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.
I. 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.
II. 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 U.S. 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
III. 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.
A. 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.
B. 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.
C. 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.
D. 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.
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.