1. Collaborative Maryland Initiative for Assuring Quality of Percutaneous Coronary Intervention Julie M. Miller, M.D., F.A.C.C., F.S.C.A.I. Associate Professor of Medicine, Johns Hopkins University Director, Vascular Cardiology Program; Interventional Cardiology On behalf of : M ARYLAND A CADEMIC C ONSORTIUM FOR P ERCUTANEOUS C ORONARY I NTERVENTION A PPROPRIATENESS AND Q UALITY (MACPAQ) A collaboration between the Divisions of Cardiology at The Johns Hopkins University and The University of Maryland

2. MHCC and House Bill 1141 (2012 Chapter 418 MD Law) Directs MHCC to revise the State Health Plan regulatory oversight New plan will replace current process (CAG) for establishing and maintaining PCI services for on-going quality assurance Update to State Health Plan: “ Regulations shall: include requirements for Peer or independent review, consistent with ACC/AHA guidelines..., of difficult or complicated cases and for randomly selected cases”

3. Peer Review Can be “Internal” or “External” Internal: outcome based, difficult to remove bias External: objective, can focus on both quality and appropriateness External review –Constructive, expert, helps enhance knowledge for future decisions –Must be confidential, non-punitive, and unbiased Few models exist for collaborative, external review in PCI –Often expensive, limited long term value, do not engage participants

4. Proposal: A Collaborative Maryland State-wide Quality Peer Review Initiative Purpose To perform independent external quality reviews for cath/PCI with the goal of providing objective feedback to hospitals / physicians : case selection, performance, reporting To provide a data quality validation and risk adjustment Methods Apply established expertise of Maryland hospitals / physicians Physician Peer reviewers from all participating hospitals Cardiologists and cardiac surgeons To achieve the “new standard” for the ongoing quality review

5. The MACPAQ Story The Maryland Academic Consortium for Percutaneous Coronary Intervention Appropriateness and Quality –Joint effort between JHU and UMD > 1 yr Combined resources Organizational agreement, approved mission and goals Incorporated into hospitals as quality assurance process –Collaborative, physician external peer review Meet needs of both health systems Physician lead blinded reviews of cath / PCI –Reduce same group / center bias –Expand educational and research missions

6. MACPAQ Review Initiative Independently review – “appropriateness” of PCI ACC/AHA guidelines Standard clinical practice –approach to revascularization (PCI/CABG) –coronary angiographic images Visual and selected computerized quantitative coronary angiography, intracoronary diagnostics –Procedural outcome –Accuracy of reporting Cath report, NCDR data

7. MACPAQ: External Peer Review System Participating UMD Hospitals Source data/records/ Films Results returned to Hospital/Cath Lab QA designee Participating JHU/JHHS Hospitals Source data/records/ Films Electronic Results returned to Hospital/Cath Lab QA designee MACPAQ – Coordinating Center - Obtain necessary documentation - Ensure blinding of films/data - Distribute blinded data to reviewers (via web-based link) Physician Peer review - Review of clinical records - Cath / PCI angiographic film* - PCI outcome review - “appropriateness” of Cath/PCI MACPAQ – Coordinating Center - Summarized results - Identify disagreements for further review and group review - Summarize results quarterly Results to Coord. Ctr. Individual Physicians Core Lab - Angio review - Quantitative (QCA) -ACC “ appropriateness” Current Members Aversano T Brinker J Gupta A Miller JM Texter J Walford G Zimrin D

8. 8 Structure Blinded cross-institutional physician-based All-inclusive, collaborative All PCI hospitals/physicians represented Goal : Objectively assess case selection, performance, reporting Clinical and angiograms Core Lab for quantitative analysis Experience and Existing Infrastructure Model ( MACPAQ) currently running (JHH & UMD ) expanding to systems Completed projects for health care system in PA Proposal: State-Wide PCI Quality Review Initiative

9. 9 Value Provides a blinded independent peer review process Tailor to State/MHCC/CAG recommendations Evolution / flexible Validated quantification analysis use unique, for standardization High value to system at low cost Provides ability for data validation Maryland hospital and physician ownership Proposed State-Wide PCI Quality Review Initiative

10. Physician Review Teams Cardiology / Cardiac surgery Teams from all participating hospitals Hospital A Physician 1, 2,3, etc. Image Sharing (Cath films) Source clinical Medical Information (NCDR data, Scanned source documents, etc) Blinded Peer-to- Peer Review Appropriateness/Quality/ CABG vs PCI Draft Peer Cath / PCI Quality Review Quantitative Angiography Resource lab (MACPAQ) Sample of studies for objectivity, quantitative analysis, and peer training and education Hospital x Hospital y Hospital B Physician 1, 2,3, etc. Hospital C Physician 1, 2,3, etc. Coordinating /Processing Center Blinding, Distribution / Storage of data (MACPAQ) Physician Reviewer 1 Physician Reviewer 2 electronic - Review information - Peer Feedback to Hospitals / Physician

11. Steering Committee Chairman (rotating) 23 PCI Hospitals physician representatives MHCC, MHA, MACPAQ representatives External Peer Review Administrative (Executive) Committee: Chairman, physicians, Financial, Administration, others Consultants American College of Cardiology, SCAI, MHCC, MHA Armstrong Institute Registry Data (NCDR) Review Education / Feedback Operations Committee Data management, IT Proposed Organizational Structure for State-Wide External Peer Review Process

12. Why Physicians Would Want to Participate Engage Educate EvaluatePerform - Uniform evaluation standards - Unbiased - Self-study to apply guidelines - Constructive, expert - Confidential, non-punitive - Educational (CME / MOC credits) -Fundamentally educational -Helps enhance knowledge for future decision making - Dissemination of updates - Helps identify areas of improvement -Helps confirm reporting (e.g. NDCR reporting) -Foster open communication / consultation and support

13. Summary Peer review is the cornerstone of quality improvement & assurance of appropriateness Physician-driven external peer review : Complementary to internal review Improves quality, confidence The proposed all-inclusive, Maryland-based system will provide a robust and sustainable mechanism for cath/PCI quality improvement state-wide

15. 1) A pre-determined algorithm for the percent of random cases per operator per institution to be established and used throughout the state a)minimum number of cases per operator and hospital. # determined by the Steering Committee, in collaboration with the MHCC, MHA, and CAG. b)In addition, the Steering committee may recommend additional triggers for case review 2) Random cases and selected cases will be identified for the review process by the Coordinating Center that meet the pre-specified criteria for review 3) Case-related documentation sent to Processing Center electronically 4) Documentation will be reviewed collated and patient, physician and hospital identifiers redacted (blinded) 5) Documentation and angiograms distributed to the reviewers electronically (projected 2 reviewers/case, third reviewer if disagreement). Quality Review Initiative : Hypothetical Process: STEPS All hospitals and their physicians participate 1 2 3 4 5

16. 6) Physicians who participate in the review process will be sent web-based links for reviewing a case, and an electronic report form for completion. 7) Cases will be reviewed for clinical appropriateness (based on published guidelines), angiographic appropriateness, approach, data accuracy and other parameters agreed to by the Steering committee. 7) Quantitative Coronary Angiographic (QCA) analysis will be performed separately to supplement the review process. 8) The Steering Committee will determine the processes for evaluating review differences between reviewers or disagreements. 9) The hospital will receive a summary report of each operator (blinded) and a hospital summary. 10) CAG will make recommendations as to other entities should receive blinded summary information, such as MHCC. Quality Review Initiative : Hypothetical Process (cont) 6 7 8 9 10 11

17. External Peer Review(e.g. MACPAQ) - Angio review - Angio appropriateness -Cath/PCI appropriateness -- Data audit and pt data validation Internal Review Performance and outcomes Self-reported Retrospective and ongoing Complications Equipment / drug utilization Hospital stay Physician Decisions / Performance External Review Peer-to-peer Peer communication Guideline adherence Cath / PCI quality review Angiographic & clinical appropriateness PCI vs CABG vs Medical Rx Risk models Validate/audit data Environment Assessment (Hospital Process Review) Equipment/resources Environmental pressures Societal pressures Knowledge Evolution Training/ Experience Outside Peer Guidelines Knowledge evolution Quality Outcomes NCDR (In-patient only, no follow-up) True Outcome Follow-up (post discharge) Internal Reviews External Review