Schachter MD / Mandell / Harshbarger Managing Relationships with Industry

A Physician's Compliance Manual
1. Auflage 2010
ISBN: 978-0-08-055955-1
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 310 Seiten

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

Autoren/Hrsg.

Schachter MD, Steven C.

Mandell, William

Harshbarger, Scott

Grometstein, Randall

Inhaltsverzeichnis

1;Front Cover;1
2;Managing Relationships with Industry;4
3;Copyright Page;5
4;Dedications;6
5;Table of Contents;8
6;FOREWORD;14
7;PREFACE;26
8;CONTRIBUTORS;34
9;CHAPTER 1. BACKGROUND;36
9.1;The Era of Big Business;39
9.2;Physicians and Industry Sales Representatives;42
9.3;Physicians Involved with Marketing to Other Physicians;50
9.4;Continuing Medical Education;51
9.5;Paying Doctors to Enroll Patients in Clinical Trials;52
9.6;Other Conflicts of Interest;53
10;CHAPTER 2. OVERVIEW OF LEGAL SOURCES;56
10.1;Anti-kickback Laws;58
10.1.1;Safe harbors;62
10.2;Interplay Between Anti-kickback and Stark Laws;74
10.3;Stark and Physician Self-Referral Laws;74
10.3.1;Drug and device companies are generally not Stark “entities”;75
10.3.2;Financial relationships under Stark;77
10.3.3;Sanctions;78
10.3.4;Indirect financial relationships and exceptions;79
10.3.5;Direct financial relationships;81
10.4;Federal False Claims Act;85
10.5;Whistleblower Qui Tam Actions;87
10.6;Use of the Federal False Claims Act (FCA) to Pursue Alleged Anti-kickback and Stark Violations;87
10.7;Civil Monetary Penalties;89
10.8;Exclusion from Medicare and Medicaid Programs;89
10.9;State False Claims Acts and Whistleblower Laws;90
10.10;State Laws Regulating Marketing to Physicians;91
10.11;Food and Drug Administration;95
10.12;Off-label Uses and Marketing;97
10.13;Medicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs Coverage;102
10.14;Risks to Physicians;105
11;CHAPTER 3. SUMMARY OF RECENT PROSECUTIONS AND INVESTIGATIONS;108
11.1;Active Enforcement;108
11.2;The Prosecutable Case;111
11.3;Whistleblower as Private Attorney General;112
11.4;Settlements and Dispositions;113
11.5;Case Examples;114
11.5.1;Anti-kickback cases;114
11.5.2;Off-label marketing cases;119
11.5.3;Free sample/"marketing the spread" cases;129
11.5.4;Food, Drug, and Cosmetic Act False Statements Cases;135
11.5.5;Group purchasing organization cases;135
11.6;Physician Defendants in Cases Involving Financial Relationships with Industry;137
12;CHAPTER 4. APPLICATIONS OF LAW AND PROFESSIONAL AND TRADE ASSOCIATION STANDARDS TO PHYSICIAN RELATIONSHIPS WITH INDUSTRY;142
12.1;Office of Inspector General Reports;143
12.2;Office of Inspector General Special Fraud Alert;146
12.3;Office of Inspector General Compliance Program Guidance;147
12.3.1;Hospitals;148
12.3.2;Medical practices;150
12.3.3;Pharmaceutical manufacturers;151
12.4;Centers for Medicare and Medicaid Services Drug Manual;155
12.5;Corporate Integrity Agreements;157
12.6;Trade Association Codes of Conduct;157
12.6.1;PhRMA Code;158
12.6.2;AdvaMed Code;160
12.6.3;International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing Practices;162
12.6.4;URAC Pharmacy Benefit Management Draft Standards;164
12.7;Medical Association and Society Codes of Conduct;165
12.7.1;American Medical Association Ethical Opinion 8.061 on Gifts to Physicians from Industry;165
12.7.2;The American Medical Association Position versus the No-Gift Movement;167
12.7.3;Other societies;169
12.8;Continuing Medical Education;174
12.8.1;Food and Drug Administration;175
12.8.2;Accreditation Council for Continuing Medical Education;176
12.8.3;Government interest;180
12.8.4;Medical education and communication companies;181
12.9;Clinical Practice Guidelines;182
12.10;Academic Medical Center Conflict-of-Interest Policies;182
12.11;Community Hospitals and Physician-Owned Medical Practices;186
13;CHAPTER 5. LEGAL AND ETHICAL ASPECTS OF SPECIFIC PHYSICIAN–INDUSTRY FINANCIAL RELATIONSHIPS;188
13.1;Gifts, Meals and Visits by Company Sales Representatives;193
13.1.1;The law on gifts to physicians;199
13.1.2;Manufacturer’s support;202
13.1.3;Applicable state laws;203
13.1.4;The ethics of gifts to physicians;206
13.2;Detailing and Training;214
13.2.1;The law on detailing and training sessions;215
13.2.2;The ethics of detailing and training sessions;216
13.3;Continuing Medical Education;233
13.3.1;The law on continuing medical education;234
13.3.2;The ethics of continuing medical education;236
13.4;Non-CME Activities/Company Speakers Bureaus;240
13.4.1;The law on speaking for companies;240
13.4.2;The ethics of non-CME educational activities;241
13.5;Consulting and Other Service Arrangements;242
13.5.1;The law on consulting;243
13.5.2;The ethics of consulting;245
13.6;Preceptorships;246
13.7;Research Funding;247
13.7.1;The law on research funding from industry;248
13.7.2;The ethics of research funding from industry;249
13.8;Food and Drug Administration Advisory Committees;251
13.9;National Institutes of Health and Conflicts of Interest;252
13.10;AMA Ethical Standards for Researchers;254
13.11;Publishing Activities;256
13.12;Off-Label Marketing;257
13.12.1;The law on off-label marketing;258
13.12.2;The ethics of off-label marketing;260
13.13;Disclosure Considerations;262
13.14;Considerations for Medical Specialty Leaders;263
13.15;Equity Interests in Drug and Device Companies;263
13.16;Committee Memberships;264
13.17;Responding to a Subpoena or Interview Request by a Law Enforcement Official;265
13.18;Conclusion;267
14;CHAPTER 6. APPROACHING AND ADOPTING EFFECTIVE COMPLIANCE PLANS;268
14.1;Current Pressures on the U.S. Healthcare System;269
14.1.1;Physician shortages;269
14.1.2;Healthcare expenditures;270
14.1.3;The pipeline of medical innovations: diminishing returns;271
14.2;Addressing the Challenges: Key Stakeholders;272
14.2.1;Public and media;272
14.2.2;Physicians and their organizations;276
14.3;The Nature and Management of Conflict of Interest;279
14.3.1;Cognizance and understanding of the rules;282
14.4;Considerations for a Compliance Plan;284
14.4.1;The absolutist approach;284
14.4.2;Any degree of industry engagement;285
14.5;Developing Compliance Plans;289
14.5.1;Compliance plan elements;289
14.6;System-wide Reforms;291
14.6.1;Knowledge-based care: academic detailing and independent data sources;291
14.6.2;Stricter conflict-of-interest standards for health system stewards;293
14.6.3;Medical school curriculum on industry relationships;295
14.6.4;Professional society leadership;295
14.6.5;Broader compliance training for physicians on industry relationships;296
14.6.6;Patient education;296
15;CONCLUSION;298
16;APPENDIX 1 LINKS TO FREQUENTLY CITED DOCUMENTS AND CODES OF CONDUCT;300
17;APPENDIX 2 KEY TO ABBREVIATIONS;304
18;APPENDIX 3 MODEL SERVICE AGREEMENT FOR SPEAKING AT A CONTINUING MEDICAL EDUCATION ACTIVITY;306
19;APPENDIX 4 MODEL AGREEMENT FOR CONSULTING;312
20;INDEX;318