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[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

                   U.S. GOVERNMENT PRINTING OFFICE
86-494                     WASHINGTON : 2004
_______________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Printing 
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800, 
DC area (202) 512-1800 Fax: (202) 512-2250 Mail: stop SSOP, Washington, 
DC 20402-0001

          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

                               __________

                               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)

                              ----------                              

                         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.]

                                    

      
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