Mammography Quality Standards Act: Background and Issues

Mammography Quality Standards Act: Background and Issues

98-809 STM
Updated October 22, 1998
CRS Report for Congress
Received through the CRS Web
Mammography Quality Standards Act:
Background and Issues
Judith A. Johnson
Specialist in Biomedical Policy
Science, Technology and Medicine Division
Summary
Mammography uses X-rays to produce an image of the internal structure of the
breast. There is a long history of public and professional concern over the safety and
quality of mammography. Between 1985 and 1992, several studies found a wide range
in image quality and patient radiation dose. National, comprehensive quality standards
that applied to all mammography facilities were nonexistent until the Mammography
Quality Standards Act (MQSA) was enacted on October 27, 1992 (P.L. 102-539).
MQSA replaced the conflicting and overlapping patchwork of private voluntary
standards and limited state and federal regulations. H.R. 4382, which reauthorized
MQSA, was passed in September 1998 by the 105th Congress and signed into law by the
President on October 9, 1998 (P.L. 105-248). This report will be updated periodically.
Background
For American women, breast cancer is the most commonly diagnosed cancer and the
second leading cause of cancer mortality behind lung cancer. The American Cancer
Society estimates that in 1998, 178,700 new cases of breast cancer will be diagnosed and
43,500 women will die from the disease. Mammography can be used as a diagnostic tool
in women with symptoms or a screening tool in women without symptoms.
Mammography screening combined with clinical breast examination is currently the best
available method of breast cancer detection. Mammography uses X-rays to produce an
image of the internal structure of the breast and can often detect breast cancer when it is
very small, before it can be found by a woman or her physician.

In current practice, an X-ray technician, rather than a radiologist, performs the actual
mammography procedure. Breast imaging is not straightforward, and an accurate image
is among the most difficult to obtain for the X-ray technician; some technicians are better
at positioning than others. After the image is taken, a technician develops the X-ray film.
The radiologist reads the mammogram. Interpretation of a mammogram is not clear cut
either; abnormalities can be very subtle and other factors can affect clarity. For example,
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younger women and women taking estrogen replacement therapy have denser breast tissue
which does not image well on X-ray. Mammograms are among the more challenging
radiographic images to read and must have optimal clarity to be interpreted correctly.
Mammography was not widely used until the publication in 1960 by Dr. Robert L.
Egan of a reproducible technique for performing the examination. In the late 1960s, the
Health Insurance Plan of Greater New York (HIP) began a randomized clinical trial to
determine whether regular screening with clinical examination and mammography could
reduce deaths from breast cancer. In the study, 60,000 women were randomly assigned
to a screening group or a control group. At a 7-year follow-up, the study showed a 30%
reduction in breast cancer mortality in the screened women. The HIP study results greatly
expanded interest in mammography and resulted in its increased use as a screening tool.
Public awareness of breast cancer grew following the revelations by various celebrities
of their personal battles with breast cancer. Consequently, the demand for and access to
mammography gradually rose over time, albeit with some ups and downs.
There has been a long history of public and professional concern over the safety and
quality of mammography. In the 1970s, the major fear was the radiation dose level.
Some facilities were using X-ray doses too low to obtain diagnostic images, whereas
others were delivering excessive radiation. By 1976, there was growing apprehension
among scientists over the possibility of breast cancer being induced in healthy women
through radiation exposure of breast tissue. When concerns over mammography safety
were reported in the mass media, the result was a radiation scare that caused a marked
decline in the use of mammography. At mammography facilities across the country, even
symptomatic women were refusing to have mammography exams prescribed by their
physicians. At the close of the 1970s, the future of mammography was uncertain.
In the 1980s, the type of equipment used in mammography was a focus of debate.
Technological changes were aimed primarily at reducing the radiation dose and replacing
general purpose X-ray equipment with dedicated mammography units. Toward the end
of the 1980s, confidence in mammography was restored in the eyes of some by two
factors: 1) the lowered X-ray dose; and, 2) the results of the European clinical trials of
mammography screening, some of which echoed the HIP study’s favorable results. As
a result, in 1989, 11 organizations, including the American Cancer Society and the
National Cancer Institute, endorsed screening mammography guidelines for women 40
and older.
Although studies had demonstrated that lower radiation and new equipment
produced an improved image, several surveys found problems in the routine use of
mammography across the country. The American Cancer Society in a 1988 study and
the General Accounting Office in a January 1990 report found a wide range of image
quality and patient radiation dose level from dedicated mammography equipment. The
Food and Drug Administration (FDA) conducted surveys of mammography equipment
in 1985, 1988, and 1992. The purpose of the surveys was to determine patient radiation
exposure and assess image quality. The surveys found wide variations in image quality
and radiation dose from site to site. Another study found variations from site to site and
from day to day at the same site. The results of all these studies confirmed the need for
ensuring compliance with mammography quality standards.
A false negative mammogram caused by poor quality mammography poses a serious
health risk for women. According to the Physician Insurers Association of America,

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“malignant neoplasms of the female breast continue to be the condition for which a
patient most frequently files a medical malpractice claim.... Breast cancer is the second
most expensive condition in terms of indemnity dollars, next to claims resulting from
neurologically impaired newborns.”1 The average cost for payment of one malpractice
case involving breast cancer is $307,000.2

Regulation of Mammography Prior to MQSA
Prior to the passage of MQSA, there were no national, comprehensive quality
standards for mammography that applied to all facilities. The regulation of
mammography involved an often conflicting and overlapping patchwork of private
voluntary standards combined with limited state and federal regulations.
Private Voluntary Standards. In response to the problems identified in the
1980s, the American College of Radiology (ACR) established a private voluntary
accreditation program in August 1987. The ACR attempted to fill a gap with a program
that was generally well received; however, its voluntary nature as well as other aspects
of the standards raised some concerns. For example, although the image quality,
(reflecting the skills of the technician) was addressed, the image interpretation (reflecting
the skills of the radiologist) was not addressed. Less than half of mammography facilities
met ACR’s professional standards. Also, the ACR program had a surprisingly high
failure rate of 28% among first-time applicants. This was especially alarming due to the
voluntary nature of the program; presumably the applicants had applied because they
believed they were performing well and would met the ACR standards.
State Regulations. Prior to MQSA, only 11 states had established comprehensive
quality assurance standards. Michigan was among the first to implement such standards
and had one of the most all-encompassing programs. The Michigan program had a
significant impact on the quality of its mammography services. When the Michigan
legislation was enacted in 1989, 34% of mammography machines tested failed the image
quality test; the rate subsequently dropped to 16%. However, upon reinspection, even
accredited machines had a failure rate of 11%. The failure rate was of great concern to
the Michigan Department of Public Health, which was responsible for on site inspections
of mammography facilities, and the agency called for federal quality standards and
oversight of mammography. The wide variation in state laws, the potential for
nonuniformity of patient care from state to state, and the resulting confusion and fear such
a situation might cause influenced many to call for national mammography standards
monitored by a central body.
Federal Regulations. Oversight of mammography prior to MQSA involved
FDA, the Centers for Disease Control and Prevention (CDC), and the Health Care
Financing Administration (HCFA) through the Medicare program. FDA was responsible
only for regulating the proper manufacture and installation of mammography equipment
by monitoring equipment alignment and radiation leakage. FDA did not monitor its use.
1Physician Insurers Association of America, PIAA Breast Cancer Study, June 1995.
2Ibid.

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CDC’s breast and cervical cancer screening program was authorized by legislation
passed in 1990 (P.L. 101-354). The program provides grants to states to establish
screening programs for low income women. CDC assisted the states in establishing
screening programs and meeting CDC quality control guidelines, but CDC had no
authority to ensure compliance. In 1992, when MQSA was being drafted, CDC’s program
was providing grants to 10 states, and CDC expected to expand the program to five more
in FY1993; therefore, the scope of CDC’s quality control guidelines was limited.
The Catastrophic Health Care Coverage Act of 1988 (P.L. 100-360) required that
Medicare cover the costs of screening mammography. The Secretary of Health and
Human Services (HHS) was directed to establish standards assuring the safety and
accuracy of Medicare-funded screening mammography. On September 1, 1989, HHS
published proposed regulations. The benefit never took effect and the proposed
regulations were withdrawn because P.L. 100-360 was repealed in November 1989 (P.L.
101-234). Medicare coverage of screening mammography began on January 1, 1991,
following passage of the Omnibus Budget Reconcilation Act of 1990. Medicare had a
somewhat limited quality standards program that was described in an interim final rule
issued on December 31, 1990. The standards were similar to those proposed previously
under the Catastrophic Health Care Coverage Act.
Concerns Over Mammography Regulation. Prior to MQSA, congressional
hearings and reports documented a wide range of problems with the country’s
mammography system including poor quality equipment, the lack of quality assurance
procedures, poorly trained technologists and physicians, false representation of
accreditation, and the lack of inspections or government oversight. The burden for
obtaining a high quality mammogram fell on each woman. She needed to find out if the
facility was accredited by ACR, certified under the Medicare program, or regularly
inspected by the state, and then verify that the information supplied by the facility was
accurate. This was often a difficult task: one TV news show (Prime Time Live) found that
half the facilities their reporters visited falsely claimed to be accredited.
House and Senate committee reports on MQSA legislation (H.Rept. 102-889 and
S.Rept. 102-448) mentioned a number of other concerns over mammography quality
standards under the Medicare program. Medicare standards did not apply to all facilities
providing mammography, but only to facilities seeking reimbursement for mammography
screening of women eligible for Medicare. Facilities that did not meet Medicare’s quality
standards lost reimbursement, but were not required to stop performing mammography.
Therefore, although screening was recommended for millions of women under the age of
65, they were not protected by federal quality standards under Medicare.
Initially site inspections were not performed and Medicare certification required only
that facilities submit a statement indicating that they met the Medicare standards;
inspections by HCFA were required after September 6, 1992. However, Congress was
concerned that the inspections were being performed by individuals with insufficient
knowledge or experience in mammography. The Medicare program did not require an
evaluation of the images obtained by the facilities, and therefore there was no assurance
that the X-ray technician was using proper positioning of the patient or proper
compression of the breast tissue. In addition the Senate report stated that HCFA lacked
sufficient personnel trained in radiology or radiological physics to properly administer its
mammography quality standards program as well as oversee inspection of facilities.

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Mammography Quality Standards Act
The Mammography Quality Standards Act (MQSA) became law on October 27,
1992 (P.L. 102-539). The law required that the Department of Health and Human
Services (DHHS) develop standards for equipment and personnel in mammography
facilities and certify the facilities by October 1, 1994 (except for mammography facilities
operated by the Department of Veterans Affairs, which are governed by another law that
mandates a similar certification program). Enforcement of the standards is achieved
through accreditation, certification, and annual inspection. All mammography facilities
must be accredited by an accrediting body (approved by DHHS) before the facility can
gain certification from the government. FDA was assigned primary responsibility for
implementing MQSA by the Secretary of DHHS on June 2, 1993. Costs to FDA related
to annual inspections of mammography facilities are covered by user fees collected from
the facilities. Other MQSA activities are funded by appropriation (see table on next page).
On December 14, 1993, the President signed legislation (H.R. 2202, P.L. 103-183)
amending MQSA and allowing DHHS/FDA to issue temporary, but immediately
enforceable, interim regulations. The interim MQSA regulations were published in the
Federal Register on December 21, 1993 and became effective on February 22, 1994. The
interim rule allowed FDA to establish legally binding initial accreditation and quality
standards based on standards used by Medicare, ACR, and some states. The interim
standards were used to accredit and certify facilities by the October 1, 1994 deadline
while FDA developed final standards. The proposed final rule was published on April 3,
1996; FDA received approximately 1,900 comments. Final regulations were published
and became effective on October 28, 1997. The final regulations expanded and
strengthened the standards for personnel, equipment, quality assurance, quality control,
patient notification of results, and performance of accreditation bodies.
The General Accounting Office (GAO) has issued three reports on MQSA. The first
report looked at MQSA’s initial impact on access to and quality of mammography
services.3 GAO found that MQSA had a positive impact on mammography services by
requiring the use of higher quality equipment, better trained personnel and improved
practices. Access to mammography services was not limited by MQSA standards; FDA’s
gradual approach to implementing the new standards encouraged providers to upgrade
their operations rather than drop their mammography services. The second report focused
on FDA’s annual inspection program.4 GAO found that FDA’s inspection program had
a positive effect on the more than 9,000 mammography facilities in the United States.
First-year inspections found that 80% of the facilities had either no violations or minor
ones and only 2% had violations serious enough to warrant a warning letter from FDA.
Second-year inspections found a considerable reduction in the proportion of facilities
cited for violations. Moreover, the serious violations identified in the first-year
inspections had not recurred at any of the facilities where they were initially found.
3General Accounting Office, Mammography Services: Initial Impact of New Federal Law Has
Been Positive, GAO/HEHS-96-17, 27 October 1995.
4General Accounting Office, FDA’s Mammography Inspections: While Some Problems Need
Attention, Facility Compliance is Growing, GAO/HEHS-97-25, 27 January 1997.

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Table 1: FDA MQSA Program Budget
FY1998
FY1999
Appropriation
$10,000,000
$10,000,000
User Fees
13,965,000
14,385,000
Total
$23,965,000
$24,385,000
Source: FDA Budget Office.
The third GAO report assessed MQSA’s effect on: (1) women’s access to
mammography services; (2) the quality of mammography services; and (3) health
outcome and lives saved due to the early detection of breast cancer.5 The report again
found that MQSA has not had a negative impact on women’s access to mammography
services and has improved the quality of X-ray images. Improving the quality of
mammography images should result in more accurate interpretation by radiologists,
leading to lives saved through better early detection of breast cancer. However, GAO was
unable to determine if MQSA has improved the accuracy and reliability of
mammography interpretation. Several academic studies have shown a wide variation in
the interpretation of the same mammogram by different radiologists. There are no data
from FDA to verify that the MQSA program has improved early detection of breast cancer
and saved lives, nor are there research methodologies in place to confirm this in the near
future. According to GAO, “FDA has established federal qualification requirements for
physicians who interpret mammograms but has not established criteria for measuring
interpretation accuracy. Furthermore, comparable pre- and post-MQSA clinical data for
measuring mammography performance and cancer outcome either do not exist or, for a
number of reasons, are too limited to be useful.”6
Congressional Action
S. 537, the Mammography Quality Standards Reauthorization Act, was passed by
the Senate on November 9, 1997. On May 8, 1998, the Health and Environment
Subcommittee of the House Committee on Commerce held a hearing on the
“Reauthorization of the Mammography Quality Standards Act.” H.R. 4382 was
introduced in the House on August 3, 1998, and referred to the Committee on Commerce.
On August 5, 1998, a committee mark-up session was held and the bill was ordered to be
reported. On September 14, 1998, H.Rept. 105-713 was filed. H.R. 4382 passed the
House on September 15, 1998, passed the Senate on September 25, 1998, and was signed
into law by the President on October 9, 1998 (P.L. 105-248). H.R. 4382 is essentially
consistent with S. 537 except for two added provisions: (1) a section that requires direct
reports of mammography results to patients; and, (2) a section that allows for a
demonstration project to determine if inspections of high-performing mammography
facilities could occur less frequently than the current annual basis.
5General Accounting Office, Mammography Services: Impact of Federal Legislation on Quality,
Access, and Health Outcome, GAO/HEHS-98-11, 21 October 1997.
6Ibid.