Managing Relationships with Industry

  • ID: 1767709
  • Book
  • 310 Pages
  • Elsevier Science and Technology
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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
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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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Schachter, Steven C.
Mandell, William
Harshbarger, Scott
Grometstein, Randall
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