By Mark A. Gittleman, MD, Mary Nicholson, MD, and Suzanne Ruiz, RN, NP-C
Community Hospital Breast Health Navigator Suzanne Ruiz, RN, NP-C
Physicians today work in an environment affected by intricate government programs, constantly changing reimbursement policies, staffing challenges, documentation requirements, societal guidelines, and high patient expectations. Added to this is the challenge of understanding technological advances and balancing the cost of that technology with the desire to provide care that distinguishes their practice from competitors. Nowhere are these intersecting pressures felt more fully than in breast imaging centers. Aging Baby Boomers have increased patient volumes for screening, treatment, and monitoring services, while guidelines have been questioned, advocacy groups have been vocal, and financial costs have continued to mount. Over the coming decade, US cancer costs, including those for breast cancer, are expected to rise to $158 billion per year by 2020, according to projections by researchers at the US National Cancer Institute (NCI). While we are cognizant of and sensitive to healthcare economics, we remain focused on the important prognostic factors affecting breast cancer survival: The cancer’s unique gene profile and accurate staging at the time of diagnosis. These two pieces of information are essential in selecting the most appropriate therapy. However, it is the latter, ie, accurate breast cancer staging, that has come under intense scrutiny as the many stakeholders evaluate not just costs and benefits but an entirely new financial framework for care delivery. As these pressures escalate, they become the impetus for innovation. We believe one such innovation, the emerging technology of molecular breast imaging, may distinguish itself at the center of a shift in breast cancer care. The need for this shift, both clinically and financially, is best understood with a bit of historical review.
Over the last 20 years, annual mammography, self-breast exams, and annual healthcare provider breast examinations have become and remain the foundation for breast cancer screening and detection. During this time, open surgical breast biopsies, for cancer diagnosis, have been replaced with image-guided needle biopsies of suspicious lesions and calcifications, at a substantial savings in healthcare costs. Multiple studies, however, confirmed the poor sensitivity of diagnostic mammograms and ultrasounds for the identification of multifocal and/or contralateral breast cancers due to their smaller size, among other factors, thus these approaches were less than ideal for accurate clinical breast cancer staging. In parallel, other breast cancer imaging technologies were developed and called upon to serve this need. New MRI breast coils and kinetic analysis of contrast-enhanced breast MRI scans showed superior sensitivity for the detection of these smaller cancerous lesions, prompting a substantial rise in MRI use. Many centers in the United States scrambled to find funds for MRI devices at an average cost of almost $2 million. Other sites started asking patients to travel substantial distances to larger regional hospitals or university centers to obtain such scans. Then it became apparent that the increased sensitivity of this new technology came at not only the price of additional expense, and additional diagnostic time for the patient—often delaying surgery for weeks—but at the additional cost of unnecessary biopsies. Breast MRI guided biopsies for “suspicious” secondary lesions have now been shown to target tissues that prove benign in approximately 75% of procedures. This suggests the cost, time delay to surgery, and morbidity/anxiety inflicted on the women were unnecessary the majority of the time.
In 2011, 1.6 million breast biopsies were performed in the United States to find just less than 300,000 breast cancers. Over 1.3 million biopsies resulted in a benign diagnosis. This cost and the frustration felt by physicians repeatedly ordering or performing negative tests has driven a search for something better. Also in 2011, a sentinel paper by Berg et al was published in the American Journal of Radiology comparing molecular breast imaging, ie, high-resolution breast positron emission tomography (PET), to breast MRI for presurgical staging. The study found high-resolution breast PET, often called positron emission mammography (PEM), provided an increase in specificity at comparable levels of sensitivity for the identification of satellite cancerous lesions in women with newly diagnosed breast cancer. This means fewer false positives and, potentially, fewer unnecessary biopsies. PEM also demonstrated a 13% absolute increase, or 24% relative improvement, in the Positive Predictive Value (PPV) over MRI for identification of secondary lesions in this study. Approximately 240,000 new breast cancers are identified annually. Of those, approximately 25% (60,000) present with satellite lesions as seen on breast MRI. Assuming a 13% reduction in unnecessary biopsies with PEM, a reduction of 7,800 fewer biopsies is extrapolated. This would result in a potential savings of $23.4M – $39.0M to the 2011 figures. Add to this the fact that the device itself costs markedly less than a MRI system, does not require special room construction, and is small and portable, allowing it to be a shared resource between centers, and the opportunity for change is further illuminated.
We each introduced PEM into our practices over the last 6 years, in August 2007 and the other at the beginning of 2013, but found that we shared common objectives for the program, including:
• Improved clinical care
• High patient satisfaction
• Streamlined workflows
• Competitive differentiation in the local market
Improved Clinical Care
Beyond the advantages described above, the clinical data yielded from PEM studies have proven to be of particular value in our practices. In one, it has increased surgical planning confidence of earlier ductal carcinoma in situ (DCIS) recognition, facilitating breast conserving treatment recommendations where appropriate, and, when doing so, providing greater confidence in excising tissue with negative margins, which reduces the trauma and expense of additional interventions. In the other practice, PEM usage has avoided unnecessary biopsies in 20% of patients and has so far achieved 83% positive findings in lesions sampled under PEM guidance. Although our patient volumes are small over the first 6 months of use in this latter example, we are encouraged by the early results, and the ability to change the care plan favorably for multiple patients.
High Patient Satisfaction
We recognized that our patients were frequently struggling to comply with MRI studies and simply unable or unwilling to complete them in a significant number of cases. The ACRIN 6666 trial publication in 2010 substantiated our clinical concerns by reporting 15% of study patients were unable to complete the MRI exam. Reasons for this were similar to those expressed by the patients in our practice, which included claustrophobia, implants such as a pacemaker, body habitus, breast size, and occasionally renal insufficiency or gadolinium allergy. PEM can be used in all of these patients. Our combined experiences have shown that PEM imaging is extremely well tolerated, with no patients reporting claustrophobia given the system configuration, and many appreciating the reduced breast immobilization pressure, at less than half the compression force of mammography. The configuration allows physicians and technologists to be in close dialogue with patients, explaining and guiding the patient through the procedure, yielding a far greater sense of satisfaction with no clinical compromise.
High satisfaction also can be delivered by expediting the time to clinical answers. PEM offers the ability to biopsy additional findings during the same patient exam, using the same FDG dose and thus eliminating scheduling challenges, return visits, or additional time suffering uncertainty and anxiety.
Streamlined Workflows
PEM studies also deliver radiologist workflow benefits through the presentation of tomographic images rather than individual slices. Whereas an MRI provides exceptional spatial detail, it also provides up to 2,000 slices per breast exam. A PEM study generates 12 slices per series, with a typical study including four series, yielding about 50 images in total. From these 3D series, a smaller set of differential diagnoses are generated than by suspicious enhancement on MRI. Both modalities have analysis tools to assist the radiologist with the read.
Technologists are well suited to PEM. The workflow closely matches another long-standing procedure, x-ray mammography. Patient positioning and imaging views with PEM, such as CC and MLO, are quite similar, which has facilitated the cross training of our staff. This in turn has allowed us to utilize the labor pool more efficiently. The technologists also have reported high personal satisfaction in learning and using the system.
Since all advanced imaging is largely covered by prior authorization requirements, in our community hospital setting, we have taken on that procedural step as an added value. In doing so, we better control the delivery of our service targets, one of which is to provide a full clinical work-up, complete with advanced imaging (including biopsy results, if performed), before the post-imaging meeting with the patient. This physician-patient discussion will be well served by having the best diagnostic data to work from, as the PEM images depict areas of concern in a manner more readily apparent than in other modality studies.
Competitive Differentiation
In the community hospital setting, we were asked to evaluate opportunities for improving patient care that also could generate growth for the organization. We evaluated multiple technologies, including tomosynthesis, before selecting PEM. In our process, we wanted to identify technology that was well supported through clinical data, would provide a clear upside to patients, and would present a marketing opportunity that could benefit the hospital at large. In 2012, the excitement about tomosynthesis was building, but we had not yet seen the clinical evidence we felt we needed to make an investment of this scale. Questions about its benefit over full field digital mammography (FFDM) were unanswered, and its reimbursement position was not established. At the same time, we were particularly attracted to the marketing opportunity it presented as a new technology introduction. In PEM, we saw that all criteria were well met through a substantial base of well-designed studies, a clear upside in patient comfort and specificity, and the potential for strong marketing opportunities as it would be the first system in our area.
The advantages of increased market share are easily understood. Even small increases in procedure volume can add substantially to the bottom line if existing resources are utilized more completely. If satisfied, patients often continue their care on-site, and return in the future. In one review, the direct revenue from a new PEM program was dwarfed by the follow-on revenue these satisfied patients generated from other services such as surgeries. While we support cost-effective healthcare, and careful consideration of the overall cost to the system, we are also prepared to compete for market share. Business pressures are a reality and it’s often a zero sum game for providers.
Challenges
With the benefits of any new program, come the challenges. We have highlighted challenges with MRI as it is likely to be more familiar to readers, but PEM has its considerations as well. For example, PEM delivers an ionizing dose to the patient given that it requires a gamma emitting radiotracer. Dose requirements for the system have been minimized through continued research, but they remain most commonly at 5 mCi of 18F-FDG. Breast tissue and whole body doses are higher than those for mammography, and obviously for MRI as well, which has none. This should be considered even in the context of a patient with a known cancer diagnosis.
The investment model for PEM supports positive cash flow at modest patient volumes, but should be scrutinized along with key variable costs including radiologist reading, technologist time and training, and radiotracer expense. CMS reimbursement is approximately $1,000 per study, while private payors differ in their coverage amounts. The single most important variable in this analysis will be patient volumes, which can be estimated from mammography screening volumes and the number of new cancer diagnoses each year. Given the transportable nature of the equipment, some sites have introduced self-contained mobile routes in an effort to expand the impact of the technology.
Conclusion
The mounting pressures of the healthcare ecosystem will challenge most if not all participants over short time periods. Arising from those challenges will be a continual pattern of innovation that in the case of breast care has taken us from x-ray mammography to minimally invasive biopsy to breast MRI and now potentially on to molecular breast imaging. It is the nature of the pressures that shape the next generation of solutions, which in this case require not only clinical improvements, but increases in financial, operational, and patient satisfaction measures as well. While all imaging modalities will continue to play an important role in breast cancer care, our experience using positron emission mammography demonstrates how multiple objectives can be simultaneously achieved by new technologies in the hands of skilled clinicians.
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Mark Gittleman, MD, is past president of the American Society of Breast Surgeons and practices in Allentown, Pa. Mary Nicholson is Regional Director of Breast Imaging Services for the Community Healthcare System. Suzanne Ruiz, RN, NP-C, is Supervisor of the Women’s Diagnostic Center of the Community Hospital.
