The significance of the MQSA updates and ACP guidelines

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The significance of the MQSA updates and ACP guidelines

July 31, 2019
Women's Health
From the July 2019 issue of HealthCare Business News magazine

By Dr. Nila H. Alsheik

The breast imaging community has witnessed a number of rapidly evolving, impactful developments over the last few months.
The U.S. Food and Drug Administration (FDA) proposed updates to its regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 for the first time in twenty years, acknowledging the pivotal role of breast density in cancer detection and requiring uniform reporting of breast density to patients and medical providers nationwide.

The American College of Physicians (ACP) then published new breast screening guidelines recommending women of average risk initiate biannual breast cancer screening at age 50, instead of annual screening mammography at age 40 as recommended by the American College of Radiology (ACR). As the ACR contends, these new recommendations have the potential to result in up to 10,000 additional and unnecessary breast cancer deaths in the U.S. each year. Most recently, the American Society of Breast Surgeons (ASBrS) released a consensus statement supporting the initiation of annual screening mammography at age 40 for women at average risk, preferably with digital breast tomosynthesis. While the proposed changes to the MQSA represent a major step forward in breast health, the new ACP guidelines represent a dangerous, unqualified regression.

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There will be an estimated 271,270 new invasive breast cancer cases in women in the U.S. in 2019, resulting in 42,260 breast cancer deaths. Screening mammography is the only breast imaging modality demonstrated to reduce mortality secondary to breast cancer in randomized, controlled clinical trials. The literature clearly substantiates the value-add of digital breast tomosynthesis (DBT) in reducing recall rate and increasing cancer detection rate across all breast densities. For this reason, Advocate Health Care uniformly operationalized DBT screening in 2014 across our broad metropolitan geographic footprint. At the site level, we are now at nearly 100 percent DBT screen utilization, with nearly 80 percent DBT screen utilization systemwide. Shortly after initiating DBT screening in 2014, our health care system began dense breast reporting to patients, despite the fact that this was not mandated in our state until January of 2019. Recognizing the critical importance of educating our referring providers, dense breast reporting was also extended to referring provider reports in 2017. We continue to provide best-in-class screening technology to all patients, prioritizing patient and referring provider education and empowerment, as shared decision-making based upon personalized screening assumes critical importance in today’s imaging ecosystem.

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