Safeguarding Women's Health

Statement of

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 Environment
House Committee on Commerce

May 8, 1998

INTRODUCTION

Mr. Chairman and Members of the Committee, I am Bruce Burlington, Director of the Center for Devices and Radiological Health (CDRH), for the Food and Drug Administration (FDA or the Agency). I am pleased to be here today to discuss a public health issue that is of critical importance to millions of women in our nation and the role of FDA in safeguarding their health. Joining me this morning is Dr. Florence Houn, who has served as the Director of the Division of Mammography Quality and Radiation Programs at CDRH.

BACKGROUND

The Mammography Quality Standards Act (MQSA) of 1992, the reauthorization of which this Committee is now considering, was enacted in response to serious concerns about the quality of mammography. This diagnostic technique is a crucial tool in combating the mortality associated with the growing incidence of breast cancer.

Today, breast cancer is the most common non-skin cancer and the second leading cause of cancer deaths among women after lung cancer. As alarming as these facts are, the prospect for early detection, successful treatment, and long-term survival is at an all-time high. One reason for this positive outlook is the widespread availability and use of high quality mammography. Without question, mammography can provide life-saving diagnostic information and dramatically increase a woman's odds in combating this threatening life-altering disease. Mammography can reveal cancerous lesions up to 2 years before a woman or her doctor can feel a lump, and over 90 percent of these early stage cancers can be cured.

To fully achieve these benefits, however, all elements of the mammography system must be of high quality. Mammography is a highly challenging radiographic examination. Therefore, the equipment must be capable of producing quality images and be maintained and operated by qualified individuals. Physicians who interpret these images, likewise, must be highly skilled.

If the quality of mammography is poor, an incipient cancerous lesion may be missed. False negative diagnoses can delay early treatment and result in avoidable deaths. Poor quality mammography also can lead to false positive diagnoses, in which normal tissue is judged to be abnormal, resulting in needless anxiety for patients, costly additional testing, and unnecessary biopsies.

In the mid-1980s, indications of problems with the quality of mammography began to appear. Significant evidence came from a 1985 study known as the Nationwide Evaluation of X-ray Trends (NEXT), which was conducted by State radiation control agencies in cooperation with FDA. Based on a survey of a representative national sample of mammography facilities, this study found that the image quality produced in perhaps as many as one-third of the facilities was less than desirable.

The findings from the NEXT study catalyzed efforts by the American College of Radiology (ACR), a private, non-profit association of radiologists, to create a voluntary mammography quality accreditation program. Begun in 1987, this program included an evaluation of the quality of clinical mammograms provided by facilities seeking accreditation. Although it reasonably could be surmised that facilities participating in this voluntary program were among the better facilities, ACR found that approximately 30 percent of the applicants failed on their first attempt to achieve accreditation.

Other evidence came from a 1990 General Accounting Office (GAO) study that reported that many mammography providers lacked adequate quality assurance programs. In 1992, hearings held by the Senate Committee on Labor and Human Resources revealed a wide range of problems with mammography services in the United States. These included poor quality equipment, lack of quality assurance procedures, poorly trained facility personnel, general lack of facility inspections, and inconsistent governmental oversight. By 1992, ACR's efforts to improve mammography were augmented by a program established by the Health Care Financing Administration (HCFA), in accordance with the Omnibus Budget Reconciliation Act of 1990. HCFA promulgated regulations for mammography equipment, personnel, and quality assurance, and conducted inspections to ensure regulatory compliance by Medicare-eligible facilities that performed screening mammography. At the same time, several states instituted programs to ensure that their residents were being provided with high quality mammography.

Although these efforts were commendable and directed to the same goal, they provided a patchwork of sometimes overlapping, but less than comprehensive, programs for assuring quality mammography. No national standards for providing safe, reliable, and accurate mammography for the over 25 million American women who undergo the procedure annually were in place.

ENACTMENT OF MQSA

To rectify this situation, Congress enacted MQSA on October 27, 1992. This law required all mammography facilities after October 1, 1994, to be certified by the Federal government, except for those operated by the Department of Veterans Affairs (DVA), because they are governed by a separate law that mandates a similar program. To obtain certification, mammography facilities must be accredited by an approved accreditation body. This entails passing an evaluation of clinical images from a facility and compliance with national regulations for personnel, equipment, quality assurance, and notification of examination results to patients. To maintain certification status, facilities must show continued compliance with the regulations during annual inspections and through reaccreditation every 3 years.

Responsibility for implementing MQSA was delegated to FDA by the Secretary of the Department of Health and Human Services (DHHS) on June 2, 1993. I am pleased to report that the Agency met the legislative deadline to certify all United States mammography facilities by October 1, 1994. Most importantly, we believe this program has succeeded in enhancing the quality of mammography without adversely affecting access to this important procedure. Specifically, in the 5 years since we initiated this program, FDA has accomplished the following:

• publication of interim regulations on December 21, 1993, to provide a mechanism for accreditation and certification of mammography facilities by October 1, 1994;
• publication on October 28, 1997, of more comprehensive final regulations, which become effective on April 28, 1999, and were developed with the advice of the National Mammography Quality Assurance Advisory Committee, composed of consumer and medical representatives, and taking into consideration public comments from approximately 1900 respondents to FDA's proposed regulations published April 3, 1996;
• evaluation and approval of four accreditation bodies (ACR, Iowa, Arkansas, and California);
• accreditation and certification of 10,161 mammography facilities as of December 31, 1997;
• establishment of an extensive public information program to help mammography facilities meet the regulations, which includes a quarterly newsletter (Mammography Matters, the 17th issue of which will shortly be mailed to all facilities), a 1-800 help line for facility inquiries, suggestions to assist facilities in preparing for inspections, and access to documents via the Internet;
• establishment of an inspection program in partnership with the states to facilitate annual inspections of certified facilities to ensure continued compliance with MQSA regulations;
• establishment of a compliance program to ensure that FDA regulatory requirements are adhered to, with an emphasis on assisting facilities in meeting the regulations; and
• initiation of a demonstration project with selected states to gather information and develop mechanisms to delegate certification authority to states, as provided for by MQSA, in preparation for development of regulations making such delegation available to all interested and qualified states.

I also would like to highlight several significant enhancements to the requirements set forth in the interim regulations that are provided for by the final regulations that were promulgated last Fall. First, there is a requirement for timely communication of examination results to patients. This requirement focuses on the desired outcome, yet affords facilities the flexibility to select communication methods that are the most effective for individual settings. Second, there are requirements for initial and continuing experience for radiologic technologists and medical physicists which parallel those for interpreting physicians. Third, there are more specific standards to ensure that the equipment is capable of producing quality images.

IMPACT OF MQSA PROGRAM

Although we are proud of these accomplishments, the more important consideration is the impact these efforts have had upon mammography in the United States.

Impact on Mammography Quality

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.

Costs and Benefits of MQSA

Another 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.

Patient Access to Mammography

Even 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.

FDA Outreach to the Mammography Community

The 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.

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.

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.