Managing Relationships with Industry (eBook)

Front Cover 1
Managing Relationships with Industry 4
Copyright Page 5
Dedications 6
Table of Contents 8
FOREWORD 14
PREFACE 26
CONTRIBUTORS 34
CHAPTER 1. BACKGROUND 36
The Era of Big Business 39
Physicians and Industry Sales Representatives 42
Physicians Involved with Marketing to Other Physicians 50
Continuing Medical Education 51
Paying Doctors to Enroll Patients in Clinical Trials 52
Other Conflicts of Interest 53
CHAPTER 2. OVERVIEW OF LEGAL SOURCES 56
Anti-kickback Laws 58
Safe harbors 62
Interplay Between Anti-kickback and Stark Laws 74
Stark and Physician Self-Referral Laws 74
Drug and device companies are generally not Stark “entities” 75
Financial relationships under Stark 77
Sanctions 78
Indirect financial relationships and exceptions 79
Direct financial relationships 81
Federal False Claims Act 85
Whistleblower Qui Tam Actions 87
Use of the Federal False Claims Act (FCA) to Pursue Alleged Anti-kickback and Stark Violations 87
Civil Monetary Penalties 89
Exclusion from Medicare and Medicaid Programs 89
State False Claims Acts and Whistleblower Laws 90
State Laws Regulating Marketing to Physicians 91
Food and Drug Administration 95
Off-label Uses and Marketing 97
Medicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs Coverage 102
Risks to Physicians 105
CHAPTER 3. SUMMARY OF RECENT PROSECUTIONS AND INVESTIGATIONS 108
Active Enforcement 108
The Prosecutable Case 111
Whistleblower as Private Attorney General 112
Settlements and Dispositions 113
Case Examples 114
Anti-kickback cases 114
Off-label marketing cases 119
Free sample/"marketing the spread" cases 129
Food, Drug, and Cosmetic Act False Statements Cases 135
Group purchasing organization cases 135
Physician Defendants in Cases Involving Financial Relationships with Industry 137
CHAPTER 4. APPLICATIONS OF LAW AND PROFESSIONAL AND TRADE ASSOCIATION STANDARDS TO PHYSICIAN RELATIONSHIPS WITH INDUSTRY 142
Office of Inspector General Reports 143
Office of Inspector General Special Fraud Alert 146
Office of Inspector General Compliance Program Guidance 147
Hospitals 148
Medical practices 150
Pharmaceutical manufacturers 151
Centers for Medicare and Medicaid Services Drug Manual 155
Corporate Integrity Agreements 157
Trade Association Codes of Conduct 157
PhRMA Code 158
AdvaMed Code 160
International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing Practices 162
URAC Pharmacy Benefit Management Draft Standards 164
Medical Association and Society Codes of Conduct 165
American Medical Association Ethical Opinion 8.061 on Gifts to Physicians from Industry 165
The American Medical Association Position versus the No-Gift Movement 167
Other societies 169
Continuing Medical Education 174
Food and Drug Administration 175
Accreditation Council for Continuing Medical Education 176
Government interest 180
Medical education and communication companies 181
Clinical Practice Guidelines 182
Academic Medical Center Conflict-of-Interest Policies 182
Community Hospitals and Physician-Owned Medical Practices 186
CHAPTER 5. LEGAL AND ETHICAL ASPECTS OF SPECIFIC PHYSICIAN–INDUSTRY FINANCIAL RELATIONSHIPS 188
Gifts, Meals and Visits by Company Sales Representatives 193
The law on gifts to physicians 199
Manufacturer’s support 202
Applicable state laws 203
The ethics of gifts to physicians 206
Detailing and Training 214
The law on detailing and training sessions 215
The ethics of detailing and training sessions 216
Continuing Medical Education 233
The law on continuing medical education 234
The ethics of continuing medical education 236
Non-CME Activities/Company Speakers Bureaus 240
The law on speaking for companies 240
The ethics of non-CME educational activities 241
Consulting and Other Service Arrangements 242
The law on consulting 243
The ethics of consulting 245
Preceptorships 246
Research Funding 247
The law on research funding from industry 248
The ethics of research funding from industry 249
Food and Drug Administration Advisory Committees 251
National Institutes of Health and Conflicts of Interest 252
AMA Ethical Standards for Researchers 254
Publishing Activities 256
Off-Label Marketing 257
The law on off-label marketing 258
The ethics of off-label marketing 260
Disclosure Considerations 262
Considerations for Medical Specialty Leaders 263
Equity Interests in Drug and Device Companies 263
Committee Memberships 264
Responding to a Subpoena or Interview Request by a Law Enforcement Official 265
Conclusion 267
CHAPTER 6. APPROACHING AND ADOPTING EFFECTIVE COMPLIANCE PLANS 268
Current Pressures on the U.S. Healthcare System 269
Physician shortages 269
Healthcare expenditures 270
The pipeline of medical innovations: diminishing returns 271
Addressing the Challenges: Key Stakeholders 272
Public and media 272
Physicians and their organizations 276
The Nature and Management of Conflict of Interest 279
Cognizance and understanding of the rules 282
Considerations for a Compliance Plan 284
The absolutist approach 284
Any degree of industry engagement 285
Developing Compliance Plans 289
Compliance plan elements 289
System-wide Reforms 291
Knowledge-based care: academic detailing and independent data sources 291
Stricter conflict-of-interest standards for health system stewards 293
Medical school curriculum on industry relationships 295
Professional society leadership 295
Broader compliance training for physicians on industry relationships 296
Patient education 296
CONCLUSION 298
APPENDIX 1 LINKS TO FREQUENTLY CITED DOCUMENTS AND CODES OF CONDUCT 300
APPENDIX 2 KEY TO ABBREVIATIONS 304
APPENDIX 3 MODEL SERVICE AGREEMENT FOR SPEAKING AT A CONTINUING MEDICAL EDUCATION ACTIVITY 306
APPENDIX 4 MODEL AGREEMENT FOR CONSULTING 312
INDEX 318