Sales And Marketing Of Medical Devices

Monday, November 12, 2007

About

Government agencies, enforcers and the media have all recently suggested that medical device companies will increasingly be the target of fraud and abuse investigations. In addition to the typical sales and marketing activities that have triggered enforcement in the past, i.e. off-label promotion, consulting agreements and direct-to-consumer marketing - medical device companies now have to contend with fraudulent allegations involving joint ventures and vendor credentialing. The possibility of steep fines and highly publicized and expensive litigation only adds fuel to the fire.

Having corporate policies in place just isn’t enough anymore in this time of increased public and private scrutiny. Developing an ethical compliance infrastructure is an essential competency to decreasing the risk of qui tam litigation. You need to be able to monitor, audit, and measure the effectiveness of the compliance program to ensure its success.

The American Conference Institute has developed this publication from the 6th National Conference on Reducing Legal Risks in the Sales and Marketing of Medical Devices to provide you with a sophisticated and comprehensive understanding of the most difficult and costly dilemmas facing device companies today, along with practical strategies for tackling these challenges.

Contents & Contributors

About

Government agencies, enforcers and the media have all recently suggested that medical device companies will increasingly be the target of fraud and abuse investigations. In addition to the typical sales and marketing activities that have triggered enforcement in the past, i.e. off-label promotion, consulting agreements and direct-to-consumer marketing - medical device companies now have to contend with fraudulent allegations involving joint ventures and vendor credentialing. The possibility of steep fines and highly publicized and expensive litigation only adds fuel to the fire.

Having corporate policies in place just isn’t enough anymore in this time of increased public and private scrutiny. Developing an ethical compliance infrastructure is an essential competency to decreasing the risk of qui tam litigation. You need to be able to monitor, audit, and measure the effectiveness of the compliance program to ensure its success.

The American Conference Institute has developed this publication from the 6th National Conference on Reducing Legal Risks in the Sales and Marketing of Medical Devices to provide you with a sophisticated and comprehensive understanding of the most difficult and costly dilemmas facing device companies today, along with practical strategies for tackling these challenges.

Contents & Contributors

COMPLYING WITH THE ADVAMED CODE OF ETHICS AND OTHER INDUSTRY GUIDELINES: OVERCOMING REAL-WORLD IMPLEMENTATION ISSUES
Tracy Palmer Berns, Covidien (Mansfield, MA)
Mark N. Bonaguro, Covidien (Mansfield, MA)
Jennifer Bragg, King & Spalding LLP (Washington, DC)

FORMULATING A GAME PLAN FOR PREVENTING AND RESPONDING TO STATE AND FEDERAL SUBPOENAS
Laurence J. Freedman, Patton Boggs LLP (Washington, DC)

GAME PLAN FOR A MEDICAL DEVICE MANUFACTURER RESPONDING TO A GOVERNMENT SUBPOENA
Brien T. O’Connor, Ropes & Gray LLP (Boston, MA)

FORMULATING A GAME PLAN FOR PREVENTING AND RESPONDING TO A STATE, FEDERAL OR CONGRESSIONAL SUBPOENA
Brett Barlag, FTI Consulting (New York, NY)

PHYSICIAN CONSULTING ARRANGEMENTS, TRAINING, EDUCATION, GRANTS AND DONATIONS: AVOIDING ANTI-KICKBACK AND FALSE CLAIMS ACT LIABILITY WHEN INTERACTING WITH HEALTHCARE PROFESSIONALS
Jody A. Gleason, IITS, GE Healthcare (Barrington, IL)

CONSULTING AGREEMENTS IN THE NEW AGE OF COMPLIANCE
Teresa I. Ford, Law Offices of Teresa I. Ford, PC (Houston, TX)

DISCOUNTS, BUNDLING, AND PRICING: KEEPING CLEAR OF ANTI-KICKBACK AND PRICING PITFALLS
Kevin G. McAnaney, Law Offices of Kevin G. McAnaney (Washington, DC)

FROM THEORY INTO PRACTICE: DESIGNING AND IMPLEMENTING AN EFFECTIVE FCPA COMPLIANCE PROGRAM
Derek Devgun, Neuromodulation, Medtronic, Inc. (Minneapolis, MN)

FCPA AND THE MEDICAL DEVICE INDUSTRY: LAW, APPLICATION & A VOLUNTARY DISCLOSURE CAUTIONARY TALE
Michael G. Scheininger, McKenna Long & Aldridge (Washington, DC)

IN-HOUSE STRATEGY SESSION ON TACKLING CRITICAL COMPLIANCE CHALLENGES
Vickie L. McCormick, St. Jude Medical, Inc. (St. Paul, MN)

IN-HOUSE STRATEGY SESSION ON TACKLING CRITICAL COMPLIANCE CHALLENGES: AUDITING / MONITORING CONDUCTING INVESTIGATIONS
Link Bonforte, Ethics & Compliance, ConvaTec (Skillman, NJ)

INTERNATIONAL COMPLIANCE PROGRAMS
William T. Fitzgerald, Alcon Laboratories Inc. (Ft. Worth, TX)

HEALTHCARE INDUSTRY REPRESENTATIVE CREDENTIALING: ONE COMPANY’S APPROACH
Kris Rapp, Global Ethics & Compliance, Hospira, Inc. (Lake Forest, IL)

HEALTH CARE INDUSTRY REPRESENTATIVE (HCIR) CREDENTIALING
John Tara, Boston Scientific Corporation (Natick, MA)

STATUS BLUE: THE VENDOR COMPLIANCE NETWORK
John Wills, Status Blue LLC (Marietta, GA)

STATE LAW COMPLIANCE: STAYING ABREAST OF NEW DEVELOPMENTSAND ENFORCEMENT ACTIONS
John Patrick Oroho, Porzio, Bromberg & Newman, PC (Morristown, NJ)
Lena Robins, Foley & Lardner LLP (Washington, DC)

THE PRACTICE OF MEDICINE EXEMPTION FOR THE OFF-LABEL USE OF MEDICAL DEVICES
Casper (“Cap”) E. Uldriks, Esq., U.S. Food and Drug Administration (Rockville, MD)

MINIMIZING EXPOSURE TO OFF-LABEL PROMOTION LIABILITY: COMPLIANCE STRATEGIES TO PREVENT HUGE FINES, GUILTY PLEAS AND NEGATIVE PUBLICITY
Peter S. Spivack, Hogan & Hartson LLP (Washington, DC)
Greer O. Lautrup, Sidley Austin LLP (Washington, DC)

DIRECT-TO-CONSUMER ADVERTISING OF MEDICAL DEVICES
James R. Ravitz, Arent Fox LLP (Washington, DC)

THE HAZARDS OF MARKETING/SALES ROI ANALYSIS: WHEN “RETURN ON INVESTMENT” BECOMES “RISK OF INCARCERATION”
Thomas S. Schroeder, Faegre & Benson LLP (Minneapolis, MN)



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