On August 25, the U.S. Court of Appeals for the Ninth Circuit issued an opinion in which it held that ex parte patent prosecutions by the Patent and Trademark Office (PTO) qualify as “other Federal . . . hearing[s]” under prong (ii) of the False Claims Act’s Public Disclosure Bar. In so ruling, the Ninth Circuit affirmed that the Public Disclosure Bar should not be read in a restrictive manner but should be given a broad construction.

Continue Reading Ninth Circuit Affirms Broad Scope of False Claims Act’s Public Disclosure Bar

In 2010, Congress amended the Anti-Kickback Statute (AKS) to provide that claims “resulting from” an AKS violation are “false or fraudulent” for False Claims Act (FCA) purposes. 42 U.S.C. § 1320a-7b(g). For over a decade, courts have wrestled with the significance of the “resulting from” requirement and the degree of causation it warrants for an FCA violation premised on an illegal kickback, as we have covered in prior posts.

Continue Reading Eighth Circuit Tightens Causation Requirement for FCA Claims Involving Anti-Kickback Statute Violations, Creating Circuit Split

The Paycheck Protection Program (PPP) was intended to provide a fast influx of assistance to small businesses during the economic shock created by the COVID-19 pandemic. The speed with which loans were distributed to businesses nationwide was striking, and so was the speed with which the Department of Justice (DOJ) began prosecuting those abusing the program. Reports of corporations and individuals seeking to take advantage of the PPP prompted a vigorous law enforcement response that has broadened its scope in recent months. As we highlighted last year, the DOJ has taken aggressive action to pursue those who engaged in misconduct involving the PPP and other CARES Act stimulus programs.

Continue Reading PPP Enforcement Actions Gather Steam

On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services (HHS) in Pfizer’s landmark challenge against the Office of Inspector General’s (OIG) interpretation of the federal Anti-Kickback Statute (AKS).

Continue Reading Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

A favorable advisory opinion from the Office of Inspector General for the United States Department of Health and Human Services (OIG) ensures that the government will not impose sanctions concerning the requesting party’s business arrangement. Requesting an advisory opinion may be a good business decision for stakeholders in the healthcare industry.

Continue Reading Download Now – How to Request an Advisory Opinion (and Why)

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)

From the Bass, Berry & Sims Blog Network
From the Bass, Berry & Sims Blog Network

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