Intensity-modulated radiation therapy study reignites urologist self-referral controversy

The publication of data in the New England Journal of Medicine (2013; 369:1629-37) showing an increase in intensity-modulated radiation therapy utilization among self-referring urologists has reignited the self-referral controversy.

The study’s findings were publicized in a news conference last week sponsored by the American Society for Radiation Oncology, which funded the study. In addition to the study’s author, Jean Mitchell, PhD, speakers included a U.S. congresswoman who is championing legislation to eliminate certain self-referral exemptions, the chair of ASTRO’s board of directors, and a leading academic urologist.

The study drew critical response from three urology groups. It also incited intense debate on Twitter.

In the study, Dr. Mitchell, of Georgetown University, Washington, reviewed data from Medicare patients in 26 geographically dispersed states who were treated at 35 self-referring urology groups in private practice matched to a control group of 35 non-self-referring urology groups in private practice (38,765 patients); and patients treated by 11 self-referring urology groups in private practice within close proximity to and matched directly to non-self-referring urologists at 11 National Comprehensive Cancer Network (NCCN) centers (6,713 patients).

Dr. Mitchell reported that IMRT utilization among self-referring groups increased from 13.1% to 32.3% once they became self-referrers, an increase of 19.2 percentage points (146%). In contrast, IMRT utilization by non-self-referring urologists who were peers practicing in the same community-based setting increased by only 1.3 percentage points.

IMRT utilization among the subset of 11 self-referring urology practices near NCCN centers increased from 9% to 42%, an increase of 33 percentage points (367%), from the pre-ownership to the ownership period, compared to an insignificant increase of 0.4 percentage points at the NCCN centers.

“Men treated by self-referring urologists, as compared with men treated by non-self-referring urologists, are much more likely to undergo IMRT, a treatment with a high reimbursement rate, rather than less expensive options, despite evidence that all treatments yield similar outcomes,” Dr. Mitchell concluded.

“Dr. Mitchell’s study provides clear, indisputable evidence that many men are receiving unnecessary radiation therapy for their prostate cancer due to self-referral,” said Colleen A.F. Lawton, MD, of ASTRO. “We must end physician self-referral for radiation therapy and protect patients from this type of abuse.”

At the news conference, Dr. Lawton introduced Rep. Jackie Speier (D-CA), who along with Rep. Jim McDermott (D-WA) has introduced H.R. 2914, which would close the self-referral loophole for radiation therapy, advanced imaging, anatomic pathology, and physical therapy services. Speier called IMRT self-referral by urologists “an enormous ethical breach” and “pure greed.”

Also at the press conference, urologist James L. Mohler, MD, of Roswell Park Cancer Institute in Buffalo, released a joint statement on the overtreatment of prostate cancer and physician self-referral from the expert members of the NCCN Prostate Cancer Guidelines Panel, which he chairs.

“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 NCCN member institutions,” Dr. Mohler said. “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.”

Dr. Mitchell’s study provoked swift condemnation from organized urology. In a statement, the AUA said the study had “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. Prior studies using the SEER database… have shown significant declines in the use of brachytherapy in the United States during the same time period, yet Dr. Mitchell’s control groups fail to show any decline in brachytherapy use [Brachytherapy, Sept. 19, 2013]. 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,” the AUA said.

The Large Urology Group Practice Association was similarly critical, calling the study “methodologically flawed and factually inaccurate.”

“The Mitchell study was commissioned and funded by the American Society for Radiation Oncology 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,” LUGPA President Deepak Kapoor, MD, said in a statement.

In a brief statement, the American Association of Clinical Urologists said it agreed with the AUA and LUGPA positions. “The AACU continues to promote the ethical and responsible use of intensity-modulated radiation therapy for the treatment of prostate cancer. Dr. Mitchell's study offers nothing to alter these positions,” the statement said.

Urologists and others took to Twitter to continue the debate.

Declan Murphy, MB BCh, of Peter MacCallum Cancer Centre tweeted that the urologist self-referral practices detailed in the study are a “proper disgrace.”

John Birkmeyer, MD, called the study the “most damning” ever published on financial incentives and treatment decisions.

Others criticized the study for its link to ASTRO and/or flaws in its design.

“You’d think [the New England Journal of Medicine] would see through this kind of hired-gun research,” tweeted Matthew R. Cooperberg, MD, MPH, of the University of California, San Francisco.

David F. Penson, MD, MPH, of Vanderbilt University, Nashville, TN, and the AUA’s Health Policy chair, tweeted that “biased science isn’t the answer.”

“All I want is good science. It may be true, but prove it properly,” Dr. Penson said.

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