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

I recently authored an article for the American Bar Association (ABA) Health Law Section detailing the growing need for private equity firms to consider the increased risk of False Claims Act (FCA) liability.

Continue Reading Increased False Claims Act Exposure for Private Equity Firms Investing in Healthcare

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)

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.

Continue Reading False Claims Act Settlements to Know from Q2 2022

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

Healthcare is one of the most highly regulated industries in the country and providers of all types will eventually be called to action, whether it be responding to an investigation, conducting a compliance review, or proceeding with a self-disclosure. Bass, Berry & Sims has designed the Healthcare How-To Instructional Webinar Series to provide simple step-by-step instructions and best practices for responding accurately and efficiently while avoiding bad tactics, questionable strategies, and unnecessary risk which can create problems and less than ideal outcomes.

The Anti-Kickback Statute’s breadth means that virtually every business arrangement can implicate the statute. Given the highly regulated nature of healthcare and the ever-present risk of enforcement, entities may wish to consider submitting an advisory opinion request to the Office of Inspector General (OIG) to obtain a legal opinion regarding whether their arrangement constitutes grounds for sanctions under OIG’s exclusion authorities.

Join us for a virtual seminar on July 26, 2022 at 12:00 p.m. Central 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. To register, click here. 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