Investigators probe self-referrals for prostate cancer radiation

Washington Federal auditors suggested that increased utilization of certain radiological cancer treatments ordered by physicians who provide the care in-practice warrants further scrutiny, but physician specialty organizations contend that the findings don’t take into account evolving clinical strategies in radiation therapy.

The Government Accountability Office had been asked by a bipartisan group of lawmakers to assess trends in Medicare self-referral practices for radiation oncology services. In examining the number of prostate cancer-related intensity-modulated radiation therapy services provided by self-referring groups over several years, GAO found they had increased significantly, from about 80,000 in 2006 to 366,000 in 2010, even as utilization of the services declined for non-self-referring groups. The number of self-referring groups and their expenditures related to these services also rose during this period (link).

GAO identified a limited range of specialty groups, which consisted mainly of urologists and a few other types of specialists, as contributing to this growth in service volume. “Providers substantially increased the percentage of their prostate cancer patients they referred for IMRT after they began to self-refer,” the report stated.

The report noted that Medicare physicians and other health professionals are under no mandate to disclose such self-referral for IMRT services, a requirement the Dept. of Health and Human Services is not authorized to establish. Under these circumstances, patients have no way of knowing about their physicians’ financial interests in referring them to IMRT over other treatments that might be less costly and lower risk, but potentially just as effective, the report stated.

Leaders on several House and Senate committees that requested the report said it reveals situations in which physicians stand to gain financially from recommending these costly treatments within their own practices. Cancer patients must not be expected to question their physicians’ motives, said Senate Finance Committee Chair Sen. Max Baucus (D, Mont.) in a statement. “Unfortunately, when you look at the numbers in this report, you start to wonder where health care stops and where profiteering begins. We have a law on the books designed to prevent these conflicts of interest, but an increasing number of physicians are skirting the law for their own personal gain,” he said.

Federal Stark law bars referrals to medical facilities in which the physician has a financial interest, although it includes an exception for in-office ancillary services. According to ASTRO, the American Society of Radiation Oncology, which agreed with the GAO’s findings, misuse of the law’s ancillary services exception has watered down the policy objectives of the self-referral statute. The exception has made it easy for doctors to skirt the law’s prohibitions “by structuring arrangements that meet the technical requirements of the law, thereby circumventing the intent of the exception,” the group said in a statement.

ASTRO is backing legislation from Reps. Jackie Speier (D, Calif.) and Jim McDermott, MD (D, Wash.), that would take measures to close this exception by prohibiting self-referral for several additional services: radiation therapy, physical therapy, advanced imaging and anatomic pathology.

In its report, GAO suggested that HHS require health care professionals to disclose to patients their financial interests in these types of services, as well as take steps to monitor and identify self-referral of the services, such as flagging them on Medicare claims forms. While these recommendations are well-intended, “new regulations of tracking and reporting fall short of what is necessary to ensure unbiased patient care — closure of the self-referral loophole,” said ASTRO Chair Michael L. Steinberg, MD.

Urologists blast lack of evidence

Organizations representing urologists countered that the GAO investigators made no recommendations toward closing the ancillary services exception, nor did they cite any evidence that patients were receiving inappropriate radiation therapy by the integrated urology practices that performed IMRT services.

“Critically, the GAO failed to properly account for the fact that the increase in the overall number of IMRT treatments performed by urology groups is directly related to the number of urologists in group practices that now incorporate radiation therapy as part of their comprehensive, integrated strategy to treat prostate cancer,” the American Assn. of Clinical Urologists, the American Urological Assn., and the Large Urology Group Practice Assn., said in a joint statement.

The report also overlooked peer-reviewed literature that evidences IMRT as the clinical standard of care for patients with prostate cancer, the urology groups stated. Evolving clinical standards on treatment, and the patient’s ability to evaluate a variety of medical opinions and make more informed choices about treatment, is what’s driving these changes, not equipment ownership, said LUGPA President Deepak A. Kapoor, MD, in the statement.

In its own comments, HHS also disagreed with the GAO’s recommendations, stating that the tracking suggestions in the report would be too complicated to administer and wouldn’t necessarily address the issue of overutilization. The department cited President Obama’s fiscal 2014 budget request, which contained a provision to remove several services from the self-referral law’s ancillary services exception.

The GAO’s report is one in a series of reports that has been examining the frequency of Medicare self-referrals. Another recent study found that self-referral of biopsies had doubled over the past decade, although specialists contended that the report overlooked quality gains and practice consolidation as the reasons for the increase.