STATEMENT BY D. BRUCE BURLINGTON, M.D. DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT,
COMMITTEE ON COMMERCE MAY 8, 1998
The initial impact of the MQSA program on mammography quality was evaluated by GAO in an October 1995 report to Congress entitled, "Initial Impact of New Federal Law Has Been Positive." The report concluded that there were improvements in the quality of mammography and attributed the positive trend to two factors.
First, all mammography facilities in the country, except those of DVA, were meeting a single uniform set of minimum national regulations that were substantially the same as those advocated by ACR. Before MQSA, the standards met by facilities were widely disparate, depending upon their regional location and whether they participated in ACR's voluntary accreditation or HCFA's Medicare screening mammography program. Second, the GAO report found that meeting these regulations had more than a symbolic effect, a fact corroborated by data from the ACR accreditation program. Automatic certification was granted to facilities that already were accredited under the ACR program. Of the approximately 5,510 additional facilities that went through ACR's first review for accreditation between October 1, 1994, and August 1, 1995, roughly 1,900 (35 percent), failed the first review. Over 85 percent of these 1,900 facilities subsequently obtained accreditation and certification after improving the quality of their performance. This represented a major improvement in the quality of mammography nationwide. The inspection program conducted under MQSA to provide national oversight also has enhanced the quality of mammography. The inspection program, including overhead costs for the training of inspectors and the provision of inspection equipment, is supported by fees paid by the mammography facilities. FDA has provided 6 weeks of intensive training to approximately 250 inspectors, most of whom are State personnel working under contract with FDA. Currently 49 states, the District of Columbia, Puerto Rico, and New York City have inspection contracts with the Agency. All mammography facilities have been inspected at least twice, and nearly half have been inspected a third time. In October 1997, another GAO report to Congress entitled, "Mammography Services - Impact of Federal Legislation on Quality, Access, and Health Outcomes," compared MQSA inspection results in Fiscal Year (FY) 95, FY 96, and FY 97. The report concluded that "overall, MQSA has had a positive impact on the quality of mammography services and no effect on access to them." An especially noteworthy observation in the GAO report was that the percentage of facilities with significant deficiencies in meeting the interim regulations declined from 23 percent in FY 95 to 13 percent in FY 97. GAO also focused on one important indicator of quality: the results from a standardized test of image quality known as the phantom image test. This test assesses the ability of a mammography facility to produce high quality images by radiographing a plastic block to determine how many of the 16 embedded test objects of varying size and type can be detected in the resultant image. The proportion of facilities with acceptable phantom images has remained at 98 percent since 1995, compared to the 89 percent level found in 1992 during a pre-MQSA NEXT survey. B. Costs and Benefits of MQSAAnother measure of the impact of the MQSA program on mammography is from a cost-benefit viewpoint. The National Mammography Quality Assurance Advisory Committee was charged by the statute with making such an analysis, but concluded in 1997 that a formal cost-benefit analysis was not possible at the time for a number of reasons, including the limited time since implementation of the law and the difficulty of measuring intangible benefits. Nonetheless, as required under Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act, the Agency did provide estimates of program costs and benefits as part of the preamble to the final regulations.
Costs of meeting the interim regulations, including staff training, equipment upgrades, enhancement of quality assurance programs, and improved notification of examination results to patients, was estimated to be $24 million annually nationwide. The additional cost of facility compliance with the more comprehensive final regulations will increase this figure to $62 million annually. Expert consultants to FDA estimated that the interim regulations improved the specificity and sensitivity of the average mammography from between 2 and 10 percent. Using a conservative value of 3 percent improvement and conservative estimates of the dollar value of lives saved and the improved quality of life if less severe treatments are made possible by early detection, we calculated the overall benefit of the interim rule to be in the range of $108 to $155 million annually. We also have estimated that an additional 5 percent improvement in mammography quality will be achieved under the final regulations, bringing the total benefits of the program up to between $289 to $416 million annually. Thus, the estimated benefit at present and in the future is several times the estimated cost. C. Patient Access to MammographyEven though the estimated benefits of MQSA far outweigh estimated costs, this would be poor consolation if access to the higher quality mammography were seriously limited by the closure of facilities unable to meet our regulations. In enacting MQSA, Congress emphasized the importance of improving mammography quality while maintaining access to mammography. We have kept these dual goals in mind in developing the program. We believe that enhancement of mammography quality will increase patient confidence and encourage women to undergo screening mammography at the recommended frequency. Adequate access will become even more important to meet increasing demand for quality services.
Another measure of the success of our efforts to maintain access to mammography is that the number of certified mammography facilities that were in operation on December 31, 1997, was only about 4 percent less than just prior to when MQSA went into effect on October 1, 1994. Another indicator came from an FDA study that examined the reasons for the closure of 369 facilities just prior to October 1, 1994. Only 113 of these closures (about 1 percent of the total facilities in the country) could be directly attributed to MQSA. These figures support the conclusion that the nationwide impact of MQSA on access to mammography is negligible. At the same time, we can appreciate the difficulties that can result with the closure of even one facility for women in a particular locality, especially if the area already was underserved. The FDA study also assessed the extent of this problem by determining the availability of other certified mammography facilities in areas where facilities had closed. We found that 92 percent of the closed facilities were within 5 miles of another certified facility, and that 99 percent of them were within 25 miles. In virtually all cases, patients examined at facilities prior to their closure still had access to another facility within a reasonable distance. D. FDA Outreach to the Mammography CommunityThe final issue on the impact of MQSA I would like to address is the success we have had in working with facilities as partners to improve mammography. FDA commissioned a contract survey of a sample of facilities during June and July 1997, that focused on facility reactions to FDA's inspections. We were pleased to learn that over 80 percent of the facilities gave the inspectors high marks. Inspectors were judged to be competent, professional, knowledgeable, and courteous. Ninety-two (92) percent of the facilities surveyed believed that the inspections at their site were educational; 94 percent reported that the inspections were a positive experience; and 97 percent used the inspection results to make enhancements at their facility. The facilities also suggested improvement in some of the ways in which information was provided to them; more specifically, they requested more advance notice of the inspections than the 10 or so days that most of them received.
We will consider these suggestions as we work to further upgrade and enhance the MQSA program. We already are developing plans to make our inspections more risk-based in nature and to conduct them more efficiently so as to shorten the inspection times and minimize interruptions of facility routines, while at the same time ensuring adequate public health protection. A two-tiered inspection program is now under development that will use a shortened inspection procedure for facilities that have demonstrated a high quality of performance, while continuing with full inspections of facilities that have experienced difficulties in maintaining adequate quality. Before the new system can be implemented, however, at least one round of full inspections for all facilities will be necessary to determine how well they are complying with the final regulations that go into effect next year. IV. SENATE PASSAGE OF MQSA REAUTHORIZATION On November 9, 1997, the Senate passed S. 537, "The Mammography Quality Standards Reauthorization Act," by unanimous consent, to reauthorize MQSA for another 5 years. No discussion or amendments were considered in the passage of S. 537. The Administration supported the bill. S. 537 is identical to the legislation, H.R. 1289, being considered by this Committee. The Administration supports its passage. V. CONCLUSION Mr. Chairman, I firmly believe that our track record in implementing the MQSA program is a good one and that women in the United States are the real winners. We have improved the overall quality of mammography by constructing and implementing an effective program that holds all providers of mammography to the same standard. We strongly believe that this program supports the public health and for that reason merits reauthorization. We look forward to working with this Committee to achieve this result. This concludes my prepared statement. Dr. Houn and I would be pleased to answer any questions you might have.