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.
Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element
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).
Download Now – How to Request an Advisory Opinion (and Why)
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.
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Court Decision Upholding OIG’s Rejection of Pharmaceutical Company’s Drug Co-Pay Assistance Program
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.
False Claims Act Settlements to Know from Q2 2022
The second quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several of $20 million or more. This post summarizes key settlements of interest to healthcare providers.
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False Claims Act Fundamentals: Damages
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.
Healthcare How-To Instructional Webinar Series: How to Request an Advisory Opinion (and Why)
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.
United States Says No Supreme Court Review Needed in False Claims Act Cases
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.
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False Claims Act Fundamentals: Anti-Kickback Statute and the Stark Law
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.
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Key Considerations: How to Conduct an Effective Internal Investigation
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.
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