Managing Relationships with Industry

“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

• ForewordPrefaceContributors1. BackgroundThe Era of Big BusinessPhysicians and Industry Sales RepresentativesPhysicians Involved with Marketing to Other PhysiciansContinuing Medical EducationPaying Doctors to Enroll Patients in Clinical TrialsOther Conflicts of Interest2. Overview of Legal SourcesAnti-Kickback LawsSafe HarborsInterplay between Anti-Kickback and Stark LawsStark and Physician Self-Referral LawsDrug and Device Companies Are Generally Not Stark "Entities"Financial Relationships Under StarkSanctionsIndirect Financial Relationships and ExceptionsDirect Financial RelationshipsFederal False Claims ActWhistleblower Qui Tam ActionsUse of The Federal False Claims Act (FCA) to Pursue Alleged Anti-Kickback and Stark ViolationsCivil Monetary PenaltiesExclusion From Medicare and Medicaid ProgramsState False Claims Acts and Whistleblower LawsState Laws Regulating Marketing to PhysiciansFood and Drug AdministrationOff-Label Uses and MarketingMedicare Part D, Medicaid Drug Coverage and Other Program Changes to Prescription Drugs CoverageRisks to Physicians3. Summary of Recent Prosecutions and InvestigationsActive EnforcementThe Prosecutable CaseWhistleblower as Private Attorney GeneralSettlements and DispositionsCase ExamplesAnti-Kickback Casesoff-Label Marketing CasesFree Sample/"Marketing The Spread" CasesFood, Drug, and Cosmetic Act False Statements CasesGroup Purchasing Organization CasesPhysician Defendants in Cases Involving Financial Relationships with Industry4. Applications of Law and Professional and Trade Association Standards to Physician Relationships with IndustryOffice of Inspector General ReportsOffice of Inspector General Special Fraud AlertOffice of Inspector General Compliance Program GuidanceHospitalsMedical PracticesPharmaceutical ManufacturersCenters for Medicare and Medicaid Services Drug ManualCorporate Integrity AgreementsTrade Association Codes of ConductPhrma CodeAdvamed CodeInternational Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing PracticesUrac Pharmacy Benefit Management Draft StandardsMedical Association and Society Codes of ConductAmerican Medical Association Ethical Opinion 8.061 on Gifts to Physicians from IndustryThe American Medical Association Position Versus The No-Gift MovementOther SocietiesContinuing Medical EducationFood and Drug Administration 1Accreditation Council for Continuing Medical EducationGovernment InterestMedical Education and Communication CompaniesClinical Practice GuidelinesAcademic Medical Center Conflict-of-Interest PoliciesCommunity Hospitals and Physician-Owned Medical Practices5. Legal and Ethical Aspects of Specific Physician–Industry Financial RelationshipsGifts, Meals and Visits By Company Sales RepresentativesThe Law on Gifts to Physicians Manufacturer’s SupportApplicable State Laws The Ethics of Gifts to PhysiciansDetailing and Training The Law on Detailing and Training Sessions The Ethics of Detailing and Training SessionsContinuing Medical EducationThe Law on Continuing Medical EducationThe Ethics of Continuing Medical EducationNon-CME Activities/Company Speakers BureausThe Law on Speaking for CompaniesThe Ethics of Non-CME Educational ActivitiesConsulting and Other Service Arrangements The Law on Consulting The Ethics of ConsultingPreceptorshipsResearch FundingThe Law on Research Funding From IndustryThe Ethics of Research Funding From Industry Food and Drug Administration Advisory CommitteesNational Institutes of Health and Conflicts of InterestAma Ethical Standards for ResearchersPublishing ActivitiesOff-Label MarketingThe Law on off-Label MarketingThe Ethics of off-Label Marketing Disclosure ConsiderationsConsiderations for Medical Specialty LeadersEquity Interests in Drug and Device CompaniesCommittee MembershipsResponding to a Subpoena or Interview Request by a Law Enforcement officialConclusion6. Approaching and Adopting Effective Compliance Plans Current Pressures on the U.S. Healthcare SystemPhysician ShortagesHealthcare ExpendituresThe Pipeline of Medical Innovations: Diminishing ReturnsAddressing The Challenges: Key StakeholdersPublic and Media Physicians and Their OrganizationsThe Nature and Management of Conflict of InterestCognizance and Understanding of The RulesConsiderations for a Compliance Plan The Absolutist ApproachAny Degree of Industry Engagement Developing Compliance PlansCompliance Plan ElementsSystem-Wide ReformsKnowledge-Based Care: Academic Detailing and Independent Data SourcesStricter Conflict-of-Interest Standards for Health System StewardsMedical School Curriculum on Industry RelationshipsProfessional Society LeadershipBroader Compliance Training for Physicians on Industry RelationshipsPatient EducationConclusionAppendix 1 Links to Frequently Cited Documents and Codes of ConductAppendix 2 Key to AbbreviationsAppendix 3 Model Service Agreement for Speaking at a Continuing Medical Education ActivityAppendix 4 Model Agreement for ConsultingIndex