Mayer looks at enforcement of rules governing 340B Program
Under the Medicaid Rebate Program, pharmaceutical manufacturers are required to report certain key price terms to CMS for each of their drugs, including the average manufacturer price and best price. Under the 340B Program, manufacturers are required to use average manufacturer price and best price to calculate the maximum price a manufacturer may charge when selling drugs to "covered entities" that participate in the Program. As a result, if a manufacturer has overstated the Best Price that it reported to CMS under the Medicaid Rebate Program, it may also have overcharged 340B Program covered entities for those same drugs. In a recent paper prepared for the American Conference Institute, Kirsten Mayer, an associate in the Government Enforcement group of Ropes & Gray, reviews settlements and recent litigation in this area and discusses the risks they reveal. To read the full article, please click "Download PDF."