Staff

1. Support HCCA Special Interest Group1-28-03New Regulations: A Strategy for ImplementationSharon SchmidVice President, Compliance and PrivacyMedica Staff Structure

2. Governing Standards Framework:Challenges for Implementation • Multiple Levels of Obligations • Multiple States’ Regulations • Overlapping State and Federal Regulation • DOL ERISA Regulations • Privacy (GLB, HIPAA, Federal Privacy Act, State Law, NCQA) • Accreditation Requirements • Type of Regulation • Governs the Core of What We Do • Volume and Complexity of Obligations

3. Implementation Process • Develop Method to Help Ensure Obligations Come to Life in the Business • Risk Based Approach to Implementation and Ongoing Compliance • Assess • Prioritize • Resource • Compliance Project Management (“CPM”) • Manage the Complexity • Builds it into the Core of What We Do

4. What is Project Management For Compliance? • Builds on Traditional Project Management Practices - Adapted to Manage and Minimize Compliance Risk • Defined Analytical and Implementation Processes that Support:  Identify  Implement  Assess  Monitoring  Plan  Audit Document

5. What Makes CPM Successful • Central Oversight With Identified Compliance Staff in All Business Units - Departments • Shared Accountability for Compliance and Business Ensures Compliance Expertise and Strong Understanding of Business • Process and Structure to Support Consistent, Documented, Completed Implementation • Tools and Training • Ongoing Support and Training

6. What are the Elements of Compliance Project Management? • Understand the Legal/Regulatory/Governance Requirements • Identify and Assess Current Business Practices • Identify Operational Gaps • Develop a Documented Action Plan • Implement the Plan and Document the Implementation Activities • Monitor the Results of the Implementation • Document “How We Know” We Are in Compliance

7. How Will Compliance Project Management Help Us Reach Our Goal? • Compliance Project Management Helps to Identify and Minimize Legal Risk • Develops Consistency In Approach and Implementation • Documents Work To Support Compliance • Builds on Expertise of All Staff from all business areas • Enhances Communication • Creates Institutional Memory

8. Why Might You Want to Use The Project Management Approach? Greater need for CPM The Higher the Level of Risk, As Determined by the “As-is” Assessment, the Greater the Need for Compliance Project Management

9. Compliance Operations Project Management Phases • Intake • Assessment • Implementation Planning • Implementation • Post Implementation Management

10. How Does Compliance Project Management Help Manage Risk?

11. Intake Phase A Key Step in Any Compliance Effort - Whether It Is a Relatively Simple or Complex Obligation - Is Understanding, Defining, and Documenting the Issue. Key Tasks for Intake • Identify the “Obligation” • Initial Legal Analysis • Intake Information Completed - Including Obligation Summary

12. Compliance Project Life Cycle - Intake in Detail Intake Phase • Identify obligation • Conduct initial legal analysis • Notify compliance operations of new obligation • Review legal analysis, enter obligation information in CPM, link relevant documentation • Conduct initial triage assessment and notify CO leads to conduct operational assessment Tasks • Documented legal analysis • Completed Intake information in CPM including Obligation Summary • Linked documentation in System • An Archive Report, if no further action is necessary Deliverables • Required information completed in CPM and Compliance Operations notified • CO staff complete Archive Summary, if applicable Exit Criteria Compliance Operations Competency Legal Business Operations Steering Council

13. Assessment Phase The Operational Assessment Is a Review of Business Operations Against the Requirements of the Obligation • Compliance Ops Leads Conduct Operational Assessment online: • Products • Processes • Departments • Vendors • Background/History • Connections • Current Business Practices • Recommendations

14. The Assessment Summary Report Is a Compilation of All of the Information Entered As Part of the Operational Assessment Assessment Summary Report • This Report Can Be Invaluable for Focusing Resources and Expertise • Helps to Identify Specific Action Steps or Tasks for Implementation. • In Some Instances, the Assessment Summary Report Will Reflect That the Organization Is Already in Compliance With the Obligation’s Requirements and Will Provide the Necessary Information for Documenting Our Compliance.

15. In the Planning Phase, the Project Manager Develops a Detailed Action Plan To: • Create the Right Solution for Compliance and Business • Establish Communication About Implementation • Foster Involvement of Team and Key Stakeholders Planning

16. Planning Phase Key Tasks • Review the Assessment Summary Report • Develop the Action Plan • Identify Team Members and Key Stakeholders • Schedule and Hold the Kickoff Meeting With the Project Team • Document Additional Tasks Based on Team Members Participation • Obtain Stakeholder Input for Plan • Define the Communication Protocols

17. Implementation Phase The Purpose of the Implementation Phase Is to Perform, Monitor, and Control Project Work So That You Can Complete the Project on Schedule and Within Defined Quality Standards. In This Phase, Staff Implement and Manage Against the Action Plan, Making Enhancements and Changes to the Action Plan As Necessary to Accomplish the Project Goal(s).

18. Implementation Phase Key Tasks • Implement Project Plan • Communicate Status to Team Members and Stakeholders • Status Updates in Application • Training As Needed • Manage Project Changes as Needed • Escalate Barriers for Resolution • Summarize Compliance

19. Post Implementation Management Phase The Purpose of the Post Implementation Management Phase Is to Complete Commitments, Check the Success of the Implementation, Plan for Transitions, Conduct Evaluations, and Identify Lessons Learned That Can Be Carried Forward to Future Projects

20. Post Implementation Management Key Tasks • Project Manager Ensures Project Documentation is Completed and Linked to Obligation in Application -Action Plan and Supporting Documentation -Policies and Procedures, training, process documentation, etc. • Post Implementation Evaluation • Monitoring Activities Completed According to Action Plan and Ongoing As Necessary

21. Compliance Project Management Supports Effective Compliance • Identify and Minimize Legal Risk • Develops Consistency In Effective Approach For Implementation • Documents Work To Support Compliance • Builds on Expertise of All Staff • Enhances Communication • Creates Institutional Memory