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Self-Referral in Radiation Oncology: Has Caveat Emptor Replaced Primum Non Nocere?
International Journal of
Radiation Oncology biology
physics
www.redjournal.org
Comments Self-Referral in Radiation Oncology: Has Caveat Emptor Replaced Primum Non Nocere? To the Editor: The treatment of localized prostate cancer in this country remains one of the most controversial topics in oncology. In men with clinically localized prostate cancer, which represents about 85% of the cases diagnosed each year in the United States, the vast majority will not die from this disease, including those with high-grade tumors (1). As concern about overdiagnosis and overtreatment of prostate cancer rages (2), the number of active, aggressive treatment options continues to proliferate. We seem to be embroiled in a technologic arms race featuring applications of increasingly sophisticated equipment to treat patients with little chance of benefit from these treatments, if “benefit” is measured in terms of prolongation of survival or improvement in quality of life beyond that achieved with active surveillance. What is leading us down this road to perdition? Unfortunately, in large measure it appears to be greed. An increasing body of evidence would suggest that a disturbingly large percentage of health care providers involved in the care of men with prostate cancer are placing their own financial interests ahead of their patients’ concerns for quantity and quality of life. At the center of this controversy are exemptions to the Ethics in Patient Referrals Act (the Stark Laws) (3), which permit physicians to refer patients to outside facilities in which the referring physician has a financial interest but no professional responsibility (ie, to self-refer). In the world of prostate cancer, this phenomenon manifests as urology groups owning radiation oncology equipment, hiring radiation oncologists, and then referring patients to the centers they own for radiation therapy. This trend has become so popular and pervasive that in 2010, it was estimated that 1 in 5 urology practices in the United States owned radiation therapy equipment. On the surface, this might sound like a good idea. Proponents argue that these “integrated health care” arrangements improve access, convenience, and continuity of care. In reality, what they appear to be doing is shifting patients away from recognized centers of excellence, thus both compromising training programs (4) and creating a potential for worse patient outcomes (5), and greatly increasing the frequency of potentially inappropriate treatment (6, 7), thus exposing patients to unnecessary risks of complications. An analysis in The Wall Street Journal found that in areas with the greatest penetration of this type of self-referral, one-third of men with prostate cancer aged over 80 years were treated with intensity modulated radiation therapy compared with 13%-24% nationwide (6), and it was shown over 20 years ago that self-referral in radiation oncology does not increase access to care in underserved areas (8). Thus the unintended consequences of these legal exemptions may be putting patients directly in harm’s way.
Int J Radiation Oncol Biol Phys, Vol. 84, No. 4, pp. 874e878, 2012 0360-3016/$ - see front matter Ó 2012 Elsevier Inc. All rights reserved.
What can we do to protect our patients and restore their confidence that we have their best interest at heart? Because these business arrangements cannot exist without the active participation of radiation oncologists, we as a specialty must police our own house. First, we must educate our trainees about the potential harm that these selfreferral arrangements pose to patients and to our specialty, and we must implore our graduating residents not to work in these practices. Second, we must educate patient groups about the risks that selfreferral poses to them. Third, we should consider professional sanctions against members of our professional societies who participate in these self-referral arrangements. Federal courts have upheld the rights of professional societies to regulate themselves with respect to determining what constitutes conduct detrimental to the profession or patient care (9). Perhaps posting a list of selfreferral participants on the Internet would help reverse this concerning trend. Mitchell S. Anscher, MD Department of Radiation Oncology Virginia Commonwealth University Medical Center Richmond, Virginia http://dx.doi.org/10.1016/j.ijrobp.2012.06.038
References 1. Lu-Yao GL, Albertsen PC, Moore DF, et al. Outcomes of localized prostate cancer following conservative management. JAMA 2009;302: 1202-1209. 2. Klotz L. Cancer overdiagnosis and overtreatment. Curr Opin Urol 2012;22:203-209. 3. Kolber MJ. Stark regulation: a historical and current review of the selfreferral laws. HEC Forum 2006;18:61-84. 4. Anscher MS, Anscher BM, Bradley CJ. The negative impact of stark law exemptions on graduate medical education and health care costs: the example of radiation oncology. Int J Radiat Oncol Biol Phys 2010; 76:1289-1294. 5. Onega T, Duell EJ, Shi X, et al. Influence of NCI cancer center attendance on mortality in lung, breast, colorectal, and prostate cancer patients. Med Care Res Rev 2009;66:542-560. 6. Carreyrou J, Tamman M. A device to kill cancer, lift revenue. The Wall Street Journal. December 7, 2010:A1, A20. 7. Wilt TJ, MacDonald R, Rutks I, et al. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008;148:435-448. 8. Mitchell JM, Sunshine JH. Consequences of physicians’ ownership of health care facilitiesdjoint ventures in radiation therapy. N Engl J Med 1992;327:1497-1501. 9. Austin v American Association of Neurological Surgeons. 253 F.3d 967 (7th Cir 2001).
Radiation Oncology biology
physics
www.redjournal.org
Comments Self-Referral in Radiation Oncology: Has Caveat Emptor Replaced Primum Non Nocere? To the Editor: The treatment of localized prostate cancer in this country remains one of the most controversial topics in oncology. In men with clinically localized prostate cancer, which represents about 85% of the cases diagnosed each year in the United States, the vast majority will not die from this disease, including those with high-grade tumors (1). As concern about overdiagnosis and overtreatment of prostate cancer rages (2), the number of active, aggressive treatment options continues to proliferate. We seem to be embroiled in a technologic arms race featuring applications of increasingly sophisticated equipment to treat patients with little chance of benefit from these treatments, if “benefit” is measured in terms of prolongation of survival or improvement in quality of life beyond that achieved with active surveillance. What is leading us down this road to perdition? Unfortunately, in large measure it appears to be greed. An increasing body of evidence would suggest that a disturbingly large percentage of health care providers involved in the care of men with prostate cancer are placing their own financial interests ahead of their patients’ concerns for quantity and quality of life. At the center of this controversy are exemptions to the Ethics in Patient Referrals Act (the Stark Laws) (3), which permit physicians to refer patients to outside facilities in which the referring physician has a financial interest but no professional responsibility (ie, to self-refer). In the world of prostate cancer, this phenomenon manifests as urology groups owning radiation oncology equipment, hiring radiation oncologists, and then referring patients to the centers they own for radiation therapy. This trend has become so popular and pervasive that in 2010, it was estimated that 1 in 5 urology practices in the United States owned radiation therapy equipment. On the surface, this might sound like a good idea. Proponents argue that these “integrated health care” arrangements improve access, convenience, and continuity of care. In reality, what they appear to be doing is shifting patients away from recognized centers of excellence, thus both compromising training programs (4) and creating a potential for worse patient outcomes (5), and greatly increasing the frequency of potentially inappropriate treatment (6, 7), thus exposing patients to unnecessary risks of complications. An analysis in The Wall Street Journal found that in areas with the greatest penetration of this type of self-referral, one-third of men with prostate cancer aged over 80 years were treated with intensity modulated radiation therapy compared with 13%-24% nationwide (6), and it was shown over 20 years ago that self-referral in radiation oncology does not increase access to care in underserved areas (8). Thus the unintended consequences of these legal exemptions may be putting patients directly in harm’s way.
Int J Radiation Oncol Biol Phys, Vol. 84, No. 4, pp. 874e878, 2012 0360-3016/$ - see front matter Ó 2012 Elsevier Inc. All rights reserved.
What can we do to protect our patients and restore their confidence that we have their best interest at heart? Because these business arrangements cannot exist without the active participation of radiation oncologists, we as a specialty must police our own house. First, we must educate our trainees about the potential harm that these selfreferral arrangements pose to patients and to our specialty, and we must implore our graduating residents not to work in these practices. Second, we must educate patient groups about the risks that selfreferral poses to them. Third, we should consider professional sanctions against members of our professional societies who participate in these self-referral arrangements. Federal courts have upheld the rights of professional societies to regulate themselves with respect to determining what constitutes conduct detrimental to the profession or patient care (9). Perhaps posting a list of selfreferral participants on the Internet would help reverse this concerning trend. Mitchell S. Anscher, MD Department of Radiation Oncology Virginia Commonwealth University Medical Center Richmond, Virginia http://dx.doi.org/10.1016/j.ijrobp.2012.06.038
References 1. Lu-Yao GL, Albertsen PC, Moore DF, et al. Outcomes of localized prostate cancer following conservative management. JAMA 2009;302: 1202-1209. 2. Klotz L. Cancer overdiagnosis and overtreatment. Curr Opin Urol 2012;22:203-209. 3. Kolber MJ. Stark regulation: a historical and current review of the selfreferral laws. HEC Forum 2006;18:61-84. 4. Anscher MS, Anscher BM, Bradley CJ. The negative impact of stark law exemptions on graduate medical education and health care costs: the example of radiation oncology. Int J Radiat Oncol Biol Phys 2010; 76:1289-1294. 5. Onega T, Duell EJ, Shi X, et al. Influence of NCI cancer center attendance on mortality in lung, breast, colorectal, and prostate cancer patients. Med Care Res Rev 2009;66:542-560. 6. Carreyrou J, Tamman M. A device to kill cancer, lift revenue. The Wall Street Journal. December 7, 2010:A1, A20. 7. Wilt TJ, MacDonald R, Rutks I, et al. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008;148:435-448. 8. Mitchell JM, Sunshine JH. Consequences of physicians’ ownership of health care facilitiesdjoint ventures in radiation therapy. N Engl J Med 1992;327:1497-1501. 9. Austin v American Association of Neurological Surgeons. 253 F.3d 967 (7th Cir 2001).