Managing Relationships With Industry available in Paperback, eBook
Managing Relationships With Industry
- ISBN-10:
- 0123736536
- ISBN-13:
- 9780123736536
- Pub. Date:
- 06/03/2008
- Publisher:
- Elsevier Science
- ISBN-10:
- 0123736536
- ISBN-13:
- 9780123736536
- Pub. Date:
- 06/03/2008
- Publisher:
- Elsevier Science
Managing Relationships With Industry
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$49.95Overview
Managing Relationships with Industry: A Physician’s Compliance Manual is an indispensable resource for doctors, professional societies, academic medical centers, community hospitals, and group practices struggling to understand the ever changing law and ethical standards on interactions with pharmaceutical and device companies. It is the first comprehensive summary of the law and ethics on physician relationships with industry written for the physician. Authored by a former state Attorney General, Harvard Medical School Professor, health care lawyer and professor of ethics, Managing Relationships approaches the topic from a balanced and reasoned perspective adding to the on-going national dialogue and debate on the proper limits to medicine’s relationship with industry.
- The first complete and up-to-date summary and analysis of the law and ethics on physician-industry relationships
- Focuses on major enforcement actions and whistleblower lawsuits and the lessons learned for physicians
- Provides options and guidance for maintaining compliant relationships and avoiding traps for the unwary
- Covers both drug and device company relationships
- Summarizes the types of industry relationships that are necessary and productive and those that are harmful and abusive
- Details the law and ethics for each type of relationship including gifts, off-label uses and marketing, CME, speaker’s bureaus, free samples, grants, consulting arrangements, etc.
- Includes sample contracts for permissible consulting and CME speaker engagements
Product Details
ISBN-13: | 9780123736536 |
---|---|
Publisher: | Elsevier Science |
Publication date: | 06/03/2008 |
Pages: | 324 |
Product dimensions: | 5.90(w) x 8.90(h) x 0.90(d) |
About the Author
Table of Contents
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