Legal and financial constraints have decreased access to screening mammography. The author presents three solutions to this growing problem.
At the time of submission, Dr. Lee was Medical Director of
HealthHelp, Inc., a radiology MSO. He is now Chief Medical
Officer/Health Care Manager with the California Department of
Corrections, Salinas, CA.
Screening mammography, the only screening procedure recommended
by the American College of Radiology, has been shown to decrease
the mortality in women from breast cancer.
To meet this challenge, guidelines have been developed recommending
screening exams beginning at age 40.
Because of this need, screening facilities began springing up all
over the nation. It was soon realized, however, that not all these
facilities performed diagnostic-quality mammograms.
In 1992, the Mammography Quality Standards Act (MQSA)
was enacted to ensure that only facilities that had passed rigorous
standards would perform those exams. Not only would the facilities
and equipment be reviewed, but the technologists and interpreting
physicians would be as well. In 1994, the first facilities were
certified. Since then, more than 9,000 facilities have been
reviewed annually. However, if every eligible woman were to get a
screening mammogram as recommended, there still might not be enough
facilities, manpower, or money to meet this need.
From 1995 to 1997, the number of facilities increased from 8803
to 9448. Then in 1998, the number decreased to 9297, only to rise
to 9537 in 1999. In September 1999, there were 9968 fully certified
facilities. This number may now be decreasing. As of April 28,
2000, there were 9570 certified facilities, a decrease of 398
If there is a decrease in the number of offices providing
mammograms, fewer women will be screened, fewer early cancers will
be detected, and the mortality rate will rise. This may have become
a serious matter, possibly to the level of a public health problem.
The basis for any decrease in the number of facilities are
threefold: (a) the high medical liability risk associated with
mammography; (b) the low reimbursement for screening mammograms;
and (c) the rigorous and costly governmental regulations.
Disincentives of mammography
High mammography liability risk
One of the areas of medicine with the most malpractice
litigation and liability is the interpretation of mammograms.
Misdiagnosis of breast cancer is the most common condition for
which claims are generated against physicians.
An informal survey of local radiologists suggests that more than
half have been involved directly or indirectly in malpractice
litigation relating to mammography. Radiologists are named in
one-quarter of all breast cancer malpractice claims.
The average judgment award in cases where there was a jury verdict
Malpractice suits are extremely disruptive to physicians and their
practices, involving time and expense, as well as an emotional toll
on the doctor. Without question, women have been injured by
negligent physicians, and there should be compensation for the harm
done. But there should be a correlation between the harm done, the
act of the doctor, and the compensation received. The risk of being
sued is, without a doubt, a reason that some qualified, competent
physicians will discontinue performing mammograms.
The low reimbursement for screening mammograms
As of January 2001, the standard reimbursement, based on
Medicare, allowable for a screening mammogram in Florida,
localities 1 & 2, was $69.23.
Other payers, such as Medicaid, provide even lower reimbursements.
A survey of 21 radiology facilities showed that their average cost
to do a mammogram is $65. This cost is dependent on volume, and
most facilities are not operating at their maximum efficiency for
mammography. In fact, some facilities regard performing mammograms
as a loss leader. It is difficult to measure the effect of
performing mammography on the other areas of the imaging business,
however. The general consensus among radiologists is that unless
they do a significant amount of ancillary breast procedures, such
as ultrasound, diagnostic follow-up, and localizations with
biopsies, they do not make money on screening mammograms, and may
in fact lose money. Some facilities that are losing money
performing mammograms have decided to discontinue providing this
In our survey, the average reimbursement was $5 less than it cost
to do the exam.
The rigorous and costly governmental regulations
The MQSA is a federal law intended to ensure that women
undergoing screening for breast cancer get that screening only at a
facility where quality is assured. The MQSA imposes high standards
on mammography facilities, technologists, and physicians. The
facilities must undergo a rigorous application and inspection
process under the auspices of the Federal Drug Administration.
Those not meeting the standards are prohibited by law from
performing mammograms, both screening and diagnostic. Detailed
records of the equipment and processor must be maintained. The
training, experience, and continuing education of the technologists
and physicians must be verified and maintained in accordance with
the Act. The purpose and goals of the Act are without question.
However, the Act places a severe burden on screening facilities.
This burden is not only one of time and labor, but also of an
out-of-pocket expense. Facilities have had to hire additional
personnel to keep up with MQSA-related paperwork. In keeping with
the intent of the regulations, once a facility is certified, that
facility must maintain its certification by: (a) having an annual
physics survey of the equipment performed by a private radiation
physicist certified by the American Board of Radiology; (b)
undergoing periodic audits and reviews by their accreditation body;
(c) permitting and undergoing an annual MQSA inspection; (d) paying
an inspection fee; and (e) correcting any deficiencies found during
The annual MQSA inspection fee is $1500.
The average cost to reach MQSA compliance has been estimated to be
as high as $18,000.
A facility may have to perform more than 20 mammograms just to pay
for the inspection fee, and more than 250 to cover the cost of
initially being compliant. In addition, the services of a physicist
must be obtained, which may cost more than $500. These additional
financial burdens are a disincentive to performing mammography.
Lessen the malpractice risk
Precedents have been established where no-fault liability is
allowed in cases in which medical malpractice litigation has
interfered with adequate delivery of healthcare.
In these settings, any patient injured in a documented medical
experience is awarded compensation without assigning fault to the
healthcare provider. This eliminates the stigma, time, and the
administrative and legal cost associated with a lawsuit, but still
provides the injured patient with appropriate compensation.
Another mechanism to lessen the malpractice effect is a scheme
such as the Florida Birth-Related Neurological Injury Compensation
Association, which is funded by a combination of state funds,
physician fees, and hospital assessments.
If a doctor (whether a family practitioner or an obstetrician)
performs obstetrical services and wishes to be covered by the
association, the fee is $5000 per year. In addition, all
physicians, regardless of specialty, must pay a mandatory fee of
$250 and hospitals pay $50 per live birth. This fund is to be used
for compensation, which lessens the medical malpractice insurance
costs to the providers.
This type of plan would have to be followed on a national level
to provide consistency throughout the states. One possibility would
be its amendment to the MQSA. The resultant lessened liability
would not create a sense of immunity in the radiologists; there
would still be the requirement of their being certified by the FDA.
If repeated negligence were identified, expulsion from the program
would be an option. Physicians don't become lackadaisical simply
because the risk is lessened. Physicians still have their pride and
reputation as well as the desire to provide to best care for the
Any business that offers its services or products to the public
should be allowed to receive a financial gain from that service or
product. This is fundamental to the American capitalist system. At
the minimum, one should not be expected to suffer from offering
that service. The American College of Radiology has been looking at
the reimbursement for imaging procedures and has had mammography at
the top of its list for evaluation.
The reimbursement for screening mammograms should cover the full
and complete costs of doing the exam and still allow a reasonable
profit. This reimbursement should also cover the added expenses of
compliance with the MQSA. A survey of 21 mammographic facilities in
our network indicated that they felt average reimbursement should
be $95, with a range from $67 to $150. The Health Care Financing
Administration sets the standard for reimbursement in its Medicare
program. The private insurance payers frequently follow suit and
adopt the Medicare fee schedules.
Revisit the regulatory controls
The accreditation standards have continuously become more
stringent and may have reached the point of overkill. Inman
suggests that the FDA look for ways to perform more cost-effective
inspection. Two suggestions he offers are that: (a) inspections be
unannounced with higher fines for noncompliance; and (b)
implementation costs be more realistic and paperwork be decreased.
Others suggest streamlining the process for those with good track
records and few negative findings at inspection.
The MQSA should be reviewed to determine if a lesser degree of
regulation would accomplish the same goal of ensuring quality. The
MQSA is a federal law, and Congress should be petitioned to amend
the law to make it workable.
There may be a public health problem looming in the future of
mammography. Women may not be able to avail themselves of screening
mammograms to the extent they deserve. Public health problems
require innovative solutions. Three solutions have been suggested
to preserve the availability of screening mammography with the goal
of saving lives.