Breast density laws: Are you in compliance?
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.
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.
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.