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7 Findings and Recommendations
Pages 221-236

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From page 221... ... Early detection is widely believed to reduce breast cancer mortality by allowing intervention at an earlier stage of cancer progression. Clinical data show that women diagnosed with early-stage breast cancers are less likely to die from the disease than those diagnosed with more advanced stages of the disease. Read the entire page →
From page 222... ... � It is the only medical imaging procedure used for breast cancer screening and the only procedure regulated in this way. � The Mammography Quality Standards Act is central to the regulation of device quality and clinical practice of mammography. Read the entire page →
From page 223... ... � Mortality from breast cancer has been decreasing in some other industrialized countries as well, and studies from the United Kingdom and Finland indicate that, in practice, screening programs can decrease breast cancer mortality. Read the entire page →
From page 224... ... � Computer-aided detection has the potential to improve the accuracy of the interpretation of screening mammography, at least among less experienced readers, but questions remain as to how this technology will ultimately be used and whether it will have a net beneficial effect on current screening practices. � MRI shows promise for the screening of women at high risk (those with BRCA mutations or a strong family history of breast cancer who want to begin screening at an earlier age and who are thus more likely to have dense breast tissue) Read the entire page →
From page 225... ... 5. Improved imaging technologies that allow clinicians to detect more lesions at an earlier, preinvasive stage may or may not lead to reduced breast cancer mortality, and may lead to more overtreatment of women unless they are coupled with biologically based technologies that can determine which lesions are likely to become metastatic and lethal. Read the entire page →
From page 226... ... 2. Technologies that might help define the biological nature of lesions found by imaging technologies and that might also help advance the field of functional imaging are being developed. Read the entire page →
From page 227... ... � The technology development process is complex and costly, and the end results of research are unpredictable, making it a financially risky undertaking. � For medical devices, the requirements for FDA approval and insurance coverage have been variable and unpredictable, adding additional levels of risk to the development process. Read the entire page →
From page 228... ... � The relatively small size of the potential market for new breast cancer detection devices is small (the United States has about 10,000 certified breast screening centers) Read the entire page →
From page 229... ... 4. NCI's Breast Cancer Surveillance Consortium was established in 1994 to study the effectiveness of breast cancer screening practices in the United States through an assessment of the accuracy, cost, and quality of screening programs and the relation of these practices to changes in breast cancer mortality or other shorter-term outcomes, such as stage at diagno Read the entire page →
From page 230... ... A number of cost-effectiveness analyses of breast cancer detection technologies have been carried out, including computer modeling of screening technologies, whose effect on patient outcome (disease-specific mortality) has not been demonstrated. Read the entire page →
From page 231... ... Quantitative data to substantiate these concerns are not currently available. � Radiologists and health care administrators have expressed concern that the reimbursement rate for mammography is too low to cover the actual costs of the procedure (including the cost of meeting federally mandated requirements promulgated under the Mammography Quality Standards Act) Read the entire page →
From page 232... ... Congress deliberately crafted the Medicare statute to preclude preventive services, reflecting the practice of commercial insurers at the time. � Congress and state legislatures have mandated coverage for mammography (as well as some other preventive services, including screening tests for cervical, prostate, and colon cancers) Read the entire page →
From page 233... ... 1. Government support for the development of new breast cancer detection technologies should continue to emphasize research on the basic biology and etiology of breast cancer and on the creation of classification schemes for breast lesions based on molecular biology. Read the entire page →
From page 234... ... � If a new device that has been approved for diagnostic use shows potential for use as a screening tool (based on evidence of accuracy) and the developers wish to pursue a screening use, an investigational device exemption should be granted for this use and conditional coverage should be provided for the purpose of conducting large-scale screening trials to assess clinical outcomes. Read the entire page →
From page 235... ... However, given the length of time required to assess that end point and the fact that early detection by screening mammography has already been proven to reduce breast cancer mortality, a surrogate end point for breast cancer detection is appropriate in some cases. As a general rule, a screening technology that consistently detects early invasive breast cancer could be presumed efficacious for the purposes of FDA approval. Read the entire page →
From page 236... ... Congress should expand the Centers for Disease Control and Prevention screening program to reach a much larger fraction of eligible women, and state legislatures should participate in the federal Breast and Cervical Treatment Act by providing funds for cancer treatment for eligible women. The Centers for Disease Control and Prevention should be expected to reach 70 percent of eligible women (as opposed to the current 15 percent) Read the entire page →

From page 221...

... Early detection is widely believed to reduce breast cancer mortality by allowing intervention at an earlier stage of cancer progression. Clinical data show that women diagnosed with early-stage breast cancers are less likely to die from the disease than those diagnosed with more advanced stages of the disease.

7 Findings and Recommendations Pages 221-236

7 Findings and Recommendations
Pages 221-236