R James Brenner, MD, JD, is medical director of breast imaging services at the Eisenberg Keefer Breast Center, St Johns Health Center, Santa Monica, Calif.

Few experts in mammography can match credentials with R. James Brenner, MD, JD, FACR, FCIM. Brenner is medical director of breast imaging services at the Eisenberg Keefer Breast Center in the John Wayne Cancer Institute at St Johns Health Center in Santa Monica, Calif. He is also clinical professor of radiology at the Geffen School of Medicine at UCLA. The holder of a law degree as well as a medical degree, Brenner is former chairman of the Medical Legal Committee of the American College of Radiology (ACR). He also has served as chairman of the ACR’s Task Force on Mammography Practice. He is a current member of the Oversight Committee for the National ACRIN Trial on Digital Mammography. He is also the president-elect of the Society of Breast Imaging. He has written hundreds of articles and more than two dozen book chapters, and is a frequent lecturer in the United States and internationally. He has served as a consultant to several companies, including those developing CAD (computer-assisted detection and diagnosis) systems for mammography.

Once a year Brenner conducts a 3-day seminar on breast imaging and its medical and legal aspects. He also writes on these subjects. He says he uses his law degree “as a teaching tool to place into context the consequences of what we do in clinical practice.” The law degree, he says, has no bearing on whether he appears as an expert witness at trial. “I do expert witness testimony,” he says, “but certainly less so than many individuals who don’t have law degrees.”

For this story, Brenner was asked to respond to 10 questions in a Q&A format.

IMAGING ECONOMICS: Mammography has taken some serious shots over the last few years. As a long-time mammographer, please weigh in on the value of the study.

BRENNER: When you look at the criteria for instituting a successful cancer screening program—whether it comes from medical economists like Dr David Eddy or social planners responsible for national screening programs in Europe—properly performed mammography pretty much fulfills all of them. PAP smears for cervical cancer may be another. Just witness the controversies regarding lung cancer screening with CT, or colon cancer screening with a variety of approaches. Then you can appreciate the applicability of mammography. Cancer is a serious disease. When detected early, there are successful treatments. There is a high prevalence of detectable disease. Mammography has low morbidity, and it’s affordable and accessible. This analysis has been subject to criticism, but at the end of the day, performed correctly, mammography survives such challenges.

IMAGING ECONOMICS: The MQSA (Mammography Quality Standards Act) reauthorization is imminent. What changes can we expect?

BRENNER: The Reauthorization Act went through pretty quietly at the end of the last session, with only small detail changes, mostly affecting the addition of industry representatives to the Advisory Committee and some fixing of temporary certification. What is just as important to notice is that the Omnibus Reconciliation Act called for two commissioned studies, one by the Government Accountability Office to look at problems with mammography access. The other, due out this May, is by the Institute of Medicine (IOM) looking at various quality improvement parameters and how regulatory methods might be improved to both relieve certain burdens and accentuate positive changes. They will look at how the data collected might be used to improve quality, including issues of personnel and access. This I presume is in response to the congressional hearing regarding the Reauthorization Act.

IMAGING ECONOMICS: Should the minimum number of annual mammograms read be raised? If so, how many radiologists would be disqualified from reading? What impact could this have on access?

BRENNER: In British Columbia, the number of required mammograms to be participating in the program is higher, with data to support this position. On the other hand, work from San Francisco suggests what many personal experiences validate, that numbers of themselves do not necessarily imply improved performance and outcomes. On the one hand, radiology practices complain about not wanting to surrender any type of imaging, and on the other hand they find mammography a burden. My own opinion is that the current number should be raised, but of course the price—and it is an important price—is access. There are ways of dealing with this, and digital mammography with teleradiology transmission capabilities may be included in the long-term outlook. The concept of centers of excellence—a real political hot potato—also weighs into the equation. We do not have a national approach toward health care, and the issues involved with the quasi-public health aspects of screening mammography expose this dilemma. Implementation of changes will require accounting for downstream consequences.

IMAGING ECONOMICS: What is the status of reimbursement? Where does it stand and where should it be? Is anyone working on bringing reimbursement in line with cost?

BRENNER: Reimbursement got a small boost when diagnostic mammography within an institutional setting was taken out of the APPS (Ambulatory Prospective Payment System) schedule and put into the Medicare Fee Schedule. But diagnostic mammography is still a problem in reimbursement. There is an inherent fallacy in the reimbursement schedules—that increased professional service reimbursement is rationally tied to increased technical reimbursement. In other words, the more sophisticated the technology, the higher the professional fee in part based on the factors used to calculate RVUs. This is true across all medical specialties. Sometimes the formula works, sometimes not. Evaluating a complex mammography problem often takes as much work as evaluating a complex CT or MRI problem. But look at the difference in reimbursement. Screening can be cost-effective, but diagnostic mammography is usually under-reimbursed at present values. This has been studied and documented. It is no wonder that radiologists are tempted to apply higher reimbursed studies to problems that are better assessed with careful mammographic evaluation.

IMAGING ECONOMICS: What about legal exposure? What do you think of the suggestion that radiology should start educating consumers about the limitations of mammography, beginning with a disclaimer that mammography does not catch all cancers?

BRENNER: Delay in diagnosis of breast cancer is the most common reason that physicians are sued for malpractice, and the radiologist is the most commonly named defendant. It is no longer news that mammography has been construed to have been oversold. On the one hand, mammography has had a tremendous impact. On the other, like any test—and especially any screening test—it is not a perfect tool. In addition, the variability of interpretation is not trivial, and this has been the subject of provocative news stories. There is a large component of judgment involved in mammographic interpretation, which, when incorrect, invites redress. Disclaimers that mammography does not catch all breast cancers is medically rhetorical and legally precatory—meaning that it bears little impact on whether one properly interpreted a study. Women pay for the examination with the expectation of a reasonable interpretation. If they are looking for perfection—and I think most people recognize limitations of any medical endeavor—that’s not what they’re buying. At the same time, we cannot hide behind the limits of mammography or any other radiologic study to excuse substandard care.

IMAGING ECONOMICS: What impact are all of these troubles having on residencies? What steps should be taken to make the subspecialty more attractive to residents?

BRENNER: I had this discussion with one of the leaders of the American Association of Health Plans a few years ago. I said, ‘Suppose I tried to recruit you for a job that had low payment, high liability, was very difficult, and was not a road to success among your peers. Would you take it?’ He smiled, of course. But we in the imaging community are not smiling. All of these factors need to be addressed, some externally, some internally. Externally, certain aspects of tort reform and reimbursement would create a more incentivizing environment. Internally, I hear group leaders complaining that they cannot recruit talented mammographers. When challenged, they confess that they are not, within their group, always ready to make the kinds of accommodations for mammographers that they might afford other types of subspecialties.

IMAGING ECONOMICS: If the question comes down to whether it is the responsibility of individual radiology practices to subsidize access to quality mammography, what is your answer? If so, what steps can individual practices take to ensure the future of the subspecialty?

BRENNER: Phrases like “loss leader” and “subsidize” are more easily spoken by those not having to ante up. Some institutions, for example in Chicago, have recognized the benefit to the health center as well as the revenues from treating early breast cancer—such as surgical and radiation therapy technical fees—and have elected to support the breast imaging divisions. Most have not and assume that radiology departments will consider this part of the overall picture of fulfilling service contracts. Many of the payors have the same feeling; namely, better reimbursement for cross-sectional imaging and lesser reimbursement for mammography—it all evens out. But it doesn’t all even out, especially if you operate a freestanding breast center. Departments and groups need to recognize the overall picture in the same way administrators and clinicians do. Conventional breast imaging simply will not generate the same revenues as other areas under current reimbursement schedules, but have a high public profile, although the consequent image-guided biopsies and higher tech subsequent staging studies do account for the kinds of finances viewed in a more favorable light. Groups need to provide sufficient incentives concerning working conditions to bring in expertise in breast imaging from an increasingly smaller pool of talent. Those who avoid this directive, do so at their own potential peril. By the time referring physicians and administrators begin to complain, the shortsighted damage has been done.

IMAGING ECONOMICS: The Institute of Medicine has recommended that non-MD readers be trained. What are your thoughts on this?

BRENNER: Prescreen readers, like any double reading or computer-assisted readers, have the potential to aid in detection, but the impact is variable, as has been shown in many studies. It is not so much that non-MD readers cannot be trained, but there are many formidable issues that need be addressed. First, if we as radiologists, familiar with aspects of both radiographic technique and signs of breast cancer, are not uniformly doing as good a job as we might, how will non-MDs fare? Second, would you send your loved one to a non-MD to read the mammogram? As a corollary to the second point, how well would a non-MD survive legal challenge for an equivocal finding under the severe circumstances already faced by MDs? I appreciate the IOM’s thinking, but we return to a common theme of this discussion: Quick fixes, without thinking through the downstream systematic implementation conditions of practice, sometimes invite more problems than they solve.

IMAGING ECONOMICS: Please address the shortcomings of the modality, and what can be done in the short term to maximize the effectiveness of the technology. What advances might we see in the long term?

BRENNER: Current mammographic capabilities are excellent for soft tissue discrimination, but they have their limitations. Digital capabilities solve some of the problems. The potential for tomosynthesis would be the first quantum jump in mammographic imaging since the early 60s, but there are enormous technical and logistic problems involved with regular commercial implementation. I believe the rate-limiting step in the current environment is not the technology, but who is interpreting the images. I think there is as much if not a greater problem with the ability to interpret and properly evaluate mammographic abnormalities as there is in the methods of acquiring such images. I think better training and more experience would assist in these efforts. You can have the greatest technology in the world, but if you have people who are not sufficiently trained and experienced to interpret that information, then the technology is not the driving force in assessing outcomes.

IMAGING ECONOMICS: What about digital mammography? What are the ACRIN (American College of Radiology Imaging Network) trials expected to reveal? How soon will techniques such as tomosynthesis be available?

BRENNER: I have the pleasure of serving on the oversight committee for the DMIST trial, which is a tribute to ACRIN that the trial is sufficient to create a special additional such committee. I cannot of course discuss the results that are likely to be published over the next 15 months, but the committee and the trial investigators have taken their work very seriously.

I think tomosynthesis is feasible and the feasibility has been shown and the results are dramatic and encouraging. But the actual implementation on a regular commercial and credible basis has a lot of bugs to work out. For instance, how the images are going to be viewed. In other words, tomosynthesis is generally viewed only in one projection. Most of the information can in fact be obtained from that one projection, but there are studies showing that you really need two projections to optimally survey the breast. That’s going to be unfeasible, probably, for current approaches toward tomosynthesis. Storage is going to be a huge issue, and comparison of different studies is going to be an issue. When you consider the amount of information that has to be stored and displayed, and you’re comparing—as some institutions currently do with mammography—two or three different studies, then both the presentation of the information and the review of the information have logistical problems. They can be solved, but it’s not trivial.

IMAGING ECONOMICS: What progress is being made in understanding the disease itself? Can we expect to see progress in understanding why some cancers are more aggressive than others, particularly in the case of ductal carcinoma in situ (DCIS)? Is radiology playing a role in this?

BRENNER: Taking a lead from the NIH’s concept of personal medicine, the real future in understanding this disease will be led by proteomic and genomic investigations. These approaches will not only help identify who is at risk for the disease, but what may be the most appropriate therapies. They may also form the basis for the elusive search for a blood screening test or vaccine. Currently, we are inching away from the one-model-fits-all: namely, screen everyone at about the same intervals; treat most people the same. We may define populations that need more or less aggressive screening. We have already identified populations with genetic profiles that are more responsive to certain therapies. The identification, for example, of a common genetic focus for atypical ductal hyperplasia and some forms of non-comedo DCIS is another example of teasing out the details from the big picture. What triggers invasion is the fascinating and critical basis for many investigations. The extent to which smart imaging probes that are in the purview of radiology will assist in such research is anyone’s guess. The only thing that exceeds our current vast knowledge of this disease is our ignorance of all its ramifications.

George Wiley is a contributing writer for Decisions in Axis Imaging News.