Financial Incentives Driving Prostate Cancer Testing and IMRT?

Zosia Chustecka

April 18, 2012

April 11, 2012 ( UPDATED April 18, 2012 ) — Two practices related to prostate cancer care and the way it is delivered by urologists have come under scrutiny in 2 studies published in the April issue of Health Affairs. In both cases, physicians stand accused of profiting financially from self-referral.

One of the issues involves the diagnosis of prostate cancer from biopsies sent to pathology laboratories; the other involves the treatment of prostate cancer with high-intensity modulated radiotherapy (IMRT) instead of standard radiotherapy.

There is a federal law in the United States that prevents physicians from referring a patient to a service with which they have a financial relationship. However, an exemption can be made be if the physician is referring the patient to self-owned services in which they have a supervisory or managerial role, and if the services are provided in the same building.

Using this exemption clause, some urology practices have in-house pathologists to examine biopsy specimens taken from men suspected of having prostate cancer; others have invested in expensive systems to deliver IMRT to patients with prostate cancer.

Because these urologists stand to gain financially from using these in-house services, there is a concern that financial incentives are driving the use — and potentially the overuse — of these services.

Such concerns have already led several medical groups to lobby Congress to close the loophole in the law. Data from 2 new studies now provide fresh ammunition that self-referral is resulting in the overuse of in-house services.

However, there are issues with both studies, said David Penson, MD, MPH, vice chair of health policy at the American Urology Association (AUA), and professor of urologic surgery at the Vanderbilt University Medical Center in Nashville, Tennessee. In both instances, there is a "turf war" going on between specialties, with pathologists and radiation oncologists competing against urologists to provide services. This is coloring some of the views that are being aired, he told Medscape Medical News in an interview.

Financial Incentives for Pathology Testing

The study on pathology testing of prostate specimens, by Jean Mitchell, PhD, economist and professor of public policy at Georgetown University in Washington, DC, analyzed data from 2005 to 2007. She found that self-referring urologists who have in-house pathologists billed Medicare for 4.3 more specimens per biopsy than the adjusted mean of 6 specimens per biopsy that nonself-referring urologists sent to independent pathology providers. This is a difference of almost 72%, she notes.

Although they sent more samples for testing, the self-referring urologists did not find any more cases of prostate cancer per patient than the group that used independent pathologists. In fact, the regression-adjusted cancer detection rate in 2007 was 12% higher for urologists who did not self-refer.

This suggests that financial incentives prompt self-referring urologists to perform prostate biopsies.

"This suggests that financial incentives prompt self-referring urologists to perform prostate biopsies on men who are unlikely to have prostate cancer," Dr. Mitchell concludes.

"These results support closing the loophole that permits self-referral to 'in-office' pathology laboratories," she added.

The study was immediately "applauded" by the Alliance for Integrity in Medicine Coalition, which includes a number of professional organizations, such as the American Society for Clinical Pathology, the College of American Pathologists, the American Clinical Laboratory Association, the American College of Radiology, and the American Society for Radiation Oncology (ASTRO). This coalition is actively urging Congress to close the legal loophole that allows self-referral.

This self-referral practice....provides no benefit to patients and only serves to drive up Medicare costs.

Dr. Mitchell's study is "particularly welcome," according to the coalition, because it provides independent peer-reviewed evidence that "this self-referral practice...provides no benefit to patients and only serves to drive up Medicare costs."

However, the Large Urology Group Practice Association (LUGPA), which represents more than 1800 urologists in the United States, disputes the study, and says that it is " methodologically flawed, misleading, and factually inaccurate."

"To suggest that certain practices are performing extra and unnecessary pathology work for their own remuneration when they are working within rational clinical guidelines is offensive," LUGPA president Deepak Kappor, MD, said in a statement.

AUA spokesperson Dr. Penson outlined several issues with the data. Dr. Mitchell and colleagues suggest that urologists with in-house pathologists are taking more biopsies, but the data actually show that they are sending more jars to the pathologist, he noted.

The standard of care for prostate testing is to take 10 to 12 core biopsies, he explained. These are then placed into jars for delivery to the pathologists, and several cores can be placed into 1 jar. However, leading pathologists and previous research suggest that it is preferable to place only 1 specimen per jar. The data that reported shows that the urologists with in-house pathologists "were sending off more jars, but I would argue that they were following evidence-based medicine, and doing exactly what the literature is telling them to do," he said.

Another issue that Dr. Penson raised was that the cancer detection rate per patient was based on diagnostic billing information provided by the pathologists, which is subject to systematic bias, he explained. There was no follow-up to see if patients received treatment for prostate cancer or if they were further investigated by the treating physician, he said.

In addition, Dr. Penson pointed out that this study was supported by an unrestricted grant from the American Clinical Laboratory Association and the College of American Pathologists, and he said that the authors laid out the data to support the pathologists in their turf war.

Dr. Kappor agrees. "This study simply furthers the political agenda of its sponsors to recapture lost market share and does not deserve credible recognition," he said.

Overuse of IMRT for Prostate Cancer

The study on IMRT for the treatment of prostate cancer, by Bruce Jacobs, MD, and colleagues from the University of Michigan in Ann Arbor, suggests that there is an overuse of this technology.

IMRT is a fairly new. It delivers higher doses of radiation with better precision than other radiotherapies and is thought to have lower toxicity, but it also costs $15,000 to $20,000 more than standard therapies, the authors point out.

Does everyone deserve a Cadillac when a Buick is almost as good?

They liken the 2 approaches to cars, and ask whether, "in the context of limited resources, does everyone deserve a Cadillac when a Buick is almost as good?"

In their study, Dr. Jacobs and colleagues analyzed data on prostate cancer treatment from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. They found that when IMRT was first introduced in the United States (2001 to 2003), it was used mainly in men with high-risk prostate cancer; from 2004 to 2007, the use of this therapy became more widespread. During this period, men whose prostate cancer was considered low risk, and therefore less likely to be clinically significant, were just as likely to receive IMRT as men who were at high risk. "This raises serious concerns about overtreatment," the authors note.

They suggest that "some physicians may view IMRT as an investment opportunity." Delivery of radiation has shifted from oncologists to urologists, they note, and some companies have been marketing IMRT aggressively to urologists as a revenue generator. "In this context, financial pressures induced by the considerable start-up costs may encourage IMRT in marginal patients," they add.

These comments drew a rapid response from ASTRO, which is one of the groups that has been lobbying Congress to close the loophole that allows self-referral.

A statement from ASTRO states that "IMRT yields benefits to prostate cancer patients through increased tumor control and fewer side effects," and that this "will ultimately reduce healthcare spending on prostate cancer and demonstrate the value of IMRT."

"At the same time, all patients may not be ideal candidates for IMRT, and patients should be presented with all of their options, including active surveillance," the statement reads.

In their article, Dr. Jacobs and colleagues note that Medicare reimbursement for IMRT is substantially more than for other radiotherapy.

According to ASTRO, this is because the technology is complex and requires more expertise, but the problem is not caused by the reimbursement rate of IMRT, which has declined by about 30% over the past 6 years. The problem is the overuse of IMRT in patients who don't need it.

Physician self-referral is significantly contributing to overuse of IMRT.

"Nearly 1 in 5 urology practices now own IMRT machines," ASTRO reports. "The expansion of these mega-urology practices can dominate prostate cancer diagnosis and treatment services in their market areas, and likely played a role in the growth of IMRT use during the study period."

ASTRO has several studies underway that it hopes will "shine light on how physician self-referral is significantly contributing to overuse of IMRT." In the meantime, the society says that it "will continue to work with Congress to close the self-referral loophole that leads to this abuse and ensure that all cancer patients receive the safest, most cost-effective cancer treatments."

Dr. Penson pointed out that this study does not provide any information on where IMRT is being delivered — there are no data on ownership. All the data show is an increase in the use of IMRT from 2001 to 2007, and that it is replacing standard radiotherapy, but this is across all settings, he noted. The authors speculate about urologist ownership of IMRT, but "I think this is a jump," he said.

A recent study (J Urol. 2012;187:1253-1258) reported that 62% of IMRT is delivered in a hospital setting. That means that 38% of prostate IMRTs were performed in free-standing radiation oncology centers. "We have no way of knowing how many of these free-standing centers were owned by urologists and how many were owned by radiation oncologists, but it is probably safe to say that a substantial number were owned by the radiation oncologist," he said.

There is a financial incentive for the owner of the IMRT facility, whether the owner is a hospital, a radiation oncologist, or a urologist, Dr. Penson said. He suggested that the stake that the radiation oncologists have in this is what fuelled the ASTRO statement.

Health Aff. 2012;31:741-749, 750-759. Abstract, Abstract

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