On December 27, 2011, the United States Supreme Court refused to hear Amgen's petition to review a lower court's decision rejecting its argument - intended to weaken the False Claims Act - by engrafting onto the FCA a requirement that there must be a federal regulation specifically prohibiting the payment of a particular claim before the FCA could apply. The drug company had argued that payment of claims should be left to the control of regulatory agencies and not the courts, an oft-cited argument by corporations accused of health care fraud. Amgen claimed that a split in the federal circuit courts on the issue of "implied certification" made this case one that the Court should accept.

Implied certification is a legal theory developed as a result of FCA defendants' position that, unless there is an express certification that a particular claim conforms with a particular law or regulation, there can be no 'false' claim, especially if CMS (or its fiscal intermediatry) goes ahead and pays the claim.

Fortunately, the Court, which takes only a small number of the petitions filed each year, has declined to hear this case. Although this case will now go back to the federal district court for trial or settlement, the arguments made here by Amgen will doubtless continue to be made in many other False Claims Act cases throughout the country.