At the core of compliance is the patient. It is a healthcare organization’s duty to ensure that laws and processes are followed to the benefit of the patient and, by extension, the benefit of the community. From the government’s perspective, healthcare compliance programs can reduce or eliminate fraud, waste, and abuse—making compliance programs a sound business decision. A proactive compliance program aims to deter and, in some cases, prevent behaviors contrary to an organization’s code of ethics, policies and procedures, and laws and regulations. There are several ways to assess how a compliance program is performing and how risk areas are being monitored and controlled. Ongoing monitoring, periodic audits, annual program assessments, and external assessments can indicate areas within the organization that need improvement, compliance-related practices that are working, and how the program is faring as a whole.
Chapter 4: Evaluation Processes, Investigations, and Noncompliance Response
Introduction to Evaluation Processes, Investigations, and Noncompliance Response
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Table of Contents
- Front Matter
- Chapter 1: Healthcare Compliance Programs: From Murky Beginnings to Established Expectation
- Chapter 2: Healthcare Compliance Program Fundamentals
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Chapter 3: Running an Effective Compliance Program
- Introduction to Running an Effective Compliance Program
- Developing Core Departmental Relationships
- Conducting an Organizational Compliance Assessment
- Hiring Compliance Staff
- Job Description, Compliance Officer
- Job Description, Vice President of Corporate Compliance
- Building Trust with Senior Management and the Board
- Educating Management and Physicians on Accountability
- Educating the Board and Defining Its Role
- Resource: Sample Board Report 1, Audit Status Update
- Resource: Sample Board Report 2, Quarterly Report
- Resource: Sample Board Report 3, Compliance Work Plan
- Resource: Sample Board Report 4, Annual Compliance Risk Assessment
- Risk Assessment and Management
- Resource: Sample Heat Map
- Sample Risk Assessment Summary
- Resource: Sample Risk Committee Charter
- Resource: Sample Risk Rating Survey
- Compliance Policies, Procedures, and Codes of Conduct
- Sample Policy Template
- Resource: Sample Policy Implementation Master Tracker
- Resource: Sample Written Standards Matrix
- Communication and Education
- Resource: Sample Communication Plan
- Compliance Training
- Resource: Designing Your Annual Compliance Education
- Resource: Sample Attestation Form
- Internal Reporting Systems
- Resource: Sample Non-Retaliation Policy
- Resource: Sample Corporate Compliance HelpLine Policy
- Resource: Reporting Poster
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Chapter 4: Evaluation Processes, Investigations, and Noncompliance Response
- Introduction to Evaluation Processes, Investigations, and Noncompliance Response
- Government and Professional Resources
- Monitoring
- Auditing
- Resource: Sample Compliance Program Audit Plan
- Program Self-Assessment
- Internal Investigations
- Resource: Sample Checklist for Assessing Investigation Capabilities
- Resource: Sample Internal Investigations Policy
- Resource: Sample Upjohn Warning
- Resource: Sample Instructions to Witnesses
- Resource: Sample Evidence Collection Worksheet
- Resource: Sample Key Allegations Worksheet
- Resource: Sample Key Facts Worksheet
- Resource: Sample Investigation Report Form 1
- Resource: Sample Investigation Report Form 2
- Resource: Sample Policy Against Retaliation
- Discipline and Incentives
- Resource: Sample Evaluation Form
- Resource: Sample Recognition Letter
- Corrective Action Plans
- Root Cause Analysis
- Self-Disclosure and Return of Overpayments
- External Investigations
- Government Settlements: Corporate Integrity Agreements and Integrity Agreements
- Resources
- Auditing
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Board and Committee Reports and Documents
- Resource: Sample Compliance Committee Charter
- Resource: Sample Compliance Committee Meeting Agenda
- Resource: Sample Compliance Committee Meeting Minutes
- Resource: Sample Compliance Committee Work Plan
- Resource: Sample Corporate Compliance Report
- Resource: Sample Governance, Compliance, and Ethics Committee Charter
- Resource: Sample Quality Committee Charter
- CMS Conditions of Participation
- General Compliance Program
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Human Research
- Resource: Sample Deferral Checklist
- Resource: Sample Exempt Research Guidance Summary
- Resource: Sample Flexible Guidance Summary
- Resource: Sample Project Transition Form
- Resource: Sample IRB Review Worksheet/Checklist
- Resource: Sample Limited IRB Review Guidance Summary
- Resource: Sample Minimal Risk Research Guidance Summary
- Resource: Sample Human Research Transition Chart
- Resource: Sample Single IRB Review Guidance Summary
- Institutional Research
- Internal Investigation
- Measuring Program Effectiveness
- Monitoring
- Post-Acute Care
- Provider-Based Rules and Regulations
- Risk Assessment
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Chapter 5: Key Laws in Healthcare Compliance
- Anti-Kickback Statute
- Civil Monetary Penalties Law
- Emergency Medical Treatment and Labor Act
- False Claims Act
- Foreign Corrupt Practices Act
- Health Information Technology for Economic and Clinical Health Act
- Health Insurance Portability and Accountability Act of 1996
- Physician Payments Sunshine Act (Affordable Care Act)
- Physician Self-Referral Law (Stark Law)
- Resource: Stark Law Compliance Checklist for Commercial Reasonableness Review
- Resource: Sample Stark Law Compliance Checklist for Employee Arrangement Exception
- Resource: Sample Stark Law Compliance Checklist for Fair Market Value Arrangement Exception
- Resource: Sample Stark Law Compliance Checklist for Personal Services Arrangement Exception
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Chapter 6: Healthcare Compliance Risk Areas
- Artificial Intelligence
- Clinical Research
- Conflicts of Interest
- Contracts with Referral Sources
- EMTALA
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Health Information Management
- Health Information Management: Coding Compliance Audits and Third-Party Reviews
- Health Information Management: Coding with ICD-10 Clinical Modification (ICD-10-CM)
- Health Information Management: Coding with ICD-10 Current Procedural Terminology/Healthcare Common Procedure Coding System (ICD-10-CPT/HCPCS)
- Health Information Management: Coding with ICD-10 Procedure Coding System (ICD-10-PCS)
- Health Information Management: Effects of Complex Coding Guidelines and Increased Workloads
- Health Information Management: Electronic Health Record Systems
- Health Information Management: Patient Access, Information Blocking, and the 21st Century Cures Act
- Patient Care
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Patient Privacy and Security
- Patient Privacy and Security: Business Associates
- Resource: Business Associate Agreement Checklist and Considerations
- Patient Privacy and Security: Cyberattacks
- Patient Privacy and Security: Hybrid Work Environment
- Resource: Sample Temporary Work from Home Agreement
- Patient Privacy and Security: Identity Theft
- Patient Privacy and Security: Protected Health Information
- Patient Privacy and Security: Right to Access
- Patient Privacy and Security: Social Media
- Pharmacy
- Physician Compensation
- Post-Acute Care
- Provider-Based Rules and Regulations
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Revenue Cycle
- Revenue Cycle: 3-Day Payment Rule
- Revenue Cycle: The 60-Day Rule—Medicare and Medicaid Overpayments
- Revenue Cycle: Advance Beneficiary Notice of Noncoverage
- Revenue Cycle: CARES Act Relief Funds
- Revenue Cycle: Credit Balances
- Revenue Cycle: Denials Management
- Revenue Cycle: Government Audits
- Revenue Cycle: Hospital Discharge Appeal Notices
- Resource 1: Detailed Notice of Discharge
- Resource 2: Notice of Denial of Medical Coverage
- Revenue Cycle: Incident-to Billing
- Revenue Cycle: Implantable Medical Device Credit Reporting
- Revenue Cycle: Surprise Billing and the No Surprises Act
- Vendor Management
- Whistleblowers
- Back Matter