Managing Relationships with Industry book cover

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.

Audience
Physicians in academic and private practice settings dealing with the research and marketing arms of pharmaceutical and device manufacturers.

Paperback, 310 Pages

Published: June 2008

Imprint: Academic Press

ISBN: 978-0-12-373653-6

Reviews

  • “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.

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


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