WASHINGTONAn Institute of Medicine (IOM) committee has launched
an assessment of technologies for the early detection of breast
cancer that will include an examination of the policies and economic
factors that delay or prevent their adoption. The year-long effort is
part of a 5-year project undertaken by the IOM, an arm of the
National Academy of Sciences.
Joyce C. Lashof, MD, professor emerita, University of California,
Berkeley, School of Public Health, chairs the 15-member panel. At the
first of four public meetings it will hold, the committee discussed
the scope and goals of its charge. The group also received briefings
on the status and potential of imaging devices and biomarkers for
breast cancer detection. Two and 4 years after the panel releases its
report, the IOM plans to hold workshops to examine the progress made
in the field.
In its Statement of Task, the IOM asked the group to begin the 5-year
process by surveying existing technologies and identifying
promising new technologies for early detection, assessing the
technical and scientific opportunities. The committee is then
to turn to policies that influence the development, adoption,
and use of technologies and include in this analysis how
breast cancer detection technologies are likely to diffuse into
practice, based, in part, on comparison to other medical technologies.
Almost immediately, committee member Janet K. Baum, MD, associate
professor of radiology, Harvard Medical School, and director of
breast imaging, Beth Israel Deaconess Hospital, raised the issue of
the threat to mammography posed by malpractice lawsuits filed against
radiologists. The primary basis for the suits is delay in
detection, but some women who suffer complications as the
result of a biopsy that proves to be negative also file suits, she said.
The number of malpractice claims in this country on delay in
diagnosis in breast cancer is staggering, Dr. Baum said.
The cost to the medical system in terms of insurance is
reflected in the fact that reimbursement from payers doesnt
even cover our malpractice insurance. People in many states are
saying, Im not going to do mammography any more. It
has already been an issue in the use of MRI in evaluation of breast
lesions, and I think it will limit the use of new technologies unless
we can find some way of dealing with the issue.
She added that in Massachusetts, some groups are considering limiting
both the number of people doing mammography and the number of
In response to one committee members query about whether data
existed to back up Dr. Baum, Morgan W. Nields, chairman and chief
executive officer of Fischer Imaging Corp., Denver, said that indeed
Physicians insurance associations have done studies on
this, said Mr. Nields, who was an invited speaker at the
meeting. In their last report, failure to diagnose breast
cancer was the number one lawsuit, not only against radiologists, but
against all physicians. Its not just the radiologist thats
involved. Its the surgeon, the family practitioner, anybody in
the chain is named. The average settlement is approximately $350,000,
and the average jury award is about $1.2 million.
Mr. Nields called this a major societal issue. Residents are
shying away from mammography. Its poorly reimbursed, and one is
frequently sued, he said.
The multifaceted issues of reimbursement and federal
regulationand their influences on the development and diffusion
of new technologiesclearly interested committee members.
The fact is that the cost of providing mammography services is
greater than the reimbursement, and I think that is just about
universal, said panel member Michael W. Vannier, MD, of the
University of Iowa School of Medicine.
According to Mr. Nields, Medicare pays $130 to reimburse an
osteoporosis screening, but only about half that for a mammogram. And
Dr. Vannier pointed out that mammography centers have the extra
burden of FDA regulations that require their inspection and certification.
Impact of FDA Regulations
Larry Norton, MD, head of solid tumor oncology, Memorial
Sloan-Kettering Cancer Center, alluded to another conflict within
todays medicine. Companies want to make a product, sell
it, and make a profit. They want a product that is useful, but there
is a profit motive there, he said. Managed care companies
want to buy as few machines as possible and do as few tests as
possible. Where government weighs in on this situation is extremely important.
The FDA regulatory process, which is time consuming and expensive,
coupled with the money issue, is already affecting imaging
technology, Mr. Nields said. If you get through the regulatory
gate, then you have to get through the reimbursement gate. So
industry is not pursuing new imaging devices for breast cancer,
Funding for the committee study is being provided by a group of seven
foundations. Because this isnt being done at the request
of a particular federal agency, this committee has a lot of leeway in
defining what its task should be, said Robert Cook-Deegan, PhD,
director of IOMs National Cancer Policy Board.
Panel members also pondered who their audience might be for the
report. Dr. Cook-Deegan cited Congress, the NCI, FDA, Department of
Defense, Health Care Financing Administration and private payers, and
even the NASA technology transfer program.
Committee vice chair I. Craig Henderson, MD, of the University of
California, San Francisco, added two others: industry and investors.
More than drugs, devices have been very dependent on the
private sector, he said. And he added another issue for the
panel to consider, one of vital interest to both groups that could
seriously influence their decisions on new technologies: Is
there greater risk in investing in early detection than in other
areas in health care?
Dr. Norton reminded the panel that not everyone holds the same view
on the need to develop new screening techniques to catch breast
cancer at an even earlier stage. Even if everyone in this room
thinks that screening is important, there are people out there who
dont, he said.