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Date: May 23, 2005
Contacts: Christine Stencel, Media Relations Officer
Michelle Strikowsky, Media Relations Assistant
Office of News and Public Information
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New Performance Audit Requirements Needed To Ensure and Improve Accuracy in Interpreting Mammograms

WASHINGTON -- To help breast imaging facilities determine how accurately they are interpreting mammograms, the Food and Drug Administration should require the facilities to collect additional data that can be used to better measure their staffs' performance, says a new report from the Institute of Medicine of the National Academies. The reimbursement rate for mammography should be boosted to cover additional staff time and other expenses needed for the enhanced audit, said the committee that wrote the report.

"The audit currently required under the Mammography Quality Standards Act (MQSA) is not as useful as it could be for improving the reliability and accuracy of these readings," said committee chair John Ball, executive vice president, American Society for Clinical Pathology, Chicago. "The effectiveness of mammography greatly depends on how well staff interpret breast images. We've proposed both mandatory and voluntary ways to enhance the measurements used to assess performance."

To prepare for the anticipated reauthorization of MQSA in 2007, Congress asked the Institute of Medicine to examine whether additional steps could be taken to improve the accuracy of mammography interpretation or to enhance regulatory oversight. Although the technical quality of mammography has improved significantly since MQSA was passed in 1992, questions remain about the quality of mammogram interpretation, which is subjective and difficult to measure. Accurate interpretation is important because missed cancers can reduce mammography's potential to save lives. On the other hand, "false positive" readings lead to unnecessary biopsies that entail pain and emotional stress for patients, as well as additional costs.

MQSA currently does not require mammography facilities to calculate any specific statistics to measure their staffs' accuracy, so the ways that facilities try to track their performance vary a great deal. The IOM report recommends that mammography facilities be required to undertake three new standardized performance measurements. All facilities should determine the proportion of their patients who are diagnosed with breast cancer after receiving a recommendation for biopsy as a result of the reading of their breast images. In addition, facilities should determine their cancer detection rate, which is the number of patients found to have breast cancer per every 1,000 examined. Facilities also should calculate the proportion of patients whose mammograms revealed a possible abnormality.

When the Centers for Medicare and Medicaid Services and other public and private health insurance providers establish reimbursement rates for mammography, the rates should be high enough to cover the additional technical and professional costs associated with fulfilling these new audit requirements, the report says. The costs for the current tracking requirements were never factored into existing reimbursement rates.

To further improve the quality of mammography interpretation, the committee called for incentives to encourage facilities to participate in two voluntary programs that would collect even more information on patients and their outcomes. A central data center should be established to store the information generated by these voluntary programs so that it can be used to provide feedback to physicians.

An incentive for participation in one of these voluntary efforts might be to handle misdiagnoses of patients through a no-fault medical liability system rather than the traditional malpractice tort system. The goal of a no-fault system would be to compensate patients more quickly and spare them and physicians lengthy and costly court battles. Physicians would have to demonstrate a track record of high-quality performance to use the no-fault system, the report noted, and the system would first have to be pilot tested.

The committee considered a number of other approaches for improving physicians' performance in interpreting mammograms, such as increasing doctors' experience by boosting the volume of images that they are required to read. Currently, physicians in the United States are required to examine 960 mammograms every two years, compared to 5,000 per year in the United Kingdom. However, studies of how volume affects accuracy have yielded mixed results, and the committee concluded that increasing the required volume could indirectly hinder the availability of mammography in some areas of the country.

To truly ensure quality cancer screening and diagnosis, MQSA should be expanded to include new and emerging breast imaging technologies in addition to mammography. Several other technologies such as ultrasound and MRI are already used routinely for diagnosing breast cancer, but the quality and accuracy of these imaging methods varies. The committee recommended mandatory accreditation for facilities that perform breast ultrasound and MRI.

The study was sponsored by the Food and Drug Administration. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.

A pre-publication version of Improving Breast Imaging Quality Standards is available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at ]

National Cancer Policy Board

Committee on Improving Mammography Quality Standards

John Ball, M.D., J.D. (chair)
Executive Vice President
American Society for Clinical Pathology

Patricia Carney, Ph.D.
Assistant Dean, Associate Professor, and Co-director of the Office of Community-Based Education and Research
Dartmouth Medical School, and
Cancer Control Program Director
Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
Lebanon, N.H.

Howard Forman, M.D., M.B.A.
Associate Professor of Diagnostic Radiology
Yale School of Medicine;
Program on Healthcare Leadership and Management
Yale School of Management; and
Lecturer, Department of Economics, and Director of the Combined M.D./M.B.A Program
Yale University
New Haven, Conn.

Jane Henney, M.D.
Senior Vice President and Provost for Health Affairs
University of Cincinnati

Carolina Hinestrosa, M.A., M.P.H.
Executive Vice President
Programs and Planning
National Breast Cancer Coalition
Washington, D.C.

Brad Hutton, M.P.H.
National Breast and Cervical Cancer Early Detection Program, and
Cancer Services Program
New York State Department of Public Health

Catherine Parsons
Administrative Director of Medical Imaging and Clinical Instructor of Radiologic Technology
Cumberland Medical Center
Crossville, Tenn.

Etta Pisano, M.D.
Director of Breast Imaging and Radiologist
Breast Imaging Center
University of North Carolina Hospitals, and
Professor of Radiology and Biomedical Engineering
University of North Carolina School of Medicine
Chapel Hill

Edward Salsberg, M.P.A.
Center for Workforce Studies
Association of American Medical Colleges
Washington, D.C., and
Clinical Associate Professor
School of Public Health
State University of New York

Robert Smith, Ph.D.
Director of Cancer Screening
American Cancer Society, and
Adjunct Professor of Epidemiology
Rollins School of Public Health
Emory University

Stephen Taplin, M.D., M.P.H.
Senior Scientist
Applied Research Branch
Division of Cancer Control and Population Studies
National Cancer Institute
Bethesda, Md.


Sharyl Nass, Ph.D.
Study Director