An estimated 23.5 million mammograms were performed in the United States in 1992 at a cost of about $2.5 billion. Both the National Cancer Institute (NCI) and the American Cancer Society recommend that all women over the age of 50 have annual screening mammograms, though the two organizations are not in total agreement on the recommended frequency of screening mammography for women under the age of 50. Utilization rates for the technology have continuously increased over the years. According to the Centers for Disease Control and Prevention, the percentage of women aged 50 and above who had received mammograms in the past year increased from 26 percent in 1987 to 54 percent in 1993. The demand for mammography services has resulted in significant growth in the number of mammography facilities, currently numbering over 10,000 nationwide. Mammography is one of the most technically challenging radiological procedures, and ensuring the quality of the radiologic image is difficult. If the image is poor, tumors and abnormalities may go undetected. To illustrate, two images of the same patient who had a cancerous tumor are presented in figure 1. The tumor is visible in the picture on the right, where the image is of higher quality, but it is blurred and indecipherable in the picture on the left. Accurate interpretation of mammograms is equally as important as image quality. According to radiological experts, mammograms are the most difficult radiographic images to read. Misreading mammograms can have considerable consequences. A mammogram that is incorrectly read as showing an abnormality could cause a woman to go through unnecessary and costly follow-up procedures, such as ultrasound or biopsies. A mammogram that is read as normal when an abnormality is actually present could result in missed diagnosis of early lesions and delayed treatment, which could cost a woman’s life. MQSA contains a number of provisions designed to ensure the quality of the image and its interpretation. Among other things, MQSA requires that FDA establish quality standards for mammography equipment, personnel, all mammography facilities be accredited by an FDA-approved accrediting body (either a nonprofit organization or a state agency) and obtain a certificate from FDA in order to legally provide mammography services after October 1, 1994; and all mammography facilities be evaluated annually by a certified medical physicist and be inspected annually by FDA-approved inspectors. FDA issued interim regulations in December 1993 that established requirements for accrediting bodies and quality standards and certification requirements for mammography facilities. Since early 1994, FDA has been working with the National Mammography Quality Assurance Advisory Committee to develop the final regulations. FDA officials estimate that they will publish the proposed final regulations for public comment in October 1995 and issue the final regulations in October 1996. As of October 1, 1994, FDA had approved ACR and the states of California, Arkansas, and Iowa as official accrediting bodies. Because of ACR’s pre-MQSA involvement in establishing a voluntary accreditation program, it serves as the major accrediting body, responsible for over 95 percent of the current MQSA accreditation workload. To minimize duplicate submission of application information to FDA and accrediting bodies, under FDA’s interim rules facilities need only submit application information to the accrediting bodies. On the basis of accrediting bodies’ notification, FDA automatically issues certificates to facilities that pass accreditation review. Early indications point to a general improvement in the quality of mammography services under the act. This improvement is mainly the result of setting national quality assurance standards and establishing enforcement mechanisms to ensure that the standards are met by all mammography providers. Before MQSA, wide variations existed in oversight provided at the state level. To provide an indication of these variations, we asked a panel of experts to develop a list of mammography standards they considered most important. Eighteen quality assurance requirements were selected and then used as a benchmark for evaluating state oversight before MQSA took effect. These requirements, listed in appendix II, include such items as the quality of clinical image evaluations and the use of equipment designed especially for mammography. Before MQSA was implemented, only two states—Michigan and Texas—had enacted legislation and regulations that included all 18 requirements. Nine states—Alabama, Connecticut, Kansas, Louisiana, Montana, Nebraska, North Dakota, West Virginia, and Wyoming—plus the District of Columbia made no mention of any of these requirements in state laws or regulations. See appendix III for state-by-state results. Our interviews with officials from 20 states indicated that the impact of MQSA on quality of mammography services was greatest in states that had no or few pre-MQSA standards. For example, officials from four states that had no pre-MQSA standards told us that they believed MQSA would greatly improve the quality of mammography services in their states. Officials from Michigan, which already had well-developed standards, welcomed the additional authority and resources that MQSA gave them to enforce the standards, but said the act’s effect would not be as significant as it would in states without such standards already in place. Another measure of variation in quality standards before MQSA was the level of voluntary participation in mammography quality assurance activities developed by ACR. ACR has managed a voluntary accreditation program since 1987, but, according to NCI and ACR records, only between 37 and 44 percent of the nation’s mammography units were accredited by ACR as of July 1993. The MQSA standards, as currently prescribed in FDA’s interim regulations, include all 18 requirements chosen by our panel as well as a number of other requirements. Thus, the October 1994 implementation of MQSA had a substantial effect in that all providers, regardless of location or setting, became responsible for complying with a single, minimum standard of care. In all, FDA’s interim regulations contain more than 30 requirements covering such matters as personnel qualification and radiation safety. In implementing these requirements, FDA adopted the standards that had been set by ACR in its voluntary compliance program. These standards have been endorsed by professional organizations as well as industry and government experts. FDA officials chose these standards because they believed the standards were based on sound scientific principles and clinical judgment gained through extensive experience; further, the legislative history of MQSA indicates that the Congress intended to use the ACR program as the model for accreditation. The current standards include specific requirements to control image quality, but the requirement for monitoring the accuracy of image interpretation is less specific. The regulations include a general requirement that each facility have a system to review outcome data, including follow-up on positive mammograms (those identified as showing tumors or abnormalities) and their correlation to biopsy results. However, the regulations do not include standards for evaluating the outcome data. How to develop a quality assurance system to monitor the accuracy of image interpretation is a controversial issue in the medical community. On one hand, several academic studies have shown wide variation in the interpretation of the same films by different radiologists, and some experts suggest that peer reviews of films or proficiency tests of radiologists are needed to ensure accuracy. On the other hand, others, including FDA, believe that those measures are too difficult and costly to implement and that a system of tracking the mammography outcomes is a better approach to achieve the goal of quality interpretation. FDA officials told us that, after consulting with the National Mammography Quality Assurance Advisory Committee, they are considering expanding the outcome data requirement in the proposed final regulations. The option under consideration is for each facility to designate at least one interpreting physician to review the outcome data at least annually, and for the facilities to use the data to evaluate the performance of each interpreting physician and the facility as a whole. FDA officials told us this option would allow facilities discretion in defining outcome standards. They said such discretion was needed because no consensus existed on appropriate outcome measures and because more research was needed before outcome standards could be prescribed. MQSA called for facilities to comply with the new standards through an accreditation process. In adopting ACR standards in its interim regulations, FDA granted automatic certification to any facility that had already demonstrated compliance with ACR requirements by being accredited under ACR’s voluntary program. All other facilities had to apply for accreditation by completing an application package and submitting materials for testing to provide evidence of meeting the standards. Accreditation was performed by one of the FDA-approved accrediting bodies. While the accreditation procedures established by Arkansas, California, and Iowa are somewhat different from ACR’s, the four accrediting bodies enforce the same FDA standards. Because ACR accounts for more than 95 percent of the current MQSA accreditation workload, we focused our review on ACR’s accreditation process. When MQSA initially took effect, many mammography units did not meet its mammography standards. According to ACR records, between October 1, 1994, and August 1, 1995, 7,525 different mammography units from approximately 5,510 facilities went through ACR’s first review for accreditation, and 2,598 units (35 percent) from roughly 1,900 facilities failed to meet the accreditation requirements. After a second review process, ACR found about two-thirds of these units to be in compliance and granted them full accreditation. Of those that were denied accreditation after failing the second review, 277 facilities have since taken sufficient corrective actions to qualify for reinstatement. These data suggest that the accreditation process has resulted in improvement at these facilities. MQSA inspection authority provides FDA with another means to ensure that facilities comply with standards on a day-to-day operating level. While accreditation is a mail-in process that involves the submission and review of application materials, inspections are conducted on site, allowing inspectors to verify information provided during the accreditation process. Actual inspections began somewhat later than initially planned. FDA entered into agreements with states to train state inspectors for annual inspections and reimburse states for their inspection costs. FDA had planned to have 200 inspectors trained by June 1995, but only 159 inspectors were trained by that date. Because of these delays in training, annual inspections did not begin until January 1995, although they had been planned to start in October 1994. Early results from annual inspections indicated that many facilities fell short of full compliance with MQSA requirements. As of June 9, 1995, inspectors had inspected 1,843 facilities and found that 601—or 33 percent—had deficiencies that needed to be corrected. Of these, 119 facilities were considered to be in serious noncompliance with MQSA standards. As table 1 shows, the most common violations noted in the serious noncompliance group involved the facilities’ use of personnel who did not meet FDA’s qualification requirements. Under the current inspection program, FDA issues a warning letter to facilities in serious noncompliance, such as those listed above. Facilities are required to respond in writing within 15 days, listing specific steps they plan to take to correct violations. Failure to promptly correct the deficiencies could result in regulatory action by FDA, such as fines, suspension or revocation of the facility’s certificate, or a court injunction prohibiting the facility from performing mammography. While many facilities had problems meeting FDA’s quality standards and deadlines for compliance, FDA and the accrediting bodies made significant efforts to work with facilities to avoid large-scale facility closures or discontinuance of services. As a result, although some facilities have discontinued services, so far the number of closures is relatively small and access to services has not been significantly affected. To prevent widespread facility closures, FDA has been working with facilities to bring them into compliance with MQSA. From the start, FDA was concerned that many facilities would need time to upgrade their practices. To provide facilities lead time for preparation, FDA issued its interim regulations in December 1993, more than 10 months before the certification deadline of October 1, 1994, and began to send quarterly newsletters to facilities informing them about MQSA requirements. Even with advance notice, however, almost 4,700 of the more than 10,000 mammography facilities nationwide failed to complete the accreditation process in time to receive full certification by the October 1 deadline. The two main reasons for this outcome, according to ACR officials, were the failure of facilities to submit materials in a timely manner and the submission of applications that did not meet the accreditation requirements. Using the maximum time allowed by MQSA, FDA issued provisional certificates to these facilities, giving them 6-month extensions. FDA also granted 90-day extensions for facilities whose provisional certificates expired before accreditation requirements could be met. In April, more than 1,500 90-day extensions were granted. On July 17, 1995, 242 facilities were still in the 90-day extension status, indicating that they still had problems satisfying all accreditation requirements (see table 2). To minimize the need for shutting down facilities permanently, in February 1995, FDA established a reinstatement process. This process allows a facility that has had to stop performing mammography because it has failed to meet accreditation requirements to apply for reinstatement by submitting a corrective action plan and applying for accreditation as a new facility. As of July 17, 1995, 279 facilities have been granted such reinstatement, which has allowed them to resume mammography services while pursuing accreditation under a new provisional certificate. As a result of FDA’s approach, although some facilities did have to cease performing mammography for some period of time, many of them have been able to reopen. According to ACR records, between October 1, 1994, and August 1, 1995, a total of 488 facilities were denied accreditation (for failing to pass the second review or to complete submission requirements) and had to suspend mammography services. As of August 1, 1995, 301 of these had either passed accreditation on appeal or had been reinstated. For these facilities, the average time from notification of denial until reinstatement was about 15 days. Only six of these denied facilities had notified ACR that they did not intend to resume providing mammography services. ACR officials said that most of the remaining facilities are in the process of evaluating the causes of their deficiencies and assessing the costs of correcting them. ACR officials expected that a substantial majority would apply for reinstatement within 30 days. FDA has adopted a similarly gradual approach to resolving deficiencies identified in annual inspections. As a result, as of July 26, 1995, FDA had not closed any facilities for noncompliance found during inspections. Facility closures, both in anticipation of the act and since the act took effect, appear to have had a limited effect on access to mammography services. Of the 10,000-plus facilities that were providing mammography services before MQSA, FDA identified 404 facilities, or about 4 percent, that had ceased to provide mammography services between October 1993 and October 1994, when MQSA became effective. FDA contracted with a private research firm to study the impact of these closures on access to mammography services. The study found that about 97 percent of the closed facilities were within 25 miles of a certified facility; 62 percent were within 1 mile of such a facility. In May 1995, FDA asked the contractor to update the study by adding into the closure population those facilities that had been denied accreditation or had voluntarily withdrawn from the process since the act took effect. The update, which covered about 350 such facilities, showed almost identical results. In addition, officials in the eight states (plus Puerto Rico) that had at least 10 percent of their facilities identified as closed consistently told us that the closures did not adversely affect access to quality mammography services in their states. This lack of negative impact may be related to the fact that most of the closed facilities were low-volume operations in independent doctors’ offices: we have previously documented that quality assurance is more difficult to maintain in low-volume facilities. Several of these state officials also told us that the main reason that many low-volume providers in their states ceased to perform mammography was that their volume could not support the costs for system upgrades necessary to meet MQSA standards. The costs associated with a system upgrade vary depending on the type and the extent of changes that are required. For example, FDA estimated that, for facilities that have to upgrade or replace equipment, the average cost would be about $50,000. FDA does not have reliable data on costs and has not been able to assess the economic impact of its interim regulations on facilities. It has contracted with a private research group to develop an industry profile and a cost model. FDA officials told us that they plan to assess the total cost impact of MQSA when the final regulations are issued. Besides the cost of upgrades, facilities also have to pay accreditation fees and annual inspection fees. To obtain ACR accreditation, a facility has to pay a fee of $700 for the first mammography unit and $600 for each additional unit. In addition, facilities must pay inspection fees, and MQSA requires that such fees entirely cover inspection costs. For fiscal year 1995, FDA established a fee schedule of $1,178 for the first unit and $152 for each additional unit for annual inspection; follow-up inspections cost $670 each. The inspection fee assessment is based on FDA’s calculation of the amount needed to cover the costs of inspections. See appendix IV for more information on total and per-inspection costs. To provide an additional perspective on how regulations might affect access, we examined whether any studies had been conducted in states where mammography standards had been strengthened before MQSA. One unpublished study by NCI staff had looked at Michigan, which enacted stringent quality standards almost 5 years before the implementation of MQSA. According to the principal researcher, access to mammography services in Michigan was not adversely affected by the tighter standards. NCI staff analyzed the number of mammography facilities and machines in Michigan between 1989 and 1994 and found that while the stringent standards had caused some facilities to discontinue mammography, there were still sufficient facilities in the state to provide services. In addition, longitudinal mammography utilization data examined through 1994 indicated that Michigan was outperforming most of the country in mammography usage and was among the very few states with the best rates of mammography screening compliance. NCI staff also concluded that, after the implementation of the Michigan standards, the technical quality of mammograms in Michigan improved in comparison with that of other states. To date, MQSA’s effects appear generally positive. Mammography quality standards are now in place in all states, and these standards do not appear to have had a negative effect on access to services. However, to avoid large-scale closures of facilities, FDA settled on an approach that allowed some delay in meeting the certification requirements. For this and other reasons, such as the availability of outcome data, more time will be needed before MQSA’s full impact can be determined. MQSA mandates that we assess the effects of MQSA again in 2 years and issue a report in 1997. We provided FDA and ACR officials with a draft copy of the report for review and comment. FDA responded that the draft was accurate and reflective of the program. While ACR did not provide formal comments, officials provided some technical comments, which we incorporated as appropriate. Appendix V contains FDA’s written response. We will send copies of this report to the Secretary of Health and Human Services, the Commissioner of FDA, the Director of NCI, the Director of the Office of Management and Budget, and other interested parties. We will also make copies available to others on request. Please contact me at (202) 512-7119 if you or your staff have any questions. Major contributors to this report are listed in appendix VI. To develop general information about how FDA has implemented MQSA, we analyzed data from FDA’s certification and annual inspection programs and from ACR’s accreditation program. To specifically address our objective of assessing the initial effect of MQSA on the quality of mammography services, we relied on two analyses: a comparison of MQSA standards with existing state standards and an outcome analysis of ACR’s accreditation and FDA’s inspection results. Because FDA’s inspection program was just getting under way at the time of our review, our analysis of FDA inspection results was limited to summary data provided by FDA from its first 4 months of inspection. The analysis of state standards was primarily based on data from an NCI study of state mammography legislation. Although we did not directly measure the quality of mammography images, the accreditation process does involve an evaluation of a facility’s quality assurance system, including a review of clinical images. To address our objective of assessing MQSA’s effect on accessibility, we examined an FDA contractor’s study on facility closures and an unpublished study by NCI staff of Michigan’s experience in implementing stringent quality standards prior to MQSA. We supplemented this work by interviewing 6 members of FDA’s National Quality Assurance Advisory Committee and 32 officials from 20 states and Puerto Rico to obtain their views on the initial impact of MQSA on quality and accessibility of mammography services. We did our work from November 1994 through August 1995 in accordance with generally accepted government auditing standards. Develop. Pers. Breakdown of MQSA inspection fee costs Contracts with states to conduct inspections FDA personnel to conduct inspections Equipment, development of calibration procedures, and instrument calibration Design, programming, and maintenance of data systems necessary to schedule inspections and track results Training and certification of inspectors (FDA and state) In addition to those named above, the following individuals made important contributions to this report: Stan Stenersen, Evaluator; Susan Lawes, Technical Advisor; Helene Toiv, Advisor; Julie Rachiele, Technical Information Specialist; and Jennifer Vieten, Intern. The first copy of each GAO report and testimony is free. Additional copies are $2 each. Orders should be sent to the following address, accompanied by a check or money order made out to the Superintendent of Documents, when necessary. Orders for 100 or more copies to be mailed to a single address are discounted 25 percent. U.S. General Accounting Office P.O. 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Summary: Pursuant to a legislative requirement, GAO examined whether the Food and Drug Administration's (FDA) implementation of the Mammography Quality Standards Act has had any effect on the: (1) quality of mammography services; and (2) access to such services. GAO found that: (1) the act has had a positive effect on the quality of mammography services; (2) a uniformed set of standards for mammography services is required in all states; (3) many facilities have had to improve their services in order to become fully certified; (4) annual inspections of mammography facilities help ensure that these facilities are in compliance with the standards set by the American College of Radiology; (5) the number of facilities ceasing mammography services rather than complying with the quality standards is relatively small; and (6) FDA has not closed many of the facilities unable to meet the new certification requirements, but it has given them time to comply with the new quality assurance requirements and to correct the problems found during inspection.