IOM Committee Recommends New Steps to Boost Mammogram Interpretation
Peggy Eastman · Oncology Times · 2005
WASHINGTON, DC—A comprehensive new report issued here by a committee of the Institute of Medicine (IOM) has recommended that the US Food and Drug Administration—which sponsored the study that led to the report—require major changes to enhance the accuracy of mammography interpretation in US mammography facilities. The report, “Improving Breast Imaging Quality Standards,” was requested by Congress and completed in anticipation of the 2007 reauthorization of the Mammography Quality Standards Act (MQSA), which was passed by Congress in 1992 to ensure that American women have access to uniformly high-quality mammograms. Prior to the passage of the MQSA, there was a voluntary accreditation program for mammography facilities, which the IOM committee concluded “achieved limited gains.” The new report makes 10 major recommendations (see box), including one on the need for the MQSA to focus on new breast imaging technologies, not just mammography. “Studies have shown that the technical quality of mammography has improved significantly since implementation of MQSA,” the report concludes. “Questions remain, however, regarding the quality of image interpretation, which depends on human factors and is difficult to measure in practice.” MQSA regulations include physician requirements for initial training in interpreting mammograms, continuing medical education, continuing experience, and medical audits to measure performance. No Standardization Currently, there is no standardization in the way mammography facilities do audits to statistically measure the accuracy of their staff's performance in identifying breast cancers and reducing the number of false positives, the committee found. IOM Committee Chair John F. Ball, MD, JD, Executive Vice President of the American Society for Clinical Pathology, said the audit now required of mammography facilities under the MQSA “is not as useful as it could be for improving the reliability and accuracy of these readings.” The IOM report concludes that “Interpreting physicians need to know and understand their current level of performance before they can determine whether and how it could be improved.” Therefore, the IOM committee recommended three new ways of standardizing the required medical audit component of the MQSA to better measure performance accuracy: ▪ All mammography facilities should calculate the proportion of their patients who are subsequently diagnosed with breast cancer after receiving a recommendation for biopsy following the interpretation of their breast images. ▪ All mammography facilities should determine their breast cancer detection rate—the number of patients found to have breast cancer per 1,000 patients examined. ▪ All mammography facilities should calculate the proportion of patients whose mammograms reveal a possible abnormality (patients whose mammogram interpretation leads to additional imaging or biopsy). To Cover Increased Costs In order to cover mammography facilities' increased costs in meeting requirements for enhanced performance measurement, the IOM committee called for the Centers for Medicare and Medicaid Services (CMS), along with other private and public health insurance companies, to set reimbursement rates for mammograms that are high enough to cover the increased work involved in assessing how well the facilities are doing. Pilot Test The report also recommends a pilot test of malpractice relief for misdiagnoses of patients for mammography facilities that participate in a voluntary advanced audit system through a no-fault medical liability system; to use the no-fault system, which would compensate patients more quickly, physicians who interpret mammograms would have to demonstrate a record of high-quality performance. And the IOM committee suggested a demonstration project to designate and monitor the performance of specialized Breast Imaging Centers of Excellence, centers that would employ high-volume mammogram interpretation; double reading; a demonstrated high proficiency of interpretation; systematic feedback and an infrastructure linking mammography performance to patient outcomes; and patient reminder systems. Statement from ACR The American College of Radiology (ACR), the professional group whose members stand to be most affected by the IOM committee report's conclusions and changes in the MQSA, stated that it is “very interested” in many of the IOM committee's recommendations, including those to raise reimbursement for mammography, explore malpractice reform, and streamline requirements of the MQSA. “The ACR looks forward to working with the IOM and other agencies on further development of the recommendations of this important report that is aimed at continuing the improvement of the quality of mammography for the women of the US,” commented James Borgstede, MD, Chair of the ACR Board of Chancellors. Dr. Borgstede added, “The ACR maintains its position that only well trained and qualified physicians should interpret any imaging procedure. The College will carefully evaluate the details of the proposed IOM demonstration projects as well as the full report and respond to all of the recommendations in the near future.” Voluntary Advanced Medical Audit The IOM committee also recommended that mammography facilities be encouraged to participate in a voluntary advanced medical audit that provides feedback to their staff on the data they submit. A central data and statistical coordinating center (independent of a regulatory authority) should be established to collect and analyze the data in order to provide feedback to interpreting physicians on quality assurance and improvement in their interpretations, the committee recommended. Incentives In order to provide incentives for mammography facilities to participate in the voluntary advanced medical auditing program, the IOM committee recommended that these participating facilities be exempt from FDA inspection of medical audit data, with documentation of participation in the new voluntary advanced audit process taking the place of the FDA audit. The new IOM report was released at a time when mammography specialists are becoming scarcer in the US. In a June 2004 IOM report, “Saving Women's Lives: Strategies for Improving Breast Cancer Detection and Diagnosis,” a previous IOM committee concluded that the term “crisis” is routinely used among radiologists to describe the shortage of breast imagers. Even as demand for breast imaging is rising as the US population ages, the ACR has noted a decline in the number of mammography screening facilities, stated the 2004 report. A combination of low reimbursement rates and a high threat of malpractice litigation have reduced incentives for physicians to become breast imagers, that report concluded. In fact, it found that breast cancer in women leads to more malpractice claims than any other medical condition and is second only to the neurological impairment of newborns in the expense of paid claims. The new IOM report agrees, citing the threat of malpractice lawsuits to the practice of mammography, and to women's access to this life-saving technology. “In the highly charged atmosphere surrounding mammography, it is perhaps not surprising that interpreting physicians are the most frequently named parties in lawsuits concerning missed breast cancer diagnoses,” states the new IOM report. National data indicate, the Committee wrote, that the costs of settlements and judgments in mammography cases nearly doubled between 1995 and 2002, to reach an average of $346,000. The IOM Committee's Recommendations at a Glance The medical audit component of the Mammography Quality Standards Act (MQSA) should be revised and standardized to make it more meaningful and useful, and mammogram reimbursement should be increased to cover the costs of the new audit procedures. Mammography facilities should be encouraged to participate in a voluntary advanced medical audit process providing feedback to facility staff, which would be coordinated by an independent data-coordinating center. A demonstration and evaluation project should be established to designate and monitor the performance of specialized Breast Imaging Centers of Excellence that strive to incorporate the best of organized breast cancer screening programs. Studies should be undertaken to determine whether continuing medical education specifically dedicated to improving interpretive skills, such as double reading and computer-aided detection, can enhance mammogram reading accuracy. These studies should be funded by the NCI. MQSA regulations should be modified to clarify the intent of the law and to recognize current technology, such as stereotactic breast biopsy. Regulations specifically addressing the use of digital mammography need to be developed. MQSA inspections should be modified to streamline the process, reduce redundancy, and address current technology and applications. FDA should have the authority to require that facilities stop performing mammography after two consecutive unsuccessful attempts at accreditation, even if their MQSA certificate is still valid. The FDA should immediately and routinely collect data on the national mammography workforce, volume of services, and capacity, and make these data available to relevant state and local agencies. Strategies and incentives need to be devised to retain highly skilled breast imagers and attract new ones into the field, especially in underserved areas. More effective use should be made of the existing supply of highly skilled breast imaging professionals, including radiologist assistants. Mandatory accreditation for breast imaging methods that don't use ionizing radiation and that are routinely used for breast cancer detection and diagnosis (such as breast ultrasound and MRI) should be required under the next MQSA reauthorization. This expansion of technology would entail a name change from the MQSA to the Breast Imaging Quality Standards Act (BIQSA).