R2 Technology believes it can put a shine on the tarnished gold standard for breast cancer screening.
The company's product, a computerized second reading of standard mammograms, had been held up by a lack of reimbursement, as payers-including Medicare-have been unwilling to pay for a double check of film. In January, Congress removed that obstacle by including in a final budget bill a $15 payment for computer-assisted "second reads."
In the past two years, approximately 30 million U.S. women age 40 and older obligingly marched to one of 15,000 mammogram facilities across the U.S. for a widely recommended breast cancer screening, even though the technology promised less-than-perfect results. The films for about 1 million of those women were fed through R2's software as a supplement to the screening.
Although annual mammograms for that age group have decreased breast cancer deaths by as much as 40%, experts acknowledge that screening mammograms fail to detect about 15% of all cancers. Some studies show about 50% of those missed cancers are attributable to observational oversights.
But using software first developed for the military to pick out potential missile targets on satellite images, the privately held Los Altos, Calif.-based R2 says it can boost a radiologist's accuracy in reading a mammogram by 20%. An independent study released at last year's annual meeting of the Radiological Society of North America supports that claim.
Two years ago, the federal Food and Drug Administration approved ImageChecker, R2's computer-aided detection system for mammography-the only CAD system commercially available. Prices for the software range from $165,000 to $200,000. The company hopes to eventually go public.
R2 Technology President and Chief Executive Officer Michael Klein couldn't ask for much more, although it's a lousy time to be asking for anything regarding mammograms. With standard mammography in crisis, even the $15 reimbursement needed to pay for a second read using R2's technology seemed like too much to expect.
"We're just a pimple on the elephant," Klein said several weeks before the budget bill that included the CAD reimbursement was approved. Even with the change in Medicare reimbursement, it remains to be seen whether other payers will follow suit.
Robert Schmidt, M.D., associate professor of radiology at New York University Medical Center, worked with the developers of the technology at the University of Chicago in the late 1980s and early 1990s, although he doesn't have access to an ImageChecker now. He says CAD "works pretty good," but money is the bigger issue. At a time when mammography clinics with months-long waiting periods are shutting their doors because of below-cost reimbursements, the last thing anyone wants to do is raise the stakes with new technologies, he says.
"There are multiple new technologies that keep proposing instrumentation for us, but we can't afford to buy them," Schmidt says. "Mammography is a big money-loser. If you can't get reimbursement (for the exam), realistically nobody will invest any money in this."
The conflict between technology and the cost of paying for it seems to be pitting radiologists against each other. At a press conference one morning at the RSNA meeting, two independent researchers sang the praises of two new mammography technologies: CAD and digital mammography, a filmless device. The next morning a panel of four doctors bemoaned below-cost reimbursement rates that threatened to bankrupt the system.
Labeling the situation "an impending crisis," the panel said Medicare pays $67 for a screening mammogram and about $80 for a more-intensive diagnostic mammogram, but those rates represent only about half the costs of the tests. Mammography centers throughout the country are operating at a loss, they said, and the larger the center, the larger the loss. Waiting times are increasing as a result.
One of the panelists, Gillian Newstead, M.D., said red ink shut down one of two centers operated by New York University Medical Center, where she is director of breast imaging. Newstead said the closed Madison Avenue center was operating at capacity-about 50 patients per day.
"The more patients we saw, the more money we lost," she said after the RSNA event.
Now the one remaining center has a 41/2-month wait for patients seeking a routine screening, she added.
So Newstead and the other panelists showed a lukewarm reaction to questions raised about CAD and digital mammography during the RSNA press conference. Newstead said later that if the panelists showed a lack of enthusiasm, it wasn't for the technology.
"Both show promise, but what concerns me mostly is that we will have limited access unless we can remedy the economic situation that breast imaging is in," she said.
Several private practices do have the new technology in Manhattan, she added, but those practices have dropped their managed-care contracts and charge patients directly for the mammograms. Some are reportedly charging as much as $50 for the second read, Schmidt said.
"Which means (the new technology) won't be widely available-only to those who can afford it," Newstead said.
That was the experience of Timothy Freer, M.D., who led an independent study of CAD at the Women's Diagnostic and Breast Health Center in Plano, Texas, where he is director. To cover the costs of the second read with R2's ImageChecker, Freer asked each woman to pay $15, which they willingly did, he says.
Screening a total of 12,860 women, 49 unsuspected cancers were detected-eight by CAD alone and all of them in the early stages when the tumors are most readily treatable. That translates to a 20% improvement rate, he says.
"It won't replace a doctor, but it can augment and it has three things a radiologist doesn't have," Freer said. "It is infinitely patient, it is unerringly methodical, and it's rarely distracted-it doesn't get telephone calls."
Mammography's spell check
R2 Technology describes the Image- Checker as a kind of spell check. After the mammogram is shot on film, it is scanned through a processing unit and digitally analyzed with a software program that has been fed data from thousands of other mammograms. The program throws markers onto the image, indicating places that deserve a second look.
The checker is better at alerting radiologists to calcifications than masses, Klein says, but because data is constantly fed into the software, it learns from its mistakes.
R2 also is developing checkers for chest X-rays and low-dose computed-tomography scans for detecting early-stage lung cancer. The company has signed a one-year marketing agreement with Milwaukee-based GE Medical Systems to combine R2's CAD technology with GE's filmless digital mammography system as soon as the technology combination is approved by the FDA.
Despite the scientific successes, R2 has sold just 150 ImageCheckers and screened more than 1 million women to date. "This is our biggest frustration," Klein says. "Women I talk to-when they know about this product-will ask where they can get their mammogram read twice."
Klein says revenue has doubled every year even without payers willing to reimburse for it, but he guesses income may triple or quadruple when payment is no longer an issue. On April 1, HCFA will begin reimbursing $15 for each Medicare patient who undergoes the second read. R2 hopes that Medicare's stamp of approval will carry weight with private insurers.
Reimbursement aside, Freer says he wants to stick with the ImageChecker. "I'm no longer comfortable reading mammograms without it because I know I'm 20% better with it."