[Congressional Record Volume 149, Number 167 (Tuesday, November 18, 2003)]
[Senate]
[Pages S15062-S15065]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Ms. MIKULSKI (for herself, Mr. Ensign, Mrs. Murray, Ms. Snowe,
Mr. Dodd, Mr. Kennedy, Mr. Jeffords, and Ms. Cantwell):
S. 1879. A bill to amend the Public Health Service Act to revise and
extend provisions relating to mammography quality standards; to the
Committee on Health, Education, Labor, and Pensions.
Ms. MIKULSKI. Mr. President, I rise to introduce the Mammography
Quality Standards Reauthorization Act of 2003. I am pleased to be
joined in introducing this bill by Senator Ensign and
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our bipartisan cosponsors. This important bipartisan bill is about
saving lives. That's what the Mammography Quality Standards Act (MQSA)
does. Accurate mammograms detect breast cancer early, so women can get
treatment and be survivors.
Mammography is not perfect, but it is the best screening tool we have
now. I authored MQSA over ten years ago to improve the quality of
mammograms so that they are safe and accurate. Before MQSA became law,
there was an uneven and conflicting patchwork of standards for
mammography in this country. There were no national quality standards
for personnel or equipment. Image quality of mammograms and patient
exposure to radiation levels varied widely. The quality of mammography
equipment was poor. Physicians and technologists were poorly trained.
Inspections were lacking.
MQSA set federal safety and quality assurance standards for
mammography facilities for: personnel, including doctors who interpret
mammograms; equipment; and operating procedures. By creating national
standards, Congress helped make mammograms a more reliable tool for
detecting breast cancer. In 1998, Congress improved MQSA by giving
information on test results directly to the women being tested, so no
woman falls through the cracks because she never learns about a
suspicious finding on her mammogram. Now it is time to renew MQSA and
lay the foundation to strengthen it even further.
The bill that I am introducing with Senator Ensign today is a
bipartisan agreement to extent MQSA for two years while making two
additional changes to certificates that facilities are required to have
to perform mammograms. First, the bill allows the Secretary of Health
and Human Services to issue a temporary renewal certificate for up to
45 days to a facility seeking reaccreditation, if the accreditation
body has issued an accreditation extension and other criteria are met.
This will help ensure that a facility is not forced to close its doors
to women seeking mammograms, while it is completing its reaccreditation
and the quality of mammography is not compromised.
Second, the bill allows the Secretary, at the request of an
accreditation body, to issue a limited provisional certificate to a
facility to enable a facility to conduct examinations for educational
purposes while an onsite visit from an accreditation body is in
progress. This certificate would only be valid during the time the site
visit team from the accreditation body is physically in the facility
and would not be valid longer than 72 hours.
The two year reauthorization of MQSA is important. It will give
Congress an opportunity to consider in the next reauthorization expert
recommendations from an Institute of Medicine (IOM) study and a General
Accounting Office (GAO) report on several issues related to MQSA. I
have been working with the Labor, Health and Human Services (HHS), and
Education Appropriations Subcommittee to get these studies going since
I included them in the Senate fiscal year 2004 Labor/HHS Appropriations
bill. The HELP Committee also heard testimony in support of a two year
reauthorization at the HELP Committee's April hearing on MQSA.
As I talked to advocacy groups about ways to improve MQSA, the need
to improve the skills of doctors reading mammograms was brought to my
attention. One study found that a woman has a 50 percent chance of
getting a ``false positive'' reading from her mammogram over 10 years.
I'm gravely concerned about reports that doctors miss about 15 percent
of breast cancers on mammograms. I was also disturbed by a New York
Times investigation last year. It found that some radiologists were
missing alarming numbers of breast cancers because they lacked the
experience or training they needed for the difficult task of
interpreting the X-ray. These are reasons why I requested the hearing
that the HELP Committee held in April on this issue. While I am
disappointed that the HELP Committee was not able to reach agreement
this year on a continuing medical education provision to address this
issue, I look forward to Congress reexamining this issue once the IOM
and GAO studies are completed.
The IOM and GAO will look at several important issues such as: ways
to improve physicians' interpretation of mammograms; possible changes
to MQSA regulatory requirements; ways to ensure the recruitment and
retention of sufficient numbers of adequately trained personnel to
provide quality mammography; how data currently collected under MQSA
could be better used; and factors that led to the closing of
mammography facilities since 2001. I look forward to working with my
colleagues in Congress to examine the recommendations from these
studies in 2005 and to consider further improvements to MQSA in its
next reauthorization.
The HELP Committee will mark up this bill tomorrow. This legislation
is supported by groups including the American Cancer Society, the Susan
G. Komen Breast Cancer Foundation, the national Alliance of Breast
Cancer Organizations, and the American College of Radiology
Association. I strongly urge Committee passage and swift Senate passage
of the bill later this week. I hope that the House will also
expeditiously pass this bill. There are an estimated 212,600 new cases
of breast cancer and an estimated 40,200 breast cancer deaths in the
United States this year. Early detection and treatment are essential to
reducing breast cancer deaths. Congress should pass this bill this year
to reauthorize MQSA and extend this valuable program that helps save
the lives of women and men with breast cancer. I ask unanimous consent
that letters of support be printed in the Record.
American Cancer Society,
November 18, 2003.
Hon. Barbara Mikulski,
U.S. Senate,
Washington, DC.
Dear Senator Mikulski: On behalf of the American Cancer
Society and its more than 28 million supporters, I would like
to thank you, along with Senator Ensign, for your continued
leadership in sponsoring the ``Mammography Quality Standards
Act of 2003.'' As the largest national, community-based
organization dedicated to eliminating the incidence and
burden of cancer and improving cancer care, the Society
strongly supports the reauthorization of the Mammography
Quality standards Act of 1992 (MQSA) in the remaining days of
this session.
In addition, we believe a two year reauthorization is
appropriate at this time, as we continue to examine methods
for mammography quality improvement. Currently, funding has
been included in the LHHS Appropriation bill for the
Institute of Medicine and General Accounting Office to study
and recommend concrete improvement to MQSA. When the results
of these studies are released, we look forward to again
working with the Congress to further improve MQSA and ensure
that women's access to high quality mammography continues.
The American Cancer Society, along with other professional
societies and advocacy groups, was actively involved in the
development of the 1992 MQSA law and its reauthorization in
1997, in an effort to further reduce deaths and disability
from breast cancer. Mammography screening has led to earlier
detection of breast cancer when it is in its most treatable
stages, thereby providing a greater chance for life-saving
treatments and a greater range of treatment options.
Increasing utilization of mammography has been a major factor
in the reduction of breast cancer deaths in the U.S. over the
last decade. Based upon ongoing scientific evidence and
improvements in technology, high-quality mammography
continues to be the best available tool for the early
detection of breast cancer. Therefore, the Society is honored
to again lend our support to Congress in its commitment to
ensure that women have access to high-quality mammograms.
The Society would like to commend you again for your
leadership on this critical public health issue, and we look
forward to continuing to work closely with you and the other
cosponsors to ensure the enactment of this important
legislation this year. If you or your staff have any
questions, please contact Kelly Green Kahn, Manager of
Federal Government Relations (202-661-5718).
Sincerely,
Daniel E. Smith,
National Vice President, Federal & State Government
Relations.
Wendy K.D. Selig,
Vice President, Legislative Affairs.
____
The Susan G. Komen Breast
Cancer Foundation,
November 17, 2003.
Re: Mammography Quality Standards Reauthorization Act of 2003
Hon. Barbara Mikulski,
Senate Hart Office Building, Washington, DC.
Dear Senator Mikulski: The Susan G. Komen Breast Cancer
Foundation supports your introduction of the Mammography
Quality Standards Reauthorization Act of 2003, and we
appreciate your leadership in ensuring patient access to
quality breast health and breast cancer care.
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Thanks to more than 75,000 volunteers dedicated to the
fight against breast cancer, the Susan G. Komen Breast Cancer
Foundation is a unique grassroots network with more than 100
Affiliates nationwide and internationally. Since its
inception in 1982, Komen has raised nearly $600 million in
furtherance of its mission--to eradicate breast cancer as a
life-threatening disease by advancing research, education,
screening and treatment. Komen dedicates millions of dollars
annually towards scientific and community outreach projects.
The Komen Foundation Research Program has awarded more than
850 grants, totaling more than $110 million for breast cancer
research. In addition, Komen Affiliates have funded hundreds
of non-duplicative, community-based breast health education
and breast cancer screening and treatment projects for the
medically underserved.
Early detection of breast cancer saves lives. Mammography
screening remains the gold standard in the early detection of
breast cancer. In the past decade, breast cancer mortality
rates have declined in the United States. This is due, in
large measure, to early detection and timely treatment. The
MQSA establishes a national standard of mammography care.
Since enactment of the MQSA, women throughout the country
have gained further confidence in their mammograms, as well
as in those individuals and facilities that provide services
as part of screening for breast cancer.
The Komen Foundation wishes to lend our continued support
to the efforts of you and your colleagues to ensure enactment
of the Mammography Quality Standards Reauthorization Act, and
we applaud your efforts in advancing an issue of utmost
importance.
Very truly yours,
Susan Braun,
President and CEO.
____
NABCO , National Alliance of Breast Cancer
Organizations,
New York, NY, November 18, 2003.
Hon. Barbara Mikulski,
U.S. Senate, Washington, DC.
Dear Senator Mikulski: On behalf of the millions of women,
families, professionals and providers served by the education
and information programs of the National Alliance of Breast
Cancer Organizations (NABCO), I am writing to express support
of 2003 legislation to reauthorize the Mammography Quality
Standards Act of 1992 (MQSA). We thank you and your Senate
co-sponsors for advancing this legislation.
Since our organization's founding in 1986, NABCO has been a
visible proponent of high-quality early detection of breast
cancer. We have worked with Congressional leaders on measures
to educate women about good breast health, and on provisions
to improve screening coverage and reimbursement, and to
eliminate barriers to early diagnosis. Without question,
early detection followed by prompt, state-of-the-art care
offers women the best chance for successful treatment, and
high-quality, regular mammograms are the best available tool
to detect breast cancer at its earliest, treatable stages.
The MQSA system of certification, inspection and
accreditation established basic standards that have improved
the quality of mammography in the United States. After
working with Congress to craft this legislation, it was my
honor to serve as a consumer representative on the FDA's
initial MQSA Advisory Committee. Since 1992, breast cancer
survival has improved markedly--in large part because more
women have taken advantage of regular, high-quality screening
mammograms, available nationwide. The current reauthorization
provisions will further strengthen this system.
However, new approaches are needed to continue to improve
the quality and efficiency of this test, reflect technology
innovations, disseminate outcomes, and attract dedicated
professionals to the breast imaging field. We hope that you
will seek NABCO's ongoing help to identify ways that MQSA can
better serve facilities, medical professionals and consumers.
We commend you and your staff for your recognition that high
quality, accessible mammography is vital to making progress
in the fight against breast cancer. With your support, we can
offer women confidence that if they have breast cancer, it is
likely to be detected, and that mammography and imaging
services in the U.S. will continue to improve in quality.
Very truly yours,
Amy S. Langer,
Executive Director.
____
American College of Radiology,
Reston, VA, November 17, 2003.
Hon. Barbara Mikulski,
U.S. Senate,
Washington, DC.
Dear Senator Mikulski: On behalf of the 30,000 physician
and physicist members of the American College of Radiology
Association (ACRa), I would like to offer the College's full
support for your introduction of legislation to reauthorize
the Mammography Quality Standards Act (MQSA).
Since enactment of MQSA in 1992, women in the United States
have gained confidence in the providers of their mammograms,
through the knowledge that mammography facilities were being
certified in accordance with federal standards. The
successful collaboration of radiologists, mammography
facility operators, federal and state regulators and consumer
groups has produced significant improvements in the quality
of mammograms nationwide. With the impending passage of this
legislation, Congress and ACRa continue this legacy.
The technical corrections contained in this legislation
will make sure that mammography facilities will not be closed
due to administrative ``Catch 22's.'' Had these problems not
been addressed, access by thousands of women seeking timely
breast cancer detection and treatment may have been
threatened. Furthermore, the Committee's willingness to work
with the breast cancer community and consider incorporating
the results of pending studies into the next reauthorization
is truly appreciated and has the potential of improving the
act even more.
The College looks forward to working with you and other
interested parties to enact this legislation and thanks you
for your leadership as we continue to improve the quality of
mammography services throughout the country.
Sincerely,
E. Stephen Amis,
Chairman, Board of Chancellors.
Mr. ENSIGN. Mr. President, I rise today to introduce, with my
distinguished colleague from Maryland, Senator Mikulski, the
Mammography Quality Standards Reauthorization Act of 2003. The purpose
of this legislation is to reauthorize the Mammography Quality Standards
Act in order to maintain access to high quality mammography services
for every woman in America.
Breast cancer is the second leading cause of cancer deaths among
American women. An estimated 211,300 new cases of invasive breast
cancer are expected to occur among women in the United States in 2003.
In my home State of Nevada alone, 1,400 new cases of breast cancer will
be diagnosed in women, and an estimated 300 women in Nevada will die of
breast cancer next year.
The MQSA was originally passed in 1992 to ensure that all women have
access to quality mammography for the detection of breast cancer in its
earliest, most treatable stages. Congress re-authorized MQSA in 1998,
extending the program through 2002. Although MQSA was scheduled for
reauthorization last Congress, we unfortunately failed to act.
The MQSA has had a positive impact on mammography quality. FDA
inspection data continues to show overall facility compliance with the
national standards to ensure the quality of x-ray images. Currently,
over 98 percent of all mammography facilities pass the phantom image
test during their facility inspection. MQSA remains as essential tool
for early detection and for combating mortality associated with breast
cancer.
The legislation I introduce today would reauthorize MQSA for 2 years,
signifying Congress' commitment to extending the life of this important
program. Reauthorizing the act for a shorter amount of time than
previously done will allow Congress the time it needs to examine some
serious issues facing the long-term effectiveness of the act while
still maintaining vital quality standards in the interim.
In addition, this legislation would permit the Secretary of the
Department of Health and Human Services to issue two additional and
temporary certificates that will allow facilities who offer mammography
services to continue to provide uninterrupted care while they go
through the process of reaccredidation. This is important as we
encourage more and more women to seek screening services each year.
With these significant changes, MQSA, I believe, will be more
effective than ever. While we are improving the act with this bill, we
need to tread carefully as we look to make further changes.
Mammography, like every health discipline, is an imperfect science. On
average, radiologists estimate that somewhere around 75 percent of
cancer can be found through mammography. Thus, until the technology
improves, the quality of the reading is limited.
We have to remember that in the medical field, human error is
unavoidable. Most doctors practicing today are excellent at what they
do, and placing additional regulations on them, especially in an
already highly-regulated subspecialty, can often times do more harm
than good. Congress needs to be increasingly vigilant in making sure
that practices below acceptable standards are eliminated. To that end,
one of the real benefits of MQSA is its required medical audit
procedure which mandates that each FDA-approved facility has a system
for following up on mammograms that reveal problems. In
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other words, each facility performs a self-check on itself, helping to
ensure quality care is being given.
The impact of medical liability on the radiological profession has
been immense, leading to a shortage of quality doctors. As bad as it
has been for the profession itself, the adverse effect it has had on
patient access to care is intolerable. In places across the country,
women are having to wait weeks, even months, to get a mammography
screening. In a speech this February in Florida, the president of the
American Medical Association stated that in a recent survey of Palm
Beach, Miami Dade and Broward Counties, 7 of the 29 radiologists said
they had stopped reading mammograms--and 8 others are considering that
possibility. In addition, Orlando Regional Hospital reports that the
average wait time for women seeking mammography rose from 20 days in
2000--to 150 days in 2002. The cause of all this is that many
radiologists can't find or afford the necessary liability insurance.
The bottom line is that at a time when the medical liability crisis
is hitting the industry harder than ever, the last thing the Federal
Government should be doing is creating more avenues for abusive
lawsuits. That is why Congress must balance the need to find ways to
improve the quality and delivery of women's health, while at the same
time preserving a positive and equitable medical environment for well-
intentioned professionals to practice.
The MQSA has been an important program in increasing the quality of
mammography services for women. I thank Senator Mikulski and HELP
Committee Chairman Gregg for all of their hard work on this issue, and
I look forward to seeing this legislation through to passage by the
Senate and ultimately signed into law.
______