Managing Relationships with Industry: A Physician's Compliance Manual Book

Foreword     XIII
Preface     XXV
Contributors     XXXIII
Background     1
The Era of Big Business     4
Physicians and Industry Sales Representatives     7
Physicians Involved with Marketing to Other Physicians     15
Continuing Medical Education     16
Paying Doctors to Enroll Patients in Clinical Trials     17
Other Conflicts of Interest     18
Overview of Legal Sources     21
Anti-kickback Laws     23
Safe harbors     27
Interplay Between Anti-kickback and Stark Laws     39
Stark and Physician Self-Referral Laws     39
Drug and device companies are generally not Stark "entities"     40
Financial relationships under Stark     42
Sanctions     43
Indirect financial relationships and exceptions     44
Direct financial relationships     46
Federal False Claims Act     50
Whistleblower Qui Tam Actions     52
Use of the Federal False Claims Act (FCA) to Pursue Alleged Anti-kickback and Stark Violations     52
Civil Monetary Penalties     54
Exclusion from Medicare and Medicaid Programs     54
StateFalse Claims Acts and Whistleblower Laws     55
State Laws Regulating Marketing to Physicians     56
Food and Drug Administration     60
Off-label Uses and Marketing     62
Medicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs Coverage     67
Risks to Physicians     70
Summary of Recent Prosecutions and Investigations     73
Active Enforcement     73
The Prosecutable Case     76
Whistleblower as Private Attorney General     77
Settlements and Dispositions     78
Case Examples     79
Anti-kickback cases     79
Off-label marketing cases     84
Free sample/"marketing the spread" cases     94
Food, Drug, and Cosmetic Act False Statements Cases     100
Group purchasing organization cases     100
Physician Defendants in Cases Involving Financial Relationships with Industry     102
Applications of Law and Professional and Trade Association Standards to Physician Relationships with Industry     107
Office of Inspector General Reports     108
Office of Inspector General Special Fraud Alert     111
Office of Inspector General Compliance Program Guidance      112
Hospitals     113
Medical practices     115
Pharmaceutical manufacturers     116
Centers for Medicare and Medicaid Services Drug Manual     120
Corporate Integrity Agreements     122
Trade Association Codes of Conduct     122
PhRMA Code     123
AdvaMed Code     125
International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing Practices     127
URAC Pharmacy Benefit Management Draft Standards     129
Medical Association and Society Codes of Conduct     130
American Medical Association Ethical Opinion 8.061 on Gifts to Physicians from Industry     130
The American Medical Association Position versus the No-Gift Movement     132
Other societies     134
Continuing Medical Education     139
Food and Drug Administration     140
Accreditation Council for Continuing Medical Education     141
Government interest     145
Medical education and communication companies     146
Clinical Practice Guidelines     147
Academic Medical Center Conflict-of-Interest Policies     147
Community Hospitals and Physician-Owned Medical Practices     151
Legal and Ethical Aspects of Specific Physician-Industry Financial Relationships     153
Gifts, Meals and Visits by Company Sales Representatives     158
The law on gifts to physicians     164
Manufacturer's support     167
Applicable state laws     168
The ethics of gifts to physicians     171
Detailing and Training     179
The law on detailing and training sessions     180
The ethics of detailing and training sessions     181
Continuing Medical Education     198
The law on continuing medical education     199
The ethics of continuing medical education     201
Non-CME Activities/Company Speakers Bureaus     205
The law on speaking for companies     205
The ethics of non-CME educational activities     206
Consulting and Other Service Arrangements     207
The law on consulting     208
The ethics of consulting     210
Preceptorships     211
Research Funding     212
The law on research funding from industry     213
The ethics of research funding from industry     214
Food and Drug Administration Advisory Committees     216
National Institutes of Health and Conflicts of Interest      217
AMA Ethical Standards for Researchers     219
Publishing Activities     221
Off-Label Marketing     222
The law on off-label marketing     223
The ethics of off-label marketing     225
Disclosure Considerations     227
Considerations for Medical Specialty Leaders     228
Equity Interests in Drug and Device Companies     228
Committee Memberships     229
Responding to a Subpoena or Interview Request by a Law Enforcement Official     230
Conclusion     232
Approaching and Adopting Effective Compliance Plans     233
Current Pressures on the U.S. Healthcare System     234
Physician shortages     234
Healthcare expenditures     235
The pipeline of medical innovations: diminishing returns     236
Addressing the Challenges: Key Stakeholders     237
Public and media     237
Physicians and their organizations     241
The Nature and Management of Conflict of Interest     244
Cognizance and understanding of the rules     247
Considerations for a Compliance Plan     249
The absolutist approach     249
Any degree of industry engagement      250
Developing Compliance Plans     254
Compliance plan elements     254
System-wide Reforms     256
Knowledge-based care: academic detailing and independent data sources     256
Stricter conflict-of-interest standards for health system stewards     258
Medical school curriculum on industry relationships     260
Professional society leadership     260
Broader compliance training for physicians on industry relationships     261
Patient education     261
Conclusion     263
Links to Frequently Cited Documents and Codes of Conduct     265
Key to Abbreviations     269
Model Service Agreement for Speaking at a Continuing Medical Education Activity     271
Model Agreement for Consulting     277
Index     283