Testimony of Diana Rowden, Breast Cancer Survivor
Committee on Health, Education, Labor and Pensions
The Mammography Quality S
April 8, 2003
Gregg, Senator Mikulski, and distinguished Members of the Committee, thank you
for the opportunity to testify on the reauthorization of the
Patient Education, Advocacy and Outreach
a result of my experience, in the spring of 1992 I became a patient advocate
volunteering for the Komen Foundation.
Komen was established in 1982 by Nancy Brinker, to honor the memory of
her sister, Suzy Komen, who died of breast cancer at the age of 36. The Komen Foundation has 1
21 domestic and
international Affiliates, with over 75,000 volunteers
across the U .S.
I was one of the first
volunteer counselors on the Foundation’s national toll-free Helpline, 1.800 I’M
AWARE®, which receives approximately 60,000 inquiries every year from women and
their families, seeking critical information about breast health and breast
cancer care. I served on the Komen
Foundation’s executive committee, first as vice-chair of education and then as
vice-chair of grants. From 1997-98, I
served as the elected Chair of Komen’s National Board of Directors. Since then I have continued my volunteer
work for Komen, participating as the Foundation’s representative on numerous
local and national committees and boards including the Intercultural Cancer Council
which, consistent with Komen’s mission, advocates the elimination of the
unequal burden of cancer on racial and ethnic minorities and the medically
underserved. In November 2002, I joined the Komen staff as the Affiliate
Service Manager overseeing
the Komen Affiliate network. d
as a member of the National Cancer Institute (NCI) Consumer Advocates in
Research and Related Activities (CARRA) Program , the National
Surgical Adjuvant Breast and Bowel Project (NSABP) Patient Advocacy Committee , and the
integration panel for the U.S. Army Breast Cancer Research Program.
My current work with Komen’s
vast Affiliate network keeps me in close touch with our many volunteers across
the nation – survivors and their loved ones dedicated to the fight against
breast cancer. Through programs like
the Komen Race for the Cure® and other education and outreach programs, as well
as our Komen Champions for the Cure™ public policy grassroots program, the
Komen Foundation remains steadfast in our commitment to eradicate breast cancer
as a life-threatening disease by advancing research, education, screening, and
Indeed, the Komen
Foundation has become the largest private funding source of breast cancer
research in the U.S. Since its
inception, the Foundation has raised more than $ 700 million in the fight
against breast cancer. In addition,
Komen Affiliates provide tens of millions of dollars annually to fund
non-duplicative education and outreach programs that address unmet breast
health needs in local communities.
Access To Early Detection Save Lives
while the Komen Foundation invests millions of dollars annually in cutting-edge
breast cancer research for the future, we recognize the
of helping to meet the needs of women facing breast cancer today. This year in the U.S. alone, more than
200,000 women and men will be diagnosed with breast cancer, and over 40,000
will die from this devastating disease.
a woman is diagnosed with breast cancer, and every twelve minutes a women dies from this disease. All of us here today will be touched by
breast cancer in some way during our lifetime.
believe that early detection of breast cancer saves lives
, and mammography screening,
while imperfect, remains the best tool available to detect breast cancer at its
earliest, most treatable stages.
ten years ago, Senator Mikulski and other
Senators recognized that the effectiveness of mammography hinges on the quality
of equipment used and the accuracy of interpreting physicians. You led the effort in 1992 to enact the MQSA
and establish national standards of mammography care.
As the GAO recognized in its 1997 report, MQSA has had a positive impact on the quality of mammography services. Citing American College of Radiology (ACR) data, the GAO reported that prior to MQSA implementation, only 37 to 44 percent of mammography units met the ACR’s quality standards; subsequent to MQSA implementation, that number increased to 66 percent in 1995, and to 82 percent in 1997.
better, the death rate from breast
cancer among women in the U.S. has been decreasing by about two percent
annually during the past decade, suggesting that public awareness, early
detection, and improved therapies are having an impact on the disease. In the early 1980s, only 13 percent of women
in the U.S. received mammograms. At
that time, the average size of a tumor when first detected was 3 cm. During the late 1990s, with 60 percent of
U.S. women obtaining mammography screening, the average size of tumors detected
decreased to 2 cm – a significant and meaningful difference. But we still have a long way to go.
Next Steps – Improving the MQSA
Few disagree that MQSA has led to the improvement of image quality and other technical aspects of mammography services. There is less certainty, however, about the Act’s impact on the quality of image interpretation. The FDA’s implementing regulations primarily focus on equipment and technical quality assurance issues. Some argue that sufficient enforcement mechanisms need to be enhanced. When it comes to quality assurance in reading and interpreting films or in collecting data related to these services, patients would benefit from strengthening MQSA in these important areas.
MQSA reauthorization process presents Congress with an important opportunity to
build upon the existing quality standards related to image interpretation.
variation is troublesome. Poor quality
interpretation can lead to false negatives, (missed cancers) and delayed
which may result in needless
anxiety, costly additional testing , unnecessary
biopsies , and even
MQSA reauthorization process, I urge Congress to consider how best to improve
current requirements related to radiologist training and medical outcomes data.
Strengthening Radiologist Training
current FDA regulations set forth minimum standards for certification of
physicians, both radiologists and non-radiologists. These rules mandate that interpreting physicians read at least
480 mammograms each year – a relatively low number. In addition, educational requirements demand
that interpreting physicians obtain 15 Category I Continuing Medical
Education (CME) units specific to mammography every three years to further
their professional development. Even though these requirements demonstrate
that the FDA understands the importance of reading a minimum number of
mammograms and completing CME courses to maintain sharp interpretation skills,
many within the survivor community do not believe that these requirements are
rigorous enough. In fact, some of the
recent medical journal studies and news articles
give me and others pause
about the adequacy of these standards.
am among the thousands of women, as well as many providers, who strongly
believe that physicians should do more to strengthen and sharpen their skills
in reading mammograms so that the lives of women are not put at increased
risk. The average radiologist is not
exposed to a high-volume of mammograms.
Radiologists who perform only the minimum number of exams required
annually will encounter a relatively small number of women with breast
cancer. Numerous studies now show a
strong correlation between the accuracy of mammography interpretation and
reader-volume, specifically as to small breast cancers. In order to develop the expertise necessary
to recognize the varied forms of breast cancers and the manner in which they
present, radiologists must be exposed to a larger number of mammograms.
The traditional forum for CME
is lecture courses. Although
beneficial, our constituents tell us that such courses are largely ineffective
for improving interpretation skills.
The Komen Foundation believes that CME requirements should direct
radiologists toward hands-on, skill-based courses
that includ e
self-assessment, rather than lecture series alone. Hands-on training would provide radiologists with more
opportunities to look at breast cancers and help them better understand suspect
images. Further, self-assessment as a
component of CME would require radiologists to look at actual cases, evaluate
them, and then compare their interpretation with the correct result. Self-assessment would also provide
radiologists with real-time feedback about how well they are doing and where
improvement is needed. This interactive
process can help radiologists determine what types of cancers they may misread
and allow them to adjust their techniques to decrease future mistakes. Since interactive tools that provide
hands-on training and opportunities for assessing interpretation skills already
exist s, it is not expected that
modification of current CME requirements would add significant costs to the
skills-assessment as part of CME can be expected to sharpen interpretation
skills, which translates into fewer missed breast cancers and more lives
saved. Given these important and
potentially life-saving benefits, the Komen Foundation urges Congress to
require skills-assessment as a component of CME. We support the current proposal mandating that one-third of CME
be dedicated to skills-assessment study.
Any such requirement should not be considered a test of competency but,
rather, an opportunity for interpreting physicians to improve and enhance their
ability to interpret mammograms.
Komen Foundation recognizes that these issues cannot be looked at
a blind eye. The MQSA
should provide incentives for mammography-related CME courses to assist
radiologists with improving their skills.
An example of a sensible step in the right direction is the Centers for
Medicare and Medicaid Services’ (CMS) recent announcement that it will award
CME credit to physicians who participate in newly designed quality improvement
courses provided by Medicare’s Quality Improvement Organizations (QIOs). This development demonstrates how the
government can create incentives for providers to attend courses designed to
improve their proficiency in mammography interpretation.
addressing the CME issue legislatively, Congress should act more deftly than
pursuing a “mammo police” approach.
While we must ensure meaningful results for women, the correct balance
must be struck so that we do not
create additional barriers to access to quality care by driving radiologists
from the field.
Improving Medical Outcomes Data
addition to strengthening the training of radiologists, it is critical that any
mammography quality assurance program be able to assess its performance. This assessment can and should occur through
evaluation of medical outcomes data.
Currently, the MQSA regulations include only a general requirement that
each facility maintain mammography data and perform a medical outcomes audit.
Nor is comprehensive information about physician performance available from other sources. Certain data sources, such as the vitally important Centers for Disease Control and Prevention’s (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCCEDP), as well as state cancer registries may contain some useful information. Nonetheless, comparable clinical data measuring outcome changes simply are not available. Furthermore, while the FDA’s regulations establish federal qualification requirements for physicians who interpret mammograms, the agency has not developed or implemented sufficient criteria to measure the accuracy of their performance.
Although there may be many ways to
improve quality assurance in performance, it is appropriate to consider
reviewing current medical outcomes audits mandated in the MQSA
regulations. Under current law, all
MQSA certified mammography facilities must collect certain quality-related
data. This data should provide
facilities with a basis for measuring current performance and comparing
relative performance over time. In
short, the audits provide the potential for improving the quality of
However, it is
not clear what data is actually collected or how it is used.
the reauthorization process, I encourage the Committee to explore th
important quality assurance issue further.
The FDA may be able
to readily provide answers to some of the existing questions. However, other answers may
require more thought and study and
could be incorporated into a GAO study, along with similar questions suggested
in earlier drafts of reauthorization proposals.
way to understand more about outcomes, of course,
to require consistent collection and utilization of outcomes data in any
program of quality assurance. Currently,
there is no such requirement. Although
the following list is not exhaustive, it includes the type of image
interpretation data that would be most helpful if collected for each facility .
v The number and types of all mammograms performed per year;
v The number of screening patients recalled for diagnostic studies;
v The number of radiologists interpreting screening mammograms;
v The number of screening mammograms interpreted by each radiologist;
v The percentage of cases reported annually in each of the five reporting categories (e.g., BI-RADS) used by each facility;
v The number biopsies performed;
v Follow-up of all findings in which any further image or other study is recommended; and
v Retrospective review of the mammograms of each patient diagnosed with breast cancer in the population receiving mammograms at a particular facility.
of this outcomes
data would be significantly enhanced if it were linked to national cancer
registries. This information
could tell us how well mammography is working by facilitating further study. It also
would allow us to determine how particular facilities are performing. Most
importantly, better data has the potential to significantly improve
the quality of care received by millions of American women and
course, any link to a national database demands that the confidentiality of the
data be protected and any results be released only in the aggregate without
individual identifiable health information attached. In addition, any corrections to the system must consider and
weigh current and future burdens to mammography facilities and to radiologists,
including economic costs, which might impede patient access to quality care.
Given that these
issues will require serious review, it may be appropriate to request
a study from the GAO
or the Institute of Medicine. This
approach would be consistent with proposals for MQSA reauthorization introduced
during the 107th Congress. A
study, if completed before the reauthorization expires, could provide greater
insight into these issues in time for the next round of MQSA reauthorization
the enactment of MQSA and the establishment of minimum quality
women throughout the country have gained further confidence in the
of mammography services. Now, we must
also ensure that these minimum
of quality apply uniformly to interventional modalities (e.g.,
needle localization and stereotactic breast biopsy).
mammography is performed in follow-up to an abnormal
mammogram. Such procedures can improve a patient’s
quality of life by allowing
examination of the abnormality while avoiding a more invasive surgical
Research and development of cutting-edge technologies for the
and treatment of breast cancer, including stereotactic breast biopsy and
localization, have dramatically improved the quality of life for many
and their families. Patients must be
assured that the care they are
as a result of these innovative technologies meets minimum quality
standards. The Komen Foundation urges Congress to
mandate the inclusion of
mammography equipment under the umbrella of MQSA oversight.
Patients and Providers
the success of any new quality assurance system, it is critically important to
enhance the quality of continued training and outcomes data collection and
analysis. Equally important is the need
to strike a balance between the interests of both patients and providers.
should not fear that the confidentiality of their personal health information
not be maintained. Therefore, I urge the Committee to be
sensitive to these concerns and develop of a
quality assurance system that complies with appropriate federal and state
addition, providers should not have to worry about the misuse of quality
information. If providers fear that
quality assurance information will be used against them, they may very well
stop providing mammography services. If
this happens, the strides we have made in providing access to mammography for
all women will diminish. Therefore, any
quality improvement initiative must contain adequate assurances to ease
radiologists’ concerns in this regard, and any information released publicly
should be aggregated by facility and not linked to particular providers.
Komen Foundation believes that quality of image interpretation is essential to
improving mammography services and building confidence in the continued use of
standards , but we also
appreciate that requiring new quality standards could impose additional burdens
Of course, it is
also essential that insurers, including Medicare, provide adequate
reimbursement to providers of mammography services. Without proper levels of reimbursement, we can expect progressive
deterioration of these potentially life-saving services, resulting in
diminished quality of life and quality of care for breast cancer patients and
others facing a diagnosis of breast cancer. As
part of MQSA reauthorization, it bears repeating that Congress must balance the need to
improve image interpretation with the competing need to maintain access to
quality mammography services. It would
be counterproductive to implement strict quality standards that result in
radiologists leaving the field because they fear potential liability and
inadequate reimbursement to implement changes necessary to improve quality.
of growing disinterest among physicians and technicians in the field of
mammography abound. Komen constituents
increasingly report and survey data suggests that radiologists are being
deterred from choosing mammography as a specialty because of the numerous disincentives
to enter this field, such as fear of liability, high costs of malpractice
insurance, inadequate reimbursement rates, workload and high stress
levels. In addition, the number of
mammography training fellowships for radiologists decreased by approximately
one quarter from 1996 to 2001
[cite: Institute of Medicine Report – Mammography and
Beyond, Developing Technologies for the Early Detection of Breast Cancer .]
contend that the reimbursement levels for mammography are too low in relation
to the time, effort and interpretive skill it requires, compared to the other
addition, numerous anecdotal reports cite facility closings and suggest that
many such closings are the result of inadequate mammography reimbursement rates
that do not adequately cover the costs of providing mammography services.
Foundation supports the
provisions of previous reauthorization bills that called for
additional studies to review
access-related issues and further
supports including such provisions in any legislation reauthorizing MQSA. The Foundation specifically suggests including
language mandating a review of the reported link
between facility closure and inadequate reimbursement rates.
of the difficult questions that must be addressed to ensure Congress strikes
the correct balance, the Komen Foundation strongly supports a two-year
reauthorization timeframe. With the
many unanswered questions about the existing quality assurance structure,
whatever system Congress adopts will need to be refined in the coming years. A two-year cycle allows for the
implementation of a system, yet provides the flexibility necessary to evaluate
concerns in a timely manner. Waiting
more than two years to evaluate the system may lead to unnecessary access
problems if radiologists, feeling overwhelmed by new requirements that are
locked in for five years, decide to stop providing mammography services and new
physicians choose to avoid entering the field entirely.
a patient advocate, I appreciate the real improvements in mammography and
marvel at the progress in breast cancer treatment over the years. In addition to the technological
advancements, technicians and radiologists are better trained and more
knowledgeable about breast cancer than ever before. These successes are based in large part on the requirements of
MQSA. However, as a society we cannot
afford to rest on these accomplishments.
We must strive to do better.
This includes enhancing MQSA to ensure high quality image interpretation
so that women who need mammography services receive the best available care.
to innovative research, what we now know about breast cancer is at an all time
; and the push for research and development
of new technologies and therapies continues. We
have made significant strides in the war against breast cancer. real
breakthroughs that could save thousands of additional lives. But, until researchers find a cure for
breast cancer and, better yet, a way to prevent this disease, we must not lose sight
of the importance of mammography screening for detecting breast cancer
early. Indeed, we must not
forget the men and women of today who rely on current technology
to help them face this devastating disease.
Reauthorizing MQSA with new provisions that result in better image
interpretation will help ensure the delivery of high quality breast health and
breast cancer care in the U.S. Please
be assured that the while the Komen Foundation will
continue in our commitment to fund ground-breaking research for future
generations, we will also remain committed to ensuring that all women and men fac ing
a diagnosis of breast cancer today have
access to the best care currently available.
I appreciate the
opportunity to present this testimony and thank you very much.
 Id. at 7.
 See, e.g., R.E. Bird, T.W. Wallace, B.C. Yankaskas, “Analysis of Cancers Missed at Screening Mammography” 184 Radiology 613-17 (1992); C.L. Robertson, “A Private Breast Imaging Practice: Medical Audit of 25,788 Screening and 1,077 Diagnostic Examinations” 187 Radiology 75-79 (1993); D.G. Sienko, R.A. Hahn, E.M. Mills, et al., “Mammography Use and Outcomes in a Community” 71 Cancer 1801-09 (1993); K. Kerlikowske, D. Grady, J. Barclay, et al., “Variability and Accuracy in Mammographic Interpretation Using the American College of Radiology Breast Imaging Reporting and Data System” 90 J. Nat’l. Cancer Inst. 1801-09 (1998).
 Michael Moss, “Spotting Breast Cancer: Doctors are Weak Link” New York Times (June 27, 2002).
 21 C.F.R. § 900.12.
 21 C.F.R. § 900.12.
 GAO, supra, at 2.