North America

Abstract

IntroductionOver the past several decades, healthcare in North America, and particularly in the United States, has experienced unprecedented growth in diagnostic and treatment capabilities. Accompanying this growth, unfortunately, has been a skyrocketing level of spending. Health care expenditures in the U.S. comprised more than 14% of the domestic gross national product. This percentage is less in Canada, but Canada has struggled with limited health care financing creating access difficulties. During the 1960s and 1970s, medicine was deeply tied to a fee-for-service payment system. In this type of system, physicians were free to make clinical decisions largely independent from those responsible for financing the cost of health care. There was little incentive to control utilization of procedures and services, which led to high expenditures. During this time, ultrasound was beginning to become popular in North America, and utilization of ultrasound proliferated among many specialists, including obstetricians, radiologists, and cardiologists. In the 1980s and 1990s, employers of large businesses saw health care spending as a percentage of corporate profit increase from 8% to approximately 70%. Seeking cost containment, companies increasingly turned to managed care. Under a managed care system, plans seek to control costs, in part by eliminating unnecessary procedures and reducing marginally beneficial studies. Following the lead of large businesses, government programs such as Medicaid and Medicare have also turned to managed care to decrease costs.This changing climate of cost management has had a particular impact on the practice of ultrasound. In the fee-for-service system, the lack of incentive for utilization control encouraged the indiscriminant ordering of ultrasound services. Under a capitated system of managed care, a fixed dollar amount is prepaid to contracting physicians based on the managed care organization’s anticipation of the cost to providing medical care for an average member for a year. Therefore, capitation provides an incentive to request the minimum amount of imaging studies needed to arrive at a diagnosis or to determine a treatment plan.Organization of service deliveryIn the U.S., ultrasound service delivery is poorly organized. This poor organization has led to competition among specialists and primary care physicians to perform, interpret and bill for ultrasound services. Even when one specialty has an established service, another specialty can often purchase equipment and offer the service, particularly to its own patients, without administrative oversight. This has led, in recent years, to turf battles that have been vehement and destructive. In Canada, many of these issues do not exist, because of the limited resources for both equipment purchases and reimbursement. The health system in each of the provinces determines the distribution of ultrasound equipment and the appropriate performing physician.In the U.S., radiologists perform approximately 25% of ultrasounds, and other specialists perform the remaining 75%. More than half of the ultrasounds performed by nonradiologists are done by cardiologists performing cardiac ultrasound studies in both offices and hospitals. The remaining ultrasound examinations are primarily performed by obstetrician/gynecologists followed by physicians in primary care specialties such as family medicine and internal medicine (Spettell et al 1998Spettell C.M. Levin D.C. Rao V.M. et al.Practice patterns of radiologists and nonradiologists Nationwide Medicare data on the performance of chest and skeletal radiography and abdominal and pelvic sonography.Am J Roentg. 1998; 171: 3-5Crossref PubMed Scopus (21) Google Scholar). The variety of physicians who perform and interpret ultrasound has led to the concern about the effect of self-referral. Hillman et al 1990Hillman B.J. Joseph C.A. Mabry M.R. et al.Frequency and cost of diagnostic imaging in office practice A comparison of self-referring and radiologist-referring physicians.N Engl J Med. 1990; 323: 1604-1608Crossref PubMed Scopus (332) Google Scholar) have shown that physicians who perform ultrasound on their own patients, perform 2–8 times more examinations than those who refer their patients to another physician, such as a radiologist. Additionally, the charges for these self-referred procedures are 4–7.5 times higher.Quality issuesReimbursements for diagnostic studies from the variety of physicians who perform ultrasound have routinely been made without monitoring the quality of the work or the equipment used to perform them. Outcomes of routine screening ultrasound in obstetrics show that the sensitivity for the detection of fetal anomalies varies from 40% to 84%. Studies have offered evidence that experience of the examiner is an important determinant in the ultrasound diagnosis of congenital malformations. The Helsinki ultrasound trial found a detection rate for fetal anomalies of 36% at the City Hospital and 77% at the University Hospital (Saari-Kemppainen et al 1990Saari-Kemppainen A. Karjalainen O. Ylostalo P. et al.Ultrasound screening and perinatal mortality Controlled trial of systematic one-stage screening in pregnancy.Lancet. 1990; 336: 387-391Abstract PubMed Scopus (328) Google Scholar). In the RADIUS trial, the sensitivity of ultrasound for congenital anomalies was significantly higher if the study was performed in a tertiary care ultrasound laboratory (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar).An important new development in quality assurance for ultrasound is the proliferation of accreditation programs. The American College of Radiology and the American Institute of Ultrasound in Medicine both have programs that cover all areas of ultrasound. The Intersociety Commission on the Accreditation of Vascular Laboratories (ICAVL) accredits vascular programs. These accreditation programs had become extremely successful because they have begun to be linked with reimbursement by both government payers and private payers. Some Medicare payers require vascular laboratories to be accredited, and Aetna-US Healthcare, a large national health plan, requires accreditation for obstetric ultrasound.Appropriateness of studiesOne of the major areas of concern among health policymakers is monitoring both quantity and quality of ultrasound and other diagnostic studies following implementation of incentives or disincentives for their performance. This may lead to a reduction in both appropriate and inappropriate services. Ultrasound examinations are generally considered cost-effective compared to more expensive clinical and surgical studies. To assure this cost-effectiveness, formal mechanisms are needed to monitor medical necessity of ultrasound studies, particularly those done as a result of self-referral. The science of evidence-based medicine has been suggested as a way to deal with these types of appropriateness determinations. Unfortunately, the evidence would suggest that, in certain instances, particularly in the screening of obstetric ultrasound, there is no medical necessity. The RADIUS study showed a similar outcome for a control and intervention group, probably related to the heterogeneity of the providers, typical of that found in the U.S. (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar).The outcomes movement which relies on evidence-based medicine has many supporters both in the U.S. and in Canada. Imaging studies such as ultrasound typically produce short-term outcomes and are part of the equation that allows analysis of patient outcomes of a longer duration. In the case of ultrasound, obstetric examinations have been studied extensively, and data indicates that screening ultrasound does not improve pregnancy outcome other than by allowing termination of pregnancy in selected cases. When treatment modalities such as in utero surgery become cost-effective and feasible, and the quality and sensitivity of screening ultrasound becomes more reliable, a consensus may be reached regarding the appropriateness of utilizing routine screening ultrasound in low-risk populations. On the other hand, one of the factors that influence utilization of health care services in the U.S. is the threat of malpractice suits. Suits have been filed for both withholding ultrasound services and misinterpretation of those services. Malpractice suits are particularly prevalent in obstetric ultrasound where, because of prolonged statute of limitations, discovery of an abnormality in a child may be delayed for many years following its birth.Future influence of ultrasoundUltrasound has had a particularly unique influence in the U.S. as compared with the rest of the world, particularly in those clinical conditions where it competes with other imaging modalities. In obstetrics, ultrasound has no competition. In the remainder of the body, and now including the heart, computed tomography and magnetic resonance imaging all compete with ultrasound for the health care dollar. This is different than in many other parts of the world where access to CT and MRI are more limited and ultrasound becomes the procedure of choice by necessity. Additionally, physicians in other countries become comfortable with ultrasound as a procedure of choice and have had the benefit of contrast agents, which are not widely available in North America.Areas where ultrasound may potentially have a large influence include: (1) contrast agents; (2) three-dimensional ultrasound; (3) novel methods such as perfusion imaging and elastography; (4) interventional procedures with focused ultrasound or using ultrasound as an interventional guidance technique; and (5) newer applications including intraoperative, endoscopic, musculoskeletal and breast ultrasound procedures (Kremkau et al 1998Kremkau F.W. Merritt C.R.B. Carson P.L. et al.Future directions in diagnostic US.Radiology. 1998; 209: 305-311PubMed Google Scholar).The role of ultrasound contrast agents in North America is problematic. As yet, no agent has been approved for use outside of the heart, except for the oral agent, Sonorx. A number of intravenous agents are undergoing clinical trials and some have been submitted for review by the U.S. Food and Drug Administration. Contrast agents have been proposed to be used to enhance color Doppler both with and without harmonic imaging but, more recently, agents have been proposed to be used with harmonic imaging as gray-scale enhancing agents. Because ultrasound has been previously one of the few imaging modalities not requiring contrast, the acceptability of contrast is yet to be tested in the U.S.Three-dimensional ultrasound is proposed to have significant advantages compared to two-dimensional ultrasound. There are currently several manufacturers who have released three-dimensional products. The applications are diverse; however, the clinical acceptance has been slow in the radiology community. Specific indications that have been shown to be helpful are in obstetrics and gynecology.New imaging methods including perfusion and elastography are currently in an investigational stage, and their clinical acceptance is not expected in the foreseeable future. Use of ultrasound as a therapeutic technique or to guide therapeutic interventions may be an important new advance for ultrasound in North America. There is considerable funding activity from Federal agencies for interventions, particularly as related to cancer. This makes ultrasound therapy very interesting to payers and providers and, with the ease of ultrasound guidance for other energies such as radio-frequency, ultrasound may be an important tool in this area.Newer applications of ultrasound include intraoperative and endoscopic. Surgeons have begun quite commonly to rely on ultrasound for both brain and liver applications. Gastroenterologists have embraced endoscopic ultrasound, particularly for staging of gastrointestinal tumors and to evaluate the pancreas. Musculoskeletal applications have begun to compete with high technology imaging such as MRI, and many radiologists have begun to use ultrasound for musculoskeletal applications with excellent results. Finally, breast imaging with ultrasound has become established as an important adjunct to mammography. There is continuing research in the ability to use ultrasound to separate benign from malignant lesions, particularly using contrast agents.Research strengthsUntil recently, research in ultrasound has been limited to basic scientists studying new technologies and occasionally in the development of contrast agents. More recently, there has been exciting new work in breast imaging where there has been a large influx of research dollars from U.S. Federal agencies. With the possibility that ultrasound may help to determine which patients should be biopsied and which patients should be followed, work is still needed to improve current capabilities for this important indication.The Society of Radiologists in Ultrasound has funded studies that assess outcomes and training issues in ultrasound. The AIUM has established an education and research fund further to advance the science of ultrasound.Using contrast agents and harmonic imaging, early research has shown the capability to determine fractional moving blood volume, potentially rivaling CT, MRI and nuclear medicine to determine organ perfusion.Other technological advances which have research potential include elastography, which provides the capability to image the hardness for elastic properties of tissues, and harmonic imaging, which allows improved imaging in patients who were previously thought to be difficult to image because of their habitus.All of this research activity must compete for funding with other technological advances including optical imaging, functional imaging and molecular imaging. Ultrasound researchers are being challenged to devise novel indications for this important technologyRole of ultrasound in 2010Ultrasound technology continues to proliferate, even in the face of the pressures of managed care. New high-end equipment is continuing to emanate from the major manufacturers, which will undoubtedly improve the quality of imaging in the heart, abdomen and extremities. Additionally, there is now in production an inexpensive portable ultrasound machine that was developed for use by the military in battle conditions but which is now being marketed to primary care physicians, emergency room physicians and obstetricians and gynecologists, to be used as an extension of the physical examination. The challenge to many of us in the ultrasound community in the U.S. is to maintain a level of quality that could support the proliferation of these small portable machines. Unfortunately, the economic model in the U.S. promotes innovation and entrepreneurism, and this could lead to a potential downfall of ultrasound if inappropriate and dangerous use is widespread. It will be the role of organizations such as the Society of Radiologists in Ultrasound, the American College of Radiology and the American Institute of Ultrasound in Medicine to try to influence payers and providers to become trained prior to attempting to perform ultrasound examinations on large numbers of patients, potentially leading to dangerous results.In the U.S. and Canada, the quest of medical care is continuing to rise at an alarming rate. It will be incumbent upon medical policymakers to attempt to decrease the cost by identifying those technologies that are most appropriate for particular clinical problems. It is in this area that I believe ultrasound will thrive and become even more popular by 2010. Although these predictions may be faulty, I take heart from a famous U.S. philosopher-baseball player, Yogi Berra, who expounded: “the trouble with predictions, is that they involve the future.” IntroductionOver the past several decades, healthcare in North America, and particularly in the United States, has experienced unprecedented growth in diagnostic and treatment capabilities. Accompanying this growth, unfortunately, has been a skyrocketing level of spending. Health care expenditures in the U.S. comprised more than 14% of the domestic gross national product. This percentage is less in Canada, but Canada has struggled with limited health care financing creating access difficulties. During the 1960s and 1970s, medicine was deeply tied to a fee-for-service payment system. In this type of system, physicians were free to make clinical decisions largely independent from those responsible for financing the cost of health care. There was little incentive to control utilization of procedures and services, which led to high expenditures. During this time, ultrasound was beginning to become popular in North America, and utilization of ultrasound proliferated among many specialists, including obstetricians, radiologists, and cardiologists. In the 1980s and 1990s, employers of large businesses saw health care spending as a percentage of corporate profit increase from 8% to approximately 70%. Seeking cost containment, companies increasingly turned to managed care. Under a managed care system, plans seek to control costs, in part by eliminating unnecessary procedures and reducing marginally beneficial studies. Following the lead of large businesses, government programs such as Medicaid and Medicare have also turned to managed care to decrease costs.This changing climate of cost management has had a particular impact on the practice of ultrasound. In the fee-for-service system, the lack of incentive for utilization control encouraged the indiscriminant ordering of ultrasound services. Under a capitated system of managed care, a fixed dollar amount is prepaid to contracting physicians based on the managed care organization’s anticipation of the cost to providing medical care for an average member for a year. Therefore, capitation provides an incentive to request the minimum amount of imaging studies needed to arrive at a diagnosis or to determine a treatment plan. Over the past several decades, healthcare in North America, and particularly in the United States, has experienced unprecedented growth in diagnostic and treatment capabilities. Accompanying this growth, unfortunately, has been a skyrocketing level of spending. Health care expenditures in the U.S. comprised more than 14% of the domestic gross national product. This percentage is less in Canada, but Canada has struggled with limited health care financing creating access difficulties. During the 1960s and 1970s, medicine was deeply tied to a fee-for-service payment system. In this type of system, physicians were free to make clinical decisions largely independent from those responsible for financing the cost of health care. There was little incentive to control utilization of procedures and services, which led to high expenditures. During this time, ultrasound was beginning to become popular in North America, and utilization of ultrasound proliferated among many specialists, including obstetricians, radiologists, and cardiologists. In the 1980s and 1990s, employers of large businesses saw health care spending as a percentage of corporate profit increase from 8% to approximately 70%. Seeking cost containment, companies increasingly turned to managed care. Under a managed care system, plans seek to control costs, in part by eliminating unnecessary procedures and reducing marginally beneficial studies. Following the lead of large businesses, government programs such as Medicaid and Medicare have also turned to managed care to decrease costs. This changing climate of cost management has had a particular impact on the practice of ultrasound. In the fee-for-service system, the lack of incentive for utilization control encouraged the indiscriminant ordering of ultrasound services. Under a capitated system of managed care, a fixed dollar amount is prepaid to contracting physicians based on the managed care organization’s anticipation of the cost to providing medical care for an average member for a year. Therefore, capitation provides an incentive to request the minimum amount of imaging studies needed to arrive at a diagnosis or to determine a treatment plan. Organization of service deliveryIn the U.S., ultrasound service delivery is poorly organized. This poor organization has led to competition among specialists and primary care physicians to perform, interpret and bill for ultrasound services. Even when one specialty has an established service, another specialty can often purchase equipment and offer the service, particularly to its own patients, without administrative oversight. This has led, in recent years, to turf battles that have been vehement and destructive. In Canada, many of these issues do not exist, because of the limited resources for both equipment purchases and reimbursement. The health system in each of the provinces determines the distribution of ultrasound equipment and the appropriate performing physician.In the U.S., radiologists perform approximately 25% of ultrasounds, and other specialists perform the remaining 75%. More than half of the ultrasounds performed by nonradiologists are done by cardiologists performing cardiac ultrasound studies in both offices and hospitals. The remaining ultrasound examinations are primarily performed by obstetrician/gynecologists followed by physicians in primary care specialties such as family medicine and internal medicine (Spettell et al 1998Spettell C.M. Levin D.C. Rao V.M. et al.Practice patterns of radiologists and nonradiologists Nationwide Medicare data on the performance of chest and skeletal radiography and abdominal and pelvic sonography.Am J Roentg. 1998; 171: 3-5Crossref PubMed Scopus (21) Google Scholar). The variety of physicians who perform and interpret ultrasound has led to the concern about the effect of self-referral. Hillman et al 1990Hillman B.J. Joseph C.A. Mabry M.R. et al.Frequency and cost of diagnostic imaging in office practice A comparison of self-referring and radiologist-referring physicians.N Engl J Med. 1990; 323: 1604-1608Crossref PubMed Scopus (332) Google Scholar) have shown that physicians who perform ultrasound on their own patients, perform 2–8 times more examinations than those who refer their patients to another physician, such as a radiologist. Additionally, the charges for these self-referred procedures are 4–7.5 times higher.Quality issuesReimbursements for diagnostic studies from the variety of physicians who perform ultrasound have routinely been made without monitoring the quality of the work or the equipment used to perform them. Outcomes of routine screening ultrasound in obstetrics show that the sensitivity for the detection of fetal anomalies varies from 40% to 84%. Studies have offered evidence that experience of the examiner is an important determinant in the ultrasound diagnosis of congenital malformations. The Helsinki ultrasound trial found a detection rate for fetal anomalies of 36% at the City Hospital and 77% at the University Hospital (Saari-Kemppainen et al 1990Saari-Kemppainen A. Karjalainen O. Ylostalo P. et al.Ultrasound screening and perinatal mortality Controlled trial of systematic one-stage screening in pregnancy.Lancet. 1990; 336: 387-391Abstract PubMed Scopus (328) Google Scholar). In the RADIUS trial, the sensitivity of ultrasound for congenital anomalies was significantly higher if the study was performed in a tertiary care ultrasound laboratory (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar).An important new development in quality assurance for ultrasound is the proliferation of accreditation programs. The American College of Radiology and the American Institute of Ultrasound in Medicine both have programs that cover all areas of ultrasound. The Intersociety Commission on the Accreditation of Vascular Laboratories (ICAVL) accredits vascular programs. These accreditation programs had become extremely successful because they have begun to be linked with reimbursement by both government payers and private payers. Some Medicare payers require vascular laboratories to be accredited, and Aetna-US Healthcare, a large national health plan, requires accreditation for obstetric ultrasound.Appropriateness of studiesOne of the major areas of concern among health policymakers is monitoring both quantity and quality of ultrasound and other diagnostic studies following implementation of incentives or disincentives for their performance. This may lead to a reduction in both appropriate and inappropriate services. Ultrasound examinations are generally considered cost-effective compared to more expensive clinical and surgical studies. To assure this cost-effectiveness, formal mechanisms are needed to monitor medical necessity of ultrasound studies, particularly those done as a result of self-referral. The science of evidence-based medicine has been suggested as a way to deal with these types of appropriateness determinations. Unfortunately, the evidence would suggest that, in certain instances, particularly in the screening of obstetric ultrasound, there is no medical necessity. The RADIUS study showed a similar outcome for a control and intervention group, probably related to the heterogeneity of the providers, typical of that found in the U.S. (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar).The outcomes movement which relies on evidence-based medicine has many supporters both in the U.S. and in Canada. Imaging studies such as ultrasound typically produce short-term outcomes and are part of the equation that allows analysis of patient outcomes of a longer duration. In the case of ultrasound, obstetric examinations have been studied extensively, and data indicates that screening ultrasound does not improve pregnancy outcome other than by allowing termination of pregnancy in selected cases. When treatment modalities such as in utero surgery become cost-effective and feasible, and the quality and sensitivity of screening ultrasound becomes more reliable, a consensus may be reached regarding the appropriateness of utilizing routine screening ultrasound in low-risk populations. On the other hand, one of the factors that influence utilization of health care services in the U.S. is the threat of malpractice suits. Suits have been filed for both withholding ultrasound services and misinterpretation of those services. Malpractice suits are particularly prevalent in obstetric ultrasound where, because of prolonged statute of limitations, discovery of an abnormality in a child may be delayed for many years following its birth. In the U.S., ultrasound service delivery is poorly organized. This poor organization has led to competition among specialists and primary care physicians to perform, interpret and bill for ultrasound services. Even when one specialty has an established service, another specialty can often purchase equipment and offer the service, particularly to its own patients, without administrative oversight. This has led, in recent years, to turf battles that have been vehement and destructive. In Canada, many of these issues do not exist, because of the limited resources for both equipment purchases and reimbursement. The health system in each of the provinces determines the distribution of ultrasound equipment and the appropriate performing physician. In the U.S., radiologists perform approximately 25% of ultrasounds, and other specialists perform the remaining 75%. More than half of the ultrasounds performed by nonradiologists are done by cardiologists performing cardiac ultrasound studies in both offices and hospitals. The remaining ultrasound examinations are primarily performed by obstetrician/gynecologists followed by physicians in primary care specialties such as family medicine and internal medicine (Spettell et al 1998Spettell C.M. Levin D.C. Rao V.M. et al.Practice patterns of radiologists and nonradiologists Nationwide Medicare data on the performance of chest and skeletal radiography and abdominal and pelvic sonography.Am J Roentg. 1998; 171: 3-5Crossref PubMed Scopus (21) Google Scholar). The variety of physicians who perform and interpret ultrasound has led to the concern about the effect of self-referral. Hillman et al 1990Hillman B.J. Joseph C.A. Mabry M.R. et al.Frequency and cost of diagnostic imaging in office practice A comparison of self-referring and radiologist-referring physicians.N Engl J Med. 1990; 323: 1604-1608Crossref PubMed Scopus (332) Google Scholar) have shown that physicians who perform ultrasound on their own patients, perform 2–8 times more examinations than those who refer their patients to another physician, such as a radiologist. Additionally, the charges for these self-referred procedures are 4–7.5 times higher. Quality issuesReimbursements for diagnostic studies from the variety of physicians who perform ultrasound have routinely been made without monitoring the quality of the work or the equipment used to perform them. Outcomes of routine screening ultrasound in obstetrics show that the sensitivity for the detection of fetal anomalies varies from 40% to 84%. Studies have offered evidence that experience of the examiner is an important determinant in the ultrasound diagnosis of congenital malformations. The Helsinki ultrasound trial found a detection rate for fetal anomalies of 36% at the City Hospital and 77% at the University Hospital (Saari-Kemppainen et al 1990Saari-Kemppainen A. Karjalainen O. Ylostalo P. et al.Ultrasound screening and perinatal mortality Controlled trial of systematic one-stage screening in pregnancy.Lancet. 1990; 336: 387-391Abstract PubMed Scopus (328) Google Scholar). In the RADIUS trial, the sensitivity of ultrasound for congenital anomalies was significantly higher if the study was performed in a tertiary care ultrasound laboratory (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar).An important new development in quality assurance for ultrasound is the proliferation of accreditation programs. The American College of Radiology and the American Institute of Ultrasound in Medicine both have programs that cover all areas of ultrasound. The Intersociety Commission on the Accreditation of Vascular Laboratories (ICAVL) accredits vascular programs. These accreditation programs had become extremely successful because they have begun to be linked with reimbursement by both government payers and private payers. Some Medicare payers require vascular laboratories to be accredited, and Aetna-US Healthcare, a large national health plan, requires accreditation for obstetric ultrasound. Reimbursements for diagnostic studies from the variety of physicians who perform ultrasound have routinely been made without monitoring the quality of the work or the equipment used to perform them. Outcomes of routine screening ultrasound in obstetrics show that the sensitivity for the detection of fetal anomalies varies from 40% to 84%. Studies have offered evidence that experience of the examiner is an important determinant in the ultrasound diagnosis of congenital malformations. The Helsinki ultrasound trial found a detection rate for fetal anomalies of 36% at the City Hospital and 77% at the University Hospital (Saari-Kemppainen et al 1990Saari-Kemppainen A. Karjalainen O. Ylostalo P. et al.Ultrasound screening and perinatal mortality Controlled trial of systematic one-stage screening in pregnancy.Lancet. 1990; 336: 387-391Abstract PubMed Scopus (328) Google Scholar). In the RADIUS trial, the sensitivity of ultrasound for congenital anomalies was significantly higher if the study was performed in a tertiary care ultrasound laboratory (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar). An important new development in quality assurance for ultrasound is the proliferation of accreditation programs. The American College of Radiology and the American Institute of Ultrasound in Medicine both have programs that cover all areas of ultrasound. The Intersociety Commission on the Accreditation of Vascular Laboratories (ICAVL) accredits vascular programs. These accreditation programs had become extremely successful because they have begun to be linked with reimbursement by both government payers and private payers. Some Medicare payers require vascular laboratories to be accredited, and Aetna-US Healthcare, a large national health plan, requires accreditation for obstetric ultrasound. Appropriateness of studiesOne of the major areas of concern among health policymakers is monitoring both quantity and quality of ultrasound and other diagnostic studies following implementation of incentives or disincentives for their performance. This may lead to a reduction in both appropriate and inappropriate services. Ultrasound examinations are generally considered cost-effective compared to more expensive clinical and surgical studies. To assure this cost-effectiveness, formal mechanisms are needed to monitor medical necessity of ultrasound studies, particularly those done as a result of self-referral. The science of evidence-based medicine has been suggested as a way to deal with these types of appropriateness determinations. Unfortunately, the evidence would suggest that, in certain instances, particularly in the screening of obstetric ultrasound, there is no medical necessity. The RADIUS study showed a similar outcome for a control and intervention group, probably related to the heterogeneity of the providers, typical of that found in the U.S. (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar).The outcomes movement which relies on evidence-based medicine has many supporters both in the U.S. and in Canada. Imaging studies such as ultrasound typically produce short-term outcomes and are part of the equation that allows analysis of patient outcomes of a longer duration. In the case of ultrasound, obstetric examinations have been studied extensively, and data indicates that screening ultrasound does not improve pregnancy outcome other than by allowing termination of pregnancy in selected cases. When treatment modalities such as in utero surgery become cost-effective and feasible, and the quality and sensitivity of screening ultrasound becomes more reliable, a consensus may be reached regarding the appropriateness of utilizing routine screening ultrasound in low-risk populations. On the other hand, one of the factors that influence utilization of health care services in the U.S. is the threat of malpractice suits. Suits have been filed for both withholding ultrasound services and misinterpretation of those services. Malpractice suits are particularly prevalent in obstetric ultrasound where, because of prolonged statute of limitations, discovery of an abnormality in a child may be delayed for many years following its birth. One of the major areas of concern among health policymakers is monitoring both quantity and quality of ultrasound and other diagnostic studies following implementation of incentives or disincentives for their performance. This may lead to a reduction in both appropriate and inappropriate services. Ultrasound examinations are generally considered cost-effective compared to more expensive clinical and surgical studies. To assure this cost-effectiveness, formal mechanisms are needed to monitor medical necessity of ultrasound studies, particularly those done as a result of self-referral. The science of evidence-based medicine has been suggested as a way to deal with these types of appropriateness determinations. Unfortunately, the evidence would suggest that, in certain instances, particularly in the screening of obstetric ultrasound, there is no medical necessity. The RADIUS study showed a similar outcome for a control and intervention group, probably related to the heterogeneity of the providers, typical of that found in the U.S. (Ewigman et al 1993Ewigman B.G. Crane J.P. Frigoletto F.D. et al.Effect of prenatal ultrasound screening on perinatal outcome.N Engl J Med. 1993; 329: 821-827Crossref PubMed Scopus (579) Google Scholar). The outcomes movement which relies on evidence-based medicine has many supporters both in the U.S. and in Canada. Imaging studies such as ultrasound typically produce short-term outcomes and are part of the equation that allows analysis of patient outcomes of a longer duration. In the case of ultrasound, obstetric examinations have been studied extensively, and data indicates that screening ultrasound does not improve pregnancy outcome other than by allowing termination of pregnancy in selected cases. When treatment modalities such as in utero surgery become cost-effective and feasible, and the quality and sensitivity of screening ultrasound becomes more reliable, a consensus may be reached regarding the appropriateness of utilizing routine screening ultrasound in low-risk populations. On the other hand, one of the factors that influence utilization of health care services in the U.S. is the threat of malpractice suits. Suits have been filed for both withholding ultrasound services and misinterpretation of those services. Malpractice suits are particularly prevalent in obstetric ultrasound where, because of prolonged statute of limitations, discovery of an abnormality in a child may be delayed for many years following its birth. Future influence of ultrasoundUltrasound has had a particularly unique influence in the U.S. as compared with the rest of the world, particularly in those clinical conditions where it competes with other imaging modalities. In obstetrics, ultrasound has no competition. In the remainder of the body, and now including the heart, computed tomography and magnetic resonance imaging all compete with ultrasound for the health care dollar. This is different than in many other parts of the world where access to CT and MRI are more limited and ultrasound becomes the procedure of choice by necessity. Additionally, physicians in other countries become comfortable with ultrasound as a procedure of choice and have had the benefit of contrast agents, which are not widely available in North America.Areas where ultrasound may potentially have a large influence include: (1) contrast agents; (2) three-dimensional ultrasound; (3) novel methods such as perfusion imaging and elastography; (4) interventional procedures with focused ultrasound or using ultrasound as an interventional guidance technique; and (5) newer applications including intraoperative, endoscopic, musculoskeletal and breast ultrasound procedures (Kremkau et al 1998Kremkau F.W. Merritt C.R.B. Carson P.L. et al.Future directions in diagnostic US.Radiology. 1998; 209: 305-311PubMed Google Scholar).The role of ultrasound contrast agents in North America is problematic. As yet, no agent has been approved for use outside of the heart, except for the oral agent, Sonorx. A number of intravenous agents are undergoing clinical trials and some have been submitted for review by the U.S. Food and Drug Administration. Contrast agents have been proposed to be used to enhance color Doppler both with and without harmonic imaging but, more recently, agents have been proposed to be used with harmonic imaging as gray-scale enhancing agents. Because ultrasound has been previously one of the few imaging modalities not requiring contrast, the acceptability of contrast is yet to be tested in the U.S.Three-dimensional ultrasound is proposed to have significant advantages compared to two-dimensional ultrasound. There are currently several manufacturers who have released three-dimensional products. The applications are diverse; however, the clinical acceptance has been slow in the radiology community. Specific indications that have been shown to be helpful are in obstetrics and gynecology.New imaging methods including perfusion and elastography are currently in an investigational stage, and their clinical acceptance is not expected in the foreseeable future. Use of ultrasound as a therapeutic technique or to guide therapeutic interventions may be an important new advance for ultrasound in North America. There is considerable funding activity from Federal agencies for interventions, particularly as related to cancer. This makes ultrasound therapy very interesting to payers and providers and, with the ease of ultrasound guidance for other energies such as radio-frequency, ultrasound may be an important tool in this area.Newer applications of ultrasound include intraoperative and endoscopic. Surgeons have begun quite commonly to rely on ultrasound for both brain and liver applications. Gastroenterologists have embraced endoscopic ultrasound, particularly for staging of gastrointestinal tumors and to evaluate the pancreas. Musculoskeletal applications have begun to compete with high technology imaging such as MRI, and many radiologists have begun to use ultrasound for musculoskeletal applications with excellent results. Finally, breast imaging with ultrasound has become established as an important adjunct to mammography. There is continuing research in the ability to use ultrasound to separate benign from malignant lesions, particularly using contrast agents. Ultrasound has had a particularly unique influence in the U.S. as compared with the rest of the world, particularly in those clinical conditions where it competes with other imaging modalities. In obstetrics, ultrasound has no competition. In the remainder of the body, and now including the heart, computed tomography and magnetic resonance imaging all compete with ultrasound for the health care dollar. This is different than in many other parts of the world where access to CT and MRI are more limited and ultrasound becomes the procedure of choice by necessity. Additionally, physicians in other countries become comfortable with ultrasound as a procedure of choice and have had the benefit of contrast agents, which are not widely available in North America. Areas where ultrasound may potentially have a large influence include: (1) contrast agents; (2) three-dimensional ultrasound; (3) novel methods such as perfusion imaging and elastography; (4) interventional procedures with focused ultrasound or using ultrasound as an interventional guidance technique; and (5) newer applications including intraoperative, endoscopic, musculoskeletal and breast ultrasound procedures (Kremkau et al 1998Kremkau F.W. Merritt C.R.B. Carson P.L. et al.Future directions in diagnostic US.Radiology. 1998; 209: 305-311PubMed Google Scholar). The role of ultrasound contrast agents in North America is problematic. As yet, no agent has been approved for use outside of the heart, except for the oral agent, Sonorx. A number of intravenous agents are undergoing clinical trials and some have been submitted for review by the U.S. Food and Drug Administration. Contrast agents have been proposed to be used to enhance color Doppler both with and without harmonic imaging but, more recently, agents have been proposed to be used with harmonic imaging as gray-scale enhancing agents. Because ultrasound has been previously one of the few imaging modalities not requiring contrast, the acceptability of contrast is yet to be tested in the U.S. Three-dimensional ultrasound is proposed to have significant advantages compared to two-dimensional ultrasound. There are currently several manufacturers who have released three-dimensional products. The applications are diverse; however, the clinical acceptance has been slow in the radiology community. Specific indications that have been shown to be helpful are in obstetrics and gynecology. New imaging methods including perfusion and elastography are currently in an investigational stage, and their clinical acceptance is not expected in the foreseeable future. Use of ultrasound as a therapeutic technique or to guide therapeutic interventions may be an important new advance for ultrasound in North America. There is considerable funding activity from Federal agencies for interventions, particularly as related to cancer. This makes ultrasound therapy very interesting to payers and providers and, with the ease of ultrasound guidance for other energies such as radio-frequency, ultrasound may be an important tool in this area. Newer applications of ultrasound include intraoperative and endoscopic. Surgeons have begun quite commonly to rely on ultrasound for both brain and liver applications. Gastroenterologists have embraced endoscopic ultrasound, particularly for staging of gastrointestinal tumors and to evaluate the pancreas. Musculoskeletal applications have begun to compete with high technology imaging such as MRI, and many radiologists have begun to use ultrasound for musculoskeletal applications with excellent results. Finally, breast imaging with ultrasound has become established as an important adjunct to mammography. There is continuing research in the ability to use ultrasound to separate benign from malignant lesions, particularly using contrast agents. Research strengthsUntil recently, research in ultrasound has been limited to basic scientists studying new technologies and occasionally in the development of contrast agents. More recently, there has been exciting new work in breast imaging where there has been a large influx of research dollars from U.S. Federal agencies. With the possibility that ultrasound may help to determine which patients should be biopsied and which patients should be followed, work is still needed to improve current capabilities for this important indication.The Society of Radiologists in Ultrasound has funded studies that assess outcomes and training issues in ultrasound. The AIUM has established an education and research fund further to advance the science of ultrasound.Using contrast agents and harmonic imaging, early research has shown the capability to determine fractional moving blood volume, potentially rivaling CT, MRI and nuclear medicine to determine organ perfusion.Other technological advances which have research potential include elastography, which provides the capability to image the hardness for elastic properties of tissues, and harmonic imaging, which allows improved imaging in patients who were previously thought to be difficult to image because of their habitus.All of this research activity must compete for funding with other technological advances including optical imaging, functional imaging and molecular imaging. Ultrasound researchers are being challenged to devise novel indications for this important technology Until recently, research in ultrasound has been limited to basic scientists studying new technologies and occasionally in the development of contrast agents. More recently, there has been exciting new work in breast imaging where there has been a large influx of research dollars from U.S. Federal agencies. With the possibility that ultrasound may help to determine which patients should be biopsied and which patients should be followed, work is still needed to improve current capabilities for this important indication. The Society of Radiologists in Ultrasound has funded studies that assess outcomes and training issues in ultrasound. The AIUM has established an education and research fund further to advance the science of ultrasound. Using contrast agents and harmonic imaging, early research has shown the capability to determine fractional moving blood volume, potentially rivaling CT, MRI and nuclear medicine to determine organ perfusion. Other technological advances which have research potential include elastography, which provides the capability to image the hardness for elastic properties of tissues, and harmonic imaging, which allows improved imaging in patients who were previously thought to be difficult to image because of their habitus. All of this research activity must compete for funding with other technological advances including optical imaging, functional imaging and molecular imaging. Ultrasound researchers are being challenged to devise novel indications for this important technology Role of ultrasound in 2010Ultrasound technology continues to proliferate, even in the face of the pressures of managed care. New high-end equipment is continuing to emanate from the major manufacturers, which will undoubtedly improve the quality of imaging in the heart, abdomen and extremities. Additionally, there is now in production an inexpensive portable ultrasound machine that was developed for use by the military in battle conditions but which is now being marketed to primary care physicians, emergency room physicians and obstetricians and gynecologists, to be used as an extension of the physical examination. The challenge to many of us in the ultrasound community in the U.S. is to maintain a level of quality that could support the proliferation of these small portable machines. Unfortunately, the economic model in the U.S. promotes innovation and entrepreneurism, and this could lead to a potential downfall of ultrasound if inappropriate and dangerous use is widespread. It will be the role of organizations such as the Society of Radiologists in Ultrasound, the American College of Radiology and the American Institute of Ultrasound in Medicine to try to influence payers and providers to become trained prior to attempting to perform ultrasound examinations on large numbers of patients, potentially leading to dangerous results.In the U.S. and Canada, the quest of medical care is continuing to rise at an alarming rate. It will be incumbent upon medical policymakers to attempt to decrease the cost by identifying those technologies that are most appropriate for particular clinical problems. It is in this area that I believe ultrasound will thrive and become even more popular by 2010. Although these predictions may be faulty, I take heart from a famous U.S. philosopher-baseball player, Yogi Berra, who expounded: “the trouble with predictions, is that they involve the future.” Ultrasound technology continues to proliferate, even in the face of the pressures of managed care. New high-end equipment is continuing to emanate from the major manufacturers, which will undoubtedly improve the quality of imaging in the heart, abdomen and extremities. Additionally, there is now in production an inexpensive portable ultrasound machine that was developed for use by the military in battle conditions but which is now being marketed to primary care physicians, emergency room physicians and obstetricians and gynecologists, to be used as an extension of the physical examination. The challenge to many of us in the ultrasound community in the U.S. is to maintain a level of quality that could support the proliferation of these small portable machines. Unfortunately, the economic model in the U.S. promotes innovation and entrepreneurism, and this could lead to a potential downfall of ultrasound if inappropriate and dangerous use is widespread. It will be the role of organizations such as the Society of Radiologists in Ultrasound, the American College of Radiology and the American Institute of Ultrasound in Medicine to try to influence payers and providers to become trained prior to attempting to perform ultrasound examinations on large numbers of patients, potentially leading to dangerous results. In the U.S. and Canada, the quest of medical care is continuing to rise at an alarming rate. It will be incumbent upon medical policymakers to attempt to decrease the cost by identifying those technologies that are most appropriate for particular clinical problems. It is in this area that I believe ultrasound will thrive and become even more popular by 2010. Although these predictions may be faulty, I take heart from a famous U.S. philosopher-baseball player, Yogi Berra, who expounded: “the trouble with predictions, is that they involve the future.”