Volume 1
Editorial Advisory Committee • x
Preface • xii
Chapter1 Healthcare Compliance Programs: From Murky Beginnings to Established Expectation • 1
Healthcare Compliance Programs:
From Murky Beginnings to Established Expectation • 3
Resource: Healthcare Compliance History Timeline • 34
Resource: Code of Ethics for Health Care Compliance Professionals • 37
Chapter 2 Healthcare Compliance Program Fundamentals • 43
Introduction to Healthcare Compliance Program Fundamentals • 45 Essential Elements of an Effective Healthcare Compliance Program • 51 Infrastructure of a Compliance Program • 63
Role of a Compliance Officer • 67 Board of Directors • 73 Compliance Committee • 77 Government Guidance • 79
Standards-Setting Organizations • 91
Chapter 3 Running an Effective Compliance Program • 101
Introduction to Running an Effective Compliance Program • 103 Developing Core Departmental Relationships • 111
Conducting an Organizational Compliance Assessment • 125 Hiring Compliance Staff • 131
Resource: Job Description, Compliance Officer • 137
Resource: Job Description, Vice President of Corporate Compliance • 140 Mentoring for Compliance Professionals • 143
Building Trust with Senior Management and the Board • 153
Educating Management and Physicians on Accountability • 159 Educating the Board and Defining Its Role • 169
Resource: Sample Board Report 1, Audit Status Update • 187
Resource: Sample Board Report 2, Quarterly Report • 198
Resource: Sample Board Report 3, Compliance Work Plan • 202
Resource: Sample Board Report 4, Annual Compliance Risk Assessment • 219 Risk Assessment and Management • 253
Resource: Sample Heat Map • 287
Resource: Sample Risk Assessment Summary • 288 Resource: Sample Risk Committee Charter • 303 Resource: Sample Risk Rating Survey • 304
Compliance Policies, Procedures, and Codes of Conduct • 305
Resource: Sample Policy Template• 331
Resource: Sample Policy Implementation Master Tracker • 334
Resource: Sample Written Standards Matrix • 335 Communication and Education • 337
Resource: Sample Communication Plan • 357 Compliance Training • 359
Resource: Sample Attestation Form • 379 Internal Reporting Systems • 381
Resource: Sample Non-Retaliation Policy • 399
Resource: Sample Corporate Compliance HelpLine Policy • 402 Enterprise Risk Management in Healthcare • 407
Resource: ExampleQuestions for Department-Specific Risk Identification • 443
Resource: Ten Examples of Risk AppetiteStatements • 444
Chapter 4 Evaluation Processes, Investigations, and Noncompliance Response • 445
Introduction to Evaluation Processes, Investigations, and Noncompliance Response • 447 Government and Professional Resources• 451
Monitoring • 465
Auditing • 475
Resource: Sample Compliance Program Audit Plan • 487 Program Self-Assessment • 489
Internal Investigations • 503
Resource: Sample Checklist for Assessing Investigation Capabilities • 551
Resource: Sample Internal Investigations Policy • 552
Resource: Sample Upjohn Warning• 556
Resource: Sample Instructions to Witnesses • 557 Resource: Sample Evidence Collection Worksheet • 559 Resource: Sample Key Allegations Worksheet • 560 Resource: Sample Key Facts Worksheet • 561 Resource: Sample Investigation Report Form 1 • 562 Resource: Sample Investigation Report Form 2 • 565 Resource: Sample Policy Against Retaliation • 568
Discipline and Incentives • 569
Resource: Sample Evaluation Form • 583
Resource: Sample Recognition Letter • 584 Corrective Action Plans • 585
Root Cause Analysis • 591
Self-Disclosure and Return of Overpayments • 601 External Investigations • 615
Government Settlements: Corporate Integrity Agreements and Integrity Agreements • 641
Resources • 657
Auditing • 659
Resource: Sample Internal Audit Plan • 661
Board and Committee Reports and Documents • 663
Resource: Sample Compliance Committee Charter • 665
Resource: Sample Compliance Committee Work Plan • 668
Resource: Sample Corporate Compliance Report • 669
Resource: Sample Governance, Compliance, and Ethics Committee Charter • 672
Resource: Sample Quality Committee Charter • 676
CMS Conditions of Participation • 683
Resource: Sample Customer Grievances Policies and Procedures • 685
General Compliance Program • 701
Resource: List of Compliance Policies • 703
Resource: Sample Compliance Program Policy • 704
Human Research• 711
Resource: Sample Deferral Checklist • 713
Resource: Sample Exempt Research Guidance Summary • 715
Resource: Sample Flexible Guidance Summary • 718 Resource: Sample Project Transition Form • 723 Resource: Sample IRB Review Worksheet/Checklist • 725
Resource: Sample Limited IRB Review Guidance Summary • 728 Resource: Sample Minimal Risk Research Guidance Summary• 731 Resource: Sample Human Research Transition Chart • 734 Resource: Sample Single IRB Review Guidance Summary • 735
Institutional Research• 743
Resource: Sample Institutional Research Policy • 745
Resource: Sample Request to Conduct Research Form • 751
Resource: Sample Research Compliance Assessment Form • 753
Internal Investigation • 763
Resource: Sample Internal Investigation Checklist • 765 Resource: Sample Interview Notes Template • 771 Resource: Sample Interview Tips • 775
Resource: Sample Investigation Checklist • 782
Resource: Sample Privacy Incident Questionnaire • 785
Measuring Program Effectiveness • 789
Resource: Sample Compliance Elements Measurement Chart • 791
Resource: Sample Evaluation of Corporate Compliance Program Checklist • 841
Monitoring • 851
Resource: Sample Compliance Monitoring Plan • 853
Post-Acute Care • 857
Resource: Rehabilitation Documentation Checklist • 859
Provider-Based Rules and Regulations • 863
Resource: Sample Provider-Based Requirements Compliance Assessment Tool • 865
Risk Assessment • 875
Resource: Compliance Program Structural Risk Assessment• 877 Resource: Sample Risk Assessment Policy and Process • 883 Resource: Sample Compliance Risk Assessment Questionnaire • 885 Resource: Sample Risk Assessment Template • 887
Volume 2
Chapter 5 Key Laws in Healthcare Compliance • 893
Anti-Kickback Statute • 895
Civil Monetary Penalties Law • 911 Eliminating Kickbacks in Recovery Act • 923
Emergency Medical Treatment and Labor Act • 929 Evaluation of Corporate Compliance Programs • 939 Exclusion from Federal Healthcare Programs • 949 False Claims Act • 959
Foreign Corrupt Practices Act • 977
Health Information Technology for Economic and Clinical Health Act • 989 Health Insurance Portability and Accountability Act of 1996 • 1011 Physician Payments Sunshine Act (Affordable Care Act) • 1043
Physician Self-Referral Law (Stark Law) • 1053
Chapter 6 Healthcare Compliance Risk Areas • 1077
Artificial Intelligence • 1079
Artificial Intelligence and Compliance Programs • 1081
Clinical Research• 1101
Financial Conflicts of Interest • 1103 Human Research Protections • 1117 Medicare Clinical Trial Policy• 1131 Research Misconduct • 1143
Conflicts of Interest • 1153
CMS Open Payments • 1155
Relationships with Industry—Medical Device Manufacturers& Pharmaceutical Companies • 1167
Contracts with Referral Sources• 1177
Entering into a Proper Physician Arrangement • 1179 Importance of Monitoring These Arrangements • 1185 Real Estate Compliance • 1193
Emergency Medical Treatment and Labor Act • 1209
Emergency Medical Treatment and Labor Act (EMTALA) • 1211
Health Information Management • 1227
Coding Compliance Audits and Third-Party Reviews • 1229 Compliance with Nontraditional Third Parties • 1251
Coding with ICD-10 Clinical Modification (ICD-10-CM) • 1259
Coding with ICD-10 Current Procedural Terminology/Healthcare Common Procedure Coding System (ICD-10-CPT/HCPCS) • 1275
Coding with ICD-10 Procedure Coding System (ICD-10-PCS) • 1289 Effects of Complex Coding Guidelines and Increased Workloads • 1299 Electronic Health Record Systems • 1309
Patient Access, Information Blocking, and the 21st Century Cures Act • 1321
Patient Care • 1335
Medical Necessity and Patient Status • 1337 Rehab • 1349
Telehealth and Telemedicine • 1367
Patient Privacy and Security • 1383
Business Associates • 1385
Cyberattacks • 1399
Hybrid Work Environment • 1407
Resource: Sample Temporary Work from Home Agreement • 1425 Identity Theft • 1429
Protected Health Information • 1439 Right of Access • 1451
Social Media • 1463
Pharmacy • 1475
340B Drug Pricing Program• 1477 Drug Diversion • 1507
The Opioid Crisis and the Risk of Diversion• 1517 Drug Diversion and Prescribing Practices• 1543
Physician Compensation • 1555
Contracts and Compensation Models• 1557 Managing Relationships and Conflicts of Interest • 1579
Post-Acute Care • 1589
Home Health • 1591 Hospices • 1609
Skilled Nursing Facilities • 1621
Provider-Based Rules and Regulations • 1633
Provider-Based Rules and Regulations • 1635
Resource: Provider-Based Compliance Audit Checklist • 1661
Revenue Cycle • 1667
3-Day Payment Rule • 1669
The 60-Day Rule—Medicare and Medicaid Overpayments • 1679 Advance Beneficiary Notice of Noncoverage • 1689
CARES Act Relief Funds • 1701 Credit Balances • 1711
Denials Management • 1721 Government Audits • 1735
Hospital Discharge Appeal Notices • 1753
Resource 1: Detailed Notice of Discharge • 1770
Resource 2: Notice of Denial of Medical Coverage • 1772 Incident-to Billing • 1779
Implantable Medical Device Credit Reporting • 1789 Surprise Billing and the No Surprises Act • 1803
Vendor Management • 1811
Monitoring Contractor Performance and Proactive Risk Management • 1813
Whistleblowers • 1825
Federal and State False Claims Acts • 1827
