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The Integration of Regulatory and Clinical Compliance

Learn about compliance oversight changes, skill application, and tools at NHS Human Services, Inc. Dive into compliance program building blocks and quality improvement processes. Explore the synchronization of regulatory and clinical compliance with quality improvement.

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The Integration of Regulatory and Clinical Compliance

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  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!

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

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

  9. 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

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

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

  12. 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?

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

  14. 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?

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

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

  17. 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

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

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

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

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

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

  23. 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?

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

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

  26. 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

  27. Synchronizing Regulatory and Clinical Compliance with Quality Improvement

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

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

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

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

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

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

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

  35. Regulatory Investigation • Initial Inquiry • Compliance Investigation

  36. 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

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

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

  39. CCMS – Main Intake Screen

  40. Issue/Outcome Tab

  41. Follow Up Tab

  42. 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

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

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

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