We recently co-authored an article published by Law360 detailing what the $12 million settlement of the U.S. Department of Justice’s (DOJ) case against medical device maker Innovasis Inc. may mean for other Anti-Kickback Statute (AKS) cases. Continue Reading Innovasis Settlement Implications
The Tale of an AKS Self-Disclosure
Last week, the Department of Justice (DOJ) announced a $12 million settlement with spinal device manufacturer, Innovasis Inc. (Innovasis) and senior executives Brent Felix and Garth Felix related to allegations that they violated the False Claims Act (FCA) by paying kickbacks to surgeons to induce their use of its spinal devices. Continue Reading The Tale of an AKS Self-Disclosure
False Claims Act Settlements to Know from Q1 2024
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically unnecessary services and equipment, pharmaceutical issues and Controlled Substances Act violations.Continue Reading False Claims Act Settlements to Know from Q1 2024
CMS Publishes New Data on Self-Referral Disclosure Protocol Settlements
The Centers for Medicare & Medicaid Services (CMS) recently published updated data regarding settlements made under the Voluntary Self-Referral Disclosure Protocol (SRDP), an important mechanism through which providers may disclose actual or potential violations of the federal physician self-referral prohibition commonly known as the Stark Law. Continue Reading CMS Publishes New Data on Self-Referral Disclosure Protocol Settlements
False Claims Act Fundamentals: Self-Disclosures
When healthcare providers and other government contractors are subject to scrutiny for bills submitted to the government, it is often the result of a whistleblower complaint filed under the qui tam provisions of the False Claims Act.
Continue Reading False Claims Act Fundamentals: Self-Disclosures
Register Now | 8th Annual Nashville Healthcare Fraud Conference
Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this complimentary program will take place on December 8th in Nashville (full day). The conference will be broadcast virtually the mornings of December 15th and 16th.
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Watch On-Demand | How to Submit a Stark Law Self-Disclosure Webinar
Watch the recording of our latest webinar, in which our panel of national healthcare fraud and abuse attorneys will discuss how to disclose a Stark Law violation to CMS.
Continue Reading Watch On-Demand | How to Submit a Stark Law Self-Disclosure Webinar
[REGISTER NOW] Healthcare How-To Instructional Webinar Series: How to Conduct an Effective Internal Investigation
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.
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Failure to Voluntarily Self-Report is a “Non-starter” under the FCA
On July 5, 2019, the D.C. Circuit Court of Appeals affirmed dismissal of a qui tam lawsuit against several chemical manufacturers that set forth a unusual theory of liability: the relator alleged that the manufacturers violated the False Claims Act (FCA) by failing to self-report information about the dangers of their chemicals under the Environmental Protection Agency’s (EPA) voluntary Compliance Audit Program.
According to the relator, the manufacturers should have self-disclosed certain information to the EPA, who in turn would have assessed civil penalties under the Toxic Substances Control Act. By failing to do so, the relator alleged that the defendant manufacturers concealed their obligations to transfer property (the risk information) and money (the unassessed penalties) to the government.Continue Reading Failure to Voluntarily Self-Report is a “Non-starter” under the FCA
The Yates Memo and Consequences for Internal Investigations
Earlier this year, Deputy Attorney General Sally Quillian Yates issued new guidance outlining the DOJ’s increased focus on individual accountability during civil and criminal investigations of corporate wrongdoing. The principles announced in the “Yates Memo” serve as the basis for revisions to the U.S. Attorney’s Manual – particularly the section outlining the Principles of Federal Prosecution of Business Organizations – released November 16, 2015. While many of the principles outlined in the Yates Memo and recent revisions to the U.S. Attorney’s Manual are consistent with DOJ’s prior practice and rhetoric regarding white collar investigations, the emphasis on individual accountability requires companies to consider carefully those aspects of an internal investigation with consequences on individual executives and employees.
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