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

The following relationships exist related to this presentation: 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 Organizational ACC (Appropriate Use Criteria Task Force)

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 The ACC is focusing on quality in cardiac imaging for the following reasons:1 There is unprecedented focus by professional societies, governmental agencies and payers, on assessment and improving the quality of cardiac imaging There has been an explosive growth of cardiovascular imaging in the United States There continues to be substantial regional variation in utilization The true nature of utilization is not known In my view, clinicians, patients and payers are seeking guidance on how to proceed. 1.Patel Mr, Spertus JA, Brindis, RG et al. ACCF Proposed Method for Evaluating the Appropriateness of Cardiovascular Imaging, J Am Coll Cardiol. 2005; 46:1606-1613.

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

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

DATA COLLECTION FORM Front page Back page Patient Demographics History & Risk Factors, Prior procedures & Tests Back page Current Study Reference section Designed to be completed in one minute or less Start with paper data collection form Designed to be completed in one minute or less

METHODS Sites of Pilot State Locale # MD’s # patients enrolled Site 1 FL Urban 17 635 Site 2 7 1293 Site 3 WI Rural 15 1597 Site 4 20 1570 Site 5 OR Suburban 328 Site 6 AZ 9 938

METHODS Enrollment 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

RESULTS Patient Characteristics (n = 6,351) Age, years 65.7±11.8 Gender, male 3,729 58.7% Diabetes 1,446 22.3% Smoker 743 11.7% Hypertension 4,856 76.7% Hyperlipidemia 4,616 72.9% Prior PCI 1,806 36.1% Prior CABG 945 19.7% Asymptomatic 2,414 38.0%

RISK ASSESSMENT Automated Calculation and Indication Assignment SYMPTOMATIC PATIENTS (Diamond & Forrester) ASYMPTOMATIC PATIENTS (Framingham; CHD Risk)

APPROPRIATENESS CLASSIFICATION (n = 6,351)

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

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

APPROPRIATENESS CATEGORY Based 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

MOST COMMON “INAPPROPRIATE” INDICATIONS % INAPPRO INDICATIONS % TOTAL STUDIES Detection of CAD Asymptomatic, low CHD risk 44.5% 6.0% Asymptomatic, post-revascularization < 2 years after PCI, symptoms before PCI 23.8% 3.2% Evaluation of chest pain, low probability pt Interpretable ECG and able to exercise 16.1% 2.2% Asymptomatic or stable symptoms, known CAD < 1 year after cath or abnormal prior SPECT 3.9% 0.5% Pre-operative assessment Low risk surgery 3.8% 0.5 % TOTAL 92.1% 12.4 %

APPROPRIATENESS CATEGORY Based on Referral 13.2% 19.5% 16.1% 9.9% 70.7% 70.7% n = 4,792 n = 1,136

APPROPRIATENESS CATEGORY Based on Referral 13.2% 20.1% 16.0% 10.1% 70.9% 69.8% n = 4,881 n = 1,047

FEEDBACK TO SITES

INAPPROPRIATE SPECT-MPI Temporal Changes Based on Site

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

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

IMPLICATIONS Physicians and other health care professionals, working with medical societies, recognize the current healthcare environment and are taking active measures to optimize performance and cost-effectiveness, while preserving patient access to evaluation and treatment procedures The development and implementation of AUC 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, imaging subspeciality society, and health plan regarding responsible approach to medical imaging and continuing emphasis on improving the quality of care

ACKNOWLEDGMENTS American Society of Nuclear Cardiology (ASNC) Support from 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