Editorial Use of Appropriate Use Criteria Is Increasing, but What Are Their Effects on Medical Care? Gregory J. Dehmer, MD; Manesh R. Patel, MD

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he first appropriate use criteria (AUC) for coronary revascularization were published in 2009 with an update published in 2012.1,2 A new version of the AUC for coronary revascularization is currently under development and will, we hope, address some of the constructive criticisms directed at the earlier versions. The use of AUC is increasing, and several other organizations have developed AUC for different procedures outside the cardiovascular arena. For example, orthopedic surgeons now have AUC for several of their common procedures, the American Academy of Dermatology has AUC for Mohs surgery, and AUC for the placement of Foley catheters recently were published.3–5 With the increasing development, promotion, and adoption of AUC, it is reasonable to ask a critical question: What are the effects of AUC on the delivery of cardiovascular care? This is a fair question because the AUC are intended to address the rational use of coronary revascularization, to provide a practical standard on which to assess and understand variability, and to evaluate overall patterns of care for coronary revascularization.

Article see p 20 The article by Bradley and colleagues6 in this issue of Circulation provides some insight into that question. Using data from the Washington State Clinical Outcomes Assessment Program, they examined temporal trends in the number of percutaneous coronary intervention (PCI) procedures performed, specifically the number of PCIs rated as inappropriate. High-performing hospitals were identified by a low or declining proportion of inappropriate PCIs or PCIs performed with insufficient preprocedural information to allow the assessment of appropriateness. They showed that, after the adoption of the Clinical Outcomes Assessment Program, there was an overall decline in the number of PCIs performed and specifically a substantial decline in the number of PCIs for elective indications. Although there was a slight increase in the number of PCIs performed for unstable angina or non–STsegment–elevation myocardial infarction during the same period, this increase was insufficient to explain the decline in The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From Baylor Scott & White Health, Temple Campus, Temple, TX (G.J.D.); Texas A&M Health Science Center College of Medicine, Temple (G.J.D.); and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.R.P.). Correspondence to Manesh R. Patel, MD, Duke University Medical Center, 2400 Pratt St, Durham, NC 27710. E-mail [email protected] (Circulation. 2015;132:4-6. DOI: 10.1161/CIRCULATIONAHA.115.017243.) © 2015 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.115.017243

elective PCIs. Therefore, the increase in PCIs for acute coronary syndromes was not felt to be the result of operators simply learning the coding system and shifting the diagnosis. The decline in the use of elective PCI was significantly larger after the onset of the statewide PCI appropriateness assessment, with a modest increase in the proportion of elective PCIs classified as appropriate and a modest decrease in the proportion of inappropriate PCIs. Of note, the decline in the proportion of inappropriate PCI was limited to the tertile of hospitals with the largest decline in PCIs classified as inappropriate (25% in 2010 to 12% in 2013). This observation must be viewed within the context that the number of PCIs in the United States has also declined in the same time period. Whether this is related to the overall adoption of the AUC for revascularization, AUC for diagnostic cardiac catheterization, and AUC for stress imaging nationwide or other factors is unclear. How should we view the findings by Bradley et al? Specifically, are the AUC making an impact on clinical care? Compared with clinical practice guidelines, the AUC documents are relatively new in the cardiovascular arena.7 Only recently have studies emerged showing the effects, potential benefits, and limitations of AUC in cardiovascular care. Some of the more notable studies to date are summarized in Table 1 in the Bradley et al article.8-14 In addition to the growing evidence base, a beneficial effect of the AUC is that they are readily adaptable for use as clinical decision support tools.8,9 For both myocardial perfusion imaging and echocardiography, such tools have been shown to increase the proportion of appropriate-rated testing and to decrease the proportion of inappropriate-rated testing. Similar clinical decision support tools exist for both diagnostic cardiac catheterization and coronary revascularization that run as Web-based or smart phone applications, but their clinical use has not been evaluated to determine whether these clinical decision support tools alter the appropriateness classification of these procedures.15 Other clinical benefits of the AUC have been demonstrated. Doukky et al10 showed that, when myocardial perfusion imaging was performed for appropriate indications, it had a high prognostic value, in contrast to inappropriate test performance, which was shown to lack effectiveness for risk stratification. Moreover, quality of life before and 1 year after revascularization, as assessed by the Seattle Angina Questionnaire and the EuroQOL 5-dimensions questionnaire, showed the greatest improvement compared with medical therapy when the revascularization was categorized as appropriate.11 Several studies have explored the association between procedure appropriateness ratings and outcomes from coronary angiography or PCI. In a large sample derived from the National Cardiovascular Data Registry, there was no relationship among the proportion of inappropriate-rated PCIs and

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Dehmer and Patel   Use of AUC and Their Effects on Medical Care   5 in-hospital mortality, periprocedural bleeding, or medical therapy at discharge.12 This led the authors to conclude that PCI appropriateness measures a different aspect of PCI quality than these 3 outcomes. Periprocedural bleeding is a function of vascular access, hemostasis, and other clinical factors that place a particular patient at risk for bleeding. These factors exist regardless of whether the PCI was rated appropriate or inappropriate, so the lack of an association seems expected. Moreover, the major defining characteristics among inappropriate PCIs are a lack of medical therapy, no or mild symptoms, or a low ischemic burden.16 In-hospital mortality occurs more frequently in higher-risk patients; therefore, the lack of association is also not surprising and potentially expected.17 Mohareb et al14 examined the relationship between the appropriateness rating of coronary angiography in patients with suspected stable ischemic heart disease and the proportion of patients subsequently found to have significant obstructive coronary artery disease. Although more patients with appropriate indications had obstructive coronary artery disease and underwent revascularization, a substantial proportion of those with inappropriate or uncertain indications also had important coronary disease. The new terminology for “uncertain” is “may be appropriate,” reflecting the fact that the procedure being evaluated may be a reasonable and acceptable choice of the patient.18 Similarly, the new term replacing “inappropriate” is “rarely appropriate,” indicating that revascularization for a few patients in this category is still the best choice. Patients are classified as uncertain or may be appropriate because there are insufficient clinical data to further characterize them into a different category, because there are other clinical variables not considered in the AUC construct that can affect the clinician’s decision, or because this particular group of patients has not been well studied and thus the best therapy is uncertain. For example, there are few studies that specifically examine the clinical utility of revascularization in patients with chronic renal failure. In the study by Mohareb et al,14 89% of the studies were either appropriate or uncertain, with the remainder (11%) considered inappropriate. The authors also expressed concern that 7.1% of patients deemed inappropriate had important left main or 3-vessel coronary artery disease. However, further examination of their data shows that their entire inappropriate group was asymptomatic and either did not have a stress test or had a low-risk stress test result. Many factors could explain this finding, including limitations of the clinical history, exercise testing, or interpretation of the angiogram. Finally, in a retrospective application of the AUC for revascularization, Ko et al13 identified substantial underutilization and overuse of coronary revascularization but significantly increased adverse outcomes (death or an acute coronary syndrome after 3 years) if an appropriate coronary revascularization was not performed. These findings highlight the fact that the AUC were originally devised to address underuse and overuse of procedures.19 With this growing evidence base, the use of AUC as a mechanism to benchmark ordering patterns and to assess variations in care has continued to gain attention, especially among payers and the government. In March 2014, Congress passed the Protecting Access to Medicare Act of 2014 (H.R. 4302), which includes a provision requiring ordering professionals to

consult with AUC through a clinical decision support mechanism for all Medicare patients receiving advanced imaging (cardiac nuclear, computed tomography, and magnetic resonance) starting in January 2017. This program will collect information about practice patterns but importantly will not tie payment to the appropriate use score for individual cases. This is an extremely important part of this legislation because some states and payers have started using the AUC to adjudicate payments, a function that the AUC were never intended to perform. Rather, the AUC were intended guide practice and to prevent or reduce prior authorization mechanisms. Implementation of the AUC directive is one of the first steps in the transition that Medicare will make over the next several years to pay for value instead of volume. Studies such as the one by Bradley and colleagues help the cardiovascular community further understand the potential role that AUC will have on the delivery of cardiovascular care in the future. At present, the AUC are imperfect instruments but will continue to be refined and to mature as more knowledge about their use and limitations is produced.

Disclosures None.

References 1. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/ STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization: a report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology: endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. Circulation. 2009;119:1330–1352. doi: 10.1161/CIRCULATIONAHA.108.191768. 2. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/ STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2012;59:857–881. doi: 10.1016/j.jacc.2011.12.001. 3. American Academy of Orthopaedic Surgeons. Appropriate use criteria for distal radius fractures. www.aaos.org/auc. Accessed May 7, 2015. 4. Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W. AAD/ACMS/ASDSA/ ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012;67:531–550. 5. Meddings J, Saint S, Fowler KE, Gaies E, Hickner A, Krein SL, Bernstein SJ. The Ann Arbor criteria for appropriate urinary catheter use in hospitalized medical patients: results obtained by using the RAND/UCLA appropriateness method. Ann Intern Med. 2015;162(suppl):S1–S34. doi: 10.7326/M14-1304. 6. Bradley SM, Bohn CM, Malenka DJ, Graham MM, Bryson CL, McCabe JM, Curtis JP, Lambert-Kerzner A, Maynard C. Temporal trends in percutaneous coronary intervention appropriateness: insights from the Clinical Outcomes Assessment Program. Circulation. 2015;132:20–26. doi: 10.1161/CIRCULATIONAHA.114.015156. 7. Hendel RC, Berman DS, Di Carli MF, Heidenreich PA, Henkin RE, Pellikka PA, Pohost GM, Williams KA; American College of Cardiology Foundation Appropriate Use Criteria Task Force; American Society of Nuclear Cardiology; American College of Radiology; American Heart Association; American Society of Echocardiography; Society

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13. Ko DT, Guo H, Wijeysundera HC, Natarajan MK, Nagpal AD, Feindel CM, Kingsbury K, Cohen EA, Tu JV; Cardiac Care Network (CCN) of Ontario Variations in Revascularization Practice in Ontario (VRPO) Working Group. Assessing the association of appropriateness of coronary revascularization and clinical outcomes for patients with stable coronary artery disease. J Am Coll Cardiol. 2012;60:1876–1884. doi: 10.1016/j.jacc.2012.06.056. 14. Mohareb MM, Qiu F, Cantor WJ, Kingsbury KJ, Ko DT, Wijeysundera HC. Validation of the appropriate use criteria for coronary angiography: a cohort study. Ann Intern Med. 2015 Apr 21;162:549–556. 15. SCAI-QIT appropriate use criteria app for diagnostic catheterization and coronary revascularization. www.scaiaucapp.org. Accessed May 10, 2015. 16. Chan PS, Patel MR, Klein LW, Krone RJ, Dehmer GJ, Kennedy K, Nallamothu BK, Weaver WD, Masoudi FA, Rumsfeld JS, Brindis RG, Spertus JA. Appropriateness of percutaneous coronary intervention. JAMA. 2011;306:53–61. doi: 10.1001/jama.2011.916. 17. Peterson ED, Dai D, DeLong ER, Brennan JM, Singh M, Rao SV, Shaw RE, Roe MT, Ho KK, Klein LW, Krone RJ, Weintraub WS, Brindis RG, Rumsfeld JS, Spertus JA; NCDR Registry Participants. Contemporary mortality risk prediction for percutaneous coronary intervention: results from 588,398 procedures in the National Cardiovascular Data Registry. J Am Coll Cardiol. 2010;55:1923–1932. doi: 10.1016/j.jacc.2010.02.005. 18. Hendel RC, Patel MR, Allen JM, Min JK, Shaw LJ, Wolk MJ, Douglas PS, Kramer CM, Stainback RF, Bailey SR, Doherty JU, Brindis RG. Appropriate use of cardiovascular technology: 2013 ACCF appropriate use criteria methodology update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force. J Am Coll Cardiol. 2013;61:1305–1317. doi: 10.1016/j.jacc.2013.01.025. 19. Laouri M, Kravitz RL, French WJ, Yang I, Milliken JC, Hilborne L, Wachsner R, Brook RH. Underuse of coronary revascularization procedures: application of a clinical method. J Am Coll Cardiol. 1997;29:891–897. Key Words: Editorials ◼ catheters ◼ percutaneous coronary intervention

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Use of Appropriate Use Criteria Is Increasing, but What Are Their Effects on Medical Care? Gregory J. Dehmer and Manesh R. Patel Circulation. 2015;132:4-6 doi: 10.1161/CIRCULATIONAHA.115.017243 Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2015 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. Online ISSN: 1524-4539

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Use of Appropriate Use Criteria Is Increasing, but What Are Their Effects on Medical Care?

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