Healthcare Regulatory Environment Review

1. Healthcare Regulatory Environment Review Marge Scott West Georgia Health Linda Corley Xtend Healthcare

2. Objectives Regulatory Challenges FY 2011 – 2012 Current Environment Enhanced Enforcement Agenda Hospital and/or System Wide Responses Hospital and/or Medical Center Service Clinical Research Compliance Coverage, Coding and Billing Compliance Physician Relationships Privacy and Security

3. The Current Enviroment New / Tougher Laws Patient Protection and Affordable Care Act (PPACA) Uncertainty Repeal and replace PPACA strengthens fraud and abuse enforcement Strengthens False Claims Act (FCA) Enhances and simplifies enforcement of FCA Enhanced protections of whistleblowers 60 day reporting requirement of overpayments (credit balances) Strengthens Anti-kickback Statute (AKS) “Intent standard” diminished Stark violations now constitute fraudulent acts under FCA

4. PPACA cont’d Anti-fraud provisions comprise several elements: Enhanced screening of providers Periodic revalidation of credentials Ongoing monitoring of claims history / payment databases Required reporting and information sharing among Medicare, Medicaid, and CHIP agencies Suspension of payments based on “credible allegation of fraud” Imposition of temporary moratorium The Current Enviroment

5. PPACA cont’d CMS publication (02/02/2011) of a Final Rule based on PPACA Anti-fraud measures created Enhanced screening requirements Payment suspension Reference to Mandated Compliance Plans The Current Environment

6. The Current Environment • Clinical research billing • Medicare, Medicaid, other third party coverage • Applicable coverage, coding and billing rules • Grant provision or contract obligations • Consistency across all study related documents • Payment of Medicare costs associated with subject illness, injury and/or medical condition

7. HIPAA – HITECH Breach notification requirement Accounting of disclosures Emphasis on EHR development requires Compliance Ensure both regulatory guidelines and HIPAA requirements are considered for EHR “Build” records with audits in mind! Ensure required data elements meet “revenue integrity” Certification requirements for both “records” and “users” The Current Environment

8. Healthcare Services (both facility and professional) 1. Recoveries of overpayment Whether innocent overpayments or fraudulent claims Offsetting rising costs in healthcare delivery and billing 2. Increase joint efforts and data sharing CMS, DHHS, and DOJ State and federal agencies Commercial payers and government funded payers 3. Focus on new relationships between hospitals and physician practices Contracts under scrutiny Re-visit “med staff directorships,” leasing of space, etc. Enhanced Enforcement Agenda

9. Enhanced Enforcement Agenda • HEAT Initiative (Healthcare Fraud & Enforcement Action Team) • New resources and technologies to detect and prevent abuse • Cabinet level priority • Data prospecting by CMS • Proactively identifying target rich environments • Inpatient vs Outpatient setting • Drug units • Data sharing between CMS and DOJ • Recovery Audit Contractors (RACs) • Medicare RACs extended to all 50 states • Medicaid Integrity Contractors (MICS) in all 50 states

10. Who are the RACs? A: Diversified Collection Svr. B: CGI C: Connolly Consulting, Inc. D: HDI - HealthDataInsights, Inc.

11. Enhanced Enforcement Agenda Cont’d • ZPICs - Zone Program Integrity Contractors • -- Expanding initiative • 4. National Initiatives as separate reviews • Medical necessity of implantable devices • Implantable cardioverter defibrillator • “Course of care” following evidence-based guidelines • Reviewing cardiology, dialysis, chemotherapy • Nursing Homes, Hospice

12. Clinical research billing Medicare 2000 National Coverage Decision (NCD) Increased scrutiny of covered services provided during clinical trials Treatments stemming from complication / subject injuries Billings to Medicare versus sponsors HIPAA – HITECH Substantial increase in monetary penalties collected by Office of Civil Rights (OCR) for privacy and security violations “Willful neglect” State attorney generals HIPAA enforcement actions Complainants to share in monetary penalties Enhanced Enforcement Agenda Cont’d

13. Hospital and/or Health System Wide Responses Ethics and compliance programs are becoming even more important for assurance of “revenue integrity” “Your” program should include: Tightly focused efforts in key compliance risk areas Periodic assessment of program “effectiveness” Senior leadership and board involvement with quality reports and current issues RAC response teams Multidisciplinary Targeted high risk areas Focus on prevention versus reaction Education and training initiatives

14. 2. RAC and/or MIC Interdisciplinary Team(s) Compliance / audit / recoupment updates Sharing information on government audits e.g., RAC audit Best practices in policy and procedure implementation for individual locations Ensure separate “types” of services are defined and compliant processes are outlined based on regulations Address pro-fee billing policy Update HIPAA privacy policy Guidelines for Write-Offs and Waivers of Co-Pays and Deductibles Are P&Ps being followed to support goal of “culture of compliance” for each risk area identified by the OIG? Hospital and/or Health System Wide Responses

15. 3. Consider a “Medical Billing Advisory Group” (new) Identifying high risk billing and coding issues Sharing best practices on auditing, monitoring and training Incorporate results into Compliance Program effectiveness evaluation Consider “education” initiative - Leave no staff member untrained! - And – leave no staff member “un-evaluated” on knowledge base Hospital and/or Health System Wide Responses

16. Conclusion Complex healthcare regulatory environment Continued need of coordination at system level Compliance, internal audit, legal, regulatory and risk services / management Comprehensive risk profile and compliance work plans Continued need for collaboration at hospital/operations level Heightened importance of outcomes measurements

17. Healthcare Regulatory Environment Review Questions

18. Linda Corley, BS, MBA, CPC Senior Leader – Compliance & Associate Development Xtend Healthcare Consulting Marge Scott, BS, MBA, CHC Chief Compliance Officer & Chief RAC Officer West Georgia Health Services, Inc.