Managing Relationships with Industry: A Physician's Compliance Manual

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

Table of Contents:
Foreword Preface Contributors 1. Background The Era of Big Business Physicians and Industry Sales Representatives Physicians Involved with Marketing to Other Physicians Continuing Medical Education Paying Doctors to Enroll Patients in Clinical Trials Other Conflicts of Interest 2. Overview of Legal Sources Anti-Kickback Laws Safe Harbors Interplay between Anti-Kickback and Stark Laws Stark and Physician Self-Referral Laws Drug and Device Companies Are Generally Not Stark "Entities" Financial Relationships Under Stark Sanctions Indirect Financial Relationships and Exceptions Direct Financial Relationships Federal False Claims Act Whistleblower Qui Tam Actions Use of The Federal False Claims Act (FCA) to Pursue Alleged Anti-Kickback and Stark Violations Civil Monetary Penalties Exclusion From Medicare and Medicaid Programs State False Claims Acts and Whistleblower Laws State Laws Regulating Marketing to Physicians Food and Drug Administration Off-Label Uses and Marketing Medicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs Coverage Risks to Physicians 3. Summary of Recent Prosecutions and Investigations Active Enforcement The Prosecutable Case Whistleblower as Private Attorney General Settlements and Dispositions Case Examples Anti-Kickback Cases off-Label Marketing Cases Free Sample/"Marketing The Spread" Cases Food, Drug, and Cosmetic Act False Statements Cases Group Purchasing Organization Cases Physician Defendants in Cases Involving Financial Relationships with Industry 4. Applications of Law and Professional and Trade Association Standards to Physician Relationships with Industry Office of Inspector General Reports Office of Inspector General Special Fraud Alert Office of Inspector General Compliance Program Guidance Hospitals Medical Practices Pharmaceutical Manufacturers Centers for Medicare and Medicaid Services Drug Manual Corporate Integrity Agreements Trade Association Codes of Conduct Phrma Code Advamed Code International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing Practices Urac Pharmacy Benefit Management Draft Standards Medical Association and Society Codes of Conduct American Medical Association Ethical Opinion 8.061 on Gifts to Physicians from Industry The American Medical Association Position Versus The No-Gift Movement Other Societies Continuing Medical Education Food and Drug Administration 1 Accreditation Council for Continuing Medical Education Government Interest Medical Education and Communication Companies Clinical Practice Guidelines Academic Medical Center Conflict-of-Interest Policies Community Hospitals and Physician-Owned Medical Practices 5. Legal and Ethical Aspects of Specific Physician–Industry Financial Relationships Gifts, Meals and Visits By Company Sales Representatives The Law on Gifts to Physicians Manufacturer’s Support Applicable State Laws The Ethics of Gifts to Physicians Detailing and Training The Law on Detailing and Training Sessions The Ethics of Detailing and Training Sessions Continuing Medical Education The Law on Continuing Medical Education The Ethics of Continuing Medical Education Non-CME Activities/Company Speakers Bureaus The Law on Speaking for Companies The Ethics of Non-CME Educational Activities Consulting and Other Service Arrangements The Law on Consulting The Ethics of Consulting Preceptorships Research Funding The Law on Research Funding From Industry The Ethics of Research Funding From Industry Food and Drug Administration Advisory Committees National Institutes of Health and Conflicts of Interest Ama Ethical Standards for Researchers Publishing Activities Off-Label Marketing The Law on off-Label Marketing The Ethics of off-Label Marketing Disclosure Considerations Considerations for Medical Specialty Leaders Equity Interests in Drug and Device Companies Committee Memberships Responding to a Subpoena or Interview Request by a Law Enforcement official Conclusion 6. Approaching and Adopting Effective Compliance Plans Current Pressures on the U.S. Healthcare System Physician Shortages Healthcare Expenditures The Pipeline of Medical Innovations: Diminishing Returns Addressing The Challenges: Key Stakeholders Public and Media Physicians and Their Organizations The Nature and Management of Conflict of Interest Cognizance and Understanding of The Rules Considerations for a Compliance Plan The Absolutist Approach Any Degree of Industry Engagement Developing Compliance Plans Compliance Plan Elements System-Wide Reforms Knowledge-Based Care: Academic Detailing and Independent Data Sources Stricter Conflict-of-Interest Standards for Health System Stewards Medical School Curriculum on Industry Relationships Professional Society Leadership Broader Compliance Training for Physicians on Industry Relationships Patient Education Conclusion Appendix 1 Links to Frequently Cited Documents and Codes of Conduct Appendix 2 Key to Abbreviations Appendix 3 Model Service Agreement for Speaking at a Continuing Medical Education Activity Appendix 4 Model Agreement for Consulting Index

Review :
“A timely balanced and thoughtful book combining important reference material, practical real world issues and broadly informed perspective that allow healthy dialogue among physicians, government, the public and the device and drug industries. An important step toward clearing the air and setting a course for de-risking physician-industry interactions and aligning incentives for improving patient care. Physicians and the public are exposed to polarized, incomplete and biased debates about how physicians and their organizations should manage their relationships with industry. This book gives one the wisdom and confidence to find the best balance between avoidance of conflicts and achieving the highest benefits for patients.” --John A. Parrish, M.D., Executive Director and Founder of CIMIT, the Center for Integration of Medicine and Innovative Technology “This book is an important contribution to the ongoing discussion inside and outside the medical profession on the legal and ethical boundaries for doctors in their relationships with pharmaceutical and device makers.” --Donald M. Berwick, MD, MPP, President and CEO, Institute for Healthcare Improvement “In these times, virtually all physicians have interactions with the industry, and this book addresses the relevant issues. Every practicing physician who makes contact with the health care industry will find this volume an invaluable reference – and a wonderful guide to both ethical and legal behavior.” --Roger J. Porter, MD, Former Deputy Director of NINDS(NIH);Co-Author of Biomedical Research Collaboration and Conflict of Interest “This book provides physicians, lawyers, and the public with an invaluable review of the ethical and legal issues raised by physician-industry relationships, and a practical guide to ethically-sound guidelines and policies” --Lachlan Forrow, MD., Associate Professor of Medicine, Harvard Medical School, President, The Albert Schweitzer Fellowship “The track record for the relief of human suffering by the pharmaceutical and device industry has been spectacular. For this progress to continue, all parties must work together, conscious of, adhering to, and always answerable to the question of conflict of self-interest. This book details solid legal and ethical guidance, which if followed, will move us in the right direction and create welcomed positive synergy between the pharmaceutical - medical device industry and physicians.” --Leonard Morse, MD, Commissioner of Public Health, City of Worcester, Massachusetts; Professor of Clinical Medicine, Family Medicine and Community Health, University of Massachusetts Medical School; Past Chair of the AMA's Council on Ethical and Judicial Affairs