Recent Trends in Imaging for Suspected Coronary Artery Disease: What Is the Best Approach?

Recent Trends in Imaging for Suspected Coronary Artery Disease: What Is the Best Approach?

ORIGINAL ARTICLE Recent Trends in Imaging for Suspected Coronary Artery Disease: What Is the Best Approach? David C. Levin, MD a,b , Laurence Parker,...

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ORIGINAL ARTICLE

Recent Trends in Imaging for Suspected Coronary Artery Disease: What Is the Best Approach? David C. Levin, MD a,b , Laurence Parker, PhD a, Ethan J. Halpern, MD a, Vijay M. Rao, MD a Abstract Purpose: The aim of this study was to ascertain recent trends in noninvasive imaging utilization for suspected coronary artery disease. Methods: The Medicare Part B databases for 2001 to 2013 were reviewed. Current Procedural Terminology primary codes for radionuclide myocardial perfusion imaging (MPI), stress echocardiography (SE), and coronary CT angiography (CCTA) were selected. Physician specialty codes were used to designate providers as radiologists, cardiologists, and all others as a group. Procedure volumes were tabulated, and utilization rates per 1,000 Medicare beneficiaries were calculated over the period of study. Results: Total MPI utilization rates per 1,000 rose rapidly from 63.4 in 2001 to a peak of 88.0 in 2006 but declined every year thereafter, dropping to 61.9 in 2013. SE rates generally held steady around 12 to 13 from 2001 to 2010 but then began to decline, reaching 10.8 in 2013. Cardiologists predominate in both MPI and SE. CCTA rates were far lower. They peaked at 2.1 in 2007, but then dropped before leveling off at 1.07 in both 2012 and 2013. Radiologists and cardiologists have approximately equal roles in this procedure. Conclusions: Both MPI and SE seem to be declining in use in recent years. This is likely due to unfavorable reimbursement trends caused by code bundling and resulting in the closure of many private cardiology offices. CCTA use is far lower than the two other types of imaging and has also declined in recent years. This is puzzling, as it is a new and promising procedure that has some advantages over MPI and SE. In 2013, 58 times as many MPI studies as CCTA studies were performed. Key Words: Noninvasive cardiac imaging, coronary CT angiography, myocardial perfusion imaging, imaging utilization, radiology and radiologists, socioeconomic issues J Am Coll Radiol 2015;-:---. Copyright  2015 American College of Radiology

Cardiovascular disease is the leading cause of death worldwide [1-3]. In 2010 in the United States, 379,559 people died of coronary artery disease (CAD). It was also estimated that each year, 620,000 individuals would have new, nonfatal myocardial infarctions (MIs), another 295,000 would have recurrent MIs, and 150,000 would have new silent MIs [1]. Noninvasive imaging plays a crucial role in diagnosing this deadly disease. The imaging techniques most commonly used are radionuclide myocardial perfusion imaging (MPI), stress a Center for Research on Utilization of Imaging Services, Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania. b HealthHelp, Inc, Houston, Texas. Corresponding author and reprints: David C. Levin, MD, Thomas Jefferson University Hospital, Department of Radiology, Main 1090, Philadelphia, PA 19107; e-mail: [email protected]. The authors have no conflicts of interest related to the material discussed in this article.

ª 2015 American College of Radiology 1546-1440/15/$36.00 n http://dx.doi.org/10.1016/j.jacr.2015.11.015

echocardiography (SE), and multidetector coronary CT angiography (CCTA). A previous study [4] suggested that after a period of very rapid growth in the early 2000s, the utilization rate of MPI was flattening by 2008 and that the utilization rate of CCTA was not growing as rapidly as anticipated. As will be discussed later, the use of the three tests in patients with suspected CAD is controversial, and some of the trends are puzzling. For example, MPI has significant shortcomings in evaluating patients with suspected CAD, yet in 2008 it was being used far more commonly than CCTA [4]. In this report, we present more recent utilization data for MPI, SE, and CCTA and discuss the implications of these data.

METHODS Our data sources were the Medicare 2001 to 2013 Physician/Supplier Procedure Summary Master Files, which contain data on each code in the Current Procedural

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Terminology, version 4 manual. The data include procedure volume, allowed payments, and other administrative information. The files cover all enrollees in traditional fee-forservice Part B Medicare (37.3 million in 2013) but not those in Medicare Advantage plans (15.1 million in 2013). We selected all primary codes for MPI, SE, and CCTA, as shown in Table 1. The primary MPI codes included those for single-photon emission computed tomographic (SPECT), planar, and PET studies, but did not include add-on codes for left ventricular wall motion or ejection fraction, which were commonly used before 2010. During the study period, code changes were made; these were carefully accounted for and are briefly summarized in Table 1. Global and professional component-only claims were tabulated, but technical component-only claims were excluded because that would have resulted in double counting. The numbers of fee-for-service Medicare enrollees each year were determined from the CMS Medicare Advantage State/County Penetration Reports, and these numbers were used to calculate the utilization rates of the procedures per 1,000 enrollees. Medicare’s physician specialty codes were used to classify providers as radiologists, cardiologists, and all others as a group. The data for all MPI, SE, and CCTA codes were aggregated into those three categories, and trend lines from 2001 through 2013 were plotted. The trend lines show total procedure utilization rates per 1,000 enrollees, along with the rates for cardiologists and radiologists. The rates for the “other” category are not shown because they were quite small. Data analysis was performed using SAS version 9.3 for Windows (SAS Institute Inc, Cary, North Carolina).

RESULTS The utilization rates for MPI are shown in Figure 1. The total Medicare fee-for-service rate per 1,000 rose from Table 1. The CPT codes used in this analysis Type of Study Codes Used Coding Notes 78451-78454 replaced MPI 78460, 78461, 78464, 78460-78465 in 2010. 78465, 78451, 78491-78492 are PET 78452,78453, 78454, MPI codes 78491, 78492 SE 93350, 93351 93351 was a new code added in 2009 CCTA 0146T, 0147T, 0148T, 75574 replaced the T 0149T, 75574 codes in 2010 Note: CCTA ¼ coronary CT angiography; CPT ¼ Current Procedural Terminology; MPI ¼ myocardial perfusion imaging; SE ¼ stress echocardiography.

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100 90 80 70 60 50 40 30 20 10 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Total

Cardiologists

Radiologists

Fig 1. Utilization rates of radionuclide myocardial perfusion imaging (MPI) in the Medicare fee-for-service population, 2001 through 2013. Vertical axis shows examinations per 1000 beneficiaries. In addition to the total rates, data are shown for cardiologists and radiologists, who together provide the vast majority of MPI studies. The small proportions of examinations performed by other specialists are not shown.

63.4 in 2001 to a peak of 88.0 in 2006 (þ39%). It then declined every year thereafter, slowly from 2007 to 2009 but then more rapidly thereafter. By 2013, the rate had dropped to 61.9, that is, slightly lower than it had been in 2001. The trend line for cardiologists generally paralleled that for total procedures. Cardiologists’ rate rose from 35.3 in 2001 to 62.0 in 2006 (þ76%), then remained generally stable for the next three years. It began a steady decline in 2010 and had dropped to 47.6 by 2013. The rate among radiologists was 20.3 in 2001, remained generally stable for the next four years, then began a slow but steady decline to reach 10.8 by 2013. PET MPI procedures were only a small fraction of the total. In 2013, total Medicare MPI procedure volume was 2,310,630, of which 91,200 (3.9%) were PET studies. The remainder used SPECT or planar technology (mostly the former). Figure 2 shows the utilization rate trends for SE. Trend lines are shown for all procedures within this category and those by cardiologists. There is no line shown for radiologists because they have essentially no involvement in SE. The total SE utilization rate was 12.5 per 1,000 in 2001. Aside from minor fluctuations, there was little change over the ensuing nine years. In 2010, the rate was 12.6. During the next three years, however, there was a steady decline to 10.8 in 2013. The trend among cardiologists generally paralleled the total trend. The CCTA trends are shown in Figure 3. Note that the scale on the vertical axis is far lower than for MPI and SE. The graph commences in 2006 because that Journal of the American College of Radiology Volume - n Number - n Month 2015

2013. The rates for both cardiologists and radiologists peaked in 2007 (1.26 for cardiologists, 0.67 for radiologists). In subsequent years, there was a steady and fairly rapid decline among cardiologists, with their rate decreasing to 0.49 in 2013. Among radiologists, there was a gradual decline, reaching 0.44 in 2010. However, over the next three years, radiologists saw a slight increase, with their rate reaching 0.52 in 2013, or slightly higher than that for cardiologists.

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12

10

8

6

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2

0 2001

2002 2003

2004

2005

2006

Total

2007 2008

2009

2010

2011 2012

2013

Cardiologists

Fig 2. Utilization rates of stress echocardiograms (SEs) in the Medicare fee-for-service population, 2001 through 2013. Vertical axis shows examinations per 1000 beneficiaries. Total rates and rates for cardiologists are shown. Radiologists have essentially no role in SE. The differences between the total rates and those for cardiologists are attributable to SEs performed by a variety of other specialists, particularly primary care physicians and internists.

was the first year in which specific CCTA codes were available. That year, the total utilization rate of these procedures was 0.99 per 1,000. It more than doubled the next year to 2.1. However, in subsequent years, the rate dropped sharply, reaching 1.07 in both 2012 and 2.5

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0 2006

2007

2008

Total

2009

2010

Cardiologists

2011

2012

2013

Radiologists

Fig 3. Utilization rates of coronary CT angiography (CCTA) in the Medicare fee-for-service population, 2006 through 2013. 2006 was the first year in which specific codes for CCTA were available. Vertical axis shows examinations per 1000 beneficiaries. In addition to total rates, data are shown for radiologists and cardiologists, who together provide the vast majority of CCTAs. The small proportions of examinations provided by other specialists are not shown.

DISCUSSION The trends in imaging for suspected CAD are interesting in several respects. MPI utilization (Fig. 1) grew rapidly among cardiologists from 2001 through 2006, then plateaued for the next three years. The rapid rise during the early years resulted primarily from the acquisition of nuclear cameras by private practice cardiologists, some of whom saw an opportunity to generate more revenue by performing what was then a highly reimbursed procedure [5]. However, from 2010 through 2013, there was a substantial decline. SE utilization (Fig. 2) fluctuated between approximately 12 and 13 per 1,000 from 2001 to 2010, then declined from 2011 through 2013. Most of these two types of examinations (MPI and SE) are done by cardiologists in private offices. The most likely reason for the recent declines in both is that beginning about 2010, private cardiology offices began closing or being acquired by hospitals [6-8]. A major reason for this was sharp reductions in reimbursements for MPI and echocardiography caused by bundling of Current Procedural Terminology codes by CMS. In 2009, add-on codes for spectral Doppler and color flow Doppler were bundled into the primary codes for transthoracic echocardiography. In 2010, add-on codes for left ventricular wall motion and ejection fraction were bundled into the primary MPI codes. In both instances, this resulted in collapsing three billable codes into a single code and substantially reducing reimbursements for those high-volume services. For example, the global relative value units (RVUs) for transthoracic echocardiography plus the two add-on codes before 2009 were 9.52. After the three codes were bundled together in 2009, the global RVU for the single new code was 7.42. Before 2010, the global RVU for SPECT MPI at rest and after exercise plus the two add-on codes was 16.48. After the three codes were bundled together in 2010, the global RVU for the single new code was 10.53. These reimbursement reductions along with more burdensome regulations and rising drug and business costs forced many cardiology offices to close [6]. It seems that once the financial inducement inherent in private office self-referral

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declined, so did utilization by ordering physicians. There may well be additional reasons for the declines in utilization of MPI and SE. These include closer adherence to cardiac imaging appropriateness criteria developed by both the ACR and the American College of Cardiology, the advent of high-deductible health plans, the lingering effects of the recession, and a decline in the incidence of CAD that has been noted in recent years [9,10]. The downtrends in these examinations are likely to be welcomed by payers and policymakers, although it is not clear whether reduced use will adversely affect patient care. The CCTA utilization trends are also of interest, albeit at much lower levels of utilization. One might ordinarily expect a new and highly promising examination, such as CCTA, to grow rapidly. However, after a single year of rapid growth in 2007 (the second year specific CCTA codes were available), a prolonged decline occurred, with the result that in 2013, the utilization rate of that examination was only slightly higher than it had been in 2006. Both cardiologists and radiologists are actively involved in CCTA. In 2007, cardiologists performed almost twice as many as radiologists. Decline then occurred among both specialties, but it was more pronounced among cardiologists. In the last several years of the study, utilization among radiologists began to edge upward, and by 2013, they were doing slightly more than cardiologists. The overall lack of growth in CCTA seems to be due to several factors, including the high cost of multidetector CT scanners with the required special software, the labor-intensive nature of the procedure, frequent denials by insurance carriers, and relatively poor reimbursement. Regarding the latter, the CMS website indicates that the 2013 national Medicare Physician Fee Schedule global payment (unadjusted for geographic locale) was $234 for SE, $463 for CCTA, and $502 for MPI [11]. Some cardiologists may have become reluctant to read CCTA studies because it would require them to report incidental abnormalities seen in the lungs or mediastinum, areas in which they had little or no training. Another factor might be ingrained habit among cardiologists, who have gotten used to doing MPI and SE on their own patients for many years and are reluctant to give them up. CCTA’s principal competing examination is MPI. In 2013, the utilization rate per 1,000 of MPI in the Medicare fee-for-service population was 61.9, whereas that of CCTA was 1.07. This means that despite the recent drop in utilization of MPI examinations, there were still 58 times as many of them performed as CCTA studies. This huge discrepancy is of concern because there is evidence suggesting that CCTA has a number of advantages over MPI in the workup of 4

patients with suspected CAD. These include (1) the inability of MPI to exclude CAD; (2) the high incidence of false positives with MPI, leading to excessive use of invasive coronary angiography (ICA); (3) the value of CCTA as a prognostic tool in low-risk patients; and (4) the efficacy of using CCTA in the emergency department (ED) setting. These are discussed below.

The Inability of MPI to Exclude CAD Negative results on an MPI study do not exclude the possibility of CAD [4,12-18]. Patients may have multiple nonobstructive coronary atherosclerotic plaques that do not impede coronary blood flow and therefore result in normal findings on MPI. CCTA will generally detect these plaques. It is important to identify such individuals on noninvasive testing so they can be started on aggressive medical therapy in the hope of averting future progression of the disease. MPI can also miss obstructive lesions. Chinnaiyan et al [18] recently reported on data from a large multicenter registry that included 6,198 patients who underwent stress testing (65% by MPI, 26% by SE) followed by CCTA. Of 1,548 patients who had normal stress test results, 15% were noted to have obstructive stenoses on CCTA. MPI false negatives can also occur in patients with obstructive lesions in all three major vessels; this can result in equally restrictive flow to all coronary artery distributions—so-called balanced ischemia—and normal results on MPI [17]. CCTA will also generally detect these kinds of lesions. In a recent discussion of whether CCTA or stress imaging (MPI or SE) can best serve as the gatekeeper to the cardiac catheterization laboratory, Marwick et al [16] commented that the 97% to 99% negative predictive value of CCTA to exclude obstructive stenosis means that a CCTA-based approach can effectively rule out anatomic CAD. They further pointed out that although stress imaging is effective for predicting risk, it is unable to exclude CAD, including severe CAD. High Incidence of False Positives With MPI In the study of Chinnaiyan et al [18], 621 patients underwent ICA, 388 of whom had abnormal results on stress imaging. Forty-one percent of these abnormal stress imaging studies proved to be false positives; at ICA, the patients had either normal coronary arteries or mild nonobstructive plaques. Patel et al [19] reported on almost 400,000 patients who had undergone elective ICA and whose results were recorded in the National Cardiovascular Data Registry. Eighty-four percent had undergone noninvasive testing before ICA, mostly with Journal of the American College of Radiology Volume - n Number - n Month 2015

MPI or SE. Among those with positive noninvasive test results, 59% had either no disease or nonobstructive disease on ICA. Other studies have shown that in large groups of patients worked up by experienced cardiologists (usually including stress imaging) who go on to have ICA, the incidence of normal coronary arteries or nonobstructive plaque formation varies from 30% to 70% [20-24]. It seems clear from these reports that MPI and SE are not serving as effective gatekeepers to cardiac catheterization. Too many patients are being sent to the catheterization laboratory who do not need it. CCTA has a very high negative predictive value [16], and so if more of them were done before referring patients for ICA, it seems likely that many unnecessary invasive coronary angiographic procedures could be avoided.

CCTA as a Prognostic Tool In a study of 2,583 symptomatic patients who underwent CCTA and were found to have either normal coronary arteries or nonobstructive plaques and were followed for a mean of 3.1 years, Lin et al [25] found that Kaplan-Meier survival was significantly lower in patients with nonobstructive plaques than in those with normal coronary arteries. In a 2011 meta-analysis of 18 earlier studies of the prognostic value of CCTA in 9,592 patients, Hulten et al [26] stratified patients by no disease, nonobstructive CAD, or obstructive CAD. They found an increasing occurrence of major adverse cardiac events with increasing degrees of CAD by CCTA. These studies emphasize the importance of early detection of mild nonobstructive CAD so that aggressive medical therapy can be instituted and patients can be counseled about necessary lifestyle modifications. The Efficacy of CCTA in the ED Setting Chest pain is the second most common cause of visits to EDs and results in approximately 8 million ED visits per year in the United States [27]. Three recent multicenter randomized trials have clearly shown the efficacy of using early CCTA in these patients, compared with MPI or standard care. Goldstein et al [28] randomized 699 such patients to CCTA or MPI. CCTA use led to a 54% reduction in time to diagnosis and a 38% reduction in the cost of ED care. In patients who had normal index imaging, there was no difference between the two groups in the 6-month incidence of major adverse cardiac events. Litt et al [29] randomized 908 ED patients to CCTA and 462 to traditional care (in which the patients’ doctors determined which other tests to order). CCTA patients had a higher rate of discharge directly

from the ED (50% vs 23%), shorter length of stay in the ED (18 vs 25 hours), and a higher rate of detection of CAD (9.0% vs 3.5%). Of 640 patients with normal results on CCTA, none died or had MIs within 30 days. Hoffmann et al [30] randomized 1,000 ED patients with acute chest pain but without ischemic electrocardiographic changes or positive troponins to early CCTA or standard evaluation. In the CCTA group, mean ED length of stay was shorter by 7.6 hours, and more patients were discharged directly from the ED (47% vs 12%). There was no significant difference in the incidence of major adverse cardiac events between the two groups at 28 days. It seems that ED physicians have become aware of and are using this evidence. Our database revealed that the volume of Medicare cardiac CT scans in EDs increased progressively every year from 194 in 2001 to 1,770 in 2013. Another important advantage of using CT in these ED patients is the so-called triple-rule-out examination [31]. Not only can CCTA assess the status of the coronary arteries, it can also determine whether any other serious causes of chest pain are present, such as pulmonary embolism, aortic dissection, pericardial or pleural effusion, lung or mediastinal tumor, pneumothorax, rib fracture, and so on. If a triple-rule-out study has negative results, the treating physician can be assured that there is no serious etiology for a patient’s chest pain.

CONCLUSIONS We do not mean to imply that MPI and SE have no value. They are tests of cardiac function, whereas CCTA provides an assessment of coronary artery anatomy. As such, the two types of examinations complement each other. CCTA does have its own drawbacks. In patients who are obese or have heavily calcified vessels, rapid heart rates, or arrhythmias, CCTA quality may be suboptimal. Nevertheless, we believe that in appropriate patients, CCTA is the best first imaging test when CAD is suspected. We agree with the position taken recently by Marwick et al [16]. They stated, “The limitations of current functional testing-based paradigms might be avoided by using coronary computed tomographic angiography (CCTA) for exclusion of obstructive coronary artery disease.” They further went on to state that CCTA is more cost effective than stress testing and has the potential to serve as an effective gatekeeper to curb unnecessary ICA. Thus, it is concerning that in 2013, MPI was used 58 times as often as CCTA in the Medicare population. As noted earlier, there are several reasons for the meager use of CCTA. Radiologists are actively involved

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in this procedure, and we hope they will do more to disseminate knowledge about its advantages and encourage greater use among their clinical colleagues.

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MPI use grew rapidly in the Medicare population from 2001 to 2006, then plateaued for three years, then declined substantially through 2013. SE use remained relatively flat from 2001 through 2010, then declined modestly through 2013. These declines probably resulted from several factors, the most important of which was code bundling, which sharply reduced the collected revenues in cardiology private offices. Many of them closed or were absorbed by hospitals. CCTA utilization has remained surprisingly low, especially in comparison with MPI. In 2013, MPI was performed 58 times as frequently as CCTA. Cardiologists strongly predominate in MPI and SE, but they and radiologists share equally in CCTA.

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