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Radiologist: Thou Shalt Disclaim by Law

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By Saurabh Jha, MD

There is an old joke. What’s a radiologist’s favorite plant? The hedge.

Radiologists are famous for equivocating, or hedging.

“Pneumonia can’t be excluded, clinically correlate”. Or “probably a nutrient canal but a fracture can’t be excluded with absolute certainty, correlate with point tenderness”.

Disclaiming is satisfying neither for the radiologist nor the referring physician. It confuses rather than clarifies. So one wonders why legislators have decided to codify this singularly unclinical practice in the Breast Density Law.

The law requires radiologists to inform women that they have dense breasts on mammograms. So far so good.

The law then mandates that radiologists tell women with dense breast that they may still harbor a cancer and that further tests may be necessary.

You may quibble whether this disclaimer is an invitation or commandment for more tests, or just shared decision-making, the healthcare equivalent of consumer choice.

But it’s hard to see why any woman would forego supplementary tests such as breast ultrasound, magnetic resonance imaging and 3 D mammogram, or all three, when their anxiety level is driven off the scale.

What piece of incontrovertible evidence inspired this law, you ask?

Perhaps a multi-center trial run over 10-15 years that randomized women with dense breasts to (a) mammograms plus additional screening and (b) screening mammograms alone, show that additional screening saves lives, not just find lots of small inconsequential cancers.

No. The law was instigated by a heart-rending anecdote, which avalanched into the “breast density awareness” movement, cloaked by an element of scientific plausibility: women with dense breasts may have a higher incidence of cancer; a conjecture of considerable controversy.

Wasn’t  the Affordable Care Act (ACA) supposed to usher an era of rational policy-making, guided by p values, statistics not anecdotes?

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The Breast Density Bill: A (Very) Dense Dilemma …

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By ANUBHAV KAUL,  MD and JENNIFER BROKAW, MD

The passage of the Affordable Care Act (Obamacare) and the reelection of President Obama was cause for real hope among those in pursuit of the Holy Grail in medicine: higher quality at lower cost. However, with the passage of what is called the Breast Density Bill in several states, the quality cost equation seems doomed on both ends.  The Affordable Care Act mandates coverage of screening mammograms, without co-pay or deductible, but the Breast Density Bill is destined to push utilization of “non-beneficial” imaging, ie imaging that does not clearly save lives, even further.

The new law, authored by Sen. Joe Simitian, was signed into law this past October in California.  Beginning April of next year, the bill requires facilities that perform mammograms to include a special notice, within the imaging report sent to patients, regarding the high density of breast tissue and the benefit of additional screening tests.   The notice will state the following; “Because your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests, depending on your individual risk factors”.

The supporters of the bill make the ethical argument that women have the right to know about how dense breast tissue can obscure mammogram visualization, and should be offered additional test such as ultrasound and magnetic resonance imaging (MRI) to alleviate the doubt.  To provide further support, the SOMO INSIGHT Breast Cancer Screening Study is a nationwide research effort to evaluate if automated breast ultrasound done together with routine screening mammogram is more accurate in detecting breast cancer in women with dense breast tissue.  The study is funded by U-Systems, Inc.; the Silicon Valley based company responsible for the sophisticated and expensive ultrasound technology used in this study.  Thus, one cannot deny the possibility of patient interest being confounded by financial interest.

The patient advocacy movement around breast cancer has been championed by several well-known non-profits, such as Susan B Komen, Are You Dense Inc. and even endorsement by the National Football League.  Yet, the confusion about screening is reflected in the variability of requirements for insurance coverage between states. For example, while Texas and Mississippi require screening mammograms to be covered for all women 35 and older, Utah has no coverage requirement and several other states do not require coverage until age 40.1 Awareness of breast cancer screening is necessary, and the complexities of picking up certain irregularities certainly deserve attention. However, the patient’s “right to know” should also include the right to know about “over-diagnosis”.
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