New Study Re-ignites Attacks on IMRT Self-referral

A study recently published in the New England Journal of Medicine (NEJM) suggests that men diagnosed with prostate cancer are more than twice as likely to undergo intensity-modulated radiation therapy (IMRT) when their urologists have an ownership interest in an IMRT facility, bolstering longstanding concerns about conflicts of interest for IMRT self-referrals. The study follows a federal report recommending new patient-transparency rules—but not an outright ban—on IMRT self-referral, and the introduction of proposed federal legislation that would end the practice.

The NEJM study has certainly sparked renewed and fierce attacks on urologists’ referrals of patients with prostate cancer to urologist-owned IMRT services. The study, funded by the American Society for Radiation Oncology (ASTRO), concluded that self-referring urologists are driving steep increases in Medicaid spending on IMRT.¹ The study “provides clear, indisputable evidence that many men are receiving unnecessary radiation therapy for their prostate cancer due to self-referral,” said ASTRO Chair Colleen A.F. Lawton, MD, FASTRO, who describes self-referral as a “type of abuse” of patients.

Self-referrals Significantly Rise, Reports Show

Published on October 24, 2013, the NEJM study looked at Medicare billing claims for more than 45,000 men treated with IMRT for prostate cancer in the United States between 2005 and 2010. Treatment patterns were analyzed before and after urology practices purchased IMRT facilities.¹

Professor Jean Mitchell, PhD, an economist at the McCourt School of Public Policy at Georgetown University in Washington, DC, compared self-referring urology groups to a control group of 35 non–self-referring urology groups at 11 National Comprehensive Cancer Network (NCCN) centers.¹

Mitchell found that, between 2005 and 2010, the use of IMRT jumped 19.2% among self-referring urologists—from 13.1% to 32.3% (P < 0.001).¹ During that same time period, non–self-referring urologists’ IMRT referral rates increased by only 1.3%.¹

“The rate of IMRT use by urologists working at NCCN centers remained stable at 8.0% but increased by 33.0 percentage points among the 11 matched self-referring urology groups
[P <0.001],” Dr. Mitchell reported. ¹

Is Regulation in the Works?

The federal Stark Law prohibits physicians from referring patients to facilities they own, but exceptions exist for “ancillary” services like radiographic procedures that can be easily performed at the physician’s office.^1,2 These exceptions create a lucrative loophole for IMRT self-referral, encouraging self-referral even when IMRT may not be justified, ASTRO officials contend—examples include elderly men who are unlikely to die of prostate cancer, and who are candidates for “watchful waiting”.²

The study appears to bolster the conclusions of a United States Government Accountability office (GAO) report, which concluded that “financial incentives were likely a major factor driving the increase of IMRT referrals among self-referring providers.”^2,3 The GAO report stopped short of recommending a ban on IMRT self-referral, but calls for transparency rules that would require disclosure of self-referrals to patients and on Medicare invoices.³

Dr. Mitchell’s before-and-after analysis of urologists’ IMRT referral rates suggests a strong association between ownership interest and increased referrals.

“Urologists who acquired ownership of IMRT services increased their use of IMRT substantially more than urologists who did not own such services,” Dr. Mitchell concluded.¹

The Promoting Integrity in Medicare Act (PIMA) legislation, championed by ASTRO and introduced in August, would halt IMRT self-referral. However, the Large Urology Group Practice Association (LUGPA) has condemned the ASTRO-funded study, stating it “provides no compelling reason to legislatively prohibit integrated practices from providing radiation and other treatment modalities to their patients.”⁴