- Email: [email protected]
Medical Value vs Cost and Risk: Redux
JAMES H. THRALL, MD ACR CHAIR’S MEMO
Medical Value vs Cost and Risk: Redux Every week seems to bring another issue forward challenging the value of imaging as a component of the health care system. The challenges hinge on two factors: costs to the health system for imaging services that have grown rapidly and perceived risks, especially from ionizing radiation, but also from over diagnosis and overtreatment from imaging examinations with false-positive results. The ACR has been diligent in addressing challenges to the value of imaging head on with scientific and economic data, but the tide of “political correctness” is clearly running against imaging. It is unfortunate that at a time when imaging methods are in the process of transforming the way medicine is practiced, the economy is in shambles, the health system is teetering on insolvency, and any medical service that seems to be growing in use has become an obvious target for savings through restrictions on use. The high cost of the American health care system balanced against a life expectancy in the United States that is lower than in most other developed countries is taken as proof by many that major cuts in services can be made without sacrificing quality or outcomes. Imaging is not the only target. In previous columns, I have noted that the imaging community could do a better job in framing the cost questions surrounding imaging services. Typically, the cost of imaging services is simply compared by insurance companies and government agencies from one year to the next, without including a broader view of associated savings and better outcomes for patients associated with the application of imaging methods. Health policy researchers and commentators have found it convenient to overlook things such as the elimination of exploratory surgery and surgery for
cancer staging, including “second look” surgery, that have been totally replaced by less expensive and safer noninvasive imaging methods. Introducing imaging methods to replace surgery raises aggregate imaging costs and reduces aggregate surgical costs, but does anyone think we should switch directions and go back to exploratory surgery? If not, why is imaging being attacked without broader based, more inclusive research into true total costs for episodes of care? The ACR and the broader imaging research community must begin reframing the discussion of costs to look at the entire range of services that go into an episode of care so that the positive trade-offs from the use of imaging are correctly recognized. When researchers at the Massachusetts General Hospital did this for the use of CT in suspected appendicitis and in making decisions to admit or send home patients from the emergency department, the cost savings from imaging were very apparent. This kind of research must be applied to more topics. Although innovative imaging services are looked upon as growing too much, many surgical procedures seem to be well controlled because they are being wholly or partly replaced. Accordingly, the ACR has fought hard to defeat a proposal in Congress that would have created a separate sustainable growth rate category for imaging. In essence, partitioning growing vs contracting services in calculations of the sustainable growth rate would reward older procedures not experiencing growth while punishing creative new areas of medical practice such as imaging that are growing because they add more value to the care process. One of the most aggravating aspects of the cost conundrum is that there are a number of avenues available in the health system for reducing costs without encumbering providers
© 2010 American College of Radiology 0091-2182/10/$36.00 ● DOI 10.1016/j.jacr.2009.12.014
with additional compliance requirements or reducing reimbursement per unit of service. Reductions in perunit reimbursement threaten to diminish access by bankrupting imaging providers and by diminishing the resources needed by hospitals to keep imaging services up-to-date. Medically unnecessary, financially motivated self-referral seems to represent about 8% to 12% of imaging costs in the United States, or around $10 billion per year. CMS or Congress could eliminate the in-office ancillary services exemption for high-cost imaging. If joined by private payers, substantial savings could be realized in excess of those projected for the Deficit Reduction Act of 2005 and current health reform combined. Self-referring physicians look at imaging devices as cash registers, but the politics surrounding self-referral apparently have been too daunting for action. However, the issue is finally becoming well understood in Washington, providing hope for the future. Another avenue for cost reduction is tort reform. It is actually not so much the cost of malpractice insurance and the legal process that drives up unnecessary costs so much as defensive medicine, the ordering of services not for a medical purpose but to protect a provider from liability. The politics of the tort system will likely continue to obstruct meaningful reform. Because of defensive medicine, the US health system is burdened with an incredible expense unprecedented elsewhere in the world. The issue is further associated with demoralizing effects on providers, also unprecedented in other health systems. Self-referral and defensive medicine related to the US tort system account for a major part of the difference in US health costs compared with those in other countries. 81
82 ACR Chair’s Memo
The ACR will continue to press these points home with members of Congress and the administration in Washington. The issues surrounding imaging-associated risks are equally problematic. The scientific evidence for cancer risk from radiation is fragmented, subject to widely different interpretations, and not of a quality that would be accepted for most scientific purposes. For obvious reasons, there are no prospective randomized controlled trials of radiation exposure, and such trials represent the highest level of scientific evidence. Virtually all radiation exposure data have been collected retrospectively without the ability to control for confounding factors. Examples of such factors include nutritional status (most studies including the atomic bomb casualty victims), smoking history (nuclear power workers), and the actual levels of radiation received. Everyone agrees that radiation in sufficient quantity can cause cancer, but at that point, the games begin. For example, a new pseudoscience has emerged wherein the risk for developing cancer or dying from a cancer related to a diagnostic procedure such as a CT scan is calculated for individual patients. Such estimates assume the linear no-threshold model for radiation injury, for which there is no definitive scientific proof and much contravening empirical evidence. Moreover, some recent estimates of cancer induction assume that the life expectancy of the scanned population and the general population are the same or the same after people with existing cancers and close to the end of life are removed from the study population. People undergoing imaging for life-threatening conditions do not have life expectancies equal to the general population, and hence such estimates of
cancer induction by radiation are almost certainly overstated. Three recent symposia have highlighted many radiation-related issues of which radiologists need to be mindful: dose optimization, dose audits, accurate record keeping, quality review, and the accreditation of equipment to ensure that it is in the best working order. Most important, although the science for linking an individual patient’s risk for developing cancer to the radiation received from a specific imaging procedure is weak and is probably being overstated because radiation in sufficient quantity is clearly carcinogenic, this places an absolute burden on radiologists to use as little radiation as reasonably achievable: the ALARA principle. To achieve this goal, there are two sources of unnecessary radiation that radiologists and the health system must eliminate: excessive radiation from procedures that are medically indicated and any radiation from procedures that are not medically indicated. With respect to the former, 3 major efforts are now under way to optimize radiation dose and match the amounts used with specific clinical scenarios. These 3 initiatives are the Image GentlySM and Step Lightly campaigns put forward by the Society of Pediatric Radiology and a new campaign aimed at imaging in adults just getting under way called Image Wisely, jointly sponsored by the ACR, the Radiological Society of North America, the American Association of Physicists in Medicine, and the American Society of Radiologic Technologists. All 3 campaigns are aimed at providing information and guidelines to imaging providers for the optimization of radiation dose. The tag line for Image Gently is “One size does not fit all.” This em-
phasizes the need to tailor dose to each patient and for myriad reasons for obtaining imaging examinations. The same principle applies to selecting protocols for adults. Radiation received from an examination that is not medically indicated is in a sense the most hurtful of all. The ACR has taken the lead among medical specialties in developing appropriateness criteria for what we do as radiologists. The ACR Appropriateness Criteria® program was established more than 15 years ago for the precise purpose of reducing and hopefully eliminating unnecessary procedures by appropriately guiding physician decision making. The program has been inclusive of specialists from other disciplines from its inception, and the College has recently increased the level of cross-specialty work in this area. Not addressed by the foregoing is the radiation received by patients linked to unneeded examinations performed in the self-referral setting. When not clinically indicated, selfreferral imaging not only drains valuable resources from the health system, it leads to unnecessary exposure of patients to radiation when performed with a method that uses ionizing radiation. Radiologists have special responsibilities for the safety of our patients because of the potential for harm if radiation is not used wisely. Risks and benefits, including lifetime exposure history, must be weighed before undertaking imaging examinations. The commitment to doing this must be reaffirmed by both radiologists and referring physicians. The ACR will continue its efforts to work with radiology practices and the health system to provide the tools to optimize imaging protocols, document best practices, and ensure that imaging is used only when appropriate.
James H. Thrall, MD, Massachusetts General Hospital, Department of Radiology, 32 Fruit Street, Room 216, Boston, MA 02114-2620; e-mail: [email protected].
Medical Value vs Cost and Risk: Redux Every week seems to bring another issue forward challenging the value of imaging as a component of the health care system. The challenges hinge on two factors: costs to the health system for imaging services that have grown rapidly and perceived risks, especially from ionizing radiation, but also from over diagnosis and overtreatment from imaging examinations with false-positive results. The ACR has been diligent in addressing challenges to the value of imaging head on with scientific and economic data, but the tide of “political correctness” is clearly running against imaging. It is unfortunate that at a time when imaging methods are in the process of transforming the way medicine is practiced, the economy is in shambles, the health system is teetering on insolvency, and any medical service that seems to be growing in use has become an obvious target for savings through restrictions on use. The high cost of the American health care system balanced against a life expectancy in the United States that is lower than in most other developed countries is taken as proof by many that major cuts in services can be made without sacrificing quality or outcomes. Imaging is not the only target. In previous columns, I have noted that the imaging community could do a better job in framing the cost questions surrounding imaging services. Typically, the cost of imaging services is simply compared by insurance companies and government agencies from one year to the next, without including a broader view of associated savings and better outcomes for patients associated with the application of imaging methods. Health policy researchers and commentators have found it convenient to overlook things such as the elimination of exploratory surgery and surgery for
cancer staging, including “second look” surgery, that have been totally replaced by less expensive and safer noninvasive imaging methods. Introducing imaging methods to replace surgery raises aggregate imaging costs and reduces aggregate surgical costs, but does anyone think we should switch directions and go back to exploratory surgery? If not, why is imaging being attacked without broader based, more inclusive research into true total costs for episodes of care? The ACR and the broader imaging research community must begin reframing the discussion of costs to look at the entire range of services that go into an episode of care so that the positive trade-offs from the use of imaging are correctly recognized. When researchers at the Massachusetts General Hospital did this for the use of CT in suspected appendicitis and in making decisions to admit or send home patients from the emergency department, the cost savings from imaging were very apparent. This kind of research must be applied to more topics. Although innovative imaging services are looked upon as growing too much, many surgical procedures seem to be well controlled because they are being wholly or partly replaced. Accordingly, the ACR has fought hard to defeat a proposal in Congress that would have created a separate sustainable growth rate category for imaging. In essence, partitioning growing vs contracting services in calculations of the sustainable growth rate would reward older procedures not experiencing growth while punishing creative new areas of medical practice such as imaging that are growing because they add more value to the care process. One of the most aggravating aspects of the cost conundrum is that there are a number of avenues available in the health system for reducing costs without encumbering providers
© 2010 American College of Radiology 0091-2182/10/$36.00 ● DOI 10.1016/j.jacr.2009.12.014
with additional compliance requirements or reducing reimbursement per unit of service. Reductions in perunit reimbursement threaten to diminish access by bankrupting imaging providers and by diminishing the resources needed by hospitals to keep imaging services up-to-date. Medically unnecessary, financially motivated self-referral seems to represent about 8% to 12% of imaging costs in the United States, or around $10 billion per year. CMS or Congress could eliminate the in-office ancillary services exemption for high-cost imaging. If joined by private payers, substantial savings could be realized in excess of those projected for the Deficit Reduction Act of 2005 and current health reform combined. Self-referring physicians look at imaging devices as cash registers, but the politics surrounding self-referral apparently have been too daunting for action. However, the issue is finally becoming well understood in Washington, providing hope for the future. Another avenue for cost reduction is tort reform. It is actually not so much the cost of malpractice insurance and the legal process that drives up unnecessary costs so much as defensive medicine, the ordering of services not for a medical purpose but to protect a provider from liability. The politics of the tort system will likely continue to obstruct meaningful reform. Because of defensive medicine, the US health system is burdened with an incredible expense unprecedented elsewhere in the world. The issue is further associated with demoralizing effects on providers, also unprecedented in other health systems. Self-referral and defensive medicine related to the US tort system account for a major part of the difference in US health costs compared with those in other countries. 81
82 ACR Chair’s Memo
The ACR will continue to press these points home with members of Congress and the administration in Washington. The issues surrounding imaging-associated risks are equally problematic. The scientific evidence for cancer risk from radiation is fragmented, subject to widely different interpretations, and not of a quality that would be accepted for most scientific purposes. For obvious reasons, there are no prospective randomized controlled trials of radiation exposure, and such trials represent the highest level of scientific evidence. Virtually all radiation exposure data have been collected retrospectively without the ability to control for confounding factors. Examples of such factors include nutritional status (most studies including the atomic bomb casualty victims), smoking history (nuclear power workers), and the actual levels of radiation received. Everyone agrees that radiation in sufficient quantity can cause cancer, but at that point, the games begin. For example, a new pseudoscience has emerged wherein the risk for developing cancer or dying from a cancer related to a diagnostic procedure such as a CT scan is calculated for individual patients. Such estimates assume the linear no-threshold model for radiation injury, for which there is no definitive scientific proof and much contravening empirical evidence. Moreover, some recent estimates of cancer induction assume that the life expectancy of the scanned population and the general population are the same or the same after people with existing cancers and close to the end of life are removed from the study population. People undergoing imaging for life-threatening conditions do not have life expectancies equal to the general population, and hence such estimates of
cancer induction by radiation are almost certainly overstated. Three recent symposia have highlighted many radiation-related issues of which radiologists need to be mindful: dose optimization, dose audits, accurate record keeping, quality review, and the accreditation of equipment to ensure that it is in the best working order. Most important, although the science for linking an individual patient’s risk for developing cancer to the radiation received from a specific imaging procedure is weak and is probably being overstated because radiation in sufficient quantity is clearly carcinogenic, this places an absolute burden on radiologists to use as little radiation as reasonably achievable: the ALARA principle. To achieve this goal, there are two sources of unnecessary radiation that radiologists and the health system must eliminate: excessive radiation from procedures that are medically indicated and any radiation from procedures that are not medically indicated. With respect to the former, 3 major efforts are now under way to optimize radiation dose and match the amounts used with specific clinical scenarios. These 3 initiatives are the Image GentlySM and Step Lightly campaigns put forward by the Society of Pediatric Radiology and a new campaign aimed at imaging in adults just getting under way called Image Wisely, jointly sponsored by the ACR, the Radiological Society of North America, the American Association of Physicists in Medicine, and the American Society of Radiologic Technologists. All 3 campaigns are aimed at providing information and guidelines to imaging providers for the optimization of radiation dose. The tag line for Image Gently is “One size does not fit all.” This em-
phasizes the need to tailor dose to each patient and for myriad reasons for obtaining imaging examinations. The same principle applies to selecting protocols for adults. Radiation received from an examination that is not medically indicated is in a sense the most hurtful of all. The ACR has taken the lead among medical specialties in developing appropriateness criteria for what we do as radiologists. The ACR Appropriateness Criteria® program was established more than 15 years ago for the precise purpose of reducing and hopefully eliminating unnecessary procedures by appropriately guiding physician decision making. The program has been inclusive of specialists from other disciplines from its inception, and the College has recently increased the level of cross-specialty work in this area. Not addressed by the foregoing is the radiation received by patients linked to unneeded examinations performed in the self-referral setting. When not clinically indicated, selfreferral imaging not only drains valuable resources from the health system, it leads to unnecessary exposure of patients to radiation when performed with a method that uses ionizing radiation. Radiologists have special responsibilities for the safety of our patients because of the potential for harm if radiation is not used wisely. Risks and benefits, including lifetime exposure history, must be weighed before undertaking imaging examinations. The commitment to doing this must be reaffirmed by both radiologists and referring physicians. The ACR will continue its efforts to work with radiology practices and the health system to provide the tools to optimize imaging protocols, document best practices, and ensure that imaging is used only when appropriate.
James H. Thrall, MD, Massachusetts General Hospital, Department of Radiology, 32 Fruit Street, Room 216, Boston, MA 02114-2620; e-mail: [email protected].