Managing Relationships with Industry

Foreword
Preface
Contributors
1. Background
The Era of Big Business
Physicians and Industry Sales Representatives
Physicians Involved with Marketing to Other Physicians
Continuing Medical Education
Paying Doctors to Enroll Patients in Clinical Trials
Other Conflicts of Interest
2. Overview of Legal Sources
Anti-Kickback Laws
Safe Harbors
Interplay between Anti-Kickback and Stark Laws
Stark and Physician Self-Referral Laws
Drug and Device Companies Are Generally Not Stark "Entities"
Financial Relationships Under Stark
Sanctions
Indirect Financial Relationships and Exceptions
Direct Financial Relationships
Federal False Claims Act
Whistleblower Qui Tam Actions
Use of The Federal False Claims Act (FCA) to Pursue Alleged Anti-Kickback and Stark Violations
Civil Monetary Penalties
Exclusion From Medicare and Medicaid Programs
State False Claims Acts and Whistleblower Laws
State Laws Regulating Marketing to Physicians
Food and Drug Administration
Off-Label Uses and Marketing
Medicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs Coverage
Risks to Physicians
3. Summary of Recent Prosecutions and Investigations
Active Enforcement
The Prosecutable Case
Whistleblower as Private Attorney General
Settlements and Dispositions
Case Examples
Anti-Kickback Cases
off-Label Marketing Cases
Free Sample/"Marketing The Spread" Cases
Food, Drug, and Cosmetic Act False Statements Cases
Group Purchasing Organization Cases
Physician Defendants in Cases Involving Financial Relationships with Industry
4. Applications of Law and Professional and Trade Association Standards to Physician Relationships with Industry
Office of Inspector General Reports
Office of Inspector General Special Fraud Alert
Office of Inspector General Compliance Program Guidance
Hospitals
Medical Practices
Pharmaceutical Manufacturers
Centers for Medicare and Medicaid Services Drug Manual
Corporate Integrity Agreements
Trade Association Codes of Conduct
Phrma Code
Advamed Code
International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing Practices
Urac Pharmacy Benefit Management Draft Standards
Medical Association and Society Codes of Conduct
American Medical Association Ethical Opinion 8.061 on Gifts to Physicians from Industry
The American Medical Association Position Versus The No-Gift Movement
Other Societies
Continuing Medical Education
Food and Drug Administration 1
Accreditation Council for Continuing Medical Education
Government Interest
Medical Education and Communication Companies
Clinical Practice Guidelines
Academic Medical Center Conflict-of-Interest Policies
Community Hospitals and Physician-Owned Medical Practices
5. Legal and Ethical Aspects of Specific Physician–Industry Financial Relationships
Gifts, Meals and Visits By Company Sales Representatives
The Law on Gifts to Physicians
Manufacturer’s Support
Applicable State Laws
The Ethics of Gifts to Physicians
Detailing and Training
The Law on Detailing and Training Sessions
The Ethics of Detailing and Training Sessions
Continuing Medical Education
The Law on Continuing Medical Education
The Ethics of Continuing Medical Education
Non-CME Activities/Company Speakers Bureaus
The Law on Speaking for Companies
The Ethics of Non-CME Educational Activities
Consulting and Other Service Arrangements
The Law on Consulting
The Ethics of Consulting
Preceptorships
Research Funding
The Law on Research Funding From Industry
The Ethics of Research Funding From Industry
Food and Drug Administration Advisory Committees
National Institutes of Health and Conflicts of Interest
Ama Ethical Standards for Researchers
Publishing Activities
Off-Label Marketing
The Law on off-Label Marketing
The Ethics of off-Label Marketing
Disclosure Considerations
Considerations for Medical Specialty Leaders
Equity Interests in Drug and Device Companies
Committee Memberships
Responding to a Subpoena or Interview Request by a Law Enforcement official
Conclusion
6. Approaching and Adopting Effective Compliance Plans
Current Pressures on the U.S. Healthcare System
Physician Shortages
Healthcare Expenditures
The Pipeline of Medical Innovations: Diminishing Returns
Addressing The Challenges: Key Stakeholders
Public and Media
Physicians and Their Organizations
The Nature and Management of Conflict of Interest
Cognizance and Understanding of The Rules
Considerations for a Compliance Plan
The Absolutist Approach
Any Degree of Industry Engagement
Developing Compliance Plans
Compliance Plan Elements
System-Wide Reforms
Knowledge-Based Care: Academic Detailing and Independent Data Sources
Stricter Conflict-of-Interest Standards for Health System Stewards
Medical School Curriculum on Industry Relationships
Professional Society Leadership
Broader Compliance Training for Physicians on Industry Relationships
Patient Education
Conclusion
Appendix 1 Links to Frequently Cited Documents and Codes of Conduct
Appendix 2 Key to Abbreviations
Appendix 3 Model Service Agreement for Speaking at a Continuing Medical Education Activity
Appendix 4 Model Agreement for Consulting
Index