Law360, New York (August 3, 2015, 10:07 AM EDT) -- Physicians often prescribe drugs for uses not approved by the U.S. Food and Drug Administration. Although this so-called "off-label" use is generally lawful and may be medically sound, the cost of expanding uses may pose challenges for insurers, who must carefully manage coverage decisions. Moreover, pharmaceutical companies that promote drugs for off-label uses may be subject to criminal and civil liability. Because drug reimbursement often involves government payors, such as Medicare and Medicaid, both the government and private relators have for years pursued False Claims Act cases alleging that off-label promotion resulted in inappropriate reimbursements. In 2014, the government recovered more than $235 million from pharmaceutical companies in FCA settlements relating to off-label promotion, but similar settlements in recent years have ranged into the billions....
Law360 is on it, so you are, too.
A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.