Managing Relationships with Industry: A Physician's Compliance Manual
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Table of contents
- Managing Relationships with Industryiii
- Copyright Pageiv
- Dedicationsv
- Contentsvii
- Forewordxiii
- Prefacexxv
- Contributorsxxxiii
- CHAPTER 1. Background1
- The Era of Big Business4
- Physicians and Industry Sales Representatives7
- Physicians Involved with Marketing to Other Physicians15
- Continuing Medical Education16
- Paying Doctors to Enroll Patients in Clinical Trials17
- Other Conflicts of Interest18
- CHAPTER 2. Overview of Legal Sources21
- Anti-kickback Laws23
- Safe harbors27
- Interplay Between Anti-kickback and Stark Laws39
- Stark and Physician Self-Referral Laws39
- Drug and device companies are generally not Stark entitiesŽ40
- Financial relationships under Stark42
- Sanctions43
- Indirect financial relationships and exceptions44
- Direct financial relationships46
- Federal False Claims Act50
- Whistleblower Qui Tam Actions52
- Use of the Federal False Claims Act (FCA) to Pursue Alleged Anti-kickback and Stark Violations52
- Civil Monetary Penalties54
- Exclusion from Medicare and Medicaid Programs54
- State False Claims Acts and Whistleblower Laws55
- State Laws Regulating Marketing to Physicians56
- Food and Drug Administration60
- Off-label Uses and Marketing62
- Medicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs Coverage67
- Risks to Physicians70
- CHAPTER 3. Summary of Recent Prosecutions and Investigations73
- Active Enforcement73
- The Prosecutable Case76
- Whistleblower as Private Attorney General77
- Settlements and Dispositions78
- Case Examples79
- Anti-kickback cases79
- Off-label marketing cases84
- Free sample/"marketing the spread" cases94
- Food, Drug, and Cosmetic Act False Statements Cases100
- Group purchasing organization cases100
- Physician Defendants in Cases Involving Financial Relationships with Industry102
- CHAPTER 4. Applications Of Law And Professional And Trade Association Standards To Physician Relatio107
- Office of Inspector General Reports108
- Office of Inspector General Special Fraud Alert111
- Office of Inspector General Compliance Program Guidance112
- Hospitals113
- Medical practices115
- Pharmaceutical manufacturers116
- Centers for Medicare and Medicaid Services Drug Manual120
- Corporate Integrity Agreements122
- Trade Association Codes of Conduct122
- PhRMA Code123
- AdvaMed Code125
- International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Mar127
- URAC Pharmacy Benefit Management Draft Standards129
- Medical Association and Society Codes of Conduct130
- American Medical Association Ethical Opinion 8.061 on Gifts to Physicians from Industry130
- The American Medical Association Position versus the No-Gift Movement132
- Other societies134
- Continuing Medical Education139
- Food and Drug Administration140
- Accreditation Council for Continuing Medical Education141
- Government interest145
- Medical education and communication companies146
- Clinical Practice Guidelines147
- Academic Medical Center Conflict-of-Interest Policies147
- Community Hospitals and Physician-Owned Medical Practices151
- CHAPTER 5. Legal and Ethical Aspects Of Specific Physician–Industry Financial Relationships153
- Gifts, Meals and Visits by Company Sales Representatives158
- The law on gifts to physicians164
- Manufacturer’s support167
- Applicable state laws168
- The ethics of gifts to physicians171
- Detailing and Training179
- The law on detailing and training sessions180
- The ethics of detailing and training sessions181
- Continuing Medical Education198
- The law on continuing medical education199
- The ethics of continuing medical education201
- Non-CME Activities/Company Speakers Bureaus205
- The law on speaking for companies205
- The ethics of non-CME educational activities206
- Consulting and Other Service Arrangements207
- The law on consulting208
- The ethics of consulting210
- Preceptorships211
- Research Funding212
- The law on research funding from industry213
- The ethics of research funding from industry214
- Food and Drug Administration Advisory Committees216
- National Institutes of Health and Conflicts of Interest217
- AMA Ethical Standards for Researchers219
- Publishing Activities221
- Off-Label Marketing222
- The law on off-label marketing223
- The ethics of off-label marketing225
- Disclosure Considerations227
- Considerations for Medical Specialty Leaders228
- Equity Interests in Drug and Device Companies228
- Committee Memberships229
- Responding to a Subpoena or Interview Request by a Law Enforcement Official230
- Conclusion232
- CHAPTER 6. Approaching and Adopting Effective Compliance Plans233
- Current Pressures on the U.S. Healthcare System234
- Physician shortages234
- Healthcare expenditures235
- The pipeline of medical innovations: diminishing returns236
- Addressing the Challenges: Key Stakeholders237
- Public and media237
- Physicians and their organizations241
- The Nature and Management of Conflict of Interest244
- Cognizance and understanding of the rules247
- Considerations for a Compliance Plan249
- The absolutist approach249
- Any degree of industry engagement250
- Developing Compliance Plans254
- Compliance plan elements254
- System-wide Reforms256
- Knowledge-based care: academic detailing and independent data sources256
- Stricter conflict-of-interest standards for health system stewards258
- Medical school curriculum on industry relationships260
- Professional society leadership260
- Broader compliance training for physicians on industry relationships261
- Patient education261
- Conclusion263
- APPENDIX 1 Links To Frequently Cited Documents And Codes Of Conduct265
- APPENDIX 2 Key to Abbreviations269
- APPENDIX 3 Model Service Agreement For Speaking At A Continuing Medical Education Activity271
- APPENDIX 4 Model Agreement for Consulting277
- Index283
Now more than ever, doctors are being targeted by government prosecutors and whistleblowers challenging the legality of their relationships with drug and device companies. With reputations at stake and the risk of civil and criminal liability, it is incumbent upon doctors to protect themselves.
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
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