In the past 10 years, urologists in the United States who acquired intensity-modulated radiation therapy (IMRT) services subsequently greatly increased their use of the treatment for newly diagnosed prostate cancer, according to a study published in the October 24 issue of the New England Journal of Medicine.
The study strikes some of the same critical notes as a report issued in August by the US Government Accountability Office (GAO), which also found a marked uptick in the use of IMRT in urology practices that own the service.
In both reports, financial incentives are cited as the likely driver of the dramatic increase in use. IMRT has the highest reimbursement from Medicare of all the definitive treatments for early prostate cancer.
For nonmetastatic prostate cancer, Medicare reimbursement for IMRT is about $31,000, which is much higher than the $17,000 for brachytherapy, another form of radiation, and the $16,000 for radical prostatectomy, said study author Jean Mitchell, PhD, at a press conference about the study.
The press conference and the study were sponsored by the American Society for Radiation Oncology (ASTRO).
Dr. Mitchell is a professor of public policy at McCourt School of Public Policy at Georgetown University in Washington, DC.
By providing radiation oncology as an ancillary service, urologists have been able to refer patients with prostate cancer to themselves for radiation therapy. This "self-referral" allows urologists to benefit from the higher Medicare reimbursement for IMRT, Dr. Mitchell pointed out.
However, it has not been proven that IMRT is more effective or has a better overall adverse effect profile than the less costly options for patients with early prostate cancer, she writes.
Timing might also have played a role in the increased adoption of IMRT. The self-referral arrangement has enabled urologists "to partially replace income losses they incurred after Medicare substantially cut payments for androgen-deprivation therapies in the mid-2000s," she asserts.
The integration of IMRT into urology practices is a product of an exception to federal law that otherwise prohibits self-referral, Dr. Mitchell notes.
Establishing an IMRT service is expensive; it requires a capital investment of about $2 million and the hiring of additional staff. But the rewards can be great.
Dr. Mitchell cites marketing materials from Urorad, a company that sells "complete packages of IMRT technology and services," that claim that by treating only 1.5 new patients a month, practices can generate more than $425,000 in additional income per urologist annually.
When the GAO study was issued, urological professional groups cried foul because of the methodologies used.
With the release of Dr. Mitchell's study, these urology groups have gone beyond calling the research flawed. The groups point out that the study was sponsored by ASTRO, and that radiation oncologists are guilty of their own narrow self-interest and are seeking a "monopoly" on prostate cancer treatment.
Before Owning IMRT, Urologists Used IMRT a Lot Less
Dr. Mitchell examined the rate of IMRT use in Medicare beneficiaries with nonmetastatic prostate cancer.
She looked at 35 urology practices that acquired IMRT and began to self-refer during the 2005 to 2010 study period. These practices were pair matched with 35 urology practices that did not acquire the service during the study period (control group).
In the self-referring group, IMRT use increased from a preownership rate of 13.1% to a postownership rate of 32.3% — an absolute increase of 19.2% (P < .001). In the control group, IMRT use increased slightly, from 14.3% to 15.6% — an absolute increase of 1.3% (P = .05).
The absolute difference in IMRT use between the 2 groups was 17.9%.
Dr. Mitchell conducted a second analysis of 11 self-referring urology practices and 11 geographically matched centers that are part of the National Comprehensive Cancer Network (NCCN) and do not self-refer. The absolute difference in IMRT use was even greater, at 33%.
"The results of this study indicate that referral by urologists to IMRT services in which they have a financial interest is associated with large increases in the rate of IMRT use," Dr. Mitchell writes.
"This is wrong on so many levels," said Colleen Lawton, MD. She is chair of ASTRO's board of directors and professor of radiation oncology at the Medical College of Wisconsin in Milwaukee. Dr. Lawton, who hosted the press conference, specializes in prostate cancer treatment.
She explained that IMRT should "ideally" be used in prostate cancer patients with "oddly shaped tumors," to take advantage of the unique capacities of IMRT. The technology is "expensive" and "complex," and not meant for common use in this setting.
There is now "overwhelming evidence" that self-referral leads to "inappropriate care," she claimed. The escalating use of IMRT in certain urology practices "injures trust" with patients and "inflates" healthcare costs, she said.
Dr. Mitchell also found that along with the increase in IMRT use by self-referring urology practices, there was an accompanying decrease in the use of less expensive treatment options.
For example, self-referring urology practices were much less likely to treat patients with brachytherapy in the postownership period than in the preownership period (2.7% vs 17.6%). In the control group, there was little or no change in practice patterns for the various treatment options, including brachytherapy.
Dr. Mitchell notes that a minority of urology practices have IMRT technology (19% as of 2011). However, she told Medscape Medical News that these practices typically are large in terms of total number of urologists and have multiple locations. She also said that their numbers are growing.
Objections and Support
The American Urological Association (AUA) issued a statement about the study, saying that it has "inherent biases and flawed methodologies."
"Specifically, there are serious concerns about the author's selection of control groups that may not be representative of general practice trends," the statement reads.
At the press conference, Dr. Mitchell emphasized that the control practices were geographically matched to account for regional variation in practice patterns.
There is also a suggestion in the AUA statement that Dr. Mitchell has compromised her academic integrity. "As the methods used to select the control groups are poorly described, one cannot help but wonder whether Dr. Mitchell chose the control groups to arrive at results that were acceptable to the study's sponsors," it reads.
Dr. Mitchell told Medscape Medical News that the total amount of study funding was about $320,000, and that $70,000 of that was spent on purchasing data from CMS. She also said that she did not personally profit from the study, and makes "the same salary whether I conduct this research or not."
A prominent urologist disagrees with his own professional organization's assessment. This is a "beautifully done study," said James L. Mohler, MD, who spoke at the press conference. He is an AUA member, chair of the Department of Urology and professor of oncology at the Roswell Park Cancer Institute in Buffalo, New York, and chair of the NCCN Guidelines Panel for Prostate Cancer.
Another urology group protested the study in a press statement. "The Mitchell study was commissioned and funded by the American Society for Radiation Oncology (ASTRO) in an attempt to persuade lawmakers to legislate a monopoly for its members in the use of radiation therapy to treat prostate cancer — an economically driven agenda that has been rejected by Congress, MedPAC, and the GAO," said Deepak A. Kapoor, MD, president of Large Urology Group Practice Association (LUGPA), and chair and CEO of Integrated Medical Professionals, a New York medical practice with 51 locations and more than 100 doctors.
"Mitchell did not match her control group for practice size, patient demographics, or severity of disease — indeed, her selection bias is evidenced by her own bizarre results," reads the LUGPA statement. "The ASTRO study serves only one purpose — to undermine competition in the market place."
At the press conference, Rep. Jackie Speier (D-California) said self-referral is "bad for healthcare." Rep. Speier is a cosponsor of the Promoting Integrity in Medicare Act (PIMA), which seeks to eliminate the current exceptions in federal law that allow for urology self-referral and other practices.
N Engl J Med. 2013;369;1629-1637. Abstract
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Cite this: Urologists Follow the IMRT Money in Prostate Cancer - Medscape - Oct 25, 2013.