Radiology and pathology associations are supporting a new bill in Congress to address self-referrals made by urologists

Criticism is mounting against urologists who refer their patients to radiation providers in which they have an ownership relationship. This criticism is strikingly similar to concerns that pathologists and others have expressed about situations where urologists refer their patients to anatomic pathology laboratories in which they have an ownership relationship.

Study about Radiation Therapy Referrals Published in NEJM

The trigger for this latest spotlight on how urologists refer patients was the publication, in the New England Journal of Medicine (NEJM) in October, of a study, “Urologists’ Use of Intensity-Modulated Radiation Therapy for Prostate Cancer.” In this study, researcher Jean M. Mitchell, Ph.D., a healthcare economist, reported that self-referring urologists recommended more expensive radiation treatments that were not necessarily more effective when compared with those of urologists who did not refer patients to treatment facilities in which they had an ownership interest.

Pictured above is Jean M. Mitchell, Ph.D, speaking at a press conference in Washington, DC, earlier this fall. Mitchell is a healthcare economist and a professor at Georgetown University. She authored a study published in the New England Journal of Medicine that compared the utilization of intensity-modulated radiation therapy among urologists who have an ownership in radiation therapy providers and urologists who don’t have such ownership interests. (Photo copyright ScrippsHealthcare Wire. Photo by Gavin Stern.)

Pictured above is Jean M. Mitchell, Ph.D, speaking at a press conference in Washington, DC, earlier this fall. Mitchell is a healthcare economist and a professor at Georgetown University. She authored a study published in the New England Journal of Medicine that compared the utilization of intensity-modulated radiation therapy among urologists who have an ownership in radiation therapy providers and urologists who don’t have such ownership interests. (Photo copyright ScrippsHealthcare Wire. Photo by Gavin Stern.)

Commenting on Mitchell’s work, a story published by Science Daily, said, “The study adds to the existing mountain of evidence that the in-office ancillary services loophole to the Stark Law costs the Medicare system billions without benefitting patients.”

GAO Made Recommendation About Self-Referral Involving Urologists

NEJM published the Mitchell study just three months after the federal Government Accountability Office (GAO) issued a report in July. In that study, the GAO recommended that Congress closely examine the practice of self-referral among urologists, noted MedPage Today.

One recommendation made by the GAO was that the secretary of the federal Department of Health and Human Services (HHS) should require providers to disclose to their patients any financial interests the providers have in IMRT facilities. Another GAO recommendation was that the federal Centers for Medicare & Medicaid Services (CMS) should identify and monitor self-referral of IMRT.

Following release of the GAO report, Representative Jackie Speier (D-California), introduced H.R. 2914: “Promoting Integrity in Medicare Act of 2013” on August 1. The bill would ban urologists from referring patients to facilities in which they have an ownership interest, noted a story published in Modern Healthcare.

Speier’s Bill Supported by Several Organizations

Speier’s bill was referred to the House Energy and Commerce Committee. Among the organizations supporting the bill are:

American Clinical Laboratory Association,

American Society for Radiation Oncology,

Alliance for Integrity in Medicine, and,

College of American Pathologists (CAP)

American College of Radiology,

American Physical Therapy Association,

American Society for Clinical Pathology,

Association for Quality Imaging,

Radiology Business Management Association.

Many pathologists are aware of the studies and the GAO report on self-referrals made by urologists. Mitchell, a professor at Georgetown University, first published research on the topic of urologist self-referrals in the health policy journal Health Affairs. Titled: “Urologists’ Self-Referral for Pathology of Biopsy Specimens Linked to Increased Use and Lower Prostate Cancer Detection,” Mitchell examined Medicare claims to determine how the in-office ancillary services exception affected the use of surgical pathology services and cancer detection rates associated with prostate biopsies.

Urologists Decried Mitchell’s Findings involving Pathology Self-Referrals

The publication of this study launched a firestorm of press releases from national urology associations decrying the findings of Mitchell’s study. In her study, Mitchell determined that self-referring urologists billed Medicare for 4.3 more specimens per prostate biopsy than the adjusted mean of 6 specimens per biopsy that non-self-referring urologists sent to independent pathology providers. This was a difference of almost 72%, Mitchell reported.

“This suggests that financial incentives prompt self-referring urologists to perform prostate biopsies on men who are unlikely to have prostate cancer. These results support closing the loophole that permits self-referral to in-office pathology laboratories,” she wrote. Others have disputed Mitchell’s findings (see “Urologists Weigh in on Prostate Biopsy Testing,” The Dark Report, March 4, 2013).

Study Included IMRT Medicare Claims from 2005 through 2010

In her latest research in NEJM, Mitchell analyzed Medicare claims from 2005 through 2010 involving IMRT. She compared the referral patterns of self-referring urologists in private practice to those of non-self-referring pathologists in private practice.

“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,” Mitchell wrote.

Once the urologists began self-referring, IMRT utilization increased from 13.1% to 32.3%, she wrote. “In contrast, IMRT utilization by non-self-referring urologists, who were peers practicing in the same community-based setting, was virtually unchanged with a modest increase of 1.3 percentage points,” Mitchell added. Mitchell also reported a decrease in utilization of effective, less expensive treatment options by self-referring urologists, but virtually no change in practice patterns for non-self-referring urologists.

Urologists Responded to Mitchell’s IMRT Study

Urologists reacted to publication of the latest Mitchell study. Within days of the NEJM study appearing in print, both the Large Urology Group Practice Association (LUGPA) and the American Urological Association (AUA) issued statements criticizing Mitchell’s study. issued statements criticizing Mitchell’s study.

“Specifically, there are serious concerns about the author’s selection of control groups that may not be representative of general practice trends,” stated AUA in a press release October 23. “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.”

One voice defending urologists in the wake of multiple studies that compared utilization of ancillary services by urologists who self-refer and urologists who don’t is Deepak A. Kapoor, M.D., a urologist and President of the Large Urology Group Practice Association. (Photo by Integrated Medical Professionals, PLLC.)

One voice defending urologists in the wake of multiple studies that compared utilization of ancillary services by urologists who self-refer and urologists who don’t is Deepak A. Kapoor, M.D., a urologist and President of the Large Urology Group Practice Association. (Photo by Integrated Medical Professionals, PLLC.)

In its press release on this matter, issued on October 23, the LUGPA wrote: “The Mitchell study was commissioned and funded by the American Society for Radiation Oncology (ASTRO) 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,” said Deepak A. Kapoor, M.D., President of LUGPA and Chairman and CEO of Integrated Medical Professionals, PLLC. “Instead of furthering our understanding of the complicated health policy issues around prostate cancer care, Dr. Mitchell’s work appears to be specifically designed to produce talking points for the sponsor’s political agenda, which is primarily to restore their virtual monopoly on the provision of pathology laboratory services.”

The publication of the three studies, two studies by Mitchell—both funded by organizations associated with ancillary service providers—and one by the GAO, has definitely put a spotlight on the Stark Law exemption for in-office ancillary services. The spat unfolding between urologists on one side and pathologists, radiologists, and radiation therapy professionals on the other side is not likely to be resolved quickly.

It appears that the next fight in this battle will be for passage of the bill introduced by Representative Speier. That bill would,  “Maintain the in-office ancillary services exception and preserve its original intent by removing certain complex services from the exception—specifically, advanced imaging, anatomic pathology, radiation therapy, and physical therapy.” That makes allies of pathologists, radiologists, and radiation therapy professionals in their desire to see this bill passed by Congress and signed into law by the President.

—By Joseph Burns

Editor’s note: The attribution for the statement above regarding “serious concerns about the author’s selection of control groups” has been corrected. It was incorrect in an earlier version.

Related Information:

Urologists’ Use of Intensity-Modulated Radiation Therapy for Prostate Cancer 

Prostate cancer radiation: Conflict of interest or better care?

LUGPA Response to ASTRO Study on Radiation Utilization Published In NEJM

Urologists Denounce Flawed New England Journal of Medicine Article Regarding Prostate Cancer Treatment

Urologist Discredit Flawed, Misleading GAO Cancer Treatment Utilization Study

High Cost of Self-Referral With No Patient Benefit

Lawmaker Introduces Bill to Close Self-Referral Loophole

Legislators call for ban on radiation therapy self-referral

Higher Use of Costly Cancer Treatment by Providers Who Self-Refer Warrants Scrutiny

GAO Targets Self-Referrals for Radiation Therapy

Urologists’ Self-Referral for Pathology of Biopsy Specimens Linked to Increased Use and Lower Prostate Cancer Detection

New study in NEJM exposes overuse of radiation therapy services when urologists profit through self-referral

New England Journal of Medicine Study Again Confirms High Cost of Self-Referral with No Patient Benefit