Urology associations have condemned a new study suggesting that urology groups that have integrated intensity-modulated radiation therapy (IMRT) into their practice make much greater use of the modality for treating prostate cancer (PCa) patients than urology groups that do not have in-office IMRT.

The study, which was funded by the American Society for Radiation Oncology (ASTRO) and conducted by Jean M. Mitchell, PhD, an economist at Georgetown University in Washington, D.C., examined Medicare claims from 2005 through 2010. The analysis revealed that the rate of IMRT use jumped by 19.2 percentage points among self-referring urologists during the study period compared with 1.3 percentage points among urologists who did not self refer.

“Permitting urologists to self-refer for IMRT may contribute to increased use of this expensive therapy,” Dr. Mitchell concluded in the current issue of The New England Journal of Medicine (2013;369:1629-1637).

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The study drew criticism from the Large Urology Group Practice Association (LUGPA), which in a prepared statement said the study was flawed and “provides no compelling reason to legislatively prohibit integrated practices from providing radiation and other treatment modalities to their patients.”

LUGPA pointed out that study data show that less than one third of newly-diagnosed PCa patients who sought treatment from an integrated urology group received IMRT in 2005-2010. “This figure is fully in line with data from academic literature that predates the development of integrated groups, when radiation therapy was only available in hospitals and free-standing radiation centers,” LUGPA observed.

Furthermore, the association noted that Dr. Mitchell’s data show that the use of active surveillance was nearly identical between integrated and referring groups (27% vs. 27.4%). “In addition, her data shows that active surveillance rates actually increased for integrated groups after they acquired IMRT technology. This demonstrates that incorporation of IMRT did not influence clinical decision-making in a manner to maximize profits.”

The study also showed relatively consistent use of radical prostatectomy by integrated groups after acquisition of IMRT technology and that integrated groups’ increased use of IMRT was offset by substantial decreases in the use of brachytherapy (from 18.6% to 5.65%) and androgen deprivation therapy (from 16.5% to 8.4%).

Prohibiting integrated practices from offering radiation and other treatment modalities to would only undermine competition in the marketplace as well as increase up costs “as many patients resort to care in the more expensive hospital setting, and harm patient access to specialized integrated care,” according to LUGPA.

The association also pointed out that Dr. Mitchell provides no rationale for her choice of control groups, which she did not match for size, patient demographics, or severity of illness.

The American Urological Association (AUA) had similar criticisms, and issued a statement that read, in part, that “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 Surveillance, Epidemiology, and End Results (SEER) database have shown significant declines in the use of brachytherapy in the U.S. during the same period, “yet Dr. Mitchell’s control groups fail to show any decline in brachytherapy use. 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 stated.

According to Dr. Mitchell’s report, recent evidence suggests that the IMRT self-referral arrangement is becoming more common. By the end of 2011, she said, about 19% of urology practices had incorporated IMRT services into their practice.

Dr. Mitchell constructed two study samples. One included 35 self-referring urology groups in private practice and a matched control group that included 35 non-self-referring urology groups in private practice. The other sample included non-self-referring urologists employed at 11 National Comprehensive Cancer Network (NCCN) centers matched with 11 self-referring urology groups in private practice.

From 2005 through 2010, the rate of IMRT use by self-referring urologists in private practice increased significantly from 13.1% to 32.3%. By comparison, the rate of IMRT use by urologists who did not self-refer increased from 14.3% to 15.6%. The rate of IMRT use by urologists at the NCCN centers remained stable at 8.0% but rose by 33 percentage points among the 11 matched self-referring urology groups.

“The findings raise concerns regarding the appropriate use of IMRT, especially among older Medicare beneficiaries, for whom the risks of undergoing intensive irradiation probably exceed the benefits,” Dr. Mitchell wrote.

Self-referral is generally illegal, but the federal prohibition against it has exceptions that allow physicians to self-refer under certain conditions, she explained. “The most notable exception concerns in-office ancillary services; this provision enables individual physicians and physician groups to integrate designed health services, including radiation therapy, into their practices without violating the law.”