Testimony Presented to the U.S. House of Representatives Committee on Ways and Means Health Subcommittee
Presented by Kim Allan Williams, M.D., F.A.C.C., F.C.C.P., F.A.H.A. on behalf of the American College of Cardiology and the Coalition for Patient-Centered Imaging

March 17, 2005

Chairman Johnson and members of the Subcommittee, on behalf of the American College of Cardiology (ACC) and more than 20 physician and other health care organizations representing a broad range of specialists and practices that comprise the Coalition for Patient-Centered Imaging (CPCI), I welcome the opportunity to testify about the use of medical imaging in the delivery of health care, and particularly its irreplaceable contribution to best practices for patient care. I am a Professor of Medicine and Radiology and Director of Nuclear Cardiology at The University of Chicago School of Medicine. I am board-certified in Internal Medicine, Cardiology, Nuclear Medicine, and Nuclear Cardiology.

Today I would also like to speak to you about the growth in utilization of medical imaging, specifically why growth is occurring, and why physician specialists depend on medical imaging. I will also address some of the myths surrounding accusations of inappropriate use of medical imaging. I will articulate why the imaging that I and other specialists perform and interpret for our patients is in the best interest of the patient, is timely, and is cost-effective. We believe imaging kept in the hands of experienced and qualified specialists is safe, appropriate, of the highest quality, and critical to the emerging demand for outcomes-based disease state management, both in the medical and public policy making arenas.

I remember being in cardiology training just a few short decades ago when invasive diagnostic testing was “standard” practice in cardiology. I was told by my mentors that if we didn’t have “30 percent normal angiograms,” we were being too selective and would miss disease in a large segment of our patients. Well, those days are gone due to highly accurate, noninvasive imaging tests that more accurately predict outcomes for cardiac patients than the old-fashioned invasive “standard.”

Medical Imaging Is Good Medicine
Advancements in medical imaging have changed the way cardiologists, oncologists, obstetricians and gynecologists, urologists, family practitioners, neurologists, orthopaedic surgeons and other surgeons and many other physicians deliver patient care on a daily basis. By integrating medical technology into care plans, patients are receiving more prompt, efficient, effective and cost-effective care. In addition to traditional diagnostics employing medical imaging, we now use imaging to guide minimally invasive treatments and to track ongoing treatment protocols through judicious use of medical imaging. We are enabled as physicians to adjust patient care plans mid-therapy to achieve the best possible outcomes. Several specialist groups intimately integrate medical imaging in the most delicate and intricate aspects of their care. The prudent use of medical imaging in the actual treatment regimen is not only excellent medicine: it also manages short- and long-term costs by minimizing wasteful and ineffective treatments.

Patient Value
We cannot overestimate the patient values of choice, comfort, convenience and peace of mind when it comes to the provision of in-office imaging. The in-office setting affords patients greater choice about who they want to perform and interpret their test results. Patients can now have imaging tests performed by physicians who know their medical history and who will ultimately make treatment decisions and provide ongoing continuity of care. Patients also can have their imaging tests performed in a setting that is comfortable and convenient to them, oftentimes resulting in one office visit instead of three – or more. This is efficient not only from a patient’s point of view, but for society as a whole.

Physician Value
In my field of cardiovascular medicine, advancements in noninvasive medical imaging have significantly changed the way we diagnose and treat patients with acquired and congenital cardiovascular disease. Today, cardiologists can do for their patients what was not possible even 10 years ago. There is unquestionable value for physicians being empowered to integrate imaging into their practices. With the aid of medical imaging, physicians make more precise diagnoses in a time-efficient manner, leading to earlier detection of disease. As Medicare and private payers begin to focus on disease state management, we are learning one of the greatest obstacles to effectively managing the care of patients with chronic conditions is compliance. Physicians know when they have to order a test for a patient outside their office, there is a question of when, or even whether, that patient will follow through. Better compliance means maintaining a continuum of care that is critical in treating and managing disease.
Most often in medicine, timeliness in imaging improves outcomes. A diagnosis delayed is essentially a treatment denied. This is true whether we are speaking of diagnosing a critically narrowed and life-threatening coronary artery which is soon to close completely, or a stress fracture in a runner’s foot that could become a complete bone break with the next training session.

Value to Payers and Society
Advances in technology can decrease health care spending, if they lead to less expensive treatments, or they can increase spending by, for example, rendering previously untreatable or partially treatable conditions treatable. Technological advancements can also lead to significant improvements in health outcomes that can clearly offset the direct costs of new technology.

Last year, a study by MEDTAP International on the value of health care spending revealed that the value of the health improvements in the U.S. population over the past 20 years has significantly outweighed the additional health care expenditures that have accompanied these improvements. According to the report, every additional dollar spent on overall treatment for heart attacks has resulted in health gains of $1.10.

A study by David M. Cutler, Ph.D., and Mark McClellan, M.D., Ph.D., published in 2001 found that benefits of improvement in heart attack treatment over a 10-year period exceeded treatment costs by $87,000 per person who had a heart attack. Another study found that more than half of the cost growth for heart attacks from 1984 to 1998 was attributable to technological developments, most often in the expansion of existing technologies within new patient populations. In general, there is a notable body of literature that finds that new medical technologies create desired value and health care improvements that far outweigh their costs.

The Medicare Payment Advisory Commission’s (MedPAC) recent report to Congress made little mention of the value that medical imaging has brought to patients, physicians or the health care system as a whole. This is a notable omission.
Before Congress considers policies that could ultimately discourage or restrict certain specialists from providing appropriate imaging services to their patients, cost-effectiveness studies are needed to better determine the incremental costs of procedures in relation to their incremental health benefits in order to determine whether imaging technologies provide reasonable value for their cost.

While there is high value for patients receiving medical imaging services by their physician specialists in an office setting, current costs to Medicare for imaging performed in hospital or non-hospital settings remain neutral. The migration, however, to office-based noninvasive diagnostic imaging and image-guided therapy, has the potential to create significant cost savings.

When physicians must refer their patients to a hospital or imaging facility for needed tests, the process of a referral to a radiologist can itself increase costs to both Medicare and to patients. The referral can result in as many as three or more appointments and visits – one to see the physician and learn an image is needed, a second to have the image taken, and then a follow-up appointment and visit to the referring physician to receive the treatment plan based on the image. Although difficult to quantify, by reducing the number of visits, in-office imaging should directly reduce costs to both patients and Medicare, while increasing convenience and improving the timeliness of subsequent diagnosis and treatment. In addition, with fewer visits and a shorter delay between the initial visit and treatment, both patient compliance and health outcomes are improved.

Analyzing Utilization of Medical Imaging

Shift in Site of Service
In its just-released report to Congress, MedPAC found that between 1999 and 2002 the growth rate in the use of imaging services was twice as high as the growth rate for all fee schedule services (10.1 percent vs. 5.2 percent). MedPAC also found that growth in imaging moderated from 2002 to 2003, but imaging services were still higher (8.6 percent) than all services (4.9 percent).

While MedPAC acknowledged about 20 percent of the growth in imaging services paid under the physician fee schedule between 1999 and 2002 was due to a shift of site of services out of hospitals and into physician offices, MedPAC does not directly account for this shift in its growth comparisons. Failure to appropriately account for site of service changes presents a misleading interpretation of growth in imaging services. In addition, MedPAC does not include all Part B services in its comparison. In particular, MedPAC omits durable medical equipment, chemotherapy drugs and other drugs covered under Part B, and ambulance services. When we include all Part B services and account for changes in site of service for imaging, imaging actually grew at an annual rate of 8 percent from 1999-2003, and all Part B services grew at an annual rate of 7.8 percent over the same period.

Furthermore, the growth rate of imaging is stable or even slowing slightly (8.1 percent in 1999-2001 and 8 percent in 2001-2003), while the growth rate for all services is increasing (5.7 percent in 1999-2001 and 10 percent in 2001-2003). These omissions are important since MedPAC bases, in part, its rationale for greater government oversight of imaging services on the competitive growth of these services.

Average Annual Growth in Physician and Outpatient Hospital Services from 2001-2003

Source: The Lewin Group’s analysis of the Medicare Physician/Supplier Master Summary File.
*All Imaging includes BETOS categories I1A-I4B
**Growth in Hospital Outpatient Services spending is estimated by using growth in allowed charges deflated by the hospital market basket. This is then weight averaged with the growth in physician services, using total allowed charges for the weights, to estimate growth in All Medical Services for Physician/Hospital Outpatient in RVU equivalents.

Among all medical specialties, cardiology has the second highest utilization of imaging services behind diagnostic radiology, a fact largely attributable to advances in treatment and improved standards of care, and to the ultimate integration of echocardiography and coronary angiography into the everyday practice of cardiologists. Consistent with results reported by MedPAC, we found that nuclear medicine, along with other advanced imaging procedures, has tended to grow faster than other imaging services. However, an analysis by The Lewin Group showed that, without accounting for shift in site of service, growth in nuclear imaging and MRI (other than of the brain) is overstated by a third.

The Case Against Self-Referral as a Cause of Increased Utilization
Because of the documented shift in site of service, physicians are performing more medical imaging tests in their offices, and the number of imaging services billed under Part B is increasing. Imaging is considered an ancillary service, and under the “Stark Laws” there is an exception for “in-office ancillary services” that permits physicians to legally perform imaging and other ancillary services in their offices. We would vigorously oppose any attempt to remove or to limit in any way the in-office ancillary exceptions protected by the Stark Laws.

Unfortunately, some have begun to equate such allowed self-referral with inappropriate utilization of imaging services. While no credible body, including MedPAC, has been able to quantify whether and to what degree imaging performed in an office setting is inappropriate, we understand there may be inappropriate use of these health care services, like any other care financed through Medicare. But self-referral, as it is labeled by self-interested groups outside the physician specialty community, is not the primary driver in growth in imaging services.

Important findings of the Lewin analysis, not examined by MedPAC, undermine the claim that the primary driver of growth in imaging services is self-referral. First, utilization of MRI and CT, which have experienced relatively high growth rates compared with other types of services, was examined. The average growth rate for CT from 2001-2003 was 16 percent, with radiology dominating 84 percent of CT scans performed. Similarly, the average growth rate for MRI during this same time period was 19 percent, with radiology dominating 65 percent of use. Because MRI and CT are dominated by radiologists, these results suggest that eliminating the ability of specialty physicians to perform and interpret imaging tests in their offices is no protection against the growth in utilization.

Second, central to the argument that self-referral is a significant cost-driver is the idea, supported by MedPAC, that physicians will automatically over-utilize imaging services to increase their practices’ revenue and income. However, two studies , demonstrate that physicians order more images when they have access to on-site imaging equipment, even when they do not own it and have no financial incentives to do so.

Clinical Substitution as a Result of More Effective Technology
In its March 2003 report, MedPAC acknowledged new indications for existing technologies may contribute to imaging growth rates, and decreases in some services, and in some cases more costly services, may result of substituting one service for another. In nuclear cardiology, my particular area of training and expertise, the data indicate that nuclear cardiology is supplanting hospital-based invasive cardiac catheterization in many cases.

The average growth rate from 2001-2003 for cardiac nuclear imaging by radiologists and cardiologists combined was 18 percent, down from an average of 19 percent during 1999-2001. Comparatively, the average annual growth rate for invasive cardiac catheterization, a procedure not performed by radiologists, dropped from 8 percent in 1999-2001 to negative-4 percent in 2001-2003. This shows a direct and positive correlation between increases in cardiac nuclear imaging and decreases in invasive diagnostic cardiac catheterization. The significance of this substitution is that nuclear cardiology and other noninvasive imaging can be done outside of hospitals, is less expensive, is less risky in terms of complications, requires no patient recuperation, and often predicts the outcome of the patient better than invasive tests.

Advancements in Technology
As we eliminate the theory that self-referral is a primary driver of medical imaging utilization, we can begin to examine the true reasons why utilization has increased in this area of medicine.

While MedPAC has acknowledged the role of technological innovation in the growth of imaging services, it does not adequately include this factor in its analysis, especially the issue of substitution of one treatment or diagnosis method for another.

Growth in the use of imaging services is, in part, reflective of growing applications for these technologies. In fact, in its March 2003 report, MedPAC states, “…it appears that use of well-established technologies is increasing. CAT, for example, was introduced in the 1970s. MRI began to diffuse as a new technology in the 1980s. Thus, the indications for use of these technologies may be changing.”

As I have mentioned, technology improvements have resulted in new imaging techniques that replace more invasive and generally more risky diagnostic procedures, and this trend of substitution isn’t just occurring in cardiology. For example, ultrasound guidance can allow needle biopsies to replace open biopsies of the breast, and it also can enable more accurate biopsies of prostate legions with fewer tissue samples.

In breast surgery, ultrasound-guided breast biopsies can reduce performance of potentially unnecessary and invasive procedures and surgeries. Ultrasound-guided breast biopsy allows for less-invasive evaluation of mammographic lesions, with more reliable tissue differentiation, more streamlined patient care and characterization, and improved staging of disease.
Urology offers another example where advancements in medical imaging have led to less-invasive and less-painful procedures. Older men often experience difficulty urinating because of prostate enlargement. To evaluate this problem, physicians must learn how much urine is retained in the bladder after voiding, known as "residual urine." For many years this was determined by passing a catheter through the urethra and into the bladder, the amount of urine drained from the bladder was then measured. Introducing a catheter into the bladder, in addition to being uncomfortable, also may introduce infection. Today, many urologists employ a small ultrasound machine designed specifically for this task. This test can be done in the urologist’s office and eliminates the use of a catheter and the danger of infection. In addition, 15 percent of Americans will have a kidney stone in their lifetime, and during acute episodes there is much pain and disability, often resulting in hospitalization and loss of work. The CT stone protocol provides for a rapid, accurate diagnosis of the vast majority of kidney stones. Using a CT scanner, a patient does not have to be given intravenous contrast, which can be toxic, as would be needed with the traditional intravenous pyleogram (IVP). The CT scan also allows for the diagnosis of non-calcium stones that may not be the case with IVP. This provides more efficient health care for the economy, for providers and far better patient care.
Today in cardiology, we routinely use an arsenal of high-tech equipment to combat and treat disease. With the use of CT, we can see the heart beating in three dimensions which allows us to define the adequacy of coronary perfusion as well as plaque within a vessel wall. We can track heart disease at every state, visualizing what we could only imagine in the past. The expectation of society, and of our patients, is that we will employ all of these marvels to achieve best practice outcomes for every care interlude. That means medical imaging as part of the treatment plan delivered in a physician’s office is here to stay.

Changing Demographics
Managing heart disease is one of the most significant success stories in modern health care. Over the past 30 years, there has been a substantial increase in the life expectancy of Americans that directly correlates with downward trends in heart disease mortality and disability. We know that prevention efforts are important contributors to the reduced mortality rates, but many of the benefits are attributed to better and earlier detection and improved treatment.

We anticipate that as the population ages, because medical imaging will continue to be an essential tool for treating heart disease, growth in utilization is bound to continue. Consider this: Based on the National Heart, Lung, and Blood Institute’s Framingham Heart Study, the average annual rates of first major cardiovascular events rise from seven per 1,000 men at ages 35-44 to 68 per 1,000 at ages 85-94. For women, comparable rates occur as men, but about 10 years later in life. At the same time, the prevalence of diseases associated with heart disease, such as obesity, hypertension, diabetes, and high cholesterol also continue to grow.

Advancements in technology and changing demographics are factors that can be expected to continue to fuel growth in Medicare and overall health expenditures. Furthermore, while technological advances sometimes increase expenditures, they can also decrease costs by allowing less invasive and less costly treatments to replace older, more invasive treatments. In addition, new imaging technologies can improve early detection, which can allow us to treat diseases at a lower level of intensity, and thus at a lower cost than if they were detected later. It is important, therefore, that Congress move cautiously when considering policies to limit the use of imaging services, because imprudent limits on the use of diagnostic imaging could increase total Medicare expenditures for non-imaging services.

Quality Medical Imaging is Safe and Appropriate

Quality
Quality is a top priority in health care as providers, payers, and regulators strive for a system that reduces errors and rewards physicians for exemplary clinical practice. CMS and private payers have begun to implement programs that tie physician reimbursement to patient care outcomes – a growing trend called "pay for performance." Emphasizing and rewarding quality is good for patients. However, this process must recognize that, by necessity, physicians will need to use advanced technology to meet high quality standards and ensure optimal care. Newer imaging modalities provide more accurate and precise images with lower patient risk, helping physicians to diagnose and treat diseases more effectively. To make objective evaluations of patient progress tied to payment, medical imaging will undoubtedly expand to provide clear, unequivocal valuations of care protocols and procedures. Who owns these technologies and how widely they are utilized have become critical questions for our patients and physicians.

The American College of Cardiology and the Coalition for Patient-Centered Imaging support the delivery of the highest quality care. But the debate over medical imaging, one that is playing out in the press, in state legislatures and here in Congress, stands to pit one physician group against another. The College has sat at the table with the leadership of the American College of Radiology, and has sought to reach agreement on what defines quality in imaging. To date, our results have been mixed. Not working together as a physician community is the ultimate disservice to our patients and, ultimately, to the payer community.

The literature comparing the quality of interpretations of imaging studies conducted by “nonradiologists,” and radiologists remains limited. Of the studies that do exist, the findings do not suggest that physician specialists (limited license providers excluded) have lower quality of performance in diagnostic imaging than radiologists. In an article published last year in the Journal of the American College of Radiology, and disconcertingly titled, “Turf Wars in Radiology: The Quality of Interpretations of Imaging Studies by Nonradiologist Physicians – A Patient Safety Issue,” the authors David Levin and Vijay Rao cite studies that compared the performance on plain radiographs (X-rays), an imaging modality dominated by radiologists, rather than more specialized modalities such as CT and MRI – which is where much of the increase in utilization is occurring. In particular, modalities primarily used by other specialties (such as echocardiography, which is used primarily by cardiologists, and transrectal prostate ultrasound, which used primarily by urologists) were excluded. Furthermore, the studies quoted by Levin and Rao actually found that cardiologists perform and interpret chest X-rays as well as radiologists, but that fact was not brought out in the article. Our point here is, specialists who learn a medical imaging technique will perform that technique with quality and will accept nothing less for patients for whom they care.

None of the studies cited in the MedPAC report examined the quality of imaging interpretations by nonradiologists and radiologists in the modalities that MedPAC actually recommended that CMS consider a “high priority” – MRI, CT, and nuclear medicine (including PET). One study by Harold Moskowitz, published in the American Journal of Roentgenology, specifically excluded CT, MR, sonography and nuclear studies from the results. The only modality analyzed in the study results was X-ray. Another study cited in the report by CareCore National also only examined X-ray studies. These studies are not relevant to the issues at hand. The inability of those practitioners, who rarely read X-rays, to read them better than radiologists who read X-rays frequently, has nothing to do with the ability of cardiologists, for example, who read echocardiographs almost daily to read them better than radiologists, who see echocardiographs as one modality among many.

MedPAC has recommended to Congress that it consider privileging as a means to improve the quality of imaging interpretations and as a condition of Medicare payment for physicians who want to interpret imaging tests.

Before Congress directs CMS to become involved in determining competencies of individual physicians in this country, we suggest that solid, credible studies be commissioned that examine the quality of imaging services among all modalities and among all physician disciplines.

We believe MedPAC’s recommendation requiring physician privileging leads us down a road that runs counter to this Subcommittee’s goal of improving the quality of patient care by tying physician payment to process and outcomes measures. By simply directing CMS to determine the competency of physicians as a condition of payment, it does not ensure that those deemed “competent” are in fact appropriately applying medical technology in a way that best benefits patients.

Appropriateness
Physicians must carefully incorporate new technologies in patient care plans only after their effectiveness has been proven. Congress and CMS should consider the dialogue occurring between physician societies and private sector payers about how to ensure that imaging being delivered to patients is indeed appropriate.

At the American College of Cardiology, we are developing specific appropriateness criteria for imaging in an effort to define “what to do,” “when to do it” and “how often” in the context of local care environments when combined with patient and family preferences. Ideally, appropriateness criteria would encompass “cost-effective” and “benefit vs. risk” analysis of available care alternatives. The criteria will be simple, reliable, valid, and transparent. They will provide cardiovascular specialists with meaningful feedback on their care practices relative to national standards. The College’s first focus will be on appropriateness criteria for nuclear cardiology. The process, expected to be complete by early summer, is underway as an abstraction, distillation, and in some cases, expansion of the scientifically sound, evidence-based ACC/American Heart Association Clinical Practice Guidelines and Expert Consensus Documents. Developing appropriateness criteria is a complex and often very divisive issue, but it will allow cardiologists, payers and patients to quantify quality.

There are some who claim if CMS simply “weeds out” all inappropriate utilization, the result would be significant cost savings to Medicare. Before arriving at this conclusion, policymakers must quantify appropriate and inappropriate utilization in order to effectively estimate cost savings. Again, I point to the efforts underway between the American College of Cardiology and the private payers to develop appropriateness criteria.

We are aware that the American College of Radiology is projecting estimates of Medicare cost savings to drive their quest for “designated imaging provider” legislation in the states and in Congress. In articles published in the Journal of the American College of Radiology, hypothetical cost savings are based arbitrarily on the assumption that the level of referrals to radiologists by physicians who do not have access to on-site imaging equipment “delineate the necessary and appropriate utilization rate of imaging.” It is no less valid to assume that patients whose physicians do not have access to on-site imaging equipment are underserved, and thus receive substandard care. Even MedPAC noted in its report that a 1994 GAO study examining referrals to specialty physician-owned imaging facilities did not address whether the additional services were appropriate or not.

Training and Safety

Training of Physicians
Radiology was first introduced into medical practice in the early 1900s with the discovery of X-rays. Since then, medical imaging has significantly progressed and gained widespread clinical use. Some of the first diagnostic imaging technologies used by cardiologists to assess cardiac conditions were chest X-rays, electrocardiography, coronary angiography, and cardiac catheterization. Cardiologists’ use of new technologies such a nuclear cardiology, cardiac MR and CT are a natural extension of the strong and appropriate dominance that cardiologists have held in cardiac imaging for the last three decades. Today, cardiologists dominate the use of chest X-rays, nuclear medicine, echocardiography, cardiac catheterization, and electrocardiography, in part because cardiologists have generally obtained better training in these areas, and have the clinical expertise to evaluate the procedures.

Cardiologists, urologists, orthopaedic surgeons, obstetricians and gynecologists, neurologists and other specialist physicians are uniquely qualified to provide imaging services specific to their specialty because they are trained in both diagnostic imaging techniques, and in the structure and function of the organs and systems they are imaging.

In ultrasound, the need to codify training and education for the performance and interpretation of examinations has already been thoroughly addressed by the medical community. There is no evidence to support additional standards being placed upon physicians and their practices. The American Medical Association (AMA) has concluded that ultrasound is integral to the practice of appropriately trained physicians and that office-based ultrasound is cost effective and essential to patient care. The AMA further recognized that it is inappropriate to apply educational standards developed for one medical specialty group to that of another. Because of the different and unique applications of ultrasound within the various physician specialties, the AMA called for each specialty to define ultrasound standards for its members to fit their clinical environment, which is what has occurred in the specialties of breast surgery and emergency medicine.

To practice clinical nuclear cardiology, for example, a physician must receive two years of general cardiology training and up to six months dedicated to nuclear cardiology training. This training is critical to accurate interpretation of imaging studies. By contrast, the American Board of Radiology has no specific requirements for training time, mentoring, or case load in nuclear cardiology prior to certifying a radiologist as competent in this area.

The American College of Cardiology and other cardiovascular health organizations have been leaders in the development of training program standards, clinical competency statements, and clinical practice guidelines that contain recommendations regarding the necessary knowledge and skills, as well as the appropriate use of imaging procedures.

Therefore, we believe all physicians who meet the appropriate level of training ought to be able to provide imaging services to patients. Specialty designation alone is not an appropriate basis on which to determine physician qualifications.

The critical piece of data for the referring physician is not just to have the dictation of the findings from the images, but to receive clinical input for the patient’s care management based on those findings from the image interpreter – something the specialist routinely does but the general imager does not necessarily do. The radiologist’s comment “please correlate clinically” is often appended to image reports, while the specialist has completed this “clinical correlation” automatically and communicates this to the referring physician.

A study published in a recent issue of The Journal of Bone & Joint Surgery further illustrates this point. The study compared the findings of a radiologist’s report and an orthopaedic surgeon’s preoperative diagnosis, following an examination and reading of any images with actual surgical findings. Not surprisingly, the surgeon’s preoperative diagnosis was significantly more accurate than the radiologist’s report. The study concluded that “the formal interpretation of the MRI scan by the radiologist commonly had inaccuracies and may not correlate with the initial diagnoses…reliance on the radiologist’s formal interpretation can lead to diagnostic inaccuracies and to delay in appropriate treatment.”

Accreditation of Facilities
Accreditation is a step payers and physicians may consider when it comes to ensuring the safety and quality of medical imaging. Let me begin by saying that I do not agree, nor do any credible studies suggest, that the imaging we are performing outside the hospital is sub-optimal or unsafe. The costs to physicians, in both time and money, to complete accreditation processes are significant. If mandatory, accreditation should be accompanied by clinical evidence that accreditation results in measurable and significant improvement in quality of care and compliance mandates should include sufficient time to allow providers to achieve accreditation.

Furthermore, and most importantly, accreditation should not be limited to the standards of just one accrediting body. For example, for cardiovascular laboratories, accreditation bodies include the Intersocietal Accreditation Commission (IAC) and the American College of Radiology (ACR), and the differences between these programs must be recognized. In a February 10, 2005, statement to this Subcommittee, that National Coalition for Quality Diagnostic Imaging Services (NCQDIS) stated that ACR has full accreditation programs for many diagnostic procedures and implied that only offices accredited by ACR perform the highest quality imaging services.

We want to set the record straight on this point and on a study cited by both MedPAC and by NCQDIS. This study stated an imaging site inspection program “revealed that over 1/3 of imaging facilities operated by non-radiologist physicians had one or more significant quality deficiencies, while only 1 percent of facilities operated by radiologists had such deficiencies.” What NCQDIS does not tell the reader is that 92 of the 150 sites that failed inspection (62%) were operated by limited license providers (chiropractic and podiatry). Cardiologists, in fact, had a lower failure rate than radiologists.

Conclusion
In closing, I want to emphasize that medical imaging performed and interpreted in physicians’ offices is an integral and cost-effective part of the specialists’ patient care continuum. To prevent or limit the practice of in-office imaging would move the field of medicine in the wrong direction, just as clinical advancements are improving patient care and outcomes. Furthermore, attempting to restrict physician eligibility to perform and interpret tests for their patients in the most efficient and effective setting is antithetical to the aggressive disease state management paradigm now being promoted by CMS through multiple pilot projects.

We also have seen a clear connection between better and faster diagnosis and improved quality of life, enhanced productivity and contained costs compared with more invasive treatments at later-stage disease arrest. Medical imaging, while not the sole factor in gaining ground in the fight against disease, certainly is a leading cause for this remarkable turnaround, particularly in heart disease.

We respectfully urge the Subcommittee to carefully weigh the complexity of the medical imaging debate before enacting any governmental restraints against specialty physicians from performing and interpreting medical images. Our patients deserve better, and they are accustomed to receiving care which incorporates medical imaging in their personal physician’s office. Turning back the clock at this stage will surely retract many of the gains we have achieved in the last 20 years through the use of medical imaging in our patient care protocols.

Thank you

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