Fraud & Abuse in healthcare sales and marketing - Update on the Law and Tips on Compliance

Instructors: Mark DuVal, Mark Gardner
Product ID: 701681
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section

Training CD

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Read Frequently Asked Questions

This healthcare sales and marketing fraud law related training Webinar will discuss the how to be in compliant with Anti-Kickback Statute, False Claims Act, FDA’s Off-Label Marketing laws, Sunshine Provision and the consequences of violating the law will be explained with examples.

Why Should You Attend:
Last year, Pfizer was handed the largest fine ever in United States history, a whopping $2.3 billion dollars for sales and marketing practices that violated fraud and abuse laws. In 2008, orthopedics companies agreed to a $311 million settlement with government over allegations of kickbacks to doctors. Smaller companies like Spectranetics are not given a pass. Last December the medical laser maker agreed to pay $5 million to end a government investigation into its marketing practices. Outcomes like these can end companies and put people in jail. Will your company be next?

Join us at this interactive program designed to enhance your understanding of how common sales and marketing practices can play a direct role in government prosecution of companies and employees. Anyone with a company actively marketing medical products needs to attend this workshop.

Learning Objectives:

In this Webinar attendees will learn:

  • About fraud and abuse laws which govern healthcare sales and marketing, e.g. Anti-Kickback Statute, False Claims Act, FDA’s Off-Label Marketing laws, Sunshine Provision, et al.
  • How to help keep their sales reps, marketing professionals, and other employees that have contact with healthcare providers in compliance with these laws.
  • About companies that have gotten into trouble by promoting their products improperly.
  • About resources that help to determine whether behavior is compliant or not, e.g. Federal Safe Harbors [and how to qualify for them], Advisory Opinions, etc.
  • Learn the right questions to ask in order to determine if a marketing or sales activity violates the law or not.
  • Learn about the consequences to violating the laws.

Areas Covered in the Seminar:

  • Introduction/Agenda/Goals.
  • Players Involved (FDA, OIG, DOJ, etc.
  • Anti-Kickback Statute.
    • Remuneration – What is it?
    • How Detect Problems
    • FDA import detention prevention
    • Safe Harbors
    • Anti-Kickback Analysis
    • Examples
  • False Claims Act.
    • Examples
  • Off-Label Marketing.
    • Examples
  • Qui Tam Suits.
    • Examples
  • Update on Sunshine Provision and State Laws.
  • Questions & Answers.

Who Will Benefit:

The following individuals or disciplines will benefit from attending this Webinar:

  • Marketing Management
  • Clinical Management
  • Attorneys – In-house or Outside Counsel
  • Senior executives of pharmaceutical and device firms
  • Regulatory Vice Presidents, Directors and Managers
  • Sales Vice presidents, Directors and Managers
  • Compliance Management

Instructor Profile:
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

Instructor Profile:
Mark Gardner, M.B.A., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on compliance (federal and state anti-fraud and abuse laws, anti-kickback analysis, HIPAA & HITECH, and development of training and compliance programs) and promotion (appropriate and lawful off-label dissemination procedures, sales contracts, labeling and advertising review, continuing medical education programs (CME), product launch campaigns, pre-approval communications programs, direct-to-consumer (DTC) advertising, and domestic and international web strategy). Prior to joining the firm, Mark worked in the medical device industry for 10 years as a marketer in product management and previously in sales roles. While working at ev3, Celleration, and Medtox Mark focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.

Mark earned his Juris Doctor from Hamline University School of Law, his Master of Business Administration from the University of St. Thomas, and his Bachelor of Science, Finance and Economics from the University of Wisconsin-La Crosse. Mark is currently serving as Co-Chair for LifeScience Alley's Regulatory Special Interest Group.

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