Do You Know if Your Compliance and Ethics Program is Effective? Tips & Strategies. Agenda

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1 Do You Know if Your Compliance and Ethics Program is Effective? Tips & Strategies Nabil Istafanous, Esq. 1 Agenda Program Performance Helpful Resources 2 Federal Sentencing Guidelines (FSG) o FSG in place since 1991 with significant amendments in 2004 after SOX o Explicitly references effective compliance and ethics programs FSG requires evaluation of effectiveness o CCEO must take reasonable steps... to evaluate periodically the effectiveness of the organization s compliance and ethics program. o FSG silent with respect to how 3 1

2 OIG guidance from 1988 for Medicare + Choice contractors o List of minimum expectations to be deemed effective o Silent on how to measure effectiveness CMS historical oversight o Required programs that met requirements o Oversight focused on specific Medicare requirements 4 CMS 2012 Compliance Program Guidance o Codified at CFR and incorporated by reference into MA contract o Significant rewrite of previous guidance o Greater focus on effective compliance and ethics program elements in addition to FWA o Arguably codifies leading and best practices as now minimum expectations o CMS guidance serves as de facto industry standard 5 Guidance emphasizes programs must be effective o Fully Implemented o Adequate Resources o Repeatedly states actions must be effective (training, controls, corrective actions) o Annual Independent Audit of effectiveness of Program o Effective Oversight by Board 6 2

3 Beginning in 2012, CMS began reviewing managed care sponsors compliance programs for effectiveness o Having elements in place is not enough o Focus on Compliance outcomes o Review of Performance of Program o Expect Internal monitoring and independent auditing of effectiveness 7 Initial Maturing Mature Establish Program Elements Basic Activity Demonstrate Elements of Effective program in place and actively monitored Performance Demonstrates Effectiveness and Continuous Improvement Comparison vs. Industry Benchmarks 8 Early generation programs established programs and documented with policies, procedures and charters Maturing programs rely on activity metrics and demonstrate reports to governing body o # of Training o % of Required Training Completed o # of Hotline Calls o # of Incidents Investigated, closed 9 3

4 Mature Programs employ performance metrics to demonstrate programs are effective and improving Performance Examples: o Percentage of Employees knowledgeable about how to report issues o Number and severity of Compliance Findings in Audits o Measure of Controls effectiveness - Percentage of Compliance Errors decrease Scorecards 10 Program Performance Culture Assessment re employees perception of ethics of organization Code of Conduct/Policies Compliance Officer/Governing Body Oversight Effective Training Effective Lines of Communication Enforcement of Disciplinary Standards HCCA National Managed Care Conference 11 Program Performance Monitoring and Auditing and Risk assessments Corrective Actions and Response to Compliance Issues (and FWA) FDR Oversight HCCA National Managed Care Conference 12 4

5 Helpful Resources Prescription Drug Benefit Manual and Compliance Program Guidelines and Medicare Managed Care Manual o Coverage/PrescriptionDrugCovContra/Downloads/Chapt er9.pdf CMS slide presentation - Focused Training Element II o Audits/Part-C-and-Part-D-Compliance-and- Audits/Compliance-Program-Policy-and-Guidance.html 13 Contact Information Nabil Istafanous, Esq. Corporate Counsel Solutions PLLC Contact: nabil@ccs-seattle.com

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