A study published in the New England Journal of Medicine sparked controversy and criticism when it claimed that many men received unnecessary radiation therapy for their prostate cancer due to self-referral.
A linear accelerator used
to administer IMRT.
The In-Office Ancillary Services Exception (IOASE) to the Stark law has been the subject of debate in recent months.
The exception is the state that allows group medical practices to offer ancillary services such as imaging, radiation therapy, and physical therapy. Proponents of these arrangements argue that integration of such services improves communication between specialists, offers better quality control of ancillary services, and enhances data collection, all of which can improve patient care while maximizing economic efficiencies. Others contend that group practice integration creates conflicts of interest and selfreferral issues which ultimately lead to increased utilization of services.
The IOASE was targeted for elimination in President Obama’s 2014 draft budget. Such a change would affect any non-hospitalbased group practice that offers in-house ancillary services— including intensity-modulated radiation therapy (IMRT) services to patients with prostate cancer.
In October, a study published in the New England Journal of Medicine (2013; 369:1629-1637) reported that there had been a significant increase, from 2005 through 2010, in the use of relatively costly IMRT for patients with newly diagnosed, nonmetastatic prostate cancer among urology groups that had an ownership interest in the technology; at the same time, the study found, the use of less expensive brachytherapy and hormone therapy had dropped in those practices.
Titled “Urologists’ Use of Intensity-Modulated Radiation Therapy for Prostate Cancer,” the study compared urologists’ use of IMRT before and after their practices acquired the technology against the patterns of community and academiccenter urologists who don’t “self-refer.” It was authored by Jean M. Mitchell, PhD, an economist and professor at the McCourt School of Public Policy at Georgetown University.
In a press release, the chairman of the American Society for Radiation Oncology (ASTRO), Colleen AF Lawton, MD, FASTRO, argued that “the study provides clear, indisputable evidence that many men are receiving unnecessary radiation therapy for their prostate cancer due to self-referral.”
Though the study was funded by ASTRO, Mitchell told the organization at the outset that she was going to publish her results regardless of outcome, and she was not paid to conduct the research, the investigator said in a press conference held by ASTRO the day the findings were released. In a separate recent statement, members of the panel that writes NCCN guidelines for clinical practice in prostate cancer expressed concern about Mitchell’s findings and urged adherence to the guidelines.
“Prostate cancer treatment recommendations should be based on the best available clinical evidence and not influenced by business or personal interests of the care provider,” the 30 panelists wrote.
“The ASTRO study provides no compelling reason to legislatively prohibit integrated practices from providing radiation and other treatment modalities to their patients,” LUGPA asserted in its written rebuttal statement. “Such a policy would only undermine competition in the market place, drive up costs as many patients resort to care in the more expensive hospital setting, and harm patient access to specialized, integrated care.”
In addition, LUGPA suggested that ASTRO’s motivation to support repeal of the IOASE is its interest in recapturing lost market share by eliminating competition in the use of IMRT, a charge Lawton denied during the press conference.
Here, Deepak Kapoor, MD, immediate past president of LUGPA, and Judd W. Moul, MD, offer an analysis of the methodology Mitchell used to conduct her study:In an era of constrained medical resources, it is essential that every dollar spent is put to effective use. As such, thoughtful analyses of factors that may influence clinical decision-making are both timely and important. Recently, urologists have come under particular criticism as more practices develop integrated, comprehensive models of care. Allegations of overutilization of services have been made by specialty organizations with historical virtual monopolies on the delivery of certain healthcare services—groups whose legislative priority1 is to regain lost market share via legislative changes to the in-office ancillary services exception (IOASE).
Deepak A. Kapoor, MD
Chairman and CEO, Integrated Medical Professionals, PLLC President, Large Urology Group Practice Association.
Judd W. Moul, MD, FACS
James H. Semans, MD Professor of Surgery Director, Duke Prostate Center Division of Urologic Surgery
ASTRO points to a recent article in the New England Journal of Medicine on IMRT use by urologists.2 This study, fully paid for by ASTRO, purports that urologists with ownership of radiation use IMRT inappropriately when compared to their peers. Unfortunately, their own study doesn’t support this allegation: the author, Jean Mitchell, PhD, found that less than one-third (32.3%) of newly diagnosed prostate cancer patients who sought treatment from an integrated urology group received IMRT in 2005-2010. This figure is fully in line with data that predate the development of integrated groups, when radiation therapy was only available in hospitals and free-standing radiation centers. In a study of 35,000 Medicare patients newly diagnosed with prostate cancer from 2002-05, 31% of men chose IMRT as their primary treatment option.3 An even larger historical study of over 85,000 Medicare beneficiaries diagnosed with prostate cancer between 1992 and 2002 showed that 31.7% chose external beam radiation treatment.4
Furthermore, Mitchell’s data show that active surveillance rates were nearly identical between integrated groups and referring groups (27% vs. 27.4%). Her data also show that active surveillance rates actually increased for integrated groups after they acquired IMRT technology. In addition, the rate of radical prostatectomy did not decline—the increase in utilization of IMRT was at the expense of brachytherapy. This mirrors national trends5,6 in radiation utilization and is consistent with practice guidelines suggesting that brachytherapy monotherapy should be limited to lower-risk prostate cancer.7
Mitchell did not compare the rate of IMRT utilization in her study group against historical norms—her allegations are that urologists with ownership of radiation facilities 1) used more IMRT than their peers without such ownership; and 2) used more IMRT than before acquiring this technology. In order to make the first claim, it is necessary to accurately match the control group of urologists against those that had in-house IMRT capability. Unfortunately, Mitchell’s only rationale for matching her control and study groups is that they were in the same state—she did not match groups by size, practice characteristics, patient demographics, or severity of illness. The absence of any a priori scientific rationale in choosing practices invalidates any conclusions based on such comparisons. Further evidence that her controls are invalid is the extremely low utilization of IMRT by her “NCCN control arm”—8.3%! The notion that less than 1 in 10 Medicare-aged patients newly diagnosed with prostate cancer received IMRT as primary therapy is simply not credible.
Mitchell’s second accusation is that urology groups increased utilization of IMRT once they acquired this technology, but she fails to take into consideration the impact that modification of practice structure has on referral patterns. Literature strongly supports the notion that specialists overwhelmingly recommend the prostate cancer therapy that they themselves deliver.8,9 Historical data demonstrates that the likelihood of a patient choosing non-surgical therapy for prostate cancer increases if a patient is afforded the opportunity to discuss treatment options with physicians of different specialties.3 This multidisciplinary approach is the sine qua non of integrated urology groups. Interestingly, the utilization of radiation as primary treatment for prostate cancer in academic centers that adopted a multidisciplinary treatment strategy was virtually identical to that reported by Mitchell for integrated urology groups.10
There are real questions to be answered as we weigh the benefits of prostate cancer therapy against the costs and risks associated with such treatments. Shifts in healthcare delivery patterns are inevitable—and healthy—as medicine becomes more integrated, historical monopolies over certain services are eliminated, and patients seek care in specialized treatment centers that are convenient and cost-effective. The focus of any responsible physician should be on ensuring access to affordable care that produces the best results—not on where that care is delivered.