[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

[[Page S15063]]

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.

[[Page S15064]]

       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

[[Page S15065]]

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.
                                 ______