BY STEVEN K. WAGNER

With screen-film fully mature and digital imaging poised to usher in a new era, mammography has never been better technologically. And new research suggests that it may be even more effective at preventing deaths from breast cancer than had been thought.

On the other hand, the field is plagued by low reimbursement, which in turn spawns a host of problems: Qualified readers are in short supply, unprofitable imaging centers are closing their doors, and providers are reluctant to purchase equipment that can't pay for itself. The result is a crisis for mammography. A few key moves by Congress and others will help determine whether the modality's future matches its potential.

As U.S. imagers lobbied for increased payment and pondered the fate of digital mammography last spring, the best news in months arrived from Sweden. One of the world's foremost practitioners of mammography found that it is actually twice as effective as previously thought.

That study, published in the May issue of Cancer by Dr. Lázló Tabár, tracked nearly 7000 Swedish breast cancer patients aged 20 to 69, 1863 of whom later died from the disease. Tabár and his associates compared breast carcinoma-specific mortality across three time periods:

• 1968 to 1971, when little screening occurred;
• 1978 to 1987, when the historic two-county randomized controlled trial involving Swedish women aged 40 to 74 was under way; and
• 1988 to 1996, when all women in the two Swedish counties aged 40 to 69 were invited to undergo screening mammography.

The researchers found that mortality from breast carcinoma diagnosed in women aged 40 to 69 who were screened between 1988 and 1996 declined 69% compared with the nonscreening era. The rate was somewhat lower, but still considerably higher than previously believed, among all women invited to undergo screening compared with rates during the time when no screening occurred.

The bottom line is that screening mammography appears to be a greater lifesaver than previous studies have shown, said Dr. Stephen Feig, director of breast imaging at Mt. Sinai Medical Center of New York University and a leading proponent of regular screening for women younger than 50.

"(Tabár's results) are significant because he showed that the benefit to women is much greater than the benefits shown in the randomized trials," Feig said. "We're talking about at least a 50% decrease in breast cancer deaths, while in the randomized trials it was 32%. This is higher than we've seen in the past, and the numbers in this study are much more accurate."

Research has built a strong case for mammographyıs effectiveness, but low reimbursement is limiting womenıs access. (Provided by Dr. William Poller, University of Pittsburgh)

Legislation before Congress could boost payment by more than $20, but this would still fall short of the actual cost of the exam.

Tabár's research has several implications, Feig said, including the likelihood that it will help refute other papers that have attempted to invalidate the results of the randomized trials.

"There are reasons why randomized trials have underestimated the benefit of screening mammography," he said. "The trials included deaths among women who were offered screening, even if they didn't accept the invitation. At the same time, if women in the control group were screened on their own and survived, their survival was not included in the results."

The new study may have bolstered the argument for mammography, but problems linked to reimbursement, not scientific evidence, may limit the number of women who will benefit from screening.

"Reimbursement remains discouraging, both in terms of attracting interest from talented radiologists and in expanding capabilities by means of new technology," said Dr. R. James Brenner, chief of breast imaging at the Joyce Eisenberg Keefer Breast Center in Santa Monica, CA. "And the legal climate is still harsh. These trends threaten to compromise the level and momentum of the positive advances made during the past 10 years."

PLEADING THE CASE

Ever-increasing wait times for women wishing to make appointments for screening or diagnostic exams plague mammography, said Dr. Robert A. Schmidt, an associate professor of radiology at New York University. And the closure of mammography facilities, as well as limitations on the allocation of resources aimed at continuing available services, decrease interest on the part of younger radiologists who might otherwise enter the field. Schmidt pleaded the case for mammography before the New York City Council Committee on Health in June.

"The most pressing problem affecting mammographic services in the postmanaged-care era is that mammography generally loses money?and considerable sums?even at centers that have high volumes and are run with typical medical efficiency," he said. "This is because it is underreimbursed by Medicare and by most third-party payers, relative to the cost of providing the service."

Medicare reimbursement has increased steadily but modestly in recent years: about 1.5% between 1997 and 2000. The Medicare reimbursement rate for a screening mammogram is $69.23, well below what it costs most centers to perform the service. Reimbursement for the technical component of a screening mammogram is just over $46.

By comparison, the Healthcare Association of New York State estimated that the technical component alone of a screening mammogram in that state exceeds $100, not including the professional fee.

Legislation pending before Congress offers some hope. One bill would increase payment for screening mammograms to $90. Additionally, the Medicare, Medicaid and State Child Health Insurance Program's Benefits Improvement and Protection Act granted a payment increase for mammograms that are completed using newer and more expensive technologies. The digital mammography rate increases the current reimbursement rate for mammography by about 50%.

But such measures move imaging into dangerous territory, according to the American College of Radiology.

"The College is opposed to a provision that would tie mammography screening reimbursement to the purchase of technology, especially technology that the College believes has not been scientifically proven to increase the detection of breast cancer better than present methods," the ACR said in a written statement released last November.

The ACR estimated that only 100 sites in the U.S. would be eligible to receive the higher reimbursement rate.

HANGING IN THERE

U.S. News & World Report reported in February that 300 unfilled positions for mammographers existed at that time, and the ACR estimated that 20 mammography centers in California alone had closed during the previous two years.

The Elizabeth Wende Breast Clinic in Rochester, NY, is bucking that trend, at least for now. Radiologists at the clinic would like to charge women above and beyond what Medicare reimburses, but HMO forces won't allow it, said clinic director Dr. Wende Logan-Young.

As a result, the clinic has held off on new equipment purchases and may eventually accept only fee-for-service patients. Bankruptcy is mentioned in hushed tones.

"We can't hang in there much longer," Logan-Young said. "You do what you have to do to stay alive."

The clinic has already dropped out of the Preferred Care HMO, which serves Kodak, the city's major employer. That irony did not go unnoticed: Kodak employees, some of whom are helping to develop cutting-edge breast imaging film and technology, had to look elsewhere for mammographic services.

The crisis in mammography follows a coming of age for the modality, during which it grew into an accepted tool that performs exceedingly well in the hands of skilled clinicians, according to Schmidt.

"Now we're geared up, we're like a NASA program preparing to go to Pluto," he said. "We're all ready to go, but our funding has been cut. Groups are questioning whether they should retain their mammography services. It's getting harder to entice new people into mammography."

Although it was intended to aid the field, the Mammography Quality Standards Act is further tightening the screws. Under the MQSA, the estimated 10,000 mammography centers across the country are required to meet certain standards or cease operating. The standards were designed to ensure that staff meet minimum proficiency requirements and that their equipment can consistently produce high-quality images. Beginning in October 2002, the MQSA will require that mammography equipment meet more stringent requirements.

DIGITAL DEBATE

In any discussion of mammography equipment, the subject of full-field digital technology is likely to surface. Thus far, the GE Senographe is the only full-field digital mammography system approved by the FDA, but other manufacturers are poised to enter the arena. These include Instrumentarium Imaging and Fischer Imaging, which claims its SenoScan full-field system reduces radiation doses to patients while enabling radiologists to view and archive high-resolution images.

One facet of debate involves whether images produced with digital technology are substantially better than those captured with screen-film technology.

"With available digital technology, I believe we would miss more cancers than with the best of screen-film technology," said Don Blomstrom, vice president of national mammography sales for Instrumentarium. "However, digital technology will continue to improve, and over time it will bring advantages compared with film. Digital must be better than film in order to justify its cost. This has not yet been done, but ultimately it will be proven."