Friday, September 20, 2013

MDRP 2013 Day 3: Current criminal and civil Enforcement Activities to improve Corporate Compliance

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Sam Woronoff, covers day 3 of MDRP 2013

Leading legal representatives from a law firm, a major manufacturer, and US Attorney’s office shared their insights and gave examples of recent lawsuits in connection with Government Pricing. GP department have definite role and responsibilities in the awareness of commercial activities and enforcing compliance policies to protect the company from unnecessary lawsuits. They pointed out some of the red flag items and key indicators that GP can look for as warning signs for potentially illegal activities.

Some of the key topics involving Anti-kickback being focused on today include: Market Share Rebates, Active Intervention Programs, and Transparency in Bundling /Volume Discounts. Also, some questionable contracting and sales activity examples such as retroactive discounts, and discounts disguised as sampling were shared. GP may not have a great visibility in the communications between the sales representatives and customers, but GP can review the contract structure to ensure that the discounts are legitimate and no side agreements are in place. Also, GP can look out for increased sampling activity of billable products which is a big red flag for the DA’s office.

The legal world relies on the “Collective Knowledge Doctrine” which means if one employee of the company is aware of an illegal activity, the company as a whole attributed to it. Be sure a firm corrective action plan is in place and enforced within the company because usually violation of internal policies precedes any illegal contracting practices.

For more detailed information and examples shared today, download the presentation from the IIR website.

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