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You May be Unknowing of Your Risk
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 January 14, 2011 Vol. IX Issue 2 Health Lawyers Weekly Court Upholds Medicare Exclusion Of Drug Company Lawyer And Executives According to a summary of remarks made at a Food and Drug Law Institute panel in late October, the FDA outlined several steps that companies should implement to prevent off-label marketing including formally monitoring of: sales and marketing operations, detailing at speaker events, promotions, and publications. The FDA and OIG have clearly defined the tremendous risk to all distributor and manufacturer personnel of uncontrolled sales promotions that "knowingly or unknowingly" qualify as misconduct" [emphasis added]. Read Full Story |
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 November 12, 2010 Vol. VIII Issue 44
HealthLawyers Weekly
RiskyBusiness:
The Pursuit Of Healthcare Industry Executives And Managers
New guidance claims OIG has the authority to exclude all "officers" as well as any "managing employees"- defined as individuals with operational or managerial control over the entity or who directly or indirectly conduct day-to-day operations. Under its newly articulated standard, they will operate with a presumption in favor of exclusion if there is evidence that the officer or managing employee knew "or should have known" of misconduct. However, the OIG can, will and has excluded individuals whether they were knowing or unknowing of wrongdoing. Read Full Story
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