Chapter 1: Healthcare Compliance Programs: From Murky Beginnings to Established Expectation
- Healthcare Compliance Programs: From Murky Beginnings to Established Expectation
- Resource: Healthcare Compliance History Timeline
- Resource: Code of Ethics for Health Care Compliance Professionals
Chapter 2: Healthcare Compliance Program Fundamentals
- Introduction to Healthcare Compliance Program Fundamentals
- Essential Elements of an Effective Healthcare Compliance Program
- Infrastructure of a Compliance Program
- Role of a Compliance Officer
- Board of Directors
- Compliance Committee
- Government Guidance
- Standards-Setting Organizations
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
- Resource: Job Description, Compliance Officer
- Resource: Job Description, Vice President of Corporate Compliance
- Mentoring for Compliance Professionals
- 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
- Resource: Sample Risk Assessment Summary
- Resource: Sample Risk Committee Charter
- Resource: Sample Risk Rating Survey
- Compliance Policies, Procedures, and Codes of Conduct
- Resource: 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
- Enterprise Risk Management in Healthcare
- Resource: Example Questions for Department-Specific Risk Identification
- Resource: Ten Examples of Risk Appetite Statements
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
- Resource: Sample Internal Audit Plan
- 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
- Resource: Sample Customer Grievances Policies and Procedures
- General Compliance Program
- Resource: Compliance Calendar
- Resource: Compliance Work Plan
- Resource: List of Compliance Policies
- Resource: Sample Compliance Program Policy
- 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
- Resource: Sample Institutional Research Policy
- Resource: Sample Request to Conduct Research Form
- Resource: Sample Research Compliance Assessment Form
- Internal Investigation
- Resource: Sample Internal Investigation Checklist
- Resource: Sample Interview Notes Template
- Resource: Sample Interview Tips
- Resource: Sample Investigation Checklist
- Resource: Sample Privacy Incident Questionnaire
- Resource: Excluded Individual Investigation Worksheet
- Measuring Program Effectiveness
- Resource: Compliance Program Evaluation OIG Tool
- Resource: Sample Compliance Elements Measurement Chart
- Resource: Sample Evaluation of Corporate Compliance Program Checklist
- Monitoring
- Resource: Sample Compliance Monitoring Plan
- Post-Acute Care
- Resource: Rehabilitation Documentation Checklist
- Provider-Based Rules and Regulations
- Provider-Based Rules and Regulations
- Resource: Provider-Based Compliance Audit Checklist
- Risk Assessment
- Resource: Compliance Program Structural Risk Assessment
- Resource: Privacy, Risk, and Discipline Assessment
- Resource: Sample Risk Assessment Policy and Process
- Resource: Sample Compliance Risk Assessment Questionnaire
- Resource: Sample Risk Assessment Template
Chapter 5: Key Laws in Healthcare Compliance
- Anti-Kickback Statute
- Civil Monetary Penalties Law
- Eliminating Kickbacks in Recovery Act
- Emergency Medical Treatment and Labor Act
- Evaluation of Corporate Compliance Programs
- Exclusion from Federal Healthcare Programs
- 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
Chapter 6: Healthcare Compliance Risk Areas
- Artificial Intelligence
- Artificial Intelligence and Compliance Programs
- Clinical Research
- Clinical Research: Financial Conflicts of Interest
- Clinical Research: Human Research Protections
- Clinical Research: Medicare Clinical Trial Policy
- Clinical Research: Research Misconduct
- Conflicts of Interest
- Conflicts of Interest: CMS Open Payments
- Conflicts of Interest: Relationships with Industry-Medical Device Manufacturers and Pharmaceutical Companies
- Resource: Conflict Management Plan
- Contracts with Referral Sources
- Contracts with Referral Sources: Entering into a Proper Physician Arrangement
- Contracts with Referral Sources: Importance of Monitoring These Arrangements
- Contracts with Referral Sources: Real Estate Compliance
- EMTALA
- Emergency Medical Treatment and Labor Act (EMTALA)
- Health Information Management
- Health Information Management: Coding Compliance Audits and Third-Party Reviews
- Health Information Management: Compliance with Nontraditional Third Parties
- 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
- Patient Care: Medical Necessity and Patient Status
- Patient Care: Rehab
- Patient Care: Telehealth and Telemedicine
- 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 of Access
- Patient Privacy and Security: Social Media
- Pharmacy
- Pharmacy: 340B Drug Pricing Program
- Pharmacy: Drug Diversion
- Pharmacy: The Opioid Crisis and the Risk of Diversion
- Pharmacy: Drug Diversion and Prescribing Practices
- Physician Compensation
- Physician Compensation: Contracts and Compensation Models
- Physician Compensation: Managing Relationships and Conflicts of Interest
- Post-Acute Care
- Post-Acute Care: Home Health
- Post-Acute Care: Hospices
- Post-Acute Care: Skilled Nursing Facilities
- Provider-Based Rules and Regulations
- Resource: Sample Provider-based Requirements Compliance Assessment Tool
- 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
- Vendor Management: Monitoring Contractor Performance and Proactive Risk Management
- Resource: Contract Approval Checklist
- Whistleblowers
- Whistleblowers: Federal and State False Claims Acts
