External beam radiation therapy refers to seven distinct treatment strategies for the delivery of radiation energy to various cancer types and locations in the body. These strategies are variously employed based on the known location, response or sensitivity of the cancer to radiation treatment.1 A patient may receive radiation therapy before, during, or after surgery. Some patients may receive radiation therapy alone, without surgery or other treatments. Some patients may receive radiation therapy and chemotherapy at the same time. The timing of radiation therapy depends on the type of cancer being treated and the goal of treatment (cure or palliation).2
One form of such external beam radiation treatment which has grown in popularity in recent years is intensity-modulated radiation therapy, or IMRT. The following summary by the Radiological Society of North America, describes and sets forth the value of IMRT in cancer radiotherapy:
Intensity-modulated radiation therapy (IMRT) is an advanced mode of high-precision radiotherapy that uses computer-controlled linear accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor. IMRT allows for the radiation dose to conform more precisely to the three-dimensional (3-D) shape of the tumor by modulating—or controlling—the intensity of the radiation beam in multiple small volumes. IMRT also allows higher radiation doses to be focused to regions within the tumor while minimizing the dose to surrounding normal critical structures. Treatment is carefully planned by using 3-D computed tomography (CT) or magnetic resonance (MRI) images of the patient in conjunction with computerized dose calculations to determine the dose intensity pattern that will best conform to the tumor shape.3
Radiation therapy equipment, which is owned outright by physician specialists in Radiation Oncology is expensive; IMRT equipment is no exception, although much of these costs are passed on to insurance carriers. The costs of IMRT are typically 400-500% higher than for more traditional therapies, referred to as conformal 3-D radiotherapy. Whether the clinical benefit of this treatment justifies its incremental cost in all clinical settings is still unclear.4
The Government Accountability office recently analyzed the application of IMRT therapy by prostate cancer specialists (Urologists) and the utilization of IMRT based on commercial self-interest (i.e. equipment ownership and self-referral).5 This report emphasized that selection of treatment strategy for a given patient with prostate cancer may be based on several options, without a clear difference in quality of care, or medical treatment outcomes. To this extent, the highly biased and preferential use of IMRT based on ownership of the IMRT treatment facilities to the exclusion of other therapies, when IMRT does not have a clear survival or quality of life advantage to the patient, raises the possibility of physician conflict of interest.
A doctor has a duty to treat a patient’s medical condition to improve that patient’s health. A conflict of interest arises when a doctor recommends or gives the patient tests or treatments, such as IMRT, for some other reason, which is not professionally acceptable; in almost all cases of impropriety, this other reason involves direct or indirect financial gain by the doctor.6
Such selection of therapeutic strategy on the part of a physician, when his or her patient lacks the knowledge and judgment to understand the potential conflict of interest on the part of the physician, and where a clear incremental clinical benefit is not demonstrated, may constitute a violation of the False Claims Act.
- Center for Healthcare Research and Transformation, Issue Brief August, 2002. Intensity-Modulated Radiation Therapy for Breast and Lung Cancer: A Review of Use, Cost, Clinical Evidence, and Safety.
- Higher Use of Costly Prostate Cancer Treatment by Providers Who Self-Refer Warrants Scrutiny. GAO Report 13-525.