[Senate Hearing 108-286]
[From the U.S. Government Publishing Office]
S. Hrg. 108-286
MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA)
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
ON
EXAMINING THE MAMMOGRAPHY STANDARDS ACT OF 1992, TO AMEND THE PUBLIC
HEALTH SERVICE ACT TO ESTABLISH THE AUTHORITY FOR THE REGULATION OF
MAMMOGRAPHY SERVICES AND RADIOLOGICAL EQUIPMENT
__________
APRIL 8, 2003
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
JUDD GREGG, New Hampshire, Chairman
BILL FRIST, Tennessee EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama PATTY MURRAY, Washington
JOHN ENSIGN, Nevada JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia HILLARY RODHAM CLINTON, New York
Sharon R. Soderstrom, Staff Director
J. Michael Myers, Minority Staff Director and Chief Counsel
(ii)
C O N T E N T S
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STATEMENTS
APRIL 8, 2003
Page
Ensign, Hon. John, a U.S. Senator from the State of Nevada....... 1
Mikulski, Hon. Barbara A., a U.S. Senator from the State of
Maryland....................................................... 2
Dershaw, David, M.D., Vice President, Society For Breast Imaging,
Reston, VA; Diana Rowden, Affiliate Service Manager, Susan G.
Komen Breast Cancer Foundation, Dallas, TX; and Leonard Berlin,
M.D., Chairman, Department of Radiology, Rush North Shore
Medical Center, Skokie, IL..................................... 6
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
D. David Dershaw, M.D........................................ 23
Diana Rowden................................................. 24
Leonard Berlin, M.D.......................................... 31
(iii)
MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA)
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TUESDAY, APRIL 8, 2003
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:05 a.m., in
room SD-430, Dirksen Senate Office Building, Senator Ensign
presiding.
Present: Senators Ensign and Mikulski.
Opening Statement of Senator Ensign
Senator Ensign. I call the hearing to order and I would
like to welcome our witnesses to the table. We will make some
brief opening statements, first by myself and then by my
esteemed colleague, Senator Mikulski, and we will then proceed
with the hearing and the very, very important topic that we are
dealing with this morning, the Mammography Quality Standards
Act.
Breast cancer is the second leading cause of cancer deaths
among women. An estimated 211,300 new cases of invasive breast
cancer are expected to occur among the 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.
Breast cancer is something that the more it affects you
personally, I think the more passionate that you become about
early detection, early diagnosis, and hopefully some day, a
complete eradication of this disease. A personal experience
that my wife and I had was a very close friend of ours was
diagnosed, actually 5 years before that. We watched her go
through chemotherapy and a mastectomy and even to the point of
a bone marrow transplant at the City of Hope. She ended up
suffering through all of that but was an incredible women, an
incredible strength of character, and was an inspiration to a
lot of people even to this day. Sadly, she ended up dying in my
wife's arms just about 10 years ago.
That is kind of our personal entre into this dreaded
disease. We have become passionate since then. We cofounded the
Breast Cancer Coalition of Nevada. We helped secure the funds
to get a mobile mammography unit for the underserved women of
Nevada. So I come to this issue with a lot of passion and also
with a little bit of a medical background as a veterinarian, so
I understand some of these issues. However, I also understand
that medicine is an art and a science and because of that,
unfortunately it is very inexact in its interpretation.
I remember in veterinary school when we started learning
radiology. That was when the radiologists said okay, now you
must put on your ``imaginoscope'', as they put it, because it
is such an inexact science. The better trained you are, the
better you get at radiology, but it is never a perfect science.
As the machines improve, radiology improves. As more training
goes into the people who are reading, as well as those taking
the pictures, obviously diagnoses improve, and that is really
what this is about today. It is about getting better diagnostic
standards so that in the future we reduce the number of false
positives and we reduce the number of false negatives.
That really is the bottom line of this hearing today, along
with the serious problem we have with medical liability abuses
in the system. I do not want to turn the whole hearing into a
debate on the medical liability issue but it certainly is an
issue that we are facing in this country. Also, because we are
dealing with an issue of access to care because more and more
physicians are leaving their practices around the country, we
do not want to do something up here that has the unintended
consequence of creating more lawsuits. That leads to fewer and
fewer people who are able and willing to go into the practice
or who leave early the practice of medicine, leaving patients
with less and less access to care.
It is a delicate balancing act and I appreciate all the
work that Senator Mikulski has put into this over the years.
She certainly comes at it from a legislative perspective with a
lot more experience than I have and I appreciate hearing from
her, as well as our witnesses today.
So after I yield to you, Senator Mikulski, for any opening
statement you wish to make, I then look forward to our
witnesses.
Opening Statement of Senator Mikulski
Senator Mikulski. Thank you very much, Mr. Chairman. I want
to thank you for chairing this hearing today on mammography
quality standards. Both in our private conversations on the
floor and in your opening statement I would like to thank you
for your compassionate and common sense approach to how to
reauthorize mammography quality standards where we get the best
mammograms for the women and make sure that we have the best
trained people and the most accurate equipment to be able to do
that. I think if we follow those two guidelines of compassion
and common sense, we will arrive at a position where I know you
and I both want to be, which is in a very sensible center to be
able to move the legislation forward.
Your own comments about the involvement of both you and
your wife really show that first of all, cancer is not only a
woman's issue; it is really a family issue, and then it becomes
a community issue. When a woman gets breast cancer, it affects
her in a most horrific, challenging kind of way, but it has an
incredible impact on her family. It affects her husband as they
struggle through what is the best treatment, the impact that it
will have on their lives, and the impact that it will have on
their children. If you are going to lose your mom, that is a
pretty big loss.
I would also like to salute you and your wife for what you
have been doing in Nevada. It is very much appreciated.
Today's hearing is about saving lives and that is what the
mammography quality standards do. Accurate mammograms detect
breast cancer early so that women can get the right treatment
at the earliest time and therefore be survivors.
Today we are looking at the reauthorization of mammography
quality standards. It is my belief that number one, we must
keep the standards that we have already arrived at in mammogram
quality standards because it is so vast improved over where we
were 10 years ago. Then we look at how we can improve the
skills of those who do the mammograms. So I look forward to
working with all of our colleagues in the committee.
Eleven years ago I was the lead authorizer of mammogram
quality standards so that they would be safe and accurate.
Before we had MQSA there was an uneven and often conflicting
patchwork for standards of mammography in this country. There
were no national standards for personnel or equipment. Image
quality of mammograms and patient exposure to radiation varied
widely. There were those who were actually even giving
mammograms using the old chest x-ray equipment. They looked at
it with the same technology and the same skill set as if you
were testing for TB. The quality of the equipment was poor and
even very well intentioned physicians and technologists had not
quite come into this.
I remember my very first mammogram. The equipment was
really klutzy, overwhelming and overpowering. I felt like some
massive airbag had gone off on my body and it was only because
I knew the importance of it that I stayed the course until the
technology changed.
Well, the technology has changed and it has so improved. It
is a tribute to the genius of America's private sector that we
now have great equipment, that we have now radiologic
technologists that are trained just in mammography, radiology
technicians and then, of course, the physicians who set about
reading it.
Right now we have personnel who interpret the mammograms,
the equipment, and even operating procedures, and by creating
those national standards through FDA, Congress helped make
mammograms a more reliable tool for detecting breast cancer.
Now, however, we are facing new challenges. A study by the
University of Washington School of Medicine found that a woman
has a 50 percent chance of getting a false positive reading for
her mammogram over 10 years. I am concerned that in some
instances, those who read mammograms miss the breast cancer
about it 15 percent of the time.
A year-long investigation by the New York Times paints a
very disturbing picture and found that while Federal standards
had improved the quality of breast x-ray films, some
radiologists were still missing an alarming number of breast
cancers because they lacked the experience or training they
needed. Misreading mammograms means one of two things. Either a
women who has it is told she does not and a life-saving
treatment is delayed, or again false positives.
We have been listening to the American Medical Association,
the Accreditation Council for Continuing Medical Education and
others. We want to hear from the witnesses today because what
we want to do is see how we can address the flashing yellow
lights and figure out what is the best way to improve the
quality standards from the last 10 years.
I know that radiologists reading mammograms face many
challenges--low reimbursement for mammography, difficulty in
reading them, and even with their technology now, high medical
malpractice rates. Also radiologists are uniquely regulated by
MQSA in a way that they are not for any other procedures or
processes they do.
So I want to find that right balance to improve the skill
of physicians, to make sure the equipment is the best
available, and to make sure that we do save the women's lives.
This is why we want to hear today from survivors with their
observations and insights, of course speaking for the wonderful
Komen Foundation, as well as physicians themselves. Again, to
get the best ideas so we can come up with the best legislation
and have no unintended consequences, either the impact on
women's lives or driving very dedicated people from the
profession.
[The prepared statement of Senator Mikulski follows:]
Prepared Statement of Senator Mikulski
Mr. Chairman, thank you for holding this hearing today on
the Mammography Quality Standards Act (MQSA). I also want to
thank Chairman Gregg for scheduling this hearing at my request.
Today's hearing is about saving lives--that's what MQSA does.
Accurate mammograms detect breast cancer early, so women can
get treatment and be survivors.
We're here today looking at the reauthorization of MQSA. We
must keep the standards we have under MQSA, and we must improve
the skills of doctors who read mammograms. I want to work with
Senators Gregg, Kennedy, Snowe and other members of this
committee to get MQSA reauthorized and strengthened this year.
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 strengthen
it further.
A study by the University of Washington School of Medicine
found that a woman has a 50% chance of getting a ``false
positive'' reading from her mammogram over 10 years. I'm
gravely concerned about reports that doctors miss about 15% of
breast cancers on mammograms. A year-long investigation by the
New York Times paints a very disturbing picture. It found that
while federal standards had improved the quality of breast x-
ray films, some radiologists were missing an alarming number of
breast cancers because they lacked the experience or training
they needed.
Misreading mammograms means one of two things: either a
woman who has breast cancer is told she doesn't and life-saving
treatment is delayed. I have also heard heartbreaking stories
from women who were told they have breast cancer, only to find
out later--after expensive and sometimes painful tests--that
they do not. I want to acknowledge that the vast majority of
doctors do a great job. They make sure women get accurate
readings of mammograms. I understand that mammograms are among
the most difficult x-ray images to read.
I have been listening to professional groups such as the
American College of Radiology, the American Medical
Association, and the Accreditation Council for Continuing
Medical Education. I have also been listening to patient groups
like: the Komen Foundation, the American Cancer Society, and
the National Alliance of Breast Cancer Organizations.
Radiologists already meet continuing education requirements
under MQSA. Some recommend that a skills assessment be included
in this requirement. This skills assessment would give
radiologists feedback on their mammogram reading skills. It
would show them where they may need additional training. I look
forward to hearing from the witnesses their ideas about the
best ways to design a skills assessment and other thoughts they
have about improving the skills of radiologists reading
mammograms.
I know that radiologists reading mammograms face many
challenges: low reimbursement for mammography; the difficulty
of reading mammograms; high medical malpractice rates; and
unique regulation by MQSA. I want to find the right balance to
improve the skills of physicians reading mammograms to make
sure women's lives are saved through the accurate reading of
quality mammograms, but not take steps that drive radiologists
away from mammography. Women need well-trained physicians to
read these mammograms.
My bottom line is quality mammography to save women's
lives. I look forward to the testimony of our witnesses to help
the Committee to strengthen and reauthorize MQSA this year.
Senator Ensign. I would like to welcome the witnesses to
the table. First we have Dr. David Dershaw, who is the director
of the Breast Imaging Section in the Department of Radiology at
Sloan-Kettering Memorial Cancer Center in New York and a
professor of radiology at Cornell University School of
Medicine. He is the in-coming president of the Society of
Breast Imaging. He has chaired the New York State Breast Cancer
Detection Education Advisory Council from 1991 to 2000. He is
the director of the American College of Radiology and Armed
Forces Institute of Pathology training program for residents in
mammography, has written over 100 peer-reviewed journal
articles, authored half a dozen books, and contributed over 60
chapters and videotapes on breast imaging.
Dr. Dershaw is a recognized authority on breast imaging,
frequently lecturing around the United States and
internationally on topics related to breast disease.
Diana Rowden was diagnosed with breast cancer in 1991 at
the age of 38. Because of her first mammogram, doctors were
able to correctly diagnose her condition and operate
accordingly. Thankfully, the procedure was a success and now
Ms. Rowden only requires follow-up visits by her medical
oncologist.
Ms. Rowden began volunteering with the Susan G. Komen
Breast Cancer Foundation in Dallas, TX as one of the first
volunteer counselors on the foundation's national toll-free
help line. She later served on the Komen Foundation's executive
committee, first as vice chair of education, then as vice chair
of grants. She was named chair-elect for 1996 and then chair of
the national board in 1997-1998.
Ms. Rowden then returned to volunteering on the help line
and continued to represent the foundation in a number of
national and local breast cancer committees and boards. In
November 2002 Ms. Rowden joined the Komen Foundation staff as
affiliate services manager.
Dr. Leonard Berlin is a professor of radiology at Rush
Medical College and also still maintains a teaching position at
the University of Illinois College of Medicine. He has written
more than 200 scientific articles, as well as a book entitled
``Malpractice Issues in Radiology.'' Dr. Berlin has also given
more than 150 lectures on various medical subjects throughout
the Nation. He is board-certified by the American Board of
Radiology and was elected as a fellow in the American College
of Radiology in 1979. He was awarded the gold medal for
distinguished service to radiology by the American Radiology
Society in 2002. In 1997-1998 he served as president of the
Chicago Radiological Society.
Welcome, all of you, and if you could now deliver your
testimony, we would appreciate it. We will start with Dr.
Dershaw and work down the table. Dr. Dershaw?
STATEMENTS OF DAVID DERSHAW, M.D., VICE PRESIDENT, SOCIETY FOR
BREAST IMAGING, RESTON, VA; DIANA ROWDEN, AFFILIATE SERVICE
MANAGER, SUSAN G. KOMEN BREAST CANCER FOUNDATION, DALLAS, TX;
AND LEONARD BERLIN, M.D., CHAIRMAN, DEPARTMENT OF RADIOLOGY,
RUSH NORTH SHORE MEDICAL CENTER, SKOKIE, IL
Dr. Dershaw. Thank you, Mr. Chairman. Good morning. I
appreciate your invitation and Senator Mikulski's invitation to
testify regarding reauthorization of the Mammography Quality
Standards Act of 1992. I am testifying on behalf of the Society
of Breast Imaging and I am also a member of the American
College of Radiology.
The Mammography Quality Standards Act has played a
significant role in improving the quality of mammography. This
program needs to be reauthorized so that women can continue to
benefit from high quality mammography.
Currently MQSA requires the physicians interpreting
mammograms participate in 15 hours of continuing medical
education every 3 years. The American College of Radiology has
designed and tested over the past decade the mammography
interpretive skills assessment, the purpose of which is to
provide the radiologist with an assessment of his or her skills
and to identify areas in which improvement is warranted. This
is not a pass/fail test or one that is intended to certify or
judge participants. The emphasis is on self-help.
While self-assessment testing may be of value, it should be
recognized that there are no data to indicate that such tests
provide feedback that currently determines competence. There is
also no science to indicate that such tests will result in
improvement in the quality of medical care. Nonetheless, by
providing the physician with seven or eight hours of CME,
depending on the version of the test that is utilized,
physicians would be strongly encouraged to use this mammography
self-assessment test for both continuing education, as well as
self-assessment.
This might be a useful method for determining skills in
addition to the data that are presently derived from the end
results assessment required under MQSA regulation. The
tabulation of these practice and results data is a strong
indicator of how a radiologist is interpreting mammograms in
comparison to others in his or her group. These data would be
more valuable if screening and diagnostic examinations were
tabulated separately, and I would encourage the committee to
recommend to the FDA that such separation of data be included
in regulations of MQSA.
The developing crisis in the availability of mammography
service is the greatest threat to quality mammography at the
present time. The best and brightest radiologists in training
are discouraged from entering breast imaging. The low level of
reimbursement, the time and effort needed to comply with
government regulation and the burden of medical malpractice all
contribute to this situation.
The committee should carefully consider the possible
perceived advantage of mandated self-evaluation against the
detrimental impact of increased regulation of mammography
facilities and radiologists interpreting mammograms. Steps that
might further discourage radiologists to incorporate
mammography into their careers may accelerate the developing
crisis in the availability of mammography services.
Radiologists interpreting mammograms are already in short
supply due to poor reimbursement rates and high litigation. It
is my belief that providing plaintiff lawyers with another
potential avenue for litigation will lead many more
radiologists to turn away from mammography, exacerbating the
already critical access problem many women face in receiving
timely mammography services. If the results of self-assessment
activities were to be subjected to discoverability in
litigation cases against physicians, the Society of Breast
Imaging would strongly oppose the incorporation of such testing
into MQSA regulation.
The committee should also recognize that the greatest
threat to the delivery of quality mammography services in the
United States is the impending shortage of radiologists,
technologists and imaging facilities to provide this service.
Inadequate reimbursement persists with payments for service
often less than the cost of performing and interpreting
mammograms.
The most tenuous financial reimbursement is for hospital-
based services. As this is the site where most women on
Medicare and Medicaid receive their health care, the
availability of mammography to these women is the most
threatened by inadequate reimbursement. Hospitals are also the
sites where most of the training of physicians and
technologists occur. Poor reimbursement, particularly when
compared to reimbursement levels for other areas of radiology
services, has left those deciding what area of radiology to
specialize in with an impression of mammography as a big money
loser. Along with high malpractice exposure and considerable
time and effort required to meet Federal and often local
regulation, this negative impression works to discourage those
in training from selecting mammography as an area of
specialization.
One of the most discouraging aspects of mammography
practice today is the excessive legal liability associated with
it. Since one of every 10 breast cancers approximately cannot
be detected on a mammogram, the radiologist reading these
studies is potentially faced with a failure-to-diagnose suit
for 10 percent of the cancers that are screened by his or her
facility. This leaves the physician with the feeling that
litigation is almost inevitable if a career path in breast
imaging is chosen. In this atmosphere it is not a surprise that
there has been a progressive decline in radiologists entering
this field.
Additionally, I would like to note that as authorized under
the original legislation and recommended by the National
Mammography Assurance Advisory Committee, regulation of
mammography services should be expanded to include stereotactic
breast biopsy and equipment used in needle localization
procedures.
Also, the current requirement for continuing medical
education credits beyond those required for initial training
does not improve quality of practice or contribute to improved
patient safety. The requirement is often difficult to meet, it
is perceived as a real burden by radiologists in the field and
the committee should recommend that it be discontinued.
I greatly appreciate the opportunity to testify and, of
course, will be happy to answer any questions.
Senator Ensign. Thank you.
[The prepared statement of Dr. Dershaw may be found in
additional material.]
Senator Ensign. Ms. Rowden?
Ms. Rowden. Mr. Chairman Ensign, Senator Mikulski, thank
you for the opportunity to testify on the reauthorization of
the Mammography Quality Standards Act.
My name is Diana Rowden and I am a breast cancer survivor.
I consider myself blessed because mammography led to the early
detection of my breast cancer. This has allowed me to have the
option of less extensive therapy, as well as enjoy a wonderful
life these past 12 years.
I am honored to be able to thank you in person for enacting
the MQSA. The Susan G. Komen Breast Cancer Foundation and its
many constituents across the Nation are grateful for your
dedicated leadership and support for improving the quality of
breast health and breast cancer care in the United States.
I have been a patient-advocate for these past 10 years and
now in my current capacity on staff with the Komen Foundation I
have the joy and pleasure of working with many volunteers
around the country who work in our affiliate network. These
affiliates and the volunteers within them raise tens of
millions of dollars every year to support programs within their
communities, as well as supporting our national research
program.
The Komen Foundation invests millions of dollars annually
in cutting edge breast cancer research. This we do for the
future, but we are also very aware of the urgent need for those
who are facing breast cancer today. The statistics are all too
familiar, as Senator Ensign pointed out.
Early detection, we know, saves lives and mammography
screening, while imperfect, remains the best tool available
today to help detect breast cancer at its earliest, most
treatable stages, and I truly believe that this is part of the
reason why I am here alive today to testify.
More than 10 years ago Senator Mikulski and other senators
recognized that the effectiveness of mammography hinges on the
quality of equipment, as well as the accuracy of the
interpreting physicians. We are grateful for these standards
and the uniformity set by MQSA.
The death rate from cancer in the U.S. has been decreasing
about 2 percent annually during the past decade, suggesting
that public awareness, early detection and improved therapies
are having an impact on the disease, but we do have a long way
to go still.
MQSA has led to the improvement of image quality and other
aspects of mammography. There is less certainty, however, about
the act's impact on the quality of image interpretation. When
it comes to quality assurance in interpreting mammograms,
patients would benefit from strengthening MQSA. Studies
demonstrate wide variation in the interpretation of the same
mammogram by different radiologists. This variation is
troublesome.
Poor quality interpretation leads to the false negatives,
as have been mentioned, which produce delayed and more costly
treatment. Poor quality interpretation also leads to false
positives, also very troubling because this leads to
unnecessary biopsies, increased anxiety for women, not to
mention increased health care costs.
Physicians can and should do more to sharpen their
interpretation skills. Radiologists who perform only the
minimum number of exams required will encounter relatively few
breast cancers in their careers. Numerous studies now show a
strong correlation between the accuracy of mammography
interpretation and reader volume. In order to develop the
necessary expertise, radiologists must be exposed to a larger
number of mammograms.
The traditional form for CME is lecture courses. Although
beneficial, our constituents tell us that such courses are
largely ineffective for improving interpretation skills. CME
requirements should direct radiologists toward hands-on, skill-
based courses, rather than lecture series alone. Self-
assessment as a component of CME would provide radiologists
with more opportunities to look at breast cancers and help them
better understand suspect images.
Given these potentially life-saving benefits, the Komen
Foundation urges Congress to require skills assessment as a
component of CME. We support the proposal to mandate that one-
third of CME be dedicated to skills assessment study.
The Komen Foundation recognizes that these issues cannot be
looked at in a vacuum. It is also essential that insurers,
including Medicare, provide adequate reimbursement to providers
of mammography services to ensure the quality of care and
quality of life. We do not want either compromised.
Reports of growing disinterest among physicians and
technicians in the field of mammography abound. We do hear that
radiologists are being deterred from choosing mammography as a
specialty because of the numerous disincentives to enter the
field--fear of liability, high cost of malpractice insurance,
inadequate reimbursement, workload and high stress levels.
Reports cite facility closings and suggest that many are the
result of reimbursement rates that do not cover the cost of
providing mammography.
The Komen Foundation is very concerned about the reported
decline in these services and its potential impact on access to
care. Further study is needed to verify the reported
correlation between inadequate reimbursement and facility
closings and to determine whether this has resulted in a
decline in available services, as we suspect. We strongly
suggest that language calling for such study be included in any
proposal for authorization.
The Komen Foundation also strongly supports a two-year
reauthorization time frame. A two-year cycle would allow for
the implementation of a system yet provide the flexibility
necessary to evaluate concerns in a timely manner.
I appreciate the real improvements in mammography and the
progress in breast cancer treatment over the years. We have
made significant strides and are on the edge of a real
breakthrough that could save thousands of lives. But until
researchers find a cure for breast cancer or better yet, a way
to prevent the disease, we must not lose sight of the
importance of mammography screening for detecting breast cancer
early. Reauthorizing MQSA with new provisions that result in
better image interpretation will help ensure the delivery of
high quality breast cancer care in the United States.
The Komen Foundation will continue in our commitment to
fund ground-breaking research for future generations but rest
assured we also remain committed to ensuring that everyone
facing a diagnosis of breast cancer today have access to the
best care currently available.
Thank you for the opportunity to present this testimony.
Senator Ensign. Thank you.
[The prepared statement of Ms. Rowden may be found in
additional material.]
Senator Ensign. Dr. Berlin?
Dr. Berlin. Mr. Chairman, Senator Mikulski, my name is
Leonard Berlin. I am a practicing radiologist, a member of the
American College of Radiology, and the chair of a radiology
department in suburban Chicago, as well as a professor of
radiology at a medical school.
I am honored to have been asked to testify regarding the
reauthorization of MQSA. At the outset let me say that I
categorically endorse reauthorizing MQSA for I believe that the
act has been of great benefit to the medical community at
large, particularly radiologists, as well as the public.
I understand that the committee also favors reauthorizing
the act but at the same time, I am aware that concern has
arisen that MQSA as currently constructed does not address
certain professional aspects of mammography, such as the
accuracy with which radiologists render mammographic
interpretations. Because of such concerns, there may be a need
to objectively assess and monitor the performance of
radiologists when interpreting mammograms so as to assure the
public that all mammograms performed in every part of the
Nation receive competent, relatively uniform radiological
evaluation.
Should Congress decide to mandate radiologist participation
in a self-assessment program, I have no doubt that the
radiologic community will accept and comply with such a
mandate, for I do not think that it represents a controversial
issue. However, what could be a controversial issue is whether
the results of such a mandated self-assessment process should
be made readily available to public scrutiny or discoverable in
a legal proceeding, and this leads me to that black threatening
cloud that looms on the horizon and has every indication of
growing, namely the quagmire of medical malpractice.
For many years I have studied, written and lectured about
the adverse impact of medical malpractice litigation on the
practice of radiology, specifically as it relates to
mammography. Statistics have shown a rampant increase in
lawsuits associated with mammography such that mammography has
now become the most common reason that malpractice lawsuits are
filed against radiologists.
Part of the reason for the high number of lawsuits
associated with mammography is the public's perception of
mammography's accuracy. Many believe that mammography is
infallible, that it is a matter of simply looking at black and
white shadows on an x-ray film and going through a simple
mathematical calculation and thus all radiologists should
arrive at the same interpretation. Alas, such as not the case.
Shadows on mammograms are far more often varying shades of
gray, normal tissues in the breast often obscure suspicious
abnormalities, and many suspicious abnormalities often
masquerade as normal structures. As a result, many breast
cancers, perhaps 15 to 20 percent, as estimated by some
researchers, are not visualized on mammograms.
Because the public perceives or rather misperceives that
mammography is 100 percent accurate, women frequently resort to
malpractice litigation if breast cancer is diagnosed subsequent
to having had a mammogram that was interpreted as normal. And
because the public perceives or rather misperceives that early
diagnosis of cancer virtually guarantees a cure and that a
delay in the diagnosis of cancer is tantamount to a death
knell, even when there is reliable and objective expert medical
testimony that a delay had no ill effect, juries are
nevertheless all too ready and willing to award compensation to
the patient. Although the average indemnification of breast
cancer approaches $500,000, awards of 3 or 5 or even 10 or 12
million dollars are not that unusual.
The specter of malpractice litigation exerts an enormous
adverse impact on radiologists who perform mammography. Being
found liable for allegedly misinterpreting a mammogram not only
significantly increases the malpractice insurance premium paid
by the radiologist but indeed may even make obtaining such
insurance impossible. The end result is that more and more
radiologists are refusing to perform mammography and fewer and
fewer young radiologists are opting even to begin practicing
mammography. In turn, mammography facilities are closing.
To illustrate the effect the medical malpractice quagmire
is having on radiologists who interpret mammograms and to put
it all on a more personal level, let me quote just briefly from
several unsolicited letters that I recently received from
radiologists around the Nation who perform mammography. ``I am
a private practicing radiologist in a western suburb of
Milwaukee, WI. I worry about the malpractice issues regarding
mammography. I consider myself an above average mammographer
and I believe I have made a positive impact on many lives by
providing quality breast imaging diagnosis. Because of the
current atmosphere of litigation, if I were given the choice to
stop manning our women's center I would seriously consider
it.'' The letter is enclosed in the written material with his
signature.
Here is another letter. ``My junior partners and I are
running scared. One recent lawsuit takes the cake. A junior
partner was sued by a woman who developed an interim breast
cancer. We all agree the screening mammogram was negative 8
months prior to discovery of the cancer, but the truth is
irrelevant. The patient developed liver and brain metastases
during the discovery process and the insurance company settled
for $800,000. Our malpractice premium rose to $50,000 per man
and the junior partner is now leaving Florida to go to New
Mexico. Even perfect professional performance provides no
protection in Florida.''
One more letter from Houston, TX. ``It is unfortunately
occurred to me of late that in a short time we will not have to
worry about mammography anymore because breast imaging simply
will be something done only in a handful of centers. The
current statistics are grim. As of now, well over 600
facilities have closed their doors and the current rate of
closings does not appear to be declining. Just this morning one
of the fellows that I trained in mammography said her facility
in Tempe, AZ was closing. It is truly a mess. I talked with a
man who is the head of a private practice mammography center in
Carmel, CA and he said they simply shut down all breast imaging
for reasons related to malpractice.''
I cite these letters not to focus on the medical
malpractice problem in general, for that is a subject with
which I know Congress is dealing at another level on another
day. The purpose of my emphasizing the adverse impact of
malpractice on radiologists who do mammography is what may
happen if the results of any self-assessment process undertaken
by radiologists is made public or discoverable. The malpractice
litigation will be exacerbated and as a result, many more
radiologists will simply refuse to undergo self-assessment or
participate in performance improvement activities. Therefore I
ask that if self-assessment is made mandatory as part of MQSA
reauthorization, the results remain privileged.
Let me summarize. Radiologists are in short supply. Breast
imagers are in even shorter supply. The combination of low
reimbursement with a high probability of being sued for a
misdiagnosis is clearly not the best tool for recruiting young
radiologists to participate in mammography. Seven hundred
mammography facilities have closed nationwide over the last 2
years and this downward trend will continue and waiting times
will continue to increase for women seeking timely mammography
services unless Congress acts responsibly with regard to
mammography self-assessment. It is my belief that given the
current litigious climate, it is imperative that any self-
assessment requirement recommended by this committee and
enacted by Congress be deemed nondiscoverable.
With deep humility and respect, I thank you for the
opportunity to testify on this important matter to women's
health and would be happy to answer any questions the committee
members may have. Thank you, sir.
[The prepared statement of Dr. Berlin may be found in
additional material.]
Senator Ensign. I want to thank all of you for your
testimony. I do not know how many of our other colleagues will
be here this morning, so we can keep this kind of free-flowing.
Senator Mikulski. Sure.
Senator Ensign. We can just have a real good discussion
this morning and even back and forth between the witnesses to
try to get some healthy dialogue.
I want to start with Ms. Rowden. The point has been brought
up about self-assessment. No studies have shown, according to
the testimony of Dr. Dershaw, as far as objective studies go,
that it actually improves quality, but the gut feeling is that
it may improve the reading and may not be a bad thing to do.
But as Dr. Berlin has testified, that could be an open door to
more liability in the future and we all know the problems that
are occurring across the country and certainly in my State.
Do you have a position, or does the Komen Foundation have a
position, on whether that should be nondiscoverable in a jury
trial?
Ms. Rowden. We would not want something like the CME skills
assessment to be punitive for the doctors who are making an
effort to learn and be up to date with their skills and their
training. In no way would we want that to come back on them
when they are trying to improve their knowledge and do the best
job that they can.
Senator Ensign. Thank you.
Dr. Berlin, I am obviously very involved on the whole
medical liability issue on a different level and I do not want
to turn this hearing into that, but I think it is important
that we focus on that issue for a moment. Sometimes the worst
laws that we make around here are the laws of unintended
consequences. More regulation can lead to more litigation. The
unintended consequence can lead to then fewer doctors and the
worst unintended consequence can lead to the unavailability of
mammography for lots of women.
I know I mentioned in my opening statement what we call the
mammovan, the portable mammography unit that drives around our
State. For months and months at a time we cannot use it because
we cannot find the technicians to perform the procedures
because they are not available. And they are paying actually a
very, very good rate, competitive rates, and they just cannot
find people to perform these procedures. So, I have had
personal experience dealing with that particular issue as far
as the lack of availability.
Can you focus maybe your answer on the medical liability
issue as far as MQSA is concerned to the potential of what
could happen in the future? Also, are there any statistics on
how much more it costs in your practice, your medical liability
coverage, if you perform mammograms versus not performing
mammograms?
Dr. Berlin. Yes, Senator. First of all, on the shortage of
radiologists and technologists, indeed there is an acute
shortage around the Nation, not only of the physicians, the
radiologists, but of all radiology technologists, and
mammography is certainly no exception. The shortage occurred
fairly abruptly over the last 2 years or so and will probably
continue for the next five or six or 7 years.
And I am sorry; the rest of your question?
Senator Ensign. The difference in rates.
Dr. Berlin. Yes, the difference in rates. I will tell you
anecdotally, and there have been several articles written, as
well, that various malpractice insurance companies have come to
radiology groups in various states and it is not a matter of
cost but it is a matter of saying to these groups we will
insure you only if you stop doing mammography. One big
mammography center, as a matter of fact, in Las Vegas was
confronted with this and I know the radiologist who runs that
personally, but this has happened elsewhere, too.
Now as you know, because of the increase in malpractice
around the Nation, and we will not get into the issue about
whether the insurance companies are at fault or not at fault
but the fact of the matter is no matter who is at fault, many
insurance companies are pulling out of the market and this
leaves less insurers available and this is one of the reasons
for the crisis around the Nation, is that radiologists, as all
physicians, are having difficulty in finding an insurance
carrier.
So if there are only one or two or three insurance carriers
in a given State that will insure physicians and radiologists
and if they tell the radiologists we will only insure you if
you give up mammography, then the radiologist has no choice but
to do so.
As far as the difference in premium, I do not have any
specific evidence on that. I will certainly check with the
college and if we do, we will certainly submit that in a
written report, sir.
Senator Ensign. I appreciate that. Also, as Ms. Rowden
testified, the more you read mammograms, the better you become.
I do not know that insurance companies have gotten to this yet
but with OB-GYNs, the more babies that you deliver, the better
you become at it. However, they have limited most OB-GYNs
because of medical liability costs. The more that you deliver,
the more chances there are that you are going to have a
problem, just because of sheer numbers.
Well, the more mammographies you read, the more chances you
are going to have of missing something, so it is a double-edged
sword, I guess is the point that I am making. So we want people
to read more but are the insurance companies addressing that
yet? Maybe they have not caught onto that yet.
Dr. Berlin. Yes, I think you are right on both counts. It
is a delicate balance. Actually there have been research
studies published pointing out that probably about 2,000
mammograms a year is when a radiologist hits peak performance--
this is a general statement in one particular article--and
fewer than that or considerably fewer or considerably more than
that, the accuracy apparently decreases slightly.
I think you are correct. I do not think the insurance
companies have caught up with that yet. There is no question
whether we are delivering babies or we are reading mammograms,
the more patients or babies we deliver or the more mammograms
we read, the greater our chance of incurring a malpractice
lawsuit. There is no question about that.
Senator Ensign. I will turn it over to you for a little bit
and we will go back and forth, okay?
Senator Mikulski. Thank you, Senator.
Ms. Rowden, I want to ask you a question. I was a little
bit confused about page 6 of your testimony and medical
outcomes. I want to be sure that I understand the Komen
Foundation recommendations. You say ``One way to better
understand outcomes would be to require consistent collection
and utilization of data.'' Then you go through this list that
you see on page 6--the number and types of all mammograms, the
number of screenings.
Is this by individual or is this by group? I kind of got
lost there.
Ms. Rowden. You mean by individual practitioner or----
Senator Mikulski. No, I am asking you. On page 6 you say
``One way to understand about outcomes would be to require
consistent collection and utilization of data,'' and then you
have a list of the data to be collected. From whom do you want
the data to be collected?
Ms. Rowden. Well, from mammography centers or centers
providing mammography services.
Senator Mikulski. So this would be a center, not an
individual.
Ms. Rowden. Correct.
Senator Mikulski. Why do you want this?
Ms. Rowden. Well, one is a way to measure whether or not
the mammography is a benefit in terms of screening. I mean it
is a way to look at some research issues in terms of benefits
of screening, as well as look at the ratio of screening to
number of actual biopsies that are performed to get a better
picture and handle on the effectiveness of this tool.
Senator Mikulski. But this then is the regulation of the
center, rather than of the physician; is this correct?
Ms. Rowden. To look at it in aggregate, yes.
Senator Mikulski. OK, I could see that.
Let me then go to the mammogram quality standards. Mr.
Chairman, I think we have a couple of issues, one of which is
the equipment itself. Even though we have excellent work done
by FDA, the Institute of Medicine has a study that says there
is potentially more promising technology out there. Mammography
is not a foolproof, 100 percent tool. It still has limited but
necessary utility. We need to look at what are the barriers,
and this also goes to some of your issues around regulation, to
new technologies being able to come on to be less intrusive,
less klutzy, and also more accurate. So that is one for us, to
really make sure we have a legislative and regulatory framework
for new thinking to come on medical diagnostic breast cancer
testing.
The second issue is the shortage of people, both in
radiology and the x-ray or radiology technologists. Mr.
Chairman, I fear that we are going into radiology technicians
the same kind of crisis we went into with nurses and I would
really respectfully suggest that the committee hold a hearing
with the radiology technologist community to identify the
reasons for the shortage and if we would look at it along the
same lines that we looked at the Nurse Reinvestment Act, again
to make sure that we have the opportunity for there to be the
technicians.
Then we get to the issue of reimbursement, which is spartan
and skimpy. This goes to then Dr. Berlin and Dr. Dershaw. When
we talk about the skimpy reimbursement, is that both from
private insurance or is that the Medicare insurance or is that
both? Dr. Dershaw, would you comment on that?
Dr. Dershaw. It is both.
Senator Mikulski. Because again we are looking to barriers
to doing mammograms.
Dr. Dershaw. It is pervasive. Not only does it often not
cover the cost of performing the mammogram or marginally cover
the cost of performing the mammogram but in addition to that, I
think it is appropriate to look at it in terms of what the
reimbursement level is for mammography compared to the
reimbursement for other tasks that radiologists perform.
Senator Mikulski. Could you give us an example of that?
Dr. Dershaw. Well, let me tell you that I had a meeting
with my chairman this week, last week, and we were going over
dollars billed per manpower hours. Mammography had the lowest
in the department and the highest billers in the mammography
section were those who also read CTs. We are notorious for
being loss leaders or marginally profitable.
Senator Mikulski. What is the reimbursement rate?
Dr. Dershaw. The reimbursement for a screening mammogram is
$81.81. The cost, the tabulated national cost of doing a
mammogram, screening mammogram in an office is $86 and in a
hospital it is $122. So we are paying for women to have
mammograms.
Senator Mikulski. In other words, there is a subsidy to do
it. I will come back to the reimbursement issue. I think this
is a real issue and I think we have to look at where government
reimburses and it goes to two issues, one of which is in the
Medicare area and to really look at our responsibility to the
physician community because I think what you are talking about
here is an average cost----
Dr. Dershaw. Yes.
Senator Mikulski. It sounds enormously reasonable, to buy
the equipment, the professional training, the salaries, etc. I
would imagine the reason that they are higher in hospitals is
because of the very nature of often they are academic centers
or world class, such as the one that you come from. But is that
not where most poor women go?
Dr. Dershaw. Yes, Medicare and Medicaid services are
largely provided through hospitals, as well as training largely
being done through hospitals, as well as training not only
being provided through hospitals but the experience that is
conveyed to the trainee during the training experience is at
the hospital. So the entire milieu that exists there is
conveyed to people making career choices.
Senator Mikulski. Mr. Chairman, I was the author, along
with Senator Olympia Snowe and other colleagues, on essentially
a screening program and detection and treatment for women in
that gray area--the non-Medicaid women, the women who do not
have health insurance--often the retail clerks, the Norma Rays,
etc.
So I think we need to look at reimbursement but then let us
go to regulation. So the barriers are one, you need to have
enough people; we need to look at that. Better equipment, and I
think you would agree.
Dr. Dershaw. Yes.
Senator Mikulski. And the private sector would agree
because the medical device community really says--and even the
Institute of Medicine says there are deterrents for them to
pursue research on how to have better equipment.
Now let us go to the doctors. We have heard now that we
want to improve skill assessment and I would really like your
advice on how we can improve the skill assessment aspects of
the legislation without it being a deterrent.
Dr. Dershaw. I think there are a variety of avenues that
you can go down. First, I think with the outcome data that has
been commented on several times already, the outcome data does
not mean very much the way it is accumulated now where we are
mixing women coming in for screening mammograms with women
coming in with symptoms of breast cancer. Those two populations
have to be separated and the data looked at separately.
So I think in the end results we should be separating
diagnosis from screening to give more meaning to the data and
have that be a more meaningful self-assessment evaluation than
what it is presently.
I think certainly a self-assessment endeavor, such as that
designed by the College of Radiology, may have a positive
impact. Now we do not know for sure whether it does or whether
it does not, but in fact, it may have a positive impact.
I think, though, the use of that has to be tempered with
the imposition of further requirements on people who are
performing breast imaging. Perhaps either radiologists could be
encouraged by the CME credits that are offered to them or
perhaps the system that presently is used, presently is
mandated by FDA could be completely reviewed so that we could
look at which mandates remain appropriate 10 years after the
system was put into effect, which ones could be set by the
wayside, and which ones could be added.
So there would be a sense at least among radiologists who
are involved in breast imaging that it is not a constant
superimposition of one regulation on top of another but it is,
in fact, a reassessment of appropriate regulation.
The breast imaging community is very proud of, has been
very aggressive about and certainly encourages endeavors that
make the quality of mammographic interpretation better. I would
remind you that before MQSA was instituted there was a
voluntary program which made this possible and it was unique to
breast imaging. So we are in favor of doing efforts that would
improve our quality.
Senator Mikulski. What do you think of a mandated
requirement requiring skill assessment as part of CME and then
there becomes the issue of its availability for either public
scrutiny or as data in a malpractice suit? What do you think
about mandating essentially what has been developed by the
American College of Radiology?
Dr. Dershaw. I think that further mandates on the practice
of breast imaging potentially have a negative effect. I think
that a mandated utilization of a self-assessment examination
would not be met with a hew and cry in the breast imaging
community but it would be met with a sigh saying there is
another regulation that we need to comply with.
So I think that it would be greeted more enthusiastically,
I think rather enthusiastically, if it were optional with
considerable CME credit attached to it. We would all be willing
to participate in it, I think, under those circumstances.
Senator Mikulski. In other words, one of the things would
be to add more CME credit to it.
Dr. Dershaw. Or make that mandate part of a review of all
of the mandates and regulations that are now associated with
MQSA to determine which ones remain valuable and which ones
could be discontinued. That would be met, I think, with the
greatest enthusiasm.
Senator Mikulski. Well, that would then go to a GAO or the
IOM study.
Dr. Dershaw. Yes.
Senator Mikulski. I want to come back to that because that
goes to the length of time of reauthorization. But----
Senator Ensign. Can I follow that up?
Senator Mikulski. Just one second. This is the last and
then I will be happy to turn it over.
In the Komen Foundation testimony, Ms. Rowden, you say an
example of a sensible step in the right direction is the
Centers for Medicaid and Medicaid Services, CMS. In a recent
announcement, they are going to award CME credit to physicians
who participate in newly designed quality improvement courses
provided by the Medicare Quality Improvement Organization.
I would like you to look, Dr. Dershaw or Dr. Berlin, at the
Rowden testimony where government essentially says okay, if you
are going to do this, it is like a good guy bonus. In other
words, you volunteer to do this and actually be more rigorous,
which hopefully you will benefit from as a clinician. We just
presume if you came into this field to save lives, help people,
you want to be good at what you do. That is your own personal
motivation. So we would like to combine your own professional
desires with this framework, make it more insistent, though,
than just voluntary.
But I would be really willing to look at what I will call
good guy or good gal bonuses, if you will, that if you
participate, there is some other way of acknowledging that this
is rigorous and more demanding than looking at other diagnostic
avenues for radiology. I mean this is a lot different than
orthopedics, that still has--you know, you can miss that
hairline.
Dr. Dershaw. Certainly.
Senator Mikulski. In other words, nobody is perfect but if
you are not always perfect all the time, we do not want you to
be nailed. Do you see where I am heading?
Dr. Dershaw. Yes.
Senator Mikulski. Mr. Chairman, you wanted to follow up but
I think that is a very good way of saying it.
Senator Ensign. I wanted to follow up and either one of the
doctors can respond to this. I was intrigued by your testimony
or your response about reviewing all the regulations. One of my
fears always is that regulations will stifle new procedures and
new innovations because if something is put in regulation,
oftentimes people are less likely to do anything new because,
once again getting back to the malpractice issue, that is not
the standard of practice. It may be a poor analogy to use there
but it is along those lines.
In finalizing this reauthorization, do you have suggestions
of any regulations to take off? And in adding new regulations,
what is the potential for hurting innovation or for hurting new
technologies coming on in the future? Are there any?
Dr. Dershaw. Well, I think we should in an organized
fashion, probably through the Institute of Medicine, look at
the regulatory package that is presently out there and examine
that. I will tell you that much of it is considered burdensome.
The inspector, the on-site examination, I have had to close
mammography, various mammography services for 11 days so far
this year in order to have inspections. That is expensive and
that is burdensome.
The paperwork that is involved when the inspector comes for
my technologist is about this high and for me is about this
high. I had 1 year an inspector come and say to me, ``How many
mammograms did each of your people read?'' I told the
inspector, who then asked for documentation of it. We had to
print out every mammogram that was done in the past year. We do
over 20,000 mammograms a year. We had to print out every
mammogram that was done in the last year and who did it. Now
that is one problem that we have that would be easily
corrected.
Now another problem that we have which has just begun is
the accumulation of end results data, unless we have approval,
IRB approval, violates the HIPAA regulations of patient
privacy, our attorneys have told us at the hospital. So we have
had to go to our IRB, which has taken me an extra day or two of
paperwork to fill out so that I can comply with the Federal law
of HIPAA and comply with MQSA. It is increasing time and
effort.
There is another regulation under MQSA by the FDA that
requires that certain words be used in every mammogram report
to State the end results. That means that in every reading
station I have where mammograms are done, we have a little
poster that has what the exact words are that you have to use.
Now it does not make an awful lot of difference to me but
when I have residents and fellows in training coming through
and I tell them that the Federal Government requires that they
use this word and if they do not use this word we are in
violation and can be fined, and in New York we can be put on
the front page of some newspaper that follows the results of
these investigations, it puts a whole different spin on what
some of these regulations mean, what the impact is, and how
they are perceived by people in training as they are coming
through the programs.
Now why would somebody want to read mammograms, where they
are told what the report has to say, when they can read a CT
and they can use whatever words they want?
Senator Mikulski. But maybe they want that language for
consistency in data gathering.
Dr. Dershaw. But what difference does it make if you say
negative or normal? If you say one you are in compliance; if
you say another, you are in violation.
Senator Mikulski. And that is why I want the IOM study.
Dr. Dershaw. Right.
Senator Mikulski. Mr. Chairman, when we did an initial
draft of this legislation before close of session last year and
I was the chair, I wanted two studies done and I think you
would like them. First of all, what I wanted was limited time,
a limited reauthorization and that we would do two studies--
one, a GAO study reporting in a year on accessibility, the role
of the states for accreditation and certification, etc, but the
IOM study, the Institute of Medicine, would be on how
physicians could interpret mammograms better, could be better
trained, what additional requirements should there be, and
essentially a whole review that you are talking about, which is
steps that should be taken to improve the quality. There would
be the professional Institute of Medicine to reach out to the
appropriate stakeholders, if you will, the physicians, the
academic centers training them, the women who are going to be
affected by their reading, and say let us take a step back that
we cannot do in a congressional hearing.
I mean no matter how diligent we want to be, we need, in
addition to the excellent academies and Komen, a true scrub of
where we are and what is really now even dated because of
technological innovation, all the way through to what we are
doing. This is why even now I would hope that we would do these
two studies and we would think of the reauthorization as an
interim and not be too heavy-handed in it or too lax, but to
find that balance. Then in 2 years--this study is due in 18
months--have a chance for everybody to look at it, come back
and then do it again without pushing docs out or pushing women
away because they think mammograms do not mean anything.
Remember we have had a lot of press that said mammograms do
not mean anything and we held a hearing on that. The
biostatisticians said we wonder about their utility, and yet
all the clinicians, like yourself, said it is still the best
thing we have going and we ought to do it.
You see where I am heading? And I do not know if the
chairman would agree.
Senator Ensign. This sounds like a direction. I am happy
that actually just the two of us are here today and we can have
a little more informal discussion. A common sense approach is
to eliminate the bad and put in the good.
Dr. Dershaw. Exactly.
Senator Ensign. Dr. Berlin?
Dr. Berlin. Senators, may I go back to one thing that
Senator Mikulski brought up a couple of minutes ago about
missing the hairline fracture on a leg? There is a basic
difference. If a patient comes to a radiologist for a leg x-ray
after an injury and we miss a hairline fracture, in a day or
two that patient is going to come back because that patient is
going to have symptoms and we will have the opportunity to find
our mistake and correct it soon so that there is no damage.
Unfortunately with a mammogram, with a screening mammogram
where we have an asymptomatic patient, the woman comes in once
a year and if for whatever reason we miss that breast cancer,
probably no one will ever know about it until a year later. So
there is that difference, so therefore the sensitivity, the
scrutiny, if you will, probably lies a little greater with the
people reading mammograms.
Now I do not think any of us here, certainly not the
college or we radiologists, are soliciting a mandatory self-
assessment. I do not think we are soliciting it. On the other
hand, my looking at it fairly, I think, and objectively, I
think Congress does have to take a look at it for the simple
reason that if we assume, and I suspect it is true, 95, 98, 99
percent of radiologists already are doing optional self-
assessment, whether they are doing it from the American College
of Radiology or alternative means in their hospitals, and so
forth; I am convinced most radiologists are doing it; however,
we all know that maybe 1 or 2 percent of radiologists are not.
If something is optional, the substandard radiologist is not
going to opt to undergo self-assessment. He or she will only do
it if it is mandatory.
So, as I say, not that I am soliciting mandatory, but it is
something, I think, for Congress to keep in mind.
Senator Mikulski. But your recommendation, if I might, Mr.
Chairman, Dr. Berlin and others, and I believe it is also the
Komen Foundation through Mrs. Rowden; she says we do not want
mammocops because we are not here to fingerprint. We are here
to pinpoint improvement.
So your recommendation would be as we look at the next
period of reauthorization to use the carrot approach to
encourage it and even if we mandate it, that we put carrots
into it through either bonuses for continuing ed and so on, so
that we encourage it. We do not use a stick and we really ask
the Institute of Medicine and so on to take a look, knowing
that we are going to come back again and see where we are.
Is that the direction you are recommending? And I would
wonder what other carrots you might recommend. Also, Ms.
Rowden, you, too.
Dr. Berlin. I personally think--let me tell you a little
about how it works. The Joint Commission, the Joint Commission
of Accreditation of Health Care Organizations comes in every 2
years and inspects hospitals. One of the regulations that they
have in there, one of the requirements, is that performance
improvement be done, specifically in radiology. We are talking
about radiology.
Now they come in, their inspectors come in and they say,
``Show us your performance improvement. Show us that you are
doing it.'' Now they are not there to micromanage. They are not
there to microdetail who is doing what, which doctor is reading
this, which doctor is reading that. They want to know that we
are doing it and that we are doing something about it and we
are monitoring ourselves.
So I think it all falls back to that if Congress does
decide to mandate some kind of self-assessment, it is what form
that self-assessment will take and if it is not too much of a
burden on us, I think the radiologic community will buy into
it.
Senator Ensign. Just to kind of summarize, I think it has
been a great discussion this morning. As we go forward I think
that we are all after the same goals, and that is to improve
the quality of mammography taking, reading, interpretation--
obviously for early diagnosis. I think that lowering the cost
as much as possible through the elimination of some regulation
is a good idea. This interim reauthorization is a direction
that we could be looking in to be able to understand what we
have to do for a permanent or at least a longer term
reauthorization beyond that point.
Our goals need to be that it does not raise the cost
through medical liability insurance rates, and that we are
encouraging more people to go into it because we are
simplifying things and maybe bringing down the cost. We do not
control the reimbursement rates on this committee--that is over
on the Finance Committee--but certainly it would be something
we could make a point of when we bring the legislation to the
floor. We can certainly make a point of that, as one of the big
deterrents to people continuing to do mammography or even
wanting to become readers of mammograms.
I think that it has been a productive hearing today. Both
Senator Mikulski and I have other commitments we have to get to
but we appreciate all of you being here today. It has been a
great start for us working together. I think you can see that
both of us are committed to working to come up with some
answers. There is no reason for this thing to be partisan. I
think everybody can get together on this and come up with
something which we can go forward on with all the stakeholders
being satisfied.
Senator Mikulski. I, too, would like to thank the
witnesses. There is a great deal of thought in it, first to the
clinicians and practitioners who bring insights and
recommendations and also to Ms. Rowden representing the Komen
Foundation. I think that this has been outstanding.
I think one, we have a long-range hearing, which is the
shortage in personnel, and that even goes to physicians, also,
as well as the technologists because I do see this as a looming
crisis, particularly in the allied health fields. We see it
with a shortage in pharmacists, etc. You know, people are
majoring in mass communication and yet we face mass health
challenges from public health to clinical practice. That is one
thing.
And here, Mr. Chairman, I would really like us to think
about a reauthorization that has a shorter time limit than we
might otherwise do and really get the studies. At the same
time, not just rubber-stamp or ratify what we have and really
think of the carrot approach, looking both to the Komen
Foundation and the American Cancer Society, as well as the
professional associations and the clinicians about what would
be some of the carrots to encourage self-assessment, but it not
break new ground as cause for action in malpractice. I think we
would all feel pretty comfortable with that. Would you agree?
Dr. Dershaw. Wonderful.
Dr. Berlin. Great.
Senator Ensign. OK, thank you all very much and you are
excused. This hearing is concluded.
[Additional material follows:]
ADDITIONAL MATERIAL
Prepared Statement of D. David Dershaw, M.D.
Good Morning. My name is David Dershaw. I am Professor of Radiology
at Cornell University Medical College and the director of breast
imaging at Memorial Sloan-Kettering Cancer Center in New York City. I
am also the incoming president of the Society of Breast Imaging, the
subspecialty professional organization of radiologists who do
mammography, and I am testifying on the Society's behalf.
Thank you, Mr. Chairman, for inviting me to testify regarding the
reauthorization of the Mammography Quality Standards Act of 1992. It is
my belief that MQSA has played a significant role in improving the
quality of mammography. This program needs to be reauthorized so that
women can continue to benefit from high quality mammography.
Since enactment of the Mammography Quality Assurance Standards Act
(MQSA) in 1992, women in the U.S. have gained confidence in the
providers of their mammograms through the knowledge that mammography
facilities were being certified in accordance with Federal standards. A
continuing decline in breast cancer death rates (almost \1/3\ reduction
for invasive cancers in the 1990's) and increasing utilization of
mammography screening services (increased from 27 percent of eligible
women in the two years before 1987 to 66 percent in the two years
before 1997) are testaments to the success of the collaboration of
radiologists, mammography facility operators, and government
regulators. This consortium was carefully designed into the law. The
improved quality of mammography services has undoubtedly saved many
lives and diminished the anxiety of women in the United States about
the quality of their screening studies. The continued force of MQSA in
maintaining this high level of service is essential. On behalf of the
Society of Breast Imaging I again urge the reenactment of this
legislation.
mammography interpretive skills assessment
Currently, MQSA requires that physicians interpreting mammograms
participate in 15 hours of Continuing Medical Education (CME) every
three years. CME is offered in a variety of ways such as attending
meetings and lectures. Although valuable in their content, these
meetings are rarely designed for radiologists to assess their skills.
The American College of Radiology has designed and tested over the
past decade the Mammography Interpretive Skills Assessment (MISA) test.
In 1999, this was made available as an interactive computer-based
CD-ROM. This offers radiologists an opportunity to participate in a
mammography self-assessment examination.
The purpose of the MISA is to provide the radiologist with an
assessment of his or her skills and to identify areas in which
additional study or skills improvement is warranted. This is not a
pass/fail test or one that is intended to certify or judge
participants. The emphasis is on self-help.
By providing the physician with seven or eight hours of CME,
depending on which CD the physician uses, physicians would be
encouraged to use the MISA for both continuing education and self-
assessment. This might be useful as a method of determining skills in
addition to the data are presently derived from the end results
assessment required under MQSA regulation.
While self-assessment testing may be of value, it should also be
recognized that there are no data to indicate that such tests provide
feedback that accurately determines competence. There is also no
science to indicate that such tests result in improvement in the
quality of medical care.
I am certain that the Committee recognizes that in order to achieve
the benefits obtained under MQSA those involved in mammography practice
have added time, effort and expense to the delivery of screening and
diagnostic mammography services because of the need to comply with
MQSA's regulations. Although the mammography community is appreciative
of the higher standard set for its care than that generally required in
radiology or other areas of medical care, these have also imposed a
burden that has discourage some from offering these services. The
possible advantage of mandated self-evaluation, an additional
regulation that would need to be fulfilled and documented by
mammography facilities, should be weighed against the detrimental
impact of increased regulation of mammography facilities and
radiologists interpreting mammograms. Steps that might further
discourage radiologists to incorporate mammography into their careers
may accelerate the developing crisis in availability of mammography
services.
Radiologists interpreting mammograms are already in short supply
due to poor reimbursement rates and high litigation. It is my belief
that providing plaintiff lawyers with another potential avenue for
litigation will lead many more radiologists to turn away from
mammography, thus exacerbating the already critical access problem many
women face in receiving timely mammography services. If results of
self-assessment activities were to be subjected to discoverability in
litigation cases against physicians, the Society of Breast Imaging
would strongly oppose the incorporation of such testing into MQSA
regulation.
The Committee should also recognize that the greatest threat to the
delivery of quality mammography services in the United States is the
impending shortage of radiologists, technologists and imaging
facilities to provide this service. Inadequate reimbursement persists
with payments for service often less than the cost of performing and
interpreting mammography. The most tenuous financial reimbursement is
for hospital-based services. As this is the site where most women on
Medicare and Medicaid receive their health care, the availability of
mammography to these women is the most threatened by inadequate
reimbursement.
Hospitals are also the sites where most of the training of
physicians and technologists occurs. Poor reimbursement, particularly
when compared to reimbursement levels for other radiology services, has
left those deciding what area of radiology to specialize in with an
impression of mammography as a big money loser. Along with high
malpractice exposure and considerable time and effort required to meet
Federal (and often local) regulation, this negative impression works to
discourage those in training from selecting mammography as an area of
specialization.
As the Committee considers reenactment of MQSA, I would like to
make a few comments about modifications that might be recommended in
current regulations.
As authorized under the original legislation and recommended by the
National Mammography Assurance Advisory Committee, regulation of
mammography services should be expanded to include stereotactic breast
biopsy and equipment used in needle localization procedures.
Furthermore, the current requirement for CME in digital mammography
beyond the initial training required before using digital mammography
on patients does not improve the quality of practice or contribute need
training to improve patient safety. This requirement is often difficult
to meet and the Committee should recommend that it be discontinued.
Thank you for the opportunity to testify. I would be happy to
answer any questions.
Prepared Statement of Diana Rowden
Chairman Gregg, Senator Mikulski, and distinguished Members of the
Committee, thank you for the opportunity to testify on the
reauthorization of the Mammography Quality Standards Act (MQSA). My
name is Diana Rowden. I am a breast cancer survivor. I consider myself
blessed because mammography led to the early detection of my breast
cancer, which allowed me to take advantage of less intrusive treatment
options and enjoy a higher quality of life during the almost 12 years
since my diagnosis. I am honored to be able to thank you in person for
enacting the MQSA, which gives women increased confidence about the
quality of mammography screening. The Susan G. Komen Foundation Breast
Cancer Foundation and its many constituents of breast cancer survivors
across the nation appreciate and are grateful for your dedicated
leadership and support for improving the quality of breast health and
breast cancer care in the United States.
Patient Education, Advocacy and Outreach
As 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 118 domestic Affiliates, with over 75,000
volunteers across the United States, and 3 international Affiliates.
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 addition, I was an ad hoc
member on the integration panel for the U.S. Army Breast Cancer
Research Program. In November 2002, I joined the Komen staff as the
Affiliate Service Manager overseeing Komen's domestic Affiliate
network. I also serve as a member of the National Cancer Institute
(NCI) Consumer Advocates in Research and Related Activities (CARRA)
Program and the National Surgical Adjuvant Breast and Bowel Project
(NSABP) Patient Advocacy Committee.
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 CureTM 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 treatment. 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 nearly $600 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
However, while the Komen Foundation invests millions of dollars
annually in cutting-edge breast cancer research for the future, we
recognize the urgency of helping to meet the needs of those who are
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. Every 3 minutes a woman
is diagnosed with breast cancer, and every 13 minutes a women dies from
this disease. All of us here today will be touched by breast cancer in
some way during our lifetime.
I believe that early detection of breast cancer saves lives.
Mammography screening, while imperfect, remains the best tool available
to detect breast cancer at its earliest, most treatable stages. It is
the reason I am alive to testify before you today.
More than 10 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. Worried about inconsistencies and the often poor
quality of mammography, Congress, through MQSA, mandated that the Food
and Drug Administration (FDA) oversee the more than 10,000 facilities
that perform mammograms across the United States through accreditation
and annual inspection programs. Congress reauthorized MQSA again in
1998, adding the helpful requirement that letters be sent to patients
to notify them of their mammography results. Komen Affiliates across
the country tell us that they are grateful for these minimum standards
and uniformity established by MQSA. Many recognize through their own
experiences that quality mammography can save lives, and they sincerely
appreciate the efforts of the Congress, the FDA, and the medical
community to continue to balance the need for both quality and
accessibility of mammography services.
As the GAO recognized in its 1997 report, the MQSA has had a
positive impact on the quality of mammography services.\1\ 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.\2\
In addition, 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.
Mortality rates in some minority populations have not declined at the
same rate as it has in other populations, and we must ensure that all
Americans, regardless of race or ethnicity, have access to quality
breast health and breast cancer care.
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.
The MQSA reauthorization process presents Congress with an
important opportunity to build upon the existing quality standards
related to image interpretation. Determining the quality of image
interpretation is essential to improving the effectiveness of
mammography. Several studies demonstrate wide variation in the
interpretation of the same mammogram by different radiologists.\3\ The
New York Times reported last summer that the ``biggest problem of all''
in the mammography industry is the skill of physicians interpreting
films.\4\
This variation is troublesome. Poor quality interpretation can lead
to false negatives, (missed cancers) and delayed treatment, and even
result in avoidable deaths. It can also lead to false positives, which
may result in needless anxiety, and costly additional testing, such as
unnecessary biopsies.
Therefore, during the 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
The 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.\5\ 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.\6\ 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 make one pause about the adequacy of
these standards.
I 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, including 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, it is
not expected that modification of current CME requirements would add
significant costs to the current system.
Requiring 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.
The Komen Foundation recognizes that these issues cannot be looked
at in a vacuum. 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.
In addressing the CME issue legislatively, Congress should act more
deftly than pursuing a ``mammo police'' approach. While we must ensure
meaningful results for women, it is essential to strike the correct
balance that we do not create additional barriers to access to quality
care by driving radiologists from the field.
Improving Medical Outcomes Data
In 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.\7\ These audits
are limited to reviewing data of patients with tests interpreted as
``positive'' (``suspicious abnormality'' or ``highly suggestive for
malignancy''). The results are meant to provide feedback to the
interpreting physician as part of a facility's own internal quality
assurance program. The regulations do not require facilities to report
this information to population-based cancer registries, other sources
maintaining pathology data, or even the FDA. Creating such links would
greatly advance the goal of quality assurance, as well as breast cancer
research-related activities, because it would then be possible to
determine the accuracy of outcomes of patients whose results were
initially interpreted as ``normal.''
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.\8\
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 interpretation.
An interesting example of this potential appeared in the New York
Times article describing a ``revolution'' in mammography commenced at
Kaiser Permanente Colorado. The Chief of Radiology began reviewing
physicians' records, counting cancers found and missed, and charting
and publishing internally the outcomes data. Physician accountability
led to some house cleaning but ultimately a much higher level of
accuracy. The Kaiser group achieved higher quality of interpretation by
directing the interpreting physicians to read more mammograms per year
and undergoing a form of self-assessment three times a year. Also,
yearly, the radiology section sent out lists of ``false negatives'' so
that the physicians could study and learn from the outcomes data.
Furthermore, Kaiser began to look at outcomes data for biopsies, as
well as mammograms. In sum, by examining medical outcomes data, the
Kaiser project discovered weaknesses, took steps to increase efficiency
and quality of interpretation, found cancers previously undetected, and
created a program that inspired additional confidence.
During the reauthorization process, I encourage the Committee to
explore these important quality assurance issues further. The FDA
should be asked and may be readily able to provide answers about its
quality assurance efforts in the area of physicians' interpretive
proficiency and medical outcomes data audits. Certainly more needs to
be known about what happens during the audits and whether anything is
done with the data beyond what the originating facility does. Some
questions, however, may require more thought and study over a longer
period of time.
One way to understand more about outcomes, of course, would be to
require consistent collection and utilization of outcomes data in any
program of quality assurance. 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:
The number and types of all mammograms performed per year;
The number of screening patients recalled for diagnostic
studies;
The number of radiologists interpreting screening
mammograms;
The number of screening mammograms interpreted by each
radiologist;
The percentage of cases reported annually in each of the
five reporting categories (e.g., BI-RADS) used by each facility;
The number biopsies performed;
Follow-up of all findings in which any further image or
other study is recommended; and
Retrospective review of the mammograms of each patient
diagnosed with breast cancer in the population receiving mammograms at
a particular facility.
It also would be extremely helpful to efforts to eliminate health
disparities if the quality assurance medical outcomes audit provisions
were to require collection of information on patient age and ethnicity,
and in a manner that would facilitate the correlation of this data to
the BI-RADS categories.
Furthermore, the value of such outcomes data would be significantly
enhanced if it were linked to national cancer registries. Not only
could such linkages help show how well mammography is working, but it
also would allow us to determine how particular facilities are
performing. In addition, it would make available better data to inform
the breast cancer research community and potentially improve
significantly the quality of care received by millions of American
women and men.
Of 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 some of these issues will require serious review, it may
be appropriate to include them in any study requested of the GAO or the
Institute of Medicine. This approach would be consistent with proposals
for MQSA reauthorization introduced during the 107th Congress. Such
study, if completed before the reauthorization expires, could provide
greater insight into these issues in time for the next round of MQSA
reauthorization deliberations.
Inclusion of Interventional Mammography Procedures
Since the enactment of MQSA and the establishment of minimum
quality standards, women throughout the country have gained further
confidence in the quality of mammography services. Now, we must also
ensure that these minimum standards of quality apply uniformly to
interventional modalities (e.g., mammography-guided needle localization
and stereotactic breast biopsy). Interventional mammography is
performed in follow-up to an abnormal mammogram. Such procedures can
improve a patient's quality of life by allowing further examination of
the abnormality while avoiding a more invasive surgical procedure.
Research and development of cutting-edge technologies for the diagnosis
and treatment of breast cancer, including stereotactic breast biopsy
and needle localization, have dramatically improved the quality of life
for many patients and their families. Patients must be assured that the
care they are receiving as a result of these innovative technologies
meets minimum quality standards. The Komen Foundation urges Congress to
mandate the inclusion of interventional mammography equipment under the
umbrella of MQSA oversight.
Additional Concerns of Patients and Providers
As previously mentioned, to ensure 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.
Patients should not fear that the confidentiality of their personal
health information would be breached. Therefore, I urge the Committee
to be sensitive to these concerns and develop a quality assurance
system that complies with appropriate federal and state confidentiality
laws.
In 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.
The Komen Foundation believes that quality of image interpretation
is essential to improving mammography services and building confidence
in the continued use of mammography. Yet we also appreciate that
requiring new quality standards could impose additional burdens on
providers.
It bears repeating that MQSA deliberations always 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.
Reports 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.\9\ Many radiologists 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
imaging procedures.
In 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. The Komen Foundation is very
concerned about the reported decline in mammography services and its
potential impact on access to quality care. This is of further concern
in light of the aging baby boomer population, which will vastly
increase the number of women who require mammography services. Further
study is needed to verify the reported correlation between inadequate
mammography reimbursement rates and facility closings and to determine
whether this has resulted in a decline in available mammography
services.
The Komen Foundation believes that all insurers, including
Medicare, must provide adequate reimbursement to providers of
mammography services, making sure that reimbursement rates increase to
keep pace with costs attendant to added requirements. Without proper
levels of reimbursement, the specter of unfunded mandates could
accelerate the deterioration of these potentially life-saving services,
and result in diminished quality of life and quality of care for breast
cancer patients and others facing a diagnosis of breast cancer.
As to what can be done in MQSA, the Komen Foundation urges adoption
of the approach proposed in previous reauthorization bills for
additional studies of access-related issues, specifically including a
review of the reported link between facility closures and inadequate
reimbursement rates.
Reauthorization Period
In view 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.
As 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.
Thanks to innovative research, what we now know about breast cancer
is at an all time high, and the push for research and development of
new technologies and therapies continues. We have made significant
strides in the war against breast cancer. Furthermore, we believe we
are on the edge of genuine 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 maintain focus on 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 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 who currently face a diagnosis of
breast cancer have access to the best care currently available.
I appreciate the opportunity to present this testimony and thank
you very much.
references
\1\ General Accounting Office, ``Mammography Services: Impact of
Federal Legislation on Quality, Access, and Health Outcomes,'' 1
(October 1997).
\2\ Id. at 7.
\3\ 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).
\4\ Michael Moss, ``Spotting Breast Cancer: Doctors are Weak Link''
New York Times (June 27, 2002).
\5\ 21 C.F.R. Sec. 900.12.
\6\ Id.
\7\ 21 C.F.R. Sec. 900.12.
\8\ GAO, supra, at 2.
\9\ Institute of Medicine Report--Mammography and Beyond,
Developing Technologies for the Early Detection of Breast Cancer
\10\ General Accounting Office, ``Mammography Services: Impact of
Federal Legislation on Quality, Access, and Health Outcomes,'' 1
(October 1997).
\11\ Id. at 7.
\12\ 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).
\13\ Michael Moss, ``Spotting Breast Cancer: Doctors are Weak
Link'' New York Times (June 27, 2002).
\14\ 21 C.F.R. Sec. 900.12.
\15\ Id.
\16\ 21 C.F.R. Sec. 900.12.
\17\ GAO, supra, at 2.
\18\ Institute of Medicine Report--Mammography and Beyond,
Developing Technologies for the Early Detection of Breast Cancer \18\
General Accounting Office, ``Mammography Services: Impact of Federal
Legislation on Quality, Access, and Health Outcomes,'' 1 (October
1997).
\18\ Id. at 7.
\18\ 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. Robertsen, ``A Private Breast Imaging Practice: Medical
Audit of 25,788Screening 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 1809-09
(1993); K. Kerlikouske, D. Grady, J. Barclay, et al., ``Variability and
Accuracy in Mammographic Interpretation Using the American College of
Radiology Breast Imaging Reporting and Data Systems'' 90 J. Cancer
Inst. 1801-09 (1998).
\18\ 21 C.F.R. Sec. 900.12.
\18\ Id.
\18\ 21C.F.R. Sec. 900.12.
\18\ GAO, supra, at 2.
\18\ Institute of Medicine Report--Mammography and Beyond,
Developing Technologies for the Early Detection of Breast Cancer
\18\ General Accounting Office, ``Mammography Services: Impact of
Federal Legislation on Quality, Access, and Health Outcomes,11 1
(October 1997).
\18\ Id. at 7.
\18\ 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 25,788Screening 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 1809-09
(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 Systems'' 90 J. Cancer
Inst. 1801-09 (1998).
\13\ Michael Moss, ``Spotting Breast Cancer: Doctors are Weak
Link'' New York Times (June 27, 2002).
\14\ 21 C.F.R. Sec. 900.12.
\15\ Id.
\16\ 21 C.F.R. Sec. 900.12.
\17\ GAO, supra, at 2.
\18\ Institute of Medicine Report--Mammography and Beyond,
Developing Technologies for the Early Detection of Breast Cancer
Prepared Statement of Leonard Berlin, M.D.
Mr. Chairman, my name is Leonard Berlin. I am a practicing
radiologist, a member of the American College of Radiology (ACR), and
Chair of the Department of Radiology at Rush North Shore Medical Center
in Skokie, Illinois, a suburb of Chicago and also Professor of
Radiology at Rush Medical College in Chicago. I am honored to have been
asked to testify regarding the reauthorization of the Mammography
Quality Standards Act (MQSA) and to specifically address
discoverability concerns related to the potential requirement of
incorporating interpretive skills self assessment into the Continuing
Medical Education (CME) requirements under MQSA.
At the outset let me say that I categorically endorse reauthorizing
MQSA, and in fact I believe that MQSA has contributed to the almost 30
percent mortality reduction from breast cancer. I truly believe that
the Act has been of great benefit to the public and to the medical
community at large, particularly radiologists. I understand that this
Committee also favors reauthorizing the Act, but at the same time I am
aware that concern has risen that MQSA as currently constructed focuses
almost exclusively on the technical aspects of mammography--namely,
equipment, filming, processing, communication of results to patients,
and follow up of abnormal or questionable abnormal findings. While the
Act as currently constructed does cover certain professional aspects,
namely, basic requirements for CME and a requirement that radiologists
interpret a certain minimum number of mammograms annually, the Act does
not address other professional aspects of mammography such as the
accuracy with which radiologists render mammographic interpretations.
Considerable attention was drawn to radiologists' consistency and
proficiency regarding mammographic diagnoses by newspaper reporter
Michael Moss in a series of articles published in the New York Times in
June 2002. It is true that there is much variance among radiologists in
rendering mammographic interpretations and that some radiologists
perform poorly in this regard. Because of such concerns, there has been
generated the need to objectively assess and monitor the performance of
radiologists when interpreting mammograms, so as to assure the public
that all mammograms performed in every part of the nation receives
competent relatively uniform radiological evaluation.
I believe that the public does indeed deserve assurance that such
an assessment is being carried out and that radiologists who do not
meet acceptable mammographic interpretive standards should be withdrawn
from the system. There are several ways in which such an assessment can
be implemented. In fact, one is almost a reality today. The ACR has
developed a self-assessment program which currently is available to
every radiologist who interprets mammography. This self-assessment
process is optional, and thus some radiologists participate in it,
while others elect not to. Whether they do or do not participate in the
ACR's process, all radiologists in hospital-based practices and many in
private-facility based practices have developed their own performance
improvement programs, in accordance with requirements of the Joint
Commission for Accreditation of Health Care Organizations. Should the
Congress decide to mandate radiologists' participation in a self-
assessment program such as that currently offered by the ACR, I have no
doubt that the radiologic community will accept and comply with such a
mandate, for I do not think that it represents a controversial issue.
However, what could well be a controversial issue is whether the
results of such a mandated self-assessment process should be readily
available to public scrutiny or discoverable in a legal proceeding. And
this leads me to that black threatening cloud that looms on the horizon
and has every indication of growing, the quagmire of medical
malpractice. For many years I have studied, written and lectured about
the adverse impact of medical malpractice litigation on the practice of
radiology, specifically as it relates to mammography. Statistics
compiled by the Physician Insurers Association of America (PIAA) have
shown a rampant increase in lawsuits associated with mammography, such
that mammography has now become the most prevalent modality in
malpractice lawsuits against radiologists, and that the allegation of
an error in the diagnosis of breast cancer has become the most
prevalent condition precipitating medical malpractice lawsuits against
all physicians. According to the latest figures released by the PIAA,
the overall indemnification for all breast cancer malpractice
litigation averaged $438,000 in 2002, a 45 percent increase in the
corresponding figure from 1995.
Part of the reason for the high number of lawsuits associated with
mammography is the public's perception of mammography's accuracy. Many
believe that mammography is infallible, that it is a matter of simply
looking at black and white shadows on an X-ray film, of going through a
simple mathematical calculation, and that thus all radiologists should
arrive at the same interpretation. Alas, such is not the case. Shadows
on mammograms are far more often varying shades of gray, normal
glandular and connective tissues in the breast often obscure suspicious
abnormalities, and many suspicious abnormalities often masquerade as
normal structures. As a result, many breast cancers, perhaps 15 percent
to 20 percent as estimated by some researchers, are not visualized on
mammograms. But the problem is far more complex than that. If we take a
batch of mammograms that today reveal a breast cancer, or a batch of
chest X-rays that today reveal lung cancer, and then look at a
corresponding X-ray film taken perhaps one year earlier on the same
patient that had been interpreted as normal, we will find that upon
retrospective review the beginnings of these cancers can be detected on
those previous X-ray films. This is why it is so crucial for
radiologists to be able to compare prior mammograms to the current
study. Many such studies have been done and have been published in the
scientific literature and they are referenced in some of the articles
that I have written that are appended to this report. Suffice it to say
that research studies performed at some of the most prestigious medical
institutions in the United States reveal that as many as 90 percent of
lung cancers, and 70 percent of breast cancers, can at least partially
be observed on previous studies read as normal. Does this mean that the
radiologist who initially read those films as normal is negligent or
guilty of malpractice? No, it does not. What these studies do mean is
that in hindsight, after a diagnosis of cancer is clearly visualized,
the diagnosis of a cancer on a previous study that was non-apparent
initially now becomes somewhat clear. But hindsight bias or so called
``Monday morning quarterbacking'' is not an indication of negligence
nor a measure of poor performance. An Illinois Appellate Court (Warren
vs Burris, 10-23-01) said it more meaningfully: ``In hindsight, almost
everything is foreseeable, but that is not the test we should employ.''
Because the public perceives--or rather, misperceives--that
mammography should be 100 percent accurate, women and/or their families
frequently resort to malpractice litigation if breast cancer is
diagnosed subsequent to having had a mammogram that had been
interpreted as normal. And, because the public perceives--or rather,
misperceives--that early diagnosis of cancer virtually guarantees a
cure and that a delay in the diagnosis of cancer is tantamount to a
death knell, even when there is reliable and objective expert testimony
that a delay had no ill-effect, juries are nevertheless all too ready
and willing to award great compensation to the patient. Although, as
noted before, the average indemnification in breast cancer approaches
$500,000, awards of $3 million or $5 million or even $12 million are
not unusual.
The degree to which public perception influences the outcome of a
malpractice lawsuit involving breast cancer is exemplified by a case in
Chicago in which a radiologist was accused of missing a cancer on a
mammogram, causing a 14-month delay in diagnosis. Once the tumor had
been found, a lumpectomy was performed and there was no evidence that
the cancer had spread to the surrounding lymph nodes. The patient filed
a malpractice lawsuit against the radiologist but it was nearly four
years before the case was finally scheduled for a jury trial. At the
time the patient was completely free of disease and every indication
was that she was cured. Nevertheless, just before trial was to begin,
the radiologist's defense attorney wrote a letter to the radiologist's
insurance company that stated, in part:
``Even though our consulting oncologist in this case is prepared to
testify that the 14-month delay in diagnosis had no effect whatsoever
in either the treatment or the prognosis of the patient, I recommend
that the case be settled because given the perception that women can be
cured of breast cancer only through early detection by screening
mammography, I believe it will be very hard to convince a jury to rule
in favor of the radiologist.''
The case was settled for $350,000.
The specter of malpractice litigation exerts an enormous adverse
impact on radiologists who perform mammography. Being found liable for
allegedly misinterpreting a mammogram not only significantly increases
the malpractice insurance premium paid by the radiologist, but indeed
may even make obtaining such insurance impossible. Being found liable
in such malpractice litigation also can make a radiologist ineligible
to contract with a managed care organization, and at times can lead to
severance of medical hospital staff credentialing. The end result is
that more and more radiologists are refusing to perform mammography,
and fewer and fewer radiology residents completing their formal
training are opting to take additional fellowship training in
mammography. In turn, mammography facilities are closing.
To illustrate the effect that the medical malpractice quagmire is
having on radiologists who interpret mammograms and to put it on a more
personal level, let me quote from several unsolicited letters that I
have received from radiologists around the nation who perform
mammography:
______
Dear Dr. Berlin: I am a private practice radiologist in Wisconsin.
I practice at a small hospital in a Western Suburb of Milwaukee in a
six-member group. The hospital that I practice at is in a fairly
affluent region and the average patient is very educated. I do worry
about the malpractice issues regarding mammography. I consider myself
an above-average mammographer and I believe I have made a positive
impact on many lives by providing quality breast imaging and diagnosis.
However, I do not have a fellowship in mammography and practice general
radiology. Because of the current atmosphere of litigation and our
patients' unrealistic expectations, if I were given the choice to stop
``manning'' our women's center, I would seriously consider it.
Signed,
Christopher Canitz, MD
______
Dear Dr. Berlin: I currently interpret over 5,000 mammograms
annually. My junior partners and I are running scared. Excessive and
unreasonable caution results in numerous unnecessary biopsies . . . One
recent lawsuit takes the cake. A junior partner was sued by a women who
developed an interim breast cancer. We all agree the screening
mammogram was negative eight months prior to discovery to the cancer,
except of course the plaintiff's so-called expert-witness. But the
truth is irrelevant. The patient developed liver and brain metastases
during the discovery process and the insurance company settled for
$800,000. Settlement in the State of Florida is at the sole discretion
of the malpractice carrier and is not subject to approval or permission
by the insured physician. Our malpractice premium rose to $50,000 per
man and the junior partner is moving to New Mexico. Even perfect
professional performance provides no protection in Florida!
Signed,
Charlie Fisher, MD, Tampa FL
______
Dear Dr. Berlin: It has unfortunately occurred to me of late that
in a short time we won't have to worry about mammography any more
because breast imaging simply will be something done only at a handful
of centers. The current statistics are grim. As of now, well over 600
facilities have closed their doors on mammography, and the current rate
of closings is 20 per month, and that does not appear to be declining.
Just this morning, one of the fellows that I trained said her facility
in Tempe, AZ was closing. It is truly a mess. I talked with a man who
is the head of a private practice in Carmel, CA and he said they simply
shut down all breast imaging for the usual reasons: nobody in his
practice wanted to do it (emotionally draining with a high ``burnout''
factor), all related to the malpractice problems. The Boca Raton, FL
breast center recently topped $5 million in settlements over breast
malpractice cases.
Signed,
Peter Dempsey, Houston, TX
______
I cite these letters not to focus on the medical malpractice
problem in general, for that is a subject with which I know Congress is
dealing at another level on another day. The purpose of my emphasizing
the adverse impact of malpractice on radiologists who do mammography is
what may happen if the results of any self-assessment process
undertaken by radiologists are made public or discoverable in legal
proceedings. The malpractice litigation problem will be exacerbated,
and as a result, many more radiologists will simply refuse to undergo
self-assessment exercises and participate in performance improvement
activities. Therefore, I urge that if self-assessment is made mandatory
as part of the MQSA reauthorization, that the results remain
privileged. A California Appellate Court (Clarke vs Hoek, 1985) spoke
to this issue far more eloquently than I:
``There is a strong public interest in supporting, encouraging and
protecting effective peer review programs and activities. The quality
of . . . medical care depends heavily upon members' frankness in
evaluating their associates' medical skills and their objectivity. The
fear of potential malpractice liability would not only discourage
participation by medical professionals in volunteer review committees,
but would stifle candor and impair objectivity in staff evaluations . .
. [California law] expresses a legislative judgment that the public
interest in medical staff candor extends beyond damage immunity and
requires a degree of confidentiality . . . External access to peer
investigations conducted by staff committees stifles candor and
inhibits objectivity. It evinces a legislative judgment that the
quality of . . . medical practice will be elevated by armoring staff
inquiries with a measure of confidentiality.''
Let me summarize. Radiologists are in short supply. Breast imagers
are in even shorter supply. The combination of low reimbursement with
the high probability of being sued for a missed diagnosis is clearly
not the best tool for recruiting young radiologists to participate in
the field of mammography. Seven hundred mammography facilities have
closed nationwide in the past two years. This downward trend will
continue and waiting times will continue to increase for women seeking
timely mammography services unless Congress acts responsibly with
regard to mammography self-assessment. It is my belief that, given the
current litigious climate, it is imperative that any self-assessment
requirement recommended by this Committee and enacted by Congress be
deemed non-discoverable.
With deep humility and respect, I thank you for the opportunity to
testify on this important matter to women's health. I would be happy to
answer any questions members of the Committee may have.
[Whereupon, at 11:13 a.m., the committee was adjourned.]