The Integration of Regulatory and Clinical Compliance

1. The Integration of Regulatory and Clinical Compliance John Ciavardone, CCE Stephanie Ziegler, CCP Debra Burock, Ph.D., CCP

2. The Obligatory Ice-Breaker

3. Learning Objectives • Acquisition of knowledge pertaining to changes in the Compliance oversight environment • Skill application in strategic processes • Tools to use

4. About NHS Human Services, Inc. • Seven states • 50,000 served annually • 13,500 employees • Community-based behavioral non-profit • Children and adults • Intellectual/Developmental Disabilities, mental health, autism, juvenile justice • Hundreds of service models

5. NHS Integrity Program Structure

6. Poll – What is the size of your Compliance Program? • 2 – 5 • 5 – 10 • 10 – 15 • Are you kidding? I’m the Lone Ranger in my organization!

8. The building blocks for a compliance program • Chief compliance officer • Reporting mechanisms • Code of conduct • Integrity policy and other policies • Auditing and monitoring

9. Brief Review • Compliance 101 - Investigations • What • Where • Why • Training/education • Risk Assessment (New)

10. What are the areas of risk and concern? • Laws and regulations • Payer and contractual requirements • Licensing requirements • Organization Mission and Values • Program descriptions • Quality of care • Policies and Standards • Sound and ethical business practices • Code of Conduct

11. How the field is changing… • Accountable Care Organizations • Health care reform • Office of the Inspector General (OIG) guidance

13. Quality and Compliance in Transition : From Content to ProcessFrom Dichotomous to Continuous Quality Analysis

14. Transition from Content to Process • Qualifications of staff • Credentials may work as a baseline for quality but clinical effectiveness and compliance effectiveness? • Documentation • Presence or absence of documentation is not an adequate indicator of quality • Auditing • What? Who? Why?

15. Guidance for Boards – Integrated Response • OIG/AHLA Guidance to Boards on Quality • Board fiduciary • “Ten” questions • Compliance/Quality interaction

16. Some Key Questions For Boards to Answer • What internal controls exist to monitor and report on quality metrics? • How are the organization’s quality assessment and improvement processes coordinated with its corporate compliance program? • Are human and other resources adequate to support safety and clinical quality?

18. What Payers Are Looking At • Evidence of trauma screening • Exploration of social elements in a person’s life • Exploration of addictive behaviors

19. Even more importantly… quality-based CIA’s

20. Quality-based Corporate Integrity Agreements • CO “ensures” quality of care issues are appropriately addressed and corrected • Quality Assurance Compliance Committee • Board “Quality Assurance Monitoring Committee” • Multiple measures targeted to quality • Internal audit and review functions • Independent Monitor

21. Poll #2: Which is the burger with the best quality? A. Burger King B. Red Robin Royal C. Kobe Burger D. Biltmore Veggie

23. Exercise: Define “Quality” as it relates to… • A burger • A progress note • A process

24. Defining Quality in Behavioral Health • Medical Necessity • Prescription Practices • Integration of treatment • Clinical conceptualization in documentation

25. Quality Indicators • “Traditional” • Licensing • Accreditation • Chart reviews • “Neo-modern” • Staff credentials/qualifications • Documentation

26. What is the Role of the Compliance Function in Quality?

27. Poll: What is the nature of your relationship with Quality Improvement in your organization? • QI and Compliance are in the same department (or person!) • QI has a regular contact with Compliance department • Compliance and QI collaborate when sentinel events occur • QI? What’s that?

29. Integration and Collaboration • COMMUNICATE • Educate • Know what’s going on!

30. Quality Control Systems • Gap analysis • Risk Assessment • Process development

32. Types of Compliance Regulatory Compliance • Fiduciary linkages • Specific laws and regulations specifying standards • Content focus Clinical Compliance • Standard of care • Not clearly specified • Process focus

33. Synchronizing Regulatory and Clinical Compliance with Quality Improvement

34. Compliance Helpline • Structure • Concern presented and logged • Review for critical incident • Case Assignment • Coordination with external departments • Report • Corrective Action Follow up

35. Capturing compliance concerns • Modes of communication to OCA • Email • Fax • Call • Disclaimer and information collection • Password issuance

36. Review of concern • Rapid review for critical incident • Concurrent review for regulatory and clinical concerns • Weekly CART

37. Case Assignment • Determine type of review • Determine who has the skill and expertise to investigate – regulatory vs clinical

38. Collaboration • Human Resources • Clinical specialists • Quality Improvement • Legal

39. Report • Determine Type: • Regulatory: • Compliance Investigation (CI) • Initial Inquiry • Clinical Compliance Assessment Review (CCAR)

40. What’s the difference between regulatory and clinical investigations?

41. Regulatory Investigation • Initial Inquiry • Compliance Investigation

42. Clinical Compliance Assessment Review • Focus on clinical and quality deficiencies • Often no clear regulation • May have history of payor focus • Results or has the potential to result in harm

43. Full Group Exercise • What type of investigation • What if…

44. Tracking the Issues • Compliance Case Management System (CCMS) • Web-based database • Report modules

45. CCMS – Main Intake Screen

46. Issue/Outcome Tab

47. Follow Up Tab

48. The next phase of synchronizing regulatory and clinical compliance… • Internal control systems • Monitoring methodology used to ensure systematic and consistent clinical compliance and quality • Enhance quality-based existing practices and systems • Risk Mitigation

49. Identifying quality-based practices • Systems that define procedures and processes • Have oversight and monitoring • Clear baselines • Measurable outcomes

50. Address what matters! • Hypothesize • Rapid Cycle Testing (NIATx) • Determine data utility BEFORE collection!