Medical Device Daily Washington Editor

The Government Accountability Office generated another report on physician self-referral, this one addressing intensity-modulated radiation therapy (IMRT) for prostate cancer. GAO claimed that such self-referred procedures increased by a factor of more than four between 2006 and 2010, and four members of Congress reacted with a letter alleging profiteering. However, provider groups are pushing back, asserting that the GAO report is "incomplete and misleading," setting up a battle of wills that may test Congress's ability to focus on narrow cost issues in the face of larger fiscal conflicts in Washington.

GAO stated that the number of self-referred uses of IMRT for prostate cancer treatment ballooned from 80,000 to more than 360,000 between 2006 and 2010, adding that this increase in self-referral was "due entirely to limited-specialty groups" of providers, rather than multi-specialty groups. The report also alleges that providers boosted their referrals for IMRT for these patients "after they began to self refer," noting that providers with a stake in an IMRT facility were "less likely to refer them for other treatments," including prostatectomy and brachytherapy.

The report recommended that the Centers for Medicare & Medicaid Services require that providers disclose the self-interest to patients, but also that CMS monitor self-referral. Jim Esquea, assistant secretary for legislation at the Department of Health and Human Services, noted that inserting a self-referral flag on claims forms would be "complex to administer" and would not disclose whether the self-referral is appropriate. Esquea also noted that the White House budget proposal for fiscal 2014 would exclude some services from the in-office ancillary services exception to self-referral law, a similar set of remarks to those he offered in the context of self-referral for anatomic pathology tests (Medical Device Daily, July 17, 2013).

The Aug. 1 letter from Capitol Hill was signed by four, including Sen. Max Baucus (D-Montana), chairman of the Senate Finance Committee, who said the report prompts speculation as to "where health care stops and where profiteering begins. Baucus alleged "an increasing number of physicians are skirting the law for their own personal gain," and argued that Congress "needs to close this loophole and fix the problem."

Deepak Kapoor, MD, President of the Large Urology Group Practice Association (LUGPA; Schaumberg, Illinois), told MDD, "I would have to take issue" with the idea that everyone in Congress sees a problem.

Kapoor said a recent letter from physicians to Congress indicates "an overwhelming majority of physicians in the U.S. are not in favor" of further regulatory activity to clamp down on self-referral in this context. He said that most physicians serving in Congress "jointly signed a leader to the House leadership voicing their very strong support" for practitioners that are the target of the GAO report.

"A limitation on the ability of physicians to provide ancillary services in the context of comprehensive care is not ultimately in the best interest of patients," Kapoor asserted. He noted that the Affordable Care Act in particular and recent trends in practice in general are a response to an ethic that calls for "physicians ... to provide integrated services that move away form a fee-for-service model."

Kapoor said the predicament is an indicator of "a turf battle between historical monopolies, which would be radiologist oncologists, radiologists and pathologists. These are individuals that quite frankly were at the upper echelon of income in the medical community," he charged. "These were doctors who never interacted with the patient, and they relied on these exorbitant technical fees to control access to care. That's not consistent with the integrated care model," Kapoor asserted.

Addressing the GAO assertion that the greater degree of self-referral to IMRT was associated with a drop in other therapeutic approaches, Kapoor said that in a close call as to which therapy might be appropriate for the patient, a specialist may tend to revert to his or her own specialty.

"Physicians talk about what they know, not because they have a financial incentive, but because its what they know," Kapoor said. He stated that as a surgical oncologist, "I don't understand radiation like a radiation oncologist, and that's the point we made" to GAO as it pursued the data that appeared in the report.

"What we told GAO – and we supported it with the peer-reviewed literature – if you only saw a surgeon, there is a better than 50% chance you're going to have surgery," Kapoor stated, noting that an even stronger correlation – one of greater than 80% – applies to radiation. He also alleged that the literature suggests that brachytherapy has not shown itself to be equivalent to many other procedures for a significant percentage of patients.

Kapoor described the GAO report as "a very blunt instrument about a very nuanced topic," stating further that while overall utilization of IMRT is flat, "the number of urologists that own IMRT has tripled." He said the use of this modality for other diseases "increased by more than 50%," over the period of the GAO study as well.

Mark McCarty, 703-365-2519

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