WASHINGTON—Research published as a “Special Article” in the October 24 issue of The New England Journal of Medicine (2013; 369:1629-1637) documents a 19.2 percent increase from 2005 to 2010 in the use of intensity-modulated radiation therapy (IMRT) for prostate cancer patients by urologists who self-refer to their own in-office IMRT centers. At a news briefing at the National Press Club here, speakers decried the “perverse financial incentives” that encourage urologists to self-refer and overuse IMRT.
The study's author, Jean M. Mitchell, PhD, an economist and Professor at Georgetown University's McCourt School of Public Policy, said the findings parallel those of the Government Accounting Office (GAO), which issued a report in August detailing abuses in radiation therapy treatment for prostate cancer by IMRT self-referring physicians. That GAO report (www.gao.gov/assets/660/656026.pdf) found a 356 percent increase in IMRT use by self-referrers, compared with a five percent decrease by non-self-referrers. Mitchell said her results were “almost the same even though the methodology differed.”
Mitchell's study—which was funded by an unrestricted educational research contract between the American Society for Radiation Oncology and Georgetown University under the proviso that the research findings would be published whatever the results—examined Medicare claims for approximately 45,000 patients from 2005 to 2010. The results showed that: nearly all of the 146 percent increase in IMRT use among urologists with an ownership interest was due to self referral; and IMRT use among a subset of 11 self-referring oncology practices near National Comprehensive Cancer Network (NCCN)-designated cancer centers (non-self-referrers) increased by 33 percentage points from the pre-ownership period to the ownership period, compared with just 0.4 percentage points at the non-self-referring NCCN centers.
These new study findings prompted the NCCN's Prostate Cancer Guidelines Panel to release a joint position statement (http://bit.ly/1bwwCFj), which said, “We are disappointed to learn that urologists who self-refer for IMRT services use this expensive technology more than urologists who don't self-refer and more than the NCCN member institutions. ... 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 statement was signed by panel members who include prominent urologists such as Patrick C. Walsh, MD, University Distinguished Professor of Urology at Johns Hopkins Medical Institutions, as well as well-known medical oncologists, radiation oncologists, and a pathologist.
In a statement released by ASTRO in September, Walsh and Theodore DeWeese, MD, Chairman of the Department of Radiation Oncology and Molecular Radiation Science and Professor in the Department of Oncology and Urology at Johns Hopkins, said, “Urology-ownership of radiation therapy presents a clear conflict of interest, often with a for-profit motive, that risks overuse of intensity modulated radiation therapy. This activity is an affront to the vast majority of urologists and radiation oncologists who partner every day to provide well-coordinated care in community practices and hospitals without self-referral's additional financial incentives.”
The Walsh-DeWeese statement says: “Self-referring centers referred more than 52 percent of men over the age of 75 for IMRT at self-referring centers. For these men, guidelines recommend active surveillance of their disease and the avoidance of aggressive treatment such as IMRT.”
The American Urological Association (AUA) and the Large Urology Group Practice Association (LUGPA), though, immediately denounced the study's findings as flawed based on the methodology used (see box).
James L. Mohler, MD, Chair of the NCCN Prostate Cancer Guidelines Panel that released the statement on self-referral, told OT, “This is as well done an analysis as I've seen ... it is a call to action.” Mohler, who also spoke at the news briefing, is Chair of the Department of Urology, Associate Director and Senior Vice President for Translational Research, and Professor of Oncology at Roswell Park Cancer Institute, as well as Vice-Chair of the Urology Committee of the Alliance for Clinical Trials in Oncology.
In the NEJM study, Mitchell said that “allowing urologists to self-refer for IMRT may contribute to increased use of this expensive therapy” for financial gain when other treatments are equally effective. To establish an IMRT center, she noted, requires an investment of about $2 million and requires hiring experienced staff with specialized skills.
For example, a marketing brochure from Urorad Healthcare (which sells complete IMRT packages to urologists) cited in the study states that treating 1.5 new patients each month with IMRT could generate more than $425,000 in added revenue per urologist each year. According to a table in the study, the mean cost estimate for treating a patient with clinically localized prostate cancer with IMRT is $31,574—far higher than the $16,762 estimate for radical prostatectomy and the $17,076 estimate for brachytherapy.
Speaking at the news briefing, Colleen A.F. Lawton, MD, FASTRO, Chairman of ASTRO's Board of Directors, said that use of IMRT—which she called “precise, complex, powerful, expensive, and ideally suited for oddly shaped tumors” —entails “great responsibility for providers.” Lawton, who is Vice-Chair of the Department of Radiation Oncology, Clinical Director of Radiation Oncology, and Professor of Radiation Oncology at the Medical College of Wisconsin, said, “No provider should allow their financial interest to influence treatment decisions.”
She added that for some elderly men with low-risk prostate cancer, “active surveillance is the right thing to do.”
“It is disheartening to hear the results of this research,” she said. “The GAO's findings were egregious. Dr. Mitchell's study adds another layer of evidence.”
Exemption to Federal Ethics in Patient Referrals Act
The federal Ethics in Patient Referrals Act, also known as the self-referral law, forbids physicians from referring patients to a medical facility in which they have a financial interest in order to ensure that treatment decisions will be based solely on the patient's needs, rather than on physicians' pocketbooks.
But this law includes an exemption that allows physicians to self-refer for “ancillary services,” including radiation therapy—reasoning that this on-site ancillary treatment is more convenient for the patient.
Previous studies over the years have identified abuse of the in-office ancillary services (IOAS) exemption. In a statement, Senate Finance Committee Chairman Sen. Max Baucus (D-MT), remarked that such research makes him wonder “where health care stops and where profiteering begins,” and added, “Enough is enough. Congress needs to close the loophole and fix the problem.”
‘Most Chilling Thing’
The “most chilling thing” about abuse of the IOAS is the “enormous ethical breach,” said U.S. Rep. Jackie Speier (D-CA), who worked to close a similar state self-referral loophole in California. “It is pure greed . . . it's really about making a buck,” added Speier, who—with U.S. Rep. Jim McDermott (D-WA)—has introduced the Promoting Integrity in Medicare Act of 2013 (PIMA) to close the self-referral loophole.
“It's not just about money,” Speier said at the news briefing, noting that unnecessary treatment not only costs Medicare hundreds of millions of dollars each year but also exposes prostate cancer patients to possible complications and side effects, such as incontinence and impotence. Asked by OT why the self-referral loophole has not been closed before, Speier said, “Specialties out there are fairly persuasive,” referring to physicians' lobbying efforts on Capitol Hill.
Asked afterwards whether increased clinical use of gene panels such as the Oncotype DX Genomic Prostate Score and Prolaris to predict prostate cancer aggressiveness will likely reduce the use of IMRT by funneling more very low-risk men into active surveillance, Mohler said, “The hope is that you can take a man with low-risk prostate cancer and decide that upfront,” which he said could lead to “a gentler active surveillance.”
But, he added, “I don't think any test will be perfect.” Mohler noted that there are now many such genomic tests under study, and predicted that one may surface as the preferred tool for use in clinical practice.
AUA, Large Urology Group Practice Association, and ‘Zero—the End of Prostate Cancer’ Dispute the Findings
In a reaction statement, the American Urological Association rebutted the NEJM article, saying that the study had “inherent biases” and “flawed methodology.” Specifically, said the AUA, the author's selection of control groups “may not be representative of general practice trends.”
The AUA has been actively working with legislators on Capitol Hill, especially physician members of Congress, and with other specialty groups to preserve the self-referral exemption (IOAE) and to “protect a physician's right to personally provide these services to patients.”
Similarly, the Large Urology Group Practice Association (LUGPA) also disputed the findings, emphasizing that integrated groups' use of IMRT is appropriate. LUGPA called Mitchell's control group “specious,” and said she did not match groups on size, patient demographics, or severity of illness: “The ASTRO study provides no compelling reason to legislatively prohibit integrated practices from providing radiation and other treatment modalities to their patients.
“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,” LUGPA said.
The national nonprofit group Zero—The End of Prostate Cancer also criticized the methodology of the new NEJM study. President and CEO Jamie Bearse called the study “a disservice to men and their loved ones fighting this disease as it continues to muddy the water for patients trying to determine the best treatment regimen for their individual prostate cancer cases.” The study, Bearse said, “attempts to create a barrier of mistrust between doctors and patients.”