Reducing Legal Risks in the

Sales and Marketing of Medical Devices

The Latest Information from the Front Lines on: Government Investigations and Enforcement, Regulatory Activity, Government Payor Systems and Compliance Strategies

Monday, November 14, 2005

About


HOW PREPARED IS YOUR COMPANY TO DEMONSTRATE COMPLIANCE WITH APPLICABLE CODES, GUIDANCES AND REGULATIONS?

In the midst of ongoing enforcement actions against the pharmaceutical industry, government enforcers are stepping up their investigations of the device industry. In March 2005, the U.S. Attorney's Office for the District of New Jersey issued subpoenas to five orthopedic companies seeking information on consulting, professional service and reimbursement agreements with surgeons. This development has the entire industry abuzz, and serves as a reminder that no company is immune from scrutiny, even if it has been vigilant in its compliance efforts.

This makes your ability to demonstrate compliance all the more important, so you can mitigate the exposures and potential costs associated with investigations. Compliance officers, sales representatives, vice presidents of sales and in-house counsel all must have a strong working knowledge of the best practices for complying with the AdvaMed Code of Ethics, the OIG Guidance and the myriad federal and state regulations, laws and ethical tenets that govern the sales and promotion of their products. It's not enough to stay updated on these best practices; you must also know how to maintain them. You must have a sophisticated knowledge concerning kickbacks, price setting and reimbursement, all while supporting aggressive sales targets.

American Conference Institute's 3rd Annual publication on Reducing Legal Risks in the Sales and Marketing of Medical Devices gives in-depth compliance analysis from leading in-house counsel and compliance officers, law firm fraud and abuse practitioners, regulatory attorneys, and government enforcers.* They provide you with first-hand, practical and comprehensive information on:
  • Recognizing the distinctions between the sales and marketing practices of the pharma and medical device industries
  • How to avoid the scrutiny of government enforcers
  • Incorporating Medicare/Medicaid reforms into medical device promotion policies
  • Managing discounts and pricing arrangements
  • How to effectively market your product directly to consumers
  • How recent government activities are impacting private medical device suits
  • Predicting litigation patterns driven by the link between government enforcement activity and the plaintiffs' bar


*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors

About


HOW PREPARED IS YOUR COMPANY TO DEMONSTRATE COMPLIANCE WITH APPLICABLE CODES, GUIDANCES AND REGULATIONS?

In the midst of ongoing enforcement actions against the pharmaceutical industry, government enforcers are stepping up their investigations of the device industry. In March 2005, the U.S. Attorney's Office for the District of New Jersey issued subpoenas to five orthopedic companies seeking information on consulting, professional service and reimbursement agreements with surgeons. This development has the entire industry abuzz, and serves as a reminder that no company is immune from scrutiny, even if it has been vigilant in its compliance efforts.

This makes your ability to demonstrate compliance all the more important, so you can mitigate the exposures and potential costs associated with investigations. Compliance officers, sales representatives, vice presidents of sales and in-house counsel all must have a strong working knowledge of the best practices for complying with the AdvaMed Code of Ethics, the OIG Guidance and the myriad federal and state regulations, laws and ethical tenets that govern the sales and promotion of their products. It's not enough to stay updated on these best practices; you must also know how to maintain them. You must have a sophisticated knowledge concerning kickbacks, price setting and reimbursement, all while supporting aggressive sales targets.

American Conference Institute's 3rd Annual publication on Reducing Legal Risks in the Sales and Marketing of Medical Devices gives in-depth compliance analysis from leading in-house counsel and compliance officers, law firm fraud and abuse practitioners, regulatory attorneys, and government enforcers.* They provide you with first-hand, practical and comprehensive information on:
  • Recognizing the distinctions between the sales and marketing practices of the pharma and medical device industries
  • How to avoid the scrutiny of government enforcers
  • Incorporating Medicare/Medicaid reforms into medical device promotion policies
  • Managing discounts and pricing arrangements
  • How to effectively market your product directly to consumers
  • How recent government activities are impacting private medical device suits
  • Predicting litigation patterns driven by the link between government enforcement activity and the plaintiffs' bar


*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors


OIG COMPLIANCE AND ENFORCEMENT TRENDS: WHAT YOU CAN'T AFFORD NOT TO KNOW
Kathleen McDermott, Blank Rome LLP

THE ADVAMED CODE OF ETHICS: OVERCOMING THE LATEST COMPLIANCE CHALLENGES
Gary S. Ange, Abbott Laboratories
Jody Gleason, Abbott Laboratories

EFFECT OF CALIFORNIA SB 1765 ON THE MEDICAL DEVICE INDUSTRY
R. Michael Scarano Jr., Foley & Lardner

EFFECT OF CALIFORNIA SB 1765 ON MEDICAL DEVICE INDUSTRY
William J. Hrubes Jr., Gambro Inc.

EMERGING RELATIONSHIPS BETWEEN PHYSICIANS, MANUFACTURERS, AND DISTRIBUTION COMPANIES
Joseph W. Metro, Reed Smith LLP

MEDICARE COVERAGE IN THE 21ST CENTURY
Robert B. Ramsey III, Buchanan Ingersoll

DISCOUNTS, BUNDLING, FREE GOODS, PREBATES: WHAT DO THE FRAUD AND ABUSE LAWS REALLY PROHIBIT?
Kevin G. McAnaney, Law Offices of Kevin G. McAnaney

ANTITRUST ISSUES IN HOSPITAL AND GPO ARRANGEMENTS: A VIEW FROM THE FEDERAL TRADE COMMISSION
Michael H. Knight, Federal Trade Commission

ANTITRUST ISSUES IN HOSPITAL/GPO ARRANGEMENTS: AN UPDATE
Scott Stein, Sidley, Austin Brown & Wood LLP

THE DEFRAUD PRONG OF THE FEDERAL CONSPIRACY STATUTE: AN IMPORTANT ARROW IN THE GOVERNMENT'S QUIVER AGAINST HEALTH CARE FRAUD
Brien T. O'Connor, Ropes & Gray
Heather S. Crall, Ropes & Gray

MEDICAL DEVICES AND THE CIVIL FALSE CLAIMS ACT
Michael G. Scheininger, McKenna Long & Aldridge LLP

RECENT DEVELOPMENTS IN OFF-LABEL USE AND PROMOTION
Harvey L. Kaplan, Shook, Hardy & Bacon LLP
Jon A. Strongman, Shook, Hardy & Bacon LLP

MEDICAL DEVICES AND DIRECT TO CONSUMER PROMOTION SMART AND SAFE PRACTICES
Joseph J. Leghorn, Nixon Peabody LLP
Tavares M. Brewington, Nixon Peabody LLP

EMERGING LEGAL ISSUES SURROUNDING CLINICAL TRIALS AND POSTMARKET SURVEILLANCE
Ellen J. Flannery, Covington & Burling

GLOBAL COMPLIANCE INFRASTRUCTURE AND THE MEDICAL DEVICE SALES FORCE Teresa I. Ford, Law Offices of Teresa I. Ford, PC

COMPLIANCE CHALLENGES FOR OVERSEAS BUSINESS
Ira Raphaelson, O'Melveny & Myers

CODES OF ETHICS OUTSIDES OF THE U.S. ADDRESSING SALES AND MARKETING PRACTICES INTERNATIONALLY
Kristine Rapp, Hospira, Inc.

A PRIMER ON EXCLUSION
Karen F. Green, Wilmer Cutler Pickering Hale and Dorr LLP

RECENT FEDERAL MEDICAL DEVICE PROSECUTIONS
Nicholas C. Theodorou, Foley Hoag LLP
Andrew B. Loewenstein, Foley Hoag LLP

MEDICAL MONITORING: THE LATEST THREAT TO MEDICAL DEVICE COMPANIES?
Joseph K. Hetrick, Dechert LLP
Allison M. Sgroi, Dechert LLP



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