Nationwide, in the offices and examination rooms of breast imaging facilities, physicians and administrators alike are attempting to decipher a difficult puzzle. Like the disassembly of a Russian Matryoshka nesting doll, a multi-tiered conundrum is facing radiologists who provide both screening and diagnostic services to women. The challenge boils down to: Can we afford universal-access breast imaging, and keep it state of the art?
In essence, the problem encompasses issues that appear to be diametrically opposed. These include not only efforts to provide ever higher-quality public health services under shrinking budgets and long-standing reimbursement caps, but also these services must be administered to increasing numbers of women in an aging population. Furthermore, there are decreasing numbers of residents-in-training who wish to enter the breast imaging field. Additionally, the federally mandated reimbursement fees are causing many hospitals to close their breast screening/imaging facilities, as the bottom line for such services continues to nose dive into the red. According to Lawrence Bassett, MD, Iris Cantor Professor of Breast Imaging, UCLA Medical Center, Los Angeles, “I can tell you that every year, the head of every section in our department is called into the chairman’s office to go over budgets. And every year they tell us how much money we lost in breast imaging. So basically, in every department, breast imaging is losing money, and in the university setting or with large hospitals, this is accepted; in other facilities they have to carry its weight via other departments.”
While breast care facilities are experiencing fiscal pressures to curtail services, the US government’s total outlay for screenings has risen. According to Health Care Financing Administration (HCFA) data, the combined screening/diagnostic cash payments (not including beneficiary coinsurance) that Medicare has reimbursed for per fiscal year show marked increases: in 1997, the amount was $270 million. For 1998, the estimated projections are $334 million, with $364 million for 1999. For this year, HCFA estimates point to $396 million, and for 2001, $432 million in reimbursements. These projections indicate an exploding patient population in need of screening as well as diagnostic services; these data additionally reflect HCFA’s decision to extend to patients annual screening as opposed to biannual mammograms. According to recent estimated data from the American Cancer Society (ACS), about 35 million women annually visit health care facilities to get mammograms, and furthermore, about 60% of women between 40 and 70 years of age report having had a mammogram within the past 2 years.
Nexus
All in all, the core of both the present conundrum as well as the regular day-to-day business of a breast imaging center is the screening and diagnostic mammogram. In 1992, the same year that the Mammography Quality Standards Act (MQSA) was instituted, Medicare began to offer mammography screenings every 2 years to its beneficiaries. In 1997, the benefit became annual. Federally mandated guidelines for both quality control as well as fees reimbursed by Medicare have created a formidable challenge for facilities. Presently, the reimbursement payment limit (as of 1999) is $66.22 for the global procedure, $21.19 for the professional component, and $45.03 for the technical component. And there has been little increase in these fees since they were instituted 8 years ago.
“In some states, there’s actually an upper limit on reimbursement on mammography screening, with good intentions, for they wanted to make it available to all women,” comments Bassett. “But the problem is they never increased the amount [in any substantive way]. Once that happens, getting it changed is very difficult. The process for screening is controlled by so many government regulations that to try to bring the fee up to what would actually cover costs is now very difficult because of all of these [well purposed] barriers that are set up. Strange how movements with good intentions at the beginning turn out to have bad results at the end.”
The criteria of the MQSA closely parallel those of the American College of Radiology (ACR) Quality Control Manual, and deal with issues related to all technical aspects of film-screen mammographic image production. For example, tracking of film speed and contrast on a daily basis affords the facility the opportunity to intercept significant problems that will degrade the film image on any given day. Other tests, such as film-screen contact, are less frequent and remind the facility to regularly assess the operational aspects of the entire film-screen cassette unit. According to James Brenner, MD, JD, director, Breast Imaging, Eisenberg Keefer Breast Center, St John’s Health Center, Santa Monica, Calif, “In a sense these are minimum [set] standards, but geared toward a reasonable compromise between ensuring quality and utilization of time and resources. Facilities may, at their election, go beyond such minimum standards, especially if a problem is suspected.” The minimum US requirement for radiologists to be licensed to read mammograms is 480 mammograms per year.
MQSA Standards and Reader Skill
In what way has MQSA affected the quality of mammogram readings? “In the first year following MQSA implementation, published reports indicated an improvement in film quality,” comments Brenner. “As I have often said, and written, ‘You can’t make good calls on bad films.’ On the other hand, satisfactory film quality does not ensure proper interpretation. A minimum number of mammographic interpretations per year is statutorily required by MQSA. The purpose is to provide a reasonable number of interpretations so that a compromise is struck between patients being afforded access to local facilities that may not have a high volume of studies, and assuring those patients that radiologists interpreting such studies perform enough examinations that proficiency may be assumed.”
He adds: “Our institution’s steady rise in interpretations is unlikely to be related to the passage of MQSA. In other areas, where some facilities may have closed because of a failure to met MQSA requirements, other facilities may see a rise in the number of studies. Most likely, all facilities are seeing a rise primarily because of the awareness of the efficacy of screening mammography and the public assurance that practicing facilities meet a minimum requirement.”
North of the border, the Canadian Association of Radiologists has a voluntary program in which the minimum requirement is 480 as well. According to Linda Warren Burhenne, MD, FRCPC, who has a practice in Vancouver, BC, “The leaders in screening in Canada got together a few years ago and looked at the question of volume, and with very little information because there was hardly any [available] internationally, came up with the idea that 3,000 mammograms a year might be good for screening programs. But this was just a suggestion, and as far as I know there were very few programs that followed this.” In the May issue of Radiology, a paper with Warren Burhenne as coauthor looked at relating mammography screener volume to the criteria of cancer detection and abnormal call rates. [1] “We found that with readers who read a minimum of 2,500 mammograms [annually], that that was the point at which abnormal call rates and cancer detection rates were best,” Warren says.
Another facet that could provide enhanced accuracy in readings is computer-aided detection (CAD). In the largest study ever produced on CAD efficacy, Warren Burhenne et al demonstrated that the use of CAD in 13 radiology centers around the United States had the potential to reduce the false negative rate by 77%. [2] As Warren comments, “Four-fifths of the false negatives could have potentially been avoided by the use of this CAD system.”
False positives also were looked at in the study. In CAD, regions of interest are marked on the film to direct the radiologist’s attention. In this study, there was one small mark per film or four marks per case. “What that meant was that the radiologists actually had to look at all the film, and discount the marks that they didn’t feel were relevant,” Warren explains. “I understand that the marks per film have been reduced drastically since then — it has been possible to reduce the number of marks per case by about half by refinement of the computer analysis techniques. As well, it is possible to apply high and standard probability mass markers to further reduce the number of marks on the films.”
Increasing Accuracy
Increasing both numbers and accuracy of film interpretations for breast cancer screening has produced encouraging statistics in earlier detection of the disease. According to recent ACS data, the proportionate change in the incidences of breast cancer in Caucasian women between 1983 and 1997 has shown marked increases. Discovery of ductal carcinoma in situ for women under the age of 50 jumped 146%; it jumped 308% in women more than 50 years old. These statistics help support the contention that cancer is being detected earlier, as well as reflect the increasing population of women that qualifies for screenings. Furthermore, for stage I cancers, the data show a 58% increase in detection for women younger than 50, and a more than 113% increase for those older than 50 years. Conversely, the number of stage II and stage III/IV cancers discovered has decreased. For stage II disease, there was a 12% drop for the former grouping (less than 50 years), and a near 11% decline in the latter (more than 50 years). In stage III/IV cancers, there was no change for those under the age of 50, but an 11% drop in incidences for those who were more than that age.
In the United States, facilities are looking at ways to improve efficiency while reducing costs. With reimbursement fee caps in place, many are hard pressed to provide even basic services, practitioners, and even equipment. In smaller facilities and private practices, Bassett says, “they tend not to buy a lot of new equipment for breast imaging, and they tend not to encourage their people to specialize in it.”
Reimbursement Issues
The present environment for recruiting and retaining breast mammographers is, according to Bassett, “not an attractive field to be in for a lot of reasons.” He mentions his own experience of training three women last year in breast imaging: “All three of them came here to train, and not one got a penny for reimbursement for their time,” he recalls. “They were fully trained, board-certified radiologists, who wanted to do breast imaging. But because we lose money every year, we couldn’t afford to pay them during their fellowships. In contrast, people in neuroradiology and MR imaging got a regular salary as fellows. So we had to find our people moonlighting jobs on weekends.” The two trainees for this year have it somewhat better, according to Bassett. “Through interceding with our chairman and telling about the hardships the women went through last year, [we were given] one salary to split between the two, so our department has at least provided meals, parking, insurance, and so on. But no salary. And I know there are a lot of places that don’t have any fellowships at all [in breast mammography].”
An in-process survey being conducted by Bassett and others is examining what interest (or lack thereof) there is in breast imaging for residents currently in training. “We don’t know how many fellowships are available, but we do know that when they finish, there are about three to four jobs per person,” comments Bassett, “which appears to point to the fact that many of them are going unfilled.” Bassett suspects that “they’re just not being trained. What we’re trying to find out from the residents via this ongoing survey is why.”
“Reimbursement issues discourage major commitments to developing breast imaging facilities,” Brenner adds. “Although hospitals may profit — in an economic sense — from the treatment of breast cancer (such as radiotherapy technical fees) and offer patients favorable outcomes, the imaging aspects of breast cancer are discouraging. Such unfavorable roles thus discourage potential talent from entering this field. Administrators of radiology facilities or departments who recognize the overall high profile of breast divisions and their important relationship to the hospital may be able to run some interference and compensate for such directed shortcomings.” But he additionally warns that “background grumbling by divisions with higher reimbursement procedures persist. Oddly enough, a proper administrative perspective recognizes that breast imagers perform studies with high legal exposure, high public profile, and essential health care facility PR consequences, thereby enabling other subspecialists to attend to other imaging fields.”
In Canada as well, fewer radiologists are entering the mammography field. “The young graduates from the programs are, by and large, not choosing breast imaging,” comments Warren, adding that those who do “are few and far between.” She feels that it may have less to do with finances, although an effort is made to explain that there are economic consequences. Warren adds that in Canada the reason may be more that mammography is viewed as “not quite as glamorous as MR, interventional, and other radiology areas that they see as the high point of their training.”
Hampering Technology Diffusion
One of the technologies most affected by the present fee environment is breast ultrasound. “Ultrasound is underdeveloped and underutilized in the mammography community in this country,” saysBruce Porter, MD, an ultrasound/MRI specialist and medical director with First Hill Diagnostic in Seattle. He adds that to change this will require a lot of “reeducation,” as well as less-expensive high-resolution equipment that breast centers can afford. “Because of reimbursement issues, meaning inadequate reimbursement for mammography and breast ultrasound, most breast centers cannot afford the high-end equipment that state-of-the-art breast ultrasound requires.” Porter believes that the reimbursement level inhibits the purchase of appropriate equipment, and is hindering the development of advanced breast ultrasound in the United States.
Brenner also raises the issue that continuing low reimbursements may have negative effects down the road. “While reimbursement is statutorily prescribed by MQSA for screening mammography (as well as some state laws), for diagnostic and other studies, these are subject to HCFA regulations,” he notes. “The ACR is currently revisiting the schedules for such studies, especially diagnostic mammography, which are considered to be significantly undervalued and under-reimbursed, given the time and resources that should be devoted to such examinations. Indeed, undervaluing such studies invites approaches that may not be as thorough as they should be. MRI reimbursement is variable, and ultrasound codes only for a single focus.”
MRI, Ultrasound Adjuncts
Breast MRI as we know it today began in Germany in the 1980s, and in 1990-1991 practitioners in the United States became aware of the potential of contrast-enhanced MRI for the diagnosis of breast cancer. Porter has developed his breast MRI expertise in more than 700 cases. “Ultrasound and MRI are powerful tools to significantly expand our ability to diagnose and stage breast cancers when used in conjunction with mammography,” he declares. “While radiographic mammography and physical breast examinations are the established best examinations to screen for cancers, MRI is a capable diagnostic tool, but it is an expensive and time-consuming effort. However, I should add that as adjuncts to mammography and breast examination, MRI with ultrasound can appropriately be considered the state of the art in advanced breast diagnosis.”
Porter further stresses that for virtually every breast MRI case he performs, high-frequency ultrasound is used as well. “Breast MRI is in many ways the most difficult examination in my MRI practice. It is very sensitive, but has a relatively lower specificity — meaning that nonmalignant areas can light up in the breast, visually simulating cancer, causing alarm and having the potential for false-positive diagnosis of possible cancer. I use high-frequency ultrasound on each patient to sort out these areas using established diagnostic ultrasound criteria with ultrasound-guided biopsy when appropriate.”
In contrast, ultrasound has been around a long time, having been first introduced to the medical world in the 1960s via Japan. The technology has become the second most widely used diagnostic imaging modality today. However, many physicians believe that breast ultrasound should be conducted by specialists. “It does not need to be,” Porter believes. “If we have better, cheaper equipment and a commitment by the imaging community to master breast ultrasound, we could have tremendous impact on breast cancer diagnosis, lowering cost and improving availability of advanced breast imaging even in rural areas. I see that happening long before breast MRI becomes routine.”
As an adjunct to mammography, ultrasound can assess worrisome but indeterminate mammographic findings to help determine whether they are likely benign or malignant. “With newer high-resolution equipment, one can characterize these problematic lesions much more precisely than before,” Porter explains. “And in some centers both here and in Europe, breast ultrasound is being used with analysis of specific ultrasound diagnostic criteria to help make decisions on whether to follow a lesion or to biopsy. It is also used to monitor benign-appearing lesions and to assess when to proceed with biopsies on lesions that demonstrate or develop malignant criteria. As such, it’s becoming an increasingly powerful adjunct to mammography, and I see this becoming more common in current clinical practice.”
Porter adds that breast ultrasound also helps shorten the decision-making process: “Instead of waiting 6 months to see on a mammogram if the lesion grew, you have a capable, complementary test that evaluates lesions from a completely different perspective. Ultrasound is also a wonderful and efficient means to biopsy suspicious areas. If ultrasound shows any malignant features, the recommendation would be to go ahead with biopsy. And you could do it now, instead of 6 months later, when the mass has had more time to grow. That’s a real benefit.”
MRI is employed as a problem-solving tool in difficult circumstances. For example, MRI is used when patients have:
- tumor-involved axillary lymph nodes, but normal mammograms and breast examinations.
“Although they represent only 0.3% of breast cancers, these women have required mastectomy in the past because the primary tumor couldn’t be found,” says Porter. “With breast MRI, we and others have been successful in locating the majority of these otherwise occult tumors — which are often only a centimeter in diameter. This allows the patient to have a breast-conserving lumpectomy instead of a mastectomy.” Porter adds that MRI used in conjunction with ultrasound helps also to cut down the number of biopsies needed in this and other situations.
- lobular breast cancers.
“Such cancers are more difficult to detect by mammography and physical examinations than the more common ductal cancers,” Porter says. “Also, they are more frequently multiple, and in about 10% of cases they are bilateral.” Lobular cancer is often well seen on MRI, even with negative or equivocal mammograms.
- neoadjuvant chemotherapy, where selected patients, not thought to have metastatic disease, but with large or locally advanced tumors, must be treated with chemotherapy prior to surgery.
“MRI does a really good job of accurately depicting the size of the cancer, as well as documenting the response of the tumor to therapy,” Porter points out.
- prior lumpectomies and radiation treatments resulting in postoperative scars may be very worrisome in appearance on mammography.
“MRI is very capable of differentiating tumor recurrence from scar when the patient is more than 9 to 12 months after therapy,” Porter notes, “because an old scar does not enhance when you inject the contrast material, but tumors do.”
Porter further adds that he is now seeing more women with breast implants, “who are getting to the age where there’s a concern for cancer, but mammography may be compromised by previous surgeries and the implants.” MRI and ultrasound are capable of differentiating between scar tissue, silicone granulomas, and cancer, with high diagnostic confidence.
While both MRI and ultrasound may be stellar adjuncts to mammography, reimbursement issues darken these two technologies’ futures as well. Echoing Brenner’s comments about ultrasound and MRI usage fees, Porter points out that reimbursement for breast ultrasound is low in comparison to the cost of the equipment, the degree of expertise required, the complexity of the examination, and the legal liability. Additionally, Porter says, “As a result, I think that some take a somewhat limited, superficial approach to breast ultrasound — looking only at the lump in question to decide if it is cystic or solid. Some are unable or unwilling to spend the additional time needed to do a detailed examination of the breast and adjacent nodes. That’s unfortunate, because ultrasound is an exceedingly powerful tool for breast diagnosis and staging. But it’s underutilized partly because it’s underreimbursed.” Porter again highlights that state-of-the-art ultrasound requires high-end equipment, and many free-standing breast imaging centers cannot afford it under the present reimbursement environment.
As for breast MRI, Porter comments that it “is marginally reimbursed, for the time it takes, as well as the examination’s complexity. It is certainly a very bad way to make a living in comparison to doing MRI of knees, heads, or spines. Because of the time it requires, the large numbers of films, and intrinsic complexity, you might break even, or lose money on them.” Furthermore, there are a number of unresolved challenges for breast MRI, says Porter. For one, MR techniques are not standardized, and as a result, results from different centers are difficult to compare. Also, there is a perception that breast MRI has a very high level of liability because of its problem with specificity. Porter adds that “I think for this reason patient selection and technique are very important. One should use a technique that looks at both the morphology and the biology of the lesion in question, meaning that a high-resolution and dynamic technique producing a series of images is advantageous to document both the anatomy and the pattern of contrast enhancement. Also, again it’s really helpful, even critical, to use ultrasound routinely, because it is a practical and efficient tool to help in sorting out enhancing fibroadenomas and other benign processes from cancer.”
Where Are We Now?
Presently, in part due to increasing usage of better technology adjuncts and diligent screening, the number of incidences of breast cancer in the United States per 1,000 women has climbed from 85.5 in 1980 to 110.4 in 1990, to 115.4 in 1997. ACS data indicate incidences have been relatively stable since 1987. The number of new invasive cases for this year has been estimated at 182,800, which compares favorably to the 1997 estimates of 180,200 breast cancer cases. Significantly, the mortality statistics show a declining trend — age-adjusted rate per 100,000 women has fallen from 26.4 in 1980 to 23.3 in 1997. ACS data show mortality has declined about 2% per year since 1990.
Federal monies to combat breast cancer correlate with these positive trends. The US Department of Health and Human Services reports that discretionary funding for breast cancer research, prevention, and treatment has increased from approximately $283 million in FY 1993 to about $623 million for FY 2000. As the Centers for Disease Control and Prevention (CDCP) has worked to increase access for women to mammography screening and follow-up services, the resources devoted to breast cancer services by the CDCP have increased from an estimated $43 million in FY 1993 to $93 million in FY 1999.
Indeed, as the number of women seeking screenings continues to rise, and with the death rates in decline, it is interesting to note that a recent study by Peter Salzmann, MD, et al offered evidence that screening women for breast cancer improved statistics for life expectancy, and supported the cost-effectiveness of screening younger women. “Screening women from 50 to 69 years of age improved life expectancy by 12 days at a cost of $704 per woman, resulting in a cost-effectiveness ratio of $21,400 per year of life saved,” the authors wrote. “Extending screening to include women 40 to 49 years of age improved life expectancy by 2.5 days at a cost of $676 per woman. The incremental cost-effectiveness of screening women 40 to 49 years of age was $105,000 per year of life saved…The cost-effectiveness of screening mammography in women 40 to 49 years of age is almost five times that in older women.[3]”
With breast facilities closing their doors because of income shortfalls, and the continued development of technologies that aid in better readings and diagnosis threatened by reimbursement fee caps, the progress made in the battle against breast cancer may be facing a clouded future. Robert Smith, PhD, Director, Cancer Screening, ACS, comments on the potential crisis looming in breast care due to low reimbursement fees: “We do not have good data on this problem, but we hear enough anecdotes to take it very seriously. There is concern that we’re seeing an erosion of our capacity to provide high-quality imaging, at a time when the size of the population at risk is increasing. Mammography is not as well respected among providers as it once was because it has low reimbursement, is low tech [relating to screening mammography], is hard work, and has the highest malpractice exposure. Unless we can improve upon these circumstances, we are likely to face a crisis in our ability to maintain the progress we’ve made in the last 2 decades.”
Peter Pesavento is associate editor of Decisions in Axis Imaging News.
References:
- Kan L, Olivotto IA, Warren Burhenne LJ, Sickles EA. Standardized abnormal interpretation and cancer detection ratios to assess reading volume and reader performance in a breast screening program. Radiology. 2000;215:563-567.
- Warren Burhenne LJ, Wood SA, D’Orsi CJ, et al. Potential contribution of computer-aided detection to the sensitivity of screening mammography. Radiology. 2000;215:554-562.
- Salzmann P, Kerlikowske K, Phillips K. Cost-effectiveness of extending screening mammography guidelines to include women 40 to 49 years of age. Ann Intern Med. 1997;127:955-965.
