At Issue: IMRT Self-Referral

Published: Friday, Feb 14, 2014
A linear accelerator

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 American Urological Association, the American Association of Clinical Urologists, and LUGPA issued statements disputing Mitchell’s findings.

“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.

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