Talk to a radiologist--if you can find one--about the pros and cons of mammography, and you'll get an earful.
The tool for catching cancerous breast tumors in their earliest stages--the mammogram--is "the best we've got," most experts are quick to say, but that's about as much praise as anyone can heap on it. It's a procedure plagued with controversial clinical studies, burdensome regulations and poor reimbursement rates. Throw lots of legal liability in there for good measure. In short, it's bitter medicine that all hospitals seemingly must swallow while holding their noses.
But take it they do. With the medical establishment insisting on once-a-year screening mammograms for every woman past the age of 40, with insurers paying for it and without any cheaper, faster or more accurate test on the near horizon, it's a technological quagmire in which the healthcare system is heavily invested.
The question: Can the healthcare system afford to extricate itself from the bog? More importantly, does it want to?
"It's a non-negotiable item," says William Poller, M.D., associate director of the breast center at 456-bed Allegheny General Hospital in Pittsburgh. "The technology has outpaced the practicality. That is the problem as it is today."
Providers have spent so much time putting out fires in recent years that there has been little time to consider the long-term prognosis for the technology. Don't expect any extravagant unveilings of any breakthrough equipment at this week's meeting of the Radiological Society of North America. Along the same lines, radiologists likely won't have mammography equipment at the top of their shopping lists.
The technology, which uses garden variety X-rays specially tailored to image a women's breast in safe-enough doses to screen annually, has been put through the wringer both scientifically and economically in recent years. First in 2000, a collective plaintive wail emanated from mammography specialists meeting at the RSNA, stating that low Medicare reimbursements were closing breast imaging centers throughout the country. The following year, Congress upped reimbursement by 50% to $69 per screening, and in 2002 reimbursement for screening mammograms rose again to $82, although many say that still isn't enough.
More recently on the clinical side of the issue, the consumer press widely reported on a study that called into question mammography's effectiveness in reducing breast cancer deaths, but the scientific community rallied quickly in protest (Feb. 4, p. 4). If patients are confused, they are not expressing it by shirking yearly exams, according to practitioners.
"Oh yes, there is, of course, concern and some confusion," says E. Stephen Amis Jr., M.D., chairman of the radiology department at 1,119-bed Montefiore Medical Center in New York. "But the bottom-line decision about whether to have a mammogram when it is reimbursed by most insurance companies and when a mammogram is not a dangerous test, practically speaking, has not influenced any significant number of patients."
Mammography is still the gold standard, says Ruth Rosenblatt, M.D., chief of women's imaging at 2,112-bed New York-Presbyterian Hospital. "With all of its limitations, it still remains the standard for screening because it is the least expensive modality and, quite simply, the most effective when done properly," Rosenblatt says.
Of more concern to practitioners is a nationwide shortage of radiologists, which dims when compared to the number of radiologists who are willing to subspecialize in mammography, experts say. David Dershaw, M.D., director of breast imaging at 431-bed Memorial Sloan-Kettering Cancer Center in New York, says he does not see much light at the end of the tunnel in resolving the radiologist shortage. Publicity of "the negative financial impact" and the high litigation rate for the subspecialty is not exactly bringing in new residents by droves. The litigation issue is similar to the one facing the vaccine industry, he says. When dealing with such large numbers of people, there are bound to be patients who suffer negative outcomes.
"In mammography, for every 10 breast cancers that walk in the door, one to three (images) don't show breast cancer. You can be sued for every one of those," Dershaw says.
The radiologist shortage has overloaded the breast imaging centers that have remained open. A four- to six-week wait seems to be the rule for an appointment; the wait at Montefiore can be as long as six months, Amis says. Montefiore's volume of screening mammograms--about 24,000 per year--has remained static because "we are limited by the number of people who can read the damn things," Amis says. Most of the subspecialists at Montefiore are part-timers, he says.
The workforce shortage problem is compounded by a decline in the number of accredited facilities that perform mammograms--to 9,261 this year from 9,873 in 2001, according to Amis, who also is chairman of the board of chancellors at the American Board of Radiology.
Manufacturers' sales of mammography scanners in the U.S. have fluctuated in recent years, according to Frost & Sullivan, a San Jose, Calif.-based consulting and research firm. Revenue for the manufacturers peaked at $177.7 billion in 1999 before dropping to $142.4 billion in 2000, then rebounding to $171.3 billion in 2001.
Still, it's must-have, high-maintenance equipment. Mammography is one of the heaviest regulated procedures in medicine, says Antonio Garcia, an industry analyst of medical imaging systems at Frost & Sullivan. Garcia says the big wave of purchases in 2001 for the most part represented mammography centers meeting a 2002 deadline to upgrade equipment under the federal Mammography Quality Standards Act, which Congress enacted in 1998 and is enforced by the Food and Drug Administration.
"In a way, the industry is still flush with cash from that," Garcia says. It remains to be seen if mammography sales will continue to grow, he says.
The market isn't exactly flush with vendors vying to offer products. In 2000, the most recent year for which data are available, General Electric Medical Systems, Waukesha, Wis., dominated the market in traditional analog mammography, which uses film, with a 53% share in Canada and the U.S., according to Garcia. Hologic, Bedford, Mass., was second with 18% and Siemens Medical Solutions, Malvern, Pa., was third with 11%. Philips Medical Systems, Best, Netherlands, a leader in other imaging devices, does not offer mammography products in North America and "continues to monitor the X-ray mammography market in North America to determine if an opportunity exists for new product offerings," says Tim Stevener, business unit director of radiography at Philips.
Digital mammography, which represents the newest development in the technology, has been slow growing as well. Clinical studies are still assessing whether the images are better than traditional mammograms on film, but by shedding the need for film processing, digital mammography promises swifter delivery of images to computer screens almost anywhere.
Three years ago, GE was the first vendor to receive FDA approval for its digital unit, and enjoyed a 100% market share in that arena until Fischer Imaging Corp., Denver, received FDA clearance 15 months ago and Hologic got its green light in October. GE's two largest competitors, Siemens and Philips, do not offer digital mammography in this country.
But apparently, what has failed to kill traditional mammography has only made it stronger, according to GE. The company is "still investing rigorously in mammography," says Michelle Heying, GE's business manager of global mammography. The company's medical systems division, which has some 25,000 mammography units in operation around the globe, sells about 3,000 systems yearly, she says.
"We believe it is catching cancers. Can it improve? We believe it can, and that is why we are investing heavily in the mammography arena," Heying says.
Based on its own review of the cumulative data, GE believes that screening mammography has reduced deaths by breast cancer 20% to 40%, says Scott Schubert, GE's manager of advanced development of global X-ray. Although Schubert admits those numbers are controversial, he also maintains that deaths can be reduced up to 60% using the latest technology. That said, the state-of-the-art technology misses as much as 30% of all cancers in women who are not showing other symptoms, he says. In addition, of every 10 women who are called back for a second screening because of ambiguous findings, only one has cancer--the equivalent of a 90% false-positive rate.
"So clearly there is an opportunity to both detect additional cancers and be more accurate upfront," Schubert says.
On the economic front, GE reports that 3,000 of its 25,000 units worldwide turn over every year--a situation ripe for the emerging digital mammography market. But high-end film-based mammography equipment, which can cost $80,000 per unit, is a fraction of the cost of digital, about $400,000. Heying says GE has sold 500 of its digital units worldwide in the three years since it came on to the U.S. market. Schubert says 30% of that turnover is going digital, and by 2004 GE expects more than 50% of the new units sold will be filmless.
Is it worth it? Schubert contends that digital mammography can reduce the false-positive rate by 20%--two out of 10 fewer callbacks--which also saves costs for providers as well as worry for patients. Hospitals that are choosing digital are doing so also because it promises greater efficiencies, allowing those too few radiologists to read the images faster, he says. And productivity-wise, one digital unit can replace two analog machines, he says.
Digital mammography still has some limitations--for one, it is not currently designed for big-breasted women--but it provides a foundation on which new technologies can be built in the future, Schubert says. Most immediately, it works well with computer-assisted interpretations of images, or CAD, which can boost a radiologist's accuracy in reading a mammogram by 20%, according to some studies (March 19, 2001, p. 62). Medicare reimburses an additional $17.74 for such "second reads."
Also on the horizon are hybrid technologies that could bring three-dimensional imaging to mammography. Some radiologists also are exploring the combination of mammography with ultrasound. Preliminary studies indicate that together the two technologies can uncover 42% more cancers, Schubert says. But don't look for any commercial launches of any of these products, whose prototypes are still in early clinical stages, before three years, he says.
"What we see in the marketplace today is that radiologists and patients are embracing mammography on a routine basis, the equipment market is strong based on overall equipment demand and we are very bullish about the future of digital mammography," Schubert says. "Now that we have a digital system platform, we are at just the beginning of the advancements you can do with digital technology."
Are hospitals buying that pitch?
Amis of Montefiore says two digital units will arrive there early next year, but he says he isn't expecting them to improve the quality of the procedure, just the "throughput" in processing and reading the images. Still, he says, the hospital will continue to be limited by the number of radiologists it has to read them. Although digital mammography is still a money-losing proposition as far as Amis is concerned, he says his department is making the investment because "we believe in the patient base having access." There also will be some "downstream revenue" associated with patients whose screens come back positive, he says.
Healthcare alliance Premier was surprised by the response when its group purchasing arm held a "group buy" for mammography equipment in anticipation of the new requirements under the Mammography Quality Standards Act. Group buys are specially priced short-term offerings of capital equipment. Vendors agree to discount their products through such purchases because they are assured that a large number of hospitals will be participating. For the mammography purchase, three Premier vendors that already are under contract for mammography equipment participated: GE, Hologic and Siemens. Premier's target goal was to sell $11.5 million in mammography equipment; in reality nearly $16 million worth of equipment was sold, including 15 of GE's digital systems, says Karen Phillips, Premier's senior director of imaging services. In total 98 member organizations purchased 132 mammography units. Phillips says it was surprising that as many as 15 chose digital machines considering the negative feedback Premier hears about poor reimbursement rates not covering even the costs of the procedure.
One hospital that made the investment was 319-bed Alamance Regional Medical Center in Burlington, N.C. The hospital is about to open a new breast-care center and invested $900,000 to purchase two new digital mammography units on top of the $2 million construction costs, says John Currin, the hospital's executive vice president. Alamance, which performs about 16,000 mammography procedures annually, has seen volumes increasing steadily each year, "which is one reason we are opening the center," Currin says. The mixed messages from clinical studies of late do not appear to have affected business, he says.
"I think the studies are controversial. One study seems to contradict another. Our physicians are continuing to recommend mammography and patients are continuing to seek it," Currin says. "I think women expect schedule convenience, quality and promptness, and those are our goals with the breast center."
Mammography is probably at best a break-even service for Alamance, but the decision to expand and enhance it "is driven by our mission, our goals and our strategic initiatives," Currin says. "I think many people in our community look for us to be a leader in the provision of breast-care services. We have a very active cancer program, and that certainly factors in our decision to be a leader in mammography in our community."
Poller of Allegheny General Hospital similarly says mammography is a "must" investment for any hospital such as his that is building a center of excellence in cancer care. The hospital recently bought four digital units that list at $420,000 each, he says.
"It will take some use to pay that back, but if a hospital is willing to create a center of excellence it will have to take the loss," Poller says. "The profit will come from all the spinoff interventional studies, so it's a great concept--like cardiology centers of excellence." To fulfill that role as a leader, the hospital also likely will participate in research studies testing the effectiveness of the newer technology, he says.
Expecting that patients increasingly will demand the option, Poller says he will be shopping for two ultrasound machines at the RSNA to use in conjunction with mammography. Until the hospital decides to charge women out of pocket for the added service, that probably will be another money-losing proposition, he says.
"If you are committed to being a center of excellence, you may be committed to being a loss leader," Poller says.
Meanwhile, Pittsburgh's largest insurer, Highmark Blue Cross and Blue Shield, says it is fully committed to the technology and has raised its mammography rates twice in the past two years "to encourage radiologists to perform them," says Carey Vinson, M.D., Highmark's medical director of quality management. Paying as much as $86 for a procedure, Highmark reimburses more than Medicare, he says. Highmark's rates of women getting regular mammograms inched up to 75% in 2001 from 74% in 1998--an important measure considering it is one of 26 clinical indicators that the National Committee for Quality Assurance uses to grade health plans, he says.
Vinson says from his perspective, hospitals are moving toward digital mammography and Highmark "makes sure our reimbursement is good enough to maintain the most accurate equipment." As in other parts of the country, the problem in Western Pennsylvania is not necessarily the closing of mammography facilities, it's finding radiologists to read film, Vinson says.
A strong future
Despite everything, Garcia of Frost & Sullivan says in his opinion, mammography is not going anywhere any time soon. Technologies such as MRI and positron emission tomography, which, unlike X-ray, images more of the body's metabolism rather than its anatomy, can't compete with screening mammography on price, he says.
"X-ray has been around a very long time and it is a very well-established procedure," Garcia says. "The biggest problem is not that the technology is not good enough but that we don't have quality trained people reading those mammograms, and that's probably where you are going to see more effort directed--on the training and preparation of mammographers as well as the cost issue."
Though the number of his kind are dwindling, Dershaw of Memorial Sloan-Kettering Cancer Center says he fundamentally believes that mammography works and people like him will continue specializing in it.
"There is real science that has showed a real decrease in the breast cancer death rates, including a declining breast cancer death rate in the U.S., so all that is encouraging despite the bad economic news and bad legal news," Dershaw says. "What we are doing is valuable, and all of us involved have a good sense of satisfaction from that."
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