By Thomas S. Crane and Brian P. Dunphy
For many years, federal courts have grappled with the issue of whether factually accurate claims submitted to the government for payment can nevertheless be “false or fraudulent,” pursuant to an implied certification theory, under the False Claims Act (FCA) because of an underlying violation of law. The First Circuit has become the most recent one to issue an opinion on this implied certification theory adding to a pre-existing split in the circuits about the viability of and standards applicable to the theory. As a result, two petitions for certiorari have been filed in the United States Supreme Court in United States ex rel. Hutcheson v. Blackstone Med. Inc. and State of New York et al. ex rel. Westmoreland v. Amgen Inc. et al. The outcome is important because the narrower the interpretation of the certification theory, the more confined is the reach of the FCA. Health care providers and pharmaceutical and medical device manufacturers should watch to see if the Supreme Court decides to provide guidance as to how far the FCA should reach to police violations of the myriad other laws and regulations under which providers operate today.