Should MDs Be Required to Report Breast Density to Patients?

Neil Osterweil

December 05, 2013

Dense breast tissue can mask cancerous tumors on mammography and is a cancer risk factor, but how should this finding be reported to patients?

It seems unclear, at present, whether physicians should be legally required to inform women about the presence of dense breast tissue and the potential diagnostic and prognostic implications of doing — or not doing — additional testing to confirm or rule out breast cancer. Currently, only the United States has such a legal requirement, and only some states.

As of this writing, 18 states have enacted dense breast notification laws, and 10 more have laws pending (a proposed law at the federal level withered on the vine in 2011). But exactly who is supposed to do the reporting and what they are supposed to tell patients varies from state to state, note Soudabeh Fazeli Dehkordy, MD, MPH, and Ruth C. Carlos, MD, MS, from the Department of Radiology at the University of Michigan School of Medicine in Ann Arbor.

Their review of the current state of breast density notification legislation in the United States is part of an imaging screening series published in the December issue of the Journal of the American College of Radiology.

In Nevada, where a notification law was enacted in June, the law specifies that reporting results is the responsibility of "the owner, lessee, or other person responsible for the radiation machine for mammography"; in other states, the onus falls on an unspecified provider or physician — radiologist, primary care practitioner, whomever.

In California, the informant — any healthcare facility or physicians' office where mammography is provided — must send a letter to patients informing them, in part, that "your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer."

The letter notes that the patient should discuss her options, including the need for additional testing, with her physician.

Yet California and most other states do not specify whether insurers must cover the extra testing, which could put women with dense breasts at a financial disadvantage.

"Regardless of the benefit of these additional screening tests, legislated recommendations for possible additional testing is typically unaccompanied by legal provision for insurance coverage. Because these additional tests are not usually covered in the screening population, implementation may place additional financial burdens on many women with dense breasts and potentially result in unequal access in states that do not mandate insurance coverage of additional testing," Drs. Dehkordy and Carlos write.

Individual Discretion

Legislating the conversation may increase uncertainty for women about what to do next. Dr. Mary Lou Smith

In another report in the series, a 2-time breast cancer survivor argues that the scope of the discussion about breast density should be left to women and their physicians, not to legislators.

Mary Lou Smith, JD, MBA, cofounder of the Research Advocacy Network in Napierville, Illinois, argues that "there are too many unanswered questions about the meaning of breast density for individual women and how much of a factor it should be in discussing a woman's overall breast cancer risk. Legislation may be asking physicians to do too much with this conversation, discussing population-level risk, translating this to an individual woman's risk, conveying uncertainty about the actual risk, and seeking to reassure patients at the same time."

She adds that because of uncertainties about clinical alternatives to mammography and whether additional testing is covered by insurance, "legislating the conversation may increase uncertainty for women about what to do next."

However, in another report, another breast cancer survivor and advocate for notification laws explains why she supports such legislation and has been lobbying the US Food and Drug Administration (FDA) to adopt national standards for notification as part of the federal Mammography Quality and Standards Act.

"Giving women information about their dense tissue, which is material to their healthcare, must not be dependent upon screening codes, workflow issues, reimbursement rates, and the myriad other reasons cited as to why the standardization of dense breast tissue notification through legislation is opposed," writes Nancy Cappello, PhD, director of Are You Dense, Inc. and Are You Dense Advocacy, Inc.

Dr. Cappello told Medscape Medical News that she learned about breast density only after being diagnosed with stage IIIC breast cancer, just 6 weeks after having a mammogram that was reported to be normal.

"No one bothered to tell me about the effects of breast density on mammogram results until I was diagnosed at such a late stage. Unfortunately, I hear similar stories from women just like me. I'm not just an 'n of 1'; I represent thousands of women across the globe who do not have access to an earlier cancer diagnosis," she said.

When her tumor was diagnosed, it was more than 1 inch in diameter and had metastasized to 13 lymph nodes.

"I expected, in the event of a cancer diagnosis, an early stage because of my faithful program of annual screening mammography. I questioned my doctors as to what had happened. This was the first time that I was told that I had extremely dense tissue and that, as breast density increases, the sensitivity of mammography decreases," she writes.

North American Phenomenon?

To date, the United States appears to be the only nation with breast density notification laws on the books, although Canada is considering a national law calling on Canadian health authorities to promote information about breast density.

Dr. Cappello reports that in Austria, the standard of practice is to offer additional imaging studies to women with dense breasts.

In the United States, the federal Mammography Quality and Standards Act currently requires that information about breast density be included in the radiology report sent to the referring clinician, but does not require patients to be informed. According to the FDA, revised regulations regarding a nationwide notification standard will likely be submitted for public comment.

Most states with breast density notification laws call for notifying women about the possible need for additional testing. Yet a 2012 position statement on reporting breast density from the American College of Radiology (ACR) notes that "the assessment of breast density is not reliably reproducible. When the same mammogram is interpreted by a different physician or by the same physician on different occasions, differing density can be reported. If these variations are reported to each woman screened on each occasion, it might result in confusion or an impression of the lack of reliability of mammography."

The significance of breast density as a risk factor for breast cancer is highly controversial. ACR position statement

The statement explains that reporting breast density could give women with fatty breasts "a false sense of security about negative mammography results," and adds that "the significance of breast density as a risk factor for breast cancer is highly controversial. Moreover, there is no consensus that density per se confers sufficient risk to warrant supplemental screening."

Dr. Smith concurs, noting that mammographic density "is an imaging finding, not a clinical finding." Highly dense breast tissue can obscure the presence of breast tumors, she writes, adding that "whether reducing breast density also reduces the risk for breast cancer remains an unanswered question."

She points to a study that looked at data from the US Breast Cancer Surveillance Consortium (J Natl Cancer Inst. 2012;104:1218-1227). It demonstrated that breast density on mammography is not associated with death from breast cancer or from any other cause in analyses adjusted for patient and tumor factors. The authors conclude that "risk factors for the development of breast cancer may not necessarily be the same as factors influencing the risk of death after breast cancer has developed."

Denial of Patient Rights

Dr. Cappello, however, says that withholding information about breast density constitutes a denial of woman's right to make informed decisions about her care. She notes that there is no clinical evidence to support the idea that tumors not visible on mammography but detected by other means (such as ultrasound or MRI) are less clinically significant.

"We've known for a decade and a half now that breast density is the strongest predictor of the failure of mammography to find breast cancer, and women with dense breasts have a 17-fold increase in interval cancers," she explained.

"Doctors have known about this, and radiologists have reported it, for years. If it's that important to report it to the referring doctor, shouldn't the woman who has it also know it?" she added.

The review by Dr. Dehkordy and Dr. Carlos was funded in part by a grant to Dr. Carlos from the ECOG-ACRIN Cancer Research Group. Dr. Carlos is chair of the Association of University Radiologists–General Electric Radiology Research Academic Fellowship. Dr. Smith has disclosed no relevant financial relationships. Dr. Cappello is director of Are You Dense, Inc., and Are You Dense Advocacy, Inc., both of which receive sponsorships and grants from imaging facilities, device manufacturers, hospitals, and healthcare businesses.

J Am Coll Radiol. 2013;10:899-902, 903-908, 909-912. Dehkordy and Carlos abstract, Cappello abstract, Smith abstract


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