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

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

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

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.
Continue Reading Register Now | 8th Annual Nashville Healthcare Fraud Conference

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.
Continue Reading [REGISTER NOW] Healthcare How-To Instructional Webinar Series: How to Conduct an Effective Internal Investigation

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

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.
Continue Reading The Yates Memo and Consequences for Internal Investigations

On March 31, 2015, DOJ announced a $10 million settlement with Robinson Health System Inc. (Robinson), a nonprofit operator of 10 Northeast Ohio healthcare facilities, including Robinson Memorial Hospital.

The settlement, announced a day before Robinson finalized a transaction involving its flagship hospital, stems from a June 2014 self-disclosure to the U.S. Attorney for the Northern District of Ohio, in which Robinson disclosed questionable financial relationships under Stark and the AKS, some dating back nearly 10 years, with more than 30 referring physicians. This self-disclosure stemmed from a due diligence review conducted while searching for a partner health system.Continue Reading Ohio Health System’s Self-Disclosure Leads to $10 Million FCA Settlement