1. MU Health Integrity and Compliance Program Health Care Compliance Board Training September 15, 2016 OPEN – HEALTH AFF – INFO 1 - 1

2. “A critical element of effective [Board] oversight is the process of asking the right questions of management to determine the adequacy and effectiveness of the organization’s compliance program, as well as the performance of those who develop and execute that program, and to make compliance a responsibility for all levels of management.” -- Office of Inspector General, et al., Practical Guidance for Health Care Governing Boards on Compliance Oversight (Apr. 20, 2015). OPEN – HEALTH AFF – INFO 1 - 2

3. Objectives of this Session This Board training will provide an overview of the compliance functions across MU Health including MU Health’s compliance program, the requirements of the Corporate Integrity Agreement (“CIA”), and the implementation plan to meet those requirements. OPEN – HEALTH AFF – INFO 1 - 3

4. Specific Topics –Board responsibilities and the corporate integrity agreement. –Overview and understanding of compliance program. –Understanding of roles and relationships between audit, compliance and legal. –Mechanism and process for issue identification and reporting. –Approach to identifying regulatory risk –Methods of encouraging enterprise-wide accountability for compliance. OPEN – HEALTH AFF – INFO 1 - 4

5. Expectations for Board Oversight As the governing board for the University, the Board of Curators’ responsibilities include reviewing and overseeing compliance of MU Health with Federal health care program requirements. To allow the Board to exercise effective oversight, there need to be processes to ensure that adequate and appropriate information is provided to the Board. OPEN – HEALTH AFF – INFO 1 - 5

6. CIA: Scope and Requirements On June 30, 2016, University of Missouri Health System (MU Health) entered into a corporate integrity agreement (CIA) with the US Department of Health and Human Services Office of Inspector general (OIG). –The term for the CIA is five years. –The persons included in the CIA include MU Health Care employees, University Physicians, the School of Medicine, as well as certain vendors and contractors. (approx. 8500 individuals) –The CIA prescribes compliance obligations for MU Health many that are already part of MU Health’s compliance program but some that are new. OPEN – HEALTH AFF – INFO 1 - 6

7. Board-specific obligations under the CIA –General review and oversight of Federal regulatory compliance and CIA obligations. –Meet at least quarterly to review and oversee MU Health’s Compliance Program including, performance of the Chief Compliance Officer (CCO) performance of the Executive Compliance Committee (ECC). Submit description of documents and other materials the Board reviewed to the OIG, and additional steps taken by Board (such as engaging third party advisors) to support Board resolution. OPEN – HEALTH AFF – INFO 1 - 7

8. Board resolution For each Reporting Period of the CIA, the Board shall adopt a resolution signed by each member of the Board stating: –that the Board or designated Board Committee has inquired into MU Health’s Compliance Program including performance of the CCO and ECC and that Board has concluded to the best of its ability that the Compliance Program is effective and meets Federal health care program requirements and obligations of the CIA. OPEN – HEALTH AFF – INFO 1 - 8

9. Board training Board members must receive at least two hours of training regarding CIA requirements, the Compliance Program (including Code of Conduct, responsibilities of board members, etc., within 90 days of the Effective Date (June 30, 2016). New Board members shall receive the compliance training within 30 days after becoming a member. OPEN – HEALTH AFF – INFO 1 - 9

10. Designation of Board Committee The CIA allows the Board to designate a committee of the Board to assume the Board’s oversight responsibilities. It is recommended that the Health Affairs Committee be designated to fill this role and an action item will be presented for Board consideration at the end of this meeting. OPEN – HEALTH AFF – INFO 1 - 10

11. Overview of MU Health’s Integrity and Compliance Program Structure and Standards –Exercise due diligence to prevent and detect criminal conduct. –Promote organizational culture that encourages ethical conduct as well as commitment to comply with the laws and regulations that govern us. OPEN – HEALTH AFF – INFO 1 - 11

12. Overview of MU Health’s Integrity and Compliance Program continued MU Health’s Integrity and Compliance Program is based upon the Federal Sentencing Guidelines and DHHS/OIG guidance which requires seven components for an “effective compliance program.” OPEN – HEALTH AFF – INFO 1 - 12

13. OIG Requirements for Effective Compliance Program 1.Designate a compliance officer and compliance committees. 2.Develop written compliance plans, policies and standards of conduct. 3.Monitor and audit compliance risk areas. 4.Develop open lines of communication. 5.Implement education and training. 6.Enforce disciplinary standards. 7.Respond to detected deficiencies. OPEN – HEALTH AFF – INFO 1 - 13

14. MU Health’s Compliance Program c/t OIG Requirements Element 1 (a): Designate a compliance officer –1998: OCC was established for hospital and clinics. The three schools (School of Medicine, Sinclair School of Nursing, School of Health Professions) and University Physicians each had their own compliance plan and designated compliance officer. –2012: Reorganization of the compliance program occurred, which included: the designation of a Chief Compliance Officer over health system, the integration of resources, and one compliance plan for all members of MU Health. OPEN – HEALTH AFF – INFO 1 - 14

15. Duties of the Chief Compliance Officer The Chief Compliance Officer is responsible for implementing and oversight of an effective compliance program for MU Health including: Develop and implement the Integrity and Compliance Program and Code of Conduct. (copies distributed) Develop and implement compliance policies and procedures that align with laws and regulations that govern health systems. Oversee compliance education and training across organization. Respond to government investigations, oversee process and reporting. Chair the Executive Compliance Committee, which serves as the compliance committee under the Corporate Integrity Agreement. Monitor day- to- day compliance activities. OPEN – HEALTH AFF – INFO 1 - 15

16. MU Health’s Compliance Program… continued Element 1 (b): Designate Compliance Committees The Executive Compliance Committee (ECC) is the compliance oversight committee for MU Health. The ECC has served in this capacity for over ten years. –The purpose of the Executive Compliance Committee is to assist the Board in fulfilling its oversight responsibilities regarding compliance with laws and regulations, policies and procedures, the Code of Conduct, and the Integrity and Compliance Program. –The ECC is the designated “compliance committee” for purposes of the corporate integrity agreement. –Membership is comprised of executive leaders, deans, and physician leaders of MU Health. –Governance structure provides for additional committees to report to the ECC. OPEN – HEALTH AFF – INFO 1 - 16

17. MU Health’s Compliance Program Element 2: Develop written compliance plans, policies and standards of conduct. –The Integrity and Compliance Program is the compliance plan for MU Health’s work force. This program sets forth what the components of the compliance plan are, and how they are implemented. (copies provided) –The Code of Conduct Manual is the foundation for the Integrity and Compliance Program, further demonstrating our commitment to ethical and legal behavior. (copies provided) –Compliance policies and procedures have been developed and implemented to reinforce the foundation for organizational integrity. OPEN – HEALTH AFF – INFO 1 - 17

18. MU Health’s Compliance Program… Element 3: Monitor and Audit Compliance Risk Areas The complexities of health systems, and the laws that govern them, create an environment where operations, services, research, and other areas may run afoul of current policy or regulations. –A three (3) year risk assessment process was implemented in 2014 in collaboration with internal auditors (PwC). Stakeholders are interviewed Potential risks categorized into areas including strategic plan, revenue cycle, compliance and regulatory, human resources, IT, etc. Risks are further prioritized by probability of occurrence and impact on organization if it occurs. Risks are mapped, and then scheduled for audit based upon timing and other factors. Risk assessment plan is approved by MU Health’s Internal Audit and Compliance Committee. OPEN – HEALTH AFF – INFO 1 - 18

19. Additional Review Procedures Required by CIA Under the CIA, MU Health is required to engage an Independent Review Organization (IRO) to perform reviews listed in Section III.D. –Claims Review as outlined in Appendix B. –Validation Review in the event the claims review fails to conform to the requirements of the CIA –IRO shall include in its report a certification of its independence and objectivity pursuant to the CIA requirements. OPEN – HEALTH AFF – INFO 1 - 19

20. Element 4: Develop open lines of communication including hotlines –Compliance is everyone’s responsibility. –All members of MU Health’s work force have a duty to report promptly and in good faith concerns of suspected or actual violations of laws, regulations, policies, or the Code of Conduct. Reporting can be completed in several ways: Speak to supervisor or manager about issue Contact the OCC Call the Ethics and Compliance Hotline to report anonymously Hotline calls regarding MU Health are directed to CCO for investigation and follow up action. The ECC receives quarterly reports regarding hotline calls received, and results of investigations. MU Health Compliance Program… OPEN – HEALTH AFF – INFO 1 - 20

21. MU Health Compliance Program… Element 5: Conduct appropriate training and education Compliance education is paramount to an effective compliance program. Mandatory education and training include: Compliance orientation for new employees Code of Conduct training Fraud, waste and abuse education Conflict of interest analysis, disclosure statements Documentation and coding modules for new faculty OPEN – HEALTH AFF – INFO 1 - 21

22. Compliance education and training… continued Coding scorecards for all coders, along with education. The Joint Commission/ tracer team initiative for ongoing survey readiness. Evaluation and management documentation for physicians. Research quality and compliance oversight Privacy/security The CIA adds additional training hours for all covered persons, completion of which are reported to the OIG Monitor annually. OPEN – HEALTH AFF – INFO 1 - 22

23. MU Health Compliance Program…. Element 6: Enforce disciplinary standards –It is important that we follow the laws, regulations and standards that govern our work, and further our mission of providing exemplary care, education, and discovery. –We are all accountable for our actions and their outcomes. –Employees, faculty and staff who violate a law or standard are subject to disciplinary action which is set forth in compliance as well as HR policies. –Sustaining organizational integrity requires a culture of ethical and legal behavior that focuses on providing exemplary patient and family-centered care, excellence in education, and quality research. OPEN – HEALTH AFF – INFO 1 - 23

24. MU Health Compliance Program… Element 7: Respond to detected deficiencies When a potential issue is identified through an audit, a hotline report, call to the OCC, or other avenues, prompt investigation is completed by members of the compliance team to determine if the issue is substantiated. If substantiated, then a corrective action plan is implemented along with follow-up reviews, audits, and education to ensure the deficiency has been corrected. When an issue involves legal and regulatory aspects, the investigation is completed by collaborative efforts of key departments including: –Office of Corporate Compliance –Office of the General counsel –Internal Audit Services –Human Resources (hospital/campus) OPEN – HEALTH AFF – INFO 1 - 24

25. Collaboration / Coordination of Efforts Office of Corporate Compliance (OCC) –provides oversight for all compliance related activities within MU Health, serves as the overall coordinator for compliance activities for all operating units. –provides oversight of regulatory affairs –responsible for implementation of the CIA including preparation of the Implementation and Annual Reports, working with the OIG Monitor, providing reports as required, and maintaining compliance with the CIA requirements. OPEN – HEALTH AFF – INFO 1 - 25

26. Collaboration / Coordination Efforts Office of General Counsel –advises the OCC and operating units regarding legal risks and statutory and regulatory interpretation. –advises on requirements of the CIA and supports other offices and units in implementation. –engages outside counsel as needed. Office of Internal Audit Services –assists in risk assessment planning, consults on specific projects, and conducts internal audits for MU Health. Human Resources offices (hospital and campus) –assist in addressing compliance matters involving individual employees including privacy breaches, hotline investigations, OIG screenings, and investigations involving residents, staff, and others. OPEN – HEALTH AFF – INFO 1 - 26

27. Encouraging Enterprise-Wide Compliance Accountability Creating a culture of organizational integrity and compliance. Connecting compliance with fulfilling mission of the organization. Incorporating compliance into individual performance evaluations (requirement of CIA). Rewarding compliance thinking and behavior. Notifications to government and third-party payers when errors occur. OPEN – HEALTH AFF – INFO 1 - 27

28. Foundation for Integrity…the Code of Conduct The Code of Conduct Manual provides practical guidelines that support our commitment to compliance across the organization. It serves as a resource for all members of MU Health as they go about their jobs. OPEN – HEALTH AFF – INFO 1 - 28

29. The Code of Conduct consists of six principles: 1) Act with integrity and treat everyone we encounter with dignity and respect. 2) Abide by the laws and regulations that govern our work. 3) Be trustworthy and maintain the confidentiality of patient and proprietary information. 4) Maintain right relationships and avoid conflicts of interest. 5) Be good stewards of the resources - people, money, supplies, equipment, organizational reputation - entrusted to us. 6) Demonstrate the highest ethical standards in achieving innovation and discovery. OPEN – HEALTH AFF – INFO 1 - 29

30. Measuring the Effectiveness of Compliance There are inherent difficulties in evaluating compliance programs. “You can’t always know when you’ve prevented a problem from occurring.” Compliance experts suggest three performance indicators to measure compliance effectiveness: 1) Activities metrics, what we are doing to improve our compliance performance; 2) Process metrics, how we are implementing and changing compliance initiatives; and 3)Outcome metrics, how we measure improvements, such as benchmarking, coding scorecards, audit findings, regulatory reviews, among others. OPEN – HEALTH AFF – INFO 1 - 30

31. Proposed Application of Metrics to MU Health Compliance Program Activities MetricProcess MetricOutcome Metric Code of Conduct/distributed to all new employees Compliance orientation for all MU Health Care employees including distribution of Code of Conduct Manual. Goal:100% Number of substantiated incidents related to Code of Conduct c/t number of calls substantiated. Goal: 0% Board and senior leadership involvement and oversight of compliance program Executive Compliance Committee /quarterly meetings Health Affairs Committee/quarterly meetings Goal: 100% Number of compliance and risk mitigation reports discussed and approved by committee. Goal: 100% Education and trainingEmployees completed annual compliance education. Goal: 100% Repayments made to resolve education-focused violations c/t repayments made for all violations. Goal: 0% OPEN – HEALTH AFF – INFO 1 - 31

32. Proposed Application of Metrics …continued Activities MetricProcess MetricOutcome Metric Communication/hotline Number of calls triaged within policy limits c/t number of potential issues reported. Goal: 100% Number of whistle blower reports c/t number of reports received via hotline. Goal: 0% Audit and Monitoring Number of audits conducted and finalized c/t number of audits on work plan. Goal: 100% Number of follow-up audits that indicate issue resolution c/t number of follow up audits completed. Goal: 100% Enforcement/ OIG ScreeningPre-hire screening against OIG/LEIE and Sam.gov and ongoing monthly screenings for all MU Health employees. Goal: 100% Number of persons employed that are disbarred or ineligible to participate in Federal funded programs. Goal: 0% OPEN – HEALTH AFF – INFO 1 - 32

33. Board Role in Overseeing Compliance Program –Designation of Health Affairs Committee as responsible committee under the CIA. –Periodic reports (at least quarterly). –Review of program, CCO, and ECC. –Additional training possibilities and resources. OPEN – HEALTH AFF – INFO 1 - 33

34. To summarize…. MU Health’s compliance program has evolved from a reactive model to a proactive model. The CIA requirements enhance our current compliance initiatives, as well as add additional requirements, such as the IRO (independent review organization) function. Once completed, MU Health will have achieved the OIG’s “gold standard” for compliance programs. Questions? OPEN – HEALTH AFF – INFO 1 - 34

35. Compliance training modules In addition to participating in this training session, members of the Board of Curators and Health Affairs Committee are asked to: Complete the Code of Conduct training module –Estimated time to complete both is approximately 1 hour. –Both modules are web-based and will be provided electronically. –CLE credit offered for participants is pending. OPEN – HEALTH AFF – INFO 1 - 35

36. Training materials: Integrity and Compliance Program Code of Conduct Manual Corporate Integrity Agreement OIG Practical Guidance for Health Care Governing Boards on Compliance Oversight OPEN – HEALTH AFF – INFO 1 - 36

37. Contact Information Peggy A Ford, BSN. MPA,JD Chief Compliance Officer 573-884-0632 Robert L. Hess II Office of the General Counsel 573-882-3211 OPEN – HEALTH AFF – INFO 1 - 37 09/15/2016