Intensity-Modulated Radiation Therapy and Self-Referral
What is behind new criticisms and liabilities?
A number of recent publications regarding urology services have ignited a storm of discussion about the propriety and effects of self-referral by urologists.
In the wake of a 2012 Government Accountability Office (GAO) report that focused attention on self-referral in advanced imaging, a June 2013 GAO report attributed a doubling of anatomic pathology services over a four-year period to self-referral by urologists who acquired and utilized their own pathology laboratory equipment.1,2 In July, another GAO report similarly attributed a four-year quadrupling of intensity modulated radiation therapy (IMRT) use to self-referral by urologists.3 Most recently, research published in the October 2013 New England Journal of Medicine showed that urologists who acquired IMRT equipment significantly increased their referrals of patients for IMRT when compared to urologists who did not own IMRT equipment.4 Georgetown University researcher Jean Mitchell, PhD, compared a group of self-referring urology groups with similar groups that did not self-refer. Much more importantly, however, using retrospective analysis of Medicare claims data, Mitchell was able to compare referral rates by the same urology groups before and after they acquired IMRT equipment. This same-practice comparison showed such a significant change in referral patterns that it effectively undercut many of the criticisms and defenses the urologists raised after the issuance of the GAO reports.
So what does any of this have to do with legal issues? Well, readers may recall our July 2013 and October 2013 columns on the use of legislation to overcome adverse court rulings. (If you need a refresher, visit http://bit.ly/JulyRADLAW and http://bit.ly/OctRADLAW.) Similarly, studies such as these IMRT publications can force both regulators and legislators to consider taking actions on topics that they would prefer to ignore. They may also induce insurers and others to reconsider their payment policies.
For example, representatives Jackie Speier (D-CA) and James McDermott (D-WA) have introduced the Promoting Integrity in Medicare Act of 2013, which would remove radiation therapy, anatomic pathology, advanced imaging, and physical therapy from the in-office ancillary services exemption of the Stark self-referral laws. While many parties have long sought a tightening of such exemption, these reports and the numerous news commentaries have given the efforts additional momentum.
In addition, the multibillion-dollar shortfalls in annual medical funding and the need for a permanent sustainable growth rate fix have forced legislators and regulators such as CMS to seek pay-fors from sources that would have been politically unpalatable as recently as two years ago. In budgetary terms, each time the federal government wishes to increase or at least avoid cutting reimbursement for physicians, it must identify and take a proportionate amount of funds from another source to “pay for” the reimbursement “fix.” Just as Congress has enabled CMS to cut payments for advanced outpatient imaging, IMRT may soon find itself in Congress’ crosshairs.
ASTRO called the NEJM study “clear, indisputable evidence that many men are receiving unnecessary radiation therapy for their prostate cancer due to self-referral” and stated, “We must end physician self-referral for radiation therapy and protect patients from this type of abuse.”5
Even some prominent urologists, like James Mohler, MD, of Roswell Park Cancer Institute, strongly criticize this type of self-referral. As chair of the National Comprehensive Cancer Network (NCCN) Prostate Cancer Guidelines Panel, which has representatives from 23 of the leading cancer hospitals, he issued a joint statement on behalf of the NCCN and the panel. The statement noted,
Most men with prostate cancer as classified by NCCN as “very low” risk and many men with “low” risk cancer are best served by careful “active surveillance.” Active Surveillance seeks to deliver treatment only to those men who require it while avoiding the side effects of operation or radiation that was not necessary in the first place. The NCCN Prostate Cancer Guidelines Panel remains committed to providing men and their physicians with the best possible guidance so they can make the best choices for management of this alltoo- common cancer.6
Mohler went on to declare, “Men should be educated and counseled about all appropriate treatment options outlined in evidenced-based guidelines so they can make the choice they feel is best for them. Prostate cancer treatment recommendations should be based on the best available clinical evidence and not influenced by business or personal interests of the care provider.”
Now, back on the legal beat, we can assure you that, inevitably, some plaintiffs’ lawyers will seize upon the words, “receiving unnecessary radiation therapy,” “protect patients from this type of abuse,” and “avoiding the side effects of operation or radiation that was not necessary in the first place,” and use them as the basis for malpractice claims against urologists who can be proven to be statistical outliers in the use of IMRT. An increasing number of such claims, or even just a number of large verdicts, may also reduce the percentage of physicians who are willing to risk being held accountable for this type of inappropriate self-referral.
Finally, if CMS and the Office of Inspector General decide to focus on this matter as an overutilization target, some IMRT use could be classified as not medically necessary, resulting in denial of claims for such treatment and, in some cases, charges of fraud and false claims, resulting in significant civil and criminal penalties. Perhaps even more seriously, statistical outliers may find themselves the targets of whistleblower suits and class-action lawsuits.
By Bill Shields, JD, LLM, CAE, and Tom Hoffman, JD, CAE