable to afford the additional imaging out of pocket. She remained anxious and upset about the alerts of her increased breast density on screening mammography.

Case 2

A 49-year-old asymptomatic woman with a recent normal check-up, including a breast exam, was referred by her ob/gyn for a screening bilateral mammogram.

The patient later received a letter from the radiology center that stated in bold at the top of the page “We wish to inform you that the results of your recent mammography examination are normal.” Below, within a descriptive paragraph, it also said, “Your mammographic breast density is considered dense. Dense breast tissue is a common finding and is not abnormal. A report of your results was sent to your physician.”

The ob/gyn received a mammography report from the radiology center, which said that the study was classified as “BI-RADS 1: Negative evaluation.” Listed under Impression were “1) No mammographic evidence of malignancy in either breast.” and “2) A bilateral mammogram is recommended in one year.” Within a descriptive paragraph was a statement, “The breast tissue is heterogenously dense.” The ob/gyn was not provided with the letter that had been sent to the patient.

Also read: Are breast density letters too dense?

The patient, believing that her “normal” mammogram required no additional action, did not contact the ob/gyn for further discussion. No further action was taken by the ob/gyn, either because he was not aware of the state law that required notification and an offer of additional imaging to patients with increased mammographic breast density, he did not notice the finding of increased breast density in the otherwise normal report, or he believed it would be taken care of by the radiologist.

 

 

One year later, after new microcalcifications were noted on the patient’s next screening mammogram, a biopsy found invasive ductal breast carcinoma. She underwent a unilateral mastectomy, axillary node dissection, chemotherapy, and radiation treatment for Stage II breast cancer.

The patient filed a lawsuit claiming that the ob/gyn negligently failed to comply with the state’s breast density notification act. The woman stated that she would have elected to undergo a breast MRI if it had been offered to her, given her increased mammographic breast density. She alleged that an MRI would have led to earlier diagnosis and treatment of her cancer, as well as a greater likelihood of survival.

Society positions

The 2015 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion 625, Management of Women With Dense Breasts Diagnosed by Mammography, relates that no studies have demonstrated earlier detection or improved prognosis when additional breast imaging is obtained in patients with mammographically dense breasts. ACOG advocates against routinely recommending additional breast imaging in otherwise asymptomatic women with increased breast density. Despite the absence of clinical evidence, it is ACOG’s opinion that physicians should comply with state laws requiring disclosure of increased mammographic breast density, many of which mandate offering additional breast imaging.2

The American College of Radiology (ACR) recommends that women with dense breasts on mammography talk to their doctor to decide which, if any, additional screening exams are right for them.3

The Society of Breast Imaging (SBI) encourages use of the ACR’s BI-RADS lexicon, including the 4 categories for breast parenchymal density, and recommends their use in all mammography reports. SBI believes that these data can be used together with other pertinent patient medical information, such as family history of breast cancer and the patient’s own cancer history and surgical history, to decide if additional overall risk assessment and/or supplemental screening is warranted.4

In a recent study performed at our institution, only 18% of asymptomatic women undergoing screening mammography were aware of breast density notification laws. Forty percent of women reported that they would be worried or anxious if notified of increased breast density in an otherwise normal mammogram. Eighty-four percent would choose to undergo additional breast imaging if the cost were completely covered by insurance. Forty-four percent, however, reported being willing to bear the out-of-pocket cost ($2400 for a breast MRI or $250 for a breast ultrasound) if denied insurance coverage. Ninety-eight percent of women believed that insurance coverage for additional imaging should be required if increased breast density was present. Eighty-eight percent believed that breast density notification laws were economically discriminatory.

Another study of ob/gyns and primary care physicians who order screening mammograms at our institution found that 59% reported having a clinical understanding of the significance of increased breast density, but only 21% were aware of the 4 different categories of breast density. Only 32% were aware of the applicable breast density notification state law. When they receive a screening mammogram report read as normal but with increased breast density in an asymptomatic woman, 60% of providers normally do nothing, 19% of respondents will personally notify the patient of increased breast density, and 21% also offer additional breast imaging (Figure 4).

Eighty-five percent of ordering providers primarily relied upon the radiologist’s recommendation regarding whether additional imaging was indicated. When reviewing a screening mammogram report, 64% of providers only focus on the radiologist’s comments under “Impression/Recommendations” rather than routinely reading the entire report.

 

Risk management problem areas

Common reasons provided for not complying with a state’s breast density law include a lack of awareness of and confusion about the law; poor results communication between radiologists and ordering providers; not believing that additional action was clinically indicated; not believing that patients would elect to undergo additional breast imaging, which often is not paid for by insurance; and an often-false assumption that any additional action was solely the responsibility of the radiologist.

An area for improvement that we identified at our institution was formatting of screening mammogram result letters sent to patients and providers. The category of breast density was included in the body of the provider report, but it was not included under the “Impression/Recommendations” section that most providers focus solely on. Mammography result letters sent to patients did mention if increased breast density was present but it was not obvious and the wording did not facilitate the legally implied discussion between patient and provider.

Only rarely did providers discuss with their patients increased mammographic breast density. These reporting issues were felt to potentially legally expose providers who order screening mammograms in regards to the state’s Breast Density Notification Act.

Additional issues

Many healthcare providers find the issue of breast density confusing because while many states require routinely notifying patients and offering them additional imaging, there are no clinical data supporting these mandates. Is written notification from the radiologist or healthcare provider legally acceptable or must a discussion occur? If a woman’s breast density is not reported as significantly changed from year to year, are providers legally required to repeat a discussion regarding increased mammographic density and possibly offer additional imaging every time a screening mammogram is performed?

Adding confusion to this point is the fact that there is considerable interobserver and intraobserver variability in the subjective classification of mammographic breast density.5 What is the economic cost to insurers and women? Do breast density notification laws actually lead to earlier detection and treatment of more breast cancers, as well as improved survival? Do these laws lead to more unnecessary benign breast biopsies, and at what emotional toll for the 50% of women being notified of their increased breast density?

Clearly, it would have been preferable to first have conducted properly designed research studies to answer these questions before enacting breast density notification laws.

 

 

Risk management interventions

To improve compliance with state breast density laws and limit legal exposure, a committee was formed at our institution from representatives of our health care system’s departments of ob/gyn, medicine, radiology, and risk management. This interdisciplinary cooperation resulted in implementation of several simple interventions.

(1) Providers who order screening mammograms have been educated regarding the significance of increased breast density on mammography and the corresponding state law. (2) Mammogram reports sent to ordering providers have been reformatted so that the breast density category is now more obvious and listed in the “Impression/Recommendations” section. (3) Result letters sent to patients now include the following wording: “The American College of Obstetricians and Gynecologists has addressed increased breast density, noting that no research studies have demonstrated earlier cancer detection or improved prognosis when additional breast imaging is obtained. ACOG advocates against routinely recommending additional breast imaging in otherwise asymptomatic women with increased breast density on mammogram. Some patients, however, wish to discuss increased breast density further or are interested in obtaining additional breast imaging. If you also do, given the complexity of the issue, you should schedule a breast density consult with your provider.”

Most providers do not comply with state laws requiring or implying patient notification and possibly offering the option of additional breast imaging. Simple interventions, such as clinician education and reformatting screening mammography result letters to both patients and providers, can improve compliance with breast density notification laws and limit legal liability.

The authors wish to acknowledge the assistance of Robin Metcalfe-Klaw, BS; Debra Copit, MD; Christopher Scaven, DO; Arnold Cohen, MD; and David Jaspan, DO.

 

References

1. Sickles EA. The use of breast imaging to screen women at high risk for cancer. Radiol Clin North Am. 2010;48:859–878.

2. ACOG Committee Opinion 625, Management of women with dense breasts diagnosed by mammography. 2015.

3. ACR Statement on Reporting Breast Density in Mammography Reports and Patient Summaries, 2012.

4. Society of Breast Imaging letter to the NMQAAC on Recording Breast Density in Mammography Reports and Patient Lay Summaries, 2011.

5.  Freer PE. Mammographic breast density: Impact on breast cancer risk and implications for screening. RadioGraphics. 2015;35:302–315.