Above: Ed Lipsit, M.D., president of Washington Radiology Associates, Washington, D.C.

Any successful relationship depends on a number of factors. Commitment and a shared sense of purpose are key. A good partner listens and supports the growth of the other partner.

The partners should share a clear vision for the future, and the vision should benefit both parties. Finally, a solid economic base doesn’t hurt.

This formula for success doesn’t change significantly when the relationship involves a radiology practice and a CAD provider. Ed Lipsit, M.D., president of Washington Radiology Associates (Washington, D.C.), says CAD is definitely a team approach between the radiology practice and the CAD provider. Mike Linver, M.D., director

of mammography for X-ray Associates of New Mexico PC (Albuquerque, N.M.), adds, "CAD software and the radiologist make a very nice marriage. The beauty of the combination is that it gives radiologists an opportunity to do a better job overall."

The literature clearly supports CAD’s use for breast cancer detection; R2 Technology, Inc.’s (Sunnyvale, Calif.) ImageChecker CAD system can increase breast cancer detection rates by up to 23.4 percent. Prior to the introduction of CAD, some centers attempted to improve their breast cancer detection rate with double readers. Patricia Sacks, M.D., medical director of Torrance Memorial Hospital’s Polak Breast Diagnostic Center (Los Angeles), explains, "It is possible to increase accuracy of diagnosis with two readers, but it is very hard to make ends meet. There are time constraints, and it is expensive and difficult. CAD is another way to do double reading." In fact, CAD may even yield greater gains. Recent studies show a 4 to 15 percent increase in breast cancer detection rates with double reading compared to up to a 23 percent increase with CAD.

 From left: California Lt. Governor Bustamante at Torrance, Calif. Press briefing on CAD; A radiologist Uses The ImageChecker system to review mammograms; A Screen capture from R2’s checkmate software;

Awareness of CAD is increasing; Medicare and many private payors now reimburse for CAD; and women are beginning to request CAD in conjunction with their mammograms. Consequently many radiology practices are beginning to consider implementing a breast CAD system. And, as with any long-term partnership, they are carefully weighing their options. An ideal CAD partner demonstrates its clinical utility and its commitment to successful implementation in the practice. This entails not only technical support but also assistance with reimbursement issues and product marketing. Final factors are a strong research and development program and continued commitment to the technology.

 The ImageChecker system marks particular regions associated with breast cancer for the radiologist’s review. Microcalcifications are marked by a triangle and masses are marked by an asterisk .

For a majority of institutions, the right CAD partner is R2. Lipsit explains why his practice opted for R2 over other CAD providers. "R2, in our opinion, is the acknowledged industry leader. They are constantly improving their algorithm. Their sales support is outstanding, and they take their responsibility very seriously." Still Washington Radiology Associates decided to evaluate all three vendors before purchasing a CAD system. R2 came out on top. Lipsit continues, "For our practice, investing in CAD meant outfitting five different sites with seven digitizers. The literature seemed to give R2 an edge over other systems, and we felt more comfortable with R2. CAD is a big investment of money, time and effort. It would have been devastating if it didn’t work out. The fact is ImageChecker has been very successful in our practice."

Gillain Newstead, M.D., associate professor of clinical radiology and clinical director of breast imaging at University of Chicago (Chicago), concurs with Lipsit’s assessment. Newstead completed a comparative study of ImageChecker and another breast CAD system. She says, "R2’s system was better in terms of lesion detection, and there were fewer false positive marks. I’m confident from my study that R2 is the preferred system out there. I also prefer R2’s display mode."

CAD’s Clinical Advantage
Linver explains, "Clearly the No. 1 and 2 reasons to use CAD are to find abnormal calcifications and spiculated masses at earlier stages." Radiologists who use R2’s ImageChecker find that it more than meets the challenge. In fact, after using ImageChecker many radiologists refuse to work without it. Gary Aragon, M.D., clinical breast specialist and medical director of Baptist St. Anthony Breast Center and High Plains Radiology (Amarillo, Tex.), previewed the R2 system at a beta site in the 1990s. At the time, he thought radiologists would not be interested in the technology. Now, the skeptic has become an R2 convert. He admits, "I really can’t live without it." In fact, in the last few years, Aragon has accepted positions at three different breast centers and insisted each purchase an ImageChecker system. And Washington Radiology Associates has adopted ImageChecker as the standard of care and refuses to do a mammogram unless a patient agrees to CAD.

Kathy Willison, R.T., director of clinical development for Elizabeth Wende Breast Center (Rochester, N.Y.), provides a look at the data. Elizabeth Wende Breast Center completed a prospective trial of 20,000 cases and found that ImageChecker increased the sensitivity over double reading by 8 percent. Moreover, a high percentage of the cancers in the study cohort were at early stages of the disease. Willison explains, "In our cohort, 87 percent of the cancers were stage 0 or stage 1 — which is well over the MQSA guideline of 50 percent. The other piece is how many cancers can be considered minimal—DCIS or less than 1 centimeter. MQSA guidelines put that number at 30 percent. In our cohort, 86 percent were minimal cancers."

While these numbers represent significant clinical gains, it is not difficult to implement the technology behind the gains. In fact, in practice, ImageChecker is actually quite simple. After mammograms are digitized, ImageChecker highlights areas of suspicion based on R2’s proprietary algorithm. Typically, the radiologist reads the mammogram and makes an initial interpretation, and then reviews the CAD image on an embedded CRT, a flat screen monitor or, if requested, on a paper printout, verifying that the highlighted areas were analyzed.

Radiologists using ImageChecker report feeling an added level of confidence in their interpretation. Sacks adds that CAD can serve as a great refocusing tool. The reality of screening mammography is that it is both boring and repetitive. Add a ringing telephone or a knock on the reading room door to the picture, and the stage is set for observational oversight, which may be a factor in a fair share of missed cancers. Lipsit explains, "Observational oversight is a problem for radiologists. If you can see it you can make a correct diagnosis. ImageChecker makes sure you’ve seen it."

Maintaining Productivity
Prior to implementing CAD, some radiologists may express concerns that the system may interrupt workflow and decrease productivity. Linver asks the $64,000 question. "Are we doing this to read quickly or are we doing it to find more cases of breast cancer earlier?"

Fortunately, with ImageChecker many practices report that they can integrate CAD and not only gain the clinical advantages but also maintain workflow and productivity. There is, of course, an initial learning curve with CAD. ImageChecker makes an average of two marks for every case and the radiologist needs to review the marks. Linver says, "You learn how to dismiss most marks pretty quickly." Mary Hayes, M.D., medical director of the Breast Center at Memorial Regional Hospital (Hollywood, Fla.), explains, "ImageChecker has not slowed our throughput at all. It does add to the radiologist’s viewing time, but the yield far outweighs the extra time. ImageChecker provides an increased sense of security for the radiologists and patients." However, potentially working up false positives may be a larger concern for some practices.

Lipsit lays these fears to rest. "The data indicate that the callback rate is not significantly elevated when CAD is introduced. In fact, one recent article put the callback rate at 8 percent regardless of whether or not CAD had been introduced." Sacks takes a different approach to callback math. "The real answer is yes the number of callbacks are higher, but you will also find more cancers. The number of false positives [with CAD] drops off after a few months. After three months, there is really no difference in terms of time and throughput with CAD."

R2 has continued to update its algorithm and feed more cases into the product’s database. The company has released several versions of its software. Linver notes, "Every new version that R2 releases is a little bit better than the last. There are fewer false marks and a higher percentage of cancers are marked." The algorithm is the heart of the ImageChecker system, and an accurate algorithm is essential for CAD to be effective. Moreover, an accurate algorithm inspires confidence and bolsters acceptance among radiologists. Willison says, ""Our radiologists are very confident in R2’s algorithm and know that R2 can mark cancers and do so very selectively."     The other dramatic workflow gain for some practices is the elimination of double reading. Double reading of screening mammography provides some of the same benefits as ImageChecker; it does help improve the breast cancer detection rate, but is expensive. Instead, ImageChecker can act as the second pair of eyes and frees up the double-reading radiologist for other work.

Support, Support, Support
CAD technology is in its infancy, and implementing it requires a certain amount of commitment and education on the radiologists’ part. A successful implementation can be aided by substantial support from the CAD vendor. As the acknowledged industry leader, R2 offers its customers unparalleled support in all areas: clinical improvements; design of flexible, scaleable solutions; marketing and reimbursement.

Washington Radiology Associates considered adding CAD systems to the practice for a few years before evaluating an ImageChecker system in 2001. Lipsit explains, "We were very impressed with the technology, but we waited. There were reimbursement issues. Finally, we were waiting for additional literature supporting CAD use. All of those factors came together in the summer of 2002 and we installed ImageChecker throughout our offices."

Concurrently equipping five offices with a new technology is a tall order, but R2 helped the practice find an ideal configuration for each site. The company recommended that Washington Radiology use one digitizer for up to 50 cases a day and outfitted two offices with two digitizers and three offices with one. The configuration recommended by R2 has worked smoothly since day one, says Lipsit.

An accurate configuration is just one step in the CAD process. Educating the local medical and payor communities and patients about the value of ImageChecker is also critical. Lipsit explains, "Prior to the introduction of CAD we mounted an educational effort. Anyone getting involved with CAD has to be willing to spend the time to educate radiologists, staff, referring doctors, patients and maybe even insurance companies." While this type of massive educational campaign may deter some practices, R2’s customers benefit from extensive vendor support. Lipsit says, "Educational support from the vendor is really critical."

Lipsit and his partners at Washington Radiology Associates are not the only beneficiaries of R2’s efforts. Willison of the Elizabeth Wende Breast Center adds, "R2 offered us excellent support. That support isn’t just here, but everywhere around the country. They have a whole team to talk with insurance companies. In fact, R2 went to our local Blue Cross Blue Shield when we were turned down for reimbursement, and the company reversed its decision."

The payoff for this massive educational campaign is acceptance of CAD among referring physicians, payors and patients. Linver and X-ray Associates of New Mexico seem to reside in an ideal CAD world. He claims, "We have a very high level of acceptance from our patients. Eighty percent of our patients request CAD. We also have arrangements with most third-party payors in our area."

CAD does not come without a price tag. And with mammography’s ultra-thin margins, some practices may assume that they cannot manage the initial outlay for an ImageChecker system. Think again, says Linver. "The economics of CAD are excellent in our practice." The practice benefits from its relationship with local payors and fee-for-service arrangements with its patients. Linver says R2 was instrumental in developing a marketing strategy and negotiating relationships with payors.

In other parts of the country, the reimbursement climate is not quite as rosy as it is in New Mexico. Last year, when Washington Radiology Associates implemented ImageChecker, many insurers were not reimbursing for CAD, so the practice set a reasonable price point for patients and asked them to pay for the service. Once Medicare approved reimbursement for CAD, however, it set a precedent for private payors to follow. Lipsit says, "I can tell you that CAD reimbursement is changing. One by one insurers are establishing a fee for CAD and covering it as an add-on procedure."

And while CAD is not transforming mammography into a tremendous profit center, it is paying for itself. Lipsit claims, "Reimbursement allows us to make a small profit on CAD." And R2 continues to lobby for reimbursement and invest in the development of CAD technology. Linver notes, "Obviously, the winners will be the patients, but a nice offshoot of this is that it makes good fiscal sense. ImageChecker is a way to supplement breast imaging income."

Gerald Kolb, president of Breast Health Management, Inc. (Bend, Ore.), agrees. The numbers are quite convincing. Before CAD was reimbursed, screening mammography reimbursement was approximately $65. Today Medicare reimburses about $82 for a screening mammograms and $19 for CAD. "What that does," explains Kolb, "is allows the mammography package to be reimbursed at a high enough rate to allow centers to at least break even."

While the figures translate into a profit for high-volume sites, how does CAD work in a lower-volume facility? According to Aragon, who oversees about 12,000 procedures a year, very well. In fact, ImageChecker has helped High Plains Radiology grow. Instead of having radiologists rotate through the small communities in the High Plains’ catchment area, Aragon’s vision is to centralize mammography for the Texas panhandle in Amarillo with dedicated breast specialists and CAD technology. The strategy is working. Referring physicians have recognized the value of ImageChecker and decided to outsource mammography to the practice, which has resulted in significant growth.

The Call for CAD Reimbursement

When breast CAD was first launched in 1998, early adopters proved that ImageChecker was economically viable without reimbursement. Many women understand the value of Image Checker and are willing to pay out of pocket for CAD. But the economic reality is irrefutable—reimbursement does facilitate the adoption and implementation of new technology.

 California Lt. Gov. Cruz M. Bustamante

The nation’s largest breast CAD provider, R2 Technology, Inc. (Sunnyvale, Calif.), recognizes the importance of reimbursement. In fact, when the company launched ImageChecker in 1998, it spearheaded a national effort to secure reimbursement. Gerald Kolb, president of Breast Health Management, Inc. (Bend, Ore.), says, "R2 was instrumental in getting the initial CAD reimbursement through Congress, and continues to take an active role in improving reimbursement. As a result, the company has created a reimbursement environment that’s very favorable for this technology."

Currently, Medicare and 85 percent of payors offer reimbursement for the use of ImageChecker. This policy, however, is not universal. A number of politicians, including Cruz M. Bustamante, lieutenant governor of California, and Charles Fuschillo, state senator in New York, have recognized the value of breast CAD and partnered with R2 on the reimbursement issue.

In New York, Fuschillo sponsored a bill, which New York Governor George Pataki signed into law, to commission a study on CAD’s value from the state health commission. After talking with New York radiologists and completing his own research, Fuschillo became a CAD advocate. He explains, "The issue of breast cancer is so important. After researching the technology, I learned that CAD can increase breast cancer detection rates by more than 20 percent. I felt it was important for the state to take a look at it and have it covered by insurance. This study will hopefully lead to [universal] insurance coverage in New York." (The efficacy study could re-define screening mammography to include CAD.)

On the other side of the country, Bustamante has held two press conferences to call for CAD coverage in California’s Medi-Cal program. Because Medi-Cal does not yet provide reimbursement for CAD, thousands of Californian women do not have access to the technology. Bustamante hopes to level the field. He says, "It is clear that women with private insurance and Medicare have greater access to new breast cancer detection technology than Californians on Medi-Cal. We must work to ensure that all women have access to life-saving technology. In California, there should be one standard of healthcare."

Vision for the Future
Clinical utility, better patient care, product support and sound economics are key factors to consider when investing in new technology. There are two more factors that need to be addressed. Is the vendor future-oriented? Can the technology be adapted and grow with your practice?

The answer with R2’s ImageChecker family of products is a resounding yes. Hayes admits, "Sometimes when you invest in a new technology, you worry that it will be outdated very soon. That is not the case with R2 and ImageChecker. This company is really moving forward."

One of the company’s latest innovations is the PeerView software package. The new software magnifies marked regions of interest, enabling radiologists to better understand the specific features detected by the algorithm. It is like shining a red spotlight on an area and then removing it so that the viewer can have a clear view of the spot in question.

There are also other developments in the works. Linver looks forward to some of the new advances from the company, including computer-aided-diagnosis to help radiologists decide if a lesion is benign or malignant and a prototypical library of images that shows cases similar to the one in question. And Sacks is eagerly waiting for a future tool from R2 that will allow radiologists to compare asymmetries and abnormalities from one year to the next. "That will be a tremendous help with false positives," she asserts. But R2’s research and development focus is not limited solely to the clinical realm.

Washington Radiology Associates incorporates fives sites, so interconnectivity, communication and storage represent significant challenges. Lipsit anticipates partnering with R2 in efforts to link the practice’s sites and to digitally store mammograms. Both advances would provide radiologists with easier access to prior mammograms, which is critical for accurate diagnosis. R2’s solution for connectivity and distributed viewing is its new OmniCAD platform, which will allow network connectivity to RIS and archiving capabilities to PACS and will provide anytime, anywhere CAD information.

Of course, one of the big words in mammography right now is digital. And digital is a natural fit for CAD. Digital mammography actually eliminates one step in the CAD process–digitizing mammograms. Elizabeth Wende Breast Center just started implementing digital mammography and fully expects to link digital mammograms to R2 products. Once again, the bridge between digital mammography and CAD will be R2’s new ImageCheckerDM with OmniCAD technology. OmniCAD, is designed as an open-architecture, universal CAD platform that allows the system to accept either film or digital images.

Within the next few years, the OmniCAD platform will address other imaging modalities and applications. R2 is working on ImageChecker CT to provide CAD for CT images of the lung. And the company is evaluating the ability to apply computer-aided detection to virtual colonoscopy and liver metastasis detection.

Shopping for CAD
A wise practice will do a bit of comparison-shopping before selecting a CAD partner. Willison recommends that radiologists considering CAD look at various vendors side by side. The literature does give R2 an edge in terms of better lesion detection and fewer false positives right now, but radiologists can undertake their own independent investigation of the various CAD products and see how many marks each system makes per case. More marks and more false positives could make for a rough implementation in terms of workflow and more post-screening workups.

There is no substitute for direct experience, and radiologists who use ImageChecker can provide valuable insight for new buyers. Torrance Memorial Hospital’s Polak Breast Diagnostic Center shows potential buyers its ImageChecker systems and shares information about breast CAD with practices considering the technology. Some key questions for buyers to consider include:

  • What will the system do in terms of breast disease detection?
  • Will it increase callbacks? How has the callback pattern of other practices been affected?
  • How will breast CAD pay for itself?

Clinical use is just one aspect of CAD. The company’s vision and focus is critical. Willison opines, "I feel very strongly that R2 went after the science of the technology before the marketing piece." And while marketing should not overshadow science, it is an important part of CAD implementation. Sacks explains, "ImageChecker is a fantastic marketing tool." Patients are becoming more aware of CAD, and even beginning to request it. An ideal CAD partner supports these efforts. In fact, the support factor can be a key differentiator. Lipsit notes, "R2 is a very impressive company. They’re very innovative. I love talking with and working with them. It helps me keep on top of things."

Willison concludes, "Now that we have reimbursement, it’s hard not to use CAD. It is easier to go with a cheaper CAD product, but at what cost? What happens if the system doesn’t work as well as ImageChecker." In fact, Willison has responded to a number of calls from other CAD vendors. Her standard reply is that the clinic is happy to evaluate other systems and place them next to an ImageChecker. "So far," she says, "no one has taken us up on the offer."

Beyond the Mark

Marking suspicious areas on a mammogram is a key part of the CAD in practice. If, however, the radiologist cannot determine why an area was marked so he can either dismiss the mark or work it up, workflow can be dramatically impacted. Patricia Sacks, M.D., medical director of Torrance Memorial Hospital’s Polak Breast Diagnostic Center (Los Angeles), says, "If a CAD system marks a lot of areas that turn out to be nothing then we are subjecting patients to more radiation and a lot of emotional misery." This scenario, however, is not the case with R2 Technology, Inc.’s (Sunnyvale, Calif.) ImageChecker CAD system. Sites that have implemented ImageChecker have found that it makes very few marks that are difficult and time-consuming to decipher. Kathy Willison, R.T., director of clinical development for Elizabeth Wende Breast Center (Rochester, N.Y.), explains, "Radiologists can get lost in the noise of the marks if there are too many. We have not run into that with ImageChecker. Overall, radiologists have been able to distinguish most of the marks as benign."

ImageChecker does place an average of just more than two marks per normal case, which means some cases pass through without any marks. Radiologists using ImageChecker report that the marks are quite intuitive and can be easily dismissed or referred for further evaluation. For example, ImageChecker does occasionally mark calcified blood vessels and presumed masses, which warrant review by the radiologist. Most of these marks, however, can be dismissed within seconds. Gillain Newstead, M.D., associate professor of clinical radiology and clinical director of breast imaging at University of Chicago (Chicago) says most radiologists handle false positive marks very easily.

Within a few short months of implementing ImageChecker, most sites report either an unchanged callback rate or a slight increase in callbacks that correlates to the detection of additional cancers detected. Mary Hayes, M.D., medical director of the Breast Center at Memorial Regional Hospital (Hollywood, Fla.), says the hospital has not seen any increase in the number of false positive biopsies since it began using ImageChecker. Gary Aragon, M.D., clinical breast specialist and medical director of Baptist St. Anthony Breast Center (Amarillo, Tex.), agrees, and says ImageChecker has not affected his false positive rate.