STATEMENT

of

Leonard Berlin, M.D.

To the

U.S. Senate Committee on Health, Education Labor and Pensions

Re: Mammography Quality Standards Act Reauthorization

April 8, 2003

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% 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% to 20%
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% of lung cancers, and 70% 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% 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 current 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.