News | Mammography | September 28, 2015

UC Davis Researcher Advocates Ending Medicare Coverage of Controversial Mammography Tool

Editorial responds to study finding computed-aided detection did not improve, and even hampered, cancer detection in mammograms

UC Davis, Joshua Fenton, computer-aided diagnosis, mammograms, breast cancer, Constance D. Lehman

September 28, 2015 — A costly tool used on nearly all mammograms does not increase cancer detection rates and should no longer be covered by Medicare, argues Joshua Fenton, a family physician and comparative effectiveness researcher. Fenton’s editorial on the subject was published online Sept. 25 in the Journal of the American Medical Association Internal Medicine.

Fenton’s editorial responds to a study published in the same issue that announces findings from the largest study ever on computer-aided detection (CAD), a tool approved by the U.S. Food and Drug Administration nearly 20 years ago to help radiologists interpret screening mammograms by automatically marking potentially suspicious spots for further radiological review.

The study was led by Constance D. Lehman, M.D., Ph.D., currently director of breast imaging and co-director of the Avon Comprehensive Breast Evaluation Center at Massachusetts General Hospital in Boston, who conducted the research while at the University of Washington in Seattle. University of California Davis Dean’s Professor in Biostatistics Diana Miglioretti was senior author on the study, which found that CAD used with mammography did not improve the accuracy of diagnosis, and that its use may in fact result in missed cancers.

“The study by Lehman, et al., provides evidence that CAD yields no clear benefits in a large, diverse U.S. sample of women undergoing digital mammography,” Fenton wrote. “Thus we should question whether society should continue to pay for CAD use.”

Using data from the Breast Cancer Surveillance Consortium, Lehman’s observational study looked at 323,973 women undergoing digital screening mammography in diverse U.S. practices between 2003 and 2009. Mammograms were interpreted by 271 radiologists from 66 facilities. Tumor registry data identified 3,159 breast cancers within one year of screening.

For the study, the researchers analyzed the mammography performance, including its sensitivity (the proportion of cancers positively detected), specificity (the proportion of accurate negative findings), the number of cancers detected during mammography and those discovered within 12 months of a negative mammogram finding. They found that screening performance was not improved with CAD on any one of the assessed metrics. In fact, they found that sensitivity was significantly decreased for mammograms interpreted with CAD among radiologists who interpreted results with and without the added technology.

In the editorial, Fenton, who also has published several research articles about the merits of CAD, said any potential positive effects of CAD may be undetectable in the context of digital mammography, which may improve the radiologist’s interpretation regardless of CAD.

Since Medicare agreed to cover the cost of CAD in 2000, its use has surged to over 90 percent of U.S. mammograms. Lehman estimated that its prolific use adds up to more than $400 million per year, or $1 of every $10,000 spent on healthcare.

Miglioretti, who was senior author on the Lehman study and has a joint appointment as a senior investigator at Group Health Research Institute, said the results of the CAD research suggest that federal regulators and payers should base coverage determinations on facts.

“We need to make sure there is stronger evidence for new technologies before we start paying for them,” she said, “and before people are charged extra money for them.”

For more information:

Related Content

Mammography Protections Included in Omnibus Spending Bill Can Save Lives
News | Mammography | March 23, 2018
An extension of current protections included in the Consolidated Appropriations Act (HR 1625), signed into law by...
Three More States Pass Breast Density Notification Bills
News | Breast Density | March 22, 2018 | Emily Clemons
March 22, 2018 – Utah, Washington state and Florida have all recently mandated that...
ASTRO Issues Clinical Guideline for Whole Breast Radiation Therapy
News | Radiation Therapy | March 12, 2018
The American Society for Radiation Oncology (ASTRO) today issued a new clinical guideline for the use of whole breast...
Fujifilm Debuts Aspire Bellus II, A New Multimodality Mammography Workstation
News | Mammography | March 08, 2018
March 8, 2018 –   Fujifilm Medical Systems U.S.A. Inc., a provider of diagnostic imaging products with a comprehensiv
Breast cancer screening guidelines may lead to delayed diagnosis in nonwhite women
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – The current guidelines for mammographic...
Four compelling reasons to begin annual mammograms at 40
News | Mammography | March 07, 2018
Turning 40 is a benchmark birthday for many women in the United States.
Fujifilm introduced a DBT option to the Aspire Cristalle full-field digital mammography (FFDM) system in 2017 following FDA approval for the upgrade.

Fujifilm introduced a DBT option to the Aspire Cristalle full-field digital mammography (FFDM) system in 2017 following FDA approval for the upgrade.

Feature | Breast Imaging | March 07, 2018 | By Jeff Zagoudis
In the world of breast imaging, digital breast tomosynthesis (DBT) is a relative newcomer, only being adopted into...
Katherine Hall, M.D.

Katherine Hall, M.D.

Sponsored Content | Case Study | Mammography | March 06, 2018
Located in a spacious 25,000-square-foot facility on the Presbyterian Hospital of Dallas campus, Southwest Diagnostic...
Another benefit of tomosynthesis is reducing patients’ radiation exposure, which is especially important if they need additional testing.

Another benefit of tomosynthesis is reducing patients’ radiation exposure, which is especially important if they need additional testing.

Feature | Women's Health | March 06, 2018 | By Katherine Hall, M.D.
Technological advances — particularly the adoption of 3-D digital breast tomosynthesis (DBT) — are making it possible...
Overlay Init