I commented on the recent ruling by the Second Circuit Court of Appeals, which upheld the district court’s rejection of Pfizer’s argument that liability under the Anti-Kickback Statute requires an element of “corrupt” intent.

Continue Reading Court Decision Upholding OIG’s Rejection of Pharmaceutical Company’s Drug Co-Pay Assistance Program

Having previously examined the falsity, materiality, and scienter elements of the False Claims Act (FCA) in our FCA Fundamentals series, we now turn to what damages can arise from violations of the False Claims Act. The False Claims Act imposes liability for each false claim. If the alleged scheme is broad, pervasive, or spans an extended period, this can result in many individual false claims and significant damages and penalties. It is essential for defendants to scope damages and consider potential exposure throughout a False Claims Act case, which often requires an expert consultant.

Continue Reading False Claims Act Fundamentals: Damages

Join us for a webinar  in which Matt Tormey, EVP Compliance and Risk, Chief Compliance Officer, Ensemble Health Partners, moderates a discussion with two former OIG officials in Bass, Berry & Sims’ healthcare practice group focusing on how, when, and why to submit an advisory opinion request.

Continue Reading Healthcare How-To Instructional Webinar Series: How to Request an Advisory Opinion (and Why)

Last week, we posted about the U.S. Supreme Court’s request for input from the Solicitor General on how False Claim Act complaints should be reviewed by courts.

Currently, the plaintiff-relators in two cases—U.S. ex rel. Owsley v. Fazzi Associates, Inc. and Johnson v. Bethany Hospice & Palliative Care, LLC—have submitted petitions for certiorari asking the Supreme Court to resolve what they see as a “long-standing circuit split” on the application of Rule 9(b) in False Claims Act cases.

In the Bethany Hospice case, which was the first to submit a petition, the plaintiff-relator argued that her complaint was dismissed under the Eleventh Circuit’s “rigid” application of Rule 9(b), which in most cases requires the specific details of at least one false claim that was actually submitted to the government, but that her complaint would have easily survived dismissal in many other circuits that only require “reliable indicia” that such claims were submitted.

Continue Reading United States Says No Supreme Court Review Needed in False Claims Act Cases

As previous False Claims Act (FCA) Fundamentals posts have discussed, the FCA, 31 U.S.C. § 3729, et seq., can be triggered by submitting claims tied to violations of certain federal statutes. This post will explain the basics of two such statutes: the Anti-Kickback Statute (AKS) and the Stark Law.

Continue Reading False Claims Act Fundamentals: Anti-Kickback Statute and the Stark Law

In recent years, the federal government has been particularly aggressive in pursuing civil and criminal enforcement against healthcare entities. The way healthcare companies conduct internal investigations so may mean the difference between a manageable resolution and staggering civil or criminal liability.

Continue Reading Key Considerations: How to Conduct an Effective Internal Investigation

I am looking forward to speaking on a panel at the ABA’s 2022 Virtual Civil False Claims Act and Qui Tam Enforcement Institute titled “Hot Topics 2022: Focus on AKS/Stark” on June 9, 2022 from 1:00 PM – 2:00 PM EST. I will be joined by Gejaa Gobena, Partner, Hogan Lovells, Jennifer Verkamp, Partner, Morgan Verkamp, and Ro Srinivas, Senior Trial Counsel, Department of Justice, Civil Division, Commercial Litigation Branch (Fraud Section).

Continue Reading [Virtual Event] Civil False Claims Act Conference