Managing Relationships with Industry: A Physician's Compliance Manual
Autor Steven C. Schachter, William Mandell, Scott Harshbarger, Randall Grometsteinen Limba Engleză Paperback – 6 iul 2008
Managing Relationships with Industry: A Physician’s Compliance Manualis 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 Relationshipsapproaches 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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Specificații
ISBN-13: 9780123736536
ISBN-10: 0123736536
Pagini: 310
Dimensiuni: 152 x 229 x 20 mm
Greutate: 0.53 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0123736536
Pagini: 310
Dimensiuni: 152 x 229 x 20 mm
Greutate: 0.53 kg
Editura: ELSEVIER SCIENCE
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Public țintă
Physicians in academic and private practice settings dealing with the research and marketing arms of pharmaceutical and device manufacturers.Cuprins
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
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
Recenzii
“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
“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