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1. Multi-center Assessment of the Utilization of SPECT Myocardial Perfusion Imaging Using the ACCF Appropriateness Criteria: The ACCF and United Healthcare SPECT Pilot Study Robert C. Hendel, Manual Cerqueira, Kathleen Hewitt, Karen Caruth, Joseph Allen, Neil Jensen, Michael Wolk, Pamela S. Douglas, Ralph Brindis, American College of Cardiology Foundation, Washington, DC, UnitedHealthcare, Minneapolis, MN Robert C. Hendel, MD, FACC Midwest Heart Specialists Winfield, IL Chairman, ACCF/UHC SPECT-MPI Pilot Study Late Breaking Clinical Trials American College of Cardiology Scientific Sessions 2009 March 29, 2009

2. Presenter Disclosure Information Robert C. Hendel, MD The following relationships exist related to this presentation: Consulting PGx Health Modest Astellas Pharma Modest GE Healthcare Modest Research support Astellas Modest GE Healthcare Modest Organizational ACC (Appropriate Use Criteria Task Force)

3. BACKGROUND • Growth and cost of CV imaging has placed renewed attention on proper/optimal test ordering • True nature of utilization unknown • Overuse/underuse/appropriate use • Development and publication of SPECT-MPI appropriate use criteria (AUC) in 2005 • Subsequent AUC for echo, CT, CMR • SPECT MPI revision 2009 • Criteria widely available and increasingly being adopted, but evaluation in community practice settings required

4. GOALS OF STUDY • Assess feasibility of tracking AUC • Point-of-service data collection • Computer derived indication assignment • Determine patterns of use for SPECT MPI in clinical practice • Evaluate the impact of referral source • Identify selected areas (indications) for quality improvement

5. METHODS • Sites selected by ACC from potential locations provided by UHC • Data collection instrument and web-based entry system developed • Automated algorithm created • Audit of automated indication assignments • On-demand reports • Periodic overall and site-specific summaries provided

6. DATA COLLECTION FORM • Front page • Patient Demographics • History & Risk Factors, • Prior procedures & Tests • Back page • Current Study • Reference section • Designed to be completed in one minute or less

8. METHODSSites of Pilot

9. METHODSEnrollment Periods 3/1/08 8/15/08 10/15/08 2/28/09 SITE 1 2 3 4 5 6 1 SITE 2 3 4 5 6 Period 1 Period 2 Period 3 On-demand Report Paper Report

10. RESULTSPatient Characteristics (n = 6,351)

11. RISK ASSESSMENTAutomated Calculation and Indication Assignment SYMPTOMATIC PATIENTS (Diamond & Forrester) ASYMPTOMATIC PATIENTS (Framingham; CHD Risk)

12. APPROPRIATENESS CLASSIFICATION(n = 6,351)

13. APPROPRIATENESS CLASSIFICATION Elimination of Unclassified (n = 5,928)

14. APPROPRIATENESS CLASSIFICATION Based on Site Inappropriate Range: 4-22% n = 578 1200 1448 1448 322 932

15. APPROPRIATENESS CATEGORYBased on Patient Factors 9.8% 19.3% 13.6% 15.5% n = 3,046 2,882 3,468 2,460 p < 0.0001 p = 0.039

16. MOST COMMON “INAPPROPRIATE” INDICATIONS

17. APPROPRIATENESS CATEGORY Based on Referral p < 0.0001 13.2% 19.5% 16.1% 9.9% 70.7% 70.7% n = 4,792 n = 1,136

18. APPROPRIATENESS CATEGORY Based on Referral p < 0.0001 13.2% 20.1% 16.0% 10.1% 70.9% 69.8% n = 4,881 n = 1,047

19. FEEDBACK TO SITES

20. INAPPROPRIATE SPECT-MPITemporal Changes Based on Site

21. CONCLUSIONS • Data collection and analysis regarding appropriate use of SPECT imaging is feasible in busy community practice environment • Easy to use, point-of-ordering tool with web-based data entry • Automated determination of appropriateness • On-demand, benchmarked reports • Variable rates of test appropriateness • Consistent inappropriate indications • Asymptomatic, low risk patient are most frequent • Feedback/education may influence on practice habits • Less inappropriate testing from cardiologists than non-cardiologists

22. IMPLICATIONS • Physicians and other health care professionals, working with medical societies, recognize the current healthcare environment • Active measures to optimize performance and cost-effectiveness • Preserve patient access to evaluation and treatment • The development and implementation of appropriate use criteria may offer an alternative to prior authorization/pre-certification approaches • Transparency • Expanded information regarding practice habits • Facilitation of on-going quality improvement • Movement toward point-of-order application • Potential for wide-scale utilization • Establishment of partnership between ACC, subspeciality societies, and health plans regarding responsible approach to medical imaging and continued emphasis on improving the quality of care

23. ACKNOWLEDGMENTS • American Society of Nuclear Cardiology (ASNC) • UnitedHealthcare • Leadership of ACC • Especially Douglas Weaver, Ralph Brindis, Michael Wolk, Pamela Douglas, Jack Lewin, and Janet Wright • Staff from ACC, NCDR, and DCRI • Notably Joseph Allen, Karen Caruth, Wenqin Pan, and Nichole Kallas

24. LIMITATIONS • Non-evaluable data • Missing information • Conflicting indications • Rolling recruitment with inconsistent time periods • Lack of validation of computer-assigned indications • Multiple indications • Audits reveal variance • Educational initiatives inconsistently applied • Non-adjudicated SPECT interpretations

25. AUDIT OF COMPUTER-ASSIGNED INDICATIONS VERSUS INDEPENDENT PHYSICIAN REVIEW

26. SPECT RESULTSBased on Appropriateness Category APPROPRIATE UNCERTAIN INAPPROPRIATE p < 0.0003

27. INDICATION AND SPECT FINDINGSMost Common “Inappropriate” Indications

28. PROBABILITY OF CORONARY ARTERY DISEASE BASED ON AGE, GENDER AND SYMPTOMS(Diamond & Forrester) CALCULATED n = 6,332 ESTIMATED n = 5,567

29. CORONARY HEART DISEASE RISKBASED ON FRAMINGHAM CRITERIA ESTIMATED n = 5,649 CALCULATED n = 6,082

30. REASON FOR TESTBased on Appropriateness Category

31. Literature Review and Synthesis of the Evidence List of indications and definitions Appropriateness Score (7-9) Appropriate (4-6) Uncertain (1-3) Inappropriate ACC METHODOLOGY FOR DEVELOPMENT OF APPROPRIATE USE CRITERIA (Rand/Modified Delphi Method) Writing Group Outside Review of Indications and Additional Modification Prior to Rating External Reviewers Balanced panel comprised of different types of experts rates the indications in two rounds 1st Round – No interaction Face-to-Face Meeting 2nd Round – Panel interaction Appropriateness Determination Technical Panel Retrospective comparison with clinical records Prospective clinical decision aids Implementation Working Group Validation % Use that is Appropriate, Uncertain, Inappropriate Increase Appropriateness Adapted from Fitch K, et al. The RAND/UCLA Appropriateness Method User’s Manual, 2001, 4